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Cardiac resynchronization therapy: Twelve-month effects of echocardiographic atrio-ventricular and inter-ventricular delay optimization. Rationale and design of the CARTEDO trial

2015; Elsevier BV; Volume: 202; Linguagem: Inglês

10.1016/j.ijcard.2015.08.182

1874-1754

Luca Donazzan, Marzia Rigolli, Vincenzo De Simone, Corinna Bergamini, Luca Tomasi, Luisa Zanolla, Corrado Vassanelli,

Cardiomyopathy and Myosin Studies

Cardiac resynchronization therapy (CRT) is the recommended device treatment in patients with heart failure (HF), severely impaired left ventricular ejection fraction (LVEF ≤35%), and left bundle branch block with QRS duration ≥120 ms, who are symptomatic despite optimal medical treatment [ [1] Brignole M. Auricchio A. Baron-Esquivias G. Bordachar P. Boriani G. Breithardt O.A. Cleland J. Deharo J.C. Delgado V. Elliott P.M. Gorenek B. Israel C.W. Leclercq C. Linde C. Mont L. Padeletti L. Sutton R. Vardas P.E. ESC Committee for Practice Guidelines (CPG) Zamorano J.L. Achenbach S. Baumgartner H. Bax J.J. Bueno H. Dean V. Deaton C. Erol C. Fagard R. Ferrari R. Hasdai D. Hoes A.W. Kirchhof P. Knuuti J. Kolh P. Lancellotti P. Linhart A. Nihoyannopoulos P. Piepoli M.F. Ponikowski P. Sirnes P.A. Tamargo J.L. Tendera M. Torbicki A. Wijns W. Windecker S. Reviewers Document Kirchhof P. Blomstrom-Lundqvist C. Badano L.P. Aliyev F. Bänsch D. Baumgartner H. Bsata W. Buser P. Charron P. Daubert J.C. Dobreanu D. Faerestrand S. Hasdai D. Hoes A.W. Le Heuzey J.Y. Mavrakis H. McDonagh T. Merino J.L. Nawar M.M. Nielsen J.C. Pieske B. Poposka L. Ruschitzka F. Tendera M. Van Gelder I.C. Wilson C.M. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur. Heart J. 2013; 34: 2281-2329 Crossref PubMed Scopus (1604) Google Scholar ]. Unfortunately, based on the current guidelines, about one-third of them do not respond clinically to CRT, and more than 40% do not show LV reverse remodeling. Device therapy optimization has been proposed to overcome this issue and the echo-guided atrio-ventricular (AV) and inter-ventricular (VV) delay adjustment is a promising and feasible technique. Observational and underpowered randomized studies have identified AV and VV suboptimal delays as predictors of poor CRT response and have shown significant clinical benefit following optimization [ 2 Auricchio A. Stellbrink C. Sack S. Block M. Vogt J. Bakker P. Huth C. Schöndube F. Wolfhard U. Böcker D. Krahnefeld O. Kirkels H. Pacing Therapies in Congestive Heart Failure (PATH-CHF) Study Group Long-term clinical effect of hemodynamically optimized cardiac resynchronization therapy in patients with heart failure and ventricular conduction delay. J. Am. Coll. Cardiol. 2002; 39: 2026-2033 Abstract Full Text Full Text PDF PubMed Scopus (903) Google Scholar , 3 Vidal B. Sitges M. Marigliano A. Delgado V. Díaz-Infante E. Azqueta M. Tamborero D. Tolosana J.M. Berruezo A. Pérez-Villa F. Paré C. Mont L. Brugada J. Optimizing the programation of cardiac resynchronization therapy devices in patients with heart failure and left bundle branch block. Am. J. Cardiol. 2007; 100: 1002-1006 Abstract Full Text Full Text PDF PubMed Scopus (82) Google Scholar ]. However, these findings have not been yet confirmed by larger randomized trials [ 4 Boriani G. Müller C.P. Seidl K.H. Grove R. Vogt J. Danschel W. Schuchert A. Djiane P. Biffi M. Becker T. Bailleul C. Trappe H.J. Resynchronization for the HemodYnamic Treatment for Heart Failure Management II Investigators Randomized comparison of simultaneous biventricular stimulation versus optimized interventricular delay in cardiac resynchronization therapy. The Resynchronization for the HemodYnamic Treatment for Heart Failure Management II implantable cardioverter defibrillator (RHYTHM II ICD) study. Am. Heart J. 2006; 151: 1050-1058 Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar , 5 Ritter P. Delnoy P.P. Padeletti L. Lunati M. Naegele H. Borri-Brunetto A. Silvestre J. A randomized pilot study of optimization of cardiac resynchronization therapy in sinus rhythm patients using a peak endocardial acceleration sensor vs. standard methods. Europace. 2012; 14: 1324-1333 Crossref PubMed Scopus (88) Google Scholar ], although positive trends have been recently shown [ [6] Delnoy P.P. Ritter P. Naegele H. Orazi S. Szwed H. Zupan I. Goscinska-Bis K. Anselme F. Martino M. Padeletti L. Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization (CLEAR) pilot study. Europace. 2013; 15: 1174-1181 Crossref PubMed Scopus (28) Google Scholar ]. Currently, the European Society of Cardiology [ [1] Brignole M. Auricchio A. Baron-Esquivias G. Bordachar P. Boriani G. Breithardt O.A. Cleland J. Deharo J.C. Delgado V. Elliott P.M. Gorenek B. Israel C.W. Leclercq C. Linde C. Mont L. Padeletti L. Sutton R. Vardas P.E. ESC Committee for Practice Guidelines (CPG) Zamorano J.L. Achenbach S. Baumgartner H. Bax J.J. Bueno H. Dean V. Deaton C. Erol C. Fagard R. Ferrari R. Hasdai D. Hoes A.W. Kirchhof P. Knuuti J. Kolh P. Lancellotti P. Linhart A. Nihoyannopoulos P. Piepoli M.F. Ponikowski P. Sirnes P.A. Tamargo J.L. Tendera M. Torbicki A. Wijns W. Windecker S. Reviewers Document Kirchhof P. Blomstrom-Lundqvist C. Badano L.P. Aliyev F. Bänsch D. Baumgartner H. Bsata W. Buser P. Charron P. Daubert J.C. Dobreanu D. Faerestrand S. Hasdai D. Hoes A.W. Le Heuzey J.Y. Mavrakis H. McDonagh T. Merino J.L. Nawar M.M. Nielsen J.C. Pieske B. Poposka L. Ruschitzka F. Tendera M. Van Gelder I.C. Wilson C.M. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur. Heart J. 2013; 34: 2281-2329 Crossref PubMed Scopus (1604) Google Scholar ] and the American Echocardiographic Society [ [7] Gorcsan III, J. Abraham T. Agler D.A. Bax J.J. Derumeaux G. Grimm R.A. Martin R. Steinberg J.S. Sutton M.S. Yu C.M. American Society of Echocardiography Dyssynchrony Writing Group Echocardiography for cardiac resynchronization therapy: recommendations for performance and reporting—a report from the American Society of Echocardiography Dyssynchrony Writing Group endorsed by the Heart Rhythm Society. J. Am. Soc. Echocardiogr. 2008; 21: 191-213 Abstract Full Text Full Text PDF PubMed Scopus (476) Google Scholar ] consider echocardiographic CRT optimization time-consuming and, on the basis of discordant evidence, recommend it just for those patients who are clinically non-responders. Such procedure does prolong visit length and requires a close collaboration between highly specialized operators (sonographer and device programmer). Therefore, we feel that there is a need to fulfill this gap of evidence by further investigation in experienced centers on the procedure outcome. In fact, not only there is a large degree of uncertainty in echo-guided CRT optimization in non-responders, but also there is no data on the technique in patients considered responders. Theoretically, the method could result in additional benefit to this class of patients as well.