Comparative clinical experience with porcine bioprosthetic and St. Jude valve replacement.
From 1976 to 1984, 656 patients underwent aortic, mitral, or double valve replacement with a Hancock or Carpentier-Edwards porcine bioprosthesis (POR; n = 293) or with a St. Jude bileaflet valve (SJ; n = 363). Recipients of the St. Jude valve were of more advanced NYHA class preoperatively, required smaller prosthetic sizes, and more often had associated coronary artery disease necessitating bypass grafting (p less than .05). Despite these differences, POR and SJ recipients demonstrated similar 30-day mortality (7.5 vs 10.2 percent), five-year freedom from embolism (92 +/- 2 percent vs 92 +/- 2 percent), freedom from all valve-related complications (79 +/- 3 percent vs 79 +/- 4 percent), and survival (72 +/- 3 percent vs 71 +/- 3 percent) (p = NS). Structural failures occurred exclusively in POR recipients (3.0-4.5 percent/pt-yr after four years), and endocarditis was more common (1.0 vs 0.5 percent/pt-yr); as a result, the reoperation rate was three times higher in POR than SJ recipients (1.4 vs 0.46 percent/pt-yr, p less than .05). Warfarin-related bleeding (2.5 percent/pt-yr) was the most common complication in SJ recipients, but occurred equally frequently in POR recipients requiring anticoagulation; seven (44 percent) of 16 valve-related late deaths were warfarin-related. In properly anticoagulated patients, the thromboembolic rate was low (2.0 percent and 1.1 percent/pt-yr, POR and SJ); this rate increased significantly in SJ recipients receiving antiplatelet drugs alone (4.2 percent/pt-yr; n = 16) or no anticoagulant or antiplatelet therapy (26.4 percent/pt-yr; n = 18) (p less than .05), but increased only slightly in POR recipients (to 1.5 percent/pt-yr, n = 108, and 2.0 percent/pt-yr, n = 63, respectively). Postoperatively, NYHA class 1 was more often achieved in SJ than POR recipients (60 vs 39 percent, p less than .05), perhaps because of the better hemodynamic performance of the SJ valve. Thus, despite differences in patient selection and the nature of complications observed with each prosthetic type, porcine and St. Jude valves provide similar early and late survival, frequency of embolism, total complication rate, and freedom from valve-related morbidity and mortality after five years of follow-up. Limited durability, susceptibility to infection, and inferior hemodynamics remain drawbacks to use of the porcine bioprosthesis. The necessity for warfarin anticoagulation and the frequency of resultant bleeding complications are the major shortcomings of the St. Jude valve.(ABSTRACT TRUNCATED AT 400 WORDS)
D000328:Adult; D000368:Aged; D000768:Anesthesia, General; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D001021:Aortic Valve; D001705:Bioprosthesis / Q000009:adverse effects / Q000401:mortality; D005069:Evaluation Studies as Topic; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000401:mortality; D006801:Humans; D008875:Middle Aged; D008943:Mitral Valve; D011182:Postoperative Care; D011183:Postoperative Complications / Q000453:epidemiology / Q000401:mortality / Q000601:surgery; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation
D000925:Anticoagulants