Consensus Document Updates Practice Standards for Cath Labs

In the last decade, cardiac catheterization laboratories have evolved into more sophisticated environments with newer devices and treatment options. As today’s interventionalists adapt to an increased emphasis on peripheral vascular and structural heart interventions, a new expert consensus document attempts to make sense of many of the novel issues and concerns that have come into play.

The consensus statement was developed by an expert panel of the American College of Cardiology Foundation and the Society for Cardiovascular Angiography and Interventions, in collaboration with the Society of Thoracic Surgeons and the Society for Vascular Medicine. It  was published online May 8, 2012, ahead of print in the Journal of the American College of Cardiology, and will be published in a forthcoming issue of Catheterization and Cardiovascular Interventions.

The document updates a prior expert consensus on cardiac cath lab standards that was published in 2001. In a telephone interview with TCTMD, writing committee member Jeffrey J. Cavendish, MD, of Kaiser Permanente (San Diego, CA), said while there are many new issues covered in the document, other topics have not changed much in the last decade.

Document Basics

According to Dr. Cavendish, one of the timeliest sections of the document concerns hybrid cath labs, which are integrated procedural suites that combine the tools and equipment available in a normal cath lab with the anesthesia, surgical facilities, and sterility of an operating room. Hybrid labs are recommended for TAVR procedures, although they are not mandated.

“This section can be a nice resource for interventionalists who are looking at doing more advanced structural heart interventions,” he said.

The committee reviews in detail the special considerations in designing, building, and equipping the lab.

“In short, the hybrid laboratory requires considerable planning and a firm understanding of how the room is to be used before its construction,” the authors write. “Its dual function provides an opportunity to expand the procedures in the catheterization laboratory. Its stringent requirements demand a cooperative working relationship with a variety of disciplines to be a safe and successful endeavor.”

Other areas addressed in the document include:

• Cardiac catheterization with or without on-site cardiac surgical back-up
• Training requirements for physicians who perform invasive and interventional procedures
• Acceptable patient outcomes
• Imaging and radiation safety
• Digital storage and archival systems
• Advances in hemodynamic monitoring
• Care of patients with kidney disease
• Pediatric cardiac catheterization

In a telephone interview with TCTMD, Sorin J. Brener, MD, of Weill Cornell Medical College (New York, NY), congratulated the task force on synthesizing vast amounts of information into a useable reference for clinicians.

“This is a tremendous service to have this information all in one place,” he said, adding that in addition to providing guidance to cath lab directors and operators, it also is useful for cardiovascular trainees to review when deciding to embark on a career in interventional cardiology.

A Question of Volume

Another key issue discussed in the document regards minimum case volumes as an indicator of physician quality in performing diagnostic cardiac catheterization. The prior cath lab standards document from 2001 suggested 150 cases per year as a minimum for facilities, and the annual minimum operator volume of 75 cases per year has become an accepted standard. However, Dr. Cavendish and colleagues believe the numbers are arbitrary and not adequately supported by data. Instead, the task force states that an effective quality assurance program is the key to ensuring that cardiac catheterization studies are appropriate, and performed and interpreted correctly.

“Obviously the relationship between volume and outcomes is complex, and many confounding issues are evident,” they write. “Low-volume operators in high-volume laboratories tend to fare better. Complicating the issue further, however, is the fact that many competent interventional cardiologists do not perform more than 75 procedures each year. Some cardiologists perform PCI primarily when on-call, and some are at the beginning or the end of careers and are either ramping up or winding down a practice. Some perform procedures at multiple facilities, and the data for such individuals are often incomplete.”

The authors add that data for primary PCI are particularly difficult to categorize because of the low volumes being performed. They recommend that all primary PCIs be evaluated by the institutional quality assurance committee, regardless of operator volume, and they say operators wishing to participate in primary PCI should be required to attend these review sessions.

Dr. Brener agreed.

“There are many issues that tie into this that need to be addressed, such as some new devices that are actually quite difficult to operate if you are not familiar with them because you don’t do a lot of procedures,” he said. “But to me the most important part of the volume/outcome relationship is with regards to primary angioplasty. These can be very sick patients and that’s where it’s critical that you are good. Ultimately, the solution is aggregation of forces so that if you don’t do a lot (of procedures) but work in a hospital that does a lot, it’s probably okay. It’s the people working on their own doing 5 cases a year where there is concern.”

Dr. Cavendish said a related document by the committee is in development and will address minimal case volume in greater detail. It is expected to be published later this year.

Spotlight on Quality Improvement

The cath lab standards document defines the essential elements of a quality assurance/improvement program, including participation in a national clinical database, tracking of specific quality indicators, benchmarking against peers, and monitoring of procedure appropriateness and quality. It also states that institutions should collect defined outcomes-related indicators including:

• Individual physician complications
• Service outcomes (eg, access, door-to-intervention times, and satisfaction surveys)
• Financial outcomes

The document states that all major complications should be reviewed by the quality assurance committee at least every 6 months, and “any individual operator with complication rates above benchmarks for 2 consecutive 6-month intervals should have the issue directly addressed by the [quality assurance] director and followed up with written consequences.” They also recommend that operators be randomly reviewed at least annually, as well as be required to attend  cardiac catheterization conferences and obtain a minimum of 12 CME hours per year.

“This continues to be an important issue as far as how we’re doing in the cath lab, lowering morbidity and mortality and decreasing complications that lead to adverse cardiac events,” Dr. Cavendish said. “I really think this document is important because it goes over not only what we are doing [now], but what we should be doing to really provide the best care for our patients.”

 

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Source:
Bashore TM, Balter S, Barac A. American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions expert consensus document on cardiac catheterization laboratory standards update. J Am Coll Cardiol. 2012;Epub ahead of print.

 

 

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• SCAI Launches Nationwide Cath Lab Quality Improvement Effort

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