Optical Sensing of Tissue Freezing Depth by Sapphire Cryo-Applicator and Steady-State Diffuse Reflectance Analysis.

This work describes a sapphire cryo-applicator with the ability to sense tissue freezing depth during cryosurgery by illumination of tissue and analyzing diffuse optical signals in a steady-state regime. The applicator was manufactured by the crystal growth technique and has several spatially resolved internal channels for accommodating optical fibers. The method of reconstructing freezing depth proposed in this work requires one illumination and two detection channels. The analysis of the detected intensities yields the estimation of the time evolution of the effective attenuation coefficient, which is compared with the theoretically calculated values obtained for a number of combinations of tissue parameters. The experimental test of the proposed applicator and approach for freezing depth reconstruction was performed using gelatin-based tissue phantom and rat liver tissue in vivo. It revealed the ability to estimate depth up to 8 mm. The in vivo study confirmed the feasibility of the applicator to sense the freezing depth of living tissues despite the possible diversity of their optical parameters. The results justify the potential of the described design of a sapphire instrument for cryosurgery.

Feasibility and safety of percutaneous intramyocardial septal cryoablation: A canine model with 6-month follow-up.

Echocardiography-guided percutaneous intramyocardial septal radiofrequency ablation (PIMSRA, Liwen procedure) is a novel treatment option for hypertrophic obstructive cardiomyopathy (HOCM). The safety and feasibility of using this procedure for cryoablation are unknown. We aimed to investigate the feasibility and safety of echocardiography-guided percutaneous intramyocardial septal cryoablation (PIMSCA) for septal thickness reduction in a canine model. Eight canines underwent PIMSCA, and had electrocardiography, echocardiography(ECG), myocardial contrast echocardiography (MCE), serological and pathological examinations during the preoperative, immediate postoperative, and 6-month follow-up. All eight canines underwent successful cryoablation and continued to be in sinus rhythm during ablation and without malignant arrhythmias. MCE showed that the ablation area had decreased myocardial perfusion after the procedure. Troponin I levels were significantly elevated [0.010 (0.005, 0.297) ng/mL vs. 3.122 (1.152, 7.990) ng/mL, p < 0.05)]. At 6-month follow-up after the procedure, all animals were alive, with thinning of the interventricular septum (7.26 ± 0.52 mm vs. 3.86 ± 0.29 mm, p < 0.05). Echocardiography showed no significant decrease in the left ventricular ejection fractions (LVEF) (54.32 ± 2.93 % vs. 54.70 ± 2.47 %, p > 0.05) or changes by pulse-wave Doppler E/A (1.17 ± 0.43 vs. 1.07 ± 0.43, p > 0.05), E/e' (8.09 ± 1.49 vs. 10.05 ± 2.68, p > 0.05). Pathological findings proved the effectiveness of cryoablation in myocardial tissues. We observed pericardial effusions and premature ventricular complexes (PVCs) associated with the procedure. Our findings provided preliminary evidence of the safety and feasibility of PIMSCA in reducing interventricular septum, which provides a potentially new treatment option for HOCM.

AGA Clinical Practice Guideline on Endoscopic Eradication Therapy of Barrett's Esophagus and Related Neoplasia.

BACKGROUND & AIMS: Barrett's esophagus (BE) is the precursor to esophageal adenocarcinoma (EAC). Endoscopic eradication therapy (EET) can be effective in eradicating BE and related neoplasia and has greater risk of harms and resource use than surveillance endoscopy. This clinical practice guideline aims to inform clinicians and patients by providing evidence-based practice recommendations for the use of EET in BE and related neoplasia. METHODS: The Grading of Recommendations Assessment, Development and Evaluation framework was used to assess evidence and make recommendations. The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients, conducted an evidence review, and used the Evidence-to-Decision Framework to develop recommendations regarding the use of EET in patients with BE under the following scenarios: presence of (1) high-grade dysplasia, (2) low-grade dysplasia, (3) no dysplasia, and (4) choice of stepwise endoscopic mucosal resection (EMR) or focal EMR plus ablation, and (5) endoscopic submucosal dissection vs EMR. Clinical recommendations were based on the balance between desirable and undesirable effects, patient values, costs, and health equity considerations. RESULTS: The panel agreed on 5 recommendations for the use of EET in BE and related neoplasia. Based on the available evidence, the panel made a strong recommendation in favor of EET in patients with BE high-grade dysplasia and conditional recommendation against EET in BE without dysplasia. The panel made a conditional recommendation in favor of EET in BE low-grade dysplasia; patients with BE low-grade dysplasia who place a higher value on the potential harms and lower value on the benefits (which are uncertain) regarding reduction of esophageal cancer mortality could reasonably select surveillance endoscopy. In patients with visible lesions, a conditional recommendation was made in favor of focal EMR plus ablation over stepwise EMR. In patients with visible neoplastic lesions undergoing resection, the use of either endoscopic mucosal resection or endoscopic submucosal dissection was suggested based on lesion characteristics. CONCLUSIONS: This document provides a comprehensive outline of the indications for EET in the management of BE and related neoplasia. Guidance is also provided regarding the considerations surrounding implementation of EET. Providers should engage in shared decision making based on patient preferences. Limitations and gaps in the evidence are highlighted to guide future research opportunities.

Cryoablation Catheter Used in the Surgical Treatment of Atrial Fibrillation May Treat Chest Tube Pain: Engin Technique.

Postoperative pain after cardiac surgery plays an important role in the patient's recovery process. In particular, pain at the chest tube site can negatively affect the comfort and recovery of these patients. Effective pain control minimizes the risk of many complications. Oral and intravenous analgesics, epidural anesthesia, paravertebral block, and intercostal nerve blockade are used in chest tube pain control. We routinely use the surgical cryoablation method in the presence of atrial fibrillation in the preoperative period of cardiac surgery in our clinic. Here we aimed to describe our method of using the cryoablation catheter for intercostal nerve blockade.

Comparative Effectiveness of Partial Gland Cryoablation Versus Robotic Radical Prostatectomy for Cancer Control.

BACKGROUND AND OBJECTIVE: There is an absence of high-level evidence comparing oncologic endpoints for partial gland ablation, and most series use prostate-specific antigen (PSA) rather than biopsy endpoints. Our aim was to compare oncologic outcomes between partial gland cryoablation (PGC) and radical prostatectomy (RP) for prostate cancer. METHODS: This was a retrospective, single-center analysis of subjects treated with PGC (n = 98) or RP (n = 536) between January 2017 and December 2022 as primary treatment for intermediate-risk (Gleason grade group [GG] 2-3) prostate cancer. Oncologic endpoints included surveillance biopsies per protocol after PGC in comparison to serial PSA testing after RP. The primary outcome was treatment failure, defined as a need for any salvage treatment or development of metastatic disease. Treatment failure and survival analyses were conducted using Cox proportional-hazard regression and Kaplan Meier survival curves. KEY FINDINGS AND LIMITATIONS: After applying the inclusion/exclusion criteria, the PGC (n = 75) and RP (n = 298) groups were compared. PGC patients were significantly older (71 vs 64 yr; p < 0.001), but there were no differences in PSA, biopsy GG, or treatment year between the groups. The PGC group had higher rates of treatment failures at 24 mo (33% vs 11%; p < 0.001) and 48 mo (43% vs 14%; p < 0.001). One PGC patient (2.1%) and one RP patient (0.7%) developed metastases by 48-mo follow-up (p = 0.4). On adjusted analysis, PGC was associated with a higher risk of treatment failure (hazard ratio 4.6, 95% confidence interval 2.7-7.9; p < 0.001). Limitations include observational biases associated with the retrospective study design. CONCLUSIONS: This is the first comparative effectiveness study of cancer control outcomes for PGC versus RP. The results demonstrate an almost fivefold higher risk of treatment failure with PGC during short-term follow-up. PATIENT SUMMARY: We compared cancer control outcomes for patients with intermediate-risk prostate cancer treated with partial gland cryoablation versus radical prostatectomy. We found that partial gland cryoablation had an almost fivefold higher risk of treatment failure. Men with prostate cancer should be counseled regarding this difference in treatment failure.

Percutaneous cryoablation of abdominal wall endometriosis: An analysis of 38 patients.

PURPOSE: The purpose of this study was to evaluate the efficacy of percutaneous cryoablation in the treatment of abdominal wall endometriosis (AWE) nodules. MATERIALS AND METHODS: Thirty-eight women treated for symptomatic AWE nodules with percutaneous cryoablation under ultrasound and computed tomography (CT) guidance between May 2020 and July 2023 were retrospectively included. Pain was estimated using visual analog scale (VAS) and assessed at baseline, three months, six months, and 12 months after percutaneous cryoablation. Baseline VAS score, volume of AWE nodule and magnetic resonance imaging (MRI) features of AWE nodules were compared to those obtained after percutaneous cryoablation. Major complications, if any, were noted. RESULTS: Thirty-eight women with a median age of 35.5 years (interquartile range [IQR]: 32, 39; range: 24-48 years) and a total of 60 AWE nodules were treated. Percutaneous cryoablation was performed under local or regional anesthesia in 30 women (30/38; 79%). Significant decreases between initial median VAS score (7; IQR: 6, 8; range: 3-10) and median VAS score after treatment at three months (0; IQR: 0, 5; range; 0-8) (P < 0.001), six months (0; IQR: 0, 1; range; 0-10) (P < 0.001) and 12 months (0; IQR: 0, 2; range: 0-7) (P < 0.001) were observed. Percutaneous cryoablation resulted in effective pain relief in 31 out of 38 women (82%) at six months and 15 out of 18 women (83%) at 12 months. Contrast-enhanced MRI at six-month follow-up showed a significant decrease in the volume of AWE nodules and the absence of AWE nodule enhancement after treatment by comparison with baseline MRI (P < 0.001). No major complications were reported. CONCLUSION: Percutaneous cryoablation is an effective, minimally invasive intervention for the treatment of AWE nodules that conveys minimal or no morbidity.

The value of cryoablation in orbital surgery.

Aim of this article is to give an overview of the technical background and the advantages of modern devices for different applications of cryoablation in cranio-orbital neurosurgery.The treatment of orbital lesions is complicated by the complex and potentially inapparent anatomy due to retro-orbital fat. With the help of cryoprobes different well-defined lesions such as cavernous venous malformations can be safely and effectively removed thanks to the cryoadhesive effect. Their use has been described in several different approaches including traditional lateral or transcranial orbitotomy but also anterior transconjunctival as well as transnasal endoscopic approaches. Recently, single-use devices were introduced that allow the use of cryosurgery also without the need for large investment or service costs.

Severe epistaxis after posterior nasal nerve ablation requiring surgical intervention: A multi-center case series.

KEY POINTS: Severe epistaxis occurs in 2% of PNN ablation cases, independent of method or device type. Major epistaxis requiring intervention after PNN ablation can occur on average 20 days post-procedure.

Histological evaluation of tissue destruction in mouse tongues caused by cryosurgery.

Introduction: Cryosurgery is recognized as a treatment option for various types of oral lesions. Although cryosurgery is less invasive and easier to perform than surgical treatments, adverse events, such as stomatitis and scarring can occur if the freezing is excessive. There are few studies regarding the effects of cryosurgery on the surrounding soft tissues. Thus, this study investigated the extent of tissue destruction and healing progress in tongues of mice who underwent cryosurgery. Methods: Eight-week-old male BALB/c mice were used. An instrument cooled with liquid nitrogen was lightly touched on the right side of the tongue for 5 s, and a second test was performed 10 s later. Histological evaluation was performed 3, 7, and 14 days after cryosurgery. Blood vessels were evaluated with India ink at 1, 3, 7, 14, and 21 days after cryosurgery. Results: Destruction of the soft tissue spread to the left side of the tongue after 3 days. At 7 days, it was confirmed that the muscle tissue was in the process of repair and was completely repaired at 14 days. Although blood vessels were not confirmed at 3 days, they were visible after seven days and were confirmed at 21 days all over the tongue. Discussion and Conclusion: These results indicated that the tissue destruction caused by cryosurgery was extensive and suggest that the duration and frequency of freezing should be minimized for clinical use. Lay Summary: Cryosurgery is a treatment method for various types of oral lesions. Freezing the lesion causes the tissue to collapse, resulting in its disappearance. Although cryosurgery is less invasive and easier to perform than surgical treatments, adverse events, such as stomatitis and scarring can occur if the freezing is excessive. This study investigated the extent of tissue destruction and healing progress in tongues of mice who underwent cryosurgery.The right side of mice tongues were frozen by an instrument cooled with liquid nitrogen for 5 s, and a second test was performed 10 s later. The tissue destruction was evaluated at 3, 7, and 14 days after freezing. Blood vessels were evaluated with India ink at 1, 3, 7, 14, and 21 days after freezing. Tissue destruction spread to the left side of the tongue after 3 days. At 7 days, it was confirmed that the muscle tissue was in the process of repair and was completely repaired at 14 days. Blood vessel repair was confirmed at 21 days in the throughout tongue. These results indicated that the tissue destruction caused by cryosurgery was large and suggest that the duration and frequency of freezing should be minimized for clinical use.

A novel in vitro model of clinical cryoablation to investigate the transition zone for focal tumor ablation.

Cryoablation (CA) of solid tumors is highly effective at reducing tumor burden and eliminating small, early stage tumors. However, complete ablation is difficult to achieve and cancer recurrence is a significant barrier to treatment of larger tumors compared to resection. In this study, we explored the relationship between temperature, ice growth, and cell death using a novel in vitro model of clinical CA with the Visual-ICE (Boston Scientific) system, a clinically approved and widely utilized device. We found that increasing the duration of freezing from 1 to 2 min increased ice radius from 3.44 ± 0.13 mm to 5.29 ± 0.16 mm, and decreased the minimum temperature achieved from -22.8 ± 1.3 °C to -45.5 ± 7.9 °C. Furthermore, an additional minute of freezing increased the amount of cell death within a 5 mm radius from 42.5 ± 8.9% to 84.8 ± 1.1%. Freezing at 100% intensity leads to faster temperature drops and a higher level of cell death in the TRAMP-C2 mouse prostate cancer cell line, while lower intensities are useful for slow freezing, but result in less cell death. The width of transition zone between live and dead cells decreased by 0.4 ± 0.2 mm, increasing from one to two cycles of freeze/thaw cycles at 100% intensity. HMGB-1 levels significantly increased with 3 cycles of freeze/thaw compared to the standard 2 cycles. Overall, a longer freezing duration, higher freezing intensity, and more freeze thaw cycles led to higher levels of cancer cell death and smaller transition zones. These results have the potential to inform future preclinical research and to improve therapeutic combinations with CA.

Intralesional Cryosurgery of a Bulky Postburned Auricular Keloid and EAR-Q Patient-reported Outcome Measure Assessment.

Postburned auricular keloids are a challenging problem for the patient and physician. We describe a successful combined treatment of a bulky postburn auricular keloid employing intralesional cryosurgery followed by multiple W-plasty. An EAR-Q pre- and postoperative patient-reported outcome assessments have revealed a significant improvement in all ear parameters of appearance, adverse effects, and quality of life. This combined treatment might be added to the armamentarium of possible treatment modalities for this perplexing problem.

Efficacy and safety of cryoablation combined with lenvatinib and anti-PD-1 monoclonal antibody in treatment of unresectable hepatocellular carcinoma / 临床肝胆病杂志

ObjectiveTo investigate whether anti-PD-1 monoclonal antibody can improve the efficacy and safety of cryoablation combined with lenvatinib in the treatment of unresectable hepatocellular carcinoma （HCC）. MethodsA retrospective analysis was performed for 232 patients with unresectable HCC who were treated at The Fifth Medical Center of Chinese PLA General Hospital from January 2018 to December 2022， among whom 128 received cryoablation combined with lenvatinib （double combination） and 104 received cryoablation combined with lenvatinib and anti-PD-1 monoclonal antibody （triple combination）. Propensity score matching was performed at a ratio of 1∶1， and finally there were 86 patients in each group. The two groups were evaluated in terms of objective response rate （ORR）， disease control rate （DCR）， overall survival （OS）， progression-free survival （PFS）， and adverse events （AEs）. The independent-samples t test was used for comparison of normally distributed continuous data between two groups， and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups； the chi-square test was used for comparison of categorical data between two groups. Survival curves were plotted， and the Kaplan-Meier method was used to calculate the survival rate of patients in both groups， while the log-rank test was used for comparison between the two groups. The Cox regression model was used to calculate hazard ratio （HR） and 95% confidence interval （CI） and perform the univariate and multivariate analyses of influencing factors for prognosis. ResultsThe median follow-up time was 28 months， and there were 33 deaths （38.0%） in the triple combination group and 40 deaths （46.0%） in the double combination group. Compared with the double combination group， the triple combination group had significantly higher ORR （35.6% vs 14.5%， P=0.008） and DCR （86.1% vs 64.1%， P=0.003）. OS and PFS in the triple combination group were significantly higher than those in the double combination group （P=0.045 and 0.026）. The univariate and multivariate Cox proportional-hazards regression model analyses showed that treatment regimen （HR=0.60， P=0.038） and alpha-fetoprotein level （HR=2.37， P=0.001） were independent risk factors for OS， and treatment regimen （HR=0.65， P=0.025）， diabetes mellitus （HR=1.94， P=0.005）， whether or not to have received local treatment （HR=0.63， P=0.014）， and distant metastasis （HR=0.58， P=0.009） were independent risk factors for PFS. There was no significant difference in the incidence rate of AEs between the two groups （P>0.05）. ConclusionFor patients with unresectable HCC， the triple combination of cryoablation， lenvatinib， and anti-PD-1 monoclonal antibody significantly improves the treatment outcome and survival of patients compared with the double combination of cryoablation and lenvatinib， without increasing AEs， which provides a clinical basis for optimizing the treatment regimen for unresectable HCC.

Cryoablation Catheter Used in the Surgical Treatment of Atrial Fibrillation May Treat Chest Tube Pain: Engin Technique

ABSTRACT Postoperative pain after cardiac surgery plays an important role in the patient's recovery process. In particular, pain at the chest tube site can negatively affect the comfort and recovery of these patients. Effective pain control minimizes the risk of many complications. Oral and intravenous analgesics, epidural anesthesia, paravertebral block, and intercostal nerve blockade are used in chest tube pain control. We routinely use the surgical cryoablation method in the presence of atrial fibrillation in the preoperative period of cardiac surgery in our clinic. Here we aimed to describe our method of using the cryoablation catheter for intercostal nerve blockade.

Cryogenic Media in Biomedical Applications: Current Advances, Challenges, and Future Perspectives.

This paper explores the crucial role of cryogenic mediums in driving breakthroughs within the biomedical sector. The objective was to investigate, critically discuss, and present the current knowledge and state-of-the-art practices, along with the challenges and perspectives of the most common applications. Through an extensive literature review, this work aims to supplement existing research, offering a comprehensive and up-to-date understanding of the subject. Biomedical research involving cryogenic mediums is advancing on multiple fronts, including the development of advanced medical technologies, clinical treatments for life-threatening conditions, high-quality biospecimen preservation, and antimicrobial interventions in industrial food processing. These advances open new horizons and present cutting-edge opportunities for research and the medical community. While the current body of evidence showcases the impressive impact of cryogenic mediums, such as nitrogen, helium, argon, and oxygen, on revolutionary developments, reaching definitive conclusions on their efficiency and safety remains challenging due to process complexity and research scarcity with a moderate certainty of evidence. Knowledge gaps further underline the need for additional studies to facilitate cryogenic research in developing innovative technological processes in biomedicine. These advancements have the potential to reshape the modern world and significantly enhance the quality of life for people worldwide.

Cryosurgery for Basal Cell Skin Cancer of the Head: 15 Years of Experience.

The clinical relevance of head and neck (H&N) tumors is related to the potential disfiguration of anatomical structures (by the tumor or surgical intervention), defining patients' individual features and emotional expression, loss or restraint of vital structures functions, and untoward socio-economic sequelae. This study is aimed to improve clinical outcomes of cryosurgery in patients with H&N basal cell skin cancer by refining the indications for cryosurgical treatment. In this study, cryosurgery was used in 234 patients with different stages of cutaneous basal cell carcinoma (BCC) of the head, including 101 patients with T1 tumors, 86-with T2, 5-T3, and 42 patients with tumors relapsing after failure of preceding various treatment modalities. Post-cryosurgery recurrence rate in patients with stage I BCC was 2.7%, with stage II tumors-5.6% and 34.9%-in patients with recurred tumors. Re-recurrence after cryoablation of recurrent tumors correlated with the tumor baseline size. The best aesthetic and long-term clinical results were documented in patients with lesions <1 cm in size with clear boundaries. Thus, cryosurgery is the method of choice for the majority of stage I basal cell carcinomas of the head. For patients with advanced and recurrent skin cancer, cryosurgery is relevant in rare cases selected according to refined indications.

Salvage radiotherapy after initial cryotherapy for localized prostate cancer: A systematic review of the literature.

The treatment of local prostate cancer recurrence after cryotherapy is challenging since the optimal management is unknown. We collected the available evidence to date to better define the risk and benefit of salvage radiotherapy (SRT) after cryotherapy failure for localized prostate cancer. This review confirms the feasibility of SRT in terms of biochemical control and late toxicity rate. However, the absence of comparative trials or prospective studies, coupled with the heterogeneity of patients treated and the variations in treatments delivered across the analyzed studies, highlights the need for cautious consideration when opting for salvage radiotherapy. Therefore, we highly recommend the inclusion of patients in dedicated clinical trials to comprehensively assess the efficacy and safety of this approach.

The Evolving Role of Cryosurgery in Breast Cancer Management: A Comprehensive Review.

Breast cancer is the most commonly diagnosed type of cancer, accounting for approximately one in eight cancer diagnoses worldwide. In 2020, there were approximately 2.3 million new cases of breast cancer globally, resulting in around 685,000 deaths. Consequently, there is an ongoing need to develop innovative therapeutic approaches that can improve both clinical outcomes and patient quality of life. The use of ultra-low cryogenic temperatures, facilitated by cryogenic media such as liquid nitrogen, has revolutionized the biomedical field and opened up new possibilities for advanced clinical treatments, including cryosurgery. Cryosurgery has demonstrated its feasibility as a minimally invasive technique for destroying breast tumors and eliciting a significant antitumor immune response in the host. This feature sets cryosurgery apart from other ablative techniques. It has been shown to be well tolerated and effective, offering several advantages such as simplicity, the avoidance of general anesthesia, minimal pain, low morbidity, short recovery time, cost-effectiveness, and notably, improved aesthetic outcomes. The reviewed studies indicate that cryosurgery holds promise in the management of early-stage breast cancer and metastatic disease, especially in triple-negative and Her2-positive molecular subtypes in conjunction with checkpoint inhibitors and anti-Her2 antibodies, respectively. Furthermore, the effectiveness of cryosurgery in the management of ductal carcinoma in situ should be investigated as an alternative modality to surgery or surveillance. The minimally invasive nature of cryosurgery has the potential to significantly enhance the quality of life for patients.

Sporotrichosis in Older Adults: A Cohort Study of 911 Patients from a Hyperendemic Area of Zoonotic Transmission in Rio de Janeiro, Brazil.

Generally, older people tend to suffer from more severe infections than younger adults. In addition, there are accumulations of comorbidities and immune senescence in some cases. This cohort study evaluated the clinical and epidemiological characteristics of older adults (≥60 years old) with sporotrichosis. The cohort consisted of 911 patients with a median age of 67 years, most of whom were female (72.6%), white (62.1%), and afflicted with comorbidities (64.5%). The lymphocutaneous form occurred in 62% of the patients, followed by the fixed form (25.7%), cutaneous disseminated form (8.9%), and extracutaneous/disseminated forms (3.3%). In this study, we draw attention to the frequency of osteoarticular involvement (2.1%) secondary to skin lesions such as osteomyelitis and/or tenosynovitis. A clinical cure was achieved in 87.3% of cases. Itraconazole was used in 81.1% of cases, while terbinafine was used in 22.7% of cases, usually in low doses. Survival analysis showed that the median treatment time was 119 days, and the multiple Cox model demonstrated that the presentation of a black coloration and diabetes was associated with a longer treatment time required to establish a cure. Therefore, these subgroups should be monitored more closely to reduce possible difficulties during treatment. It would be interesting to conduct more studies analyzing older adults with sporotrichosis from different geographic areas to better comprehend the disease in this group.

Breast Cancer Cryoablation in the Multidisciplinary Setting: Practical Guidelines for Patients and Physicians.

Breast cancer cryoablation has emerged as a minimally invasive alternative to lumpectomy for treating early-stage breast cancer. However, no consensus exists on what should be considered the standard of care for the multidisciplinary management of patients treated with breast cancer cryoablation. In lieu of national guidelines, this review of the literature provides a multidisciplinary framework and an evidence-based discussion of the integration of "standard of care practices" in the comprehensive management of breast cancer cryoablation patients.