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Clinical durability of the Hancock porcine bioprosthetic valve
Insights
Long-term durability of Hancock xenograft bioprostheses is demonstrated, with low rates of valve failure in adult aortic and mitral replacements. Continued clinical use is supported by these findings.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Medical Device Durability
Background:
- Long-term durability of the Hancock xenograft bioprosthesis requires further definition.
- Assessing valve durability is crucial for patient outcomes in cardiac valve replacement surgery.
Purpose of the Study:
- To provide extended data on the long-term durability of the Hancock xenograft bioprosthesis.
- To evaluate valve failure rates in patients undergoing aortic and mitral valve replacements.
Main Methods:
- Analysis of a database of 1,407 patients (707 aortic, 700 mitral) receiving Hancock bioprostheses (1971-1979).
- Cumulative follow-up of 1,732 patient-years (AVR) and 1,843 patient-years (MVR), with maximum follow-up of 8.4 years.
- Valve failure defined by specific criteria including regurgitation, thrombosis, endocarditis, and hemodynamic dysfunction.
Main Results:
- Actuarial freedom from valve failure (all causes) was 95.4% at 5 years (AVR) and 90.9% at 6 years (MVR).
- Probability of freedom from primary tissue failure in adults was 99% at 5 years (AVR) and 94.3% at 6 years (MVR).
- Linearized incidence of primary tissue failure in children was 9.8% per patient-year, significantly higher than 0.2% in adults.
Conclusions:
- The Hancock xenograft bioprosthesis demonstrates acceptable durability through 6 years of follow-up in adult patients.
- A slight acceleration in tissue failure between 5 and 6 years was observed in adults.
- Continued clinical use of the Hancock xenograft bioprosthesis appears warranted based on long-term data.
Abstract:
The principal feature of the Hancock xenograft bioprosthesis which remains to be completely defined is long-term durability. This report provides extended data regarding valve durability derived from a data base of 1,407 patients (707 aortic [AVR] and 700 mitral [MVR] replacements) who received Hancock bioprostheses between 1971 and 1979; cumulative duration of follow-up was 1,732 patient-years for AVR and 1,843 for MVR patients, with a maximum follow-up duration of 8.4 years. One hundred seventy-nine patients were followed for more than 5 years and 67 for more than 6 years. Valve failure was defined on the basis of one or more of the following criteria: (1) postoperative development of a new regurgitant murmur, (2) thrombotic valvular occlusion, (3) infective endocarditis resulting in reoperation or death, and (4) hemodynamic valvular dysfunction confirmed by catheterization and resulting in reoperation or death. Twenty-one such failures occurred among all AVR patients and 23 among all MVR patients. The actuarial probability of freedom from valve failure (all causes) was 95.4% +/- 1.2% (+/- SEM) for adult AVR patients 5 years postoperatively and 90.9% +/- 2.6% for adult MVR patients 6 years postoperatively. The probability of freedom from primary tissue failure in adults was 99% +/- 1% in AVR patients at 5 years and 94.3% +/- 2.4% in MVR patients at 6 years. The linearized incidence of primary tissue failure in children (< 15 years old) was 9.8% per patient-year (combined AVR and MVR patients), compared to 0.2% per patient-year among all adult patients in the analysis. The combined actuarial incidence of primary tissue failure among adults with AVR and MVR was 98.6% +/- 0.7% at 5 years and 94.2% +/- 2.3% at 6 years; thus there appears to be a slight acceleration in the rate of valve tissue failure between 5 and 6 years after operation. The incidence of failure, however, remains acceptably low through 6 years of follow-up, and continued clinical use of the xenograft bioprosthesis seems warranted.