The ICD Registry: First-Year Data and Future Plans

Interview with Stephen Hammill, MD, FHRS

Tell us about the Baseline ICD Registry. How many participating physicians and hospitals were there? How many device implants were reported? In the first year of the Baseline ICD Registry, 3,249 physicians participated from 1,117 hospitals; the number of implants continues to grow. In the 2006 annual report published in the September 2007 edition of HeartRhythm Journal, there were 108,341 ICD implantation procedures recorded; the current number of implantations is at about 195,000 with 1,480 hospitals enrolled.

Is it too late for more hospitals to start reporting data for the Baseline ICD Registry? No. Any hospital that implants ICDs in Medicare patients is required to participate in this registry. In addition, any new hospital that starts an ICD implantation program also must take part in this registry. New participants should contact NCDR at 1-800-257-4737.

One of the key findings in the 2006 annual report was that there were minimal complications found from device implantations. Were you at all surprised by this finding? What does this tell us about possible complications? It has to be taken into perspective; currently we are only evaluating the in-hospital data from the device implantation, including any data from the patient s hospital stay after the procedure (typically a day and a half). We do not have any data on long-term complications at this time. Therefore, if an infection or lead dislodgement occurs after implantation whether it is two weeks or two months post implantation it will not be recorded in the Baseline ICD Registry. We plan on merging the Baseline ICD Registry data with Medicare claims data in the future; this will give us a better view of longitudinal complications. Nonetheless, I believe the number of in-hospital complications at the time of implantation were low; the most remarkable adverse procedure-related event was the low death rate in the laboratory (0.02 percent). Previously reported clinical trials had ranged anywhere from 0.5-1.0 percent, so this decrease is a tremendous difference. I think in part this can be attributed to increased experience with the device, and also because we are putting devices in primary prevention patients, which is a different population than what was reported in the earlier clinical trials.

Another finding showed that almost 15 percent of physicians reported having no formal training in device implantation. How do you explain this? As the article showed, 15 percent of physicians indicated that they have not undergone any formal training. These physicians may still be highly experienced implanters they just may have learned how to do this after they got out of their training program. Whether or not a physician is credentialed to implant ICDs is dependent upon the local credentialing committee at that physician s hospital. The credentialing committee looks at the physician s experience, training and record, and decides at that point whether or not to approve him or her to perform the procedure. The Heart Rhythm Society did send to hospitals the recommended training guidelines. Many credentialing committees utilize our guidelines, while others do not and instead credential physicians based on other criteria.

Tell us about the Longitudinal Registry Study design. What is the purpose of this? When and why was this formed? The Longitudinal ICD Registry is a new component of the ICD Registry program designed to answer what are called the Coverage with Evidence Development (CED) questions, posed by the Centers for Medicare and Medicaid Services (CMS). When CMS expanded coverage in 2005, they identified three groups of Medicare patients in which they would cover ICD implantation, as long as the data was entered into the ICD Registry. CMS felt that the randomized trials did not have large enough samples to cover these three groups without the collection of additional data. The three groups are as follows: (1) patients with an ejection fraction of 31 to 35 percent; (2) patients who are receiving CRT therapy and are in Class IV heart failure; and (3) patients who have had a diagnosis of non-ischemic dilated cardiomyopathy for less than 9 months. In order to answer these questions, we had to develop the Baseline ICD Registry to collect the in-hospital implant data and a separate Longitudinal ICD Registry that will follow a subset of patients to collect ICD firing data. The Longitudinal Registry design was approved by CMS in May 2007.

How many will participate in the Longitudinal ICD Registry? When will patient enrollment begin? The Longitudinal ICD Registry will enroll approximately 200-350 implanting physicians and capture follow-up data for 2,000-3,000 ICD patients. The Registry will analyze patient survival as well as the time when the first ICD shock or treatment occurred. We also plan to merge ICD Registry data with Medicare claims data. Whenever a patient is admitted to a hospital for an ICD-related procedure, the patient is of course registered in the Medicare claims process. As the Medicare claims data becomes available 6-12 months later, we will be able to start merging these two data sets to begin collecting additional longitudinal follow-up clinical information. We anticipate announcing the launch data for the Longitudinal ICD Registry this November.

How far have we come in understanding ICDs one year later? In addition, what changes or improvements are being made, if any, to improve data collection and analysis in the coming year? What particular information do you hope to learn about for the future? We started a process six weeks ago through NCDR, which runs the ICD Registry by which we are developing the next version upgrade of the Baseline ICD Registry, in which we will look at the data elements that are being collected, see which ones can be removed, determine which ones need to be added, and make sure the definitions are clear in general, improve the basic structure of the data collection form. We will also expand data entry to include the ICD leads in addition to the generator. This next version upgrade is a maturing of the registry and will be a quality improvement tool in tracking both the devices and leads. In addition, we are looking into the ICD implantation guidelines that were developed by the ACC, American Heart Association, and the Heart Rhythm Society; a new version of those clinical guidelines will be available in 2008. This is to make sure that the version 2.0 upgrade of this registry is collecting all the data in order to determine if patients are being implanted according to the established clinical guidelines.

How does the ICD Registry help benefit hospitals and patients? The most obvious benefit is through the quality improvement and the benchmarking process. Benchmarking reports are sent during every quarter to hospitals, reporting every piece of data that they entered on their patients and comparing that data with national averages and also the averages with other hospitals of similar size. If a hospital sees that they have a higher complication rate, they can evaluate their practice to determine why. They will be able to look at their own process and see what could be changed to lower the complication rate. It will give them the ability to benchmark their outcomes with other hospitals, something they haven t been able to do up to this point in time. Lastly, insurance companies are also interested in using the ICD Registry to follow the population of patients they insure. The first one to do this is UnitedHealthcare; they will use the term premium cardiac specialty center. Any hospital that wants this designation has to participate in the ICD Registry and track performance.