5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients

CoreValve U.S. Pivotal High Risk Trial Clinical Investigators

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Background: The CoreValve U.S. 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. Objectives: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. Methods: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. Results: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. Conclusions: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)

Original languageEnglish (US)
Pages (from-to)2687-2696
Number of pages10
JournalJournal of the American College of Cardiology
Volume72
Issue number22
DOIs
StatePublished - Dec 4 2018

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Aortic Valve
Surgical Instruments
Mortality
Transcatheter Aortic Valve Replacement
Stroke
Safety
Bioprosthesis
Aortic Valve Insufficiency
Aortic Valve Stenosis
Thrombosis
Survival Rate
Hemodynamics

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

CoreValve U.S. Pivotal High Risk Trial Clinical Investigators. / 5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients. In: Journal of the American College of Cardiology. 2018 ; Vol. 72, No. 22. pp. 2687-2696.
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abstract = "Background: The CoreValve U.S. 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. Objectives: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. Methods: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. Results: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4{\%}. All-cause mortality rates at 5 years were 55.3{\%} for TAVR and 55.4{\%} for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3{\%} for TAVR and 13.2{\%} for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2{\%} for TAVR and 98.3{\%} for SAVR (p = 0.32), and freedom from valve reintervention was 97.0{\%} for TAVR and 98.9{\%} for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0{\%} of TAVR and 19.8{\%} of SAVR patients at 5 years. Conclusions: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve{\circledR} System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)",
author = "{CoreValve U.S. Pivotal High Risk Trial Clinical Investigators} and Gleason, {Thomas G.} and Reardon, {Michael J.} and Popma, {Jeffrey J.} and Deeb, {G. Michael} and Yakubov, {Steven J.} and Lee, {Joon S.} and Kleiman, {Neal S.} and Stan Chetcuti and Hermiller, {James B.} and John Heiser and William Merhi and Zorn, {George L.} and Peter Tadros and Newell Robinson and George Petrossian and Hughes, {G. Chad} and Harrison, {J. Kevin} and John Conte and Mubashir Mumtaz and Oh, {Jae K.} and Jian Huang and Adams, {David H.}",
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5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients. / CoreValve U.S. Pivotal High Risk Trial Clinical Investigators.

In: Journal of the American College of Cardiology, Vol. 72, No. 22, 04.12.2018, p. 2687-2696.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients

AU - CoreValve U.S. Pivotal High Risk Trial Clinical Investigators

AU - Gleason, Thomas G.

AU - Reardon, Michael J.

AU - Popma, Jeffrey J.

AU - Deeb, G. Michael

AU - Yakubov, Steven J.

AU - Lee, Joon S.

AU - Kleiman, Neal S.

AU - Chetcuti, Stan

AU - Hermiller, James B.

AU - Heiser, John

AU - Merhi, William

AU - Zorn, George L.

AU - Tadros, Peter

AU - Robinson, Newell

AU - Petrossian, George

AU - Hughes, G. Chad

AU - Harrison, J. Kevin

AU - Conte, John

AU - Mumtaz, Mubashir

AU - Oh, Jae K.

AU - Huang, Jian

AU - Adams, David H.

PY - 2018/12/4

Y1 - 2018/12/4

N2 - Background: The CoreValve U.S. 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. Objectives: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. Methods: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. Results: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. Conclusions: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)

AB - Background: The CoreValve U.S. 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. Objectives: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. Methods: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. Results: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. Conclusions: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)

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