COMPARISON OF LOW-PRESSURE VERSUS STANDARD-PRESSURE FIXATION CARPENTIER-EDWARDS BIOPROSTHESIS

Intermediate-phase clinical results of 51 low-pressure (LP) and 234 st andard-pressure (SP) fixation porcine Carpentier-Edwards (CE) valves i mplanted between 1977 and 1991 were compared for valve-related events. Group similarities included New York Heart Association functional cla ss, ejection fraction, and sex. Patients with SP valves were younger ( mean age, 58 versus 68 years; p = 0.0001). There were 20 in-hospital d eaths (8.6%) in the SP valve group and 5 (9.8%) in the LP valve group (p = 0.79). Follow-up was 99%, with a mean of 104 months in the SP val ve group versus 55 months in the SP valve group (p = 0.0001). The actu arial survival rate was 48.2% and 22.3% at 10 and 15 years, respective ly, in the SP valve group and 34.1% at 10 years in the LP valve group (p = 0.42). Freedom from events at 5, 10, and 15 years in the SP valve group and at 5 years in the LP valve group was as follows: for late v alve-related events, 86.3%, 51.4%, and 20.2%, respectively, in the SP valve group versus 85% in the LP valve group (p = 0.44); for valve-rel ated death, 96.4%, 93.6%, and 87.3% in the SP valve group versus 100% in the LF valve group (p = 0.20); for structural valve failure, 96%, 6 8%, and 35% in the SP valve group versus 100% in the LP valve group (p = 0.09); and for reoperation, 95%, 61%, and 30% in the SP valve group versus 92% in the LP valve group (p = 0.82). In conclusion, this stud y revealed no significant statistical difference between LP and SP val ves. In the LP valve group, structural valve failure/valve-related dea th was not observed, perhaps indicating a more favorable result. Absol ute verification of this trend awaits long-term follow-up.