Ileana L. Piña, MD, MPH


July 14, 2014

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A Packed House in Athens

Hello. I'm Ileana Piña, Associate Chief of Cardiology at Montefiore Medical Center and Albert Einstein College of Medicine in New York. Today I want to talk about the European Society of Cardiology (ESC).

Often, we are so America-centric that we forget that the rest of the world has the same issues with heart disease that we do, and certainly the same issues with heart failure. I recently attended the Heart Failure Congress of the ESC, and I want to convey the tone of the meeting and familiarize you with the Heart Failure Association (HFA) of the ESC. They have yearly meetings, and what has continuously impressed me is the number of people that attend. This year, more than 4500 people attended the meeting in Athens, Greece, in a relatively small convention center. The sessions were absolutely packed, and they were fabulous. I attended last year's meeting as well and left then, as now, with a sense of admiration.

The HFA is run by a group of heart failure specialists from all over Europe, including Eastern European countries. This group does not include any South American countries. They have an incredible focus on training the young to do their part in the world of heart failure care, and many of the sessions were dedicated to young investigators. Along with another professor, I chaired a session in which young investigators were given a rapid-fire 5-minute time to talk about their studies -- most of which were small, single-center studies, but well thought out and well done.

Some of the investigators were from the United Kingdom. John Cleland has a wonderful history. He has been at the University of Hull in the United Kingdom for many years, and many of you may know his name because he publishes rather extensively on heart failure. He is a terrific clinician and has been mentoring young people for a long time. His young investigators were very much present at this meeting, as were investigators from Sweden, Denmark, and The Netherlands.

What else happened at this meeting? There weren't any late-breaking clinical trials that I would call blockbusters, but there were many substudies of larger trials with a concentration on home monitoring. Home monitoring of patients after discharge is a huge area of interest in Europe. They have the same readmission issues that we do, but they would like to use the technology even more than we do here in the United States to try to capture those patients and keep them out of the hospital.

Why Target Aldosterone in Heart Failure?

I want to spend a little time relating a wonderful lecture that was given by Dr. Bertram Pitt from the University of Michigan. Many of you know Bert from the RALES trial,[1] which used spironolactone in class IV heart failure, his involvement in the EPHESUS (eplerenone in myocardial infarction) trial,[2] or from the EMPHASIS trial[3] that was conducted strictly in Europe with eplerenone in class II-III heart failure. Bert has had a long-standing interest in the effects of aldosterone on the myocardium, causing fibrosis -- not just retention of sodium, but actively causing remodeling in the heart. Every trial that has been done with spironolactone or eplerenone in the heart failure with reduced ejection fraction (HFREF) population has been positive.

Turning our attention to the heart failure with preserved ejection fraction (HFPEF) population, I have discussed diastolic dysfunction in these patients many times previously, because we are so frustrated with the fact that none of the large trials have given us a clear road map on how to take care of these patients. I often wonder whether we even understand diastolic dysfunction well enough to classify it. It may be a compendium of several diseases, and these patients have multiple risk factors. You probably see them in your practice, and they comprise 30%-40% of all admissions for decompensated heart failure. Because of the changes of remodeling and the fibrosis that happens in the ventricles, it is natural that aldosterone would be targeted for these patients.

The National Institutes of Health embarked on a very large trial called TOPCAT[4] which randomly assigned more than 4000 [Editor's note: TOPCAT had a total of 3445 patients] patients with HFPEF around the world to receive either spironolactone or placebo. The physicians who were caring for these patients were allowed to use other medications; for example, for control of blood pressure or diabetes. The primary endpoint was a combination of hospitalization and mortality, but the study did not meet this endpoint.

Bert's talk[5] at this meeting was about the different countries. We don't like subgroup analyses because we think they may be flawed, but it is important here to look at the diagnosis in different countries. I have learned through the years that heart failure diagnosed in one place may not be the same as heart failure diagnosed elsewhere. Many patients who entered from Russia had a very different result from those in patients who came from the Americas. Dr. Pitt's point was that perhaps the patients from the Americas had real HFPEF, and in those patients, the trial would have been positive. What was positive throughout was a reduction in heart failure hospitalizations.

Give Spiro, Watch the K

In the absence of anything else that we can rely on that has a class IA indication for this population, I want to leave my audience with a recommendation for using spironolactone in this population. Yes, hyperkalemia will occur, and some patients will have worse renal function (as was seen in TOPCAT), but many patients can be managed well with once-daily dosing of 25 mg of spironolactone. If the potassium level gets a little too high, you can always cut down to 12.5 mg daily, or even every other day.

If your patients' potassium levels are high, ask what they are using as a salt substitute. I recently interviewed a patient after my fellow said, "I can't use the drugs because her potassium is way up." I said to the patient, "What do you use for salt substitute?" She said, "I use the Morton salt substitute that's right next to the salt in the grocery store." I said, "That is pure potassium chloride. It may be a great salt substitute, but it should not be used when you are on these drugs." Make sure that you get a list of potassium-containing foods (available on the Internet) and teach your patients about lowering their potassium intake so that you can try to get them on some of these lifesaving drugs.

Certainly, in HFREF, spironolactone has a much earlier role than we ever thought, and I want you to try it in your HFPEF patients. All is not lost from the TOPCAT trial, and I'm sure we are going to see many more subgroup analyses.


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