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 Kuen Oh, Shuzhen LiNeal S. Kleiman, David H. Adams, Jeffrey J. Popma

Research output: Contribution to journalArticle

41 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)1034-1044
Number of pages11
JournalJACC: Cardiovascular Interventions
Volume10
Issue number10
DOIs
StatePublished - May 22 2017

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Bioprosthesis
Surgical Instruments
Aortic Valve Insufficiency
Mortality
Pathologic Constriction
Transcatheter Aortic Valve Replacement
Hemodynamics
Stroke
Aortic Valve Stenosis
Aortic Valve
Reoperation
Prostheses and Implants
Quality of Life

Keywords

  • prospective trial
  • surgical valve failure
  • TAV in SAV
  • TAVR

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Deeb, G. M., Chetcuti, S. J., Reardon, M. J., Patel, H. J., Grossman, P. M., Schreiber, T., ... 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

1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses. / Deeb, G. Michael; Chetcuti, Stanley J.; Reardon, Michael J.; Patel, Himanshu J.; Grossman, P. Michael; Schreiber, Theodore; Forrest, John K.; Bajwa, Tanvir K.; O'Hair, Daniel P.; Petrossian, George; Robinson, Newell; Katz, Stanley; Hartman, Alan; Dauerman, Harold L.; Schmoker, Joseph; Khabbaz, Kamal; Watson, Daniel R.; Yakubov, Steven J.; Oh, Jae Kuen; Li, Shuzhen; Kleiman, Neal S.; Adams, David H.; Popma, Jeffrey J.

In: JACC: Cardiovascular Interventions, Vol. 10, No. 10, 22.05.2017, p. 1034-1044.

Research output: Contribution to journalArticle

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
Deeb, G. Michael ; Chetcuti, Stanley J. ; Reardon, Michael J. ; Patel, Himanshu J. ; Grossman, P. Michael ; Schreiber, Theodore ; Forrest, John K. ; Bajwa, Tanvir K. ; O'Hair, Daniel P. ; Petrossian, George ; Robinson, Newell ; Katz, Stanley ; Hartman, Alan ; Dauerman, Harold L. ; Schmoker, Joseph ; Khabbaz, Kamal ; Watson, Daniel R. ; Yakubov, Steven J. ; Oh, Jae Kuen ; Li, Shuzhen ; Kleiman, Neal S. ; Adams, David H. ; Popma, Jeffrey J. / 1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses. In: JACC: Cardiovascular Interventions. 2017 ; Vol. 10, No. 10. pp. 1034-1044.
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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.",
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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 Kuen

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

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