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HeartMate II LVAD improves life of patients with heart failure

Susan Neikens, RN, holds the controls of her left ventricular assist device during her first appointment with her cardiologist, James Semertzides, MD, of Long Island Cardiology Associates, since the lifesaving device was implanted at Stony Brook (N.Y.) University Heart Center.

For thousands of heart failure patients, the HeartMate II left ventricular assist device offers an opportunity for improved quality of life.

“It’s an absolutely wonderful device,” said Susan Neikens, RN, who received a HeartMate II last year at Stony Brook (N.Y.) University Heart Center and has returned to practicing as a school nurse. “It has made major changes [in my life].”

Neikens, with an ejection fraction of about 10%, was chairbound, having difficulty walking from the chair to the bathroom before the implant.

“My cardiac output is close to normal, and I feel enormously better, almost as good as I did before I was first diagnosed 12 years ago,” Neikens said. “I am still gaining strength and stamina.”

More than 8,000 patients have received the device. Neikens is one of more than 4,000 people living on HeartMate II support, reports manufacturer Thoratec Corporation of Pleasanton, Calif. More than 1,300 patients have been supported for two years or longer, more than 170 for four years or longer, and many are surpassing six years of support. During clinical trials, Thoratec reported 91% of patients were transplanted, recovered or supported within six months.

Margaret Flannery, RN

Columbia University Medical Center in New York City has a patient who received the HeartMate II in 2005 and still is going strong, said Margaret Flannery, FNP-c, chief ventricular assist nurse practitioner at Columbia, which has implanted more than 900 ventricular assist devices, including but not limited to the HeartMate II.

“You are going to see a lot more of these patients in the community,” said Kimberly Ashley, MSN, FNP-BC, ventricular assist device program manager at Mount Sinai Medical Center in New York City. “This is the next best thing to transplant. They prolong and give quality of life.”

Kathleen Lopez-Newton, RN, MS, ANP, LVAD coordinator in the Cardiothoracic Surgery Department at Stony Brook University Medical Center, said the hope is the devices will last at least 10 years. At that time, the device may need changing or something new may become available. Other pumps are in clinical trials.

At the present time, the only U.S. Food and Drug Administration-approved LVAD is the HeartMate II. It is smaller, quieter and lasts longer than first-generation LVADs, said Pauline Edwards, RN, BSN, CCRN, CCTC, patient care coordinator on the cardiac ICU at Montefiore Medical Center in the Bronx, N.Y.

How it works

Tony Martin, RN

HeartMate II works with the patient’s heart. The pump’s electric rotary motor continuously sends blood into the aorta, boosting circulation.

“It takes over the pumping function of the left ventricle,” said Tony Martin, APRN-BC, ventricular assist device coordinator in the Heart Failure Treatment and Transplant Program at Newark (N.J.) Beth Israel Medical Center, which participated in HeartMate II clinical trials.

Patients may not have a palpable pulse or audible blood pressure, so clinicians use a Doppler blood pressure monitor. However, patients may experience some recovery of heart function after implantation and will produce a pulse, Edwards said.

The surgeon, during an open-heart procedure, implants the pump below the diaphragm and attaches it to the entrance to the left ventricle and the exit to the aorta. He or she sets the speed, typically, between 8,400 and 9,800 rpm, depending on the dimensions of the left ventricle and the opening and closing of the aortic valve, Lopez-Newton said. A flexible driveline passes through the skin and connects to an external controller and power supply, which patients cannot get wet.

Candidates for implantation

Kathleen Lopez-Newton, RN

Patients may be relatively young or older adults. Lopez-Newton’s youngest patient was 42 and the oldest 68. Mount Sinai’s patients range in age from 12 to 80. They may have long-standing heart failure or failure following a myocardial infarction.

Thoratec received FDA approval in 2010 for the use of HeartMate II in patients who have received optimal medical treatment and are not candidates for a heart transplant, and in 2008 obtained the right to market the device as a bridge to transplant.

The device is contraindicated for patients who cannot tolerate anticoagulation therapy, which is required to prevent clots from forming in the pump. In addition, Martin said, patients too frail for the surgery or too debilitated are not candidates, nor are some people without caregiver support.

Post-op care

Pauline Edwards, RN

Patients come out of the OR on a ventilator and drips and are weaned off. Nurses monitor for bleeding, arrhythmias and transient renal or liver failure, Flannery said, with bleeding being the biggest post-op concern. Infection is a long-term risk.

Patients often get up the first post-op day and teaching begins about the device, the thrice-weekly sterile driveline dressing changes and handling emergencies. After a few days, patients transfer to step-down.

“On the step-down or telemetry unit, nurses reinforce the teaching by making the patient go through the exercises they have been taught, such as changing the power and the family member changing the dressing,” Martin said.

Patients also require emotional support. “These patients undergo a major lifestyle change,” Edwards said. “We have to provide them with the tools to enjoy their quality of life, teaching them well, so they have the confidence to take care of themselves.”

Patients often return to work or sporting activities. When home, they plug the device’s power module into a wall outlet and recharge the batteries, which may last eight to 14 hours.

Community outreach

Facilities performing LVAD implantation often conduct community-education programs to ensure emergency medical service personnel understand the devices and associated prehospital care. Mount Sinai advises patients to contact their police and fire departments to inform them of their special needs.

“If the person is talking, obviously, they are alive, but if they are unconscious, that’s a problem,” Flannery said. “They have to assess to see if the pump is working and treat accordingly.”

EMS personnel can perform an ECG. Patients may receive defibrillation and cardioversion, if indicated. The first responders should call the implanting hospital to help troubleshoot whether the device is working properly. Lights and alarms on the device can indicate the status. The device has a hum, which a paramedic can hear with a stethoscope.

“We ask them to question before they start CPR and get in touch with us before doing compressions on these patients,” Lopez-Newton said.

Patients can travel with the HeartMate II but cannot go through electronic airport screenings. Stony Brook sends patients home with a letter to explain the device to Transportation Security Administration agents.

Newark Beth Israel coordinates patients’ travels with other centers, so they are prepared to assist if the device requires a replacement controller or battery charger.

“If it stops, you need to be within two hours flight time or an hour drive time to a place that can change the pump,” Martin said.

Lopez-Newton also notifies each patient’s electrical company they are on life support to ensure priority service in an outage. Patients also may evacuate to a fire department, which typically has a generator.

Neikens accompanies a Thoratec representative on calls to physicians to explain how it has changed her life.

“It’s such a meaningful device and makes so much difference in the quality of life,” Neikens said. “I am living, not sitting and waiting to die.”

By | 2020-04-15T09:53:26-04:00 May 28th, 2012|Categories: National|0 Comments

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