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May 8, 2012

ACCF/SCAI Publish Updated Consensus on Cardiac Catheterization Laboratory Standards

May 8, 2012—The American College of Cardiology Foundation (ACCF) and the Society for Cardiovascular Angiography and Interventions (SCAI) announced the upcoming publication of the consensus statement, “2012 ACCF/ SCAI Expert Consensus Document on Cardiac Catheterization Laboratory Standards Update.” The document was developed by ACCF and SCAI in collaboration with the Society of Thoracic Surgeons and Society for Vascular Medicine. The 2012 consensus document updates the standards issued in 2001.

The ACCF has published the document online ahead of print in the Journal of the American College of Cardiology, and SCAI has published it online ahead of print in Catheterization and Cardiovascular Interventions

“There have been a lot of changes since 2001, some of them dramatic,” commented Thomas M. Bashore, MD, Chair of the Writing Committee, in a press release. “This document sets the stage for what's really happening in cath labs today and updates everyone on accepted quality standards and best practices.”

Dr. Bashore added, “We don't always have randomized clinical trials to rely on. The purpose of this document is to define a practice standard for how you set up and run a cath lab, the people in the cath lab, the quality assurance programs—all the things cath lab teams should be thinking about.”

As the ACCF and SCAI outline, changes addressed in the updated document include: 

(1) A shift in focus from diagnostic tests to catheter-based therapies, from coronary disease alone to include the treatment of valvular heart disease, congenital defects of the heart, and arterial disease in the legs, brain, and other organs. 

(2) An increasing number of medical centers developing hybrid catheterization labs that combine all the features of a surgical suite with those of a catheterization lab. 

(3) Pediatric catheterization labs, many of which are now devoted almost exclusively to therapy, apply minimally invasive catheter techniques to congenital disease that once required major heart surgery. Procedures are now performed on unborn fetuses and newborns, as well as older children.

The new consensus document addresses cardiac catheterization labs at facilities without on-site cardiac surgical back up, stating that the risk of major complications with most invasive coronary procedures is very low. There are also proposed requirements for establishing off-site surgical back up, while lifting many previous restrictions on the types of patients eligible for such procedures.

For percutaneous coronary interventions performed to treat myocardial infarction patients in hospitals without on-site cardiac surgical back-up, the document stresses that partnership with a major medical center with cardiac-surgery capability is mandatory, and should include the establishment of a written plan for transfer should complications arise. The document also withholds endorsement of programs that offer PCI for myocardial infarction only during daytime business hours.

An effective quality assurance program (rather than minimum case volumes) is recommended as the key to ensuring that cardiac catheterization studies are appropriate and performed and interpreted correctly. The investigators advised that a related document is in development and will address minimal case volume for physicians who perform percutaneous coronary interventions.

The document also outlines essential elements of quality assurance/quality improvement programs; the role of the hybrid catheterization labs; the current training requirements for interventionists treating coronary arteries, peripheral arteries, and structural heart disease; preprocedural steps to protect kidney function during invasive procedures; the major changes in x-ray imaging; techniques to reduce radiation exposure to patients and staff; and the special requirements of pediatric cardiac catheterization labs.

On March 20, SCAI also published its clinical expert consensus statement on CCL best practices online ahead of print, as reported in Cardiac Interventions Today.

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May 9, 2012

Covidien to Introduce Its OneShot Renal Denervation System at EuroPCR

May 9, 2012

Covidien to Introduce Its OneShot Renal Denervation System at EuroPCR