Axillary vein puncture guided by ultrasound vs cephalic vein dissection in pacemaker and defibrillator implant: A multicenter randomized clinical trial.
Aged
Aged, 80 and over
Arrhythmias, Cardiac
/ diagnosis
Axillary Vein
/ diagnostic imaging
Catheterization, Peripheral
/ methods
Defibrillators, Implantable
Female
Follow-Up Studies
Humans
Male
Middle Aged
Pacemaker, Artificial
Phlebography
Prospective Studies
Prosthesis Implantation
/ methods
Punctures
/ methods
Surgery, Computer-Assisted
/ methods
Ultrasonography
Axillary vein
Cephalic vein
Implantable cardioverter-defibrillator
Pacemaker
Randomized clinical trial
Ultrasound-guided venous puncture
Journal
Heart rhythm
ISSN: 1556-3871
Titre abrégé: Heart Rhythm
Pays: United States
ID NLM: 101200317
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
28
03
2020
revised:
12
04
2020
accepted:
18
04
2020
pubmed:
4
5
2020
medline:
7
9
2021
entrez:
4
5
2020
Statut:
ppublish
Résumé
Axillary vein puncture guided by ultrasound (US-Ax) has emerged as a valid alternative access route to pacemaker and defibrillator lead insertion. The purpose of this study was to evaluate whether US-Ax compared to cephalic vein dissection (CV) improves success and early complications in pacemaker or defibrillator implant. This prospective, multicenter clinical trial included 88 adult patients randomized 1:1 to US-Ax (n = 44) or CV (n = 44). All procedures were performed by operators with no previous experience in axillary approach. Primary endpoint was defined as success rate. Secondary endpoints were venous access site change, time to obtain venous access, total procedural time, and early complication rate. Analyses were performed using the intention-to-treat principle. Median age was 70.5 years (58.2-79.7), and 60.2% were male. For the primary outcome, a higher success rate was observed in the axillary group (97.7% vs 54.5%; P <.001), as well as a lower rate of venous access site change (2.3% vs 40.9%; P <.001) and shorter time to obtain venous access (5 vs 15 minutes; P <.001) and procedural time (40 vs 51 minutes; P = .010), with no difference in complication rate (2.3% vs 11.4%; P =.20). In multivariate analysis, US-Ax (P <.001), single-chamber device (P = .015), and body mass index (P = .015) were independent predictors of overall success. This is the first randomized trial comparing self-learned US-Ax to CV in cardiac lead implantation. Our results indicate that the axillary approach was superior in terms of success rate, time to obtain venous access and procedural time, with similar complication rate.
Sections du résumé
BACKGROUND
Axillary vein puncture guided by ultrasound (US-Ax) has emerged as a valid alternative access route to pacemaker and defibrillator lead insertion.
OBJECTIVE
The purpose of this study was to evaluate whether US-Ax compared to cephalic vein dissection (CV) improves success and early complications in pacemaker or defibrillator implant.
METHODS
This prospective, multicenter clinical trial included 88 adult patients randomized 1:1 to US-Ax (n = 44) or CV (n = 44). All procedures were performed by operators with no previous experience in axillary approach. Primary endpoint was defined as success rate. Secondary endpoints were venous access site change, time to obtain venous access, total procedural time, and early complication rate. Analyses were performed using the intention-to-treat principle.
RESULTS
Median age was 70.5 years (58.2-79.7), and 60.2% were male. For the primary outcome, a higher success rate was observed in the axillary group (97.7% vs 54.5%; P <.001), as well as a lower rate of venous access site change (2.3% vs 40.9%; P <.001) and shorter time to obtain venous access (5 vs 15 minutes; P <.001) and procedural time (40 vs 51 minutes; P = .010), with no difference in complication rate (2.3% vs 11.4%; P =.20). In multivariate analysis, US-Ax (P <.001), single-chamber device (P = .015), and body mass index (P = .015) were independent predictors of overall success.
CONCLUSION
This is the first randomized trial comparing self-learned US-Ax to CV in cardiac lead implantation. Our results indicate that the axillary approach was superior in terms of success rate, time to obtain venous access and procedural time, with similar complication rate.
Identifiants
pubmed: 32360827
pii: S1547-5271(20)30361-1
doi: 10.1016/j.hrthm.2020.04.030
pii:
doi:
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1554-1560Informations de copyright
Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.