Key result
Trifecta valve shows comparable all-cause reoperation rates to 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 to 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 AVR?
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 AVR?
Hazard Ratio: 2.68 (95% CI 0.97–7.39)
p-value: p=0.06
While overall 6-year reoperation rates were comparable between Trifecta and Perimount aortic valves, the Trifecta valve may be associated with higher reoperation rates in patients under 60 years of age and smokers.
Comparable reoperation rates should not change valve selection; leaves open age- and smoking-related durability signals for prospective study.
Background The Carpentier-Edwards Perimount valves have a proven track record in aortic valve replacement: good durability, hemodynamic performance, rates of survival, and infrequent valve-related complications and PPM. 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 to Perimount valves, with a few recent studies bringing into focus early 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 to Perimount. Methods The Maritime Heart Centre Database was searched for isolated AVR or AVR+CABG between January 2011 and December 2016. Primary end point of the study was all-cause reoperation rate. Results 711 Perimount and 453 Trifecta implantations were included. The reoperation hazards were determined for age: 0.96 (0.92-0.99, p=0.02), female (vs male): 0.35 (0.08-1.53, p=0.16), smoker (vs non-smoker): 2.44 (0.85-7.02, p=0.1), and Trifecta (vs Perimount): 2.68 (0.97-7.39, p=0.06). Kaplan-Meier survival analysis in subgroups—age < 60, age ≥ 60, male, female, smoker, and non-smoker—showed Perimount having lower reoperation rates than Trifecta in patient younger than 60 (p=0.02) and those with smoking history (p<0.01). 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.
No takes yet. Share an insight, caveat, or question.
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 rate to the Carpentier-Edwards Perimount valve (HR 2.68; 95% CI 0.97-7.39; p=0.06).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: