Atrial fibrillation progression after cryoablation vs. radiofrequency ablation: the CIRCA-DOSE trial.

BACKGROUND AND AIMS: Atrial fibrillation (AF) is a chronic progressive disorder. Persistent forms of AF are associated with increased rates of thromboembolism, heart failure, and death. Catheter ablation modifies the pathogenic mechanism of AF progression. No randomized studies have evaluated the impact of the ablation energy on progression to persistent atrial tachyarrhythmia. METHODS: Three hundred forty-six patients with drug-refractory paroxysmal AF were enrolled and randomly assigned to contact-force-guided RF ablation (CF-RF ablation, 115), 4 min cryoballoon ablation (CRYO-4, 115), or 2 min cryoballoon ablation (CRYO-2, 116). Implantable cardiac monitors placed at study entry were used for follow-up. The main outcome was the first episode of persistent atrial tachyarrhythmia. Secondary outcomes included atrial tachyarrhythmia recurrence and arrhythmia burden on the implantable monitor. RESULTS: At a median of 944.0 (interquartile range [IQR], 612.5-1104) days, 0 of 115 patients (0.0%) randomly assigned to CF-RF, 8 of 115 patients (7.0%) assigned to CRYO-4, and 5 of 116 patients (4.3%) assigned to CRYO-2 experienced an episode of persistent atrial tachyarrhythmia (P = .03). A documented recurrence of any atrial tachyarrhythmia ≥30 s occurred in 56.5%, 53.9%, and 62.9% of those randomized to CF-RF, CRYO-4, and CRYO-2, respectively; P = .65. Compared with that of the pre-ablation monitoring period, AF burden was reduced by a median of 99.5% (IQR 94.0%, 100.0%) with CF-RF, 99.9% (IQR 93.3%-100.0%) with CRYO-4, and 99.1%% (IQR 87.0%-100.0%) with CRYO-2 (P = .38). CONCLUSIONS: Catheter ablation of paroxysmal AF using radiofrequency energy was associated with fewer patients developing persistent AF on follow-up.

Piezo1 stretch-activated channel activity differs between murine bone marrow-derived and cardiac tissue-resident macrophages.

Macrophages (MΦ) play pivotal roles in tissue homeostasis and repair. Their mechanical environment has been identified as a key modulator of various cell functions, and MΦ mechanosensitivity is likely to be critical - in particular in a rhythmically contracting organ such as the heart. Cultured MΦ, differentiated in vitro from bone marrow (MΦBM), form a popular research model. This study explores the activity of mechanosensitive ion channels (MSC) in murine MΦBM and compares it to MSC activity in MΦ enzymatically isolated from cardiac tissue (tissue-resident MΦ; MΦTR). We show that MΦBM and MΦTR have stretch-induced currents, indicating the presence of functional MSC in their plasma membrane. The current profiles in MΦBM and in MΦTR show characteristics of cation non-selective MSC such as Piezo1 or transient receptor potential channels. While Piezo1 ion channel activity is detectable in the plasma membrane of MΦBM using the patch-clamp technique, or by measuring cytosolic calcium concentration upon perfusion with the Piezo1 channel agonist Yoda1, no Piezo1 channel activity was observed in MΦTR. The selective transient receptor potential vanilloid 4 (TRPV4) channel agonist GSK1016790A induces calcium entry in MΦTR and in MΦBM. In MΦ isolated from left-ventricular scar tissue 28 days after cryoablation, stretch-induced current characteristics are not significantly different compared to non-injured control tissue, even though scarred ventricular tissue is expected to be mechanically remodelled and to contain an altered composition of pre-existing cardiac and circulation-recruited MΦ. Our data suggest that the in vitro differentiation protocols used to obtain MΦBM generate cells that differ from MΦ recruited from the circulation during tissue repair in vivo. Further investigations are needed to explore MSC identity in lineage-traced MΦ in scar tissue, and to compare mechanosensitivity of circulating monocytes with that of MΦBM. KEY POINTS: Bone marrow-derived (MΦBM) and tissue resident (MΦTR) macrophages have stretch-induced currents, indicating expression of functional mechanosensitive channels (MSC) in their plasma membrane. Stretch-activated current profiles show characteristics of cation non-selective MSC; and mRNA coding for MSC, including Piezo1 and TRPV4, is expressed in murine MΦBM and in MΦTR. Calcium entry upon pharmacological activation of TRPV4 confirms functionality of the channel in MΦTR and in MΦBM. Piezo1 ion channel activity is detected in the plasma membrane of MΦBM but not in MΦTR, suggesting that MΦBM may not be a good model to study the mechanotransduction of MΦTR. Stretch-induced currents, Piezo1 mRNA expression and response to pharmacological activation are not significantly changed in cardiac MΦ 28 days after cryoinjury compared to sham operated mice.

Size selection of intrahepatic lesions for cryoablation contributes to abscopal effect and long-term survival in patients with liver metastatic melanoma receiving PD-1 blockade therapy.

OBJECTIVES: In this study, we aimed to examine parameters of cryoablation, tumor characteristics, and their correlations with distant tumor response and survival of liver metastatic melanoma patients receiving cryoablation and PD-1 blockade (cryo-PD-1) combination treatment. MATERIALS AND METHODS: A retrospective study was conducted among 45 melanoma patients who received combined PD-1 blockade therapy and cryoablation for liver metastasis from 2018 to 2022. Cox regression was utilized to determine the associations between factors and overall survival (OS). Changes in cytokines and immune cell compositions in peripheral blood samples following the combined treatment were investigated, along with their correlations with treatment response. RESULTS: The mean cycle of cryo-PD-1 combination treatment was 2.2 (range, 1-6), and the 3-month overall response rate (RECIST 1.1 criteria) was 26.7%. Of the 21 patients who failed previous PD-1 blockade therapy after diagnosis of liver metastasis, 4 (19.0%) achieved response within 3 months since combination treatment. The diameter of ablated lesion ≤ 30 mm, metastatic organs ≤ 2, and pre-treatment LDH level ≤ 300 U/L were independent prognostic factors for favorable OS. Further analysis showed patients with intrahepatic tumor size of 15-45 mm, and ablated lesion size of ≤ 30 mm had significantly higher 3-month response rate (42.9% vs 12.5%; P = 0.022) and survival time (30.5 vs 14.2 months; P = 0.045) than their counterparts. The average increase in NLR among patients with ablated tumor size of ≤ 3 cm and > 3 cm were 3.59 ± 5.01 and 7.21 ± 12.57, respectively. The average increase in serum IL-6 levels among patients with ablated tumor size of ≤ 3 cm and > 3 cm were 8.62 ± 7.95 pg/ml and 15.40 ± 11.43 pg/ml, respectively. CONCLUSION: Size selection of intrahepatic lesions for cryoablation is important in order to achieve abscopal effect and long-term survival among patients with liver metastatic melanoma receiving PD-1 blockade therapy.

Pre-surgical cryoablation in ≤ 2 cm ER + /HER2-tumors. Prognostic factors for the presence of residual invasive carcinoma.

BACKGROUND: Breast cancer remains the most commonly diagnosed cancer in women. Breast-conserving surgery (BCS) is the standard approach for small low-risk tumors. If the efficacy of cryoablation is demonstrated, it could provide a minimally invasive alternative to surgery. PURPOSE: To determine the success of ultrasound-guided cryoablation in achieving the absence of Residual Invasive Cancer (RIC) for patients with ER + /HER2- tumors ≤ 2cm and sonographically negative axillary nodes. MATERIALS AND METHODS: This prospective study was carried out from April 2021 to June 2023, and involved 60 preoperative cryoablation procedures on ultrasound-visible, node-negative (cN0) infiltrating ductal carcinomas (IDC). Standard diagnostic imaging included mammography and tomosynthesis, supplemented by ultrasound-guided biopsy. MRI was performed in patients with associated intraductal carcinoma (DCIS) and an invasive component on core needle biopsy (18 out of 22 cases). All tumors were tagged with ferromagnetic seeds. A triple-phase protocol (freezing-thawing-freezing) with Argon was used, with an average procedure duration of 40 min. A logistic regression model was applied to determine significant correlation between RIC and the study variables. RESULTS: Fifty-nine women (mean age 63 ± 8 years) with sixty low-risk unifocal IDC underwent cryoablation prior to surgery. Pathological examination of lumpectomy specimens post-cryoablation revealed RIC in only one of 38 patients with pure IDC and in 4 of 22 mixed IDC/DCIS cases. All treated tumors had clear surgical margins, with no significant procedural complications. CONCLUSIONS: Cryoablation was effective in eradicating 97% of pure infiltrating ER + /HER2-tumors ≤ 2cm, demonstrating its potential as a surgical alternative in selected patients.

Evolution of Initial Treatment for Desmoid Tumors.

INTRODUCTION: Desmoid tumors (DTs) are rare, fibroblastic cell proliferations that can exhibit locally aggressive behavior but lack metastatic potential. Initial management has traditionally involved upfront resection; however, contemporary guidelines and expert panels have increasingly advocated for prioritizing active surveillance strategies. METHODS: A single-institution, retrospective chart review identified all patients diagnosed with a primary DT at any site from 2007 to 2020. The primary outcome was the initial management strategy over time. Secondary outcomes included treatment-free survival (TFS) and time to treatment (TTT) for those undergoing active surveillance, as well as recurrence-free survival (RFS) and time to recurrence for those undergoing resection. RESULTS: Overall, 103 patients were included, with 68% female and a median follow-up of 44 months [24-74]. The most common tumor locations included the abdominal wall (27%), intra-abdominal/mesenteric (25%), chest wall (19%), and extremity (10%). Initial management included resection (60%), systemic therapy (20%), active surveillance (18%), and cryoablation (2%). Rates of surgical resection significantly decreased (p < 0.001) over time, from 69.6% prior to 2018 to 29.2% after 2018. For those treated with upfront resection, 5-year RFS was 41.2%, and for patients undergoing initial active surveillance, TFS was 66.7% at 2 years, with a median TTT of 4 months [4-10]. CONCLUSIONS: This single-institution cohort at a tertiary medical center spanning over a decade demonstrates the transition to active surveillance for initial management of DTs, and highlights salient metrics in the era of surveillance. This trend mirrors recommended treatment strategies by expert panels and consensus guidelines.

Integrated dilator-needle transseptal crossing device in atrial fibrillation cryoballoon ablation procedures.

INTRODUCTION: In cryoballoon ablation (CBA) procedures, transseptal access (TSA) is generally achieved using a standard sheath and needle system that is exchanged for the cryoballoon delivery sheath and dilator over a long wire. Sheath exchange has been related with air embolic events. Recently, an integrated dilator-needle system assembled to the cryoballoon sheath was introduced. We aimed to evaluate the efficacy and safety of an integrated TSA tool compared with the traditional approach in atrial fibrillation CBA procedures. METHODS: Patients scheduled for CBA procedures were randomized 1:1 to traditional TSA (t-TSA) or integrated TSA (i-TSA). TSA time was defined as time from superior vena cava to LA insertion of the cryoballoon delivery sheath, after sheath exchange (t-TSA) or directly (i-TSA). RESULTS: Ninety-seven patients (76 males, mean age 59 ± 10 years) were randomized, 48 patients underwent t-TSA, and 49 i-TSA. Mean TSA time was 5 min 59 s ± 5 min 36 s in the t-TSA group and 2 min 59 s ± 2 min 14 s in the i-TSA group (p < .001). Total fluoroscopy time, skin-to-skin procedure time, and LA dwell time were respectively 15 ± 6, 69 ± 16, and 44 ± 12 min in the t-TSA group and 13 ± 6, 65 ± 15, and 43 ± 11 min in the i-TSA group (p = ns). No clinically significant acute complications related to TSA were noted in both cohorts. CONCLUSION: This is the first randomized study comparing both TSA approaches. TSA in CBA procedures using this integrated tool enables a safe and efficient workflow, reducing TSA time and avoiding sheath exchange.

Cryoablation of atrial fibrillation in "very severe" obese patients (BMI ≥ 40): Indications, feasibility, procedural safety and efficacy, and clinical outcome (the ICE-Obese Extreme).

BACKGROUND: Management of atrial fibrillation (AF) in very severe obese patients is challenging. Cryoballoon ablation (CBA) represents an effective rhythm control strategy. However, data in this patient group were limited. METHODS: Highly symptomatic AF patients with body mass index (BMI) ≥ 40 kg/m2 who had failed antiarrhythmic drug therapy and electrocardioversion and failure to achieve targeted body-weight-reduction underwent CBA. RESULTS: Data of 72 very severe obese AF patients (Group A) and 129 AF patients with normal BMI (Group B, BMI < 25 kg/m2) were consecutively collected. Group A had significantly younger age (60.6 ± 10.4 vs. 69.2 ± 11.2 years), higher BMI (44.3 ± 4.3 vs. 22.5 ± 1.6 kg/m2). Procedural pulmonary vein isolation (PVI) was successful in all patients (2 touch-up ablation in Group A). Compared to Group B, Group A had similar procedural (61.3 ± 22.6 vs. 57.5 ± 19 min), similar fluoroscopy time (10.1 ± 5.5 vs. 9.2 ± 4.8 min) but significantly higher radiation dose (2852 ± 2095 vs. 884 ± 732 µGym2). We observed similar rates of real-time-isolation (78.6% vs. 78.5%), single-shot-isolation (86.5% vs. 88.8%), but significantly longer time-to-sustained-isolation (53.5 ± 33 vs. 43.2 ± 25 s). There was significantly higher rate of puncture-site-complication (6.9% vs. 1.6%) in Group A. One-year clinical success in paroxysmal AF was (Group A: 69.4% vs. Group B: 80.2%; p < .001), in persistent AF was (Group A: 58.1% vs. Group B: 62.8%; p = .889). In Re-Do procedures Group A had a numerically lower PVI durability (75.0% vs. 83.6%, p = .089). CONCLUSION: For very severe obese AF patients, CBA appears feasible, leads to relatively good clinical outcome.

Effect of early cryoballoon ablation on atrial fibrillation recurrence-A Danish nationwide register study.

INTRODUCTION: Cryoballoon ablation is a safe and efficient rhythm control strategy in atrial fibrillation (AF) patients. The impact of time from diagnosis to ablation is unclear. The aim of this study was to examine the impact of timing of first-time cryoballoon ablation on AF recurrence in a nationwide cohort of AF patients. METHODS AND RESULTS: From nationwide registers, all AF patients ≥18 years of age who underwent first-time AF cryoballoon ablation in Denmark from 2012 to 2018 were included. The AF patients were stratified by ablation timing: Early group (≤1 year after AF diagnosis), intermediate group (1-3 years after AF diagnosis), and late group (≥3 years after AF diagnosis). By adjusted Cox regression models, the effect of timing on AF recurrence was examined. This study included 1064 AF patients with a median age of 63 years. Most patients were male (66%) and had paroxysmal AF (67%). The 1-year risk of AF recurrence increased from 31% in the early group to 41% and 44% in the intermediate and late group. The hazard ratios (95% confidence intervals) were 1.28 (0.95, 1.74) in the intermediate group and 1.42 (1.09, 1.86) in the late group when compared to the early group. Continuous diagnosis-to-ablation time seemed to have the greatest impact on AF recurrence within the first 2 years. CONCLUSION: In AF patients undergoing cryoballoon ablation, late timing of ablation was associated with a significantly higher AF recurrence rate when compared to early timing of ablation. These findings support early cryoballoon ablation to improve the outcomes after ablation.

Quality of Life and Safety Outcomes after First-Line Treatment of Symptomatic AF with Cryoablation or Drug Therapy: A Meta-Analysis of Randomized Controlled Trials.

Background: Cryoablation has emerged as a recognized interventional strategy for the treatment of atrial fibrillation (AF). Numerous trials have investigated cryoablation as a first-line therapy for AF. This meta-analysis aimed to evaluate the impact of cryoablation on quality of life (QoL) and safety outcomes compared to antiarrhythmic drugs (AADs) in patients with symptomatic AF. Methods: A comprehensive search of the PubMed, EMBASE, and Cochrane Library databases was conducted for randomized controlled trials (RCTs) comparing cryoablation and AADs as first-line treatments for AF until May 2023. Continuous outcome data were analyzed using mean differences (MDs) with 95% confidence intervals (CIs), and dichotomous outcome data were analyzed using relative risks (RRs) with 95% CIs. The primary outcomes assessed were QoL and serious adverse events. Results: Our analysis included four RCTs involving 928 patients. Cryoablation was associated with a significant improvement in the AF Effect on Quality of Life (AFEQT) score (3 trials; MD 7.46, 95% CI 2.50 to 12.42; p = 0.003; I 2 = 79%) and EQ-VAS score (2 trials; MD 1.49, 95% CI 1.13 to 1.86; p < 0.001; I 2 = 0%) compared to AAD therapy. Additionally, cryoablation demonstrated a modest increase in EQ-5D score from baseline compared to AAD therapy, with no statistically significance (2 trials; MD 0.03, 95% CI -0.01 to 0.07; p = 0.07; I 2 = 79%). Furthermore, the rate of serious adverse events was significantly lower with cryoablation compared to AAD therapy (4 trials; 11.8% vs. 16.3%; RR, 0.73; 95% CI, 0.54-1.00; p = 0.05; I 2 = 0%). Cryoablation was also associated with a reduction in overall adverse events, incidence of persistent AF, hospitalizations, and additional ablation. However, there was no significant difference in major adverse cardiovascular events and emergency department visits between the two treatment groups. Conclusions: Cryoablation, as a first-line treatment for symptomatic AF patients, significantly improved AF-specific quality of life and reduced serious adverse events, as well as overall adverse events, persistent AF, hospitalizations, and additional ablation compared to AADs.

Influence of cryoablation versus operation on circulating lymphocyte subsets in patients with early-stage renal cell carcinoma.

Immune response is known to play an important role in local tumor control especially in renal cell carcinoma (RCC), which is considered highly immunogenic. For localized tumors, operative resection or local ablative procedures such as cryoablation are common therapeutical options. For thermal ablative procedures such as cryoablation, additional immunological anti-tumor effects have been described.The purpose of this prospective study was to determine changes in peripheral blood circulating lymphocytes and various of their subsets in RCC patients treated with cryoablation or surgery in a longitudinal approach using extensive flow cytometry. Additionally, lymphocytes of RCC patients were compared to a healthy control group.We included 25 patients with RCC. Eight underwent cryoablation and 17 underwent surgery. Univariate and multivariable analysis revealed significantly lower values of B cells, CD4 and CD8 T cells, and various of their subsets in the treatment groups versus the healthy control group. Comparing the two different therapeutical approaches, a significant decline of various lymphocyte subsets with a consecutive normalization after three months was seen for the surgery group, whereas cryoablation led to increased values of CD69 + CD4 + and CD69 + CD8 + cell counts as well as memory CD8 + cells after three months.Treatment-naïve RCC patients showed lower peripheral blood lymphocyte counts compared to healthy controls. The post-treatment course revealed different developments of lymphocytes in the surgery versus cryoablation group, and only cryoablation seems to induce a sustained immunological response after three months.

Comparative efficacy of cryoablation versus robot-assisted partial nephrectomy in the treatment of cT1 renal tumors: a systematic review and meta-analysis.

PURPOSE: This study utilizes a meta-analytic approach to investigate the effects of cryoablation and robot-assisted partial nephrectomy on perioperative outcomes, postoperative renal function, and oncological results in patients. METHODS: This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Four electronic databases (PubMed, Embase, Web of Science, and the Cochrane Library database) were systematically searched to identify relevant studies published in English up to November 2023. The primary outcomes were perioperative results, complications, postoperative renal function and oncologic outcomes. Review Manager 5.4 was used for this analysis. RESULTS: This study included a total of 10 studies comprising 2,011 patients. Compared to RAPN (Robot-Assisted Partial Nephrectomy), the CA (Cryoablation) group had a shorter hospital stay [MD -1.76 days; 95% CI -3.12 to -0.41; p = 0.01], less blood loss [MD -104.60 ml; 95% CI -152.58 to -56.62; p < 0.0001], and fewer overall complications [OR 0.62; 95% CI 0.45 to 0.86; p = 0.004], but a higher recurrence rate [OR 7.83; 95% CI 4.32 to 14.19; p < 0.00001]. There were no significant differences between the two groups in terms of operative time, minor complications (Clavien-Dindo Grade 1-2), major complications (Clavien-Dindo Grade 3-5), changes in renal function at 12 months post-operation, RFS (Recurrence-Free Survival), and OS (Overall Survival). CONCLUSION: The evidence provided by this meta-analysis indicates that the therapeutic effects of Cryoablation (CA) are similar to those of Robot-Assisted Partial Nephrectomy (RAPN) in terms of perioperative outcomes and renal function. However, the recurrence rate of tumors treated with CA is significantly higher. SYSTEMATIC REVIEW REGISTRATION: The study has been registered on the International Prospective Register of Systematic Reviews (PROSPERO: CRD42023465846).

Potent induction of antitumor immunity by combining cryo-thermal ablation with immune checkpoint inhibitors in hepatocellular carcinoma.

BACKGROUND: The low response rate of immune checkpoint inhibitors (ICIs) prompts the exploration of novel combination therapies for patients with hepatocellular carcinoma (HCC). Here, we aimed to examine the efficiency and potential mechanism of cryo-thermal ablation (Cryo-A) combined with anti-programmed death protein 1 (αPD1) and/or cytotoxic T-lymphocyte antigen 4 (αCTLA4) inhibitors in a murine hepatoma model. METHOD: Immunocompetent C57BL/6 mice inoculated with unilateral or bilateral H22 hepatic tumour cells were treated with Cryo-A and/or ICIs (αPD1 and/or αCTLA4). Flow cytometry, immunohistochemistry, ELISpot assay, time-of-flight cytometry, tumour rechallenging, and T-cell depletion assay were used to assess the dynamic changes of immune cell subsets following therapy. RESULTS: We found Cryo-A resulted in immunogenic cell death of tumour cells, activation of dendritic cells, and enhancement of antitumor immunity. Cryo-A alone was insufficient to extend survival, combining Cryo-A with αPD1 and αCTLA4 further modulated the tumour microenvironment, inducing a durable antitumor immune response by tumour-reactive CD8+ T cells and significantly prolonged survival. Time-of-flight cytometry (CyTOF) data revealed that combination therapies reshaped the tumour microenvironment by the increase of intratumoral CD8+ T cells expressed higher levels of cytotoxic markers and immune checkpoint molecules, and by downregulation of intratumoral granulocytes. The combination also resulted in the eradication of remote unablated tumours (abscopal effect). CONCLUSIONS: These findings suggested that Cryo-A turned HCC from "cold" tumours to "hot" tumours and the combination of Cryo-A with αPD1 and αCTLA4 may be a promising approach to improve the prognosis of HCC.

Cryotherapy versus radical prostatectomy as a salvage treatment for radio-recurrent prostate cancer.

INTRODUCTION: The aim of this study is to compare outcomes of SRP (salvage radical prostatectomy) with SCAP (salvage cryoablation of the prostate) in local radio-recurrent PCa (prostate cancer) patients. MATERIALS AND METHODS: A retrospective analysis of a multicentric European Society of Uro-technology (ESUT) database was performed. Data on patients with local recurrent PCa after radiotherapy who underwent salvage treatment were collected. Patients and their respective disease characteristics, perioperative complications as well as oncological outcomes were then described. The treatment success rate was defined as PSA nadir < 0,4 ng/ml. Any complications were graded according to the modified Clavien system. A descriptive and comparative analysis was performed using SPSS software. RESULTS: 25 patients underwent SRP and 71 patients received SCAP. The mean follow-up was 24 months. The median PSA level before initial treatment was 8.3 (range 7-127) ng/ml. The success rates of SRP and SCAP were largely comparable (88% (22 patients) vs. 67.7% (48 patients), respectively, p = 0.216). The mean serum PSA levels at 12 months after salvage treatment were 1.2 ± 0.2 ng/mL vs. 0.25 ± 0.5 ng/mL, p > 0.05). During the follow-up period, only 3 (12%) patients in the SRP group had PSA recurrence compared with 21 patients (29.6%) in the SCAP group. The 5-year BRFS was similar (51,6% and 48,2%, p = 0,08) for SRP and SCAP respectively. The 5-year overall survival rate was 91.7%, and 89,7% (p = 0.669) and the 5-year cancer-specific survival was 91.7%, and 97,1% (p = 0.077), after SRP and SCAP respectively. No difference was found regarding the complications. CONCLUSIONS: Both SRP and SCAP should be considered as valid treatment options for patients with local recurrence of PCa after radiotherapy. SCAP has a potentially lower risk of morbidity and acceptable intermediate-term oncological efficacy, but a longer follow up and a higher number of patients is ideally needed to draw any long-term conclusions regarding the oncological data.

Long-term outcomes after percutaneous cryoablation of abdominal wall endometriosis.

OBJECTIVE: To retrospectively evaluate the long-term outcomes after percutaneous cryoablation of abdominal wall endometriosis (AWE). METHOD: The Institutional Review Board approved this retrospective observational review of 40 consecutive patients, of a median age of 37 years (interquartile range [IQR] 32-40 years), presenting with a total of 52 symptomatic AWE nodules. All patients underwent cryoablation between January 2013 and May 2022 with a minimum follow-up period of 12 months. Outcomes were assessed using a visual analog scale (VAS) that measured pain, as well as by magnetic resonance imaging (MRI). The pain-free survival rates were derived using the Kaplan-Meier estimator. Adverse events were analyzed and graded using the classification system of the Cardiovascular and Interventional Radiological Society of Europe. RESULTS: The median follow-up time was 40.5 months (IQR 26.5-47.2 months). The median VAS score before cryoablation was 8 (IQR 7-9). Complete relief of symptoms was documented in 80% (32/40) of patients at 3 months after initial cryoablation and correlated with the absence of residual endometriosis nodules on MRI. The median pain-free survival rates were 89.2% [95% CI, 70.1-96.4%] at 36 months and 76.8% [95% CI, 55.3-83.8%] after 60 months. No patient or lesion characteristics were found to be prognostic of failure. No major adverse events or side effects were reported in long term. CONCLUSION: Cryoablation safely and effectively afforded long-term pain relief for patients with AWE nodules. CLINICAL RELEVANCE STATEMENT: AWE cryoablation was found to be safe and effective in the long-term. KEY POINTS: • Cryoablation is highly effective with 80% of patients experiencing complete relief of AWE symptoms after a single procedure. • Cryoablation is safe without long-term adverse events or side effects. • The median pain-free survival rates are 89.2% at 36 months and 76.8% at 60 months.

Cryoablation Reduces Opioid Consumption and Length of Stay After Pulmonary Metastasectomy.

INTRODUCTION: Intraoperative cryoablation of intercostal thoracic nerves is gaining popularity as a technique that decreases postoperative pain in thoracic surgery. Our study evaluates the efficacy and safety of cryoablation in pain management of pediatric cancer patients undergoing thoracotomy. METHODS: We reviewed cancer patients undergoing thoracotomies for pulmonary metastasis resection at our children's hospital from 2017 to 2023. Patients who received cryoablation were compared to those who did not. Our primary outcomes were self-reported postoperative pain scores (from 0 to 10) and opioid consumption, measured as oral morphine equivalent per kilogram. RESULTS: Thirty eight procedures were performed in 17 patients, of which 11 (64.7%) were males. Cryoablation was used in 14 (32.4%) procedures, while it was not in 24 (67.6%). Median age (17 y in both groups, P = 0.84) and length of surgery (300 cryoablation versus 282 no cryoablation, P = 0.65) were similar between the groups. Patients treated with cryoablation had a shorter hospital stay compared to those who did not (3.0 versus 4.5 d, respectively, P = 0.04) and received a lower total dose of opioids (2.2 oral morphine equivalent per kilogram versus 14.4, P = 0.004). No significant difference was noted in daily pain scores between the two groups (3.8 cryoablation versus 3.9 no cryoablation, P = 0.93). There was no difference in rates of readmissions between the cryoablation and no-cryoablation groups (14.3% versus 8.3%, P = 0.55). CONCLUSIONS: Our study suggests that cryoablation of the thoracic nerves during a thoracotomy is associated with reduced opiate consumption and shorter hospital stay. Cryoablation appears to be a promising technique for pain management in this patient population.

Inpatient Outcomes of Intercostal Nerve Cryoablation With Surgical Rib Fixation.

INTRODUCTION: Rib fractures are associated with significant pain and morbidity. Intercostal nerve cryoablation (INCA) offers targeted, prolonged pain relief for these patients. Over the last decade, more patients have undergone surgical stabilization of rib fractures (SSRF) after injury. However, data on INCA use in SSRF patients are limited. This study aimed to identify the relationship of INCA in blunt trauma patients (BTPs) undergoing SSRF, hypothesizing INCA coupled with SSRF would decrease hospital length of stay (LOS). METHODS: The Trauma Quality Improvement Program database (2017-2021) was queried for BTPs ≥18 y old who underwent SSRF. Patients who received INCA ((+)INCA) were compared to patients who did not ((-)INCA). The primary outcome was LOS. Secondary outcomes included intensive care unit (ICU) LOS and in-hospital complications. A subgroup analysis of only flail chest patients was performed. RESULTS: From 15,784 BTPs, 750 (4.8%) received INCA. Hospital LOS was similar between groups (12 versus 12 d, P = 0.10); however, the (+)INCA patients had decreased ICU LOS (6 versus 7 d, P < 0.001). The (+)INCA cohort also had decreased hospital complications (20.4% versus 24.4%, P = 0.01), including pulmonary embolism (0.7% versus 1.8%, P = 0.02) and ventilator-associated pneumonia (2.1% versus 3.8%, P = 0.02). On subgroup analysis of flail chest patients, decreased ICU LOS in the (+)INCA patients remained a significant outcome (7 versus 8 d, P = 0.02). CONCLUSIONS: Nearly 5% of SSRF patients received INCA. While overall LOS was similar, the (+)INCA cohort had decreased ICU LOS and in-hospital complications. Future studies are needed to corroborate these findings and evaluate any long-term complications associated with INCA before widespread adoption.

Enhanced Recovery After Surgery 2.0: Optimizing Pain Management in Nuss Procedure: Cryoablation and Nerve Block Strategies for Reduced Opioid Use.

INTRODUCTION: Our study assesses the association between cryoablation, with and without nerve block supplementation, post-Nuss procedure pain, and opioid use in pectus excavatum (PE) patients. METHODS: We conducted a retrospective cohort study at a single center for PE patients who underwent the Nuss procedure from 2017 to 2022. Outcomes included postoperative opioid use (measured in oral morphine milligram equivalent per kilogram [OME/kg]), average pain score (scale 0-10), and length of stay (LOS). RESULTS: One hundred sixty-four patients (146 males and 18 females) were included, with 79 (48.2%) receiving neither cryoablation nor nerve block, 60 (36.6%) receiving intraoperative cryoablation alone, and 25 (15.2%) receiving both cryoablation and nerve block. The median age was 16 y. Nerve block recipients consumed fewer opioids during hospitalization than cryoablation alone and nonintervention groups (1.5 versus 2.3 versus 5.8 OME/kg, respectively, P < 0.0001). Average pain scores over the total LOS were lower in nerve block recipients (3.5 versus 3.8 versus 4.2, P = 0.03), particularly on postoperative day 0 (P = 0.002). Nerve block recipients had a shorter LOS than cryoablation alone and nonintervention groups (43.4 versus 54.7 versus 66.2 h, P < 0.0001). On multivariate analysis, cryoablation alone resulted in significantly less opioid use compared to no intervention (3.32 OME/kg reduction, 95% confidence interval -4.16 to -2.47, P < 0.0001). Addition of nerve block further reduced opioid use by 1.10 OME/kg (95% confidence interval -2.07 to -0.14, P = 0.04). CONCLUSIONS: Cryoablation with nerve block supplementation is associated with reduced pain, opioid use, and LOS post-Nuss for PE repair compared to cases without cryoablation or with cryoablation only. Cryoablation with regional nerve blocks should be considered for Nuss repair under the enhanced recovery after surgery pathway.

Intercostal nerve cryoablation reduces opioid utilization after thoracotomy in children with cancer.

BACKGROUND: Intercostal nerve cryoablation (INC) has shown promise as an adjunct method for analgesia in adults undergoing thoracotomy, but has yet to be widely used in children for this indication. We hypothesize that INC decreases opioid utilization in children undergoing thoracotomy for cancer operations. METHODS: A retrospective review was performed of children who underwent thoracotomy for cancer diagnosis at a freestanding children's hospital from 2018 to 2023. Patient characteristics, intraoperative data, and data on clinical course were collected. Patients were divided into those who underwent INC and those who underwent routine care for comparison. RESULTS: Twenty-six patients underwent 38 procedures at a median age of 16 years (range 5-21 years). INC was performed in 23 cases over a median of five intercostal levels (range 2-7). Total oral morphine equivalents during inpatient admission were significantly lower in INC patients (137.6 vs. 514.5 mg, p = .002). Routine care patients were more likely to be discharged with an opioid prescription (30.4% vs. 80.0%, p = .008). Length of stay was similar between patients with INC and routine care (4 vs. 5 days, p = .15). There were no differences in rates of reoperation or 30-day re-admission (emergency department or inpatient). CONCLUSTIONS: INC is a feasible and safe adjunct for children undergoing thoracotomy for cancer. INC is associated with reduced postoperative opioid utilization with respect to both inpatient use and outpatient prescriptions.

Cryoablation of Primary Breast Cancer in Patients Ineligible for Clinical Trials: A Multiinstitutional Study.

BACKGROUND. Breast cancer cryoablation clinical trials have strict inclusion criteria that exclude patients with potentially treatable disease. OBJECTIVE. The purpose of this study was to evaluate the safety and outcomes of breast cancer cryoablation without surgical excision in patients ineligible for prospective cryoablation clinical trials due to unfavorable patient or tumor characteristics. METHODS. This retrospective study included women who underwent cryoablation of biopsy-proven unifocal primary breast cancer with locally curative intent, without surgical excision, despite being ineligible for (and thus excluded from) cryoablation clinical trials, across seven institutions between January 1, 2000, and August 26, 2021. Adverse events (AEs) were recorded. Cryoablation procedures were classified as technically successful if they were not prematurely terminated and achieved intended treatment parameters and if the first follow-up imaging examination showed no evidence of residual disease. The results of follow-up biopsies were recorded. Ipsilateral breast tumor recurrences (IBTRs) diagnosed during follow-up were identified and classified as true recurrence or new primary disease. A competing-risk model was used to estimate the cumulative incidence of IBTR accounting for death before IBTR as a competing risk. RESULTS. The final study sample included 112 patients (median age, 71 years). A total of seven of 112 (6.3%) patients had a minor AE; no moderate or major AEs occurred. A total of 110 of 112 cryoablation procedures (98.2%) were technically successful. During a median follow-up of 2.0 years, 22 of 110 patients (20.0%) underwent biopsy for suspicious imaging findings in the ipsilateral breast, which yielded benign concordant findings in nine of 22 patients (40.9%) and IBTR in 12 of 22 patients (54.5%). Overall, 12 of 110 patients (10.9%) experienced IBTR, including seven with true recurrence and five with new primary disease; three of 12 patients (25.0%) with IBTR had received earlier adjuvant or neoadjuvant therapy. When death was accounted for as a competing risk, the cumulative incidence of IBTR was 5.3%, 12.2%, and 18.2% at 1, 2, and 3 years, respectively. CONCLUSION. In select individuals with unfavorable patient or tumor characteristics, breast cancer cryoablation provides a safe alternative to surgery and has good outcomes. These findings may be particularly relevant in patients who are also poor surgical candidates. CLINICAL IMPACT. Breast cancer cryoablation can be safely applied in a larger patient populations than those defined by clinical trial inclusion criteria.

The Role of Contrast-Enhanced Mammography After Cryoablation of Breast Cancer.

Image-guided cryoablation is an emerging therapeutic technique for the treatment of breast cancer and is a treatment strategy that is an effective alternate to surgery in select patients. Tumor features impacting the efficacy of cryoablation include size, location in relation to skin, and histology (e.g., extent of intraductal component), underscoring the importance of imaging for staging and workup in this patient population. Contrast-enhanced mammography (CEM) utilization is increasing in both the screening and diagnostic settings and may be useful for follow-up imaging after breast cancer cryoablation, given its high sensitivity for cancer detection and its advantages in terms of PPV, time, cost, eligibility, and accessibility compared with contrast-enhanced MRI. This Clinical Perspective describes the novel use of CEM after breast cancer cryoablation, highlighting the advantages and disadvantages of CEM compared with alternate imaging modalities, expected benign postablation CEM findings, and CEM findings suggestive of residual or recurrent tumor.