Key result
Second-generation TAVR valves demonstrate ~6% 30-day mortality with low short-term complication risks.
Why the study?
What is the safety profile and short-term complication rate of second-generation transcatheter aortic valves in patients undergoing TAVI?
Systematic Review (n=1,708)
What is the safety profile and short-term complication rate of second-generation transcatheter aortic valves in patients undergoing TAVI?
Second-generation transcatheter aortic valves demonstrate a low risk of short-term TAVI-related complications, comparing favorably to historical events reported for first-generation devices.
Answers are grounded in this paper and cite their sources.
Supports second-generation valve use in TAVI given low short-term risks; confirms improvement versus historical first-generation data.
AIMS: To review the outcomes of studies and the safety of newer transcatheter aortic valves (THV). METHODS AND RESULTS: All studies reporting on second-generation THV were identified and pooled using the systematic review guidelines. Twenty-four reports on 1,708 patients and eight THV were included in the analysis. The pooled 30-day event rate for mortality after transcatheter aortic valve implantation (TAVI) was 5.7% (95% CI: 4.0-7.8), myocardial infarction (MI) was 1.7% (95% CI: 1.1-2.6), stage 3 acute kidney injury (AKI) was 3.4% (95% CI: 2.0-5.6), life-threatening bleeding was 5.1% (95% CI: 3.3-7.8), major vascular complications was 4.9% (95% CI: 3.5-6.6%), major bleeding was 10.5% (95% CI: 5.1-20.4), major stroke was 2.4% (95% CI: 1.7-3.4), permanent pacemaker utilisation was 13.5% (95% CI: 10.8-16.9), and coronary obstruction was 1.2% (95% CI: 0.6%-2.4%). Moderate or severe aortic insufficiency (AI) after TAVI was 4.2% (95% CI: 2.0-8.5). The pooled 30-day mean gradient and effective orifice area (EOA) were 11.63 mmHg (95% CI: 10.19-13.07) and 1.60 cm2 (95% CI: 1.5-1.7), respectively. All estimates compare favourably to events reported for first-generation valves. CONCLUSIONS: Our findings suggest that the new THV have a low risk of TAVI-related short-term complications.
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Athappan et al. (2016) conducted a systematic review in Aortic valve disease requiring TAVI (n=1,708). Second-generation transcatheter aortic valves (THV) vs. First-generation valves was evaluated on 30-day mortality (95% CI 4.0-7.8). Second-generation transcatheter aortic valves demonstrated a pooled 30-day mortality rate of 5.7% (95% CI 4.0-7.8) and low risks of short-term complications.
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