Structural
Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement

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Abstract

Objectives

This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation.

Background

Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR).

Methods

This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days.

Results

Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of –0.12 (95% confidence interval: –0.20 to –0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001).

Conclusions

Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896)

Key Words

left ventricular pacing
left ventricular stimulation
transcatheter aortic valve implantation
transcatheter aortic valve replacement

Abbreviations and Acronyms

CI
confidence interval
DRG
diagnosis-related group
LV
left ventricle/ventricular
MACE-TAVR
major adverse cardiovascular event-transcatheter aortic valve replacement
RV
right ventricle/ventricular
TAVR
transcatheter aortic valve replacement

Cited by (0)

The EASY TAVI trial was funded by Edwards Lifesciences, the Paul Bennetot Foundation, Fondation de l'avenir, and Groupe Hospitalier Mutualiste, Grenoble. Dr. Souteyrand has served as a consultant for Abbott Vascular, Boston Scientific, Medtronic, and Terumo. Dr. Dumonteil has served as a proctor for and received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Durand-Zaleski has served on the advisory board for and received speaker fees from AbbVie, Bayer, Bristol-Myers Squibb, Merck Sharp & Dohme, Takeda, Medtronic, and Boston Scientific. Dr. Lefèvre has served as a proctor for Edwards Lifesciences and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.