Co-Author(s):
Petr Neuzil, MD PhD
Petr Peichl, MD PhD
Gediminas Rackauskas, MD PhD
Elad Anter, MD
Jan Petru, MD
Moritoshi Funasako, MD
Kentaro Minami, MD
Audrius Aidietis, MD PhD
Germanas Marinskis, MD PhD
Andrea Natale, MD
Hiroshi Nakagawa, MD PhD
Warren Jackman, MD
Josef Kautzner, MD PhD
Icahn School of Medicine at Mount Sinai
One Gustave L Levy Place Box 1030
Introduction | Objectives: There is scant data on the clinical efficacy of durable atrial ablation lesion sets, largely due to the challenges of achieving durability.  But in a first-in-human trial (NCT04210622), a lattice-tip radiofrequency ablation catheter with a large thermal footprint was able to create point-by-point lesion sets that proved durable upon invasive remapping – including 99% of pulmonary veins (PVs), and 91%, 100% & 100% of mitral isthmus (MI), cavotricuspid (CTI) and left atrial roof lines, respectively.  As all patients have now completed follow-up, herein we report the 1-year clinical outcomes.
Methods: In a 3-center single arm trial of paroxysmal (PAF) or persistent AF (PerAF), 8 operators performed PVI and, per operator preference, linear lesions.  Other “atrial substrate” was not targeted.  Using a custom electroanatomic mapping system, the saline-irrigated lattice catheter was used for temperature-controlled (Tmax 73° – 80°C; 2-7 s) point-by-point AF ablation.  Follow up included 48-hr Holters at 3, 6 and 12 mo; symptoms prompted additional monitoring.  Compliance with monitoring was 77% overall – 91% for the 12 mo Holter.
Results: The cohort (65 pts; 40 PAF / 25 PerAF) received various ablation lesion sets: PVI (all pts), MI (5 PAF/17 PerAF), roof (8 PAF/16 PerAF), and CTI (22 PAF/20 PerAF).  During remapping procedures (n=27 pts), additional ablation was performed in 8 pts.  Most pts (85%) ceased Class I/III AADs by last follow-up.  After a mean follow up of 391±54 days, sinus rhythm was maintained in >90% of pts, across a range of sensitivity analyses (Figure ).  There were no long-term safety events (e.g., PV stenosis, AE fistula).  Limitations include: absence of continuous ECG monitoring, and limited number of pts/operators.
Conclusions: These data indicate that an anatomically-driven radiofrequency ablation lesion set, when durable , translates to excellent long-term clinical outcomes.  It remains to be determined whether these outcomes are specific to the large thermal footprint lattice catheter, or is generalizable to other ablation catheters and energy sources.