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®
C OURTESY U.S.A RMY /C HUCK R OBERTS
THE OFFICIAL
NEWSPAPER
OF THE
Transporting a military patient in the Landstuhl Regional Medical
Center, Germany, where SVS volunteers have played a key role.
Fifth Year of Military and
SVS Partnership Begins
BY SUE CROSSONKNUTSON
Society for Vascular Surgery ®
ince September 2007,
civilian Society for Vascular Surgery members
have volunteered at America’s
largest hospital outside its borders at the U.S. Army’s Landstuhl Regional Medical Center
(LRMC), a state-of-the-art Level I trauma center in Germany
that provides medical care for
coalition forces from 48 countries who are fighting “down
range” in both Iraq and
Afghanistan.
For the fifth year, SVS
members have volunteered to
provide continuous two-week
rotations of vascular surgeons at LRMC. SVS members are helping to repair
damaged arteries and veins of
military personnel who are
fighting the Global War on
Terror.
The Army, Air Force, Navy,
Marine, and civilian medical
S
staff at LRMC have treated
more than 64,000 wounded
warriors since 2001.
Most patients remain at
LRMC for 3 to 5 days before
being transported to other military medical facilities. The survival rate at LRMC is 99.5%.
Additionally, LRMC provides
medical care for the more than
245,000 U.S. military personnel
and their families stationed in
Africa, Europe, and the Middle
East.
Yet the Army has only 24 active duty vascular surgeons.
These medical officers are stationed at combat hospitals and
stateside U.S. military facilities.
LRMC does not have permanently assigned military vascular or cardiothoracic surgeons
although there is often a need
for these specialties.
The void created an opportunity for SVS members.
“I asked fellow SVS members to support the troops and
See Military/SVS • page 2
VOL. 7
•
NO. 5
•
SEPTEMBER 2011
Protocol Shrinks
Ruptured AAA
Treatment Times
Our new editors provide an
international dimension to our
editorial advisory board. • 4
Transfer from ED to OR time improved.
DVT & PE
B Y P AT R I C E W E N D L I N G
Else vier Global Medical Ne ws
CHICAGO – A dedicated
protocol that streamlines the
care pathway dramatically improved the timely care of patients with life-threatening
ruptured abdominal aortic
aneurysms, although overall
outcomes held relatively
steady.
Among 62 patients, the median overall door-to-treatment
time decreased significantly
from a preprotocol 183.5 minutes to 157 minutes post protocol (P = .05).
That included a significant
drop in median emergency department–to–operating room
time (35 minutes vs. 23 minutes; P = .035), and nonsignificant reductions in time spent
at the referring hospital (150.5
minutes vs. 110 minutes) and
in transit (52 minutes vs. 35
minutes), Dr. Raghu Mota-
ganahalli reported on behalf
of his colleagues at Indiana
University, Indianapolis.
Data available on threefourths of the patients suggest
that the expedited care improved immediate outcomes.
The percentage of patients
who had a Glasgow Aneurysm
Score greater than 100 and
who survived increased from
20% to 69% post implementation, Dr. Motaganahalli said at
the annual meeting of the Peripheral Vascular Surgery Society.
“Various therapeutic interventions, including endovascular therapy, have added to
patient mortality,” he said.
“However, there’s still a need
to have a dedicated protocol
that enables early recognition
by increasing awareness, effective communication, and
rapid transfer to centers taking
I N S I D E
News
Welcome, Editors
VTE Prophylaxis
Computerized assessment tool
aids in hospitals. • 6
News from the SVS
SVS Foundation
Annual Report
The renamed foundation looks
ahead to a vibrant future. • 1 0
Devices, Drugs & Trials
The Blind Leading
FDA reaffirms its preference for
randomized, blinded trials,
even for devices. • 1 4
See Ruptured AAA • page 7
CMS Bundled Payments Move Forward
B Y M A RY E L L E N
SCHNEIDER
fficials at the Centers for
Medicare and Medicaid SerO
vices in August released a request for applications (RFA)
inviting physicians, hospitals,
and other health care providers
to participate in the Bundled
Payments for Care Improvement initiative. The program,
which was mandated under
the Affordable Care Act, offers
options for bundling payments
for a hospital stay, for post-discharge services, or for both the
hospital stay and the post-discharge care.
Instead of paying hospitals,
physicians, and other providers
separately, this initiative would
combine the payment over an
episode of care for a specific
condition. The aim of the pro-
gram is to encourage clinicians
to work together and provide
better continuity of care, resulting in better quality and
lower costs.
“Today, Medicare pays for
care the wrong way,” Health
and Human Services Secretary
Kathleen Sebelius said during a
teleconference to announce
the bundling program. “PaySee CMS • page 2
VA S C U L A R
SPECIALIST
ONLINE!
Visit our interactive
editions and exclusive
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NEWS
SEPTEMBER 2011 • VASCULAR SPECIALIST
Landstuhl
Military/SVS• from page 1
serve as two-week volunteer
vascular surgeons at LRMC,”
said Dr. David Gillespie COL
(ret), MC, USA, Chief and
Professor, Division of Vascular Surgery, University of
Rochester, School of Medicine and Dentistry, Rochester,
N.Y.
“The Army agreed to provide overseas transportation
and base housing.”
With the details finalized, Dr.
Ruth L. Bush of Texas A & M
University became the first of
the many SVS volunteer vascular surgeon at LRMC.
“Since September 2007, 76
SVS members have donated
their time and talents,” according to Dr. Gillespie.
“The surgeons find the expe-
rience rewarding. Many return
year after year. There’s a waiting
list for surgeons wanting to volunteer in 2012.”
The unique military and civilian medical collaboration is a
“win-win” for the surgeons and
their patients.
SVS surgeons witness military
efficiency, especially real-time
record-keeping.
“Extraordinary telecommunications make it possible for surgeons ‘down range’ to speak
with staff at LRMC and hospi-
Bundled Payments
CMS
•
from page 1
ments are based on the quantity of care,
the amount of services delivered, not the
quality of that care. And that leaves us
too often with a system that actually can
punish the providers that are most successful at getting and keeping their patients healthy.”
The new bundling program offers
three ways for health care providers to
receive payment retrospectively, and one
way to receive a prospective payment.
Under some of the retrospective payment models, CMS and the providers
would agree on a target payment
amount for the episode of care and
providers would be paid under the original Medicare fee-for-service system, but
at a negotiated discount of 2% to 3% or
greater. At the end of the care episode,
the total payment would be compared
with the target price and providers
would be able to share in the savings, according to CMS.
Under prospective payment model,
CMS would make a single bundled payment to the hospital to cover all services
provided during the inpatient stay by the
hospital, physicians, and other providers.
That payment would offer at least a 3%
discount to Medicare. Under this option,
physicians and other providers would
submit “no pay” claims to Medicare and
the hospital would pay them out of the
single bundled payment.
In addition to the options of prospective or retrospective payment, providers
could choose how long the episode of
care will be and what conditions they
want to bundle payment for, and what
services would be included in the payment. CMS officials said they wanted to
make the program flexible so that a
range of hospitals, physicians, and other providers could participate.
The American College of Surgeons
General Surgery Coding and Reimbursement Committee (GSCRC) has
been actively studying how bundled payments could be applied in surgery. The
ACS believes that critical to the success
of any bundling initiative is ensuring
that the bundle is clinically coherent. The ACS GSCRC will continue this
work and their discussions with the administration, CMS, and other stakeholders to ensure that any possible
bundled payments in surgery will improve patient care.
Organizations interested in applying
must submit a letter of intent by Sept. 22
for Model 1 and by Nov. 4 for Models 2,
3, and 4. More information on the program and how to apply is available at
www.innovations.cms.gov/areas-of-focus/patient-care-models/bundled-payments-for-care-improvement.html.
er of the University of Medicine & Dentistry of New Jersey–Robert Wood Johnson
Medical School possess the skill
to complete the procedure but
he also had the contacts at German companies to access the
necessary surgical supplies,”
said Col. John Cho, Commanding Officer of LRMC.
“If it weren’t for our Visiting
Vascular Surgeon Program with
SVS, the graft procedure wouldn’t have been an option at all,”
Dr. Cho added.
■
tals in the United States,” said
Dr. Michael Weingarten of
Drexel University, Pennsylvania.
“This facilitates continuity of
care from point of injury.”
Likewise, SVS surgeons
performed the first thoracic
endovascular graft implant
procedure at LRMC.
Although commonly performed at civilian hospitals to
repair diseased or torn aortas,
the procedure had never been
attempted at LRMC.
“Not only did Dr. Paul Has-
Dr. Richard Gilfillan, the acting director of the CMS Innovation Center,
which is overseeing the bundling initiative, said he expects that hundreds of organizations will apply. The program is a
unique opportunity for hospitals to redesign their systems to promote better
care coordination, Dr. Gilfillan said, and
have that effort supported through
Medicare payments.
The idea is to eliminate the traditional barriers between physicians and other providers – both inpatient and
outpatient – all of whom may be involved in the care of a single condition,
said Dr. Nancy Nielson, senior advisor to
the CMS Innovation Center and past
president of the American Medical Association.
The AMA was still reviewing the bundled payment details at press time, but
Dr. Cecil B. Wilson, AMA immediate
past president, said the organization will
urge federal officials to encourage applications for physician-led bundling projects. “For this to be successful, and for
physicians to participate actively, then
they need to be a part of that process
rather than just some larger corporation
or larger hospital system or health plan
that’s organizing these,” he said. “We
think those are important as well, but we
also think it’s important that physicians
be a part of that leadership.”
Health care consultant Robert Minkin
urged physicians to seriously consider
applying for the bundling program. The
program is a sentinel event in the move
from fee for service to more centralized,
coordinated care model, he said.
■
PERSPECTIVE
01_2_4_6_7VS11_9.qxp
his program should result in
multiple benefits to everyone. By identifying and reducing
frontline costs incurred by
surgeons,
physicians,
and other
providers,
costs to the
entire system are
eliminated
rather than
simply
shifted to another part of the
system. We should applaud this
kind of incisive “surgical strike”
and help CMS identify other
similar opportunities.
T
DR. MAGRUDER C. DONALDSON
is the chairman of surgery at
Metrowest Medical Center in
Framingham, Mass. He is also an
associate medical editor of
VASCULAR SPECIALIST.
For Dr. Donalson’s complete
editorial on this article, please
visit our website at www.
vascularspecialistonline.com.
VASCULAR S PECIALIST
VASCULAR SPECIALIST
Medical Editor George Andros, M.D.
to the products, drugs, or services mentioned herein.
POSTMASTER Send changes of address (with old mailing label) to
Circulation, VASCULAR SPECIALIST, 60 B Columbia Rd., 2nd flr.,
Morristown, NJ 07960.
ASSOCIATE EDITORS
Ali AbuRahma, M.D., Charles A. Andersen, M.D., Magruder Craighead
Donaldson, M.D., Ronald Fairman, M.D., Rob Fitridge, M.D., Larry
Kraiss, M.D., Joan Lohr, M.D., James McKinsey, M.D., Mark Morasch,
M.D., Frank Pomposelli, M.D., Brian Rubin, M.D., Russell H. Samson
M.D., Cliff Shearman, M.D., Cynthia Shortell, M.D., Frank J. Veith,
M.D., Robert Eugene Zierler, M.D.
The Society for Vascular Surgery headquarters is located at 633 N.
St. Clair St., 24th Floor, Chicago, IL 60611.
Executive Director SVS Rebecca Maron
©Copyright 2011, by the Society for Vascular Surgery
VASCULAR SPECIALIST (ISSN 1558-0148) is published bimonthly for the
Society for Vascular Surgery by Elsevier Inc., 60 B Columbia Rd., 2nd
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VASCULAR SPECIALIST is the official newspaper of the Society for Vascular
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Vascular Surgery and Elsevier Inc., will not assume responsibility for
damages, loss, or claims of any kind arising from or related to the
information contained in this publication, including any claims related
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VAS_3.qxp
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2 Vardanian A, Chau A, Quinones-Baldrich W, and Lawrence P. Arterial allograft allows in-line reconstruction of prosthetic
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NEWS
VEITH’S VIEWPOINT
Can RCTs be Misleading and Biased?
andomized controlled trials It was originally designed to compare
(RCTs) constitute level 1 evi- CAS and CEA only in symptomatic padence, which is widely consid- tients. When adequate numbers of paered the best data upon which to base tients could not be recruited,
medical practice. This is particularly asymptomatic patients were added,
true when the RCTs are published in thereby diluting the power of the study
leading journals like the New England and impairing the statistical significance
of some of its results.
Journal of Medicine or
Other design flaws include
Lancet. Such trials are
questionable competence of
viewed by many as the Holy
operators in a trial (e.g. the
Grail of medicine and thus
CAS operators in the EVA-3S
infallible and inviolate.
and ICSS trials); problems with
However, RCTs can have
randomization (e.g. SAPmany flaws that render them
PHIRE in which only 10% of
obsolete, non-applicable or
eligible patients were randomoutright misleading. More
ized); and questionable applicimportantly RCTs can be
ability of RCT results to real
misinterpreted or spun by
world practice (e.g. CAS opertheir authors or others so
BY FRANK J.
ators in CREST were highly
that they exert an effect on
VEITH, M.D.
vetted and more skilled than
practice trends or standards
others performing the procedure).
unjustified by their data.
There are also idiosyncratic flaws, as
Possible flaws in RCTs are of two
in the EVAR 2 trial in patients unfit for
types:
1. Timeliness flaws can occur when open repair. Although this trial, pubprogress is made in the treatment un- lished in Lancet, showed EVAR to have
der evaluation arm or the control arm. similar mortality to no treatment, half
Examples would be the early trials of the deaths in the group randomized to
carotid stenting (CAS) vs. carotid en- EVAR occurred from rupture during a
darterectomy (CEA). If progress in CAS lengthy (average 57 days) waiting peritechnology or patient selection occurs, od before treatment. Had these deaths
a trial showing CAS inferiority becomes been prevented by a more timely EVAR,
invalid. In contrast, the landmark trials the conclusion of EVAR 2 might have
showing CEA to be superior to medical been different.
Inappropriate or questionable primatreatment in preventing strokes have
become obsolete because dramatic ry endpoints in RCTS are another design
progress has been made with medical flaw that can lead to misleading conclusions. An example is the inclusion of mitreatment.
2. Many design flaws can impair the nor myocardial infarctions (MIs) with
validity of RCTs. These include patient strokes and deaths as a composite endselection flaws (e.g. in SAPPHIRE, pa- point in a CAS vs. CEA trial (e.g. SAPtients were selected for randomization PHIRE and CREST).
The components of the primary endonly if they were high risk for CEA).
SAPPHIRE also included 71% asympto- point in the CAS and CEA arms of
matic patients in whom the high adverse CREST were death, stroke, and myocarevent rates for both CEA and CAS were dial infarction. Total stroke and minor
unjustified. Good medical treatment strokes were both significantly different
would have served these patients better. in the two groups in favor of CEA, and
CREST also had patient selection flaws. death and major strokes, although not
R
significantly different between the two
groups were both numerically higher for
CAS. (See complete table oline at
www. vascularspecialistonline.com)
Although it is arguable, it is hard to understand how minor MIs are the equivalent of strokes and deaths, and only
when MIs were included were the adverse event rates in the two groups similar (7.2% for CAS vs 6.8% for CEA,
P = .051).
So much for the flaws in RCTs. What
about good trials or those with only minor weaknesses? Even these can result in
misleading conclusions when the authors reach conclusions unjustified by
their own data. SAPPHIRE and CREST
are two recent examples.
Despite the flaws in these trials, both
of which were reported in the New England Journal of Medicine, the authors
concluded that “with high risk patients
CAS and CEA are equivalent treatments”
(SAPPHIRE) and “among patients with
symptomatic and asymptomatic carotid
stenosis, the risk of the composite primary end-point … did not differ significantly in the group undergoing CAS and
the group undergoing CEA” (CREST).
Although the CREST authors pointed
out the higher incidence of stroke with
stenting, others have used the CREST
study to claim equivalence of CAS and
CEA. Nowhere is this more apparent
than in the recent American Heart Association (AHA) Guideline on the management of patients with extracranial
carotid and vertebral artery disease.
This important and influential document, which was also approved by 13
other organizations including the SVS,
stated that “CAS is indicated as an alternative to CEA for symptomatic patients
at average or low risk of complications
associated from endovascular interventions….” In Webster’s Dictionary one definition of “alternative” is “a choice
between 2 things”.
This clearly implies equivalence, and it
has been so interpreted by many others,
particularly those biased toward catheter
based treatment. Of note, the AHA
Guideline appears to be based largely on
CREST, and did not even consider the
findings of the ICSS trial, published in
Lancet the same day as the main article
reporting CREST.
Although ICSS may also have flaws, it
showed, in a large group of only symptomatic patients, that CAS produced significantly more strokes and diffusion
weighted MRI defects than did CEA. It
is hard to understand why these ICSS results did not have more of an influence
on the AHA Guideline.
Although my bias as a CAS enthusiast
makes me believe that CAS will ultimately have a major role in the treatment of carotid stenosis patients, that
bias is not yet sufficient for me to spin the
data and believe we are now there. One
has to wonder if bias more intense than
mine was involved in the conclusion
reached in the AHA Guideline.
Thus, it is apparent that misleading
conclusions can be reached in articles reporting RCTs in leading journals. These
can be the result of flaws in the RCTs
and/or unrecognized author bias. More
importantly, the results of even good
trials can be further misinterpreted by
others to guide practice standards in a
way unjustified by the data.
It is important for all to recognize the
possible role of bias in these misinterpretations. By recognizing the possible
flaws in RCTs and that physicians, like all
other people, are influenced by bias, we
can exercise the judgment to use RCTs
fairly to help us treat individual patients
optimally.
■
DR. FRANK J. VEITH is professor of surgery
at New York University Medical Center
and professor of surgery and William J.
von Liebig Chair in vascular surgery at
Case Western Reserve University and The
Cleveland Clinic.
Introducing Our New International Editors
Professor Fitridge is professor of vascular surgery at
Professor Shearman is professor of vascular surgery
at the University of Southampton and a consultant vas- the University of Adelaide and Head of Vascular
Surgery at The Queen Elizabeth Hospital.
cular surgeon at Southampton
He became chairman of the Board of VasUniversity Hospitals NHS
Board of a current copy of the JVS to recular Surgery in 2002 and during his tenure
Trust. He was on the Council
alize that the Society for Vascular Surgery
the online curriculum was developed. In
and Chairman of the Training
is unquestionably an international organicollaboration with Matt Thompson he editand Education Committee of
zation. This sort of globalization, in coned “Mechanisms of Vascular Disease: A
the Vascular Society of Great
trast to the variety that, according to Tom
Textbook for Vascular Surgeons” published
Britain and Ireland, and PresiFriedman, makes the world flat instead
by Cambridge University Press. His redent of the Society (2009-2010)
makes our specialty more vibrant and insearch interests include the systemic efHe has a long time interest in
teresting than ever.
fects of skeletal muscle reperfusion injury
training and was appointed
Because of this world change we believe
and outcome modelling in aortic surgery.
head of the Wessex Post Gradthat our journals should better represent
He recently was elected president of the
uate School of Surgery in 2007.
the people that write and read our journals,
PROFESSOR CLIFF
PROFESSOR ROB
ANZSVS and is president of the World
He is currently president elect
and so, too, this newspaper. For this reason,
SHEARMAN
FITRIDGE
Federation of Vascular Societies.
of the Society for Academic
we introduce in this issue our two newest
We welcome these new additions to our editorial
members of the VASCULAR SPECIALIST Editorial Board: Research Surgery and Director of Professional Practice
From England, we have Professor Cliff Shearman, and for the Association of Surgeons of Great Britain and Ire- team.
from Australia, Professor Rob Fitridge. Both have a land. His main clinical interest is in the vascular comGeorge Andros, M.D.
well-deserved preeminence and will broaden the view plications of diabetes and in particular trying to reduce
Medical Editor
the rate of amputation in this group.
and the viewpoint of your SVS newspaper.
our readers have any doubt, all they need do is cascan the program for the recent VAM in ChicaIgofsually
or examine the content and Editorial
VAS_5.qxp
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11:24 AM
Page 1
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Page 6
NEWS
Computerized Tool Improves VTE Prophylaxis
CHICAGO – By implementing an online risk assessment tool, researchers at
one institution were able to improve
hospital-wide prophylaxis and significantly cut the number of venous thrombotic events, according to Dr. Nicholas J.
Morrissey.
“Our overall level of prophylaxis at
both campuses was 98%; whereas preimplementation, we had about a 71% level
of appropriate prophylaxis,” said Dr.
Morrissey of the department of surgery
at Columbia University in New York at
the Vascular Annual Meeting.
Starting June 2010, all patients admitted
to New York–Presbyterian Hospital were
required to have their venous thromboembolism (VTE) risk assessed as part of
their electronic admission orders. Physicians were free to use a specially developed
online risk assessment tool or their own
judgment regarding prophylaxis.
The VTE risk assessment tool was created by a bicampus committee of clinicians from various specialties, IT
support, nursing, and data management
staff. This group also reviewed all documented VTE events from June 2010 to
the present. Each event was subjected to
clinical adjudication for accuracy.
Risk assessment and prophylaxis were
monitored using AMALGA (Microsoft)
software that allows real-time accumulation of clinical data that goes into the
patient’s hospital electronic health
record. VTE rates were monitored
through chart review by certified coders.
Patients who were positive for VTE
events were further examined and rates
were compared before and after implementation of the assessment tool. In addition, a random sampling of patients on
several inpatient floors was performed to
determine if the adequate level of VTE
was being used.
“Through a very recent random sampling of 503 patients in the entire hospital,
we looked to see what the adequate prophylaxis level was after the implementation of our tool,” said Dr. Morrissey. This
was defined as appropriate pharmacologic prophylaxis when indicated.
They also compared pre- and post-implementation periods to assess VTE
rates. At New York–Presbyterian’s Columbia University Medical Center campus, the VTE rate prior to assessment
implementation was 1.08/1,000 patientdays from January through June 2010. At
the same campus, the VTE rate dropped
to 0.80/1,000 patient-days from July
through December. Similarly, at New
York–Presbyterian’s other campus, Weill
Cornell Medical Center, the VTE rate
was 1.19/1,000 patient-days from January through June 2010; it dropped to
0.84/1,000 patient-days from July
through December 2010.
“Interestingly, what we found at both
institutions was that our pulmonary embolism rate dropped significantly between the first and second half of 2010,”
said Dr. Morrissey. At Columbia, the
number of pulmonary embolisms
dropped from 24 to 15. At Cornell, the
number of PEs dropped from 41 to 15.
“We saw that a significant number of
patients actually suffered from upperextremity line-associated clots,” he noted. At Columbia, there were 31 upper
extremity events from January to June
2010; there were 33 from July to December. At Cornell, there were 38 upper
extremity events in the first half of the
year and 33 in the second half.
Both institutions used the AMALGA
system to provide clinicians with feedback. The software calculates the patient’s risk score in real time as patients
are admitted, based on their past medical
history. The software also collects all of
the information entered into the electronic order set. This allows staff to look
and see which patients are listed as high
risk or low risk and whether the clinician
used the tool appropriately. “So we’re ac-
tually able to assess hospital wide how
these patients are receiving prophylaxis.”
The tool also allows the identification
of patients that are inappropriately classified based on risk and who are receiving inappropriate prophylaxis. “We can
reach out to those clinicians in real time
and discuss with them the issues related
to prophylaxis.”
The authors reported that they have
no relevant disclosures.
■
PERSPECTIVE
BY KERRI WACHTER
n this evolving age of electronic medical records it is
very easy to add prompters that
require the physician to indicate if a patient is on prophylaxis and if not to justify why
they are not being utilized. As
pointed out in this review it will
improve adherence and ultimately outcomes. I look at this
as a prompter rather than dictating medical care.
I think this is the wave of the
future.
I
CHARLES ANDERSEN, M.D., is
chief of vascular surgery at the
Madigan Army Medical Center,
Tacoma, Washington.
®
3RZHUHGE\
Quality Improvement = Reduced Healthcare Costs
The Vascular Quality Initiative® (VQI) provides benchmarked reports of key quality measures
for high impact vascular procedures to drive regional quality improvement efforts. Quality
improvement practice changes are implemented through regional groups, translating directly
to hospital cost reductions.
Example from VQI: Decrease in length of stay for Lower
Extremity Bypass = estimated savings of $80,800 per
admission, using HCUP mean cost of $19,700 per day*
Join Today!
Call 603.298.5509 or
email vqi@m2s.com
www.vascularqualityinitiative.org
*Source: HCUP Nationwide Inpatient Sample (NIS). Healthcare Cost and Utilization Project (HCUP). 2007-2009. Agency for Healthcare Research and Quality, Rockville, MD. www.hcup-us.ahrq.gov/nisoverview.jsp.
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Page 7
ANEURYSMS
S E P T E M B E R 2 0 1 1 • W W W. VA S C U L A R S P E C I A L I S T O N L I N E . C O M
Treatment Times
care of patients with ruptured
aneurysms.”
The level I vascular emergency program at Indiana University Methodist
Hospital instituted a protocol for acute
aortic emergencies, as well as limbthreatening ischemia, in August 2009.
The transferring emergency department
(ED) or attending physician initiates the
process by calling a Lifeline Telecom
toll-free number.
Lifeline Telecom arranges the transportation of the patient and calls the
hospital operator, who sends out a
burst page to the on-call vascular surgeon, OR charge nurse, and vascular
fellow as well as the emergency medicine and trauma center (EMTC) charge
nurse, cardiovascular critical care
charge nurse, patient access team
leader, level I vascular coordinator,
main admission office, transfer center,
chaplain, and security.
Meanwhile, the transferring ED faxes
the patient’s face sheet to Lifeline, and
the referring ED nurse calls in the patient
report to the receiving ED charge nurse,
Dr. Motaganahalli explained.
Upon receiving the page, the receiving
surgeon and OR charge nurse call the
same Lifeline number and hold a conference call with the transferring ED
•
from page 1
physician to determine whether the patient should go to the ED or directly to
an OR.
The surgeon then directs the OR
charge nurse on the type of procedure to
©E LSEVIER I NC.
Ruptured AAA
reads the CT scans if they’re available.
Indiana University Methodist Hospital
is developing a central site where referring hospitals can upload images directly to its website, but for now, the
hospital relies on transmission via CV
Express or discs that arrive with the patient, Dr. Motaganahalli said.
The patients are mostly male, are
This CT image demonstrates a [lethal] ruptured abdominal aortic aneurysm. The
aneurysm has a calcified rim (short arrow). Note the surrounding hemorrhage
(long arrow).
transported by air, and have CT scans
obtained at the referring facility. Of the
90 patients who have been treated since
the protocol was adopted through No-
prepare, and the nurse sends a burst
page to the OR team.
The surgeon is transferred by the operator to the EMTC physician, who
VESAP 2
vember 2010, eight have died in transit
or upon arrival.
Although all 26 preprotocol patients
were treated with open repair, 36% of
the 36 postprotocol patients have undergone endovascular repair, according
to Dr. Motaganahalli
In all, 8 (30.7%) preprotocol patients
died, compared with 11 (30.5%) postprotocol patients, including 3 who were
treated endovascularly. Hospital length
of stay and patient disposition were also
similar.
The invited discussant, Dr. Ravi
Veeraswamy, who is a vascular surgeon from Emory University in Atlanta, asked Dr. Motaganahalli whether
there is a protocol in place for endovascular repair, and why the shorter
treatment times seen in the study did
not translate into a greater improvement in outcomes.
Dr. Motaganahalli replied that the
university is attracting more sick patients from across the state who previously would have died, and that these
patients generally have worse hemodynamic values when they arrive.
He said that endovascular repair is
based on purely anatomical criteria, and
that they may use aortic balloon occlusion to temporarily obtain hemodynamic stability, but that these patients
usually go on to open repair.
The authors reported that they had no
disclosures.
■
®
Purchase at VESAP.org
Kim J. Hodgson, MD and John F. Eidt, MD, Editors-in-Chief
Section Editors
About VESAP ® 2
Objectives
Ronald M. Fairman, MD; Thomas S. Riles, MD; Peter A.
Schneider, MD; Anton N. Sidawy, MD, MPH; Mark F. Fillinger,
MD; J. Gregory Modrall, MD; Anthony J. Comerota, MD;
Benjamin W. Starnes, MD.
• 450 all new questions, with detailed discussions
and references for each question — a significant
increase in the number of questions.
• Describe the current treatment of aortoiliac
aneurysmal and occlusive disease.
Accreditation and Continuing
Medical Education Credit
The Society for Vascular Surgery® (SVS) is accredited
by the Accreditation Council for Continuing Medical
Education to provide continuing medical education
for physicians.
SVS designates this enduring material for a maximum of
60 AMA PRA Category 1 Credits™. Physicians should
only claim credit commensurate with the extent of their
participation in the activity.
Contact education@vascularsociety.org
or 800-258-7188 with questions.
• VESAP ® 2 is a self-assessment program designed to meet
the Maintenance of Certification requirements of the
Vascular Surgery Board of the American Board of Surgery.
• It is an invaluable aid for vascular surgeons
in preparing for the qualifying, certification,
and recertification examinations in vascular
surgery and to remain current in the specialty of
vascular surgery and endovascular therapy.
• Vascular residents and fellows will find it a useful
study aid for their ABSITE or VSITE examinations.
• Interventional radiologists, cardiologists, vascular
medicine specialists, and allied health care
professionals focusing on vascular diseases may use
VESAP ® 2 self-assessment to keep abreast of the current
practice of vascular surgery and endovascular therapy.
Purchase VESAP 2 at www.vesap.org.
®
SVS Member — $400
SVS Candidate Member — $300
SVS General Surgery Resident/Student Member —$250
Non-member — $500
®
7
• Discuss the possible etiologies of extremity
arterial disease and appropriate interventions.
• Identify the evaluation and management of
brachiocephalic and cerebrovascular disease.
• Explain the medical management of vascular
disease and critical features of dialysis access.
• Describe the non-invasive vascular laboratory tests, CT
and MR angiography used in the evaluation of vascular
disease, including the benefits and limitations of each.
Review the assessment and treatment of renovascular
hypertension and mesenteric ischemia.
• Discuss the etiology and treatment of acute and
chronic venous disease and lymphatic disease.
• Review vascular trauma management and the surgical
nutrition and critical care essentials of the vascular patient.
08_9VS11_9.qxp
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Page 8
DVT & PULMONARY EMBOLISM
Dalteparin Same as Unfractionated Heparin for DVT?
B Y M A RY A N N M O O N
he low-molecular-weight heparin
dalteparin was found to be no better than unfractionated heparin in
preventing proximal leg deep vein
thrombosis among critically ill adults, according to an international study published online in the New England Journal
of Medicine.
Rates of venous thrombosis, venous
thromboembolism, major bleeding, and
death also were similar with the two
agents. Although dalteparin was associated with significantly fewer pulmonary
emboli and significantly less heparin-induced thrombocytopenia, these were
not primary outcomes, and “caution is
warranted in making inferences about
nominally significant findings in secondary outcomes,” said Dr. Deborah
Cook and her coinvestigators in the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT).
The study was published online simultaneously with its presentation at
the International Symposium on Intensive Care and Emergency Medicine in
Brussels.
The study was done because two previous randomized trials comparing the
two types of heparin were inconclusive.
T
PROTECT was conducted in 67 ICUs
within academic or community hospitals
in Australia, Brazil, Canada, Saudi Arabia, the United Kingdom, and the United States. A total of 3,746 patients were
randomly assigned in equal numbers to
receive either dalteparin or unfractionated heparin to prevent thromboembolism.
Approximately three-fourths of the
study subjects were medical patients and
DALTEPARIN WAS ASSOCIATED
WITH SIGNIFICANTLY FEWER
PULMONARY EMBOLI AND
SIGNIFICANTLY LESS HEPARININDUCED THROMBOCYTOPENIA.
the remainder were surgical patients.
Ninety percent required mechanical ventilation and 45% required vasopressors.
“Throughout the trial, the rates of
cointerventions with drugs or devices
that influence bleeding or thrombotic
risk were similar in the two groups,” according to Dr. Cook of the departments
of medicine and clinical epidemiology
and biostatistics at McMaster University, Hamilton, Ont., and her colleagues.
Twice a week until discharge, the
study subjects underwent ultrasonography of the proximal venous system in the
leg at 1-cm intervals to detect deep vein
thrombosis (DVT). Compressibility was
documented at the common femoral,
proximal, middle, and distal superficial
femoral and popliteal veins, and at the
venous trifurcation.
Even though screening compression
ultrasonography has limitations in this
regard, it was chosen because “classic
signs and symptoms of DVT do not develop in comatose, recumbent, critically
ill patients.” Moreover, it is safe, noninvasive, readily available, and recommended for such research, the
investigators said.
The median duration of the use of
both drugs was 7 days.
The primary end point – incident
proximal leg DVT – developed in 96
(5.1%) of the patients receiving dalteparin, compared with 109 (5.8%) of
those receiving unfractionated heparin,
a nonsignificant difference.
However, “the confidence interval
around the hazard ratio for the primary end point was fairly wide, so it did
not exclude either a 32% benefit or a
23% harm associated with dalteparin,
as compared with unfractionated heparin. Thus, the result for the primary
outcome was not clinically directive,”
the researchers said (N. Engl. J. Med.
2011 March 22 [doi:10.1056/NEJMoa1014475]).
The rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar between
the two groups.
Patients in the dalteparin group had
significantly fewer pulmonary emboli
(1.3% vs. 2.3% of patients) and significantly less heparin-induced thrombocytopenia (0.3% vs. 0.6% of patients), but
these outcomes must be interpreted with
caution, given the small numbers, Dr.
Cook and her associates said.
These study findings were consistent
in further adjusted analyses of the data,
as well as in sensitivity analyses and a perprotocol analysis.
“Our results might have been different
if the study enrollment had been larger
or if we had used different drugs or doses,” they noted.
The PROTECT study was funded by
the Canadian Institutes of Health Research, the Australian and New Zealand
College of Anesthetists Research Foundation, and the Heart and Stroke Foundation of Canada. Study drugs were
provided by Pfizer and Eisai. The investigators reported ties to numerous industry sources.
■
Join your colleagues in Washington, D.C. for the 66th Vascular Annual
Meeting ® of the Society for Vascular Surgery ®
The premier annual meeting for vascular health professionals
s Earn continuing education credit through breakfast, plenary,
and concurrent sessions
s Enjoy exciting scientific presentations
s Attend the E. Stanley Crawford Critical Issues Forum
s Experience the extensive trade exhibition
s Attend Industry supported clinical symposia
s Learn during the Postgraduate Courses Day prior to the meeting, June 6, 2012
Visit VascularAnnualMeeting.org or telephone 800-258-7188
for complete and updated meeting information.
June 7- 9, 2012 | Gaylord National
Resort & Convention Center
National Harbor, MD
located just outside Washington, D.C.
Call for abstracts deadline
is January 3, 2012
Registration and housing
opens March 1, 2012
®
08_9VS11_9.qxp
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Page 9
CAROTID ARTERY DISEASE
Carotid IMT Predicts Coronary
Events in Rheumatoid Arthritis
NEW YORK – Imaging seems to be the
sine qua non of determining cardiovascular disease risk in patients with
rheumatoid arthritis.
Dr. Jeffrey D. Greenberg noted that,
over the last 10-15 years, epidemiologic
studies have shown patients with
rheumatoid arthritis (RA) have a twofold
increase in the risk of myocardial infarction and stroke and an increase in cardiovascular-related deaths.
The need for precise tools with which
to predict risk has become more urgent
with the recently published findings that
carotid ultrasound measurement of
carotid intima-media thickness has been
found to predict coronary events in patients with RA, independent of traditional cardiovascular risk factors and
manifestations of RA.
The study, conducted by Dr. Matthew
R. Evans and his associates at Brooke
Army Medical Center, Fort Sam Houston, Tex., found that there appears to be
a dose-dependent relationship between
plaque and risk, with a 2.5-fold increase
with unilateral plaque and 4.3-fold increase with bilateral carotid plaque, suggesting that atherosclerosis plays a
significant role in acute coronary events
in patients with RA (Arthritis Rheum.
2011 [doi:10.1002/art.30265]).
In discussing Dr. Evans’s research at his
presentation at a rheumatology meeting
sponsored by New York University, Dr.
Greenberg said that this is the first study
to demonstrate the predictive value of
measuring carotid IMT and plaque for
cardiovascular events in RA patients.
In the Evans study, carotid ultrasounds
were performed on 636 RA patients as
part of the prospective ORALE (Outcome of Rheumatoid Arthritis Longitudinal Evaluation) study. These patients
were followed for 3,402 person-years
and, during that time, 84 patients experienced 121 new or recurrent acute coronary syndrome (ACS) events, such as
myocardial infarction, unstable angina,
cardiac arrest, or death from ischemic
heart disease. The rate of ACS events
was 3.5/100 patient-years for this group.
If only those without a prior history of
ACS were analyzed, this group had 66
ACS events, with an incidence of 2.1
ACS/100 person-years.
Multivariate analysis of baseline factors
associated with incident or recurrent acute
coronary syndromes revealed that two
markers of atherosclerosis were independent predictors of a subsequent coronary
event. Having a past cardiovascular event
raised the risk almost threefold (hazard ratio, 2.87 [1.75, 4.73]; P = .001) and carotid
intima-media thickness also raised the risk
significantly (HR, 1.61 [1.24, 2.08]; P =
.001). After substituting carotid plaque for
intima-media thickness, the investigators
found a 2.5-fold increase in risk for unilateral plaque and almost a sixfold increase
in risk for bilateral plaque.
The findings confirmed traditional demographic and
cardiovascular risk factors. These included male sex (HR,
1.94 [1.11, 3.39]); diabetes (HR, 2.24 [1.44, 3.50]), and hypertension (HR, 1.56 [1.00, 2.44]). Measures of RA
severity, such as swollen joint counts (HR, 1.03 [1.01,
1.06]) and cumulative prednisone dose of 20 g (HR, 2.12
[1.32, 3.42]) also had predictive value.
Dr. Greenberg receives consulting fees from Genentech Inc.
■
©E LSEVIER I NC.
BY AMY ROTHMAN SCHONFELD
Intima-media
thickness (IMT)
was defined as
the distance
between the first
echogenic line
(inner membrane
of the far wall)
and the second
echogenic line,
showing the
border between
the middle and
outer coats.
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10_11_12_13VS11_9.qxp
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Page 10
NEWS FROM THE SVS
T H E SVS F O U N D AT I O N ¨ A N N U A L R E P O R T 2011
A Message from SVS Foundation® Chair,
Robert Zwolak, MD
Dr. G. Patrick
Clagett, last year’s
chair, succeeded in
To strengthen the
raising funds to
Society for Vascular
present the K08, K23,
Surgery’s® (SVS)
EJ Wylie Traveling
presence in advocacy
Fellowship Resident
and continuing
Research Price, and
education, SVS
Student Research
replaced its
Fellowships to our
foundation, the
specialty’s most
American Vascular
promising future
Association® (AVA),
leaders this year. The
ROBERT M. ZWOLAK, MD,
with the SVS®
awardees are featured
CHAIR, SVS FOUNDATION
Foundation. The
(below) receiving their
AVA’s accomplishawards at the 2011 Vascular Annual
ments have been remarkable, and
Meeting®.
the new SVS Foundation will
The SVS Foundation will
continue its mission by assuming all
continue
to be the focal point for
its activities.
advancing
the role of vascular
Because of the generosity of
surgeons
in
clinical and
vascular health medical
translational
research, activities so
professionals, industry, and
often
dominated
by non-surgeons.
affiliated societies, the AVA has
To ensure these important grants
helped some of the specialty’s
and
scholarships are awarded
current leaders advance their
annually
requires the commitment
careers. Many of our most
of
the
entire
SVS membership,
prominent surgeons have used their
industry,
and
affiliated societies. As
awards to conduct research that
a
specialty,
it
is
our responsibility to
improves the health of vascular
lead
in
vascular
health
patients. We need to continue on
management.
this path.
Dear Colleague:
Your contributions fund clinical and
translational research grants
including:
P Clinical research seed grants
provide direct support for pilot
clinical projects which have
potential to grow into larger studies
fundable by industry or
governmental sources.
P A clinical study planning grant
supports development of all the
components necessary for a
competitive, multi-center clinical
trial application.
P Medical student and resident
awards stimulate development of
research skills and exploration of
investigative careers.
P Partner grants with the National
Institutes of Health, the Mentored
Clinical Scientist Development
Award and the Mentored PatientOriented Research Career
Development Award, both
directed at vascular surgeon
scientists in the early stages of
their careers.
I want to thank everyone,
including our industry partners and
generous affiliate societies, for their
loyalty and commitment to our
future. We ask for their continued
support. For those of you who have
not yet contributed, I encourage
you to take this request seriously
and make a donation to the SVS
Foundation.
Your contribution is taxdeductable. Contributions may be
made at www.SVSFoundationsite.org
or by completing the contribution
form included in this annual report.
Sincerely,
Robert M. Zwolak, MD
Chair, SVS Foundation
®
he SVS Foundation Awards were presented at
the opening SVS session of the 2011 Vascular AnT
nual Meeting. The SVS Foundation supports research
in vascular disease.
SVS Foundation/American College of Surgeons
Mentored Clinical Scientist Development Award
(K08)
Philip P. Goodney, MD (below middle), of Dartmouth Medical School, received the SVS Founda-
®
P HOTOS : C ATHERINE H ARRELL /E LSEVIER G LOBAL M EDICAL N EWS
2011 SVS Foundation Awards
tion/American College of Surgeons Mentored Clinical Scientist Development Award. Dr. Goodney is
shown with Robert M. Zwolak, MD (at left), and
Alan Dardik, MD.
EJ Wylie Traveling Fellowship
Rabih A. Chaer, MD (middle), of the University of
Pittsburgh School of Medicine, received the EJ Wylie
Traveling Fellowship from Dr. Zwolak and Dr. Dardik. The primary purpose of the fellowship is to provide an opportunity to visit a number of excellent
vascular surgery centers in the United States and
abroad.
SVS Foundation Resident Research Prize
Clay C. Quint, MD, PhD (middle), of the Cleveland
Clinic Lerner College of Medicine, received the
SVS Foundation Resident Research Prize for his paper “Decellularized Human Tissue Engineered Vessel as an Arterial Conduit” from Dr. Zwolak and
Dr. Dardik. The prize consists of a monetary award
and a 1-year complimentary subscription to the
Journal of Vascular Surgery. Dr. Quint presented his
research at the Vascular Annual Meeting and it will
be considered for publication in the journal.
10_11_12_13VS11_9.qxp
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Page 11
NEWS FROM THE SVS
11
T H E SVS F O U N D AT I O N ® A N N U A L R E P O R T 2011
SVS Foundation Grants to Future Leaders in
Vascular Research
SVS Foundation thanks the following individuals for
their generous contributions made from April 1, 2010 to
March 31, 2011
Babak Abai, MD
Christopher M. Abbot, MD
Harry B. Abramowitz, MD
Ali F. AbuRahma, MD
John A. Adeniyi, MD
Donald L. Akers, MD
George Andros, MD
Marvin D. Atkins, Jr., MD
Arthur I. Auer, MD
Mario H. Avila, MD
J. Dennis Baker, MD
William H. Baker, MD
Jeffrey L. Ballard, MD
Michael Belkin, MD
Donald D. Bell, MD
Marshall E. Benjamin, MD
Thomas M. Bergamini, MD
Victor M. Bernhard, MD
Edwin G. Beven, MD
James H. Black, III, MD
John Blebea, MD
Charles W. Bouch, MD
Jason S. Burgess, MD
Christopher H. Byrne, MD
Phillip L. Cacioppo, MD
Keith D. Calligaro, MD
G. Patrick Clagett, MD
Alexander W. Clowes, MD
J. Louis Cohen, MD
William B. Cohen, MD
William Cole, MD
Paul S. Collins, MD
Michael S. Conte, MD
David V. Cossman, MD
Jack L. Cronenwett, MD
John A. Curci, MD
Michael A. Curi, MD
Michael C. Dalsing, MD
Alan Dardik, MD
Herbert Dardik, MD
James P. David, MD
Mark G. Davies, MD, PhD
Luis R. Davila-Santini, MD
Giacomo A. DeLaria, MD
Howard E. Denbo, MD
Deepak Deshmukh, DO
Magruder C. Donaldson,
MD
Joseph R. Durham, MD
Matthew J. Eagleton, MD
Luis G. Echeverri, MD
John D. Edwards, MD
Matthew S. Edwards, MD
Ronald M. Fairman, MD
Rumi Faizer, MD
Antoine M. Ferneini, MD
Thomas L. Forbes, MD
David Fox, MD
Randall W. Franz, MD
Julie Ann Freischlag, MD
Nicholas D. Garcia, MD
Robert M. Gasior, MD
Bruce L. Gewertz, MD
Gary Giangola, MD
Joseph S. Giglia, MD
Peter Gloviczki, MD
James M. Goff, Jr, MD
John F. Golan, MD
Philip P. Goodney, MD
Wayne S. Gradman, MD
Louie H. Griffin, MD
Raul J. Guzman, MD
Vivienne J. Halpern, MD
Sachinder S. Hans, MD
Linda M. Harris, MD
Nancy L. Harthun, MD
Robert W. Heidepriem, III,
MD
G. Ken Hempel, MD
Peter K. Henke, MD
Anil P. Hingorani, MD
Robert W. Hopkins, MD
Tam Huynh, MD
Robert J. Hye, MD
Mark D. Iafrati, MD
Daniel M. Ihnat, MD
Karl A. Illig, MD
Eric C. Jaxheimer, MD
K. Wayne Johnston, MD
Clyde Kamm, MD
Vikram S. Kashyap, MD
Andres U. Katz, MD
Steven G. Katz, MD
Gregory J. Kechejian, MD
Glenn L. Kelly, MD
Melina R. Kibbe, MD
Robert B. McLafferty, MD
George H. Meier, MD
Donna M. Mendes, MD
Charles S. Mesh, MD
Louis M. Messina, MD
Joseph L. Mills, Jr., MD
Erica L. Mitchell, MD
Gregory L. Moneta, MD
Satish Muluk, MD
Richard F. Neville, MD
Charles S. O’Mara, MD
C. Keith Ozaki, MD
Robert L. Kistner, MD
Larry W. Kraiss, MD
Marvin E. Kuehner, MD
John A. Kutz, MD
Christopher J. Kwolek, MD
Gregory J. Landry, MD
Peter Lawrence, MD
Christopher J. LeCroy, MD
Jason T. Lee, MD
Stephen E. Lee, MD
Scott A. LeMaire, MD
Edward Li, MD
Timothy K. Liem, MD
Fred N. Littooy, MD
Gregg L. Londrey, MD
Graham W. Long, MD
Joseph Magnant, MD
Michel S. Makaroun, MD
Rafael D. Malgor, MD
M. Ashraf Mansour, MD
Vito A. Mantese, MD
Rebecca M. Maron, CAE
Gordon H. Martin, MD
Douglas W. Massop, MD
John H. Matsuura, MD
Kenneth M. McDonald, MD
W. Burley McIntyre, MD
Frank T. Padberg, MD
Ramesh Paladugu, MD
Richard C. Pennell, MD
Juan Carlos Pereda, MD
Bruce A. Perler, MD
William C. Pevec, MD
Ralph B. Pfeiffer, MD
Ernest Poulos, MD
C. Steven Powell, MD
Kevin B. Raftery, MD
Jeffrey K. Raines, MD, PhD
Rajeev K. Rao, MD
Jeffrey M. Rhodes, MD
Norman M. Rich, MD
Thomas S. Riles, MD
Andrew B. Roberts, MD
Sean P. Roddy, MD
L. Richard Roedersheimer,
MD
Joel C. Rosenfeld, MD
Matthew B. Rossi, MD
Timothy S. Roush, MD
Steven T. Ruby, MD
Fred W. Rushton, Jr., MD
Ulka Sachdev, MD
Farouq Ali Samhouri, MD
Richard J. Sanders, MD
Bhagwan Satiani, MD
Jon V. Schellack, MD
Marc L. Schermerhorn, MD
Thomas A. Schneider, MD
Peter J. Schubart, MD
Martin L. Schulman, MD
Gary R. Seabrook, MD
Piergiorgio G. Settembrini,
MD
Maureen K. Sheehan, MD
Gregorio A. Sicard, MD
Anton N. Sidawy, MD
Michael J. Singh, MD
Mahalingham Sivakumar,
MD
Christopher L. Skelly, MD
Gus J. Slotman, MD
W. Charles Sternbergh, III,
MD
David H. Stubbs, MD
David S. Sumner, MD
Bauer E. Sumpio, MD
Anthony M. Sussman, MD
Robert B. Swersky, MD
Mellick T. Sykes, MD
Gale L. Tang, MD
Gary A. Tannenbaum, MD
Jay Vasquez, MD
James S. Wagner, MD
Willis H. Wagner, MD
Thomas W. Wakefield, MD
Daniel B. Walsh, MD
Shenming Wang, MD, PhD
Dean H. Wasserman, MD
Fred A. Weaver, MD
Mell B. Wellborn III, MD
John V. White, MD
Anthony Whittemore, MD
Richard A. Yaeger, MD
Wei Zhou, MD
Robert M. Zwolak, MD, PhD
SVS Foundation Student Research Fellowships
The following individuals received SVS Foundation Student Research Fellowships:
Sara Bartlett
Washington University,
St. Louis, MO
Julia Glaser
Beth Israel Deaconess Medical
Center, Boston, MA
Calvin Harberg
University of Wisconsin–Madison
School of Medicine, Madison, WI
Matthew Huber
University of Florida,
Gainesville, FL
Daniel Lee
University of Rochester School of
Medicine and Dentistry, Rochester, NY
John Mitchell
University of Nebraska Medical
Center, Omaha, NE
Doran Mix
University of Rochester Medical
Center, Rochester, MN
Viraj Raygor
University of California San
Francisco, San Francisco
®
10_11_12_13VS11_9.qxp
12
9/9/2011
12:02 PM
Page 12
NEWS FROM THE SVS
Inspired by a Poster Award,
Dr. Halpern Donates to
SVS Foundation
Foundation Development Committee.
t was a poster award that inspired
Dr. Halpern has provided financial
Vivienne Halpern, MD, of Phoenix,
support to SVS Foundation during the
AZ, to support vascular research in
general and the SVS Foundation in par- last four years. “I want to improve research funds for vasticular. “More than 10
cular research and
years ago, I won a
help up-and-coming
poster award through
‘I WANT TO IMPROVE
surgeon scientists,”
the Eastern Vascular
she said. “That’s why
Society from the
RESEARCH FUNDS FOR
I donate to SVS
William J. Von Liebig
VASCULAR RESEARCH AND Foundation.”
Foundation,” said Dr.
Funds donated to
Halpern. “This preHELP UP-AND-COMING
the SVS Foundation
dates the SVS FoundaSURGEON SCIENTISTS.’
by Dr. Halpern and
tion, but the award
others provide
inspired me to do
awards for clinical
more.”
and translational research. The funds
A practicing vascular surgeon since
enable researchers to develop new ad1998, Dr. Halpern became an active
vances in vascular care. “To improve
member of SVS in 2004. She donates
the care of vascular patients and
her time and has served on the SVS
progress the field of vascular surgery
Women’s Leadership Committee, the
and vascular medicine, those are the
Quality and Performance Measures
Committee, the Public and Profession- reasons I contribute to SVS Foundation,” she said.
al Outreach Committee, and the SVS
■
I
Dr. Andros: An Ardent
Supporter of SVS Foundation
and translational research,
harity begins at
the SVS Foundation prohome,” said SVS
“C
vides the following clinical
Member George Andros,
The SVS Foundation® FY 2012
Budgeted Revenue and Expense
MARCH 2011 TOTAL ASSETS: $5.2M*
SVS Foundation Total Income
Corporate support
19%
Individual
contributions
17%
64%
Society
contributions**
Total Income
$634,000
SVS Foundation Total Expenses
Administration &
governance
13%
and translational research
MD, of Los Angeles, CA.
3%
grants:
“Since SVS is my profesFundraising
sional home, I support the
P Clinical research seed
84%
future of my profession by
grants
Career
development
donating to the SVS FounP Clinical study planning
awards
dation.”
grant
Total Expenses
For years, Dr. Andros
P Medical student and resi$491,800
has generously supported
dent awards
SVS Foundation research
GEORGE ANDROS, MD
P Partner grants.
Source: Society for Vascular Surgery
efforts. He has donated his
“In order to continue to
time, talents, and treasure to the Foun- advance the science of vascular redation since the days in which it was
search, I encourage all SVS members
*includes cash, investments, and value of pledges of future support
**includes SVS, ACS, and regional society contributions
known as the American Vascular Foun- to donate to the SVS Foundation,” said
dation / Lifeline Foundation. That
Dr. Andros. “It is through support for
name began in 1989.
our Foundation that SVS will remain at
In 2004, the foundation became
the forefront of vascular research.” ■
known as the AVA Foundation. Today,
it’s the SVS Foundation. To Dr. Andros, the name of the Foundation is irrelevant. He remains an ardent
supporter.
SVS Foundation thanks the following
P Medtronic
“I served on the AVA Foundation’s
corporations and societies for their generous P New England Vascular Surgical Society
Executive Committee from 2007 to
2009,” said Dr. Andros. “Many of my
contributions made from April 1, 2010 to
P GE Healthcare
colleagues have been Foundation
March 31, 2011
P Philips Healthcare
award recipients and have benefitted
P Atrium
P Siemens
from the assistance provided.”
P
American
College
of
Surgeons
P Spectranetics
As the focal point for advancing the
role of vascular surgeons in clinical
P Cook Medical
P W.L. Gore & Associates
P Eastern Vascular Society
P Western Vascular Society
P Massachusetts General Hospital, Division
P von Liebig Foundation
®
SVS Foundation Thanks Organizational Donors
of Vascular and Endovascular Surgery, Dr.
Richard Cambria, Chief
10_11_12_13VS11_9.qxp
9/9/2011
12:03 PM
Page 13
NEWS FROM THE SVS
13
Support the Hobson
Resident Research Fund
presented to an outstanding vascular or
general surgery resident.
The SVS Foundation Resident Research Prize is funded with a principal
of $100,000. A
portion of the
Hobson Resident Research
Fund has been
raised. Additional contributions will
keep alive Dr. Hobson’s
dreams for vascular surgery.
Hobson Resident Research Fund contributors
are listed with the SVS
Foundation individual
donors.
The SVS Foundation
contribution form in
this annual report
may be used to make
a donation to the
Hobson Resident
Research Fund. Online
donations are
welcome at www.
Robert Hobson, MD, is shown during his days in
SVSFoundationsite.org.
the United States military.
■
he Hobson Resident Research
Fund was established by the New
Jersey Medical School Vascular
Alumni in honor of Robert Hobson II,
MD, for his dedication to future vascular and general surgeons. Contributions
to the fund enable young surgeons to
continue their vascular research efforts.
It endows the SVS Foundation Resident
Research Prize, an annual $5,000 award
C OURTESY SVS
T
Dr. John Blebea ‘Gives
Back’ to SVS Foundation
ment,” said Dr. Blebea. “Giving to the
SVS Foundation is a
form of thanksgiving
from the Lifeline Founand a contribution
dation in
for the future and
2001,” said
those who follow in
John Blebea,
our footsteps.”
MD, of
Dr. Blebea has doCleveland,
nated to SVS FounOH. “The award prodation for the past
vided funds to continue
six years. “It is critiresearch on ultrasound
cal for our success
diagnosis and developas a specialty and for
ment of an implantable
JOHN BLEBEA, MD
the care of our paflow sensor. This intertients, that we support research at
est continues with the hope for huboth the clinical and basic research
man trials in the near future.”
To “give back” to the Foundation, levels,” he said.
“The most effective way of doDr. Blebea became a financial
ing this on the national level is
donor.
“Although we are asked to donate through a donation to the SVS
Foundation.”
to many worthwhile causes, we
■
should also allocate a portion of our
®
charitable giving to our specialty because it has provided us with both
our economic sustenance as well as
personal and professional fulfillwas fortunate to
have received a
“I
clinical research award
Donation
I wish to make a voluntary contribution to further the
mission of the SVS Foundation through a contribution of:
P$2,500
P$1,000
P$250
POther:_______________
P$500
Name as you wish to be recognized
Support Vascular Surgery Research
Address
City/State/Zip
Telephone
The SVS® Foundation awards grants to young vascular surgeon scientists to help develop their careers
in research. Contributions to the SVS Foundation are used to award these grants to promising, young
surgeons to create a foundation for significant research accomplishment as their careers mature. It
is the focal point for advancing the role of vascular surgeons in clinical and translational research,
activities so often dominated by non-surgeons.
The SVS Foundation replaces and assumes all of the activities of the American Vascular Association®
(AVA) and consolidates the clinical and translational research grants that were previously
administered by the SVS and AVA including:
Clinical Research Seed Grants
Email
Payment
Pay Donation by Check
Make check payable to: SVS Foundation
Mail check and donation SVS Foundation
form to:
35312 Eagle Way
Chicago, IL 60678-1353
Pay Donation by Credit Card
Make donation online at svsfoundationsite.org
Or fax completed form to 312-334-2320
A Clinical Study Planning Grant
Medical Student and Resident Awards
Partner Grants with the National Institutes of Health
Name on Card
Cardholder Signature
Credit Card Number
Expiration Date
CSC Number
Thank you for your generosity
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14_15VS11_9.qxp
9/9/2011
12:06 PM
Page 14
DEVICES, DRUGS & TRIALS
14
CLINICAL TRIALS TRACK
FDA Emphasizes Randomized, Blinded Trials for Devices
BY JESSICA BYLANDER
“The Pink Sheet”
linical studies in support of premarket approval applications
should ideally be randomized and
blinded, the Food and Drug Administration maintains in recent draft guidance
for sponsors and staff to help researchers
and manufacturers design better quality
clinical trials for device submissions.
The draft guidance spells out different
clinical study designs that may be appropriate to support device approval, includ-
C
VOL.
6
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ELSEVIER
w w w. v a s c u l a r s p e c i a l i s t o n l i n eSOCIETY
. c oGROUP
m
NEWS
ing the advantages and disadvantages of
each. But the FDA emphasized randomized, blinded (or masked) trials above all
else, as other study designs may provide
less robust evidence and introduce bias.
These study designs, however, are generally the most expensive to carry out
and difficult to enroll.
The FDA’s guidance acknowledges
these studies might not be practical, feasible, or even ethical in all cases. In those
situations, the onus is on the sponsor to
justify why an alternative study design was
chosen and how it will adequately control
bias, the draft guidance emphasizes. Some
in the medical community have been
critical of the relatively small proportion
of premarket approval (PMA) pivotal
trials that are randomized, controlled
studies.
The guidelines apply mainly to PMA
device trials, but could also inform the
design of clinical trials for 510(k) devices, the FDA suggests.
Pivotal studies are meant to determine whether a new device is reasonably
safe and effective, and whether the probable benefits outweigh the potential
risks. The FDA is addressing what specific factors go into its risk-benefit determinations in separate draft guidance
also issued Aug. 15.
Comparative studies generally provide
a higher level of evidence than single-
arm trials, the clinical trials draft guidance explains.
Comparative trials may be parallel design, in which comparisons are made between groups treated with different
therapies; paired, in which each subject
receives all of the interventions or tests
at the same time, such as with a “splitface” test where each side of the face is
treated with a different device; or
crossover, in which each subject receives
two or more interventions at different,
predetermined time points.
These study designs may be randomized or nonrandomized, but randomized, double-blinded, controlled studies
are preferred, the FDA maintains.
The FDA recommends the device be
compared with an active control, such as
another effective therapy; or a placebo
control, such as an ineffective device
used in conditions that mimic the investigational device as much as possible.
“Deviation from this study design is especially problematic in situations where
there is a possible placebo effect,” the
guidance notes.
The FDA also prefers that pivotal trials be masked, or blinded, meaning participants in the trial have limited
knowledge as to which intervention they
were assigned.
“If study participants are not masked,
it is very difficult to assess the size of the
resulting bias, and it can threaten the scientific validity of an otherwise solid
study, even when a truly objective end
point is used,” the guidance states.
If the trial subjects and investigators
cannot be masked, the FDA strongly recommends that independent, third-party
evaluators of the study measurements or
end points be denied knowledge of the
intervention assignment.
“Even if it is inconvenient or difficult,
FDA recommends that masking be considered and attempted, if at all possible,”
the guidance notes.
But a range of other study options are
available to sponsors who cannot conduct the ideal trial, the guidance clarifies.
In any case, the FDA strongly recommends that sponsors consult with the
agency about trial design in a pre-submission meeting.
The sponsor’s investigational device
exemption application should include
not only the details of the proposed
study design and why it was chosen, but
also an explanation of alternative study
designs that were considered and why
they were deemed “inappropriate, impractical, or not possible,” the guidance
states.
This coverage is provided courtesy of
“The Pink Sheet.” This news organization
and “The Pink Sheet” are owned by Elsevier.
■
Dalcetrapib Boosts HDL Without Bumping BP
B Y P AT R I C E W E N D L I N G
PARIS – The investigational cholesteryl ester transfer
protein inhibitor dalcetrapib increased HDL cholesterol
without the toxic effects that have raised safety concerns
over the use of CETP inhibitors as a cardiovascular therapy.
Dalcetrapib reduced CETP activity by 49% and increased HDL cholesterol by 31% without affecting
LDL cholesterol among patients with or at risk of coronary heart disease in the randomized phase II dal-VESSEL
trial.
Dalcetrapib did not cause endothelial dysfunction nor did it
improve it. Unlike the CETP inhibitor torcetrapib, dalcetrapib
did not raise blood pressure, providing further reassurance regarding the safety of the
compound, Dr. Thomas Lüscher
said at the annual congress of the European Society of
Cardiology.
“I think we can say it’s safe and has no untoward effects like the others, and it does the job as far as the lipid
profile is concerned,” he told reporters. “It’s a bit less
potent than torcetrapib, which increased HDL by about
60% to 70%, but [it] may be that’s even an advantage.
We’ll see.”
Dr. Lüscher said it was a bit disappointing that dalcetrapib (manufactured by Hoffmann-La Roche) did
not improve vascular function, but noted that it was not
worsened either.
Whether the novel CETP inhibitor will have an effect on cardiovascular events will be determined by the
phase III dal-OUTCOMES trial, with results expected
sometime in 2013, said Dr. Lüscher, professor and
chair of cardiology at University Hospital Zurich,
Switzerland.
A total of 15,872 patients with stable heart disease following a recent acute coronary event have been enrolled, according to the drug maker’s website.
Invited discussant Dr. Keith A. A. Fox, with the University of Edinburgh/British Heart Foundation Centre
for Cardiovascular Science, said the positive dal-VESSEL
data represent a “clear advance,” but urged caution because of the limited size of the
trial.
‘I think we can
“We need to know whether
say it’s safe and
the modest changes in blood
has no untoward
pressure are real or have an imeffects like the
others, and it does pact on outcomes,” he said.
The recent DEFINE trial of
the job as far as
Merck’s CETP inhibitor anacethe lipid profile.’
trapib, however, illustrates the
very real difficulties in achieving
DR. LÜSCHER
this goal. Anacetrapib raised
HDL cholesterol 138% and reduced LDL cholesterol by
40% compared with placebo, but did not reduce cardiovascular events in 1,623 patients with or at high risk
for coronary heart disease (N. Engl. J. Med.
2010;363:2406-15).
Torcetrapib, the first CTEP to be tested, increased
HDL cholesterol by 61% and decreased LDL cholesterol by 20%, but was associated with a roughly 4.6 mm Hg increase in blood pressure (N. Engl. J. Med.
2007;356:1304-16).
Development of the agent came to a screeching
halt, however, when the ILLUMINATE trial subsequently reported that torcetrapib also increased the
risk of cardiovascular events by 25% and all-cause
mortality by 58% in patients at high cardiovascular
risk (N. Engl. J. Med. 2007;357:2109-22).
Further research suggested that the negative effects
were caused not by reducing CTEP activity, but by offtarget effects on renal glands, diminished nitrous oxide
levels, and increased endothelin-1, Dr. Lüscher explained.
The dal-VESSEL study was conducted at 19 centers
in Europe and randomized 476 patients with coronary
heart disease or CHD risk equivalents and HDL cholesterol of less than 50 mg/dL to dalcetrapib 600
mg/day or placebo plus their standard medication for
a total of 36 weeks.
Endothelial function was measured at 12 weeks using brachial flow-mediated dilation (FMD), a validated
marker of endothelial dysfunction. Their mean age was
62 years, and roughly 97% were on statins, according
to the researchers.
The mean change in HDL cholesterol from baseline
at week 4 was 2.7% for placebo and 27.5% for dalcetrapib; at week 36 it was –0.14% vs. 30.7%, respectively (P less than .0001 for both), Dr. Lüscher said.
At 36 weeks lipoprotein A-1 levels were significantly increased with dalcetrapib, but lipoprotein B levels
were not affected.
There was no significant change with dalcetrapib in
the co-primary safety endpoints of 24-hour ambulatory BP at week 4 and FMD at week 12.
Death from coronary heart disease occurred in one
patient given placebo and none given dalcetrapib. Nonfatal myocardial infarctions were reported in 3 and 2 patients, respectively.
The trial was sponsored by Hoffmann-La Roche. Dr.
Lüscher reports receiving research grants from Pfizer,
Eli Lilly and Merck and consultancy or lecture fees from
CSL, Merck, Pfizer and F. Hoffmann-La Roche.
■
14_15VS11_9.qxp
9/9/2011
12:06 PM
Page 15
DEVICES, DRUGS & TRIALS
15
Scar Prevention ‘Band-Aid’ Shows Early Promise
BY DOUG BRUNK
N EODYNE B IOSCIENCES, I NC.
P HOTOS
tion and fibrosis can be reduced by altering the mechanical environment of
wounds, results from a phase I study
found. At the Summit in Aesthetic Medicine, sponsored by Skin Disease Education Foundation (SDEF), Dr. Geoffrey
C. Gurtner presented findings from a
study in which nine patients undergoing elective abdominal surgery were
treated postoperatively with a stressshielding polymer on one side while the
other side was treated with standard
wound care.
The device, manufactured by Neodyne Biosciences, looks like a Band-Aid
strip and is stretched over the incision after sutures are removed. It conforms to
the wound and adheres to skin, creating
“a compressive region that has no level
of mechanical stimulation or distractive
strain,” said Dr. Gurtner, professor of
surgery at Stanford (Calif.) University.
“Essentially, you create stress risers in the
unwounded skin and a mechanically
privileged environment in the wounded
skin.”
A panel of three independent plastic
surgeons reviewed 18 photos of the scars
(nine treated, nine control) taken 6-12
COURTESY
DANA POINT, CALIF. – Scar forma-
Half of the surgical scar was treated
with standard protocols as shown above.
The surgical area 8 months later is
shown after polymer treatment.
months after surgery. They used a visual
analog scale (VAS) that ranged from 0
(very good scar) to 100 (very poor hypertrophic scar). Dr. Gurtner reported that
the average VAS score in the treated
group was 18.6, while the average VAS
score in the control group was 50.5, a difference that was statistically significant (P
= .0039) (Ann. Surg. 2011 May 19 [doi:
10.1097/SLA.0b013e318220b159]).
“In none of the cases was the treated
scar worse than the control scar, which I
think is different than some of the biologic agents we’ve seen over the last few
years,” he said.
A panel of lay persons who reviewed
the photos reported similar results that
favored the treated group (P = .004).
In earlier mouse studies of wound environment manipulation, Dr. Gurtner
and his associates found that focal adhesion kinase (FAK) is a critical regulator in
the formation of hypertrophic scars.
He described FAK as “a molecule that
exists on the inner surface of cell membranes and transmits forces that are set
in the external extracellular matrix to the
inside of the cell. FAK transmits those
forces into biological or biochemical cues
that then turn on genes in the nucleus
and make the cells do different things.
This seems to be a very important mol-
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If you take out FAK, you can prevent
hypertrophic scar formation.”
FAK is a target that has been examined
extensively in cancer, Dr. Gurtner said,
suggesting that in the next few years,
“We should have products that will not
only be able to treat incision wounds but
will also be able to treat large burn injuries. You need to fool the cells into
thinking they’re in a different mechanical environment, either by using small
molecule or pharmacologic blocking
therapies such as fat inhibitors, or by using biomaterials that provide cues in a
controlled way that minimize the
amount of mechanical stimulation that
the fibroblasts feel in the healing wound
so as to mitigate the inflammation and
subsequent fibrosis.”
The study was supported by a Wallace
H. Coulter Translational Partners Grant;
the Armed Forces Institute of Regenerative Medicine; the Hagey Family Endowed Fund in Stem Cell Research and
Regenerative Medicine; and the Oak
Foundation. Neodyne Biosciences supplied the surgical dressings used in the
study. Dr. Gurtner disclosed that he holds
an equity interest in Neodyne.
SDEF and this news organization are
owned by Elsevier.
■
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Page 1
Endurant
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