We report herein our experience with the Toronto Stentless Porcine Val
ve((TM)) (Toronto SPV, manufactured by St.Jude Medical Inc., Minneapol
is; MN, USA) for aortic valve replacement (AVR). To date 146 SPV valve
s have been implanted, 29 in an initial clinical trial (from October 1
987 to April 1987) and 117 in the current FDA trial (September 1991 to
January 1994). in the current trial the majority of patients were mal
e (76%), aortic stenosis was the dominant lesion (73%) and 68% of the
patients received a valve size 27 mm or greater. The mean age was 61.3
+/-12.0 years. For the entire group there has been no hospital death a
nd no patient has required a pacemaker. Perioperative complications we
re myocardial infarction in three patients and suspect subacute bacter
ial endocarditis (medically treated) in three patients. There have bee
n two late deaths (2%), two patients have had transient ischemic attac
ks (2%), and one patient suffered stroke with complete neurological re
covery (1%). To date there has been no case of primary valve failure.
Echocardiographic assessment of the SPV valve has demonstrated excelle
nt effective valve orifice areas with very low transvalvular gradients
and 95% of the patients had either 0 or 1+ insufficiency. These resul
ts are encouraging and justify the continued use of this valve in clin
ical trials. further follow-up is required to determine its durability
.