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J Thorac Cardiovasc Surg 2010;139:339-348
© 2010 The American Association for Thoracic Surgery

Congenital Heart Disease

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

^a Indiana University School of Medicine, Indianapolis, Ind
^b University of Oklahoma Health Sciences Center, Oklahoma City, Okla
^c The Children's Hospital Heart Institute, Denver, Colo
^d Children's Hospital of Wisconsin, Milwaukee, Wis
^e St Louis Children's Hospital, Washington University School of Medicine, St Louis, Mo
^f Intermountain Medical Center, Salt Lake City, Utah
^g Methodist Hospital of Indiana, Indianapolis, Ind
^h Erasmus Medical Center, Rotterdam, The Netherlands

Read at the Thirty-fourth Annual Meeting of The Western Thoracic Surgical Association, Kailua-Kona, Hawaii, June 25–28, 2008.

Received for publication June 24, 2008; revisions received April 2, 2009; accepted for publication April 27, 2009.

^_* Address for reprints: John W. Brown, MD, Section of Cardiothoracic Surgery, Indiana University School of Medicine, 545 Barnhill Dr, EH 215, Indianapolis, IN 46202-5123. (Email: jobrown{at}iupui.edu).

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.

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