Eric J Velazquez1, Zainab Samad2, Hussein R Al-Khalidi3, Chithra Sangli4, Paul A Grayburn5, Joseph M Massaro6, Susanna R Stevens3, Ted E Feldman7, Mitchell W Krucoff8. 1. Duke Clinical Research Institute, Duke University Medical Center, Durham, NC; Division of Cardiology, Duke University Medical Center, Durham, NC. Electronic address: eric.velazquez@duke.edu. 2. Division of Cardiology, Duke University Medical Center, Durham, NC. 3. Duke Clinical Research Institute, Duke University Medical Center, Durham, NC. 4. Abbott Vascular, Abbott Park, IL. 5. Baylor Heart and Vascular Institute, Dallas, TX. 6. Harvard Clinical Research Institute, Boston, MA. 7. NorthShore University HealthSystem Evanston Hospital, Evanston, IL. 8. Duke Clinical Research Institute, Duke University Medical Center, Durham, NC; Division of Cardiology, Duke University Medical Center, Durham, NC.
Abstract
BACKGROUND: We compared 30-day and 1-year survival among high-risk mitral regurgitation (MR) patients treated with the MitraClip (Abbott Vascular, Abbott Park, IL) with matched non-surgically treated patients from the Duke Echocardiography Laboratory Database (DELD). METHODS AND RESULTS: High-risk patients with 3+/4+ MR managed non-surgically between years 2000 and 2010 in the longitudinal DELD were matched to high-risk MitraClip patients. Patient matching was performed using the method of nearest available Mahalanobis distance metric within calipers defined by the propensity score. Kaplan-Meier estimates and stratified Cox proportional hazards models were used to compare survival at 30 days and 1 year. Among 953 high-risk DELD patients available for matching, 30-day and 1-year mortality were 6.5% and 26.2%. Close matches were obtained for 239 of the 351 MitraClip patients. The 30-day mortality in MitraClip patients was lower (4.2%) when compared with matched DELD patients (7.2%). The 1-year relative risk of mortality of the MitraClip compared with non-surgical treatment was 0.64 (95% CI 0.45-0.91; log-rank P = .013). These results in favor of the MitraClip remained significant upon further adjustment for baseline differences between groups (P = .043). CONCLUSIONS: This matched comparison of severe MR patients at high surgical risk supports the safety of the MitraClip relative to medical therapy at 30 days and a survival benefit at 1 year.
RCT Entities:
BACKGROUND: We compared 30-day and 1-year survival among high-risk mitral regurgitation (MR) patients treated with the MitraClip (Abbott Vascular, Abbott Park, IL) with matched non-surgically treated patients from the Duke Echocardiography Laboratory Database (DELD). METHODS AND RESULTS: High-risk patients with 3+/4+ MR managed non-surgically between years 2000 and 2010 in the longitudinal DELD were matched to high-risk MitraClip patients. Patient matching was performed using the method of nearest available Mahalanobis distance metric within calipers defined by the propensity score. Kaplan-Meier estimates and stratified Cox proportional hazards models were used to compare survival at 30 days and 1 year. Among 953 high-risk DELD patients available for matching, 30-day and 1-year mortality were 6.5% and 26.2%. Close matches were obtained for 239 of the 351 MitraClip patients. The 30-day mortality in MitraClip patients was lower (4.2%) when compared with matched DELD patients (7.2%). The 1-year relative risk of mortality of the MitraClip compared with non-surgical treatment was 0.64 (95% CI 0.45-0.91; log-rank P = .013). These results in favor of the MitraClip remained significant upon further adjustment for baseline differences between groups (P = .043). CONCLUSIONS: This matched comparison of severe MRpatients at high surgical risk supports the safety of the MitraClip relative to medical therapy at 30 days and a survival benefit at 1 year.
Authors: Friso A Kortlandt; Thomas de Beenhouwer; Martin J Swaans; Marco C Post; Jan A S van der Heyden; Frank D Eefting; Benno J W M Rensing Journal: Cardiovasc Diagn Ther Date: 2016-04
Authors: Daniel J Friedman; Marat Fudim; Robert Overton; Linda K Shaw; Divyang Patel; Sean D Pokorney; Eric J Velazquez; Sana M Al-Khatib Journal: Am Heart J Date: 2018-04-04 Impact factor: 4.749
Authors: Edward Sze; Zainab Samad; Allison Dunning; Kristen Bova Campbell; Zak Loring; Brett D Atwater; Karen Chiswell; Joseph A Kisslo; Eric J Velazquez; James P Daubert Journal: J Am Coll Cardiol Date: 2018-01-23 Impact factor: 24.094