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2. medicine
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Winter 2015
Miami Cardiac & Vascular Institute: New Name Reflects Integration
I
n May, Baptist Cardiac & Vascular
Institute announced a name change to
Miami Cardiac & Vascular Institute.
The transformation, however, goes much
deeper than a simple name revision. The
Institute is now extending its services,
expertise and innovation across Baptist
Health South Florida to bring benefits
in clinical care that will enhance the
Institute’s vision to become one of the
leading cardiac and vascular centers in
the country.
These newly integrated heart and
vascular services are available at Baptist
Hospital, Doctors Hospital, Homestead
Hospital, Mariners Hospital, South
Miami Hospital and West Kendall
Baptist Hospital, along with more than
15 outpatient centers spanning three
counties. Combining the unique talents and
technologies of each facility and allowing
for the sharing of clinical data make it
possible for cardiac and vascular patients
to experience consistent, exceptional,
evidence-based care no matter the location.
Barry T. Katzen, M.D., who founded
the Institute in 1987, remains at the helm
with the title of chief medical executive.
Carol Mascioli has assumed the title of
chief operating officer, and Bo Boulenger,
CEO of Baptist Hospital, will provide
oversight for the Institute as the executive
champion for Baptist Health.
“The integration involves the continued
development of multidisciplinary cooperation
and partnerships between physician leaders
and administrators that will be based on
quality and outcomes, service, efficiency
and cost,” Mr. Boulenger said.
Part of Baptist Health’s commitment
to the community and beyond is a $100
million expansion project that is underway
on the Baptist Hospital campus. It will
include the development of unique programs
for aneurysms, structural heart disease and
endovascular therapies, advanced procedure
suites and a larger gallery where physicians
can collaborate and teach the techniques
they have pioneered to others from across
the world. It will open in 2016.
DOTTER LECTURE
James Benenati, M.D., Delivers Dotter Lecture
For more than 50 years, Baptist Health
has provided excellent heart and vascular
care. The Institute has long been known as
a pioneer in multidisciplinary, less invasive
techniques. Not only has the Institute
participated in hundreds of clinical trials,
but its groundbreaking research has led to
new approaches in medicine. Its physicians
lecture around the world.
Although its name has changed, one
priority of the Institute has not faltered —
its desire to help patients from throughout
Florida and around the world. If you have
a patient who may qualify for one of our
research trials, we hope you will contact
Miami Cardiac & Vascular Institute at
786-596-5974.
For a full list of research trials, please
visit BaptistHealth.net/Research. n
James Benenati, M.D., medical director of both the Peripheral Vascular Laboratory at
Miami Cardiac & Vascular Institute (formerly Baptist Cardiac & Vascular Institute) and
Interventional Radiology for Baptist Health, received the honor of delivering the opening talk
at the Society of Interventional Radiology’s 39th Annual Scientific Meeting in San Diego. It is
the largest national meeting of interventional radiologists. The lecture is named after one of
the founding fathers of interventional radiology, Dr. Charles T. Dotter, who was nominated
for the Nobel Prize in Physiology for Medicine in 1978. “I am deeply humbled to be included
among past Dotter lecturers — interventional radiology pioneers who solved difficult medical
problems with creativity, innovation and research,” said Dr. Benenati, who is credited with
developing one of the country’s most coveted and sought-after fellowships and is best known
for his work to establish a nationally renowned, accredited peripheral vascular laboratory. “I
have known Jim since the early days of our founding and I am pleased that he is recognized for
his dedication, brilliance and ability to lead while encouraging collaboration among our teams
at the Institute,” said Barry T. Katzen, M.D., founder and chief medical executive. n
James Benenati, M.D.
This is the final issue under the name Baptist Cardiac & Vascular Institute. In the future, this publication
will reflect the Institute’s new name, Miami Cardiac & Vascular Institute.
If you prefer to receive this in an electronic format, please email AmyEr@BaptistHealth.net.
Assessing Potentially Safer, Faster and Easier AAA Repair
Patients with challenging infrarenal abdominal aortic
aneurysms (AAA) – and the physicians who treat them – may
soon benefit from a new treatment option. A clinical trial at
Miami Cardiac & Vascular Institute examined the long-term
safety and efficacy of completely sealing these risky aneurysms
with a biocompatible polymer.
Minimally invasive repair with the Nellix EndoVascular
Aneurysm Sealing System (Endologix, Inc.) was provided to
appropriate candidates with an infrarenal AAA larger than 5 cm.
Institute researchers plan to assess the safety of the Nellix
polymer strategy relative to more-traditional shunt repairs.
The Institute participated in this multicenter trial because this
intervention could prove beneficial for many aneurysm patients,
including those with more-challenging aortic presentations.
Shorter procedure time could be a benefit for both patients
and physicians. The Nellix permits easier endovascular
delivery and deployment compared to many existing devices
for aneurysm repair.
Once injected in the aneurysm sac, the biocompatible
polymer hardens in three to five minutes. Researchers hope
that complete sealing of the sac will preclude the need for any
secondary interventions.
Pending results of this and other trials set to evaluate Nellix
in up to 180 patients at 30 sites in the United States, Canada
and Europe, the study could be expanded to anyone with a
treatable size AAA.
The study duration is 24 months. Institute physicians plan to
evaluate participants twice in the first year post-intervention
and then annually for life. n
Researchers Evaluate the Potential of
Sutureless Aortic Valve Implantation
potential benefits compared to existing aortic valve replacement
technology. People who require aortic valve replacement are
typically complex, highly comorbid patients who can benefit
in particular from a shorter duration of cross-clamping and
cardiopulmonary bypass.
The Perceval S device is placed through a minimally invasive
procedure or implanted in combination with more-conventional
heart surgery. People experiencing symptomatic aortic valve
stenosis and small annuli and/or calcified annuli could benefit
from this valve procedure. Additionally, the Perceval could be
appropriate for some patients who require redo valve procedures.
Medium-to-high-risk patients over the age of 60 who require
aortic valve replacement were considered for the trial.
The Perceval S is a collapsible profile valve positioned and
secured without the need for sutures. Commissural, straight struts
hold the valve to the heart anatomy and sinusoidal struts attach the
valve to the sinus of Valsalva.
By making this new technology available for aortic valve
replacement, the Institute remains on the forefront of providing
innovative technology for our patients.
Institute researchers plan to
specifically assess the five-year
results for improved gradients
across the valves, a decreased heart
size over time and a lower rate of
overall complications, including
the incidence of perivalvular leak.
Ideally, investigators would like
to see fewer patients returning
because of complications, a reduced
need for pacemaker placement and
improved five-year survival. n
Sutureless Aortic Valve that anchors itself during the aortic
valve replacement surgery, shortening the surgery time for
the patient to spend supported by the heart and lung bypass
machine and improving performance of the operation through
smaller and better-tolerated incisions.
Miami Cardiac & Vascular Institute researchers are evaluating
new technology with the potential to permit faster and easier
replacement of an aortic heart valve.
The Institute was the only site in Florida that participated in
the prospective, multicenter trial to evaluate the Perceval S Sutureless
Heart Valve (Sorin Group USA, Inc.). Although the trial is now
closed, researchers plan to monitor participants for a minimum of
five years after implantation. Investigators will specifically evaluate
complication and survival rates versus historic controls, and will
compare outcomes against performance measures for other stented
bioprostheses reported in the literature.
Shorter cross-clamp duration, faster overall cardiopulmonary
bypass time and quicker recovery for patients are among the
a) Intra-luminal catheterization of the aneurysm in the
abdominal aorta.
b)Covered stent-grafts placed inside the aneurysm to preserve the
intraluminal flow. Proximal ending of the stent at the orifice of
the renal arteries and distal end in the common Iliac artery.
c) Endovascular aneurysm sealing with polymer to minimize risk
of leaking.
Taking a New Route to Aneurysm Repair
A
young woman with a large
intracranial aneurysm and bad
headaches came to Miami Cardiac
& Vascular Institute for consultation.
Having met the criteria for an innovative,
minimally invasive new trial of flow
diverter technology, she underwent the
procedure and fared well. Noteworthy,
yes; but her story also represents hope to
other high-risk patients – people with giant
irregular aneurysms and few options.
Large or giant brain aneurysms can be
deadly if left untreated. Although some
people remain symptom-free, others
experience debilitating symptoms when
the aneurysms grow so large that they
compress on nerves or other structures in
the brain. Large or giant aneurysms are
difficult to treat with traditional “open”
surgery due to the high mortality rate.
Smaller aneurysms elsewhere in the
body are commonly repaired through
conventional endovascular or surgical
approaches. However, internal carotid
artery aneurysms larger than 10 mm come
with bigger challenges.
Physicians at the Institute are now
enrolling patients in this new trial to
evaluate the Surpass Flow Diverter
(Stryker Neurovascular Corp.).
Enrollment criteria include having an
unruptured, complex internal carotid
artery aneurysm greater than 10 mm in
diameter. The Institute is the only site
in South Florida participating in the
multicenter Safety and Effectiveness of
an Intracranial Aneurysm Embolization
System for Treating Large or Giant Wide
Neck Aneurysms (SCENT) trial. Safety and
efficacy over 12 months are the primary
outcomes of the trial.
Although not the first flow diverter
device, the mesh component is different.
The Surpass system also is designed to
be easier to deliver and deploy at the
aneurysm site. It could soon become a new
endovascular option for physicians treating
these challenging patients.
Under X-ray guidance, physicians insert
a catheter in the groin and advance it to
the site of the aneurysm. A microcatheter
delivers the flow diverter. Once properly
positioned, the device is deployed.
Before
Immediately after
deployment
stagnation of flow
in the aneurysm
This device received FDA approval in 2013.
A flow diverter is essentially a special
stent with very tight mesh. The device
diverts blood flow from the aneurysm into
the normal vessel to cause the shrinking
and permanent sealing of the aneurysm.
Over time, full diversion of blood flow
results in rerouting and reconstruction of
the vessel.
Initially the flow diverter technology
was reserved for aneurysms considered
otherwise untreatable, such as giant
fusiform dissecting aneurysms. If the
initial promise of the SCENT and other
trials continues, flow diverters could
revolutionize how physicians repair a
wider scope of aneurysm types. Exploring
the full potential of this new-generation
device aligns with the Institute’s goal to
remain on the forefront and offer new
technology to patients.n
Setting the Pace on Leadless Technology
Potential problems for some patients with
traditional pacemakers include the risk of infection
and the need to retrieve and replace the leads
over time.
New technology offers a possible solution. Miami
Cardiac & Vascular Institute physicians are enrolling
candidates in a Phase I clinical trial to assess the
safety and efficacy of a leadless, single-chamber
ventricular pacemaker system.
Study participants will be among the first humans
worldwide to undergo implantation with the
Micra Transcatheter Pacing System (Medtronic).
The miniaturized pacemaker is about the size
of a vitamin, making it about 10 times smaller
than a traditional pacing system. Physicians
deliver the device directly into the heart using a
catheter inserted in a femoral vein. They attach the
pacemaker in the muscle wall using tines only a
few millimeters long. A tiny electrode then delivers
electrical pulses to pace the heart.
Because the Micra device does not require leads
that connect to the heart, researchers hope patients
will experience fewer complications. For example,
although risk of infection is low with current leadbased devices, when they do occur, infections can be
devastating for patients.
In addition to potentially safer pacing, patients
will likely be more comfortable and experience
fewer limitations on activities of daily living
immediately post-procedure and over the long term.
Appropriate candidates for the trial will need
ventricular pacing and must be capable of walking
one to three minutes on a treadmill during
evaluation. In addition, people must be able to
return for follow-up evaluation during the trial in
order to be considered for enrollment.
Physicians will use radiofrequency technology
to communicate with the implanted pacemaker.
This allows them to noninvasively calibrate and
communicate with the device. Morbidly obese
patients are not candidates for the trial because of
the small chance that physicians will be unable to
properly communicate with the device.
The Institute is the only site in South Florida
enrolling patients in this international trial.
Demonstrating the safety of the Micra system is the
main objective of the trial. It’s also a non-inferiority
study, meaning researchers at the Institute hope to
show that the device is as good as, if not better than,
commercially available pacemakers.
The retrievable device is designed to last at least
seven years. Retrieval, if any, will depend in part on
how patients fare over the duration of study followup. As engineering and technology progress, the
next generation of miniaturized technology may be
wireless, dual-chamber devices. n
Wireless advanced
pacing technology
with a miniaturized
devise that represents
the world’s smallest
pacemaker, delivered
directly into the
heart through a
catheter inserted in
the femoral vein. The
pacemaker is MRI
compatible.
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Miami, FL 33176-2197
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Leading the Way on Lipid Management
The Role of PCSK9 in the Regulation
of LDL Receptor Expression
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Miami, FL
remove them, disposing of them through
the bile. Typically the receptors regenerate
and remove the particles over and over.
However, PCKS9 doesn’t allow the receptor
to recirculate. As a result, elevated lipid
levels remain.
Institute physicians are on the forefront
of this research and conducting multiple
Phase 3 studies to further evaluate PCKS9
inhibition, including:
Statin Intolerant Trial.
Patients who cannot tolerate statins
because of side effects or a relevant family
history may be candidates for this research.
A sizable minority of people cannot tolerate
statin therapy (approximately 10 percent
to 15 percent of Caucasians, for example).
Participants will be evaluated for response
to PCKS9 treatment over 24 months.
13
13
Cholesterol travels inside lipoprotein particles. The main way excess cholesterol is
removed by the body is by these cholesterol containing particles to fit a receptor in
the liver and the entire particle and receptor is taken in by the liver. The cholesterol
is removed in the bile and the receptor is recycled to pick up another particle.
PCSK9 is a protein that prevents the receptor from recycling. Blocking PCSK9
increases the receptors and, thus, particle and cholesterol removal.
Clinical trials underway at Miami Cardiac
& Vascular Institute explore the promise
of a new strategy to treat people with lipid
abnormalities. This novel treatment takes
advantage of the body’s own mechanism
for removing LDL cholesterol from the
bloodstream.
For some people, favorable genes enable
them to live with naturally lower levels of
LDL cholesterol. For others who are not
as fortunate, an antibody therapy could
provide the same advantage.
By harnessing and enhancing the liver’s
own cholesterol-clearing action, inhibition
of PCKS9 (proprotein convertase subtilisin/
kexin type 9) could revolutionize how
physicians prevent cardiovascular events.
This approach may even help people with
lipid abnormalities who do not respond or
who respond only partially to traditional
cholesterol-lowering medication. In
fact, some initial PCKS9 inhibitor trials
demonstrated benefits for patients with
elevated cholesterol despite statin therapy.
Institute researchers are capitalizing
on recent discoveries about PCKS9. The
PCKS9 protein is an adverse player in the
liver’s natural mechanism for removing
LDL cholesterol and triglycerides from
the blood. Normally, lipoprotein particles
travel the bloodstream, where they pick
up and encapsulate LDL cholesterol
and triglycerides. When these particles
reach the liver, special receptors grab and
Baptist Cardiac & Vascular Institute LLC Management Company
Founder and Medical Director Barry T. Katzen, M.D., James F. Benenati, M.D.,
Lawrence Blacher, M.D., Abilio A. Coello, M.D., Nestor Demorizi, M.D.,
Rajesh Dhairyawan, M.D., Jonathan Fialkow, M.D., Julius Gasso, M.D.,
Alvaro A. Gomez, M.D., Efrain H. Gonzalez, M.D., Curtis A. Hamburg, M.D.,
Dean Heller, M.D., Howard E. Katzman, M.D., Karl H. Lembcke, M.D.,
Ramon L. Lloret, M.D., Madeleen Mas, M.D., Alvaro Mayorga-Cortes, M.D.,
Niberto L. Moreno, M.D., Constantino Peña, M.D., Edward Peron, M.D.,
Gerardo A. Polanco, M.D., Alex Powell, M.D., Orlando Puente, M.D., The FOURIER Outcomes Trial.
People with elevated LDL cholesterol
despite statin treatment (including partial
responders) and those with diabetes and/
or a history of myocardial infarction might
be suitable candidates for an outcomes
trial. This international, double-blind,
placebo-controlled study is called the
Further Cardiovascular Outcomes Research
with PCKS9 in Subjects with Elevated
Risk (FOURIER) trial. Researchers hope
to demonstrate that PCKS9 inhibition is
associated with a decrease in “hard events,”
including heart attack and stroke. They also
plan to track secondary outcomes, such
as the incidence of stent placements and
hospitalizations.
Consider referring your patients to the
Institute if they meet the criteria for these
PCKS9 Phase 3 trials. Thought leaders and
experts in multiple areas of cardiovascular
medicine collaborate in research and
clinical treatment at the Institute for the
benefit of patients. n
Ramon Quesada, M.D., Jonathan S. Roberts, M.D., Ignacio Rua, M.D.,
Shaun Samuels, M.D., Paul Seigel, M.D., Marcus St. John, M.D., Richard E. Tannenbaum, M.D., Athanassios Tsoukas, M.D., Billy K. Yeh, M.D.
Editors: Barry T. Katzen, M.D., and Ramon Lloret, M.D.
Managing Editor: Amy Erez
Writer: Damian McNamara
Editorial Contributors: Ripal Gandhi, M.D., Jonathan S. Roberts, M.D.,
Adrienne Sylver