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Heart. 2018 Sep;104(18):1529-1535. doi: 10.1136/heartjnl-2017-312546. Epub 2018 Mar 14.

Device complications with addition of defibrillation to cardiac resynchronisation therapy for primary prevention.

Author information

1
Cardiology Department, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
2
Barts Heart Centre, Barts Health NHS Trust, London, UK.
3
Cardiology Department, Clinique Pasteur, Toulouse, France.
4
Cardiovascular Epidemiology, Paris Cardiovascular Research Center, Paris, France.
5
Cardiology Department, MaxCure Hospitals, Hyderabad, India.
6
Cardiology Department, Centre Cardiologique du Nord, St Denis, France.
7
Cardiology Department, Lille University Hospital, Lille, France.
8
Cardiology Department, Grenoble University Hospital, Grenoble, France.
9
Cardiology Department, Nouvelles Cliniques Nantaises, Nantes, France.
10
Cardiology Department, La Timone University Hospital, Marseille, France.
11
Cardiology Department, Caen University Hospital, Caen, France.
12
Cardiology Department, St Etienne University Hospital, St Etienne, France.
13
Cardiology Department, Toulouse University Hospital, Toulouse, France.
14
Cardiology Department, Rennes University Hospital, Rennes, France.
15
Cardiology Department, Nancy University Hospital, Nancy, France.
16
Paris Descartes University, Paris, France.
17
Cardiology Department, European Georges Pompidou Hospital, Paris, France.

Abstract

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.

KEYWORDS:

heart failure; implanted cardiac defibrillators; pacemakers; quality and outcomes of care

PMID:
29540431
DOI:
10.1136/heartjnl-2017-312546
[Indexed for MEDLINE]

Conflict of interest statement

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.

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