Background Transcatheter aortic valve implantation (TAVI), widely used to treat high-risk patients with severe symptomatic aortic stenosis, has recently been extended to younger patients at lower operative risk in whom long-term durability of TAVI devices is an important concern. Therefore, we conducted a systematic review and meta-analysis of observational studies addressing the frequency of structural valve deterioration (SVD) after TAVI.
Methods We searched Medline, Embase, Cochrane Database of Systematic Reviews, and Cochrane CENTRAL from 2002 to September 2016. We included observational studies following patients with TAVI for at least 2 years. Independently and in duplicate, we evaluated study eligibility, extracted data, and assessed risk of bias for SVD post-TAVI. Our review used the GRADE system to assess quality of evidence. We pooled incidence rates using a random effects model.
Results Thirteen studies including 8914 patients, with a median follow-up between 1.6 and 5 years, reported an incidence of SVD post-TAVI between 0 to 1.34 per 100 patient years. The pooled incidence of SVD was 28.08 per 10 000 patients/year (95% CI 2.46 to 73.44 per 100 patient years). Of those who developed SVD, 12% underwent valve re-intervention. Confidence in the evidence was moderate due to inconsistency among studies.
Conclusion Structural valve deterioration is probably an infrequent event within the first 5 years after TAVI. Ascertaining the impact of SVD and the need for valve-related re-interventions to inform recommendations for patients with a longer life-expectancy will require studies including a large number of patients with longer follow-up (>10 years).
- aortic stenosis
- systematic review
- transcatheter valve interventions
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Contributors FF, GG, POV conceived the study idea. FF, GG coordinated the systematic review. FF wrote the first draft of the manuscript. FF, RAS designed the search strategy. FF, SB screened abstracts and full texts. FF, SB, RB acquired the data and judged risk of bias in the studies. FF, SS performed the data analysis. All authors interpreted the data analysis and critically revised the manuscript. FF had full access to all of the data in the study, and takes responsibility for the integrity of the data and the accuracy of the data analysis. FF is the guarantor.
Competing interests None declared.
Patient consent No patients were involved in production of this manuscript.
Provenance and peer review Not commissioned; externally peer reviewed.