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Ralph G. Brindis, MD, MPH, MACC


Clinical Professor of Medicine, Department of Medicine & the Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco; Senior Medical Officer, External Affairs, American College of Cardiology, National Cardiovascular Data Registry

How Can the ACC Cardiovascular Registry Help Prevent Unnecessary Procedures?

“If you don’t measure it, you can’t manage it”

 

In response to growing concerns of inappropriate cardiac procedures along with fostering a culture in which cardiovascular professionals can become better stewards of our nation’s healthcare expenditures, the American College of Cardiology in collaboration with many other professional organizations has developed Appropriate Use Criteria (AUC) for cardiovascular imaging, coronary revascularization such as coronary angioplasty (PCI), implantable cardioverter defibrillators (ICDs), aortic valve surgery along with other cardiovascular (CV) therapies (1,2,3,4). AUC assess the benefits and risks of a test or procedure in the context of the potential benefits to patients’ outcomes with an implicit understanding of the associated resource use and costs. Although not intended to be entirely comprehensive, the indications are meant to identify common scenarios encompassing the majority of contemporary practice in an effort to assist clinicians in the rational use of CV tests and procedures. Appropriate Use Criteria publications reflect an ongoing effort by the ACCF to critically and systematically create, review, and categorize clinical situations where tests and procedures are utilized by physicians caring for CV patients with the goal to practice care more efficiently with an equitable allocation of health care resources. The AUC process is based on current understanding of the technical capabilities of the procedures examined, the evidence base, and clinical experience. AUC are intended to assist patients and clinicians, but are not intended to diminish the acknowledged difficulty or uncertainty of clinical decision-making and cannot act as substitutes for sound clinical judgment and practice experience. Rather, the aim of these criteria is to allow critical assessment of utilization patterns for a test or procedure. Comparing utilization patterns across a large subset of provider’s patients can allow for an assessment of a provider’s management strategies with those of his/her peers.  Adherence to AUC can improve patient care and intelligently prevent misuse of procedures while reducing costs. The ACC believes that the “mirror” of AUC helps the CV specialist reflect on the value of care we provide to patients while maintaining the privilege of self-regulation and most importantly the trust of the healthcare community and patients.

 

To help health care provider groups and institutions respond to increasing requirements to document their processes and outcomes of care in the cardiac catheterization laboratory, the ACC National Cardiovascular Registry (NCDR®) was started in 1997 (5).  Today, the NCDR® is the most comprehensive, outcomes-based data repository program in the United States with eight hospital-based and two practice-based registries covering ICDs, PCIs, myocardial infarctions (heart attacks), congenital heart disease catheterization procedures, peripheral vascular interventions, transcatheter valvular therapy and more. More than 2,500 hospitals nationwide participate in the NCDR® amassing well over 80 million patient records. Participation in some of the NCDR® registries is now required by several states and several payers. Moreover, the Center for Medicare and Medicaid Services (CMS) requires participation in the NCDR® -Implantable Cardioverter Defibrillator (ICD) Registry, the Transcatheter Valvular Therapy (TVT) Registry, and the Left Atrial Appendage Occlusion (LAAO) Registry to receive coverage and reimbursement for ICD implantation for primary prevention of sudden cardiac death, percutaneous valve replacements and left atrial appendage occlusion device therapy. Comprehensive benchmarked data from the NCDR are provided back to member institutions for their internal quality assessment and care improvement efforts in addition to use by the FDA for post-market surveillance, device post approval studies, and investigational device exemption evaluations. An equally important use of the NCDR® registry portfolio is for continued feedback to hospital and clinicians regarding the implementation and adherence of Appropriate Use Criteria. The registries have been designed to benchmark participants based on their performance not only as to clinical outcomes but also in terms of AUC for PCIs, ICDs and aortic valve surgery.

 

Recent evidence has demonstrated the substantial impact of the creation of AUC for PCI along with its measurement and feedback to clinicians and hospitals through the NCDR® registry in preventing unnecessary PCI procedures in the United States. Desai and colleagues (6) evaluated nearly 2.7 million PCI patients at 766 hospitals participating in the NCDR registry between July 2009 and December 2014. The number of PCIs performed in acute coronary syndrome cases (viewed as appropriate by AUC) was about the same: 377,540 in 2010 and 374,543 in 2014. Importantly however, non-acute PCIs dropped 34% from 89,704 to 59,375 in the same time period. In 2010, 21,281 or 26% of non-acute cases were classified as inappropriate compared with 7,921 or 13% of those performed in 2014 representing a 50% reduction in inappropriate PCI. Ko and colleagues (7) validated the use of appropriateness use criteria in stable coronary artery disease patients to identify both underutilization and overutilization of coronary revascularization in clinical practice. Failing to treat appropriate patients with coronary revascularization was associated with a significantly increased risk for adverse outcomes at three-year follow-up, whereas treating inappropriate patients was not associated with lower mortality or readmission rates for ACS.

 

Through the development of Appropriate Use Criteria and the National Cardiovascular Data Registry, the ACC has developed the tools needed to prevent unnecessary CV procedures and is poised to meet that challenge when given the opportunity by governmental agencies, payers, and other policy makers.

 

References:

 

1. Wolk MJ, Peterson E, Brindis R, Eagle K “President’s Page: The Appropriate Cardiologist: Responsible Stewardship in a Golden Age of Cardiology” J Am Coll Card 2004;44:933-935.

 

2. Hendel RC, Patel MR, Allen JM, et al. Appropriate use of cardiovascular technology: 2013 ACCF appropriate use criteria methodology update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force. J Am Coll Cardiol. 2013;61:1305–17.

 

3. Wolk MJ, Bailey SR, Doherty JU, Douglas PS, Hendel RC, Kramer CM, Min JK, Patel MR, Rosenbaum L, Shaw LJ, Stainback RF, Allen JM. ACCF/AHA/ASE/ASNC/HFSA/HRS/SCAI/SCCT/SCMR/STS 2013 multimodality appropriate use criteria for the detection and risk assessment of stable ischemic heart disease: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons. J Am Coll Cardiol 2014;63:380–406.

 

4. Patel MR, Calhoon JH, Dehmer GJ, Grantham JA, Maddox TM, Maron DJ, Smith PK. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 appropriate use criteria for coronary revascularization in patients with stable ischemic heart disease: a report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society of Thoracic Surgeons. J Am Coll Cardiol 2017;69:2212–41.

 

5. Brindis RG, Fitzgerald S, Anderson HV, Shaw RE, Weintraub WS, Williams JF, "The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR): Building a National Clinical Data Repository” J Am Coll Cardiol 2001;37:2240-2245.

 

6. Desai NR, Bradley SM, Parzynski CS, et al. Appropriate use criteria for coronary revascularization and trends in utilization, patient selection, and appropriateness of percutaneous coronary intervention. JAMA.2015;314:2045–53.

 

7. Ko DT, Guo H, Wijeysundera HC, et al. Assessing the association of appropriateness of coronary revascularization and clinical outcomes for patients with stable coronary artery disease. J Am Coll Cardiol. 2012;60:1876–84.


 

Dr. Ralph Brindis is a Clinical Professor of Medicine at the Phillip Lee Institute for Health Policy Studies at UCSF following a thirty-year career at Northern California Kaiser Permanente retiring as their Senior Advisor for Cardiovascular Disease.

 

Dr. Brindis is a national innovator responsible for the promotion of cardiovascular quality having served as President of the American College of Cardiology (ACC) from 2010-2011. In his role as previous Chair and present Chief Medical Officer of the ACC’s National Cardiovascular Data Registry (NCDR) he helped launch and expand the NCDR to a portfolio of 10 CV registries now used by 2500 US hospitals with a repository of well over 70 million patient records.

 

The NCDR, viewed by the FDA as a national treasure, is used as a key component for the nation’s infrastructure for assessing CV quality, Post-Market Device Surveillance, CV Comparative Effectiveness Research and Post Approval Studies with well over 250 published manuscripts.

 

Dr. Brindis also was the initial Chair of the ACC’s Appropriate Use Criteria Task Force and served on the ACC/AHA Clinical Guidelines Task Force along with many CV practice guidelines writing groups.

 

He presently serves on the FDA CV Device Panel, the California Technology Assessment Forum Panel, and is Chair of the California OSHPD Cardiac Advisory Panel for CABG public reporting.

 

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