Aortic valve replacement with a stentless porcine bioprosthesis: multicentre trial. Canadian Investigators of the Toronto SPV Valve Trial.
OBJECTIVE
To evaluate the clinical and hemodynamic performance of a new bioprosthesis for replacement of the aortic valve in humans.


METHODS
In a multicentre clinical trial between July 1991 and January 1994, 118 patients underwent aortic valve replacement with the Toronto SPV valve.


RESULTS
Valvular pathology was aortic stenosis in 58%, insufficiency in 12% and mixed valvular disease in 30%; congenital bicuspid aortic valve was seen in 42% while heavy calcification was present in 86%. In approximately a third of the patients, concomitant coronary artery bypass surgery was performed. The mean period of aortic occlusion was 89 mins (range 48 to 180). Valve sizes implanted were: 22 mm (1%), 23 mm (7.6%), 25 mm (22.9%), 27 mm (37.3%) or 29 mm (31.4%). There were three deaths in the series: two from subacute bacterial endocarditis and one suicide. Early complications were cardiac arrest (0.8%), thromboembolism (2.5%) and arrhythmia (12.7%), while late complications were cardiac arrest (0.8%), arrhythmia (4.7%), angina (0.8%), thromboembolism (4.4%), endocarditis (1.7%) and other sepsis (0.8%). There were no valve related failures in 119 valve-years (mean follow-up 1.01 valve-year per patient). Follow-up echocardiography demonstrated an average decrease in mean systolic gradient of 36% from early to late postoperative period (P < 0.001) and an average increase in effective orifice area of 35% (P < 0.001) in the same period. No regurgitation was noted in 91% of patients at early, and 89% of patients at late, follow-up.


CONCLUSIONS
The Toronto SPV valve offers excellent hemodynamics, is relatively easy to insert and has few valve related complications. The observed changes in transvalvular area over time are consistent with a hypothesis that the ventricle undergoes remodelling following aortic valve replacement with this bioprosthesis. Longer follow-up is required to determine durability.
Del Rizzo
D F
DF
Toronto Hospital, Ontario.
Goldman
B S
BS
David
T E
TE
D000818:Animals; D001022:Aortic Valve Insufficiency / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis / Q000009:adverse effects; D002170:Canada; D001026:Coronary Artery Bypass; D005069:Evaluation Studies as Topic; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D006439:Hemodynamics; D006801:Humans; D011183:Postoperative Complications / Q000453:epidemiology; D013552:Swine