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Clinical results of Hancock II versus Hancock Standard at long-term follow-up
Carlo Valfrè1, Giulio Rizzoli, Claudio Zussa
1Cardiac Surgery Unit, Cà Foncello Hospital of Treviso, Treviso, Italy.
Insights
The Hancock II bioprosthesis offers significantly improved long-term durability compared to the Hancock Standard model, with reduced structural valve deterioration. This enhanced longevity was observed across various patient age groups in a multi-institutional study.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Clinical Trials
Background:
- Bioprosthetic heart valves are crucial for treating valvular heart disease.
- Long-term structural valve deterioration (SVD) remains a primary limitation of bioprostheses.
- Comparing different generations of bioprosthetic valves is essential for optimizing patient outcomes.
Purpose of the Study:
- To compare the long-term structural valve deterioration (SVD) between isolated Hancock Standard and Hancock II bioprostheses.
- To evaluate survival rates and durability of these two bioprosthetic valve models.
Main Methods:
- A multi-institutional study involving 714 Hancock Standard and 1293 Hancock II bioprostheses implanted between 1983 and 2002.
- Long-term follow-up (median 12 years, 14,749 patient-years) with 96% completeness.
- Survival analyzed using Cox analysis, durability using Weibull analysis, and risk factors balanced with a logistic propensity score model.
Main Results:
- Hancock II had lower perioperative mortality (6% vs. 12%).
- Age-adjusted 15-year survival was significantly higher for Hancock II (46% vs. 25%).
- At 15 years, structural valve deterioration (SVD) hazard was 6% for Hancock II vs. 17.5% for Hancock Standard in patients ≥65 years, and 18% vs. 37% in younger patients.
Conclusions:
- The Hancock II bioprosthesis demonstrates significantly increased durability compared to the Hancock Standard model.
- After balancing risk factors, Hancock II bioprostheses showed similar survival but substantially improved long-term structural integrity.
- These findings support the Hancock II as a superior option for long-term valve replacement.
Objective:
We performed a multi-institutional study to compare the long-term structural valve deterioration of isolated Hancock Standard versus Hancock II bioprostheses.
Methods:
From 1983 to 2002, 714 Hancock Standard and 1293 Hancock II bioprostheses were implanted at hospitals of the Venetian territory (Padova, Treviso, and Venice). Follow-up on January 1, 2003, included 14,749 patient-years with a median of 12 years and was 96% complete: 115 Hancock Standard and 53 Hancock II bioprostheses were at risk at 15 years. The 2 series were nonconcomitant, and many covariates differed (Table 1). Survival was analyzed with Cox analysis, and durability was analyzed with Weibull analysis. Balancing analysis with the logistic propensity score model was performed.
Results:
Perioperative mortality was 6% in Hancock II and 12% in Hancock Standard operations. The overall unadjusted 15-year survival was identical (39.7% +/- 2.3% vs 39.9% +/- 2.4%, respectively), but age-adjusted survival at 15 years was 46% versus 25% (P < .001). Late survival was unrelated to the prosthetic model, whereas it was adversely affected by older age, previous operations, aortic regurgitation, male sex, higher New York Heart Association class, atrial fibrillation, and coronary artery bypass grafting. In Hancock II patients aged 65 years and older, the cumulative hazard of structural valve deterioration at 15 years was 6%, versus 17.5% in Hancock Standard patients. In younger patients, it was 18% and 37%, respectively. Analysis of 541 propensity-balanced patients showed a hazard ratio of the Hancock Standard prosthesis of 2 and a risk reduction of older age of approximately 10% every 10 years.
Conclusion:
After balancing risk factors and calibrating age effects, Hancock II propensity-matched bioprostheses showed similar survival but definitely increased durability.