Abstract
Catheter ablation (CA) technology evolves as practitioners look to improve treatment options for atrial fibrillation (AF). A novel diamond tip, irrigated, radiofrequency (RF) ablation system accurately measures tip-tissue temperature in real-time and modulates power to maintain a target therapeutic tissue temperature. Recently, the DiamondTemp Ablation (DTA) system demonstrated strong outcomes against a contact force-sensing RF ablation system in a paroxysmal AF (PAF) population. However, no data pertaining to persistent AF (PsAF) has been reported in literature. This study sought to characterize the performance of the DTA system for the treatment of patients with drug-refractory PAF and PsAF with the second-generation RF DTA generator. DIAMOND FASTR-AF (NCT03626649) was a prospective, single-arm, multicenter European trial. Primary effectiveness endpoint was freedom from atrial arrhythmia recurrence following a 90-day blanking period through 12 months. Primary safety endpoint was a composite of serious adverse events. In total, 60 subjects (34 PAF and 26 PsAF) underwent CA with the DTA system at three centers. Patient demographics were consistent with contemporary AF studies (male 71.7%, age 63.9 ± 10.2 yrs, AF history 3.1 ± 3.9 yrs, LA size 4.4 ± 0.8 cm). The PAF cohort showed marked procedural efficiencies, as compared to PsAF, in total procedure time (76.9 ± 21.7 min vs 108.9 ± 33.6 min, p<0.001, respectively), total RF time (10.4 ± 3.5 min vs 20.4 ± 8.0 min, p<0.001), and number of RF applications (62.1 ± 25.3 vs 109.5 ± 45.5, p<0.001). Pulmonary vein isolation only was performed in 82% of PAF and 23% of PsAF subjects. Additional left-sided lesions were performed in 69% of PsAF subjects (vs 6% of PAF subjects). Safety event rate in the PAF and PsAF groups were 5.9% (2/34) and 11.5% (3/26), respectively. Freedom from recurrence was observed in 67.6% (23/34) of PAF and 61.5% (16/26) of PsAF subjects. The DiamondTemp Ablation system demonstrated long-term safety and effectiveness through 12 months post-ablation for patients with PAF or PsAF. Procedures were demonstrated to be highly efficient, with shorter time and fewer applications seen in PAF procedures.
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