SCAI expert panel sets high standards for PCI without on-site cardiac surgical backup
(5 February 2007: VIDYYA MEDICAL NEWS SERVICE) -- The Society for Cardiovascular Angiography and Interventions (SCAI), a leading organization for interventional cardiologists, today released a document recommending the adoption of stringent quality standards by those who perform percutaneous coronary intervention (PCI) in hospitals not equipped for cardiac surgery. The document has been endorsed by 12 medical societies representing more than a dozen countries, including the Asia-Pacific region, Australia, Belgium, Brazil, Bulgaria, Egypt, Great Britain, India, Italy, Latvia, New Zealand, Poland, and Venezuela.
The document, which represents the consensus of a panel of experts in interventional cardiology, acknowledges that an increasing number of patients suffering from heart attack or coronary artery disease are undergoing stenting and other catheter-based heart therapies in hospitals without on-site cardiac surgery, both in the United States and around the world. When PCI is performed without on-site surgical back-up, physicians and hospitals should adhere to the highest standards of quality to ensure patient safety and excellent clinical outcomes, the document recommends.
"This is not an open endorsement of PCI without on-site surgical back-up. Instead, we are acknowledging that it may be appropriate in some settings, and offering our expert consensus on how such programs should be organized, supervised, and performed," said Dr. Gregory J. Dehmer, SCAI President and chair of the expert panel. "The goal is to improve the quality of coronary interventional care worldwide."
The consensus document recommends that PCI programs operating without on-site cardiac surgery:
*Maintain case volumes of at least 200 PCIs per year;
*Employ highly skilled interventional cardiologists who have performed more than 500 PCIs throughout their career, have an annual case volume of more than 100 PCIs, and meet national benchmarks for procedural success and complication rates;
*Train all support personnel in the management of PCI patients;
*Select patients carefully to control the risk of complications;
*Establish a close alliance with cardiovascular surgeons, including formalized and tested protocols for emergency transfer of patients;
*Activate emergency transport at the first clear signs of a PCI complication, thereby ensuring that the time to the initiation of cardiopulmonary bypass does not exceed 120 minutes; and
*Collect appropriate outcomes data and submit them for comparison with state or national performance standards.
The consensus document addresses an ongoing health policy debate. Current PCI guidelines—co-authored by SCAI in partnership with the American College of Cardiology and the American Heart Association and released in November 2005—indicate that performing PCI for heart attack patients in a hospital with cardiac surgery is widely accepted as beneficial, useful, and effective and is supported by scientific studies. (In the terminology of guidelines documents, it is designated a Class I indication.)
Performing PCI for heart attack patients in hospitals without on-site cardiac surgery is, in guidelines terminology, a Class IIb indication, meaning its usefulness and effectiveness are less well established by scientific evidence and opinion. As for routine "elective" PCI in hospitals without on-site cardiac surgery, the 2005 guidelines recommend against the practice, rating it a Class III indication, as did an earlier set of guidelines issued in 2001.
Many studies have shown that PCI is a highly effective treatment for heart attack and offers key advantages over clot-busting drugs. Rapid treatment is critical, however. Patients benefit most when blood flow is restored within 90 minutes—a goal that can be considerably more difficult to meet if patients must be transferred to a PCI center with cardiac surgery. As a result, PCI for heart attack is being performed in hospitals without on-site cardiac surgery in all but 10 states.
"The advantages of PCI for the treatment of heart attack patients started the movement toward PCI without on-site surgery, especially in smaller communities without cardiac surgery," Dr. Dehmer said. "The sooner the patient undergoes PCI, the better."
Some hospitals performing PCI for heart attack have also started elective PCI programs, using stenting and other catheter-based procedures to treat patients with narrowed coronary arteries. Survey data collected by SCAI show that elective PCI without on-site cardiac surgery is increasingly common. In fact, it is performed in 28 states in the United States and in many other developed countries.
One key reason for offering elective PCI without on-site cardiac surgery is the difficulty of maintaining a high level of skill among the nurses, technicians, and physicians in a program that treats only a small number of heart attack patients each month. In addition, if elective PCI is unavailable in some rural areas, elderly or economically disadvantaged patients may forgo PCI altogether, rather than face travel to an urban medical center.
Also fueling the growing trend is the safety of PCI. The need for emergency bypass surgery after PCI has fallen dramatically over time, to around 3–6 in 1000 procedures. In fact, emergency surgery is so infrequent, hospitals with on-site cardiac surgery no longer hold operating rooms open while PCI is performed. Several small studies have shown good results for PCI without on-site surgery, but more definitive evidence must come from large randomized trials. One such study has just started to enroll patients.
"The focus of PCI programs must always be on providing the best quality of care for the patient under all circumstances," Dr. Dehmer said. "This document addresses the realities of our healthcare system while setting performance standards very high."
The complete text of the full-text consensus document, an executive summary, and an editorial by Dr. Dehmer all are available online at www.scai.org.
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