EP Lab Benchmarking and the Recent Consensus Document on EP Lab Standards
For decades, cardiology has been at the forefront of a national trend towards standardization of practice and public reporting of outcomes. This began in cardiac surgery and interventional cardiology,1,2 and is now moving into the realm of invasive cardiac electrophysiology. There are a variety of reasons that practice standardization and outcomes reporting began in cardiology: a large volume of high-cost procedures are performed in these fields, with substantial potential for both patient benefit and harm.3 This was not a smooth or flawless process, and clear downsides to outcome reporting became clear, but benefits to the setting of standards and reporting of outcomes also became evident. This trend is now spreading to many other fields in medicine in an attempt to maximize quality and reduce costs.
While there are sound arguments that can be made both for and against public outcomes reporting,4 strong forces (particularly those at the national level such as the Centers for Medicare and Medicaid Services) are increasingly mandating practice standardization and outcomes reporting. In the past, it may have been possible for “negative outliers” (i.e., those providers or hospitals with worse outcomes) to hide their outcomes and practices from public view and avoid scrutiny from the payers, but those days are rapidly waning. On the balance, this should be good for patient care, but it does impose new burdens on providers and hospitals to ensure health care for patients that meets established benchmarks for high quality.
Invasive clinical cardiac electrophysiology began in many hospitals as a “poor stepchild” of more established interventional cardiology, and EP often shared the same facilities and personnel as interventional cardiology, with EP procedures performed during off hours and when the procedural suite was not needed for cardiac catheterization. While some of the equipment and techniques can be shared between interventional cardiology and EP, the increasing volume and sophistication of EP procedures has resulted in dedicated EP procedural suites and support staff at most high volume centers. As EP has matured into its own discipline, the importance of establishing what is required to deliver high-quality EP procedures has become increasingly clear.
In 2012, the American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI) published an expert consensus document (which updated a prior 2001 expert consensus) on cardiac catheterization laboratory standards.5 In recognition of the need for invasive EP to provide similar consensus on standards for the EP laboratory, a consensus document has just been published by collaboration between the Heart Rhythm Society (HRS), the ACC, the American Heart Association (AHA), the Pediatric and Congenital Electrophysiology Society (PACES), and endorsed by international EP societies.6 Major topics of this EP consensus include the equipment and personnel required to run an EP laboratory, as well as the oversight required both on a day-to-day basis and when issues and problems arise.
The equipment required to run a state-of-the-art EP lab is complicated and expensive, and varies greatly depending on the procedure being performed. Purchasing this equipment is not enough, however: the training required to properly use the equipment (both for the EP physician and associated staff) is extensive. Some smaller EP labs may choose to perform only limited types of EP procedures (i.e., implantation of cardiac devices but not catheter ablation, or simple but not complex catheter ablation procedures) which can substantially reduce the equipment required. Life threatening complications can rapidly develop even in relatively simple EP procedures, however, and established practices and equipment to deal with emergencies, such as cardiac tamponade, are necessary to have in place in all EP labs.
Training and credentialing of EP lab staff is also a critical element to providing high-quality care. The requirement for an EP-trained physician may seem obvious, but it should be noted that procedural EP has become sub-specialized to the point that most practicing EPs do not perform all types of EP procedures, including but not limited to implantation of cardiac devices, extraction of chronically implanted leads, and ablation of complex atrial and ventricular arrhythmias). It should not be assumed that each EP physician is competent to perform all EP procedures. This extreme specialization in EP has led to the publication of consensus documents describing best practices in regard to specific EP procedures, such as ablation of atrial fibrillation7 and ventricular arrhythmias8.
Beyond the EP physician, however, are the equally critical roles of EP lab nurses and technologists who require extensive training specific to EP and can have a major impact on the quality and safety of EP procedures. There is also a great importance to the availability of affiliated professionals, such as anesthesiologists and cardiac surgeons, who may be needed on a regular or emergent basis during EP procedures. As is true for many aspects of medicine, children are not “just little adults” when it comes to EP procedures, and specific training is required for pediatric EP laboratories. The EP lab consensus document describes the personnel and training required to properly staff an EP lab.
Despite making the best effort to ensure a safe and effective EP lab, problems and complications can and do occur. It is critical that each EP lab keeps track of procedural outcomes and complications in a database (both for the center as a whole, and for each physician separately), and benchmarks these to accepted rates at other centers. Rigorous peer review is essential to ascertain the cause of complications, and to develop strategies to reduce them in the future. Ultimately, it is the responsibility of the EP lab director to ensure that the EP lab facility and staff are able to provide high-quality and safe EP procedures, and to intervene when this is not the case.
Outcomes reporting is available for cardiac surgery and interventional cardiology, and is now on the doorstep of invasive EP. Whether we like it or not, our outcomes will be compared to those from other physicians and facilities, and this will impact reimbursement and referral patterns.1 A first step is to describe the benchmarks of what is required to run a high-quality EP laboratory, and this EP consensus document6 does that. For those planning to build an EP lab, this lays out what is necessary. For those who already run or work in a well-functioning EP lab, a careful reading of this consensus will almost certainly provide some ideas for improvement. The time has come for everyone in the EP field to understand and adopt best practices, and the establishment of a consensus benchmark is a critical step in the process.
- Brown DL, Epstein AM, Schneider EC. Influence of cardiac surgeon report cards on patient referral by cardiologists in New York state after 20 years of public reporting. Circ Cardiovasc Qual Outcomes 2013;6:643-8.
- McCabe JM, Joynt KE, Welt FGP, Resnic FS. Impact of public reporting and outlier status identification on percutaneous coronary intervention case selection in Massachusetts. JACC Cardiovasc Interv 2013;6:625–30.
- Topol EJ, Califf RM. Scorecard cardiovascular medicine. Its impact and future directions. Ann Intern Med 1994;120:65-70.
- Young M, Yeh RW. Public reporting and coronary revascularization: risk and benefit. Coron Artery Dis 2014;25:619-26.
- Bashore TM, Balter S, Barac A, et al. 2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions expert consensus document on cardiac catheterization laboratory standards update: A report of the American College of Cardiology Foundation Task Force on Expert Consensus documents developed in collaboration with the Society of Thoracic Surgeons and Society for Vascular Medicine. J Am Coll Cardiol 2012;59:2221-305.
- Haines DE, Beheiry S, Akar JG, et al. Heart Rhythm Society expert consensus statement on electrophysiology laboratory standards: process, protocols, equipment, personnel, and safety. Heart Rhythm 2014;11: e9-51.
- Calkins H, Kuck KH, Cappato R, et al. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Heart Rhythm 2012;9:632-96.
- Aliot EM, Stevenson WG, Almendral-Garrote JM, et al. EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias: developed in a partnership with the European Heart Rhythm Association (EHRA), a Registered Branch of the European Society of Cardiology (ESC), and the Heart Rhythm Society (HRS); in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA). Heart Rhythm 2009;6:886-933.
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