CardioExchange Archive

A new initiative involving a wide variety of stakeholders — the FDA, the American College of Cardiology, the Society of Thoracic Surgeons, industry, medical journals, and others — could lead to an enormous international cooperative effort to make device registries a standard part of the practice of cardiology. This will be a “huge step,” said David Holmes, a former president of the ACC and one of the initiative’s leaders.

The initiative is a natural outgrowth and expansion of the STS/ACC TVT Registry, the registry for transcatheter valve therapies that includes every patient and every implanting center in the U.S. In the wake of the success of the TVT Registry, said Holmes, “we talked with different colleagues around the world and began to think about the possibility of global registries.” (See this for my earlier discussion about the importance of the TVT Registry.)

The initiative will be the subject of a meeting later this month at the FDA, entitled the “International Consortium of Cardiovascular Registries.”(News of the meeting was first reported by Alexander Gaffney in Regulatory Focus.) As described by the FDA, the purpose of the meeting “is to discuss the development of an international consortium of cardiovascular registries with a broad array of interested stakeholders. The initial pilot phase of this effort will be developing relationships and analysis strategies for transcatheter cardiac valve registries, with the understanding that these efforts would be expanded to additional cardiovascular devices in the future.”

Holmes said that the initial product of the meeting will be a white paper, which will then be used as a road map for future development of the registries. Data from the registries will allow for a more efficient approval process and should substantially improve post-approval monitoring of the safety and efficacy of cardiovascular devices, said Holmes. In recent years, the FDA and other regulatory agencies have received heavy criticism from all sides over the approval process and the subsequent monitoring of approved devices. The new registries, said Holmes, will allow regulators to avoid being either “too slow or too fast.”

The FDA announcement explains the limitations of the current system: “Information obtained from clinical trials is often limited due to small size, short followup, and lack of generalizability. Observational studies and registries… are often limited in scope and size to a specific country, region, or health care provider system.”

One important possible benefit of international registries will be the increased ability to discover and understand comparative differences between nations involving genomics or other factors that impact device safety and efficacy.

The resulting registries could be “a massive step up” from existing registries, notes Gaffney. The closest model for the new proposal is the International Consortium of Orthopedic Registries (ICOR).