Predictors of first pass isolation of the pulmonary veins in real world ablations: An analysis of 2671 patients from the REAL-AF registry.

INTRODUCTION: During atrial fibrillation ablation (AFA), achievement of first pass isolation (FPI) reflects effective lesion formation and predicts long-term freedom from arrhythmia recurrence. We aim to determine the clinical and procedural predictors of pulmonary vein FPI. METHODS: We reviewed AFA procedures in a multicenter prospective registry of AFA (REAL-AF). A multivariate ordinal logistic regression, weighted by inverse proceduralist volume, was used to determine predictors of FPI. RESULTS: A total of 2671 patients were included with 1806 achieving FPI in both vein sides, 702 achieving FPI in one, and 163 having no FPI. Individually, age, left atrial (LA) scar, higher power usage (50 W), greater posterior contact force, ablation index >350 posteriorly, Vizigo™ sheath utilization, nonstandard ventilation, and high operator volume (>6 monthly cases) were all related to improved odds of FPI. Conversely sleep apnea, elevated body mass index (BMI), diabetes mellitus, LA enlargement, antiarrhythmic drug use, and center's higher fluoroscopy use were related to reduced odds of FPI. Multivariate analysis showed that BMI > 30 (OR 0.78 [0.64-0.96]) and LA volume (OR per mL increase = 1.00 [0.99-1.00]) predicted lower odds of achieving FPI, whereas significant left atrial scarring (>20%) was related to higher rates of FPI. Procedurally, the use of high power (50 W) (OR 1.32 [1.05-1.65]), increasing force posteriorly (OR 2.03 [1.19-3.46]), and nonstandard ventilation (OR 1.26 [1.00-1.59]) predicted higher FPI rates. At a site level, high procedural volume (OR 1.89 [1.48-2.41]) and low fluoroscopy centers (OR 0.72 [0.61-0.84]) had higher rates of FPI. CONCLUSION: FPI rates are affected by operator experience, patient comorbidities, and procedural strategies. These factors may be postulated to impact acute lesion formation.

Consistency of ablations with trainee and increasing independence during fellowship training-Analysis of ablation data by CARTONET.

INTRODUCTION: Training in clinical cardiac electrophysiology (CCEP) involves the development of catheter handling skills to safely deliver effective treatment. Objective data from analysis of ablation data for evaluating trainee of CCEP procedures has not previously been possible. Using the artificial intelligence cloud-based system (CARTONET), we assessed the impact of trainee progress through ablation procedural quality. METHODS: Lesion- and procedure-level data from all de novo atrial fibrillation (AF) and cavotricuspid isthmus (CTI) ablations involving first-year (Y1) or second-year (Y2) fellows across a full year of fellowship was curated within Cartonet. Lesions were automatically assigned to anatomic locations. RESULTS: Lesion characteristics, including contact force, catheter stability, impedance drop, ablation index value, and interlesion time/distance were similar over each training year. Anatomic location and supervising operator significantly affected catheter stability. The proportion of lesion sets delivered independently and of lesions delivered by the trainee increased steadily from the first quartile of Y1 to the last quartile of Y2. Trainee perception of difficult regions did not correspond to objective measures. CONCLUSION: Objective ablation data from Cartonet showed that the progression of trainees through CCEP training does not impact lesion-level measures of treatment efficacy (i.e., catheter stability, impedance drop). Data demonstrates increasing independence over a training fellowship. Analyses like these could be useful to inform individualized training programs and to track trainee's progress. It may also be a useful quality assurance tool for ensuring ongoing consistency of treatment delivered within training institutions.

Real-world trends in atrial fibrillation ablation indicate increasing durability of pulmonary vein isolation at repeat ablation.

BACKGROUND: Durable electrical isolation of pulmonary veins (PVs) is associated with better outcomes after atrial fibrillation (AF) ablation, but previous studies of AF recurrence have reported high rates of reconnection despite successful acute isolation. This study aims to quantify historical trends in the durability of PV isolation (PVI) as radiofrequency (RF) ablation catheters, additional ablation technologies, and associated workflows have evolved. METHODS: The study population included adult patients receiving a first repeat ablation for AF between September 2013 and July 2019 at the study site. All index ablations were performed at the same site with an RF catheter and included PVI. Three generations of irrigated RF catheters based on the same technology platform were used by the site during the timeframe of this study. RESULTS: A total of 224 patients were included in the analysis. At repeat ablation, the mean number of patients with at least one reconnected PV dropped significantly with subsequent catheter generation, from 78.3% to 56.7% to 27.0% (p < .0001). Moreover, the mean number of reconnected PVs were significantly reduced from 1.48 to 0.92 to 0.47 (p < .0001), representing a 68.3% reduction across the 3 generations of devices. CONCLUSION: Significant improvement in durable PVI was seen with successive generations of RF catheter over a 6-year period. In addition to catheter technology, ancillary advances in ablation technologies, workflows, and operator experience likely contributed to these improvements.

Diagnostic outcomes of robotic-assisted bronchoscopy for pulmonary lesions in a real-world multicenter community setting.

BACKGROUND: Robot-assisted bronchoscopy (RAB) is among the newest bronchoscopic technologies, allowing improved visualization and access for small and hard-to-reach nodules. RAB studies have primarily been conducted at academic centers, limiting the generalizability of results to the broader real-world setting, while variability in diagnostic yield definitions has impaired the validity of cross-study comparisons. The objective of this study was to determine the diagnostic yield and sensitivity for malignancy of RAB in patients with pulmonary lesions in a community setting and explore the impact of different definitions on diagnostic yield estimates. METHODS: Data were collected retrospectively from medical records of patients ≥ 21 years who underwent bronchoscopy with the Monarch® Platform (Auris Health, Inc., Redwood City, CA) for biopsy of pulmonary lesions at three US community hospitals between January 2019 and March 2020. Diagnostic yield was calculated at the index RAB and using 12-month follow-up data. At index, all malignant and benign (specific and non-specific) diagnoses were considered diagnostic. After 12 months, benign non-specific cases were considered diagnostic only when follow-up data corroborated the benign result. An alternative definition at index classified benign non-specific results as non-diagnostic, while an alternative 12-month definition categorized index non-diagnostic cases as diagnostic if no malignancy was diagnosed during follow-up. RESULTS: The study included 264 patients. Median lesion size was 19.3 mm, 58.9% were peripherally located, and 30.1% had a bronchus sign. Samples were obtained via Monarch in 99.6% of patients. Pathology led to a malignant diagnosis in 115 patients (43.6%), a benign diagnosis in 110 (41.7%), and 39 (14.8%) non-diagnostic cases. Index diagnostic yield was 85.2% (95% CI: [80.9%, 89.5%]) and the 12-month diagnostic yield was 79.4% (95% CI: [74.4%, 84.3%]). Alternative definitions resulted in diagnostic yield estimates of 58.7% (95% CI: [52.8%, 64.7%]) at index and 89.0% (95% CI: [85.1%, 92.8%]) at 12 months. Sensitivity for malignancy was 79.3% (95% CI: [72.7%, 85.9%]) and cancer prevalence was 58.0% after 12 months. CONCLUSIONS: RAB demonstrated a high diagnostic yield in the largest study to date, despite representing a real-world community population with a relatively low prevalence of cancer. Alternative definitions had a considerable impact on diagnostic yield estimates.

Predictors of clinical success after paroxysmal atrial fibrillation catheter ablation.

INTRODUCTION: Contact force (CF) guided ablation of paroxysmal atrial fibrillation (PAF) with stable catheter-tissue contact optimizes clinical success and may increase an operator's ability to achieve pulmonary vein isolation (PVI) in a single encirclement. First pass PVI reduces procedure time but the relationship with long term clinical success is not well understood. This study evaluated patient characteristics and procedural details as predictors of 1-year clinical success after PAF ablation, including first pass isolation. METHODS: Consecutive de novo PAF ablations were performed with a porous tip CF catheter in 2017 and 2018. All ablations used wide-area circumferential ablation, with first pass isolation captured separately for the left and right pulmonary veins (PVs). CF was held between 10 and 20 g and the catheter was moved every 10-20 s. Radiofrequency energy was set at 40-45 W throughout the atrium. Patient characteristics and procedural details were tested for association with clinical success, defined as freedom from recurrent atrial tachyarrhythmia through 1 year. RESULTS: A total of 404 patients were included in the study. Clinical success at 1 year was 86.6%. Achieving first pass isolation on at least one ipsilateral PV pair was the most significant predictor of clinical success (p = .0126). After controlling for first pass isolation, only recurrence within the 90-day blanking period was independently predictive (p = .0015). First pass isolation was not associated with early recurrence (p = .2454). CONCLUSION: In a real-world setting, first pass isolation was highly predictive of 12-month clinical success after CF-guided ablation in a PAF population.

Safety and Effectiveness of Silicone Gel-Filled Breast Implants in Primary Augmentation Patients.

BACKGROUND: Results from the MemoryGel Breast Implants Core Clinical Study suggest these devices are safe and effective at 10 years after implantation. Although clinical trials are essential for measuring the safety and effectiveness of a device, real-world evidence can supplement clinical trials by providing information on outcomes observed in diverse clinical settings for a more heterogeneous population, without fixed treatment patterns, and without continuous patient monitoring, such that follow-up is more representative of normal clinical practice. OBJECTIVES: The aim of this study was to measure real-world outcomes, including safety and effectiveness, in patients who underwent primary breast augmentation with smooth MemoryGel implants. METHODS: This was a case series looking at patients, age 22 years and older, who underwent primary breast augmentation at a single site between December 2006 and December 2016 and who had a minimum of 2 years of follow-up. Descriptive statistics were used to summarize baseline characteristics and outcomes. Kaplan-Meier models were used to estimate safety outcomes for capsular contracture (Baker grade III/IV), infection, and rupture. RESULTS: A total of 50/777 (6.4%) patients reported a complication, with an average time to complication of 3.9 years (range, 19 days-11.8 years) postprocedure. Kaplan-Meier estimates of the 10-year cumulative incidence of capsular contracture (Baker grade III/IV), infection, and rupture were 4.7%, 0.1%, and 1.6%, respectively. CONCLUSIONS: Analyses of a large population from a single site provide further support for the long-term safety and effectiveness of MemoryGel breast implants in a primary augmentation cohort.

Healthcare Utilization and Quality of Life Improvement after Ablation for Paroxysmal AF in Younger and Older Patients.

BACKGROUND: Atrial fibrillation (AF) prevalence increases significantly with age. Little is known about the effect of AF ablation on quality of life and healthcare utilization in the elderly. The objective of this study was to quantify the healthcare utilization and quality of life benefits of catheter ablation for AF, for patients ≥65 years compared to patients <65 years. METHODS: Two multicenter U.S. registry studies enrolled patients with paroxysmal AF. Baseline characteristics and acute outcomes were collected for 736 patients receiving catheter ablation with the Navistar® ThermoCool® SF Catheter (Biosense Webster, Inc., Diamond Bar, CA, USA). Healthcare utilization and quality of life outcomes were collected through 1 year postablation for 508 patients. RESULTS: The rates of acute pulmonary vein isolation were high and similar between patients ≥65 years and <65 years (97.5% vs 95.8%, P = 0.2130). Length of stay for the index procedure was similar between age groups with 82.2% of the older group and 83.2% of the younger group having one-day hospitalization. Disease-specific quality of life instrument scores improved significantly and similarly for older and younger patients at 1 year postablation, compared to baseline. AF-related hospitalizations and emergency department visits were similar or lower in older patients compared to younger patients, as reported at 1 year postablation. CONCLUSION: For older patients undergoing catheter ablation for paroxysmal AF, healthcare utilization parameters were lower or not significantly different than for younger patients, and quality of life outcomes were similarly improved. These findings support the use of catheter ablation as a treatment option in older patients with paroxysmal AF.

Patient comorbidities increase postoperative resource utilization after laparoscopic and open cholecystectomy.

BACKGROUND: An understanding of the relationship between patient factors and healthcare resource utilization represents a major point of interest for optimizing clinical care and overall net savings, yet maintaining financial margins for provider revenues. This study aims to review resource utilization after cholecystectomy in order to characterize patient factors associated with increased postoperative ED visits and 30-day readmissions. METHODS: A total of 53,632 open and laparoscopic cholecystectomies were reviewed from July 2009 to December 2010 in a large private payer claims database. ICD-9 and CPT codes were available for each event, as well as basic demographics. Data regarding 30-day postoperative resource utilization metrics (emergency department visits and inpatient hospitalizations) were analyzed and stratified by key patient comorbidities. Differences between subgroups were evaluated with univariate and multivariable methods. RESULTS: Of the 53,632 patients studied, 71.2 % (38,171) were female and 28.8 % (15,461) male. Resource utilization within 30 days of surgery included: 6.6 % (3538) of patients with an ED visit and 7.7 % (4103) with an inpatient hospitalization. The most common comorbidities in the study population were: hypertension, hyperlipidemia, GERD/hiatal hernia, and diabetes mellitus. Patients with heart failure, cirrhosis, and a history of MI or acute ischemic heart disease all had a significant association with postoperative ED visit and the highest likelihood of inpatient hospitalization. Angina, diabetes, and hypertension similarly increased both ED utilization and inpatient readmissions to a lesser but still significant extent. Although patients with GERD/hiatal hernia and sleep apnea had a significant association with ED use, they did not have an increased likelihood of readmission. CONCLUSIONS: Patient comorbidity indexing plays a major role in clinical risk stratification and resource utilization for cholecystectomy. These factors should be considered in bundled reimbursement packages and in the creation of preventive postoperative ambulatory strategies given their role in determining potential resource utilization in the postoperative setting.

Acute safety of an open-irrigated ablation catheter with 56-hole porous tip for radiofrequency ablation of paroxysmal atrial fibrillation: analysis from 2 observational registry studies.

INTRODUCTION: This report presents safety data on the use of a new open-irrigation radiofrequency ablation (RFA) catheter with a 56-hole porous tip in 742 patients enrolled in 2 US prospective, multicenter observational registry studies representing real-world use of the catheter. METHODS: This analysis is comprised of patients who underwent RFA of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (AF). Acute adverse events (AEs) were collected and categorized by seriousness, timing, and relatedness, with 7 days of follow-up data in one study and at least 120 days of data from a 1-year follow-up in the other. Acute serious adverse events (SAEs) that were identified as potentially related to the device and/or procedure were adjudicated by an independent safety committee. RESULTS: A total of 30 patients (4.0%) in the combined studies experienced an acute SAE related to the device and/or procedure, which was similar in the subset of patients age 65 and over (4.2%). These SAEs included 1.2% cardiac tamponade/perforation, 0.7% pericarditis, 0.5% pulmonary events, and 0.8% vascular access complications. No myocardial infarction, stroke, transient ischemic attack, or atrioesophageal fistulas within 7 days postprocedure were reported. In the study with extended follow-up, 1 pulmonary vein stenosis and 1 esophageal injury were seen beyond 7 days postprocedure (0.2% each). There were no device or procedure related deaths. CONCLUSION: Results from 2 large observational studies demonstrated that a new porous tip RFA catheter was safe for the treatment of drug refractory, recurrent, symptomatic paroxysmal AF, including treatment of older patients (≥65 years).

Threefold increased bile duct injury rate is associated with less surgeon experience in an insurance claims database: more rigorous training in biliary surgery may be needed.

INTRODUCTION: Bile duct injury (BDI) remains the dreaded complication of laparoscopic cholecystectomy (LC) over the last two decades. Although the Fundamentals of Laparoscopic Surgery (FLS) certification is now required for new applicants by the American Board of Surgery, the impact of FLS on procedure-specific outcomes is unknown. Moreover, the FLS content centers on fundamental education and not procedure-specific complication reduction such as BDI, magnifying the importance of understanding the educational impact of FLS on specific case types. This study reviewed the impact of FLS certification and other factors on the incidence of bile duct injury in a large insurance claims database. METHODS: In total, 53,632 LCs were reviewed from July 2009 to December 2010 from a large private payer claims database. Surgeon National Provider Identifier (NPI), FLS certification status, International Classification of Diseases, Ninth Revision (ICD-9) and Current Procedural Terminology (CPT) were available for each event. Each record was analyzed for evidence of any bile duct injury based on associated CPT or ICD-9 data in the claim record. Characteristics of the FLS+ and FLS- surgeon groups were analyzed by a separate reviewer blinded to clinical outcome on a large scale. RESULTS: A total of 53,632 LCs were reviewed; 1748 LC were performed by 441 FLS+ surgeons; and 58,870 LCs by 10,851 FLS- surgeons. (Some procedures involved more than one surgeon). Eighty-two BDIs were identified: 8 in the FLS+ and 74 in the FLS- group. The FLS+ group had a higher rate of BDI than the FLS- group (0.47 vs. 0.14 %, p = 0.0013); however, the FLS+ group was also younger (mean age 38.2 FLS+ vs. 50.4 years) and had significantly fewer years in practice (FLS+ = 6.1 vs. FLS- = 20.7, p = 0.0012). No other complications showed differences between the groups. CONCLUSION: NPI can be used as a linking intermediary between skills certification and outcomes on claims databases. FLS certification was not associated with a reduction in bile duct injury in this analysis, but FLS+ surgeons were also younger and less experienced overall. Since FLS lacks content specific to BDI, large-scale validated training and assessment programs targeted at BDI prevention are needed to impact the rate of this complication during cholecystectomy.

Costs and clinical outcomes of conventional single port and micro-laparoscopic cholecystectomy.

BACKGROUND AND OBJECTIVE: This study compares hospital costs and clinical outcomes for conventional laparoscopic, single-port, and mini-laparoscopic cholecystectomy from US hospitals. METHODS: Eligible patients were aged ≥18 years and undergoing laparoscopic cholecystectomy with records in the Premier Hospital Database from 2009 through the second quarter of 2010. Patients were categorized into 3 groups-conventional laparoscopic, single port, or mini-laparoscopic-based on the International Classification of Diseases, Ninth Revision and Current Procedural Terminology codes and hospital charge descriptions for surgical tools used. A procedure was considered mini-laparoscopic if no single-port surgery products were identified in the charge master descriptions and the patient record showed that at least 1 product measuring 5 mm was used, not more than 1 product measuring <5 mm was used, and the measurements of the other products identified equaled >5 mm. Summary statistics were generated for all 3 groups. Multivariable analyses were performed on hospital costs and clinical outcomes. Models were adjusted for demographics, patient severity, comorbid conditions, and hospital characteristics. RESULTS: In the outpatient setting, for single-port surgery, hospital costs were approximately $834 more than those for mini-laparoscopic surgery and $964 more than those for conventional laparoscopic surgery (P < .0001). Adverse events were significantly higher (P < .0001) for single-port surgery compared with mini-laparoscopic surgery (95% confidence interval for odds ratio, 1.38-2.68) and single-port surgery versus conventional surgery (95% confidence interval for odds ratio, 1.37-2.35). Mini-laparoscopic surgery hospital costs were significantly (P < .0001) lower than the costs for conventional surgery by $211, and there were no significant differences in adverse events. CONCLUSIONS: These findings should inform practice patterns, treatment guidelines, and payor policy in managing cholecystectomy patients.

Patient-Reported Outcomes After Ferric Carboxymaltose Treatment for Iron Deficiency Anemia: A Prospective Observational Study.

Background: Iron deficiency anemia (IDA) is a common cause of fatigue and impaired quality of life. The present study aimed to evaluate the impact of intravenous iron supplementation with ferric carboxymaltose (FCM) on fatigue, physical function, and general health among patients with IDA attending routine clinical care. Methods: This was a prospective, single arm, observational study of adult patients prescribed with intravenous FCM for the treatment of IDA during routine clinical care. We used Patient-Reported Outcomes Measurement Information System (PROMIS) instruments to evaluate fatigue (PROMIS Short Form v1.0 13a [FACIT-Fatigue]), general health status (PROMIS Scale v1.2), and physical function (PROMIS Short Form v2.0 4a) before and at 3 and 6 months after FCM treatment. Results: A total of 152 patients were enrolled. Mean age was 47.4 ± 16.0 years and 82.2% were female. Mean serum hemoglobin was 10.2 ± 1.4 g/dL at baseline. All patients were treated with at least one FCM dose at baseline, with 77.6% receiving a two-dose treatment course. The mean baseline FACIT-Fatigue score was 61.0 ± 9.0, improving significantly to 50.2 ± 9.5 at 3 months after FCM treatment. A minimum 5-point improvement, pre-defined as clinically meaningful, was seen in the FACIT-Fatigue, PROMIS Global Physical Health, Global Mental Health and PROMIS Physical Function scores for 72.7%, 52.8%, 41.7% and 39.8% of patients at 3 months (p < 0.0001 for each change from baseline), with statistically significant improvement continuing at 6 months. Mean serum hemoglobin was significantly increased at both 3 and 6 months (12.8 g/dL [N = 44] and 12.4 g/dL [N = 54], respectively). Conclusion: IDA patients attending routine clinical practice reported substantial levels of fatigue and impairments in physical function and global health prior to intravenous iron treatment. Patients experienced significant improvements in fatigue symptoms, physical function, and global health at 3 months after treatment with FCM, which were sustained at 6 months.

Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy.

BACKGROUND: Advances in technology and workflows have facilitated substantial reductions in fluoroscopy utilization and procedure times for atrial fibrillation (AF) ablations. A recently available steerable sheath, visualizable on a 3D electroanatomical map (EAM), may further simplify low/zero fluoroscopy ablation workflows by facilitating understanding of the relative positions of the catheter and sheath. The objective of this study was to demonstrate feasibility, safety, procedural efficiency, and clinical effectiveness of incorporating the new visualizable sheath into a low-fluoroscopy workflow. METHODS: Consecutive de novo paroxysmal AF procedures were performed with a porous tip contact force catheter at a high-volume site between January 2018 and May 2019. Procedures performed with and without the VIZIGO™ EAM-visualizable sheath (Vizigo) were compared. All ablations employed the same standardized low-fluoroscopy workflow. Statistical analyses employed stabilized inverse probability of treatment weights (IPTW) to balance cohorts by operator and key patient characteristics. RESULTS: Cohorts of 142 Vizigo and 173 non-Vizigo patients were similar at baseline. Use of the Vizigo sheath was associated with approximately 10% improvement in catheter stability (p = 0.0005), 16% reduction in radiofrequency time (p < 0.0001), and 7% fewer ablations that used fluoroscopy (p = 0.0030). There was one cardiac tamponade in each cohort and no deaths, atrioesophageal fistulas, or strokes. Single-procedure freedom from atrial arrhythmia recurrence through 12 months was similar between cohorts (p = 0.9556). CONCLUSIONS: Use of a 3D EAM-visualizable sheath resulted in improved catheter stability, reduced radiofrequency time, and more procedures performed without fluoroscopy, without compromise to safety or effectiveness.

Porous tip radiofrequency ablation catheter reduced heart failure-related complications and healthcare resource utilization in paroxysmal atrial fibrillation patients.

Introduction: A 56-hole porous tip radiofrequency catheter was developed to provide more uniform cooling with less fluid delivery than a prior 6-hole irrigated design. This study aimed to evaluate the impact of contact force (CF) ablation with the porous tip on complications (congestive heart failure [CHF] and non-CHF related), healthcare resource utilization, and procedural efficiency in patients undergoing de novo paroxysmal atrial fibrillation (PAF) ablations in a real-world setting. Methods: Consecutive de novo PAF ablations were performed between February 2014 and March 2019 by six operators at a single US academic center. The 6-hole design was used through December 2016 with the 56-hole porous tip adopted in October 2016. The outcomes of interest included symptomatic CHF presentation and CHF-related complications. Results: Of 174 patients who were included, mean age was 61.1 ± 10.8 years, 67.8% were male, and 25.3% had a history of CHF. Ablation with the porous tip catheter significantly decreased fluid delivery (1177 vs. 1912 mL with the 6-hole design; p < .0001). CHF-related complications within 7 days, particularly fluid overload, were substantially reduced with the porous tip (15.2% vs. 5.3% of patients; p = .0281) and the proportion of patients with symptomatic CHF presentation within 30 days postablation was significantly lower (14.7% vs. 32.5%; p = .0058). Conclusion: The 56-hole porous tip led to significantly reduced CHF-related complications and healthcare utilization in PAF patients undergoing CF catheter ablation when compared to the prior 6-hole design. This reduction likely results from the significant decrease in fluid delivery during the procedure.

Economic Evaluation of Contact Force Catheter Ablation for Persistent Atrial Fibrillation in the United States.

Background: Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, and it increases the risk of stroke, heart failure, and other cardiac complications. Catheter ablation is well-established as a treatment for paroxysmal AF, and the recent PRECEPT (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic Persistent AF) clinical trial resulted in the catheter gaining approval for the treatment of persistent AF in the United States. Objectives: To construct an economic simulation model, based on the results of the PRECEPT trial, to monetize the impact of radiofrequency catheter ablation (RFCA) compared with medical therapy (MT). Methods: Cost-offset and break-even analyses were performed to assess the economic impact of RFCA vs MT for adult persistent AF patients. Three perspectives were considered: commercial payers, Medicare, and self-insured employers. A cohort-level decision tree model was developed and validated in TreeAge Pro 2019. Sensitivity analyses were performed to determine the robustness of findings. Results: For all 3 types of payer, RFCA had a higher initial cost compared with MT. However, reductions in health care utilization after ablation, driven by decreased cardiovascular hospitalizations, led to an annual cost offset of between $5037 and $8402 after the first year. Projecting this forward resulted in an estimated cost break-even after 5.9, 4.2, and 5.1 years for commercial payers, Medicare, and self-insured employers, respectively. Conclusion: In addition to providing clinical benefits, RFCA may be a valuable economic investment for U.S. payers, substantially reducing utilization after the first year.

Prospective implementation of a same-day discharge protocol for catheter ablation of paroxysmal atrial fibrillation.

PURPOSE: Overnight stays associated with catheter ablation (CA) for paroxysmal atrial fibrillation (PAF) account for a significant proportion of treatment cost. Same-day discharge (SDD) after CA may be attractive to both patients and hospitals, especially in light of current restrictions on overnight stays due to COVID-19. This study reports on the selection criteria, protocol, and safety of SDD after CA of PAF. METHODS: Patients undergoing CA for PAF were evaluated to assess the risk of groin, respiratory, cardiac, or bleeding complications. SDD eligibility criteria were stable anticoagulation with no bleeding history, systolic heart failure, respiratory conditions, or interventional procedures within 60 days, and recommended BMI < 35. Patient proximity to the hospital was also considered. Anesthesia with propofol was used, and ablations were performed with a contact force catheter. Patients rested for 6 h post-procedure and then ambulated over 1-2 h. Discharge followed if they were stable without evidence of complications. A nurse called all patients the following morning to elicit evidence of complications. RESULTS: Of 44 planned SDD procedures between April 2017 and June 2018, 41 resulted in SDD after 7.2 ± 1.0 h, 2 patients stayed overnight for observation, and one by choice. Average age was 59 ± 10 years with CHA2DS2-VASc of 1.6 ± 1.1. No SDD-related complications occurred, and no return visits resulted from the follow-up calls. CONCLUSION: Appropriate low-risk patients identified by well-defined clinical criteria can be safely discharged the same day after CA for PAF. Evaluation in a larger population across different centers is required for generalizability of this SDD protocol.

Real-world safety of catheter ablation for atrial fibrillation with contact force or cryoballoon ablation.

PURPOSE: Real-world data can help medical administrators, physicians, and payers make evidence-based decisions regarding treatment choices. The objective of this study was to compare real-world safety outcomes with the latest catheter technologies used for the treatment of atrial fibrillation (AF). METHODS: The Vizient Health Systems database, a large US hospital database, was used to compare acute complications in AF ablation with the contact force sensing THERMOCOOL SMARTTOUCH® Catheter or the THERMOCOOL SMARTTOUCH® SF Catheter (ST) versus the second-generation Arctic Front Advance™ Cryoablation Catheter (CB2) between September 2015 and June 2017. The primary outcome was a composite safety endpoint of acute ablation-related complications defined via ICD-10 diagnosis and procedure codes, including tamponade and other pericardial events, respiratory complications, stroke, cerebral or pre-cerebral occlusion/stenosis without infarction, vascular access complications, hemorrhage, phrenic nerve injury, myocardial infarction, and pulmonary embolism. RESULTS: In total, 1473 ablations met all inclusion criteria (407 ST, 1066 CB2). Ablations for paroxysmal AF (PAF) had a lower complication rate than ablations for persistent AF (PsAF) (6.1% vs. 7.3%), as did ablations with ST compared with CB2 within each AF type (PAF 6.0% vs. 6.1%, PsAF 6.3% vs. 7.8%). Neither ablation catheter nor AF type was statistically significant after controlling for site volume, patient age, and comorbid conditions (ST vs. CB2: OR 0.86, p = 0.5544; PsAF vs. PAF: OR 1.08, p = 0.7376). CONCLUSION: Acute ablation-related complication rates were low and were not significantly associated with catheter technology. Increased risk of complication was attributable to low-volume sites and baseline patient characteristics.

Safety of CPX4 Breast Tissue Expanders in Primary Reconstruction Patients.

In the United States, 2-stage expander-to-implant-based breast reconstruction accounts for more than half of all breast reconstruction procedures. Tissue expansion technology has undergone significant advancements in the past few decades. Previous reports suggest that the most common perioperative complications associated with breast tissue expanders are infection and skin flap necrosis. However, little clinical data are available for CPX4 Breast Tissue Expanders. The aim of the study was to measure real-world outcomes related to safety and effectiveness of the tissue expansion process, in patients who underwent primary breast reconstruction following the use of CPX4 Breast Tissue Expanders. METHODS: This was a single-arm retrospective cohort design looking at patients who underwent 2-stage, expander-to-implant-based primary breast reconstruction at a single site between April 2013 and December 2016 and who had a minimum of 2 years follow-up. Descriptive statistics were used to summarize baseline characteristics and safety outcomes. RESULTS: A total of 123 patients were followed for an average of 3.73 ± 0.94 years. At least 1 complication during the time of tissue expansion, before the permanent implant, was reported in 39/123 (31.7%) patients [51/220 implants (23.2%)]. The most frequently reported complications were delayed wound healing (13.8%) and cellulitis/infection (9.7%). CONCLUSION: Analyses of real-world data from a single site provide further support for the safety and effectiveness of the CPX4 Breast Tissue Expander for women undergoing 2-stage expander-to-implant primary breast reconstruction.

The industrialization of ablation: a highly standardized and reproducible workflow for radiofrequency ablation of atrial fibrillation.

BACKGROUND OR PURPOSE: The purpose of this analysis was to report on efficacy of a standardized workflow for atrial fibrillation (AF) ablation using technology advances such as 3D imaging and contact force sensing in a real-world setting. METHODS: Consecutive AF ablations from 2014 to 2015 at a high-volume site in Belgium were included. The workflow consisted of a pre-specified procedure sequence including 3D modeling followed by radiofrequency encircling of the pulmonary veins (25 W posterior wall, 35 W anterior wall) with a THERMOCOOL SMARTTOUCH® Catheter guided by CARTO VISITAG™ Module (2.5 mm/5 s stability, 50% > 7 g) and ablation index (targets: 550 anterior wall, 400 posterior wall). Efficiency endpoints were procedure time, fluoroscopy time, and radiation dose. The primary effectiveness endpoint was freedom from atrial arrhythmia recurrence. RESULTS: A total of 605 paroxysmal AF (PAF) and 182 persistent AF (PsAF) patients were followed for 436 ± 199 days. Mean procedure times were short (PAF: 96.1 ± 26.2 min; PsAF: 109.2 ± 35.6 min) with most procedures (90.6% PAF; 81.3% PsAF) completed in ≤ 120 min. Minimal fluoroscopy was utilized (PAF: 6.1 ± 3.8 min, 5.9 ± 3.4 Gy*cm2; PsAF: 6.9 ± 4.7 min, 7.4 ± 4.9 Gy*cm2). Freedom from atrial arrhythmia recurrence was higher for PAF than PsAF patients (OR: 2.0, 95% CI: 1.4-2.9, p = 0.0003), but adjusted mean rates were high in both groups (81.0% vs. 67.9%). Rates were adjusted for prior ablation and age (at 65 years). CONCLUSION: AF ablation using a standardized workflow resulted in low procedure times and variability, with minimal fluoroscopy exposure. Long-term freedom from atrial arrhythmia recurrence was high in both PAF and PsAF populations.

Touch-up and recurrence rates after voltage mapping for verification of pulmonary vein isolation following cryoablation of paroxysmal atrial fibrillation.

PURPOSE: The procedural endpoint following cryoballoon ablation (CA) for paroxysmal atrial fibrillation (PAF) is pulmonary vein isolation (PVI), which is typically confirmed by entrance/exit block using a circular mapping catheter. The present study added an assessment of ablation gaps with high-density voltage mapping after standard confirmation of PVI. Relationships between the need for touch-up ablation, patient characteristics, and atrial arrhythmia recurrence were explored. METHODS: PAF patients received CA through standard of care treatment, with PVI assessed by bidirectional block confirmation, followed by voltage mapping. Radiofrequency ablation was performed as needed for voltage breakthrough and or additional rhythms. Freedom from atrial arrhythmia recurrence through 12-month follow-up was analyzed retrospectively with statistical survival models. RESULTS: A total of 77 PAF patients (age 66.1 ± 11.6, CHADS2 1.8 ± 1.0) were followed for 1.2 ± 0.3 years after CA. During the index procedure, pulmonary vein (PV) touch-up was required in 59 patients (76.6%) and ablation of additional atrial fibrillation targets beyond PV was required in 26 patients (33.8%). Kaplan-Meier estimates of freedom from atrial arrhythmia recurrence at 1 year were 62 ± 6%. Rates were lower for patients requiring touch-up ablation (58 ± 6% vs. 78 ± 10%) or with CHADS2 scores > 2 (33 ± 12% vs. 69 ± 6%). Cox regression models showed that the need for touch-up ablation increased recurrence (p = .045, HR = 2.6) after adjusting for hypertension and heart failure. CONCLUSION: The high rate of PV touch-up suggests that initial CA lesions may be less durable than previously assumed, while the higher recurrence rate in patients requiring touch-up may indicate that additional factors make these patients more difficult to treat.