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Clinical Policy Bulletin:
Coblation Non-thermal Volumetric Tissue Reduction
Number: 0475


Policy

  1. Aetna considers Coblation tonsillectomy medical necessary for the treatment of any of the following:

    1. Peri-tonsillar abscess; or
    2. Recurrent middle ear infection where tonsillar hypertrophy is believed to be an exacerbating factor; or
    3. Recurrent or chronic tonsillar infection; or
    4. Tonsillar hypertrophy leading to respiratory symptoms or airway obstruction.
  2. Aetna considers Coblation non-thermal volumetric tissue reduction experimental and investigational for removing soft tissue during arthroscopic surgery because the peer-reviewed medical literature does not support the clinical value of this approach.

  3. Aetna considers Coblation devices (e.g., Topaz Microdebrider) experimental and investigational for the treatment of musculoskeletal conditions because their effectiveness for these conditions has not been established in the peer-reviewed literature.

  4. For Coblation non-thermal volumetric tissue reduction for treatment of hypertrophy of nasal turbinates, see CPB 0592 - Radiofrequency Ablation of Hypertrophied Nasal Turbinates.

  5. For Coblation (Nucleoplasty) for treatment of herniated discs, see CPB 0602 - Thermal Intradiscal Procedures.

  6. Aetna considers Coblation non-thermal volumetric tissue reduction experimental and investigational for all other indications (e.g., dysphagia, laryngo-tracheal papillomatosis, nasopharyngeal angiofibroma, spinal osteoid osteomas, and wound debridement) due to insufficient evidence in the peer-reviewed literature.



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.

A review by the National Institute for Clinical Excellence (NICE, 2003) recommended Coblation tonsillectomy for the following indications: (i) recurrent or chronic tonsillar infection, (ii) tonsillar hypertrophy leading to respiratory symptoms or airway obstruction, (iii) peri-tonsillar abscess, and (iv) recurrent middle ear infection where tonsillar hypertrophy is believed to be an exacerbating factor.  Subsequent guidance from NICE (2005) concluded that "[c]urrent evidence on the safety and efficacy of electrosurgery (diathermy and coblation) for tonsillectomy appears adequate to support the use of these techniques, provided that normal arrangements are in place for consent, audity, and clinical governance."

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."

Freeman and Mehdian (2008) evaluated the evidence for 3 minimally invasive methods in the treatment of discogenic low back pain (LBP) and radicular pain: (i) intra-discal electrothermal therapy (IDET), (ii) percutaneous discectomy, and (iii) 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.  Two randomized controlled trials (RCTs) assessed the effectiveness of IDET; 1 demonstrated a positive effect on pain severity only, whereas the other demonstrated no substantial benefit.  Other RCTs showed that percutaneous intra-discal RF thermocoagulation is ineffective for the treatment of discogenic LBP.  Trials of automated percutaneous discectomy suggested that clinical outcomes after treatment are at best fair and often worse when compared with microdiscectomy.  There are no published RCTs assessing Coblation (ArthroCare Spine, Stockholm, Sweden) technology.

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.

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 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 appears 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.

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.

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.

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.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
There are no specific codes for coblation non-thermal volumetric tissue reduction:
Other CPT codes related to the CPB:
29800 - 29999
31254 - 31288
42820 - 42826
ICD-9 codes covered if selection criteria are met:
463 Acute tonsillitis
474.00 Chronic tonsillitis
474.11 Hypertrophy of tonsils
475 Peritonsillar abscess
ICD-9 codes not covered for indications listed in the CPB (not all inclusive):
210.7 Benign neoplasm of nasopharynx
212.1 Benign neoplasm of respiratory and intrathoracic organs [papillomatosis of larynx]
212.2 Benign neoplasm of respiratory and intrathoracic organs [papillomatosis of trachea]
213.2 Benign neoplasm of vertebral column, excluding sacrum and coccyx [spinal osteoid osteomas]
478.0 Hypertrophy of nasal turbinates
707.00 - 707.9 Chronic ulcer of skin
710.0 - 739.9 Diseases of the musculoskeletal system and connective tissue
787.20 - 787.29 Dysphagia
870.0 - 897.7 Open wound of head, neck, trunk and limbs
940.0 - 949.5 Burns
Other ICD-9 codes related to the CPB:
381.00 - 381.4, 382.00 - 382.9 Otitis media
496 Chronic airway obstruction, not elsewhere classified


The above policy is based on the following references:
  1. Sherk HH, Black JD, Prodoehl JA, et al. The effects of lasers and electrosurgical devices on human meniscal tissue. Clin Orthop. 1995;310:14-20.
  2. Kramer J, Rosenthal A, Moraldo M, et al. Electrosurgery in arthroscopy. Arthroscopy. 1992;8(1):125-129.
  3. Hainer BL. Fundamentals of electrosurgery. J Am Board Fam Pract. 1991;4(6):419-426.
  4. ArthroCare Corporation. Coblation [website]. Sunnyvale, CA: Arthrocare; 1999. Available at: http://www.arthrocare.com/. Accessed June 15, 1999.
  5. Bortnick DP; Plastic Surgery Educational Foundation DATA Committee. Coblation: An emerging technology and new technique for soft-tissue surgery. Plast Reconstr Surg. 2001;107(2):614-615.
  6. Alberta Heritage Foundation for Medical Research (AHFMR). RF tonsillar ablation. Emerging Technology Report. Edmonton, AB: AHFMR; 2000.
  7. Timms MS, Temple RH. Coblation tonsillectomy: A double blind randomized controlled study. J Laryngol Otol. 2002;116(6):450-452.
  8. National Institute for Clinical Excellence (NICE). Coblation tonsillectomy. Interventional Procedure Guidance 9. London, UK: NICE; September 2003. Available at: http://www.nice.org.uk/pdf/ip/IPG009guidance.pdf. Accessed July 2, 2004.
  9. Belloso A, Chidambaram A, Morar P, Timms MS. Coblation tonsillectomy versus dissection tonsillectomy: Postoperative hemorrhage. Laryngoscope. 2003;113(11):2010-2013.
  10. Arya A, Donne AJ, Nigam A. Double-blind randomized controlled study of coblation tonsillotomy versus coblation tonsillectomy on postoperative pain. Clin Otolaryngol. 2003;28(6):503-506.
  11. Stoker KE, Don DM, Kang DR, et al. Pediatric total tonsillectomy using coblation compared to conventional electrosurgery: A prospective, controlled single-blind study. Otolaryngol Head Neck Surg. 2004;130(6):666-675.
  12. Friedman M, Ibrahim H, Lowenthal S, et al. Uvulopalatoplasty (UP2): A modified technique for selected patients. Laryngoscope. 2004;114(3):441-449.
  13. Tasto JP, Cummings J, Medlock V, et al. Microtenotomy using a radiofrequency probe to treat lateral epicondylitis. Arthroscopy. 2005;21(7):851-860.
  14. Parsons SP, Cordes SR, Comer B. Comparison of posttonsillectomy pain using the ultrasonic scalpel, coblator, and electrocautery. Otolaryngol Head Neck Surg. 2006;134(1):106-113.
  15. Chan KH, Friedman NR, Allen GC, et al. Randomized, controlled, multisite study of intracapsular tonsillectomy using low-temperature plasma excision. Arch Otolaryngol Head Neck Surg. 2004;130:1303-1307.
  16. Chang KW. Randomized controlled trial of Coblation versus electrocautery tonsillectomy. 2005:132(2):273-280.
  17. Temple RH, Timms MS. Paediatric Coblation tonsillectomy. Int J Pediatr Otorhinolaryngol. 2001:61:195-198.
  18. Grimmer JF, Mulliken JB, Burrows PE, Rahbar R. Radiofrequency ablation of microcystic lymphatic malformation in the oral cavity. Arch Otolaryngol Head Neck Surg. 2006;132(11):1251-1256.
  19. National Institute for Health and Clinical Excellence (NICE). Electrosurgery (diathermy and coblation) for tonsillectomy. Interventional Procedure Guidance 150. London, UK: NICE; December 2005. Available at: http://guidance.nice.org.uk/IPG150. Accessed July 17, 2007.
  20. Scott A. Hot techniques for tonsillectomy. Issues in Emerging Health Technologies. Issue 93. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); 2006.
  21. Timms MS, Bruce IA, Patel NK. Radiofrequency ablation (coblation): A promising new technique for laryngeal papillomata. J Laryngol Otol. 2007;121(1):28-30.
  22. Burton MJ, Doree C. Coblation versus other surgical techniques for tonsillectomy. Cochrane Database Syst Rev. 2007;(3):CD004619.
  23. Carney AS, Timms MS, Marnane CN, et al. Radiofrequency coblation for the resection of head and neck malignancies. Otolaryngol Head Neck Surg. 2008;138(1):81-85.
  24. Xie X, Dendukuri N, McGregor M. Comparison of coblation tonsillectomy and electrocautery tonsillectomy in pediatric patients. Report No. 34. Montreal, QC: Technology Assessment Unit of the McGill University Health Centre (MUHC); November 12, 2008.
  25. Freeman BJ, Mehdian R. Intradiscal electrothermal therapy, percutaneous discectomy, and nucleoplasty: What is the current evidence? Curr Pain Headache Rep. 2008;12(1):14-21.
  26. Chou R, Atlas SJ, Stanos SP, Rosenquist RW. Nonsurgical interventional therapies for low back pain: A review of the evidence for an American Pain Society clinical practice guideline. Spine. 2009;34(10):1078-1093.
  27. Yeap EJ, Chong KW, Yeo W, Rikhraj IS. Radiofrequency coblation for chronic foot and ankle tendinosis. J Orthop Surg (Hong Kong). 2009;17(3):325-330.
  28. Gallagher TQ, Wilcox L, McGuire E, Derkay CS. Analyzing factors associated with major complications after adenotonsillectomy in 4776 patients: Comparing three tonsillectomy techniques. Otolaryngol Head Neck Surg. 2010;142(6):886-892.
  29. Sean NY, Singh I, Wai CK. Radiofrequency microtenotomy for the treatment of plantar fasciitis shows good early results. Foot Ankle Surg. 2010;16(4):174-177.
  30. Carney AS, Evans AS, Mirza S, Psaltis A. Radiofrequency coblation for treatment of advanced laryngotracheal recurrent respiratory papillomatosis. J Laryngol Otol. 2010;124(5):510-514.
  31. Mowry SE, Ament M, Shapiro NL. Lingual tonsil hypertrophy causing severe dysphagia: Treatment with plasma-mediated radiofrequency-based ablation (Coblation). Ear Nose Throat J. 2010;89(3):134-136.
  32. Rachmanidou A, Modayil PC. Coblation resection of paediatric laryngeal papilloma. J Laryngol Otol. 2011;125(8):873-876.
  33. Dasenbrock HH, Gandhi D, Kathuria S. Percutaneous plasma mediated radiofrequency ablation of spinal osteoid osteomas. J Neurointerv Surg. 2012;4(3):226-228.
  34. Trial C, Brancati A, Marnet O, Teot L. Coblation technology for surgical wound debridement: Principle, experimental data, and technical data. Int J Low Extrem Wounds. 2012;11(4):286-292.
  35. Pierson B, Powitzky R, Digoy GP. Endoscopic Coblation for the treatment of advanced juvenile nasopharyngeal angiofibroma. Ear Nose Throat J. 2012;91(10):432, 434, 436, 438.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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