Coverage Policy Manual
Policy #: 2000041
Category: Surgery
Initiated: November 2000
Last Review: October 2022
  Cryoablation of Neoplastic Conditions

Description:
Cryosurgical ablation (hereafter referred to as cryosurgery or cryoablation) involves freezing of target tissues; this is most often performed by inserting a coolant-carrying probe into the tumor. Cryosurgery may be performed as an open surgical technique or as a closed procedure under laparoscopic or ultrasound guidance.
 
Renal Tumors
Localized kidney cancer is treated with radical nephrectomy or nephron-sparing surgery. Prognosis drops precipitously if the tumor extends outside the kidney capsule because chemotherapy is relatively ineffective against metastatic renal cell carcinoma.
 
Lung Tumors and Lung Metastases
Early-stage lung tumors are typically treated surgically. Patients with early-stage lung cancer who are not surgical candidates may be candidates for radiotherapy with curative intent. Cryoablation is being investigated in patients who are medically inoperable, with small primary lung cancers or lung metastases from extrapulmonary primaries. Patients with a more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. Treatment is rarely curative; rather, it seeks to retard tumor growth or palliate symptoms.
 
Breast Tumors
Early-stage primary breast cancers are treated surgically. The selection of lumpectomy, modified radical mastectomy, or another approach is balanced against the patient's desire for breast conservation, the need for tumor-free margins in resected tissue, and the patient's age, hormone receptor status, and other factors. Adjuvant radiotherapy decreases local recurrences, particularly for those who select lumpectomy. Adjuvant hormonal therapy and/or chemotherapy are added, depending on the presence and number of involved nodes, hormone receptor status, and other factors. Treatment of metastatic disease includes surgery to remove the lesion and combination chemotherapy.
 
Fibroadenomas are common benign tumors of the breast that can present as a palpable mass or a mammographic abnormality. These benign tumors are frequently surgically excised to rule out a malignancy.
 
Pancreatic Cancer
Pancreatic cancer is a relatively rare solid tumor that occurs almost exclusively in adults, and it is largely considered incurable. Surgical resection of tumors contained entirely within the pancreas is currently the only potentially curative treatment. However, the nature of the cancer is such that few tumors are found at such an early and potentially curable stage. Patients with a more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. Treatment focuses on slowing tumor growth and palliation of symptoms.
 
Bone Cancer and Bone Metastases
Primary bone cancers are extremely rare, accounting for less than 0.2% of all cancers. Bone metastases are more common, with clinical complications including debilitating bone pain. Treatment for bone metastases is performed to relieve local bone pain, provide stabilization, and prevent impending fracture or spinal cord compression.
 
 
Regulatory Status
Several cryoablation devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for use in open, minimally invasive, or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, proctology, thoracic surgery, and ear, nose, and throat. Examples include:
 
    • Cryocare® Surgical System (Endocare);
    • CryoGen Cryosurgical System (Cryosurgical);
    • CryoHit® (Galil Medical) for the treatment of breast fibroadenoma;
    • IceSense3™, ProSense™, and MultiSense Systems (IceCure Medical);
    • SeedNet™ System (Galil Medical); and
    • Visica® System (Sanarus Medical).
 
FDA product code: GEH.
 
Coding
There are CPT codes for cryosurgical ablation of renal mass lesions:
50250 Ablation, open, one or more renal mass lesion(s), cryosurgical, including intraoperative ultrasound guidance and monitoring, if performed
50593 Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy
 
CPT 50542 may be used for ablation of renal tumors by cryosurgery or radiofrequency. Radiofrequency of renal tumors is addressed in policy # 2004007
 
There is a CPT code for cryosurgical ablation of fibroadenoma:
19105 Ablation, cryosurgical, of fibroadenoma, including ultrasound guidance, each fibroadenoma
 
There is no specific CPT code describing cryosurgical ablation of pancreatic tumors.

Policy/
Coverage:
Coverage policies 2000041 (Cryosurgical Ablation of Renal Tumors), 2004003 (Ablation Therapy, Radiofrequency and Cryoablation of Pulmonary Tumors), 2003062 (Cryosurgical Ablation of Breast Tumors, Benign and Malignant), and 2003063 (Cryosurgical Ablation of Pancreatic Cancer) were combined into one policy effective November 2022. Policies 2003062 and 2003063 are now archived, and the cryoablation information was removed from policy 2004003.
 
Effective November 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Cryosurgical ablation of renal tumors meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness to treat localized renal cell carcinoma that is no more than 4 cm in size when either of the following criteria is met:
 
    • Preservation of kidney function is necessary (i.e., the individual has 1 kidney or renal insufficiency defined by a glomerular filtration rate of <60 mL/min/m2), and standard surgical approach (i.e., resection of renal tissue) is likely to worsen kidney function substantially; OR
    • The individual is not considered a surgical candidate.
 
 
Cryosurgical ablation for the treatment of lung cancer meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when either of the following criteria is met:
 
    • The individual has early-stage non-small-cell lung cancer and is a poor surgical candidate; or
    • The individual requires palliation for a central airway obstructing lesion.
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Cryosurgical ablation for the treatment of benign or malignant renal, lung, breast, pancreatic, bone or any other solid tumor type involving any other organ or location in the body not listed above or addressed in a specific policy as covered does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, cryosurgical ablation for the treatment of benign or malignant renal, lung, breast, pancreatic, bone or any other solid tumor type involving any other organ or location in the body not listed above or addressed in a specific policy is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to November 2022
 
Biopsy of lesion/s must be obtained and diagnosis of malignancy confirmed to guide surveillance, cryosurgery, and radiofrequency ablation strategies unless clear contraindication to biopsy or the size of the lesion precludes biopsy.
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Cryosurgical ablation of neoplastic renal tumors in patients with stage I (T1a) renal cell carcinoma who are unable to tolerate nephron-sparing surgery or nephrectomy meets primary coverage criteria for effectiveness in improving health outcomes when:
 
    • the tumor is 4.0 cm  or less in size
    • the tumor is not in the medullary portion of the kidney, and
    • the tumor is not adjacent to a significant vessel.
  
 Active surveillance in patients with stage I (T1a) renal cell carcinoma meets primary coverage criteria for effectiveness.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of cryosurgical ablation of renal tumors in any circumstance other than that described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, the use of cryosurgical ablation of renal tumors in any circumstance other than that described above is considered investigational and is not covered.  Investigational services are an exclusion in the member certificate of coverage.
 
EFFECTIVE PRIOR TO MARCH 2019
 
Cryoablation of benign tumors measuring 4.0 cm or less meets primary coverage criteria that there be scientific evidence of effectiveness.
 
Cryoablation of neoplastic renal tumors meets primary coverage criteria for effectiveness and is covered for patients who cannot tolerate nephron-sparing surgery or nephrectomy when:
    • the tumor is equal to or less than 4 cm,
    • the tumor is not located in the medullary portion of the kidney, and
    • the tumor is not adjacent to a significant vessel.
 
The use of cryoablation to treat renal tumors in any circumstance other than those noted above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For those contracts that do not contain Primary Coverage Criteria the use of cryoablation to treat renal tumors in any circumstance other than those noted above is considered investigational and is not covered.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
This evidence review was created in October 2003 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through June 12, 2022.
 
There are no randomized controlled trials of cryoablation compared to surgery for kidney cancer.
 
Multiple systematic reviews of comparative observational studies have compared cryoablation to partial nephrectomy in patients with early kidney cancer. The 3 most recent, relevant, and comprehensive reviews and meta-analyses were reported by Uhlig et al, Klatte et al, and Tang et al (Uhlig, 2019; Klatte, 2014; Tang, 2014).
 
Uhlig et al published a systematic review and meta-analysis comparing partial nephrectomy, radiofrequency ablation (RFA), cryoablation, and microwave ablation for small renal masses (Uhlig, 2019). Forty-seven studies published between 2005 and 2017, with a total of 24,077 participants, were included. Of these, 24 studies conducted in 668 patients, compared cryoablation to partial or another ablative technique.
 
No significant difference in cancer-specific mortality for partial nephrectomy (p=.8065), cryoablation (p=.5519), RFA (p=.3496), and microwave ablation (p=.2920) was found. Local recurrence was higher for cryoablation, RFA, and microwave ablation compared with partial nephrectomy (respectively, incidence rate ratio=4.13; incidence rate ratio=1.79; incidence rate ratio=2.52; p<.05). There was a less pronounced decline in renal function for RFA compared with partial nephrectomy, cryoablation, and microwave (respectively, mean difference in glomerular filtration rate 6.49; 5.82; 10.89; p<.05).
 
Tang et al reported on a systematic review and meta-analysis comparing renal laparoscopic renal cryoablation with laparoscopic partial nephrectomy in the treatment of small renal masses (Tang, 2014). Reviewers identified 9 trials (2 prospective, 7 retrospective) in which the 2 techniques were assessed (555 cases, 642 controls). Laparoscopic cryoablation was associated with statistically significant shorter surgical times, less blood loss, and fewer overall complications; however, it was estimated that laparoscopic partial nephrectomy might have a significantly lower local recurrence rate (odds ratio [OR]=13.03; 95% confidence interval [CI], 4.20 to 40.39; p<.001) and lower distant metastasis rate (OR=9.05; 95% CI, 2.31 to 35.51; p=.002).
 
Klatte et al also reported on a systematic review and meta-analysis comparing laparoscopic renal cryoablation with laparoscopic partial nephrectomy for small renal tumors (Klatte, 2014). Thirteen nonrandomized studies were selected for analysis, which found cryoablation was associated with better perioperative outcomes than laparoscopic partial nephrectomy. Oncologic outcomes, however, were inferior with cryoablation, which was significantly associated with greater risk of local (relative risk, 9.39) and metastatic (relative risk, 4.68) tumor progression.
 
This section summarizes recent comparative studies of cryoablation and partial nephrectomy not included in any of the systematic reviews discussed above.
 
Andrews et al reported on 1,798 patients with primary stage 1 renal masses treated with partial nephrectomy, percutaneous RFA, or percutaneous cryoablation between 2000 and 2011 at Mayo Clinic (Andrews, 2019). A total of 1,422 patients were treated with partial nephrectomy (n=1055), RFA (n=180), or cryoablation (n=187) for stage 1a renal masses, and 376 patients were treated with partial nephrectomy (n=324) or cryoablation (n=52) for stage 1b renal masses. Comparisons of cryoablation to partial nephrectomy among 1,422 patients with stage 1a masses resulted in hazard ratios (HRs) of 1.88 (95% CI 0.76 to 4.66, p=.18), 0.23 (95% CI, 0.03 to 1.72, p=.15), and 0.29 (95% CI, 0.01 to 6.11, p=.40) for local recurrence, metastases, and death from renal cell carcinoma. Five-year cancer-specific survival was 99%, 96%, and 100% for partial nephrectomy, RFA, and cryoablation, respectively. Among 376 stage 1b patients, 324 and 52 underwent partial nephrectomy and cryoablation with median clinical follow-up of 8.7 and 6.0 years, respectively. Comparisons of cryoablation with partial nephrectomy resulted in HRs of 1.22 (95% CI, 0.33 to 4.48, p=.80), 0.95 (95% CI, 0.21 to 4.38, p>.90), and 1.94 (95% CI, 0.42 to 8.96, p=.40) for local recurrence, metastases, and death from renal cell carcinoma, respectively. Five-year cancer specific survival was 98% and 91% for partial nephrectomy and cryoablation, respectively.
 
A retrospective, nonrandomized analysis of prospectively collected data compared robot-assisted partial nephrectomy with percutaneous ablation in patients with T1b renal cell carcinoma. Rembeyo et al compared patients treated with robot-assisted partial nephrectomy (n=36), cryoablation (n=55), and RFA (n=11) (Rembeyo, 2020). Median tumor sizes in each group were 4.5, 4.6, and 4.2 cm, respectively, and median follow-up times were 23.7, 19.9, and 51.3 months. Compared with partial nephrectomy, local recurrence-free survival was significantly shorter with cryoablation (adjusted HR, 4.3; 95% CI, 1.78 to 10.37). Two-year local recurrence-free survival rates for the partial nephrectomy, cryoablation, and RFA groups were 89.1%, 73.5%, and 81.8%, respectively (p<.001).
 
A retrospective, nonrandomized study also compared partial nephrectomy with cryoablation and RFA, specifically in patients with T1aN0M0 renal cell carcinoma with tumor size 4 cm. Yan et al, using Medicare Surveillance, Epidemiology, and End Results (SEER) data, compared OS and cancer-specific survival in patients treated with partial nephrectomy (n=15,395), cryoablation (n=1,381), and RFA (n=457) (Yan, 2019). Median follow-up was 30 months in all groups. Overall survival was significantly improved with partial nephrectomy compared with cryoablation (HR, 2.995; 95% CI, 2.363 to 3.794) and RFA (HR, 4.085; 95% CI, 2.683 to 6.220). Similarly, cancer-specific survival was significantly improved with partial nephrectomy compared with cryoablation (HR, 3.562, 95% CI, 1.399 to 6.220) and RFA (HR, 3.457; 95% CI, 2.043 to 5.850). In subgroup analyses of patients with tumor size 2 cm, OS was again significantly improved with partial nephrectomy versus cryoablation (HR 1.958; 95% CI, 1.204 to 3.184) and RFA (HR, 2.841; 95% CI, 1.211 to 6.662); however, cancer-specific survival was not different. In patients with tumor size 2 to 4 cm, OS was significantly improved with partial nephrectomy versus cryoablation (HR 3.284; 95% CI, 2.513 to 4.292) and versus RFA (HR, 4.497; 95% CI, 2.782 to 7.269), as was cancer-specific survival (partial nephrectomy vs. cryoablation: HR, 3.536; 95% CI, 2.006 to 6.234; partial nephrectomy vs RFA: HR, 4.339; 95% CI, 1.573 to 11.971).
 
Another analysis of Medicare SEER data retrospectively compared partial nephrectomy with cryoablation in patients with T1b nonmetastatic renal cell carcinoma. Pecoraro et al compared patients undergoing cryoablation (n=434) with propensity score-matched patients undergoing partial nephrectomy (n=228) (Pecoraro, 2019). In patients treated with cryoablation versus partial nephrectomy at 5 years, cancer-specific mortality rates were 7.6% versus 2.8%, respectively (p=.02), and other-cause mortality rates were 17.9% versus 11.8% (p=.1). Findings were consistent in multivariable analyses, where other-cause mortality remained nonsignificant, and cryoablation was associated with higher risk of mortality (adjusted HR, 2.50).
 
There are no RCTs or comparative observational studies comparing cryoablation to active surveillance in patients with kidney cancer.
 
Although there are no systematic reviews directly comparing cryoablation with active surveillance in patients who are not surgical candidates, multiple systematic reviews of cryoablation compared to surgery or other ablative strategies have reported on outcomes in patients who received cryoablation for kidney tumors. These reviews consistently found that although oncological outcomes were better with surgery, cryoablation was associated with better perioperative outcomes, lower incidence of complications, and less decline in kidney function.
 
In a review of strategies for treating stage 1 renal cell carcinoma, Cronan et al identified 17 articles published since 2010 describing 2,320 lesions treated with cryoablation (Cronan, 2019). Mean tumor size was 2.6 cm. The overall recurrence rate was 8.1% in studies with overall median follow-up of 41.4 months, and the technical success rate was 94.3%. Five-year OS and cancer-specific survival rates were 77.1% to 97.8% and 88% to 100%, respectively. Of the 568 lesions treated since 2016, the local recurrence rate was 3.0%. Renal function was not assessed in this review.
 
Recent case series have shown cryoablation associated with good oncological outcomes and preservation of renal function.
 
In a single-center series reported by Morkos et al, 5 of 132 patients (3.8%) transitioned to hemodialysis (Morkos, 2020). The dialysis-free probability was 98% (95% CI, 0.95 to 1) at 5 years, and 95% (95% CI, 0.89 to 1) at 10 years.
 
In a series of 338 patients treated at 4 centers in Italy, Stacul et al reported that 93.3% of patients treated with cryoablation did not experience a significant decrease in renal function (Stacul, 2021).
 
Lee et al conducted a systematic review of endoscopic cryoablation of lung and bronchial tumors (Lee, 2011). Included in the review were 15 case studies and a comparative observational study. Cryoablation was performed for inoperable, advanced lung and bronchial cancers in most studies. Some studies included patients with comorbid conditions and poor general health who would not be considered surgical candidates. Complications occurred in 11.1% of patients (10 studies) and consisted of hemorrhage, mediastinal emphysema, atrial fibrillation, and dyspnea. Within 30 days of the procedure, death from hemoptysis and respiratory failure, considered to be most likely related to disease progression, occurred in 7.1% of patients.
 
Niu et al reviewed the literature on lung cryoablation and reported on their own experience with percutaneous cryoablation in 150 patients with NSCLC followed for 12 to 38 months (Niu, 2012). The study population had stage IIIB or IV lung cancer. Overall survival rates at 1, 2, and 3 years were 64%, 45%, and 32%, respectively. Thirty-day mortality was 2.6% and included cardiac arrest and hemopneumothorax. Complications included hemoptysis, pneumothorax, hemothorax, pleural effusion, and pulmonary infection.
 
The Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation (SOLSTICE) assessed the safety and local recurrence-free survival after cryoablation for treatment of pulmonary metastases. Callstrom et al performed this multicenter, prospective, single-arm, phase 2 study in 128 patients with 224 lung metastases 3.5 cm (Callstrom, 2020). Median tumor size was 1.0 cm. Local recurrence-free response was 85.1% at 12 months and 77.2% at 24 months. Secondary local recurrence-free response after retreatment with cryoablation for recurrent tumors was 91.1% at 12 months and 84.4% at 24 months. Overall survival at 12 and 24 months was 97.6% and 86.6%, respectively.
 
The Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients-Safety and Efficacy trial was a prospective, multicenter trial of cryoablation for metastatic disease in the lungs; interim results at 1-year follow-up were published by de Baere et al (de Baere, 2015). The trial enrolled 40 patients with 60 metastatic lung lesions who were treated with cryoablation and had at least 12 months of follow-up. Outcomes included survival, local tumor control, quality of life, and complications. Local tumor control was achieved in 94.2% (49/52) of treated lesions, and the 1-year OS rate was 97.5% (39/40). There were no significant changes in quality of life over the 12-month study. The most common adverse event was pneumothorax requiring chest tube intubation in 18.8% (9/48 procedures). No subsequent analyses have been identified.
 
Moore et al reported on a prospective consecutive series of 45 patients (47 tumors) managed with cryoablation during a 5-year period (2006-2011) (Moore, 2015). All patients had biopsy-confirmed early-stage (T1a and T1b) primary lung tumors and had been assessed by a tumor board to be medically inoperable. Lesions were as small as 5 mm, with an average of 1.9 cm (range, 0.5-3 cm). Cryoablation was performed under general anesthesia. The primary endpoint was the completion of the freeze-thaw cycle. Mean follow-up was 51 months, with an observed 5-year survival rate of 67.8%, 5-year cancer-specific survival rate of 56.6%, and 5-year progression-free survival rate of 87.9%. There were 7 (14.8%) local recurrences; 2 had device failure and retreatment, and another had retreatment for a tumor recurrence at 1 year after initial treatment. The ablation zone was less than 5 mm outside the margin of the tumor in 5 of the 47 treatments, and 4 of these 5 had local recurrences. Complications primarily included 19 (40%) patients with hemoptysis, 2 of which required bronchoscopy, and 24 (51%) cases of pneumothorax, 1 of which required surgical chest intubation with prolonged placement and mechanical sclerosis. These 3 (6.4%) patients were considered major complications, but there were no reports of 30-day mortality.
 
Ratko et al conducted a comparative effectiveness review on local nonsurgical therapies for stage I and symptomatic obstructive NSCLC for the Agency for Healthcare Research and Quality (Ratko, 2013). Cryoablation was included as a potential therapy for airway obstruction due to endoluminal NSCLC. The reviewers identified 1 RCT that randomly allocated patients to external beam radiation therapy or endobronchial treatment (clinician choice of any one endobronchial treatment: brachytherapy, laser therapy or cryotherapy). The trial was discontinued before completion due to lack of patient accrual, and therefore the reviewers did not include the trial in their report. Reviewers were unable to draw any conclusions about local nonsurgical therapies, including cryoablation, due to lack of quality evidence.
 
Maiwand and Asimakopoulos reported on a consecutive series of 521 patients with symptomatic obstructive tracheobronchial malignant tumors who underwent cryosurgery with a mean of 2.4 treatments per patient (Maiwand, 2004). The patients were treated between 1995 and 2003, had a mean age of 67.9 years, and 72% were diagnosed with stage IIIB or IV disease. Improvement in 1 or more symptoms (hemoptysis, cough, dyspnea, chest pain) was demonstrated in 86.0% of patients. Postoperative complications were 9%, including 21 (4%) cases of hemoptysis, 12 (2%) cases of postoperative atrial fibrillation, and 16 (3%) patients developed respiratory distress and poor gas exchange that eventually resolved. There were 7 (1.2%) in-hospital deaths (cause of death was a respiratory failure in all 7 patients).
 
Zhao and Wu reported on a systematic review of minimally invasive ablative techniques of early-stage breast cancer (Zhao, 2010). They noted that studies assessing cryoablation for breast cancer were primarily pilot and feasibility studies. Complete ablation of tumors was reported within a wide range (36%-83%). Reviewers raised many areas of uncertainty, including patient selection criteria and the ability to precisely determine the size of tumors and achieve 100% tumor cell death. They suggested minimally invasive thermal ablation techniques for breast cancer treatment, including cryoablation, be limited until results from prospective, RCTs become available.
 
A prospective, single-arm, phase 2 trial was published by Simmons et al for the American College of Surgeons Oncology Group Z1072 (Simmons, 2016). This trial enrolled 86 evaluable patients from 19 institutions with invasive ductal breast carcinoma that was 2 cm or less in size. The primary endpoint was complete ablation, defined as no residual evidence of tumor on magnetic resonance imaging. The investigators assigned a priori the success rates indicating that cryoablation would be a potentially efficacious treatment (>90%) or that the results of cryoablation would be unsatisfactory (<70%). Following cryoablation and determination of complete ablation, all patients underwent surgery according to standard protocols for treatment of early breast cancer. Of 87 cancers in 86 patients, complete ablation was achieved in 66 (75.9%; 95% CI, 67.1% to 83.2%). Most cases without complete ablation were the result of multifocal disease outside the targeted lesion.
 
Niu et al reported on a retrospective study of 120 patients with metastatic breast cancer, including 30 metastases to the contralateral breast and other metastases to the lung, bone, liver, and skin treated with chemotherapy (n=29) or cryoablation (n=91; 35 of whom also received immunotherapy) (Niu, 2013). At 10-year follow-up, the median OS of all study participants was 55 months in the cryoablation group versus 27 months in the chemotherapy group (p<.001). Moreover, the median OS was greater in patients receiving multiple cryoablation and in those receiving immunotherapy. Complications with cryotherapy to the breast included ecchymosis and hematoma, pain, tenderness, and edema; all of these complications resolved within 1 week to 1 month.
 
In a case series by Manteni et al, who assessed 15 breast cancer patients, percutaneous cryoablation was performed 30 to 45 days before surgical resection (Manenti, 2011). Resection of the lesions confirmed that complete necrosis had occurred in 14 patients, but 1 lesion had residual disease considered to be due to incorrect probe placement. In a small series of 11 patients with breast cancer tumors less than 2 cm in diameter, Pusztaszeri et al found residual tumors present in 6 cases when follow-up lumpectomies were performed approximately 4 weeks after cryoablation (Pusztaszeri, 2007). A case series by Sabel et al explored the role of cryoablation as an alternative to surgical excision as a primary treatment for early-stage breast cancer (Sabel, 2004). This phase 1 study included 29 patients who underwent cryoablation of primary breast cancers measuring less than 2 cm in diameter, followed 1 to 4 weeks later by standard surgical excision. Cryoablation was successful in patients with invasive ductal carcinoma less than 1.5 cm in diameter, and with less than 25% ductal carcinoma in situ identified in a prior biopsy specimen.
 
Other studies have described outcomes from cryosurgery for advanced primary or recurrent breast cancer (Tanaka, 1995; Pfleiderer, 2002; Suzuki, 1995; Morin, 2004). Collectively, these reports either did not adequately describe selection criteria for trial enrollees, procedure details, or procedure-related adverse events or had inadequate study designs, analyses, and reporting of results.
 
A variety of case series has focused on the role of cryosurgery as an alternative to surgical excision of benign fibroadenomas. Kaufman et al (2002-2005) have published several case series on office-based ultrasound-guided cryoablation as a treatment of breast fibroadenomas (Kaufman, 2002; Kaufman, 2004; Kaufman, 2004; Littrup, 2005; Kaufman, 2005). These case series reported on a range of 29 to 68 patients followed for 6 months to 2.6 years. It is likely that these case series included overlapping patients. At 1 year, patients reported 91% patient satisfaction and fibroadenomas became nonpalpable in 75% of cases. At follow-up averaging 2.6 years in 37 patients, the authors noted only 16% of 84% palpable fibroadenomas remained palpable after treatment and, of the fibroadenomas initially 2 cm or less in diameter, only 6% remained palpable (Kaufman, 2005). In this series, the authors also noted that cryoablation did not produce artifacts that could interfere with the interpretation of mammograms. These small case series, which were done by the same group of investigators, are inadequate to permit scientific conclusions.
 
Nurko et al reported on outcomes at 6 and 12 months for 444 treated fibroadenomas reported to the FibroAdenoma Cryoablation Treatment registry by 55 different practice settings (Nurko, 2005). In these patients, before cryoablation, 75% of fibroadenomas were palpable by the patient. Follow-up at 6- and 12-month intervals showed palpable masses in 46% and 35%, respectively. When fibroadenomas were grouped by size, the treatment area was palpable in 28% of subjects for lesions 2 cm or less in diameter and 59% for lesions more than 2 cm at 12 months.
 
Tao et al reported on a systematic review of cryoablation for pancreatic cancer (Tao, 2012). Reviewers identified 29 studies and included 5. All 5 were case series and considered of low quality. Adverse events, when mentioned, included delayed gastric emptying (0%-40.9% in 3 studies), pancreatic leak (0%-6.8% in 4 studies), biliary leak (0%-6.8% in 3 studies), and a single instance of upper gastrointestinal hemorrhage. Pain relief was reported in 3 studies and ranged from 66.7% to 100%. Median survival times reported in 3 studies ranged from 13.4 to 16 months. One-year total survival rates, as reported in 2 studies, were 57.5% and 63.6%. Keane et al reported on a systematic review of ablation therapy for locally advanced pancreatic cancer (Keane, 2014). Reviewers noted that studies had demonstrated ablative therapies, including cryoablation, are feasible, but larger studies are needed. No conclusions could be made on whether ablation resulted in better outcomes than best supportive care.
 
Li et al reported on a retrospective study of 142 patients with unresectable pancreatic cancer treated with a palliative bypass with (n=68) or without cryoablation (n=74) from 1995 to 2002 (Li, 2011). Median dominant tumor sizes decreased from 4.3 to 2.4 cm in 36 (65%) of 55 patients 3 months after cryoablation. Survival rates did not differ significantly between groups, with the cryoablation group surviving a median of 350 days versus 257 days in the group without cryoablation. Complications did not differ significantly between groups. However, a higher percentage of delayed gastric emptying occurred in the cryoablation group (36.8%) than in the group without cryoablation (16.2%).
 
A pilot study assessing combination cryosurgery plus iodine 125 seed implantation for treatment of locally advanced pancreatic cancer was reported by Xu et al (Xu, 2008). Forty-nine patients enrolled in the pilot study, and 12 had liver metastases; 20 patients received regional chemotherapy. At 3 months posttherapy, most patients showed tumor necrosis, with 20.4% having a complete response. Overall, the 6-, 12-, 24-, and 36-month survival rates were 94.9%, 63.1%, 22.8%, and 9.5%, respectively.
 
Kovach et al reported on 10 cryoablations in 9 patients with unresectable pancreatic cancer using intraoperative ultrasound guidance during laparotomy (Kovach, 2002). The authors reported adequate pain control in all patients postoperatively and no intraoperative morbidity or mortality. At publication, all patients had died at an average of 5 months postoperatively (range, 1-11 months).
 
Meller et al retrospectively analyzed a single-center experience with 440 bone tumor cryosurgery procedures performed between 1988 and 2002, two-thirds of them for primary benign-aggressive and low-grade malignant lesions, and one-third for primary high-grade and metastatic bone tumors (Meller, 2008). At a median follow-up of 7 years (range, 3-18 years), the overall recurrence rate was 8%. Based on their data, the authors suggested that the ideal case for cryosurgery is a young adult with involvement of long bone, a benign-aggressive or low-grade malignant bone tumor, a good cavity with greater than 75%-thick surrounding walls, no or minimal soft-tissue component, and at least ±1 cm of subchondral bone left near a joint surface after curettage and burr drilling.
 
Callstrom et al reported on 61 patients treated with cryoablation for pain from 69 tumors (size, 1-11 cm) metastatic to the bone (Callstrom, 2013). Before treatment, patients rated their pain with a 4+ on a 1-to-10 scale using the Brief Pain Inventory, with a mean score of 7.1 for worst pain in a 24-hour period. The mean pain score gradually decreased after cryoablation to 1.4 (p<.001) at 24 weeks for worst pain in a 24-hour period. A major complication of osteomyelitis was experienced by 1 (2%) patient.
 
Jennings et al reported on a multicenter, single-arm prospective study of 66 patients with metastatic bone disease who were treated with cryoablation, all of whom were not candidates for or had not benefited from standard therapy (Jennings, 2021). The primary endpoint was the change in pain score from baseline to week 8 and patients were followed for 24 weeks. The mean decrease in pain score from baseline to week 8 was 2.61 points (95% CI 3.45 to 1.78). Pain scores decreased further after the primary endpoint and reached clinically meaningful levels (more than a 2-point decrease) after week 8. This study was limited by its lack of a comparator, potential for selection bias, and lack of blinding combined with subjective outcome measures.
 
2017 Input
Clinical input was sought to help determine whether the use of cryoablation for individuals with non small cell lung cancer (NSCLC)who are either poor surgical candidates or who required palliation for a lesion obstructing the central airway would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from 9 respondents, including 2 specialty society-level responses, 3 physician-level responses identified by specialty societies, and 4 physicians identified by 1 health system.
 
For individuals with NSCLC who are either poor surgical candidates or who required palliation for a lesion obstructing the central airway who receive cryoablation, clinical input supports this use provides a clinically meaningful improvement in net health outcome and indicates this use is consistent with generally accepted medical practice.
 
2009 Input
In response to requests, input was received from 2 physician specialty societies (5 reviews) and from 2 academic medical centers (3 reviews) while this policy was under review in 2009. There was strong support for the use of cryoablation in the treatment of select patients with renal tumors. There also was support for its use in the treatment of benign breast disease. Reviewers generally agreed cryoablation was investigational in the treatment of pancreatic cancer.
 
American College of Radiology
The American College of Radiology Appropriateness Criteria (2009, updated 2019) for post-treatment follow-up and active surveillance of renal cell carcinoma [RCC] indicated that "Ablative therapies, such as radiofrequency ablation, microwave ablation, and cryoablation, have been shown to be an effective and safe alternative [to surgical resection] for the treatment of small, localized RCCs" (Purysko, 2019). These recommendations are based on a review of the data and consensus.
 
American Urological Association
The American Urological Association (2017) updated its guidelines on the evaluation and management of clinically localized sporadic renal masses suspicious for renal cell carcinoma (Campbell, 2017). The guideline statements on thermal ablation (radiofrequency ablation, cryoablation) are listed below.
 
Guidelines on Localized Masses Suspicious for Renal Cell Carcinoma:
  • Guideline statement 24 - Physicians should consider thermal ablation (TA) as an alternate approach for the management of cT1a renal masses <3 cm in size. For patients who elect TA, a percutaneous technique is preferred over a surgical approach whenever feasible to minimize morbidity. (Level of Recommendation Conditional; Level of Evidence C)
  • Guideline statement 25 - Both radiofrequency ablation and cryoablation are options for patients who elect thermal ablation. (Level of Recommendation Conditional; Level of Evidence C)
  • Guideline statement 27 - Counseling about thermal ablation should include information regarding an increased likelihood of tumor persistence or local recurrence after primary thermal ablation relative to surgical extirpation, which may be addressed with repeat ablation if further intervention is elected. (Level of Recommendation Strong; Level of Evidence B)
 
National Comprehensive Cancer Network
Kidney Cancer
The NCCN (v.2.2022) guidelines on kidney cancer state that "thermal ablation (cryosurgery, radiofrequency ablation) is an option for the management of patients with clinical stage T1 renal lesions. Thermal ablation is an option for masses <3 cm but may also be an option for larger masses in select patients. Ablation in masses >3 cm is associated with higher rates of local recurrence/persistence and complications. Biopsy of small lesions confirms a diagnosis of malignancy for surveillance, cryosurgery, and radiofrequency ablation strategies. Ablative techniques are associated with a higher local recurrence rate than conventional surgery and may require multiple treatments to achieve the same local oncologic outcomes. The NCCN guidelines also note that "ablative techniques such as cryo- or radiofrequency ablation are alternative strategies for selected patients, particularly the elderly and those with competing health risks." Additionally, the guidelines note that "randomized phase III comparison with surgical resection (i.e., radical or partial nephrectomy by open or laparoscopic techniques) has not been done" and "ablative techniques are associated with a higher local recurrence rate than conventional surgery and may require multiple treatments to achieve the same local oncologic outcomes” (NCCN, 2022).
 
Non-Small Cell Lung Cancer
The NCCN (v.3.2022) guidelines for NSCLC made the following relevant recommendations (NCCN, 2022):
    • Resection is the preferred local treatment modality for medically operable disease.
    • Image-guided thermal ablation (IGTA) techniques include radiofrequency ablation, microwave ablation, and cryoablation.
    • IGTA may be an option for select patients not receiving stereotactic ablative radiotherapy or definitive radiotherapy.
    • IGTA may be considered for those patients who are deemed "high risk"- those with tumors that are for the most part surgically resectable but rendered medically inoperable due to comorbidities. In cases where IGTA is considered for high-risk or borderline operable patients, a multidisciplinary evaluation is recommended.
    • IGTA is an option for the management of NSCLC lesions <3 cm. Ablation for NSCLC lesions >3 cm may be associated with higher rates of local recurrence and complications.
    • The guidelines do not separate out recommendations by ablation technique and note that "each energy modality has advantages and disadvantages. Determination of energy modality to be used for ablation should take into consideration the size and location of the target tumor, risk of complication, as well as local expertise and/or operator familiarity."
 
Cancer Pain
The NCCN Guidelines on Adult Cancer Pain (v.1.2022) do not address cryoablation specifically for pain due to bone metastases, but note that "ablation techniques may...be helpful for pain management in patients who receive inadequate relief from pharmacological therapy (NCCN, 2022).
 
Ongoing and Unpublished Clinical Trials
There is an ongoing trial for rectal cancer (NCT02399124a). The name of the trial is ICE­SECRET PROSENSE™ Cryotherapy for Renal Cell Carcinoma Trial. There is a planned enrollment of 120participants with an anticipated completion date of February 2026.

CPT/HCPCS:
0581TAblation, malignant breast tumor(s), percutaneous, cryotherapy, including imaging guidance when performed, unilateral
19105Ablation, cryosurgical, of fibroadenoma, including ultrasound guidance, each fibroadenoma
20983Ablation therapy for reduction or eradication of 1 or more bone tumors (eg, metastasis) including adjacent soft tissue when involved by tumor extension, percutaneous, including imaging guidance when performed; cryoablation
32994Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, including imaging guidance when performed, unilateral; cryoablation
50250Ablation, open, 1 or more renal mass lesion(s), cryosurgical, including intraoperative ultrasound guidance and monitoring, if performed
50542Laparoscopy, surgical; ablation of renal mass lesion(s), including intraoperative ultrasound guidance and monitoring, when performed
50593Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy

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