Advanced heart failure is a debilitating and lifethreatening disease that has become increasingly common as our population ages. Patients who have reached a point where their disease threatens their survival are not always candidates for heart transplantation. Even for those that are, only a limited number of donor hearts are available. In the last two decades, implantable pumps to supplement the heart’s function have become available. A left ventricular assist device (LVAD) is a mechanical pump that is implanted in heart failure patients to help the heart’s left ventricle pump blood throughout the body. An LVAD can be used as either a “bridge-to-transplant” to help a patient survive until a donor heart becomes available, or as “destination therapy,” to provide long-term support in patients who are not candidates for a transplant. An LVAD can in some cases prolong the life of heart failure patients whose symptoms can no longer be controlled with medications.
As with any other medical intervention, there are risks and burdens associated with LVAD implantation. The medical risks of the procedure include bleeding, development of blood clots, infection, respiratory failure, kidney failure, stroke, and device failure. LVAD patients must be connected to electricity at all times and are advised not to drive. Each LVAD patient must have a dedicated caregiver to assist with batteries, changing dressings, transportation, and activities of daily living. Heart failure patients often suffer from other medical problems that are not alleviated by LVAD placement. Quite a bit of emotional stress and in some cases financial stress is involved. In addition to heart failure cardiologists and cardiac surgeons, social workers and in some cases bioethicists and palliative medicine specialists meet with the patient to ensure that he or she understands the risks, benefits and alternatives to device placement. The patient must be in a position to make a well-informed decision as to whether to have an LVAD implanted, and it is not uncommon for patients to decline the procedure.
It must be recognized that cardiac surgery, including LVAD implantation, is big business for many medical centers. I was reminded of this when I received the Fall 2014 edition of Center Scope, the newsletter sent to patients and former patients of Medstar Washington Hospital Center (WHC), Washington, DC. I have embedded the newsletter below. The cover story focuses on a 66-year-old patient named Alberto Gomez, who received an LVAD at Washington Hospital Center. Mr. Gomez appears to be a somewhat atypical patient, in that he had enjoyed excellent health up until suddenly developing extreme fatigue and being diagnosed with advanced heart failure. In any case, Mr. Gomez seems to be a great guy, and I want to make clear that I do not intend to criticize him at all. Rather, my beef is with the way the public affairs & marketing department of WHC, which produces Center Scope, has used Mr. Gomez’s story to spin a happy tale in which “hope,” “determination,” and “faith” are the only things a person needs to manage serious illness.
Alberto’s mental strength and determination served him well. He did not need a blood transfusion during surgery, an often needed measure, and declined pain medication in recovery. And when a stroke he suffered after discharge initially left him with weakness and speech deficits, Alberto overcame them with hard work and perseverance. Currently, Alberto is on a transplant list for a new heart, which doesn’t stop him from living life. “I stay very busy,” he shares. “And I have no time for complaining.”
While Alberto’s heart now requires a LVAD to ensure proper function, his heart needs no assistance in dispensing generosity, kindness and faith. Since recovering from surgery, Alberto has made it a priority to return to the Hospital Center to visit with patients facing similar procedures. “I share my experiences,” Alberto says. “I pray with them and I cry with them. I tell them to trust in the doctors and the technology.”
I’m very glad that Mr. Gomez is doing well. However, I couldn’t help thinking that the message (from WHC, not Mr. Gomez) that a positive attitude can conquer all is a bit insulting to the many LVAD patients who don’t do well. Were their complications — or their need for pain medication — due to lack of determination?
At the end of the story is the following sentence: “For more information on our heart failure services, visit MedStarHeartInstitute.org/Trust.” I thought to myself that even though the story consisted of one long human interest anecdote, at least at this link I can find some more objective information. On going to the indicated webpage, however, I was disappointed to find only a shortened version of Mr. Gomez’s story and a link to the full version. (The WHC website does have some information on heart failure and LVADs, but I had to click around a bit in order to find it.) I get that hospitals want to advertise their services, but my message for Washington Hospital Center is, how about a little more objective information and a little less schmaltz.
The long-awaited IMPROVE-IT trial was presented last month at the American Heart Association Scientific Sessions. Here are the presentation slides:
IMPROVE-IT was a trial that tested the ability of ezetimibe (Zetia) to lower the risk of heart attacks and strokes when added to simvastatin. See Larry Husten’s background post here, and if you type “ezetimibe” in the search box on this blog or on the Gooznews blog, you will find some previous posts of mine relating to ezetimibe. I admit I was a bit surprised that the trial was positive. I was expecting it to be negative, based on the negative results of the ENHANCE trial. Still, the benefit was small, a 6.4% reduction in risk of the primary endpoint (composed of cardiovascular death, heart attack, unstable angina requiring hospitalization, coronary revascularization, and stroke). In the high-risk trial participants — all patients who had been hospitalized for acute coronary syndrome within the 10 days before randomization — this translated to a 2% absolute benefit over 7 years. Of note, there was no reduction in all-cause or cardiovascular mortality.
I only want to make a few comments now, but I intend to write more when the trial is published. First, a 6.4% reduction is risk is a very small benefit, and many people would only consider that reduction in risk meaningful in a high risk population. Second, it is regrettable that we had to wait 12 years after the drug’s approval to find out whether it improves outcomes.
Here are great summaries by Larry Husten and Matt Herper. And here is a video of Harlan Krumholz giving his take on the results.
Addendum, May 5, 2015: Unfortunately, the GoozNews blog is no longer up on the web. I asked Merrill Goozner what happened and he said he decided to stop paying the annual fee for the website. So the posts I wrote on ezetimibe for GoozNews are no longer up.
Heart and Stroke Foundation “make death wait” campaign: effective advocacy or unnecessary scare tactics?
I would be interested to know what my readers think of the two Heart and Stroke Foundation of Canada (HSF) ads shown below. The ads are part of HSF’s “Make death wait” awareness and fundraising campaign that’s been going on for the last few months. In the first ad, shown in this You Tube video, several different women are shown as a male voice, meant to personify death, intones “I love women. I love older women, professional women, stay-at-home moms. I love how women put their family first. I love how you’re so concerned that I’ll get to your husband.” In the last scene a woman in a bathing suit looks apprehensively over her shoulder as the voice warns, “You have no idea that I’m coming after you.” Eileen Melnick McCarthy, director of communications for the foundation, told a reporter that the intent of the campaign is to “wake up Canadians to the threat of heart disease and stroke.”
In addition, the print ad that appears below has appeared in a Canadian magazine. The copy, in case you can’t make it out, reads as follows:
Death loves menopause. He loves that menopause makes women more vulnerable to heart disease and stroke. And that women are far more likely to die of a heart attack. Most of all, he loves that heart disease and stroke is the #1 killer of women. Please donate, and make death wait.
Is this a legitimate way to “wake up” people to the threat of cardiovascular disease? Or unnecessary and counterproductive scare tactics? I lean toward the latter.