STENTLESS PORCINE BIOPROSTHESIS FOR AORTIC-VALVE REPLACEMENT

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 .