Francis D Pagani1, Ryan Cantor2, Jennifer Cowger3, Daniel J Goldstein4, Jeffrey J Teuteberg5, Claudius W Mahr6, Pavan Atluri7, Arman Kilic8, Nader Maozami9, Robert H Habib10, David Naftel2, James K Kirklin2. 1. Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan. Electronic address: fpagani@umich.edu. 2. Kirklin Institute for Research in Surgical Outcomes, University of Alabama at Birmingham, Birmingham, Alabama. 3. Henry Ford Health System, Detroit, Michigan. 4. Department of Cardiothoracic & Vascular Surgery, Montefiore Einstein Center for Heart and Vascular Care, New York, New York. 5. Division of Cardiovascular Medicine, Stanford University Medical Center, Stanford, California. 6. Department of Medicine, University of Washington Medical Center, Seattle, Washington. 7. Division of Cardiothoracic Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania. 8. Division of Cardiac Surgery, Medical University of South Carolina, Charleston, South Carolina. 9. Department of Cardiothoracic Surgery, Langone Medical Center, New York University, New York, New York. 10. The Society of Thoracic Surgeons Research Center, The Society of Thoracic Surgeons, Chicago, Illinois.
Abstract
BACKGROUND: The Society of Thoracic Surgeons (STS) Intermacs Registry represents a real-world data source of durable, left ventricular assist devices that can address knowledge gaps not informed through randomized clinical trials. We sought to compare survival with contemporary left ventricular assist device technologies using multiple analytic approaches to assess concordance of treatment effects and to validate prior STS Intermacs observations. METHODS: Patients (≥19 years of age) enrolled into STS Intermacs between August 2017 and June 2019 were stratified by device type (continuous flow, centrifugal left ventricular assist device with hybrid levitation [CF-HL] or full magnetic levitation [CF-FML]). The primary outcome was 1-year survival assessed by 3 statistical methodologies (multivariable regression, propensity score matching, and instrumental variable analysis). RESULTS: Of 4448 patients, 2012 (45.2%) received the CF-HL and 2436 (54.8%) received the CF-FML. One-year survival for the CF-FML was 88% vs 79% for the CF-HL (overall P < .001), with a hazard ratio for mortality of 3.18 for the CF-HL (P < .0001) after risk adjustment. With propensity score matching (n = 1400 each cohort), 1-year survival was 87% for the CF-FML vs 80% for the CF-HL, with a hazard ratio of 3.20 for mortality with the CF-HL (P < .0001) after risk adjustment. With an instrumental variable analysis, the probability of receiving the CF-HL was associated with a hazard ratio of 3.11 (P < .0001). CONCLUSIONS: Statistical methodology using propensity score matching and instrumental variable analysis increased the robustness of observations derived from real-world data and demonstrates the feasibility of performing comparative effectiveness research using STS Intermacs. These analyses provide additional evidence supporting a survival benefit of the CF-FML vs CF-HL.
BACKGROUND: The Society of Thoracic Surgeons (STS) Intermacs Registry represents a real-world data source of durable, left ventricular assist devices that can address knowledge gaps not informed through randomized clinical trials. We sought to compare survival with contemporary left ventricular assist device technologies using multiple analytic approaches to assess concordance of treatment effects and to validate prior STS Intermacs observations. METHODS: Patients (≥19 years of age) enrolled into STS Intermacs between August 2017 and June 2019 were stratified by device type (continuous flow, centrifugal left ventricular assist device with hybrid levitation [CF-HL] or full magnetic levitation [CF-FML]). The primary outcome was 1-year survival assessed by 3 statistical methodologies (multivariable regression, propensity score matching, and instrumental variable analysis). RESULTS: Of 4448 patients, 2012 (45.2%) received the CF-HL and 2436 (54.8%) received the CF-FML. One-year survival for the CF-FML was 88% vs 79% for the CF-HL (overall P < .001), with a hazard ratio for mortality of 3.18 for the CF-HL (P < .0001) after risk adjustment. With propensity score matching (n = 1400 each cohort), 1-year survival was 87% for the CF-FML vs 80% for the CF-HL, with a hazard ratio of 3.20 for mortality with the CF-HL (P < .0001) after risk adjustment. With an instrumental variable analysis, the probability of receiving the CF-HL was associated with a hazard ratio of 3.11 (P < .0001). CONCLUSIONS: Statistical methodology using propensity score matching and instrumental variable analysis increased the robustness of observations derived from real-world data and demonstrates the feasibility of performing comparative effectiveness research using STS Intermacs. These analyses provide additional evidence supporting a survival benefit of the CF-FML vs CF-HL.
Authors: Michael J Pienta; Xiaoting Wu; Thomas M Cascino; Alexander A Brescia; Ashraf Abou El Ela; Min Zhang; Jeffrey S McCullough; Supriya Shore; Keith D Aaronson; Michael P Thompson; Francis D Pagani; Donald S Likosky Journal: Ann Thorac Surg Date: 2022-02-15 Impact factor: 5.102