The clinical course of patients with implantable cardioverter-defibrillators: Extended experience on clinical outcome, device replacements, and device-related complications.
BACKGROUND
Large randomized trials demonstrated the beneficial effect of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) treatments in selected patients. Data on long-term follow-up of patients outside the setting of clinical trials are scarce.


OBJECTIVE
The aim of this study was to evaluate the long-term outcome of ICD and CRT-D recipients.


METHODS
All patients who underwent ICD (n = 1729 [57%]) or CRT-D (n = 1326 [43%]) implantation at the Leiden University Medical Center since 1996 were evaluated. Follow-up visits were performed every 3-6 months, and events were registered. Cumulative incidence curves of device therapy and device-related complications were adjusted for the competing risk of all-cause mortality.


RESULTS
After a median follow-up of 5.1 years (25th-75th percentile 3.1-7.8 years), 842 patients (28%) died. The cumulative incidence of all-cause mortality was 49% (95% confidence interval [CI] 45%-54%) in ICD recipients after 12 years of follow-up and 55% (95% CI 52%-58%) in CRT-D recipients after 8 years of follow-up. A total of 1081 patients (35%) received appropriate defibrillator therapy. The cumulative incidence of appropriate therapy in ICD patients was 58% (95% CI 54%-62%) after 12 years of follow-up and 39% (95% CI 35%-43%) in CRT-D patients after 8 years of follow-up. Twelve-year cumulative incidences of adverse events were 20% (95% CI 18%-22%) for inappropriate shock, 6% (95% CI 5%-8%) for device-related infection, and 17% (95% CI 14%-21%) for lead failure.


CONCLUSIONS
After long-term follow-up of ICD (12 years) and CRT-D (8 years) recipients, 49% of ICD recipients and 55% of CRT-D recipients had died. Appropriate ICD therapy was received by the majority (58%) of ICD recipients and by almost 40% of CRT-D recipients.
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Aafke C
AC
van der Heijden
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
C Jan Willem
CJ
Borleffs
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Maurits S
MS
Buiten
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Joep
J
Thijssen
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Johannes B
JB
van Rees
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Suzanne C
SC
Cannegieter
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Martin J
MJ
Schalij
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: L.van_Erven@lumc.nl.
Lieselot
L
van Erven
D000368:Aged; D058409:Cardiac Resynchronization Therapy Devices / Q000009:adverse effects; D017147:Defibrillators, Implantable / Q000009:adverse effects; D020878:Device Removal; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
Cardiac resynchronization therapy; Defibrillator therapy; Device replacements; Device-related complications; Implantable cardioverter-defibrillator