TY - JOUR
T1 - Concordance of Treatment Effect
T2 - An Analysis of The Society of Thoracic Surgeons Intermacs Database
AU - Pagani, Francis D.
AU - Cantor, Ryan
AU - Cowger, Jennifer
AU - Goldstein, Daniel J.
AU - Teuteberg, Jeffrey J.
AU - Mahr, Claudius W.
AU - Atluri, Pavan
AU - Kilic, Arman
AU - Maozami, Nader
AU - Habib, Robert H.
AU - Naftel, David
AU - Kirklin, James K.
N1 - Funding Information:
Francis D. Pagani is a member of the data safety monitoring board for Carmat, Inc.; a member of the data safety monitoring board for the National Heart, Lung, and Blood Institute PumpKIN clinical trial; and Chair of The Society of Thoracic Surgeons (STS) Intermacs Task Force. Jennifer Cowger is an unpaid member of the Endotronix, Inc., Steering Committee; an unpaid member of the Procyrion, Inc., Steering Committee; and receives clinical trial funding to Henry Ford Health System from Abbott and Medtronic. Pavan Atluri reports membership on the Steering Committee for Abiomed and is Chair of the STS Intermacs Data Access and Publications and Participant User File task forces. James Kirklin reports receiving partial salary support from STS to University of Alabama at Birmingham for his position as Director of the Data Center for STS Intermacs. Statistical analyses were performed at the Kirklin Institute for Research in Surgical Outcomes, University of Alabama at Birmingham, Birmingham, Alabama, by Dr Ryan Cantor under the direction of Dr James Kirklin. All authors had access to summary statistical data. Funding for the study was provided by STS through the STS Access and Publications Task Force under the Workforce on Research Development and the Workforce on National Databases.
Funding Information:
Francis D. Pagani is a member of the data safety monitoring board for Carmat, Inc.; a member of the data safety monitoring board for the National Heart, Lung, and Blood Institute PumpKIN clinical trial; and Chair of The Society of Thoracic Surgeons (STS) Intermacs Task Force. Jennifer Cowger is an unpaid member of the Endotronix, Inc. Steering Committee; an unpaid member of the Procyrion, Inc. Steering Committee; and receives clinical trial funding to Henry Ford Health System from Abbott and Medtronic. Pavan Atluri reports membership on the Steering Committee for Abiomed and is Chair of the STS Intermacs Data Access and Publications and Participant User File task forces. James Kirklin reports receiving partial salary support from STS to University of Alabama at Birmingham for his position as Director of the Data Center for STS Intermacs. Statistical analyses were performed at the Kirklin Institute for Research in Surgical Outcomes, University of Alabama at Birmingham, Birmingham, Alabama, by Dr Ryan Cantor under the direction of Dr James Kirklin. All authors had access to summary statistical data. Funding for the study was provided by STS through the STS Access and Publications Task Force under the Workforce on Research Development and the Workforce on National Databases.
Publisher Copyright:
© 2022 The Society of Thoracic Surgeons
PY - 2022/4
Y1 - 2022/4
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85108940933&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85108940933&partnerID=8YFLogxK
U2 - 10.1016/j.athoracsur.2021.05.017
DO - 10.1016/j.athoracsur.2021.05.017
M3 - Article
C2 - 34087236
AN - SCOPUS:85108940933
SN - 0003-4975
VL - 113
SP - 1172
EP - 1182
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
IS - 4
ER -