Midterm, multicenter clinical and hemodynamic results for the Trifecta aortic pericardial valve
Why the study?
Does the Trifecta aortic pericardial valve provide safe and effective midterm hemodynamic performance and clinical outcomes in patients requiring aortic valve replacement?
Population
710 patients undergoing surgical implantation of a pericardial stented aortic prosthesis, mean age 72.4 ±…
Design
Cohort
Follow-up
6 years
Authors
Discussion
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Implication
Supports Trifecta use in aortic replacement; leaves open need for randomized comparisons to other bioprostheses.
Key Points
- The aim is to evaluate midterm hemodynamic performance and clinical outcomes of the Trifecta aortic pericardial valve.
- Multicenter, prospective, nonrandomized follow-up study
- 710 patients underwent surgical implantation of Trifecta valve
- Patients were followed annually for 6 years.
- 95.8% of patients improved to NYHA class I or II at 6 years postoperatively
- 98.3% freedom from valve-related mortality at 6 years
- Average mean gradient was 11.0 mm Hg across all valve sizes.
Structured PICO
Does the Trifecta aortic pericardial valve provide safe and effective midterm hemodynamic performance and clinical outcomes in patients requiring aortic valve replacement?
P
Population
710 patients undergoing surgical implantation of a pericardial stented aortic prosthesis, mean age 72.4 ± 9.3 years, 66.3% men, 50.8% NYHA class III or IV preoperatively.
I
Intervention
Surgical implantation of the Trifecta aortic pericardial valve (bovine pericardium mounted externally onto a titanium stent)
O
Outcome
Midterm hemodynamic performance and clinical outcomes (including NYHA class, mean gradient, effective orifice area index, valvular regurgitation, and freedom from valve-related mortality, nonstructural dysfunction, paravalvular leak, and reoperation due to structural valve deterioration) at 6 yearshard clinical
The Trifecta aortic pericardial valve demonstrates excellent midterm durability, safety, and hemodynamic performance at 6-year follow-up.
Cite This Study
Goldman et al. (2016) studied this question.