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September 28, 2016BMJOpen Access

Transfemoral TAVI is linked to ~3% lower mortality versus SAVR, while transapical TAVI carries higher risk.

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Why the study?

Does transcatheter aortic valve implantation improve mortality and other patient-important outcomes compared to surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk?

Population

3,179 patients across 4 randomized trials with severe aortic stenosis at low and intermediate risk of…

Comparison

Transcatheter aortic valve implantation… vs Surgical replacement of an aortic valve (SAVR)

Design

Meta-analysis, Randomized trials included

Follow-up

median two years

Key result

Transfemoral TAVI was associated with reduced mortality compared with SAVR (risk difference -30 per 1000 patients; 95% CI -49 to -8), whereas transapical TAVI was associated with higher mortality.

Authors

RSReed SiemieniukTAThomas AgoritsasVMVeena Manja

Discussion

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Overview

Favors transfemoral TAVI over SAVR in low- to intermediate-risk severe AS; confirms mortality benefit while highlighting access-route differences.

Key Points

  • To compare the effectiveness of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis at low and intermediate risk.
  • Conducted systematic review and meta-analysis of randomized trials comparing TAVI and SAVR.
  • Included 4 trials with a total of 3179 patients and a median follow-up of two years.
  • Data were extracted and assessed for risk of bias using the GRADE system to evaluate the quality of evidence.
  • Transfemoral TAVI showed reduced mortality (risk difference -30 per 1000 patients, 95% CI -49 to -8, moderate certainty).
  • Stroke rates were lower with transfemoral TAVI (-20 per 1000 patients, 95% CI -37 to 1, moderate certainty).
  • Transapical TAVI was associated with higher mortality (57 per 1000 patients, 95% CI -16 to 153, P=0.015 for interaction) compared to SAVR.

Study Design

Type

Meta-Analysis (n=3,179)

Structured PICO

Does transcatheter aortic valve implantation improve mortality and other patient-important outcomes compared to surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk?

P
Population
3,179 patients across 4 randomized trials with severe aortic stenosis at low and intermediate risk of perioperative death (mean perioperative risk of death <8%).
I
Intervention
Transcatheter aortic valve implantation (TAVI), including transfemoral and transapical approaches
C
Comparator
Surgical replacement of an aortic valve (SAVR)
O
Outcome
Patient-important outcomes selected a priori, including mortality, stroke, life-threatening bleeding, atrial fibrillation, and acute kidney injury at median 2 years follow-uphard clinical

Main Result

Effect estimate: Risk difference -30 per 1000 patients (95% CI -49 to -8)

In patients with severe aortic stenosis at low to intermediate surgical risk, transfemoral TAVI reduces mortality and stroke compared to SAVR, though it increases the risk of pacemaker insertion and short-term reintervention.

Limitations

  • No study reported long term follow-up, which is particularly important for structural valve deterioration.
  • No study reported long term follow-up, which is particularly important for structural valve deterioration

Cite This Study

Siemieniuk et al. (2016) conducted a meta-analysis in Severe aortic stenosis at low and intermediate risk of perioperative death (n=3,179). Transcatheter aortic valve implantation (TAVI) vs. Surgical replacement of an aortic valve (SAVR) was evaluated on Mortality (Risk difference -30 per 1000 patients, 95% CI -49 to -8). Transfemoral TAVI was associated with reduced mortality compared with SAVR (risk difference -30 per 1000 patients; 95% CI -49 to -8), whereas transapical TAVI was associated with higher mortality.

synapsesocial.com/papers/6a0e302caf86e8b097c83909https://doi.org/10.1136/bmj.i5130
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