Registries and Improvement of EP Care: ICDs, AFib Ablation, LAAO
The healthcare environment in the United States has changed dramatically; Medicare reimbursement to health care providers is becoming more founded on quality of patient care than volume. In fact, rewarding physicians for providing quality patient care is one of the highlights of the 2015 Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted to repeal the sustainable growth rate (SGR) and improve Medicare payment for physicians' services.1 By the year 2019, it is expected that a big portion of Medicare payment to physicians and hospitals will be based on the outcomes of their patients. To that end, MACRA underscores the need to measure, and as a result improve, health care providers' performance using evidence-based, clinically impactful, reliable and well-validated performance measures, and it emphasizes the role of a qualified clinical data registry in reporting on these measures.1 This emphasis on the role of registries has elevated the significance of registries nationally, and has extended their role beyond internal quality improvement (QI) efforts to public reporting.
Although several data sources, such as administrative claims data, can be used for the development and implementation of performance measures; registries and electronic heath records hold the most promise in relation to the feasibility and usability of such measures.2 For the purpose of measuring performance, registries are far better than administrative claims data, as they provide more granular information on clinical data elements that is almost impossible to garner from administrative data sources. For this reason, performance measure developers have increasingly been using registries.
Both the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) have used data from the National Cardiovascular Data Registry (NCDR) ICD Registry™ to develop nationally-endorsed performance measures.3 The ACC's performance measures involve the use of beta-blockers and angiotensin-converting-enzyme inhibitor (ACE inhibitors) in patients with systolic heart failure. The HRS' performance measure involves the rate of complications of de novo ICD implants including 30 day-death, pneumothorax or hemothorax plus a chest tube, hematoma plus a blood transfusion or evacuation, or cardiac tamponade/pericardiocentesis and 90-day mechanical complications requiring a system revision, device related infection, or additional ICD implantation.4 Other QI efforts utilizing the ICD Registry™ include implementation of the ICD appropriate use criteria. In fact, the new ICD Registry™ data collection form that has been in use since April 2016 maps data elements on the form to appropriate use criteria. This will provide data to participating hospitals on the appropriateness of their ICD implants.3
Two additional NCDR registries on heart rhythm disorders were recently introduced: the atrial fibrillation (AFib) Ablation Registry™ and the left atrial appendage occlusion (LAAO) Registry.5,6 The AFib Ablation Registry™ is a voluntary QI initiative whose purpose is to assess the prevalence, demographics, acute management, and outcomes of patients undergoing atrial fibrillation ablation. It is expected that data from this registry will support the development of evidence-based guidelines and quality metrics for atrial fibrillation management.5 One of the performance measures developed by HRS that has been endorsed by the National Quality Forum relates to cardiac tamponade and/or pericardiocentesis complicating atrial fibrillation ablation.4 While HRS proposed the use of administrative claims data for this measure, the NCDR AFib Ablation Registry™ may lend itself well to the implementation of this measure. However, the feasibility of this approach will have to be proven, and the measure will likely have to be re-tested in the context of this registry before using the registry for this purpose. The AFib Ablation Registry™ undoubtedly offers a platform for the development and implementation of future performance measures.
The NCDR LAAO Registry was launched in response to the Centers for Medicare and Medicaid Services' mandate to enroll all Medicare patients undergoing this procedure in a prospective registry aimed at collecting data on the following endpoints: operator-specific complications, device-specific complications including device thrombosis, stroke, adjudicated, by type, transient ischemic attack (TIA), systemic embolism, death, and major bleeding, by site and severity.6,7 This registry too will provide the needed infrastructure for creating new performance measures.
Among the opportunities offered by the ICD Registry™, the AFib Ablation Registry and the LAAO Registry for QI are reports that are provided to all participating hospitals every quarter regarding their performance in key quality areas such as procedure indications and complications. In addition, data are provided on national averages for quality metrics that allow hospitals to benchmark their performance against national average performances.3,5,6,8 It will be important to see data on whether and how this type of feedback has improved physicians' and hospitals' performance.
Despite the aforementioned advantages of registries, current national registries have some limitations that should be acknowledged. Given that most existing registries were not built for implementing specific performance measures, they may not have all the data needed to implement a measure. For example, one might not have data on important exceptions or exclusions that should be applied to make the measure fair and clinically sound. One might lack data on clinical variables that should be adjusted for in outcome measures. Another potential challenge of registries is they typically do not allow for the nuances of clinical decision making. Finally, the quality of data entered into registries is variable, and robust quality checks that should be implemented require a large amount of resources.
Major efforts are being committed to building and maintaining registries and to developing and implementing performance measures. Therefore, it is important to create efficient processes that will allow collecting and entering data only once that can then auto-populate different databases. It is also important to assess and publicly report the impact of such initiatives on quality of care. It is only with such assessments that we will be able to abandon ineffective initiatives and focus our efforts on initiatives that will make the biggest difference in improving quality of care and patient outcomes.
- MACRA (Centers for Medicare & Medicaid Services). Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html; Accessed 07/08/2016.
- National Quality Forum. Available at: http://www.qualityforum.org. Accessed 07/08/2016.
- Registries (Quality Improvement for Institutions). Available at: http://cvquality.acc.org/NCDR-Home/Registries. Accessed 07/08/2016.
- Heart Rhythm Society. Available at: https://www.hrsonline.org. Accessed 07/10/2016.
- AFib Ablation Registry (Quality Improvement for Institutions). Available at: http://cvquality.acc.org/en/NCDR-Home/Registries/Hospital-Registries/AFib-Registry. Accessed 07/10/2016.
- Left Atrial Appendage Occlusion Registry (Quality Improvement for Institutions). Available at: http://cvquality.acc.org/en/NCDR-Home/Annual-Conference/Agenda/Wednesday-Preconferences/LAAO. Accessed 07/10/2016.
- Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (Centers for Medicare & Medicaid Services. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=281. Accessed 07/10/2016.
- Kremers MS, Hammill SC, Berul CI, et al. National ICD registry report: version 2.1 including leads and pediatrics for years 2010 and 2011. Heart Rhythm 2013;10:e59-65.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Pericardial Disease, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure, Chronic Heart Failure
Keywords: Angiotensin-Converting Enzyme Inhibitors, Atrial Appendage, Atrial Fibrillation, Blood Transfusion, Cardiac Tamponade, Chest Tubes, Decision Making, Embolism, Health Personnel, Heart Failure, Systolic, Hematoma, Hemothorax, Ischemic Attack, Transient, Medicaid, Medicare, Outcome Assessment, Health Care, Patient Care, Pericardiocentesis, Pneumothorax, Quality Improvement, Registries, Stroke, Thrombosis, Arrhythmias, Cardiac
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