In recent years, the University of Michigan Frankel Cardiovascular Center has played a key role in a flurry of research in how to conquer heart failure. A number of ongoing studies at the university hope to add to available treatment options.
“The EXPAND trial is probably the most important trial we have ongoing now. It might transform the way we do heart transplantation in this country,” said Francis Pagani, MD, PhD, a cardiac surgeon at the Frankel Cardiovascular Center.
“We are one of 12 centers participating in EXPAND,” he said. The trial is evaluating a new portable organ care system that perfuses the heart with oxygen and nutrients and keeps a donor heart functioning at normal body temperature while it is transported to a recipient. The trial is testing whether this method of maintaining the donor organ is superior to the current method of storing the heart on ice.
CENTER FOR LVAD RESEARCH
The MOMENTUM III trial, ongoing at 60 centers in the United States, is evaluating a new left ventricular assist device (LVAD) called HeartMate 3 (Thoratec). This implantable device circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. Patients must have advanced heart failure that is refractory to current treatment to be eligible for the study. So far, 200 patients have been enrolled in the trial at the Frankel Cardiovascular Center.
The SynCardia Total Artificial Heart 50-cc trial is testing a smaller total artificial heart for use in women and smaller men. “One of the limitations with artificial heart technology is that it is so large it only fits in large-bodied people,” said Dr. Pagani, speaking about the 70-cc total artificial heart. “The 50-cc size of this model makes it more suitable for smaller-bodied individuals.”
The Cardiothoracic Surgical Trials Network Cell Therapy LVAD Trial II is examining whether injecting allogeneic stem cells into the heart during implantation of an LVAD can improve long-term myocardial function. “This is a significant trial that could give us important insights into the potential for stem cells to improve heart function in patients with advanced heart failure,” said Dr. Pagani.
Heart Failure Studies and Support
Scott Hummel, MD, MS, a cardiologist at the Frankel Cardiovascular Center, said his main area of interest is “diastolic” or “preserved ejection fraction” heart failure (HFpEF). “There are no broad evidence-based therapies for HFpEF yet, but we use exercise testing, imaging and sometimes catheterization to phenotype patients and direct treatment to the underlying mechanisms,” said Dr. Hummel. “We also lead several clinical studies that are looking at the importance of dietary modifications.”
For example, the DASH-DHF 2 (Dietary Approaches to Stop Hypertension in ‘Diastolic’ Heart Failure 2) study is investigating how recommended dietary changes affect heart and blood vessel function in patients with hypertensive HFpEF.
Patient Management and Referral
In addition to the expertise of heart failure specialist physicians, nurse practitioners and physician assistants, patients benefit from a team of nurse case managers whose sole responsibility is to manage patients with heart failure. “We are studying the best methods for patient telemonitoring across the spectrum of heart failure, including patients with LVADs,” said Dr. Hummel.
Dr. Hummel said the Frankel Cardiovascular Center welcomes referrals from and collaboration with other practices. Referring physicians should consult the suggested guidelines for referral of advanced heart failure patients. See table.
“One of the biggest challenges that can happen is when someone is referred too late, when other organs in the body are failing besides the heart,” said Dr. Hummel. “Getting involved in a patient’s care when he or she is not yet critically ill is the best time to have conversations about what treatments are available.”
New Drugs Offer New Options
In the past year, two new drugs have been approved for heart failure. Ivabradine (Corlanor, Amgen) was approved for patients:
- who have stable, symptomatic chronic heart failure with a left ventricular ejection fraction of 35% or less;
- who are also in sinus rhythm with a resting heart rate of at least 70 beats per minute; and
- who either are on maximally tolerated doses of β-blockers or have a contraindication to β blocker use.
Sacubitril-valsartan (Entresto, Novartis) was approved for the treatment of chronic heart failure with reduced ejection fraction. The drug is a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker already used to treat heart failure.
“In a large clinical trial, Entresto was compared to an angiotensin-converting enzyme inhibitor and found to reduce cardiovascular death and heart failure hospitalization by 20%. The results are undeniably impressive, and the drug may have a big impact on our patients,” said Scott Hummel, MD, MS. He said one challenge for clinicians is determining whether to use sacubitril-valsartan in patients who don’t meet the enrollment criteria that were used in the clinical trial, for example, those with low blood pressure or more than moderate chronic kidney disease.
MEET DAVID PIERCE
WARM FEET AGAIN
After a heart attack at 41 years of age and an eventual diagnosis of heart failure, David Pierce underwent implantation in 2004 of a left ventricular assist device (LVAD), at the age of 52. Today, he is the long living recipient of a HeartMate II LVAD in the entire United States.
Before receiving an LVAD, David had difficulty negotiating stairs, and a favored pastime, dancing with his wife, was becoming a thing of the past “I couldn’t walk more than 15 feet without stopping,” he said. “I had zero stamina—none whatsoever.”
He was very concerned about what doctors could do for him as his disease progressed, and was worried about what would happen to his wife and whether he would be able to watch his grandkids grow up. At first, upon hearing about the option of LVAD implantation, Mr. Pierce was not enthusiastic, struggling with the notion of having the medical device implanted in him. But as he discussed it with his doctors he gradually realized that this was his one option, the only way he could stay alive.
As Mr. Pierce’s condition inexorably worsened, he was referred for implantation to Francis D. Pagani, MD, PhD, the director of U-M’s Center for Circulatory Support.
Patients approved for LVAD implantation suffer not only from a steadily deteriorating disease state but also a greatly reduced quality of life. LVAD implantation is a game changer for many of these patients, as it can suddenly improve a patient’s quality of life and immediately heighten his or her chances for survival.
The U-M Frankel Cardiovascular Center’s LVAD program has successfully implanted about 600 of these devices, amassing extensive, vital experience in the procedure.
Mr. Pierce’s health sharply improved after implantation of the LVAD device. His wife noted that, on the morning of surgery, “David went in with cold feet and came out with warm feet, and a new outlook on life. He was so nice and warm, which he hadn’t been in a long time.”
He spent a week or two in the ICU, and with multiple lines hooked up to him he thought the experience was difficult at the time. He now looks back on those days as not being as onerous as he imagined, and realizes that the operation he had back then has set up years of enjoying a life that had been slipping away from him.
Commonly among heart patients, Mr. Pierce suffered from some depression around this time, but worked with a psychologist to regain perspective, a process he recommends for others. “It’s helped me immensely.”
He is still waiting for a heart, but he can accept living the rest of his life with the LVAD if necessary since he is satisfied with its performance and is used to it. “I have a good life right now, and [the LVAD] keeps me there … it keeps me happy.”
The U-M’s LVAD team can be reached at 800-962-3555.