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Photo: In his free time. clinical trial participant Loran Swanson enjoys the writing group at his retirement community. He’s recording his life’s experiences to share with his grandchildren.
Loran Swanson used to stop breathing about 60 times every hour while he slept. That was before he became one of the first 42 people in the world to receive a new therapy for congestive heart failure and central sleep apnea. Now among six participants in a new clinical trial at BryanLGH, Loran is sleeping better, has more energy and no longer carries 20 extra pounds of fluid which had been putting pressure on his heart and kidneys. This renewed vibrancy is due to better heart function and discontinuance of the equipment previously used for his sleep apnea. “Not only do I feel better today than before the trial, I think there will be other benefits that could improve the quality of my life,” Loran remarks.
In good hands at BryanLGH
When Loran and his wife, Janet, decided to move to Lincoln 1 ½ years ago to be closer to their children, they were concerned they wouldn’t have access to the high quality health care they experienced in the Phoenix area. But, as Loran would soon discover, Lincoln has even more sophisticated options for his condition. That’s because the clinical trial in which Loran is enrolled is only being offered in five hospitals in the United States, one each in Ohio, Pennsylvania, Virginia, Tennessee, and Nebraska — with BryanLGH Heart Institute and The Ohio State University Medical Center having the most enrollees. There also are eight European locations involved in the study.
Photo: Electrophysiologist Andrew Merliss, MD, of BHI is involved in several clinical trials.
The objective of the study is to evaluate sleep quality and heart function of patients who have central sleep apnea. This is a rare form of sleep apnea, accounting for about 5 percent of cases overall, but it’s more common among patients who have heart disease, occurring in approximately 35 percent of those with heart failure. Most sleep apnea is related to obstructions that prevent patients from breathing, but the problem with central sleep apnea is that the brain isn’t sending signals to the breathing muscles and telling the diaphragm to breathe. “The one place where we see higher percentages of people with central sleep apnea is in patients who have congestive heart failure,” says Andrew Merliss, MD. “Central sleep apnea is an incurable disease which may be a cause of congestive heart failure or perhaps the other way around,” he points out. “Imagine coming up with a cure for central sleep apnea — that would be huge and definitely appealing to everyone working on this project.” Respicardia, the sponsor of the study, approached BryanLGH Heart Institute to be a site for this clinical trial for two primary reasons: Cardiologist Steven Krueger, MD, is a well-known and respected researcher and is sought after for collaboration with such trials; and BryanLGH’s experience, expertise and facilities are outstanding. “High volumes of implantation of pacemakers and defibrillators have resulted in a team that has seen everything and has been trained to anticipate problems before they arise,” says Dr. Merliss.
What’s involved
The clinical trial involves implanting a device in the patient’s chest that has leads which stimulate the nerve that makes the diaphragm move. The device, called a pulse generator, looks like a big pacemaker, but unlike a pacemaker, its function has nothing to do with the heart. It has only to do with the diaphragm, which is the breathing muscle. “It’s like a hemisphere of muscle on which the lungs rest, and when we breathe, that hemisphere becomes flattened and makes the lungs expand,” Dr. Merliss explains. “When you stimulate the phrenic nerve, it makes the diaphragm move and allows the lungs to fill with air, and thus normal breathing occurs.” The system is designed to deliver electrical pulses at night during sleep to restore more natural breathing.
Implanting the device
Dr. Merliss is one of a select group of electrophysiologists in the world who implant the devices used in the trial. He says it takes time, patience, experience and special skills, since the physicians are inserting leads in locations not typical for cardiac devices. “After every single case, I collaborate with their engineers about design modifications to try to make this therapy more accessible and to improve the implant procedure,” he adds. Though a portion of the procedure itself is similar to putting in a defibrillator or a pacemaker that is tucked underneath the skin, finesse is needed when it comes to threading the veins. “The vein we target is about the diameter of a toothpick,” Dr. Merliss notes. “The wire portion of the device is threaded through a vein which is sometimes hard to find. The wire must then be delicately negotiated through the vein to its intended destination. I am grateful to have a specially trained team of BryanLGH nurses and technicians that supports me.”
Photo: Teaching the finer points of playing pool is serious fun for Loran.
Loran’s experience
Though many patients are referred to such trials by their physicians, Loran actually heard about the trial through his daughter, whose friend was not able to initially qualify for the trial. Loran contacted Becky Goeke, RN, the study coordinator at BryanLGH; he was screened, became eligible and had the pulse generator implanted in his chest on Nov. 7, 2011. Every three months Loran spends two nights being evaluated in the Sleep Lab at BryanLGH West. That’s when technicians from Respicardia fit him with electrodes and wires, monitor his sleep, reprogram his implanted device and ensure the adjustments have been successful. These evaluations soon will be less frequent. “I almost look forward to going for the sleep studies as the BryanLGH staff and the Respicardia team are very special people,” he says. Dr. Merliss says Loran and the other participants are doing well. This study is still open, with room for about eight more patients worldwide, and Dr. Merliss already is looking forward to Respicardia’s next clinical trial — the Pivotal Study.
Channeling new-found energy
Though no longer playing his favorite game of softball because his knees complain, Loran’s renewed energy is channeled into teaching women to play pool at the Grand Lodge at the Preserve, where he and Janet live. “My goal is for them to have fun — if they are enjoying themselves, I feel like I’ve made a good contribution to their lives,” he says. Contributing to the lives of future generations also is very important to Loran, whether it be recording his life experiences in The Grand Lodge’s writing group or participating in the success of the clinical trial. “This has been a most interesting and rewarding experience for me,” he says. “Hopefully many people with central sleep apnea will benefit from the clinical evaluation of this therapy.”
Photo: Dr. Merliss unwinds with a few tunes on his mandolin, while Izzy listens in. The electrophysiologist notes, “Heart rhythms are like music on a page. If I can read the notes and understand their heart rhythms and then help my patients, that’s the greatest symphony in the world.”
Medicine and music
Dr. Merliss is involved in several research projects and is intrigued by an upcoming study that involves a procedure to reduce clots in patients, eliminating their need to take anticoagulants. In addition to his research, Dr. Merliss has been on the forefront of new treatments for all kinds of arrhythmias since he was recruited from Harvard Medical School in 2001 to build the electrophysiology program at BryanLGH. “Electrophysiology is exciting, as it is one of the few areas in medicine where you can actually cure a patient of a rhythm problem,” he says. Cure rates for atrial fibrillation keep getting higher, while complication rates are getting lower as techniques and equipment continue to improve. “BryanLGH has been amazingly supportive of our development of the program,” he adds. “They’ve encouraged me to have the most advanced equipment so we have the most cutting-edge program available.”
Away from the hospital, Dr. Merliss enjoys traveling and spending time with his wife, Jaine, and children. As a means of relaxation after busy days at the hospital, he likes to play the mandolin. Dr. Merliss sees a relationship between his passion for his music and his profession. “Patients’ heart rhythms are like music on a page to me,” he says. “If I can read the musical notes, if I can understand their heart rhythms, and then help my patients, that’s the greatest symphony in the world."
For more information visit: http://www.bryanlgh.com/bhi