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.

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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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