Discussion
In comparison, CE Perimount and SJM Trifecta reoperation hazards were 1.64% for Perimount and 3.93% for Trifecta (p = 0.06) at 6 years, which while a 2.75-fold difference, was not statistically significant (p=0.06). The hazard function for reoperation with Trifecta implants was significantly higher among patients younger than 60 years of age and among patients with a history of smoking. A recent study of mid-term Trifecta durability has shown Trifecta was associated with high rates of SVD in patients younger than 65 years compared to non-Trifecta group composed of Magna Ease (80.4%), Intuity (13.1%), Mitroflow (3.8%), and Avalus (2.7%), and the rate difference was also approximately 3-fold.18 However, other studies have shown Perimount and Trifecta having similar rates of reoperation or reintervention. For Perimount Magna, reintervention rate was 1% at 10 years,19 and cumulative incidences of explantation for endocarditis and SVD were 1.2% and 1.0% at 10 years.20 For Trifecta, three studies have reported the freedom from all-cause aortic bioprosthesis reintervention at 5 years to be 98.6%,21 96%,22 and 84.5%.23 There is variability between studies and surgical centers, which demonstrates Perimount and Trifecta can have comparable rates of reoperation, but with a slight preponderance in current literature for higher rates of SVD in Trifecta.
In this study, Trifecta demonstrated a noticeably high rate of reoperations at <6 months of the study period in higher risk subgroups: age < 60 years, males, and smokers (Fig. 2). Trifecta failures at <46 months have also been described before and attributed in part to insufficient surgeon experience with a new valve leading to PPM and higher postoperative peak and mean AV gradients,20 and to mechanical issues: tear of the noncoronary cusp, circumferential pannus formation composed of fibrofatty tissue in the inflow portion, and leaflet calcification concentrated around the posts in the outflow portion leading to restricted leaflet mobility, stenosis, and regurgitation.24,25 Only 1 out of 16 patients had active endocarditis during reoperation, due to which the prosthesis may have failed. Otherwise, the cause of reoperation was not available, which is a limitation of this study.