|Medtronic’s newest implantable cardioverter defibrillator (ICD), Virtuoso, received FDA approval in May 2006. The stop watch-sized device is equipped with Medtronic’s Conexus wireless telemetry with SmartRadio technology, which uses the Medical Implant Communications Service. When the ICD detects notable changes in the patient’s condition or device status, a CareAlert is sent to the physician via the internet.|
As the quest for more data in cardiac care grows with its link to reimbursement and quality of care measures, the number of national registries is sure to blossom. Last year, at the urging of the Centers for Medicare & Medicaid Services (CMS), the National ICD Registry was developed through a partnership of the American College of Cardiology Foundation (ACCF) and the Heart Rhythm Society (HRS).
The implantable cardioverter defibrillator (ICD) Registry joins the other registries in ACC’s National Cardiovascular Data Registry: ACTION Registry for acute coronary syndrome patients; Cath PCI Registry for diagnostic cardiac catheterizations and percutaneous coronary interventions; and CARE Registry for carotid revascularization and endarterectomy procedures.
The idea of the ICD registry was prompted from the National Coverage Decision that was published by CMS in 2005 and based on the Sudden Cardiac Death in Heart Failure Trial. HRS took the lead by chairing the National ICD Registry Working Group which then developed defining core characteristics and questions to be answered.
The National ICD Registry became the sole repository of ICD implantation data for Medicare beneficiaries as of April 1, 2006. From that date through July 2007, data were collected from 1,117 U.S. hospitals. Some 108,341 implantable cardioverter defribillators implantation procedures were included that were performed by 3,249 physicians during those first 15 months.
To provide a more accurate picture on the scope of the procedures, hospitals have been encouraged to enter data on all device recipients, not just Medicare beneficiaries. Nearly three-quarters (73 percent) of the participating hospitals elected to enter all of their ICD implementations into the registry. Because these hospitals are for the most part large institutions, their data accounts for 88 percent of the implementations.
In April 2007, the first benchmarking report was sent to participating hospitals. Reports are sent quarterly and include the entire outcome report for each hospital comparing their volume and data with results of similar-sized hospitals and a national aggregate. Additionally, as of July, quality improvement reports highlight key registration and utilization metrics comparing the individual hospital with a registry aggregate.
The first report showed an average patient age of 68. More than 74 percent were male and 83 percent were white. CMS beneficiaries accounted for 70 percent of the patients.
In July, the data and a review of the registry’s first year were published in the National ICD Registry Annual Report 2006, which was approved by the Hearth Rhythm Society board of trustees on July 13.
Now, as a well-functioning database, the ICD registry and its proponents face analyzing the information. According to their report, “Aspects of the current data collection require correction including missing and ambiguous data elements. Recognized limitations include the absence of device firing data and the need for longer follow-up to record complications that occur after discharge such as infection and lead dislodgement.” To address these matters, they are currently developing Version 2.0 to correct the limitations.
Some of its next steps include: affirming its purpose, goals and target audience; streamline data collection by removing data fields not used and clarifying data definitions; expanding the registry to follow pacemaker and ICD leads; meeting public policy, including use as a performance reporting tool; and adding longitudinal data collection that includes merging data with Medicare claims data, the National Death Index and home device monitoring systems.
As one answer to refining the registry, the working group developed the Longitudinal ICD Registry study to complement the baseline registry and obtain device firing data, which was approved by CMS in May. The study will include 350 randomly selected physicians and follow some 3,500 CMS beneficiaries receiving a primary prevention ICD. End points will include survival at three years and five years; death