TEMPLE, Tex. -- Only high-volume cardiac interventionalists with meticulous track records should consider performing percutaneous coronary procedures without onsite surgical backup, according to a consensus statement.
TEMPLE, Tex., Feb. 5 -- Only high-volume cardiac interventionalists with meticulous track records should consider performing percutaneous coronary procedures without onsite surgical backup, according to a consensus statement.
Without endorsing the use of such procedures without onsite surgical backup, the Society for Coronary Angiography and Interventions said that only cardiologists who perform a minimum of 100 interventions annually -- including at least 18 of them primary -- should be eligible to intervene without a surgical safety net.
Moreover, no cardiologists should begin working at such a facility until "they have a lifetime experience of more than 500 percutaneous coronary interventions as primary operator after completing fellowship."
Gregory J. Dehmer, M.D., of the Texas A & M School of Medicine, and SCAI president, said that by spelling out those requirements the society "has defined 'expert' interventionalist." Only experts, he said, should be working without a safety net.
The consensus statement was published in the February issue of Catheterization and Cardiovascular Interventions and a shorter version was published on the journal's website.
Although the SCAI statement sets forth minimum volume requirements, Dr. Dehmer said the statement gives equal emphasis to quality, noting that it recommends that free-standing percutaneous coronary intervention centers and interventionalists at those centers should also meet quality benchmarks.
Those benchmarks should include door-to-balloon time of 90 minutes or less, as well as revascularization, overall vascular complication, and mortality rates better than or as good as the median rates in the ACC-National Cardiovascular Data Registry.
The American College of Cardiology, the American Heart Association, and SCAI issued percutaneous coronary interventions guidelines in 2005. The guidelines stated that there was no evidence from randomized controlled trials to support procedures without onsite surgical backup, although they noted that it might be permissible as primary percutaneous coronary interventions if the operators performed at least 75 procedures-including at least 11 of them primary-annually (class IIb indication).
The ACC/AHA/SCAI guidelines stated that elective PCI should not be done without surgical backup (class III indication).
Despite the guidelines, the practice of percutaneous coronary interventions without onsite surgical backup has been growing in this country and overseas, Dr. Dehmer said.
Nine states (Alaska, Arkansas, Delaware, Georgia, Mississippi, North Dakota, Rhode Island, South Dakota, and Vermont) and the District of Columbia prohibit percutaneous coronary interventions without surgical backup, but in 28 states the number of facilities offering "no net" elective and primary percutaneous coronary interventions has been growing.
Fueling this interest, two institutions-the Mayo Clinic and Duke University-initiated satellite no-backup percutaneous coronary intervention centers at distant locations and have published the favorable results from these experiences.
Moreover, even states that generally prohibit the practice allow exemptions for participation in randomized trials and demonstration projects.
And outside the U.S., onsite surgery "is not a consideration," Dr. Dehmer said, noting that guidelines issued from the European Society of Cardiology don't mention onsite surgery and British guidelines allow percutaneous coronary interventions without onsite surgical backup.
In response to this "real world situation, SCAI believed it was necessary to bring a reasoned expert analysis to what has been a very emotional debate," Dr. Dehmer said.
In addition to recommending standards for physicians, the SCAI statement recommended:
In a commentary published along with the consensus statement, Dr. Dehmer said that if he were faced with the need for percutaneous coronary interventions for himself, his preference would be to have "the best cardiac surgeon and cardiac anesthesiologist in the world standing by during my procedure and a fully staffed operating room immediately available just waiting for my arrival should percutaneous coronary interventions fail."
But having a surgeon available onsite-any cardiac surgeon-is not always feasible in the real world, he added.
Failing that, he said the focus should be on quality and promoting quality in all procedures in all settings.