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JACC Cardiovasc Interv. 2019 Dec 23;12(24):2449-2459. doi: 10.1016/j.jcin.2019.09.029. Epub 2019 Sep 28.

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

Author information

1
Institut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France; Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France. Electronic address: faurieb@gmail.com.
2
Cardiology Department, Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France.
3
Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France.
4
Cardiology Department, Clinique Saint Hilaire, Rouen, France.
5
Cardiology Department, Institut Mutualiste Montsouris, Paris, France.
6
Département de cardiologie, Institut Cœur Poumon, Centre Hospitalier Universitaire de Lille, Lille, France.
7
Cardiology Department, Centre Hospitalier Annecy Genevois, Epagny, France.
8
Cardiology Department, Institut Arnault Tzanck, Saint-Laurent-du-Var, France.
9
Cardiology Department, Clinique Pasteur, Toulouse, France.
10
Institut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France; Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France.
11
Cardiology Department, URC-Eco Île de France, Hôpital de l'Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.
12
Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.

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).

KEYWORDS:

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

PMID:
31857014
DOI:
10.1016/j.jcin.2019.09.029

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