Are Stentless Valves Hemodynamically Superior to Stented Valves? Long-term Follow-Up of a Randomized Trial
Gideon Cohen, Brandon Zagorski, George T. Christakis, Campbell D. Joyner, Jeri Sever, Stephen E. Fremes, Fuad Moussa, Randi Feder-Elituv, Bernard S. Goldman; Cardiovascular Surgery, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
Comment on this Abstract
Objective: The benefit of stentless valves remains in question. In 1999, a randomized trial comparing stentless and stented valves was unable to demonstrate any hemodynamic or clinical benefits at one year post implant. This study reviews long term outcomes of patients randomized in the aforementioned trial.
Methods: Between 1996 and 1999, 99 patients undergoing aortic valve replacement were randomized to receive either a stented CE pericardial valve (CE), or a Toronto Stentless Porcine valve (SPV). Amongst these, 38 patients were available for late follow up (CE-17;SPV-21). Echocardiography was undertaken both at rest and with dobutamine stress (DSE), and functional status (Duke Activity Status Index; DASI) was compared at a mean of 9.3 yrs postoperatively (Range 7.5-11.1 yrs).
Results: Although labelled mean valve size implanted was significantly larger in the SPV group, actual valve size based on internal diameter was no different between groups (CE: 21.9±2.0; SPV: 22.3±2.0 mm;p=0.286). Preoperative characteristics were similar between groups. Late mortality and/or morbidity were no different between groups (p=0.80). Two patients in the SPV group required reoperation, both for structural valve deterioration. Effective orifice areas (EOAs) increased in both groups over time. Although there were no differences in EOAs at 1 year, at 10 years EOAs were significantly greater in the SPV group (CE:1.49±0.59, SPV: 2.00±0.53 cm2;p=0.011). Similarly, mean and peak gradients decreased in both groups over time; however at 10 years, gradients were lower in the SPV group (Mean- CE: 10.8±3.8, SPV: 7.8±4.8 mmHg;p=0.011)(Peak- CE: 20.4±6.5, SPV: 14.6±7.1 mmHg;p=0.022). Such differences were magnified with DSE (Mean- CE: 22.7±6.1, SPV: 15.3±8.4 mmHg;p=0.008)(Peak- CE: 48.1±11.8, SPV: 30.8±17.7 mmHg;p=0.001). Ventricular mass regression occurred in both groups, however no differences were demonstrated between groups(Figure 1;p=0.74). Similarly, DASI scores of functional status improved in both groups over time, however, no differences were noted between groups (CE:27.5±19.1, SPV:19.9±12.0;p=0.69). Measures of ventricular function including ejection fraction and fractional shortening, along with NYHA functional class were similar between groups both at 1 and 10 years postoperatively (p>0.3).
Conclusion: Although offering improved hemodynamic outcomes, stentless valves did not afford superior mass regression or clinical outcomes up to 10 years post implantation.
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