Potential Benefits Appear to Largely Outweigh

Transcription

2012veith_fridaySat.qxp
11/15/2012
1:00 PM
Page 1
HILTON NEW YORK
NOVEMBER 14-18, 2012
39TH ANNUAL SYMPOSIUM
FRIDAY/SATURDAY
Schedule of Events
6:00 a.m.
General Registration – 2nd Floor Promenade
Faculty Registration – Morgan Suite, 2nd Floor
Continental Breakfast – Sutton Complex, 2nd Floor
VEITHsymposium
Concurrent Programs E and F
Program E – New Techniques and Technologies;
TAAAs and Chimps; Lower Extremity Ischemia
(CLI); Medical Therapy and Medical Problems
Grand Ballroom East, 3rd Floor
6:40 a.m. - 12:00 p.m.
Session 26: New Techniques and New Endovascular
Technology
Session 27: Thoracoabdominal Aortic Aneurysms
(TAAAs) and Techniques to Revascularize Renal and
Visceral Arteries: Chimneys, Periscopes, and Sandwich Grafts (Chimps)
Session 28: New Developments in the Treatment of
Lower Extremity Ischemia and CLI
Session 29: Advances in Medical Therapy or Treatment of Medical Problems or Complications
Program F – Miscellaneous Hot Topics Related to
Lower Extremity and Aortic Disease and
Venous Topics
Grand Ballroom West, 3rd Floor
6:40 a.m. - 12:00 p.m.
Session 30: New Late-Breaking Concepts, Updates,
and Miscellaneous Hot Topics Related to Lower Extremity and Aortic Disease
Session 31: Progress in the Treatment of Venous
Disease – Part IA
INCLUDING
AIMSYMPOSIUM
AND
AVIDSYMPOSIUM
Potential Benefits Appear to Largely
Outweigh Risks of Statin Use
R
ecent studies and the popular betes. This is especially important
press have called into question among patients with peripheral arterthe widespread use of statins, ial disease, as approximately 80% of
this population has diaciting among the possible
betes mellitus.
risks an increase in the inThe well-known potencidence of type 2 diabetes.
tial side effects of statins
However, no drug will proinclude muscle pain, liver
vide health benefits withdamage, digestive probout some degree of risk,
lems, and rash or flushing.
according to Dr. Donald
But Dr. Poldermans will
Poldermans.
focus on two side effects
During his presentation,
more recently reported –
“What’s All This Hoopla
neurological problems
About Statins and Mental
and diabetes mellitus –
Fogginess, Increased Blood
DR. DONALD
that led the U.S. Food and
Sugar and Diabetes:
POLDERMANS
Drug Administration to
Should It Make a Difference in Statin Usage or Is It a Witch issue warnings on statin labels regardHunt?” on Friday morning, he will ing blood glucose levels and the dediscuss the risks of developing dia- velopment of type 2 diabetes, as well
betes and memory loss in patients on as the risk of memory loss or confustatins, and how physicians should sion while taking statins.
Memory loss problems occurred
weigh the risks and benefits.
Statins reduce LDL-cholesterol. within 60 days of starting on statin
Over a 4-year period, an LDL reduc- therapy. Fortunately, most people with
tion of 1 mmol/L (39 mg/dL) trans- this problem return to normal after
lates into a 9% reduction in death discontinuing the statin drug. Howfrom any cause in patients with dia- ever, especially in vascular surgery pa-
tients, a recent study raises the possibility that statins increase the risk of
delirium in patients after surgery.
Researchers at the University of
Toronto looked at data from 284,000
people after surgery. Delirium is
known to be underdiagnosed in these
cases, but the researchers estimated
that it occurs after 10% of all surgical
procedures, and after 13% of procedures in people taking statins. Because
delirium can increase recovery time,
this is an area of concern. The hypothesis is that the statins cause blood
flow to the brain to decrease in favor
of flow to the heart. Importantly, in
the DECREASE III study, fluvastatin
use was associated with a twofold reduction in cardiac death and myocardial infarction (MI) after surgery
(10.8% vs. 19%).
“Therefore, the benefits outweigh
the risk substantially, and we do not
recommend stopping statins before
surgery until more is known,” advised
Dr. Poldermans, who is an internist at
the Ruwaard van Putten Hospital,
See Statins on page 11
Concurrent Programs G and H
Thrombectomy:
One Option for PCD
SFA Stents Show
Long-Term Success
Program G – TAAAs and Multilayered Stents;
Progress in Vascular Imaging
1:00 p.m. – 3:30 p.m.
hlegmasia
cerulea
dolens is an acute masP
sive thrombotic occlusion
results of
stenting as an alternaLtiveong-term
to open reconstruction
Session 32: Progress in the Treatment of Venous
Disease – Part IB
Session 33: More on TEVAR, TAAAs, and Pararenal
Aneurysms and The Multilayer Stent
Continued on page 4
Top Cover Image: ©Robert Churchill/iStockphoto.com
Bottom Cover Image: ©Xavier Arnau/iStockphoto.com
age requires extremity amputation, with mortality
reported to be 25%-41%.
PCD may be
of the venous
treated by usdrainage of an
ing methods
extremity insuch as anticluding the micoagulation,
c r ov a s c u l a r
f a s c i o t o m y,
collaterals.
thrombolysis,
PCD is characor
venous
terized
by
thrombectopain, edema,
my. Uncompliand cyanosis
cated
early
of the affected
cases can be
extremity.
DR. KAMPHOL
treated by bed
A potentialLAOHAPENSANG
rest, extremity
ly reversible
phase of the ischemic ve- elevation, and heparin
nous occlusion may therapy, Dr. Kamphol Laoprogress to venous gan- hapensang said.
In his presentation,
grene in 40%-60% of cases,
and a significant percent- See Thrombectomy on page 8
He and his colleagues evaluated the long-term effects
of patient-specific factors
and anatomic
for long lesions
characteristics
of the superfiof the lesions.
cial femoral
He will share
artery (SFA)
their results in
have been unhis presentaknown.
tion, “LongOn Friday
Term
(2-5
morning, Dr.
Years) Results
Giovanni
of SFA Stent
Torsello will
Performance
present the results of a study DR. GIOVANNI TORSELLO in 1000 Patients (a Belthat compared
the clinical results and gium/Germany Registry
long-term patency of Report).”
Dr. Torsello and his colfemoropopliteal stenting
for long (TASC C and D) leagues collected data from
and short (TASC A and B) 1,000 patients treated for
lesions using nitinol stents.
See SFA on page 8
11/15/2012
1:00 PM
Page 2
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Page 3
VEITHsymposium
Friday/Saturday Issue
3
Ulcer Healing Rates Clarify Merits of Iliac Vein Stents
A
lthough iliac vein stenting has been
noted to result in improved quality of life as measured by diseasespecific questionnaires, these assessments can be somewhat subjective and
have not been the result of blinded data,
according to Dr. Anil P. Hingorani.
To examine this therapy on the basis
of ulcer healing, Dr. Hingorani and his
colleagues reviewed data from 376 patients who had venograms with intravascular ultrasound (IVUS) of the iliac veins from January 2008 to June 2011
at their facility. He will discuss the results
of their study in his presentation, “Iliac
Vein Stenting for Advanced Chronic Venous Disease: When Will It Improve
Symptoms and
When Will It
Not: Is IVUS Essential?” on Friday morning.
At the time of
IVUS, a total of
99 patients had
failed prior conservative measures and were
assessed
as
DR. ANIL P. HINGORANI
CEAP (clinical,
etiologic, anatomic, and pathophysiologic) class 6, the worst class.
Of these, 49 patients underwent iliac
vein stenting based upon a 50% diameter or area reduction as determined by
IVUS measurements (stented group).
The remaining 50 patients were not
found to have significant stenosis (nonstented group), said Dr. Hingorani, an associate professor of surgery at Mount
Sinai Medical Center in New York and an
attending vascular surgeon at Lutheran
Medical Center in Brooklyn, N.Y.
A comparison of ulcer healing rates
found no significant differences in age or
gender distribution, or in laterality of the
ulcers (right vs. left) between the two
Download the
Mobile App
groups. No significant differences were
seen in pre-IVUS distribution of severe
reflux on duplex examination in ipsilateral greater saphenous veins, short
saphenous veins, accessory veins, or perforators. In addition, no significant differences were noted in the average size
of the ulcers (stented group, 2,026 mm2;
nonstented group, 2,330 mm2).
Results showed that 29% of patients in
the stented group were found to be
healed by 6 months, compared with 36%
of the nonstented group, a nonsignificant difference. There were three recurrences in each group. However, 13 of the
stented patients and 8 of the nonstented
patients did not follow up after their
procedures, cautioned Dr. Hingorani.
“While these data are limited, they do
not suggest a significant difference in ulcer healing rates in the stented and nonstented groups as detected by IVUS,”
said Dr. Hingorani, calling into question
whether the quality-of-life questionnaire
results after stenting truly reflect objective results.
■
Session 31 – VEITH: Iliac Vein
Stenting for Advanced Chronic
Venous Disease: When Will It
Improve Symptoms and When
Will It Not: Is IVUS Essential?
Friday, 10:07 a.m. – 10:12 a.m.
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from the Apple App Store (iPhone,
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Page 4
39th Annual Symposium
November 14-18, 2012
Treatment Options Assessed for Calf-DVT
M
anagement of calf deep vein
thrombosis has long been controversial, yet it is commonly encountered in clinical practice, according
to Dr. Elna M. Masuda.
Calf deep vein thrombosis (C-DVT)
serves as the locus for most lowerextremity DVT, and can be the source of
serious pulmonary embolism; therefore,
it warrants careful attention, said Dr. Masuda, who will discuss the issue Friday
morning.
Prior to 2012, multiple societies including the American College of Chest
Physicians (ACCP), British Society of
Hematology, and Australian Society of
Thrombosis and Hemostasis supported
treating all C-DVT with anticoagulation.
But a 2009 electronic poll at the American Venous Forum (AVF) and American
College of Phlebology (ACP) showed a
40%-45% vote in favor of duplex surveillance with clinical follow-up as opposed to anticoagulation for all. “Although not a majority opinion, the
finding was compelling enough to
prompt us to evaluate the literature by
systematic review,” said Dr. Masuda, a
clinical assistant professor of surgery at
the University of Hawaii, and chief of
the vascular surgery department at the
Straub Clinic & Hospital in Honolulu.
Unfortunately, the quality of the data
found was not high enough to meet the
Continued from page 1
Session 34: Progress in Vascular Imaging and Guidance
Program H – Abdominal and Thoracic Aneurysms;
AAAs/TAAAs, CHIMPS
1:00 p.m. – 3:30 p.m.
rigorous standards of a meta-analysis
when evaluated by two independent statisticians; therefore, the study must be
presented as a review, she explained.
Dr. Masuda and her colleagues examined 1,513 citations, and by using predefined criteria, identified 6 randomized
controlled trials and 25 observational
cohort studies or case series. Four outcome parameters were examined: clot
propagation, pulmonary embolism (PE),
recurrence, and post-thrombotic syndrome (PTS).
Clot propagation appeared to be reduced by anticoagulation based on two
studies of moderately strong methodology. With duplex scan surveillance,
2:00 p.m. – 3:10 p.m.
Session 47: More About Health Care Reform, FDA, Ethics,
Costs, Standards, and Guidelines
hands-on activities to provide an educational experience for
all levels of participants.
AVIDsymposium – Friday
3:10 p.m. – 4:37 p.m.
6:00 a.m.
Concurrent Programs K and L
General Registration
Session 35: More New Concepts About AAAs, EVAR, and
Other Treatments of Aortic Disease
Program K – Vascular Disease; Medical Treatment;
Complications; New Techniques and Concepts
3:10 p.m. – 6:10 p.m.
Session 36: More New Concepts and Data Related to Thoracoabdominal and Pararenal Aneurysms and Chimps
Session 48: Vascular Disease Natural History; Medical
Treatment; Prevention and Treatment of Complications
Concurrent Programs I and J
Session 49: New Techniques; New Concepts
Program I – Arterial Sessions
3:30 p.m. – 6:00 p.m.
Program L – Updates, New Technology and Concepts;
More New Concepts, Updates and Techniques
3:10 p.m. – 6:05 p.m.
Session 37: Updates, Controversies, and New Concepts in
the Treatment of Ruptured AAAs
pooled analysis showed that the propagation rate to the popliteal vein or higher was 8%. The rate of PE ranged from
0% to 6.2% despite type of treatment,
whereas pooled analysis of duplex surveillance studies revealed a PE rate of
0.4%.
These rates of PE during surveillance
were notably lower than the high rate of
“PE at presentation” of about 30% reported in the literature, possibly because
a proximal thrombus in the thigh may
have detached, leaving residual C-DVT
found at the time of embolism. Pulmonary embolism by definition describes a clot arising from another site,
Continued on page 6
Session 50: Updates, New Technology, New Concepts
7:50 a.m. - 9:00 a.m.
Session 1: Waveforms, Pressure and Flow
9:30 a.m. - 10:40 a.m.
Session 2: Visceral Vascular, Aorta, and Endoleak Detection
10:45 a.m. - 11:55 a.m.
Session 3: Workshop Rotation 1
11:55 a.m. - 1:10 p.m. Lunch on your own
1:10 p.m. - 2:10 p.m.
2:15 p.m. - 3:00 p.m.
Session 5: Novel Technologies and Cutting-Edge Techniques
Session 38: New Late-Breaking Concepts and Results in Aortic Traumatic Transection and Type B Aortic Dissections
Session 51: More New Concepts, Updates, and New Techniques
Program J – Venous Sessions
3:30 p.m. – 6:00 p.m.
3:05 p.m. – 3:50 p.m.
Session 6: Practice Enhancements – Part I: Lab Management, Personnel, Training, and Quality of Life Issues
SUNDAY
6:00 a.m.
4:20 p.m. - 5:45 p.m.
Session 7: Diagnosis and Management of Chronic Venous
Disease
Continental Breakfast – Grand Ballroom Foyer, 3rd Floor
AVIDsymposium – SATURDAY
Session 39: More Progress in The Treatment Of Venous
Disease – Part IIA
Session 40: Progress in Endovascular Treatment of Massive
and Submassive Pulmonary Emboli and Other Hot Venous
Topics – Part IIB
SATURDAY
6:00 a.m.
Continental Breakfast – Sutton Complex, 2nd Floor
Grand Ballroom East and West, 3rd Floor
6:40 a.m. – 8:12 a.m.
Session 41: New Developments in AAAs and Their
Treatment
8:13 a.m. – 10:20 a.m.
Session 42: New Developments in Treatment of the
Aorta and Its Branches
6:00 a.m.
6:40 a.m. – 8:28 a.m.
Session 52: New Developments and Updates: Early Carotid
Treatment, Takayasu’s Disease, and Techniques for Evaluating Carotid Plaques Noninvasively
8:28 a.m. – 10:00 a.m.
Session 53: More About Thoracic and Abdominal
Aneurysms: Management of Complications
10:00 a.m. – 11:42 a.m.
Session 54: New Developments in Carotid Disease Treatment and Associated Issues
11:42 a.m. – 1:20 p.m.
Session 55: New Developments and Controversial Issues
Related to CAS and CEA
1:20 p.m. – 3:20 p.m.
Session 56: New Horizons, New Concepts and Late-Breaking Developments
General Registration
7:40 a.m. - 8:35 a.m.
Session 8: Vascular Ultrasound: “Curveballs and
Controversies”
8:40 a.m. - 9:45 a.m.
Session 9: Current Critical Governmental, Intersocietal,
and Reimbursement Issues
9:45 a.m. – 10:45 a.m.
Session 10: Cerebrovascular Imaging
10:50 a.m. – 11:50 a.m.
11:50 a.m. - 1:00 p.m. Lunch on your own
1:00 p.m. - 2:00 p.m.
Session 12: Practice Enhancements – Part 2: Issues Related
to Training, Education, Cost, Efficiency, and Other Important Concepts in Vascular Ultrasound
10:20 a.m. – 11:43 a.m.
Session 43: Future Issues Regarding Health Care; Conflict
of Interest; Government; Industry Relations; Business of
Medicine; Practice Costs; and Reimbursements
3:20 p.m. – 4:35 p.m.
Session 57: Late-Breaking Topics of Particular Interest
11:43 a.m. – 12:00 p.m.
Session 44: Tribute to Our Military
AIMsymposium – FRIDAY
12:01 p.m. – 1:00 p.m.
Session 45: Luncheon Session: New or Improved Endovascular Devices
3:35 p.m. - 4:15 p.m.
Session 14: Arterial Imaging
Workshops
4:15 p.m. – 5:15 p.m.
Session 15: Dialysis Access
1:00 p.m. – 2:00 p.m.
Session 46: Issues Related to Training, Certification, Simulation, Specialties, Guidelines and Randomized Controlled
Trials
SYMPOSIUM ENDS
6:00 a.m.
Murray Hill Suites A&B, 2nd Floor
Session 20: Workshops/Case Presentations: All workshops
will combine didactic lectures, case presentations, and
2:10 p.m. – 3:30 p.m.
Session 13: Venous Session: Background, Techniques for
Diagnosis and Treatment of Venous Disease of the Lower
Extremities
SYMPOSIUM ENDS
11/15/2012
1:00 PM
Page 5
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11/15/2012
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Page 6
Oxygenation and Compression Heal Diabetic Foot
T
opical oxygenation to treat chronic
wounds of the lower limb is applied
to the body in a horizontal position,
which leads to increased perfusion pressure by the force of gravity. It has been
hypothesized that applying compression
or suction to a growing tissue will modify its healing capacity. If the two techniques were combined, many patients
might grow enough tissue to produce a
stump, which would perhaps be big
enough for proper ambulation.
Dr. J. Magdiel Trinidad-Vazquez will
present the results of using an oxygen
chamber to provide intermittent pneumatic compression-oxygenation (IPCO)
to the limb. This provides an atmosphere
of oxygen surrounding the foot and increases hyperoxygenated blood flow, thus
changing the chemical environment of ischemic and infected wounds.
On Friday morning, in his presentation
“A New Device for Topical Intermittent
Compression and Hyper-Oxygenation
to Improve Healing of Infected Ischemic
Foot Wounds,” Dr. Trinidad-Vazquez
will discuss the results of using this new
device on a series of 24 patients.
IPCO is performed by placing the leg
within a bag that is supplied with continuous oxygen input. The compression
boot is formed by a compression chamber placed at the calf and by two cham-
bers to boost foot level, according to Dr.
Trinidad-Vazquez, a professor of surgery
at the Hospital Bernardette in Guadalajara, Mexico, and a vascular surgeon at
the Instituto Cardiovascular de Guadalajara.
The upper chamber is fastened to the
calf via Velcro. At the anterior aspect,
two zippers are placed to change its vol-
HYPEROXYGENATED BLOOD IS
INCREASED AND THE CHEMICAL
ENVIRONMENT IS CHANGED.
ume. An air compressor provides a 10second compression to the upper chamber, increasing pressure from 0 to 140
mmHg in 0.3 seconds, and then diminishing it slowly to 60 mmHg. This permits the entry of oxygen, allows arterial blood flow, and avoids venous return.
Three seconds later, the second impulse
increases the pressure from 0 to 180
mmHg to the foot chambers and increases oxygen pressure to 20-90 mmHg
for 7 seconds over the wound. The release of pressure from the calf produces
exhalation of the trapped oxygen. A period of 25 seconds of inactivity ends the
cycle.
j oi n us for a
Pre-Thanksgiving
Lunc h
Friday, November 16, 2012
Main Exhibit Hall (Americas Hall I, 3rd Floor)
12:00 pm - 1:00 pm
IPCO is applied for 2 hours. The arterial and venous hemodynamic response
is measured by duplex ultrasound before
and after compression. The blood saturation in the wound is also measured.
There were 24 limbs treated in 24 patients (mean age, 61.5 years), 13 of
whom were men. All patients had a
threatening infection and had rejected
amputation.
The average ankle-brachial index was
greater than 0.9; all patients had painless
deep tissue infection and received the
best medical treatment. Debridement
and minor amputations were performed
under local anesthesia. Maggots were
applied on 10 occasions for 24 hours to
aid debridement.
After being removed from the chamber, the wounds changed to a bright red,
with capillary bleeding and a reduction
of foot edema. Sixteen of the patients
preserved their foot with sufficient plantar surface to allow ambulation; 4 of
them lost the foot at the tallus level and
rejected below-knee amputation in order
to preserve their natural height.
Continued stimulation produced vigorous growth of granulation tissue in
previously exposed bone, added Dr.
Trinidad-Vazquez, with wounds changing from pale to a deep red. Popliteal
artery blood flow increased 3.2%. Blood
saturation increased to 100%, PO2
reached 377 mmHg, and pH changed to
7.8, while hydrogen ions decreased from
45 to 12.9, and lactate increased from 0.5
to 14.7.
Hypoxia and acidosis are two main factors present in infected wounds with delayed healing. The low oxygen concentration results in a low level of function
of all the cells involved in wound repair.
Even though topical oxygen therapy has
been used in many wound care centers
with clinical success, the relationship between oxygen tension applied and the
oxygen pressure reached in human
wound tissues has not yet been quantified, according to Dr. Trinidad-Vasquez.
“We applied 100% compressed oxygen, and gas measurements showed up
to 350 mmHg of oxygen partial pressure.
The pH became alkaline, thus favoring
cell function in wounds. We believe that
the old methods must be replaced by a
new one that allows deeper and greater
tissue oxygenation. The new IPCO device described increases the flow of hyperoxygenated blood and changes the
chemical environment to alkaline, allowing greater healing,” he said.
■
Continued from page 4
The important challenge, though, is to
determine which group is composed of
patients who should be considered high
risk, and thus candidates for anticoagulation; and which patients may be safely
managed by duplex surveillance and
close clinical follow-up, Dr. Masuda said.
Risk factors for clotting have typically
included active malignancies, persistent
immobility, known thrombophilia, and
idiopathic DVT. These high risk factors
warrant early anticoagulation, she said.
Other risk factors for C-DVT that have
been associated in the literature with increased clinical risk are calf-related factors such as bilateral calf vein thrombi,
multiple calf vein DVT in the same leg,
and thrombosed calf vein diameter
greater than 7 mm, all of which may
benefit from early anticoagulation.
“In contrast, C-DVT associated with
low risk such as asymptomatic state,
mild symptoms, or transient risk factors
may be followed by duplex scan surveillance with close clinical follow-up to ensure clinical stability or improvement,
with repeat duplex scanning at least
every 5-7 days for at least 2 weeks,” Dr.
Masuda concluded.
■
and the known entity is often associated
with no identifiable source in the leg or
pelvis, yet the clot must have arisen from
these seemingly “normal veins.”
Recurrence of C-DVT appeared lower than the recurrence of DVT involving
thigh veins in those treated with anticoagulation, and data regarding duplex surveillance and recurrence are lacking.
Studies of PTS showed that C-DVT patients fared better than those with proximal DVT.
One out of 10 cases was classified as
CEAP class 4-6. Most were class 4, and
ulcerations were uncommonly encountered with isolated C-DVT. No studies of
strong methodology could be found to
resolve the controversy of optimal treatment of C-DVT, Dr. Masuda said.
Clearly, doing nothing for C-DVT is
considered unacceptable, she said. The
findings, as shown, support the option of
duplex scan surveillance and close clinical follow-up for managing C-DVT, and
they challenge the recommendations
made by the aforementioned societies
supporting anticoagulation for all.
In early 2012, the ACCP published
new guidelines for isolated C-DVT, altering their position, and suggested that
imaging surveillance for 2 weeks rather
than anticoagulation was appropriate for
non–high-risk groups; they assigned this
a grade 2C rating. In contrast, they recommended anticoagulation over serial
imaging for those with severe symptoms
or risk factors for extension.
Session 26 – VEITH: A New Device for Topical Intermittent
Compression and Hyper-Oxygenation to Improve Healing of
Infected Ischemic Foot Wounds
Friday, 6:52 a.m. – 6:57 a.m.
Session 32 – VEITH: Current
Status of the Optimal Treatment
for Managing Calf Vein DVT
Based on the Latest Meta-analysis and Systematic Review
Friday, 11:23 a.m. – 11:28 a.m.
11/15/2012
1:00 PM
Page 7
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Supervised Exercise Evaluated for Aortoiliac Disease
R
esults of the CLEVER trial will be ondary end points included claudication
discussed on Friday morning by onset time, health-related quality of life
Dr. Anthony J. Comerota. This Na- (QOL), free-living step activity, and cardiovascular risk factors. All
tional
Institutes
of
patients underwent full carHealth–sponsored trial was
diovascular risk evaluation;
designed to evaluate patients
performed a standardized
with intermittent claudicagraded treadmill exercise
tion due to aortoiliac occlutest or a pedometer test to
sive disease.
quantify their 7-day walking
Patients were randomized
distance; and had QOL meaeither to optimal medical
sures recorded using the SFcare plus supervised exercise
12 Walking Impairment
or to optimal medical care
Questionnaire and Peripherplus angioplasty/stenting.
al Artery Questionnaire.
The optimal medical care
DR. ANTHONY J.
These were all repeated at 6
group alone was discontinCOMEROTA
months.
ued early in the trial due to
All patients received cilostazol 100 mg
compromised trial enrollment.
The primary trial end point was b.i.d. Those who were randomized to suchange in walking time at 6 months. Sec- pervised exercise had structured exercise
Treating PCD
Thrombectomy
•
from page 1
“Current Optimal Surgical Treatment of Phlegmasia Cerulea Dolens,” on Friday, Dr. Laohapensang
will discuss how the failure of clinical response in
6-12 hours should be followed by iliofemoral venous
thrombectomy or thrombolysis. For patients presenting with severe ischemia or impending venous
gangrene, venous thrombectomy is recommended
as the primary intervention.
Venous thrombectomy is aimed at preventing
propagation of the thrombosis and subsequent gangrene, preventing pulmonary embolism, and avoiding a serious postphlebitic sequel.
Early reports on thrombectomy for simple
iliofemoral thrombosis claimed an 85% patency
rate if the procedure was done within 10 days of the
onset of thrombosis, and found normal legs with
minimal or no edema in 81% of survivors. However,
higher rates of rethrombosis have been reported in
thrombectomy for PCD, although the addition of
a temporary arteriovenous fistula (AVF) can reduce
rates of rethrombosis, according to Dr. Laohapensang, who is based at the department of surgery,
Chiang Mai (Thailand) University Hospital.
Thrombectomy offers a treatment that can provide rapid relief of venous and compartmental hypertension. Pulmonary embolism occurs in 12%40% of PCD patients, and the incidence is greater
when tissue necrosis is present, he added. Caval interruption should be performed if pulmonary embolism has already occurred or if thrombectomy is
incomplete because of massive distributed thrombus, which makes pulmonary embolism a serious
threat.
The 2004 American College of Chest Physicians
consensus statement on the treatment of thromboembolic disease recommended against the routine use of venous thrombectomy in acute deep vein
thrombosis (DVT) except in cases of PCD. Open
surgical thrombectomy is associated with significant
blood loss, and rethrombosis occurs in many patients despite postoperative anticoagulation because
of damage to the venous endothelium – either
from the clot itself or from the mechanical damage
done in an effort to remove the thrombus. The success of open surgical thrombectomy depends on the
complete removal of thrombus from the affected
veins. This requires multiple lower-extremity incisions and multiple procedural maneuvers, such as
balloon embolectomy, milking of thrombus with sequential wrapping of the lower extremity, copious
irrigation, and the creation of an AVF.
3 days/week, 1 hour/day, for 26 weeks.
Patients randomized to angioplasty and
stenting had a self-expanding or balloonexpandable stent placed within the aortoiliac lesion. Femoropopliteal revascularization was not performed, according
to Dr. Comerota, director of the Jobst
Vascular Institute at ProMedica Toledo
(Ohio) Hospital.
The primary end point, change in peak
walking time, was significantly better in
the structured exercise group than in the
stent group (P = .042). Changes in claudication onset time were not different between the two groups. The anklebrachial index was higher at 6 months in
the stenting group, and physical measures of QOL were higher in the stenting group. There were significantly higher HDL (high-density lipoprotein) levels
and lower fibrinogen levels in patients
randomized to exercise.
“Supervised exercise provided superior improvement in walking performance, improved self-reported walking
distance, an increase in HDL, and a decrease in fibrinogen compared to angioplasty and stenting,” Dr. Comerota concluded.
■
Session 28 – VEITH: For Claudication From Aortoiliac Occlusive
Disease, Supervised Exercise
Produces More Relief Than Best
Medical Therapy or Stenting:
Results of the CLEVER Trial
Friday, 10:32 a.m. – 10:37 a.m.
Large Data Analysis
Dr. Laohapensang will also discuss the results of
a study he and his colleagues conducted at their institution between 1991 and 2002. Among 125 patients with acute DVT of the lower extremities, they
surgcially managed 15 patients with PCD. Of those,
6 patients showed impending gangrene, and failed
initial management with bed rest, extremity elevation, fluid resuscitation, and systemic anticoagulation for 6-12 hours. These patients therefore underwent iliofemoral venous thrombectomy and
distal AVF, which preserved the limbs in all of
them. The 9 other patients, who had venous gangrene, underwent iliofemoral thrombectomy, and
those who required inevitable below-knee and transmetatarsal amputation had it performed after decreasing leg edema. All patients underwent caval filter insertion before venous thrombectomy, and
there was no pulmonary embolism or immediate
mortality.
“The rate of PCD in our patients was 12%
(15/125), and progression to venous gangrene was
60% (9/15),” said Dr. Laohapensang.
After iliofemoral venous thrombectomy, the patients had less pain and decreased limb edema.
Four patients (five extremities) underwent belowknee amputation because their venous gangrene involved skin and subcutaneous tissue down to the
muscle compartment; seven patients underwent
transmetatarsal amputation. There was no immediate mortality. Anticoagulation treatment was given for 6 months. The distal AVF was closed as one
secondary operation 6 weeks after initial operation.
During follow-up, seven patients died from advanced carcinomas 7-20 months after the operation.
The remaining 8 patients have been followed up regularly over 72 months. Two of these patients (25%)
had recurrence of DVT; three patients (37.5%) developed reflux in at least one deep venous segment
without signs or symptoms of postphlebitic syndrome.
“Vascular surgeons should include contemporary venous thrombectomy as part of their routine
operative armamentarium, offering this procedure
to patients with extensive deep vein thrombosis involving the iliofemoral venous system, especially if
other options are not available or have failed,” said
Dr. Laohapensang.
■
claudication or critical limb ischemia (CLI) between October 2006 and March 2012. Of these, 517 patients who
reached a follow-up of at least 2 years were included in the
study.
A total of 827 stents were implanted in 543 limbs. Patients’ survival, limb salvage, and primary and secondary
patency were analyzed using the Kaplan-Meier method.
Primary patency was defined as the absence of hemodynamically significant stenosis on duplex ultrasound imaging (systolic velocity ratio less than 2.4) at the target lesion
and without target lesion revascularization, according to
Dr. Torsello, of the department of vascular surgery at St.
Franziskus-Hospital in Münster, Germany.
Multivariate analysis as a time-to-event evaluation for
risk factors concerning restenosis or occlusion was done
by Cox proportional hazard analysis.
The average patient age was 70.6 years, and a majority
(65%) were men. In all, 22.1% of the patients were treated for CLI and 77.9% for claudication. Angiography
showed TASC II C or D lesions in 35.5% of patients, a complete occlusion in 42.7%, and popliteal involvement in
13.8%. A total of 827 nitinol stents were used to treat (1.53
stents per limb). The average lesion length was 154 mm.
After a mean follow-up of 93.4 months, 69 (18.8%) patients died. Mean ankle-brachial index increased from
0.67 to 0.98 at follow-up, a significant difference.
Primary patency rates at 1, 3, and 5 years were 86%,
75%, and 61%, respectively, with no significant difference
between TASC A/B and C/D lesion groups or between
bare metal or drug-eluting stents. Target lesion revascularization was performed in 27.8% of the limbs treated.
Secondary patency rates were 95%, 90%, and 76% after 1,
3, and 5 years. A total of 8 patients (1.5%) underwent major amputation, and the amputation rate was significantly higher in the CLI group, he said.
“Stenting of the SFA is associated with an acceptable success rate even after 5 years and in patients with long SFA
lesions. Outcome was independent of TASC classification,” Dr. Torsello said. “The use of femoropopliteal stenting has expanded considerably in recent years. While
most prospective studies have shown data for 2-3 years, we
now have long-term results showing the role of stenting
even in long SFA lesions.”
■
Session 31 – VEITH: Current Optimal
Surgical Treatment of Phlegmasia
Cerulea Dolens
Friday, 9:31 a.m. – 9:36 a.m.
Session 28 – VEITH: Long-Term (2-5 Years)
Results of SFA Stent Performance in 1000
Patients (a Belgium/Germany Registry Report)
Friday, 9:26 a.m. – 9:31 a.m.
SFA
•
from page 1
11/15/2012
1:01 PM
Page 9
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November 20 – 24, 2013
Sponsored by
www.VEITHsymposium.org
www.AIMsymposium.org
www.AVIDsymposium.org
LOCATION
Hilton New York
1335 Avenue of the Americas
New York, NY
Para la información en Español,
visita por favor:
www.VEITHsymposium.org/Español
View the Complete 2012 VEITHsymposium
Conference Online: www.veithondemand.com
Level 1 Evidence Helps
Guide Proper Statin Use
tatins are associated with several tervention, Winchester et al. noted sigbeneficial actions in patients un- nificantly reduced postprocedural MIs
dergoing open surgical or en- for all noncardiac surgical procedures.
dovascular procedures, but the patho- RCT data from the largest vascular
physiological mechanisms of action surgery study, on 497 patients, agreed
remain unclear. Previous reviews of that statins reduced the risk of mythe literature emphasized their periop- ocardial ischemia, and indicated an aderative impact and indicated the im- ditional significance in risk reduction of
portance of timing and dosage of oral death from cardiovascular causes or
statin therapy, based mainly on level II MI.
Despite the overwhelming evidence
evidence, according to Dr. Christos D.
favoring perioperative statin use, the
Liapis.
In his presentation, “Why Do Statins search results indicate that relevant ranDecrease Preoperative and Periproce- domized clinical research in the field of
dural Risks: What Is Optimal Drug vascular surgery patients is considerDose and Timing?” on Friday morning, ably poorer than in the fields of cardiac
surgery and intervenDr. Liapis will review
tional/clinical cardiollevel I evidence for the
ogy, said Dr. Liapis.
use of statins in the
STATINS REMAIN
“This is surely an
perioperative/periproUNDERUTILIZED IN
expression of the uncedural period, focusderutilization and subing on modes of acVASCULAR SURGERY.
optimal employment
tion, timing of oral
of statins in vascular
administration, and
surgery, but it could
dosage effects.
He and his colleagues searched Med- also reflect the impact of ethics inline, using the terms “statins and vas- volved in depriving the high-risk vascular surgery” and “statins and periop- cular surgery patient of statin therapy,
erative and vascular surgery,” and or even the lack of funding,” he suglimited the results to randomized con- gested.
Dr. Liapis will explain why statins extrolled trials (RCTs) and systematic reviews (SRs). Apart from relevance, the ert these perioperative protective carinclusion criteria employed were ran- diovascular effects as determined by
domization to statin vs. placebo or their pathophysiological mechanisms
statin vs. different dosage of statin and of action, specifically their effects on
English language. The full text of the vascular systems. Beyond their lipidremaining articles was retrieved, and lowering effects, statins also have been
references were evaluated for further shown to directly alter vascular physiology. However, vascular surgery RCT
relevant papers.
The search yielded eight papers de- data are quite limited in number comtailing vascular surgery RCTs pertain- pared with respective studies conducting to the effects of perioperative statin ed on cardiac surgery and cardiology
administration. Of those, three studies patients, and have been confined to
had clinical end points, and five inves- aneurysmal and carotid disease.
These vascular studies show that
tigated biomarkers and histopathology
for aneurysmal and carotid disease. atorvastatin seems to inhibit abdominal
The search also yielded 127 non-vas- aortic aneurysm (AAA) disease procular surgery RCTs (cardiology, car- gression by reducing a proximal sigdiac surgery, and noncardiovascular naling molecule in the pathogenesis of
surgery), addressing statin influence AAA, including dendritic cells (key playduring peri-interventional, periopera- ers in the inflammatory reaction and
tive, or peri-ischemic event periods. In degradation of the extracellular maaddition, the search found 15 SRs that trix), resulting in reduced inflammatowere recognized as relevant to the sub- ry cell content. In addition, ezetimibe,
ject, 9 of which involved cardiac a cholesterol absorption inhibitor used
surgery or percutaneous coronary in- in combination with statins, was retervention (PCI). No SR addressing vas- cently shown to reduce aortic wall procular surgery patients alone was iden- teolysis and inflammation, key processtified, according to Dr. Liapis, who is a es that drive AAA expansion. With
professor of vascular surgery at the regard to carotid atherosclerosis, an
University of Athens in Greece and older, small RCT with 24 patients that
chairman of the department of vascu- looked at histopathology biomarkers
lar surgery at “Attikon” University Hos- noted that statins promote atherosclerotic plaque stabilization, again involvpital in Athens.
Two recent meta-analyses of RCT ing inflammation down-regulation.
To further elucidate statins’ mechadata agree that perioperative statin use
decreases the risk of myocardial in- nisms of action on perioperative vasfarction (MI) during the periprocedur- cular and microvascular physiology, Dr.
al period. More specifically, Chopra et Liapis and his colleagues reviewed the
al. reported on 2,292 statin-naive pa- richer RCT literature on cardiac phystients and found that in cardiac and iology from the past 2 years for newer
noncardiac surgery, perioperative statin evidence. Improvement of direct entreatment reduced the risk of MI. For dothelial function through flow-medi4,805 patients on statins before the inContinued on following page
S
11/15/2012
1:01 PM
Page 11
VEITHsymposium
Benefits vs. Risks
Statins • from page 1
Spijkenisse, the Netherlands.
Statin trials have reported conflicting results with
regard to the risk of developing type 2 diabetes. In
the WOSCOPS (West of Scotland Coronary Prevention Study) trial, there was a 30% decreased risk
of new-onset diabetes with pravastatin compared
with placebo. However, in the JUPITER (Justification
for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) study, an
increased hazard ratio of 25% for newly diagnosed
diabetes was seen in patients randomized to rosuvastatin. In this study, patients with an LDL-cholesterol level below 3.4 mmol/L were enrolled. Despite
the increased risk of diabetes in patients randomized
to rosuvastatin, the combined end point for MI,
stroke, arterial revascularization, unstable angina,
and cardiovascular death over a period of only 1.9
years was 44% lower than for the placebo group.
Several studies have now specifically addressed the
question of whether statins lead to an increase in diabetes. In a meta-analysis of 91,140 patients, 4,278
developed diabetes (2,226 patients on statins and
2,052 controls); the odds ratio for the development
of diabetes with statins was 9% during 4 years of follow-up. So for every 255 patients treated for 4 years
with a statin, one patient will develop diabetes. The
authors calculated that one additional patient developed diabetes for every three protected from a
major CV event. Age appeared to be a contributing
factor, as the odds ratio for the development of diabetes was higher in older patients. The meta-analysis showed that risk was not associated with the type
of statin, but the effect appeared to be dose dependent. The odds ratio for newly diagnosed diabetes
was 12% higher for intensive-dose therapy compared
with moderate-dose therapy, although there was also
a 16% greater risk reduction for cardiovascular
events.
The effect of dosing was studied in a recently published meta-analysis investigating whether intensivedose statin therapy is associated with a greater risk
of developing diabetes than moderate-dose therapy.
Five statin trials were evaluated. The intensive-dose
therapy was associated with a 12% increased risk of
new-onset diabetes during a 4.9-year follow-up.
Compared with moderate-dose allocated patients,
the number needed to harm per year for intensivedose statin therapy was 498 for newly diagnosed diabetes, while the number needed to treat per year
was 155 for cardiovascular events.
Recently, data were published from the Women’s
Health Initiative study. A total of 153,840 postmenopausal women aged 50-80 years were enrolled
Continued from previous page
ated dilatation of the brachial artery was
attributed to statin treatment in cardiac
surgery patients by Brili et al. Endothelial function was also found to be augmented by direct improvement in vascular nitric oxide (NO) bioavailability
and reduction in vascular oxygen
through tetrahydrobiopterin-mediated
endothelial NO synthase coupling, independently of LDL-cholesterol levels.
Finally, an RCT by Antoniades et al.
showed that the endothelial redox state
of saphenous vein bypass grafts was improved by preoperative statin administration through inhibition of vascular
Rac1-mediated activation of NADPH
oxidase.
On a molecular level, apart from reducing interleukins, short-term (12-
in the study. In this observational study, women taking statins had a 48% increased risk of diabetes
compared with women not taking statins.
These various studies did have limitations that
should be considered, according to Dr. Poldermans.
The diagnosis of diabetes differed among the
studies, varying from fasting glucose measurements
to physician-reported diagnosis. Interestingly, when
the authors used only fasting blood glucose measurements when evaluating the trials, the differences in incident diabetes between the statin and
placebo groups were no longer statistically significant.
The patients who appear to be most at risk are
those over 65 taking multiple medications to lower
cholesterol; women; and those with a smaller body
frame, kidney or liver disease, and type 1 or 2 diabetes. Of note, these are also components of the
metabolic syndrome. Perhaps statins unmask disease
in people who will develop diabetes soon anyway.
There is an interesting hypothesis suggesting that the
increased muscle complaints can make patients less
likely to exercise, resulting in more diabetes.
Overall, patients with diabetes benefit from statins
by having fewer cardiovascular events. There is also
enough evidence now from clinical trials to conclude
that statins, at least at high doses, are associated with
a significantly increased risk of developing type 2 diabetes. Despite the risk of diabetes, however, in people who are at high risk for heart attacks and strokes,
the use of statins significantly reduces the overall risk
of having a serious cardiovascular event. In addition
to the tests performed during follow-up of statintreated patients, glucose tests should be given.
“The immediate benefits of statins on cardiac
mortality heavily outweigh the potential risk of late
cardiac events in newly diagnosed diabetes,” said Dr.
Poldermans. The absolute risk is rather low, and the
reduction in cardiovascular events is much greater.
Although treating 255 patients with statin therapy for
4 years would result in one case of incident diabetes,
it would prevent 5.4 coronary deaths or MIs per 1mmol/L reduction in LDL-cholesterol.
“It may, however, be prudent to periodically screen
patients for the development of diabetes, particularly
those who are on intensive-dose therapy,” he concluded.
■
Session 29 – VEITH: What’s All This
Hoopla About Statins and Mental Fogginess, Increased Blood Sugar and Diabetes:
Should It Make a Difference in Statin Usage
or Is It a Witch Hunt?
Friday, 11:03 a.m. – 11:08 a.m.
hour) statin preload prior to PCI has
been proven to significantly lower circulating cellular adhesion molecules
such as intercellular cell adhesion molecule-1 and vascular cell adhesion molecule-1, an effect associated with reduction of procedural myocardial injury in
these patients. Cellular response to inflammation is also altered by statins that
seem to upregulate the beneficial expression of CD4+CD25+ regulatory T
cells (Tregs), transcription factor FoxP3,
and transforming growth factor-beta expression in the infarct-related coronary
artery in patients with ST-segment elevation myocardial infarction. Finally, arterial remodeling and endothelialization
are promoted by statins through mobilization of endothelial progenitor cells,
as recently reported by Hibbert et al.
Dr. Liapis will discuss specific dosage
11
Don’t Miss
Friday’s Poster
Competition
oin your colleagues at the 6th Annual ISVS/
VEITHsymposium Poster Competition, which
takes place at 2 p.m. on Friday in the
Rhinelander Gallery on the 2nd Floor. Vascular
surgeons, including fellows in training, will present their work to a panel of esteemed judges:
J
Peter Gloviczki, MD
Ali F. AbuRahma, MD
Kenneth Ouriel, MD, MBA
Ali Amin, MD, RVT
Enrico Ascher, MD
Giorgio M. Biasi, MD
Piergiorgio Cao, MD
Nicholas J.W. Cheshire, MD
Krassi Ivancev, MD, PhD
Christos D. Liapis, MD
Frans L. Moll, MD, PhD
Dieter Raithel, MD, PhD
Vicente Riambau, MD, PhD
Norman M. Rich, MD
Carlo Setacci, MD
Eric L.G. Verhoeven, MD, PhD
Judges will select the best posters based on a
3-minute oral presentation, and winners will
receive cash prizes of $1,000, $500, and
$250 for first, second, and third place, respectively. Winners will also receive a certificate of merit presented by Dr. Enrico Ascher,
president of the International Society for Vascular Surgery.
The International Society for Vascular Surgery was
formed in 2003 under the initiative and guidance of
Sir Peter RF Bell, MD, and Frank J. Veith, MD, in
response to the need for an international organization committed to the recognition and promotion of
vascular surgery as a specialty that is separate and
distinct from general and cardiothoracic surgery.
The award presentation will take place on Saturday at noon in the Grand Ballroom. The
ISVS/VEITHsymposium Poster Competition is
sponsored by the International Society for Vascular Surgery and is made possible through a grant
from Medtronic.
data as well. Atorvastatin is the most
studied statin among recent RCTs. Based
on these data, patients should receive
atorvastatin 40 mg daily for at least 3
days prior to any intervention. An additional high loading dose (80 mg) of atorvastatin 12 hours before, followed by a
preprocedural (2-4 hours) 40- to 60-mg
dose, seems to further augment the beneficial effects sustained at 24 hours after
the intervention, without adverse events.
Postoperative statin therapy should be
continued, because published evidence
suggests that statin withdrawal is associated with worse cardiac outcomes. It is
also suggested that higher statin dosage
be considered for polyvascular disease
patients due to increased atherosclerotic burden.
“Statins are associated with several
beneficial actions in patients undergoing
open surgical or endovascular procedures. Nevertheless, statin use in vascular patients still remains underutilized
and suboptimal, as reflected by the low
number of randomized control trials in
the field. Ideally, statins should be initiated a minimum of 3 days before the
procedure, and a preprocedural high
loading dose 12 hours prior to the intervention should be implemented,” Dr.
Liapis concluded.
■
VEITH: Session 29 – Why Do
Statins Decrease Preoperative
and Periprocedural Risks: What
Is Optimal Drug Dose and
Timing?
Friday, 10:57 a.m. – 11:02 a.m.
Grand Ballroom, East Third Floor
11/15/2012
1:01 PM
Page 12
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the aneurysm, with an inner wall diameter of no less than 16 mm and no greater than 30 mm, and with an aortic angle of ≤ 60 degrees if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is < 10 mm; adequate distal iliac landing zo
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11/15/2012
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Page 13
COMPELLING OUTCOMES
OVATION CLINICAL TRIAL
R ESULTS
S AF E TY *
Tre a tme nt
to 3 0 Da y s
(N=161)
Tre a tme nt
3 1 - 3 6 5 Da y s
(N=158)
2.5% (4)
3.8% (6)
0%
0%
(N=153)
(N=138)
Technical Success
100%
N/A
Freedom from Type I and III Endoleaks**
100%
100%
Freedom from Migration**
100%
100%
Freedom from Rupture
100%
100%
Freedom from Conversion to Open Repair
100%
100%
M a j o r A dv e r s e E v e nts
D e vi c e R e l a t e d M a j o r A d v e r s e E v e nts
E F F E C TI V E N E S S
Results include first in man (FIM) experience.
* Major adverse events reported as of 6th of June 2012 based on CEC adjudicated data from Ovation study.
** Results reported as of 6th of June 2012 based on Core Lab Data from Ovation study.
EXPANDING EVAR - SAFELY
ANATOMICALLY CHALLENGING 63 PATIENT SUBGROUP
39
%
NECK LENGTH
(63 / 161)
<1 0 M M
of patients treated in the
13 pts.
Ovation pivotal trial had
MI N I MU M
AC C E SS V E SSE L
access vessels <6mm,
<6 M M
aortic neck lengths
38 pts.
39%
<10mm, or both.
Ovation had excellent
61%
(63/161)
(98/161)
results in this anatomically
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no subjects experiencing
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BOT H C R I T E R I A
12 pts.
14
11/15/2012
1:02 PM
Page 14
Total Endo Approaches to TAAA Repair Envisioned
“In the meantime, we should now beue to the widespread popularity of
endovascular approaches being gin dialogue to assess and clarify which
used to repair the thoracic and ab- patients will be best served by eTAAA redominal aorta, there is considerable in- pair and which will be best served by
terest in developing a similar approach contemporary open TAAA approaches,”
for patients who have experienced he counseled. “Part of this dialogue must
thoracoabdominal aortic aneurysms acknowledge the reduced risk of repair
(TAAAs). Traditionally, open TAAA re- in contemporary open TAAA repair, especially the greatly reduced
pair has presented a substanrisk of paraplegia,” accordtial risk of death, paralysis,
ing to Dr. Coselli, of the
and renal failure – another
Texas Heart Institute at St.
reason to envision an enLuke’s Episcopal Hospital
dovasculuar alternative, acand Baylor College of Medcording to Dr. Joseph S.
icine in Houston.
Coselli.
He will focus on the issue
Current endovascular apof clarifying which patients
proaches to TAAA repair inmay benefit from emerging
volve either experimental,
eTAAA repair.
purely endovascular repair
Obvious first choices inor hybrid repair. The latter DR. JOSEPH S. COSELLI
clude:
approach uses standard offthe-shelf endovascular aortic devices Patients with relatively limited physicombined with open repair to reroute ologic reserve. Individuals who are genthe major branching visceral arteries, erally understood to be at enhanced opDr. Coselli said.
erative risk due to multiple existing
Largely poor experience with these comorbidities may benefit from eTAAA
hybrid approaches has led to interest in repair.
perfecting a purely endovascular apComorbidities include preoperative reproach to TAAA repair (eTAAA repair) nal dysfunction (especially the need for
rather than improving hybrid method- preoperative hemodialysis), impaired left
ologies.
ventricular function, liver disease, poor
In his presentation on Friday after- pulmonary function, frailty or debilitanoon, “I Have Been Converted: For tion, and advanced age.
Some TAAAs Open Surgery Should Be Patients with limited life expectancy.
Replaced by Endovascular Treatments: Such patients may benefit from the reWhen Should It Not Be?” Dr. Coselli duced hospitalization that is common in
will discuss how eTAAA repair will be- most endovascular repairs. Any lingering
come a more practical option in careful- concerns regarding durability would not
ly selected TAAA patients within the be an issue in this patient set.
next decade.
Patients in need of lifesaving emergent
More widespread use of the procedure measures. Those with conditions such as
will depend on sufficient development of rupture, trauma, fistula, or acute dissecnew devices, greater device availability, tion with malperfusion may benefit from
and improved imaging technology – in- endovascular therapy to stabilize and
cluding contrast agents.
serve as a bridge-to-repair.
D
Patients with a hostile operative field.
This could occur after radiation therapy
of the chest or abdomen or in the presence of a sternal plate, but should be
more significant than a redo lateral thoracotomy (as mortality related to open
reoperation is not excessive).
Patients capable of following a rigorous surveillance protocol. It is highly
probable with these complex pathologies
and devices that significant numbers of
patients will require additional intervention. This will need to be determined by
follow-up imaging, and it is to be expected that many patients will be unable
or unwilling to follow surveillance imaging protocols.
On the flip side, there are patients
who are unlikely to benefit from emerging eTAAA repair. These include:
Patients with connective tissue disorders. Endovascular aortic repair is generally inadvisable in patients with connective tissue disorders.
Patients who are relatively young (under age 60). While vascular surgeons
may have a better understanding of patient-specific factors that affect durability in the next decade, it makes sense to
restrict eTAAA repair to older patients,
at least in the initial period.
By necessity, eTAAA repair will involve devices with greater complexity
than devices used for thoracic endovascular aortic repair (TEVAR) or endovascular aortic repair (EVAR), and premarket experience alone may not identify
possible sites of device failure.
Patients with known or suspected infection.
Patients with TAAA related to chronic aortic dissection may not benefit from
eTAAA repair, as the false lumen may
continue to perfuse the aneurysm in a
retrograde fashion.
Patients with unusual anatomic features that do not match whatever specifications future eTAAA approaches may
have when these devices come to market.
Great care must be taken when extrapolating outcomes of lesser-extent
TAAA repairs to more extensive TAAA
repairs. Whether it would be wise to limit eTAAA repair to lesser extents solely
on the extent of repair alone is not yet
clear. Currently, the best method to repair extensive TAAAs – surgical, hybrid,
or purely endovascular – is quite controversial.
In the near future, while the need for
aortic intervention is expected to greatly increase, it is likely that only a handful of centers will have sufficient experience and available equipment to perform
eTAAA repair. However, a similar argument can be made for open TAAA repair,
because low-volume centers have much
worse outcomes than do experienced,
high-volume centers, Dr. Coselli pointed
out.
“Cardiothoracic and vascular surgeons, [and] interventional radiologists
and cardiologists, should be working toward identifying which TAAA and other aortic pathology patients will be best
served by any given specialty and perhaps move in the direction of establishing additional tertiary centers of aortic
expertise,” he concluded.
■
Session 36 – VEITH: I Have Been
Converted: For Some TAAAs
Open Surgery Should Be Replaced by Endovascular Treatments: When Should It Not Be?
Friday, 2:30 p.m. – 2:35 p.m.
Non-CME Events on Friday and Saturday
Cardiovascular Systems, Inc.
Advanced Access Skill Development Cadaver
Course: Antegrade/Retrograde Tibial Access and
Treatment with Orbital Atherectomy
This hands-on cadaver training course is for the
experienced vascular surgeon who wants to learn
antegrade access and retrograde tibial access via
the anterior, posterior, peroneal, dorsalis pedal,
plantar, and digital arteries.
Friday, 3:30 p.m. – Murray Hill Suite B, 2nd Floor
Cook Medical
Zenith Annual Luncheon
Friday, Noon – Petit Trianon
Pavilion open 8 a.m. – 5 p.m. Friday and
8 a.m. – 2 p.m. Saturday, Trianon
2 p.m., Clinton & Gibson Suites, 2nd Floor
Ventana™ Fenestrated System (Daniel Clair,
MD)
AFX™ Endovascular AAA System Hands-On
Glass Model Demo (Julio Rodriguez, MD,
Venkatesh Ramaiah, MD, Jean Paul de Vries, MD,
Jeffrey P. Carpenter, MD)
Nellix® Endovascular Sealing System Polymer
Technology Hands-On Demo (Andrew Holden, MD)
Friday, 1:30 p.m. – 4:30 p.m., Gramercy Suite,
2nd Floor
Edited Live Cases – AFX™
Endovascular AAA
Presenter: Chris Kwolek, MD
Saturday, 10 a.m., Gibson Suite
Gore
Covidien
Pavilion open 8 a.m. – 5 p.m. Friday and
8 a.m. – noon Saturday, Sutton Parlor Center
Endologix
Pavilion featuring live cases and hands-on
demos addressing endovascular techniques and
AAA systems.
Friday, 8 a.m. – 5 p.m. and Saturday, 8 a.m. –
Medical Mastery Series – Experience first-hand
the GORE® Hybrid Vascular Graft and a lifelike virtual environment with the Conformable GORE®
TAG® Device and the GORE® EXCLUDER® Device
featuring C3® Delivery System.
Friday, 9 a.m. – 5 p.m. and Saturday, 9 a.m. –
2 p.m., Nassau Suite
Lunch Symposium:
Maximizing Economic Value of Aortic Endovas-
cular Procedures: Site Experience and Outcomes
Friday, Main Pavilion, Mercury Ballroom
Networking Breakfast for Women:
Saturday, 6 a.m., Concourse G, Concourse Level
Evening Event:
Innovation Showcase, an interactive poster session
Saturday, 6 p.m., Main Pavilion, Mercury Ballroom
Lunch Symposium:
Latin American Day
G.R.E.A.T. Aortic Brazil Registry _ Global and
Brazilian Update
EVAR Treatmemt With GORE® EXCLUDER® AAA
Endoprosthesis Featuring C3 Delivery System –
Welcoming a Second Opportunity
Endovascular Treatment of Acute Thrombosis in a
Previous Aortobifemoral and Femoropopliteal Bypass
Saturday, Main Pavilion, Mercury Ballroom
VEITHsymposium
EVEREST (European Virtual reality Endovascular RESearch Team) Simulation Luncheon Symposium and Hands-On Training
Lunch Symposium: Friday, 12:10 p.m. –
1:15 p.m., Gramercy Suite A, 2nd Floor
Hands-On Training: Friday, 1:30 p.m. – 4:30
p.m., Gramercy Suites A & B, 2nd Floor
11/15/2012
1:02 PM
Page 15
16
11/15/2012
1:02 PM
Page 16
2nd Floor
2012 VEITHsymposium Exhibitors and Exhibit Hall
Aastrom Biosciences
1117
Aastrom Biosciences is the leader in developing therapies for patients suffering from severe, chronic cardiovascular diseases. The
company’s proprietary cell-processing technology enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy
expanded from a patient’s own bone marrow
and delivered directly to damaged tissues.
Aastrom has advanced ixmyelocel-T into latestage clinical development, including a Phase
3 clinical program to study patients with critical limb ischemia and a Phase 2b clinical
trial in patients with ischemic dilated cardiomyopathy. For more information, visit
www.aastrom.com. For more information on
the pivotal REVIVE Phase 3 clinical trial, visit
www.revivecli.com.
Abbott Vascular
1306
Abbott Vascular is one of the world’s leading
vascular care businesses. Abbott Vascular is
focused on transforming the treatment of vascular disease and improving patient care by
combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and
education. Visit www.abbottvascular.com.
Alseal
1124
Alseal develops innovative technologies for
minimally invasive cardiovascular surgery.
On July 31, 2012, the FDA approved the
HQS introducer (510 K from 18 Fr to 26 Fr
length 300 mm). The HQS valve, dedicated
to large endovascular access, provides full
sealing. It minimizes blood loss and improves the safety of aortic endoprosthesis
procedures. The valve diameter is actively
adapted via a pusher to the outer diameter
of the device, introduced into the femoral
artery either surgically or percutaneously.
The device accepts and seals around any
endoprosthesis delivery system. Complementary products are developed to secure a
percutaneous approach for endoaortic procedures and complex endoprosthesis deployment. Visit us at www.alseal.net.
AngioDynamics, Inc.
105
AngioDynamics, Inc. is a leading provider of
innovative, minimally invasive medical devices used by professional health care
providers for vascular access, surgery, peripheral vascular disease, and oncology. Product
lines include market-leading ablation systems; fluid management systems; angiographic products and accessories; and vascular access, angioplasty, drainage,
thrombolytic, and venous products. Visit
www.AngioDynamics.com.
AngioScore, Inc.
1105
AngioScore, Inc. is the developer of the AngioSculpt family of angioplasty balloon
catheters for coronary and peripheral artery
disease. AngioSculpt® balloon catheters feature a semi-compliant balloon surrounded by
a unique nitinol scoring element that provides circumferential scoring of plaque for
precise and predictable luminal enlargement
across a wide range of lesion types.
Aptus Endosystems, Inc.
WP13
Aptus Endosystems, a privately held medical device company, develops and manufactures advanced technology for endovascular aneurysm
repair (EVAR). We are developing innovative
technologies to transform EVAR, empowering
physicians to perform minimally invasive
aneurysm repair while still providing the control and potential long-term durability of open
surgical repair. Our initial product offering includes an innovative helical anchor technology, the HeliFX™ Aortic Securement System
(bears the CE Mark and US FDA clearance).
Visit www.aptusendosystems.com.
ARDMS
1304
The American Registry for Diagnostic Medical
Sonography® (ARDMS) is an independent,
nonprofit organization that administers examinations and awards credentials in the areas
of diagnostic medical sonography (RDMS),
diagnostic cardiac sonography (RDCS), vascular interpretation (RPVI), vascular technology
(RVT), and musculoskeletal sonography
(RMSK). ARDMS has more than 77,000 certified individuals throughout the world and is
considered the global standard in medical ultrasound credentialing.
Artegraft, Inc.
WP19
Artegraft Collagen Vascular Graft is a Fistula
in a Bottle. A 3-year randomized, prospective
study at Massachusetts General Hospital confirms superior primary patency and lower intervention rate vs. ePTFE. Artegraft is pulsatile, available for access within 10 days,
and triple pressure–tested to ensure quality
and reliability. It offers superior surgical handling and anastomotic compliance with no
suture line bleeding. Visit www.artegraft.com.
Atrium Medical Corporation
WP6, 7, 15
Atrium Medical Corporation offers innovative
products for the interventional and vascular
market, including ClearWay™ OTW local therapeutic infusion catheter, Xpress-Way™ RX
manual extraction catheter, Advanta™ V12
covered stent, and FLIXENE™ dialysis access
grafts. Visit www.atriummed.com.
Avinger
1113
Avinger develops next-generation catheterbased technologies for the treatment of peripheral artery disease. Leveraging core competencies in medical device catheter
engineering, Avinger markets Wildcat and
Kittycat catheters, and recently received the
CE Mark to market advanced technologies
that guide endovascular therapy and intervention using real-time positioning capability.
Visit www.avinger.com.
B. Braun Interventional
Systems, Inc.
1102
B. Braun Interventional Systems, Inc. is a
worldwide leader in vena cava filters and interventional accessories, notably the Vena Tech
IVCTM filter. In the U.S., B. Braun offers vascular access, interventional accessory, and angioplasty and valvuloplasty balloon products.
Bard Peripheral Vascular, Inc. 403, 405, 407
Bard Peripheral Vascular, Inc. features a
range of interventional medical devices designed to facilitate central lumen CTO re-
canalization; vascular stent systems, the only
commercially available SFA indicated stent;
endovascular stent grafts, the only AV access
indicated stent graft; and market-leading offerings of PTA catheters and vena cava filters. Visit www.bardpv.com.
Baylis Medical Company
1106
Baylis Medical Company designs, manufactures, and distributes products with applications in interventional cardiology, electrophysiology, and interventional radiology. The
PowerWire™ radiofrequency guidewire is
used for crossing lesions in totally occluded
peripheral vessels. Radiofrequency energy vaporizes a channel through occlusions with
minimal trauma to surrounding tissue.
Biocompatibles, Inc.
1118
Biocompatibles, with its heritage of leadership and innovation in interventional oncology, is now a BTG International group company. We are investing in product development
and clinical trials to deliver a shared vision of
excellence in interventional medicine.
Bolton Medical
110, 112
Bolton Medical is a subsidiary of the Werfen
Life Group, which manufactures and distributes medical diagnostic solutions and medical devices worldwide. Bolton Medical provides endovascular therapies including the
Relay stent graft and Relay NBS for thoracic
repair. In the United States, the Relay thoracic stent graft has an investigational device
exemption.
Boston Scientific
WP 16, 17
Boston Scientific is a worldwide developer,
manufacturer, and marketer of medical devices that are used in a broad range of interventional medical specialties. Boston Scientific has advanced the practice of
less-invasive medicine by providing clinicians
an extensive portfolio of innovative products
and technologies to improve the quality of
patient care. Visit www.bostonscientific.com.
Continued on following page
11/15/2012
1:02 PM
Page 17
VEITHsymposium
Cardiovascular Systems, Inc.
1114, 1116
Cardiovascular Systems, Inc. (CSI) develops
innovative solutions for treating peripheral
and coronary vascular disease. Our primary
focus is helping physicians conquer calcium.
CSI is committed to clinical rigor, ingenuity,
and a defining drive to set the standard in
safe, effective, economical medical devices
that improve patient outcomes.
Carolon Company
1402
CeloNova BioSciences
1120
CeloNova BioSciences develops, manufactures, and markets a family of products
based upon the unique properties of
Polyzene®-F, a coating material transparent
to the human body’s natural immune system.
CeloNova markets Embozene® Microspheres
and CATANIA™ Coronary Stents.
Charing Cross Symposium/Vascular
News/BIBA Medical
R1
Charing Cross (CX) attracts more than 3,600
vascular specialists from 80 countries to CX
Symposium, which provides a multidisciplinary forum for senior vascular and endovascular specialists. Save the date for CX 2013,
April 6-9, in Olympia, London, U.K. Visit
www.cxvascular.com/cxsymposium.
Vascular News International, a quarterly
newspaper with the latest news and features
on innovations and debates in the vascular
and endovascular world, reaches more than
19,500 subscribers in Europe and the United States. Visit our booth and
subscribe free of charge or online:
www.vascularnews.com; NEW: iphone/ipad
App is available for free download.
Dornier MedTech
1107
Dornier MedTech, committed to providing innovative solutions for a variety of health care
fields worldwide, revolutionizes spider and
varicose vein treatments by offering multifunctional, state-of-the-art, high-performance
diode lasers.
Edwards Lifesciences
1300, 1302
Edwards Lifesciences is a world leader in advanced cardiovascular and noncardiovascular
disease treatments. Genuine Fogarty® clot
management catheters, exclusively available
from Edwards, have evolved and advanced to
meet specialists’ unique needs. We also have
Fogarty® surgical atraumatic occlusion products. Visit www.edwards.com.
EKOS Corp.
WP18
The EkoSonic® endovascular system with
MACH4e-EKOS ultrasound accelerated
thrombolysis is the safe alternative for dissolving thrombi completely. It is currently
used by interventional radiologists, cardiologists, and vascular surgeons to treat patients
with peripheral arterial occlusions and deepvein thrombosis. Visit www.ekoscorp.com.
Endologix, Inc.
213, 215
Endologix, Inc. manufactures endovascular
stent-grafts to treat abdominal aortic
aneurysms (AAA). Endologix develops minimally invasive treatments for aortic disorders
including an endovascular AAA system. Future technologies include an off-the-shelf
fenestrated stent-graft system and an endovascular aneurysm sealing system.
Endovascular Today
Cook Medical
Rendezvous and
Petit Pavilion
Cook Medical is the world’s largest privately
held developer and manufacturer of minimally invasive medical device technology. A
leader in the advancement of diagnostic and
therapeutic products for vascular disease,
Cook continues a tradition of innovation with
comprehensive device offerings in EVAR, leg
therapies, PE prevention, and embolization.
1202
Endovascular Today and Cardiac Interventions Today provide interventional specialists
with information encompassing techniques,
technology, and clinical data. Endovascular
Today is the premier peripheral vascular publication; Cardiac Interventions Today is dedicated to covering procedures for interventional coronary disease and structural heart
defects.
Ethicon Endo-Surgery
Cool Touch, Inc.
1400
CoolTouch develops and supplies advanced
laser technologies to medical professionals.
The CTEV 1320-nm laser for endovenous ablation of varicose veins is available in a 10and 15-watt platform to meet your practice
needs. The 15-watt system can be upgraded
with a laser-assisted lipolysis capability to incorporate aesthetics into your practice.
Cordis Corp.
108
Cordis pioneers less invasive treatments for
vascular disease. Cordis, a Johnson & Johnson company, is the world’s leading developer
and manufacturer of breakthrough products
for interventional medicine.
Covidien
205
Covidien is committed to advancing the treatment of vascular disease worldwide. With the
recent acquisition of ev3 and areas of focus
in peripheral, venous, and neurovascular disease, we offer the world’s broadest portfolio
of innovative vascular therapies. Visit
www.covidien.com/vasculartherapies.
CryoLife
1108
Delcath Systems, Inc.
1115
Delcath Systems, Inc. is a pharmaceutical
and medical device company focused on oncology. Our proprietary system is designed to
administer high-dose chemotherapy and other
therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure to those agents. We received
WP14
Ethicon Endo-Surgery, a Johnson & Johnson
company, develops and markets energy devices that are gentle on surrounding tissue
for a variety of procedures across bariatric,
colorectal, ENT, general, gynecologic, orthopedic, plastic, and thoracic specialties. Ultrasonic HARMONIC® technology offers a
unique combination of precision and multifunctionality. And ENSEAL® technology offers devices that are strong on sealing. Visit
www.ees.com.
EVC 17th European Vascular Course
(March 2013)
GE Healthcare
R3
WP2, 3, 4
GE Healthcare’s broad expertise in medical
imaging and information technologies, medical diagnostics, patient monitoring systems,
drug discovery, biopharmaceutical manufacturing technologies, and performance improvement services help customers to deliver
better care to more people around the world
at a lower cost. Visit www.gehealthcare.com.
Gore & Associates
207
More than 30 million innovative Gore Medical devices have been implanted, saving and
improving the quality of lives worldwide. Gore
Medical products include vascular grafts; endovascular and interventional devices; surgical materials for hernia repair, soft tissue reconstruction, and staple line reinforcement;
and sutures for use in vascular, cardiac, and
general surgery. Visit www.goremedical.com.
3rd Floor
CE mark approval for the hepatic
CHEMOSAT® delivery system in April 2011.
17
18
11/15/2012
1:02 PM
Hansen Medical, Inc.
202, 206
Hansen Medical, Inc., the global leader in intravascular robotics, was founded in 2002 to
develop a new generation of advanced medical robotics designed to provide a safer environment for physicians and patients, and to
enable physicians to deliver improved care for
their patients. Hansen has developed robotic
systems for peripheral vasculature and for
electrophysiology. Both systems are cleared in
the U.S. and EU for distribution.
HRA – Healthcare Research
Analytics
1111
Our team of experienced interviewers will distribute questionnaires designed to answer vital marketing and clinical questions about
the introduction of new products or the continuation of existing health care products and
services.
International Society for Vascular Surgery
(ISVS)
R2
The ISVS’s mission is to promote vascular
surgery as a distinct medical specialty worldwide through the dissemination of administrative, scientific, and clinical information
and through the creation of strategic alliances. Visit www.isvs.com.
LeMaitre Vascular
LINC
104
R4
The Leipzig Interventional Course (LINC) is
committed to advancing the scientific and
clinical evaluation and treatment of patients
with complex vascular disease through an interdisciplinary discussion of novel endovascular techniques. LINC is a comprehensive and
international live course designed to foster
collaboration and to promote the development of endovascular therapies for daily clinical practice.
Lombard Medical Technologies
209
Lombard Medical Technologies PLC is focused on providing innovative endovascular
products. Aorfix™ endovascular stent-graft
combines a pioneering design and technology
that result in outstanding clinical performance in EVAR patients with complex anatomy including highly angulated necks and tortuous iliacs. Aorfix™, currently being
commercialized in the EU, has been submitted for U.S. FDA for approval.
M2S
201
M2S provides the cloud-based data entry and
reporting system for the Vascular Quality Initiative®. VQI® is designed to improve the
quality, safety, effectiveness, and cost of vascular health care by collecting and exchanging information. It consists of a network of
regional quality groups that function under
the SVS Patient Safety Organization.
Medical Components, Inc.
(Medcomp)
1204
Medcomp advances patient outcomes through
catheter innovation and design. Recognized
as the world leader in long-term dialysis
catheters, Medcomp has leveraged its engineering expertise into the peripherally inserted central catheter and port market.
Medrad Interventional
1112
Medrad Interventional designs, manufactures,
and markets endovascular and interventional
cardiology products such as the AngioJet
thrombectomy system, the Mark V ProVis angiographic injection system, the FETCH aspiration catheter, and the Jetstream atherectomy system.
Medtronic
Page 18
103
Medtronic is committed to innovating for life by
pushing the boundaries of medical technology
and changing the way the world treats chronic
disease. We’re thinking beyond products and
beyond the status quo to continually find more
ways to help people live better and longer.
Merit Medical Systems, Inc.
WP5
Merit Medical Systems, Inc. is a leading
manufacturer of medical devices used in diagnostic and interventional cardiology and radiology procedures such as inflation devices
used in angioplasty, stent placement, and
discography; catheters; guidewires; embolotherapeutic products; products used in
administration of contrast and other fluid solutions; thrombolytic catheters; angiography
accessories; and angiography kits.
Natural Molecular Testing Corp.
1104
Penumbra
1308
Sanofi Biosurgery
107
Sanofi discovers, develops and distributes
therapeutic solutions focused on patients’
needs. Sanofi has core strengths in the field
of health care with seven growth platforms:
diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer health
care, emerging markets, and animal health.
Sanofi is listed in Paris (EURONEXT: SAN)
and in New York (NYSE: SNY). Sanofi operates in the United States as Sanofi US, also
referred to as Sanofi-Aventis U.S. LLC. Visit
www.sanofi.us or call 1-800-981-2491.
Scanlan International
1109
Simbionix is the world’s leading provider of
simulation, training, and education solutions
for medical professionals. The ANGIO Mentor™ endovascular training system includes
an ever-expanding library of simulated interventional procedures. In combination with
the PROcedure Rehearsal Studio™, the training system takes preparedness for endovascular procedures to a whole new level.
Sirtex Medical, Inc.
1406
SIR-Spheres® microspheres, manufactured
by Sirtex Medical Inc., is the first and only
fully FDA-approved radiolabeled product for
the treatment of colorectal liver metastases.
SIR-Spheres microspheres are approved for
use in Australia, the United States, the European Union (CE Mark), and Argentina
(ANMAT). Additionally, SIR-Spheres microspheres are supplied in countries such as
Hong Kong, Malaysia, Singapore, Thailand,
Taiwan, India, Israel, and Turkey. For more
information, visit www.sirtex.com. SIRSpheres® is a registered trademark of Sirtex
SIR-Spheres Pty Ltd.
Society for Vascular Surgery
TeraRecon
Transonic
1122
Tri-Medics has re-engineered the way precision surgical instruments like scissors and
needle holders are manufactured. Our products are made of a very hard but lightweight,
flexible yet resilient stainless steel that results in highly durable instruments – a scissor that cuts to the tip and remains sharp
and a needle holder that can hold any size
needle securely.
1412tt
Stryker Neurovascular
1312
Surefire Medical, Inc.
1418tt
Surefire Medical, Inc. was founded in 2009
to develop innovative infusion systems for the
interventional radiology and interventional oncology markets. Surefire’s infusion systems
are designed to precisely deliver embolic
agents through a unique microcatheter with
an expandable tip that collapses in forward
flow and dynamically expands to the vessel
wall in reverse flow in order to increase embolization efficiency, minimize reflux, and re-
TriVascular, Inc.
101
TriVascular’s initial product offerings are novel endovascular grafts focused on significantly advancing EVAR. Building on partnerships
with thought-leading clinicians worldwide,
TriVascular designs products to address unmet clinical needs and expand the pool of
patients who are candidates for EVAR.
Vascular Flow Technologies, Inc.
1200
Vascular Flow Technologies (VFT) has
launched a simple and elegant solution to the
problem of peripheral vessel stenosis through
restoration of normal (Spiral Laminar Flow™)
blood flow patterns in ePTFE grafts. SLF™
grafts also provide access for patients undergoing hemodialysis. More than 2,300 grafts
have been implanted to date and a recent
publication in Annals of Vascular Surgery
shows very encouraging 81% primary patency
at 30 months. For more information, contact
Caroline Thoms Call: +44 (0) 1382 598
532; e-mail: [email protected].
Visit:www.vascular-flow.com.
Vascular Insights
1110
Vascular Insights LLC’s therapeutic devices,
based on mechanically enhanced drug delivery, enable interventionists, vascular surgeons, phlebologists, and others to treat peripheral vascular diseases.
Vascutek, Ltd.
WP8,9
Vascutek, a Terumo Company, is a world
leader in the design and manufacture of
products that address the needs of vascular
and cardiovascular clinicians. For 30 years,
Vascutek has applied advanced and innovative technologies to develop a wide portfolio
of products that include Anacoda™, featuring
the new ONE-LOK™ body design. Visit
www.terumois.com.
Venous Symposium/Complete
Conference Management
Volcano Corporation
Wexler Surgical
1404
Wexler Surgical designs and manufactures a
variety of titanium and stainless steel specialty surgical instruments and products for cardiac, vascular, thoracic, and microsurgery.
Come see our new VATS/MICS instruments
and ask about our Optimus Series. Visit
www.wexlersurgical.com.
1310
Transonic is the recognized global leader in
gold standard, biomedical flow measurement
technology. Our trio of flow measurements
provides clinicians with the criticalmeasurements needed for access creation, monitoring, and revision. The HD03, which is used
for dialysis access monitoring, can help facilities reduce catheter usage, meet the QIP Total Performance Score, and help preserve optimal reimbursement. The HVT100 is used to
confirm the success of PTA and guide precise
endovascular banding procedures.
Tri-Medics LLC
light as the guiding elements. Volcano is
changing the assumption about what is possible in improving patient outcomes.
1101, 1103
TeraRecon is the largest independent provider
of advanced image-processing innovation for
CT, MR, and PET; advanced imaging-based
decision support; and 3-D visualization techniques. The full suite of iNtuition tools brings
unmatched flexibility and power to the medical imaging professional.
1100
Scanlan International produces more than
3,000 titanium and stainless steel instruments, including SCANLAN® LEGACY titanium forceps and needle holders, Super Cut™
scissors, Heifetz™ temporary occlusion clips,
minimally invasive instruments, and singleuse products such as the Vascular and A/V
Access Tunneling System and VASCU-STATT®
bulldog clamps. To learn more, visit
www.scanlaninternational.com.
Simbionix
duce damage to healthy tissue. For more information, visit www.surefiremedical.com.
1414tt
102
Volcano Corporation’s technologies make
imaging and therapy simpler, more informative, and less invasive. Our products empower
physicians around the world with a new generation of analytical tools that deliver more
meaningful information, using sound and
Current as of Nov. 7, 2012.
These exhibitors advertised in
VEITHsymposium News.
Last Chance
To Win Cash
On Friday
f you haven’t yet visited the Exhibit Hall, you are missing a
chance to win cash prizes.
All practicing physicians, 2ndyear fellows, and 5th-year vascular surgery residents are eligible
to participate in the Passport
Program.
Visit the exhibits in the main
Exhibit Hall on Friday between
the hours of 9:30 a.m. and
11:30 a.m. and 1:30 p.m. and
3:30 p.m., engage in meaningful discussion with industry representatives, and get your Passport stamped.
The goal is to visit as many of
the designated booths as possible and to obtain the maximum
number of stamps.
After you collect your stamps,
bring your completed Passport to
the Exhibitor Registration Desk
on the 2nd Floor Promenade by
3:45 p.m. for entry in the raffle.
Winners will be posted in the
back of the Exhibit Hall (Americas Hall 1), and cash prizes will
be presented at 4:45 p.m.
I
First Prize: $500 U.S.
Second Prize: $250 U.S.
Name Badges
For the convenience of our exhibitors and attendees, the bar
code on your name badge includes your name, address,
telephone and fax numbers,
and e-mail address. Exhibitors
can scan your name badge for
this information.
Please wear your name
badge at all times.
11/15/2012
1:02 PM
Page 19
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20
11/15/2012
1:02 PM
Page 20
It’s Debatable – Debates To Be Held Friday – Sunday
E
xperts will present broadly based
opposing views on topics of critical importance to the vascular
community each day of the VEITHsymposium.
If you missed the debates on Thursday, try to attend at least some of the
debates on Friday, Saturday, and Sunday to hear what your colleagues have
to say about how they do things.
SESSION 27: Thoracoabdominal Aortic
Aneurysms (TAAAs) and Techniques to
Revascularize Renal and Visceral
Arteries: Chimneys, Periscopes, and
Sandwich Grafts (CHIMPS)
Debate
8:15 a.m. – 8:26 a.m.
CHIMPS Are Better and Cheaper Than
Branched and Fenestrated Grafts for
Treating Complex Aneurysms:
CHIMPS Will Always Have a Major
Role
Presenter: Ralf R. Kolvenbach, MD
CHIMPS Are Inferior to Branched and
Fenestrated Grafts for Complex
Aneurysms: Long-Term Results Will
Prove it: CHIMPS Will Have Only a
Minor Role
Presenter: Stephan Haulon, MD
VEITHsymposium
SESSION 28: New Developments
in the Treatment of LowerExtremity Ischemia and CLI
Debate
9:44 a.m. – 9:55 a.m.
All CLI Patients Should Be
Treated First by Endovascular
Techniques
Presenter: Gary M. Ansel, MD
Some CLI Patients Should Be
Treated by a Bypass First: Which
Ones and Has Anything Changed
in the Past Year?
Presenter: Michael S. Conte, MD
ON DEMAND
SESSION 29: Advances in
Medical Therapy or Treatment of
Medical Problems or
Complications
(Grand Ballroom East, 3rd Floor)
www.veithondemand.com
Debate
11:21 a.m. – 11:32 a.m.
Why We Should Not Stop
Screening for Asymptomatic
Carotid Stenosis
Presenter: Glenn Jacobowitz, MD
We Should Stop Screening for
Asymptomatic Carotid Stenosis
Even Though There Is a Substantial Incidence of Silent Cerebral
Events in These Patients: What
Should We Do About It?
Presenter: Alun H. Davies, MA, DM
VIEW THE
ENTIRE 2012
VEITHsymposium
ONLINE
Debate
11:39 a.m. – 11:50 a.m.
Should Vascular Patients Be Taking a Polypill (or Multiple Pills)
for Secondary Prophylaxis? – Yes,
It Decreases Risk and Is Cost
Effective
Presenter: Don Poldermans, MD
Should Vascular Patients Be Taking a Polypill (or Multiple Pills)
for Secondary Prophylaxis? – No,
It Is Too Dangerous; Better to
Wait for Symptoms
Presenter: Erich Minar, MD
SESSION 30: New Late-Breaking
Concepts, Updates, and
Miscellaneous Hot Topics
Related to Lower-Extremity and
Aortic Disease
Purchase all the Talks, Slides, and Videos - fully synchronized - and all the Panels.
All talks will be indexed in the Accredited Online version of the meeting to correspond exactly to
the program brochure.
This Library or Components thereof can be used as an Educational Resource or Teaching Tool.
For more information on how to obtain the VEITHsymposium Online Library,
please call 800-987-9314, ext. 300.
Debate
8:05 a.m. – 8:16 a.m.
The Long-Term Results of Open
Repair Are Better Than Those of
EVAR in Most Patients
Presenter: Wilhelm Sandmann, MD
The Long-Term Results of EVAR
Are Better Than Those of Open
Repair: The EVAR I Late
Results Have Been Misinterpreted in the NEJM Article
Presenter: Juan C. Parodi, MD
Debate
8:23 a.m. – 8:34 a.m.
11/15/2012
1:02 PM
Page 21
VEITHsymposium
IFUs for EVAR Should Not Be
Stretched: The Results Don’t
Justify It
Presenter: Andres Schanzer, MD
A Propensity-Matched Comparison of EVAR and Open Repair
Shows That EVAR Is Superior
Even When IFUs Are Stretched
Because of Imperfect Anatomy
Presenter: William D. Jordan Jr.,
MD
Debate
8:35 a.m. – 8:46 a.m.
Bare Stents Are the Best Treatment for Most Adult Aortic
Coarctations: Why Is This So?
Presenter: Christoph A. Nienaber,
MD, PhD
Covered Stents Are the Best
Treatment for Most Adult Aortic
Coarctations
Presenter: Dietmar H. Koschyk, MD
SESSION 32: Progress in the
Treatment of Venous Disease –
Part 1B
Debate
11:11 a.m. – 11:22 a.m.
The Postthrombotic Syndrome
Is Underestimated in Iliofemoral
DVT: It Is Decreased by Endovascular Treatment and Benefit Correlates With Elimination
of Clot
Presenter: Anthony J. Comerota, MD
The Postthrombotic Syndrome
Is Not So Bad: Endovascular
Treatment Is Rarely Indicated
Presenter: Gregory L. Moneta, MD
SESSION 33: More on Tevar,
TAAAs, and Pararenal
Aneurysms, Their Treatment, and
the Multilayer Stent
Debate
1:48 p.m. – 1:59 p.m.
The Multilayer Stent Is Going to
Work for the Treatment of
Complex Aortic Aneurysms:
Theoretical Considerations and
Clinical Experience
Presenter: Edward B. Diethrich, MD
The Multilayer Stent Is Not Going to Work for the Treatment
of Complex Aneurysms:
Theoretical Considerations
Presenter: Zvonimir Krajcer, MD
SESSION 36: More New
Concepts and Data Related to
Thoracoabdominal and
Pararenal Aneurysms and
Chimps
Debate
2:48 p.m. – 2:59 p.m.
CHIMPS Will Have a Major Role
Even When Fenestrated and
Branched Grafts Are Widely
Available
Presenter: Frank J. Criado, MD
The Current State of the Art in Fenestrated and Branched Endografts:
When Widely Available They Will and
Should Eliminate the Need for
CHIMPS
Presenters: Roy K. Greenberg, MD, and
Tara M. Mastracci, MD
SESSION 37: Updates, Controversies,
and New Concepts in the Treatment of
Ruptured AAAs
Debate
3:36 p.m. – 3:47 p.m.
We Still Need Level I Evidence to
Support Use of EVAR With Ruptured
AAAs: Update on the Findings of the
UK IMPROVE Trial
Presenter: Janet T. Powell, MD, PhD
We Don’t Need an RCT: All Ruptured
AAAs Can Be Treated Endovascularly
and the Results Are Excellent
Presenters: Dieter O. Mayer, MD, and
Thomas Larzon, MD
21
Debate
4:00 p.m. – 4:11 p.m.
With Ruptured AAAs the Turn-Down
Rate for Treatment Is Key
Presenter: Ian Loftus, MD
Technique, Not Turn-Down Rate, Is
Important: Tips and Tricks to Get
Good Outcomes From EVAR for AAAs
Short Term and Long Term
Presenters: Mario Lachat, MD, Dieter O.
Mayer, MD, and Frank J. Veith, MD
22
11/15/2012
1:02 PM
Page 22
SESSION 38: New Late-Breaking
Concepts and Results in Aortic
Traumatic Transection and Type B
Aortic Dissections
Debate
5:35 p.m. – 5:46 p.m.
Fenestrated and Branched Endograft
Solutions Are Better Than a Petticoat
Graft (Proximal Covered Stent and
Distal Bare Stent) for Complicated
Type B Aortic Dissections
Presenter: Eric L.G. Verhoeven, MD, PhD
Fenestrated and Branched Endografts
Are Not Better Than a Petticoat Graft
for Complicated Type B Dissections –
Even If Chronic
Presenters: Germano Melissano, MD, and
Roberto Chiesa, MD
SATURDAY
SESSION 41: New Developments in
AAAs and Their Treatment
Debate
7:10 a.m. – 7:21 a.m.
Laparoscopic Vascular Surgery
Should Be Growing and Vascular
Surgeons Should Learn It and
Do It
Presenter: Joseph S. Giglia, MD
Why Laparoscopic and Robotic Aortic Surgery Are Losing Their Appeal
and Will Not Become Widespread
Presenter: Willem Wisselink, MD
Treatment of the Aorta and Its
Branches
Debate
9:14 a.m. – 9:25 a.m.
Treatment of Mid-Aortic Syndrome
in Young Adults: Interventional
Treatment Is Indicated in Some
Presenter: Ramesh K. Tripathi, MD
Interventional Therapy Is Never Indicated for Mid-Aortic Syndrome at
Any Age: Open Surgery Is Best
Presenter: Wilhelm Sandmann, MD
Debate
9:32 a.m. – 9:43 a.m.
Open Surgery Is Still Needed for
Some Aortoiliac Occlusive Lesions:
Which Ones?
Presenter: Michel S. Makaroun, MD
Endovascular Treatment Is Best for
All Aortoiliac Occlusive Lesions
Presenter: Martin Malina, MD, PhD
SESSION 48: Vascular Disease
Natural History, Medical Treatment,
Prevention, and Treatment of
Complications
Debate
3:34 p.m. – 3:45 p.m.
The Truth About Statin Toxicity: Has
It Been Overplayed by the FDA and
by the Media?
Presenter: Bruce A. Perler, MD, MBA
Statins May Be Harmful and Should
Be Used Less
Presenter: Sherif Sultan, MD
WE WOULD LIKE TO
HEAR FROM YOU
Please take a moment to complete this questionnaire and
return it to the registration desk.
What is your age?
How many years have you been out of training?
How many years have you been in practice?
What type of practice are you in? Private____ Academic_____
VA_____ Military _____ Other _____
What is your specialty?
How many open procedures do you perform each month (approximate)? ____
How many endovascular procedures do you perform each
month (approximate)? ____
Thank you for your time.
SUNDAY
SESSION 52: New Developments and
Updates: Early Carotid Treatment,
Takayasu’s Disease, and Techniques
for Evaluating Carotid Plaques
Noninvasively
Debate
7:34 a.m. – 7:45 a.m.
Key Findings in the SAMMPRIS Trial
Showing Intracranial Stents to Be
Less Effective Than Best Medical
Treatment in Preventing Strokes
Presenter: Colin P. Derdeyn, MD
SAMMPRIS Had Major Flaws and
Reached Misleading Conclusions
Presenter: L. Nelson Hopkins, MD
Carotid Disease Treatment and
Associated Issues
Debate
10:30 a.m. – 10:41 a.m.
When Should a Shunt Be Used During CEA? – From the VSGNE
Presenters: Philip P. Goodney, MD, MS,
and Jack L. Cronenwett, MD
A Shunt Should Never Be Used During CEA: What Is Required to Use
the No-Shunt Technique Safely
Presenter: Russell H. Samson, MD, RVT
Debate
11:24 a.m. – 11:35 a.m.
AHA and European Cardiology
Guidelines for CAS Have It Right:
CAS Is an Alternative to CEA for
Symptomatic Patients With Carotid
Stenosis
Presenter: Alberto Cremonesi, MD
Nonsense: The SVS Guidelines Have
It Right: CAS Is Not an Alternative to
CEA for Most Symptomatic Patients
With Carotid Stenosis
Presenter: Michel S. Makaroun, MD
SESSION 55: New Developments and
Controversial Issues Related to CAS
and CEA
Debate
12:00 – 12:11 p.m.
CEA vs. CAS in Symptomatic
Patients: The Heart Should Not Rule
the Head When Deciding Treatment
Strategies
Presenter: A. Ross Naylor, MD
CEA vs. CAS in Symptomatic
Patients: The Heart Should Rule the
Head When Deciding Treatment
Strategies
Presenter: Peter A. Schneider, MD
Debate
12:24 p.m. – 12:35 p.m.
Many Selected Asymptomatic
Carotid Stenosis Patients Benefit
From CEA: How Should They Be
Picked?
Presenter: Bruce A. Perler, MD, MBA
Not So: With Asymptomatic Carotid
Stenosis Patients, Any Benefit of
Invasive Treatment Is Outweighed by
the Risks
Presenter: Anne L. Abbott, MD, PhD
VEITHsymposium
IMNG Society Partners
Frank J. Veith, MD
VEITHsymposium Chairman
Mark Branca
Director, IMNG Society Partners
Enrico Ascher, MD
VEITHsymposium Co-Chairman
Betty Ann Gilchrist
Advertising Sales
Kenneth Ouriel, MD, MBA
Mark S. Lesney, Elizabeth Wood
Publication Editors
Daniel G. Clair, MD,
Jacob Cynamon, MD
AIMsymposium Chairman
Allan L. Brook, MD
AIMsymposium Co-Chairman
George L. Berdejo, BA, RVT, FSVU
AVIDsymposium Chairman
Nicos Labropoulos, PhD, RVT
AVIDsymposium Co-Chairman
Sergio X. Salles-Cunha, PhD, RVT
AVIDsymposium Co-Chairman
Jacqueline M. Simpson, BBA
Managing Director, VEITHsymposium,
AIMsymposium, and AVIDsymposium
Robin D. Bridgewater, MBA
Consultant to VEITHsymposium,
AIMsymposium, and AVIDsymposium
Steven Kawczak, PhD Associate Director, Center for Continuing Education
William D. Carey, MD Director, Center
for Continuing Education
Yenling Liu
Publication Designer
Maria Aquino
Production Specialist
Nick Piegari
Photographer
Produced and distributed for VEITHsymposium by IMNG Society Partners. All rights reserved. No part of this publication may be reproduced or transmitted in any form, by any
means, without prior written permission of
VEITHsymposium. The information in this
publication is provided for general medical education purposes only and is not meant to substitute for the independent medical judgment
of a physician relative to diagnostic and treatment options of a specific patient's medical
condition. The viewpoints expressed are those
of the authors/faculty. They do not represent
an endorsement by The Cleveland Clinic Foundation, VEITHsymposium LLC, or IMNG Society Partners. In no event will The Cleveland
Clinic Foundation, VEITHsymposium LLC, or
IMNG Society Partners be liable for any decision made or action taken in reliance upon the
information provided through this publication.
Copyright 2012.
11/15/2012
1:03 PM
Page 23
VEITHsymposium
23
Impact of Fenestrations on TEVAR Outcomes Studied
F
enestrated endografts were conceived as a means study on the GLOBALSTAR Registry, a database of outof allowing endovascular repair of abdominal aor- comes from endovascular treatment of complex aortic
tic aneurysms when the infrarenal neck is too short aneurysms. The fEVAR (fenestrated endovascular aorto permit safe sealing of the endograft below the renal tic repair) study of fenestrated endografts used data collected retrospectively from U.K. centers
arteries. The most common construction is
where a minimum of 10 such procedures
to have two fenestrations, one for each rehad been performed.
nal artery, and a scallop for the superior
The fEVAR procedure was completed
mesenteric artery. This device has CE Mark
successfully in 316 of 318 patients (99%).
regulatory approval in Europe, according to
Three groups of patients were identified
Dr. Peter L. Harris, a vascular surgeon at
according to the upper limit of the sealing
The London Clinic, London, U.K.
zone: group 1, above the renal arteries
By incorporating additional fenestrations
with a fenestration or scallop for one or
and/or scallops, and using covered stents to
both renal arteries; group 2, above the subridge the gap across the sac of the
perior mesenteric artery (SMA) with fenaneurysm between the fenestrations and
estrations for the renal arteries and either
the target vessels, the “sealing zone” can be
DR. PETER L. HARRIS
a scallop or a fenestration for the SMA; and
extended further proximally to treat aortic
aneurysms in which there is no infrarenal neck, in- group 3, above the celiac artery with fenestrations for
cluding suprarenal and thoracoabdominal aneurysms. the renal and SMAs and either a scallop or a fenestraCustomized devices of this type are available in Europe, tion for the celiac artery.
The operative mortality rate for the whole series of
said Dr. Harris.
In a previous report from Dr. Harris’s group at Uni- 318 patients was 4.1% (13/316). In group 1 there were
versity College London Hospital, patients treated with 73 patients, of whom 2 (2.7%) died. In group 2 there
triple or quadruple fenestrated endografts for pararenal were 168 patients with 5 deaths (2.9%). In group 3 there
and suprarenal aortic aneurysms had significantly were 64 patients, of whom 6 died (9.4%).
Nonlinear logistic regression analysis, with a 95%
longer operations and spent more time in intensive care
postoperatively than did those with single or double fen- confidence interval, of the relationship between the inestrated grafts. Higher rates of morbidity and mortal- cremental extent of repair in groups 1, 2, and 3 and
ity were seen in these patients. However, this study in- postoperative mortality failed to reach statistical sigcluded only 20 patients, and there was no statistical nificance. Although more deaths were associated with
evidence to indicate that the number of fenestrations procedures involving the celiac arteries, this analysis of
the relationship between incremental anatomical extent
significantly affected the risk of operative mortality.
Dr. Harris and his colleagues based their current of endovascular repair and risk of death failed to reveal
Indications
The Endurant® II Stent Graft System is indicated for
the endovascular treatment of infrarenal abdominal
aortic or aorto-iliac aneurysms in patients with the
following characteristics:
t "EFRVBUF JMJBDGFNPSBM BDDFTT UIBU JT DPNQBUJCMF XJUI
WBTDVMBS BDDFTT UFDIOJRVFT EFWJDFT BOEPS BDDFTTPSJFT
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t *OGSBSFOBM OFDL BOHVMBUJPO PG ź ¡
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t *MJBD EJBNFUFST XJUI B SBOHF PG UP NN
t .PSQIPMPHZ TVJUBCMF GPS BOFVSZTN SFQBJS
Contraindications
The Endurant II Stent Graft System is contraindicated in:
t 1BUJFOUT XIP IBWF B DPOEJUJPO UIBU UISFBUFOT UP JOGFDU
the graft.
t 1BUJFOUT XJUI TFOTJUJWJUJFT PS BMMFSHJFT UP UIF
device materials.
Warnings and Precautions
t 5IF MPOHUFSN TBGFUZ BOE FòFDUJWFOFTT PG UIF &OEVSBOU **
Stent Graft System has not been established. All patients
TIPVME CF BEWJTFE UIBU FOEPWBTDVMBS USFBUNFOU SFRVJSFT
lifelong, regular follow-up to assess the health and the
performance of the implanted endovascular stent graft.
1BUJFOUT XJUI TQFDJöD DMJOJDBM öOEJOHT FH FOEPMFBLT
enlarging aneurysms or changes in the structure or
position of the endovascular graft) should receive
FOIBODFE GPMMPXVQ 4QFDJöD GPMMPXVQ HVJEFMJOFT BSF
described in the Instructions for Use.
t 1BUJFOUT FYQFSJFODJOH SFEVDFE CMPPE øPX UISPVHI UIF
HSBGU MJNC BOFVSZTN FYQBOTJPO BOE QFSTJTUFOU FOEPMFBLT
NBZ CF SFRVJSFE UP VOEFSHP TFDPOEBSZ JOUFSWFOUJPOT PS
surgical procedures.
t 5IF &OEVSBOU ** 4UFOU (SBGU 4ZTUFN JT OPU SFDPNNFOEFE
in patients unable to undergo or who will not be
compliant with the necessary preoperative and
postoperative imaging and implantation studies
as described in the Instructions for Use.
t 3FOBM DPNQMJDBUJPOT NBZ PDDVS 'SPN BO FYDFTT VTF
of contrast agents. 2) As a result of emboli or a misplaced
TUFOU HSBGU 5IF SBEJPQBRVF NBSLFS BMPOH UIF FEHF PG UIF
stent graft should be aligned immediately below the
lower-most renal arterial origin.
t 4UVEJFT JOEJDBUF UIBU UIF EBOHFS PG NJDSPFNCPMJ[BUJPO
increases with increased duration of the procedure.
t 5IF TBGFUZ BOE FòFDUJWFOFTT PG UIF &OEVSBOU ** 4UFOU (SBGU
System has not been evaluated in some patient
populations. Please refer to the product Instructions for
Use for details.
MRI Safety and Compatibility
Non-clinical testing has demonstrated that the Endurant II
Stent Graft is MR Conditional. It can be scanned safely in
both 1.5T & 3.0T MR systems under certain conditions as
described in the product Instructions for Use. For additional
information regarding MRI please refer to the product
Instructions for Use.
Adverse Events
1PUFOUJBM BEWFSTF FWFOUT JODMVEF BSSBOHFE JO BMQIBCFUJDBM
order): Amputation; Anesthetic complications and
TVCTFRVFOU BUUFOEBOU QSPCMFNT FH BTQJSBUJPO
"OFVSZTN
enlargement; Aneurysm rupture and death; Aortic damage,
including perforation, dissection, bleeding, rupture and
EFBUI "SUFSJBM PS WFOPVT UISPNCPTJT BOEPS
QTFVEPBOFVSZTN "SUFSJPWFOPVT öTUVMB #MFFEJOH
IFNBUPNB PS DPBHVMPQBUIZ #PXFM DPNQMJDBUJPOT FH
ileus, transient ischemia, infarction, necrosis); Cardiac
DPNQMJDBUJPOT BOE TVCTFRVFOU BUUFOEBOU QSPCMFNT
any statistical significance. Therefore, it cannot be concluded from this study that the extent of anatomical repair, or the number of fenestrations involved, is an independent risk factor for postoperative death, according
to Dr. Harris. The event rate was low, and type 2 statistical error remains possible.
“It stands to reason that an increased number of fenestrations to be alighed and connected to target vessels will take longer and involve more radiation exposure and contrast load than simpler procedures,”
Dr. Harris said. “However, in the most experienced
centers, application of the latest intraoperative imaging technologies, together with adjuvant techniques
to minimize contrast load and radiation dose impact
favorably upon procedure-related mortality risk.” As
for mortality risk that is not procedure related, the focus needs to be on perioperative medical and anesthetic management and, above all, on patient selection, he added.
Dr. Harris acknowledges the British Society of Endovascular Therapies GLOBALSTAR study collaborators who contributed to the data and his coauthor, Dr.
Rao Vallabhaneni, director of the GLOBALSTAR database.
■
Session 36 – VEITH: Is There a Difference in
Outcome Between Double and Triple or
Quadruple Fenestrated Grafts: Findings of the
GLOBALSTAR Registry
Friday, 2:36 p.m. – 2:41 p.m.
FH BSSIZUINJB NZPDBSEJBM JOGBSDUJPO DPOHFTUJWF IFBSU
GBJMVSF IZQPUFOTJPO IZQFSUFOTJPO
$MBVEJDBUJPO FH
CVUUPDL MPXFS MJNC
%FBUI &EFNB &NCPMJ[BUJPO NJDSP
and macro) with transient or permanent ischemia or
JOGBSDUJPO &OEPMFBL 'FWFS BOE MPDBMJ[FE JOøBNNBUJPO
(FOJUPVSJOBSZ DPNQMJDBUJPOT BOE TVCTFRVFOU BUUFOEBOU
QSPCMFNT FH JTDIFNJB FSPTJPO öTUVMB JODPOUJOFODF
hematuria, infection); Hepatic failure; Impotence; Infection
of the aneurysm, device access site, including abscess
formation, transient fever and pain; Lymphatic complications
BOE TVCTFRVFOU BUUFOEBOU QSPCMFNT FH MZNQI öTUVMB
/FVSPMPHJD MPDBM PS TZTUFNJD DPNQMJDBUJPOT BOE TVCTFRVFOU
BUUFOEBOU QSPCMFNT FH DPOGVTJPO TUSPLF USBOTJFOU
JTDIFNJD BUUBDL QBSBQMFHJB QBSBQBSFTJT QBSBMZTJT
0DDMVTJPO
of device or native vessel; Pulmonary complications and
TVCTFRVFOU BUUFOEBOU QSPCMFNT 3FOBM DPNQMJDBUJPOT BOE
TVCTFRVFOU BUUFOEBOU QSPCMFNT FH BSUFSZ PDDMVTJPO
contrast toxicity, insufficiency, failure); Stent graft: improper
component placement; incomplete component
EFQMPZNFOU DPNQPOFOU NJHSBUJPO TVUVSF CSFBL PDDMVTJPO
JOGFDUJPO TUFOU GSBDUVSF HSBGU UXJTUJOH BOEPS LJOLJOH
insertion and removal difficulties; graft material wear;
EJMBUBUJPO FSPTJPO QVODUVSF BOE QFSJHSBGU øPX 4VSHJDBM
conversion to open repair; Vascular access site
complications, including infection, pain, hematoma,
QTFVEPBOFVSZTN BSUFSJPWFOPVT öTUVMB EJTTFDUJPO 7BTDVMBS
TQBTN PS WBTDVMBS USBVNB FH JMJPGFNPSBM WFTTFM EJTTFDUJPO
bleeding, rupture, death); Vessel damage; Wound
DPNQMJDBUJPOT BOE TVCTFRVFOU BUUFOEBOU QSPCMFNT
FH EFIJTDFODF JOGFDUJPO IFNBUPNB TFSPNB DFMMVMJUJT
Please reference product Instructions for Use for more
information regarding indications, warnings, precautions,
contraindications and adverse events.
CAUTION: 'FEFSBM 64"
MBX SFTUSJDUT UIJT EFWJDF UP TBMF
by or on the order of a physician.
www.medtronic.com
www.medtronicendovascular.com
Medtronic Vascular, Inc.
3576 Unocal Place
Santa Rosa, CA 95403
USA
Product Services
Support Center
Tel: 888.283.7868
Fax: 800.838.3103
CardioVascular LifeLine
Customer Support
Tel: 877.526.7890
Tel: 763.526.7890
For distribution in the USA only.
UC201201589 EN © Medtronic, Inc. 2012. All Rights Reserved.
11/15/2012
1:03 PM
Page 24
MEASURED IN RESULTS.
M E D T R O N I C S E T S T H E S TA N D A R D F O R G L O B A L
A O R T I C C L I N I C A L E V I D E N C E L E A D E R S H I P.
At 1 and 2 Years 1
MIGRATION
TYPE I ENDOLEAK
RUPTURE POST IMPLANT
0
%
Most comprehensive abdominal aortic clinical program: 1,500+
patients studied worldwide2
1 out of 2 EVAR patients worldwide receives an Endurant stent graft3
Get results at www.medtronicendovascular.com
1. US IDE Trial. Endurant 2011 Clinical Update.
2. Data on file at Medtronic.
3. BOXI data as of March 16, 2012.
UC201301782 EN © Medtronic, Inc. 2012. All Rights Reserved.
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Potential Benefits Appear to Largely Outweigh

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