Leading Edge Technology Helps Heart Patients
One day last July, Irene Armendarez, 59, went to her local hospital in Stockton. The prior February she had a heart attack and her Stockton physician told her that she lost a lot of muscle around her heart but she would recuperate. But here she was, not feeling well again – and this time, her doctor wasn’t sure what was wrong.
Armendarez was transferred to California Pacific Medical Center, under the care of Ernest Haeusslein, MD, Medical Director of the Heart Failure and Transplant Program. It was then that she was told she needed a heart transplant. But her health was unstable and her antibodies were high, making it difficult to find a donor heart that her body would not reject. Haeusslein recommended using a ventricular assisted device, known as a VAD, as a temporary solution. This is a mechanical device that is used for up to several years to partially or completely replace the function of a failing heart.
“We never would have been able to keep her stable until she was ready for her heart transplant without using a VAD,” says Haeusslein. “Medication alone was not enough.”
Luckily, California Pacific Medical Center has a long history of VAD use and research. In 1984, we were the first hospital in the West Coast to successfully use a VAD for a patient waiting for a heart transplant and have implanted 132 VADs since then. Now, California Pacific is the only medical facility in the Bay area participating in an FDA-approved trial of the newest, leading-edge VAD, the Thoratec® HeartMate II® Left Ventricular Assist Device (LVAD).
The HeartMate II® is a much smaller device than its predessor, which means it is easier to implant in smaller patients, such as women. The size of a D-cell battery, the HeartMate II is designed to have a much longer functional life than the previous generation of devices and using this device can result in less bleeding and less infection. Like a healthy heart, this LVAD can pump up to10 liters of blood per minute and is designed to provide long-term cardiac support. Here’s how it works. The LVAD is implanted alongside a patient’s own heart and is designed to take over the pumping ability of the weakened heart’s left ventricle. Through a tube, it is attached to an external computer, which weighs 4-5 pounds, which is then attached to batteries. Most people keep the computer and batteries attached to their waist and hidden under their clothes or in a “fanny pack.”
“This device is easier to implant,” states G. James Avery, MD, Interim Director, Cardiac Transplantation and Assist Devices, the surgeon who performs these surgeries at California Pacific. “Because of its size, we no longer need to disturb a patient’s intestines during the implant process. The most appealing thing is its durability. There are no parts that will wear out on this device, as opposed to earlier models which had a more limited lifespan. That’s because they used materials which wore down and needed to be replaced at some point after implant. The HeartMate II® is supposed to last up to 10 years.
“Earlier model VADs had larger components that moved back and forth, which made them noisy, distracting and unpleasant for the patient. The HeartMate II® is silent, there is no vibration and no motion. It just sits there.”
“You can sit in a movie theater and no one knows you’re attached to a ventricular device system,” explains Nina Topic, RN, MS, Clinical Nurse Specialist for Transplantation. Topic, who has worked in California Pacific’s VAD program since 1993 says that when she started, doctors were still using devices developed in the 1970’s and ‘80s. “The HeartMate II is a world away from those devices. Besides being quieter, it is smaller and lighter, which is why it is good for women, and there are fewer side effects.”
“If it wasn’t for the batteries, I wouldn’t even remember that I have the device!” proclaims Armendarez, who says she feels better than she did even before her heart attack. “Now I walk three blocks, twice a day!”
The HeartMate II is designed for two types of patients: for people like Armendarez, who use it as a temporary support while waiting for a heart transplant or as permanent support for advanced-stage heart failure patients who are not eligible for heart transplants. When other options have unsuccessfully been used – such as medication – this is the option to turn to.
“This device is especially important to advanced-stage heart failure patients because they will have this device for the foreseeable future – so durability is very important,” explains Avery. “Even after someone receives a heart transplant, this device can be used as a bridge to recovery – supporting the new heart until the patient is fully recovered – and then you take it out.”
California Pacific has a history of drug trials and clinical trials of ventricular support devices. “We were selected to be one of a very few hospitals in the country to participate in the HeartMate II trial because of our long history of working with medical assist devices and heart failure,” explains Haeusslein. “If a medical device or a drug that is being studied fills a treatment gap, then we are more than happy to participate in a clinical trial and offer this option to our patients.”
In fact, California Pacific Medical Center has been designated one of 43 Heart Hope Centers nationwide by Thoratec Corporation – and the only Center in Northern California – meaning we are committed to advancing clinical outcomes associated with mechanical circulatory assist devices and other advanced therapies in the treatment of heart failure. As a Heart Hope Center, California Pacific is committed to offering the latest in technology for treating heart failure. California Pacific was chosen because we
“It is an advantage to our patients that California Pacific participates in these trials – it enables us to have all the newest devices available,” adds Avery. But isn’t it a bit scary that these devices are not yet FDA-approved? Explains Avery: “By the time we do the trials here, the device has had many years of clinical experience in Europe. With the HeartMate II, for example, we know there is a three-year clinical experience and approximately 300 patients have had the device implanted. So we can say with confidence to our patients ‘This is a good device.’”
Recovery from this type of surgery can last anywhere from six to eight weeks, though Armendarez was out in three weeks. California Pacific is also the only hospital in the Bay area to have a dedicated nursing unit for VAD and heart transplant patients. There are two nurses for every five patients at all times. The nurses have been specially trained and, in turn, help train patients and their families for life after discharge.
Explains Topic: “It’s important that we properly train patients and their families on how to respond to an emergency, use the computer and batteries, do sterile dressing changes, shower and keep the machine dry and how to properly care for the tube that goes through a patient’s skin from the VAD to the external power supply.”
Because patients are in the hospital for a longer period of time, the VAD unit has private rooms and a family room outfitted for patient and family’s use with exercise and video equipment, movies and even a garden, created by a former VAD patient’s wife.
“I had trouble walking after the implant procedure because I had been in bed for two months, so my legs were really weak,” says Armendarez. “I started walking down the hallway, but it was wonderful that I was able to use the treadmill on the unit. It enabled me to walk out of the hospital at discharge using only a walker – and now, I walk on my own.”
The VAD program and The Barry S. Levin, M.D. Department of Transplantation are associated with California Pacific’s Heart and Vascular Center, which offers quality, comprehensive, patient-centered cardiovascular care by a team of pioneering physicians integrating leading-edge technology.
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