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J Thorac Cardiovasc Surg 2008;136:52-57
© 2008 The American Association for Thoracic Surgery

Surgery for Acquired Cardiovascular Disease

Deleterious outcome of No-React–treated stentless valved conduits after aortic root replacement: Why were Warnings ignored?

Thierry P. Carrel, MD*, Florian S. Schoenhoff, MD, Juerg Schmidli, MD, Mario Stalder, MD, Friedrich S. Eckstein, MD, Lars Englberger, MD

Department of Cardiovascular Surgery, University Hospital, Berne, Switzerland

Received for publication August 22, 2007; accepted for publication September 11, 2007.

* Address for reprints: Thierry P. Carrel, MD, Department of Cardiovascular Surgery, University Hospital, CH-3010 Berne, Switzerland. (Email: thierry.carrel{at}insel.ch).

Objective: The implantation of a composite graft is the treatment of choice for patients with aortic root disease if the valve cannot be preserved and the patient is not a suitable candidate for a Ross procedure. Several years ago, the Shelhigh NR-2000C (Shelhigh, Inc, Millburn, NJ) was introduced in Europe. Being a totally biologic conduit and considering the lack of homografts, the graft seemed an ideal conduit for patients with destructive endocarditis, as well as for older patients who were not suitable candidates for oral anticoagulation.

Methods: From 2001 until 2006, the Shelhigh NR-2000C stentless valved conduit was implanted in 115 patients for various aortic root pathologies. The conduit consists of a bovine pericardial straight graft with an incorporated porcine stentless valve. Aortic root repair was performed during standard cardiopulmonary bypass and mild hypothermia in the majority of patients. Deep hypothermic circulatory arrest combined with selective antegrade cerebral perfusion was used when the repair extended into the arch.

Results: Seven patients with uncomplicated early outcome presented with unexpected sudden disastrous findings at the level of the aortic root, although 1-year follow-up computed tomographic scans were normal. Four of these patients underwent emergency operations because of desintegration of the graft, along with rupture of the aortic root. Retrospectively, the main findings were persistent fever or subfebrility over months and a halo-like enhancement on computed tomographic scans. Extensive microbiologic examinations were performed without finding a causative organism.

Conclusion: The use of the Shelhigh aortic stentless conduit can no longer be advocated, and meticulous follow-up of patients in whom this device has been implanted has to be recommended.

Abbreviations and Acronyms CT = computed tomography; FDA = US Food and Drug Administration






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