J Matthew Brennan1, Laine Thomas2, David J Cohen3, David Shahian4, Alice Wang5, Michael J Mack6, David R Holmes7, Fred H Edwards8, Naftali Z Frankel9, Suzanne J Baron3, John Carroll10, Vinod Thourani11, E Murat Tuzcu12, Suzanne V Arnold3, Roberta Cohn9, Todd Maser13, Brenda Schawe13, Susan Strong13, Allen Stickfort13, Elizabeth Patrick-Lake13, Felicia L Graham5, Dadi Dai5, Fan Li14, Roland A Matsouaka14, Sean O'Brien15, Fan Li14, Michael J Pencina2, Eric D Peterson2. 1. Duke University School of Medicine, Durham, North Carolina. Electronic address: j.matthew.brennan@dm.duke.edu. 2. Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. 3. Saint Luke's Mid America Heart Institute, Kansas City, Missouri. 4. Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. 5. Duke Clinical Research Institute, Durham, North Carolina. 6. The Heart Hospital Baylor Plano Research Center, Plano, Texas. 7. Mayo Clinic, Rochester, Minnesota. 8. University of Florida Health Science Center, Jacksonville, Florida. 9. Caregiver Collaborator, Duke Clinical Research Institute, Durham, North Carolina. 10. University of Colorado Hospital, Aurora, Colorado. 11. Emory University School of Medicine, Atlanta, Georgia. 12. Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates. 13. Patient Collaborator, Duke Clinical Research Institute, Durham, North Carolina. 14. Duke University School of Medicine, Durham, North Carolina. 15. Duke University School of Medicine, Durham, North Carolina; Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
Abstract
BACKGROUND: Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged. OBJECTIVES: The aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort. METHODS: Using data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ≥3%) U.S. patients who underwent commercial TAVR or SAVR were examined. Death, stroke, and days alive and out of the hospital to 1 year were compared, as well as discharge home, with subgroup analyses by surgical risk, demographics, and comorbidities. RESULTS: In a propensity-matched cohort (median age 82 years, 48% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score 5.6%), TAVR and SAVR patients experienced no difference in 1-year rates of death (17.3% vs. 17.9%; hazard ratio: 0.93; 95% confidence interval [CI]: 0.83 to 1.04) and stroke (4.2% vs. 3.3%; hazard ratio: 1.18; 95% CI: 0.95 to 1.47), and no difference was observed in the proportion of days alive and out of the hospital to 1 year (rate ratio: 1.00; 95% CI: 0.98 to 1.02). However, TAVR patients were more likely to be discharged home after treatment (69.9% vs. 41.2%; odds ratio: 3.19; 95% CI: 2.84 to 3.58). Results were consistent across most subgroups, including among intermediate- and high-risk patients. CONCLUSIONS: Among unselected intermediate- and high-risk patients, TAVR and SAVR resulted in similar rates of death, stroke, and DAOH to 1 year, but TAVR patients were more likely to be discharged home.
BACKGROUND: Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged. OBJECTIVES: The aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort. METHODS: Using data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ≥3%) U.S. patients who underwent commercial TAVR or SAVR were examined. Death, stroke, and days alive and out of the hospital to 1 year were compared, as well as discharge home, with subgroup analyses by surgical risk, demographics, and comorbidities. RESULTS: In a propensity-matched cohort (median age 82 years, 48% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score 5.6%), TAVR and SAVR patients experienced no difference in 1-year rates of death (17.3% vs. 17.9%; hazard ratio: 0.93; 95% confidence interval [CI]: 0.83 to 1.04) and stroke (4.2% vs. 3.3%; hazard ratio: 1.18; 95% CI: 0.95 to 1.47), and no difference was observed in the proportion of days alive and out of the hospital to 1 year (rate ratio: 1.00; 95% CI: 0.98 to 1.02). However, TAVR patients were more likely to be discharged home after treatment (69.9% vs. 41.2%; odds ratio: 3.19; 95% CI: 2.84 to 3.58). Results were consistent across most subgroups, including among intermediate- and high-risk patients. CONCLUSIONS: Among unselected intermediate- and high-risk patients, TAVR and SAVR resulted in similar rates of death, stroke, and DAOH to 1 year, but TAVR patients were more likely to be discharged home.
Authors: Hasan Jilaihawi; Tarun Chakravarty; Robert E Weiss; Gregory P Fontana; James Forrester; Raj R Makkar Journal: Catheter Cardiovasc Interv Date: 2012-03-13 Impact factor: 2.692
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Authors: Martin B Leon; Craig R Smith; Michael J Mack; Raj R Makkar; Lars G Svensson; Susheel K Kodali; Vinod H Thourani; E Murat Tuzcu; D Craig Miller; Howard C Herrmann; Darshan Doshi; David J Cohen; Augusto D Pichard; Samir Kapadia; Todd Dewey; Vasilis Babaliaros; Wilson Y Szeto; Mathew R Williams; Dean Kereiakes; Alan Zajarias; Kevin L Greason; Brian K Whisenant; Robert W Hodson; Jeffrey W Moses; Alfredo Trento; David L Brown; William F Fearon; Philippe Pibarot; Rebecca T Hahn; Wael A Jaber; William N Anderson; Maria C Alu; John G Webb Journal: N Engl J Med Date: 2016-04-02 Impact factor: 91.245
Authors: Peter E Umukoro; Paul Yeung-Lai-Wah; Sunil Pathak; Sabri Elkhidir; Deepa Soodi; Brooke Delgoffe; Richard Berg; Kelley P Anderson; Romel J Garcia-Montilla Journal: Clin Med Res Date: 2020-10-14
Authors: Harun Kundi; Kamil F Faridi; Yun Wang; Rishi K Wadhera; Linda R Valsdottir; Jeffrey J Popma; Daniel B Kramer; Robert W Yeh Journal: Circulation Date: 2019-09-09 Impact factor: 29.690