Clínica Universidad de Navarra Implants Spain’s First SynCardia Total Artificial Heart

Suffering from severe dilated cardiomyopathy, the 47-year-old patient
had been on the transplant waiting list for more than a year due to
difficulty finding a suitable donor heart.

TUCSON, Ariz.–(BUSINESS WIRE)–#TotalArtificialHeart–A medical team from Clínica
Universidad de Navarra
in Pamplona has successfully
performed Spain’s first implant of the SynCardia
temporary Total Artificial Heart
.


Óscar, the 47-year-old patient, was suffering from severe dilated
cardiomyopathy with biventricular heart failure. He had been on the
transplant waiting list for more than a year due to difficulty finding a
donor heart.

“It was this or it was over,” Óscar said in Spanish. “My situation
before the operation was pretty bad because I could hardly take a
shower, tie my shoes and do many things. I could not even sleep. I would
lie down on the bed and feel like I was drowning because my heart had no
strength.”

VIDEO:
Oscar, el primer caso de éxito con un corazón artificial total

According to Óscar, he could only fall asleep standing at the window of
his bedroom, leaning on a pillow. He had slept this way for more than
two weeks prior to receiving the Total Artificial Heart. Now, he is able
to sleep lying down again.

“The progressive worsening of the patient’s health left us no choice but
to seek an urgent alternative,” said Dr.
Gregorio Rábago
, director of cardiac surgery at Clínica
Universidad de Navarra. “That is why we decided to implant the SynCardia
Total Artificial Heart — so that we could stop his deterioration and
recover his health until a matching donor heart is found.”

Óscar had been listed for transplant since August 2015, but finding a
donor heart proved difficult because of his rare blood type and his
large size, which would require the donor to weigh at least 220 pounds
(100 kg).

“They could not put a 600[cc] engine in a Ferrari,” Óscar said.

As his condition deteriorated, the frequency of his hospital admissions
increased. In 2016, Óscar was hospitalized eight times. During his most
recent stay in the clinic — which lasted for more than a month — he
responded poorly to medical treatment.

“The month before the implant, the severity of the patient’s condition
had reached the point of him having to stay permanently connected to a
continuous infusion pump and being unable to go home,” said Dr. Rábago.
“In view of this situation, on September 21 we performed surgery to
implant the SynCardia Total Artificial Heart.”

The operation involved a multidisciplinary team led by Dr. Rábago and Dr.
Juan José Gavira
of Clínica Universidad de Navarra, and Dr. Jesus
Berjón
from Hospitalario de Navarra, which referred the
patient.

Similar to a heart transplant, the SynCardia Total Artificial Heart
replaces both failing heart ventricles and the four heart valves,
eliminating the symptoms and source of end-stage, biventricular heart
failure. Unlike a donor heart, the Total Artificial Heart is readily
available at SynCardia
Certified Centers
, allowing patients to receive a new heart without
the wait.

Two months after receiving his Total Artificial Heart, Óscar was able to
stop dialysis because his kidneys had recovered. In addition to walking
around the clinic, he exercises on the bike and the treadmill in the gym
regularly — something he could not imagine doing just three months ago.

In November, Óscar was switched to the Freedom®
portable driver
, a wearable power supply for the Total Artificial
Heart that allows stable patients to return home while they wait for a
donor heart. Worldwide, more than 300 patients have been supported by
the Freedom driver, accounting for more than 76,000 patient days of
support.

Dr. Rábago says they hope to discharge Óscar from the hospital soon.
When he does go home, Óscar says he is looking forward to having dinner
with his friends and seeing his dogs, who have not seen him for four
months.

“If there’s anyone in my situation,” he added, “let them cheer up.”

About SynCardia Systems, LLC

SynCardia Systems, LLC (www.syncardia.com)
in Tucson, Ariz., is the privately held manufacturer of the world’s
first and only FDA, Health Canada and CE approved Total Artificial
Heart. For people suffering from end-stage heart failure affecting both
sides of the heart (biventricular failure), the SynCardia temporary
Total Artificial Heart is used as a bridge to transplant, helping them
survive until a matching donor heart becomes available. SynCardia also
manufactures the Freedom® portable driver, which powers the SynCardia
Total Artificial Heart and allows clinically stable patients to be
discharged from the hospital to enjoy life at home while they wait for a
heart transplant.

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Contacts

SynCardia Systems, LLC
Janelle Drumwright, 520-547-7463
jdrumwright@syncardia.com