CLINICAL INNOVATORS
therapy is all about getting a new valve in there.
Conversely, for the other valves such as mitral or
pulmonic, it is a more complex disease process,
both in the diagnosis and imaging, as well as the
treatment options. We are just on the forefront of
learning so much more about treating atrioventricular valve disease.
You were involved in piloting MitraClip therapy
for mitral regurgitation. What is unique about
this technique?
There have been a number of different transcatheter therapies for mitral regurgitation, and what
is unique so far about the MitraClip is its success.
We’ve learned that mitral regurgitation is complex,
and that of all the other therapies that have been
tried, the Mitraclip is the only therapy that has
been through randomized clinical trials here in
the U.S. and has been approved for use in a select
population of patients with degenerative mitral regurgitation. We certainly have come a long way in
our learning about who would optimally benefit,
and how to optimally use the MitraClip. At present time, for the majority of patients with mitral
regurgitation, we approach them as a multi-disciplinary team, looking at them with a number of
therapeutic options in mind, such as open surgical
repair, robotic surgical repair, mini-thoracotomy
approach, standard valve replacement, MitraClip,
and even percutaneous or transcatheter valve
replacement options. At the end of the day, this
allows us to tailor our approach to both the patient
and the patient’s valve.
One of the reasons why the MitraClip has had
success for treating certain patients with degenerative mitral regurgitation is that the operator can
grab the pathologic mitral tissue into the clip’s
arms, and even place multiple clips together to do
so. All this can be done in real-time on the beating heart, with 2- and 3-dimensional echocardiographic visualization, to sort out the effect of the
therapy on the mitral regurgitation. This is unique
compared with open surgical approaches, which
rely on cardioplegia and cardiopulmonary bypass,
in which case your ability to assess the efficacy of
the approach is limited.
You were the top award recipient of the
Cardiovascular Research Technology’s
Cardiovascular Innovations Award this year for
your work in developing the Trialign System to
perform transcatheter tricuspid repair. Could
you tell us a bit about this interventional
option?
The Trialign system was designed in partnership
with the company Mitralign. We had the idea to
modify their mitral valve repair system, so that it
would work for patients with tricuspid regurgitation. At present, tricuspid regurgitation is both
under-appreciated and under-treated, and there
are no approved interventional options for it.
The surgical options also have issues that make
it not ideal in all patients, and, in particular, not
38 CardioSource WorldNews
for high-risk patients. The Trialign system uses
radiofrequency energy to perforate the tricuspid
annulus and throw pledgeted sutures at set places
across the annulus, with the goal of placating the
annulus and turning a regurgitant tricuspid valve
into a competent bicuspid (tricuspid) valve. We did
the early animal work, and now we are conducting an early feasibility study here in the U.S. The
initial experience in compassionate use options
in Europe has been quite encouraging, and we are
learning a tremendous amount while helping some
high-risk patients.
I anticipate that
we will spend
the next decade
focusing on
improving our
therapies for heart
valve disease.
Last year you joined the TranScatheter Aortic
Valve Replacement System U.S. Feasibility Trial
(SALUS) as national co-principal investigator,
along with Dr. Isaac George. What are the aims
of this study, and where do things currently
stand?
The SALUS trial is evaluating the DirectFlow
Medical (DFM) transcatheter heart val ve in high
and extreme surgical risk patients with aortic stenosis, and comparing the outcomes in a randomized fashion with patients receiving a clinically
approved transcatheter valve. We obtain anatomic
data using CT scans on every patient prior to the
patient being randomized to receiving either the
DirectFlow valve or any of the commercially available valves, and at the end of the trial, not only
will we better understand the benefits of some
of the unique features of the DFM valve, we will
have randomized clinical trial data helping us to
better know the answer to “what valve for what
anatomy.”
It is an exciting trial and enrollment is underway, with over a third of the trial having been
enrolled already. We are also anticipating presentation of the 2-year data from the original SALUS
feasibility study, which focused on reduction in
aortic regurgitation, conduction system disease, and
other complications after TAVR.
You started a partnership between the
University of Virginia and Cedimat Hospital in
the Dominican Republic for care and education
on rheumatic heart disease. Could you tell
us about what inspired your work in Santa
Domingo and what projects you have underway
there?
When I decided to focus on helping patients with
heart valve disease, I initially focused on rheumatic mitral stenosis. I realized that a humanitarian collaboration in a developing country would
both maintain my experience with this procedure,
which is relatively uncommon in the U.S., as
well as find ways to contribute to impoverished
patients. I made a connection with a Dominican
colleague there, and this has led to three to four
missions per year, with both open surgical valve
missions, mitral balloon valvuloplasty missions,
and, more recently, TAVR missions. Underlying all
of this is the teaching of the local physicians so
that they will need our involvement less and less
in the future.
What are some of your clinical and research
goals for the coming years?
In addition to my current projects involving the
aortic valve (SALUS trial), mitral valve (MitraClip
in the COAPT trial) and tricuspid valve (TriAlign
device in the SCOUT trial), we also have just
begun what will be a series of clinical trials for
children and young adults with pulmonic valve
disease. The first trial is with an existing valve
from Edwards Lifesciences, the Sapien 3 valve, and
in the COMPASSION-S3 trial we are evaluating it
for transcatheter valve replacement in failing pulmonic conduits. We will then branch out to newer
options in patients with native right ventricular
outflow tracts.
I anticipate that we will spend the next decade
focusing on improving our therapies for heart valve
disease. ■
Katlyn Nemani, MD, is a physician
at New York University.
September 2016