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FDA discusses establishment of international consortium of CV registries
The FDA today held a public meeting to discuss the development of an international consortium of CV registries. The initial pilot phase will focus on developing relations and analysis strategies for transcatheter valve registries, with the understanding that these efforts would be expanded to additional CV devices in the future.
“The agency views these efforts as an extremely important collaborative effort on an international front. Unique device system-like registries are critical to the modernization of post-market devices,” William Maisel, MD, MPH, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said at the meeting.
William Maisel
In the United States, the Edwards Sapien valve is the only FDA-approved device for the treatment of high-risk aortic stenosis through both the transfemoral and transapical approaches. Because the transcatheter valve field is relatively new, with limited randomized trials and long-term results, an international registry of outcomes and data could play an important role in patient care.
FDA vision
The International Consortium of Cardiovascular Registries project is modeled after the International Consortium of Orthopedic Registries.
Initial discussion about the International Consortium of Cardiovascular Registries focused on transcatheter aortic valve replacement data collection. Experts at the FDA and others involved with established TAVR registries discussed the need for international safety and effectiveness outcome reports, such as 30-day and longer-term outcomes; strategies to fund the initiatives; functioning and quality of life data; and which countries to include in the international consortium.
The collaboration would involve a variety of stakeholders: FDA officials, academics, industry, third-party payers and patients. “These efforts must meet the needs of all stakeholders,” Maisel said.
Established registries and worldwide needs
Worldwide, several TAVR registries have been developed to collect outcomes data.
In the United States, the Society of Thoracic Surgeons and American College of Cardiology created the STS/ACC Transcatheter Valve Therapy Registry in 2011 to track safety and real-world outcomes of TAVR. This registry serves as the main repository for all clinical TAVR data and is posited to incorporate additional catheter-based procedures that have yet to come to market in the United States.
Two German medical societies initiated the German Aortic Valve Registry (GARY) in 2010 to address the growing number of TAVR procedures performed in recent years. The goal of GARY is to evaluate benefits and risks of the new interventional procedures as compared with standard surgery. One barrier for GARY, according to Christian W. Hamm, MD, PhD, professor of internal medicine and cardiology and medical director of the Kerckhoff Heart and Thorax Center, Germany, has been funding.
The French Transcatheter Aortic Valve Intervention Registry (FRANCE 2) was established to collect real-world data on all TAVR procedures performed in France.
Experiences from other established transcatheter valve registries, including the Canadian TAVI Registry and UK TAVI Registry, were also considered.
Roadmap for implementation
The public meeting serves as a roadmap for linking together worldwide TAVR registries.
Michael J. Mack
“It is a tremendous initiative,” said Michael J. Mack, MD, president of the Society of Thoracic Surgeons.
“[This discussion] is a template,” Mack said. “TAVR is not the last technology to come along. We hope that this pilot project is used to develop new approaches and evaluate new technologies.”
The international consortium is still in the formative stages of development. Cardiology Today will follow and report more on this effort. – by Deb Dellapena
Perspective
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The registries provide us with real-world information about the efficacy and safety of new treatment modalities. Naturally, if the quality of data entering the registry are suboptimal, the information coming out of the registry will not be reliable.
The TVT registry is a very important step in the field of new therapeutic devices. Within the TVT registry framework, the collaboration of the ACC and STS set the stage for the formation of a multi-party team, including the FDA, CMS, National Heart, Lung and Blood Institute, Duke Clinical Research Institute and industry, as well as patient groups. The TVT registry will allow us to have a full picture of the real-world practice in the area of TAVR. It will provide a tremendous amount of data about all aspects of TAVR — from patient selection to procedural complications and long-term outcome in different centers. It will provide centers a valuable tool for quality improvement.
High-quality data in the registry will give regulatory agencies opportunity to evaluate the performance of new technologies in the post-market phase. Furthermore, the high-quality data from a national registry can potentially be used for pre-approval studies.
New therapeutic modalities are frequently used earlier and more extensively outside the United States. There is more experience with TAVR in Europe and Canada than in the United States. There are a number of national TAVR registries, including robust registries in Germany, United Kingdom, France, Netherlands and Canada. We would have a bigger data set if we can join the US and international registries in a usable form.
The International Consortium meeting organized by FDA is the first step in this direction.