Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is among the most advanced treatments available to open blocked arteries in the heart, thereby preventing or treating a heart attack. The procedure may be done on an elective, scheduled basis when the patient is free of symptoms or it may be done on an emergent (primary) basis when the patient is having a heart attack. In either the elective or primary setting, it involves inserting a thin, pliable catheter into a major blood vessel of the arm or leg and manipulating the tip of the catheter to the heart. Then a balloon or mechanical stent at the tip of the catheter is used to reopen blocked or partially blocked arteries and restore blood flow to the heart muscle. When the procedure is done in appropriate patients, the benefit can be great. If President Bill Clinton had been a suitable candidate with less extensive disease, he might have gone home later the same day of the procedure with a small puncture wound in the arm or leg, his heart problem fixed, and resumption of his usual life in a few days.
Department regulations state that PCI may be performed only in a hospital that has an open heart surgery program onsite. These regulations are consistent with the current guidelines of the American College of Cardiology (ACC). This is a safety measure to deal with possible complications that may be severe enough to require emergency open heart surgery. Over recent years, however, PCI has evolved and improved so that such complications do not occur as frequently as they once did. In any event, Department regulations allow PCI to be done in any hospital without a formal PCI program and open heart surgery program onsite if it is an emergency situation.
Hospitals in rural and medically underserved areas have petitioned the Department to waive the regulations requiring onsite open heart surgery as a prerequisite to offering PCI to their patients. Their premise is that access to the benefits of PCI should not be denied to patients as a consequence of geography or demographics. To explore the notion of improving access to care, a decision was made to allow PCI in a few community hospitals without onsite cardiac surgery as part of a limited program involving a waiver of Department regulations. Participating hospitals must agree to certain operating conditions that are largely based on the ACC guidelines. This includes a formal written agreement for immediate (within 1 hour) transfer of a patient to a cardiac surgical facility should the need arise. Furthermore, the hospitals’ informed consent form must state that the PCI procedure is being done under a waiver from the Department’s regulations and is not completely supported by the ACC guidelines. Patients considered for elective PCI must also undergo careful screening and risk stratification. Those who cannot meet the selection criteria and may be more likely to have an adverse outcome are transferred to a cardiac surgical facility for PCI.
Hospitals in the PCI project must report their performance data to the Department. This is done through an intermediary entity, the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR). The Department chose to utilize the NCDR because it is a mature system that has been collecting and analyzing PCI data for over five years and currently does so for more than 350 hospitals. Member hospitals are required to fill out a standardized record for every patient who undergoes PCI and submit that raw data to the NCDR. As data is analyzed, a member hospital receives a confidential institutional report on a quarterly and annual basis that addresses various outcomes including success, adverse events and mortality. The report compares a hospital’s performance to an NCDR benchmark, to a national average of all member hospitals, and to a comparison group consisting of hospitals that perform a comparable volume of cardiac catheterization procedures. This comparative data is more robust than if the Department had just collected data from participating facilities. Hospitals in the PCI project must share their institutional reports with the Department.
The Department is using the NCDR reports to monitor outcomes to help prevent or minimize harm to patients while permitting the benefits of PCI to become available in medically underserved geographic areas. As experience and data accumulate, decisions will be made regarding a hospital’s continued participation in the project. Furthermore, action may be warranted regarding the regulations that govern PCI. Possible options span the gamut from dropping the regulations, or keeping the regulations and allowing waivers, to keeping the regulations with no waivers. At this time, however, the Department does not intend to grant any additional waiver requests to participate in the PCI project.
