[Updated]– A study in JAMA earlier this week received a lot of attention when it reported that 22.5% of ICD implantations in the US did not have a firm basis in evidence. The study was derived from a very large dataset taken from the NCDR ICD registry, which was established by the American College of Cardiology and the Heart Rhythm Society in 2004 and 2005 “as a condition of coverage of ICDs for primary prevention” by CMS.
I believe that the key challenge raised by this article is that we need to develop improved methods for using these data about our selection practices. Do we need to start reporting at an individual operator level? Do we need to start holding physicians accountable? Should there be a prospective worksheet to document why a physician chooses to defy the evidence and treat a patient? Should there be mandatory “secondary opinions” prior to treatment to minimize this practice in the future? These are key issues facing our profession and we need to start addressing them.
A very different response to the study was issued by the ACC and HRS. Despite the fact that these groups run the NCDR ICD registry, they sought to downplay the significance of the findings, and to absolve implanting physicians of any guilt or responsibility for unnecessary implantations:
ACC and HRS acknowledge that there are instances that inappropriate use of ICD implantation is occurring and that it is our responsibility as professional societies to provide measurement tools, such as the NCDR, that can help address inappropriate use. With that caveat, the vast majority of implanting physicians are prescribing ICDs with the confidence that they are providing the best care for their patients.
But here’s the question: are we really reassured because “the vast majority of implanting physicians” are confident that they are providing the best care for their patients, despite the complete lack of evidence to support that belief? The ACC/HRS statement goes on to point out, correctly, that deviations from the guidelines can be appropriate in some circumstances. But the paper’s authors conclude that a large percentage of the non-evidence based implantations were likely not appropriate, and the ACC/HRS statement fails to discuss this important distinction. Instead, we get the bland and meaningless assertion:
We believe ICDs to be effective in stopping life-threatening arrhythmias…
But remember: the registry was established in the first place because CMS was concerned that physicians would run amuck and bankrupt the healthcare system by implanting ICDs in practically anyone with a heartbeat. That didn’t happen, but as the JAMA study indicates, there are problems. And instead of the ACC and HRS reacting with a knee-jerk defense of the integrity of their members, they should join the papers’ authors and commentators like Spertus in facilitating a meaningful response to the problems identified in the paper.
Update–Mission accomplished! I guess the statement had its intended effect. Larry Biegelsen, a Wall Street analyst who had raised concerns that the JAMA study might reduce sales of ICDs, issued a report late on Friday afternoon about the ACC/HRS statement. He concludes:
Our recent conversations with physicians suggest to us that there may be a small negative impact from the JAMA study but the ACC/HRS statement could help reduce the fallout.
(As an aside, it should be noted that there is another very legitimate problem concerning people who really need ICDs and don’t get them, but it’s a separate problem, and in no way diminishes the importance of the opposite problem raised by the JAMA paper.)
Here is the statement from the ACC and the HRS:
Joint Statement from American College of Cardiology and the
Heart Rhythm Society on Recent ICD Study
In response to the study, Non-Evidence-Based Implantable Cardioverter-Defibrillator (ICD) Implantations in the United States, published in the January 5 issue of the Journal of the American Medical Association (JAMA), the American College of Cardiology (ACC) and Heart Rhythm Society (HRS) reiterate the importance of research and measurement tools designed to improve patient care. The message and teachings of this important study indicate that substantial variations exist among hospital ICD implantation strategies. This variation clearly demonstrates an opportunity for improvement in care delivery. The findings are critical for the cardiovascular community and our patients in moving forward our commitment to change practice patterns to deliver higher quality, evidence-based, cost-effective care.
The NCDR ICD Registry™ was created in partnership by the ACC and HRS in response to a mandate by the Centers for Medicare and Medicaid Services (CMS). Every U.S. hospital that implants ICDs for the purpose of primary prevention of sudden cardiac death participates in the NCDR ICD Registry™. The Registry has developed the ability to connect longitudinal Medicare administrative data of patient outcomes such as mortality and repeat hospitalizations with our in-patient hospital registry data.
The evaluation of what clinicians are doing through the collection of the Registry data can help us to learn about practice patterns and gain a better understanding of how clinical practice guidelines are implemented but also potentially extend our knowledge and evidence base.
ACC and HRS acknowledge that there are instances that inappropriate use of ICD implantation is occurring and that it is our responsibility as professional societies to provide measurement tools, such as the NCDR, that can help address inappropriate use. With that caveat, the vast majority of implanting physicians are prescribing ICDs with the confidence that they are providing the best care for their patients. The study authors emphasize that “the ultimate judgment of the care of a particular patient must be made by the physician and the patient in light of all of the circumstances presented by the patient. There are circumstances in which deviations from these guidelines are appropriate.” While guidelines are designed to account for the majority of clinical scenarios, there are clinical challenges in which the guidelines do not address the unique circumstances of a patient’s treatment options which require physicians to utilize their clinical expertise and judgment.
We are dedicated to improving the care of patients by promoting research, education and optimal health care policies and standards. We believe ICDs to be effective in stopping life-threatening arrhythmias and encourage research that will further improve the use and effectiveness of this therapy to enhance survival and overall quality of care.
The NCDR ICD Registry™ has reaped substantial benefits in understanding and improving clinical practice related to ICD implantation with much more on the horizon. The ACC and HRS strongly support additional measures that would advance the safety of patients living with ICDs.