November 16, 2020Frontiers in Cardiovascular MedicineOpen Access

Efficacy and Safety of Transcatheter vs. Surgical Aortic Valve Replacement in Low-to-Intermediate-Risk Patients: A Meta-Analysis

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Why the study?

The study aimed to investigate the efficacy and safety of TAVR versus SAVR in patients at low to intermediate surgical risk.

Does transcatheter aortic-valve replacement (TAVR) reduce all-cause mortality compared to surgical aortic valve replacement (SAVR) in patients with low-to-intermediate surgical risk?

Structured PICO

Does transcatheter aortic-valve replacement (TAVR) reduce all-cause mortality compared to surgical aortic valve replacement (SAVR) in patients with low-to-intermediate surgical risk?

Population

12,467 patients with severe aortic stenosis at low-to-intermediate surgical risk (low risk defined as mean STS score <4% and/or logistic EuroSCORE <10%; intermediate risk defined as mean STS score 4-8% and/or logistic EuroSCORE 10-20%), pooled from 8 RCTs and 13 propensity score matched observational studies.

Intervention

Transcatheter aortic-valve replacement (TAVR) as a class

Comparator

Surgical aortic valve replacement (SAVR)

Outcome

All-cause mortality assessed at 30 days, 1 year, and 2 years after aortic valve replacementhard clinical

TAVR is a safe and effective alternative to SAVR in low-to-intermediate surgical risk patients, offering similar 2-year mortality with a different complication profile (less bleeding, AF, and AKI, but more PPI and paravalvular leak).

Limitations

Inclusion of both RCTs and observational studies
Study-level rather than patient-level data analysis
Small sample sizes (<100) in some included studies
Potential underestimation of real effect due to use of mean STS scores
Missing echocardiographic baseline characteristics in some studies
Lack of long-term follow-up data beyond 2 years for most studies

Implication

Supports TAVR as alternative to SAVR in low-intermediate risk patients; confirms mortality equivalence up to 2 years.

Abstract

Purpose: We aimed to investigate the efficacy and safety of transcatheter aortic-valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) for low- intermediate surgical risk patients. Methods: PubMed, Cochrane Library, and Embase databases were searched to identify potential references. Only randomized controlled trials (RCTs) or observational studies using propensity score matching were eligible for screening. The primary endpoint was all-cause death. The secondary outcomes were bleeding, stroke, myocardial infarction (MI) and other complications of aortic-valve replacement. In addition, we performed subgroup analysis based on surgical risk and study type. Results: Eight RCTs and 13 observational studies covering 12467 patients were included in the current meta-analysis. For patients with low-surgical risk, compared with SAVR, TAVR was found to be associated with a lower mortality at a follow-up period of 1-year (odds ratio, OR: 0.66, 95%CI: [0.46, 0.96], P=0.03). This benefit disappeared when the follow-up was extended to 2-year (OR: 0.89, 95% CI: [0.61, 1.30], P=0.56). For patients with intermediate-surgical risk, TAVR showed to have similar mortality with SAVR regardless of follow-up period (30-day, 1-year or 2-year). TAVR could reduce the incidence of bleeding, AF, AKI. For complications, such as MI and stroke, TAVR exhibited to have similar safety with SAVR. However, TAVR was found to be associated with a higher incidence of reintervention, major vascular complication, paravalvular leak, and PPI. Conclusion: For patients with low to intermediate surgical risk of AVR, TAVR have at least equal clinical effect as SAVR at 2 years after procedure.