Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons

Raj R. Makkar, Hasan Jilaihawi, Michael Mack, Tarun Chakravarty, David J. Cohen, Wen Cheng, Gregory P. Fontana, Joseph E. Bavaria, Vinod H. Thourani, Howard C. Herrmann, Augusto Pichard, Samir Kapadia, Vasilis Babaliaros, Brian K. Whisenant, Susheel K. Kodali, Mathew Williams, Alfredo Trento, Craig R. Smith, Paul S. Teirstein, Mauricio G Cohen & 4 others Ke Xu, E. Murat Tuzcu, John G. Webb, Martin B. Leon

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Objectives The goal of this study was to examine the impact of reasons for surgical inoperability on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Background Patients with severe aortic stenosis may be deemed inoperable due to technical or clinical reasons. The relative impact of each designation on early and late outcomes after TAVR is unclear. Methods Patients were studied from the inoperable arm (cohort B) of the randomized PARTNER (Placement of Aortic Transcatheter Valve) trial and the nonrandomized continued access registry. Patients were classified according to whether they were classified as technically inoperable (TI) or clinically inoperable (CLI). Reasons for TI included porcelain aorta, previous mediastinal radiation, chest wall deformity, and potential for injury to previous bypass graft on sternal re-entry. Reasons for CLI were systemic factors that were deemed to make survival unlikely. Results Of the 369 patients, 23.0% were considered inoperable for technical reasons alone; the remaining were judged to be CLI. For TI, the most common cause was a porcelain aorta (42%); for CLI, it was multiple comorbidities (48%) and frailty (31%). Quality of life and 2-year mortality were significantly better among TI patients compared with CLI patients (mortality 23.3% vs. 43.8%; p < 0.001). Nonetheless, TAVR led to substantial survival benefits compared with standard therapy in both inoperable cohorts. Conclusions Patients undergoing TAVR based solely on TI have better survival and quality of life improvements than those who are inoperable due to clinical comorbidities. Both TI and CLI TAVR have significant survival benefit in the context of standard therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

Original languageEnglish
Pages (from-to)901-911
Number of pages11
JournalJournal of the American College of Cardiology
Volume63
Issue number9
DOIs
StatePublished - Mar 11 2014

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Aortic Valve
Dental Porcelain
Survival
Aorta
Comorbidity
Quality of Life
Mortality
Transcatheter Aortic Valve Replacement
Aortic Valve Stenosis
Thoracic Wall
Quality Improvement
Registries
Arm
Radiation
Transplants
Wounds and Injuries
Therapeutics

Keywords

  • inoperable
  • risk
  • TAVI
  • TAVR
  • transcatheter aortic valve

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons. / Makkar, Raj R.; Jilaihawi, Hasan; Mack, Michael; Chakravarty, Tarun; Cohen, David J.; Cheng, Wen; Fontana, Gregory P.; Bavaria, Joseph E.; Thourani, Vinod H.; Herrmann, Howard C.; Pichard, Augusto; Kapadia, Samir; Babaliaros, Vasilis; Whisenant, Brian K.; Kodali, Susheel K.; Williams, Mathew; Trento, Alfredo; Smith, Craig R.; Teirstein, Paul S.; Cohen, Mauricio G; Xu, Ke; Tuzcu, E. Murat; Webb, John G.; Leon, Martin B.

In: Journal of the American College of Cardiology, Vol. 63, No. 9, 11.03.2014, p. 901-911.

Research output: Contribution to journalArticle

Makkar, RR, Jilaihawi, H, Mack, M, Chakravarty, T, Cohen, DJ, Cheng, W, Fontana, GP, Bavaria, JE, Thourani, VH, Herrmann, HC, Pichard, A, Kapadia, S, Babaliaros, V, Whisenant, BK, Kodali, SK, Williams, M, Trento, A, Smith, CR, Teirstein, PS, Cohen, MG, Xu, K, Tuzcu, EM, Webb, JG & Leon, MB 2014, 'Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons', Journal of the American College of Cardiology, vol. 63, no. 9, pp. 901-911. https://doi.org/10.1016/j.jacc.2013.08.1641
Makkar, Raj R. ; Jilaihawi, Hasan ; Mack, Michael ; Chakravarty, Tarun ; Cohen, David J. ; Cheng, Wen ; Fontana, Gregory P. ; Bavaria, Joseph E. ; Thourani, Vinod H. ; Herrmann, Howard C. ; Pichard, Augusto ; Kapadia, Samir ; Babaliaros, Vasilis ; Whisenant, Brian K. ; Kodali, Susheel K. ; Williams, Mathew ; Trento, Alfredo ; Smith, Craig R. ; Teirstein, Paul S. ; Cohen, Mauricio G ; Xu, Ke ; Tuzcu, E. Murat ; Webb, John G. ; Leon, Martin B. / Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons. In: Journal of the American College of Cardiology. 2014 ; Vol. 63, No. 9. pp. 901-911.
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abstract = "Objectives The goal of this study was to examine the impact of reasons for surgical inoperability on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Background Patients with severe aortic stenosis may be deemed inoperable due to technical or clinical reasons. The relative impact of each designation on early and late outcomes after TAVR is unclear. Methods Patients were studied from the inoperable arm (cohort B) of the randomized PARTNER (Placement of Aortic Transcatheter Valve) trial and the nonrandomized continued access registry. Patients were classified according to whether they were classified as technically inoperable (TI) or clinically inoperable (CLI). Reasons for TI included porcelain aorta, previous mediastinal radiation, chest wall deformity, and potential for injury to previous bypass graft on sternal re-entry. Reasons for CLI were systemic factors that were deemed to make survival unlikely. Results Of the 369 patients, 23.0{\%} were considered inoperable for technical reasons alone; the remaining were judged to be CLI. For TI, the most common cause was a porcelain aorta (42{\%}); for CLI, it was multiple comorbidities (48{\%}) and frailty (31{\%}). Quality of life and 2-year mortality were significantly better among TI patients compared with CLI patients (mortality 23.3{\%} vs. 43.8{\%}; p < 0.001). Nonetheless, TAVR led to substantial survival benefits compared with standard therapy in both inoperable cohorts. Conclusions Patients undergoing TAVR based solely on TI have better survival and quality of life improvements than those who are inoperable due to clinical comorbidities. Both TI and CLI TAVR have significant survival benefit in the context of standard therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).",
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T1 - Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons

AU - Makkar, Raj R.

AU - Jilaihawi, Hasan

AU - Mack, Michael

AU - Chakravarty, Tarun

AU - Cohen, David J.

AU - Cheng, Wen

AU - Fontana, Gregory P.

AU - Bavaria, Joseph E.

AU - Thourani, Vinod H.

AU - Herrmann, Howard C.

AU - Pichard, Augusto

AU - Kapadia, Samir

AU - Babaliaros, Vasilis

AU - Whisenant, Brian K.

AU - Kodali, Susheel K.

AU - Williams, Mathew

AU - Trento, Alfredo

AU - Smith, Craig R.

AU - Teirstein, Paul S.

AU - Cohen, Mauricio G

AU - Xu, Ke

AU - Tuzcu, E. Murat

AU - Webb, John G.

AU - Leon, Martin B.

PY - 2014/3/11

Y1 - 2014/3/11

N2 - Objectives The goal of this study was to examine the impact of reasons for surgical inoperability on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Background Patients with severe aortic stenosis may be deemed inoperable due to technical or clinical reasons. The relative impact of each designation on early and late outcomes after TAVR is unclear. Methods Patients were studied from the inoperable arm (cohort B) of the randomized PARTNER (Placement of Aortic Transcatheter Valve) trial and the nonrandomized continued access registry. Patients were classified according to whether they were classified as technically inoperable (TI) or clinically inoperable (CLI). Reasons for TI included porcelain aorta, previous mediastinal radiation, chest wall deformity, and potential for injury to previous bypass graft on sternal re-entry. Reasons for CLI were systemic factors that were deemed to make survival unlikely. Results Of the 369 patients, 23.0% were considered inoperable for technical reasons alone; the remaining were judged to be CLI. For TI, the most common cause was a porcelain aorta (42%); for CLI, it was multiple comorbidities (48%) and frailty (31%). Quality of life and 2-year mortality were significantly better among TI patients compared with CLI patients (mortality 23.3% vs. 43.8%; p < 0.001). Nonetheless, TAVR led to substantial survival benefits compared with standard therapy in both inoperable cohorts. Conclusions Patients undergoing TAVR based solely on TI have better survival and quality of life improvements than those who are inoperable due to clinical comorbidities. Both TI and CLI TAVR have significant survival benefit in the context of standard therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

AB - Objectives The goal of this study was to examine the impact of reasons for surgical inoperability on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Background Patients with severe aortic stenosis may be deemed inoperable due to technical or clinical reasons. The relative impact of each designation on early and late outcomes after TAVR is unclear. Methods Patients were studied from the inoperable arm (cohort B) of the randomized PARTNER (Placement of Aortic Transcatheter Valve) trial and the nonrandomized continued access registry. Patients were classified according to whether they were classified as technically inoperable (TI) or clinically inoperable (CLI). Reasons for TI included porcelain aorta, previous mediastinal radiation, chest wall deformity, and potential for injury to previous bypass graft on sternal re-entry. Reasons for CLI were systemic factors that were deemed to make survival unlikely. Results Of the 369 patients, 23.0% were considered inoperable for technical reasons alone; the remaining were judged to be CLI. For TI, the most common cause was a porcelain aorta (42%); for CLI, it was multiple comorbidities (48%) and frailty (31%). Quality of life and 2-year mortality were significantly better among TI patients compared with CLI patients (mortality 23.3% vs. 43.8%; p < 0.001). Nonetheless, TAVR led to substantial survival benefits compared with standard therapy in both inoperable cohorts. Conclusions Patients undergoing TAVR based solely on TI have better survival and quality of life improvements than those who are inoperable due to clinical comorbidities. Both TI and CLI TAVR have significant survival benefit in the context of standard therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

KW - inoperable

KW - risk

KW - TAVI

KW - TAVR

KW - transcatheter aortic valve

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