ABSORB III Trial - Baptist Health South Florida

Winter 2014
ABSORB III Trial: A Long-Term Test of Vascular Scaffold System
N
ow you see it, later you won’t.
Physicians at the Institute
plan to compare a new drugeluting vascular scaffold that completely
resorbs over time versus current stent
technology for long-term maintenance
of vessel patency.
Positive five year results from this ABSORB III Randomized Controlled
With the ABSORB III, the scaffolding is
expected to resorb after healing —
within two years.
Trial could signal a new era in coronary interventions, investigators say. Currently, the Institute is the only site in
South Florida participating in this trial.
Unlike a more permanent stent,
researchers expect the scaffolding to
resorb after healing — within two years.
They predict this will eliminate the need
for long-term dual antiplatelet therapy
as the vessel remodels to a normal physiologic state. Vasoactive substances
from the endothelium might even
promote lumen growth, something not
possible with a stent.
In terms of safety, researchers are
hoping for a decreased incidence of
thrombosis compared to the stent, thus
supporting promising results reported in
earlier ABSORB trials.
Patients with coronary artery disease
(with vessel diameters up to 3.5 mm and
up to 2 lesions) will be randomized to
the ABSORBTM Bioresorbable Vascular
Scaffold System (BVS) or the Xience
Xpedition Everolimus Eluting Coronary
Stent System and followed over five
years in this Phase IV study.
The ABSORB scaffold system is the
first to undergo clinical trial evaluation
in the United States and Institute physicians are playing an integral role in orchestrating these pivotal trials.
Unlike the metal alloy stent covered
in biocompatible material, the scaffold
is bioresorbable poly-L-lactide, a material already used by plastic surgeons,
aesthetic dermatologists and other physicians for volume replacement.
Another difference is in the deployment
— the scaffold material can break more
easily than a metal stent so placement
requires a little more finesse.
For more information, please contact Ramon Quesada, M.D., Rajesh
Dhairyawan, M.D., Alvaro A. Gomez,
M.D., Bernardo Lopez-Sanabria, M.D.,
Ramon L. Lloret, M.D., Jonathan S.
Roberts, M.D. or Marcus St. John, M.D.
at 786-596-5992. n
On the Forefront of Innovation
A first-of-its-kind intervention holds significant promise
for critical limb ischemia patients who require endoscopic
vein harvesting. Baptist Cardiac & Vascular Institute vascular
surgeon Athanassios I. Tsoukas, M.D., utilizes a technique
allowing less invasive harvesting in a very sick patient under
conscious sedation instead of riskier general anesthesia.
The solution ended up being a solution — a tumescent
combination of the vasodilator papaverine and local anesthetics xylocaine and marcaine. Dr. Tsoukas and his team slowly
injected the solution around the vein under ultrasound guidance and successfully performed a femoral-popliteal bypass in
this challenging patient.
The patient fared well, despite a presentation that included
heart disease, a cardiac ejection fraction of 20% and history
of lymphoma.
The technique also holds promise for other critical limb
ischemia patients, especially when radiologists see anatomy
unfavorable for a minimally invasive endovascular treatment. Less morbidity, quicker recovery time and less scarring
compared to traditional vein bypass procedures are potential
advantages. The shorter length of hospital stay afforded by
the tumescent solution/minimally invasive technique could
yield significant cost savings, as well. n
If you prefer to receive this in an electronic format, please email [email protected].
CLINICAL TRIALS
The Institute is currently involved
in nearly 30 clinical trials. For more
information on a specific study, please contact the Institute’s Research and Outcomes Department at 786-596-2959.
New Trials and Devices Target More Patients With Resistive Hypertension
As widely reported, the Symplicity
HTN 3 trial failed to meet its primary efficacy endpoint and is being discontinued in the United States. Baptist Cardiac
& Vascular Institute remains committed to expanding the types of technology and clinical trials designed to help patients with resistive hypertension.
The Symplicity HTN 3 trial did achieve its safety endpoint. In addition,
approximately eight to 10 other clinical
trials evaluating the Symplicity device
yielded positive results. As many as 10
devices to treat resistive hypertension are
being utilized successfully in Europe.
Resistive hypertension remains a formidable clinical challenge. By definition, resistive hypertension patients
are on three antihypertensive medications
at optimal dose, yet remain uncontrolled,
with a systolic blood pressure of 160
mmHg or greater.
The Institute remains at the forefront
by working on the next generation of
technology to treat resistive hypertension. In the near future, the Institute plans
to enroll patients using a second-
generation device. This device is already in use in Europe and shows promise in effectively treating resistive hypertension.
Members of the Institute play essential roles in these clinical trials, including remaining active in their design and development through participation on key steering committees.
For additional information, please contact Barry T. Katzen, M.D., Alex Powell, M.D., James F. Benenati, M.D.,
Shaun Samuels, M.D., Constantino
S. Peña, M.D., Ripal T. Gandhi, M.D.,
Antony A. Farias, M.D. or Ian Del Conde M.D. at 786-596-5992. n
Structural Heart Disease Device Studies Become More Selective
I
nnovative clinical trials underway at
Baptist Cardiac & Vascular Institute
show the promise of new medical
device technologies for select patients
with mitral valve insufficiency or atrial
fibrillation.
Careful patient selection might optimize outcomes for these structural heart
disease patients considered high-risk
or not suitable for traditional surgery.
This is one reason researchers at the
Institute are participating in the Clinical
Outcomes Assessment of the MitraClip
Percutaneous Therapy (COAPT). The
COAPT randomized trial compares
MitraClip to medical therapy in patients
with functional mitral regurgitation.
Driven to improve the outcomes of
the Endovascular Valve Edge-to-Edge
Repair Study (EVEREST) that evaluated
the MitraClip Mitral Valve Repair System (Abbott Vascular, Inc.), following
the EVEREST trial, researchers found
high-risk surgical patients had a better
outcome with MitraClip than with surgery, including lower expected mortality.
Also, the investigators plan to assess
efficacy of the MitraClip in patients
with dilated left ventricles and severe
3+ or 4+ mitral valve insufficiencies in
REALISM. REALISM is a registry of
patients with severe mitral regurgitation
considered high-risk for surgery.
FDA approval of the MitraClip system on October 25, 2013, means
many more patients can potentially benefit from this innovative treatment. Dr. Quesada, the first physician
to perform the MitraClip procedure in
Florida, continues his drive to optimize
outcomes through ongoing enrollment
in both trials.
Alternatives for AFib
This device received FDA approval in 2013.
Institute physicians also are helping
patients with atrial fibrillation in ways
supported by the latest study findings.
Compared to long-term warfarin therapy
alone, use of the Watchman Left Atrial
Appendage Closure device (Boston
Scientific) was associated with a 40%
reduction in a composite endpoint of
cardiac-related death, stroke and systemic embolism in 4-year PROTECTion in Patients with Atrial
Fibrillation (PROTECT AF) Trial results.
Findings were presented at both the Society of Cardiovascular Angiography
and Interventions and Heart Rhythm
Society 2013 annual meetings.
Although potentially good news for
most atrial fibrillation patients, a select
group cannot tolerate the antithrombic
regimen required after placement of the
Watchman device.
Innovation to the Rescue
For these patients, Institute investigators are taking the lead and closing
the left atrial appendage using some
innovative technology. The technique
involves two wires with magnetic tips.
They place one wire in an endovascular approach inside the heart, another
outside, and join them together to advance the Lariat Suture Delivery Device
(SentreHeart, Inc.). They then can snare,
ligate and close the left atrial appendage
in these high-risk patients. The Lariat
is FDA approved for soft tissue removal but this off-label technique offers
promise to patients with otherwise few
therapeutic options.
For additional information, please
contact Ramon Quesada, M.D. at 786-596-5992. n
Critical Advances for Critical Limb Ischemia
A
n integrated team of medical experts, the latest technological advances and a critical sense of timing together provide the greatest promise to patients with critical limb ischemia.
One simple goal drives the multidisciplinary collaboration at Baptist Cardiac & Vascular Institute: to intervene early, aggressively and
in the most minimally invasive way to avoid an otherwise inevitable limb amputation from critical limb ischemia.
The interventional radiologists, vascular surgeons and other experts
at the Institute work as a cohesive team. They evaluate, treat and monitor
each patient and devise an individualized plan to deliver maximum benefit
from the most appropriate treatment.
The Institute aims to increase awareness about critical limb ischemia
and the need for speedy diagnosis and timely referral among community
healthcare providers. One message is to always consider critical limb
ischemia in the differential diagnosis of leg pain. From simple noninvasive
screening to sophisticated imaging that guides a wide range of advanced
interventional technologies, patients with compromised circulation benefit
when they come to the Institute.
The earlier the intervention, the better the outcome for most patients.
For example, leg ulcers caused by critical limb ischemia can become more
and more difficult to treat. Patients may even pass a “point of no return”
where the severity of tissue damage precludes complete healing, even
following restoration of blood flow.
From initial integrated team assessment to discharge planning, organizing
all these state-of-the-art intervention options for patients with critical limb
ischemia in one program has led to better patient outcomes. For additional
information, please contact Barry T. Katzen, M.D., James F. Benenati, M.D.,
Abilio A. Coello, M.D., Ripal T. Gandhi, M.D., Howard E. Katzman, M.D.,
Constantino S. Peña, M.D., Alex Powell, M.D., Ignacio Rua, M.D.,
Shaun Samuels, M.D., Athanassios Tsoukas, M.D. or Libby Watch, M.D.
at 786-596-5992. n
Initial angiogram demonstrates occluded
anterior and posterior tibial arteries in a
patient with critical limb ischemia manifested as a nonhealing ulcer of the foot.
Before
After
Following recanalization and angioplasty,
postintervention angiogram demonstrates
patent anterior tibial, posterior tibial and
peroneal arteries to the foot.
Dr. Barry T. Katzen Receives Society
of Interventional Radiology 2013
Leaders in Innovation Award Barry T. Katzen, M.D.,
the Institute’s founder and
medical director, received the
2013 Leaders in Innovation
Award from the Society of
Interventional Radiology.
The Society bestows this
award to clinical innovators
Dr. Katzen
such as Dr. Katzen who have
significantly improved the quality of patient
care or economics of interventional practice.
The award recognizes those who develop and
implement new devices, techniques or physician
practice models that truly advance the field of
interventional radiology.
Dr. Abilio A. Coello Appointed to
Society Leadership Role
Baptist Cardiac &
Vascular Institute vascular
surgeon Abilio A. Coello,
M.D., is now serving as
2013-2014 president of the
Florida Vascular Society. Dr. Coello is an integral part
of the multidisciplinary team
Dr. Coello
at the Institute with special
expertise in surgical repair of lower extremity venous ulcers and endovascular repair of
abdominal aortic aneurysms. Dr. Coello also is a past president of the South Florida Chapter of the American College of Surgeons
and was also governor for the American College of Surgeons representing Florida. n
Targeting Acute Ischemic Stroke Clot Removal
Management of acute ischemic stroke
can be challenging. With only one FDAapproved medical therapy — IV tissue
plasminogen activator or tPA — and up to
90% severe disability or mortality possible
with large cerebral vessel occlusion, the
search continues for the ideal strategy to
help these patients.
Institute physicians are leading this
quest in South Florida. They are set to
launch three new clinical trials that compare the latest clot-grabbing and stent
retrieval devices in conjunction with IV tPA
versus tPA alone to find the optimal acute
ischemic stroke intervention.
For example, the Randomized, Concurrent Controlled Trial to Assess the
Safety and Effectiveness of the Separator 3D as a Component of the Penumbra
System in the Revascularization of Large
Vessel Occlusion in Acute Ischemic Stroke
(Separator 3D Trial) will test if this nextgeneration clot engagement device in
combination with the Penumbra aspiration thrombectomy system (both made by
Penumbra, Inc.) yields better outcomes for
patients with large vessel occlusion versus
Penumbra clot aspiration alone.
Also coming soon is the THERAPY
Trial. Acute ischemic stroke patients with
large clot burdens will be randomized in
this study to intervention with the Separator 3D clot engagement device — a
component of the Penumbra system
Penumbra Separator 3D device and aspiration thrombectomy versus IV tPA alone.
Patient enrollment in these innovative
studies at the Institute is underway. No
matter which intervention is appropriate, data suggest better outcomes when
patients seek care at a high-volume stroke center with highly trained clinicians
available 24/7.
For additional information, please
contact Italo Linfante, M.D. or Guiherme
Dabus, M.D. at 786-596-5992. n
Baptist Health South Florida
8900 North Kendall Drive
Miami, FL 33176-2197
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Expanding Walls and Possibilities
A
n ambitious $90 million expansion to Baptist Cardiac
& Vascular Institute and Baptist Hospital’s Surgery
Center will go beyond a brick-and-mortar expansion
and renovation. After completion of construction and the
opening of the new facility, patients across South Florida, the
region and the world will benefit from seamless care and the
latest technological innovations.
The expansion also builds on the Institute’s mission to
foster the best multidisciplinary team approach to patient
care. This close collaboration is not only expected to optimize individual patient outcomes, but also to change in a
fundamental way how different physicians work together in
a setting without the traditional specialty barriers.
A National Center for Aneurysm Therapy, a Center
for Structural Heart Therapy and a Center for Advanced
Endovascular Therapies are among the planned highlights,
each designed to provide the best minimally invasive procedures for maximum patient benefit. An integrated team at
the Center for Advanced Endovascular Therapy will employ
advanced imaging to create unique, cutting-edge clinical interventions.
The expansion will feature four new endovascular procedure suites that offer this latest technology, in addition to an
expansive renovation. For patients, this means many different levels of intervention become possible in the same suite —
from the least invasive therapy to complex surgery to a
combination of clinical strategies, as warranted. The new
expansion construction and renovation is scheduled for
completion in 2016. n
Construction to expand Baptist Cardiac & Vascular Institute and Baptist Hospital’s Surgery Center broke ground in 2013 and will be
completed in 2016.
Baptist Cardiac & Vascular Institute Leadership Physicians
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., 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
Designer: Wendy Kornfield