Clinical outcomes at 1 year following transcatheter aortic valve replacement

For The Sts/acc Tvt Registry

Research output: Contribution to journalArticle

266 Citations (Scopus)

Abstract

Importance: Introducing new medical devices into routine practice raises concerns because patients and outcomesmay differ from those in randomized trials. Objective: To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States. Design, Setting, and Participants: Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30, 2013, and the end of the follow-up period was June 30, 2014. Exposure: Transcatheter aortic valve replacement. Main Outcomes and Measures: One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling. Results: The median age of patients was 84 years and 52%were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1%. Following the TAVR procedure, 59.8%were discharged to home and the 30-day mortality was 7.0% (95%CI, 6.5%-7.4%) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4%(n = 2074) of survivors were rehospitalized once and 12.5%(n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7%(95%CI, 22.8%-24.5%) (n = 2450 deaths), the stroke rate was 4.1%(95%CI, 3.7%-4.5%) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0%(25.1%-26.8%) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio [HR] for ≥95 vs <75 years, 1.61 [95%CI, 1.24-2.09]; HR for 85-94 years vs <75 years, 1.35 [95%CI, 1.18-1.55]; and HR for 75-84 years vs <75 years, 1.23 [95%CI, 1.08-1.41]), male sex (HR, 1.21; 95%CI, 1.12-1.31), end-stage renal disease (HR, 1.66; 95%CI, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95%CI, 1.25-1.55), nontransfemoral access (HR, 1.37; 95%CI, 1.27-1.48), STS PROM score greater than 15%vs less than 8%(HR, 1.82; 95%CI, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95%CI, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95%CI, 1.15-1.71). Conclusions and Relevance: Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7%, the stroke rate was 4.1%, and the rate of the composite outcome of death and stroke was 26.0%. These findings should be helpful in discussions with patients undergoing TAVR.

Original languageEnglish (US)
Pages (from-to)1019-1028
Number of pages10
JournalJAMA - Journal of the American Medical Association
Volume313
Issue number10
DOIs
StatePublished - Mar 10 2015

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Stroke
Mortality
Transcatheter Aortic Valve Replacement
Atrial Flutter
Sex Ratio
Medicaid
Medicare
Atrial Fibrillation
Chronic Obstructive Pulmonary Disease
Chronic Kidney Failure
Survivors
Registries
Outcome Assessment (Health Care)
Equipment and Supplies
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Clinical outcomes at 1 year following transcatheter aortic valve replacement. / For The Sts/acc Tvt Registry.

In: JAMA - Journal of the American Medical Association, Vol. 313, No. 10, 10.03.2015, p. 1019-1028.

Research output: Contribution to journalArticle

@article{df1d69b370bc4db382f826f3a96753de,
title = "Clinical outcomes at 1 year following transcatheter aortic valve replacement",
abstract = "Importance: Introducing new medical devices into routine practice raises concerns because patients and outcomesmay differ from those in randomized trials. Objective: To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States. Design, Setting, and Participants: Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30, 2013, and the end of the follow-up period was June 30, 2014. Exposure: Transcatheter aortic valve replacement. Main Outcomes and Measures: One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling. Results: The median age of patients was 84 years and 52{\%}were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1{\%}. Following the TAVR procedure, 59.8{\%}were discharged to home and the 30-day mortality was 7.0{\%} (95{\%}CI, 6.5{\%}-7.4{\%}) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4{\%}(n = 2074) of survivors were rehospitalized once and 12.5{\%}(n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7{\%}(95{\%}CI, 22.8{\%}-24.5{\%}) (n = 2450 deaths), the stroke rate was 4.1{\%}(95{\%}CI, 3.7{\%}-4.5{\%}) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0{\%}(25.1{\%}-26.8{\%}) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio [HR] for ≥95 vs <75 years, 1.61 [95{\%}CI, 1.24-2.09]; HR for 85-94 years vs <75 years, 1.35 [95{\%}CI, 1.18-1.55]; and HR for 75-84 years vs <75 years, 1.23 [95{\%}CI, 1.08-1.41]), male sex (HR, 1.21; 95{\%}CI, 1.12-1.31), end-stage renal disease (HR, 1.66; 95{\%}CI, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95{\%}CI, 1.25-1.55), nontransfemoral access (HR, 1.37; 95{\%}CI, 1.27-1.48), STS PROM score greater than 15{\%}vs less than 8{\%}(HR, 1.82; 95{\%}CI, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95{\%}CI, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95{\%}CI, 1.15-1.71). Conclusions and Relevance: Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7{\%}, the stroke rate was 4.1{\%}, and the rate of the composite outcome of death and stroke was 26.0{\%}. These findings should be helpful in discussions with patients undergoing TAVR.",
author = "{For The Sts/acc Tvt Registry} and David Holmes and Brennan, {J. Matthew} and Rumsfeld, {John S.} and David Dai and O'Brien, {Sean M.} and Sreekanth Vemulapalli and Edwards, {Fred H.} and John Carroll and David Shahian and Fred Grover and Tuzcu, {E. Murat} and Peterson, {Eric D.} and Brindis, {Ralph G.} and Mack, {Michael J.}",
year = "2015",
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doi = "10.1001/jama.2015.1474",
language = "English (US)",
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pages = "1019--1028",
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TY - JOUR

T1 - Clinical outcomes at 1 year following transcatheter aortic valve replacement

AU - For The Sts/acc Tvt Registry

AU - Holmes, David

AU - Brennan, J. Matthew

AU - Rumsfeld, John S.

AU - Dai, David

AU - O'Brien, Sean M.

AU - Vemulapalli, Sreekanth

AU - Edwards, Fred H.

AU - Carroll, John

AU - Shahian, David

AU - Grover, Fred

AU - Tuzcu, E. Murat

AU - Peterson, Eric D.

AU - Brindis, Ralph G.

AU - Mack, Michael J.

PY - 2015/3/10

Y1 - 2015/3/10

N2 - Importance: Introducing new medical devices into routine practice raises concerns because patients and outcomesmay differ from those in randomized trials. Objective: To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States. Design, Setting, and Participants: Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30, 2013, and the end of the follow-up period was June 30, 2014. Exposure: Transcatheter aortic valve replacement. Main Outcomes and Measures: One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling. Results: The median age of patients was 84 years and 52%were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1%. Following the TAVR procedure, 59.8%were discharged to home and the 30-day mortality was 7.0% (95%CI, 6.5%-7.4%) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4%(n = 2074) of survivors were rehospitalized once and 12.5%(n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7%(95%CI, 22.8%-24.5%) (n = 2450 deaths), the stroke rate was 4.1%(95%CI, 3.7%-4.5%) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0%(25.1%-26.8%) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio [HR] for ≥95 vs <75 years, 1.61 [95%CI, 1.24-2.09]; HR for 85-94 years vs <75 years, 1.35 [95%CI, 1.18-1.55]; and HR for 75-84 years vs <75 years, 1.23 [95%CI, 1.08-1.41]), male sex (HR, 1.21; 95%CI, 1.12-1.31), end-stage renal disease (HR, 1.66; 95%CI, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95%CI, 1.25-1.55), nontransfemoral access (HR, 1.37; 95%CI, 1.27-1.48), STS PROM score greater than 15%vs less than 8%(HR, 1.82; 95%CI, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95%CI, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95%CI, 1.15-1.71). Conclusions and Relevance: Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7%, the stroke rate was 4.1%, and the rate of the composite outcome of death and stroke was 26.0%. These findings should be helpful in discussions with patients undergoing TAVR.

AB - Importance: Introducing new medical devices into routine practice raises concerns because patients and outcomesmay differ from those in randomized trials. Objective: To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States. Design, Setting, and Participants: Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30, 2013, and the end of the follow-up period was June 30, 2014. Exposure: Transcatheter aortic valve replacement. Main Outcomes and Measures: One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling. Results: The median age of patients was 84 years and 52%were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1%. Following the TAVR procedure, 59.8%were discharged to home and the 30-day mortality was 7.0% (95%CI, 6.5%-7.4%) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4%(n = 2074) of survivors were rehospitalized once and 12.5%(n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7%(95%CI, 22.8%-24.5%) (n = 2450 deaths), the stroke rate was 4.1%(95%CI, 3.7%-4.5%) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0%(25.1%-26.8%) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio [HR] for ≥95 vs <75 years, 1.61 [95%CI, 1.24-2.09]; HR for 85-94 years vs <75 years, 1.35 [95%CI, 1.18-1.55]; and HR for 75-84 years vs <75 years, 1.23 [95%CI, 1.08-1.41]), male sex (HR, 1.21; 95%CI, 1.12-1.31), end-stage renal disease (HR, 1.66; 95%CI, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95%CI, 1.25-1.55), nontransfemoral access (HR, 1.37; 95%CI, 1.27-1.48), STS PROM score greater than 15%vs less than 8%(HR, 1.82; 95%CI, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95%CI, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95%CI, 1.15-1.71). Conclusions and Relevance: Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7%, the stroke rate was 4.1%, and the rate of the composite outcome of death and stroke was 26.0%. These findings should be helpful in discussions with patients undergoing TAVR.

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