Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet)

Abstract

The Medical Device Epidemiological Network Initiative (MDEpiNet) is a public-private partnership between the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and participating partners. The Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) program is an MDEpiNet-sponsored program which aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle (TPLC). To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included four areas of cardiovascular medicine intended to cultivate interest in four MDEpiNet Disease Specific/Device Specific Working Groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the Working Groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program.

One-Year Follow-Up of Vascular Intervention Trials Disrupted by the COVID-19 Pandemic: A Use-Case landscape

“…The PAIINTERS working group convened in May 2020 to discuss how trials involving coronary and peripheral vascular devices had been disrupted during the COVID-19 pandemic, and what mitigation strategies had been used to foster patient and staff safety, as well as to preserve the integrity and interpretability of the evidence collected regarding device benefit/risk and safety. The group was configured across the PASSION CV community, a pre-competitive collaborative public private partnership [15] , including academic clinicians and trialists, industry and Federal agency experts on cardiovascular devices. PASSION CV is actively conducting demonstration programs for the National Evaluation System for health Technologies (NEST) [16] leveraging complementary interoperable real work networks [17] in cardiovascular devices including heart failure, heart valves, peripheral and coronary intervention.…”

System of clinical indicators for patients with chronic coronary artery disease

“…С помощью регистров ССЗ осуществляется сбор, хранение и анализ данных о процессах диагностики и лечения большого числа пациентов. За рубежом существуют регистры больных ССЗ, специально разработанные для оценки качества медицинской помощи на национальном уровне, например американские госпитальные и амбулаторные регистры NCDR [10,11]. Регистры, разработанные с применением грамотной методологии, дают возможность получить информацию о большом количестве пациентов в оперативном режиме, позволяют внедрять в их аналитический аппарат систему клинических индикаторов и являются основным источником данных для проведения клинического аудита.…”