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Europace Advance Access published online on May 31, 2007
Europace, doi:10.1093/europace/eum080
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© The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety

D. Gras1, D. Böcker2, M. Lunati3, H.J.J. Wellens4, M. Calvert5, N. Freemantle5, R. Gervais6, L. Kappenberger7, L. Tavazzi8, E. Erdmann9, J.G.F. Cleland10, J.-C. Daubert on behalf of The CARE-HF Study Steering Committee and Investigators6,*

1 Nouvelles Cliniques Nantaises, Nantes, France; 2 Departement of Cardiology and Angiology, University Hospital, Münster, Germany; 3 Ospedale Niguarda Ca' Granda, Dipartimento di Cardiologia ‘De Gasperis’, Elettrofisiologia, Milano, Italy; 4 Cardiovascular Research Institute, Maastricht, The Netherlands; 5 University of Birmingham, Edgbaston, UK; 6 Département de Cardiologie et maladies vasculaires, Centre cardio-pneumologique, Hôpital Pontchaillou, Centre hospitalier universitaire, 2, rue Henri le Guilloux, 35033 Rennes Cedex 9, France; 7 Division of Cardiology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; 8 Istituto di Ricovero e Cura a Carattere Scientifico, Policlinico San Matteo, Pavia, Italy; 9 Department of Internal Medicine III, University of Cologne, Cologne, Germany; 10 Department of Cardiology, Castle Hill Hospital, Kingston-upon-Hull, UK

Aims To assess procedural characteristics and adjudicated procedure-related (≤30 days) major adverse events among patients who underwent cardiac resynchronization therapy (CRT) implantation in the CARE-HF study. The CARE-HF study shows that CRT improves symptoms and reduces morbidity and mortality in New York Heart Association (NYHA) class III/IV chronic heart failure (CHF) patients. However, safe and proper implantation of pacing systems remains key to effective CRT delivery.

Methods and results Generalized linear modeling was used to examine the relationships between first implant success/failure and: NYHA class; beta-adrenergic blocker use; underlying ischemic vs. non-ischemic heart disease; history of coronary artery bypass graft or valve surgery; left ventricular (LV) end-diastolic volume ≤ vs. >300 cm3; and, influence of the participating study-centres. Implantation was attempted in 404/409 patients assigned to CRT, and in 65/404 patients assigned to medical therapy. Among these 469 patients, 450 (95.9%) received a successfully implanted and activated device. Complications occurred within 24 h in 47 patients (10.0%), mainly lead dislodgments (n = 10, 2.1%) and coronary sinus dissection/perforation (n = 10, 2.1%), and between 24 h and 30 days in 26 patients (5.5%), mainly lead dislodgment (n = 13, 2.8%). Mean LV lead stimulation threshold was significantly higher than at the right atrium or right ventricle, though remained stable, delivering effective, and reliable CRT. Implanting experience was the only predictor of procedural outcome.

Conclusion Transvenous CRT system implantation, using a CS lead designed for long-term LV pacing, was safe and reliable. As implanting centres become more experienced, this success rate is expected to increase further.

Key Words: Cardiac resynchronization therapy, Heart failure, Procedural complications, Operative complications, Left ventricular stimulation

* Corresponding author. Tel: +33 299 282 525; fax: +33 299 282 510. E-mail address: jean-claude.daubert{at}chu-rennes.fr

Manuscript submitted 13 December 2006. Accepted after revision 30 March 2007.


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