Author + information
- Received September 13, 2019
- Revision received September 17, 2019
- Accepted September 18, 2019
- Published online September 25, 2019.
- Benjamin Faurie, MDa,b,c,∗ (, )
- Géraud Souteyrand, MDb,
- Patrick Staat, MDc,
- Matthieu Godin, MDd,
- Christophe Caussin, MDe,
- Eric Van Belle, MD, PhDf,
- Lionel Mangin, MDg,
- Pierre Meyer, MDh,
- Nicolas Dumonteil, MDi,
- Mohamed Abdellaoui, MDa,b,c,
- Jacques Monségu, MDa,b,c,
- Isabelle Durand-Zaleski, MD, PhDj,
- Thierry Lefèvre, MDk,
- for the EASY TAVI investigators
- aGroupe Hospitalier Mutualiste de Grenoble, Institut Cardiovasculaire, Grenoble, France
- bCentre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France
- cMédipole HP Lyon-Villeurbane, Villeurbane, France
- dClinique Saint Hilaire, Rouen, France
- eInstitut Mutualiste Montsouris, Paris, France
- fInstitut Cœur Poumon, Département de cardiologie, Centre Hospitalier Universitaire de Lille, Lille, France
- gCentre Hospitalier Annecy Genevois, Epagny, France
- hInstitut Arnault Tzanck, Saint-Laurent-du-Var, France
- iClinique Pasteur, Toulouse, France
- jAP-HP URCEco Ile de France, Hôpital de l’Hôtel Dieu, Paris, France
- kInstitut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France
- ↵∗Address for Correspondence: Benjamin Faurie, MD GHM Grenoble-CRCA 8 rue Dr Calmette 38000 Grenoble, France
Background Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve implantation (TAVI).
Objectives We investigated whether left ventricular (LV)-stimulation via a guidewire reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV)-stimulation.
Methods This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVI with a Sapien valve (Edwards Lifesciences) were allocated to LV- or RV-stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days. This trial is registered at clinicaltrials.gov (NCT02781896).
Results Between May 2017 and May 2018, 307 patients were randomised but 4 were excluded because they did not receive the intended treatment: 303 patients were analysed in the LV- (n=151) or RV-stimulation (n=152) groups. Mean procedure duration was significantly shorter in the LV-stimulation group (48.4±16.9 vs. 55.6±26.9 min, p=0.0013), with a difference of -0.12 (95% CI -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%) vs. 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%) vs. 151 (99.3%) patients (p=0.99); 30-day MACE-TAVI occurred in 21 (13.9%) vs. 26 (17.1%) patients (p=0.44); fluoroscopy time 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 TAVI was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety.
- left-ventricular stimulation
- left-ventricular pacing
- transcatheter aortic valve implantation
- transcatheter aortic valve replacement
Edwards Lifesciences, Paul Bennetot Foundation, Foundation of the Future, and Groupe Hospitalier Mutualiste, Grenoble
Dr Lefèvre is proctor for Edwards Lifescience.
All other authors have no conflict of interest to declare.
Discover the first randomized trial comparing standard RV stimulation to direct wire pacing via the LV backup wire. This disruptive technique optimize TAVR procedures (reducing costs, procedural and scopy time) while maintaining safety and efficacy!
- Received September 13, 2019.
- Revision received September 17, 2019.
- Accepted September 18, 2019.
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