Porcine xenograft for aortic, mitral and double valve replacement: long-term results of 2544 consecutive patients.

OBJECTIVES

The aim of this study was to evaluate the results after stented porcine xenograft implantation with Linx™ anticalcification treatment in the aortic and/or mitral position in elderly patients.

METHODS

Over a decade, a total of 2544 patients receiving aortic (AVR = 1920), mitral (MVR = 347) or double valve (DVR = 277) replacement (between November 2001 and March 2012) were evaluated. The study was designed on an 'all comers' basis including all patients with elective, urgent or emergent need for valve replacement. Outcome was assessed by reviewing the prospectively acquired hospital database as well as regular follow-up information obtained by annual written interviews.

RESULTS

Mean patient age was 76.5 ± 6 (AVR), 73.8 ± 7 (MVR) and 74.2 ± 7 (DVR) years, respectively; 54.2%/41.9%/42.0% were male, and active endocarditis was diagnosed in 4.5%/19.9%/22.1%; indication for valve surgery and the logistic EUROSCORE I predicted risk for mortality was 15.4 ± 15%/19.9 ± 19%/22.3 ± 21%, respectively. Concomitant mitral valve repair was required in 196 (10.2%) (AVR) patients; coronary artery bypass graft surgery (CABG) in 840 (43.8%) (AVR), 82 (23.7%) (MVR) and 94 (34.1%) (DVR) patients; cryoablation in 232 (12.1%)/81 (23.4%)/67 (24.3%) patients and surgery on the thoracic aorta in 166 (8.7%)/12 (3.5%)/41 (14.9%) patients, respectively. The mean follow-up was 4.5 ± 3.5 years. The rate of freedom from endocarditis after 10 years was 98.3 ± 0.4%/97.5 ± 1.0%/97.4 ± 1.6% (P = n.s.). The rate of freedom from structural valve disease was 96.3 ± 0.6%/93.8 ± 2.4%/92.8 ± 2.2% (AVR versus DVR, P = 0.009), and from thromboembolic events was 94.8 ± 1.0%/91.5 ± 2.9%/97.9 ± 1.3%. The 30-day survival rate was 97.3 ± 0.4%/95.1 ± .1.2%/92.8 ± 1.6% and the 10-year survival rate was 42.1 ± 1.5%/33.9 ± 4.7%/22.1 ± 7.1%, respectively.

CONCLUSIONS

The Epic™ stented porcine xenograft is associated with acceptable survival, with large proportions of patients free from valve-related complications and freedom from valve reintervention for all older, in-coming patients.