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EuroIntervention. 2016 Jan 22;11(9):1034-43. doi: 10.4244/EIJV11I9A211.

A systematic review on the safety of second-generation transcatheter aortic valves.

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1
Department of Cardiovascular Medicine, Mount Sinai Hospital, New York, NY, USA.

Abstract

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.

PMID:
26788706
DOI:
10.4244/EIJV11I9A211
[Indexed for MEDLINE]
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