PMID- 29540431
OWN - NLM
STAT- MEDLINE
DCOM- 20190215
LR  - 20190215
IS  - 1468-201X (Electronic)
IS  - 1355-6037 (Linking)
VI  - 104
IP  - 18
DP  - 2018 Sep
TI  - Device complications with addition of defibrillation to cardiac resynchronisation
      therapy for primary prevention.
PG  - 1529-1535
LID - 10.1136/heartjnl-2017-312546 [doi]
AB  - 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.
CI  - (c) Article author(s) (or their employer(s) unless otherwise stated in the text
      of the article) 2018. All rights reserved. No commercial use is permitted unless 
      otherwise expressly granted.
FAU - Barra, Sergio
AU  - Barra S
AD  - Cardiology Department, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
FAU - Providencia, Rui
AU  - Providencia R
AD  - Barts Heart Centre, Barts Health NHS Trust, London, UK.
FAU - Boveda, Serge
AU  - Boveda S
AD  - Cardiology Department, Clinique Pasteur, Toulouse, France.
FAU - Duehmke, Rudolf
AU  - Duehmke R
AD  - Cardiology Department, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
FAU - Narayanan, Kumar
AU  - Narayanan K
AD  - Cardiovascular Epidemiology, Paris Cardiovascular Research Center, Paris, France.
AD  - Cardiology Department, MaxCure Hospitals, Hyderabad, India.
FAU - Chow, Anthony W
AU  - Chow AW
AD  - Barts Heart Centre, Barts Health NHS Trust, London, UK.
FAU - Piot, Olivier
AU  - Piot O
AD  - Cardiology Department, Centre Cardiologique du Nord, St Denis, France.
FAU - Klug, Didier
AU  - Klug D
AD  - Cardiology Department, Lille University Hospital, Lille, France.
FAU - Defaye, Pascal
AU  - Defaye P
AD  - Cardiology Department, Grenoble University Hospital, Grenoble, France.
FAU - Gras, Daniel
AU  - Gras D
AD  - Cardiology Department, Nouvelles Cliniques Nantaises, Nantes, France.
FAU - Deharo, Jean-Claude
AU  - Deharo JC
AD  - Cardiology Department, La Timone University Hospital, Marseille, France.
FAU - Milliez, Paul
AU  - Milliez P
AD  - Cardiology Department, Caen University Hospital, Caen, France.
FAU - Da Costa, Antoine
AU  - Da Costa A
AD  - Cardiology Department, St Etienne University Hospital, St Etienne, France.
FAU - Mondoly, Pierre
AU  - Mondoly P
AD  - Cardiology Department, Toulouse University Hospital, Toulouse, France.
FAU - Gonzalez-Panizo, Jorge
AU  - Gonzalez-Panizo J
AD  - Cardiology Department, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
FAU - Leclercq, Christophe
AU  - Leclercq C
AD  - Cardiology Department, Rennes University Hospital, Rennes, France.
FAU - Heck, Patrick
AU  - Heck P
AD  - Cardiology Department, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
FAU - Virdee, Munmohan
AU  - Virdee M
AD  - Cardiology Department, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
FAU - Sadoul, Nicolas
AU  - Sadoul N
AD  - Cardiology Department, Nancy University Hospital, Nancy, France.
FAU - Le Heuzey, Jean-Yves
AU  - Le Heuzey JY
AD  - Paris Descartes University, Paris, France.
AD  - Cardiology Department, European Georges Pompidou Hospital, Paris, France.
FAU - Marijon, Eloi
AU  - Marijon E
AD  - Cardiovascular Epidemiology, Paris Cardiovascular Research Center, Paris, France.
AD  - Paris Descartes University, Paris, France.
AD  - Cardiology Department, European Georges Pompidou Hospital, Paris, France.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20180314
PL  - England
TA  - Heart
JT  - Heart (British Cardiac Society)
JID - 9602087
SB  - AIM
SB  - IM
MH  - Aged
MH  - Cardiac Resynchronization Therapy/adverse effects/*methods
MH  - Cardiomyopathy, Dilated/complications/*therapy
MH  - Defibrillators, Implantable/*adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Pacemaker, Artificial/*adverse effects
MH  - Primary Prevention/*methods
MH  - Propensity Score
MH  - Risk Factors
MH  - Tachycardia, Ventricular/etiology/physiopathology/*prevention & control
MH  - Treatment Outcome
OTO - NOTNLM
OT  - *heart failure
OT  - *implanted cardiac defibrillators
OT  - *pacemakers
OT  - *quality and outcomes of care
COIS- 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.
EDAT- 2018/03/16 06:00
MHDA- 2019/02/16 06:00
CRDT- 2018/03/16 06:00
PHST- 2017/10/10 00:00 [received]
PHST- 2018/02/13 00:00 [revised]
PHST- 2018/02/25 00:00 [accepted]
PHST- 2018/03/16 06:00 [pubmed]
PHST- 2019/02/16 06:00 [medline]
PHST- 2018/03/16 06:00 [entrez]
AID - heartjnl-2017-312546 [pii]
AID - 10.1136/heartjnl-2017-312546 [doi]
PST - ppublish
SO  - Heart. 2018 Sep;104(18):1529-1535. doi: 10.1136/heartjnl-2017-312546. Epub 2018
      Mar 14.