One-Year Clinical Outcomes with SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients with Severe Aortic Stenosis

Howard C. Herrmann*, Vinod H. Thourani, Susheel K. Kodali, Raj R. Makkar, Wilson Y. Szeto, Saif Anwaruddin, Nimesh Desai, Scott Lim, S Chris Malaisrie, Dean J. Kereiakes, Steven Ramee, Kevin L. Greason, Samir Kapadia, Vasilis Babaliaros, Rebecca T. Hahn, Philippe Pibarot, Neil J. Weissman, Jonathon Leipsic, Brian K. Whisenant, John G. WebbMichael J. MacK, Martin B. Leon

*Corresponding author for this work

Research output: Contribution to journalArticle

99 Citations (Scopus)

Abstract

Background: In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24% in HR and 31% in inoperable patients. A recent report of the 30-day outcomes with the low-profile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device. Methods: Between October 2013 and September 2014, 583 HR (65%) or inoperable (35%) patients were treated via the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory. Results: Baseline characteristics included age of 83 years, 42% female, and median Society of Thoracic Surgeons score of 8.4%. At the 1-year follow-up, survival (all-cause) was 85.6% for all patients, 87.3% in the HR subgroup, and 82.3% in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7% and 93.3%, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7%) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1% to 7.7% at 1 year; P<0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4; P<0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke. Conclusions: In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365 days, the incidence of moderate paravalvular aortic regurgitation did not increase, and no association between mild paravalvular leak and 1-year mortality was observed, although a small increase in disabling stroke occurred. These results, which likely reflect device iteration and procedural evolution, support the use of transcatheter aortic valve replacement as the preferred therapy in HR and inoperable patients with aortic stenosis. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01314313.

Original languageEnglish (US)
Pages (from-to)130-140
Number of pages11
JournalCirculation
Volume134
Issue number2
DOIs
StatePublished - Jul 12 2016

Fingerprint

Aortic Valve Stenosis
Mortality
Stroke
Equipment and Supplies
Survival
Aortic Valve Insufficiency
Transcatheter Aortic Valve Replacement
Cardiomyopathies
Aortic Valve
Registries
Clinical Trials
Incidence

Keywords

  • aortic valve
  • aortic valve stenosis
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Herrmann, H. C., Thourani, V. H., Kodali, S. K., Makkar, R. R., Szeto, W. Y., Anwaruddin, S., ... Leon, M. B. (2016). One-Year Clinical Outcomes with SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients with Severe Aortic Stenosis. Circulation, 134(2), 130-140. https://doi.org/10.1161/CIRCULATIONAHA.116.022797
Herrmann, Howard C. ; Thourani, Vinod H. ; Kodali, Susheel K. ; Makkar, Raj R. ; Szeto, Wilson Y. ; Anwaruddin, Saif ; Desai, Nimesh ; Lim, Scott ; Malaisrie, S Chris ; Kereiakes, Dean J. ; Ramee, Steven ; Greason, Kevin L. ; Kapadia, Samir ; Babaliaros, Vasilis ; Hahn, Rebecca T. ; Pibarot, Philippe ; Weissman, Neil J. ; Leipsic, Jonathon ; Whisenant, Brian K. ; Webb, John G. ; MacK, Michael J. ; Leon, Martin B. / One-Year Clinical Outcomes with SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients with Severe Aortic Stenosis. In: Circulation. 2016 ; Vol. 134, No. 2. pp. 130-140.
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abstract = "Background: In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24{\%} in HR and 31{\%} in inoperable patients. A recent report of the 30-day outcomes with the low-profile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device. Methods: Between October 2013 and September 2014, 583 HR (65{\%}) or inoperable (35{\%}) patients were treated via the transfemoral (84{\%}) or transapical/transaortic (16{\%}) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory. Results: Baseline characteristics included age of 83 years, 42{\%} female, and median Society of Thoracic Surgeons score of 8.4{\%}. At the 1-year follow-up, survival (all-cause) was 85.6{\%} for all patients, 87.3{\%} in the HR subgroup, and 82.3{\%} in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7{\%} and 93.3{\%}, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7{\%}) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1{\%} to 7.7{\%} at 1 year; P<0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4; P<0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke. Conclusions: In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365 days, the incidence of moderate paravalvular aortic regurgitation did not increase, and no association between mild paravalvular leak and 1-year mortality was observed, although a small increase in disabling stroke occurred. These results, which likely reflect device iteration and procedural evolution, support the use of transcatheter aortic valve replacement as the preferred therapy in HR and inoperable patients with aortic stenosis. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01314313.",
keywords = "aortic valve, aortic valve stenosis, transcatheter aortic valve replacement",
author = "Herrmann, {Howard C.} and Thourani, {Vinod H.} and Kodali, {Susheel K.} and Makkar, {Raj R.} and Szeto, {Wilson Y.} and Saif Anwaruddin and Nimesh Desai and Scott Lim and Malaisrie, {S Chris} and Kereiakes, {Dean J.} and Steven Ramee and Greason, {Kevin L.} and Samir Kapadia and Vasilis Babaliaros and Hahn, {Rebecca T.} and Philippe Pibarot and Weissman, {Neil J.} and Jonathon Leipsic and Whisenant, {Brian K.} and Webb, {John G.} and MacK, {Michael J.} and Leon, {Martin B.}",
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Herrmann, HC, Thourani, VH, Kodali, SK, Makkar, RR, Szeto, WY, Anwaruddin, S, Desai, N, Lim, S, Malaisrie, SC, Kereiakes, DJ, Ramee, S, Greason, KL, Kapadia, S, Babaliaros, V, Hahn, RT, Pibarot, P, Weissman, NJ, Leipsic, J, Whisenant, BK, Webb, JG, MacK, MJ & Leon, MB 2016, 'One-Year Clinical Outcomes with SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients with Severe Aortic Stenosis', Circulation, vol. 134, no. 2, pp. 130-140. https://doi.org/10.1161/CIRCULATIONAHA.116.022797

One-Year Clinical Outcomes with SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients with Severe Aortic Stenosis. / Herrmann, Howard C.; Thourani, Vinod H.; Kodali, Susheel K.; Makkar, Raj R.; Szeto, Wilson Y.; Anwaruddin, Saif; Desai, Nimesh; Lim, Scott; Malaisrie, S Chris; Kereiakes, Dean J.; Ramee, Steven; Greason, Kevin L.; Kapadia, Samir; Babaliaros, Vasilis; Hahn, Rebecca T.; Pibarot, Philippe; Weissman, Neil J.; Leipsic, Jonathon; Whisenant, Brian K.; Webb, John G.; MacK, Michael J.; Leon, Martin B.

In: Circulation, Vol. 134, No. 2, 12.07.2016, p. 130-140.

Research output: Contribution to journalArticle

TY - JOUR

T1 - One-Year Clinical Outcomes with SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients with Severe Aortic Stenosis

AU - Herrmann, Howard C.

AU - Thourani, Vinod H.

AU - Kodali, Susheel K.

AU - Makkar, Raj R.

AU - Szeto, Wilson Y.

AU - Anwaruddin, Saif

AU - Desai, Nimesh

AU - Lim, Scott

AU - Malaisrie, S Chris

AU - Kereiakes, Dean J.

AU - Ramee, Steven

AU - Greason, Kevin L.

AU - Kapadia, Samir

AU - Babaliaros, Vasilis

AU - Hahn, Rebecca T.

AU - Pibarot, Philippe

AU - Weissman, Neil J.

AU - Leipsic, Jonathon

AU - Whisenant, Brian K.

AU - Webb, John G.

AU - MacK, Michael J.

AU - Leon, Martin B.

PY - 2016/7/12

Y1 - 2016/7/12

N2 - Background: In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24% in HR and 31% in inoperable patients. A recent report of the 30-day outcomes with the low-profile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device. Methods: Between October 2013 and September 2014, 583 HR (65%) or inoperable (35%) patients were treated via the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory. Results: Baseline characteristics included age of 83 years, 42% female, and median Society of Thoracic Surgeons score of 8.4%. At the 1-year follow-up, survival (all-cause) was 85.6% for all patients, 87.3% in the HR subgroup, and 82.3% in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7% and 93.3%, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7%) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1% to 7.7% at 1 year; P<0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4; P<0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke. Conclusions: In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365 days, the incidence of moderate paravalvular aortic regurgitation did not increase, and no association between mild paravalvular leak and 1-year mortality was observed, although a small increase in disabling stroke occurred. These results, which likely reflect device iteration and procedural evolution, support the use of transcatheter aortic valve replacement as the preferred therapy in HR and inoperable patients with aortic stenosis. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01314313.

AB - Background: In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24% in HR and 31% in inoperable patients. A recent report of the 30-day outcomes with the low-profile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device. Methods: Between October 2013 and September 2014, 583 HR (65%) or inoperable (35%) patients were treated via the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory. Results: Baseline characteristics included age of 83 years, 42% female, and median Society of Thoracic Surgeons score of 8.4%. At the 1-year follow-up, survival (all-cause) was 85.6% for all patients, 87.3% in the HR subgroup, and 82.3% in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7% and 93.3%, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7%) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1% to 7.7% at 1 year; P<0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4; P<0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke. Conclusions: In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365 days, the incidence of moderate paravalvular aortic regurgitation did not increase, and no association between mild paravalvular leak and 1-year mortality was observed, although a small increase in disabling stroke occurred. These results, which likely reflect device iteration and procedural evolution, support the use of transcatheter aortic valve replacement as the preferred therapy in HR and inoperable patients with aortic stenosis. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01314313.

KW - aortic valve

KW - aortic valve stenosis

KW - transcatheter aortic valve replacement

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