Phi Kappa Phi Forum

patients. This type of innovation has led to closer working relations between cardiologists and cardiac surgeons, emanating in the cardiovascular specialist, who works both in the catheterization laboratory and hybrid operating room.

Another way cardiac surgeons have been able to minimize patient trauma is through the development of robotic surgical devices. At first it sounds like a robot is doing the heart operation, but it is just emulating the surgeon’s hand motions. Miraculously, the device provides better ergonomics, when operating through tiny incisions, than could be produced by long, manual instruments and the surgeon’s hands. After being impressed by a prototype of the surgical robot in 1997, I began to think of the ways that we could repair mitral valves through tiny port-like incisions. In 1999, we were fortunate to obtain the first commercial daVinci™ robot in the U.S. Soon thereafter, our surgeons began to work in the laboratory to develop and perfect robotic repair operations. By 2000, we were prepared to begin the first FDA safety and efficacy clinical trial, which was premonitory to a multicenter trial that eventuated in approval to use the daVinci™ surgical robot for mitral valve repair surgery. In 2008, we reported excellent results of our first 300 operations. 8 Learning from clinical trials, we were able to devise new robotic instruments to go with the 3-D magnifying, high definition camera. An entirely new vista had evolved from lateral thinking between surgeons and engineers. This was truly a great collaboration between industry and cardiac surgeons. To date, I have performed more than 1,000 cardiac operations robotically with excellent clinical outcomes. Additionally, many large reference centers now perform robotic mitral valve and arrhythmia surgery routinely.

These two examples of evolving technol-
ogy typify how the cardiovascular specialist
has the opportunity to see a clinical problem,
develop a new innovative idea, design a de-
vice prototype, refine it, prove patient
safety and efficacy, and then
complete a clinical trial
before distribution as
a new standard
of care.
This really is a process of observation, imagi-
nation, innovation, engineering and application.
There are many other examples in cardiac
surgery that have followed this process —
all benefiting patients. These include small
cardiac assist devices and endovascular stent
grafts to treat aortic aneurysms. Moreover,
new imaging techniques are being applied
in cardiac surgery to design and serve as a
“blueprint guide” for aortic and mitral valve
repair surgery. Some investigators are even
able to make 3-D printed plastic models of a
diseased aortic or mitral valve in preparation
for an operation.
In the last twenty years, cardiac surgeons
have “rekindled the flames of innovation”
and, along with cardiologists, have merged
to become the new cardiovascular specialist.
This is the best way to deliver the optimal
care to patients and to achieve the best out-
comes — as each patient gets “tailor-made”
knowledge and therapy. No one knows how
that innovation will spawn new modalities of
heart care in the next twenty years. However,
my prediction is that all surgical operations
will be minimally invasive, cell therapy may
restore damaged heart muscle, gene therapy
will help treat coronary artery disease, heart
valves will be repaired or replaced using cath-
eters or robotic devices, 3-D image guidance
will plan and direct operations and there only
will be cardiovascular specialists — not the
traditional way of managing heart
disease — but the best for the
patient! For these hopes
to come to fruition in
a timely manner,
we must have
faster and
more efficient
government
regulatory
path-
ways.
It is
only through well-planned and well-execut-
ed clinical trials that we can determine the
comparative effectiveness of new cardiac
devices and procedures. Innovation is truly
the “initiator” but clinical trials have become
the “finisher.”

W. Randolph Chitwood Jr., M.D.
FACS, FRCS, recently retired from
the Brody School of Medicine at East
Carolina University, also home to his
Phi Kappa Phi chapter. In 2005, he
was awarded the National Phi Kappa
Phi Scholar Award. He is a graduate of
Hampden-Sydney College, the University
of Virginia Medical School, and the Duke University Surgical
Training Program. He is a former chairman of the Department
of Surgery at ECU and the founder of the East Carolina Heart
Institute. Moreover, he started the cardiac surgery program at
Vidant Medical Center, the ECU teaching hospital. Throughout
his 30-year academic career he focused on clinical care,
education, innovation and research, and during that time
published more than 300 scientific articles and book chapters.
As a very active cardiac surgeon and lead FDA investigator, he
pioneered minimally invasive and robotic heart valve surgery,
performing the first robotic complete heart valve repair in
the United States. He has received many honors from his
professional societies, as well as being awarded the Ellis Island
Medal of Honor, the Bakulev Medal from the Russian Academy
of Sciences, the National Mended Hearts National Harken
Award, and the O. Max Gardner Award from the University of
North Carolina Board of Governors. His current interests relate
to the development of innovative less-invasive heart valves
and robotic surgical devices, as well as teaching surgeons new
technology and the safe application in patient care. Email him
at Chitwoodw@ecu.edu.