Impact on All-Cause and Cardiovascular Mortality of Cardiac Implantable Electronic Device Complications: Results From the POINTED Registry.
cardiac implantable electronic device complications
device infection
lead dislodgement
lead failure
pneumothorax
pocket hematoma
Journal
JACC. Clinical electrophysiology
ISSN: 2405-5018
Titre abrégé: JACC Clin Electrophysiol
Pays: United States
ID NLM: 101656995
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
05
08
2019
revised:
13
11
2019
accepted:
13
11
2019
entrez:
25
4
2020
pubmed:
25
4
2020
medline:
19
8
2021
Statut:
ppublish
Résumé
This study aimed to determine how CIED-related complications affect all-cause and cardiovascular mortality over a long-term follow-up. Although complications related to implantable electronic device (CIED) implantation are steadily increasing in Europe, little is known about the impact of complications other than device infection on mortality. The POINTED (Impact on Patient Outcome and health care utilization of cardiac ImplaNTable Electronic Device complications) registry was a prospective, multicenter, observational study designed to collect data on complications in patients undergoing de novo CIED implantation (NCT03612635). All consecutive patients were enrolled in 6 high-volume centers between January 2010 and December 2012 and followed up for at least 3 years. A complication was defined as any CIED-related adverse event requiring surgical revision after implantation. During follow-up (median 56.9 months), we observed 283 complications in 263 of 2811 consecutive patients (71 ± 14 years of age, 66.7% men). Early complications (≤30 days) were associated with significantly lower cumulative survival from cardiovascular death in comparison with late complications and with freedom from complications. On multivariate analysis, early complication, pneumothorax, and pocket hematoma were significantly associated with a higher risk of all-cause death, while device infection remained the only complication significantly associated with a higher risk of cardiovascular death. All CIED-related complications are associated with an increased risk of cardiovascular mortality, and early complications are associated with an increased risk of all-cause mortality. These data underline the importance of specific measures aimed at reducing CIED complications and improving their management.
Sections du résumé
OBJECTIVES
This study aimed to determine how CIED-related complications affect all-cause and cardiovascular mortality over a long-term follow-up.
BACKGROUND
Although complications related to implantable electronic device (CIED) implantation are steadily increasing in Europe, little is known about the impact of complications other than device infection on mortality.
METHODS
The POINTED (Impact on Patient Outcome and health care utilization of cardiac ImplaNTable Electronic Device complications) registry was a prospective, multicenter, observational study designed to collect data on complications in patients undergoing de novo CIED implantation (NCT03612635). All consecutive patients were enrolled in 6 high-volume centers between January 2010 and December 2012 and followed up for at least 3 years. A complication was defined as any CIED-related adverse event requiring surgical revision after implantation.
RESULTS
During follow-up (median 56.9 months), we observed 283 complications in 263 of 2811 consecutive patients (71 ± 14 years of age, 66.7% men). Early complications (≤30 days) were associated with significantly lower cumulative survival from cardiovascular death in comparison with late complications and with freedom from complications. On multivariate analysis, early complication, pneumothorax, and pocket hematoma were significantly associated with a higher risk of all-cause death, while device infection remained the only complication significantly associated with a higher risk of cardiovascular death.
CONCLUSIONS
All CIED-related complications are associated with an increased risk of cardiovascular mortality, and early complications are associated with an increased risk of all-cause mortality. These data underline the importance of specific measures aimed at reducing CIED complications and improving their management.
Identifiants
pubmed: 32327071
pii: S2405-500X(19)30914-4
doi: 10.1016/j.jacep.2019.11.005
pii:
doi:
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
382-392Informations de copyright
Copyright © 2020 American College of Cardiology Foundation. All rights reserved.