BACKGROUND: Because of its safety, "single-shot" pulsed field ablation (PFA) catheters have been developed for pulmonary vein isolation (PVI). However, most atrial fibrillation (AF) ablation procedures are performed with focal catheters to permit flexibility of lesion sets beyond PVI. OBJECTIVES: This study sought to determine the safety and efficacy of a focal ablation catheter able to toggle between radiofrequency ablation (RFA) or PFA to treat paroxysmal or persistent AF. METHODS: In a first-in-human study, a focal 9-mm lattice tip catheter was used for PFA posteriorly and either irrigated RFA (RF/PF) or PFA (PF/PF) anteriorly. Protocol-driven remapping was at ∼3 months postablation. The remapping data prompted PFA waveform evolution: PULSE1 (n = 76), PULSE2 (n = 47), and the optimized PULSE3 (n = 55). RESULTS: The study included 178 patients (paroxysmal/persistent AF = 70/108). Linear lesions, either PFA or RFA, included 78 mitral, 121 cavotricuspid isthmus, and 130 left atrial roof lines. All lesion sets (100%) were acutely successful. Invasive remapping of 122 patients revealed improvement of PVI durability with waveform evolution: PULSE1: 51%; PULSE2: 87%; and PULSE3: 97%. After 348 ± 652 days of follow-up, the 1-year Kaplan-Meier estimates for freedom from atrial arrhythmias were 78.3% ± 5.0% and 77.9% ± 4.1% for paroxysmal and persistent AF, respectively, and 84.8% ± 4.9% for the subset of persistent AF patients receiving the PULSE3 waveform. There was 1 primary adverse event-inflammatory pericardial effusion not requiring intervention. CONCLUSIONS: AF ablation with a focal RF/PF catheter allows efficient procedures, chronic lesion durability, and good freedom from atrial arrhythmias-for both paroxysmal and persistent AF. (Safety and Performance Assessment of the Sphere-9 Catheter and the Affera Mapping and RF/PF Ablation System to Treat Atrial Fibrillation; NCT04141007 and NCT04194307).

• MeSH
• ablace * MeSH
• fibrilace síní * chirurgie   MeSH
• katetrizační ablace * škodlivé účinky   metody   MeSH
• katétry MeSH
• lidé MeSH
• venae pulmonales * chirurgie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

OBJECTIVES: DIAMOND-AF (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation) was a prospective, multicenter, noninferiority, randomized trial that compared the safety and effectiveness of the DTA system versus those of a force-sensing RF ablation system (control) for the treatment of patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (AF). BACKGROUND: Irrigated radiofrequency (RF) ablation catheters lose tissue temperature acuity, which is vital in assessing lesion formation. DiamondTemp Ablation (DTA) was designed to re-establish accurate tissue temperature measurements during ablation. METHODS: A total of 482 patients with paroxysmal AF were randomized (239 DTA, 243 control) to undergo pulmonary vein isolation and were followed up at 23 sites. Patients were screened for disease progression, cardiac characteristics, and prior interventions. Primary endpoints were effectiveness (freedom from atrial arrhythmia recurrence) and safety (composite of procedure- and device-related serious adverse events). RESULTS: The primary safety event rate was 3.3% in the DTA group versus 6.6% in the control group (p < 0.001 vs. 6.5% noninferiority margin). Primary effectiveness was met in 79.1% of DTA subjects and 75.7% of control subjects (p < 0.001 vs. -12.5% noninferiority margin). Secondary endpoint analysis found that off-drug effectiveness favored DTA compared with the control (142 [59.4%] vs. 120 [49.4%], respectively; p = 0.03). Total RF time and individual RF ablation duration were significantly shorter with less saline infused through the DTA catheter (p < 0.001). Both arms saw clinically meaningful improvements in quality of life at 12 months. CONCLUSIONS: Safety and efficacy of the DTA system proved noninferior to force-sensing RF ablation in a paroxysmal AF population. Efficiencies were observed using DTA with shorter total RF times, individual RF ablation durations, and less saline infusion. (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation; NCT03334630).

• MeSH
• fibrilace síní * chirurgie   MeSH
• katetrizační ablace * škodlivé účinky   MeSH
• katétry MeSH
• kvalita života MeSH
• lidé MeSH
• prospektivní studie MeSH
• teplota MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

OBJECTIVES: This study sought to evaluate the safety and acute performance of the lattice tip for the treatment of atrial flutter and fibrillation (AF). BACKGROUND: A novel catheter using an expandable lattice structure with a wide thermal footprint incorporating multiple surface thermocouples/mini-electrodes has been designed for high-resolution mapping and high-current, temperature-controlled radiofrequency ablation (RFA). METHODS: Patients with typical right atrial flutter or AF were prospectively enrolled in a single-arm study at 3 centers. Patients with atrial flutter underwent cavotricuspid isthmus (CTI) ablation. Patients with paroxysmal AF underwent pulmonary vein isolation (PVI) and CTI if desired, and for patients with persistent AF, mitral isthmus and left atrial roof lines were also permitted. Mapping was performed with the lattice (Sphere-9) catheter and a novel compatible electroanatomic mapping system (Prism-1). RFA was performed in a point-by-point fashion (Tmax, 73°C to 80°C; range 2 to 7 s). Patients were followed for 3 months. RESULTS: A total of 71 patients underwent ablation: 65 PVI (38% with persistent AF) and 22 mitral isthmus, 24 roof, and 48 CTI lines. PVI was achieved in 64 of 65 (98.5%) by using the lattice alone and required a mean of 2.7 ± 0.70 RFA min. Mitral block was achieved in 100% by using 11.5 ± 10.7 applications and 1.0 ± 0.92 RFA min; only 1 patient required adjunctive epicardial coronary sinus ablation. Roof line and CTI block were achieved in 95.8% and 100% of patients, using 4.9 ± 1.9 and 5.9 ± 3.1 applications for 0.4 ± 0.16 and 0.5 ± 0.24 RFA min, respectively. At 3 months, there were no deaths, strokes, tamponade, or atrioesophageal fistula. CONCLUSIONS: This first-in-human study demonstrated clinical feasibility and safety for rapid high-current, temperature-controlled point-by-point PVI and linear ablation.

• MeSH
• fibrilace síní * chirurgie   MeSH
• katetrizační ablace * MeSH
• katétry MeSH
• lidé MeSH
• teplota MeSH
• venae pulmonales * chirurgie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

OBJECTIVES: This study was designed to evaluate lesion durability on invasive electrophysiologic remapping. BACKGROUND: The lattice-tip catheter generates a large thermal footprint during temperature-controlled irrigated radiofrequency ablation. In a first-in-human study, this catheter performed rapid point-by-point pulmonary vein isolation (PVI) and other linear atrial ablations. METHODS: In a prospective 3-center single-arm study, paroxysmal or persistent atrial fibrillation patients underwent PVI and, as needed, linear ablation at the cavotricuspid isthmus (CTI), mitral isthmus (MI), and/or left atrial roof; no other atrial substrate was ablated. Using the lattice catheter and a custom electroanatomic mapping system, temperature-controlled (Tmax 73° to 80°C; 2 to 7 s) point-by-point ablation was performed. Patients were followed for 12 months. RESULTS: A total of 65 patients (61.5% paroxysmal/38.5% persistent) underwent ablation: PVI in 65, MI in 22, left atrial roof in 24, and CTI in 48 patients. At a median of 108 days after the index procedure, protocol-mandated remapping was performed in 27 patients. The pulmonary veins (PVs) remained durably isolated in all but 1 reconnected PV-translating to durable isolation in 99.1% of PVs, or 96.3% of patients with all PVs isolated. Of 47 linear atrial lesions initially placed during the index procedure, durability was observed in 10 of 11 (90.9%) MI lines, all 11 (100%) roof lines, and all 25 (100%) CTI lines. After a median follow-up of 270 days, the 12-month Kaplan-Meier estimate for freedom from atrial arrhythmias was 94.4 ± 3.2%. CONCLUSIONS: Temperature-controlled lattice-tip point-by-point ablation showed not only highly durable PVI lesion sets, but also durable contiguity of linear atrial lesions.

• MeSH
• katetrizační ablace * MeSH
• katétry MeSH
• lidé MeSH
• prospektivní studie MeSH
• teplota MeSH
• venae pulmonales * chirurgie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH