Randomized Comparison of Stentless Versus Stented Valves for Aortic Stenosis

• DOI: 10.1161/circulationaha.104.521161
• Publication Date: 2005-10-18T00:33:48Z
• Authors: Diego Perez de Ar...; Belinda Lees; Marcus Flather; Fiona Nugara; Trygve Husebye; Marek Jasinski; Marek Cisowski; Mohammed Khan; Michael Henein; Jullien Gaer; Levant Guvendik; Andrzej Bochenek; Stanislaw Wos; Mons Lie; Guido Van Nooten; Dudley Pennell; John Pepper
• Keywords: Heart Valve Prosthesis Implantation; Male; Time Factors; Patient Selection; 610; Aortic Valve Stenosis; Organ Size; Middle Aged; Magnetic Resonance Imaging; Ventricular Function, Left; 3. Good health; Ventricular Dysfunction, Left; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Echocardiography; 617; Humans; Female; Stents; Aged; Follow-Up Studies

Background—

Aortic valve replacement (AVR) is the established treatment for severe aortic stenosis. In response to the long-term results of aortic homografts, stentless porcine valves were introduced as an alternative low-resistance valve. We conducted a randomized trial comparing a stentless with a stented porcine valve in adults with severe aortic stenosis.

Methods and Results—

The primary outcome was change in left ventricular mass index (LVMI) measured by transthoracic echocardiography and, in a subset, by cardiovascular MR. Measurements were taken before valve replacement and at 6 and 12 months. Patients undergoing AVR with an aortic annulus ≤25 mm in diameter were randomly allocated to a stentless (n=93) or a stented supra-annular (n=97) valve. There were no significant differences in mean LVMI between the stentless versus stented groups at baseline (176±62 and 182±63 g/m 2 , respectively) or at 6 months (142±49 and 131±45 g/m 2 , respectively), although within-group changes from baseline to 6 months were highly significant. Changes in LVMI measured by cardiovascular MR (n=38) were consistent with the echo findings. There was a greater reduction in peak aortic velocity ( P <0.001) and a greater increase in indexed effective orifice area ( P <0.001) in the stentless group than in the stented group. There were no differences in clinical outcomes between the 2 valve groups.

Conclusions—

Despite significant differences in indexed effective orifice area and peak flow velocity in favor of the stentless valve, there were similar reductions in left ventricular mass at 6 months with both stented and stentless valves, which persisted at 12 months.