Cardiology's Top 10 Stories of 2014

COMMENTARY

Cardiology's Top 10 Stories of 2014: Back-to-Basics Promises Big Advancements

John M. Mandrola, MD

Disclosures

December 11, 2014

41

There were many great stories in cardiology this year. Some of the most useful ones stemmed from negative findings. That's OK; finding out what doesn't work is helpful. Other choices are less about specific trials and more about changes in ways of thinking. Here's my list.

1. The Failure of Renal Denervation

Few negative trials teach us as much as the sham-controlled, prospective, single-blinded, randomized clinical trial of renal denervation called SYMPLICITY-HTN-3.[1]

Before 2014, the excitement at medical meetings surrounding kidney ablation was striking. The unblinded trials that preceded SYMPLICITY HTN-3 declared dramatic blood pressure reductions. Millions of patients have hypertension and millions suffer from its complications. Renal denervation promised an easy solution: We could thread a catheter up to the kidneys, deliver radiofrequency energy, not measure an ablation effect, and voilà—hypertension would be vanquished. Proceduralists and medical device companies were tingling with anticipation.

Then reality hit. The nonsignificant blood pressure reductions in the properly controlled SYMPLICITY HTN-3 trial confirmed the old adage: If something looks unbelievable, it probably is. Other lessons included the power of hype, the misthink of treating systemic lifestyle diseases with focal solutions, the temptation of intervention bias, and the importance of basing clinical practice on sound science.

Dr Anthony DeMaria was the editor of the Journal of the American College of Cardiology (JACC) at the time. His introspection on renal denervation is notable.[2]

As JACC editors, we tend to place a very high importance on novelty in deciding whether to accept or reject a submitted manuscript... these considerations may help to explain how studies that have relatively small sample sizes, no or limited controls, and less than absolutely perfect methodology achieve such prominence in the medical literature.

It's worth closing this topic on a positive note. It would be incurious to consider renal denervation a hopeless strategy. It was never going to be an antidote for eating too much and moving too little, but one can see its potential value in small cohorts of patients with diseases of catecholamine excess, such as ventricular tachycardia storm.[3]

2. ARNI: A New Class of Drug for Congestive Heart Failure

The impressive results of the PARADIGM-HF trial may be the first breakthrough in drug therapy for heart failure in more than two decades.[4]

Investigators compared the novel combination drug LCZ696 (valsartan/sacubitril; Novartis still has not given it a brand name) with standard-dose enalapril in a multicenter clinical trial. The idea behind angiotensin-neprilysin inhibition (ARNI) drugs is that the addition of the neprilysin inhibitor (sacubitril) to the angiotensin-receptor blocker (ARB) will help counter the unfavorable vasoconstriction, sodium retention, and negative remodeling seen with neurohormonal activation in heart failure patients.

The results of PARADIGM-HF were clear. LCZ696 lowered the rate of the primary endpoint, a composite of cardiovascular (CV) death or first hospital admission for heart failure, by 4.7%. The novel drug also lowered the most important endpoint, premature death from any cause, by 2.8%. Functional status and quality-of-life measures favored LCZ696. Renal function remained stable with the study drug.

But there are still reasons for concern. One problem with LCZ696 may be its more potent blood pressure–lowering effect. The run-in phase before the trial excluded approximately 12% of patients because of adverse effects (mostly hypotension). There are no run-in phases in the real world. Another criticism of PARADIGM-HF centered on the (low) dosing of the comparator agent, enalapril. Were the benefits of LCZ696 simply due to more potent afterload reduction? Finally, the drug has yet to be submitted for FDA approval, a process that often uncovers relevant details.

3. Cardiac Monitoring

This was a good year for novel cardiac monitoring technologies.

The CRYSTAL AF trial[5] showed that an implantable loop recorder (ILR) was six times more likely than conventional monitoring to detect atrial fibrillation (AF) in patients who had just suffered ischemic stroke. The majority of ILR-detected cases of AF were asymptomatic. The EMBRACE trial,[6] published alongside CRYSTAL-AF in the same issue of the New England Journal of Medicine, confirmed the value of extended monitoring after cryptogenic stroke or transient ischemic attack. In that study, Canadian researchers detected new AF in one in six patients using 30-day ambulatory ECG recorders.

These are notable studies because detecting AF may lead to beneficial changes in therapy—namely, anticoagulation.

LINQ implantable loop recorder next to the Reveal XT implantable cardiac monitoring device. Photo courtesy of John Mandrola, MD

AF monitoring really took off in 2014 when Medtronic released their newest ILR, which they call the LINQ. The generously reimbursed wireless device can be injected under the skin of an un-sedated patient in as little as 90 seconds. Enthusiasm among cardiologists is high. And, on paper, these devices hold promise for improving outcomes in patients at risk for stroke. The problem is that truly helping patients is not about implanting the device but about the labor-intense process of data interpretation. Whether we are up to being good stewards of this new technology remains to be seen.

Patients with AF and stroke weren't the only beneficiaries of new monitoring capabilities. Patients with pacemakers and ICDs also benefited from remote wireless monitoring technology built into their devices. Four studies[7,8,9,10] presented at the Heart Rhythm Society Scientific Sessions confirmed that patients with cardiac devices enrolled in remote monitoring programs are less likely to die during follow-up. Although these were not randomized clinical trials, these plausible and consistent findings have changed my practice. I now actively promote remote monitoring to patients, and I choose devices that have wireless capabilities.

4. Aspirin Loses Its Mystique

Aspirin is one of the more common drugs I deprescribe. Numerous studies published this year urged us to think twice about using the old drug.

An analysis of the SPRINT-AF[11] Canadian registry revealed that 40% of AF patients treated with oral anticoagulants were taking antiplatelet drugs without an indication. I see this often. In the absence of recent stent placement, acute coronary syndrome, or the presence of a mechanical valve, there are no data to support combining these classes of drugs.[12] In fact, the combination increases the risk of bleeding. A Danish cohort study[13] of 37,464 hospitalized patients with heart failure and vascular disease found that adding antiplatelet therapy to vitamin K antagonists was associated with a higher risk of bleeding (HR = 1.31) but not with a lower risk of myocardial infarction or thromboembolism over a median 3 years.

The matter of aspirin for the primary prevention of CV events was debated this year. In May, the FDA issued a statement[14] concluding that the evidence does not support the use of aspirin for primary prevention. Then, in July, a European Society of Cardiology working group published a position paper[15] (in an American journal, JACC) recommending that aspirin be considered for primary prevention in cases where two or more major CV events were projected per 100 subject-years. Finally, at the American Heart Association (AHA) sessions in November, a Japanese research group presented a trial[16] of 14,464 high-risk patients in which aspirin failed to prevent CV events.

The problem I see with aspirin is not that it lacks benefit in some patients, but rather the misplaced view that it offers harm-free protection against untreated lifestyle factors. An obese sedentary patient recently told me that her doctor recommended aspirin "to take care" of her mild asymptomatic carotid thickening. I wondered (to myself) why better eating and exercise wasn't recommended, and why she even had undergone a carotid ultrasound.

5. Resistance to Board Certification Mandates

In putting together this year-end summary, I reached out to colleagues and asked them for a few of their top stories. This year, nearly everyone I spoke with cited the controversy over the new mandates from the American Board of Internal Medicine (ABIM).

A few clicks on the computer leads to ample evidence that the term "board-certified" may be on life support. The opposition to ABIM has moved from practicing physicians to state medical societies, and now, even the American Medical Association and the American College of Physicians have issued statements declaring that licensure should not be tied to maintenance of certification.

No reasonable person opposes the idea of having informed and capable doctors. The main problem I have with the new ABIM mandates is the utter lack of evidence that this brand of medical education provides benefit. It seems as though ABIM is exposing doctors and patients to a huge experiment.

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