Clinical
Transcatheter versus surgical aortic valve replacement in low-risk surgical patients: A meta-analysis of randomized clinical trials

https://doi.org/10.1016/j.carrev.2018.12.023Get rights and content

Highlights

  • Among low-risk patients, TAVR offered comparable efficacy outcomes and fewer bleeding events compared with SAVR.

  • There were increased risks of pacemaker implantation and PVL associated with TAVR.

  • The risk of atrial fibrillation is increased with SAVR.

Abstract

Background

Transcatheter aortic valve replacement (TAVR) is a valid option for patients with high or intermediate surgical risk. However, clinical outcomes of TAVR in low-risk patients are lacking. Our aim was to evaluate the efficacy and safety of TAVR versus surgical aortic valve replacement (SAVR) in low-surgical-risk patients.

Methods

Electronic database review was conducted for all randomized clinical trials (RCTs) that compared TAVR versus SAVR in low-risk patients. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) using a random-effects model.

Results

We included 3 RCTs totaling 604 patients (310 TAVR and 294 SAVR). Our results showed no significant difference in mortality between TAVR compared with SAVR (RR = 0.71; 95% CI = 0.22–2.30; P = 0.56), however, there was a significantly increased risk of pacemaker implantation (RR = 7.28; 95% CI = 3.94–13.42; P < 0.01) and moderate/severe paravalvular leakage (PVL) (RR = 6.74; 95% CI = 1.31–34.65; P = 0.02) with TAVR. Nevertheless, TAVR demonstrated a significantly reduced risk of post-procedural bleeding (RR = 0.40; 95% CI = 0.30–0.54; P < 0.01) and new-onset atrial fibrillation (RR = 0.36; 95% CI = 0.27–0.47; P < 0.01). Other clinical outcomes were not significantly different between the groups and included cardiovascular mortality, stroke, transient ischemic attack, and myocardial infarction.

Conclusions

Among low-risk patients, TAVR offered comparable efficacy outcomes and fewer bleeding events compared with SAVR. There were increased risks of pacemaker implantation and PVL associated with TAVR, though lower atrial fibrillation risks.

Introduction

When approaching patients with symptomatic severe aortic stenosis, transcatheter aortic valve replacement (TAVR) is typically preferable over surgical aortic valve replacement (SAVR) in inoperable and high-risk-surgical patients who often have multiple risk factors such as frailty [1,2]. Regarding intermediate-surgical-risk patients, TAVR is considered a valid option as well [3]. However, in low-risk patients, SAVR continues to be the standard of care (Ib recommendation) [4]. Nevertheless, the desire for expansion of TAVR for low-surgical risk patients has grown largely due to a combination of successful results in intermediate- and high-surgical risk patients, technical advancements, TAVR device improvements, and increased operator experience [5]. Registry data show mixed results with regard to low-risk patients undergoing TAVR [[5], [6], [7], [8]], thus, we conducted our study to evaluate the efficacy and safety of TAVR in low-surgical-risk patients when compared with SAVR.

Section snippets

Materials and methods

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) Statement 2015 was followed [9]. HA and AS independently performed a comprehensive search of electronic databases from establishment to July 2018 using the following terms: “transcatheter aortic valve replacement”, “TAVR”, “surgical aortic valve replacement”, “SAVR”, “TAVI”, “SAVI”, AND “low risk.” Our inclusion criteria were: (1) the study must be a RCT, (2) patients have low surgical risk (defined as a

Results

Among 142 studies, we included 3 RCTs totaling 604 patients (310 TAVR and 294 SAVR) [6,10,11]. The median follow-up period was 12 months. The mean age was 79.5 ± 4.7 with an average aortic valve area of 0.7 cm2 and a gradient of 59 mmHg. The average STS and EuroScore were 2.8% and 8.8%, respectively. Two trials used a self-expandable bioprosthesis (SURTAVI and NOTION), and one trial utilized a balloon-expandable one (STACCATO). The majority of TAVR procedures were performed via transfemoral

Discussion

Our meta-analysis revealed that TAVR was associated with similar efficacy, lower bleeding, and higher risks of pacemaker implantation and PVL compared with SAVR, however, the risk of AF was increased with SAVR.

In addition to surgical risk assessment, the mode of intervention should be carefully determined based on the patients' individual risk factors, characteristics, anatomical aspects, and operator experience in a heart team [10,12]. Current guidelines recommend surgical intervention for

Conclusions

In low-risk-surgical patients undergoing aortic valve replacement, TAVR is associated with comparable efficacy compared with SAVR. TAVR does, however, have an increased risk of pacemaker implantation and PVL. In contrast, SAVR is associated with a higher risk of AF and post-procedural bleeding.

Acknowledgments

None.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Conflict of interest

Dr. Deepak L. Bhatt discloses the following relationships - Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now

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    Current guidelines recommend surgical interventions for those at low surgical risk (Ib recommendation).5 However, technical advancement and increased operator experience have led to the expansion of the TAVR procedure to include low-risk patients.6 Therefore, we conducted a meta-analysis of the related randomized controlled trials to evaluate the efficacy and safety of TAVR in low-risk patients compared with SAVR.

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    Furthermore, a sub-analysis of this randomized study explored the outcomes of TAVR vs. SAVR in patients with a STS-PROM score below 3% demonstrating a significantly lower rate of all-cause mortality or disabling stroke in TAVR vs. SAVR at 1-year follow-up (1.5% vs. 6.5% p = 0.04) [14]. These results are confirmed by different meta-analysis of RCTs comparing TAVR vs. SAVR in low to intermediate risk patients that consistently report no significant difference in mortality between the groups, increased risks of pPM implantation, major vascular complications and moderate-to-severe PVL associated with TAVR, though lower incidence of atrial fibrillation, severe bleeding, AKI and early stroke [15–19]. Although the data coming from PARTNER 2A, SURTAVI and meta-analysis of RCTs are consistent, longer-term follow-up (>2 years) are needed to better understand the performance of a THV vs. a surgical prosthesis over a long time period in lower risk patients.

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