HCRI, MAHVI present transcatheter aortic valve data in severe stenosis at ACC meeting

The Harvard Clinical Research Institute (HCRI) and Saint Luke's Mid America Heart and Vascular Institute (MAHVI) today announced that Matthew R. Reynolds, M.D., Director of the Economics and Quality of Life Research Center (EQOL) at HCRI, presented results of a cost-effectiveness analysis of transcatheter aortic valve replacement versus standard therapy for severe aortic stenosis, as part of the opening plenary session on April 3 at the American College of Cardiology 60^th Annual Scientific Session & Expo. The analysis was performed on a specific cohort of the PARTNER Trial, which is sponsored by Edwards Lifesciences. Dr. Reynolds and David Cohen, M.D., M.Sc., Medical Director of the Health Economics and Technology Assessment (HETA) group of MAHVI, were co-principal investigators for this economic sub-study of the PARTNER Trial.

HCRI and MAHVI are each well known for their expertise in designing, implementing and evaluating clinical trials that assess the economics and comparative effectiveness of new and existing therapeutics, devices and procedures. Drs. Reynolds and Cohen are both experts in the field of health care cost-effectiveness studies, each having participated in numerous such analyses and extensively publishing on the topic.

"Information about the economic impact of this device is important, because the cohort studied included a very sick and elderly patient population, for which quality of life and cost effectiveness issues are particularly vital to understand," said Dr. Reynolds. "Our team at HCRI is experienced in understanding, investigating and analyzing these cost-related issues, as well as working with clinical trial sponsors to conduct economic assessments that aid in the development of new medical interventions. These economic analyses are part of HCRI's broader support of comparative effectiveness studies that provide evidence-based information to support informed medical decision-making."

"These results clearly demonstrate that despite its high upfront cost, transcatheter aortic valve replacement is an economically attractive therapy for these patients who otherwise lack viable treatment options," said Dr. Cohen. "New medical therapies and technologies are an important contributor to increased health care costs, so cost-effectiveness analysis is increasingly being utilized to objectively examine the relationship between the additional costs and health benefits of new devices and procedures. At MAHVI, the HETA research group seeks to improve health care by applying formal health economic analyses to a broad range of novel interventions to diagnose and treat cardiovascular disease."

Clinical results for this cohort of the PARTNER Trial, Cohort A, were also presented as part of the plenary session at the American College of Cardiology meeting. Clinical results for Cohort B were announced by Edwards Lifesciences in September 2010.