Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses

Harold L. Dauerman; G. Michael Deeb; Daniel P. O'Hair; Ron Waksman; Steven J. Yakubov; Neal S. Kleiman; Stanley J. Chetcuti; James B. Hermiller; Tanvir Bajwa; Kamal Khabbaz; Eduardo De Marchena; Tomas Salerno; Jessica L. Dries-Devlin; Shuzhen Li; Jeffrey J. Popma; Michael J. Reardon

doi:10.1161/CIRCINTERVENTIONS.119.008155

Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses

Harold L. Dauerman, G. Michael Deeb, Daniel P. O'Hair, Ron Waksman, Steven J. Yakubov, Neal S. Kleiman, Stanley J. Chetcuti, James B. Hermiller, Tanvir Bajwa, Kamal Khabbaz, Eduardo De Marchena, Tomas Salerno, Jessica L. Dries-Devlin, Shuzhen Li, Jeffrey J. Popma, Michael J. Reardon

Research output: Contribution to journal › Article › peer-review

44 Scopus citations

Abstract

Background: Valve-in-valve transcatheter aortic valve replacement (TAVR) is an option when a surgical valve demonstrates deterioration and dysfunction. This study reports 3-year results following valve-in-valve with self-expanding TAVR. Methods: The CoreValve US Expanded Use Study is a prospective, nonrandomized, single-arm study that evaluates safety and effectiveness of TAVR in extreme risk patients with symptomatic failed surgical biologic aortic valves. Study end points include all-cause mortality, need for valve reintervention, hemodynamic changes over time, and quality of life through 3 years. Patients were stratified by presence of preexisting surgical valve prosthesis-patient mismatch. Results: From March 2013 to May 2015, 226 patients deemed extreme risk (STS-PROM [Society of Thoracic Surgeons Predicted Risk of Mortality] 9.0±7%) had attempted valve-in-valve TAVR. Preexisting surgical valve prosthesis-patient mismatch was present in 47.2% of the cohort. At 3 years, all-cause mortality or major stroke was 28.6%, and 93% of patients were in New York Heart Association I or II heart failure. Valve performance was maintained over 3 years with low valve reintervention rates (4.4%), an improvement in effective orifice area over time and a 2.7% rate of severe structural valve deterioration. Preexisting severe prosthesis-patient mismatch was not associated with 3-year mortality but was associated with significantly less improvement in quality of life at 3-year follow-up (P=0.01). Conclusions: Self-expanding TAVR in patients with failed surgical bioprostheses at extreme risk for surgery was associated with durable hemodynamics and excellent clinical outcomes. Preexisting surgical valve prosthesis-patient mismatch was not associated with mortality but did limit patient improvement in quality of life over 3-year follow-up. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01675440.

Original language	English (US)
Article number	e008155
Journal	Circulation: Cardiovascular Interventions
Volume	12
Issue number	10
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.119.008155
State	Published - Oct 1 2019

Keywords

aortic valve
aortic valve stenosis
bioprosthesis
transcatheter aortic valve replacement

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1161/CIRCINTERVENTIONS.119.008155

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Dauerman, H. L., Deeb, G. M., O'Hair, D. P., Waksman, R., Yakubov, S. J., Kleiman, N. S., Chetcuti, S. J., Hermiller, J. B., Bajwa, T., Khabbaz, K., De Marchena, E., Salerno, T., Dries-Devlin, J. L., Li, S., Popma, J. J., & Reardon, M. J. (2019). Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses. Circulation: Cardiovascular Interventions, 12(10), Article e008155. https://doi.org/10.1161/CIRCINTERVENTIONS.119.008155

Dauerman, HL, Deeb, GM, O'Hair, DP, Waksman, R, Yakubov, SJ, Kleiman, NS, Chetcuti, SJ, Hermiller, JB, Bajwa, T, Khabbaz, K, De Marchena, E, Salerno, T, Dries-Devlin, JL, Li, S, Popma, JJ & Reardon, MJ 2019, 'Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses', Circulation: Cardiovascular Interventions, vol. 12, no. 10, e008155. https://doi.org/10.1161/CIRCINTERVENTIONS.119.008155

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title = "Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses",

abstract = "Background: Valve-in-valve transcatheter aortic valve replacement (TAVR) is an option when a surgical valve demonstrates deterioration and dysfunction. This study reports 3-year results following valve-in-valve with self-expanding TAVR. Methods: The CoreValve US Expanded Use Study is a prospective, nonrandomized, single-arm study that evaluates safety and effectiveness of TAVR in extreme risk patients with symptomatic failed surgical biologic aortic valves. Study end points include all-cause mortality, need for valve reintervention, hemodynamic changes over time, and quality of life through 3 years. Patients were stratified by presence of preexisting surgical valve prosthesis-patient mismatch. Results: From March 2013 to May 2015, 226 patients deemed extreme risk (STS-PROM [Society of Thoracic Surgeons Predicted Risk of Mortality] 9.0±7\%) had attempted valve-in-valve TAVR. Preexisting surgical valve prosthesis-patient mismatch was present in 47.2\% of the cohort. At 3 years, all-cause mortality or major stroke was 28.6\%, and 93\% of patients were in New York Heart Association I or II heart failure. Valve performance was maintained over 3 years with low valve reintervention rates (4.4\%), an improvement in effective orifice area over time and a 2.7\% rate of severe structural valve deterioration. Preexisting severe prosthesis-patient mismatch was not associated with 3-year mortality but was associated with significantly less improvement in quality of life at 3-year follow-up (P=0.01). Conclusions: Self-expanding TAVR in patients with failed surgical bioprostheses at extreme risk for surgery was associated with durable hemodynamics and excellent clinical outcomes. Preexisting surgical valve prosthesis-patient mismatch was not associated with mortality but did limit patient improvement in quality of life over 3-year follow-up. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01675440.",

keywords = "aortic valve, aortic valve stenosis, bioprosthesis, transcatheter aortic valve replacement",

author = "Dauerman, \{Harold L.\} and Deeb, \{G. Michael\} and O'Hair, \{Daniel P.\} and Ron Waksman and Yakubov, \{Steven J.\} and Kleiman, \{Neal S.\} and Chetcuti, \{Stanley J.\} and Hermiller, \{James B.\} and Tanvir Bajwa and Kamal Khabbaz and \{De Marchena\}, Eduardo and Tomas Salerno and Dries-Devlin, \{Jessica L.\} and Shuzhen Li and Popma, \{Jeffrey J.\} and Reardon, \{Michael J.\}",

year = "2019",

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doi = "10.1161/CIRCINTERVENTIONS.119.008155",

language = "English (US)",

volume = "12",

journal = "Circulation: Cardiovascular Interventions",

issn = "1941-7640",

publisher = "Lippincott Williams and Wilkins",

number = "10",

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T1 - Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses

AU - Dauerman, Harold L.

AU - Deeb, G. Michael

AU - O'Hair, Daniel P.

AU - Waksman, Ron

AU - Yakubov, Steven J.

AU - Kleiman, Neal S.

AU - Chetcuti, Stanley J.

AU - Hermiller, James B.

AU - Bajwa, Tanvir

AU - Khabbaz, Kamal

AU - De Marchena, Eduardo

AU - Salerno, Tomas

AU - Dries-Devlin, Jessica L.

AU - Li, Shuzhen

AU - Popma, Jeffrey J.

AU - Reardon, Michael J.

PY - 2019/10/1

Y1 - 2019/10/1

N2 - Background: Valve-in-valve transcatheter aortic valve replacement (TAVR) is an option when a surgical valve demonstrates deterioration and dysfunction. This study reports 3-year results following valve-in-valve with self-expanding TAVR. Methods: The CoreValve US Expanded Use Study is a prospective, nonrandomized, single-arm study that evaluates safety and effectiveness of TAVR in extreme risk patients with symptomatic failed surgical biologic aortic valves. Study end points include all-cause mortality, need for valve reintervention, hemodynamic changes over time, and quality of life through 3 years. Patients were stratified by presence of preexisting surgical valve prosthesis-patient mismatch. Results: From March 2013 to May 2015, 226 patients deemed extreme risk (STS-PROM [Society of Thoracic Surgeons Predicted Risk of Mortality] 9.0±7%) had attempted valve-in-valve TAVR. Preexisting surgical valve prosthesis-patient mismatch was present in 47.2% of the cohort. At 3 years, all-cause mortality or major stroke was 28.6%, and 93% of patients were in New York Heart Association I or II heart failure. Valve performance was maintained over 3 years with low valve reintervention rates (4.4%), an improvement in effective orifice area over time and a 2.7% rate of severe structural valve deterioration. Preexisting severe prosthesis-patient mismatch was not associated with 3-year mortality but was associated with significantly less improvement in quality of life at 3-year follow-up (P=0.01). Conclusions: Self-expanding TAVR in patients with failed surgical bioprostheses at extreme risk for surgery was associated with durable hemodynamics and excellent clinical outcomes. Preexisting surgical valve prosthesis-patient mismatch was not associated with mortality but did limit patient improvement in quality of life over 3-year follow-up. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01675440.

AB - Background: Valve-in-valve transcatheter aortic valve replacement (TAVR) is an option when a surgical valve demonstrates deterioration and dysfunction. This study reports 3-year results following valve-in-valve with self-expanding TAVR. Methods: The CoreValve US Expanded Use Study is a prospective, nonrandomized, single-arm study that evaluates safety and effectiveness of TAVR in extreme risk patients with symptomatic failed surgical biologic aortic valves. Study end points include all-cause mortality, need for valve reintervention, hemodynamic changes over time, and quality of life through 3 years. Patients were stratified by presence of preexisting surgical valve prosthesis-patient mismatch. Results: From March 2013 to May 2015, 226 patients deemed extreme risk (STS-PROM [Society of Thoracic Surgeons Predicted Risk of Mortality] 9.0±7%) had attempted valve-in-valve TAVR. Preexisting surgical valve prosthesis-patient mismatch was present in 47.2% of the cohort. At 3 years, all-cause mortality or major stroke was 28.6%, and 93% of patients were in New York Heart Association I or II heart failure. Valve performance was maintained over 3 years with low valve reintervention rates (4.4%), an improvement in effective orifice area over time and a 2.7% rate of severe structural valve deterioration. Preexisting severe prosthesis-patient mismatch was not associated with 3-year mortality but was associated with significantly less improvement in quality of life at 3-year follow-up (P=0.01). Conclusions: Self-expanding TAVR in patients with failed surgical bioprostheses at extreme risk for surgery was associated with durable hemodynamics and excellent clinical outcomes. Preexisting surgical valve prosthesis-patient mismatch was not associated with mortality but did limit patient improvement in quality of life over 3-year follow-up. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01675440.

KW - aortic valve

KW - aortic valve stenosis

KW - bioprosthesis

KW - transcatheter aortic valve replacement

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AN - SCOPUS:85073148950

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ER -

Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses

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