Surgical vs transfemoral aortic valve replacement in low-risk patients: An updated meta-analysis of trial and registry data.
SAVR
TAVR
aorta and great vessels
aortic stenosis
cardiovascular pathology
valve repair/replacement
Journal
Journal of cardiac surgery
ISSN: 1540-8191
Titre abrégé: J Card Surg
Pays: United States
ID NLM: 8908809
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
26
05
2020
revised:
13
06
2020
accepted:
15
06
2020
pubmed:
12
7
2020
medline:
15
5
2021
entrez:
12
7
2020
Statut:
ppublish
Résumé
Transfemoral aortic valve replacement (TAVR) has been studied extensively in patients with improving safety and efficacy in high to intermediate-risk patients with aortic stenosis. TAVR has been now approved for patients with low surgical risk. The purpose of this study is to integrate the evidence from randomized controlled trials (RCT) and large registry data comparing TAVR to surgical aortic valve repair (SAVR). Seven studies (three RCTs, one post hoc study of a RCT, and three registries) were included. Incidence rate ratios (IRR) of outcomes of interest (overall mortality, 30-day mortality, cardiovascular death, stroke, pacemaker implantation [PPMI], myocardial infarction, moderate-severe paravalvular leak [PVL], and re-intervention) were compared using a random-effects model. The pooled analysis included 24 819 patients (TAVR, 8227 and SAVR, 16 592). 2,952 (11.9%) patients were from RCTs and 21 867 (88.1%) were registry patients. Thirty-day mortality was lower in TAVR (logIRR, -0.43; 95% CI. -0.61 to -0.25; P < .001), whereas the rate of moderate-severe PVL (logIRR, 1.44; 95% CI, 0.58-2.3; P < .001) and PPMI (logIRR, 1.13; 95% CI, 1.02-1.24; P < .001) were higher. There were no significant differences in the rates of overall mortality, reintervention, cardiovascular death, myocardial infarction, or stroke between SAVR and TAVR. Early mortality is higher in SAVR while rates of PVL and PPMI are substantially higher in TAVR. There is no significant advantage with TAVR for overall survival, cardiovascular death, stroke, MI, and re-intervention rates.
Sections du résumé
BACKGROUND
BACKGROUND
Transfemoral aortic valve replacement (TAVR) has been studied extensively in patients with improving safety and efficacy in high to intermediate-risk patients with aortic stenosis. TAVR has been now approved for patients with low surgical risk.
OBJECTIVE
OBJECTIVE
The purpose of this study is to integrate the evidence from randomized controlled trials (RCT) and large registry data comparing TAVR to surgical aortic valve repair (SAVR).
METHODS
METHODS
Seven studies (three RCTs, one post hoc study of a RCT, and three registries) were included. Incidence rate ratios (IRR) of outcomes of interest (overall mortality, 30-day mortality, cardiovascular death, stroke, pacemaker implantation [PPMI], myocardial infarction, moderate-severe paravalvular leak [PVL], and re-intervention) were compared using a random-effects model.
RESULTS
RESULTS
The pooled analysis included 24 819 patients (TAVR, 8227 and SAVR, 16 592). 2,952 (11.9%) patients were from RCTs and 21 867 (88.1%) were registry patients. Thirty-day mortality was lower in TAVR (logIRR, -0.43; 95% CI. -0.61 to -0.25; P < .001), whereas the rate of moderate-severe PVL (logIRR, 1.44; 95% CI, 0.58-2.3; P < .001) and PPMI (logIRR, 1.13; 95% CI, 1.02-1.24; P < .001) were higher. There were no significant differences in the rates of overall mortality, reintervention, cardiovascular death, myocardial infarction, or stroke between SAVR and TAVR.
CONCLUSIONS
CONCLUSIONS
Early mortality is higher in SAVR while rates of PVL and PPMI are substantially higher in TAVR. There is no significant advantage with TAVR for overall survival, cardiovascular death, stroke, MI, and re-intervention rates.
Types de publication
Journal Article
Meta-Analysis
Langues
eng
Sous-ensembles de citation
IM
Pagination
2264-2274Informations de copyright
© 2020 Wiley Periodicals LLC.
Références
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