1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses

G. Michael Deeb; Stanley J. Chetcuti; Michael J. Reardon; Himanshu J. Patel; P. Michael Grossman; Theodore Schreiber; John K. Forrest; Tanvir K. Bajwa; Daniel P. O'Hair; George Petrossian; Newell Robinson; Stanley Katz; Alan Hartman; Harold L. Dauerman; Joseph Schmoker; Kamal Khabbaz; Daniel R. Watson; Steven J. Yakubov; Jae K. Oh; Shuzhen Li; Neal S. Kleiman; David H. Adams; Jeffrey J. Popma

doi:10.1016/j.jcin.2017.03.018

1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses

G. Michael Deeb, Stanley J. Chetcuti, Michael J. Reardon, Himanshu J. Patel, P. Michael Grossman, Theodore Schreiber, John K. Forrest, Tanvir K. Bajwa, Daniel P. O'Hair, George Petrossian, Newell Robinson, Stanley Katz, Alan Hartman, Harold L. Dauerman, Joseph Schmoker, Kamal Khabbaz, Daniel R. Watson, Steven J. Yakubov, Jae K. Oh, Shuzhen LiNeal S. Kleiman, David H. Adams, Jeffrey J. Popma

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

94 Scopus citations

Abstract

Objectives This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). Background Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. Methods The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. Results SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). Conclusions Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.

Original language	English (US)
Pages (from-to)	1034-1044
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	10
Issue number	10
DOIs	https://doi.org/10.1016/j.jcin.2017.03.018
State	Published - May 22 2017

Keywords

Prospective trial
Surgical valve failure
TAV in SAV
TAVR

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1016/j.jcin.2017.03.018

Cite this

Deeb, G. M., Chetcuti, S. J., Reardon, M. J., Patel, H. J., Grossman, P. M., Schreiber, T., Forrest, J. K., Bajwa, T. K., O'Hair, D. P., Petrossian, G., Robinson, N., Katz, S., Hartman, A., Dauerman, H. L., Schmoker, J., Khabbaz, K., Watson, D. R., Yakubov, S. J., Oh, J. K., ... Popma, J. J. (2017). 1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses. JACC: Cardiovascular Interventions, 10(10), 1034-1044. https://doi.org/10.1016/j.jcin.2017.03.018

Deeb, GM, Chetcuti, SJ, Reardon, MJ, Patel, HJ, Grossman, PM, Schreiber, T, Forrest, JK, Bajwa, TK, O'Hair, DP, Petrossian, G, Robinson, N, Katz, S, Hartman, A, Dauerman, HL, Schmoker, J, Khabbaz, K, Watson, DR, Yakubov, SJ, Oh, JK, Li, S, Kleiman, NS, Adams, DH & Popma, JJ 2017, '1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses', JACC: Cardiovascular Interventions, vol. 10, no. 10, pp. 1034-1044. https://doi.org/10.1016/j.jcin.2017.03.018

@article{a98c636dfcf6464c8253b5a7d2585d6d,

title = "1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses",

abstract = "Objectives This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). Background Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. Methods The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. Results SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). Conclusions Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.",

keywords = "Prospective trial, Surgical valve failure, TAV in SAV, TAVR",

author = "Deeb, {G. Michael} and Chetcuti, {Stanley J.} and Reardon, {Michael J.} and Patel, {Himanshu J.} and Grossman, {P. Michael} and Theodore Schreiber and Forrest, {John K.} and Bajwa, {Tanvir K.} and O'Hair, {Daniel P.} and George Petrossian and Newell Robinson and Stanley Katz and Alan Hartman and Dauerman, {Harold L.} and Joseph Schmoker and Kamal Khabbaz and Watson, {Daniel R.} and Yakubov, {Steven J.} and Oh, {Jae K.} and Shuzhen Li and Kleiman, {Neal S.} and Adams, {David H.} and Popma, {Jeffrey J.}",

note = "Publisher Copyright: {\textcopyright} 2017 American College of Cardiology Foundation",

year = "2017",

month = may,

day = "22",

doi = "10.1016/j.jcin.2017.03.018",

language = "English (US)",

volume = "10",

pages = "1034--1044",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier",

number = "10",

}

TY - JOUR

T1 - 1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses

AU - Deeb, G. Michael

AU - Chetcuti, Stanley J.

AU - Reardon, Michael J.

AU - Patel, Himanshu J.

AU - Grossman, P. Michael

AU - Schreiber, Theodore

AU - Forrest, John K.

AU - Bajwa, Tanvir K.

AU - O'Hair, Daniel P.

AU - Petrossian, George

AU - Robinson, Newell

AU - Katz, Stanley

AU - Hartman, Alan

AU - Dauerman, Harold L.

AU - Schmoker, Joseph

AU - Khabbaz, Kamal

AU - Watson, Daniel R.

AU - Yakubov, Steven J.

AU - Oh, Jae K.

AU - Li, Shuzhen

AU - Kleiman, Neal S.

AU - Adams, David H.

AU - Popma, Jeffrey J.

PY - 2017/5/22

Y1 - 2017/5/22

N2 - Objectives This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). Background Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. Methods The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. Results SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). Conclusions Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.

AB - Objectives This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). Background Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. Methods The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. Results SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). Conclusions Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.

KW - Prospective trial

KW - Surgical valve failure

KW - TAV in SAV

KW - TAVR

UR - http://www.scopus.com/inward/record.url?scp=85019206247&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85019206247&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2017.03.018

DO - 10.1016/j.jcin.2017.03.018

M3 - Article

C2 - 28521921

AN - SCOPUS:85019206247

SN - 1936-8798

VL - 10

SP - 1034

EP - 1044

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 10

ER -

1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this