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Cardiovascular

Transcatheter- vs surgical aortic valve replacement in high-risk patients: 5-years survival

By: News Feed | Last updated: 28th September 2018 | In: Cardiovascular

Article Keywords

CoreValve, Medtronic, SAVR, TAVR

Transcatheter aortic valve replacement (TAVR) with the CoreValve® system (Medtronic) and surgical aortic valve replacement (SAVR) show similar 5-year survival and stroke rates in high-risk patients, as shown by the MCV-US-2009-01 study (NCT01240902). Most patients remained free from severe structural valve deterioration (SVD) and valve reinterventions (VR).

“The CoreValve United States Pivotal High Risk trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients.”

The MCV-US-2009-01 study randomised 797 surgical high-risk patients at 45 United States (US) centres 1:1 to undergo TAVR with a self-expanding bioprosthesis or SAVR. The primary endpoint was Extreme Risk (all-cause death or major stroke) in TAVR patients and High-Risk Surgical (all-cause mortality) for SAVR patients; both measured in the 1st-year and according to the Valve Academic Research Consortium I (VARC-1) criteria. Severe hemodynamic SVD was defined as a mean gradient ≥40 mm Hg, a change in gradient ≥20 mm Hg, or new onset severe aortic regurgitation. The preplanned analysis of the mid-term 5-year outcomes focussed on safety, performance, and durability.

Among the 797 patients randomised, the mean age was 83 years and the Society of Thoracic Surgeons (STS) score was 7.4%. Ninety-four per cent (N=750) underwent an attempted implant (TAVR: N=391; SAVR: N=359). The all-cause mortality rates at 5-years for TAVR vs SAVR were 55.3% vs 55.4%, respectively. No differences in mortality for subgroups were identified. The major stroke rates at 5-years for TAVR vs SAVR were 12.3% vs 13.2%, respectively. The mean aortic valve gradients were 7.1 ± 3.6 mm Hg (TAVR) and 10.9 ± 5.7 mm Hg (SAVR). The authors did not report any clinically significant valve thrombosis.

Finally, 99.2% of TAVR patients and 98.3% of SAVR patient remained free from severe SVD (p = 0.32). Moreover, 97.0% and 98.9% of patients were free from VR (p = 0.04), for TAVR and SAVR respectively. A third of TAVR patients had received a pacemaker at the 5-year follow-up vs 19.8% of SAVR patients.

References

Gleason TG, et al. J Am Coll Cardiol. 2018; doi: 10.1016/j.jacc.2018.08.2146.


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Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

© Copyright 2018 MediPaper Medical Communications Ltd. – TAVR vs SAVR – Transcatheter- vs surgical aortic valve replacement in high-risk patients: 5-years survival

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