Dataset Information

Transcatheter versus surgical aortic valve replacement: a systematic review and meta-analysis of randomised and non-randomised trials.

ABSTRACT:

Introduction

Many patients deemed inoperable for surgical aortic valve replacement (SAVR) have been treated successfully by transcatheter aortic-valve replacement (TAVR). This meta-analysis is designed to evaluate the performance of TAVR in comparison with SAVR.

Methods

A systematic search was conducted using MEDLINE, PubMed, EMBASE, Current Contents Connect, the Cochrane library, Google Scholar, Science Direct and Web of Science. Original data were abstracted from each study and used to calculate a pooled OR and 95% CI.

Results

Among three randomised controlled trials (RCTs), differences between the two cohorts were not statistically significant for the frequency of stroke (OR=1.94, 95% CI=0.813 to 4.633), incidence of myocardial infarction (MI), (OR=0.765, 95% CI=0.05 to 11.76) 30-day mortality rate, 1-year mortality rate (0.82, 95% CI=0.62 to 1.09) and acute kidney injury incidence rate. The non-RCTs demonstrated that the TAVR group had an amplified frequency aortic regurgitation at discharge (OR=5.465, 95% CI=3.441 to 8.680). While differences between the two cohorts were not statistically significant for the incidence of MI (OR=0.697, 95% CI=0.22 to 2.21), stroke (OR=0.575, 95% CI=0.263 to 1.259), acute renal failure requiring haemodialysis (OR=0.943, 95% CI=0.276 to 3.222), 30-day mortality (OR=0.869, 95% CI=0.621 to 1.216) and the need for a pacemaker (OR=1.832, 95% CI=0.869 to 3.862), a lower incidence of patients needing transfusion (OR=0.349, 95% CI=0.121 to 1.005) and new-onset atrial fibrillation (OR=0.296, 95% CI=0.124 to 0.706) was seen in the TAVR group.

Conclusions

Randomised and observational evidence adjusted on the baseline patient's characteristics finds a similar risk for 30?days mortality, 1-year mortality, stroke, MI and acute kidney injury in TAVR and SAVR.

SUBMITTER: Nagaraja V

PROVIDER: S-EPMC4189306 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

Transcatheter versus surgical aortic valve replacement: a systematic review and meta-analysis of randomised and non-randomised trials.

Nagaraja Vinayak V Raval Jwalant J Eslick Guy D GD Ong Andrew T L AT

Open heart 20140812 1

<h4>Introduction</h4>Many patients deemed inoperable for surgical aortic valve replacement (SAVR) have been treated successfully by transcatheter aortic-valve replacement (TAVR). This meta-analysis is designed to evaluate the performance of TAVR in comparison with SAVR.<h4>Methods</h4>A systematic search was conducted using MEDLINE, PubMed, EMBASE, Current Contents Connect, the Cochrane library, Google Scholar, Science Direct and Web of Science. Original data were abstracted from each study and ...[more]

PMID: 25332780

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Project description:BackgroundRandomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged.ObjectivesThe aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort.MethodsUsing data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ≥3%) U.S. patients who underwent commercial TAVR or SAVR were examined. Death, stroke, and days alive and out of the hospital to 1 year were compared, as well as discharge home, with subgroup analyses by surgical risk, demographics, and comorbidities.ResultsIn a propensity-matched cohort (median age 82 years, 48% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score 5.6%), TAVR and SAVR patients experienced no difference in 1-year rates of death (17.3% vs. 17.9%; hazard ratio: 0.93; 95% confidence interval [CI]: 0.83 to 1.04) and stroke (4.2% vs. 3.3%; hazard ratio: 1.18; 95% CI: 0.95 to 1.47), and no difference was observed in the proportion of days alive and out of the hospital to 1 year (rate ratio: 1.00; 95% CI: 0.98 to 1.02). However, TAVR patients were more likely to be discharged home after treatment (69.9% vs. 41.2%; odds ratio: 3.19; 95% CI: 2.84 to 3.58). Results were consistent across most subgroups, including among intermediate- and high-risk patients.ConclusionsAmong unselected intermediate- and high-risk patients, TAVR and SAVR resulted in similar rates of death, stroke, and DAOH to 1 year, but TAVR patients were more likely to be discharged home.

Project description:BackgroundPrevious studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system.ObjectivesThe goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk.MethodsWe performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S.ResultsRelative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ∼$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained.ConclusionsIn a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S.StandardsWith expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902).

Dataset Information

Transcatheter versus surgical aortic valve replacement: a systematic review and meta-analysis of randomised and non-randomised trials.

Introduction

Methods

Results

Conclusions

Publications

Transcatheter versus surgical aortic valve replacement: a systematic review and meta-analysis of randomised and non-randomised trials.

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