A Pawleys Island retiree has become the second person in the United States to have a wireless electrode put into the left ventricle of his heart as a potential treatment for heart failure. It’s part of the international SOLVE-CRT trial, of which the Medical University of South Carolina is a part.
“I’m really optimistic about this, based on everything I’ve read,” said Robert Hendriks, back at home after having the high-tech heart device implanted at MUSC Health. “My wife Shirley and I saw this as a real opportunity, a way to improve my quality of life and maybe extend my life."
The trial is testing a wireless system to see if it’s safe and helps the heart beat properly in people with heart failure who have tried other treatments that haven’t worked for them. SOLVE stands for stimulation of the left ventricle endocardially. CRT stands for cardiac resynchronization therapy.
MUSC Health cardiologist Michael Gold, a pioneer in the field of cardiac resynchronization therapy, is on the steering committee for the study. “It’s a very novel, creative approach, using ultrasound to avoid putting leads in a heart. Similar to how we use Bluetooth with cell phones, only in this case it’s not Bluetooth — it’s ultrasound. It’s using some great new concepts, but we need to prove that it’s safe and effective before the FDA can approve it for general use.”
He said the metal transducer that goes into the heart is about the size of a grain of rice. “It receives very safe ultrasound pulses and converts them to electrical energy to stimulate the heart. It has no battery or computer in it. That’s what makes it so small.”
The technology being tested is called WiSE, or wireless stimulation endocardially. The company that makes it, EBR Systems, is funding the trial as it seeks Food and Drug Administration approval.
Gold said heart failure is a problem of epidemic proportions, affecting about 5.7 million American adults. “In heart failure, the blood does not pump strongly enough, so patients get shortness of breath, have leg swelling and can’t do the things they want to do.”
In some cases, he said, it’s due to an electrical problem combined with a heart that isn't squeezing in a coordinated fashion. “We can correct that in part by pacing both sides of the heart, which is called cardiac resynchronization therapy. Many studies for many years have shown that this therapy improves people’s heart function, makes them able to walk further, reduces hospitalizations and even prolongs their life, so it is a great therapy.”
But up to 30 percent of people won’t respond to it for a variety of reasons, Gold said. “The implanting physician may not be able to get the pacemaker lead into the right part of the heart with the conventional way we do it. Also, there may not be branches where we can put the lead. For these reasons, everyone has been looking for alternative approaches.”
John Lacy Sturdivant, the MUSC Health cardiologist who operated on Hendriks, said the SOLVE-CRT trial is a promising part of that quest. “I’m accustomed at the Medical University to operating in the leading wave of technology. But this is really the cutting edge. It’s really gratifying for me to be able to operate at that high level on the forefront of technology.”
High-tech doesn’t mean risk-free, Sturdivant said. “It’s not a minimally invasive procedure, and there are some potentially serious risks. Perforating the heart, damage to the vascular system, we always worry about infection. And death is a possibility. So we don’t take implantation lightly. We use a very regimented approach to identifying patients for the clinical trial that may benefit, and we spend a lot of time with full disclosure.”
It’s also important to note, he said, that the patients selected for the trial are people who either couldn’t get a traditional biventricular heart pacing device for anatomical reasons or had one that didn’t work for them. “This is not front-line treatment.”
Hendriks’ heart trouble began in 2004 on Pawleys Island. “I was here at the beach, and my back started hurting really bad and I asked my wife to take me to the emergency room in case I’m having a heart attack. As soon as I got there I went into cardiac arrest.”
He had quadruple bypass surgery. “They told me my ejection fraction, which is a measure of how much your heart puts out, was very low. My whole pumping capabilities were kind of low.”
Hendriks got a defibrillator that could detect when his heartbeat was abnormal and send an electric current to get it going normally again. “I did fine,” he said of the years that followed. “I played golf. I didn’t run any marathons for the next 13, 14 years, but I was fine.”
That changed about a year ago. “I was sitting on the porch and I passed out. My defibrillator kicked in. My heart went into fibrillation. We called the ambulance, and I went to ER and my defibrillator went off 3 or 4 more times before they got me stabilized.”
Sturdivant told Hendriks he might be a good candidate for the SOLVE-CRT trial. Hendriks, who trained as a chemical engineer and did research for the Environmental Protection Agency to develop air and water techniques before retiring, understood what’s involved in a randomized control trial. The participants don’t know if they’re getting the treatment being tested until after it’s over.
In the SOLVE-CRT trial, all participants will have the WiSE device implanted, but in half of those cases, the device will not be turned on for the first 6 months so they can serve as a control group.
“Either way, a few months difference whether they start it up or not, I can wait,” Hendriks said.
The device is designed to work in tandem with previously implanted defibrillators such as the one Hendriks has, so even if he’s in the control group, he still has the defibrillator to protect his heart.
Gold said the researchers will be looking for more patients to enroll in the trial. “It’s a great opportunity for the patients of South Carolina that we have this possibility, because heart failure is the leading cause of hospitalization in the United States. There are lots of patients with heart failure, and many, despite our best medical and device therapy, need something more. That's why we think having this opportunity for patients is a very good thing.”