Introduction



[Date][Carrier Medical Director][Carrier Name][Coverage Reconsideration Department][Carrier Address]Sub:[Patient Name][Patient Id][Group No.][Claim No.:]Request for coverage for Percutaneous Cryoablation of Pulmonary Tumor(s)[Carrier Medical Director]:On [insert date of request denial], an insurance coverage denial notice was received from your company that Cryoablation of [type of pulmonary tumor] is considered experimental and medically unnecessary, hence not covered by insurance. This is a formal request to extend coverage for cryoablation of pulmonary tumor(s) for[Patient Name], who has been diagnosed with [Insert Diagnosis: LungCancer, Lung Metastases, Lung Malignancies, Including Stage].[Patient Name] has been seen and evaluated by a [Select ReferringPhysician Type: Thoracic Surgeon/Oncologist/Oncology Physician Team] who [is/are] in agreement that pulmonary tumor Cryoablation is the best treatment option for management of this lung tumor.This letter is an appeal for approval of Cryoablation for treatment of lung [and pleural metastatic disease] to be rendered at [center]. The use of Radiofrequency ablation (RFA) ablative techniques for treatment of lung cancer and metastasis has already been established. Once a candidate is deemed eligible for ablation, the choice of ablation modality should lie on the performing physician to be able to use the modality to best serve the patient with comparable efficacy and equal safety.[Patient Signature][Patient Name] IntroductionThe Society of Interventional Radiology (SIR) is a professional medical association that represents approximately 8,000 members, including most US physicians who are practicing in the specialty of vascular and interventional radiology. The society is dedicated to improving public health through pioneering advances in minimally invasive, image-guided therapies. The society appreciates the opportunity to comment on expending the coverage for percutaneous pulmonary cryoablation as a preferred ablative technique in select patient populations.Background informationThe Society of Interventional Radiology has been notified that the Medicare Administrative Contractor for Florida (First Coast) is denying coverage for cryoablation of pulmonary tumor(s) because they consider the intervention experimental and medically unnecessary. The code 32994 is listed on the noncovered services list on the local coverage determination (LCD) #L33777. This is a formal request to appeal the denial and extend coverage for percutaneous cryoablation for the treatment of primary and metastatic lung tumor(s).While the use of radiofrequency (RF) and microwave (MW) ablative techniques for the treatment of lung cancer and pulmonary metastases have already been established, cryoablation, in specific clinical scenarios, has emerged as a safer thermal ablative technology and demonstrated similar or sometimes superior efficacy. Cryoablation has proven to be a successful treatment modality in various cancer types, including breast, prostate, kidney tumors, and melanoma. Sufficient supporting research data exists to clearly define the benefits of cryoablation and allowed the AMA Current Procedural Terminology Panel to approve a Category 1 Code for percutaneous cryoablation (32994) effective for procedures performed on or after 1/1/2019.With the recent publication of the SOLSTICE1 and ECLIPSE2 trials, there is irrefutable evidence supporting the safety, efficacy, and preserving the quality of life of pulmonary cryoablation of metastatic lung nodules and masses. In addition, cryoablation has been comprehensively discussed by the expert panel during the pulmonary ablation session at the Society of Interventional Radiology (SIR) Annual Meeting, emphasizing the importance of sparing the normal parenchyma and preserving the low pulmonary reserve of these patients. Finally, the updated 2020 National Comprehensive Cancer Network (NCCN) guidelines3 specifically emphasize cryotherapy in the curative local treatment algorithm for non-small cell lung cancer. The NCCN lists image-guided thermal ablation such as cryotherapy and RF as definitive local therapy for multiple lung cancers, oligometastatic disease, and recurrent disease. For a solitary lung lesion, ablation is a method of surgical resection for patients who are high-risk or borderline operable candidates. The physician community leans heavily on the NCCN guidelines and expert opinions of professional societies like SIR. Once a candidate is deemed eligible for percutaneous thermal ablation, the choice of ablation modality should be determined by a multidisciplinary team and the performing physician to serve the patient best.Services interventions: Diagnostic and therapeuticCryoablation is a controlled image-guided percutaneous ablation technique that uses cold temperature to induce thermal injury to the target tissue. During the cryoablation, compressed non-ideal argon gas is transmitted through a closed circuit in the ablation probes expanding and cooling down the gas via the Joule-Thomson effect. This creates an ice ball zone at the active probe tip with temperatures as low as ? 170 °C.5 Cryotherapy is based on the lethal effect of repeated freeze/thaw cycles that at temperatures below – 40°C induce tumor cells death. Similar to RFA and MWA, cryoablation is recommended for lesions less than 3 cm, and requires the generation of a cryozone 1 cm beyond the radiographically imaged tumor.6 Rapid freezing results in the formation of intra- and extracellular crystals that cause protein denaturation and post-thaw cell rupture due to osmotic shifts. The additional indirect effect includes vasoconstriction and microvascular thrombosis, causing tissue ischemia and coagulative necrosis. Finally, cryoablation induces the release of inflammatory cytokines and immunologic response that may exert systemic tumoricidal effect.4,5,6 Scope and clinical indicationsLung cancer is the most common malignancy in the world and is the most common cause of cancer death. At many centers across the globe, percutaneous pulmonary cryoablation is now widely practiced locoregional technique with good safety and efficacy along with RFA.4 Thermal lung ablation can provide a cure in patients with stage I and II non-small cell lung cancer. In patients with higher stage cancer, ablation alone or in combination with other therapies can provide prolongation of survival. Palliative ablative treatments can be used in patients with large tumor burdens causing compression of vital thoracic structures or pleura and in patients with intractable hemoptysis.4,5 The minimally invasive nature of the procedure indicated explicitly in patients who are high-risk or borderline surgical candidates due to medical comorbidities, patients with low pulmonary reserve, patients with the recurrent disease following surgery, as well as in patients who refuse the surgery. Radiofrequency ablation has been used over a decade as a treatment option for lung malignancies. However, more recent ablative modalities such as microwave and cryoablation, provide more diverse and improved treatment options, especially in patients with pulmonary oligometastases. Finally, treatment of pulmonary malignancies specifically with cryoablation has been shown to improve the susceptibility of the tumor to future chemotherapy and radiotherapy as well as demonstrate synergistic effect with immunotherapy that is often used in the treatment of non-small cell lung cancer.4,5,7RationaleCryoablation has already established itself as one of the treatment modalities for prostate cancer, bone tumors, renal cell carcinoma, hepatocellular carcinoma, and fibroadenoma of the breast. The interest in the use of cryoablation in lung tumors arises from its non-inferior efficacy and safety profile as well as several advantages over other heat-based ablative modalities:Cryoablation preserves the collagenous structure of the tissues that are safer and preferred ablative modality for the treatment of central masses or masses adjacent to the chest wall, pleura, or diaphragm.4,6,8 The ability to maintain collagenous matrix architecture also decreases the risk of life-threatening delayed hemorrhage from pulmonary artery pseudoaneurysms.4, 9Procedure-associated pain is significantly decreased due to an inherent analgesic effect of cold on the intercostal nerves.5, 6, 8, 10, 11 Minimal sedation is well tolerated by conscious patients during percutaneous cryoablation and can be a treatment option for patients with increased risk of general anesthesia.8Cryoablation provides real-time CT visualization of the cryozone ice ball during the procedure that well correlates with the pathologic zone of ablation and allows for superior operator control and precision during the procedure.4,5, 6, 11 This is especially advantageous in the treatment of tumors abutting the critical thoracic structures such as aorta, trachea, airways, and other large vessels.Unlike heat-based ablation techniques, cryoablation causes a significant systemic antitumor immune response. In cryotherapy, tumor cells die by both necrosis and apoptosis inducing the release of tumor-associated antigens and proinflammatory factors into the microenvironment allowing the immune system to induce an immune-specific reaction. This allows to also treat cancer cells outside of the ablated tissue, known as the abscopal effect, decreasing the rate of recurrence and metastatic disease. This effect is particularly relevant for non-small cell lung cancer (NSCLC) treated with targeted immunotherapy, where the synergistic effect of two treatment modalities demonstrates excellent results for nonresponding metastases.4, 7, 12Contrary to microwave and radiofrequency modalities, cryoablation does not interfere with pacemakers and defibrillators and can be safely used in this patient population.5Current data:Two prospective multi-center clinical trials, ECLIPSE2 and SOLSTICE1, have been reported evaluating the use of percutaneous pulmonary cryoablation for metastatic lung lesions. The ECLIPSE2 trial was conducted to assess the feasibility, safety, and local tumor control of cryoablation for the treatment of pulmonary metastases. It was a HIPAA compliant, IRB-approved, multi-center, prospective, single-arm study that included 40 patients with 60 lung metastases treated during 48 cryoablation sessions. Currently, the results from a minimum of 12 months of follow-up are available and published: , patients were enrolled according to the following key inclusion criteria: 1 to 5 metastases from extrapulmonary cancers, with a maximal diameter of 3.5 cm. Local tumor control, disease-specific and overall survival rates were estimated using the Kaplan–Meier method. Complications and changes in physical function and quality of life were also evaluated using the Karnofsky performance scale, Eastern Cooperative Oncology Group performance status classification, and Short Form-12 health survey. Patients were 62.6 ± 13.3 years old (26–83). The most common primary cancers were colon (40%), kidney (23%), and sarcomas (8%). The mean size of metastases was 1.4 ± 0.7 cm (0.3–3.4), and metastases were bilateral in 20% of patients. Cryoablation was performed under general anesthesia (67%) or conscious sedation (33%). Local tumor control rates were 56 of 58 (96.6%) and 49 of 52 (94.2%) at 6 and 12 months, respectively. The patient's quality of life was unchanged over the follow-up period. One-year overall survival rate was 97.5%. The rate of pneumothorax requiring chest tube insertion was 18.8%. There were three Common Terminology Criteria for Adverse Events grade 3 procedural complications during the immediate follow-up period (pneumothorax requiring pleurodesis, noncardiac chest pain, and thrombosis of an arteriovenous fistula), with no grade 4 or 5 complications.2The SOLSTICE1 trial was a multi-center, prospective trial conducted to assess the safety and local recurrence-free survival in patients following cryoablation for treatment of pulmonary metastases: multi-center, prospective, single-arm, phase II study included 128 patients with 224 lung metastases treated with percutaneous cryoablation, with 12- and 24-months follow-up. Patients were enrolled according to the following key inclusion criteria, including 1 to 6 metastases from extrapulmonary cancers with a maximal diameter of 3.5 cm. Time to progression of the index tumor(s), and metastatic disease and overall survival rates were estimated using the Kaplan–Meier method. Complications were captured for 30 days post-procedure, and changes in performance status and quality of life were also evaluated. The median size of metastases was 1.0 ± 0.6 cm (0.2–4.5) with a median number of tumors of 1.0 ± 1.2 cm (1–6). Local recurrence-free response (local tumor efficacy) of the treated tumor at 12 months was 172 of 202 (85.1%) and 139 of 180 (77.2%) at 24 months following the initial treatment and, following a second cryoablation treatment for recurrent tumor, secondary local recurrence-free response (local tumor efficacy) at 12 months of 184 of 202 (91.1%) and 152 of 180 (84.4%) at 24 months. Kaplan-Meier estimates of 12- and 24-months overall survival rate was 97.6% (95% CI: 92.6, 99.2) and 86.6% (95% CI: 78.7, 91.7), respectively. The rate of pneumothorax requiring pleural catheter placement was 26% (44/169). There were 8 grade 3 complication events during 169 procedures (4.7%) and one (0.6%) grade 4 event.1SIR coverage recommendations for change in policy's current methodologyThe prospective multi-center clinical trials as well as multiple peer-reviewed studies and metanalyses indicate efficacy and safety of pulmonary percutaneous cryoablation that are comparable to those of radiofrequency ablation. Notably, none of the studies suggest that pulmonary cryoablation is less effective than RF ablation, which is approved for payment by CMS and other private insurance companies. The Society of Interventional Radiology recommends to expend the coverage for percutaneous pulmonary cryoablation as a preferred ablative technique in select patient populations and, once a candidate is deemed eligible for percutaneous thermal ablation, to leave the decision of ablative modality to the operating physician to serve the best patient outcome.Thus, it is in this regard that this appeal is written for reconsideration and the ultimate reversal of the decision of ineligibility for percutaneous pulmonary cryoablation rendered. Appendix 1: Additional Evidence Table: Pulmonary CryoablationStudy IDMethodPatient CharacteristicsIntervention(s)Results primary outcomeResults secondary and other outcomesCritical appraisal of review qualityAarts, B. M., Klompenhouwer, E. G., Rice, S. L., Et. al. (2019). Cryoablation and immunotherapy: An overview of evidence on its synergy. Insights into Imaging, 10(1), 53. Design: Systematic Review n = n/aSources of funding: undisclosedEligibility criteria: Available publications between 2001-2017 about cryoablation, its effect on the immune system and the combination of cryoablation and immunotherapyPatient Characteristics: Review of 45 Studies; 28 Mice Studies + 17 Human StudiesCryoablation and cryoablation with immunotherapy41/45 publications show favorable effects for cryoablation when combined with other therapies, potentially enhancing the anti-cancer immune response. This emphasizes the potential advantage of this ablation technique as an adjunct with immunotherapy.Technical success of procedure: not reported30-day mortality: not reportedProcedure-related morality: not reportedLevel of Evidence:CCallstrom, M. R., Woodrum, D. A., Nichols, F. C., Et. al. (2020). Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation (SOLSTICE). Journal of Thoracic Oncology, 15(7), 1200–1209. Study Design: Prospectiven = 128, 226 tumorsSources of funding: N/AMulti-center, Single arm. 10 centers including 2 in Europe and 8 in the United States.Eligibility criteria: 1 to 6 metastases from extrapulmonary cancers with a maximal diameter of 3.5 cm.Patient Characteristics: Mean age: 65 ± 12 (32-85). 53% Male, 47% FemaleCryoablation for pulmonary metastasesPercutaneous cryoablation is a safe and effective treatment for pulmonary metastases.Technical success of procedure: Technical success was achieved in 97.2 % (217/224) of evaluable tumors.30-day mortality: noneProcedure-related morality: noneNo reported adverse effectsLevel of Evidence:CChoe, Y. H., Kim, S. R., Lee, K. S., Et. al. (2009). The use of PTC and RFA as treatment alternatives with low procedural morbidity in non-small cell lung cancer. European Journal of Cancer, 45(10), 1773–1779. Study Design Prospective Studyn = 65Sources of funding: grant from the Korea Health- care Technology R&D Project, Ministry for Health, Welfare and Family Affairs, Republic of KoreaEligibility criteria: n/aPatient Characteristics: 53% Male, 12% Female. Mean age: 68.4 ± 10.181.5% Male, 18.5% Female.Percutaneous thoracic cryotherapy (PTC) and radiofrequency ablation (RFA)67 sessions of RFA and 9 sessions of PTC.RFA and percutaneous cryoablation are promising treatment modalities for pulmonary malignant tumors with satisfactory outcome of tumor destruction, especially for tumors less than or equal to 3.0 cm in diameter.Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aThe complete ablation rate for the target lesions by RFA or PTC was significantly higher in smaller sized tumors than those in tumors larger than 3.0 cmLevel of Evidence: DChou, H.-P., Chen, C.-K., Shen, S.-H., Et. al. (2015). Percutaneous cryoablation for inoperable malignant lung tumors: Midterm results. Cryobiology, 70(1), 60–65.Design: Retrospectiven = 26 Sources of funding: undisclosedEligibility criteria: Eligibility criteria: (1) multiple prior surgical resections with recurrence; (2) advanced age; (3) poor lung function; (4) refuse to surgery; (5) comorbidities not suitable for surgery; (6) synergic with chemo- therapy for advanced disease; and (7) palliative for tumor volume reduction. Patient Characteristics:Percutaneous CT-guided cryoablation for 45 malignant lung tumors 41 sessions from 2009 to 2013 were performed. Mean Age: 65±18. 81% Male, 19% Female.Cryoablation for malignant lung tumors.Cryoablation for malignant lung tumors is effective and feasible in local control of tumor growth, with good short- to mid-term survival rate, as an alternative option for inoperable patients.Technical success of procedure: not reported30-day mortality: noneThere was no procedural-related mortality. Overall survival rate of 1, 2, 3 years are 96%, 88%, 88%. For curative intent, local tumor control (LTC) rate of 1, 2, 3 years are 75%, 72%, 72%.Level of Evidence: DEiken, P. W., & Welch, B. T. (2019). Cryoablation of Lung Metastases: Review of Recent Literature and Ablation Technique. Seminars in Interventional Radiology, 36(04), 319–325.Study Design: Prospective Review n = n/aSources of funding: undisclosedEligibility criteria: n/aPatient Characteristics: n/aStereotactic body radiation therapy (SBRT) and image-guided thermal ablation (IGTA)An increasing volume of literature supports the use of local therapy for patients with oligometastatic and oligoprogressive disease in the lung.No patient had any complications.Technical success of procedure: not reported30-day mortality: noneProcedure-related morality: noneNo reported adverse effectsLevel of Evidence: DGao, W., Guo, Z., Shu, S., Et. al. (2018). The application effect of percutaneous cryoablation for the stage IIIB/IV advanced non-small-cell lung cancer after the failure of chemoradiotherapy. Asian Journal of Surgery, 41(6), 530–536.Study Design: Retrospective Review n=22Sources of funding: None reportedEligibility criteria: n/aPatient Characteristics: 22 cases with stage IIIB/IV advanced NSCLC after failure of chemoradiotherapy were enrolled.Percutaneous cryoablation on the stage IIIB/IV advanced non-small-cell lung cancer (NSCLC) after the failure of chemoradiotherapy.(n=379) 72% recipients obtaining an average of 86% reduction in pain for a period of 12 months. Technical success of procedure: 100%30-day mortality: noneProcedure-related morality: noneDecreased scores of total quality of life at one week after cryoablation (P = 0.006), but increased scores at one month after cryoablation (P = 0.024) were observed, compared with pre-cryoablation.Level of Evidence:D Inoue, M., Nakatsuka, S., Yashiro, H., Et. al. (2012). Percutaneous Cryoablation of Lung Tumors: Feasibility and Safety. Journal of Vascular and Interventional Radiology, 23(3), 295–302. Study Design: Prospective Clinical Trialn=117Sources of funding: None reportedEligibility Criteria: (i) surgical unsuitability because of multiple previous thoracotomies, tumor multifocality, refusal of surgery, respiratory dysfunction, or advanced age; (ii) projected life expectancy greater than 1 year; (iii) absence of active extrapulmonary metastasisPatient Characteristics: This study included 193 cryoablation sessions for 396 lung tumorsPercutaneous cryoablation for lung tumorPercutaneous cryoablation for lung tumor could be performed minimally invasively with acceptable rates of complications. CTCAE grade 4 and 5 complications were not observed.Technical success of procedure: not reported30-day mortality: noneProcedure-related morality: noneLevel of Evidence:DJones, G. C., Kehrer, J. D., Kahn, J., Et. al. (2015). Primary Treatment Options for High-Risk/Medically Inoperable Early Stage NSCLC Patients. Clinical Lung Cancer, 16(6), 413–430.Study Design: Reviewn=n/aFunding: NoneEligibility Criteria: Studies were limited to those reported in the English language and involving human subjects. Review articles and original data from the last 30 years were reviewed independently.Patient Characteristics: n/aSublobar resection with or without intraoperative brachytherapy, radiofrequency ablation, microwave ablation, percutaneous cryoablation, photodynamic therapy, and stereotactic body radiotherapy.Early stage NSCLC deemed to be at high risk or medically inoperable, or patients who otherwise refuse lobectomy, have new options for treatment with evidence to support promising results and manageable toxicities.Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aRFA and SBRT, provide options for patients unable to undergo lobectomy or even limited resection, and they allow for the possibility of improved LC and OS compared to historical controls.Level of Evidence:C Lin, M., Liang, S.-Z., Wang, X.-H., Et. al. (2017). Clinical efficacy of percutaneous cryoablation combined with allogenic NK cell immunotherapy for advanced non-small cell lung cancer. Immunologic Research, 65(4), 880–887. Study Design: prospective clinical trialn = 60Funding: International Scientific Fund of Fuda Cancer Hospital, Guangzhou, ChinaConflicts of interest: Authors declare that they have no conflict ofEligibility Criteria: (1) expected survival >3 months; (2) aged between 30 and 80 years; (3) Karnofsky performance status >60; (4) all patients had confirmed NSCLC by pathology; and (5) the absence of level 3 hypertensionPatient Characteristics: Cryoablation (n = 30)M/F= 16/14, Median age, 53.Cryo-NK (n = 30)M/F= 12/18, Median age, 47.Cryosurgery with allogenic NK cell immunotherapy for the treatment of advanced non-small cell lung cancer (NSCLC)Cryoablation showed a safety and efficacy to advanced NSCLC patients for short-term observation.Technical Success: 100%30-day mortality: n/aProcedure-related Mortality: NoneLevel of EvidenceDLyons, G. R., Askin, G., & Pua, B. B. (2018). Clinical Outcomes after Pulmonary Cryoablation with the Use of a Triple Freeze Protocol. Journal of Vascular and Interventional Radiology, 29(5), 714–721. Study Design: Clinical Trialn = 42Sources of funding: None reportedEligibility Criteria:n/aPatient Characteristics: Average patient age was 68.1 years (range 39.6–89.6), and the male-female ratio was 1.3:1Cryoablation of pulmonary tumors with the use of a triple freeze protocol.Cryoablation of pulmonary tumors with the use of a triple freeze protocol is a viable modality with low recurrence and complication rates.Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aPneumothorax occurred in 19 cases (33.9%), 7 (12.5%) requiring chest tube, the likelihood of which was significantly greater in patients with 3 or more cryoprobes (P < .01).Level of EvidenceDMcDevitt, J. L., Mouli, S. K., Nemcek, A. A., Et. al. (2016). Percutaneous Cryoablation for the Treatment of Primary and Metastatic Lung Tumors: Identification of Risk Factors for Recurrence and Major Complications. Journal of Vascular and Interventional Radiology, 27(9), 1371–1379.Study Design: Retrospective Reviewn = 46Sources of funding: None reportedEligibility Criteria: n/aPatient Characteristics: 31% over 71, 69% at or under 70. 57% femalePercutaneous cryoablation of lung tumorsPercutaneous cryoablation is more efficacious and has fewer complications when offered to patients with small, previously untreated lesions. Percutaneous cryoablation of lung tumors is technically feasible with a complication rate comparable to other percutaneous ablation techniques. Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aMajor complications (occurred in 12 (25%) cases, and minor complications occurred in 13 (27%) cases. Median time to local progression was 14 months (16 mo for primary tumors and 10 mo for metastatic tumors), and median overall survival was 33 months (43 mo for patients with primary tumors and 22 mo for patients with metastatic tumors).Level of EvidenceCMoore, W., Talati, R., Bhattacharji, P., Et. al. (2015). Five-Year Survival after Cryoablation of Stage I Non–Small Cell Lung Cancer in Medically Inoperable Patients. Journal of Vascular and Interventional Radiology, 26(3), 312–319.Study Design: Retrospective Reviewn = 45Sources of funding: None reportedEligibility Criteria: n/aPatient Characteristics: 47 T1N0M0 NSCLCs in 45 consecutive patients between 2006 and January 2011. All ablative procedures were performed with 16-gauge or 13-gauge cryoprobes.Cryoablation on NSCLCCryoablation is a potentially curative, viable therapeutic option for patients with stage I NSCLC who are deemed medically inoperable. Cryoablation is associated with a good overall long-term survival with minimally significant complications.Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aLevel of EvidenceDPusceddu, C., Sotgia, B., Fele, R. M., Et. al. (2013). CT-guided thin needles percutaneous cryoablation (PCA) in patients with primary and secondary lung tumors: A preliminary experience. European Journal of Radiology, 82(5), e246–e253.Study Design: Retrospective Reviewn = 32Sources of funding: None reportedEligibility Criteria: n/aPatient Characteristics: (24 men and 8 women; mean age 67?±?10 years) not suitable for surgical resection.CT-guided thin cryoprobes for percutaneous cryoablationPreliminary experience suggests that PCA is a feasible treatment option.Technical success of procedure: Technical success 82%, 97% and 91% of treated lesions at 1-, 3- and 6-months CT follow-up scan, respectively ( p?<?.000). Morbidity consisted of 21% (7 of 34) pneumothorax and 3% (1 of 34) cases asymptomatic small pulmonary hemorrhage, respectively, all of CTCAE grade 1Level of Evidence DQiu, B., Liang, Y., Li, Q., Et. al. (2017). Local Therapy for Oligoprogressive Disease in Patients With Advanced Stage Non–small-cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation. Clinical Lung Cancer, 18(6), e369–e373. Study Design: Retrospective Reviewn = 46Sources of funding: None reportedEligibility Criteria: n/aPatient Characteristics: This cohort included 46 patients, with 28 females and 18 males. The median age was 54 years (range, 33-71 years). Thirty-eight (82.6%) patients had an ECOG PS of 0 to 1, and 8 patients had an ECOG PS of 2. Six (34.0%) and 40 (66.0%)Local therapy (LT) for oligoprogressive epidermal growth factor receptor (EGFR)-mutatednonesmall-cell lung cancer (NSCLC)This study revealed that LTs are feasible and effective for EGFR-mutated NSCLC with oligoprogression.Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aWith a median follow-up of 32 months, the 2-year OS was 65.2%, and the estimated OS was 35.0months. The median OS after LT (LT-OS) was 13.0 months. The median PFS after LT (LT-PFS) was 7.0 months. Level of EvidenceDWang, H., Littrup, P. J., Duan, Y., Et. al. (2005). Thoracic Masses Treated with Percutaneous Cryotherapy: Initial Experience with More than 200 Procedures. Radiology, 235(1), 289–298.Study Design: Prospective Clinical Studyn = 187Sources of funding: None reportedEligibility criteria: They had (a) single or multiple peripheral lung masses larger than 1.0 cm in diameter, with previous therapies having failed; (b) nonresectable (c) fewer than four metastases to the lung with controlled primary cancer; (d) a mass or adenopathy involving the mediastinum (e) malignant pleural effusion.Patient Characteristics: Mean age was 61 years (range, 41– 83 years). 73% Male. 27% Female.Percutaneous cryotherapy (PCT) of the thoraxCT-guided PCT yielded low procedural morbidity given the extent of freezing, even near mediastinal structures.Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aThe overall rate of pneumothorax was only 12% (22 of 187 patients), and other side effects appeared to be self limited.Level of EvidenceCYamauchi, Y., Izumi, Y., Hashimoto, K., Et. al. (2012). Percutaneous Cryoablation for the Treatment of Medically Inoperable Stage I Non-Small Cell Lung Cancer. PLoS ONE, 7(3), e33223.Study Design: Prospective Clinical Studyn = 22Sources of funding: None reportedEligibility Criteria: Patients who were considered medically inoperable because of risks such as impaired cardiac function, poor pulmonary function, and/or other comorbidities.Patient Characteristics: 50/50 Male/Female. Median age: 72Percutaneous cryoablation for medically inoperable stage I non-small cell lung cancer.cryoablation may be a feasible option in medically inoperable stage I lung cancer patients.Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aComplications were pneumothoraces in 7 treatments (28%, chest tube required in one treatment), and pleural effusions in 8 treatments (31%). The observation period ranged from 12–68 months, average 29619 months, median 23 months.Level of Evidence DYamauchi, Y., Izumi, Y., Kawamura, M., Et. al. (2011). Percutaneous Cryoablation of Pulmonary Metastases from Colorectal Cancer. PLoS ONE, 6(11), e27086.Study Design: Prospective Clinical Studyn = 24Sources of funding: This study was supported by grants (#21591823 and #22591374) to MK and to SN respectively, from the Japanese Ministry of Education, Culture, Sports, Science and Technology.Eligibility Criteria: A patient was deemed non-surgical due to any of the following: (1) multiple previous thoracotomies (2) multifocal disease (3) concomitant tumors (4) patient refused surgery, (5) respiratory dysfunction, or (6) advanced age.Characteristics: (36–82 years of age, median age: 62 years; 17 male patients, 7 female patients) for 55 metastatic lung tumors from colorectal cancer in 30 sessionsCryoablation for metastatic lung tumors from colorectal cancer.The results indicated that percutaneous cryoablation is a feasible treatment option. The local progression free interval was satisfactory at least for tumors that were ≤15 mm in diameter.Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aLevel of EvidenceDAPPENDIX 2: References from Policy DenialStudy IDMethodPatient CharacteristicsIntervention(s)Results primary outcomeResults secondary and other outcomesCritical appraisal of review qualityAbtin, F. G., Eradat, J., Gutierrez, A. J., Et. al. (2012). Radiofrequency Ablation of Lung Tumors: Imaging Features of the Postablation Zone. RadioGraphics, 32(4), 947–969. Study Design: Article/Case Seriesn = n/aSources of funding: National Institutes of HealthEligibility Criteria: n/aPatient Characteristics: n/aRadiofrequency ablationReliable imaging surveillance after RFA is essential for the success of the treatment.Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aLevel of Evidence:DAlexander, E., & Dupuy, D. (2013). Lung Cancer Ablation: Technologies and Techniques. Seminars in Interventional Radiology, 30(02), 141–150. Design: Articlen = n/aSources of funding: UndisclosedEligibility Criteria: n/aPatient Characteristics: n/aAvailable technologies and techniques available for tumor ablation of thoracic malignanciesGiven the high rates of mortality attributable to lung cancer, the emergence of new and efficacious treatment options remains a priority.Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aLevel of Evidence:EBeland, M. D., Wasser, E. J., Mayo-Smith, W. W., Et. al. (2010). Primary Non–Small Cell Lung Cancer: Review of Frequency, Location, and Time of Recurrence after Radiofrequency Ablation. Radiology, 254(1), 301–307.Study Design: Retrospective Reviewn = 79, 79 tumorsSources of funding: UndisclosedEligibility Criteria: From departmental ablation database, all patients with primary NSCLC who had undergone lung RF ablation from Jan 1998 to Jan 2008.Patient Characteristics: Mean age 75. Tumor size: 62 at 1-3cm and 17 >3cm. There were 15 (19%) central tumors and 64 (81%) peripheral tumors.NSCLC treated with percutaneous image-guided radiofrequency ablationThe most common pattern of recurrence was local, which suggests that more aggressive initial RF ablation and adjuvant radiation may offer improvement in outcomes.Technical success of procedure: Unreported30-day mortality: n/aProcedure-related morality: n/aLevel of Evidence:DChua, T. C., Sarkar, A., Saxena, A., Et. al. (2010). Long-term outcome of image-guided percutaneous radiofrequency ablation of lung metastases: An open-labeled prospective trial of 148 patients. Annals of Oncology, 21(10), 2017–2022. Study Design: CT, non-randomizedn = 148Sources of funding: UndisclosedEligibility Criteria: (i) age 18-85; (ii) early-stage non-small-cell lung carcinoma pulmonary metastases (iii) patient refusing to undergo surgery. Patient Characteristics: 56% Male, 44% Female. 98 Patients >60; 50 at or under 60 years.Image-guided percutaneous radiofrequency ablation (RFA) of lung metastases188 RFA Procedures. Of 148 patients, 46% complete response, 26% partial response, 39% had stable disease and 16% had progressive disease. Median progression-free survival was 11 months [95% CI 9–14].Technical success of procedure: Unreported30-day mortality: n/aProcedure-related morality: n/aLevel of Evidence: Cde Baere, T., Tselikas, L., Woodrum, D., Et. al. (2015). Evaluating Cryoablation of Metastatic Lung Tumors in Patients—Safety and Efficacy The ECLIPSE Trial—Interim Analysis at 1 Year. Journal of Thoracic Oncology, 10(10), 1468–1474. Study Design: Prospective Studyn = 40, 60 tumorsSources of funding: UndisclosedEligibility Criteria: 1-5 metastases from extrapulmonary cancers, with a maximal diameter of 3.5 cm. Local tumor control, disease-specific and overall survival rates were estimated using the Kaplan–Meier method.Patient Characteristics: Patients were 62.6 ± 13.3 years old (26–83). The most common primary cancers were colon (40%), kidney (23%), and sarcomas (8%). Mean size of metastases was 1.4 ± 0.7 cm (0.3–3.4). 60% Male and 40% Female.Safety and local tumor control of cryoablation for treatment of pulmonary metastasesCryoablation was performed under general anesthesia (67%) or conscious sedation (33%). Local tumor control rates were 56 of 58 (96.6%) and 49 of 52 (94.2%) at 6 and 12 months, respectively. Technical success of procedure: Unreported30-day mortality: n/aProcedure-related morality: n/aOne-year overall survival rate was 97.5%. The rate of pneumothorax requiring chest tube insertion was 18.8%.Level of Evidence:DKawamura, M., Izumi, Y., Tsukada, N., Et. al. (2006). Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. The Journal of Thoracic and Cardiovascular Surgery, 131(5), 1007–1013.Study Design: Prospective Studyn = 20, 35 tumorsSources of funding: UndisclosedEligibility Criteria: (1) tumor at or less than 3 cm in diameter; (2) <5 metastatic tumors; (3) projected life expectancy < 1 year; (4) absence of active extrapulmonary metastasis; (5) performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale; (6) pathologic diagnosis of a metastatic tumor or obvious clinical features of pulmonary metastasis;Patient Characteristics: 12 male and 8 female patients; mean age, 57 years.Cryoablation of pulmonary metastasesPercutaneous cryoablation therapy for metastatic lung tumors is feasible and minimally invasive, with satisfactory local control.Technical success of procedure: Unreported30-day mortality: n/aProcedure-related morality: n/a22 sessions, pneumothorax occurred in 11, hemoptysis in 8, and 1 case of phrenic nerve palsy. Mean hospital stay was 2.6 days. Local recurrence of 7 tumors in 7 patients during a 9-28-month follow-up. 1 year survival was 89.4%Level of Evidence:DSimon, C. J., Dupuy, D. E., DiPetrillo, T. A., Et. al. (2007). Pulmonary Radiofrequency Ablation: Long-term Safety and Efficacy in 153 Patients. Radiology, 243(1), 268–275. Study Design: Retrospective Studyn = 153, 189 tumorsSources of funding: UndisclosedEligibility Criteria: Nov 1998 to Aug 2005, consecutive patients with primary NSCLCs or metastatic lung cancers who underwent percutaneous CT-guided RF ablation sessions.Patient Characteristics: Mean age, 68.5 years; Range 17–94. 56.8% Male, and 43.2% Female.CT-guided pulmonary tumor radiofrequency ablationsLung RF ablation appears to be safe and linked with promising long-term survival and local tumor progression outcomes, especially given the patient population treated.Technical success of procedure: 159 (98.1%) of 162 tumors ablated for local control.30-day mortality: 3.9% (six of 153 patients)Procedure-related morality: 2.6% (four of 153 patients)Level of Evidence:DSonntag, P. D., Hinshaw, J. L., Lubner, M. G., Et. al. (2011). Thermal Ablation of Lung Tumors. Surgical Oncology Clinics of North America, 20(2), 369–387.Study Design: ReviewRF Ablation Studies:n = 527, 10 studiesMW Ablation:n = n/aCryoablation:n = n/aSources of funding: UndisclosedEligibility Criteria: n/aPatient Characteristics: n/aThis article discusses the unique challenges of performing thermal ablation in lung tissue and reviews the current literature regarding RF, MW, and cryoablation in the lung.The 5-year survival of all stages of NSCLC remains bleak, having only increased from 13% to 16% over the past 30 years. RF ablation, MW ablation, and cryoablation are each intriguing possibilities with some track record in patients with NSCLC and pulmonary metastatic disease who are poor surgical candidatesTechnical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aLevel of Evidence:CZemlyak, A., Moore, W. H., & Bilfinger, T. V. (2010). Comparison of Survival after Sublobar Resections and Ablative Therapies for Stage I Non?Small Cell Lung Cancer. Journal of the American College of Surgeons, 211(1), 68–72. Study Design: ReviewSLR:n = 25RFA:n = 12PCT:n = 27Sources of funding: UndisclosedEligibility Criteria: n = 64; Stage I NSCLC treated at Stony Brook University Hospital 2003-2008.Patient Characteristics:SLR:44% male, 56% female; Age: median 66; 49-85.RFA:67% male, 33% female; Age: median 74; 62-83.PCT:59% male, 41% female; Age: median 74; 59-88.Sublobar resections (SLR):Radiofrequency ablation (RFA):Percutaneous cryablation therapy (PCT):in treatment of stage I NSCLC.Suggest comparable survival after SLR and ablative therapies at 3 years. Ablative therapies appear to be a reasonable alternative in high-risk patients not fit for surgery. Larger randomized studies with longer follow-up are needed.Technical success of procedure: n/a30-day mortality: n/aProcedure-related morality: n/aAll p values >0.05Local Recurrence:SLR: 12%RFA: 33%PCT: 11%Complications:Pneumothorax:SLR: 0%RFA: 58%PCT: 37%Hemoptysis:SLR: 0%RFA: 8.3%PCT: 22%Level of Evidence:CAuthorsSIR's Carrier Advocacy Workgroup (CAW)Chair/Steering: C. Matthew Hawkins, MD, FSIR.Workgroup members: Curtis L. Anderson, MD, Ph.D.; Jacob Bundy, MD; Evan W. Harris, MD; Caleb Heiberger, MD; Robert J. Kennedy, MD; Minhaj S. Khaja, MD, MBA, FSIR; Nishita Kothary, MD, FSIR; Gary (Harry) Kramer, Oleksandra Kutsenko, MD; Michelle Shnayder, MD; Dave M. Tabriz, MD. Consulting: Meridith J. Englander, MD, FSIR; Raymond W. Liu, MD, FSIR; Waleska M. Pabon-Ramos, MD, MPH, FSIR; Keith M. Sterling, MD, FSIR; Rajesh Shah, MD, FSIR; Adam D. Talenfeld, MD, FSIR; and the SIR Service Line Advisers. Staff support: Miata Koroma, Caleb Gilbert.Financial statementsThese coverage recommendations were developed in their entirety by the Society of Interventional Radiology (SIR). All participating authors have disclosed potential conflicts of interest consistent with SIR's disclosure policy. MethodologySIR coverage policy methodology: Carrier advocacy workgroup is to address urgent carrier advocacy issues by reviewing existing research and coverage caps within specific policies. Each workgroup is assigned tasks every week. The chair and staff liaison have weekly conference calls to divvy up the work assigned to the volunteers. The committee holds a monthly conference call to review and approve the weekly submissions. The group hosts twice a year for an in-person mentsComments regarding the coverage recommendations may be submitted to economics@ and will be considered in the development of future revisions of the work.Disclaimer: Disclaimer: This coverage recommendation is proprietary information owned by the Society of Interventional Radiology (SIR). SIR members and other lawful purchasers of this document are authorized to use this recommendation for personal use only. Distribution beyond the member or purchaser's personal use is expressly forbidden, absent written consent from SIR. SIR coverage recommendations should not be construed as including all proper methods of care or excluding other acceptable practices of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment is to be made by the physician and patient in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. The coverage recommendations do not represent a "standard of care," nor are they intended as a fixed treatment protocol. It is anticipated that there will be patients who will require less or more treatment than the average. It is also acknowledged that in atypical cases, treatment falling outside these criteria will sometimes be necessary. This document should not be seen as prescribing the type, frequency or duration of intervention. Treatment and accompanying payment should be based on this information in addition to an individual patient's needs as well as the doctor's professional judgment and experience. This document is designed to function as a guide and should not be used as the sole reason for denial of treatment and services. It is not intended to supersede applicable ethical standards or provisions of law. This is not a legal document.ReferencesCallstrom, M.R., Woodrum, D.A., Nichols, F.C., Palussiere, J., Buy, X., Suh, R.D., Abtin, F.G., Pua, B.B., Madoff, D.C., Bagla, S.L. and Papadouris, D.C., 2020. Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation (SOLSTICE). Journal of Thoracic Oncology.De Baere, T., Tselikas, L., Woodrum, D., Abtin, F., Littrup, P., Deschamps, F., Suh, R., Aoun, HD and Callstrom, M., 2015. Evaluating cryoablation of metastatic lung tumors in patients—safety and efficacy the ECLIPSE trial—interim analysis at 1 year. Journal of Thoracic Oncology, 10(10), pp.1468-1474.NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. Version 6.2020 – June 15, 2020. accessed 7/17/2020.Tafti BA, Genshaft S, Suh R, Abtin F. Lung Ablation: Indications and Techniques. Semin Intervent Radiol. 2019;36(3):163–175. doi:10.1055/s-0039-1693981Robert Sheu Y, Hong K. Percutaneous lung tumor ablation. Tech Vasc Interv Radiol. 2013;16(4):239–252. doi:10.1053/ir.2013.09.001Jones, G. C., Kehrer, J. D., Kahn, J., Koneru, B. N., Narayan, R., Thomas, T. O., Camphausen, K., Mehta, M. P., & Kaushal, A. (2015). Primary Treatment Options for High-Risk/Medically Inoperable Early Stage NSCLC Patients. Clinical Lung Cancer, 16(6), 413–430.Aarts, B. M., Klompenhouwer, E. G., Rice, S. L., Imani, F., Baetens, T., Bex, A., Horenblas, S., Kok, M., Haanen, J. B. A. G., Beets-Tan, R. G. H., & Gómez, F. M. (2019). Cryoablation and immunotherapy: An overview of evidence on its synergy. Insights into Imaging, 10(1), 53. , H., Littrup, P. J., Duan, Y., Zhang, Y., Feng, H., & Nie, Z. (2005). Thoracic Masses Treated with Percutaneous Cryotherapy: Initial Experience with More than 200 Procedures. Radiology, 235(1), 289–298.Eiken, P. W., & Welch, B. T. (2019). Cryoablation of Lung Metastases: Review of Recent Literature and Ablation Technique. Seminars in Interventional Radiology, 36(04), 319–325. YH, Kim SR, Lee KS, Lee KY, Park SJ, Jin GY, and Lee YC. 2009. The use of PTC and RFA as treatment alternatives with low procedural morbidity in non-small cell lung cancer. Eur J Cancer 45: 1773-1779.Inoue M, Nakatsuka S, Yashiro H, Ito N, Izumi Y, Yamauchi Y, Hashimoto K, Asakura K, Tsukada N, Kawamura M, Nomori H, and Kuribayashi S. 2012. Percutaneous cryoablation of lung tumors: feasibility and safety. J Vasc Interv Radiol. 23: 295-302.Qiu, B., Liang, Y., Li, Q., Liu, G., Wang, F., Chen, Z., Liu, M., Zhao, M., & Liu, H. (2017). Local Therapy for Oligoprogressive Disease in Patients With Advanced Stage Non–small-cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation. Clinical Lung Cancer, 18(6), e369–e373. , H.-P., Chen, C.-K., Shen, S.-H., Sheu, M.-H., Wu, M.-H., Wu, Y.-C., & Chang, C.-Y. (2015). Percutaneous cryoablation for inoperable malignant lung tumors: Midterm results. Cryobiology, 70(1), 60–65. , W., Guo, Z., Shu, S., Xing, W., Zhang, W., & Yang, X. (2018). The application effect of percutaneous cryoablation for the stage IIIB/IV advanced non-small-cell lung cancer after the failure of chemoradiotherapy. Asian Journal of Surgery, 41(6), 530–536. , M., Liang, S.-Z., Wang, X.-H., Liang, Y.-Q., Zhang, M.-J., Niu, L.-Z., Chen, J.-B., Li, H.-B., & Xu, K.-C. (2017). Clinical efficacy of percutaneous cryoablation combined with allogenic NK cell immunotherapy for advanced non-small cell lung cancer. Immunologic Research, 65(4), 880–887. , G. R., Askin, G., & Pua, B. B. (2018). Clinical Outcomes after Pulmonary Cryoablation with the Use of a Triple Freeze Protocol. Journal of Vascular and Interventional Radiology, 29(5), 714–721. , J. L., Mouli, S. K., Nemcek, A. A., Lewandowski, R. J., Salem, R., & Sato, K. T. (2016). Percutaneous Cryoablation for the Treatment of Primary and Metastatic Lung Tumors: Identification of Risk Factors for Recurrence and Major Complications. Journal of Vascular and Interventional Radiology, 27(9), 1371–1379. , W., Talati, R., Bhattacharji, P., & Bilfinger, T. (2015). Five-Year Survival after Cryoablation of Stage I Non–Small Cell Lung Cancer in Medically Inoperable Patients. Journal of Vascular and Interventional Radiology, 26(3), 312–319. , C., Sotgia, B., Fele, R. M., & Melis, L. (2013). CT-guided thin needles percutaneous cryoablation (PCA) in patients with primary and secondary lung tumors: A preliminary experience. European Journal of Radiology, 82(5), e246–e253. , Y., Izumi, Y., Hashimoto, K., Yashiro, H., Inoue, M., Nakatsuka, S., Goto, T., Anraku, M., Ohtsuka, T., Kohno, M., Kawamura, M., & Nomori, H. (2012). Percutaneous Cryoablation for the Treatment of Medically Inoperable Stage I Non-Small Cell Lung Cancer. PLoS ONE, 7(3), e33223. , Y., Izumi, Y., Kawamura, M., Nakatsuka, S., Yashiro, H., Tsukada, N., Inoue, M., Asakura, K., & Nomori, H. (2011). Percutaneous Cryoablation of Pulmonary Metastases from Colorectal Cancer. PLoS ONE, 6(11), e27086. References:22. Abtin, F. G., Eradat, J., Gutierrez, A. J., Lee, C., Fishbein, M. C., & Suh, R. D. (2012). Radiofrequency Ablation of Lung Tumors: Imaging Features of the Postablation Zone. RadioGraphics, 32(4), 947–969. . Alexander, E., & Dupuy, D. (2013). Lung Cancer Ablation: Technologies and Techniques. Seminars in Interventional Radiology, 30(02), 141–150. . Beland, M. D., Wasser, E. J., Mayo-Smith, W. W., & Dupuy, D. E. (2010). Primary Non–Small Cell Lung Cancer: Review of Frequency, Location, and Time of Recurrence after Radiofrequency Ablation. Radiology, 254(1), 301–307. . Chua, T. C., Sarkar, A., Saxena, A., Glenn, D., Zhao, J., & Morris, D. L. (2010). Long-term outcome of image-guided percutaneous radiofrequency ablation of lung metastases: An open-labeled prospective trial of 148 patients. Annals of Oncology, 21(10), 2017–2022. . de Baere, T., Tselikas, L., Woodrum, D., Abtin, F., Littrup, P., Deschamps, F., Suh, R., Aoun, H. D., & Callstrom, M. (2015). Evaluating Cryoablation of Metastatic Lung Tumors in Patients—Safety and Efficacy The ECLIPSE Trial—Interim Analysis at 1 Year. Journal of Thoracic Oncology, 10(10), 1468–1474. . Kawamura, M., Izumi, Y., Tsukada, N., Asakura, K., Sugiura, H., Yashiro, H., Nakano, K., Nakatsuka, S., Kuribayashi, S., & Kobayashi, K. (2006). Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. The Journal of Thoracic and Cardiovascular Surgery, 131(5), 1007–1013. . Simon, C. J., Dupuy, D. E., DiPetrillo, T. A., Safran, H. P., Grieco, C. A., Ng, T., & Mayo-Smith, W. W. (2007). Pulmonary Radiofrequency Ablation: Long-term Safety and Efficacy in 153 Patients. Radiology, 243(1), 268–275. . Sonntag, P. D., Hinshaw, J. L., Lubner, M. G., Brace, C. L., & Lee, F. T. (2011). Thermal Ablation of Lung Tumors. Surgical Oncology Clinics of North America, 20(2), 369–387. . Zemlyak, A., Moore, W. H., & Bilfinger, T. V. (2010). Comparison of Survival after Sublobar Resections and Ablative Therapies for Stage I Non?Small Cell Lung Cancer. Journal of the American College of Surgeons, 211(1), 68–72. LEFT BLANK ................
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