Coblation
Number: 0475
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses coblation.
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Medical Necessity
Aetna considers Coblation tonsillectomy medical necessary for the treatment of any of the following:
- Peri-tonsillar abscess; or
- Recurrent middle ear infection where tonsillar hypertrophy is believed to be an exacerbating factor; or
- Recurrent or chronic tonsillar infection; or
- Tonsillar hypertrophy leading to respiratory symptoms or airway obstruction.
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Experimental, Investigational, or Unproven
Aetna considers the following interventions experimental, investigational, or unproven because the effectiveness of these approaches has not been established (not an all-inclusive list):
- Cervical Coblation nucleoplasty for the treatment of cervicogenic headache
- Coblation adenoidectomy
- Coblation annuloplasty for the treatment of cervical discogenic pain
- Coblation-assisted arytenoidectomy for the treatment of infants with vocal cord paralysis
- Coblation-assisted management of airway stenosis
- Coblation-assisted surgical resection for the treatment of rhinosporidiosis
- Coblation-assisted turbinoplasty and nasal Coblation plasma surgery for the treatment of allergic rhinitis
- Coblation devices (e.g., Topaz Microdebrider) for the treatment of musculoskeletal conditions including insertional Achilles tendinopathy, and lateral epicondylitis
- Coblation for soft tissue stenosis of the external auditory canal
- Coblation for the treatment of MRSA infection in wounds with shrapnel
- Coblation nasal septal swell body reduction for the treatment of nasal obstruction
- Coblation non-thermal volumetric tissue reduction for:
- Dysphagia
- Laryngo-tracheal papillomatosis
- Nasopharyngeal angiofibroma
- Removing soft tissue during arthroscopic surgery
- Spinal osteoid osteomas, and
- Wound debridement (not an all-inclusive list)
- Coblation of femoral and sciatic nerve for the treatment of stump pain and phantom limb pain
- Coblation nucleoplasty for the treatment of cervical discogenic dizziness
- Computed tomography (CT)-guided percutaneous Coblation of the thoracic nerve root for the treatment of post-herpetic neuralgia
- Cordotomy by Coblation for the treatment of vocal fold immobility
- CT-guided Gasserian ganglion nerve Coblation for the treatment of trigeminal neuralgia
- Endoscopic Coblation cauterization for the treatment of pyriform sinus fistula
- Endoscopic transcanal Coblation excision for the treatment of glomus tympanicum tumors
- Percutaneous disc decompression with Coblation nucleoplasty for the treatment of cervical vertigo
- Percutaneous thoracic paravertebral nerve Coblation for the treatment of thoracic neuropathic pain
- Radiofrequency (RF) Coblation for the treatment of congenital nasopharyngeal teratoma
- RF Coblation-assisted transoral surgery for the treatment of oropharyngeal squamous cell carcinoma, and supraglottic laryngeal carcinoma
- RF Coblation for arthroscopic shoulder surgery
- RF Coblation for the treatment of glottis cancer
- RF Coblation for the treatment of laryngeal cancer
- RF Coblation for the treatment of osteochondritis dissecans lesions
- RF Coblation for the treatment of peri-scapular tendinopathy
- RF Coblation for the treatment of tracheal tumors
- RF Coblation, with and without gastrocnemius release, for the treatment of plantar fasciitis
- RF to the nasal valve (Vivaer Nasal Airway Remodeling (Aerin Medical)) for the treatment of nasal airway obstruction
- Surgical excision with Coblation for the treatment of inflammatory myofibroblastic tumor of the larynx
- Transoral RF Coblation for the treatment of laryngopharyngeal vascular lesions
- Videolaryngoscope-assisted Coblation for the treatment of epiglottic cysts.
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Related Policies
- CPB 0592 - Intranasal Radiofrequency Ablation - for coblation non-thermal volumetric tissue reduction for treatment of hypertrophy of nasal turbinates
- CPB 0602 - Thermal Intradiscal Procedures - for coblation (nucleoplasty) for treatment of herniated discs
Background
Standard electro-surgical tools and lasers remove tissue by thermal energy. Other methods of tissue decomposition have evolved to try to address the problems associated with high heat and damage to the surrounding tissue.
Coblation is a new surgical method for removing soft tissue during arthroscopic surgery developed by ArthroCare Corporation (Sunnyvale, CA). Coblation is a method of non-thermal volumetric tissue removal through molecular dissociation, similar to that of excimer lasers. Coblation uses the electrically conductive fluid employed in arthroscopic surgeries in the gap between the electrode and tissue. When electrical current is applied to this fluid, it turns into a charged layer of particles, called a plasma layer. Charged particles accelerate through the plasma and gain sufficient energy to break the molecular bonds within cells. This causes the cells to disintegrate molecule by molecule, so that tissue is volumetrically removed.
Coblation-assisted surgery uses a continuous mode of operation rather than the pulsed mode required for lasers. The purpose of a continuous mode of operation is to allow for coagulation of smaller blood vessels, and when used in sub-ablation mode, the intent is to produce hemostasis in larger vessels as well as shrinkage of collagen. Coblation uses a relatively low-temperature plasma, compared with lasers of high-power density beam of photons with their subsequent heat production. Because Coblation uses a low-temperature, the intent is to decrease the risk for thermal damage to surrounding tissues. ArthroCare believes Coblation will provide a more precise operative result, reduce surgical time, speed recovery and reduce post-operative pain. However, these claims are not supported by well controlled randomized studies.
Coblation devices such as the Topaz Microdebrider (ArthroCare, Sunnyvale, CA) are also being studied for their use in treating musculoskeletal conditions. In a prospective, non-randomized consecutive case series, Tasto and colleagues (2005) assessed the safety and effectiveness of microtenotomy using a radiofrequency (RF) probe to treat chronic tendinosis of the common extensor tendon origins of the elbow (lateral epicondyle). The average age of the 13 patients was 48.3 +/- 5.5 years. Before receiving the microtenotomy, all patients had tendinosis symptoms for 6 months or longer and had failed conservative treatment. The RF-based microdebridement was performed on the symptomatic tendon using the Topaz Microdebrider device. Patients were followed-up at regular post-operative intervals for 24 months. Pain status was documented using a visual analog scale self-reported measure. Functional outcome was assessed using the upper limb DASH evaluation and grip-strength measures. Quality of life assessment was evaluated using the SF-36 questionnaire. Magnetic resonance imaging was performed at regular intervals over the follow-up period. Patients reported significantly reduced pain from baseline at the 7- to 10-day post-operative examination (p < or = 0.01). Pain reduction was statistically stable from 7 to 10 days through the 24-month post-operative period (p < or = 0.01). Limb-specific functional outcomes and quality of life scores were improved over baseline values. There were no peri-operative or post-operative complications related to the procedure. The authors concluded that the RF-based microtenotomy procedure was safe and effective through at least 2 years. This procedure provides a valuable addition for treating patients with lateral epicondylitis associated with tendinosis who have failed conservative therapy. This was a small, short-term, non-randomized study; its findings need to be validated by future prospective randomized studies with large sample sizes and longer follow-up. In addition, evidence is needed regarding the effectiveness of this approach compared to established methods of management of these musculoskeletal conditions.
There is insufficient evidence in the medical literature to support the use of Coblation non-thermal volumetric tissue reduction for removing soft tissue during arthroscopic surgery or for treating musculoskeletal conditions.
On the other hand, there is evidence to support the use of Coblation tonsillectomy. In a double-blind, randomized controlled study, Arya et al (2003) compared post-operative pain following Coblation tonsillotomy versus Coblation tonsillectomy. No statistically significant difference in pain was demonstrated in the group of 14 patients studied. Nevertheless, the authors recommended tonsillectomy over tonsillotomy. Furthermore, in a study to measure the benefits of Coblation tonsillectomy (n = 844) against traditional tonsillectomy (n = 743), Belloso et al (2003) concluded that Coblation tonsillectomy was associated with a lesser incidence of delayed hemorrhage, more significantly in the pediatric population. The new technique using tissue Coblation for tonsil dissection offers significant advantages in the post-operative period compared with dissection tonsillectomy with bipolar diathermy hemostasis. Coblation is associated with less post-operative pain and early return to daily activities. Also, there are fewer secondary infections of the tonsil bed and significantly lower rates of secondary hemorrhage with Coblation.
In a prospective, controlled single-blind study, Stoker et al (2004) compared post-operative recovery after tonsillectomy using Coblation excision (CES, n = 44) or conventional electro-surgery (ES, n = 45). The authors concluded that children who received CES tonsillectomy appeared to experience a better quality post-operative course, with no detriment to operative benefits of conventional ES.
- recurrent or chronic tonsillar infection,
- tonsillar hypertrophy leading to respiratory symptoms or airway obstruction,
- peri-tonsillar abscess, and
- recurrent middle ear infection where tonsillar hypertrophy is believed to be an exacerbating factor.
A Cochrane evidence review (Burton and Doree, 2007) concluded that, "In terms of postoperative pain and speed and safety of recovery, there is inadequate evidence to determine whether coblation tonsillectomy is better or worse than other methods of tonsillectomy. Evidence from a large prospective audit suggests that it has been associated with a higher level of morbidity, in terms of postoperative bleeding. Large, well-designed randomised controlled trials supplemented by data from large prospective audits are needed to produce information on effectiveness and morbidity respectively."
- intra-discal electrothermal therapy (IDET),
- percutaneous discectomy, and
- Coblation nucleoplasty. An electronic search of the literature carried out using the Cochrane Library database (2007) and Medline (1966 to 2007) identified 77 references relating to IDET, 363 to percutaneous discectomy, and 36 to nucleoplasty.
In an American Pain Society's clinical practice guideline on non-surgical interventional therapies for LBP, Chou et al (2009) noted that although use of certain interventional therapies is common or increasing, there is also uncertainty or controversy about their efficacy. These investigators performed electronic database searches on Ovid Medline and the Cochrane databases through July 2008 to identify RCTs and systematic reviews of local injections, botulinum toxin injection, prolotherapy, epidural steroid injection, facet joint injection, therapeutic medial branch block, sacroiliac joint injection, intra-discal steroid injection, chemonucleolysis, RF denervation, IDET, percutaneous intra-discal RF thermocoagulation, Coblation nucleoplasty, and spinal cord stimulation. All relevant studies were methodologically assessed by 2 independent reviewers using criteria developed by the Cochrane Back Review Group (for trials) and by Oxman (for systematic reviews). A qualitative synthesis of results was performed using methods adapted from the U.S. Preventive Services Task Force. For sciatica or prolapsed lumbar disc with radiculopathy, these researchers found good evidence that chemonucleolysis is moderately superior to placebo injection but inferior to surgery, and fair evidence that epidural steroid injection is moderately effective for short-term (but not long-term) symptom relief. They found fair evidence that spinal cord stimulation is moderately effective for failed back surgery syndrome with persistent radiculopathy, though device-related complications are common. They also found good or fair evidence that prolotherapy, facet joint injection, intra-discal steroid injection, and percutaneous intra-discal RF thermocoagulation are not effective. Insufficient evidence exists to reliably evaluate other interventional therapies. The authors concluded that few non-surgical interventional therapies for LBP have been shown to be effective in RCTs.
Sean et al (2010) stated that microtenotomy coblation using a RF probe is a minimally invasive procedure for treating chronic tendinopathy. It has been described for conditions including tennis elbow and rotator cuff tendinitis. There have been no studies to show the effectiveness of such a procedure for plantar fasciitis. In this case-serieis study, a total of 14 patients with plantar fasciitis who had failed conservative treatment underwent TOPAZ RF treatment for their symptoms. The RF-based microdebridement was performed using the TOPAZ Microdebrider device (ArthroCare, Sunnyvale, CA). There were 6 men and 8 women with an average age of 44.0 years (23 to 57). There were 15 feet, with 6 right and 9 left feet. Subjects were followed-up for up to 6 months thereafter. Pre-operative, 3 and 6 months post-operative AOFAS ankle-hindfoot and SF-36 scores were analysed. There was a significant improvement in mean pre-operative, post-operative 3- and 6-month AOFAS hindfoot scores from 34.47 to 69.27 and 71.33 (p = 0.00), respectively. There was a significant decrease in SF-36 for bodily pain, and significant increases in physical and social function scores. Overall, 12 out of 14 (85.7 %) patients reported good to excellent satisfaction results at 6 months, and 12 out of 14 (85.7 %) patients have had their expectations met from the procedure at 6 months follow-up. The authors concluded that TOPAZ RF coblation is a good and effective method for the treatment of recalcitrant plantar fasciitis. T hey stated that these early results are encouraging, and they will continue to evaluate the patients over a longer follow-up period.
Dasenbrock and colleagues (2012) stated that plasma mediated RF ablation (pmRFA) may allow for the percutaneous treatment of spinal tumors with a decreased risk of thermal injury to neural structures compared with traditional (RF or interstitial laser) ablation. However, usage of pmRFA has not been previously reported for a primary bone tumor, including an osteoid osteoma. In this small study, 3 patients with a spinal osteoid osteoma underwent pmRFA. The procedure was performed under computed tomography guidance using the 11-gauge Coblation SpineWand (ArthroCare). One lesion (at T11) was directly abutting the spinal canal. With an average follow-up of 20.7 (range of 16 to 24) months, the mean visual analog scale score for back pain decreased from 8.67 to 0.67 and no patient experienced tumor recurrence. The authors concluded that pmRFA of spinal osteoid osteomas is feasible, even when the tumor is abutting the spinal canal. Moreover, they stated that larger studies with a longer follow-up are needed to further delineate the safety and effectiveness of this technique.
Pierson et al (2012) presented 2 cases of advanced juvenile nasopharyngeal angiofibroma (JNA) to illustrate the advantages of endoscopic Coblation-assisted resection of intra-nasal extensions of these masses. Both patients (an 11-year old boy and a 14-year old boy) presented with a large, extensive mass (Radkowski stage IIIb and Fisch stage IVb in both cases). After embolization was performed on each patient, his JNA was partially ablated via an endoscopic approach with the Coblator II Surgery System with an EVac Xtra Plasma Wand in conjunction with an image-guided navigation system. Both patients experienced resolution of their nasal obstruction with removal of the intra-nasal extension of the tumor. Coblation allowed for a controlled debulking of the tumors with less blood loss and without the need for multiple instruments. To the best of their knowledge, the authors’ report was one of the first to describe image-guided endoscopic Coblation of advanced JNA tumors. They stated that future studies in adequately sized populations are needed to determine the safety and effectiveness of Coblation-assisted endoscopic removal of both advanced and lower-stage JNAs.
- the surgical group who received radiofrequency thermal ablation inferior turbinoplasty and medical therapy, and
- the medical group who received medical therapy only.
Groups were further divided into 2 allergen types based on antigen sensitivity: perennial and seasonal. Subjective complaints (nasal obstruction, itching, rhinorrhea, sneezing), clinical rhinoendoscopy and rhinomanometry tests results were recorded at the start of the study and 2 months post-treatment. Effect sizes for the mean improvements after treatment were tabulated for all groups. All study outcomes improved within all groups. Comparison between medical and surgical groups showed higher improvement in both perennial and seasonal, respectively, in nasal obstruction, sneezing, rhinomanometry, and rhinomanometry after nasal provocation test (NPT). Itching improved only in perennial allergen type. Rhinoendoscopy clinical score showed improvement in surgical group over medical group in both allergen types. The authors concluded that Coblation-assisted turbinate reduction is a promising adjunct to medical therapy in patients with persistent symptoms associated with AR. Patients undergoing this surgery had greater reduction of symptoms than patients receiving medical therapy alone, where patients with perennial allergies appeared to benefit most.
Li and colleagues (2013) examined the therapeutic effect of nasal Coblation plasma surgery for the treatment of persistent allergic rhinitis (PAR). A total of 100 patients with mite-sensitized moderate to severe PAR who underwent nasal Coblation plasma surgery (inferior turbinoplasty plus nasal agger ablation) were enrolled in this study. There were 68 males and 32 females patients aged 16 to 62 years (mean of 36.3 years). The visual analog scale (VAS) for global rhinitis symptoms, NPT, anterior rhinomanometry, and T&T olfactometry were used to assess the short-term outcomes, pre-operatively and post-operatively at the end of 3 months after surgical procedure. SPSS19.0 software was applied for statistical analysis. At 3months after treatment, the total nasal symptom VAS scores significantly decreased from 7.0 ± 2.0 to 2.5 ± 1.5 (X(-) ± s; t = 18.00, p = 0.0001). All patients were allergic to house dust mites with positive NPT before treatment. At 3 months from the Coblation intervention, 88.0 % of the patients changed from positive NPT to negative, while 12.0 % remained as positive. There was a significant reduction in total nasal resistance, which diminished from 0.772 ± 0.224 to 0.221 ± 0.112 kPa·s·L(-1) after treatment (t = 22.00, p = 0.0001). Pre-operative olfactory tests showed hyposmia in 31.0 % of the patients, with 22 cases for slight and 9 cases for moderate disorder. Three months after treatment, 13.0 % were diagnosed as hyposmic, with 7 cases for slight and 6 cases for moderate disorder (χ(2) = 10.44, p = 0.005). The authors concluded that nasal Coblation plasma surgery provided favorable short-term outcomes in terms of remarkable improvement in nasal symptoms, hyper-reactivity of nasal mucosa, nasal flow and olfactory function in patients with moderate to severe PAR, but long-term effect needed further observation.
Coblation-Assisted Surgical Resection for the Treatment of Rhinosporidiosis
Khan et al (2014) stated that rhinosporidiosis seeberi causes a chronic granulomatous disease of upper airway, usually involving the nose and nasopharynx, and has a notorious tendency to reoccur. The current line of management is surgical excision of the lesion along with cauterization of the base, which does not prevent reoccurrence of the disease. Coblation EVAC 70 is a novel surgical tool which seems to provide excellent option in management of this notorious disease. These researchers presented an interesting case and the innovative approach in its management, using Coblation system. A 65-year old male resident of rural India reported a history of breathing difficulty and change in voice. Patient is a Hindu priest by profession, who according to their rituals has to take bath in local pond or river. The authors concluded that rhinosporidiosis is a difficult-to-treat pathology due to its tendency to reoccur. To-date the management of the disease is far from satisfactory.. They stated that the Coblation system, which has already found its roots in otorhinolaryngology, can be used as a novel tool in surgical resection of recurrent rhinosporidiosis and has added advantage of low temperature dissection along with clear surgical field due to constant suctioning. These preliminary findings need to be validated by well-designed studies.
Biradar et al (2024) stated that rhinosporidiosis is a granulomatous disease commonly affecting the mucous membrane. It is caused by Rhinosporidium seeberi, an aquatic parasite, which affect the nose, and paranasal sinuses most commonly. In a retrospective study, 5 patients who were diagnosed and treated for rhinosporidiosis were analyzed. Surgical excision by coblator along with medical management using dapsone 100 mg once-daily for 6 months given promising results in view of reducing recurrence. The authors concluded that the combined approach of management including surgical excision using coblator and medical therapy with dapsone was effective in managing the rhinosporidiosis with no recurrence. This was a small (n = 5) retrospective study, and its findings were confounded by the combined use of coblation and dapsone. These preliminary findings need to be validated by well-designed studies.
Endoscopic Coblation Cauterization for the Treatment of Pyriform Sinus Fistula
Zhang and Tian (2016) stated that recurrent neck lesions associated with 3rd or 4rth branchial arch fistula are much less common than those of 2nd arch and usually present with acute suppurative thyroiditis or neck abscess. These investigators described clinical features, management and treatment outcomes of 64 cases of congenital pyriform sinus fistula (PSF). Medical record of these 64 patients (33 males, 31 females) treated at the First Affiliated Hospital of Zhengzhou University from 2011 to 2014 were reviewed. The patients comprised 33 males and 31 females, and their ages ranged from 18 months to 47 years (median of 10 years, mean of 12.7 years). Neck abscess and recurrent infection was the mode of presentation in 37 cases (57.8 %), 4 patients (6.3 %) presented with acute suppurative thyroiditis, neck mass was the mode of presentation in 17 cases (26.6 %), 2 patients (3.1 %) presented with neck mass with respiratory distress, and cutaneous discharging fistula was the mode of presentation in 1 cases (1.6 %). The remaining 3 patients (4.7 %) presented with cutaneous discharging fistula with neck infection. Investigations performed include barium swallow, computed tomography (CT) scan, and ultrasound, which were useful in delineating PSF tract pre-operatively. Barium swallow was taken as the gold standard for diagnosis. Patients were treated by fistulectomy with hemi-thyroidectomy, fistulectomy, fistulectomy with endoscopic electric cauterization, endoscopic electric cauterization or endoscopic Coblation cauterization, respectively. Histopathologic examination of the surgical specimens revealed that they were lined with ciliated epithelium, stratified cuboid epithelium with chronic inflammatory cell infiltration and fibrosis. Voice hoarseness occurred after operation in 7 patients, but disappeared 1 week later. Pyriform sinus fistula recurred in 6 patients, 4 of them were cured by a successful re-excision. One patient was cured by successful endoscopic electric cauterization. The other 1 has remained asymptomatic for 5 months. In this series, mean follow-up period was 13.3 months and median follow-up period was 12.5 months (range of 2 to 40 months). Presence of congenital PSF should be suspected when intra-thyroidal abscess formation occurs as the gland is resistant to infection. Strong clinical suspicion, barium swallow study, CT scan and ultrasound are the key to diagnosis. Both fistulectomy with hemi-thyroidectomy and endoscopic treatment have comparable success rate. The authors stated that endoscopic Coblation cauterization may prove a useful and equally effective method of treatment for PSF in future.
Coblation of Femoral and Sciatic Nerve for Stump Pain and Phantom Limb Pain
Zeng and colleagues (2016) noted that there is currently no reliable treatment for stump pain and phantom limb pain. Peripheral factors play a significant role in the pathophysiology of stump pain and phantom limb pain. Coblation technology is a relatively new technology that has shown promise in treating neuropathic pain. In a case report, these researchers described the use of Coblation on femoral and sciatic nerve for stump pain and phantom limb pain. An ultrasound-guided perineural infiltration anesthesia surrounding the neuroma was first performed and achieved approximately 60 % stump pain relief that lasted for 2 hours, but no relief of the phantom limb pain. An ultrasound-guided femoral and sciatic nerve block was performed to obtain longer pain relief. The patient reported approximately 80 % pain relief in both stump pain and phantom limb pain that lasted for 40 hours. This finding suggested other factors in addition to the ultrasound-detected neuroma in the residual limb generating pain for this patient. Coblation of femoral and sciatic nerves was performed. The stump pain was completely relieved immediately after operation. At 1, 3, and 6 months post-operative review, 80 % relief of both stump and phantom limb pain was achieved. Overall activity was improved and there was no need for pain medications. The analgesic effect was stable during the 6-month follow-up period. The authors concluded that their findings suggested that Coblation may be useful in the treatment for stump pain and phantom limb pain; treatments focusing on peripheral nerves may be more effective than those focusing on the neuroma. They stated that additional investigation is needed to confirm these findings.
Radiofrequency Coblation of Congenital Nasopharyngeal Teratoma
Hwang and associates (2015) stated that congenital nasopharyngeal teratomas are rare tumors that pose difficulties in diagnosis and surgical management. These investigators reported the first use of radio-frequency (RF) Coblation in the management of such tumors. They presented the findings of a premature baby (with a perinatal diagnosis of a large, obstructing nasooropharyngeal mass) who was referred to the ENT service for further investigations and management. The initial biopsy was suggestive of a neuroblastoma, but the tumor demonstrated rapid growth despite appropriate chemotherapy. In a novel use of RF Coblation, the nasooropharyngeal mass was completely excised, with the final histopathology revealing a congenital nasopharyngeal teratoma. The authors reported the first use of RF Coblation to excise a congenital nasopharyngeal teratoma. These preliminary findings need to be validated by additional studies.
Cervical Coblation Nucleoplasty for the Treatment of Cervicogenic Headache
He and associates (2016) stated that a degenerative cervical disc is a pain generator for headaches, and headaches can benefit from cervical prolapse surgery. However, as an alternative intervention for open cervical surgery, no study has reported whether headaches can benefit from cervical nucleoplasty. In a prospective cohort study, these researchers evaluated the effectiveness of cervical Coblation nucleoplasty in the treatment of cervicogenic headaches (CEHs). A total of 20 patients with CEHs undergoing cervical nucleoplasty for shoulder-arm pain were recruited into group C, and 20 patients with CEHs undergoing lumbar nucleoplasty for LBP, matched for age and sex, were recruited into group L. Cervicogenic pain was diagnosed according to the International Headache Society criteria. During the 24-month follow-up, pain VAS scores were collected as the primary outcomes, and significant pain relief rate, Neck Disability Index (NDI) headache scores, and Patients Satisfaction Index (PSI) scores were recorded as secondary outcomes to evaluate headache severity and physical function post-operatively. During the 24-month follow-up, a significant decrease in headache VAS scores was observed in group C, but not in group L; NDI and PSI scores in group C were better than those in group L. In comparison with the final follow-up, no significant differences in the NDI and PSI scores were found in all observations after surgery. In comparison to group L, greater than or equal to 50 % pain relief was significantly better in group C. No serious complications were observed except for less than or equal to 20 % of ecchymoma at the needle insertion site. The authors concluded that the findings of this study indicated that CEHs may benefit from cervical Coblation nucleoplasty.
- t ignored the notion that the upper cervical discs C2 to C3/C3 to C4 were also potential sources of the headaches. This was related to the study design. According to the inclusion criteria, all subjects with CEHs were recruited from a group of patients who had undergone nucleoplasty for discogenic or radicular pain in the neck, shoulder, or arm, which mostly originated from lower degenerative cervical discs, and
- the outcomes derived from this study did not indicate that CEH without discogenic or radicular pain can benefit from cervical nucleoplasty.
Coblation-Assisted Management of Airway Stenosis
In a retrospective, case-series study, Fastenberg and colleagues (2016) evaluated the use of bipolar RF plasma ablation (Coblation) in the treatment of pediatric airway stenosis. The medical records of 6 pediatric patients at Cohen Children's Medical Center from July 2009 to December 2015 were reviewed. All cases involved the use of RF plasma ablation to address airway stenosis. Patient presentation, surgical intervention(s), post-operative course and complications were analyzed. All 6 cases involved pediatric airway stenosis, including glottic stenosis (n = 2), bilateral vocal fold immobility (n = 2), and intra-tracheal lesions (n = 2). Coblation was used to perform a range of different procedures, including removal of scar/granulation tissue, partial arytenoidectomy, and posterior cordectomy. All patients experienced good results without major complications, peri-operative, or post-operative sequelae. The authors concluded that the findings of this study suggest that RF plasma ablation may be an effective endoscopic tool for the treatment of pediatric airway stenosis. Moreover, they stated that further study and more patients are needed as this technique becomes increasingly applied.
Li et al (2024) noted that benign central airway stenosis poses a significant challenge to respiratory and thoracic surgeons due to the high recurrence rate associated with current treatment methods, resulting in severe breathing difficulties and potentially life-threatening complications. In a retrospective study, these investigators examined the effectiveness of Coblation in the management of benign central airway stenosis in adults. This trial included patients who were treated at the Second Hospital of Hebei Medical University from 2017 to 2020. Furthermore, a comparative analysis of whole-genome sequencing (WGS) was carried out between the afore-mentioned patient group and healthy populations to examine the underlying etiology of this stenotic condition. This trial entailed 32 patients who underwent a total of 43 treatments between 2017 and 2020. All subjects exhibited alleviation of airway stenosis and an improvement in clinical symptoms following surgery, without any significant surgical or post-operative complications. Whole-genome analysis showed significant changes in gene expression in the airway mucosa of patients with benign airway stenosis in comparison to healthy populations. A total of 91 differentially expressed genes were identified, among which 44 up-regulated genes displayed characteristics of promoting inflammatory responses. The authors concluded that Coblation showed promise as an effective treatment modality for adults suffering from benign central airway stenosis. Moreover, these researchers stated that further investigations with larger sample sizes and extended follow-up duration are needed to ascertain the optimal surgical treatment for benign central airway stenosis with different etiologies. The authors stated that the drawbacks of this trial included its retrospective design, a limited dataset size along with the presence of multiple pathological etiologies, a short-term follow-up period (up to 24 months), and a potential uncontrolled false discovery rate.
Coblation Nasal Septal Swell Body Reduction for the Treatment of Nasal Obstruction
In a retrospective, case-series study, Kim and associates (2016) presented the results of Coblation nasal septal swell body (NSB) reduction for the treatment of nasal obstruction in patients with abnormally thickened NSB. The study was conducted at a single tertiary medical center; 8 patients underwent Coblation NSB reduction. Pre-operative and post-operative nasal functions were evaluated by acoustic rhinometry and subjective symptom scales. These researchers also analyzed pre-operative CT scan images and nasal endoscopic findings. The mean maximal NSB width was 16.4 ± 2.2 mm on pre-operative coronal CT scan images. The mean VAS score for nasal obstruction was decreased from pre-operative 7.63 ± 0.99 points to 3.88 ± 0.92 points (post-operative 3 months), 4.16 ± 0.78 points (post-operative 6 months), and 4.63 ± 0.69 points (post-operative 1 year); 6 of the 8 patients were satisfied with the clinical outcome at 1 year after the procedure. The authors stated that, to the best of their knowledge, Coblation NSB reduction has not yet been reported in the medical literature; these findings showed that it can be an effective treatment modality for nasal valve narrowing in patients with abnormally thickened NSB. However, these preliminary findings need to be validated by well-designed studies.
Percutaneous Thoracic Paravertebral Nerve Coblation for the Treatment of Thoracic Neuropathic Pain
Yang an colleagues (2017) noted that patients with thoracic neuropathic pain often do not respond to medication and physical therapy. Coblation technology has been demonstrated to have potential for pain management. A total of 15 patients underwent CT-guided percutaneous Coblation to ablate the thoracic paravertebral nerve for their medication-resistant thoracic neuropathic pain. The pain intensity was assessed by VAS 1 day before surgery and 1 week and 1, 3, and 6 months after surgery, and the difference between pre-operative and post-operative VAS values was determined to evaluate the pain relief effectiveness. Patients who achieved greater than 50 % pain relief were defined as responders and the ratio in all patients was calculated. The number of patients who reported mild pain (VAS less than or equal to 3) was recorded and the ratio in all responders was calculated. In addition, adverse events (AEs) were also recorded to examine the security of procedure; 12 (80 %) responders achieved greater than 50 % pain relief. The VAS score of responders significantly decreased from 7.42 ± 1.38 before surgery to 2.17 ± 1.11 (p = 0.000), 1.92 ± 1.16 (p = 0.000), 1.75 ± 0.97 (p = 0.000), and 1.58 ± 1.08 (p = 0.000) at 1 week, 1 month, 3 months, and 6 months after surgery, respectively. The number of responders with mild pain was 10 (83.3 %), 11 (91.7 %), 12 (100 %), and 12 (100 %) at 1 week, 1 month, 3 months, and 6 months after surgery, respectively. All responders and 1 non-responder reported slight numbness after the surgery. The authors concluded that CT-guided percutaneous thoracic paravertebral nerve Coblation is a potential method for the treatment of thoracic neuropathic pain. These preliminary findings need to be validated by well-designed studies.
Radiofrequency Coblation for the Treatment of Glottis Cancer
Liu and colleagues (2016) evaluated the feasibility, complications, and effectiveness of low-temperature (40 to 70° C) RF Coblation as a treatment modality for the early-stage glottic cancer. These investigators presented the data obtained from a 1-year study ofT1 glottic cancer patients treated at their department. A total of 6 early-stage glottic cancer (Tla = 5; Tlb = 1) patients (male; mean age of 60.1 years) were enrolled in this study. Study outcomes were analyzed (noted and/or photographed). All patients were able to eat on the next day after the surgery. No gastric tube or tracheotomy was required. No post-operative cough, discomfort or difficult breathing was noted. No complications, such as recurrence or cervical lymph node metastasis, occurred over the 6 to 12 months follow-up. All patients regained satisfactory voice 2 months after the surgery. The authors concluded that due to the small number of patients included in this study, these findings need to be taken only as the preliminary data that need to be further validated by large-cohort multi-center studies. Furthermore, RFA surgery has a few disadvantages as well. For instance, due to the scalpel tip design, this technique may not be applicable for certain sites such as subglottic and anterior commissure tumors without compromising safe margins. Nonetheless, with the modified tip types, such as the ones with more angles available or smaller sizes, doing more accurate surgery will be possible. This study was also limited by a short post-operative follow-up period (up to 12 months).
Coblation for Wounds Debridement / Management
Trial et al (2012) noted that debridement is needed to prepare the wound bed, essentially in removing undesired tissues observed both in acute wound after burns or trauma and in chronic wounds (e.g., diabetic foot ulcers, leg ulcers, and pressure ulcers). Surgical debridement has been described as one of the most effective methods but can be contraindicated in the elderly, arteriopathic context, or patients under effective anti-coagulation. Recently described debridement technologies are based on application of important mechanical severing forces over the wound surface using high-power hydrojets. High water flux acts as a vector for separating necrotic and sloughy tissues from the wound bed and aspirates them out of the wound immediately. Electrical powered techniques and lasers were also scarcely described. The Coblation debridement technology presented here was based on the local induction of a focused plasma field chemically deleting undesired tissues. This technique is a modification of conventional electro-surgical devices, developed in 1928 where tissue excision and coagulation of tissues were observed. Principles of plasma-mediated debridement were based on a bipolar radiofrequency energizing the molecules, thus creating a plasma field. This glow discharge plasma produces chemically active radical species from dissociation of water, breaking molecular bonds, and causing tissue dissolution. The thermal effects are a by-product, which can be modulated by modifying the electrode construction, limiting the local temperature to less than 50°C in order not to induce wound bed re-necrosis. The authors described the principle, the first technical adaptation for wound debridement, and the potential clinical interest of the Coblation technology. Well-designed studies are needed to develop clinical evidence of Coblation technology for surgical wound debridement.
Bekara and colleagues (2018) noted that debridement is a crucial component of wound management. Recent technologies such as hydrosurgery (Versajet), ultrasound therapy (the MIST therapy device), or plasma-mediated bipolar RFA therapy (Coblation) appeared to represent interesting alternatives for wound debridement. These investigators evaluated and compared these 3 recently developed methods for the management of chronic wounds. In January 2016, an electronic database search was conducted of Medline, PubMed Central, and Embase for articles concerning these 3 innovative methods for the management of chronic wounds. A total of 389 references were identified by the search strategy, and 15 articles were included. These researchers extracted data regarding the number and age of patients, indications, operating time, number of procedures, costs, wound healing time, decrease in exudation, peri-operative blood loss, bacterial load, and the occurrence of complications. The 15 articles included studies that involved a total of 563 patients who underwent hydrosurgery (7 studies), ultrasound therapy (6 studies), or Coblation (2 studies); 6 RCTs were included that compared the use of a scalpel or curette to hydrosurgery (2 studies) or ultrasound therapy (6 studies). Hydrosurgery, in addition to being a very precise and selective tool, allowed significantly faster debridement. Ultrasound therapy provided a significant reduction of exudation, and improved the wound healing time. No comparative study dedicated to Coblation was identified. The authors concluded that the review of the current literature revealed a lack of prospective randomized studies comparing these devices with each other or with standard techniques, particularly for Coblation and hydrosurgery.
Coblation of Soft Tissue Stenosis of the External Auditory Canal
Gu and Bauman (2017) noted that soft tissue occlusion of the external auditory canal (EAC) can cause intense pruritis, recurrent foul smelling otorrhea, recurrent otitis externa, and conductive hearing loss. Occlusion of the EAC can be challenging to treat as the area is prone to circumferential scarring. These researchers described the novel use of serial bipolar RFA (Coblation) to treat 3 children with complete EAC occlusion from congenital and acquired conditions including lymphedema (n = 1), microcystic lymphatic malformation (n = 1), and venolymphatic malformation (n = 1). Patients underwent a mean of 3 procedures with post-operative EAC stenting (7 days) and antibiotic and steroid aural preparations (10 days). Otologic symptoms resolved in all patients, and their EACs remained patent 14 months after last procedure (range of 4 to 32 months); 1 patient experienced a pinpoint tympanic membrane perforation that healed spontaneously 2 weeks later. The authors concluded that Coblation of soft tissue stenosis of the EAC can be an effective treatment for this problematic condition. These preliminary findings need to be validated by well-designed studies.
Cordotomy by Coblation for the Treatment of Vocal Fold Immobility
Benninger and associates (2018) stated that bilateral vocal fold immobility (BVFI) can result in considerable voice and airway impairment. Although the CO2 laser is commonly used in transverse cordotomy, the Coblator, a minimally invasive, low-thermal technology, has been increasingly used in otolaryngology. In a retrospective, case-series study, these investigators examined outcomes associated with Coblation to treat BVFI. This trial included 19 patients with BVFI who underwent cordotomy by Coblation in a single tertiary-care institution. Clinical, operative, and health status data for all patients were reviewed. Quality of life (QOL) was measured by the EuroQol 5-Dimensions (EQ-5D), and the Voice Handicap Index (VHI) was used to measure vocal cord function. A total of 19 patients were eligible for inclusion, 15 of which underwent cordotomy by Coblation for BVFI without stenosis. Mean age was 57 years with 13 (68 %) women. The etiology of BVFI included thyroidectomy in 8 (42 %) patients and prolonged intubation in 7 (37 %). Mean length of surgery for BVFI without stenosis was 17 minutes; mean operating room (OR) time was 63 minutes compared with 88 scheduled OR minutes (effect size, 25 minutes; 95 % confidence interval [CI]: 9 to 40 minutes). During follow-up, 4 (27 %) of these patients developed granulation tissue post-operatively. Following surgery, patient-reported shortness of breath significantly improved, with 10 of 14 (71 %; 95 % CI: 45 % to 88 %) patients with some level of pre-operative breathing difficulty experiencing improvement in their breathing. Stridor also significantly improved, with 10 of 12 (83 %; 95 % CI: 55 % to 95 %) patients with some level of pre-operative stridor improved after surgery. The EQ-5D results trended toward improvement post-operatively (0.67 to 0.80; effect size, 0.13; 95 % CI: -0.10 to 0.34). The functional (22 to 12; effect size, -10; 95 % CI: -19 to -2), emotional (23 to 11; effect size, -12; 95 % CI: -23 to -3), and total VHI all significantly improved (68 to 39; effect size, -29; 95 % CI: -49 to -8). The authors concluded that initial outcomes of cordotomy by Coblation revealed that this technique was a safe and efficient approach to treating BVFI; Coblation was associated with significant reduction in OR time compared with scheduled time, and patients experienced significant improvement in shortness of breath, stridor, and vocal cord function. These preliminary findings from a small (n = 15), retrospective study need to be validated by well-designed studies.
In a retrospective chart review, Benniger et al (2022) examined the use of unilateral Coblator cordotomy for the treatment of BVFI. This trial included a total of 94 patients having undergone Coblation cordotomies for BVFI performed by surgeons at 2 different institutions. Parameters evaluated were etiology of BVFI, prior tracheotomy, the number of revision procedures, post-operative de-cannulations, breathing outcomes as measured by Dyspnea Index, and voice outcomes as measured by the VHI. The main causes of immobility were thyroidectomy and prolonged endotracheal intubation. A total of 21 procedures were carried out in patients who had a tracheotomy already in place, 2 needed concurrent tracheotomy with cordotomy, and 2 underwent tracheotomy sometime after cordotomy. The mean follow-up was 16 months (range of 1 to 38 months). Of the 25 patients who had a tracheotomy tube placed before or during the course of their care, these investigators were unable to de-cannulate 4 of them following initial or revision cordotomy. A total of 20 of the 94 patients needed a secondary revision unilateral cordotomy, usually on the previously un-operated vocal fold. This was more common in bilateral fixation than in paralysis. In 44 patients where VHI data were known both pre- and post-operatively, the median VHI scores improved from 62.2 to 37.4, while the VHI worsened in only 4 patients; 8 patients had a Dyspnea index performed both pre- and post-operatively and the median score was lowered from 18.3 to 12.5. The authors concluded that Coblation cordotomy is a reasonable option for vocal fold lateralization in BVFI. In this trial, this method allowed for de-cannulation in 21 of 25 patients who had a tracheotomy. The initial Coblator cordotomy was sufficient for the majority of patients, with 22 % (20/94) requiring a revision procedure. Interestingly, this trial also showed promising voice outcomes with improvements in VHI in all but 4 patients. These preliminary findings need to be validated by well-designed studies.
Laryngeal Papillomatosis
In a retrospective case-series study, Carney et al (2010) examined the effectiveness of RF cold ablation (Coblation) for the treatment of laryngo-tracheal recurrent respiratory papillomatosis, by comparing treatment intervals for coblation and carbon dioxide (CO2) laser vaporization. A total of 6 adult patients with advanced laryngo-tracheal recurrent respiratory papillomatosis were treated for at least 2 years by CO2 laser vaporization with or without intra-lesional cidofovir. All 6 subsequently underwent treatment with RF Coblation with or without intra-lesional cidofovir. Coblation resulted in longer periods between interventions, compared with CO2 laser (p = 0.03). The authors concluded that RF Coblation appeared to be an attractive alternative technique to CO2 laser for the surgical treatment of advanced laryngo-tracheal papillomata. The findings of this small study need to be validated by well-designed studies.
Awad and colleagues (2019) stated that recurrent respiratory papillomatosis is a disease caused by the human papilloma virus (HPV), which is frequently localized in the larynx. The disease tends to recur and frequent intervention is often needed. Management modules include surgical intervention using micro-debride or laser ablation as well as adjuvant treatments that aim mainly at maintaining an adequate airway and secondly to manage dysphonia caused by the growth on the vocal folds. In a pilot study, another surgical modality is tried using plasma-mediated RF ablation (Coblation). These researchers examined management of 15 adult patients diagnosed with recurrent laryngeal papillomatosis and surgically treated using RF Coblation; 1 patient needed multiple procedures. Pre-operative assessment in voice clinic evaluating voice quality and its impact on patients' life-quality using voice parameters and self-assessment questionnaires. Follow-up post-operatively using the same parameters from 4 to 6 weeks after surgery until up to 2 years later to check recurrence rate. No other adjuvant treatment was used and all patients received post-operative voice therapy. A total of 78.6 % of patients did not show evidence of recurrence during the study period. Improvement in voice handicap following 1st intervention was reported and recurrence rate in the rest of the sample reported. The authors concluded that the findings of this small sample (n = 15) appeared to support the previous small studies' findings that RF Coblation is a good excisional technique to use for removal of laryngeal papillomatosis; recurrence rates appeared to be slightly lower than rates reported in the literature for the other surgical modalities. Level of evidence = IV.
Radiofrequency Coblation for the Treatment of Laryngeal Cancer
Gong and colleagues (2019) examined the safety, efficacy and prognosis of low-temperature plasma RF Coblation for early-stage laryngeal cancer(Tis, T1 and T2). These researchers carried out a retrospective analysis of 202 patients with early-stage laryngeal cancer who underwent the low-temperature RF Coblation surgery, including 34 cases of Tis (16.83 %), 49 cases of stage T1aN0M0 (24.26 %), 50 cases of stage T1bN0M0 (24.75 %) and 69 cases of stage T2N0M0 (34.16 %). Surgical patients were followed-up closely for 6 to 60 months, with a median follow-up of 29 months. Of the 202 patients,165 (81.68 %) had no recurrence and achieved good surgical results. None of them suffered severe complications such as post-operative hemorrhage and asphyxia; 37 cases (18.32 %) had recurrence, including 1 case (0.50 %) in stage Tis, 7 cases (3.47 %) in stage T1a, 7 cases (3.47 %) in stage T1b, and 22 cases (10.89 %) in stage T2; 13 patients who had recurrence underwent total laryngectomy (5 of which had a recurrence of T3 and 8 of which progressed to T4), including 1 in the stage T1a,2 in the stage T1b, and 10 in the stage T2. Vertical hemi-laryngectomy were performed in 4 cases, 3 cases of stage T1a and 1 case of stage T2; 5 cases underwent plasma RF Coblation again, including 3 cases of stage T1b and 2 cases of stage T2, no recurrence was found in all the patients; 1 patient had no obvious recurrence in the larynx but had cervical lymph node metastasis, radical neck dissection was performed; 1 patient with stage T2 recurrence was treated with a tracheotomy to relieve laryngeal obstruction without further treatment; 3 cases showed improvement by radiotherapy and chemotherapy treatment after recurrence; 9 death cases, 5 patients died after radiotherapy and chemotherapy, and 4 patients stopped getting treatment after recurrence. The authors concluded that low-temperature RF Coblation surgery for patients with early-stage laryngeal cancer has great advantages in the preservation of laryngeal function and reduction of surgical trauma after surgery compared with traditional surgical method, and could obtain satisfactory results, but the selection of surgical indications for some patients with clinical stage T2 still needs to be carefully considered.
Furthermore, National Comprehensive Cancer Network’s clinical practice guideline on “Head and neck cancers” (Version 1.2019) does not mention radiofrequency Coblation as a therapeutic option.
Coblation Adenoidectomy
Singh and Bhardwaj (2020) stated that microdebrider adenoidectomy and Coblation adenoidectomy are the 2 new techniques available for adenoidectomy these days. As adenoidectomy is one of the most common pediatric surgical procedure there is always a concern to improve the outcomes and make post-operative experience more pleasant for the pediatric population. Cost difference between a Coblator wand and microdebrider blade is always a confounding factor in decision-making. In a prospective, randomized, single-blind study, these researchers compared both techniques in terms of certain intra-operative and post-operative parameters. This trial was carried out in a university hospital on 140 subjects. Patients diagnosed with chronic adenoiditis grade 3 to 4 were randomly allocated to 2 groups after following the exclusion and inclusion criteria. The adenoidectomy in 2 groups: the Microdebrider group (Group A) and the Coblation group (Group B) were compared in terms of intra-operative time, post-operative pain score; intra-operative bleeding, surgical field and some common complications. Data were analyzed for significance by various statistical tests. The average adenoid size operated in both groups was Grade-3. The intra-operative time taken to complete the procedure in group A was 12.78 ± 3.8 mins and in group B was 22 ± 3.3 mins (p value < 0.05). There was statistically significant difference in grade of Intra-operative Bleeding in both groups with mean grade of intra-operative bleeding being 1.4 ± 1.04 in group B and 3.5 ± 0.9 in Group A. The surgical field was poor to average in 33 cases (n = 70) in group A as compared to only 1 case (n = 70) in group B; the difference being statistically significant. The average post-operative pain score was 2.69 ± 0.99 and 1.17 ± 1.1 after post-operatively 24 hours and 72 hours, respectively in group B; 7.14 ± 0.99 and 4.08 ± 1.42, respectively in group A. The p value for the same was < 0.05. However there was no statistically significant difference between 2 groups in terms of any complications or completeness of removal. The authors concluded that although both techniques were highly effective in adenoid removal with low complication rate in this study, more studies with large sample size are needed to validate these findings and to establish the comparative efficacy of both techniques in terms of the intra-operative parameters as well as post-operative recovery along with recurrence rates.
Furthermore, an UpToDate review on “Tonsillectomy and/or adenoidectomy in children: Indications and contraindications” (Paradise and Wald, 2020) does not mention Coblation as a management/therapeutic option.
CT-Guided Gasserian Ganglion Nerve Coblation for Treatment of Trigeminal Neuralgia
Yang and colleagues (2019) stated that trigeminal neuralgia (TN) is a severe type of neuropathic pain that is often inadequately managed using conventional therapies. These researchers presented the 1st case of TN treated with Gasserian ganglion nerve Coblation (NC). The subject was a 58-year old man who presented with right facial pain, mostly localized in the right zygomatic zone, alveolar region, and jaws. Similar to acupuncture and shock pain, the pain lasted about 5 seconds after each attack before resolving unaided. A diagnosis of TN was made, after which treatment with acupuncture therapy and oral carbamazepine was given. However, the pain was not satisfactorily controlled. Subsequently, Gasserian ganglion NC of the right trigeminal nerve guided by CT was performed on the patient. Following this procedure, the right zygomatic, alveolar, submandibular, and cheek pain disappeared completely. The right zygomatic and alveolar areas experienced mild numbness (level II). At 1-, 2-, 3-, and 6-month follow-ups after surgery, the patient was painless and the numbness score was level I. The authors concluded that CT-guided Gasserian ganglion NC is a promising, effective treatment for TN and associated with minimal or non-post-operative numbness or hypoesthesia.
These researchers stated that as an emerging technology, NC for the treatment of TN has not been extensively studied globally. This is a very promising minimally invasive interventional technique that holds multiple benefits to the patient not least because of effective pain control. They stated that a larger patient sample and longer follow-up period are needed to ascertain the effectiveness of NC in the management of TN.
Percutaneous Disc Decompression with Coblation Nucleoplasty for the Treatment of Cervical Vertigo
Li and colleagues (2019) noted that surgical treatment of cervical vertigo has been rarely reported. In a retrospective study, these researchers examined the clinical outcomes of percutaneous disc decompression with Coblation nucleoplasty (PDCN) for treatment of patients with cervical vertigo who have failed conservative care. A total of 74 consecutive patients with cervical vertigo underwent PDCN and were followed for at least 1 year. Outcome measures included the dizziness intensity VAS, dizziness frequency, the Dizziness Handicap Inventory (DHI), and neck pain intensity. Clinical efficacy was evaluated by rating scale and the modified MacNab evaluation criteria. Surgical complications during the operation and follow-up were also recorded. The vertigo VAS score, frequency of dizziness, DHI, and neck pain intensity were all decreased significantly from evaluation before surgery to 1 week after surgery and to the last follow-up, giving a mean effective rate of 94.6 % 1 week after surgery and 90.6 % at the last follow-up. Good-to-excellent results were attained in 85.1 % of these patients 1 week after PDCN and in 75.7 % of the sufferers at the last follow-up (p < 0.001). There were 5 patients with transient adverse effects (6.25 %) reported within the 1st month after surgery; they all recovered after conservative treatment. No neurological complications were found and no patient went on to spinal fusion surgery thereafter. The authors concluded that the clinical outcomes of PDCN for cervical vertigo were satisfactory in both the early and late post-operative period; PDCN was an effective, low-complication, minimally invasive procedure used to treat cervical vertigo. Moreover, these researchers stated that further prospective RCTs are needed to validate this conclusion. The authors stated that the main drawbacks of this study were that the rate of follow-up was 70 % and a placebo effect could not be excluded. There is no gold standard for the diagnosis and treatment of cervical vertigo so far.
Videolaryngoscope-Assisted Coblation for Epiglottic Cysts
In a prospective, clinical series study, Meng and colleagues (2020) examined the safety and effectiveness of videolaryngoscope-assisted Coblation of epiglottic cysts (VACECs) under general anesthesia. The pre-operative electronic flexible laryngoscopic or 70° rigid laryngeal endoscopic examination was performed to evaluate the location and size of ECs. There was a periodical follow-up survey for all patients. A total 28 of consecutive patients with ECs were enrolled in this trial, including 12 men and 16 women, with an average age of 55 years (range of 24 to 78). Subjects’ medical history ranged from half a month to 2 years. The size of the cyst ranged from 0.8 to 1.5 cm. All patients were cured without pharyngeal or systemic complications. Loosening of anterior teeth occurred in 5 patients (17.9 %). Specimen pathology confirmed the diagnosis in all patients. No recurrence was found after more than 6-month follow-up. The authors concluded that VACECs brought together the advantages of Coblation and videolaryngoscope. These researchers stated that videolaryngoscope-assisted Coblation is a simple, safe and feasible procedure for patients with ECs and is worthy of clinical application. These preliminary findings need to be validated by well-designed studies.
Coblation Annuloplasty for the Treatment of Cervical Discogenic Pain
He and colleagues (2020) noted that the nerve fibers innervating the annulus fibrosus are the major origin of degeneration-associated discogenic pain. Coblation is a tissue-dissociating technique in which the nerve fibers in the degenerative disc tissue are ablated. These researchers hypothesized that Coblation annuloplasty would be an effective approach for the treatment of cervical discogenic pain without radiculopathy. They examined the effectiveness of Coblation annuloplasty in the treatment of patients with cervical discogenic pain without radiculopathy. A total of 40 patients diagnosed with cervical discogenic pain without radiculopathy were screened for Coblation annuloplasty. The patient-rated VAS score for pain, significant pain relief rate, and Modified MacNab pain-relieving effect were adopted to examine the therapeutic effect within a 1-year follow-up period. A total of 33 patients completed the study. The average pain duration was 4.6 ± 1.6 years (range of 0.5 to 8 years). The mean VAS pain score decreased from pre-operative 6.8 ± 0.9 to post-operative 2.5 ± 1.3 (p < 0.01). For all subjects, the immediate pain relief rate was 78.7 % (26/33), which continued to post-operative 6 months. One year later, 22 (66.6 %) subjects reported that their pain was significantly alleviated. According to the Modified MacNab criteria, 63.6 to 82.1 % of participants considered the effect of surgery for their pain therapy as "excellent" during the 1-year follow-up period. No significant complications such as hemorrhage, paresthesia, or infection were observed. The authors concluded that this study was the 1st to demonstrate that Coblation annuloplasty was an effective approach in providing significant alleviation of neck pain from cervical discogenic injury without radiculopathy. They noted that few significant complications were observed, suggesting that Coblation annuloplasty was a feasible and minimally invasive technique for cervical discogenic pain management.
The authors stated that this study had several drawbacks. First, they only followed-up subjects for a 1-year period post-operatively; thus, they could not claim that the technique was effective at relieving this kind of pain for a much longer duration. Second, the pain duration prior to the surgical procedures was 0.5 to 8 years. This wide-ranging pain duration made the final therapeutic effect varied widely; however, these investigators did not carry out stratified analyses of the therapeutic effect according to pain duration, so their combined results only reflected an average effect of the technique. That is, these researchers could not exclude the possible association between different pain durations and the eventual interventional effect. Third, although the VAS pain rating system was the widely used tool for evaluation of pain, these researchers could not eliminate the subjective preference of patients on their own pain ratings. Fourth, the subject’s labor type and socioeconomic status were 2 important factors affecting their perception of pain. The authors did not conduct a sub-analysis of the impacts of these 2 factors on their final pain rating. Fifth, these investigators could not exclude the influence of different extents of disc injury prior to the interventional surgery on the final therapeutic effects. Finally, Coblation annuloplasty itself is a blind technique; thus, it was difficult for the physician to completely destroy the nerve endings and remove the inflamed nucleus and annular fissure, which would undoubtedly reduce its therapeutic efficacy.
Computed Tomography-Guided Percutaneous Coblation of the Thoracic Nerve Root for the Treatment of Post-Herpetic Neuralgia
Luo and colleagues (2020) noted that post-herpetic neuralgia (PHN) is one of the most intractable pain disorders and often does not respond to medication, physical, and interventional procedures. Coblation technology has been reported to have potential for the treatment of neuralgia; however, there are rare reports on the safety and efficacy of Coblation for PHN. The thoracic segment is the most common predilection part of PHN. These researchers examined the safety and efficacy of CT-guided Coblation of the thoracic nerve root for the treatment of PHN. A total of 77 patients with thoracic PHN sustained for at least 6 months and refractory to conservative therapy were identified. Patients underwent CT-guided percutaneous Coblation to ablate the thoracic nerve root for thoracic PHN. The therapeutic effects were evaluated using a VAS, medication doses, and pain-related QOL scale before Coblation, and at 1 week, and at 1, 3, and 6 months after the procedure. Patients who achieved more than 50 % pain relief were defined as responders. Furthermore, AEs were also recorded to examine the safety of this procedure. The VAS score significantly decreased from 7.22 ± 1.15 before the Coblation to 3.51 ± 1.12 (p = 0.01), 3.02 ± 1.21 (p = 0.006), 3.11 ± 2.15 (p = 0.014), and 2.98 ± 2.35 (p = 0.008) at 1 week, and at 1, 3, and 6 months after the procedure, respectively. The number of responders were 56 (77.78 %), 54 (75 %), 55 (76.39 %), and 54 (75 %) at 1 week, and at 1, 3, and 6 months after the procedure, respectively. The doses of anticonvulsants and analgesics consumed decreased significantly at all time-points after the procedure compared with before treatment (p < 0.05). Patient responses on the Brief Pain Inventory Short Form indicated mean scores that were significantly lower than baseline across all domains of pain interference with QOL at all evaluations (p = 0.001). Most of the subjects had mild numbness and it did not affect the daily activities after the procedure. No other severe AEs occurred during or after the procedure. The authors concluded that CT-guided percutaneous thoracic nerve root Coblation was a safe and effective method for the treatment of thoracic PHN, and the procedure could also significantly improve the QOL in patients with PHN.
The authors stated that several limitations in this study should be addressed in future trials. First, this study comprised a retrospective clinical trial that lacked a control group. Second, the study was a single-center study, the included patients may also not be generalizable to different patient populations. Third, the long time-span of some patient’s condition, which may affect the overall therapeutic effect. Fourth, because the sample size was relatively small, the subgroup analysis of therapeutic effect was not carried out according to the course of disease. Future studies should include a large, prospective study across multiple sites with the inclusion of a non-intervention control group, and a longer follow-up period should be carried out to further examine its risks and benefits.
Bian et al (2024) noted that RF thermocoagulation (RFT) of the thoracic nerve root is often used in the treatment of medication-refractory thoracic PHN; however, RFT procedures' sub-optimal pain relief as well as high occurrence of post-operative skin numbness present persistent challenges. Previous single-cohort studies indicated that the low-temperature plasma Coblation technique may potentially improve pain relief and reduce the incidence of skin numbness. Nevertheless, conclusive evidence favoring Coblation over RFT is lacking. In a retrospective, matched-cohort, single-center study, these researchers compared the clinical outcomes associated with Coblation to those associated with RFT in the treatment of refractory PHN. A total of 68 PHN patients underwent Coblation procedures between 2019 and 2020, and 312 patients underwent RFT between 2015 and 2020 in the authors’ department. A matched-cohort analysis was performed based on the criteria of age, gender, weight, pain intensity, pain duration, side of pain, and affected thoracic dermatome. Pain relief was evaluated using the numeric rating scale (NRS), the Medication Quantification Scale (MQS) Version III and the Neuropathic Pain Symptom Inventory (NPSI), which were used to indicate pain intensity, medication burden, and comprehensive pain remission at 6, 12, and 24 months. Numbness degree scale scores and complications were recorded to examine safety. These investigators successfully matched a cohort of 59 patients who underwent Coblation and an equivalent number of patients who underwent RFT as a PHN treatment. At the follow-up time-points, both groups' NRS, MQS, and NPSI scores showed significant reductions from the pre-operation scores (p < 0.05). The Coblation group's NRS scores were significantly lower than the RFT group's at the 6th and the 24th months (p < 0.05). At 24 months, the MQS values in the Coblation group were significantly lower than those in the RFT group (p < 0.05). In addition, the Coblation group's total intensity scores on the NPSI were significantly lower than the RFT group's at the 12- and 24-month follow-ups (p < 0.05). At 6 months, the Coblation group's temporary intensity scores on the NPSI were significantly lower than the RFT group's (p < 0.05). Furthermore, the occurrence of moderate or severe numbness in the Coblation group was significantly lower than in the RFT group at 6 and 12 months (p < 0.05). No serious AEs were reported during the follow-up. The authors concluded that in this matched cohort analysis, Coblation attained longer-term pain relief with a more minimal incidence rate of skin numbness than did RFT. Moreover, these researchers stated that further RCTs are needed to validate Coblation's clinical superiority to RFT as a PHN treatment. These researchers noted that the main drawbacks of this analysis were its retrospective, single-center design and its small sample size (n = 59 in the Coblation group).
Radiofrequency Coblation for the Treatment of Osteochondritis Dissecans Lesions
Estes (2020) noted that osteochondritis dissecans (OCD) lesions entail disruption of the osteochondral unit along articular surfaces, with significant potential for joint deterioration if not managed appropriately. These investigators reported on the case of a 15-year old male who presented with persistent and insidious right knee pain, which had worsened following a collision with another player during a basketball game, resulting in episodes of locking. Magnetic resonance imaging (MRI) revealed a lateral trochlear OCD extending into the anterior lateral femoral condyle. Chondral fraying was observed along the margins of the OCD. Retrograde drilling ensued with use of a 0.045-inch Kirschner wire throughout the lesion to a depth that would allow for penetration of healthy underlying subchondral bone to create an influx of healing factors. Three resorbable pegs were arthroscopically placed through an accessory portal overlying the lesion to stabilize the fracture and compress the gapped cartilage mantle to reduce flow of synovial fluid behind the lesion. Bi-polar RF Coblation was used to stabilize the chondral fraying and seal the gap along the periphery of the lesion. The patient was put on a non-weight bearing protocol for 6 weeks, after which crutches and brace were discontinued, but therapy persisted. Repeat imaging at 3 months demonstrated excellent interval healing. The patient was released to slowly engage impact activities. Although he returned at approximately 8 months post-operatively with a contralateral anterior cruciate ligament (ACL) tear, he reported the operated knee with the OCD was doing extremely well. The author concluded that RF Coblation appeared to be a viable strategy as an adjunct to management for OCD in children, although further follow-up studies are needed to confirm this.
Radiofrequency Coblation for the Treatment of Peri-Scapular Tendinopathy
Tham and colleagues (2020) stated that overuse injuries of the tendon -- tendinopathy -- account for 30 % to 50 % of all sporting injuries and a high proportion of orthopedic referrals from primary care physicians. Tendinopathies often have a multi-factorial etiology and injury can be due to a combination of both acute and chronic trauma that contributed to loss of tissue integrity and eventual rupture. The incomplete understanding of the mechanisms surrounding tendon pathophysiology continues to cause difficulties in treatments beyond loading regimes that can be unsuccessful in up to 30 % of cases. These investigators described an uncommon case of tendinopathy affecting the peri-scapular muscle/tendon unit in a 35-year old woman with persistent pain around the inferior posterior pole of her right scapula; MRI findings confirmed edema of the muscles around the inferior scapular margin in keeping with enthesopathy/tendinopathy; and the patient was treated with RF Coblation. The authors concluded that this case highlighted RF Coblation may be a useful surgical adjunct in patients who have failed non-operative treatment for persistent peri-scapular tendon pathology. This was a single-case study; its findings need to be validated by well-designed studies.
Transoral Radiofrequency Coblation for the Treatment of Laryngopharyngeal Vascular Lesions
In a retrospective study, Jia and colleagues (2021) examined the feasibility and efficacy of transoral RF Coblation surgery (TRS) in the treatment of laryngopharyngeal vascular lesion (LVL) in adults. A total of 15 patients with LVL were studied, including 11 capillary lesions and 5 cavernous lesions (there was 1 case with 2 separate lesions). All of the lesions were treated with TRS alone (capillary lesion) or with a combination of TRS and sclerotherapy (cavernous lesion). The treatment efficacy was evaluated according to the modified Achauer criteria: grade-1, no change in size; grade-2, a decrease of less than 50 % in size; grade-3, a decrease of greater than or equal to 50 % but less than 100 %; and grade-4, the disappearance of the lesion with no recurrence for at least 6 months. The surgical procedures were successfully completed in all patients. According to the modified Achauer criteria, the treatment outcomes were grade-4 for 10 capillary lesions and 1 cavernous lesion; grade-3 for 1 capillary lesion and 1 cavernous lesion; grade-2 for 1 cavernous lesion; and grade-1 for 2 cavernous lesions, respectively. No complications related to the surgery, including bleeding, dysphagia, and infections, were observed following treatment. The authors concluded that TRS was an effective therapeutic option for LVL, especially for patients with laryngopharyngeal capillary lesions. Level of Evidence = IV. This was a small (n = 15), retrospective study; its findings need to be validated by well-designed studies.
Vivaer Nasal Airway Remodeling System
Brehmer et al (2019) noted that weak or inward-bent cartilage of the nasal sidewall at the level of the internal nasal valve (INV) can produce narrowness or collapse of the nasal valve. This is a common cause of impaired nasal breathing during daily activities and there is also an established connection between nasal obstruction and snoring. The condition is often difficult to treat, although even a small enlargement of the lumen at the nasal valve can lead to a significant improvement in the ease of nasal breathing. In a prospective study, these researchers examined the safety and effectiveness of the Vivaer system for the treatment of narrowed nasal valves and to measure changes in the symptoms of nasal obstruction and snoring. The Vivaer system uses low energy RF to remodel the nasal sidewall in order to improve airflow. The study involved 31 patients presenting from September 1, 2017 to May 1, 2018 with symptoms of nasal obstruction and snoring. In all patients, an improvement was observed in nasal breathing measured by Nasal Obstruction Symptom Evaluation Scale (NOSE) score, sleep quality by SOS questionnaire and QOL as measured by EQ-5D and SNOT-22. The authors concluded that Vivaer intra-nasal re-modeling could provide a durable and well-tolerated non-invasive treatment for those patients who were suffering congestion due to narrowness or collapse of the INV.
The authors stated that the inherent limitation of this study was certainly the absence of a placebo group (non-treatment group) and the short follow-up period (average of 3 months). These researchers stated that a further improvement to the study would be the substitution of the Epworth Sleepiness Scale (ESS) for the SOS questionnaire, which suffers some difficulties in administration and interpretation.
In a prospective, non-randomized, multi-center, case-series study, Jacobowitz et al (2019) examined the safety and effectiveness of in-office bipolar RF treatment of nasal valve obstruction. Adult patients with a NOSE Scale score greater than or equal to 60 were selected. Patients were clinically diagnosed with dynamic or static INV obstruction as primary or significant contributor to obstruction and were required to have a positive response to nasal mechanical dilators or lateralization maneuvers. Bilateral RF treatment was applied intra-nasally using a novel device, under local anesthesia in a single session. Safety and tolerance were assessed by event reporting, inspection, and VAS for pain. Efficacy was determined using the NOSE Scale score and patient-reported satisfaction survey at 26 weeks. A total of 50 patients were treated. No device or procedure-related serious AEs occurred. Soreness, edema, and crusting resolved by 1 month. The mean baseline NOSE Scale score was 79.9 (standard deviation [SD] 10.8, range of 60 to 100), and all had severe or extreme obstruction. At 26 weeks, mean NOSE Scale score was 69 % lower at 24.7 (p < 0.0001) with 95 % 2-sided CIs 48.5 to 61.1 for decrease. The decrease in NOSE Scale score did not differ significantly between patients who did or did not have prior nasal surgery. Patient satisfaction mean by survey was 8.2 of 10. The authors concluded that in office treatment of INV obstruction using a bipolar RF device was safe and well-tolerated. Nasal obstruction, as assessed using the NOSE questionnaire at 26 weeks, was markedly improved with high patient satisfaction. Level of Evidence = IIb.
The authors stated that the limitations of this study include its uncontrolled, non-randomized, unblinded design that can be prone to selection bias. The NOSE Scale score is a validated outcome tool, but consists of subjective reporting; thus, the outcome was susceptible to the Hawthorne effect where subjects may respond differently due to being in a study. While a placebo effect could not be excluded, the high magnitude of response was supportive for a true clinical response. With respect to the patient population, the cohort was almost entirely Caucasian, and limited to 50 subjects. A placebo-controlled study with a larger and more diverse population would be desirable. Furthermore, the endpoint analysis was performed at 26 weeks post-procedure; therefore, relatively short follow-up. These researchers stated that follow-up for outcome over several years is needed to examine longevity of the patients’ outcome and this study will be performed.
In a prospective, non-randomized, case-series study, Wu et al (2019) examined the effectiveness of low-energy RF for the treatment of narrow or obstructed nasal valve. A total of 20 patients with internal nasal valve obstruction underwent office-based Vivaer treatment under local anesthesia. Computational fluid dynamics (CFD) models were constructed based on the pre- and 90 days post-procedure CT scans to identify salient changes in nasal airflow parameters. Patients' NOSE score (pre-treatment 78.89 ± 11.57; post-treatment 31.39 ± 18.30, p = 5e-7) and VAS of nasal obstruction (pre-treatment 6.01 ± 1.83; post-treatment 3.44 ± 2.11, p = 1e-4) improved significantly at 90 days after the minimally invasive approach. Nasal airway volume in the treatment area increased approximately 7 % 90 days post-treatment (pre-treatment 5.97 ± 1.20, post-treatment 6.38 ± 1.50 cm3, p = 0.018), yet there were no statistically significant changes in the measured peak nasal inspiratory flowrate (PNIF, pre-treatment: 60.16 ± 34.49; post-treatment: 72.38 ± 43.66 ml/s; p = 0.13) and CFD computed nasal resistance (pre-treatment: 0.096 ± 0.065; post-treatment: 0.075 ± 0.026 Pa/(ml/s); p = 0.063). As validation, PNIF correlated significantly with nasal resistance (r = 0.47, p = .004). Among all the variables, only the peak mucosal cooling posterior to the nasal vestibule significantly correlated with the NOSE at baseline (r = -0.531, p = 0.023) and with post-treatment improvement (r = 0.659, p = 0.003). The authors concluded that minimal remodeling of the nasal valve (7 % in this study) may have a profound effect on perceived nasal obstruction, despite little effect on nasal resistance, or PNIF. These findings corroborated their previous findings that subjective relief of nasal obstruction correlated with regional mucosal cooling rather than nasal resistance or peak flow rate, a potential target for future effective, personalized therapeutic approaches. Level of Evidence = IV.
Jacobowitz, et al. (2019) conducted a prospective cohort study to assess the safety and effectiveness of in-office bipolar radiofrequency treatment of nasal valve obstruction. Adult patients with a Nasal Obstruction Symptom Evaluation scale (NOSE) score ≥60 were selected. Patients were clinically diagnosed with dynamic or static internal nasal valve obstruction as primary or significant contributor to obstruction and were required to have a positive response to nasal mechanical dilators or lateralization maneuvers. Bilateral radio-frequency treatment was applied intranasally using a novel device, under local anesthesia in a single session. Safety and tolerance were assessed by event reporting, inspection, and Visual Analogue Scale (VAS) for pain. Efficacy was determined using the NOSE score and patient-reported satisfaction survey at 26 weeks. Fifty patients were treated. No device or procedure-related serious adverse events occurred. Soreness, edema, and crusting resolved by 1 month. The mean baseline NOSE score was 79.9 (SD 10.8, range 60-100), and all had severe or extreme obstruction. At 26 weeks, mean NOSE score was 69% lower at 24.7 (P < .0001) with 95% two-sided confidence intervals 48.5 to 61.1 for decrease. The decrease in NOSE score did not differ significantly between patients who did or did not have prior nasal surgery. Patient satisfaction mean by survey was 8.2 of 10. The authors noted that weaknesses of this study include its uncontrolled, nonrandomized, unblinded design which can be prone to selection bias. Also, the endpoint analysis was performed at 26 weeks postprocedure, thus relatively short term.
Ephrat et al (2021) noted that insufficiency of the nasal valve is increasingly being recognized as a cause of nasal airway obstruction (NAO). The condition is associated with many symptoms, including nasal congestion, sleep disturbance, snoring, and an overall decline in QOL. An in-office, minimally invasive RF treatment of the nasal valve has been associated with improved symptoms of nasal obstruction and patients’ QOL for a 6-month period in a non-controlled, prospective, single-arm study. In a non-controlled, single-arm study, these researchers examined if the results achieved with RF treatment at 6 months would be sustained through 24 months. A total of 39 adult patients from an original cohort of 49 patients with severe-to-extreme NOSE Scale scores and dynamic or static INV obstruction as the primary or significant contributor to obstruction were studied. Patients received intra-nasal bilateral RF treatment in a clinical study with a follow-up to 6 months, and were prospectively evaluated at 12, 18, and 24 months at 8 community-based otolaryngology practices. The patient-reported NOSE Scale score and 21 QOL questions were assessed. Clinically significant improvement from baseline in NOSE Scale score change demonstrated at 6 months (mean of 55.9; standard deviation [SD], 23.6; p < 0.0001) was maintained through 24 months (mean of 53.5; SD, 24.6; p < 0.0001). Responders (greater than or equal to 15-point improvement) consisted of 92.3 % of participants at 6 months and 97.2 % at 24 months. Responses to the QOL questions also showed improvement in patients’ QOL. The authors concluded that treatment of the nasal valve with an in-office, trans-nasal temperature-controlled RF procedure was associated with stable and lasting improvement in symptoms of nasal obstruction and QOL through 24 months in this non-controlled, single-arm study. Moreover, these researchers stated that it will be necessary to confirm the findings of this study in additional patients as part of a planned RCT that may help determine the relative true treatment effect versus potential placebo effects.
The authors stated that the main drawbacks of this study were the single-arm, non-randomized design and lack of a control group. Based on the study design utilized, the observed association of treatment and NOSE Scale score could be due to a placebo effect. Future studies will use a single-blinded, randomized, sham-controlled approach and larger sample sizes. Another limitation was the lack of objective measures of nasal obstruction and nasal airflow. However, there were numerous studies in the literature that showed a poor correlation between objective measures of nasal resistance and airflow and the symptoms of nasal obstruction. The NOSE Scale is a validated survey that measures the reduced QOL attributed to nasal obstruction; thus, the NOSE Scale score is generally used as a primary outcome in studies of therapy for nasal obstruction. Another limitation was that the extended follow-up study enrolled 39 of the 50 original participants in the original 6-month clinical study (49 were eligible for enrollment). Comparison of demographic characteristics of original study participants who chose to enroll with those who did not enroll did not reveal any signs of symptomatic bias. All of the original sites were represented in this study. An initial concern that participants with less improvement or satisfaction with the procedure would choose not to enroll did not appear to take place. Baseline and 26-week NOSE Scale scores for those enrolled in the follow-up study were slightly worse than for those that did not enroll, and all 3 of the non-responders at the 6-month endpoint of the original study enrolled in this follow-up study, indicating that bias toward enrollment of the most improved study participants was unlikely. However, for consideration of worst case, if the 10 unenrolled participants from the original study and the 3 lost to follow-up in this study were all considered non-responders, then the overall 24-month responder percent was 71.4 %.
William et al (2021) stated that nasal valve collapse is a primary cause of nasal obstruction. Patients with NAO suffer from a variety of symptoms that affect QOL including congestion, headache, sleep problems, daytime sleepiness, and snoring. In a prospective, single-arm, multi-center study, these researchers examined the effectiveness of a low-power temperature-controlled RF procedure for the treatment of the nasal obstruction and measured symptomatic improvement in patients diagnosed with nasal airway obstruction due to nasal valve collapse. This trial was carried out at 12 otolaryngology centers across the U.S. in adults greater than 18 years of age suffering from NAO that responded to temporary nasal valve dilation, and with a baseline NOSE Scale score of greater than or equal to 60. Patients were treated in the nasal valve region with temperature-controlled RF energy and followed-up at 3 months. A total of 122 adult patients underwent the procedure and 3 patients were lost to follow-up at the 3 months visit. The NOSE total scores at 3 months post-procedure were significantly improved relative to baseline, from 80.3 (± 12.6; range of 60 to 100) to 32.9 (± 24.2; range of 0 to 100), p < 0.001. At baseline, 100 % of patients' total NOSE scores were in the “extreme” (score of 80 to 100) or “severe” (55 to 75) categories; at 3 months post-procedure this decreased to 18.5 %. At the 3-month visit, 91.6 % of the patients had either a 20 % improvement in NOSE total score relative to baseline or at least 1 severity category improvement. The authors concluded that minimally-invasive temperature-controlled RF treatment of the INV resulted in significant improvement in NOSE Scale scores at 3 months. These investigators stated that this treatment was safe and effective for the treatment of NAO due to valve collapse. Moreover, these researchers stated that longer-term follow-up is needed to further evaluate the durability of the effect.
The authors stated that a limitation of this study was its lack of a control arm; thus, outcome reporting may be biased and improvement in symptoms scores could be partly due to a placebo effect. These investigators stated that future RCTs are needed. Moreover, 3-month outcomes reflected the acute effect but remain preliminary. However, previous work has shown that 3-month data were predictive of long-term follow-up, and it is expected that these results will be similarly durable. Patients continue to contribute data in this study and future reports will evaluate the durability of the longer-term treatment effect.
Silvers et al (2021) stated that nasal valve collapse is one of several causes of nasal obstruction. The safety and effectiveness of a temperature-controlled RF device for the treatment of the nasal valve for NAO has been established in single-arm studies. In a prospective, multi-center, single-blinded RCT, these researchers compared active device treatment against a sham procedure (control). Subjects were assigned to bilateral temperature-controlled RF treatment of the nasal valve (n = 77) or a sham procedure (n = 41), in which no RF energy was transferred to the device/treatment area. The device was applied to the mucosa over the lower lateral cartilage on the lateral nasal wall. The primary endpoint was responder rate at 3 months, defined as a greater than or equal to 20 % reduction in NOSE Scale score or greater than or equal to 1 reduction in clinical severity category. At baseline, patients had a mean NOSE Scale score of 76.7 (95 % CI: 73.8 to 79.5) and 78.8 (95 % CI: 74.2 to 83.3) (p = 0.424) in the active treatment and sham-control arms, respectively. At 3 months, the responder rate was significantly higher in the active treatment arm (88.3 % [95 % CI: 79.2 % to 93.7 %] versus 42.5 % [95 % CI: 28.5 % to 57.8 %]; p < 0.001). The active treatment arm had a significantly greater decrease in NOSE Scale score (mean of −42.3 [95 % CI: −47.6 to −37.1] versus −16.8 [95 % CI: −26.3 to −7.2]; p < 0.001); 3 AEs at least possibly related to the device and/or procedure were reported, and all resolved. The authors concluded that this RCT showed temperature-controlled RF treatment of the nasal valve was safe and effective in reducing symptoms of NAO in short-term follow-up.
The authors stated that this study had several drawbacks. Among them were those common to randomized, sham-controlled studies for medical devices and procedures. Physicians were not blinded to treatment-arm assignment, which may have been a source of bias; however, this was mitigated by patient blinding and use of patient-reported outcome measures (i.e., NOSE Scale, ease-of-breathing VAS, pain VAS). Unlike a placebo in pharmaceutical trials, which could appear identical to the active compound to patient, sham devices and procedures may differ enough from treatment that the patients guessed their arm allocation. However, these researchers believed that the sham device and procedure in this trial closely replicated the treatment experience. Medication use was not dictated by the protocol and could potentially have had some confounding effect on symptom relief. However, primary endpoint analysis after converting responders to non-responders if they increased medication/mechanical nasal aid use did not change the superiority of active treatment over sham control. Finally, the results reported here were through 3 months and longer-term follow-up will reveal the durability of the effect observed in this trial to-date.
Yao et al (2021) stated that nasal valve collapse is a primary cause of nasal obstruction. Patients with nasal airway obstruction suffer from a variety of symptoms that affect QOL including congestion, headache, sleep problems, daytime sleepiness, and snoring. In a prospective, single-arm, multi-center study, these researchers examined the effectiveness of a low-power temperature-controlled RF procedure to treat the nasal valve and measure symptomatic improvement in patients diagnosed with NAO due to nasal valve collapse. This study was carried out at 12 otolaryngology centers across the U.S. in adults aged 18 years and older suffering from NAO that responded to temporary nasal valve dilation, and with a baseline NOSE scale score of 60 or higher. Patients were treated in the nasal valve region with temperature-controlled RF energy and followed-up at 3 months. A total of 122 adult patients underwent the procedure and 3 patients were lost to follow-up at the 3 months visit. NOSE scale total scores at 3 months post-procedure were significantly improved relative to baseline, from 80.3 (± 12.6; range of 60 to 100) to 32.9 (± 24.2; range of 0 to 100; p < 0.001). At baseline, 100 % of patients' total NOSE scale scores were in the “extreme” (score of 80 to 100) or “severe” (55 to 75) categories; at 3 months post-procedure this decreased to 18.5 %. At the 3-month visit, 91.6 % of the patients had either a 20 % improvement in NOSE scale total score relative to baseline or at least 1 severity category improvement. The authors concluded that minimally invasive temperature-controlled RF treatment of the internal nasal valve resulted in significant improvement in NOSE scale scores at 3 months. This treatment is safe and effective for the treatment of NAO due to valve collapse. Moreover, these researchers stated that longer-term follow-up is needed to further examine the durability of the effect.
The authors stated that a drawback of this trial was the lack of a control arm; thus, outcome reporting may be biased and improvement in symptoms scores could be partly due to a placebo effect. These investigators noted that future RCTs are needed. Moreover, 3-month outcomes reflect the acute effect but remain preliminary. However, previous work has shown that 3-month data were predictive of long-term follow-up; and it is expected that these findings will be similarly durable. Patients continue to contribute data in this study and future reports will evaluate the durability of the longer-term treatment effect.
Jacobowitz et al (2022) provided long-term (48 months) outcomes following repair of nasal valve collapse with temperature-controlled RF treatment for patients with nasal obstruction. Patients in this extended 48-month follow-up study were invited to participate after completing an initial 26-week study with an extension to 24 months. The initial study was a prospective, single-arm, multi-center study enrolling patients with chronic severe nasal obstruction with nasal valve collapse identified as the primary cause of obstruction. Patients with prior nasal valve surgery or other surgical nasal procedures within the past 12 months were excluded. Medication use was not controlled during the study, but patients were medically treated before surgery. Patients underwent bilateral treatment with a Vivaer device, which maintains treatment temperature at 60 degrees C. The stylus tip was placed against mucosa underlying the lower edge of the upper lateral cartilage; 3 to 4 non-overlapping sites on the lateral nasal wall received treatment for 12 seconds. No concomitant treatments were allowed. Extended follow-up assessments included use of the validated NOSE scale score, completed in person, by telephone, or via mail at 36- and 48-month post-procedure. Of the 49 patients in the initial study, 39 agreed to participate in follow-up through 24 months. Of these 29 patients agreed to extended follow-up through 48 months (5 declined participation, 3 did not respond to the invitation, and 2 had a surgical procedure for nasal airway obstruction and were ineligible to continue). Demographic and baseline characteristics were presented for initial and long-term follow-up cohorts, including those who declined to participate. The baseline mean NOSE score was 81.0 (± 9.9), and at 6 months it was 21.6 (± 18.6) with 93 % responders. Except for mean age, participants versus non-participants had no significant differences in characteristics. The proportion of 6-month responders among the non-enrolled group was 95 %, confirming that early treatment response was unlikely to be associated with participation in extended follow-up. Compared with baseline, mean total NOSE scores significantly improved after treatment and were maintained throughout the 48 months. NOSE scores decreased from 81.0 (± 9.9) at baseline to 21.6 (± 18.6) after 6 months (73.3 % change), 25.6 (± 21.1) after 12 months (68.3 % change), 29.3 (± 26.6) after 18 months (63.8 % change), 22.5 (± 20.9) after 24 months (72.2 % change), 32.3 (± 21.4) after 36 months (60.1 % change), and 25.7 (± 19.1) after 48 months (68.3 % change) (p < 0.001 for all comparisons). Mean NOSE domain scores showed sustained improvement through 48 months, including patients with NOSE scores in the “extreme” (score of 80 to 100) or “severe” (score of 55 to 75) categories at baseline. At 48 months, 67.9 % of patients had severity scores in the “no problems” or “mild” categories, 21.4 % were in the “moderate” and 10.7 % were in the “severe” categories, and none in the “extreme” category, representing significant changes in the proportion of patients in each category (p < 0.001). Based on a greater than or equal to 15-point improvement on the NOSE score scale, 93.1 % (27 of 29), 96.3 % (26 of 27), 96.6 % (28 of 29), 100 % (27 of 27), 92.9 % (26 of 28), and 96.4 % (27 of 28) of patients were considered responders at the 6-, 12-, 18-, 24-, 36-, and 48-month follow-up times, respectively. The authors concluded that in the longest follow-up report to-date, significant and sustained improvements in symptoms of nasal airway obstruction were shown through 4 years following treatment of nasal valve collapse via a single temperature-controlled RF procedure.
The authors stated that this study was limited by its use of a single-arm design without randomized control, no control of medication usage, and significant patient attrition relative to the primary study. Two non-participants were known to have undergone subsequent surgery for nasal obstruction and it was possible that the effectiveness declined in the extended follow-up non-participants, although participants and non-participants had similar baseline characteristics and both groups experienced robust NOSE score reductions at 6 months.
Han et al (2022) stated that nasal valve collapse is a primary cause of nasal airway obstruction (NAO). Patients with NAO and nasal valve collapse experience a variety of symptoms that lower their quality of life (QOL) such as nasal congestion, headache, sleep disturbance, daytime sleepiness, and snoring. In a prospective, randomized, single-blinded, multi-center trial, these researchers examined if active treatment of the nasal valve with a temperature-controlled radiofrequency (TCRF) device, previously demonstrated superior to a sham procedure at 3 months, was safe and associated with sustained improvements in symptoms of NAO through 12 months. Participants in 16 centers in the U.S. with index procedures between August and December 2020 were assigned to TCRF device treatment of the nasal valve or a sham control procedure (no RF energy). Patients had a baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score of 55 or greater with nasal valve collapse as the primary or substantial contributor to NAO. After primary endpoint evaluation at 3 months, eligible patients in the sham control arm crossed over to active treatment. Data analysis was carried out between April and May 2022. Patients were treated bilaterally with the TCRF device at 4 or fewer non-overlapping areas on the nasal mucosa at the junction of the upper and lower lateral cartilage on the lateral nasal wall. The primary endpoint measure was responder rate, defined as 20 % or greater reduction in NOSE Scale score or 1 or greater reduction in NOSE Scale clinical severity category. A total of 108 patients received active treatment (77 as index active treatment, 31 after cross-over). The mean (SD) age of patients was 48.5 (12.3) years; 66 (61.1 %) were women. The combined group of patients receiving active treatment had a mean baseline NOSE Scale score of 76.3 (95 % CI: 73.6 to 79.1). At 12 months (n = 88), the responder rate was 89.8 % (95 % CI: 81.7 % to 94.5 %). The NOSE Scale score improved from baseline (mean change of -44.9 [95 % CI: -52.1 to -37.7]). No device/procedure-related serious adverse events (AEs) were reported. The authors concluded that in this follow-up of a cohort from a randomized clinical trial, the minimally invasive TCRF device, previously demonstrated to be superior to a sham procedure, was safe and associated with improvement in symptoms of NAO through 12 months post-procedure.
The authors stated that this study had several drawbacks. First, medication use was not dictated by the protocol and could potentially have had some confounding effect on symptom relief; however, an overall decrease in medication use was observed. Second, the results reported were through 12 months, and although consistent with previously reported data for this technology, continued follow-up in this trial will provide additional data on the longer-term durability of effect. Third, while this study included patients who may have had additional potential contributors to NAO, only patients with nasal valve collapse as the primary driver of NAO symptoms were enrolled. For this reason, the eligibility criteria, especially exclusion criteria, should be taken into account when considering the results of this trial and patient selection in clinical practice. The majority of the trial population were White, potentially limiting the generalizability of the results to patients of different races and ethnicities who may have meaningful differences in nasal anatomy.
Casale et al (2023) noted that surgical treatment for nasal obstruction caused by nasal valve collapse (NVC) requires a significant recovery period and risks of complications, while nasal dilators are uncomfortable. Recently, RF treatment of lateral walls has been employed under local anesthesia as an office-based surgery. In a systematic review and meta-analysis, these investigators examined the effectiveness of a new RF device, the Vivaer System for the treatment of nasal obstruction. Two researchers independently reviewed the literature up to December 2021. Studies on patients seeking treatment for nasal obstruction due to NVC were included in the analysis. A total of 4 studies (218 patients) met the inclusion criteria; and participants were treated the nasal valve regions bilaterally with the Aerin Medical Vivaer System. After the treatment, the NOSE score was reduced at 3 months post-operatively. Minor AEs were reported in the included studies, and 2 showed no complications. None of the studies reported changes in the external appearance of the nose. The authors concluded that the RF treatment using the Vivaer device could be useful in the treatment of patients with NVC, significantly improved subjective breathing symptom scores. These investigators noted that the drawbacks of this review were the heterogeneity of the results, the limited number of studies examining small populations with short follow-up periods. They stated that more extensive comparative studies and well-designed randomized clinical trials with validated patient-reported outcome measures are needed to confirm these promising findings.
The authors stated that given the moderate heterogeneity of the results and the limited number of studies entailing small populations with short follow-up periods, the outcomes of this review must be considered with caution. This procedure is one of several non-surgical procedures suggested for the treatment of NVC. It is a minimally invasive procedure associated with less pain, a shorter hospital length of stay (LOS), and fewer complications. These investigators stated that more extensive comparative studies and well-designed randomized clinical trials with validated patient-reported outcome measures (PROMs) are needed to provide more definitive recommendations.
In a prospective, single-arm, multi-center study, Yao et al (2023) examined long-term symptom improvements in patients with NAO secondary to NVC following minimally invasive TCRF treatment. This trial enrolled subjects over the age of 18 years with NAO due to NVC. Inclusion criteria were response to nasal valve dilation (e.g., modified Cottle maneuver) and baseline NOSE Scale score of 60 or higher. Participants were treated in the nasal valve region with a TCRF device and followed-up for 2 years. A responder was defined as 20 % or greater reduction in NOSE Scale score or 1 or greater reduction in severity class. A total of 122 patients were treated and 91 reached 2 years follow-up. The mean baseline NOSE Scale score was 80.3 (95 % CI: 78.1 to 82.6). The adjusted mean change in score at 2 years was -45.8 (95 % CI: -53.5 to -38.1, p < 0.001; a 57.0 % improvement). The 2-year responder rate was 90.1 % (95 % CI: 82.3 % to 94.7 %). Significant and sustained symptom improvement was achieved in subpopulations based on sex, age, body mass index (BMI), baseline NAO severity, nasal surgery history, NVC mechanism, septal deviation, and other anatomic contributors of NAO. No serious AEs with a relationship to the study device and/or procedure were reported. The authors concluded that minimally invasive TCRF device treatment of the internal nasal valve for NAO was well-tolerated and resulted in significant and sustained improvement in NAO symptom severity through 2 years, including in patients with both static and dynamic NVC, septal deviation, turbinate enlargement, or prior nasal surgery. Level of Evidence = IIb.
The authors stated that one drawback of this trial was the lack of a control arm. While RCTs result in the highest level of evidence of treatment effectiveness, they are associated with practical constraints such as cost, operational complexity, and randomization to a suitable non‐interventional arm, resulting in a smaller sample size, which limits the assessment of long‐term safety and effectiveness in a larger population. Thus, a single‐arm study was carried out to allow the collection of real‐world evidence for long‐term safety and effectiveness in the largest‐to‐date interventional cohort from multiple centers. The large cohort also allowed multi-variable analyses to identify patients who may be more or less likely to experience different treatment outcomes. Non‐blinded, single‐arm studies may contribute bias; however, this study used a before‐and‐after design employing a validated patient reported outcome measure (i.e., NOSE Scale score) rather than physician assessments to evaluate symptoms before and after treatment to mitigate such bias. To further qualify the results of this largest multi-center study, the improvement in the NOSE Scale scores was comparable to the previously performed RCT as well as other smaller studies evaluating similar patient sets. In addition, these researchers noted that this trial was limited to treatment of the internal nasal valve, even though the TCRF device is indicated for treatment of soft tissues such as inferior turbinate, and septal swell bodies, and the results of this present study may not represent the total effect that may be achievable using TCRF in a comprehensive NAO treatment protocol. These researchers stated that further studies that incorporate more liberal application of TCRF to address multiple NAO contributors are needed to examine the full potential of TCRF‐based treatment of NAO. The subpopulation analyses were exploratory and future studies focusing on discreet subpopulations may be useful in determining optimal TCRF treatment protocols to address NAO in specific patient populations. Finally, the study population was predominantly White, which limited the analysis of outcomes in patient populations with different races and ethnicities, who may have meaningful differences in nasal anatomy.
In a prospective, open-label, single-arm, multi-center study, Pritikin et al (2023) examined the clinical use of a TCRF device for the treatment of septal swell body (SSB) to improve symptoms in adults with NAO. This trial included patients with severe or extreme NAO related to SSB hypertrophy who received bilateral TCRF treatment in the SSB area. The primary endpoint was improvement in NOSE Scale scores from baseline to 3 months post-procedure. A subset of study patients underwent CT imaging to evaluate post-treatment changes in SSB size. Mean NOSE Scale scores significantly improved from 73.5 (SD 14.2) at baseline to 27.9 (SD 17.2) at 3 months post-procedure, a reduction of -45.3 (SD 21.4, 95 % CI: -50.4 to -40.1; p < 0.0001); the responder rate was 95.7 % (95 % CI: 0.88 to 0.99; p < 0.0001). CT evaluation at 3 months showed statistically significant reductions in the SSB with the greatest reduction in the middle thickness (mean change of -3.4 [SD 1.8] ml, 95 % CI: -4.0 to -2.8; p < 0.0001). Minimal AEs with any relationship to the device or procedure were reported; none was serious in nature and no septal perforations occurred. The authors concluded that the findings of this study showed that TCRF treatment of SSB hypertrophy was well-tolerated and effective at reducing both SSB size and symptoms of NAO at 3 months post-treatment.
The authors stated that this study had several drawbacks. First, this was an open-label, single-arm study. Because all patients received the procedure, it was possible that bias was introduced by study team members and/or physicians. As such, future research could incorporate a control treatment to minimize potential bias. Second, the study included patients with SSB hypertrophy as the primary contributor to NAO, which may not be representative of patient populations with multiple contributors to NAO. Further studies incorporating TCRF treatment of the SSB in combination with other treatments addressing additional NAO contributors will aid clinicians in understanding how to incorporate this treatment in a broader patient population. Furthermore, medication use was not restricted for this study that may have a confounding effect on symptom reduction. Finally, these findings were only assessed through 3 months post-procedure. These investigators stated that longer-term follow-up of patients will allow for investigation of the durability of the procedure's effects.
Han et al (2024) stated that nasal valve dysfunction (NVD) is a substantial contributor to nasal airway obstruction. Minimally-invasive TCRF treatment of the nasal valve is available and comparison with surgical techniques is needed. In a systematic review and meta-analysis, these investigators compared TCRF with functional rhinoplasty surgery. Databases for literature search included Medline (PubMed), Embase, Cochrane Library. Adults with pre-procedural NOSE score of 45 or higher were included. Treatment effects were derived from a random effects model and reported as weighted mean difference (WMD) in NOSE score between baseline; 3, 6, and 12 months post-procedure. Of 2,529 initial studies, 5 describing TCRF treatment and 63 studies describing functional rhinoplasty were included. Pooled effect sizes for TCRF treatment and functional rhinoplasty were comparable in all analyses. The authors concluded that TCRF treatment of the internal nasal valve for NVD was associated with sustained effects comparable to functional rhinoplasty addressing the nasal valve only, rhinoplasty without concomitant turbinate treatment, and all rhinoplasty procedures.
The authors stated that this systematic review and meta-analyses had several drawbacks. First, the focus on NOSE score as an outcome measure, and the difference in the number of data points when comparing TCRF treatment with all functional rhinoplasty procedures. However, NOSE score is a validated outcome measure across a wide range of cultures and languages and with strong specialty consensus around its use, which enabled the inclusion of a large number of studies, and published data on TCRF treatment continues to increase as more practitioners adopt the approach. Second, follow-up was limited to 12 months to maximize the amount of evaluable data in each analysis group as studies with greater than 12-month follow-up were substantially fewer. Third, it was possible that individual patients in a data-set had a NOSE score reflecting less than moderate NAO, however, the NOSE score cut-off of 45 maximized the potential that most of the patients in a data-set exhibited at least moderate NAO based on the NOSE score severity classification system. The number of individual patients with less than moderate NAO was likely to be small and unlikely to influence the overall outcomes of the meta-analyses. While the included traditional procedure studies were mostly of moderate-to-poor quality, and heterogeneity scores were often very high, the large number of studies included in these meta-analyses were a broad representation of the functional rhinoplasty literature.
In a systematic review and meta-analysis, Kang et al (2024) examined the effectiveness of TCRF device in alleviating nasal obstruction by rectifying NVC. These investigators carried out a comprehensive review of studies retrieved from PubMed, SCOPUS, Embase, Web of Science, and Cochrane databases (up to December 2022). They included studies that examined the QOL and nasal obstruction scores before and after TCRF treatment; sham-controlled studies were also analyzed. A total of 451 patients across 8 studies were included in the analysis. Patients who underwent TCRF reported a significantly enhanced QOL 24 months after treatment compared to pre-treatment scores. The rates of clinically improved states and positive responses regarding QOL after treatment were 82 % and 91 %, respectively. Moreover, the disease-specific QOL, as indexed by the NOSE score, significantly improved. The authors concluded that TCRF may help improve nasal obstruction symptoms. Moreover, these researchers stated that further randomized clinical studies on larger cohorts are needed to validate its effectiveness in enhancing nasal valve function.
Silvers et al (2024) stated that TCRF device treatment of NVD was superior to a sham procedure control in reducing the symptoms of NAO in this RCT. These investigators reported the 2-year outcomes for 108 patients actively treated in a prospective, patient-blinded, multi-center RCT that examined the treatment effect durability and changes in medication/nasal dilator usage. A responder was defined as 20 % or greater reduction in NOSE score or 1 or greater reduction in severity class. The mean (SD) age of patients was 48.5 (12.3) years; 61.1 % (n = 66) of subjects were women. Baseline NOSE score was 76.3. The 2-year responder rate was 90.4 %; and NOSE score treatment effect was -41.7; 54.7 % improvement. Of 57 patients using medications/nasal dilators at baseline, 45 (78.9 %) either stopped all use (33.3 %) or stopped/decreased (45.6 %) use in 1 or greater class at 2 years. Concurrent septal deviation, septal swell body, or turbinate enlargement did not significantly affect the odds of exhibiting a NOSE score of 25 or less at 2 years. The authors concluded that TCRF device treatment of NVD resulted in significant and sustained improvements in the symptoms of NAO at 2 years, accompanied by a substantial reduction in medication/nasal dilator use. It should be noted that this trial was sponsored by Aerin Medical; and Dr Silvers is a research consultant for Aerin Medical, 3D matrix, and Lyra Therapeutics, and on the medical advisory board for STS stent.
The authors stated that this study had several drawbacks. First, long-term follow-up in this trial was a single group; however, this trial was an RCT at inception with the primary endpoint at 3 months. Long-term blinded follow-up (1 to 2 years) of a control arm is not practical as it may not be in the best interests of patients and carries a high level of patient attrition. Second, the sub-population analyses were exploratory and future studies focusing on discreet subpopulations may be useful in determining optimal TCRF treatment protocols to address NAO in specific patient populations. Third, while medication/nasal dilator use was not dictated by the protocol, which could be perceived as a drawback, the pragmatic approach meant that the results were likely reflective of clinical practice, with the decreases substantial enough to be unlikely due to chance. Fourth, the NOSE score is a patient-reported outcome measure, which, while widely used, is considered subjective; including an objective measurement such as rhinomanometry or acoustic rhinometry would add value to future study results. Fifth, the study population was predominantly White, which limited the analysis of outcomes in patient populations with different races and ethnicities, who may have meaningful differences in nasal anatomy.
Abello et al (2024) noted that NAO is caused by various disorders including NVC. A bi-polar RF device (VivAer, Aerin Medical, Sunnyvale, CA) has been used to treat NAO via RF heat generation to the upper lateral cartilage (ULC). These researchers measured temperature elevations in nasal tissue, using infra-red (IR) radiometry to map the spatial and temporal evolution of temperature. Composite porcine nasal septum was harvested and sectioned (1 mm and 2 mm). The device was used to heat the cartilage in composite porcine septum. An IR camera (FLIR ExaminIR, Teledyne, Wilsonville, OR) was used to image temperature on the back surface of the specimen. These data were incorporated into a heat transfer finite element model that also calculated tissue damage using Arrhenius rate process. IR temperature imaging demonstrated peak back surface temperatures of 49.57° C and 42.21° C in 1- and 2-mm thick septum, respectively. Temperature maps were generated demonstrating the temporal and spatial evolution of temperature. A finite element model generated temperature profiles with respect to time and depth. Rate process models using Arrhenius coefficients showed 30 % chondrocyte death at 1 mm depth after 18 s of RF treatment. The authors concluded that the use of this device creates a thermal profile that may result in thermal injury to cartilage. Computational modeling suggested chondrocyte death extending as deep as 1.4 mm below the treatment surface. These investigators stated that further studies should be performed to improve dosimetry and optimize the heating process to reduce potential injury.
Torabi et al (2024) stated that with the widespread adoption of intra-nasal RF devices, these researchers reported national AEs associated with their use. The FDA's Manufacturer and User Facility Device Experience (MAUDE) was queried. A total of 24 device-related AEs were reported, 11 (45.8 %) for Celon (Olympus), 3 (12.5 %) for Vivaer (Aerin), 2 (8.3 %) for Neuromark (Neurent), and 8 (33.3 %) for Rhinaer (Aerin); 7 (63.6 %) of the Celon-related complications were related to tissue necrosis (largely user error-related), but 1 (9.1 %) episode of pediatric ocular palsy was also reported. Vivaer complications included synechiae formation, a mucosal perforation, and a case of empty nose syndrome. Of the posterior nasal nerve ablating devices, 9 of 10 AEs were epistaxes, of which 7 (77.8 %) required operative intervention. The authors concluded that surgeons should exercise vigilance and tissue-appropriate device settings when utilizing RF devices. Epistaxis and tissue necrosis may occur, as well as rarer, but more devastating, complications.
Simmons et al (2024) noted that nasal obstruction is a prevalent issue affecting up to 1/3 of adults, often requiring surgical intervention. Low-temperature RF treatment, specifically VivAer, has emerged as a promising alternative, especially for the treatment of NVC. However, its effectiveness in patients with a history of rhinoplasty or nasal valve repair remains unexplored. In a retrospective, single-center study, these investigators carried out a chart review on 37 patients with a history of rhinoplasty or nasal valve repair who underwent VivAer RF treatment. Treatment outcomes were assessed using the NOSE scale. The primary outcome was defined as a decrease in NOSE score by at least 1severity category or a 20 % reduction in total NOSE score. The study found a statistically significant average reduction in NOSE score of 22.4 points or 36.6 %. Among patients with a positive treatment response (n = 21 or 56.8 %), the average NOSE score reduction was 34.7 points or 55.6 %. Repeat RF treatment in non-responders resulted in a 50 % response rate. No significant difference was observed in treatment outcomes based on the type of prior rhinoplasty or NVC. The authors concluded that TCRF with VivAer could effectively alleviate nasal obstruction in patients with a history of rhinoplasty or nasal valve repair, offering a viable alternative to revision surgery. The study also highlighted the potential benefit of repeat RF treatment in non-responders. Moreover, these researchers stated that further investigations, including RCTs, are needed to validate these promising results and expand the therapeutic options for this complex patient population.
Yong et al (2024) examined the economic impact of a minimally invasive TCRF device for the treatment of NAO. These researchers developed a budget impact model for 2 scenarios: a reference scenario of functional rhinoplasty surgery with concomitant septoplasty and inferior turbinate reduction (ITR) performed in the hospital outpatient department where TCRF is not an available therapeutic option; and a new scenario consisting of in-office TCRF treatment of the nasal valve and ITR. A payor perspective was adopted with a hypothetical population plan size of 1 million members. Costs were estimated over a time horizon of 4 years. The eligible population included patients with severe/extreme NAO and NVC as the primary cause or significant contributor. Data inputs were sourced from targeted literature reviews. Uncertainty within the model structure and input parameters was assessed using 1-way sensitivity analysis. The introduction of a TCRF device resulted in population-level cost savings of $20,015,123 and per-responder average cost savings of $3,531 over a 4-year time horizon due to lower procedure costs and complication rates of the device relative to the surgical comparator. Results were robust when varying parameter values in sensitivity analyses, with cost savings being most sensitive to the prevalence of NAO and estimated response rates to functional rhinoplasty and TCRF. The authors concluded that in patients with severe/extreme NAO, with NVC as the primary or major contributor, introducing TCRF with ITR as a therapeutic option showed the potential for significant cost savings over functional rhinoplasty with septoplasty and ITR.
The authors stated that a drawback of the model based on the lack of available data was that all non-responders to procedural treatment were assumed to be treated with continued medical management, which may not be the case as patients may opt to undergo revision procedures with uncertainty around expected rates of subsequent response. However, it could be that patients who were non-responders to functional rhinoplasty and who go onto require revision rhinoplasty would incur significantly greater costs when compared to patients treated with TCRF with ITR. There is currently insufficient data to explore the projected costs of patients who undergo revision procedures. Another drawback was found in the treatment uptake inputs included in the model. Treatment uptake inputs were based on expert opinion on the treatment landscape projections and historical commercial data for the TCRF device. However, the uncertainty of TCRF with ITR uptake inputs was tested in the 1-way sensitivity analysis, which resulted consistently in cost-saving budget impacts. Finally, the analysis was limited by a lack of available data for the medical resources used post-procedure. The assumption was made that medical resource utilization (MRU) within a 12-month post-treatment period was equivalent between responders to TCRF and functional rhinoplasty, as well as non-responders. It is likely that when additional data reflecting changes in MRU is avail-able, cost savings associated with post-procedural MRU will be higher for responders than estimated in this analysis. Moreover, these investigators stated that future areas for research include characterizing MRU associated with NAO for both untreated and treated patients, including responders and non-responders. Furthermore, incorporating quality of life data would enable a cost-effectiveness analysis comparing therapeutic options. This would provide a more comprehensive understanding of the potential economic advantages of incorporating a minimally invasive TCRF option for the management of NAO into a health system, which may ultimately result in additional cost and quality of life (QOL) advantages.
In a prospective, single-blind, long-term, multi-center (16 sites) RCT, Han et al (2025) examined the safety, effectiveness, and durability of TCRF treatment of the nasal valve in patients with severe or extreme NAO. Participants received TCRF treatment on the lateral nasal valve; all subjects were followed through 3 years. Outcome measures included the NOSE Scale, ESS, and AEs. Treatment responders were defined as a 1 or greater reduction in severity class or 20 % or more reduction in NOSE score. Out of 108 patients who received TCRF treatment, 54 reached the 3-year follow-up time-point. The baseline mean NOSE score was 76.3 (95 % CI: 73.6 to 79.1). The 3-year NOSE score treatment effect was -49.4 (95 % CI: -56.5 to -42.4; p < 0.001) a 64.7 % improvement from baseline; 88.7 % of patients were responders. Most patients reported significant improvements in sleep post-treatment with a mean ESS score of 4.5 (95 % CI: 3.4 to 5.7) at 3 years compared to 10.3 (95 % CI: 9.2 to 11.4) at baseline. The authors concluded that TCRF treatment was a safe, and effective method with long-term durability for improving NAO in patients with NVD and should be considered as a potential alternative to surgical approaches to NV repair when evaluating therapeutic options with patients as part of a shared decision-making process.
The authors stated that this study had several drawbacks. First, participants were not restricted in their nasal medication usage as an enrollment criterion throughout the study. Second, the study was limited to the treatment of the NV alone and may not represent a real-world scenario in which multiple contributors to NAO may be treated with TCRF. Further investigations examining the potential additive value of TCRF treatment of septal swell body and inferior turbinate hypertrophy in addition to the NV may better reveal the full potential effect. Third, clinically objective measures for nasal air-flow, such as rhinomanometry, acoustic rhinometry, and peak nasal inspiratory flow, were not employed and should be considered for future studies to evaluate the quantitative impact of TCRF. Fourth, these researchers did not capture CPAP data between the initial procedure and final follow-up, which may be a confounding factor to the changes demonstrated in ESS and would provide useful information regarding the benefit of TCRF to OSA patients.
Tang et al (2025) stated that nasal valve treatment with TCRF results in NAO symptom improvement in the presence of septal deviation. Data from 2 prospective studies were considered. Inclusion criteria for the pooled dataset were pre-treatment baseline and 3-month NOSE scale score data, and pre-treatment images of sufficient quality for review on both sides. The pooled eligible cohort consisted of 167 adult patients (50.9 %, and 49.1 %); 122 were evaluable at 2 years. NOSE scores, treatment effects, and responder rates following TCRF treatment were comparable regardless of the septal deviation grade range and NV involvement. The outcomes were also comparable at 3 months and 2 years. The mean treatment effects for patients with septal deviation severity grades 3 to 4 with nasal valve involvement (combined) were -45.3 (95 % CI: -54.3 to -36.3) at 3 months (n = 33) and -52.8 (95 % CI: 64.1 to -41.5) at 2 years (n = 27). The authors concluded that minimally invasive TCRF treatment of NVD resulted in significant improvements in the symptoms of NAO at 3 months and 2 years, regardless of the presence and severity of septal deviation and its involvement on the NV region. TCRF device treatment of NVD may be a practical and durable alternative for patients considering surgical rhinoplasty and septoplasty to treat their NAO.
These researchers stated that retrospective review of images and video of variable quality was a drawback of this trial and likely contributed to the moderate exact septal deviation severity grade-based agreement. Other drawbacks of this study stemmed from pooling of existing data and potentially limited the generalizability of the findings. Patients with severe septal deviations were potentially screened out of the original studies as inclusion criteria included NVD as the primary or significant cause of NAO. This study was focused on septal deviation and did not consider other anatomical contributors to NAO, although these have been considered previously. Lastly, this study examined a predominately White population (87.4 %).
In an extended follow-up from a prospective, single-arm, multi-center study, Yao et al (2025) examined long-term safety and effectiveness of TCRF treatment of NVC in patients with NAO. The initial study included subject from 12 sites across the U.S. who were followed for 24 months and additionally agreed to participate in the extended 36-month follow-up. Procedure was carried out in-office with an in-person follow-up at 3 months and subsequent follow-up assessment remotely. Participants received TCRF treatment of only the nasal valve and participated in the extended 36-month follow-up. The effect of TCRF treatment was determined by analyzing changes in NOSE score at each follow-up compared to the baseline. Of the 122 participants in the primary study, 66 participated in the extended 36-month follow-up. Compared to baseline, there was a 52.6 % decrease in the NOSE score at 36 months (mean change -45.3 [95 % CI: -52.3 to -38.3]; p < 0.001), and 83.3 % of the participants met the criteria for treatment response at 36 months, as defined by the study end-point. Post-hoc sensitivity analysis of the treatment response for all participants from the time of enrollment was 73.9 %. No device or procedure-related AEs or serious AEs were reported in the interval between 24 and 36 months. The authors concluded that TCRF treatment of only the nasal valve resulted in significant and durable improvement in NAO symptoms through 36 months in participants with NAO due to NVC.
The authors stated that his study had several drawbacks. First , this was an open‐label, single‐arm, multi-center study, which could result in personnel bias/differences among the study team and/or the physician. Although outcomes were self‐reported at all sites, variability was limited by using a standardized treatment protocol and physician training. Thus, all subjects underwent the same treatment across all sites, and all outcomes were self‐reported by the subjects. Second, the absence of in‐person nasal examinations beyond the 3‐month follow‐up hindered the safety portion of this study. Although no device‐ or procedure‐related AEs were reported between the 24‐ and 36‐month follow‐up periods, it was important to note that complications such as intra-nasal adhesions could not be definitively ruled out based solely on patient‐reported outcomes. Future studies with standardized in‐person nasal examinations during long‐term follow‐up could provide more robust safety data. Third. medication use was not restricted for the subjects in this trial due to its pragmatic study design. A total of 8 (12.1 %) of participants started new medication after baseline, including anti-histamines (4.5 %), nasal steroid sprays (4.5 %), nasal anti-cholinergic sprays (1.5 %), and “other” (1.5 %). Notably, all had rhinitis that could contribute to NAO but considered different as the patients in the current study received treatment in the lateral wall in the NV region. The study was designed to examine the effectiveness of TCRF for treating NAO, specifically the NV, not rhinitis, which may have been better addressed by treating additional anatomic structures, such as the inferior turbinate. This drawback was similar to the case of participants who underwent additional ENT procedures after the study procedure, suggesting that targeting other anatomic contributors with TCRF may provide additional benefits. A future registry study could provide real‐world evidence by examining outcomes where multiple anatomic locations are treated in combination. Furthermore, these researchers stated that future studies incorporating an objective measure, such as rhinometry measurements, 3D computational models, or an active comparator, may provide additional information with which to examine the potential benefits of TCRF treatment of the NV in the context of existing therapeutic options.
Coblation-Assisted Arytenoidectomy for the Treatment of Infants with Vocal Cord Paralysis
Hu and associates (2019) noted that there are many causes for vocal cord paralysis (VCP) that can result in difficulty in breathing in serious cases. The common surgical methods for treating VCP include laryngeal splitting or laser surgery; however, there are limitations. Plasma RF ablation is a new treatment with good achievements in clinical applications. These investigators examined the effect of Coblation-assisted arytenoidectomy (CSA) in the treatment of bilateral VCP (BVCP). All patients had undergone pre-operative electro-laryngoscopic examination of the glottidis rima; electronic laryngoscopy can assess the width of the glottis. The purpose of pre-operative electronic laryngoscopic evaluation was to examine the width of the glottis, and arytenoid cartilage movement. Unilateral arytenoid cartilage and a section of the vocal cords were removed in all cases. Of the 14 patients, 13 were successfully extubated after CSA; 1 patient could not be extubated and underwent a 2nd CSA of the contralateral arytenoid cartilage, after which extubation was achieved. All patients were continuously followed-up (6 months to 2 years), and all achieved satisfactory results. The authors concluded that CSA could effectively relieve post-CSA dyspnea in patients with BVCP. More patients underwent tracheal cannula extubation after tracheotomy compared with other surgeries.
These researchers stated that Coblation is useful in the treatment of BVCP; however, it also has limitations. For example, the knife is more expensive; and all the supplies are disposable, putting it out of economic reach of some patients. However, the improvement in QOL associated with this technique, and better understanding of the advantages made it likely that more patients will choose this new technology. Currently, the patients with BVCP treated in the authors’ department are still few, the follow-up time is short, and there is a lack of comparison with traditional surgical methods; thus, large-scale studies and long-term follow-up are needed for the observation of long-term effectiveness. In the future, these investigators hope to carry out larger studies to confirm the value of Coblation in the treatment of BVCP.
In a retrospective study, Tan and colleagues (2022) reviewed their experience with endoscopic Coblation-assisted and partial arytenoidectomy (ECPA) in the treatment of idiopathic BVCP. This analysis included 33 infants (19 boys and 14 girls, aged 1 to 10 months) with idiopathic BVCP undergoing ECPA. The therapeutic process and outcomes (surgical success, swallowing function, and voice) were reviewed. The follow-up period was greater than 33 months. Among the 33 infants with idiopathic BVCP, surgery was successful in 29 cases (87.9 %) but failed in 4 cases (12.1 %); 21, 9, and 3 patients underwent right, left, and bilateral ECPA, with surgical success rates of 90.5 %, 100.0 %, and 33.3 %, respectively. Furthermore, 4 and 6 cases were combined with subglottic stenosis (SGS) and laryngomalacia, respectively. The surgical success rates of BVCP alone and BVCP+ other airway abnormalities were 95.6 % and 70.0 %, respectively. During the follow-up, 5 infants had slight difficulty swallowing, 12 infants had partial or complete recovery movement of at least 1 vocal cord with satisfactory voice outcome, and 5 infants had early granuloma formation, which disappeared spontaneously. The authors concluded that ECPA appeared to be a promising alternative to tracheostomy and initial management in infants with idiopathic BVCP who were free of other airway abnormalities.
Radiofrequency Coblation for the Treatment of Tracheal Tumors
Wang and colleagues (2023) stated that RF Coblation is a new method of electro-surgical intervention. Most recently, its use has been reported in the treatment of laryngo-tracheal pathology. However, studies on Coblation for tracheal tumors have not been reported. These researchers described a novel use of Coblation technology, in which a new type of airway-specific wand was employed to ablate tracheal benign or malignant tumors in 3 cases. The authors concluded that the results suggested the possibility of using Coblation in the treatment of tracheal tumors. However, these researchers stated that more studies with larger sample size and longer follow-up are needed to examine the use of RF Coblation in the treatment of tracheal tumors.
The authors stated that this case-series study had several drawbacks. First, this was an initial attempt to examine the use of Coblation in the treatment of tracheal tumors and only 3 cases were included. Second, due to the rarity of primary tracheal tumors, the 2 cases of benign tumors in this report were not representative of benign lesions typically observed in the trachea. Third, patients still needed to be followed due to the limitation of follow-up period.
Coblation Devices (e.g., Topaz Microdebrider) for the Treatment of Insertional Achilles Tendinopathy / Lateral Epicondylitis
Song et al (2022) stated that no conclusive evidence recommends a prior treatment for insertional Achilles tendinopathy (IAT). It is theorized that both percutaneous RF Coblation and extracorporeal shockwave therapy (ESWT) relieve pain within the insertion. However, no clinical evidence showed that either treatment promotes the regeneration of the tendon or if the combination of these 2 interventions would offer better function and less pain than one therapy. These researchers presented the study protocol for a RCT that will examine if ESWT would improve the effect of isolated percutaneous RF Coblation in patients with IAT. The study will allocate patients in a 1:1 ratio to 1 of 2 parallel groups. Patients with IAT who are not satisfied with the effect of conservative treatment will be screened. A minimum of 38 patients will be enrolled after deciding to participate in the trial on an informed basis. Then the intervention group and the control group perform radial ESWT and sham-ESWT, respectively at 6 months after percutaneous RF Coblation. The primary outcome will be the Victorian Institute of Sports Assessment Achilles (VISA-A) Score. Secondary outcome measures will be Foot and Ankle Outcome Score (FAOS) scale, VAS, Tegner Score, and MRI ultra-short echo time (UTE) T2* value. The assessments will occur in 6 months, 1 year, and 2 years, post-operatively. The differences between the 2 groups will be conducted as intention-to-treat (ITT) basis. These investigators aim to examine if RF Coblation associated with ESWT can provide more encouraging imaging findings as well as functional and clinical outcomes regarding the treatment of IAT comparing to the single RF Coblation treatment.
Velez et al (2022) noted that lateral epicondylitis is one of the most common causes of elbow pain. Most patients recover with conservative treatments; however, some patients require surgical intervention. There are 3 common procedures offered: open tenotomy, arthroscopic tenotomy, and percutaneous microtenotomy. In comparison, percutaneous microtenotomy has been proven as a less invasive procedure for the treatment of lateral epicondylitis. In a systematic review, these investigators examined the available evidence on the safety and effectiveness of using a microdebrider Coblation wand to treat lateral epicondylitis, and they compared its outcomes to open and arthroscopic tenotomy. These researchers carried out a literature search via PubMed Central, Google Scholar, EBSCO host, and Embase for studies that conducted percutaneous microtenotomy with a microdebrider Coblation wand to treat lateral epicondylitis. Studies were then screened to determine if they met inclusion and exclusion criteria and were reviewed for data analysis and potential risks of bias. A total of 27 articles were identified and 9 articles (8 studies) met the inclusion criteria. Small sample sizes in the studies and heterogeneity of the methodology limited the capacity to perform a meta-analysis. Percutaneous microtenotomy outcomes appeared to be favorable for reduced pain, increased grip strength, and improved functional outcomes, which were similar to outcomes reported with the other surgical techniques. There were no major AEs reported in the studies secondary to the use of the microdebrider coblation wand. Procedure time and return to daily activities were shorter for the microtenotomy group. The authors concluded that percutaneous microtenotomy performed with a microdebrider coblation appeared to be an effective treatment for lateral epicondylitis that provided similar outcomes to the surgical techniques with a lower rate of complications. Moreover, these researchers stated that future studies should collect data at multiple follow-up times from 2 weeks to 2 years post-treatment to evaluate better the overall outcomes of patients treated with the microdebrider Coblation wand versus the other available therapeutic options. Future investigations should gather more specific data from patients in regard to their return-to-work status. Furthermore, studies should compare return to activity between the percutaneous microtenotomy, open tenotomy, and arthroscopic tenotomy using standardized outcome measurement tools such as the DASH score.
The authors stated that this review had 2 main drawbacks. First, there were only 10 studies on percutaneous microtenotomy for the treatment of lateral epicondylitis that qualified for inclusion in this systematic review and the sample sizes in each of the studies were small. Thus, the meta-analysis lacked power due to the limited sample size. The meta-analysis was also affected by the heterogeneity in the control groups. Some of the studies did not provide sufficient data in their manuscripts, which limited the extent of the data analysis. Second, there was also a wide range of follow-up times reported by the studies. Some studies had their final follow-up 12 months post-procedure, while other studies had as low as 6 months or as high as 24 months. This variability in timeframe for collecting data limited the comparison of the different studies.
Viswanathan and Shanker (2022) stated that lateral epicondylitis is a common cause of elbow pain in the middle-aged group caused by tendinosis of the common extensor origin of the forearm muscles. although no obvious etiology is identified in most cases, it could be attributed to repetitive overuse of wrist extensors or supinator muscles. In a retrospective, case-series study, these researchers examined the effectiveness and recurrences in patients with lateral epicondylitis treated with RF microtenotomy (RFM). They presented long-term results with a mean 8-year follow-up in a case series of 19 patients. All patients had a minimum of 6 months (mean of 23.25 months and range of 6 to 36 months) of conservative management that included steroid injections before being offered RFM. This was a trial of 20 elbows (in 19 patients) who underwent RFM; the majority of patients (65 %) were females. The operation was performed in the dominant arm in 55 % of patients. Results were analyzed by comparing pre-operative and post-operative QuickDASH scores (Disabilities of the Arm, Shoulder and Hand Score) obtained at 1 year and 8 years post-operatively. These investigators found an improvement in QuickDASH scores from a mean of 61.7 pre-operatively to 18.9 (p < 0.0001) and 8.5 (p < 0.0001) at 1 year and 8 years, respectively. The mean pain component of the QuickDASH scores decreased from 4.8 to 2.0 and 1.5, respectively, at 1 year and 8 years (p < 0.0001). More than 83 % of the patients had excellent-to-good functional improvement. The authors concluded that RFM was a reliable modality for the treatment of recalcitrant lateral epicondylitis of the elbow with excellent long-term results. Moreover, these researchers noted that the main drawbacks of this trial were its retrospective design and a relatively small sample size (n = 19). They stated that further prospective studies involving a larger number of patients are needed to examine the effectiveness of this treatment.
Radiofrequency Coblation-Assisted Transoral Surgery for the Treatment of Oropharyngeal Squamous Cell Carcinoma, and Supraglottic Laryngeal Carcinoma
In a retrospective study, Guan et al (2022) examined the feasibility and effectiveness of radiofrequency Coblation (RFC)-assisted transoral surgery for the treatment of supraglottic laryngeal carcinoma by comparing with concurrent patients treated with conventional transcervical approach. A total of 46 patients with supraglottic laryngeal carcinoma treated in department of otorhinolaryngology head and neck surgery, Peking University First Hospital from March 2014 to January 2021 were analyzed. Among them (43 men, 3 women, age of 45 to 79 years), 23 patients were treated with RFC and 23 patients with partial laryngectomy with conventional transcervical approach. The operation time, intra-operative blood loss volume, recovery time, inpatient total medical cost and follow-up information of the 2 groups were analyzed. SPSS 26.0 software was used for statistical analysis. There were no significant differences in age, gender, TNM staging, tumor staging and post-operative radiotherapy between the 2 groups (all p > 0.05). The operation time, intra-operative blood loss volume, recovery time, inpatient total medical cost of the RFC-TOS group were 110.0 (60.0 to 150.0) mins, 5.0 (5.0 to 30.0) ml, 3.0(2.0 to 5.0) days, 6.0 (4.0 to 14.0) days and 26,100.7 (16,145.5 to 47,044.4) yuan. The data of conventional transcervical approach group were 205.0 (156.5 to 272.3) mins, 150.0 (50 to 200) ml, 18.0 (16.3 to 22.8) days and 56,520.1 (40,992.5 to 67,109.9) yuan, (Z= -4.03, -4.94 to -4.97, -4.98 and -4.13; all p < 0.001). The 5-year local control (LC) rate, disease-specific survival (DSS) rate and overall survival (OS) rate of the 2 groups were 86.96 %, 95.65 %, 91.30 % and 86.96 %,91.30% ,73.90 %, respectively, which had no significant difference between the 2 groups (all p > 0.05). The authors concluded that compared with conventional transcervical surgeries, RFC-TOS could be a reliable new surgical option for organ-function preservation strategy in the treatment of supraglottic laryngeal carcinoma. The RFC is a suitable new technique and deserving more multi-center clinical trials for its clinical promotion.
Zhao and Li (2022) noted that transoral supraglottic laryngectomy (TSL) has been widely used in the treatment of supraglottic cancers. These researchers examined a simplified technique for excising properly selected supraglottic tumors with a transoral Coblation-assisted system. A total of 8 patients with T1-3N2M0 supraglottic cancer were treated with TSL with the Coblation-assisted system. Tumors in all patients were en bloc resected with negative surgical margins and the selective neck dissection was also carried out. The mean operation time for TSL was 39 mins (range of 25 to 65 mins). The average time for the removal of the nasogastric tube was 8.6 days (range of 1 to 28 days). All patients were extubated and shifted to the ward following operation; and none of the patients required tracheotomy. The authors concluded that TSL for early supraglottic carcinoma is a new trend. In this trial, these investigators reported their preliminary experience with Coblation-assisted TSL, which is relatively simple and easy to perform with a low risk. It could be a feasible and safe procedure for patients with properly selected supraglottic cancer. These preliminary findings need to be validated by well-designed studies.
Du et al (2023) noted that RFC is a relatively new method that has opened up new perspectives in treating oropharyngeal squamous cell carcinoma (OPSCC). In a retrospective, comparative study, these researchers examined the feasibility and effectiveness of RFC-assisted transoral surgery (RFC-TOS) for primary OPSCC. A total of 69 cases of OPSCC from February 2005 to November 2020 were analyzed, including 31 in the RFC-TOS group and 38 in the open surgery group. No difference was observed in demographic and oncological characteristics. The significance between the RFC-TOS group and the open surgery group was proved in intra-operative bleeding volume (34.10 ± 10.10 ml versus 193.68 ± 21.00 ml, p < 0.001), durations of surgery (79.58 ± 8.45 mins versus 217.87 ± 17.65 mins, p < 0.001), time to resume oral feeding (1.64 ± 0.41 days versus 11.58 ± 1.41 days, p < 0.001), duration of hospitalization (7.84 ± 0.66 days versus 15.66 ± 1.62 days, p < 0.001), and the total costs (22,846.22 ± 1,821.55¥ versus 41,792.24 ± 4,150.86¥, p < 0.001). The rates of 5-year OS, 5-year DSS, and 5-year LC rate were 69.1 %, 71.7 %, and 75.7 %, respectively, in the RFC-TOS group and 71.0 %, 73.4 %, and 73.7 % in the open surgery group (p > 0.05). The authors concluded that RFC-TOS was a feasible alternative transoral approach for OPSCC. The reported peri-operative and oncologic outcomes were satisfactory.
The authors stated that this study had several drawbacks. First, this trial was designed to examine the feasibility and oncological prognosis of RFC-TOS for OPSCC as a retrospective study; thus, it was not planned as a blinded and controlled clinical trial, which might decrease the power of this investigation. Second, data were collected from 2 different medical centers, which could have an impact on the comparison of peri-operative and oncological results. Third, the comparison of RFC-TOS directly with transoral laser microsurgery or TORS, instead of open surgery, could be more illustrative, which is the direction of these researchers’ future investigation.
Furthermore, National Comprehensive Cancer Network’s clinical practice guideline on “Head and Neck Cancers” (Version 1.2023) does not mention radiofrequency Coblation as a management option.
Radiofrequency Coblation With and Without Gastrocnemius Release for the Treatment of Plantar Fasciitis
Yuan et al (2020) stated that heel pain is one of the most common complaints in foot and ankle clinic, and one of the leading causes of heel pain is plantar fasciitis (PF). In a retrospective analysis, these researchers compared the therapeutic outcomes between open plantar fascia release and percutaneous RF ablation (RFA) in the treatment of intractable PF (31 cases, 39 feet). In the enrolled 26 cases, 16 patients (19 feet) received open plantar fascia release, and the other 15 patients (20 feet) received percutaneous RFA. The surgical results were assessed by VAS and American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AH) before and after surgery in all patients. All 31 patients were followed-up successfully, with a mean follow-up time of 58.77 months. There were no differences of patient's demographics and characteristics information between the 2 groups. The average operative time of the feet in the open plantar fascia release was longer than that in the percutaneous RFA. In addition, the percutaneous RFA group had a shorter recovery time to normal activity than the open plantar fascia release group. There were no differences of post-operative VAS scores and the AOFAS-AH scores between the 2 groups. All patients reported satisfaction following either operation. The authors concluded that the observations made in this trial suggested that the treatment of plantar fasciitis with plantar fascia lysis or percutaneous RFA was equally effective; however, percutaneous RFA was a better technique from the point of shorter operative time and post-operative recovery time.
The authors stated that with the design limitation of a retrospective study, these findings could be affected by various factors (e.g., selection bias, small sample size, and lack of long-term follow-up period) compared with randomized clinical trials. On the other hand, small sample size was common in many of the available reports. Percutaneous RFA is a new technique of intractable plantar aponeurositis. These researchers believed that the findings of this study will be helpful for relevant design of prospective studies in the future. Compared with conservative treatments such as ESWT, these 2 surgeries are invasive ways to treat intractable plantar aponeurositis, which meant these techniques will only be used when conservative treatments showed limited effects.
Koh et al (2022) stated that PF is the most common cause of plantar heel pain. Although most are self-limiting, recalcitrant conditions could be debilitating, significantly reducing patient's QOL. Various surgical procedures are available for the treatment of recalcitrant PF (RPF) with little consensus on best practice. In a retrospective, cohort comparative study, these researchers examined the effectiveness of RFC with and without gastrocnemius release on the surgical management of RPF. Between June 2013 and June 2019, a total of 128 patients with RPF and tight gastrocnemius were treated surgically. Presence of tight gastrocnemius was assessed clinically by a positive Silfverskiold test. Group A (n = 73) consisted of patients who underwent RF Coblation alone; group B (n = 55) consisted of patients who underwent RF Coblation and endoscopic gastrocnemius release. The primary outcome measure was VAS score. Secondary outcome measures included AOFAS hindfoot score; physical (PCS) and mental component summaries (MCS) of the 36-Item Short Form Health Survey; overall assessment of improvement, expectation fulfilment, and satisfaction; as well as complication rates. Both groups reported significant improvement in VAS, AOFAS, and PCS scores post-operatively at 6 and 24 months. Group B (RF Coblation with gastrocnemius release) was associated with better VAS at both 6 months (3.0 ± 2.9 versus 1.7 ± 2.6, p < 0.05) and 24 months post-operatively (1.9 ± 3.1 versus 0.8 ± 2.0, p < 0.05) compared with group A (RF Coblation without gastrocnemius release). At 24 months post-operatively, no differences were found in AOFAS, PCS, MCS scores, expectation fulfilment, or overall satisfaction. No wound complications were reported in either group; 1 patient (group B) has persistent symptoms consistent with tarsal tunnel syndrome. The authors concluded that treatment of RPF with RF Coblation alone was associated with slightly inferior results than RF Coblation combined with endoscopic gastrocnemius release in terms of pain relief without an increase in complication rates. However, at 2 years, these researchers did not find a significant difference in other measures of outcome. Level of Evidence = III.
Coblation Nucleoplasty for Cervical Discogenic Dizziness
Li et al (2019) noted that surgical treatment of cervical vertigo has been rarely reported. In a retrospective study, these researchers examined the clinical outcomes of percutaneous disc decompression with coblation nucleoplasty (PDCN) for treatment of cervical vertigo. A total of 74 consecutive patients with cervical vertigo underwent PDCN and were followed for at least 1 year. Outcome measures included the dizziness intensity VAS, dizziness frequency, the Dizziness Handicap Inventory (DHI), and neck pain intensity. Clinical efficacy was assessed by rating scale and the modified MacNab evaluation criteria. Surgical complications during the operation and follow-up were also recorded. The vertigo VAS score, frequency of dizziness, DHI, and neck pain intensity were all decreased significantly from evaluation before surgery to 1 week after surgery and to the last follow-up, giving a mean effective rate of 94.6 % 1 week after surgery, and 90.6 % at the last follow-up. Good-to-excellent results were attained in 85.1 % of these patients 1 week after PDCN, and in 75.7 % of the sufferers at the last follow-up (p < 0.001). There were 5 patients with transient adverse effects (6.25 %) reported within the 1st month after surgery; they all recovered after conservative treatment. No neurological complications were found and no patient went on to spinal fusion surgery thereafter. The authors concluded that the clinical outcomes of PDCN for cervical vertigo were satisfactory in both the early and late post-operative period. These investigators stated that PDCN was an effective, low-complication, minimally invasive procedure used to treat cervical vertigo. Moreover, they stated that further prospective RCTs are needed to verify this conclusion. These researchers stated that the drawbacks of this trial included the rate of follow-up was 70 % and a placebo effect could not be excluded. Additionally, there was no gold standard for the diagnosis and treatment of cervical vertigo.
Li et al (2023) stated that there is limited evidence on comparing the effectiveness of coblation nucleoplasty with conservative interventions in the treatment of cervical discogenic dizziness; and on reports of the achieved rate of minimal clinically important differences (MCID) and patient acceptable symptom state (PASS) following surgery. In a retrospective study, these researchers examined the patient-reported outcome measures (PROM) following coblation nucleoplasty for cervical discogenic dizziness and compared the therapeutic effect of coblation nucleoplasty with prolonged conservative therapy. A total of 61 patients with cervical discogenic dizziness and a positive intra-discal diagnostic test eligible for single-level cervical coblation nucleoplasty were included in this trial. Among these 61 patients, 40 patients underwent cervical coblation nucleoplasty, while the remaining 21 patients refused surgery, and received continued conservative treatment. The primary PROMs were the intensity and frequency of dizziness and secondary PROMs were related to the NDI and VAS for neck pain (VAS-neck) during a 12-month follow-up period. Moreover, the achieved rate of MCID and PASS in both groups was assessed 12 months following surgery. Dizziness intensity, dizziness frequency, VAS-neck score, and NDI score were significantly improved from the baseline at all follow-up time-points in both treatment groups, except for showing no significant improvement in dizziness frequency in the conservative treatment group at 6 and 12 months after surgery. However, at each follow-up time-point, the afore-mentioned indexes were lower in the surgery group than in the conservative treatment group. Furthermore, the achieved rates for PASS and MCID in all indexes in the surgery group were significantly higher than those in the conservative treatment group at 12 months after surgery. The authors concluded that cervical coblation nucleoplasty significantly improved the intensity and frequency of dizziness, neck pain, and NDI in patients with cervical discogenic dizziness, and the results were superior to those from prolonged conservative treatment. These investigators stated that the findings of this study suggested that intervertebral disc degeneration alone, without cervical spinal cord and/or nerve root compression, can cause cervical discogenic dizziness and pain; therefore, a cervical intra-discal diagnostic test can provide support for the diagnosis of cervical discogenic dizziness; and cervical coblation nucleoplasty is a good choice for patients with chronic neck pain and refractory cervical discogenic dizziness who have not demonstrated the indications for open surgery and have not responded well to conservative treatment. Moreover, these researchers stated that further prospective RCTs are needed to better ascertain the outcome of coblation nucleoplasty surgery for the treatment of cervical discogenic dizziness and neck pain.
The authors stated that this trial had several drawbacks. First, because the exact pathogenesis of cervical discogenic dizziness is still unclear, the diagnostic criteria are mainly in terms of exclusivity; thus, further studies are needed to examine in detail the validity and sensitivity of the proposed diagnostic criteria for cervical discogenic dizziness and the cervical intra-discal diagnostic test Second, although the use of a cervical brace as a conservative treatment for cervical discogenic dizziness is not an up-to-date treatment strategy, the immobilization provided by a cervical brace can aid in improving neck pain; therefore, helping to further reduce dizziness. In the conservative treatment group, these investigators employed a temporary cervical collar fixation, while in the surgical group, they used a conventional cervical brace for protection for 2 weeks after surgery. These differences may interfere with the comparison of results between the 2 groups. Third, this trial only completed 1 year of follow-up, and further follow-up is needed to examine long-term effects. Fourth, this study was a retrospective review of prospective data collection, and selection bias may be present.
Radiofrequency Coblation for Arthroscopic Shoulder Surgery
Vij et al (2023) noted that RF has seen an increase in use in orthopedics including cartilage lesion debridement in the hip and knee as well as many applications in arthroscopic shoulder surgery. In a systematic review, these investigators examined the safety and usage of RF in the shoulder. This systematic review followed the preferred reporting items for systematic review and meta-analysis protocols (PRISMA) guidelines. Embase and PubMed were searched using: "shoulder", "rotator cuff", "biceps", "acromion" AND "monopolar", "bipolar", "ablation", "coblation", and "radiofrequency ablation". The title and abstract review were performed independently. Any discrepancies were addressed via open discussion. A total of 63 studies were included. RF is currently used in impingement syndrome, fracture fixation, instability, nerve injury, adhesive capsulitis, post-operative stiffness, and rotator cuff disease; and AEs, namely superficial burns, are limited to case reports and case series, with higher-level evidence demonstrating safe use when used below the temperature threshold. Bi-polar RF may decrease operative time and decrease the cost per case. The authors concluded that shoulder RF has a wide scope of application in various shoulder pathologies. Shoulder RF was safe; however, requires practitioners to be cognizant of the potential for thermal burn injuries. Bi-polar RF may represent a more effective and economic treatment modality. Safety precautions have been executed by institutions to reduce patient complications from shoulder RF. Moreover, these researchers stated that further investigation is needed to determine what measures can be taken to further minimize the risk of thermal burns. Level of Evidence = IV.
The authors stated that this systematic review had 2 main drawbacks. First, as a systematic review of Level I to Level IV evidence, the findings were limited to Level IV. Due to heterogeneous data reporting, this is a comprehensive summary of all studies delineating the use of RF in the shoulder as defined by the inclusion and exclusion criteria; however, many of the studies included were limited by unspecified use of RF. Second, this review was unable to comment on the clinical outcomes of RF based on the inclusion criteria regarding temperature profile and safety/complications of shoulder RF. The results pertaining to safety and complication were based on a limited subset of select articles; therefore, the findings of this systematic review may be limited by selection bias.
Coblation for the Treatment of MRSA Infection in Wounds with Shrapnel
Gil et al (2024) stated that debridement plays an important role in wound management. In addition to removing necrotic tissue, debridement can eliminate bacteria often harbored within the tissue. These researchers examined a novel debridement method that employed plasma-based RF technology to remove tissue and bacteria. Coblation is a technology that uses RF energy to excite the electrolytes in a conductive medium, such as saline, to create a precisely focused plasma. This plasma field contains highly energized particles that possess sufficient energy to break tissue molecular bonds, causing the tissue to dissolve at relatively low temperatures (typically 40 °C to 70 °C). A total of 18 deep dermal wounds measuring 22 mm × 22 mm × 3 mm deep were created on pigs. Wounds were inoculated with methicillin-resistant Staphylococcus aureus USA300 (MRSA USA300) in combination with shrapnel and then covered with a polyurethane dressing for 24 hours. Wounds were then randomly assigned to 1 of the 3 treatment groups: Coblation, surgical debridement, and no debridement. Wounds were biopsied on days 0, 5, 9, and 12, and specimens were processed for MRSA counts using selective media. Statistical analysis was carried out using IBM SPSS statistics 27 using 1-way ANOVA. Comparison between Coblation and surgical debridement demonstrated a decrease in bacterial count in all assessment times. The lowest bacterial count in all assessment times was observed in wounds debrided with Coblation showing a statistically significant (p ≤ 0.05) decrease in more than 2 Log CFU/g on days 0, 5, and 9 compared to no debridement. On day 12, Coblation-debrided wounds exhibited 6.10 ± 0.22 Log CFU/g, and this value represents 99.99 % of reduction compared with non-debrided wounds (p ≤ 0.05). More than 96 % of reduction (p ≤ 0.05) resulted in wounds treated with Coblation compared with surgically debrided. The authors concluded that reduction of MRSA bacterial infection counts, especially of biofilm-associated organisms, in combination with shrapnel may have important clinical implications, especially for the military personnel. Moreover, these researchers stated that further investigations are needed to examine the use of Coblation in wound management.
Endoscopic Transcanal Coblation Excision for the Treatment of Glomus Tympanicum
In a retrospective study, Salem et al (2024) examined the feasibility of Coblation in excision of glomus tympanicum tumors. This trial included 28 patients with types I and II glomus tympanicum tumors according to GLASSCOCK-JACKSON classification. Pre-operative radiological and endocrinal evaluation were carried out. All participants underwent endoscopic transcanal excision of their glomus tympanicum tumors using Coblation. None of the subjects developed recurrence during the 1-year follow-up period proved radiologically; and no participant developed facial palsy post-operatively. Differences between pre-operative and post-operative dizziness and taste disturbance were statistically non-significant. Tinnitus disappeared completely in 22 patients post-operatively. A statistically significant reduction in Tinnitus Handicap Inventory (THI) following surgery was found. Statistically significant reductions in post-operative air conduction (AC) threshold and air bone gap (ABG) were recorded while bone conduction (BC) threshold revealed statistically non-significant change. The authors concluded that Coblation was a safe and effective tool in excision of glomus tympanicum tumors. Moreover, these researchers stated that further investigations comparing Coblation with laser and piezo-surgery are strongly recommended in the management of glomus tympanicum tumors. Furthermore, these investigators recommend additional studies with long follow-up duration and larger sample size. The authors stated that the main drawbacks of this trial were the short-term follow-up period (1 year) and the small number of the study population (n = 28).
Surgical Excision with Coblation for the Treatment of Inflammatory Myofibroblastic Tumor of the Larynx
Sivesind et al (2023) noted that inflammatory myofibroblastic tumor (IMT) is a rare tumor composed of mesenchymal myofibroblastic spindle cells enveloped by an inflammatory infiltrate. Historically, this tumor sparked debate regarding whether it was a true malignancy with metastatic potential or merely a locally destructive physiologic inflammatory response. Few reports of IMT exist in the recent literature, with the majority of cases occurring in the pediatric population and favoring the lungs. Thes investigators presented an exceedingly rare case of IMT involving the larynx of a 22-year-old woman. A hemorrhagic and solid mass of the right true membranous vocal fold was excised and sent for histopathological assessment. Features of the surgical specimens were diagnostic for IMT. Intralesional steroid therapy was employed for additional treatment. Pan-endoscopy facilitated surveillance for any additional or recurrent lesions, of which there were none. At 11 months post-excision, follow-up MRI showed symmetric vocal cords without evidence of any masses. The authors concluded that although rare, laryngeal IMT should be considered in any patient presenting with hoarseness due to a vocal fold mass. Based on the successful treatment of this patient, these investigators suggested that their approach of surgical excision followed by intralesional corticosteroid injection may be an effective approach for this rare tumor. Moreover, these researchers stated that further investigations are needed to ascertain the most effective, safe, and cost-effective therapeutic approach.
Kasliwal et al (2024) stated that IMT of larynx is a rare and an unexplored area. Although benign, it has capabilities to transform into malignancy and also has a very high recurrence rate. These researchers shed light on treatment modality for IMT of the supraglottis. The authors concluded that, per their experience, wide excision of the tumor with coblation is not an ideal treatment; and further investigations are needed to determine better and effective treatment for this tumor.
Furthermore, an UpToDate review on “Uncommon sarcoma subtypes” (Schuetze and Jones, 2025) states that “Inflammatory myofibroblastic tumor (ІMΤ) is a very rare mesenchymal neoplasm that tends to occur in children and young adults, with a mean age of 9 to 10 years. However, patients can present at any age, from newborn infants to over the age of 70 years. Its incidence in children is significant, representing 20 % of all primary lung tumors in this age group …. Patients with localized ΙΜΤ are initially treated with complete surgical resection as the standard of care. Patients with locally recurrent disease may be offered re-resection, depending on the anatomic location and the tempo of disease. There are limited data to support the use of radiation or systemic chemotherapy”. Coblation is not mentioned as a therapeutic option.
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