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Assessing the safety and efficacy of TAVR compared to SAVR in low-to-intermediate surgical risk patients with aortic valve stenosis: An overview of reviews.

ABSTRACT: BACKGROUND:Transcatheter aortic valve replacement (TAVR) was initially introduced to treat patients with aortic valve stenosis (AS) at high-risk for surgical aortic valve replacement (SAVR). Today, there is ample evidence supporting TAVR in high-risk groups. However, in recent years TAVR has been extended to low-to intermediate risk groups and relevant clinical evidence is still emerging, leaving some uncertainties. METHODS:To obtain information on TAVR versus SAVR in low-to intermediate risk groups, we conducted an overview of systematic reviews following PRISMA guidelines and based on a systematic search of EMBASE, MEDLINE, Cochrane and CRD databases. We focused on systematic reviews assessing mortality and VARC 2 as clinical outcomes. RESULTS:The majority of the 11 systematic reviews included in our study reported no differences in mortality between TAVR and SAVR at short and long-term follow-up times. Two reviews that included the most recent RCTs on low-risk patients reported a decreased mortality risk with TAVR at one-year follow-up. Regarding the secondary endpoints of stroke and MI, the majority of studies presented similar results for TAVR and SAVR. Acute Kidney Injury, Bleeding Complications, Atrial Fibrillation were less frequent with TAVR, with lower risk of Permanent Pacemaker Implantation and Aortic Regurgitation with SAVR. CONCLUSIONS:Our overview indicated that TAVR is a promising intervention for low-to-intermediate surgical risk patients; however additional evidence from longer term follow-up is needed to confirm these findings. This overview highlights inconsistencies about reporting and presentation of data, most notably limited clarity on effects of risk of bias on trial results.

SUBMITTER: Mc Morrow R

PROVIDER: S-EPMC7322533 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Assessing the safety and efficacy of TAVR compared to SAVR in low-to-intermediate surgical risk patients with aortic valve stenosis: An overview of reviews.

Mc Morrow Roisin R Kriza Christine C Urbán Patricia P Amenta Valeria V Amaro Juan Antonio Blasco JAB Panidis Dimitris D Chassaigne Hubert H Griesinger Claudius Benedict CB

International journal of cardiology 20200411

<h4>Background</h4>Transcatheter aortic valve replacement (TAVR) was initially introduced to treat patients with aortic valve stenosis (AS) at high-risk for surgical aortic valve replacement (SAVR). Today, there is ample evidence supporting TAVR in high-risk groups. However, in recent years TAVR has been extended to low-to intermediate risk groups and relevant clinical evidence is still emerging, leaving some uncertainties.<h4>Methods</h4>To obtain information on TAVR versus SAVR in low-to inter ...[more]

PMID: 32434749

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Project description:ObjectiveThe objective was to assess the cost-effectiveness of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis with intermediate surgical risk in Singapore.MethodsA de novo Markov model with three health states - stroke with long-term sequelae, no stroke, and death - was developed and simulated using Monte Carlo simulations with 10,000 iterations over a five-year time horizon from the Singapore healthcare system perspective. A 3% annual discount rate for costs and outcomes and monthly cycle lengths were used. By applying the longest available published clinical evidence, simulated patients received either TAVI or surgical aortic valve replacement (SAVR) and were at risk of adverse events (AEs) such as moderate-to-severe paravalvular aortic regurgitation (PAR).ResultsWhen five-year PARTNER 2A data was applied, base-case analyses showed that the incremental cost-effectiveness ratio (ICER) for TAVI compared to SAVR was US$315,760 per quality-adjusted life year (QALY) gained. The high ICER was due to high incremental implantation and procedure costs of TAVI compared to SAVR, and marginal improvement of 0.10 QALYs as simulated mortality of TAVI exceeded SAVR at 3.75 years post-implantation. One-way sensitivity analysis showed that the ICERs were most sensitive to cost of PAR, utility values of SAVR patients, and cost of TAVI and SAVR implants and procedures. When disutilities for AEs were additionally applied, the ICER decreased to US$300,070 per QALY gained. TAVI was dominated by SAVR when the time horizon increased to 20 years. Clinical outcomes projected from one-year PARTNER S3i data further reduced the ICER to US$86,337 per QALY gained for TAVI, assuming early all-cause mortality benefits from TAVI continued to persist. This assumption was undermined when longer term data showed that TAVI's early mortality benefits diminished at five years.Limitations and conclusionTAVI is unlikely to be cost-effective in intermediate surgical-risk patients compared to SAVR in Singapore.

Dataset Information

Assessing the safety and efficacy of TAVR compared to SAVR in low-to-intermediate surgical risk patients with aortic valve stenosis: An overview of reviews.

Publications

Assessing the safety and efficacy of TAVR compared to SAVR in low-to-intermediate surgical risk patients with aortic valve stenosis: An overview of reviews.

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