Author + information
- Received September 13, 2019
- Revision received September 17, 2019
- Accepted September 18, 2019
- Published online December 16, 2019.
- Benjamin Faurie, MDa,b,∗ (, )
- Géraud Souteyrand, MDc,
- Patrick Staat, MDb,
- Matthieu Godin, MDd,
- Christophe Caussin, MDe,
- Eric Van Belle, MD, PhDf,
- Lionel Mangin, MDg,
- Pierre Meyer, MDh,
- Nicolas Dumonteil, MDi,
- Mohamed Abdellaoui, MDa,b,
- Jacques Monségu, MDa,b,
- Isabelle Durand-Zaleski, MD, PhDj,
- Thierry Lefèvre, MDk,
- for the EASY TAVI Investigators
- aInstitut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France
- bCardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France
- cCardiology Department, Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France
- dCardiology Department, Clinique Saint Hilaire, Rouen, France
- eCardiology Department, Institut Mutualiste Montsouris, Paris, France
- fDépartement de cardiologie, Institut Cœur Poumon, Centre Hospitalier Universitaire de Lille, Lille, France
- gCardiology Department, Centre Hospitalier Annecy Genevois, Epagny, France
- hCardiology Department, Institut Arnault Tzanck, Saint-Laurent-du-Var, France
- iCardiology Department, Clinique Pasteur, Toulouse, France
- jCardiology Department, URC-Eco Île de France, Hôpital de l’Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France
- kInstitut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France
- ↵∗Address for correspondence
: Dr. Benjamin Faurie, GHM Grenoble-CRCA, 8 rue Dr Calmette, 38000 Grenoble, France.
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)
- left ventricular pacing
- left ventricular stimulation
- transcatheter aortic valve implantation
- transcatheter aortic valve replacement
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.
- Received September 13, 2019.
- Revision received September 17, 2019.
- Accepted September 18, 2019.
- 2019 American College of Cardiology Foundation
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