Deep Sedation with Intravenous Anesthesia Is Associated with Outcome in Patients Undergoing Cryoablation for Paroxysmal Atrial Fibrillation.

Whether deep sedation with intravenous anesthesia will affect the recurrence after cryoballoon ablation (CBA) of paroxysmal atrial fibrillation (AF) is yet to be examined. Thus, in this study, we hypothesize that there is difference in terms of the recurrence between local anesthesia and deep sedation with intravenous anesthesia after an index ablation procedure.In total, 109 patients were enrolled and received CBA, of which 68 (58.2 years) patients underwent pulmonary vein (PV) isolation with a local anesthesia (group 1) and 41 patients (63.2 years) underwent PV isolation with deep sedation using intravenous anesthesia (group 2).During the index procedure, isolation of all major PVs was achieved in 66 patients in group 1 and in 41 patients in group 2. There was no difference in non-PV triggers between the two groups. The periprocedural complication was found to be similar between the two groups (2.9% in group 1 and 4.9% in group 2). Further, 17 patients in group 1 and 4 patients in group 2 experienced recurrences after a follow-up of 19.3 months (P = 0.019). Repeat procedures revealed similar PV reconnection rates between the two groups. It has also been noted that the number of reconnected PV and incidence of atypical flutter seem to increase in group 1.Deep sedation with intravenous anesthesia during CBA for paroxysmal AF is safe and had a better long-term outcome than those with local anesthesia.

Cold Technique in Adult Tonsillectomy Reduces Waste and Cost.

OBJECTIVES: To quantify differences in waste and cost of disposable equipment between different tonsillectomy techniques. METHODS: Prospective study of waste attributable to disposable waste produced by tonsillectomy surgery. Disposable equipment required for tonsillectomy using cold, monopolar electrocautery (ME), and coblation techniques was measured; and differences in mass, volume, and cost of equipment between the 3 techniques were quantified. RESULTS: Cold technique was found to produce the least waste and have the lowest cost attributable to disposable surgical equipment. Projected single-case savings in mass and volume of waste resulting from using cold technique compared to ME were 1.272 kg and 1.013 L, respectively, and 1.043 kg and 1.723 L compared to coblation. Projected single-case savings in cost of disposable equipment for cold technique compared to ME were US$9.35 and US$185.05 compared to coblation. DISCUSSION: Using cold technique for adult tonsillectomy reduces waste and cost of disposable equipment compared to ME and coblation. Implications for Practice: Surgeons desiring to reduce cost and waste associated with tonsillectomy surgery may consider transitioning to cold technique.

Efficacy of Cryotherapy as a Primary Endoscopic Ablation Modality for Dysplastic Barrett's Esophagus and Early Esophageal Neoplasia: A Systematic Review and Meta-Analysis.

INTRODUCTION: Cryotherapy is a cold-based ablative therapy used primarily as second line therapy in patients with Barrett's esophagus (BE) who have persistent dysplasia after undergoing endoscopic treatment with radiofrequency ablation (RFA). Few studies have described the use of cryotherapy as a primary treatment modality for dysplastic or neoplastic BE. AIM: To evaluate the efficacy of cryotherapy as primary treatment of dysplastic and/or neoplastic BE by conducting a systemic review and meta-analysis. METHODS: A systematic search of Medline, Embase, and Web of Science was performed from January 2000 through March 2020. Articles included were observational studies and clinical trials which included patients who had biopsy confirmed dysplastic or neoplastic BE (i.e., high grade dysplasia (HGD), low grade dysplasia (LGD) or intramucosal adenocarcinoma (ImCA)), underwent ≥1 session of cryotherapy, and had a follow-up endoscopy. Primary outcomes were pooled proportions of patients achieving complete eradication of dysplasia (CE-D) and/or intestinal metaplasia (CE-IM) by using a random effects model. RESULTS: Fourteen studies making up 405 patients with follow-up ranging from 3-54 months were included. In 13 studies, a total of 321/405 patients achieved CE-D with a pooled proportion of 84.8% (95% confidence interval [CI] 72.2-94.4), with substantial heterogeneity (I2 = 88.3%). In 13 studies, a total of 321/405 patients achieved CE-D with a pooled proportion of 84.8% (95% confidence interval [CI] 72.2-94.4), with substantial heterogeneity (I2 = 88.3%). Subgroup analysis of only high-quality studies revealed a pooled proportion of CE-D 91.3% (95% CI, 83.0-97.4, I2 = 69.5%) and pooled proportion of CE-IM of 71.6% (95% CI, 59.0-82.9, I2 = 80.9%). Adverse events were reported in 12.2% patients. CONCLUSION: Cryotherapy is a safe and effective primary therapy for dysplastic/early neoplastic BE. CE-D and CE-IM rates are comparable to those for other ablation modalities, including RFA. Cryotherapy should be considered for primary therapy of dysplastic BE and early esophageal neoplasia.

Repeat ablative therapy in hereditary or multifocal renal cancer: Functional and oncological outcomes.

OBJECTIVES: To report managing renal tumors in patients at greater risk of repeated interventions (genetic predisposition, multifocal tumors) with thermoablative treatments (AT). A known significant challenge in these patients is the balance between nephron preservation and oncologic outcome. MATERIAL AND METHODS: This retrospective, single-center study was based on data from patients treated with one or more AT for hereditary or multifocal renal tumors between 2007 and 2017. All medical records were systematically reviewed, and 10 patients meeting inclusion criteria were selected. Six patients had confirmed von Hippel-Lindau disease, 1 Bird-Hogg-Dubé syndrome, 1 chromosome 3 translocation, and 2 had a presumed genetic predisposition. RESULTS: Median age at cancer diagnosis was 39.5 years (±8.9). Fifty-seven tumors, including 41 de novo tumors that appeared during follow-up, were treated with 32 AT sessions (cryotherapy or radiofrequency) with an average tumor size of 13.5 mm (±9) and a median RENAL score of 6 [5; 7]. One patient underwent concomitant partial nephrectomy for a 55 mm lesion which was close to the bowel. Treatment was unsuccessful in 2 cases, subsequently managed successfully by retreatment with AT. Median delay of appearance of de novo tumor after the first AT was 18 months [6 ; 24]. One patient had metastatic progression. Overall and cancer specific survival was 90% and 100%, respectively, with a mean follow-up of 7.5 years (±4.9). The mean decrease in Chronic Kidney Disease - Epidemiological Collaboration equation-estimated glomerular filtration rate at the end of follow-up was 5.5 ml/min/1.73 m2 (±24). CONCLUSION: This study suggests that AT allows to meet the oncological objectives whilst preserving renal function in patients with renal cancer at greater risk of repeated treatments.

Comparison of the recurrence rate of 3 treatment modalities for Bowen disease in an aging city: A retrospective multivariate analysis.

A wide range of therapeutic options are available for the treatment of Bowen disease. However, few studies have been conducted on wide excision using various resurfacing methods. The objectives of this study were:One hundred forty-eight lesions were studied. All lesions were histopathologically confirmed as Bowen disease. Lesions were classified by anatomical site and treatment modality and their dimensions were measured. Punch biopsy was reperformed when a treated lesion was considered to have possibly recurred. Recurrence rates were then compared. Preoperative and intraoperative photos and follow-up images were also taken.The most common site of Bowen disease was the head and neck region. Wide excision was found to provide good outcomes with minimal tumor recurrence. Recurrence after cryotherapy occurred relatively quickly (mean 0.2 years, median 0.2 years) while recurrence after wide excision occurred at a mean 2.5 years. Treatment modality was significantly associated with recurrence (P < .05).The optimal treatment for Bowen disease has not been determined. Wide excision provided lower recurrence than other treatment modalities. Providers should be aware of the multiple treatment options available and select the method most appropriate for each patient. The limitations of our study are that it was retrospectively designed and conducted at a single institution.

Esophageal Thermal Injury Following Cryoballoon Ablation for Atrial Fibrillation.

OBJECTIVES: This study evaluated the rate and predictors of endoscopically detected esophageal thermal lesions (EDEL) in patients who underwent cryoballoon atrial fibrillation (AF) ablation (CBA). BACKGROUND: EDEL is a known complication of catheter ablation for AF and is the inciting factor for atrial esophageal fistula formation. METHODS: An observational study was conducted of patients with AF presenting for CBA. Pre-procedural magnetic resonance imaging was used to retrospectively evaluate the distance between the atrial endocardium and the esophageal lumen (AED). Intraprocedural esophageal luminal temperature and balloon temperatures were recorded. All patients underwent upper endoscopy (EGD) 24 h post-ablation. Clinical, anatomical, and ablation parameters were analyzed using logistic regression for association with thermal injury. RESULTS: A total of 95 patients (37% women; 71% paroxysmal AF) were included in the study. Esophageal thermal injury was detected on EGD in 21 patients (22%). EDEL was mostly mild (20 of 21 patients) and severe in only 1 of 21 patients. Univariate logistic regression identified gastroesophageal reflux disease to be associated with increased risk of thermal injury (odds ratio [OR]: 3.2; 95% confidence interval [CI]: 1.00 to 10.46; p = 0.04), whereas a wider AED was protective (OR: 0.16; 95% CI: 0.05 to 0.515; p = 0.002). Esophageal wall thickness was also protective (OR: 0.04; 95% CI: 0.002 to 0.864; p = 0.04). In multivariate analysis, only AED (OR: 0.22; 95% CI: 0.06 to 0.77; p = 0.018) and obesity (OR: 4.63; 95% CI: 1.13 to 18.97; p = 0.033) were associated with EDEL. Esophageal luminal temperature, number, and duration of cryoballoon applications and balloon temperature were not predictors of EDEL. CONCLUSIONS: EDEL following CBA occurred in 22% of patients and was mostly mild. Obesity and atrioesophageal distance were independently associated with increased risk.

Comparing between second-generation cryoballoon vs open-irrigated radiofrequency ablation in elderly patients: Acute and long-term outcomes.

BACKGROUND: Limited comparative data are available regarding catheter ablation (CA) of atrial fibrillation (AF) using second-generation cryoballoon (CB-2) vs radiofrequency (RF) ablation in elderly patients (>75-year-old). HYPOTHESIS: CB-2 ablation may demonstrate different outcomes compared with that using RF ablation for elderly patients with AF. METHOD: Elderly patients with symptomatic drug-refractory AF were included in the study. Pulmonary vein isolation was performed in all patients. RESULTS: A total of 324 elderly patients were included (RF: 176, CB-2:148) from September 2016 to April 2019. The CB-2 was associated with shorter procedure time and left atrial dwell time (112.9 ± 11.1 vs 135.1 ± 9.9 minutes, P < .001; 53.7 ± 8.9 vs 65.1.9 ± 9.0 minutes, P < .001), but marked fluoroscopy utilization (22.1 ± 3.3 vs 18.5 ± 3.6 minutes, P < .001). Complications occurred in 3.3% (CB-2) and 6.2% (RF) of patients with no significant different (P = .307). The length of stay after ablation was shorter, but the costs were higher in the CB-2 group (1.94 vs 2.53 days, P < .001 and 91 132.6 ± 3723.5 vs 81 149.4 ± 6824.1 CNY, P < .001) compared to the RF group. Additionally, the rate of early recurrence of atrial arrhythmia was lower in the CB-2 group (14.2 vs 23.3%, P = .047), but the long-term success rate was similar between two groups. CONCLUSIONS: CB-2 is associated with shorter procedure time, left atrial dwell time, and length of stay after ablation, but its costs and fluoroscopy time are greater than the RF group. Moreover, the rate of complications and long-term success are similar between the two groups.

Percutaneous Ablation Versus Robotic Partial Nephrectomy in the Treatment of cT1b Renal Tumors: Oncologic and Functional Outcomes of a Propensity Score-weighted Analysis.

INTRODUCTION: The purpose of this study was to assess oncologic and functional outcomes of both percutaneous ablation (cryoablation and radiofrequency ablation) and robot-assisted partial nephrectomy (RAPN) in the treatment of renal tumors larger than 4 cm. MATERIALS AND METHODS: We retrospectively analyzed prospectively collected data from 102 consecutive patients, who underwent minimally invasive treatment for cT1b renal tumors at our institution. Primary renal function outcome was assessed by estimated glomerular filtration rate preservation at baseline and 1 year postoperatively. Perioperative data and functional and oncologic outcome were collected. Multivariate regression models were used to compare functional outcomes between groups. Cancer-specific survival and recurrence-free survival were estimated at 2 years using the Kaplan-Meier method and compared with Cox proportional hazards regression model to calculate hazard ratios (HRs). To control for selection bias between the different treatments, we adjusted our models with an inverse probability of treatment weighting propensity score. RESULTS: There was no significant difference in renal preservation between the groups (P = .664). Multivariate analysis did not show a statistically significant difference in terms of renal function outcomes between the RAPN and percutaneous thermal ablation groups. The adjusted HR regarding the local recurrence-free survival was significantly shorter for the cryoablation group (HR, 4.3; 95% confidence interval, 1.78-10.37; P = .001). CONCLUSIONS: Our study demonstrated the equivalence between RAPN and percutaneous ablative techniques for the preservation of renal function in the treatment of T1b tumors. RAPN offers a better local control than percutaneous ablation, in terms of primary success rate.

Prognostic factors, treatment, and survival in cutaneous pleomorphic sarcoma.

BACKGROUND: Limited information exists on the influence of demographics, tumor characteristics, and treatment on survival in cutaneous pleomorphic sarcoma (CPS). OBJECTIVE: To describe incidence rates and prognostic factors affecting survival in CPS. METHODS: National Cancer Institute's Surveillance, Epidemiology, and End Results data (1972-2013) was analyzed for 2423 patients with CPS diagnoses. RESULTS: The age-adjusted incidence rate was 0.152 cases/100,000 person-years and was 4.5-fold higher in male than female patients. Male sex, white race, and increasing age >40 years were significantly associated with decreased overall survival. Head and neck tumors, tumors >15 mm, and tumors with grade III or IV histology were associated with significantly decreased survival. Surgical excision had a survival benefit compared with no treatment. Radiation therapy did not provide a survival benefit. Patients with localized disease had the greatest survival followed by regional and distant disease. LIMITATIONS: Surveillance, Epidemiology, and End Results data might not be reflective of all CPS patients. Recurrences, restaging, or other nonmortality events over time were not tracked. CONCLUSION: Tumor size, grade, sex, age at diagnosis, and race appear to influence survival as prognostic factors in CPS. Surgical tumor extirpation provides a survival benefit over no treatment whereas primary or adjuvant radiation does not provide a survival benefit.

Pediatric dermatologic surgery: our experience.

BACKGROUND: Surgical treatment for pediatric skin disorders is used for diagnostic and therapeutic reasons. We underline these procedures are usually easy and uncomplicated without the need for general anesthesia. Objective of this study was to share our experience in the field of pediatric dermatologic surgery. METHODS: We retrospectively analysed records of all pediatric patients receiving surgical therapy at the Dermatology Department of Spedali Civili of Brescia. Demographic data and treatments characteristics were recorded and analyzed. RESULTS: During the study period of one year, 670 surgical treatments concerning pediatric patients were collected. Number of procedures progressively grows with increasing age. All treatments were performed under local anesthesia except for a dermatofibrosarcoma protuberans for which general anesthesia was needed. CONCLUSIONS: Our data show that cryosurgery, electrodessication and excisional surgery constitute with equal proportion almost the whole of surgical procedures in dermatologic pediatric patients. Dermatologist's habit to perform surgery in local anesthesia avoids the risk of overtreatments, limits discomfort, anxiety, and pain perception linked to procedures performed.

Effect of cryoballoon ablation parameters on recurrence in patients with paroxysmal atrial fibrillation.

OBJECTIVE: The aim of this research was to investigate the relationship between atrial fibrillation (AF) recurrence and second generation cryoballoon ablation (CBA) procedural parameters in patients with non-valvular paroxysmal AF (PAF). METHODS: A total of 131 patients with a PAF diagnosis who underwent second-generation CBA (59 male; mean age: 55.2±10.6 years) were enrolled. Recurrence was defined as the detection of AF on a 12-lead electrocardiography (ECG) recording, or an attack lasting at least 30 seconds observed on Holter ECG records. CBA procedural data and echocardiographic findings were recorded and compared. RESULTS: After 1 year of follow-up, AF recurrence was detected in 27 patients. Patients with recurrence were older and had higher rates of hypertension and diabetes (p<0.05 for both). Left atrial diameter, left atrial volume (LaV), left atrial volume index, and the averaged warming angle (calculated by combining lowest temperature point and balloon temperature at 20°C point) were significantly higher in the recurrence group. Balloon warming time was significantly longer in the non-recurrence group (p<0.001). In binary logistic regression analysis, the averaged warming angle (odds ratio [OR]: 1.559, 95% confidence interval [CI]: 1.342-1.811; p<0.001) and LaV (OR: 1.063, 95% CI: 1.028-1.100; p<0.001) were found to be independent parameters for predicting recurrence. The cutoff value of the warming angle obtained with ROC curve analysis was 50° for the prediction of recurrence (sensitivity: 94.3%, specificity: 88.5%, area under the curve: 0.909; p<0.001). The cutoff value of LaV obtained by ROC curve analysis was 53.5 for prediction of recurrence (sensitivity: 77.8%, specificity: 74.5%; p<0.001). CONCLUSION: Measurement of balloon warming angle during CBA and increased LaV may predict the AF recurrence.

Impact of Cryoballoon Freeze Duration on Long-Term Durability of Pulmonary Vein Isolation: ICE Re-Map Study.

OBJECTIVES: This study sought to evaluate the durability of pulmonary vein isolation (PVI) after 2 different freeze durations by using time-to-effect guided (ICE-T) second generation cryoballoon (CB2) ablation strategy in patients with atrial fibrillation (AF) undergoing repeat procedure. BACKGROUND: CB2 represents a powerful technology for PVI. Recently, the ICE-T CB2 ablation strategy targeting a 240-s single freeze demonstrated fast and efficient PVI. To further optimize safety and efficacy, a shortened 3-min freeze duration has been suggested, but PVI durability remains unclear. METHODS: Between May 1, 2013 and December 31, 2017, all CB2 ablations followed the ICE-T concept (target freeze: 240 s or 180 s). Patients undergoing a second procedure for arrhythmia recurrence were analyzed. Two groups were defined based on the index freeze duration (group A: 240 s vs. group B: 180 s). In all repeat procedures a 3-dimensional left-atrial map was obtained. Durability of PVI and localization of conduction gaps were compared. RESULTS: Of 788 total patients, 106 (13%) underwent a second procedure (group A: 80 of 604 vs. group B: 26 of 184) after a mean of 377 days. There was no difference regarding PV occlusion and time-to-isolation in the index procedure between the 2 groups. No major complications occurred. During the second procedure, significantly more patients demonstrated durable isolation of all PV in group A (61% vs. 35%; p = 0.02) along with a significantly increased rate of PVI durability (88% vs. 69%, per vein; p < 0.001). Left-sided PV did significantly benefit from 240-s freeze (reconnection left superior PV: 6% vs. 27%; p = 0.004, left inferior PV: 14% vs. 39%; p = 0.006). CONCLUSIONS: The ICE-T ablation strategy is associated with a high rate of durable PVI in patients with arrhythmia recurrence. Target freeze duration of 240 s versus 180 s is associated with significantly increased lesion durability, particularly at left-sided PV, without increasing complications.

Second-Generation Cryoballoon Atrial Fibrillation Ablation in Patients With Persistent Left Superior Caval Vein.

OBJECTIVES: This study sought to assess the acute success rate, periprocedural complications, and long-term outcomes in patients with atrial fibrillation (AF) and persistent left superior vena cava (PLSVC) treated with second-generation 28-mm cryoballoon (CB2). BACKGROUND: PLSVC is a cardiac anomaly associated with AF. METHODS: Between July 2012 and October 2018, 8 patients from 4 German high-volume centers referred for pulmonary vein isolation (PVI) demonstrated a PLSVC. PVI and ablation within the PLSVC was performed using the CB2. RESULTS: A total of 2,876 patients were treated with CB2-based PVI. Eight patients (0.28%; mean 65 ± 7 years of age, 2 paroxysmal, 6 with persistent AF, mean left atrial size of 44 ± 4 mm) presenting with PLSVC were evaluated. All patients underwent PVI, and 3 of 8 patients with documented triggered activity from PLSVC underwent PLSVC ablation with CB2. Electrical isolation of PLSVC was achieved in 2 of 3 patients. Mean procedure and fluoroscopy times were 120 ± 22 min and 32 ± 18 min, respectively. In 2 of 8 patients, major complications (right phrenic nerve palsy) occurred during right PV ablation. After 3 months, 1 of 2 patients recovered from right phrenic nerve palsy. Two patients underwent a redo procedure after AF recurrence, demonstrating PV reconnection but no triggers from PLSVC. Freedom from AF after 332 days of follow-up was 63%. CONCLUSIONS: CB2 ablation for AF in patients with PLSVC is feasible, with an increased risk for right phrenic nerve palsy. Electrical isolation of PLSVC can be achieved with the CB2 in most patients.

The effectiveness of RENAL nephrometry score in ablated renal tumors via radiofrequency ablation or cryoablation

Background/aim: This study aimed to evaluate the clinical efficacy of radiofrequency ablation (RFA) and cryotherapy and to scrutinize the therapeutic success of the RENAL (radius, exophytic/endophytic, nearness to collecting system, anterior/posterior, and location) nephrometry score in terms of possible complications and the predictive status of oncological results. Materials and methods: Forty-five patients with biopsy-proven renal cell carcinomas (32 males, 13 females) treated with RFA and cryotherapy were included. Patients were 22­90 years old (average: 59.2 years). Statistical analyses were performed using SPSS for Windows. Results: A total of 79 lesions with dimensions varying between 0.9 and 4.5 cm (average: 2.2 cm) were ablated. Complete ablation was achieved for 72 (91.1%) lesions. Six repeat RFA sessions were applied for 4 (5%) lesions with residue/recurrence. The average RENAL nephrometry scores of lesions that underwent complete ablation and those that developed residue/recurrence were 6.3 and 7.7, respectively. The average recurrence-free survival time was 34.8 months (range: 3­55 months), while it was 44.6 months (range: 6­55 months) for cryotherapy and 28.6 months (range: 3­50 months) for RFA. Conclusion: Ablative therapies are minimally invasive and effective methods for treating small renal tumors. RENAL nephrometry scoring is a valuable system for standardizing renal tumors and evaluating the success of ablative therapies, possible complications, and oncological results.

Cryoablation of low-flow vascular malformations.

PURPOSE: We aimed to evaluate the safety and effectiveness of cryoablation in the treatment of low-flow malformations, specifically venous malformation (VM) and fibroadipose vascular anomaly (FAVA). METHODS: We conducted a retrospective review of 11 consecutive patients with low-flow malformations (14 lesions; 9 VM, 5 FAVA), median lesion volume 10.8 cm3, (range, 1.8-55.6 cm3) with a median age of 19 years (range, 10-50 years) who underwent cryoablation to achieve symptomatic control. Average follow-up was at a median of 207 days postprocedure (range, 120-886 days). Indications for treatment included focal pain and swelling. Technical success was achieved if the cryoablation ice ball covered the region of the malformation that corresponded to the patient's symptoms. Clinical success was considered complete if all symptoms resolved and partial if some symptoms persisted but did not necessitate further treatment. RESULTS: The technical success rate was 100%. At 1-month follow-up, 13 of 14 lesions (93%) had a complete response and one (7%) had a partial response. At 6-month follow-up 12 of 13 (92%) had a complete response and 1 (8%) had a partial response. A total of 6 patients underwent primary cryoablation. Out of 9 VM cases, 7 had prior sclerotherapy and 2 had primary cryoablation. Out of the 5 FAVA cases, 1 had prior sclerotherapy and the remaining 4 cases underwent primary cryoablation. There were 3 minor complications following cryoablation including 2 cases of skin blisters and 1 case of transient numbness. These complications resolved with conservative management. CONCLUSION: Cryoablation is safe and effective in the treatment of low-flow vascular malformations, either after sclerotherapy or as primary treatment.

Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial.

PURPOSE: Minimally-invasive repair of pectus excavatum by the Nuss procedure is associated with significant postoperative pain, prolonged hospital stay, and high opiate requirement. We hypothesized that intercostal nerve cryoablation during the Nuss procedure reduces hospital length of stay (LOS) compared to thoracic epidural analgesia. DESIGN: This randomized clinical trial evaluated 20 consecutive patients undergoing the Nuss procedure for pectus excavatum between May 2016 and March 2018. Patients were randomized evenly via closed-envelope method to receive either cryoanalgesia or thoracic epidural analgesia. Patients and physicians were blinded to study arm until immediately preoperatively. SETTING: Single institution, UCSF-Benioff Children's Hospital. PARTICIPANTS: 20 consecutive patients were recruited from those scheduled for the Nuss procedure. Exclusion criteria were age < 13 years, chest wall anomaly other than pectus excavatum, previous repair or other thoracic surgery, and chronic use of pain medications. MAIN OUTCOMES AND MEASURES: Primary outcome was postoperative LOS. Secondary outcomes included total operative time, total/daily opioid requirement, inpatient/outpatient pain score, and complications. Primary outcome data were analyzed by the Mann-Whitney U-test for nonparametric continuous variables. Other continuous variables were analyzed by two-tailed t-test, while categorical data were compared via Chi-squared test, with alpha = 0.05 for significance. RESULTS: 20 patients were randomized to receive either cryoablation (n = 10) or thoracic epidural (n = 10). Mean operating room time was 46.5 min longer in the cryoanalgesia group (p = 0.0001). Median LOS decreased by 2 days in patients undergoing cryoablation, to 3 days from 5 days (Mann-Whitney U, p = 0.0001). Cryoablation patients required significantly less inpatient opioid analgesia with a mean decrease of 416 mg oral morphine equivalent per patient (p = 0.0001), requiring 52%-82% fewer milligrams on postoperative days 1-3 (p < 0.01 each day). There was no difference in mean pain score between the groups at any point postoperatively, up to one year, and no increased incidence of neuropathic pain in the cryoablation group. No complications were noted in the cryoablation group; among patients with epidurals, one patient experienced a symptomatic pneumothorax and another had urinary retention. CONCLUSIONS AND RELEVANCE: Intercostal nerve cryoablation during the Nuss procedure decreases hospital length of stay and opiate requirement versus thoracic epidural analgesia, while offering equivalent pain control. TYPE OF STUDY: Treatment study. LEVEL OF EVIDENCE: Level I.

Partial nephrectomy vs cryoablation for T1a renal cell carcinoma: A comparison of survival benefit stratified by tumour size.

OBJECTIVE: We compared the impact on survival outcomes of partial nephrectomy (PN) and cryoablation (CA) for patients diagnosed with T1a renal cell carcinoma (RCC). PATIENTS AND METHODS: Among patients diagnosed between 2004 and 2014 in the Surveillance, Epidemiology and End Results program, we identified histologically confirmed T1aN0M0 RCC treated with PN (n = 17644) or CA (n = 868). Propensity score matching (PSM) was performed. Kaplan-Meier method, Cox proportional hazards model were used to calculate cancer specific mortality (CSM) and overall mortality (OM) in the unmatched and matched cohort, and in subgroups based on tumour size (< 2 cm, 2-3 cm, 3-4 cm). Sensitivity analyses were performed. RESULTS: A total of 18512 patients were identified: PN (93.88%) and CA (6.12%). In the propensity-score matched cohort, for tumours ≤ 2 cm, the CA and PN groups had similar CSM (HR: 1.41, 95% CI: 0.32-6.31, p = 0.65) and OM (HR 0.97, 95%CI: 0.47-2.01, p = 0.93). For tumours 2-3 cm, CA was associated with similar CSM (HR 1.64, 95%CI: 0.67-4.03, p = 0.28) but higher OM (HR 2.05, 95%CI: 1.35-3.11, p < 0.001), compared with PN. For tumours 3-4 cm, CA was associated with increased CSM (HR: 3.76, 95% CI: 1.62-8.69, p = 0.002) and OM (HR 2.17, 95%CI: 1.48-3.18, p < 0.001). CONCLUSION: For RCC ≤ 2 cm, PN and CA are equal in survival outcomes. For RCC 2-4 cm, PN may have a possible advantage over CA.

Medium- and long-term outcome after a single second-generation cryoballoon ablation in patients with paroxysmal and persistent atrial fibrillation.

INTRODUCTION AND OBJECTIVES: To report medium- and long-term results following a single second-generation cryoballoon (CB2)-based ablation procedure in patients with paroxysmal (PAF) and persistent (PeAF) atrial fibrillation. METHODS: A retrospective study was performed of consecutive patients undergoing a first CB2-based ablation procedure in a tertiary center. Cryoenergy was applied for 3 min if a time to effect <60 s was documented or 4 min otherwise, with a bonus application in cases of late isolation or suboptimal temperature. Follow-up was obtained from the regional health electronic records system and by telephone or personal interviews. Recurrence was defined as any atrial arrhythmia >30 s beyond a three-month blanking period. The clinical impact of recurrences was classified using a severity score. RESULTS: A total of 172 patients (134 PAF and 38 PeAF) were included, of whom 25 (14.5%) had structural heart disease and 120 (69.7%) had a normal or mildly dilated left atrium. Acute success was achieved in 167 (97.1%). After a median follow-up of 27 (14-41) months, 100 patients (58.1%) remained free of atrial arrhythmias (64.2% for PAF and 36.8% for PeAF, p=0.006). Left atrial size (p=0.05) and clinical presentation as PeAF (p=0.006) were predictors of recurrence. Of patients with recurrences, 11.1% did not require further therapies and an additional 16.7% had good control with antiarrhythmic drugs. CONCLUSIONS: A single CB2 procedure resulted in 58.1% of patients remaining free of atrial arrhythmias at 27-month follow-up. Conservative management was useful in 27.8% of patients with recurrences.

Single-Procedure Outcomes and Quality-of-Life Improvement 12 Months Post-Cryoballoon Ablation in Persistent Atrial Fibrillation: Results From the Multicenter CRYO4PERSISTENT AF Trial.

OBJECTIVES: The CRYO4PERSISTENT AF (Cryoballoon Ablation for Early Persistent Atrial Fibrillation) trial aims to report long-term outcomes after a single pulmonary vein isolation (PVI)-only ablation procedure using the second-generation cryoballoon in persistent atrial fibrillation (PerAF) patients. BACKGROUND: Pulmonary vein isolation is recognized as the cornerstone of atrial fibrillation (AF) ablation, including ablation of PerAF. METHODS: The CRYO4PERSISTENT AF trial (NCT02213731) is a prospective, multicenter, single-arm trial designed to assess single-procedure outcomes of PVI using the cryoballoon. The primary endpoint was freedom from AF, atrial flutter, or atrial tachycardia ≥30 s after a 90-day blanking period. After enrollment, but before ablation, patients without 100% AF burden (18-h Holter monitoring or 3 consecutive electrocardiograms in a time frame ≥14 days) were excluded. Patients were followed at 3, 6, and 12 months, with 48-h Holter monitoring at 6 and 12 months. Quality of life and symptoms were evaluated at baseline and 12 months. Arrhythmia recurrence and adverse events were adjudicated by an independent committee. RESULTS: A total of 101 patients (62 ± 11 years of age, 74% men, left ventricular ejection fraction 56 ± 8%, left atrial diameter 43 ± 5 mm) meeting criteria, undergoing cryoballoon-based PVI, with follow-up data, were included. Kaplan-Meier estimate of freedom from AF, atrial flutter, or atrial tachycardia recurrence was 60.7% at 12 months. Compared with baseline, there were significantly fewer patients with arrhythmia-related symptoms at 12 months (16% vs. 92%; p < 0.0001). The symptom reduction was supported by significant improvement in 36-Item Short Form Health Survey composite scores and European Heart Rhythm Association score at 12 months. The only device related event was transient phrenic nerve injury in 2 (2%) patients, with resolution pre-discharge. CONCLUSIONS: Cryoballoon ablation for treatment of PerAF demonstrated 61% single-procedure success at 12 months post-ablation in addition to significant reduction in arrhythmia-related symptoms and improved quality of life. (Cryoballoon Ablation for Early Persistent Atrial Fibrillation [Cryo4 Persistent AF]; NCT02213731).