Na Homolce Hospital, Roentgenova 37/2 150 00, Prague 5, Prague, Czech Republic.
Clinique du Tonkin, Valleurbanne, France.
J Interv Card Electrophysiol. 2023 Mar;66(2):343-351. doi: 10.1007/s10840-022-01234-9. Epub 2022 May 18.
Catheter ablation (CA) technology development reflects the need to improve the effectiveness of atrial fibrillation (AF) treatment. Recently, the DiamondTemp Ablation (DTA) RF generator software was updated with a more responsive power ramp.
DIAMOND FASTR-AF was a prospective, single-arm, multicenter trial. This study sought to characterize the performance of the updated DTA system for the treatment of patients with drug-refractory paroxysmal and persistent AF (PAF and PsAF). The primary effectiveness endpoint was freedom from atrial arrhythmia recurrence following a 90-day blanking period through 12 months, and the primary safety endpoint was a composite of serious adverse events.
In total, 60 subjects (34 PAF and 26 PsAF) underwent CA at three centers. Patients were 71.7% male, (age 63.9 ± 10.2 years, with an AF diagnosis duration 3.1 ± 3.9 years and left atrial size 4.4 ± 0.8 cm). Pulmonary vein isolation-only ablation strategy was performed in 34 (56.7%) subjects. The procedural characteristics show a procedure time 90.8 ± 31.6 min, total RF time 14.7 ± 7.7 min, ablation duration 10.7 ± 3.6 s, and fluid infusion 284.7 ± 111.5 ml. The serious adverse event rate was 8.3% (5/60), 3 pulmonary edema and 2 extended hospitalizations. Freedom from atrial arrhythmia recurrence was achieved in 67.6% of subjects by 12 months.
The updated DTA system demonstrated long-term safety and effectiveness through 12 months of post-ablation follow-up for patients with atrial fibrillation. Additionally, procedures were demonstrated to be highly efficient with short procedure times and low levels of fluid infusion.
Sponsored by Medtronic, Inc.; FASTR-AF ClinicalTrials.gov; NCT03626649.
导管消融（CA）技术的发展反映了提高房颤（AF）治疗效果的需要。最近，DiamondTemp 消融（DTA）RF 发生器软件进行了更新，增加了响应更灵敏的功率斜坡。
DIAMOND FASTR-AF 是一项前瞻性、单臂、多中心试验。本研究旨在描述更新后的 DTA 系统治疗药物难治性阵发性和持续性房颤（PAF 和 PsAF）患者的性能。主要有效性终点是在 90 天空白期后通过 12 个月无房性心律失常复发，主要安全性终点是严重不良事件的综合指标。
共有 60 例患者（34 例 PAF 和 26 例 PsAF）在三个中心进行 CA。患者中 71.7%为男性，（年龄 63.9±10.2 岁，房颤诊断时间 3.1±3.9 年，左心房大小 4.4±0.8cm）。34 例（56.7%）患者行单纯肺静脉隔离消融策略。手术特点显示手术时间 90.8±31.6min，总 RF 时间 14.7±7.7min，消融时间 10.7±3.6s，灌流液输注 284.7±111.5ml。严重不良事件发生率为 8.3%（5/60），包括 3 例肺水肿和 2 例延长住院。12 个月时，67.6%的患者达到无房性心律失常复发。
更新后的 DTA 系统在房颤患者消融后 12 个月的随访中表现出长期安全性和有效性。此外，该手术程序具有很高的效率，手术时间短，灌流液用量低。
由美敦力公司赞助；FASTR-AF ClinicalTrials.gov；NCT03626649。
