Cartier P C, Dumesnil J G, Métras J, Desaulniers D, Doyle D P, Lemieux M D, Raymond G
Department of Cardiac Surgery, Laval Hospital, Ste-Foy, Quebec, Canada.
Ann Thorac Surg. 1999 Feb;67(2):345-9; discussion 349-51. doi: 10.1016/s0003-4975(98)01350-2.
The objective of this study is to assess the clinical and hemodynamic performance of a stentless porcine bioprosthesis, the Freestyle aortic root bioprosthesis.
Consenting patients requiring isolated aortic valve or aortic root replacement received the Freestyle bioprosthesis. Clinical follow-up and echocardiographic data were obtained at discharge, 3 to 6 months, 1 year, and annually thereafter.
Two hundred seventy-six patients received a Freestyle aortic root bioprosthesis between January 1993 and July 1997. The mean age was 67.7 years. Preoperatively, 86.3% were either New York Heart Association class III or IV. Two hundred thirty-eight patients underwent valve (subcoronary) replacement, 36 underwent aortic root replacement, and 2 underwent valve replacement using the root-inclusion technique. The early mortality was 5.4%, with 3.3% mortality for the subcoronary technique and 19.4% mortality for aortic root replacement. The mean gradient decreased significantly between discharge and the 3- to 6-month follow-up and stabilized thereafter. The effective orifice area increased significantly from discharge to 3 to 6 months' follow-up. At 3 years, 84.4% of the patients had either no or trivial regurgitation.
The Freestyle bioprosthesis has good clinical performance and good short-term hemodynamic performance. The majority of the regurgitation identified is not clinically significant.
本研究的目的是评估一种无支架猪生物瓣膜——Freestyle主动脉根部生物瓣膜的临床和血流动力学性能。
同意接受单纯主动脉瓣或主动脉根部置换术的患者接受Freestyle生物瓣膜。在出院时、3至6个月、1年及此后每年获取临床随访和超声心动图数据。
1993年1月至1997年7月期间，276例患者接受了Freestyle主动脉根部生物瓣膜置换术。平均年龄为67.7岁。术前，86.3%的患者为纽约心脏协会III级或IV级。238例患者接受瓣膜（冠状动脉下）置换术，36例接受主动脉根部置换术，2例采用根部植入技术进行瓣膜置换术。早期死亡率为5.4%，冠状动脉下技术的死亡率为3.3%，主动脉根部置换术的死亡率为19.4%。平均压差在出院至3至6个月随访期间显著降低，此后趋于稳定。有效瓣口面积从出院至3至6个月随访期间显著增加。3年时，84.4%的患者无反流或仅有微量反流。
Freestyle生物瓣膜具有良好的临床性能和良好的短期血流动力学性能。所发现的大多数反流在临床上并不显著。
