Percutaneous Implantation of the CoreValve Self-Expanding Valve Prosthesis in High-Risk Patients With Aortic Valve Disease The Siegburg First-in-Man Study

Columbia University, New York, New York, United States
Circulation (Impact Factor: 14.43). 10/2006; 114(15):1616-24. DOI: 10.1161/CIRCULATIONAHA.106.639450
Source: PubMed


The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve).
Symptomatic high-risk patients with an aortic valve area <1 cm2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2+/-10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4+/-3.0 mm Hg; P<0.0001). The mean aortic regurgitation grade was unchanged. Major in-hospital cardiovascular and cerebral events occurred in 8 patients (32%), including mortality in 5 patients (20%). Among 18 patients with device success surviving to discharge, no adverse events occurred within 30 days after leaving the hospital.
Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.

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    • "Following TAVI, DAPT consisting of aspirin (lifelong) and clopidogrel (initial period) is currently recommended [5–7]. However, this is largely based on retrospective registries and 2 cases of severe postprocedural thrombocytopenia in patients treated with clopidogrel without a loading dose in a preliminary first-in-man study with the CoreValveTM [20]. A second rationale for adding clopidogrel to aspirin is supported by the histopathological finding that incorporation of the CoreValveTM prosthesis into the aortic wall by means of endothelialisation is a chronological integration over a period of approximately 3 months [21]. "
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    ABSTRACT: To assess current antithrombotic treatment strategies in the Netherlands in patients undergoing transcatheter aortic valve implantation (TAVI). For every Dutch hospital performing TAVI (n = 14) an interventional cardiologist experienced in performing TAVI was interviewed concerning heparin, aspirin, thienopyridine and oral anticoagulation treatment in patients undergoing TAVI. The response rate was 100 %. In every centre, a protocol for antithrombotic treatment after TAVI was available. Aspirin was prescribed in all centres, concomitant clopidogrel was prescribed 13 of the 14 centres. Duration of concomitant clopidogrel was 3 months in over two-thirds of cases. In 2 centres, duration of concomitant clopidogrel was based upon type of prosthesis: 6 months versus 3 months for supra-annular and intra-annular prostheses, respectively. Leaning on a small basis of evidence and recommendations, the antithrombotic policy for patients undergoing TAVI is highly variable in the Netherlands. As a standardised regimen might further reduce haemorrhagic complications, large randomised clinical trials may help to establish the most appropriate approach.
    Netherlands heart journal: monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation 11/2013; 22(2). DOI:10.1007/s12471-013-0496-6 · 1.84 Impact Factor
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    • "The Cribier-Edwards valve is a trileaflet valve composed of three equal sections of equine pericardium integrated into a stainless steel balloon expandable stent frame [20,21]. CoreValve is a self-expanding aortic valve prosthesis intended for retrograde delivery across the aortic valve [22,23]. It has been reported that the coronary artery flow could be effect by aortic valved stents when TAVI was performed in animal experiments and clinical treatments, especially in the cases of aortic insufficiency [24,25]. "
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    ABSTRACT: To evaluated the feasibility and safety of new aortic valved stents in transcatheter aortic valve implantation (TAVI) using retrograde approach by in vitro testing and animal implantation.Materials and Methods: The fluid passing test, expanding and releasing tests, static and releasing tests in tube were performed for new valved stents. Transvalvular pressure gradient, effective orifice area, pre-implantation and post-implantation regurgitant volume for the new stents were detected. Then, the new stents were implanted in six pigs using retrograde approach. These pigs were euthanized 12 h after the implantation for anatomic evaluation. In vitro tests showed that the closure of the new stents leaflets were effective, and stents could be released through catheter, then expanded completely and fixed fast in the tube. The coronary artery flow rates did not changed significantly after implantation (P > 0.05), while aortic regurgitant volumes were obviously reduced (P < 0.05). No significant difference in the transvalvular pressure gradient and effective orifice area of the new stents implanted within or above the valve leaflets was found (P > 0.05). In vivo experiments indicated that TAVI was successfully performed in six pigs using retrograde approach. However, one pig was died 10 h after the implantation since the stent was not expanded completely. The leaflets in stents were opening well and no valvular regurgitation was observed in the other five pigs. And thrombosis was not found.Discussion and Conclusion: The new type of aortic valved stent designed in this study was characterized with good stability and could avoid the impact caused by valve leaflets on the coronary artery.
    Journal of Cardiothoracic Surgery 11/2013; 8(1):210. DOI:10.1186/1749-8090-8-210 · 1.03 Impact Factor
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    • "In the last decade, a minimally-invasive therapeutic option, called transcatheter aortic valve implantation (TAVI), has become a valuable alternative to open-heart surgery for the treatment of AS [3] [4]. It consists in the delivery and positioning of an aortic valve prosthesis, made of a biological valve sewn into a metallic frame, over the stenotic native valve. "

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