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2014: A year of important advances; challenges ahead

The Cardiology Today Editorial Board looks back at major developments in cardiology and what may change practice moving forward.

Issue: January 2015

ByCarl J. Pepine, MD, MACC

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Each year, the Cardiology Today Editorial Board selects, ranks and reviews their Top 10 Stories of the Year based on important advances, challenges and new data in CV medicine.

This has been a great year in cardiology. In my opinion, the most exciting development has been the continuing attention on the development and investigation of PCSK9 inhibitors. I don’t remember seeing a dataset so consistent as the PCSK9 inhibitor findings for alirocumab (Sanofi/Regeneron) and evolocumab (Amgen), and others in development, in all of my years in CV medicine. The data continue to demonstrate overwhelming reductions in LDL with a very clean side-effect profile. It will be interesting to see what 2015 brings us regarding the promise of the PCSK9 inhibitors.

On the other hand, 2014 brought with it a few challenges, such as the evolution of maintenance of certification, declining Medicare reimbursements and the continuing quagmire of the electronic medical records (EMR). The EMR is extraordinarily disruptive to the cardiologist’s ability to interact with the patient. Current EMRs are forcing cardiologists into a physician-computer interaction with the patient looking on as an observer, rather than what should be a physician-patient interaction. Most of the information in the EMR represents completion of pull-down menus that may or may not have anything to do with the patient’s reason for a visit. Ending on a positive note, we look forward to the increased use and incorporation of EMR scribes into our practices for data collection (but not for coding/billing).

Read more below about our Top 10 Stories of the Year (see Table below) and other important topics that didn’t make it onto our list.

Aspirin for primary prevention

Michael A. Weber, MD: There has been confusion regarding the use of aspirin for primary prevention. Although there is strong evidence for aspirin’s benefit for secondary prevention, the evidence for primary prevention is less compelling and the risks for major or disabling bleeds become relatively more important. Many physicians routinely recommend low-dose aspirin simply on the basis of patient age or the presence of risk factors. This is understandable, but the FDA’s [advisement against the use of aspirin for primary prevention] brings much needed reality and hopefully will produce a more evidence-based use of this therapy.

Leadless pacemakers

Peter R. Kowey, MD: The Achilles heel of pacing has been lead complications. The ability to pace the heart without leads will represent a major advance, especially in older patients who frequently have access difficulties.

PARADIGM-HF results

Barry Greenberg, MD: PARADIGM-HF was an extremely well-done study that assessed a novel approach to treating chronic HF with reduced ejection fraction. The results showed that LCZ696, a combined angiotensin receptor blocker and neprilysin inhibitor, reduced the likelihood for the combined endpoint of HF hospitalization or CV mortality by 20% compared with enalapril. There was also a highly significant reduction in CV mortality with LCZ696 and a very acceptable safety profile. This study provided compelling evidence that this dual-acting neurohormonal-modulating agent more favorably influences outcome than does a standard guideline-approved therapy that targets the renin-angiotensin alone. These results are likely to alter the therapeutic approach to managing patients with HF and reduced EF.

Cholesterol guideline controversy

Seth S. Martin, MD: Continued discussion surrounding the American College of Cardiology/American Heart Association cholesterol guidelines was a top story and advance in cardiology in 2014. My view is that collegial discussion about the guidelines has been critical to moving forward their successful implementation. I personally have learned a lot from my colleagues while striving to optimally interpret the thoughtful recommendations of the guideline authors and apply the recommendations to individual patients in clinical practice. Hopefully constructive discourse will continue to bring attention to these important guidelines, including key elements like the clinician-patient risk discussion, and improve the care of our patients.

Dan M. Roden, MD: The change in the ACC/AHA cholesterol guidelines represents a dramatic shift away from use of statins guided by LDL cholesterol to much broader population implementation. This is a recognition of the very substantial benefit these drugs confer in patients at risk for CAD and their very impressive safety record.

Carl J. Pepine, MD: It seems that the results of IMPROVE-IT and emerging results of PCSK9 inhibitor trials will reopen the ‘lower-is-better’ notion, perhaps extending it to ‘even more lowering is much better.’ These findings, along with mounting concerns about the accuracy of the risk calculator, will refocus attention back to on-treatment LDL and away from the simplified notion of ‘is the patient on a statin?’

Renal denervation

Allan S. Jaffe, MD: There is a sound experimental and observation basis for being enthused about renal denervation. However, we have all observed apparent innovations which, when put to the test, failed. There are a huge number of reasons to continue to study this approach and perhaps there are technical issues or patient selection issues that will in the long run explain the data. However, for now, its use should be reserved, if it is used at all for highly selected cases.

Duration of dual antiplatelet therapy

Michael A. Weber, MD: Duration of dual antiplatelet therapy is a common clinical dilemma. The major trials provided evidence of benefit for up to 12 months, but what do clinicians do after 12 months of treatment have been reached? Major bleeds are a genuine concern, even in patients apparently doing well. So, guidance on when to stop DAPT, if at all, has been a long-awaited clinical need. Results of the new DAPT trial [presented at the AHA Scientific Sessions in November 2014] appear to answer that critical question.

Defibrillation testing

Bruce Wilkoff, MD: The SIMPLE trial adds some clinical outcomes to the current desire to avoid defibrillation testing. Although it has been interpreted to say that defibrillation testing is not needed in a majority of device implantations, it is also an acceptable procedure with little risk. However, it is one trial and needs to be placed in context of entire literature that shows that defibrillation testing also has value.

Use of polypills

Ami E. Iskandrian, MD: I think compliance and cost are real problems in many of our patients. Mind you, compliance is not because patients do not care, but rather because it is hard to remember when you have so many pills to take; some are once a day while others are two or three times a day. The polypill makes it easier for those on multiple pills, which most patients are. This is a simple approach and is not driven by high-tech or genomics. It will have a role, but not in the immediate future.

BP targets

Michael A. Weber, MD: The JNC 8 recommendation for treatment targets in older patients was controversial and, to many experts in the field of hypertension, it represented a narrow and potentially troubling overinterpretation of the limited evidence available. Patients aged 60 to 80 years are a major part of the hypertension population and often are at high CV risk. To relax a well-established and safe target of 140/90 mm Hg in favor of 150/90 mm Hg simply because evidence differentiating between the two targets is unavailable or inconclusive is difficult to justify, and potentially dangerous. If the JNC 8 recommendation is wrong, vulnerable patients in this age group could pay the price of premature mortality, coronary events and particularly strokes.

Carl J. Pepine, MD: I am concerned about the ‘relaxed’ BP thresholds for initiating drug treatment for hypertension and treatment targets because they have the potential to disadvantage very large segments of our hypertensive population aged 60 years and older (women; African Americans; those with comorbidities like CAD, HF, etc.). Furthermore, when I read that six of the nine JNC 8 panel recommendations were based upon “expert opinion” as the evidence, I became even more concerned. The areas where they failed to opine are considerable. For example, how and where should we measure BP (office, out of office, home, ambulatory BP monitoring, kiosks, grocery stores, pharmacies, etc.)?

Drug-coated balloons

Peter R. Kowey, MD: Peripheral interventionalists need more tools to deal with complex lesions, and the drug-coated balloon certainly adds to their toolkit in a meaningful way.

Vorapaxar approval

Allan S. Jaffe, MD: It has been known for a long time that thrombin activity is increased in many patients with acute CAD and some with more chronic disease as well. If so, it is not surprising that this approach/agent (Zontivity, Merck) might be of value over and above any increases in bleeding that its anticoagulant properties might cause. The critical issue now is how to define the group that might benefit so we can refine its clinical use.

Oral anticoagulation

L. Samuel Wann, MD: As the population ages, the prevention of embolic complications of atrial fibrillation becomes ever more important. The introduction of new anticoagulants in attempt to improve on the well-established efficacy of warfarin while reducing complications and increasing patient compliance is an ongoing process. Elderly patients are at higher risk for both embolic complications and adverse bleeding effects of anticoagulation. The balance of benefit and risk for anticoagulation continues to be a subject of intense investigation.