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Ten-Year Outcomes of Mitral Valve Replacement with Edwards Bovine Pericardial Mitral Bioprostheses in the Medicare Population
Ely Erez1, Cody W. Dorton1, Jasjit Banwait1, MohamadBader AboHajar1, John Squiers2, J. Michael DiMaio2, Justin Schaffer2
1Baylor Scott & White Research Institute, Dallas, TX, 2Cardiothoracic Surgery, Baylor Scott & White The Heart Hospital Plano, Plano, TX
Objective:
Leading mitral bioprostheses differ by tissue source (bovine versus porcine) as well as by tissue fixation, anti-calcification, and structural design. Long-term outcomes are essential for evaluating prosthesis performance; however, 10-year outcomes data are currently available for only a single porcine tissue valve. This study evaluated 10-year survival following mitral valve replacement (MVR) with Edwards bovine pericardial mitral bioprostheses in a national Medicare cohort.
Methods:
In this retrospective cohort study, Medicare hospital claims were used to identify beneficiaries who underwent surgical MVR between 2008-2019. Medicare claims were linked using a probabilistic matching algorithm to a device-registration dataset of Edwards bovine pericardial mitral prostheses (Edwards Lifesciences). Patients were stratified by isolated MVR (with or without TV and/or ASD repair) versus MVR with additional cardiac surgery (e.g. CABG, AVR, etc). Unadjusted 10-year Kaplan-Meier survival estimates were compared.
A flexible parametric survival model adjusting for demographics, social determinants of health, insurance status, comorbidities (identified using Elixhauser criteria), transfer and admission status, mitral disease etiology, and procedural characteristics was developed. Regression standardization was applied to generate standardized survival probability (SSP) curves. SSPs were compared across Edwards valve types during isolated MVR, and across mitral disease etiologies. 95% confidence intervals are shown in brackets.
Results:
After matching, 35,500 beneficiaries met inclusion criteria: 18,153 (51.1%) underwent isolated MVR (with or without ASD repair and/or TV surgery) and 17,347 (48.9%) underwent MVR with concomitant cardiac procedures (Table). Median follow-up was 5.19 years (IQR: 5.13-5.25). Over time, there was increased use of the Magna Mitral Ease (7300TFX) model and decreased use of the Carpentier-Edwards Plus (6900P), Perimount Theon (6900PTFX), and Magna Mitral (7000TFX) prostheses (Figure 1).
Compared with patients undergoing concomitant procedures, isolated MVR recipients were younger (72.2 ± 8.9 vs 73.3 ± 8.1 years), more often female (59.9% vs 46.8%), had a higher prevalence of endocarditis (8.7% vs 7.2%) but a lower prevalence of rheumatic valve disease (39.2% vs 50.6%), and received slightly larger prostheses (28.1 ± 2.4 vs 27.8 ± 2.3 mm) (Table).
Unadjusted Kaplan-Meier survival estimates demonstrated substantially higher median survival after isolated MVR compared with MVR plus concomitant cardiac surgery (7.91 [7.76-8.11] vs 5.87 [5.70-6.04] years) (Figure 2).
Among patients undergoing isolated MVR, SSPs were similar across prosthesis types (Figure 3), with median survival of 8.04 [7.70-8.40] years for 6900P valves, 7.85 [7.57-8.14] years for 6900PTFX valves, 8.03 [7.63-8.46] years for 7000TFX valves, and 7.84 [7.63-8.05] years for 7300TFX valves.
In contrast, SSPs after isolated MVR varied significantly by mitral disease etiology (Figure 4). Median survival probabilities were lower among patients with mitral valve endocarditis (6.80 [6.47-7.15] years) compared with those with rheumatic mitral disease (8.32 [8.07-8.57] years) or non-endocarditis, non-rheumatic mitral disease etiologies (7.75 [7.56-7.96] years).
Conclusions:
This study, linking Medicare data to a device-registration dataset maintained by Edwards, represents the largest contemporary evaluation of long-term outcomes following MVR with bovine bioprosthetic valves. Important trends in valve model utilization were identified, and 10-year survival compared favorably with previously published outcomes for a commonly used porcine mitral prosthesis. Survival did not differ meaningfully across Edwards prosthesis types, while mitral disease etiology and the need for concomitant procedures substantially influenced long-term survival.
Figure 1. Distribution of Carpentier-Edwards Perimount Mitral Prosthesis Types Over the Study Period
Figure 2. Ten-Year Unadjusted Kaplan-Meier Survival Estimates for Isolated MVR Versus MVR With Concomitant Cardiac Procedures
Figure 3. Ten-Year Standardized Survival Probabilities After Isolated MVR, Stratified by Mitral Prosthesis Type
Figure 4. Ten-Year Standardized Survival Probabilities, Stratified by Etiology of Mitral Valve Disease
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