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Transcatheter vs. surgical aortic valve replacement and medical treatment

Systematic review and meta-analysis of randomized and non-randomized trials

Transkatheter- vs. operative Aortenklappenimplantation und medikamentöse Therapie

Systematische Übersicht und Metaanalyse randomisierter und nichtrandomisierter Studien

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Abstract

Background

Transcatheter aortic valve replacement (TAVR) has emerged as the procedure of choice for patients with severe aortic stenosis (AS) and high perioperative risk. We performed a meta-analysis to compare the mortality related to TAVR with medical therapy (MT) and surgical aortic valve replacement (SAVR).

Methods

A systematic literature search was conducted by two independent investigators from the database inception to 30 December 2014. Relative risk (RR) and odds ratio (OR) were calculated and graphically displayed in forest plots. We used I 2 for heterogeneity (meta-regression) and Egger’s regression test of asymmetry (funnel plots).

Results

We included 24 studies (n = 19 observational studies; n = 5 randomized controlled trials), with a total of 7356 patients in this meta-analysis. Mean age had a substantial negative impact on the long-term survival of AS patients (OR = 1.544; 95% CI: 1.25–1.90). Compared with MT, TAVR showed a statistically significant benefit for all-cause mortality at 12 months (OR = 0.68; 95% CI: 0.49–0.95). Both TAVR and SAVR were associated with better outcomes compared with MT. TAVR showed lower all-cause mortality over SAVR at 12 months (OR = 0.81; 95% CI: 0.68–0.97). The comparison between SAVR and TAVR at 2 years revealed no significant difference (OR = 1.09; 95% CI: 1.01–1.17).

Conclusion

In AS, both TAVR and SAVR provide a superior prognosis to MT and, therefore, MT is not the preferred treatment option for AS. Furthermore, our data show that TAVR is associated with lower mortality at 12 months compared with SAVR. Further studies are warranted to compare the long-term outcome of TAVR versus SAVR beyond a 2-year follow-up period.

Zusammenfassung

Hintergrund

Die Transkatheter-Aortenklappenimplantation („transcatheter aortic valve implantation“, TAVI) hat sich für Patienten mit relevanter Aortenklappenstenose (AS) und hohem perioperativem Risiko zu einem Standardverfahren entwickelt. Die Autoren untersuchten die Mortalität der TAVI vs. medikamentöse Therapie (MT) und operativen Aortenklappenersatz („surgical aortic valve replacement“, SAVR) in einer Metaanalyse.

Methoden

Eine systematische Literaturrecherche wurde von 2 unabhängigen Untersuchern bis 30.12.2014 durchgeführt. Das relative Risiko (RR) wurde kalkuliert und grafisch in „forest plots“ dargestellt. Die Autoren verwendeten I2 für Heterogenität (Metaregression) und den Egger-Regressionstest für Asymmetrie („funnel plots“).

Ergebnisse

Es wurden n = 24 Studien (n = 19 Beobachtungsstudien, „observational studies“, OS; und n = 5 randomisierte kontrollierte Studien, „randomized controlled trials“, RCT), mit insgesamt n = 7356 Patienten in diese Metaanalyse eingeschlossen. Das mittlere Alter der Patienten hatte einen entscheidenden negativen Einfluss auf das Langzeitüberleben der AS-Patienten (Odds Ratio, OR: 1,544; 95%-Konfidenzintervall, 95%-KI: 1,25–1,90). Sowohl die TAVI als auch die SAVR waren mit besserem Überleben assoziiert als die MT. Bei 12 Monaten Follow-up-Dauer war die TAVI im Vergleich zur MT mit einem signifikanten klinischen Vorteil für die Gesamtmortalität bei 12 Monaten assoziiert (OR = 0,68; 95%-KI: 0,49–0,95). Während die TAVI bei 12 Monaten Follow-up eine signifikant niedrigere Gesamtmortalität als die SAVR zeigte (OR = 0,81; 95%-KI: 0,68–0,97), war dieser Vergleich bei 2 Jahren Follow-up ohne signifikanten Unterschied (RR = 1,09; 95%-KI: 1,01–1,17).

Schlussfolgerung

Sowohl die TAVI als auch die SAVR sind der MT bei AS überlegen. Die MT stellt keine bevorzugte Option bei AS dar. Darüber hinaus zeigen die vorliegenden Daten eine Überlegenheit der TAVI versus SAVR hinsichtlich der Mortalität bei 12 Monaten. Weitere Studien sind erforderlich, um das Überleben bei AS nach TAVI versus SAVR über das 2‑Jahres-Follow-up hinaus zu vergleichen.

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Correspondence to P. Schlattmann.

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Conflict of interest

M. Noutsias has received honoraria for presentations and/or attended advisory boards for Novartis, Pfizer, Bayer, Fresenius, Miltenyi Biotech, and Zoll, and was consultant to the IKDT (Institut für Kardiale Diagnostik und Therapie, Berlin, Germany). A. Ak, I. Porokhovnikov, F. Kuethe, P. C. Schulze, and P. Schlattmann declare that they have no competing interests.

This article does not contain any studies with human participants or animals performed by any of the authors.

Additional information

M. Noutsias and P. Schlattmann contributed equally to this study. Availability of supporting data and materials The data and corresponding materials of the study are only available upon individual request directed to the corresponding author.Author contributions A. A. and I. P. collected data for the meta-analysis. A. A. and P. S. participated in analysis and interpretation of the data: A. A. wrote the manuscript. F. K., P. S., M. N., A. A. conceived and designed the study. A. A., F. K., M. N., and P. S. were involved in discussions and analysis plans of the paper from its inception, including the idea for the data analysis. All authors have read and approved the final manuscript.

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Ak, A., Porokhovnikov, I., Kuethe, F. et al. Transcatheter vs. surgical aortic valve replacement and medical treatment. Herz 43, 325–337 (2018). https://doi.org/10.1007/s00059-017-4562-5

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