Background - The limited effectiveness of endocardial catheter ablation (CA) for persistent and long-standing persistent atrial fibrillation (Ps/LSP-AF) treatment led to the development of a minimally-invasive epicardial/endocardial ablation approach (Hybrid Convergent) to achieve a more comprehensive lesion set with durable transmural lesions. The multi-center randomized controlled CONVERGE trial (NCT01984346) evaluated the safety of Hybrid Convergent and compared its effectiveness to CA for Ps/LSP-AF treatment. Methods - One-hundred fifty-three patients were randomized 2:1 to Hybrid Convergent vs. CA. Primary effectiveness was freedom from AF/AFL/AT absent new/increased dosage of previously failed/intolerant class I/III anti-arrhythmic drugs (AADs) through 12-months. Primary safety was major adverse events through 30 days. CONVERGE permitted left atrium size up to 6cm and imposed no limits on AF duration, making it the only ablation trial to substantially include LSP-AF i.e. 42% patients with LSP-AF. Results - Of 149 evaluable patients at 12 months, primary effectiveness was achieved in 67.7% (67/99) patients with Hybrid Convergent and 50.0% (25/50) with CA (p=0.036) on/off previously failed AADs and in 53.5% (53/99) versus 32.0% (16/50) (p=0.0128) respectively off AADs. At 18-months using 7-day Holter, 74.0% (53/72) Hybrid Convergent and 55% (23/42) CA patients experienced ≥90% AF burden reduction. A total of 2.9% (3/102) patients had primary safety events within 7 days, and 4.9% (5/102) between 8-30 days post-procedure. No deaths, cardiac perforations or atrioesophageal fistulas occurred. All but one primary safety event resolved. Conclusions - The Hybrid Convergent procedure has superior effectiveness compared to the CA for the treatment of Ps/LSP-AF.

BACKGROUND Left ventricular (LV) endocardial pacing is a promising method to deliver cardiac resynchronization therapy (CRT). WiSE-CRT is a wireless LV endocardial pacing system, and delivers ultrasonic energy to an LV electrode.OBJECTIVE The purpose of this study was to present short-term outcomes with the WiSE-CRT system in centers with no prior implanting experience.METHODS Data were prospectively collected from 19 centers where WiSE-CRT systems were implanted during the roll-in phase of the SOLVE-CRT trial. Patients were followed at 1, 3, and 6 months, including transthoracic echo (TTE) at 6 months. RESULTSThe WiSE-CRT was successfully implanted in all 31 attempted cases, and 30 patients completed the 6-month followup. One patient underwent heart transplantation 1 month after implantation, and was excluded. Fourteen (46.7%) patients demonstrated 1 NYHA class improvement. TTE data were available in 29 patients. LV ejection fraction, LV end-systolic volume, and LV enddiastolic volume improved from 28.3% 6 6.7% to 33.5% 6 6.9% (P , .001), 134.9 6 51.3 mL to 111.1 6 40.3 mL (P 5 .0004), and 185.4 6 58.8 mL to 164.9 6 50.6 mL (P 5 .0017), respectively. There were 3 (9.7%) device-related type 1 complications: 1 insufficient LV pacing, 1 embolization of an unanchored LV electrode, and 1 skin infection.CONCLUSIONS We demonstrated a high success rate of LV endocardial electrode placement in centers with no prior implanting experience. Favorable clinical responses in heart failure symptoms and significant LV reverse remodeling were noted.

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Acute Safety from 2 AF Ablation RegistriesIntroductionThis 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.MethodsThis 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.ResultsA 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.ConclusionResults 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).

Purpose Catheter ablation has become a mainstay therapy for atrial fibrillation (AF) with rapid innovation over the past decade. Variability in ablation techniques may impact efficiency, safety, and efficacy; and the ideal strategy is unknown. Real-world evidence assessing the impact of procedural variations across multiple operators may provide insight into these questions. The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation registry (Real-AF) is a multicenter prospective registry that will enroll patients at high volume centers, including academic institutions and private practices, with operators performing ablations primarily with low fluoroscopy when possible. The study will also evaluate the contribution of advent in technologies and workflows to real-world clinical outcomes. Methods Patients presenting at participating centers are screened for enrollment. Data are collected at the time of procedure, 10-12 weeks, and 12 months post procedure and include patient and detailed procedural characteristics, with short and long-term outcomes. Arrhythmia recurrences are monitored through standard of care practice which includes continuous rhythm monitoring at 6 and 12 months, event monitors as needed for routine care or symptoms suggestive of recurrence, EKG performed at every visit, and interrogation of implanted device or ILR when applicable. Results Enrollment began in January 2018 with a single site. Additional sites began enrollment in October 2019. Through May 2021, 1,243 patients underwent 1,269 procedures at 13 institutions. Our goal is to enroll 4000 patients. Discussion Real-AF's multiple data sources and detailed procedural information, emphasis on high volume operators, inclusion of low fluoroscopy operators, and use of rigorous standardized follow-up methodology allow systematic documentation of clinical outcomes associated with changes in ablation workflow and technologies over time. Timely data sharing may enable real-time quality improvements in patient care and delivery. Trial registration Clinicaltrials.gov: NCT04088071

(PACE 2017; 40:391-400) atrial fibrillation, catheter ablation, healthcare utilization, quality of life, elderly, Medicare