1. Aetna considers percutaneous radiofrequency ablation medically necessary for treatment of osteoid osteoma, as a less invasive alternative to surgical resection of the tumor.

2. Aetna considers radiofrequency ablation medically necessary as an alternative to surgical (cold knife) resection for debulking of primary and metastatic malignant neoplasms.

3. Aetna considers radiofrequency ablation medically necessary 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.

4. Aetna considers radiofrequency ablation experimental and investigational for curative treatment of primary or metastatic malignant neoplasms (e.g., sarcoma, breast cancer, lung cancer, kidney cancer, and recurrent well-differentiated thyroid carcinoma; not an all inclusive list) in persons who are able to tolerate surgical resection because the effectiveness of radiofrequency tumor ablation in improving clinical outcomes has not been established.

5. For Aetna's policy on radiofrequency ablation for the treatment of Barrett's esophagus, See CPB 728 - Barrett's Esophagus Surgery.

6. For Aetna's policy on radiofrequency ablation of hepatic tumors, see  CPB 274 - Ablation of Hepatic Lesions.

7. For Aetna's policy on radiofrequency ablation of benign prostatic hypertrophy (transurethral needle ablation or TUNA), see CPB 079 - Benign Prostatic Hypertrophy (BPH) Treatments.

8. Aetna considers radiofrequency tumor ablation experimental and investigational for all other indications.

Radiofrequency ablation involves percutaneous or intraoperative 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, overgrowth 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 radiofrequency thermal ablation has been used as a less invasive alternative to surgical resection of osteoid osteoma. The primary advantage of percutaneous radiofrequency thermal ablation is a reduction in the need for postoperative hospitalization and a reduced duration of convalescence.

Several studies have been published reporting successful removal of osteoid osteoma using percutaneous radiofrequency ablation. Rosenthal et al., 1998 compared percutaneous radiofrequency ablation with standard resection in 87 patients who were treated with operative excision and 38 patients who were treated with percutaneous radiofrequency ablation. The former group did not require postoperative hospitalization (avg. 0.2 days), whereas the latter group required an average of about 5 days of postoperative hospitalization. The rates of recurrence between the two treatments were approximately the same. The rate of pain relief, as measured by questionnaire, was also similar between the two groups. An assessment conducted for the National Institute for Clinical Excellence (2004) concluded that the evidence supporting percutaneous radiofrequency ablation 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 cannot 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 radiofrequency ablation therapy for human lung neoplasms. There are, however, no adequate prospective clinical studies that demonstrate that radiofrequency ablation of lung metastases is as effective as surgical (cold knife) resection in curative resection of malignant neoplasms. An important concern is that radiofrequency ablation 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 radiofrequency ablation for pancreatic cancer consists of case reports and a phase II (safety) study; the latter concluded that radiofrequency ablation was a relatively safe treatment for pancreatic cancer. However, this evidence is insufficient to draw conclusions about the effectiveness of radiofrequency ablation for this indication.

Several authorities have noted that radiofrequency ablation 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 radiofrequency ablation of renal tumors. Prospective clinical studies are needed to determine if radiofrequency ablation of renal cell carcinomas improve survival and are as effective as total or partial nephrectomy.

An assessment conducted by the National Institute for Clinical Excellence (2004) reached the following conclusions about radiofrequency ablation 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 radiofrequency ablation 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 (five 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 & 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).

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 radiofrequency ablation of metastatic lesions to bone.

In a review of the evidence on radiofrequency ablation 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 radiofrequency ablation (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 gastrointestinal cancers with a mortality rate over 90 %. The principal risk factors for esophageal adenocarcinoma are gastroesophageal reflux disease (GERD) and its sequela, BE. Gastroesophageal 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 Barrett's esophagus is balloon-based, bipolar radiofrequency ablation (Stellartech Research Coagulation System; BARRx, Inc, Sunnyvale, Calif), 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 radiofrequency generator and a preselected amount of energy is delivered in less than 1 second at 350 W.

In a review of evidence on ablative techniques for Barrett's esophagus, 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, radiofrequency ablation 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 radiofrequency ablation 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 gastro-esophageal reflux disease (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 radiofrequency 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, interquartile range [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 et al (2009) examined if endoscopic radiofrequency (RF) ablation could eradicate dysplastic Barrett's esophagus (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 RF ablation (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, RF ablation 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 RF ablation 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 RF ablation with other interventions, such as photodynamic therapy and esophagectomy, these researchers can not determine which of these interventions is superior, (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 RF ablation 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 RF ablation 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 RF ablation 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 cannot 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.

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, 17.0 mm; range of 8 to 40 mm), while 6 had ultrasound-guided EtOH injection treatment (mean size, 11.4 mm; range of 6 to 15 mm). Four patients underwent RFA treatment of focal distant metastases from WTC. Three of these patients had CT-guided RFA of bone metastases (mean size, 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.

In a systematic review on focal therapy for kidney cancer, Kutikov et al (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.