Uses of clinical data from registries like those that fall under the umbrella of ACC's National Cardiovascular Data Registry (NCDR) have been expanding over the last several years as consumers, industry, and state and federal policymakers increasingly look to quantify outcomes, improve care and lower health care costs.
When it comes to the ACC, the College is embarking on a number of efforts that leverage its NCDR registries and their data to further clinical trial research; identify gaps in care; and changing culture to change care. A special ACC.13 press briefing highlighted three such efforts aimed at enhancing medical research; decreasing identified gaps in anticoagulation use; and changing hospital culture to improve survival after myocardial infarction.
Fred Masoudi, MD, FACC, senior medical officer for NCDR, kicked off the conference with an overview of the College’s registries that now total seven – six-hospital-based and one ambulatory care. "The NCDR is based on clinical data and provides practices and hospitals with nearly 18 million patient records, a figure that continues to grow," he said.
In addition, Masoudi noted that registries are being increasingly used for research studies, with 27 abstracts featured at ACC.13 alone. The U.S. Food and Drug Administration's (FDA's) recent decision to grant an investigational device exemption (IDE) to the ACC and The Society of Thoracic Surgeons to conduct a study assessing alternative access approaches for TAVR is another research example.
According to Ralph Brindis, former ACC president and NCDR senior medical officer, the ACC and STS worked closely with the FDA, the Centers for Medicare and Medicaid Services and Edwards Lifesciences to develop the trial, which will be tracked using the STS/ACC TVT Registry™. As part of the trial, patients not eligible for aortic valve surgery will receive TAVR through transapical, transaortic, and other non transfemoral approaches. These data will be compared to those of patients in the original PARTNER Cohort A trial who received TAVR through the transapical approach, he said.
The goal behind the study is to expand the field and extend the benefits of TAVR to broader patient groups, with the hope that it can be a model for specialty societies, industry and federal regulators aligning efforts to ensure appropriate patient access to a new technology in a cost-effective and evidence-based way moving forward.
Richard Kovacs, MD, FACC, chair of the ACC’s Best Practices and Quality Improvement Committee, shed light on how the College is using registries to both identify gaps in care and track progress towards improvements. For example, he said the ACC’s new Anticoagulation Initiative was born after research studies examining PINNACLE Registry data identified gaps in anticoagulation care. Among patients with medium to high risk of stroke, the overall rate of anticoagulation therapy in 2012 was only 58 percent, he noted.
Kovacs, who also chairs the new initiative, said the initiative will help facilitate a greater understanding of atrial fibrillation (AFib) treatments and practice patterns, particularly given an increasing number of new anticoagulant treatment options entering the marketplace. He noted that the initiative will serve as an umbrella for the growing number of ACC AFib tools targeted for use by cardiovascular professionals and their patients, including a new point-of-care mobile app for iPads called the Anticoag Evaluator, education programs and online clinical communities for both patients and clinicians.
Henry Ting, MD, FACC, chair of the Surviving MI Steering Committee, rounded out the conference with an inside look at the College’s newest national quality initiative called Surviving MI. According to Ting, research is showing that a person’s chances of surviving a heart attack are dependent on factors like hospital culture, teamwork and leadership. As such, Surviving MI, will be focused on reducing 30-day mortality rates for patients hospitalized with MI by disseminating and implementing the evidence-based strategies of top performing hospitals.
He noted that the initiative is unique in that it is one of the first to explicitly focus on patient outcomes and organizational culture change. The program will initially target the hospital participants in the NCDR ACTION Registry®-GWTG™ which through their participation in the registry have a commitment to quality improvement for the acute coronary syndrome patient, he said.