The stentless xenograft aortic valve: the wheel turns around

A brief overview of the historical pathways of both stented and stentless porcine xenografts is presented in order to understand the return to and continuing clinical use of stentless devices. In addition, 7-11 years of durability with various models of stentless porcine valves has now accumulated and is beginning to be of relevance in determining the future place of this xenograft. Stentlessness and anticalcium agents, coupled with the poor results of stented xenografts in certain patient groups, have led to a resurgence of the clinical use of stentless xenograft valves for aortic valve replacement. An overview of the present state and future of stentless valves is given.

At both The Prince Charles Hospital and St Andrew's War Memorial Hospital, Queensland, Australia, 307 patients have received the Model 300 CryoLife-O'Brien stentless composite aortic xenograft from December 1992 to February 2000. Associated procedures were required in 56% of patients (mostly coronary artery bypass, mean 2.4 grafts, in 144 patients (47%) and left ventricular myomectomy in 34 patients (11%)).

The hospital mortality (four early deaths) has been 1.3 +/- 1% (CL 95%) and the follow-up 100% for this analysis. The mean patient age was 73 years (range 57-89 years with 16% being 80 years and over). Morbid events have included six perivalvar leaks: four trivial and identified only on echo Doppler (no clinical murmurs) and two patients requiring reoperation at 10 days and 12 weeks with simple successful repair verified on subsequent echocardiograms. Of the 307 patients over the 7 year period, three valves only have been explanted, two for endocarditis at 1.5 and 3.5 years and one for possible technically induced structural failure at 15 months (probable needle damage). With this exception, there has been as yet no other intrinsic leaflet failure. Four early thromboembolic events (4 days-5 weeks) in patients with atrial fibrillation (no anticoagulants used postoperatively with the first 80 patients) constituted the important early morbid events. Late mortality of this elderly patient cohort has occurred in 27 patients over 7 years of maximum follow-up. One death (endocarditis) has been valve related at 5 years. Serial echocardiography (some 700 echoes in the study of this valve) has demonstrated a mean gradient of 7-9 mmHg with a very low incidence of trivial incompetence (96%) on Doppler examination with implant valve sizes ranging from 21 to 29 mm. One patient had significant regurgitation requiring reoperation. There has been no progression of either incompetence or stenosis of the remaining patients in this follow-up, now into the eighth postoperative year.

The early and intermediate results appear excellent in this elderly patient cohort. Nevertheless, important surveillance is obviously required to determine the durability at 10-12 years, a crucial time when stented porcine xenografts began to show an obvious failure rate from structural deterioration, in the middle and elderly aged patient cohort. An attempt is made to outline the future of this type of stentless xenograft and to justify that its cautious use should probably be extended down to the over 50 year age patient cohort.