Mani Arsalan1, Molly Szerlip2, Sreekanth Vemulapalli3, Elizabeth M Holper2, Suzanne V Arnold4, Zhuokai Li3, Michael J DiMaio2, John S Rumsfeld5, David L Brown2, Michael J Mack6. 1. The Heart Hospital Baylor Plano, Plano, Texas; Kerckhoff Heart-Center, Bad Nauheim, Germany. 2. The Heart Hospital Baylor Plano, Plano, Texas. 3. Duke Clinical Research Institute, Durham, North Carolina. 4. Saint Luke's Mid America Heart Institute, Kansas City, Missouri. 5. Denver VA Medical Center, Denver, Colorado. 6. The Heart Hospital Baylor Plano, Plano, Texas. Electronic address: MichaeMa@baylorhealth.edu.
Abstract
BACKGROUND: Data demonstrating the outcome of transcatheter aortic valve replacement (TAVR) in the very elderly patients are limited, as they often represent only a small proportion of the trial populations. OBJECTIVES: The purpose of this study was to compare the outcomes of nonagenarians to younger patients undergoing TAVR in current practice. METHODS: We analyzed data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. Outcomes at 30 days and 1 year were compared between patients ≥90 years versus <90 years of age using cumulative incidence curves. Quality of life was assessed with the 12-item Kansas City Cardiomyopathy Questionnaire. RESULTS:Between November 2011 and September 2014, 24,025 patients underwent TAVR in 329 participating hospitals, of which 3,773 (15.7%) were age ≥90 years. The 30-day and 1-year mortality rates were significantly higher among nonagenarians (age ≥90 years vs. <90 years: 30-day: 8.8% vs. 5.9%; p < 0.001; 1 year: 24.8% vs. 22.0%; p < 0.001, absolute risk: 2.8%, relative risk: 12.7%). However, nonagenarians had a higher mean Society of Thoracic Surgeons Predicted Risk of Operative Mortality score (10.9% vs. 8.1%; p < 0.001) and, therefore, had similar ratios of observed to expected rates of 30-day death (age ≥90 years vs. <90 years: 0.81, 95% confidence interval: 0.70 to 0.92 vs. 0.72, 95% confidence interval: 0.67 to 0.78). There were no differences in the rates of stroke, aortic valve reintervention, or myocardial infarction at 30 days or 1 year. Nonagenarians had lower (worse) median Kansas City Cardiomyopathy Questionnaire scores at 30 days; however, there was no significant difference at 1 year. CONCLUSIONS: In current U.S. clinical practice, approximately 16% of patients undergoing TAVR are ≥90 years of age. Although 30-day and 1-year mortality rates were statistically higher compared with younger patients undergoing TAVR, the absolute and relative differences were clinically modest. TAVR also improves quality of life to the same degree in nonagenarians as in younger patients. These data support safety and efficacy of TAVR in select very elderly patients.
RCT Entities:
BACKGROUND: Data demonstrating the outcome of transcatheter aortic valve replacement (TAVR) in the very elderly patients are limited, as they often represent only a small proportion of the trial populations. OBJECTIVES: The purpose of this study was to compare the outcomes of nonagenarians to younger patients undergoing TAVR in current practice. METHODS: We analyzed data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. Outcomes at 30 days and 1 year were compared between patients ≥90 years versus <90 years of age using cumulative incidence curves. Quality of life was assessed with the 12-item Kansas City Cardiomyopathy Questionnaire. RESULTS: Between November 2011 and September 2014, 24,025 patients underwent TAVR in 329 participating hospitals, of which 3,773 (15.7%) were age ≥90 years. The 30-day and 1-year mortality rates were significantly higher among nonagenarians (age ≥90 years vs. <90 years: 30-day: 8.8% vs. 5.9%; p < 0.001; 1 year: 24.8% vs. 22.0%; p < 0.001, absolute risk: 2.8%, relative risk: 12.7%). However, nonagenarians had a higher mean Society of Thoracic Surgeons Predicted Risk of Operative Mortality score (10.9% vs. 8.1%; p < 0.001) and, therefore, had similar ratios of observed to expected rates of 30-day death (age ≥90 years vs. <90 years: 0.81, 95% confidence interval: 0.70 to 0.92 vs. 0.72, 95% confidence interval: 0.67 to 0.78). There were no differences in the rates of stroke, aortic valve reintervention, or myocardial infarction at 30 days or 1 year. Nonagenarians had lower (worse) median Kansas City Cardiomyopathy Questionnaire scores at 30 days; however, there was no significant difference at 1 year. CONCLUSIONS: In current U.S. clinical practice, approximately 16% of patients undergoing TAVR are ≥90 years of age. Although 30-day and 1-year mortality rates were statistically higher compared with younger patients undergoing TAVR, the absolute and relative differences were clinically modest. TAVR also improves quality of life to the same degree in nonagenarians as in younger patients. These data support safety and efficacy of TAVR in select very elderly patients.
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