An updated standards document for cardiac catheterization laboratories lifts almost all restrictions on the types of patients eligible for diagnostic procedures in laboratories without cardiovascular surgical backup, details the role of hybrid cath labs, and emphasizes quality improvement and assurance programs.
Compiling the 80-page document took nearly 3 years, a Herculean task according to some, but on May 8, the Society for Cardiovascular Angiography and Interventions (SCAI) and the American College of Cardiology Foundation (ACCF) released an update to the 2001 (J. Am. Coll. Cardiol. 2001;37:2170-214) Cardiac Catheterization Laboratory Standards (J. Am. Coll. Cardiol. 2012 May 8 [doi:10.1016/jacc.2012.02.010]).
"There have been a lot of changes since 2001, some of them dramatic," Dr. Thomas M. Bashore, chair of the writing committee and professor of medicine and clinical chief of cardiology at Duke University, Durham, N.C., said in a statement. "This document sets the stage for what’s really happening in cath labs today and updates everyone on accepted quality standards and best practices."
Over the last decade, advancements in technology have changed imaging and reporting systems, the authors wrote. Due to lower risk of invasive procedures, there are now cardiac cath labs without on-site surgical backup, a trend that highlights the importance of quality assurance and quality improvement initiatives. Meanwhile, the cath lab has become "multipurpose suite" for diagnostic and therapeutic procedures for pediatric and adult patients, the authors noted. And while hybrid cath labs are not a new phenomenon, more medical centers are looking into creating them as they consider starting transcatheter aortic valve replacement (TAVR) programs.
The consensus document details examples of procedures suitable for hybrid cath labs; staffing, location, and equipment requirements; room, floor, and ceiling design; and addition to audio/video input and output needs.
The document also addresses several issues including:
– Cardiac cath labs without on-site cardiac surgical back-up. The document proposes requirements for establishing off-site surgical back-up, but lifts many prior limitations on the types of patients eligible for diagnostic procedures. Specifically, age, heart failure status, severity of stress test abnormalities, left ventricular function, and valve disease no longer restrict patients from receiving diagnostic procedures at standalone cath labs. Therapeutic procedures that should still be done only in facilities with cardiovascular surgical back-up include those in adults with congenital heart disease and in children. Primary percutaneous coronary intervention in patients with acute coronary syndrome can be performed in a standalone cath lab, provided that the facility complies "with all current guidelines on the establishment of such a program."
– Quality assurance and improvement initiatives. The document details elements of such initiatives, such as benchmarking against peers, participation in a national clinical database, and monitoring the procedures’ quality and appropriateness.
– X-ray imaging. The document summarizes major changes in x-ray imaging that have occurred since the last statement in 2001, in addition to measurement and prevention of exposure to radiation.
– Training requirements. The document summarizes the already-established requirements for training. It also recommends "that both training and practice activity associated with structural heart disease intervention be concentrated among a limited number of laboratories and operators with a particular interest in these procedures."
Dr. Charles E. Chambers, who represented SCAI on the document’s writing committee, said that the document is also a resource for institutions and cath labs.
"Pay-for performance is what is potentially down the road, if we aren’t already there. And issues such as benchmarking and risk factor stratification are important in quality programs and tracking outcomes, and that’s what’s covered nicely in this paper," said Dr. Chambers, director of Cardiac Catheterization Laboratories at Penn State Hershey Heart and Vascular Institute, Hershey, Pa.
But will the document be embraced by practicing physicians?
"This document certainly shows best practice, and I think that’s what [physicians] are interested in. We want to give best patient care, and there are enough questions out there that I think this will be embraced as a reference when questions arise," said Dr. Chambers.
The authors’ disclosures are listed at in the consensus document. Dr. Bashore and Dr. Chambers had no relevant disclosures.