Increased life expectancy and younger patients' desire to avoid lifelong anticoagulation requires a better understanding of bioprosthetic valve failure. This study evaluates risk factors associated ...with explantation for structural valve deterioration (SVD) in a long-term series of Carpentier-Edwards PERIMOUNT aortic valves (AV).
From June 1982 to January 2011, 12,569 patients underwent AV replacement with Edwards Lifesciences Carpentier-Edwards PERIMOUNT stented bovine pericardial prostheses, models 2700PM (n = 310) or 2700 (n = 12,259). Mean age was 71 ± 11 years (range, 18 to 98 years). 93% had native AV disease, 48% underwent concomitant coronary artery bypass grafting, and 26% had additional valve surgery. There were 81,706 patient-years of systematic follow-up data available for analysis. Demographics, intraoperative variables, and 27,386 echocardiographic records were used to identify risks for explant for SVD and assess longitudinal changes in transprosthesis gradients using time-varying covariable analyses.
Three hundred fifty-four explants were performed, with 41% related to endocarditis and 44% to SVD. Actuarial estimates of explant for SVD at 10 and 20 years were 1.9% and 15% overall, respectively, and in patients younger than 60 years, 5.6% and 46%, respectively. Younger age (p < 0.0001), lipid-lowering drugs (p = 0.002), prosthesis-patient mismatch (p = 0.001), and higher postoperative peak and mean AV gradients were associated with explant for SVD (p < 0.0001). The effect of gradient on SVD was greatest in patients younger than 60 years.
Durability of the Carpentier-Edwards PERIMOUNT aortic valve is excellent even in younger patients. Explant for SVD is related to gradient at implantation, especially in younger patients. Strategies to reduce early postoperative AV gradients, such as root enlargement or more efficient prostheses, should be considered.
Objective Stent graft coverage of the left subclavian artery (LSA) may be required to achieve an adequate landing zone in up to 40% of descending thoracic aneurysms (DTAs). The Valiant Mona LSA ...Thoracic Stent Graft System (Medtronic, Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency while diverting circulation through the encroaching aneurysm. Participating in the United States Food and Drug Administration's new Innovation Pathway, this first-in-human, early feasibility study evaluates early clinical experience of the Valiant Mona LSA Stent Graft System in patients with DTAs where the proximal landing zone necessitates LSA coverage. Methods This premarket, nonrandomized, single-arm prospective study recruited nine patients (age 72.9 ± 7.6 years). Primary end points were aneurysm-related mortality, stroke, paraplegia, left arm/hand ischemia, and treatment success. Neurologic events were assessed by imaging and by independent neurologists. Inclusion criteria required patients with a DTA or penetrating aortic ulcer to have a distance of ≥10 mm between the left common carotid artery and the LSA. Mean aneurysm diameter was 53.7 ± 10.0 mm. The indication for repair was for saccular DTA in five patients or fusiform DTA in four. Seven patients were at American Society of Anesthesiologists Physical Status Classification III/IV. Results All nine patients received one main stent graft (diameter 28 to 42 mm) and one branch stent graft (diameter 10 to 14 mm). To extend device coverage distally, a commercial Valiant Captivia device was implanted in seven patients. No uncorrected endoleaks were observed at the end of the implant procedure. Four endoleaks developed before discharge in four of eight evaluable patients. Two were identified as type II and two were of undetermined type. No endoleak resulted in a secondary intervention. Technical success, defined by the clinical investigational plan, was achieved in all nine patients intraoperatively, and treatment success was achieved in all eight evaluable patients at 1 month. There were no major, disabling strokes. Four minor nondisabling strokes were reported in three patients ≤30 days (days 1, 1, 5, and 24). To date, there have been no reports of death, left arm ischemia, paraplegia, rupture, conversion to open surgery, or secondary endovascular procedure. No patients required surgical LSA revascularization. Conclusions The Valiant Mona LSA system demonstrates technical and treatment success, relative safety, and early durability in its initial use in DTA patients. Midterm results are expected as patients are monitored at regular intervals to 5 years.
Enhanced Recovery After Surgery (ERAS) evidence-based protocols for perioperative care can lead to improvements in clinical outcomes and cost savings. This article aims to present consensus ...recommendations for the optimal perioperative management of patients undergoing cardiac surgery. A review of meta-analyses, randomized clinical trials, large nonrandomized studies, and reviews was conducted for each protocol element. The quality of the evidence was graded and used to form consensus recommendations for each topic. Development of these recommendations was endorsed by the Enhanced Recovery After Surgery Society.
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