Editor's Note: Medscape recently sat down with Eric N. Prystowsky, MD, Director of the Clinical Electrophysiology Laboratory at St. Vincent Hospital (Indianapolis, Indiana), to get his views on the proposed rule by the United States Centers for Medicare and Medicaid Services (CMS) to expand Medicare coverage for implantable cardioverter defibrillators (ICDs) in heart failure patients. The draft proposal, based largely on the results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) released earlier this year, extends ICD coverage to include patients with ischemic dilated cardiomyopathy and a history of myocardial infarction as well as those with nonischemic dilated cardiomyopathy > 9 months duration. Although the proposal stipulates that patients must have a left ventricular ejection fraction (EF) </= 30%, which falls short of the </= 35% criteria used in SCD-HeFT, the proposal does eliminate a previous caveat requiring that patients have a QRS duration > 120 ms, a stipulation that has been a major frustration for physicians. Medscape: Dr. Prystowsky, can you give us your impression of the recent CMS proposal to expand Medicare coverage of ICDs for heart failure patients? Dr. Prystowsky: Sure. Let me give you some background as I take a look at this. Up to the last decision made by CMS on MADIT II [the second Multicenter Automatic Defibrillation Implantation Trial],[1] coverage decisions had mostly been data-driven and they've come almost entirely out of the trials. When MADIT II data were published and the FDA [United States Food and Drug Administration] gave an indication for MADIT II, CMS, for the first time, took a departure and added a QRS criterion to the data, which really put a big monkey wrench into how we were supposed to take care of these patients. And, in fact, I even published an abstract on it. We looked at our own data to see how many people would be excluded [with the long QRS duration criteria], and it turned out that over half of the patients would automatically have been excluded. That was fairly upsetting to all of us in the EP [electrophysiology] community, because it really didn't make sense. It wasn't really based on anything, other than a possible attempt to target for payment only those patients who seemed likely to derive the greatest benefit. Since then, two other trials have been published. One of them, the DEFINITE [Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation][2] trial, did not actually meet statistical significance for mortality endpoint, but the other one, SCD-HeFT, did. These studies added more data to the pot and, in fact, brought into it nonischemic cardiomyopathy. The DEFINITE trial looked at dilated cardiomyopathy with an EF of 35% or less. It met criteria for a significant reduction in sudden death, but the all-cause mortality was close but not quite there. SCD-HeFT was a much larger trial that enrolled people with class II and III heart failure with dilated ischemic or nonischemic cardiomyopathy and EF 35% or under. This trial showed that the defibrillator and not [the antiarrhythmic drug] amiodarone significantly prolonged survival in those patients. So, now we have much more data and CMS is taking another look at this issue. I actually participated at a meeting in Washington, DC, with a number of senior people in the arrhythmia and heart failure area who had met with CMS as well as FDA senior officials. It was quite a productive day, and many of these issues, such as QRS duration, were discussed in detail. The fact is, as it was pointed out, QRS duration is really not a good measure on which to base ICD indications. So now CMS has honed in on the 30% or lower ejection fraction. They've included ischemic and nonischemic cardiomyopathies and they've dropped the QRS duration criterion, which was a big stumbling block for patients who were trying to get the defibrillator. I'm pleased that CMS has listened to the variety of opinions from the cardiology community regarding QRS duration and were willing to reevaluate their opinion in the face of the newer data. And, while we didn't get everything I would have liked, which would have been to say, "Reimburse strictly by the trial data with LVEF 35% or less," I think that there are some other aspects of this opinion that are contentious. Medscape: CMS is proposing that ICDs will be covered only for heart failure patients enrolled in either an FDA-approved category B IDE [investigational device exemption] clinical trial or a qualifying national database (registry), unless patients have another standard indication for the device. What is your opinion of this stipulation? Dr. Prystowsky: I'm not opposed to a registry. I think that a registry could be quite beneficial for all parties concerned, because trials have enrolled relatively small numbers. Some of the trials have involved only a few hundred patients, although SCD-HeFT included over 2000. But compare that to what will happen when there are tens of thousands of defibrillators implanted in the country. These data could prove very useful. But, it's a double-edged sword. A registry must be done correctly. It's very important that it be set up with the ability to monitor how the data are input, so they mean something. And that's what worries me, because if it's done incorrectly, we're going to have, potentially, dangerous data, because we may make conclusions based on the wrong data. But, on the other hand, there's a very positive side to it. CMS made a statement that I applaud, and we've been asking for it for a long time. They suggested that both facilities (hospitals) and providers demonstrate competence in ICD implantation. I think that is a major step forward, and I congratulate CMS for taking it. And, in fact, it dovetails very nicely with a very long effort by the Heart Rhythm Society [HRS] on how to judge competency for people who are not trained electrophysiologists but want to implant ICDs. On the HRS Web site, there is a competency document that delineates those points and, frankly, I would hope, when CMS finalizes this, if they do finalize this, that they refer to the HRS task force report. A lot of effort and a long time went into that to generate what HRS thinks is a reasonable competency requirement for a primary prevention device implantation for physicians who haven't gone through an electrophysiology program. Medscape: Some have suggested that the registry requirement will prevent some doctors from participating or prevent some eligible patients from getting the device. Is this a good trade-off to ensure that appropriately trained physicians are implanting these devices? Dr. Prystowsky: The concept that a registry, per se, should deny care to people makes absolutely no sense to me. You can't expect the people implanting the devices to hire research coordinators out of their pocket to give data to the CMS. I think that you have to be reasonable about this. So, CMS will need to support this with money. But those details have to be worked out. Further, I also don't think it's fair to hold up the whole process while we're trying to work this out. In other words, while there may not be a registry initially, They'll still get the vast majority of patients enrolled. Regarding who implants your ICD, would you want somebody who's incompetent putting in a device, just because someone thinks that's a better thing to do than not getting a device at all? I say that's a bad trade-off. This will likely lead to people who don't meet the criteria getting devices; there will be devices put in incorrectly, there will be patients getting shocks that shouldn't have gotten shocks because the devices weren't set up correctly, and the story goes on and on. My point is that, until someone can show me that people are being denied care because of the lack of good implanters, I fully support CMS in wanting only qualified physicians to implant ICDs — and so should the public. Remember, these ICDs are not emergency implants. These are primary prevention devices. So, if somebody lives 60 miles away from a major center, while I do understand it may be inconvenient to get there, if the only alternative is somebody who doesn't know much at all about defibrillators, I submit to you, it's better to drive the 60 miles one time than have an incompetent person put in your defibrillator. So I'm actually quite positive about the [validity of the] CMS decision to require some type of competency certification. Everyone wants what's best for the patient, and what's best for the patient is that the appropriate patient receive an appropriate device implanted by someone with appropriate training. That will give you your best outcomes. Medscape: There doesn't seem to be any provision in the CMS proposal right now to cover the implants while the registry is being organized. Is this something that will have to be worked out before the final rule is issued? Dr. Prystowsky: Well, yes, of course. To deny life-saving therapy for this reason is unethical, in my opinion. Medscape: The proposal also states that "A provider implanting any ICD other than a single-lead, shock-only device for primary prevention must maintain and furnish, upon request to CMS, its agents or other authorized personnel, the documentation to verify the medical necessity for a more advanced ICD." Is this problematic language? Dr. Prystowsky: We had mentioned to CMS when we were at this [earlier] meeting that this language was inappropriate. If they are implying that a device that merely shocks the heart and doesn't have backup pacing and doesn't have antitachycardia pacing therapy is an appropriate device, that is absolutely wrong and it's a huge step backwards in technology for patient care. To not have backup pacing and to be unable to offer patients pacing therapies would be disgraceful. Medscape: The text of the proposal also says "In SCD-HeFT, single lead, single-chamber defibrillators programmed for shock therapy only were used. Since SCD-HeFT demonstrated significant reduction in mortality from a single-lead, shock-only device, a single-lead, shock-only device is clinically appropriate and positioned for primary prevention of sudden cardiac death." Dr. Prystowsky: Okay, but here's the point. The devices used in the study were not shock-only devices. They were programmed for shock therapy. But, in a nontrial situation, you would clearly have shock therapy, but you might also program antitachycardia pacing. I think the correct way to state this is that you don't need anything other than a single-lead device unless you can show justification for other types of devices. And by that I mean, a right ventricular lead-only device that has the capability of pacing the heart, shocking the heart, and antitachycardia pacing. That is a baseline standard defibrillator. Where I think CMS makes a reasonable request is asking implanters to justify the need for a dual-chamber defibrillator or a biventricular defibrillator. A dual-chamber defibrillator means that you would need to have a reason for an atrial lead in addition to the ventricular lead. So anybody who has a clear indication for needing a pacemaker is a possible candidate. If a patient has known supraventricular arrhythmias where an atrial lead will help you to program the defibrillator and avoid unnecessary shocks, that person is a candidate. If you meet the criteria for biventricular pacing, those patients get a biventricular defibrillator; pretty clear-cut. Medscape: What about the exclusion of class IV patients in the CMS proposal? Dr. Prystowsky: The trials excluded class IV patients other than those for a biventricular defibrillator. So we can't say, at this point, that if you have a patient with class IV heart failure, we have enough data to support putting in a defibrillator. The exception is for patients who meet criteria for a biventricular ICD. Now, if CMS means that they're going to disallow a biventricular defibrillator for all class IV patients, then I totally disagree. In the COMPANION [Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure][3] trial, there were class IV patients who received defibrillators Medscape: Thank you for taking the time to speak with us.
References Moss AJ, Zareba W, Hall WJ, et al., for the Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation on a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877-883.Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004;350:2151-2158.Bristow MR, Saxon LA, Boehmer J, et al, for the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350:2140-2150. Eric N. Prystowsky, MD, Editor-in-Chief of Medscape CRM; Director, Clinical Electrophysiology Laboratory at St. Vincent Hospital, Indianapolis, Indiana; and Consulting Professor of Medicine at Duke University Medical Center, Durham, North Carolina Disclosure: Mary Thompson has no significant financial interests or relationships to disclose. Disclosure: Eric Prystowsky, MD, has disclosed that he has received grants for educational activities from AstraZeneca. He has also served as an advisor or consultant for Guidant, Bard, CV Therapeutics, and Stereotaxis, and owns stock, stock options, or bonds in Cardio Net. Medscape Cardiology. 2004; 8 (2): ©2004 Medscape
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