Background-Functional mitral regurgitation (FMR), a well-recognized component of left ventricular remodeling, is associated with increased morbidity and mortality in heart failure patients. Percutaneous mitral annuloplasty has the potential to serve as a therapeutic adjunct to standard medical care. Methods and Results-Patients with dilated cardiomyopathy, moderate to severe FMR, an ejection fraction Ͻ40%, and a 6-minute walk distance between 150 and 450 m were enrolled in the CARILLON Mitral Annuloplasty Device European Union Study (AMADEUS). Percutaneous mitral annuloplasty was achieved through the coronary sinus with the CARILLON Mitral Contour System. Echocardiographic FMR grade, exercise tolerance, New York Heart Association class, and quality of life were assessed at baseline and 1 and 6 months. Of the 48 patients enrolled in the trial, 30 received the CARILLON device. Eighteen patients did not receive a device because of access issues, insufficient acute FMR reduction, or coronary artery compromise. The major adverse event rate was 13% at 30 days. At 6 months, the degree of FMR reduction among 5 different quantitative echocardiographic measures ranged from 22% to 32%. Six-minute walk distance improved from 307Ϯ87 m at baseline to 403Ϯ137 m at 6 months (PϽ0.001). Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved from 47Ϯ16 points at baseline to 69Ϯ15 points at 6 months (PϽ0.001). Conclusions-Percutaneous reduction in FMR with a novel coronary sinus-based mitral annuloplasty device is feasible in patients with heart failure, is associated with a low rate of major adverse events, and is associated with improvement in quality of life and exercise tolerance. (Circulation. 2009;120:326-333.)
This article outlines general concepts of, and strategies for, therapeutic embolization throughout the body, touching on all major arterial distributions. Clinical scenarios that allow or prevent safe embolization of vessels are presented. Specific agents are recommended where appropriate, as are alternate approaches when embolization is not an option. Pre-embolization precautions and adjunctive measures are described in highrisk areas.
The healthcare industry is facing increasing pressures to embrace new technologies that support greater patient access to, and higher quality of (but at the same time offer cost-effective), healthcare delivery. This pressure has spawned a plethora of initiatives to embrace the possibilities and potentials of technologies to develop and then diffuse new devices, new pharmaceutical products and support minimal invasive surgical techniques that will facilitate superior healthcare delivery. Pursuing such initiatives from idea generation to commercialisation and adoption, however, also necessitates new alliances between academe and industry to ensure rigorous research followed by rapid diffusion to support the realisation of these initiatives so that the patient becomes the ultimate beneficiary. This in turn requires new research methodologies for such applied research scenarios. The Accelerated Mapping-to-Realisation (AMR) methodology is used as an appropriate knowledge-based methodology to ensure academic rigour and validation and also facilitate rapid diffusion and commercialisation of m-health initiatives.
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