Personalised external aortic root support (PEARS) in Marfan syndrome: Analysis of 1-9 year outcomes by intention-to-treat in a cohort of the first 30 consecutive patients to receive a novel tissue and valve-conserving procedure, compared with the published results of aortic root replacement

Objective: Among people with Marfan syndrome who have a typical aortic root aneurysm, dissection is a characteristic cause of premature death. To pre-empt Type A dissection, composite root replacement with a mechanical valve became the standard of care in the 1980s and 1990s. This is being superseded by valvesparing aortic root replacement to avoid lifelong anticoagulation. In 2004, a total root and valve-sparing procedure, personalised external aortic support, was introduced. We report here results among the first 30 recipients. Methods: From cross-sectional digital images, the patient's own aorta is modelled by computer aided design and a replica is made in thermoplastic by rapid prototyping. On this, a personalised support of a macroporous polymer mesh is manufactured. The mesh is positioned around the aorta, closely applied from the aortoventricular junction to beyond the brachiocephalic artery. The operation is performed with a beating heart and usually without cardiopulmonary bypass. Results: Between 2004 and 2011, 30 patients, median age 28 years (IQR 20-44) had this operation and have been prospectively followed for 1.4-8.8 years by February 2013. During a total of 133 patient-years there were no deaths or cerebrovascular, aortic or valve-related events. These early outcomes are better than published results for the more radical extirpative root replacement operations. Conclusions: The aortic valve, the root architecture, and the blood/endothelia interface are conserved. The perioperative burden is less and there has been freedom from aortic and valvular events. A prospective comparative study is planned

Forming effective relationships between academia and the medical devices industry with a focus on launching a smart heart valve prosthesis for pediatric patients

Background This article presents examples of how to utilize the research output, to initiate academia-industry interaction, with the ultimate task of launching a new product: a smart heart valve prosthesis for pediatric patients. The article summarizes our efforts in a way that may also be informative to researchers working in fields other than medical devices development. Our task is not to provide a step-by-step guide, but rather to create inspiration, also by describing differences in expectations of business and academic entities. Methods We analyzed market reports, surveyed the scientific literature and conducted interviews with the key players in the field of medical devices. We also obtained a feedback from clinicians, academia and industry-related researchers, technology transfer centres, representatives of public organization and the creators of legislation. Results We have obtained and reported the definitive answers that together constitute a critical review of strategies that should be used by researchers who seek to commercialize the outputs of their research. Conclusion As a result of our investigation, we discovered that the commercialization of research is a complex process, which in some critical aspects does not depend solely on the researcher himself. The most promising ideas, supported by strong experimental evidence, can simply be overlooked by industry representatives, without the proper support of institutions such as a technology transfer centre. Besides, the involvement of scientists in a business project takes them, at least temporarily, outside the regular academic environment, which may cause discomfort and pose a risk to the career path. The limitation to be addressed is the reluctance to report the unsuccessful attempts, which should be considered a legitimate educational experience that ultimately leads to improvement.Other Information Published in: Translational Medicine Communications License: http://creativecommons.org/licenses/by/4.0/See article on publisher's website: http://dx.doi.org/10.1186/s41231-019-0046-3</p