Key result
St. Jude Trifecta valve shows comparable all-cause reoperation risk versus Carpentier-Edwards Perimount valve.
Why the study?
Midterm data for the St. Jude Medical Trifecta valve are sparse, and confirmation of its early low reoperation rates compared with Carpentier-Edwards Perimount over time is needed.
Does the St. Jude Medical Trifecta valve reduce all-cause reoperation rates compared to the Carpentier-Edwards Perimount valve in patients undergoing aortic valve replacement?
Cohort (n=1,164)
Does the St. Jude Medical Trifecta valve reduce all-cause reoperation rates compared to the Carpentier-Edwards Perimount valve in patients undergoing aortic valve replacement?
Hazard Ratio: 2.68 (95% CI 0.97–7.39)
p-value: p=0.06
While overall 6-year reoperation rates were comparable, the St. Jude Medical Trifecta valve may be associated with higher reoperation rates than the Carpentier-Edwards Perimount valve in patients younger than 60 and current smokers.
BACKGROUND: The Carpentier-Edwards Perimount valves have a proven track record in aortic valve replacement: good durability, hemodynamic performance, rates of survival, and low rates of valve-related complications and prosthesis-patient mismatch. The St. Jude Medical Trifecta is a newer valve that has shown comparable early and midterm outcomes. Studies show reoperation rates of Trifecta are comparable with Perimount valves, with a few recent studies bringing into focus early structural valve deterioration (SVD), and increased midterm SVD in younger patients. Given that midterm data for Trifecta is still sparse, we wanted to confirm the early low reoperation rates of Trifecta persist over time compared with Perimount. METHODS: The Maritime Heart Centre Database was searched for AVR between 2011 and 2016, inclusive. The primary endpoint of the study was all-cause reoperation rate. RESULTS: In total, 711 Perimount and 453 Trifecta implantations were included. The reoperation hazards were determined for age: 0.96 (0.92-0.99; p = .02), female (vs. male): 0.35 (0.08-1.53; p = .16), smoker (vs. nonsmoker): 2.44 (0.85-7.02; p = .1), and Trifecta (vs. Perimount): 2.68 (0.97-7.39; p = .06). Kaplan-Meier survival analysis in subgroups-age <60, age ≥60, male, female, smoker, and nonsmoker-showed Perimount having lower reoperation rates than Trifecta in patients younger than 60 (p = .02) and current smokers (p < .01). CONCLUSIONS: The rates of reoperation of Perimount and Trifecta were comparable, with Trifecta showing higher rates in patients younger than 60 years, and current smokers. Continued diligence and further independent reporting of midterm reoperation and SVD rates of the Trifecta, including detailed echocardiographic follow-up, are needed to confirm these findings.
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Stubeda et al. (2020) conducted a cohort in Aortic valve replacement (n=1,164). St. Jude Medical Trifecta valve vs. Carpentier-Edwards Perimount valve was evaluated on All-cause reoperation rate (HR 2.68, 95% CI 0.97-7.39, p=0.06). The St. Jude Medical Trifecta valve had a comparable overall all-cause reoperation hazard compared to the Carpentier-Edwards Perimount valve (HR 2.68; 95% CI 0.97-7.39; p=0.06).
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