Co-Author(s):
Ayman Hussein, MD - Cleveland Clinic Foundation
M. Craig Delaughter, MD - Texas Health Heart & Vascular
George Monir, MD - Florida Hospital
Andrea Natale, MD - Texas Cardiac Arrhythmia Research
Srinivas Dukkipati, MD - Mount Sinai School of Medicine
Saumil Oza, MD - St Vincent’s Medical Center
Emile Daoud, MD - Ohio State University Medical Center
Luigi Di Biase, MD - Montefiore Hospital
Moussa Mansour, MD - Massachusetts General
Robert Fishel, MD - JFK Medical Center
Miguel Valderrabano, MD - Houston Methodist Research Institute
Kenneth Ellenbogen, MD - Virginia Commonwealth University
Grandview Medical Center
Grandview Medical Center Alabama Cardiovascular Group 3686 Grandview Parkway, Suite 720 Birmingham, AL
Introduction | Objectives: The initial safety and feasibility of a novel temperature sensing catheter with microelectrodes and 6 thermocouples, used with both conventional power (CP; 25-50 W) and very high power short duration (vHPSD; 90 W/4 s) in temperature controlled modes for paroxysmal atrial fibrillation (PAF) ablation have previously been described. Longer-term clinical safety and effectiveness in a larger population has yet to be reported. Initial safety and interim 6M effectiveness of the vHPSD catheter in the treatment of symptomatic PAF are reported.
Methods: This prospective, non-randomized, multi-center study utilized vHPSD as the primary temperature control mode for PVI while the combination of vHPSD and CP could be used for PV touch-up or ablation outside of the PV. Primary safety endpoint was the incidence of any primary adverse events (PAEs) occurring within 7 days of the index procedure. Effectiveness was defined as freedom from documented atrial arrhythmia recurrence and freedom from additional 3 pre-defined primary effectiveness failure modes (acute failure, repeat ablation, new/higher dose AAD).
Results: A total of 191 PAF subjects were enrolled (mean age: 63.5±10.7 years, CHADS2-VASc 2.4 ±1.5, 60.7% male) across 22 sites in the United States. Of those enrolled, 166 subjects underwent ablation with the investigational catheter. Refer to the Table for the procedural characteristics. Mean maximum temperatures recorded remained similar in both modes (vHPSD: 45.0±5.3ºC; CP: 44.2±4.3ºC) with no esophageal injuries reported. Average applied contact force was similar between cases utilizing only vHPSD (15.8±5.3g) and those that used a combination of vHPSD and CP (15.2±5.3g) for ablation. Six patients (3.6%) experienced PAEs (vascular access complication [3]; cardiac tamponade [2], and phrenic nerve injury [1]). At 6M post-ablation, freedom from effectiveness failure was 86.5%.
Conclusions: vHPSD temperature controlled PAF ablation, in combination with CP, is highly efficient without compromising safety.