COMMENTARY

Heart Rhythm Society's Choosing Wisely List Disappoints

John Mandrola

Disclosures

February 12, 2014

Part 1: Grading the Recommendations

The Heart Rhythm Society (HRS) waited a long time to introduce its Choosing Wisely list of "Five Things Physicians and Patients Should Question"[1].

The Choosing Wisely campaign began in 2009 when the American Board of Internal Medicine (ABIM) Foundation invited medical societies to own their role as "stewards of finite healthcare resources." At the time of this writing, 50 medical societies have already contributed lists.

The optimist in me had hoped that the delay meant HRS leadership was working hard at designing a meaningful and robust list. A recent New England Journal of Medicine Perspective piece made it clear that while some medical societies looked inward and made tough calls (American College of Cardiology), others phoned it in (American Academy of Orthopaedic Surgeons)[2].

The list from HRS is important because of the nature of electrophysiology. Heart-rhythm therapies are no small thing. Our interventions are big, expensive, and almost always preference sensitive. These are therapies that may provide great benefit but also come with significant burden. It's one thing to overuse pink-eye treatments, it's another to overuse shocking devices, catheter ablation, or antiarrhythmic drugs.

This is why I had anticipated an HRS list that would be bold, one that would go beyond restating guidelines and one that would have me saying: "See . . . electrophysiologists get it."

Darn it, that's not what happened. The HRS's Choosing Wisely list was tentative and cursory. Some recommendations left out important details, others stated the obvious, and two bordered on insulting.

In part 1 of this appraisal, I will offer opinion on each of the five recommendations. In Part 2, I will suggest wiser choices for an electrophysiology Choosing Wisely list.

Let's start with the positive:

1. Don't implant pacemakers for asymptomatic sinus bradycardia in the absence of other indications for pacing. This was the best of the five recommendations. I'll give it a B.

It is clearly true that great misunderstanding exists on what constitutes a "normal" sinus rate. This knowledge deficit leads to pacemaker overuse. So it is right that the HRS emphasizes the importance of symptoms in making decisions on pacing. Good.

This recommendation falls short of an A grade because it left out asymptomatic AV nodal Wenckebach-type block. In the real world, implanting pacemakers in nonsymptomatic patients with second-degree (suprahisian) block is common. And it's a more consequential mistake, as it is difficult to program a pacemaker to avoid RV pacing in these patients. RV pacing exposes patients to potential harm, and this fact is even more relevant when AV node disease is present.

2. Don't implant an implantable cardioverter-defibrillator (ICD) for the primary prevention of sudden cardiac death in patients with NYHA class 4 who are not candidates for cardiac transplantation, a left ventricular assist device as destination therapy, or cardiac resynchronization therapy (CRT).

I'll give this one a B-.

Although this declaration of the obvious merely restates guidelines, an argument can be made that it's worth using one of the five Don'ts on this tragic misuse of ICDs, which still happens in the real world. When a hospice doctor has to deactivate an ICD in a patient who still has steri-strips present, you know we have a problem. I use the words tragic misuse, because, in my mind, one of the worst possible complications of an ICD is changing one's mode of death from a good death to a bad one.

3. Don't implant an ICD for the primary prevention of sudden cardiac death in patients unlikely to survive at least one year due to noncardiac comorbidity.

This one limps to a C+.

On a positive note, promoting the concept of competing comorbidity in the ICD decision is laudable. It is too often forgotten that the Kaplan-Meier survival curves from the ICD primary-prevention trials took 18 to 24 months to (significantly) separate. The pool of "easy" ICD-eligible patients—those with heart disease only—is diminished. Patients who present for ICD consideration in this era increasingly come with competing causes of mortality, like advanced age, frailty, COPD, vascular disease, renal disease, dementia, and a host of others.

The problem I have with this recommendation is what it leaves out. There is much more than "surviving at least one year." From the 2012 ACC/AHA/HRS Focused Update of Device-Based Therapy of Cardiac Rhythm Abnormalities[3](emphasis mine):

The committee believes that comorbidities, life expectancy, and quality-of-life (QoL) issues must be addressed forthrightly with patients and their families. We have repeatedly used the phrase "reasonable expectation of survival with a good functional status for more than one year" to emphasize this integration of factors in decision-making.

In this medical climate, where futile end of life seems the default, it is not so hard to prolong death for 12 months. Common sense and compassion call for electrophysiologists to use much more than one-year survival as a cutoff for recommending expensive 750V delivery devices. There are now at least seven risk-stratification algorithms that use simple clinical factors to predict mortality[4,5,6,7,8,9,10].Such risk scores inform clinicians and patients as to the percentage of the same result of death—with or without an ICD.

The fourth and fifth items fail. Both recommendations seem to say: do not commit malpractice.

4. Don't ablate the atrioventricular node in patients with atrial fibrillation when both symptoms and heart rate are acceptably controlled by well-tolerated medical therapy.

AV-node ablation and pacing is one of the most useful procedures an electrophysiologist performs. In selected AF patients, those with persistently high heart rates and symptoms, the palliative response of this procedure is both striking and gratifying. But . . . and this is a big but . . . creating permanent AV block, pacemaker dependence, and RV apical pacing are big trade-offs that bring us very close to breaking our oath to do no harm.

It is close to insulting to suggest that any reasonable practitioner would do this in a patient with adequate heart-rate control on medical therapy.

5. Don't use Vaughan-Williams class Ic antiarrhythmic drugs as a first-line agent for the maintenance of sinus rhythm in patients with ischemic heart disease who have experienced prior MI.

This is simply not a problem. No one does this. In fact, most cardiologists are frightened to use Ic antiarrhythmic drugs in patients with even a hint of coronary heart disease, even though a critical appraisal of the evidence yields scant evidence of harm for patients without LV dysfunction[11].

That the HRS writers included encainide as a Ic agent strains credibility. This drug has been unavailable in the US for nearly two decades.

Part 2: Wiser Choices for Electrophysiology Choosing Wisely List

In this section, I'll identify common scenarios where HRS could use its influence to improve clinical practice. The areas of electrophysiology with the most relevance include ICD-generator changes, shared decision-making, AF treatment, CRT, and a few honorable mentions.

Why not address the ICD generator change? Three facts make this a critical issue in electrophysiology:

  • Generator change is a common procedure.

  • Registry studies of real-world data reveal that changing an ICD (especially with lead revision) confers significant risk.

  • The ICD benefit/harm trade-off changes over time.

Drs Daniel Kramer, Peter Zimetbaum, and Alfred Buxton (Beth Israel Deaconess Hospital, Boston, MA) addressed this important issue in a Perspective piece in the New England Journal of Medicine in 2012[12]. They convincingly argued that the ICD-generator change presented an important opportunity for good care. They reminded us of the possibility that a patient's condition may have changed over time—for better or worse. Consider this abstract presented at the 2013 Heart Rhythm Society Sessions in which researchers from the University of Pennsylvania reported that one-third of patients who presented for ICD-generator change no longer met implant criteria[13]. On the flip side, patients who come for ICD-generator change may have accumulated diseases that limit continued ICD benefit. And it's not just changes in disease states; patients' experiences in the years since initial implant may have changed their goals for care.

For these reasons, I had hoped for this recommendation: Don't perform an ICD generator change without reassessing both the net clinical benefit of ICD therapy and the patient's goals for care.

Why not address a real problem in AF treatment? The biggest mistake I see in AF care is the overuse of rhythm-control strategies (cardioversion, antiarrhythmic drugs, and ablation), especially in the elderly. The inherent problem here is conceptual. Too often AF is treated as if it's fixable rather than manageable. You have heart disease; heart disease is bad; therefore you need treatment. This logic might be okay if we weren't prescribing QT- or QRS-prolonging drugs that fail two-thirds of the time or delivering burns/freezes in the atrium that fail half the time. Or this: that in many cases, patients with AF could help themselves if we told them the truth—the hard truth that losing weight and managing major risk factors can reduce atrial fibrillation symptom burden and severity[14].

Someday, far-off in the future, clinicians will have better ways to manage AF, although I doubt there will ever be an antidote for inflammation overdose. In 2014, however, the current evidence is clear. Rhythm-control strategies do not reduce the risk of stroke or death. (Though to be fair, observational studies on AF ablation are encouraging [15].) Rhythm-control strategies work best in patients with short-lived AF who have yet to develop structural heart disease. Rhythm-control strategies expose patients to significant risk.

The Choosing Wisely recommendation for AF treatment that would have made the most sense: Don't begin an AF rhythm-control strategy in asymptomatic elderly patients or in those who have little chance of maintaining sinus rhythm.

Why not address decision quality surrounding ICD implantation? Here is a challenge: Take a random sample of patients from any ICD clinic and ask them some basic questions about their ICD. Ask them what it is for; whether it can be deactivated; whether it makes the heart contract more strongly; whether they received detailed information about the device before implantation. Researchers have done this. And the results are not good; the state of patients' understanding of ICDs is sobering[16,17,18,19].

And it's not just patients who are confused. Cardiologists, too, experience decision conflict around ICDs. In this small but telling survey of cardiologists who knew they were being studied, researchers from the University of Colorado found that doctors overemphasized ICD benefits while minimizing harms. Their conclusion was daunting: "Cardiologists' desire to adhere to published guidelines appears to inhibit shared decision making"[20].

What a huge opportunity for a Choosing Wisely recommendation: Don't implant an ICD without first being assured that a patient understands the absolute (not relative) benefits, harms, and expectations of ICD therapy.

A few words on CRT: In preparing this piece, I asked a number of colleagues to suggest Choosing Wisely ideas. Many mentioned CRT. The summary was this: Don't implant CRT devices in patients unlikely to respond—those with RBBB, QRS duration <130 ms, or high scar burden.

The problem I have with putting CRT in a Don't list is that the gray area of CRT response is wide, and the benefits can be great. Any electrophysiologist who implants CRT devices can tell stories of superresponders who on paper did not have perfect criteria. Not only that, the incremental risk of placing an LV lead, at least in experienced hands, is minimal. For these reasons, I am reticent to add CRT to a Don't list.

I would, however, have no problem if the HRS decided to bring attention to CRT pacing. For instance, this Choosing Wisely recommendation would garner high marks: Don't implant a CRT-D device without having first discussed CRT-P as an option.

There are other honorable mentions that, although small in clinical impact, would have been worthy choices. Here are three:

Don't implant primary prevention ICDs in patients with advanced kidney disease. It's little surprise that patients with chronic kidney disease (CKD) do not benefit from ICDs: First, CKD is a strong competing cause of death. Second, patients with CKD are at increased risk for blood-borne infection. Third, lead implantation complicates venous access.

Don't order tilt-table studies in patients with obvious historical evidence of vasovagal syncope. For the clinician who takes a careful history and pays attention to pertinent objective findings, tilt-table studies rarely help and often obfuscate.

Don't treat recurrent typical right atrial flutter with Na-channel blockers like propafenone or flecainide, as these drugs create a more favorable milieu for reentry and increase the risk of rapid AV conduction. Cavo-tricuspid-isthmus (CTI)–dependent flutter can be considered a surgical—not medical—disease. Interruption of the CTI circuit with catheter ablation is easy and low-risk. It is the preferred strategy for recurrent flutter.

Summary:

One of the reasons I was drawn to cardiology as a young learner was that we were leaders. I saw cardiologists as bold and courageous. We led the medical community in clinical science. We did not back down from challenges.

In another era, the challenge of medicine was finding better treatments of acquired heart disease. It wasn't long ago that patients with MI were treated with bed rest and opiates. We've come a long way. We've done a lot.

But these are different times—with different challenges.

The challenge for medical doctors and their societies now is not about delivering more medicine and surgery; it's about using our many tools wisely and aligning them with our patient's goals.

The game has changed. Can we?

JMM

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....