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Central Surgical Association

49th Annual Meeting

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Externally Versus Internally Mounted Leaflet Aortic Bioprosthesis Up To 10-Year Follow-up: Choice of Valve Truly Matters
Shinichi Fukuhara, Yoyo Wang, Suzuna Shiomi, Himanshu Patel, Bo Yang, Karen Kim, George M. Deeb
Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, United States

Objective: Externally mounted leaflet aortic bioprosthesis has been used during surgical aortic valve replacement (SAVR) and implanted in large number of SAVR arm patients in the landmark clinical trials comparing transcatheter aortic valve replacement (TAVR) and SAVR. However, recent studies reported higher-than-expected failure rates at mid-term. We sought to compare the long-term outcomes of a representitive externally (the Trifecta) and internally (the Magna Ease) mounted leaflet prosthesis.

Methods: We retrospectively reviewed 1,445 consecutive patients who received the Trifecta (746; 52%) and the Magna (699; 48%) bioprosthesis between January 2011 and December 2017. Among implanted Trifectas, 106 (14%) were the second-generation Trifecta. Clinical characteristics and outcomes were compared between groups.

Results: The Trifecta Group was characterized by older age (70.0 vs 66.0 years; p<0.001), more female (39 vs 30%; p<0.001) and more frequent pledget use, while less frequent severe aortic insufficiency (AI) (14 vs 22%; p<0.001), concurrent aortic repair (11 vs 17%; p=0.001) and smaller valve size (23.0 vs 25.0; p<0.001). The cumulative incidence of structural valve degeneration (SVD) at 10 years assessed by competing risks regression was significantly higher in the Trifecta Group for the entire (35.5 vs 10.5%, subdistribution hazard ratio (SHR) 3.9, 95% confidence interval (CI) 2.3–6.9; p<0.001) and younger cohort (≤ 65 years old) (73.2 vs 24.3%, SHR 4.7, 95%CI 2.6–8.5; p< 0.001). Furthermore, subgroup analysis comparing the first- and second-generation Trifecta showed similar SVD rate at 5 years (2.5 vs 4.7%; SHR 0.53, 95%CI 0.18–1.6, p=0.25). Among patients with SVD, AI or mixed stenosis/AI as the mode of failure was seen in 51% and 7% of patients in the Trifecta and Magna Group, respectively (p<0.001). Among the 504 propensity-matched pairs, created by adjusting age, gender, body size, previous surgery, valve pathology, medical comorbidities, implanted valve size, pledget use, concomitant surgery and post-SAVR anticoagulation usage, the cumulative incidence of SVD remained significant in the Trifecta Group (31.6 vs 7.6%, SHR 4.8, 95%CI 2.5–9.2; p<0.001) (Figure 1A) and the 10-year survival was lower (41.8 ± 4.6 vs 55.4 ± 4.9%, p=0.021) (Figure 1B) despite the matched group comparison.

Conclusions: This represents the first study reporting the "long-term" outcomes of the representative prosthesis with externally mounted leaflet design. Moreover, the second-generation Trifecta did not appear to have provided durability benefit. Choosing the right SAVR valve is part of life-time management of aortic valve disease. Further subgroup analyses of TAVR landmark clinical trials excluding externally mounted leaflet valves are highly warranted, considering the higher SVD and worse survival at 10 years among the Trifecta recipients.

(A) Cumulative incidence of structural valve degeneration up to 10 years among propensity-matched cohort patients. Death and prosthetic valve endocarditis were counted as competing events. (B) 10-year survival among propensity-matched cohort patients.


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