First-in-Human Experience With Novel Temporary LVAD Support During VT Ablation
The novel Impella 5.0/5.5 temporary left ventricular assist device (t-LVAD) used in high-risk patients undergoing catheter ablation of scar-mediated ventricular tachycardia (VT) facilitated mapping and ablation during the procedure, but it was associated with procedure-related complications and no significant impact on short- and long-term adverse outcomes, according to a first-in-human study reported in a late-breaking clinical trial session at Heart Rhythm 2023 and simultaneously published May 20 in JACC.
Jakub Sroubek, MD, PhD, et al., included 41 consecutive high-risk patients undergoing catheter VT ablation supported with the Impella 5.0/5.5, a high-output t-LVAD capable of full LV hemodynamic support, who were matched with 41 cases captured from their VT ablation database for a control group. The mean age of the study cohort was 66 and most (90-92%) were men.
The composite primary endpoint, defined as all-cause death, permanent LVAD implant and heart transplant, occurred in 47 cases (57.3%) over the median follow-up of 467 (128-879) days. The study’s secondary endpoint, recurrent VT/ventricular fibrillation during follow-up, was identified in 52 cases (63.4%). Researchers reported no statistically significant difference between the t-LVAD and control groups for either the primary [hazard ratio, 1.11; p=0.734] or secondary endpoints [Fine-Gray subhazard ratio, 1.08; p=0.768].
During the procedure, the t-LVAD group, compared with the control group, had a higher mean number of induced VTs (2.73 vs. 1.45; p=0.032), more mapped VT circuits (2 [1-2] vs. 1 [0-1]; p<0.001) and more VTs terminated with ablation (1 [0-2] vs. 0 [0-1]; p<0.001), along with fewer shocks or anti-tachycardia pacing (11 [26.8%] vs. 25 [61.0%]; p=0.004) and less periprocedural acute hemodynamic decompensation (7 [17%] vs. 14 [34%]; p=0.128). However, more periprocedural complications were recorded within the t-LVAD group (12 [29.3%] vs. 1 [2.4%]; p=0.002). The rate of 30-day death, permanent LVAD and transplant was similar between the groups.
The study authors write that the higher rate of procedure-related complications may reflect “a more liberal adoption of prolonged mapping in VT and more aggressive ablation approaches,” adding that “this may have offset a potential benefit in terms of [acute hemodynamic decomposition] reduction.”
Keywords: Catheters, Hemodynamics, Catheter Ablation, Ventricular Fibrillation, Tachycardia, Ventricular, Follow-Up Studies, Cicatrix
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