Objective In patients indicated for cardiac resynchronisation therapy (CRT), the choice between a CRT-pacemaker (CRT-P) versus defibrillator (CRT-D) remains controversial and indications in this setting have not been well delineated. Apart from inappropriate therapies, which are inherent to the presence of a defibrillator, whether adding defibrillator to CRT in the primary prevention setting impacts risk of other acute and late device-related complications has not been well studied and may bear relevance for device selection.
Methods Observational multicentre European cohort study of 3008 consecutive patients with ischaemic or non-ischaemic dilated cardiomyopathy and no history of sustained ventricular arrhythmias, undergoing CRT implantation with (CRT-D, n=1785) or without (CRT-P, n=1223) defibrillator. Using propensity score and competing risk analyses, we assessed the risk of significant device-related complications requiring surgical reintervention. Inappropriate shocks were not considered except those due to lead malfunction requiring lead revision.
Results Acute complications occurred in 148 patients (4.9%), without significant difference between groups, even after considering potential confounders (OR=1.20, 95% CI 0.72 to 2.00, p=0.47). During a mean follow-up of 41.4±29 months, late complications occurred in 475 patients, giving an annual incidence rate of 26 (95% CI 9 to 43) and 15 (95% CI 6 to 24) per 1000 patient-years in CRT-D and CRT-P patients, respectively. CRT-D was independently associated with increased occurrence of late complications (HR=1.68, 95% CI 1.27 to 2.23, p=0.001). In particular, when compared with CRT-P, CRT-D was associated with an increased risk of device-related infection (HR 2.10, 95% CI 1.18 to 3.45, p=0.004). Acute complications did not predict overall late complications, but predicted device-related infection (HR 2.85, 95% CI 1.71 to 4.56, p<0.001).
Conclusions Compared with CRT-P, CRT-D is associated with a similar risk of periprocedural complications but increased risk of long-term complications, mainly infection. This needs to be considered in the decision of implanting CRT with or without a defibrillator.
- implanted cardiac defibrillators
- heart failure
- quality and outcomes of care
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Contributors Conceived and designed the research: SBa, RP, SBo, EM. Data collection: SBa, RP, SBo, RD, OP, DK, PD, DG, J-CD, PMi, ADC, PMo, JG-P, CL, NS. Data analysis: SBa, RP, SBo, KN, MV, EM. Performed statistical analysis: SBa, RP. Handled funding and supervision: AWC, PH, MV, NS, J-YLH, EM. Drafted the manuscript: SBa, RP, SBo, KN, EM. Made critical revision of the manuscript for key intellectual content: All authors.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests RP received training grant from Boston Scientific and Sorin Group and a Research Grant from Medtronic. SBo received consulting fees from Medtronic, Boston Scientific and Sorin Group. OP received travel support and consulting fees from Abbott, Boston Scientific, LivaNova and Medtronic. DK received consultant fees from St. Jude Medical, Medtronic, Sorin Group, Boston Scientific and Biotronik. PD received consulting fees from Boston Scientific, Medtronic, St Jude Medical and LivaNova. DG receiving consulting fees from Boston scientific, Medtronic, Biotronik, Abbot. PM received consulting fees from Biotronik, Boston Scientific and St Jude Medical. NS received consulting fees from Biotronik, Boston Scientific, Medtronic, Sorin Group and St. Jude Medical. J-YLH received consulting fees from Astra Zeneca, Bayer, BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo, Meda, Novartis , Sanofi, Servier. All other authors have reported that they have no relationships relevant to the contents of this article to disclose.
Patient consent Not required.
Ethics approval French Ethics and Data Protection National Committees and Institutional Review Boards.
Provenance and peer review Not commissioned; externally peer reviewed.