Co-Author(s):
Petr Peichl, MD PhD
Gediminas Rackauskas, MD PhD
Elad Anter, MD
Jan Petru, MD
Moritoshi Funasako“, MD
Kentaro Minami, MD
Jacob Koruth, MD
Germanas Marinskis, MD PhD
Audrius Aidietis, MD PhD
Josef Kautzner, MD PhD
Petr Neuzil, MD PhD
Icahn School of Medicine at Mount Sinai
One Gustave L Levy Place Box 1030
Introduction | Objectives: The tissue selectivity of pulsed field ablation (PFA) provides safety advantages over RF ablation.  One-shot PFA catheters for PVI exist, but they don’t permit the flexibility in lesion sets, such as linear lesions, that are often desirable to treat patients with persistent atrial fibrillation (PerAF).  In a first-in-human trial, we previously reported that a novel lattice-tip ablation catheter able to deliver either focal RF or PF energy, was used to treat AF with a strategy of either: i) PFA posteriorly and RFA anteriorly (RF/PF), or ii) PFA only (PF/PF).  Herein, in a multicenter study, we present the performance characteristics with use of the lattice catheter to treat persistent AF.
Methods: The 8Fr lattice catheter has a compressible 9 mm nitinol tip, and is used with a custom mapping system and RF/PF generators (Sphere-9, Prism-1, HexaGen and HexaPulse, respectively; Affera Inc).  In an IRB-approved clinical trial (NCT04141007, NCT04194307), toggling between energy sources, point-by-point PV encirclement was performed using biphasic PFA (2-5 sec) posteriorly, and either temp-controlled irrigated RFA (Tmax 73°C; 5 sec) or PFA anteriorly.  PVI was confirmed with bidirectional pacing, and adenosine or after a 20 min wait.  Linear lesions were placed with PFA or RFA.
Results: At 3 centers (6 operators), a 54-pt persistent AF cohort (age 62 ± 9.6 yrs; M / F = 44 / 10) underwent either RF/PF (20 pts; 56.9±18.5 lesions/pt) or PF/PF (34 pts; 61.9±13.6 lesions/pt) ablation.  The PVI therapy duration time (transpired time from first to last lesion) was 23.6±8.8 min/pt.  Linear lesions included 37 mitral (14 RF / 7 RF+PF / 16 PF), 48 LA roof (4 RF / 2 RF + PF / 42 PF) and 44 CTI (32 RF / 12 PF) lines, with therapy duration times of 4.3±1.8, 2.2±2.2 and 2.2±1.6 min/pt, respectively.  All lesion sets were acutely successful.  Total fluoroscopy time was 4.3±2.5 min.  There were no device complications; there were 4 vascular injuries.  Post-procedure EGD revealed no thermal injury in 18 RF/PF and 26 PF/PF pts.
Conclusions: To treat patients with persistent AF, the focal lattice catheter could safely and rapidly ablate AF using either a combined RF/PF approach (capitalizing on the safety of PFA and the years of experience with RFA) or an entirely PF approach.
AFS 2021-02