Five-Year Follow-up of Hancock Pericardial Valves: Management of Premature Failure

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Abstract
The durability and function of bovine pericardial valves are dependent upon design, preservation, patient factors (age, sex), and site of valve implantation. In 1983, a shelf recall of all Hancock bovine pericardial valves (HPV) was instituted by the manufacturer. This report represents the results of an organized 5‐year follow‐up in a hospital Prosthetic Valve Registry of 129 HPV implanted in 122 patients (79 males, 43 females) between May 1982 and April 1985 using echo Doppler and careful clinical evaluation. Mean age was 56 ± 15 years. There were 81 AVR, 33 MVR, 7 DVR, and 1 TVR. Concomitant coronary bypass was performed in 38 patients (31%). Surgery was on a redo basis in 25 patients (20%), urgent in 14 (11%), and for SBE in 8 patients (7%). There were seven hospital deaths (5.7%). Mean follow‐up was 44 months (maximum 66 months) for 114 patients (99% complete), representing 417 patient years. There have been 20 late deaths (18%), of which 7 were directly valve related. Linearized frequency of major events (per pt‐yr) was: thromboembolism, 1.6%; anticoagulant related hemorrhage, 0.8% (1 late death); prosthetic valve endocarditis 1.3%; primary tissue failure, 5.8%. Patient symptomatology was a more accurate predictor of bioprosthetic failure requiring reoperation than echo Doppler studies, which were completed in 74 of 97 patients examined during scheduled follow‐up visits. Twenty‐four of the 96 patients (25%) have required re‐replacement at a mean interval of 44 months (27–59 months) from initial implantation. This was due to vertical shear starting at the top of the strut anchoring commissural attachments in every case. There have been two redo operative deaths (8%), one in a patient with severe prosthetic endocarditis and one in a patient requiring double valve rereplacement with extensive coronary artery disease and biventricular failure. At 60 months, actuarial patient survival was 65% ± 14% and freedom from valve‐related complications was 54% ± 13%. There was no difference in rate of failure in relation to valve site or patient sex or age. We conclude that structural design has led to premature failure of Hancock bovine pericardial valves and predict that an increasing number will fail and should require interval re‐replacement.