Expert Consensus Document Addresses PCI Without On-Site Surgical Backup

March 17, 2014—The Society for Cardiovascular Angiography and Intervention, the American College of Cardiology Foundation, and the American Heart Association have published an expert consensus document on percutaneous coronary intervention (PCI) without on-site surgical backup. The document notes that the increasing number of PCIs being performed at low-volume centers without on-site cardiac surgery backup has driven the need for new safety and quality protocols. The document, which updates a 2007 consensus document, was drafted by a multisociety committee led by Gregory J. Dehmer, MD, who is Director of the Division of Cardiology at Baylor Scott & White Health, Central Texas in Temple, Texas.

In the societies’ press release, Dr. Dehmer commented, “This issue was last reviewed in 2007, and since that time, interventional cardiology has seen important changes. The new recommendations aim to increase safety while maintaining access to quality care for underserved patients.”

The document outlines steps hospitals can take to provide the safest possible environment for PCI when the facility does not provide cardiac surgery as a backup should complications occur. It compiles the recommendations made by various organizations in several different documents into one resource for use by facilities without on-site surgery. These include a greater emphasis on quality review programs, the recommended number of procedures physicians should perform per year to maintain their skills, mentoring for newly trained cardiologists, and criteria to evaluate PCI programs. It also recommends a shift in focus to system-wide planning for rational distribution of PCI services.

Additionally, the document also supports the ongoing study and surveillance of all PCI programs through participation in national databases, encourages public reporting of results, and acknowledges that further declines in PCI volumes might necessitate the closure of some PCI programs in the future. 

The document is available online in Catheterization & Cardiovascular Interventions, the Journal of the American College of Cardiology, and Circulation: Journal of the American Heart Association. The announcement on SCAI’s website includes a web interview with Dr. Dehmer.

As noted in the societies’ announcement, although PCI use has increased significantly since the procedure was introduced more than 30 years ago, use peaked in 2006 and has since dropped by nearly a third for a variety of reasons. Advances in drug-eluting stents, greater use of medication to treat some types of blockages, increased emphasis on heart disease prevention, and new technologies to help physicians better evaluate blockages have all contributed to a decrease in PCI use.

The decrease in PCI use has led to an increase in the number of facilities that are considered “low volume,” performing fewer than 200 PCIs per year, according to the consensus document. Overall, one-third of facilities performing PCI had no on-site cardiac surgery backup, and among those hospitals, approximately two-thirds were considered low volume.

The consensus document cites studies and meta-analyses since 2006 that find no indication of increased mortality or a greater need for emergency bypass surgery for either heart attack or elective PCI patients at sites without on-site cardiac surgery. In general, safety questions about sites without surgical backup have diminished “in the presence of a proven, well-defined, and protocol-driven approach,” advised the document.

However, the paper echoed an earlier joint recommendation that low-volume PCI programs “must have stringent systems and process protocols in place” with close monitoring of outcomes and strategies that encourage collaboration with higher-volume facilities.

In the announcement, Dr. Dehmer stated, “As the technique and equipment for PCI has improved, the evidence from randomized studies suggests that procedures can be performed safely without on-site surgery. But at the same time, the number of low-volume centers is increasing, making it essential that those facilities without backup cardiac surgery have strict protocols in place to ensure the highest level of patient safety.”

He continued, “The expansion of small PCI programs without on-site surgery has not substantially improved access to PCI. Although the number of facilities capable of performing PCI has increased 44%, the number of people who live within a 1-hour drive of a PCI facility has increased only slightly. Today, about 80% of the population is within 1-hour of a PCI hospital.” Recent surveys found expansion of reduced drive times for just 9% of the population, noted the announcement.