TAVR registry expected to serve as collaborative model

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David R. Holmes, Jr., MD, FACC - 15.91 Kb
David R. Holmes, Jr., MD, FACC
A registry jointly administered by the American College of Cardiology (ACC) and Society of Thoracic Surgeons (STS) for monitoring patients who receive transcatheter aortic valve replacement (TAVR) therapy in the U.S. will provide a template for future collaborative projects, ACC’s president said in an interview. A long-term goal is to grow the registry into a robust, disease-specific resource for clinicians, regulators and others.

In a continuation of patient-focused efforts that partner the two societies, the ACC and STS announced Dec. 1 the launch of the TVT Registry. The registry is expected to provide reliable data for tracking outcomes of all TAVR patients in the U.S.

“This is the first time we have worked so closely together,” said David R. Holmes Jr., MD, president of the ACC. “It forms the framework and expectation that we will continue to collaborate and not let opportunities of working together fall by the way side.”

The registry combines both complementary skill sets and assets, Holmes explained. The model follows the example of the heart team, a concept in which cardiac surgeons and interventional cardiologists work side by side to treat patients with severe aortic stenosis. Both societies have recommended that TAVR, which offers a minimally invasive option for some patients who are not suitable for surgery, be performed in a hybrid operating environment by a multidisciplinary team of physicians. The societies jointly have promoted the heart team approach in guidelines as well.

“Both specialties bring different strengths, so it is a good match,” Holmes said. Each has demonstrated expertise in developing and managing registries such as the ACC’s National Cardiovascular Data Registry (NCDR) and the STS’ National Database. “The datasets both specialty societies have are complementary.”

The Duke Clinical Research Institute in Durham, N.C., will serve as the data analytic center.

The partnership will allow the two societies to combine and harmonize their clinical and administrative data for a comprehensive resource for investigations, Holmes said. The Society of Cardiovascular Angiography and Intervention (SCAI) and the American Association for Thoracic Surgery (AATS), which also were consulted about the registry, are likely to make use of the registry.

The registry was developed in collaboration with the Centers for Medicare & Medicaid Services (CMS) and the FDA, which recently approved the use of the Sapien transcatheter aortic valve (Edwards Lifesciences). The approval paved the way for expected growth in this field as well as the need for a reliable source of data for FDA post-approval and post-marketing analyses.

Holmes added that the goal of enrolling every patient in the U.S. who undergoes a TAVR procedure will provide a valuable tool for evaluating outcomes beyond the FDA’s studies. For instance, an FDA study may focus on a subset of 200 patients with a certain trait. But the patient population may include 1,000 patients, some who share that trait and some who do not.

“We would like to know how that technology worked in those different patients,” Holmes said.

The registry poses immediate challenges, he offered, including mechanisms to ensure the data are complete and accurate and the system is equipped with protocols for access and use of data, including industry data. In the long run, Holmes envisions the registry database growing beyond transcatheter valves to the broader disease state.

“The other part of this registry is a plan to include patients who are treated medically,” he said, to assess issues such as timing and dosage. “It will be a disease-specific registry. Maybe some of the medical therapy we have used was applied too late or too aggressively.”

More information on the registry is available here.