Performance of the CryoValve* SG human decellularized pulmonary valve in 342 patients relative to the conventional CryoValve at a mean follow-up of four years

Objective: This study compared clinical outcomes of patients receiving CryoValve SG decellularized pulmonary valves with those of patients receiving conventionally processed CryoValve pulmonary valves. Methods: All consecutive patients undergoing Ross procedures and right ventricular outflow tract reconstructions with SG valves at 7 institutions (February 2000-November 2005) were assessed retrospectively (193 Ross procedures, 149 right ventricular outflow tract reconstructions). Patient, procedural, and outcome data were compared with those from 1246 conventional implants (665 Ross procedures, 581 right ventricular outflow tract reconstructions). Hemodynamic function was assessed at latest follow-up. Results: Follow-up was complete for 99% in SG group and 94% in conventional group, with mean follow-ups of 4.0 years (range, 0-6.7 years) for SG and 3.7 years (range, 0-6.7 years) for conventional. Five-year cumulative survivals and freedoms from adverse events were comparable between SG and conventional valves. Among patients undergoing Ross procedures, peak gradient at last follow-up was lower with SG valves (P<.01); no difference was observed in the right ventricular outflow tract reconstruction population. Pulmonary insufficiency was significantly reduced with SG valves in patients undergoing both Ross procedures (P<.01) and right ventricular outflow tract reconstructions (P<.01). Valve type was not a significant predictor of valve-related failure in propensity-adjusted analysis of either procedure. Conclusions: CryoValve SG decellularized pulmonary valves have acceptable clinical outcomes and favorably compare with conventionally processed valves. Improved hemodynamic function observed with SG valves could signify improved long-term outcomes and may be due to the decreased antigenicity of these valves. (J Thorac Cardiovasc Surg 2010; 139: 339-48)