Randomized Prospective Hemodynamic Comparison of St. Jude Trifecta and Carpentier-Edwards Perimount Magna Ease - the COTRIP Trial

Objectives: The Trifecta (St. Jude Medical) and the Perimount Magna Ease (Edwards Lifesciences) valves are supra-annular aortic bioprostheses with a special design for maximized opening area and thus improved hemodynamics. Aim of this study was a prospective comparison of both valves, randomized 1:1 by intraoperative metric annulus sizing.

Methods: 98 patients with aortic valve stenosis were prospectively included. Aortic valve replacement (AVR) with or without concomitant bypass and or ablation surgery was performed in the standard fashion. After decalcification of the aortic annulus, the annulus-diameter was measured using metric hegar-dilators and the prosthesis randomization was based on the hegar-dilator size. Valve size was then based on the manufacturer's sizers. Medical history and clinical status were recorded. Echocardiography were performed pre- and postoperatively.

Results: Mean age was 69 years with 36% female. Mean metric annulus size was 24.8mm and in 95% of the patients the implanted valve was of the same size or smaller than the hegar-dilator. The predominant valve sizes were 23mm (40%) and 25mm (32%). For all valve sizes, unadjusted mean pressure gradient (MPG) was significantly lower and indexed effective orifice area larger for the Trifecta group (10.9 ± 5 versus 13.2 ± 4mmHg, p = 0.02 and 0.95 ± 0.3 versus 0.85 ± 0.2 cm²/m²). The same significant difference in MPG was seen in the predominant group of valve size 23/25 mm. There was a trend toward lower incidence of severe prosthesis-patient mismatch for the Trifecta group (6.4% versus 10.4%, p = 0.7)

Conclusion: The Trifecta and the Perimount Magna Ease prostheses both show excellent hemodynamic performance after AVR. The Trifecta valve seems to be even superior to the Magna Ease, which may be advantageous in very obese patients. Six month follow-up in this trial will be performed.