Regular issueNews from the Heart Rhythm SocietyReview of the Registry's Fourth Year, Incorporating Lead Data and Pediatric ICD Procedures, and Use as a National Performance Measure
Introduction
The Center for Medicare and Medicaid Services (CMS) selected the National ICD Registry as the sole repository for ICD implantation data for Medicare beneficiaries April 1, 2006.1, 2, 3, 4 The registry was developed through a partnership of the Heart Rhythm Society (HRS; www.HRSonline.org) and the American College of Cardiology Foundation (ACCF; www.acc.org) utilizing the expertise of the National Cardiovascular Data Registry (NCDR; www.accncdr.com) and has continued to make substantial progress. The registry is currently collecting data from 1,489 hospitals in the United States and has data from over 550,000 implants to date. The registry has proven to be a useful source for research with 23 abstracts presented and 10 published peer-reviewed manuscripts. The registry is accruing ICD implants at the rate of 10,000 per month with 79% of implants in the registry being performed in hospitals that enter all data on patients regardless of device indication or patient age. Thus, approximately 90% of all ICD implants performed in the United States are entered into the registry. The Longitudinal ICD Registry Study designed to answer the Coverage with Evidence Development (CED) questions proposed by CMS has begun under the direction of the Cardiovascular Research Network (CVRN). In April 2010, the National ICD Registry expanded to include data on atrial, ventricular, defibrillation, left heart, and epicardial leads placed at the time of ICD implant and whenever existing leads are repositioned, replaced, extracted or abandoned. The ICD registry has worked with HRS and the U.S. Food and Drug Administration (FDA) to assist with surveillance of lead performance. Pediatric ICD implantations will now be included in the Registry. Finally, the Registry is positioned to serve as a tool for performance measure reporting in combination with data from Medicare claims.
Section snippets
National ICD Registry Activities
ICD coverage was expanded by CMS on January 27, 2005 based on the results of the Sudden Cardiac Death and Heart Failure Trial (SCD-HeFT).5 The National ICD Registry Working Group was chaired by HRS and CMS selected the ICD Registry developed by HRS and ACCF based on the NCDR as the sole repository of ICD implant data October 27, 2005. The National ICD Registry started collecting data on ICD implantation procedures January 1, 2006 and requires collection of data for all ICD implantations for
Site Performance and Quality
The Registry provides benchmarking reports to all hospitals on a quarterly basis, detailing the outcome for all data elements plus an executive summary that includes performance metrics. Each hospital is compared with hospitals of similar procedure, volume, and the national aggregate. The Registry has stressed the importance of entering data on all patients and not just Medicare beneficiaries as the metrics for hospitals that elect to enter only Medicare beneficiaries may be difficult to
Outcome Performance Measure
CMS and other payors are increasingly interested in reporting valid measures of patient outcomes. Administrative data bases developed by payors and clinical data bases, including the National ICD Registry, are potential data sources to assess provider outcomes including the morbidity and mortality associated with a specific procedure.7, 8, 9, 10, 11, 12 The exclusive use of administrative data to assess provider outcomes has several substantial limitations, including:
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Data definitions are often
Overview of the Data Submitted to the National ICD Registry
Physicians and hospitals can use Registry data to further quality improvement efforts at a local level and physician associations can evaluate data to determine the effectiveness of existing clinical guidelines.15 The National ICD Registry collects over 280 data elements at the time of initial ICD and lead implantation, upgrade, replacement, or removal. The ICD Registry contains Protected Health Information as defined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Version 2.0 ICD Registry—Lead data and Pediatric ICD Implants
A working group comprised of clinical electrophysiology and heart failure physicians, nurses, abstractors, and registry experts spent over 2 years enhancing the ICD Registry data form, eliminating data elements that were not used, better defining data elements that were confusing (for example, the high risk data element has been expanded to include hypertrophic cardiomyopathy, long-QT syndrome, Brugada syndrome, etc.) and adding data fields to allow entry of pediatric patients and lead
Longitudinal ICD Registry Study
The CED Policy developed by CMS helped to expand access to ICD therapy and treatments for Medicare beneficiaries. However, CMS believed there was insufficient data from randomized controlled trials to allow full coverage for primary prevention ICD implantation without participation in CED in the following groups:
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Patients with a LVEF of 31–35%
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Patients with a diagnosis of non-ischemic cardiomyopathy for less than nine months' duration
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Patients receiving a CRT-D device who are NYHA Class IV at the
Summary
The National ICD Registry is a successful partnership between HRS and ACCF collecting data from 486,025 ICD implantations from 1,434 hospitals and 5,246 implanting physicians during 2006–2009. Quarterly benchmarking reports are sent to each hospital allowing assessment of their outcomes from ICD implantation compared with hospitals of similar procedure volume and a national aggregate. Several important research studies have been published highlighting the use of ICDs in the general population
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This document was approved by the Board of Trustees of the Heart Rhythm Society on July 16, 2010. The document can also be found on the Heart Rhythm Society webpage at http://www.hrsonline.org/Policy/ClinicalGuidelines/
Address reprint requests and correspondence: Ms. Donna Goldberg, Heart Rhythm Society, 1400 K Street, NW, Suite 500, Washington, DC 20005. E-mail address: [email protected].