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

被引:62
作者
Faurie, Benjamin [1 ,2 ]
Souteyrand, Geraud [3 ]
Staat, Patrick [2 ]
Godin, Matthieu [4 ]
Caussin, Christophe [5 ]
Van Belle, Eric [6 ]
Mangin, Lionel [7 ]
Meyer, Pierre [8 ]
Dumonteil, Nicolas [9 ]
Abdellaoui, Mohamed [1 ,2 ]
Monsegu, Jacques [1 ,2 ]
Durand-Zaleski, Isabelle [10 ]
Lefevre, Thierry [11 ]
机构
[1] Grp Hosp Mutualiste Grenoble, Inst Cardiovasc, Grenoble, France
[2] Medipole HP Lyon Villeurbane, Cardiol Dept, Villeurbanne, France
[3] Ctr Hosp Univ Gabriel Montpied, Cardiol Dept, Clermont Ferrand, France
[4] Clin St Hilaire, Cardiol Dept, Rouen, France
[5] Inst Mutualiste Montsouris, Cardiol Dept, Paris, France
[6] CHU Lille, Inst Coeur Poumon, Dept Cardiol, Lille, France
[7] Ctr Hosp Annecy Genevois, Cardiol Dept, Epagny, France
[8] Inst Arnault Tzanck, Cardiol Dept, St Laurent Du Var, France
[9] Clin Pasteur, Cardiol Dept, Toulouse, France
[10] Hop Hotel Dieu, AP HP, URC Eco Ile France, Cardiol Dept, Paris, France
[11] Hop Prive Jacques Cartier, Inst Cardiovasc Paris Sud, Massy, France
关键词
left ventricular pacing; left ventricular stimulation; transcatheter aortic valve implantation; transcatheter aortic valve replacement; PACEMAKER IMPLANTATION; OUTCOMES; STENOSIS; DEFINITIONS; MULTICENTER; PREDICTORS; DEVICES; ACCESS;
D O I
10.1016/j.jcin.2019.09.029
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 ((sic)18,807 +/- 1,318 vs. (sic)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) (C) 2019 by the American College of Cardiology Foundation.
引用
收藏
页码:2449 / 2459
页数:11
相关论文
共 28 条
[21]   Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients [J].
Smith, Craig R. ;
Leon, Martin B. ;
Mack, Michael J. ;
Miller, Craig ;
Moses, Jeffrey W. ;
Svensson, Lars G. ;
Tuzcu, E. Murat ;
Webb, John G. ;
Fontana, Gregory P. ;
Makkar, Raj R. ;
Williams, Mathew ;
Dewey, Todd ;
Kapadia, Samir ;
Babaliaros, Vasilis ;
Thourani, Vinod H. ;
Corso, Paul ;
Pichard, Augusto D. ;
Bavaria, Joseph E. ;
Herrmann, Howard C. ;
Akin, Jodi J. ;
Anderson, William N. ;
Wang, Duolao ;
Pocock, Stuart J. .
NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (23) :2187-2198
[22]  
Thiele H. A, 2018, TCT 2018 SEPT 23
[23]   Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review [J].
van Rosendael, Philippe J. ;
Delgado, Victoria ;
Bax, Jeroen J. .
EUROPEAN HEART JOURNAL, 2018, 39 (21) :2003-+
[24]   Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration [J].
Vlastra, Wieneke ;
Chandrasekhar, Jaya ;
Munoz-Garcia, Antonio J. ;
Tchetche, Didier ;
de Brito, Fabio S., Jr. ;
Barbanti, Marco ;
Kornowski, Ran ;
Latib, Azeem ;
D'Onofrio, Augusto ;
Ribichini, Flavio ;
Baan, Jan ;
Tijssen, Jan G. P. ;
Trillo-Nouche, Ramiro ;
Dumonteil, Nicolas ;
Abizaid, Alexandre ;
Sartori, Samantha ;
D'Errigo, Paola ;
Tarantini, Giuseppe ;
Lunardi, Mattia ;
Orvin, Katia ;
Pagnesi, Matteo ;
del Valle, Raquel ;
Modine, Thomas ;
Dangas, George ;
Mehran, Roxana ;
Piek, Jan J. ;
Delewi, Ronak .
EUROPEAN HEART JOURNAL, 2019, 40 (05) :456-465
[25]   A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery [J].
Webb, John G. ;
Doshi, Darshan ;
Mack, Michael J. ;
Makkar, Raj ;
Smith, Craig R. ;
Pichard, Augusto D. ;
Kodali, Susheel ;
Kapadia, Samir ;
Miller, D. Craig ;
Babaliaros, Vasilis ;
Thourani, Vinod ;
Herrmann, Howard C. ;
Bodenhamer, Mark ;
Whisenant, Brian K. ;
Ramee, Stephen ;
Maniar, Hersh ;
Kereiakes, Dean ;
Xu, Ke ;
Jaber, Wael A. ;
Menon, Venu ;
Tuzcu, E. Murat ;
Wood, David ;
Svensson, Lars G. ;
Leon, Martin B. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2015, 8 (14) :1797-1806
[26]  
Webster M, 2018, J INVASIVE CARDIOL, V30, P163
[27]   Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes [J].
Wenaweser, Peter ;
Pilgrim, Thomas ;
Roth, Nadja ;
Kadner, Alexander ;
Stortecky, Stefan ;
Kalesan, Bindu ;
Meuli, Fabienne ;
Buellesfeld, Lutz ;
Khattab, Ahmed A. ;
Huber, Christoph ;
Eberle, Balthasar ;
Erdoes, Gabor ;
Meier, Bernhard ;
Jueni, Peter ;
Carrel, Thierry ;
Windecker, Stephan .
AMERICAN HEART JOURNAL, 2011, 161 (06) :1114-1124
[28]   SOURCE 3 Registry Design and 30-Day Results of the European Postapproval Registry of the Latest Generation of the SAPIEN 3 Transcatheter Heart Valve [J].
Wendler, Olaf ;
Schymik, Gerhard ;
Treede, Hendrik ;
Baumgartner, Helmut ;
Dumonteil, Nicolas ;
Ihlberg, Leo ;
Neumann, Franz-Josef ;
Tarantini, Giuseppe ;
Luis Zamarano, Jose ;
Vahanian, Alec .
CIRCULATION, 2017, 135 (12) :1123-1132