Jihad Mustapha, MD

Transcription

Jihad Mustapha, MD
NCVH Continues to Focus on
Patient Care, Global Reach
Thursday
Highlights
A
7:00 – 7:50 a.m.
Breakfast Symposium
Crescent City Ballroom,
Mezzanine Level
8:00 a.m. – 6:00 p.m.
General Session
Crescent City Ballroom,
Mezzanine Level
9:00 a.m. – 4:00 p.m.
Exhibit Hall Open
Roosevelt Ballroom,
Mezzanine Level
10:00 a.m. – 5:00 p.m.
The Business of Wound Care
Chambers I & III,
Mayor’s Suite Level
10:00 a.m. – 7:00 p.m.
Multidisciplinary Nursing
for Limb Preservation
Orpheum Ballroom,
Second Level
12:10 – 12:50 p.m.
Lunch Symposia
1:30 – 6:00 p.m.
Coronary Artery
Disease: Update for
Primary Care Physicians
Chambers II & IV,
Mayor’s Suite Level
Attendees focus on the live case presentation led by Dr. Frank Bunch on
Wednesday morning, as the panel discusses the case with Dr. Bunch.
Today’s Live Case Schedule
8:40 – 9:00 a.m.
Thomas Zeller, MD
UniversitätsHerzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
9:00 – 9:20 a.m.
Jihad Mustapha, MD
Metro Health Hospital
Wyoming, MI
10:40 – 11:00 a.m.
Thomas Zeller, MD
UniversitätsHerzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
10:50 – 11:10 a.m.
Jihad Mustapha, MD
Metro Health Hospital
Wyoming, MI
Inside This Issue
Clinical Data................. 3
Podiatry/Wound Care... 4
AAA Outreach............11
MLMC 5k....................12
12:20 – 12:40 p.m.
D. Christopher Metzger, MD
Wellmont CVA
Heart Institute
Kingsport, TN
(Chambers I and III)
12:20 – 12:40 p.m.
Jihad Mustapha, MD
Metro Health Hospital
Wyoming, MI
(Orpheum Ballroom)
1:250 – 2:10 p.m.
D. Christopher Metzger, MD
Wellmont CVA
Heart Institute
Kingsport, TN
s NCVH grows in
scope, the mission
remains the same: to
bring different specialties together and establish peripheral artery disease (PAD) as
a marker of high risk for cardiovascular death and disability.
“This was an idea born
out of simply helping patients, and originally educating locals, and now it
has spread over the world,”
said NCVH Course Chairman Craig Walker, M.D.,
as he welcomed attendees
on Wednesday morning.
“We’re not just this meeting. With regional meetings, three in China and one
in Latin America, we have
formed a family. It’s beyond
what we ever dreamed.”
And attendees are taking
what they learn back to their
patients. Dr. Walker said
they receive letters from past
attendees reporting that attending NCVH has resulted
in better patient care at their
facilities.
PAD patients who were
once out of options are now
receiving treatment.
“There’s been an explosion in the number of endovascular procedures being
performed,” said Dr. Walker.
“There have been profound
advancements in technologies and treatment options
for helping treating PAD.
These breakthroughs allow
for safer and more effective
treatment. We can now treat
patients who previously had
no options.”
Improving care for PAD
patients continues to be the
conference’s mission.
“PAD is more than just leg
pain, it’s a matter of life and
death.”
2:10 –2:30 p.m.
Jihad Mustapha, MD
Metro Health Hospital
Wyoming, MI
4:40 – 5:10 p.m.
D. Christopher Metzger, MD
Holston Valley
Medical Center
Kingsport, TN
Live case presentations
occur in the Cresecent City
Ballroom unless noted.
REDEFINING
INNOVATION
Dr. David Slovut, far left, moderates the live case panel discussion during the
Multidisciplinary Nursing session on Wednesday morning.
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New Cardiovascular Horizons 2015
Thursday, May 28, 2015
Attendees Hear Latest Data from EXCITE ISR Trial, VISION Study
and JETSTREAM-ISR Feasibility Study
C
linical data drives innovation.
NCVH was the site of three
clinical data presentations –
driving home the conference’s positon to remain on the cutting-edge in
the industry.
EXCITE ISR Trial
Twelve-month data from the EXCITE ISR clinical trial were presented
by NCVH Chairman Craig Walker,
M.D., who was one of the trial’s principle investigators.
Results of the landmark study
show that Spectranetics’ laser atherectomy devices used with PTA (also
known as balloon angioplasty), are
safer and more effective than PTA
alone for treating femoropopliteal
(FemPop) in-stent restenosis (ISR),
demonstrating continued durability
in 12-month results.
“Instent restenosis (ISR) is a plague
– it’s a plague that’s really hitting us
hard,” said Dr. Walker, adding that
with stent volume estimated to grow
6-7 percent annually, ISR occurrence
is rising.
“ISR has been very hard to treat,”
said Dr. Walker. “Anytime we spoke
on this, we were speaking out of line
because nothing was approved.”
Factors that he said need to be considered before attempting fempop,
instent restenosis intervention:
• Length of lesion
• Type of stent (covered vs bare
metal)
• Stenosis versus occlusion
• Stent fractures
• Location of lesion (in-stent or
edge stenosis)
• Runoff vessel status
• Location in the artery
The EXCITE ISR trial was a randomized control study that looked
at safety and efficacy of exicmer laser
atherectomy, and was concluded prematurely because it reached its primary endpoints.
“Why is this significant? We’ve
seen a lot of trials performed outside
the U.S.,” said Dr. Walker. “When we
do the trials here, we often don’t see
the same results.”
He explained that in the study,
there were no lesion length limits,
multiple stents were allowed, stent
fractures were common (grades 1-3),
and popliteal stents were included.
“Procedural success was higher in
laser plus angioplasty group – which
is highly statistically significant,”
said Dr. Walker.
Critical data findings include:
• Treatment using Turbo-Tandem
resulted in significantly less residual
stenosis and need for bailout stenting.
• 92.9% procedural success rate
using Turbo-Tandem with PTA vs.
81.7% with PTA alone (p<0.01).
• Primary safety endpoint, major
adverse events (MAEs) rates at 30
days 5.4% vs. 20.8% with PTA alone
(p<0.001).
• Primary efficacy endpoint, freedom from target lesion revascularization (TLR) through 6-months 78.3%
vs. 58.9% with PTA alone (p=0.002)
• Excimer laser atherectomy with
adjunctive PTA was associated with
a 43% reduction in TLR through
12-months. (Hazard Ratio 0.57; 95%
CI 0.38-0.84; p=0.005).
“Looking at the safety and efficacy
endpoints, this proved to be safer
with less events and more effective
than balloon angioplasty,” said Dr
Walker.
“I think this is a very promising
therapy – and we’re just beginning to
pry open this enigma that is ISR.”
VISION Clinical Study
Patrick Muck, M.D., presented 30day interim results for the Avinger
VISION clinical study. VISION is
designed to evaluate the safety and
efficacy of the Pantheris™ system
to perform directional atherectomy,
while for the first time ever allowing
physicians to use real-time intravascular imaging to aid in the removal of
plaque from diseased lower extremity arteries.
VISION interim results demonstrated that following Pantheris treatment residual stenosis of less than or
equal to 50% was achieved in 96% of
lesions, surpassing the primary efficacy endpoint performance goal.
Both blood flow measurement (Ankle
Brachial Index) and symptom-based
(Rutherford Classification) outcomes
measures showed statistically significant improvement across all patients
undergoing 30-day follow-up. Safety
data at the time of procedure and
through 30 days also indicated an
extremely favorable acute safety profile, with zero dissections and zero
perforations related to the use of the
Pantheris catheter as adjudicated by
an independent Clinical Events Committee (CEC). The study’s primary
safety endpoint is defined as freedom
from a composite of major adverse
events (MAEs) through six-month
follow-up. While not representative
of six-month results, 7% of patients
in the VISION trial had experienced
an MAE through 30 days.
“With this device, you can see
what you want to cut,” Dr Muck
said. “Often times with angiography,
you’re not certain if it’s a flap or a dissection.”
He reviewed the major inclusion
and exclusion criteria of the study,
which enrolled 128 patients, for a total of 164 lesions. Two patients were
lost to follow-up.
Looking at the co-morbidites and
demographics, he said “these are real
world patients.”
Continued on page 11
Dr. Nicolas Shammas presents data from the JETSTREAM-ISR Feasibility Study.
NCVH
New Cardiovascular Horizons
UPCOMING EVENTS
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REDDING
NCVH at GW-ICC
BEIJING, CHINA
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OCT - NOV
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NEW ORLEANS
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• 3
4 • Thursday, May 28, 2015
What do you hope to take
away from NCVH’s comprehensive wound care/podiatry
program?
Brian Cain, DPM
Marrero, La.
“I’m here to learn about new
innovations. I work at LSU, and
on the West Bank, we have a high
rate of amputations. We actually
beat the national average. Financially, the health care system
can’t sustain such a high number of amputations. This conference is a great value. NCVH has
nationally known speakers and
multi-faceted information, and I
come every year.”
Jo-Anna McGrath, CNS
Chicago, Ill.
“I’m an advanced practice
nurse, and we see a lot of patients with wound care issues.
My education didn’t cover the
care of long-term wounds, which
is why this session is valuable. I
enjoy the breakouts of various
aspects of care here at NCVH.”
Justin Green, DPM
New Iberia, La.
“I try to keep up on emerging
technology and treatments. I believe in a team approach, so this
conference is ideal because it is
so well rounded and covers all
disciplines. Wound care is a big
deal, which is why I attend this
session. Here in Southern Louisiana, diabetes is prevalent, but
I’m shocked by how many patients don’t fit the stereotype.”
New Cardiovascular Horizons
América Latina
Monterrey, México | 6 a 9 de Abril 2016
New Cardiovascular Horizons 2015
Podiatry/Wound Care Track Highlights Diagnostic Technologies
T
he Podiatry/Wound Care
two-day session opened on
Wednesday morning with a focus on the diagnosis and treatment of
vascular disease. Different diagnostic techniques, both established and
emerging, were featured in the session, which was moderated by Frank
Tursi, DPM.
Dr. Tursi opened the session with
personal stories that he said hoped
would “highlight the enormity of
what peripheral artery disease (PAD)
means to me.” After the loss of a patient who had no symptoms or history prior to consulting with Dr. Tursi,
he said he became more passionate
about treating the condition.
The numbers are staggering: PAD
is more prevalent and has a higher
mortality rate than HIV and all forms
of cancer combined, according to
Dr. Tursi. And, with modifiable risk
factors, Dr. Tursi believes that PAD
is preventable, even though about
60 percent of PAD patients have no
symptoms.
Early detection and treatment of
PAD can have a huge financial impact
on the industry. “$3 billion per year
can be saved with just a 25 percent reduction in amputations,” said Dr. Tursi. He believes that initial detection is
a crucial component in limb salvage.
According to Guy Pupp, DPM,
Doppler ultrasounds are a helpful
tool in early PAD detection. A Doppler device can record arterial flow,
and the procedure is non-invasive,
one of its biggest attributes. Vascular
Doppler ultrasounds can establish
how fast blood flows by measuring
the rate of change in pitch and frequency. Doppler measurements can
be used to diagnose:
• Blood clots
• PAD
• Heart valve defects
“The more you know,” said Dr.
Pupp, “the more you can battle for
your patients.”
Dr. Pupp also stressed the importance of limb salvage for patient quality of life. “There are psychological,
social and financial repercussions of
Dr. Robert Coronado discusses venous insufficiency during the Podiatry/Wound Care session.
amputation, and we need to get back
to early detection and aggressive
treatment of PAD.”
Robert Coronado, M.D., followed
Dr. Pupp with a discussion of the diagnostic tools available for venous
reflux disease (VRD), which he called
the “most prevalent cardiovascular
disorder today.” Dr. Coronado said
that one in four people have visible
symptoms of venous insufficiency, including varicose veins and skin ulcers.
VRD is five times more prevalent
than PAD and twice as common as
CAD, according to Dr. Coronado, and
the U.S. spends about $3 million annually dealing with venous ulcers.
He believes compression is the easiest
way to reduce the symptoms of VRD.
Continuing on the same ideas,
Alan Block, DPM, discussed chronic
venous insufficiency, which he said
has been recognized since ancient
times. Dr. Block said that 80 percent
of leg ulcerations are venous in nature, and many don’t require surgery.
Besides the reduction of ulcer reoccurrence, Dr. Block said that surgery
is no better than compression in reducing the symptoms of VRD.
Venous compression, he said,
“may achieve narrowing of veins,
restoration of valvular competence
or acceleration of venous flow.”
Cheryl Bongiovanni, Ph.D., also be-
Foro Interdisciplinario
de Terapia Endovascular
Co-Chairmen:
Dr. Alejandro Fabiani | Dr. Miguel Montero-Baker
Dr. Antonio Muñoa | Dr. Luis Sanchez Escalante
Dr. Craig M. Walker
www.ncvh.org/latinamerica
Dr. Jeffrey Niezgoda discusses pain management on Wednesday afternoon.
lieves in non-invasive techniques as a
first step of PAD treatment. According
to Dr. Bongiovanni, the symptoms of
PAD can be separated into two categories: macrovascular and microvascular. Arterial ultrasonography may
help medical professionals measure
arterial pressure accurately.
The pros of arterial ultrasonography, said Dr. Bongiovanni, are that
the technology permits the “mapping” of sites of arterial flow restriction. It also allows a medical professional to establish the degree of stenosis caused by visible lesions, both
physically and hemodynamically.
There are cons to the technology
as well. Dr. Bongiovanni cited downsides to arterial ultrasonography, including the fact that the mapping is
time-consuming, and the testing is
only reimbursed when performed by
certified personnel.
Charles Andersen, M.D., expanded on Dr. Bongiovanni’s ideas while
discussing fluorescence imaging and
the limitations of PAD diagnosis using typical modalities.
“The measurement of tissue perfusion is critical to every component of
a limb preservation initiative,” said
Dr. Andersen.
One of the limiting factors of a
fluorescein angiography is that it requires an IV injection of Indocyanine
Green (ICG). However, Dr. Andersen
said that positive attributes of ICG is
that the substance is safe for clinical
use and has a 3-5 minute half-life.
Fluorescein angiography can help
answer many questions, said Dr. Andersen, including:
• Is revascularization required?
• Did revascularization provide
adequate tissue perfusion to the involved angiosome?
• What is the optimal time for a
secondary procedure?
Dr. Andersen believes that fluorescein angiography offers an added option to measure tissue perfusion.
“We believe that fluorescence imaging has become a critical component of limb preservation,” said Dr.
Andersen.
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6 • Thursday, May 28, 2015
New Cardiovascular Horizons 2015
Speakers Look at Approach, Device Options
E
ndovascular surgery requires a
lot of decisions to be made, including procedural approach
and device selection. Wednesday
morning’s session, Global Summit
for Advanced Aorto-Iliac and Femoral Interventions for Peripheral Artery Disease, featured presentations
went into these choices in greater
detail.
Carlos Mena, M.D., spoke about
the factors that lead to the decision to
treat aortoiliac occlusions with stenting, as opposed to bypass surgery.
“The endovascular approach has
become the preferred way to proceed,” said Dr. Mena. “And more
so as new devices become available.
Cost effectiveness can also be superior.”
He reviewed the minimum requirements needed to perform interventions, and warned the audience
to recognize the dangers and complications that can develop.
“It is important to assess the anatomy to plan your approach,” said Dr.
Mena.
With a carefully devised plan and
the right equipment, he said the
percutaneous approach can achieve
good results.
The internal iliac artery anatomy was described by Craig Walker,
M.D., as “the forgotten artery. It does
not affect your pulses or ABI, but it
does impact a lot of other things.”
He looked at the present indications for internal iliac intervention,
which include buttock claudication,
impotence, internal iliac aneurysm,
colonic ischemia and penis salvage.
Dr. Walker stressed the importance
of asking male patients about impotence, because it’s not something
they often will openly admit to. He
also reviewed the results of the ZEN
Trial, zotorolimus eluting stent for
erectile dysfunction.
Louis Salvaggio, M.D., then
turned the focus to device selection.
He provided a comprehensive overview of guidewires.
“We have many different tools as
interventionists in the lab, and the
guidewire is most often the least un-
derstood,” he said.
Among the attributes impacting
guidewire selection are:
• Wire length
• Wire diameter
• Tip penetrance
• Shaft support
•Visibility
• Device compatibility
•Cost
•Durability
He also went into greater detail
on the six building blocks of guidewires – core material, core diameter,
core taper, tip design, coils and covers and coatings.
Dr. Salvaggio urged attendees
to not limit their knowledge to one
guidewire.
“When you are familiar with a
multitude of wires, you are more apt
to succeed,” he said. “Understanding a wire’s technical attributes will
help select the right wire for the right
case.”
Hinan Ahmed, M.D., opened his
presentation on techniques and tools
for chronic total occlusions (CTOs)
with a statistic: CTOs are estimated
to be found in 40 percent of patients
presenting with CLI.
“CTOs are anatomically challenging,” he said. “CTOs have a lower
procedural success – failure to cross
is the primary method of failure.”
Dr. Ahmed stressed the importance of planning and preparation in
the cath lab. He said you must know
the anatomy, have a plan, choose
your access and have all the equipment available (wires, catheters,
crossing devices and reentry devices.).
Before taking attendees through a
detailed look at the features of different crossing devices currently on the
market, he urged practice.
“The more you practice, the better
you get,” said Dr. Ahmed. “It’s important to become familiar with the
different options.”
He also warned that it could be
slow going in the beginning, but
urged patience. “Some of our first
cases took three to four hours, now
they take about 60 minutes.”
Dr. Pradeep Nair looks at the role of ultrasound guidance in gaining femoral and popliteal access during
his presentation on Wednesday morning.
Dr. Christopher Zarins discusses a human predisposition for the development of atherosclerosis.
The Big Picture: PAD by the Numbers, Role
of Medical Therapies and Radial Access
Y
esterday’s speakers presented
statistics that do not paint a
pretty picture – peripheral artery disease (PAD) is an epidemic.
“At almost 20 million in 2015, PAD
[cases] exceeds coronary disease and
cancer,” said Mary Yost of the Sage
Group. Each year, Yost sets the stage
for three days of cutting-edge education with her presentation on the
numbers associated with PAD.
“PAD continues to be underdiagnosed, undertreated and underestimated,” she said. “Early diagnosis
and treatment are important because costs rise with disease severity. PAD’s economic burden is higher
than diabetes, coronary disease and
all cancers.”
Yost reported that hospital costs
represent between 65-90% of PAD
costs.
She also looked at critical limb
ischemia (CLI), including amputation rates and factors that may impact the decision to perform an amputation on a CLI patient.
“Today most limb salvage experts
would argue that most CLI patients
should not undergo primary amputation,” she said.
Christopher Zarins, M.D., took the
audience back to Egypt more than
3,500 years ago to look at coronary
atherosclerosis.
“It’s a common belief that atherosclerosis is a lifestyle-related disease,” said Dr. Zarins.
He presented data from the
HORUS Study, which looked at the
evidence of atherosclerosis in ancient Egyptian mummies. The study
found that almost half, 45 percent,
had evidence of atherosclerosis.
“The study showed that cardiovascular disease was quite common
in ancient Egypt,” he said, further
explaining that this data raises the
question of a human predisposition
for the development of atherosclerosis. “The mummies tell us that atherosclerosis is not a lifestyle-related
disease of modern civilization. It
has been with us for more than 4,000
years. Atherosclerosis may be inherent to the process of human aging.”
Alvaro Alonso, M.D., discussed
the role of medical therapies as a
PAD treatment option.
“PAD is more prevalent and deadly than many leading diseases,” he
said. “The goals of medical therapy
are to improve the patient’s ability to
walk and prevent progression to CLI
and amputation.”
He looked at the roles of smoking cessation, antiplatelet therapies,
blood pressure control and glycemic
control.
“When patients do require revascularization, patients should continue with medications, smoking cessation and exercise to control other
cardiovascular risk factors,” he said.
“The goals of medical therapy are to
improve cardiovascular outcomes
and manage symptoms.”
Cezar Staniloae, M.D., presented
data to support the radial access approach.
“Radial access is an ideal access
site – easily accessible even with
patients with severe PAD,” he said,
adding that the United States lags behind other countries in the adoption
of radial access.
His presentation included an illustration on the anthropometric measurements for reaching the popliteal
and iliac arteries.
He also looked at when carotid
artery stenting via transradial access (TRA) is, and is not, the best
approach. He reviewed the technical considerations for TRA for other
procedures, including:
• Abdominal vessels
• Renal artery stenting
• Iliac artery stenting
• CFA interventions
Dr. Staniloae said the limitations
of radial access are device-related.
“New frontiers for radial access include SFA/popliteal,” he said. “But
there are currently severe limitations
due to lack of equipment.”
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INDICATIONS
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For Important Safety Information, see page XX.
83%
Overall freedom
from TLR in
SUPERB at
3 years1
94%
when nominally
deployed1*
86.3
%
Patency (K-M)
in SUPERB
at 12 mo2
90.5
%
when nominally
deployed2*
0
Fractures at 1-yr
across all
analyses3,4
REDEFINING
INNOVATION
PLEASE VISIT US
BOOTH #102
Supera® Peripheral
Stent System
INDICATIONS
The Supera Peripheral Stent System is indicated to improve luminal diameter in
the treatment of patients with symptomatic de novo or restenotic native lesions or
occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery
with reference vessel diameters of 4.0 to 6.5 mm, and lesion lengths up to 140 mm.
CONTRAINDICATIONS
The Supera Peripheral Stent System is contraindicated in:
• patients who are judged to have a lesion that prevents complete inflation of an
angioplasty balloon or proper placement of the stent or stent delivery system
• patients who cannot receive antiplatelet or anticoagulation therapy. Based on in
vivo thrombogenicity testing, the device should not be used in patients who cannot
be anticoagulated as there may be some thrombus formation in the absence of
anticoagulation.
WARNINGS
• This device is intended for single-use only. Do not reuse. Do not resterilize. Do
not use if the package is opened or damaged. • Use this device prior to the “Use By”
date as specified on the device package label. Store in a dry, dark, cool place. • DO
NOT use if it is suspected that the sterility of the device has been compromised.
• Persons with known hypersensitivities to Nitinol and/or its components (e.g.
nickel titanium) may suffer an allergic reaction to this implant. • Administer
appropriate antiplatelet therapy pre- and post- procedure. • Careful attention
should be paid when sizing and deploying the stent to prevent stent elongation.
In the SUPERB clinical study, stent elongation was associated with a decrease in
patency at 12 months.
POTENTIAL ADVERSE EVENTS
Potential adverse events include, but are not limited to:
• Abrupt stent closure • Allergic reaction (contrast medium; drug; stent material)
• Amputation or limb loss • Aneurysm or pseudoaneurysm in vessel or at vascular
access site • Angina or coronary ischemia • Arrhythmia (including premature
beats, bradycardia, atrialor ventricular tachycardia, atrial or ventricular
fibrillation) • Arteriovenous fi stula • Bleeding complications from anticoagulant
or antiplatelet medication requiring transfusion or surgical intervention • Death
• Detachment of a system component or implantation in an unintended site
• Embolization, arterial or other (e.g. air, tissue, plaque, thrombotic material, or
stent) • Fever • Hematoma or hemorrhagic event, with or without surgical repair
• Hypertension/Hypotension • Infection, local or systemic, including bacteremia
or septicemia • Ischemia requiring intervention (bypass or amputation of toe,
foot, or leg) • Ischemia or infarction of tissue or organ (e.g., occlusion of SFA/
PPA or distal vasculature) • Myocardial Infarction • Pain (leg, foot, and/or
insertion site) • Partial stent deployment • Pulmonary embolism • Renal failure
insuffi ciency secondary to contrast medium (with or without treatment including
dialysis) • Restenosis of vessel in stented segment • Shock • Stent malapposition
or migration, which may require emergency surgery to remove stent • Stent strut
fracture • Stent thrombosis or occlusion • Stroke • Thrombosis/occlusion at the
puncture site, treatment site or remote site • Transient ischemic attack • Venous
Thromboembolism • Vessel dissection, perforation or rupture.
PRECAUTIONS
The Supera Peripheral Stent System should only be used by physicians and medical
personnel trained in vascular interventional techniques and trained on the use of
this device.
• The long-term safety and effectiveness of the Supera Peripheral Stent System has
not been established beyond two years. • The safety and effectiveness of the Supera
Peripheral Stent System has not been established in patients who:
• are less than 18 years old • are pregnant or lactating • have instent restenosis
of the target lesion • have known hypersensitivity to any component of the stent
system (e.g., nickel) • cannot tolerate contrast media and cannot be pre-treated
• have uncontrolled hypercoaguability and/or other coagulopathy • This device
is not designed for use with contrast media injection systems or power injection
systems. • The fl exible design of the Supera stent may result in variation in the
deployed stent length.
Magnetic Resonance Imaging (MRI)
Non-clinical testing has demonstrated the Supera Stents are MR Conditional for
lengths up to 250 mm. A patient with this stent can be scanned safely, immediately
after placement, under the following conditions:
• Static magnetic field of 1.5 or 3.0 Tesla
• Highest spatial gradient magnetic fi eld of 2,500 Gauss/cm or less
• Maximum MR system reported whole body averaged specific absorption rate
(SAR) of
 2 W/kg for landmarks (i.e. center of RF coil) above the umbilicus
 1 W/kg for landmarks below the umbilicus and above the mid-thigh
 0.5 W/kg for landmarks below the mid-thigh for 15 minutes of scanning (per
pulse sequence), operating in the Normal Operating Mode (i.e., MR system
mode of operation where there is no physiological stress to the patient).
Abbott Vascular 3200 Lakeside Dr., Santa Clara, CA 95054 USA, Tel: 1.800.227.9902
Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use at www.abbottvascular.com/ifu
for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Photos taken by and on file at Abbott Vascular.
Supera is a trademark of the Abbott Group of Companies.
www.AbbottVascular.com
©2015 Abbott. All rights reserved. AP2940860-US Rev B.
New Cardiovascular Horizons 2015
Nonprofit Raise AAA Awareness
E
ducation and awareness, regardless of the medical condition targeted, will go a long
way towards screening and diagnosis of fatal diseases. AAAneurysm
Outreach, exhibiting at NCVH, is
the only nonprofit organization
dedicated to raising awareness of
abdominal aortic aneurysms (AAA).
Founded by AAA advocate Sheila
Arrington, who lost her father to a
ruptured AAA and has a strong family history herself, the organization
stresses the need for early detection
in at-risk populations.
“My dad was the victim of an
AAA rupture,” said Arrington. “I
understand how horrible this is.”
The organization was established
in 2000, and held its first screening
event in Baton Rouge, La., in 2001.
“We’re one-of-a-kind,” she said.
“We create partnerships so we can
provide free screenings. To date, we
have saved more than 300 lives. Early
detection is critical with AAA – rupture entails a 70-90% fatality rate.”
During a four-hour screening, the
goal is to have 288 ultrasounds performed. “When we screen the targeted population, we always find a
AAA.”
When a AAA is found during
a screening, the patient will learn
about the importance of regular ultrasounds. “The doctor will confirm
the finding, and then the patient enters the watchful waiting period,”
said Arrington. “It could take 10-25
years for the AAA to rupture. Early
detection is critical.”
Last year, the organization created a primary care provider initiative
that provides kits with a large AAA
poster and risk assessment cards.
NCVH attendees are encouraged
to visit the AAA tabletop, located
outside the Roosevelt ballroom to
learn more about the organization’s
mission and pick up education materials that explain the risk factors
that go along with AAA.
“Our goal at NCVH is to inform
people of the services we provide as
an organization and how they can
become involved in our program,
specifically getting physicians involved in our life-saving screenings,” said Arrington. “We want to
take the lead in educating this unaware public by creating partnerships to provide free AAA screening programs for those most at risk
throughout the country.”
For more information on the organization, including a schedule of upcoming screening events, visit www.
aoutreach.org.
Trial Data
Dr. Shammas, the study’s principle
investigator, reported that the study
met both its primary and secondary
endpoints:
• Primary: acute procedural success, less than or equal to 30% residential narrowing, with no serious
adverse events.
• Secondary: acute device success.
The inclusion criteria were included:
• Lesions of more than 50%
stenosis
• No lesion length limit.
He reported that device success
was 75.9%, and procedural success
(no SAE) was 90.6%.
The primary safety endpoint was
met at both 30 days and 6 months. At
30 days, amputation was 0%, and at
six months, it was also 0%, and sixmonth patency was 72%.
“The data is highly encouraging,”
said Dr. Shammas. “It appears to be safe,
and when we look at patient improvement and ABI, symptoms improved.”
He concluded that one-year data is
currently being collected, and while
these results are encouraging, the
data will need to be validated in a
larger trial. Porcine data, he added,
will be published in Endovascular Today in the next six months.
Continued from page 3
Dr. Muck said the take-home message from the study: “cut what you
want to cut and leave what you want
to leave.”
JETSTREAM-ISR Feasibility Study
The JetStream (JS) Atherectomy in
Femoropopliteal In-Stent Restenotic
Lesions (JetStreamISR) study hypothesized that simultaneous tissue excision and aspiration using the JetStream
Navitus device can lead to a high rate
of acute procedural success with low
intraprocedural complications and an
acceptable recurrence rate of restenosis
at 6-month follow-up.
Nicolas Shammas, M.D., presented the study’s six-month data on
Wednesday, noting as he began that
this is an offlabel application. He cited statistics showing that fempop ISR
occurs in 20-30% of stented patients
at 1 year and up to 49% at 2 years.
The study enrolled 29 patients (32
limbs) at two clinical sites between
October 2012 and August 2014 in the
United States, using angiographic
core lab adjudication. He noted that
one patient died (two limbs) and one
patient withdrew (one limb).
Thursday, May 28, 2015
• 11
PAID LISTINGS
New Product Showcase
Advanced Catheter Therapies
Booth #422
The FDA Cleared Occlusion Perfusion Catheter™ (OPC) creates a
localized treatment chamber for the delivery of various types of therapeutic agents for the treatment of different disease states. The OPC’s
multi‐lumen design temporarily occludes a specific region from blood
flow. Isolating and flushing the treatment chamber eliminates ad mixture of agent and blood. Therapeutic agents delivered by the OPC are
designed to be used for treating stenosis/restenosis, DVT, dialysis access, venous insufficiency, and solid tumors. Treatment chamber pressure is monitored in real- time. Broad range of sizes allows for ability
to treat long or multiple lesions. Visit the OPC at booth 422.
Bard Peripheral Vascular
Booth #202
Bard Peripheral Vascular, Inc. launched the LUTONIX 035 Drug
Coated Balloon PTA Catheter for percutaneous transluminal angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 150mm
in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm. LUTONIX 035 was proven safe and
effective in LEVANT 2, a rigorous, randomized, blinded, controlled
clinical trial that studied 476 patients with femoropopliteal disease at
54 trial sites. At 12 months, treatment with LUTONIX 035 resulted in
superior primary patency compared to PTA, quality of life improvements versus PTA, and noninferiority to PTA in terms of safety.
ThermopeutiX, Inc.
Booth # 426
The PRIMI™ and SECONDI™ provide guidewire support and exchange capabilities for complex interventions, including chronic total
occlusions and retrograde access. They are unique in that they have
the ability to sub-selectively inject contrast media and/or other diagnostic and therapeutic agents during the intervention, without removing the guidewire. Use of these catheters may significantly minimize
the amount of contrast and radiation used. The Secondi™ features
dual wire use and exchange capabilities, which greatly facilitates wiring bifurcations, and may be uniquely valuable in avoiding subintimal
dissection and untoward collateral/side-branch selection, commonly
encountered in complex vascular intervention.
Have you connected with NCVH on Twitter? @NCVHonline
Are you tweeting today? Be sure to use the hashtag #NCVH!
12 • Thursday, May 28, 2015
New Cardiovascular Horizons 2015
Finding Patients, Growing Your Practice: Marketing, New Avenues
T
o take a closer look at the economic impact of these diseases,
NCVH added a preconference
course, “Understanding the Business
of Peripheral Interventions.”
Beyond the financial implications
of peripheral artery disease (PAD),
there’s a constant need for healthcare
providers to expand their reach, to
both grow one’s practice and reach
more patients.
Alan Block, DPM, and Frank
Bunch, M.D., tag-teamed the topic of
marketing: how to get these patients
into treatment before amputation.
Advocating for yourself and establishing credibility among other specialties treating PAD is very important.
“If you don’t educate me, I can’t
make your practice better,” said Dr.
Block. “If I know you want that patient, I will seek you out.”
Early detection is still the best approach.
“We are saving people that yesterday we couldn’t,” he said. “I tell my
residents, even though we are podiatrists, the first thing you do when you
are with a patient is look up.”
In addition to educating other specialties to raise awareness, communication amongst a patient’s different
providers is a must.
“When I finish with a patient, I call
the family physician, the internal medicine doctor, even the dentist,” said Dr.
Block. “It’s also important that the patient be involved in their care.”
Dr. Bunch followed, by first characterizing the role of cardiologists in
the care of PAD patients.
“Cardiologists are tenacious,” he
said. “Cardiologists learn the global
approach to vascular disease, from
head to toe. Treatment strategies to
treat vascular disease in the lower
extremities are very similar to those
used when treating the heart.”
He advised the audience to get to
know their patient populations.
“You need to know what you’re
going to be treating,” he said. “You
need to know your area medical providers. Some of my best referrers are
nurse practitioners.”
He echoed Dr. Block’s comments
about communication, with the patient, their medical providers and
Dr. Frank Bunch offers tips on marketing your practice.
Practice What You Preach: Run the
My Leg My Choice 5K on Saturday
H
inan Ahmed, M.D., physician chairman, encourages
NCVH attendees to join him
on Saturday, May 30, at the My Leg
My Choice 5K.
“I think the concept of PAD is really connected to walking and running and what patients can do – it’s
the perfect ending to this meeting,”
he said.
Dr. Ahmed is an avid runner, completing approximately 2-3 full marathons and 20 half marathons annually.
He also works to share his love of
running of others, forming running
groups at his clinics. “I’ve have had
patients start running after interventions who have gone on to complete
5ks.”
He advocates for run/walk programs for many different reasons.
“In addition to the obvious benefits, it’s scientifically proven that long
term symptom relief comes from
regularly walking,” he said. “It also
improves cardiovascular risk factors
Dr. Hinan Ahmed is all smiles at the first My Leg
My Choice 5K, held at the conclusion of NCVH
2014.
and helps patients live happier, longer and healthier lives.”
Asked for his final message to his
fellow attendees,: “Come support
this good cause,” he said. “And what
other way is there to see beautiful
downtown New Orleans.”
Dr. Elias Kassab looks at the growth of outpatient labs in the endovascular arena on Tuesday
afternoon.
staff (yours, theirs, hospital).
“The patient needs to know what
you can do for them,” he said. “Give
the patients a reasonable expectation
on what they are going to get.”
Dr. Bunch said, the best marketing
tool you have is good results.
“From results comes word of
mouth – and word of mouth spreads,”
he said. “You can go tell people what
you do, but if you have bad results –
that will get out there too.”
The growth of the venous field set
up Rob Coronado, M.D., to share his
experiences on developing a successful venous practice.
“If you’re going to go into this
field, you have to believe there’s a
true need to treat these patients,”
he said. “Is there enough substrate?
What’s the competition like?”
He reported that venous reflux disease is five times more prevalent than
PAD, and two times more prevalent
that coronary artery disease. “Venous
insufficiency is a true vascular abnormality, not just a cosmetic disorder,”
said Dr. Coronado.
He encouraged attendees to pursue
training in all aspects of venous vascular care, and to learn all of the modalities and their indications – ablation,
sclerotherapy and microphlebectomy.
“If you are going to build a successful vein practice, train in areas
that include adjunctive therapies,”
he said. “Once you have the fundamentals, inform your community
and care providers. You then have to
educate the medical community and
care providers.”
Dr. Coronado advocated for directto-consumer advertising.
“These patients are ignored – but
have all these symptoms,” he said.
“When the patient is convinced that
they need something done, they will
come to you. When you put the ad out
there – this is the ROI of all marketing.”
To deliver your message, Dr. Coronado said it is important to dispel the
myths associated with venous disease:
• True disorder – not just cosmetic
• Covered by most insurance plans
• Recovery or downtime is usually
a matter of minutes
• No need for hospitalization or
even any sedation
• Venous stripping is not the way
to treat the disorder
“When patients realize you are
paying attention and treating a problem that they have had, and no one
else has treated, they will greatly appreciate it.”
Another practice-building concept
is the growth of the office-based lab.
Elias Kassab, M.D., shared a wealth
of information on the trend towards
outpatient labs.
“Today there are more than 450
outpatient endovascular centers in
the United States,” he said. “Most are
privately owned and were originally
opened to provide outpatient management of dialysis.”
Among the drivers of the growth
of office-based surgery that he covered included the development of
minimally invasive surgical techniques, new forms of anesthesia and
patients being drawn to the advantages of office-based surgery.
“When appropriately screened, almost all peripheral interventions can
be performed in the office with minimal complications,” he said. “We’re
gaining momentum.”
Office-based procedures are convenient for both the patient and physician, and less costly. They can also
increase the provider’s productivity
by cutting out travel time and the
need to wait for a hospital procedure
room to be free.
“It creates a continuity of care,” he
said. “It’s flexible to schedule and offers a friendly and familiar environment for the patient.”
Are there limitations to what can
be performed in an office setting? Yes.
“You cannot do carotid stenting or
cardiac interventions, but you can do
a lot,” he said. “We’re here to stay.”
In terms of setting up an officebased practice, Dr. Kassab reviewed
the pros and cons of starting a solo
practice, creating a joint venture with
a hospital or partnering with a management company.
JETSTREAM
TM
Atherectomy System
CUT THE CRUD.
DELIVER THE DRUG.
CALCIUM. PLAQUE. THROMBUS.
Vessel Preparation to remove this crud is often needed prior
to delivering adjunctive therapies, such as Drug Coated Balloons.
Optimize Vessel Prep with the Jetstream™ System.
- CONCENTRIC LUMENS
creating a uniform delivery zone for DCB
and other adjunctive therapies
- DEBULKING WITH ACTIVE ASPIRATION
to remove mixed morphology
Visit us at our booth
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events,
and Operator’s Instructions. Jetstream™ System INDICATIONS: The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is
not intended for use in coronary, carotid, iliac or renal vasculature. CONTRAINDICATIONS: No known contraindications. WARNINGS: The Jetstream Catheter and Control Pod may only be used with the PV Console. PRECAUTIONS: Do not manipulate the
Catheter against resistance unless the cause for that resistance has been determined. Use only listed compatible guidewires and introducers with the Jetstream System. The use of any supplies not listed as compatible may damage or compromise the
performance of the Jetstream System. Prior to use of the Jetstream System, confirm the minimum vessel diameter proximal to the lesion per the following table: Jetstream SC Atherectomy Catheter 1.6 : Minimum Vessel diameter proximal to lesion:
2.5mm • Jetstream SC Atherectomy Catheter 1.85: Minimum Vessel Diameter Proximal to Lesion 2.75 mm • Jetstream XC Atherectomy Catheter 2.1/3.0: Minimum Vessel Diameter, Blades Down 3.0 mm • Minimum Vessel Diameter, Blades Up 4.0 mm •
Jetstream XC Atherectomy Catheter 2.4/3.4: Minimum Vessel Diameter, Blades Down 3.5 mm • Minimum Vessel Diameter, Blades Up 4.5 mm ADVERSE EVENTS: Potential adverse events associated with use of this device and other interventional
catheters include, but are not limited to the following (alphabetical order): Abrupt or sub-acute closure • Amputation • Bleeding complications, access site • Bleeding complications, non-access site • Death • Dissection • Distal emboli • Hypotension •
Infection or fever • Perforation • Restenosis of the treated segment • Vascular complications which may require surgical repair • Thrombus • Vasospasm Jetstream PV Console INDICATIONS: The PV Console is designed for use only with the
Jetstream Catheter and Control Pod. See the current revision of the applicable Catheter and Control Pod Instructions for Use for further information. PRECAUTIONS AND WARNINGS: WARNING: To avoid the risk of electric shock, this equipment must
only be connected to a supply mains with protective earth. • Do not open either pump door during operation of the System. Doing so could result in loss of aspiration and/or infusion and will halt device activation. • Ensure the PV Console display is visible
during the entire procedure. Observe normal safety practices associated with electrical/electronic medical equipment. • Avoid excessive coiling or bending of the power cables during storage. • Store the PV Console using appropriate care to prevent
accidental damage. • Do not place objects on the PV Console. • Do not immerse the PV Console in liquids. Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are property of their
respective owners. PI-294806-AB MAR2015
14 • Thursday, May 28, 2015
New Cardiovascular Horizons 2015
Managing Ulcers at Forefront of
Multidisciplinary Nursing Session
L
A packed house watches live cases on Wednesday.
Exhibitor News
Exhibitor News features items submitted by companies advertising in
What’s on the Horizon? NCVH and CustomNEWS are not responsible for this content.
The Next-Generation Solution for AV
Access and Arterial Lesions
The Fortrex™ 0.035” OTW PTA
balloon catheter is the next-generation high pressure solution for AV
access and arterial lesions. The Fortrex PTA balloon can crack the short,
fibrous lesions that can block AV access, and also treat lesions in the peripheral vascular system.
Engineered around three primary
areas of interventional need—deliverability, predictability, and efficiency—the Fortrex PTA balloon offers
physicians several desired product
features and procedural advantages. First, the low tip entry profile
and robust, flexible shaft design
combine to enable tight tracking
to the wire and successful navigation in tortuous vessels. Second, the
balloon material and design permit
shape retention at rated burst pressure, ensuring focused pressure on
the lesion for controlled, targeted
and predictable treatment. Finally,
the combination of balloon material and wall thickness enables reliable balloon rewrap and reinsertion
along with a rapid deflation time,
all of which contribute to the efficiency of an interventional procedure.
To learn more about the Fortrex
PTA balloon, visit Booth 104 or www.
covidien.com/fortrex.
See the Latest Jetstream™ Atherectomy
System at Boston Scientific’s NCVH Booth
Boston Scientific’s 2014 acquisition of Bayer Interventional products
includes the Jetstream Atherectomy
System. Physicians who haven’t used
the system lately will learn that the
product has evolved since its first
introduction. Recent innovations include the launch of “SC” and “XC”
catheters, improved ergonomics, and
simplified wire management. As the
only atherectomy system with active aspiration, Jetstream is designed
to debulk mixed morphology such
as calcium, plaque, and thrombus.
Front-cutting
expandable
“XC”
blades deliver concentric lumens,
optimizing Vessel Prep prior to delivering adjunctive therapies such as
Drug-Coated Balloons. Stop by the
booth to see the latest iteration and
experience a hands-on demo.
The Bayer Interventional acquisition also includes the AngioJet™
Thrombectomy System, an advanced
system designed to restore blood flow
to a wide range of thrombosed arteries and veins. Used in over 700,000
cases worldwide, the system offers
reliable and predictable performance
to treat clots in vessels as small as 1.5
mm to the largest clot burdens in iliofemoral veins.
Boston Scientific’s Peripheral Interventions division develops and
commercializes products to treat the
27 million people worldwide who
suffer from peripheral vascular disease. The portfolio of technologies
features products used for a variety
of therapies, including restoring and
preserving blood flow to the peripheral vasculature. Other devices are
used in the treatment of liver cancer,
to help maintain dialysis access or to
occlude blood vessels selectively.
For more information, stop by the
booth or visit www.bostonscientific.
com
imb preservation is one of the key
subjects NCVH attendees want
to learn about, and Wednesday
afternoon’s Multidisciplinary Nursing for Limb Preservation II included
plenty of multi-faceted information,
including the benefits of hyperbaric
oxygen therapy (HBOT) and even the
use of medical-grade honey on wound
healing.
Cheryl Bongiovanni, Ph.D, stressed
the importance of nursing in regards to
wound care.
“Without nurses, there is no wound
healing,” Dr. Bongiovanni said. “You
guys are the key element.”
Opening the session, Helen Gelly,
M.D., called amputation the “big elephant in the room.” Dr. Gelly presented
two lectures on Wednesday, and her
first focused on care of the diabetic foot.
Diabetes both directly and indirectly
impacts wound healing, according to
Dr. Gelly. The good news in the field
of amputations, Dr. Gelly said, is that
amputations are on the decline. The
downside is that 47 percent of amputees have a 5-year mortality rate. In
order to reduce that number, foot management and ulcer prevention are important considerations, said Dr. Gelly.
Many types of ulcer management
were discussed in the session. Julio
Garcia, RN, laid out the nursing considerations of HBOT.
This type of therapy can increase
blood flow, as oxygen has physiologic
effects on the body that can lead to accelerated wound healing, and not only
for diabetic foot ulcers: A mechanical
effect in the reduction of bubble size
and increase of partial pressure of oxygen in all the tissues of the body.
Garcia implored that HBOT is not
appropriate for every patient, however.
Nurses should be aware of the hemodynamic changes that occur in a hyperbaric chamber, which include:
• Decreases in cardiac output by 24
– 35 percent
• Increases afterload by 30 – 60 percent
• Decreases in left ventricular index
by 11 – 30 percent
Dr. Gelly also reminded the attendees that HBO under pressure is a drug
and should be treated as such. HBO is
dose-dependent and has a discrete life.
With patients who are not a good fit
for HBOT, surgery may be an option.
Frank Tursi, DPM, showed concrete
results of the use of human amniotic
membranes in wound healing.
One patient, a 60-year-old male,
chose membrane use after he did not
respond to other treatment types, including HBOT. After one application,
said Dr. Tursi, the patient’s ulcer was
completely healed three weeks later.
Melinda Oberleitner, DNS, offered a
more unique treatment option, one that
she said has been in use for more than
4,000 years.
“There is a re-emergence in the use
of honey in wound care because there
is evidence of increasing resistant
pathogens,” she said.
Medical-grade honey has been reported to have an inhibitory effect on
approximately 60 species of bacteria,
including:
• Aerobes
• Anaerobes
• Gram-positive organisms
• Gram-negative organisms
The difference between edible honey and medical-grade honey is that the
medical variety is processed with gamma radiation, so contaminants have
been removed.
While not all the data is conclusive, Oberleitner did say that there is
high-quality evidence that honey heals
partial thickness burns about 4-5 days
more quickly than conventional dressings. One of medical-grade honey’s
most important attributes is that, unlike antibiotics, patients do not develop
resistance to honey.
Among the information attendees
took away from the Limb Preservation
session was the major differences and
similarities of ulcer types. Dr. Bongiovanni discussed the various types
of ulcers, including pressure, autoimmune, arterial and venous.
She believes, however, that most ulcers are not completely discrete.
“Single-etiology ulcers are uncommon,” she said. “Always suspect arterial involvement in any ulcer accompanied by diabetes.”
Be sure to visit the exhibit hall, open today from 9:00 a.m. to 4:00 p.m.
SAV E
LI M B
The only
2.9 Fr system
below the knee
Micropuncture®
2.9 Fr Pedal
Introducer Access Set
.014”
2.3, 2.6 Fr
Approach CTO
Microwire Guide
2.5 Fr
CXI®
Support Catheter
Advance Micro™ 14
Ultra Low-Profile PTA
Balloon Catheter
2.9 FR
SYSTEM
TECHNOLOGIES FOR
BELOW THE KNEE
www.cookmedical.com
© COOK 05/2015
D19621-EN-F
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A
APPROV
E
G
N
OO
DRU
C
L
·
FIRST
·
D
F
You’re Invited to a Lunch Symposium
OA
TED
BA
L
Not All DCBs Are Created
Equal: Side By Side PreClinical Evaluation of
Leading DCBs
Presented by:
Renu Virmani, MD
CVPath Institute, Inc. | Gaithersburg, MD
A First Look and Interim
Analysis of 12 Month
Outcomes from the Real
World Global SFA Registry
Presented by:
Marcus Thieme, MD
MEDINOS Hospital | Sonneberg, Germany
Live Case
Presented by:
Jihad Mustapha, MD
Metro Health Hospital | Grand Rapids, MI
Thursday, May 28, 2015
12:00-1:00pm
Orpheum Room
2nd Floor of the Roosevelt Hotel
RSVP to JoAnn Dirtadian
480.303.2754 | [email protected]
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