Aetna considers radiofrequency ablation (RFA) medically necessary for the following indications:
As an alternative to surgical (cold knife) resection for debulking of primary and metastatic malignant neoplasms
Removal of primary or metastatic malignant neoplasms, when removal of the neoplasm may be curative, and the member is unable to tolerate surgical resection
Treatment of distant metastases of medullary thyroid carcinoma
Treatment of metastatic gastro-intestinal stromal tumors (GIST) with limited progression
Treatment of osteoid osteoma, as a less invasive alternative to surgical resection of the tumor
Treatmnt of soft tissue sarcoma of the trunk or extremities in symptomatic persons with disseminated metastases.
Aetna considers RFA experimental and investigational for all other indications including the following because its effectiveness for indications other than the ones listed above has not been established:
Curative treatment of primary or metastatic malignant neoplasms (e.g., breast cancer, chondroblastoma, gallbladder cancer, kidney cancer including renal angiomyolipoma, lung cancer, and pancreatic cancer; not an all- inclusive list) in persons who are able to tolerate surgical resection
Radiofrequency ablation (RFA) involves percutaneous or intra-operative insertion of an electrode into a lesion under ultrasonic guidance. Radiofrequency energy is emitted through the electrode and generates heat, leading to coagulative necrosis.
Osteoid osteoma is a benign neoplasm most often seen in young males. Most osteoid osteomas are found in the first 3 decades of life, but an occasional lesion in an older patient has been reported. Almost any bone can be involved. The typical patient has pain that is worse at night and relieved by aspirin. When the growth is near a joint, swelling, stiffness, and contracture may occur. When in a vertebra, scoliosis may occur. In children, over-growth and angular deformities may occur. Routine roentgenograms are often diagnostic, but bone scans or computed tomographies commonly are required to accurately localize the lesion. To effect a cure the entire nidus must be removed. The standard method of removal is surgical resection. Recurrence after apparently complete excision has been reported but is rare.
Percutaneous RF thermal ablation has been used as a less invasive alternative to surgical resection of osteoid osteoma. The primary advantage of percutaneous RF thermal ablation is a reduction in the need for post-operative hospitalization and a reduced duration of convalescence.
Several studies have been published reporting successful removal of osteoid osteoma using percutaneous RFA. Rosenthal et al (1998) compared percutaneous RFA with standard resection in 87 patients who were treated with operative excision and 38 patients who were treated with percutaneous RFA. The former group did not require post-operative hospitalization (average of 0.2 days), whereas the latter group required an average of about 5 days of post-operative hospitalization. The rates of recurrence between the 2 treatments were approximately the same. The rate of pain relief, as measured by questionnaire, was also similar between the 2 groups. An assessment conducted for the National Institute for Clinical Excellence (2004) concluded that the evidence supporting percutaneous RFA of osteoid osteoma appears adequate to support its use, provided that the normal arrangements are in place for consent, audit and clinical governance.
Radiofrequency ablation has been advocated as an alternative to resection in persons with lung nodules who can not be treated surgically because of medical problems, multiple tumors, or poor surgical risk. Satisfactory clinical results have been reported using this method for liver tumors, and several reports have been published regarding RFA therapy for human lung neoplasms. There are, however, no adequate prospective clinical studies that demonstrate that RFA of lung metastases is as effective as surgical (cold knife) resection in curative resection of malignant neoplasms. An important concern is that RFA does not allow for examination of surgical margins to ensure that cancer is completely resected. Le and Petrik (2005) considered RFA as a promising technique for the treatment of early states (state I and stage II) non-small cell lung cancer. Stamatis (2005) stated that for the treatment of lung metastases, RFA in particular is currently being investigated. An assessment by the National Institute for Health and Clinical Excellence (NICE, 2006) concluded: "Current evidence on the safety and efficacy of percutaneous radiofrequency ablation for primary and secondary lung cancers shows that there are no major safety concerns with this procedure. There is evidence that the treatment can reduce tumour bulk; however, this evidence is limited and is based on heterogeneous indications for treatment. The procedure should therefore be used only with special arrangements for consent, audit and clinical governance."
Radiofrequency ablation has been used as a treatment of pancreatic cancer for a number of years in Japan. Current evidence of effectiveness of RFA for pancreatic cancer consists of case reports and a phase II (safety) study; the latter concluded that RFA was a relatively safe treatment for pancreatic cancer. However, this evidence is insufficient to draw conclusions about the effectiveness of RFA for this indication.
Girelli et al (2010) examined the feasibility and safety of RFA as a treatment option for locally advanced pancreatic cancer. A total of 50 patients with locally advanced pancreatic cancer were studied prospectively. Ultrasound-guided RFA was performed during laparotomy. The main outcome measures were short-term morbidity and mortality. The tumor was located in the pancreatic head or uncinate process in 34 patients and in the body or tail in 16; median diameter was 40 (inter-quartile range [IQR] of 30 to 50) mm. Radiofrequency ablation was the only treatment in 19 patients; it was combined with biliary and gastric bypass in 19 patients, gastric bypass alone in 8, biliary bypass alone in 3 and pancreatico-jejunostomy in 1. The 30-day mortality rate was 2 %. Abdominal complications occurred in 24 % of patients; in half they were directly associated with RFA and treated conservatively. Three patients with surgery-related complications needed re-operation. Reduction of RFA temperature from 105 degrees C to 90 degrees C resulted in a significant reduction in complications (10 versus 2 of 25 patients; p = 0.028). Median post-operative hospital stay was 10 (range of 7 to 31) days. The authors concluded that RFA of locally advanced pancreatic cancer is feasible and relatively well-tolerated, with a 24 % complication rate. This was a feasibility and safety study; it did not provide any data on the effectiveness of RFA in treating pancreatic cancer.
Several authorities have noted that RFA of renal tumors is a promising investigational alternative to partial or total nephrectomy (Janzen et al, 2002; Russo, 2001; Wood et al, 2002). Studies performed to date have focused on the technical feasibility of RFA of renal tumors. Prospective clinical studies are needed to determine if RFA of renal cell carcinomas improve survival and are as effective as total or partial nephrectomy.
An assessment conducted by the NICE (2004) reached the following conclusions about RFA of renal tumors: "Limited evidence suggests that percutaneous radiofrequency ablation (RFA) of renal cancer brings about reduction of tumor bulk as assessed by computed tomography, and that the procedure is adequately safe. However, the procedure has not been shown to improve symptoms or survival …. Patient selection is important and the procedure should normally be limited to patients who are unsuitable for surgery."
An assessment of the evidence for RFA of kidney cancer prepared by the Canadian Coordinating Office for Health Technology Assessment (Hailey, 2006) reached the following conclusions: "RFA is emerging as a useful alternative to nephrectomy in the management of some types of kidney cancer. It appears to be useful for smaller, non-central tumours, and for cases where surgery is contraindicated. A disadvantage is the possibility of residual cancer that cannot be detected by diagnostic imaging during follow-up. There are no results from randomized trials, and the period of follow-up for patients who have had the procedure is short. Only with longer follow-up evaluations (5 years to 10 years) will relevant comparison with radical and partial nephrectomy be possible."
Furthermore, Hinshaw and Lee (2004) stated that RFA, cryoablation, microwave ablation, and laser ablation have all shown promise for the treatment of renal cell carcinomas (RCC), with high local control and low complication rates for RFA and cryoablation. However, the clinical trial data remain early, and survival data are not yet available for a definitive comparison with conventional surgical techniques for removal of RCC (Hinshaw and Lee, 2004). Mahnken et al (2004) noted that the increasing number of clinical reports on RFA of the kidney show the promising potential of renal RFA for minimally invasive tumor treatment. Due to its technical benefits, RFA seems to be advantageous when compared to cryoablation or laser ablation. However, there are no long-term follow-up or comparative data proving an equal effectiveness to surgery (Mahnken et al, 2004).
In a systematic review on focal therapy for kidney cancer, Kutikov and colleagues (2009) stated that most cryoablations are performed using a laparoscopic approach, whereas RFA of the localized small renal masses (SRM) is more commonly administered percutaneously. Pre-treatment biopsy is performed more often for lesions treated by cryoablation than RFA with a significantly higher rate of indeterminate or unknown pathology for SRMs undergoing RFA versus cryoablation (p < 0.0001). Currently available data suggest that cryoablation results in lower re-treatments (p < 0.0001), less local tumor progressions (p < 0.0001) and may be associated with a decreased risk of metastatic progression compared with RFA. It is unclear if these differences are a function of the technologies or their application. The extent to which focal ablation alters the natural history of SRMs has not yet been established. The authors concluded that currently, data on the ability of interventions for SRMs to affect the natural history of these masses are lacking. They stated that prospective randomized evaluations of available clinical approaches to SRMs are needed. This is in agreement with the observations of Carraway et al (2009) who noted that continued studies on renal RFA are needed, especially in regards to oncological outcomes.
A Cochrane systematic evidence review (Nabi et al, 2010) of surgical management of localized RCC found that the main source of evidence for the current practice of laparoscopic excision of renal cancer is drawn from case series, small retrospective studies and very few small randomized controlled trials. "The results and conclusions of these studies must therefore be interpreted with caution." The authors of the systematic evidence review did not identify any randomized trials meeting the inclusion criteria reporting on the comparison between open radical nephrectomy with laparoscopic approach or new modalities of treatment such as RFA or cryoablation. Three randomized controlled trials compared the different laparoscopic approaches to nephrectomy (transperitoneal versus retroperitoneal) and found no statistical difference in operative or peri-operative outcomes between the 2 treatment groups. There were several non-randomized and retrospective case series reporting various advantages of laparoscopic renal cancer surgery such as less blood loss, early recovery and shorter hospital stay.
Sooriakumaran and co-workers (2010) examined the presentation, management and outcomes of patients with renal angiomyolipoma (AML) over a period of 10 years. These investigators evaluated retrospectively 102 patients (median follow-up of 4 years); 70 had tuberous sclerosis complex (TSC; median tumor size of 3.5 cm) and the other 32 were sporadic (median tumor size of 1.2 cm). Data were gathered from several sources, including radiology and clinical genetics databases. The 77 patients with stable disease were followed-up with surveillance imaging, and 25 received interventions, some more than one. Indications for intervention included spontaneous life-threatening hemorrhage, large AML (10 to 20 cm), pain and visceral compressive symptoms. Selective arterial embolization (SAE) was performed in 19 patients; 10 received operative management and 4 had a RFA. Selective arterial embolization was effective in controlling hemorrhage from AMLs in the acute setting (n = 6) but some patients required further intervention (n = 4) and there was a significant complication rate. The reduction in tumor volume was only modest (28 %). No complications occurred after surgery (median follow-up of 5.5 years) or RFA (median follow-up of 9 months). One patient was entered into a trial and treated with sirolimus (rapamycin). The authors concluded that the management of AML is both complex and challenging, especially in those with TSC, where tumors are usually larger and multiple. Although SAE was effective at controlling hemorrhage in the acute setting it was deemed to be of limited value in the longer term management of these tumors. Thus, novel techniques such as focused ablation and pharmacotherapies including the use of anti-angiogenic molecules and mammalian target of rapamycin inhibitors, which might prove to be safer and equally effective, should be further explored.
Radiofrequency ablation has also been used to treat bone metastases. However, there are no adequate clinical studies reported in the literature on the use of RFA of metastatic lesions to bone.
In a review of the evidence on RFA of tumors, Wood et al (2002) concluded that “[m]ore rigorous scientific review, long-term follow-up, and randomized prospective trials are needed to help define the role of RFA [radiofrequency ablation] in oncology.” Rhim (2004) noted that although RFA represents a paradigm shift in local therapy for many commonly seen tumors, more sophisticated strategies to enhance the therapeutic effectiveness are needed and more randomized, controlled trials to estimate its clinical benefit are warranted. de Baere (2005) stated that RFA, although very efficient in local tumor control, has neither proven to prolong survival or to be equivalent to surgery in randomized trial, even if some retrospective studies have done so. Further studies are needed to evaluate the exact benefit of this promising technique.
Agnese and Burak (2005) stated that ablative therapies, including RFA have been shown promise in the treatment of small cancers of the breast. However, more research is needed to ascertain the effectiveness of these techniques when they are used as the sole therapy and to determine the long-term local recurrence rates and survival associated with these treatment strategies. van der Ploeg et al (2007) reviewed the literature on the use of RFA for the treatment of small breast carcinoma. The authors concluded that RFA is a promising new tool for minimally invasive ablation of small carcinomas of the breast. They noted that a large randomized control study is needed to ascertain the long-term advantages of RFA compared to the current breast conserving therapies.
Barrett's esophagus (BE) is defined as the presence of specialized intestinal metaplasia within the tubular esophagus, and is the pre-malignant precursor of esophageal adenocarcinoma. Esophageal cancer is one of the most deadly gastro-intestinal cancers with a mortality rate over 90 %. The principal risk factors for esophageal adenocarcinoma are gastro-esophageal reflux disease (GERD) and its sequela, BE. Gastro-esophageal reflux disease usually leads to esophagitis. However, in a minority of patients, ongoing GERD leads to replacement of esophageal squamous mucosa with metaplastic, intestinal-type Barrett's mucosa. In the setting of continued peptic injury, Barrett's mucosa can give rise to esophageal adenocarcinoma (Feagins and Souza, 2005).
A new method of endoscopic ablation of BE is balloon-based, bipolar RFA (Stellartech Research Coagulation System; BARRx, Inc, Sunnyvale, CA), also known as Barrett's endoscopy. This technique requires the use of sizing balloons to determine the inner diameter of the targeted portion of the esophagus (Johnson, 2005). This is followed by placement of a balloon-based electrode with a 3-cm long treatment area that incorporates tightly spaced, bipolar electrodes that alternate in polarity. The electrode is then attached to a RF generator and a pre-selected amount of energy is delivered in less than 1 second at 350 W.
In a review of evidence on ablative techniques for BE, Johnston (2005) stated that it is not clear which of the numerous endoscopic ablative techniques available -- photodynamic therapy, laser therapy, multi-polar electrocoagulation, argon plasma coagulation, endoscopic mucosal resection, RFA or cryotherapy -- will emerge as superior for treatment of BE. In addition, it has yet to be determined whether the risks associated with ablation therapy are less than the risk of BE progressing to cancer. Whether ablation therapy eliminates or significantly reduces the risk of cancer, eliminates the need for surveillance endoscopy, or is cost-effective, also remains to be seen. Comparative trials that are now underway should help to answer these questions.
Hubbard and Velanovich (2007) stated that endoscopic endoluminal RFA using the Barrx device (Barrx Medical, Sunnyvale, CA) is a new technique to treat BE. This procedure has been used in patients who have not had anti-reflux surgery. This report presented an early experience of the effects of endoluminal ablation on the reflux symptoms and completeness of ablation in post-fundoplication patients. A total of 7 patients who have had either a laparoscopic or open Nissen fundoplication and BE underwent endoscopic endoluminal ablation of the Barrett's metaplasia using the Barrx device. Pre-procedure, none of the patients had significant symptoms related to GERD. One to 2 weeks after the ablation, patients were questioned as to the presence of symptoms. Pre-procedure and post-procedure, they completed the GERD-HRQL symptom severity questionnaire (best possible score, 0; worst possible score, 50). Patients had follow-up endoscopy to assess completeness of ablation 3 months after the original treatment. All patients completed the ablation without complications. No patients reported recurrence of their GERD symptoms. The median pre-procedure total GERD-HRQL score was 2, compared to a median post-procedure score of 1. One patient had residual Barrett's metaplasia at 3 months follow-up, requiring re-ablation. The authors concluded that this preliminary report of a small number of patients demonstrated that endoscopic endoluminal ablation of Barrett's metaplasia using the Barrx device is safe and effective in patients who have already undergone anti-reflux surgery. There appears to be no disruption in the fundoplication or recurrence of GERD-related symptoms. Nevertheless, they stated that studies with longer-term follow-up and with more patients are needed.
Ganz et al (2008) evaluated the safety and effectiveness of endoscopic circumferential balloon-based ablation by using RF energy for treating BE that contains high-grade dysplasia (HGD). Patients with histologic evidence of intestinal metaplasia (IM) that contained HGD confirmed by at least 2 expert pathologists were included in this study. A prior endoscopic mucosal resection (EMR) was permitted, provided that residual HGD remained in the BE region for ablation. Histologic complete response (CR) end points: (i) all biopsy specimen fragments obtained at the last biopsy session were negative for HGD (CR-HGD), (ii) all biopsy specimens were negative for any dysplasia (CR-D), and (iii) all biopsy specimens were negative for IM (CR-IM). A total of 142 patients (median age of 66 years, IQR 59 to 75 years) who had BE HGD (median length of 6 cm, IQR 3 to 8 cm) underwent circumferential ablation (median of 1 session, IQR 1 to 2 sessions). No serious adverse events were reported. There was 1 asymptomatic stricture and no buried glands. Ninety-two patients had at least 1 follow-up biopsy session (median follow-up of 12 months, IQR 8 to 15 months). A CR-HGD was achieved in 90.2 % of patients, CR-D in 80.4 %, and CR-IM in 54.3 %. The authors concluded that endoscopic circumferential ablation is a promising modality for the treatment of BE that contains HGD. In this multi-center registry, the intervention safely achieved a CR for HGD in 90.2 % of patients at a median of 12 months of follow-up. Major drawbacks of this study were a non-randomized study design, absence of a control arm, a lack of centralized pathology review, ablation and biopsy technique not standardized, and a relatively short-term follow-up.
Shaheen and colleagues (2009) examined if endoscopic RFA could eradicate dysplastic BE and decrease the rate of neoplastic progression. In a multi-center, sham-controlled trial, these researchers randomly assigned 127 patients with dysplastic BE in a 2:1 ratio to receive either RFA (ablation group) or a sham procedure (control group). Randomization was stratified according to the grade of dysplasia and the length of BE. Primary outcomes at 12 months included the complete eradication of dysplasia and intestinal metaplasia. In the intention-to-treat analyses, among patients with low-grade dysplasia, complete eradication of dysplasia occurred in 90.5 % of those in the ablation group, as compared with 22.7 % of those in the control group (p < 0.001). Among patients with high-grade dysplasia, complete eradication occurred in 81.0 % of those in the ablation group, as compared with 19.0 % of those in the control group (p < 0.001). Overall, 77.4 % of patients in the ablation group had complete eradication of intestinal metaplasia, as compared with 2.3 % of those in the control group (p < 0.001). Patients in the ablation group had less disease progression (3.6 % versus 16.3 %, p = 0.03) and fewer cancers (1.2 % versus 9.3 %, p = 0.045). Patients reported having more chest pain after the ablation procedure than after the sham procedure. In the ablation group, 1 patient had upper gastrointestinal hemorrhage, and 5 patients (6.0 %) had esophageal stricture. The authors concluded that in patients with dysplastic BE, RFA was associated with a high rate of complete eradication of both dysplasia and intestinal metaplasia and a reduced risk of disease progression.
As stated by the authors, this study has several limitations: (i) these investigators used eradication of intestinal metaplasia and dysplasia, along with neoplastic progression, as surrogate markers for death from cancer, even though long-term data demonstrating an association between eradication of intestinal metaplasia and a decreased risk of cancer are sparse, (ii) the study duration was 1 year. Although other data suggest that reversion to neosquamous epithelium after RFA is durable, it is unclear if the results of the study will persist, (iii) because of stratified randomization according to the degree of dysplasia and the 2:1 ratio for assignment of patients to the ablation group and the control group, the number of patients in some groups was small, (iv) since this study did not compare RFA with other interventions, such as photodynamic therapy and esophagectomy, these researchers can not determine which of these interventions is superior, and (v) whether these findings can be generalized to community-practice settings is unknown.
Furthermore, the risk of subsquamous intestinal metaplasia following ablative therapy is a concern for all ablative techniques. However, the malignant potential of subsquamous intestinal metaplasia is unknown. In this study, subsquamous intestinal metaplasia was quite common in patients (25.2 %) before enrollment and, similar to previous reports, was low after RF ablation (5.1 %). Although the biopsy regimen in this study was aggressive, it is possible that some patients had undetected subsquamous intestinal metaplasia.
Finally, because these investigators sought to define the efficacy of RFA for the spectrum of dysplasia, they enrolled patients with both low-grade dysplasia and high-grade dysplasia. However, the implications of these 2 diagnoses are markedly different. Low-grade dysplasia implies a risk of progression to cancer of less than 1 % per patient-year, whereas the risk associated with high-grade dysplasia may be higher by a factor of 10. In making decisions about the management of pre-cancerous conditions, clinicians, patients, and policy-makers consider possible benefits and risks of competing strategies. Because high-grade dysplasia has a more ominous natural history than low-grade dysplasia (or non-dysplastic intestinal metaplasia), greater risks and costs are tolerable. For less severe disease, the safety profile and associated costs become increasingly important. Detailed consideration of these trade-offs is beyond the scope of this study. Regardless, both of the dysplasia subgroups showed high rates of reversion to squamous epithelium after RFA and reduced rates of disease progression with few serious adverse effects, suggesting that the application of ablative therapy in patients with low-grade dysplasia is worth further investigation and consideration.
In the accompanying editorial, Bergman (2009) stated that it is still too early to promote RFA for patients with non-dysplastic BE. Dr. Bergman also asked the following questions: (i) is complete response after ablation maintained over time, thus reducing the risk of progression to high-grade dysplasia or cancer?, (ii) will ablation improve patients' quality of life and decrease costs, as compared with the surveillance strategy?, and (iii) can we define a stratification index predicting disease progression or response to therapy? The author noted that "[w]e run the risk of losing the momentum to enroll patients in a trial that is required at this stage: a randomized comparison of endoscopic surveillance and radiofrequency ablation for non-dysplastic Barrett's esophagus. Such a study might truly revolutionize the management of this condition and answer the question as to whether radiofrequency ablation is great just for some or justified for many".
Furthermore, the American College of Gastroenterology's updated guidelines for the diagnosis, surveillance and therapy of BE (Wang and Sampliner, 2008) states that "further evaluation of the most recent technology; radiofrequency ablation is awaited. Cryotherapy is beginning clinical trials and older technologies are becoming more refined (e.g., photodynamic therapy with the development of new agents). Documentation of the frequency and duration of the surveillance protocol after endoscopic ablation therapy requires careful study".
Yeh and Triadafilopoulos (2005) noted that a wide variety of endoscopic mucosal ablative techniques have been developed for early esophageal neoplasia. However, long-term control of neoplasic risk has not been demonstrated. The authors explained that most studies show that specialized intestinal metaplasia may persist underneath neo-squamous mucosa, posing a risk for subsequent neoplastic progression.
Shaheen (2005) noted that the pathogenesis of BE is poorly understood. Given that some patients will have repeated bouts of severe erosive esophagitis and never develop BE, host factors must play an important role. The author stated that the utility of neoadjuvant radiation and chemotherapy in those with adenocarcinoma, although they are widely practiced, is not of clear benefit, and some authorities recommend against it. Ablative therapies, as well as endoscopic mucosal resection, hold promise for those with superficial cancer or high-grade dysplasia. The author noted that most series using these modalities feature relatively short follow-up; longer-term studies are needed to better ascertain the effectiveness of these treatments.
Pedrazzani et al (2005) evaluated the effectiveness of 90 W argon plasma coagulation (APC) for the ablation of BE that is considered to be the main risk factor for the development of esophageal adenocarcinoma. They found that high-power setting APC showed to be safe. The effects persist at a mean follow-up period of 2 years with a comparable cost in term of complications with respect to standard power settings. The authors stated, however, that further studies with greater number of patients are required to confirm these results and to assess if ablation reduces the incidence of malignant progression.
Hage et al (2005) stated that although endoscopic removal of BE by ablative therapies is possible in the majority of patients, histologically complete elimination can not be achieved in all cases. Persistent BE may still harbor molecular aberrations and must therefore be considered still to be at risk of progression to adenocarcinoma.
Guidelines on thyroid cancer from the National Comprehensive Cancer Network (NCCN, 2010) state that distant metastases from recurrent or persistent medullary thyroid carcinoma that are causing symptoms (e.g., those in bone) could be considered for pallative resection, RFA, or other regional treament. The guidelines state that these interventions may also be considered for asymptomatic distant metastases (especially for progressive disease) but observation is acceptable, given the lack of data regarding alteration in outcome.
Monchik and colleagues (2006) evaluated the long-term effectiveness of RFA and percutaneous ethanol (EtOH) injection treatment of patients with local recurrence or focal distant metastases of well-differentiated thyroid cancer (WTC). A total of 20 patients underwent treatment of biopsy-proven recurrent WTC in the neck. Sixteen of these patients had lesions treated by ultrasound-guided RFA (mean size of 17.0 mm; range of 8 to 40 mm), while 6 had ultrasound-guided EtOH injection treatment (mean size of 11.4 mm; range of 6 to 15 mm). Four patients underwent RFA treatment of focal distant metastases from WTC; 3 of these patients had CT-guided RFA of bone metastases (mean size of 40.0 mm; range of 30 to 60 mm), and 1 patient underwent RFA for a solitary lung metastasis (size, 27 mm). Patients were then followed with routine ultrasound, whole body scan, and/or serum thyroglobulin levels for recurrence at the treatment site. No recurrent disease was detected at the treatment site in 14 of the 16 patients treated with RFA and in all 6 patients treated with EtOH injection at a mean follow-up of 40.7 and 18.7 months, respectively. Two of the 3 patients treated for bone metastases were disease-free at the treatment site at 44 and 53 months of follow-up, respectively. The patient who underwent RFA for a solitary lung metastasis was disease-free at the treatment site at 10 months of follow-up. No complications were experienced in the group treated by EtOH injection, while 1 minor skin burn and 1 permanent vocal cord paralysis occurred in the RFA treatment group. The authors concluded that RFA and EtOH ablation show promise as alternatives to surgical treatment of recurrent WTC in patients with difficult reoperations. They stated that further long-term follow-up studies are needed to ascertain the precise role these therapies should play in the treatment of recurrent WTC.
The Food and Drug Administration (FDA) has issued a Public Health Notification as clarification for healthcare providers that no RFA devices are specifically approved for use in partial or full ablation of lung tumors (2008). This notification was sent in follow-up to an earlier notice in December 2007, which indicated that a number of deaths have been associated with the use of RFA for lung tumors. Radiofrequency ablation devices are minimally invasive tools used for general removal of soft tissue, such as those that contain cancer cells. It is an image-guided technique that heats and destroys cancer cells. Imaging techniques such as ultrasound and computed tomography (CT) are used to help guide a needle electrode into a cancerous tumor. High-frequency electrical currents are then passed through the electrode, creating heat that destroys the abnormal cells.
Radiofrequency ablation devices have been cleared by the FDA for the general indication of soft tissue cutting, coagulation, and ablation by thermal coagulation necrosis. This clearance was based only on bench testing or animal testing performance data. Under this general indication, RFA can be used as a tool to ablate tumors, including lung tumors. In addition, some RFA devices have been cleared for additional specific treatment indications, including partial or complete ablation of non-resectable liver lesions, and palliation of pain associated with metastatic lesions involving bone. Clearance for specific treatment indications requires the submission of clinical data to justify the indications by showing that the device, when used on a well-defined target population, consistently achieves the desired treatment effect.
As sufficient clinical data has not been submitted, the FDA emphasizes that it has not cleared any RFA devices for the specific treatment indication of partial or complete ablation of lung tumors. Therefore, FDA regulations prevent manufacturers from marketing or promoting the devices for this treatment, which would also include specific training programs; this does not apply to training available from sources other than the manufacturer. The FDA has received reports of death and serious injuries associated with the use of RFA devices in treatment of lung tumors. The actual rate of these adverse events is unknown because no pre-market clinical data have been obtained. It is unclear if these deaths or injuries occur more frequently with RFA devices than with other forms of treatment for lung tumors. These adverse events could be related to a number of factors, including patient selection and management, technical use of the RFA device, post-procedural treatments, and management of complications.
The FDA urges all clinicians to use MedWatch, the FDA’s voluntary reporting program, to report any adverse events related to this or any other device at: http://www.fda.gov/medwatch/report.htm.
Guidelines from the National Comprehensive Cancer Network (NCCN, 2010) include recommendations for RFA of the trunk and extremities in metastatic soft tissue sarcoma. The guidelines include metastasectomy with RFA as an alternative method for control of metastatic lesions in limited metastases. The guidelines also include RFA as options for symptomatic patients with disseminated metastases. "The guidelines are intentionally nonspecific about this group of options, because many different issues are factored into this decision (e.g., patient performance status, patient preferences, specific clinical problems from the metastases, treatment availability.)"
The guidelines (NCCN, 2010) also recommend the use of RFA for the treatment of gastro-intestinal stromal tumors with limited progression. Progression is defined as a new lesion or increase in tumor size. The NCCN guidelines state that, for limited progressive disease that is potentially easily resectable, surgical resection should be considered. Other treatment options include RFA or embolization.
In an open-label, pilot study, Steel et al (2011) examined the safety of endobiliary bipolar RFA in patients with malignant biliary obstruction and reported the 90-day biliary patency of this novel procedure. Main outcome measures were immediate and 30-day complications as well as 90-day stent patency. A total of 22 patients (16 pancreatic, 6 cholangiocarcinoma) were includedin this study. Deployment of an RFA catheter was successful in 21 patients. Self-expandable metal stents (SEMSs) placement was achieved in all cases of successful RFA catheter deployment. One patient failed to demonstrate successful biliary decompression after SEMS placement and died within 90 days. All other patients maintained stent patency at 30 days. One patient had asymptomatic biochemical pancreatitis, 2 patients required percutaneous gallbladder drainage, and 1 patient developed rigors. At 90-day follow-up, 1 additional patient had died with a patent stent, and 3 patients had occluded biliary stents. The authors concluded that endobiliary RFA treatment appears to be safe. They stated that randomized studies with prolonged follow-up are needed.
Lee and colleagues (2008) noted that Brunner's gland hyperplasia is a benign tumor of the duodenum and it is rarely associated with clinical symptoms. These investigators reported on the case of a 64-yr old man with Brunner's gland hyperplasia who had undergone a duodenocephalo-pancreatectomy. The reason was that he presented upper gastro-intestinal obstructive symptoms and the esophago-gastroduodenoscopic finding revealed the lesion to be an infiltrating type mass on the second portion of the duodenum with luminal narrowing. An abdominal computed tomography showed a 2.5 cm-sized mass in the duodenal second portion with a suspicious pancreatic invasion and 7 mm-sized lymph node around the duodenum. Duodenocephalo-pancreatectomy was successfully performed. Histological examination revealed a Brunner's gland hyperplasia. The final diagnosis was the co-existence of Brunner's gland hyperplasia and pancreatic heterotopia with a pancreatic head invasion. These researchers (2008) stated that there is no consensus on the treatment of Brunner's gland hyperplasia because follow-up study is insufficient. The medical treatment is to control gastric hyper-acidity, which is one cause of Brunner's gland hyperplasia. However, the regression of Brunner's gland hyperplasia is rare. Thus, excision appears to be the treatment of choice. Lee and associates (2008) recommended complete removal of the lesion by endoscopic resection or surgical resection when Brunner's gland hyperplasia results in symptoms and complications or when definite diagnosis is necessary. There is a lack of evidence on RFA as a treatment for Brunner's gland hyperplasia.
Stewart et al (2009) stated that Brunner's gland hamartomas (BGHs) are uncommon benign tumors of the duodenum forming mature Brunner's glands. These researchers reported an unusual case of a giant BGH that was not amenable to endoscopic or surgical local resection; thus requiring a pancreatico-duodenectomy for extirpation.
Euanorasetr and Sornmayura (2010) noted that BGHs are uncommon benign tumor of the duodenum. Most lesions are small and asymptomatic. Occasionally, those lesions may be large and manifest as a rare cause of upper gastro-intestinal hemorrhage or duodenal obstruction. The authors reported 2 cases of BGHs presenting with upper gastro-intestinal hemorrhage that were not amenable to endoscopic polypectomy; thus requiring surgical resection.
Kroon et al (2011) summarized the consensus developed by a group of Australasian subspecialists in reproductive endocrinology and infertility (the ACCEPT group) on the evidence concerning the impact and management of fibroids in infertility. The location of a fibroid within the uterus influences its effect on fertility. Subserosal fibroids do not appear to impact on fertility outcomes. Intra-mural (IM) fibroids may be associated with reduced fertility and an increased miscarriage rate (MR); however, there is insufficient evidence to inform whether myomectomy for IM fibroids improves fertility outcomes. Submucosal fibroids are associated with reduced fertility and an increased MR, and myomectomy for submucosal fibroids appears likely to improve fertility outcomes. The relative effect of multiple or different sized fibroids on fertility outcomes is uncertain, as is the relative usefulness of myomectomy in these situations. It is recommended that fibroids with suspected cavity involvement are defined by magnetic resonance imaging, sonohysterography or hysteroscopy because modalities such as trans-vaginal ultrasound and hysterosalpingography lack appropriate sensitivity and specificity. Medical management of fibroids delays efforts to conceive and is not recommended for the management of infertility associated with fibroids. Newer treatments such as uterine artery embolization, RFA, bilateral uterine artery ligation, magnetic resonance-guided focussed ultrasound surgery and fibroid myolysis require further investigation prior to their establishment in the routine management of fibroid-associated infertility.
Fegrachi et al (2014) noted that median survival in patients with unresectable locally advanced pancreatic cancer lies in the range of 9 to 15 months. Radiofrequency ablation may prolong survival, but data on its safety and effectiveness are scarce. These investigators performed a systematic literature search in PubMed, EMBASE and the Cochrane Library with the syntax '(radiofrequency OR RFA) AND (pancreas OR pancreatic)' for studies published until January 1, 2012. In addition, a search of the proceedings of conferences on pancreatic disease that took place during 2009 to 2011 was performed. Studies with fewer than 5 patients were excluded as they were considered to be case-reports. The primary endpoint was survival; secondary endpoints included morbidity and mortality. A total of 5 studies involving a total of 158 patients with pancreatic cancer treated with RFA fulfilled the eligibility criteria. These studies reported median survival after RFA of 3 to 33 months, morbidity related to RFA of 4 to 37 %, mortality of 0 to 19 % and overall morbidity of 10 to 43 %. Pooling of data was not appropriate as the study populations and reported outcomes were heterogeneous. Crucial safety aspects included ensuring a maximum RFA tip temperature of less than 90 °C and ensuring minimum distances between the RFA probe and surrounding structures. The authors concluded that RFA seems to be feasible and safe when it is used with the correct temperature and at an appropriate distance from vital structures. It appears to have a positive impact on survival. Moreover, they stated that multi-center randomized trials are needed to determine the true effect size of RFA and to minimize the impacts of selection and publication biases.
Grotenhuis et al (2013) summarized the reported treatment outcomes of ultrasound-guided RFA for early-stage breast cancer and high-lighted practical considerations with regard to this treatment. A search of the English-language literature concerning RFA for breast cancer treatment was performed. Radiofrequency ablation is a technique that can be safely applied in patients with early-stage breast cancer, which is restricted to cT1-T2N0 ductal carcinoma with radiologically defined borders without any signs of multi-focality or multi-centricity. However, before RFA can be adopted as local therapy for early-stage breast cancer, more research is needed to assess the post-treatment pathological complete response and margin status, the long-term oncologic outcome in comparison to current standard breast conserving therapy and the potential cosmetic superiority of percutaneous RFA. The authors concluded that RFA appeared to be a feasible technique for the treatment of early-stage breast cancer, but considerable practical considerations form an obstacle to introduce RFA as a standard of care.
In a phase II clinical trial, Takaki et al (2013) evaluated the safety and effectiveness of RFA with a multiple-electrode switching system for the treatment of RCC. From November 2009 to December 2010, a total of 33 patients (mean age of 70.7 years; range of 44 to 86 years) with histologically proved RCCs -- including 24 men (mean age of 69.5 years [range of 44 to 86 years]) and 9 women (mean age of 74.1 years [range of 64 to 83 years]) -- were enrolled in this study. The institutional review board approved the study after patients provided written informed consent. The mean maximum tumor diameter was 2.9 cm ± 1.0 (standard deviation) (range of 1.5 to 5.0 cm). Radiofrequency ablation was conducted with a multiple-electrode switching system. The primary end-point was evaluated with the Common Terminology Criteria for Adverse Events. Secondary end-points were changes in renal function, technique effectiveness, local tumor progression, and survival. Changes in renal function were evaluated by using the Mann-Whitney U test. No severe adverse events occurred, but 3 of 33 patients (9 %) had grade-2 adverse events. Although the mean glomerular filtration rate at 1 year after RFA was similar to the baseline value in 26 patients with bilateral kidneys (p = 0.14), it was decreased significantly in 6 patients with a single kidney (p = 0.03). Tumor enhancement disappeared after a single RFA session in 31 patients and after 2 RFA sessions in the other 2 patients (rates of primary and secondary technique effectiveness, 94 % [31 of 33] and 100 % [33 of 33], respectively). No local tumor progression was found during the mean follow-up of 20.0 months (range of 11.6 to 27.6 months). The respective 1-year overall and RCC-related survival rates were 97 % (95 % confidence intervals [CI]: 91 % to 100 %) and 100 %. The authors concluded that RFA with a multiple-electrode switching system is safe and effective for treatment of RCCs. Moreover, they stated that further study is needed to examine if this technology is superior to other previously described methods.
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
Other HCPCS codes related to the CPB:
Catheter, extravascular tissue ablation, any modality (insertable)
ICD-9 codes covered if selection criteria are met:
151.0 - 153.9
Malignant neoplasm of stomach, small intestine, and colon [metastatic gastrointestinal stromal tumors (GIST) with limited progression]
171.2 -171.3 171.7
Malignant neoplasm of connective tissue and other soft tissue of upper limb, including shoulder, lower limb, including hip, and trunk unspecified [in symptomatic persons with disseminated metastases]
Malignant neoplasm of thyroid gland [distant metastases of medullary thyroid carcinoma]
213.0 - 213.9
Benign neoplasm of bone and articular cartilage [osteoid osteoma] [not covered for chondroblastoma]
ICD-9 codes not covered for indications listed in the CPB [for radiofrequency ablation]:
Benign neoplasm of duodenum, jejunum and ileum [Brunner's Gland hyperplasia]
ICD-9 codes not covered for indications listed in the CPB [for curative treatment in persons who are able to tolerate surgical resection]::
156.0 - 156.9
Malignant neoplasm of gallbladder and extrahepatic bile ducts
157.0 - 157.9
Malignant neoplasm of pancreas
162.2 - 162.9
Malignant neoplasm of bronchus or lung
170.0 - 170.9
Malignant neoplasm of bone and articular cartilage [chondroblastoma]
174.0 - 175.9
Malignant neoplasm of breast
189.0 - 189.1
Malignant neoplasm of kidney and renal pelvis
223.0 - 223.1
Benign neoplasm of kidney and renal pelvis [renal angiomyolipoma]
Malignant neoplasm and secondary malignant neoplasm [covered as an alternative to surgical (cold knife) for debulking of primary and metastatic malignant neoplasms and for removal of primary or metastatic malignant neoplasms when removal of the neoplasm may be curative and the member is unable to tolerate surgical resection]
The above policy is based on the following references:
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