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Transcatheter vs surgical aortic-valve replacement in low- to intermediate-surgical-risk candidates: A meta-analysis and systematic review.

ABSTRACT: The American and European expert documents recommend transcatheter aortic valve replacement (TAVR) for inoperable or high-surgical-risk patients with severe aortic stenosis. In comparison, efficacy of TAVR is relatively less studied in low- to intermediate-surgical-risk patients. We sought to discover whether TAVR can be as effective as surgical aortic valve replacement (SAVR) in low- to intermediate-surgical-risk candidates. Four randomized clinical trials (RCTs) and 8 prospective matched studies were selected using PubMed/MEDLINE, Embase, and Cochrane Library (inception: March 2017). Results were reported as random-effects odds ratio (OR) with 95% confidence interval (CI). Among 9851 patients, analyses of RCTs showed that all-cause mortality was comparable between TAVR and SAVR (short term, OR: 1.19, 95% CI: 0.86-1.64, P?=?0.30; mid-term, OR: 0.97, 95% CI: 0.75-1.26, P?=?0.84; and long term, OR: 0.97, 95% CI: 0.81-1.16, P?=?0.76). The analysis restricted to matched studies showed similar outcomes. In the analysis stratified by study design, no significant differences were noted in the RCTs for stroke, whereas TAVR was better than SAVR in matched studies at short term only (OR: 0.46, 95% CI: 0.33-0.65, P?

SUBMITTER: Khan SU

PROVIDER: S-EPMC6490337 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Transcatheter vs surgical aortic-valve replacement in low- to intermediate-surgical-risk candidates: A meta-analysis and systematic review.

Khan Safi U SU Lone Ahmad N AN Saleem Muhammad A MA Kaluski Edo E

Clinical cardiology 20171123 11

The American and European expert documents recommend transcatheter aortic valve replacement (TAVR) for inoperable or high-surgical-risk patients with severe aortic stenosis. In comparison, efficacy of TAVR is relatively less studied in low- to intermediate-surgical-risk patients. We sought to discover whether TAVR can be as effective as surgical aortic valve replacement (SAVR) in low- to intermediate-surgical-risk candidates. Four randomized clinical trials (RCTs) and 8 prospective matched studi ...[more]

PMID: 29168984

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Project description:ImportanceTranscatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce.ObjectiveTo compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS.Design, setting, and participantsThis retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts.ExposuresPrimary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization.Main outcomes and measuresThe primary outcomes were 30-day and 3-year survival.ResultsOverall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P = .12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P = .45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who received recent aortic valve prostheses vs those who did not.Conclusions and relevanceTranscatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients.

Project description:Objective To examine the effect of transcatheter aortic valve implantation (TAVI) versus surgical replacement of an aortic valve (SAVR) in patients with severe aortic stenosis at low and intermediate risk of perioperative death.Design Systematic review and meta-analysis DATA SOURCES: Medline, Embase, and Cochrane CENTRAL.Study selection Randomized trials of TAVI compared with SAVR in patients with a mean perioperative risk of death <8%.Review methods Two reviewers independently extracted data and assessed risk of bias for outcomes important to patients that were selected a priori by a parallel guideline committee, including patient advisors. We used the GRADE system was used to quantify absolute effects and quality of evidence.Results 4 trials with 3179 patients and a median follow-up of two years were included. Compared with SAVR, transfemoral TAVI was associated with reduced mortality (risk difference per 1000 patients: -30, 95% confidence interval -49 to -8, moderate certainty), stroke (-20, -37 to 1, moderate certainty), life threatening bleeding (-252, -293 to -190, high certainty), atrial fibrillation (-178, -150 to -203, moderate certainty), and acute kidney injury (-53, -39 to -62, high certainty) but increased short term aortic valve reintervention (7, 1 to 21, moderate certainty), permanent pacemaker insertion (134, 16 to 382, moderate certainty), and moderate or severe symptoms of heart failure (18, 5 to 34, moderate certainty). Compared with SAVR, transapical TAVI was associated higher mortality (57, -16 to 153, moderate certainty, P=0.015 for interaction between transfemoral versus transapical TAVI) and stroke (45, -2 to 125, moderate certainty, interaction P=0.012). No study reported long term follow-up, which is particularly important for structural valve deterioration.Conclusions Many patients, particularly those who have a shorter life expectancy or place a lower value on the risk of long term valve degeneration, are likely to perceive net benefit with transfemoral TAVI versus SAVR. SAVR, however, performs better than transapical TAVI, which is of interest to patients who are not candidates for transfemoral TAVI.Systematic review registration PROSPERO CRD42016042879.

Dataset Information

Transcatheter vs surgical aortic-valve replacement in low- to intermediate-surgical-risk candidates: A meta-analysis and systematic review.

Publications

Transcatheter vs surgical aortic-valve replacement in low- to intermediate-surgical-risk candidates: A meta-analysis and systematic review.

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