Long-term durability of the Hancock II porcine bioprosthesis

• Published in: The Journal of thoracic and cardiovascular surgery Vol. 126; no. 1; pp. 66 - 74
• Main Authors: Rizzoli, Giulio, Bottio, Tomaso, Thiene, Gaetano, Toscano, Giuseppe, Casarotto, Dino
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Mosby, Inc 01-07-2003; AATS/WTSA; Elsevier
• Subjects: Adult; Age Factors; Aged; Aged, 80 and over; Anticoagulants - adverse effects; Anticoagulants - therapeutic use; Aortic Valve - pathology; Aortic Valve - surgery; Biological and medical sciences; Bioprosthesis; Durable Medical Equipment; Female; Follow-Up Studies; Heart Valve Diseases - mortality; Heart Valve Diseases - surgery; Heart Valve Prosthesis; Humans; Male; Medical sciences; Middle Aged; Mitral Valve - pathology; Mitral Valve - surgery; Postoperative Complications - etiology; Postoperative Complications - mortality; Postoperative Complications - therapy; Prosthesis Design; Reoperation; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the heart; Survival Analysis; Time; Time Factors; Treatment Outcome; Tricuspid Valve - pathology; Tricuspid Valve - surgery; Human; Mitral valve; Prognosis; Mortality; Animal origin; Heterograft; Long term; Morbidity; Pig; Vertebrata; Mammalia; Surgery; Artiodactyla; Tricuspid valve; Aortic valve; Ungulata
• ISSN: 0022-5223; 1097-685X
• DOI: 10.1016/S0022-5223(02)73618-0

Survival and prosthetic complications of patients receiving the Hancock II second-generation bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in the aortic, mitral, mitral-aortic, and tricuspid positions were analyzed at 15 years’ follow-up.
Between May 1983 and December 1993, 212 patients (104 men and 108 women; mean age, 63 ± 9 years; age range, 29-81 years) received 66 aortic, 114 mitral, 26 mitral-aortic, and 6 tricuspid Hancock II valves. Thirty-one percent of patients had previous valve operations, 15% had concomitant cardiac procedures, and 87% were in New York Heart Association class III or IV. Follow-up included 1704 patient-years and was 98% complete, with a median of 9 patient-years (range, 0.013-17.4 years). Forty-six patients were at risk at 14 to 15 years, and 30 were at risk after 15 years.
One hundred twenty-two (57%) of 212 patients died, 20 of them perioperatively. Fifteen-year actuarial Kaplan-Meier survival was 35.2% ± 3.8%, and freedom from valve-related mortality was 84% ± 3.5%, with no difference on the basis of position or age (<65 or ≥65 years). Percentages for freedom from thromboembolism, anticoagulant-related hemorrhage, endocarditis, and paravalvular leak were, respectively, 78.2% ± 4%, 83.5% ± 3.6%, 95.7% ± 2%, and 97.3% ± 1.4%, with no significant difference between the aortic and mitral positions. Freedom from structural valve deterioration was 71.8% ± 5.6%: 88.9% ± 6.2% in the aortic position versus 59.5% ± 3.9% in the mitral position (
P = .01) and 64.3% ± 3% in the mitral-aortic position. In patients younger than 65 years, actual freedom from structural valve deterioration was less than that seen in older patients (84.5% ± 3.5% vs 95% ± 3.0%) and was better in the aortic versus the mitral position (92% ± 4.5% vs 82% ± 4.2%).
The Hancock II porcine valve showed excellent 15-year durability. We recommend its use in patients 65 years of age, as well as in younger patients undergoing aortic replacement.
35