Implanting an implantable cardioverter-defibrillator (ICD) is serious business. Although the clinical trials established benefit in a wide swath of patients, it is well established that most patients who receive an ICD are exposed to the risk without getting any benefit. What's more, the device prevents a painless death. Patients have varying preferences about goals of care, and in my mind, no therapy should be more patient-centered than an ICD.
This is why I was dismayed by comments made from a prominent thought leader in electrophysiology during a debate at the 2013 Heart Rhythm Society Sessions. With the utmost respect, I will disagree with Dr. Eric Prystowsky's opinion about ICD use in the United States.
Clash of the Titans: Are Primary-Prevention ICDs Overused or Underused?
That was the name of the debate. Two giants of the field of clinical electrophysiology took the stage. Dr. Mark Josephson from Beth Israel Hospital in Boston, Massachusetts, staked out his unwavering opinion that ICDs are overused. The equally prominent and influential Dr. Eric Prystowsky, from St. Vincent Hospital, Indianapolis, Indiana, made the case that ICDs are underused.
The large ballroom was packed. Despite the late-afternoon time, attendees lined the walls. As it often goes in these debates, there were areas of agreement: the importance of having a nuanced discussion with the patient before implanting, giving weight to comorbidities, and seeking the preference of the patient, for instance. But that was about it on agreement.
Dr. Josephson made the same case he has made in multiple editorials over the years. He wants clinicians to critically appraise the clinical trials, consider the burdens of the ICD, and above all else, apply heaping doses of common sense to the decision to implant. Dr. Prystowsky emphasized clinical guidelines and cited data from the Get-With-The-Guidelines movement, which reports a low use of ICDs in eligible patients.
The Essence of the Debate
Take 100 ICD-eligible primary-prevention patients. After careful explanation of the benefits, burdens, and expectations, Dr. Josephson believes the number that would benefit and accept an ICD is between 10 and 20. Dr. Prystowsky believes the number to be closer to 70.
The problem I have with Dr. Prystowsky's take centers on 2 frightful statements he made.
He called the underutilization of primary prevention ICDs in the US a "national disgrace." The second, and equally disturbing, statement was that he called for ICD implantation in eligible patients to be an outcome measure for heart-failure therapy.
My Dissent, in 5 Components
Let's start with science: The 2007 JAMA paper Dr. Prystowsky cites for ICD underuse is flawed. First, it was a voluntary observational study that abstracted clinical information from databases (gulp). Second, it recruited patients from 2005 through 2007-- a different era of cardiovascular care. Third, ICDs were used less often in nonischemic patients and women -- 2 groups in which ICD benefit is less. (Perhaps the doctors were onto something.) Finally, and the main reason to be cautious with this trial, it studied inpatients. Recall that most patients in the clinical trials had their ICD implanted out of the hospital. It's an important distinction, as inpatients often have higher heart-failure burden, experience less detailed preimplant ICD discussions, and may fare worse after the implant.
Second, what is disgraceful about ICD practice in the United States is the state of decision quality surrounding the ICD. Both debaters agreed on the importance of having a nuanced discussion about the burdens and benefits of the ICD. Yet paper after paper document the woeful state of patient/physician communication on the ICD. I have just reviewed the literature on this topic, and not a single study yields encouraging results. The evidence suggests few patients who receive ICDs have experienced a truly shared decision.
Third, Dr. Prystowsky suggested that the decrease in ICD implants over the past 2 to 3 years indicates underuse. That's one way to look at the data. Another is that we have depleted the pool of cardiomyopathy that existed at the completion of the clinical trials. Or, perhaps, there is less ischemic cardiomyopathy now because ST-segment myocardial infarction (STEMI) care is improved.
Fourth, as for making ICD implants an outcome measure for heart failure: Dr. Prystowsky compared the greater relative risk reduction from ICDs with typical heart-failure drugs. That's a foul! I believe it is flawed to compare ICDs with statins, beta-blockers, and angiotensin-converting enzyme (ACE) inhibitors. Having an ICD is nothing like taking a pill. Drugs don't shock people, drugs don't cause intravascular infection, and a drug will not change one's mode of death from peaceful to something else. A patient can stop taking a drug; but it may not be so easy to stop an ICD. A not-insignificant number of cardiologists believe turning off an ICD is unethical. ICDs may have a lower number-needed-to-benefit than medication, but they also have a greater burden.
Finally, from a journalistic standpoint: Isn't it a problem when thought leaders with deep financial ties to industry stand on a podium and call for more ICD implants? Whether through hyperbole (a "national disgrace") or influence of outcome measures, this sort of thing gives fodder to the skeptics. I don't have a problem with scientists having financial ties to industry. In a device-intense field like electrophysiology, such relationships are necessary for innovation. But transparency is critical. Dr. Prystowsky's disclosure slide was up for 2 seconds and it listed multiple industry relationships. I left the debate room wondering about such conflicts.
It was hard to write this. I deeply respect Dr. Prystowsky's contributions and intellect. He is an influential thought leader, and I'm just a regular doctor struggling to use ICDs in the wisest and most patient-centered way. I have lived through the irrational-exuberance phase of ICD implants. I have seen the good and the bad. The more I study the evidence, the harder the ICD decision has become.
This is what I believe: What we need now, more than ever, from our thought leaders, is a call for higher-quality decisions -- not hyperbole and mandates. Clinical guidelines don't call us to implant; they call us to discuss, educate, and present options to the patient.
As for outcome measures, how about this one: What if we measured our patient's knowledge of the benefits and risks of their newly implanted ICD?
Cite this: John M. Mandrola. ICD Use: Disagreeing With an Influential Thought Leader - Medscape - May 24, 2013.