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Ann Thorac Surg 2001;71:1471-1476
© 2001 The Society of Thoracic Surgeons

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Original article: cardiovascular

Midterm evaluation of the Tissuemed (Aspire) porcine bioprosthesis: 493 patients, 506 bioprostheses

^a Cardiothoracic Surgical Unit of Walsgrave Hospital, Coventry, United Kingdom
^b Cardiothoracic Surgical Unit of Glenfield General Hospital, Leicester, United Kingdom
^c Cardiothoracic Surgical Unit of South Cleveland Hospital, Middlesbrough, Cleveland, United Kingdom

Accepted for publication December 13, 2000.

Address reprint requests to Dr Goldsmith, Department of Cardiothoracic Surgery, Walsgrave Hospital, Clifford Bridge Rd, Coventry, CV2 2DX United Kingdom
e-mail: ira{at}iragoldsmith.freeserve.co.uk

Background. Valve durability has been a major concern with bioprostheses, and the Tissuemed (Aspire) porcine bioprosthesis was designed to provide a solution to structural valve failure. Because bioprostheses tend to fail by 8 years, the aim of our study was to determine its midterm durability and performance.

Methods. We reviewed 506 prostheses that were implanted in 493 patients (287 men; mean age 73 ± 6 years) between 1991 and 1999. Preoperatively 316 (68%) patients were in New York Heart Association class III or IV. There were 417 (85%) aortic, 61 (12%) mitral, 13 (2.6%) aortic and mitral, and two (0.4%) tricuspid procedures. Concomitant procedures were performed in 163 (33%) patients. Follow-up was complete in 488 (98.9%) patients with a total cumulative follow-up of 1,402 patient-years.

Results. The 30-day mortality in this elderly population was 10% (95% confidence interval, 8 to 13), with no early valve-related deaths. Patients’ survival at 8 years was 46% ± 7%. This was influenced by the following factors: (1) the patient’s age, being worse for those 70 years or older (p = 0.005); (2) those in New York Heart Association functional class III and IV (p = 0.004); (3) those in atrial fibrillation before the operation (p = 0.006); (4) those with poor left ventricular function (p = 0.009); and (5) those who had a previous cardiac operation (p = 0.003). Valve-related complications (expressed as percent per patient-year) were thromboembolism at 0.9%/patient-year; major hemorrhage at 1.4%/patient-year; bacterial endocarditis at 0.4%/patient-year; nonstructural dysfunction at 0.2%/patient-year, and reoperation at 0.2%/patient-year. At 8 years, freedom from thromboembolism was 93% ± 7%, major hemorrhage, 90% ± 4%, nonstructural dysfunction, 99% ± 1%, structural valve failure, 100%, and reoperation, 99% ± 1%. At follow-up, 98% of survivors were in New York Heart Association class I or II.

Conclusions. Our study suggests that at 8 years, the Tissuemed (Aspire) porcine bioprosthesis is durable and has satisfactory performance with low complication rates.

This article has been cited by other articles:

				J. Sierra, J. A. Rubio, D. Sanchez, A. L. Fernandez, and J. Garcia-Bengochea Tissuemed porcine bioprosthesis Ann. Thorac. Surg., June 1, 2003; 75(6): 2007 - 2008. [Full Text] [PDF]