Mid-term results after Epic xenograft implantation for aortic, mitral, and double valve replacement

Abstract

Background and aim of the study: The study aim was to evaluate the mid-term results after implantation of the stented porcine xenograft (Epic valve with Linx anticalcification treatment) in elderly patients.

Methods: A total of 1,368 patients undergoing aortic valve replacement (AVR; n = 1,168), mitral valve replacement (MVR; n = 101) or double valve replacement (DVR; n = 105) between November 2001 and November 2006, was evaluated. The indication for Epic implantation was patient age > or = 70 years, with pathology not amenable to valve repair. Outcome was assessed by reviewing a prospectively acquired hospital database, in addition to annual clinical follow up.

Results: The mean patient age was 76 +/- 6 years (AVR), 73.7 +/- 6 years (MVR), and 73.1 +/- 7 years (DVR); among these patient subgroups, 50.3%, 65.3% and 57.7%, respectively, were female, and 16.4%, 25.5% and 40.0% presented with endocarditis. The logistic EuroSCORE predicted risk for mortality was 14.1 +/- 14%, 19.3 +/- 18%, and 20.3 +/- 20%, respectively. Additional surgical procedures included mitral valve repair in 103 patients (all AVR), CABG in 587 patients (515 AVR, 29 MVR, 43 DVR), left atrial ablation therapy in 70, 16 and nine patients respectively, and surgery on the thoracic aorta in 54, zero and 12 patients, respectively. The mean aortic cross-clamp time was 72 +/- 28, 84 +/- 44 and 133 +/- 48 min after AVR, MVR and DVR, respectively. Freedom from stroke events after five years was 99.0 +/- 0.3%, 97.3 +/- 1.9% and 100%, respectively; freedom from bleeding events after five years was 99.5 +/- 0.2%, 100% and 99.0 +/- 1.0%, and actuarial freedom from reoperation due to prosthetic valve endocarditis 98.9 +/- 0.7%, 96.7 +/- 1.9% and 92.4 +/- 3.4%. Among these patients groups, early mortality was 8.0 +/- 0.8%, 17.8 +/- 3.8% and 21.9 +/- 4.0%, and five-year survival 77.0 +/- 4.1%, 71.7 +/- 4.5% and 55.5 +/- 6.3%. Perioperative survival in non-endocarditis patients undergoing isolated valve surgery was 95.8 +/- 0.9%, 96.4 +/- 3.5% and 90.0 +/- 6.7% after AVR, MVR or DVR, respectively, while the five-year survival was 90.6 +/- 1.5%, 89.3 +/- 5.8% and 90.0 +/- 6.7%.

Conclusion: Clinical outcome at five years after porcine valve replacement using the Epic xenograft was satisfactory in elderly patients. The clinical effectiveness of the Linx anticalcification treatment remains to be proven during longer-term follow up.