Hopkins Angio Study Stirs Controversy
Guidelines developed by the American Heart Association (AHA) and the American College of Cardiology (ACC) recommend that in non-emergent cases, angioplasty should only be performed at institutions where cardiac surgeons are on site to address complications, should they arise. This guidance was codified by many state legislatures; smaller centers without cardiac surgery staff on-site were not permitted to perform elective angioplasty. Interventional cardiologists, the ACC, and AHA are now questioning these regulations. They cite reduced morbidity and mortality attributed to angioplasty and poorer outcomes among patients who might not otherwise be offered the procedure.
In late 2005, Johns Hopkins University initiated a clinical trial to examine outcomes among patients who undergo angioplasty, comparing community hospitals to larger centers which have on-site back up provided by cardiothoracic surgeons. The Hopkins researchers documented superior outcomes for patients treated with angioplasty compared to less invasive techniques in community settings in a 2002 report in the Journal of the American Medical Association. Last week, the Society for Cardiovascular Angiography released recommendations (pdf) to promote patient safety in that setting. That report references the documented need to reassess the requirement for on-site surgical back up for performance of elective angioplasty. The Hopkins study was crafted to answer this question.
The goal of the Hopkins study was to provide clear evidence to reformulate guidelines for elective angioplasty and includes requirements for participating community-based institutions that do not have on-site cardiac surgery. Community hospitals participating must have experienced interventional cardiologists who meet the training standards designated by the American College of Cardiology, in addition to institutional experience conducting angioplasty.
Conflict with regulations governing angioplasty, cited above, require state waivers for community hospital participation. The state waiver is under review in New Jersey. Three hospitals in the Delaware Valley filed suit to block the performance of angioplasty through this study at Virtua-West Jersey Hospital. The State Health and Senior Services Commissioner, Dr. Fred Jacobs, waived the state regulation to allow participation of Virtua in addition to eight other hospitals in New Jersey. In October 2006, the New Jersey Appellate Division upheld Jacob’s decision. The case is scheduled to be heard by the New Jersey Supreme Court on March 20.
March 12, 2007 Related topics: Legal & legislative, Quality, Safety, Errors, Radiology, Cardiology