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.