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.