George "Mac" McAllister had already endured two heart
attacks, quadruple-bypass surgery, myopathy, ischemia of the heart and a
congestive heart failure diagnosis by the time he arrived at the University of
Alabama at Birmingham Heart & Vascular clinic in October 2014. Actually,
McAllister, a Hayden, Alabama, native, had experienced all of those things,
including the congestive heart failure diagnosis, some five and a half years
So it wasn't a surprise when UAB physicians told McAllister he had finally
reached end-stage congestive heart failure and would need a transplant.
McAllister's health had declined so much in the months leading up to his
October visit, however, that he wasn't a candidate for transplant and would
have a difficult time becoming a candidate without marked improvement.
"In short," McAllister said, "my heart would not have held out long enough for
a transplant without some kind of assistance."
McAllister was admitted to UAB Hospital on Dec. 1 after a two-week outpatient
evaluation for a heart transplant, and on Dec. 17, he became the first person
outside Japan to receive the Evaheart Left Ventricular Assist Device, a
potentially more physiologic L-VAD device than others currently available to
help bridge patients to transplant.
McAllister's milestone surgery began the US Pivotal Trial,
which will include up to six VAD clinical sites along with UAB and enroll up to
UAB was chosen to participate in the Evaheart trial in part
because of its international prominence in the field. Salpy Pamboukian, M.D.,
associate professor of medicine and section chief of Advanced Heart Failure,
Transplantation and Pulmonary Vascular Disease in the School of Medicine, is
the principal investigator for the UAB site. The current phase of the study is
getting patients successfully to transplant, and Pamboukian says McAllister is
on his way.
"Mr. McAllister is a pioneer," Pamboukian said. "It takes a
lot of courage to be the first person to go through this kind of experience. He
was unwavering, and the best news is that he has done so well since the implant
that he is now a candidate for a heart transplant."
Heart-assist devices, or VADs, are implantable mechanical
pumps that support blood flow in patients with severe heart failure.
Implantable VADs can sustain the heart function of a patient for years and
essentially serve either as a bridge-to-cardiac transplantation or for
permanent use as a destination therapy.
The Evaheart continuous-flow mechanical support device is
similar to two others available in the United States the HVAD and the
HeartMate II. UAB surgeons implant approximately 40 of these devices per year
and have implanted more than 430 total VAD pumps since 1989. UAB ranks among
the leading hospitals in the United States for these therapies.
The Evaheart presents different challenges for surgeons than
the other L-VAD devices, however. One of those is that the Evaheart is larger,
says James Kirklin, M.D., professor and director of the Division of
Cardiothoracic Surgery, who, assisted by William Holman, M.D., professor of
surgery, implanted the Evaheart into McAllister.
Another challenge is that the surgery is more complex and
longer, in large part because the device requires surgeons to develop a pocket
in the muscles of the abdominal wall much larger than that required for other
"The downside of the device is that everything is a bit more
cumbersome," Kirklin said. "The driveline is bigger. The VAD is bigger.
However, the larger size accommodates a water-cooling system, which is unique
to the Evaheart pump. Part of this experiment with the device is to see if
having everything a bit larger and bulkier translates into fewer adverse
That has been the case in Japan, where the system is
manufactured and where it has been commercially available since 2010. The
Evaheart has shown to have the advantages of a higher pump-flow capacity,
augmentation of the native pulsatility of the heart and a lower risk of
gastrointestinal bleeding in the Japanese clinical experience.
"The output from this pump is one of the highest we have
seen," Kirklin said. "Mr. McAllister had a tremendous cardiac output after
surgery. And there is some evidence that, because of the increased pulsatility,
the fragility of small vessels in the brain and the GI tract may be more
favorably affected. That's what the Food and Drug Administration is trying to
determine with this trial."
"One of the things that we worry about with L-VADs is blood
clots' forming within the pump, something that is a known complication with
other pumps," Pamboukian added. "If we can minimize this type of long-term
complication, it could be viewed as a destination therapy for those who for
whatever reason could not receive a transplant."
Although McAllister is the first person outside Japan to
receive the Evaheart, more than 130 Japanese patients have been implanted with
the device. Sixty-seven of those patients are still on the device, and 19
patients have been transplanted. The total accumulated support time for these
patients thus far is 203 years, with an average support time of 693 days, or
1.89 years, according to Evaheart, Inc., the company who will distribute the
device upon market clearance.
Under the U.S. Investigational Device Exemption Clinical
Trial, Evaheart is appropriate for bridge-to-transplant patients. Until
clinical trial data becomes available, it is considered too early to discern
additional characteristics of the "ideal" Evaheart patient. Evaheart, Inc.,
believes the study will demonstrate that the pump is ideal for candidates who
have a larger body size, prior history of GI bleeding or mild end-organ
Both Pamboukian and Kirklin were impressed that McAllister
researched the Evaheart and asked to be part of the trial.
"My wife, Pat, and I prayed about it, and we decided we
wanted to do this," McAllister said. "For our own purposes we wanted to,
perhaps, have a better unit installed and the Japanese trial turned out
really well, which gave us hope this pump was better."
"And maybe the overriding factor with me and my final
decision was that, if this device can work and we can get it FDA-approved, then
hopefully down the road many will benefit from it". I really wanted to be a part
of making that happen. It's not that I'm a brave person or that there is really
anything special about me, but that really weighed heavily in my decision. "I
just thought if we could get the ball rolling here in the United States, maybe
we could get on down the road toward getting this approved and hopefully moving
into a brave new future with the L-VAD and folks benefiting from the devices
even more than they do now."
Enrollment in the trial will continue through 2015, as will
ongoing consultation with the FDA. Evaheart, Inc., plans to expand the trial to
40 sites and 140 patients upon completion of the pivotal safety group.