1. health and fitness
2. disease

®
Patrice Wendling/Frontline Medical n eWs
THE OFFICIAL
NEWSPAPER
OF THE
Dr. Thomas C. Bower said that EVAR infections “are uncommon,
but we are seeing more of them.”
Planning, creativity key
to EVAR infection care
Frontline Medical News
CHICAGO – Successful
management of infected
aortic endovascular grafts
requires careful operative
planning and execution, meticulous postoperative care,
and a fair bit of creativity,
according to Dr. Thomas C.
Bower, chair of vascular and
endovascular surgery at Mayo
Clinic, Rochester, Minn. “I’ve
found the operations to be
more challenging and more
difcult than explanting portions or total graft excision
when the infection has occurred in a hand-sewn graft.”
Unlike the typical bimodal
distribution seen with handsewn graft infections, infec-
tion following endovascular
repair of aortic aneurysms occurs from days up to 3 years
after surgery. “These infections are uncommon, but we
are seeing more of them,” he
said at a symposium on vascular surgery sponsored by
Northwestern University.
Roughly two-thirds of
patients will present with
fever, nonspecifc abdominal or back pain, malaise,
weight loss, or night sweats.
If time permits, preoperative
assessments include echocardiography for left ventricular
function, arterial blood gases
for pulmonary function since
many patients are smokers,
and renal ultrasound if creatinine is ≥1.5 mg/dL after
See EVAR · page 16
Vascular specialist
151 Fairchild Ave.,
Suite 2,
Plainview, NY 11803-1709
BY PATRICE WENDLING
VOL. 11
Private-academic
surgeon salary gap
raises concerns
Would you pick academia if you stood
to lose $1.3 million over your career?
BY PATRICE WENDLING
Frontline Medical News
LAKE BUENA VISTA,
FLA. – Academic surgeons earn an average of
10% or $1.3 million less in
gross income across their
lifetime than surgeons in
private practice, an analysis
shows.
Some surgical specialties
fare better than others,
with academic neurosurgeons having the largest
reduction in gross income
at $4.2 million (–24.2%),
while academic pediatric
surgeons earn $238,376
more (1.53%) than their
private practice counterparts. They were the only
ones to do so.
Several academic surgical
specialties did not make
the 10% average, including
trauma surgeons whose
lifetime earnings were
down 12% or $2.4 million,
vascular surgeons at 13.8%
or $1.7 million, and surgical
oncologists at 12.2% or $1.3
million.
“The concern that we
have is that the academic
surgeons are where the
education of the future
lies,” lead study author Dr.
Joseph Martin Lopez said at
See Gap · page 10
•
NO. 3
•
MARCH 2015
I N S I D E
Opinion
Editors Weigh In
Our associate editors give
their own take on the PAD
stenting issue. • 4
He Got Letters
SVS President Peter
Lawrence received an
outpouring of member
letters regarding his New
York Times article response
last month. • 6
Point/Counterpoint
Renal Artery
Occlusive Disease
Dr. George Hamilton and
Dr. Matthew A. Corriere
debate the proper treatment
of renal artery stenosis. • 8
News From Washington
FDA Says OK
Two new devices, a
transcarotid angioplasty
system and a new adhesive
for use in varicose veins,
were approved. • 17
FROM THE EDITOR
More on the PAD stenting issue
BY RUSSELL SAMSON, M.D.
Medical Editor
I
suspect that most members
of the SVS are aware of
the recent New York Times
article entitled “Medicare
payments surge for stents
to unblock blood vessels in
limbs” and which was the
subject of our front page
news article last month
(http://vswebn.org/NYTstents). In that article Dr. Peter Lawrence, the President
of the SVS, described steps
that the SVS has taken to
address the appropriateness
of vascular interventions. It
was his inspired leadership
that led to his devoting the
Stanley Crawford symposium at last year’s Vascular
Annual Meeting specifcally
to the problem of unnecessary procedures. Those of
you who have read my editorials over the last year will
recognize that I also have
See PAD · page 3
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Innovating for life.
3/4/2015 9:55:26 AM
OPINION
VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5
Stenting issue
PAD from page 1
been on a campaign against the indis- that may be less efective. However,
criminate use of both venous and en- most vascular surgeons who utilize
dovascular procedures, especially by
such centers will nevertheless do
non–vascular physicians.
what is best for the patient
However, we must acin spite of higher costs.
knowledge that even some
Further, patients may benof our own are abusing the
eft from these centers besystem for fnancial gain.
cause of convenience and
One of the major points
for the provision of a more
made by the New York
personable environment
Times article is that many
than can be found in a hosof these unnecessary
pital inpatient or outpatient
procedures are being perfacility. Additionally, since
DR. SAMSON
formed by cardiologists in
the risk of complications
outpatient centers with litfrom complex interventle or no oversight. In full disclosure
tions, which can be difcult to manI must admit that my group does
age in an outpatient facility, most
lease space in an outpatient center.
ethical physicians will ensure that
I have also published on the benefts
only the safest procedures are underof such a center and the mechanism
taken. Personally, I have performed
for its installation ( J. Vasc. Surg. 2009; more than 500 procedures in our
49:1073-6).
facility over the last 7 years and have
The reimbursement for a procenever encountered a pseudoaneudure performed in a physician-owned rysm, retroperitoneal hematoma, or
or -leased outpatient facility is far
other complication needing hospitalgreater than can be achieved in a hos- ization.
pital-owned facility. However, since
It is my belief that the excessive
the physician is responsible for the
procedures delineated in the New
expenses incurred in such outpatient
York Times article are probably not
facilities, there is a fnancial incentive representative of the majority of
to do more with inexpensive devices
such centers. It is, however, quite
Indications
The Valiant® Thoracic Stent Graft with the Captivia® Delivery System is
intended for the endovascular repair of all lesions of the descending
thoracic aorta (DTA) in patients having appropriate anatomy, including:
• iliac/femoral access vessel morphology that is compatible with vascular
access techniques, devices, and/or accessories;
• nonaneurysmal aortic diameter in the range of 18 mm to 42mm (fusiform
and saccular aneurysms/penetrating ulcers), 18 mm to 44 mm (blunt
traumatic aortic injuries), or 20 mm to 44 mm (dissections); and
• nonaneurysmal aortic proximal and distal neck lengths ≥ 20mm (fusiform
and saccular aneurysms/penetrating ulcers), landing zone ≥20 mm proximal
to the primary entry tear (blunt traumatic aortic injuries, dissections).
The proximal extent of the landing zone must not be dissected.
Contraindications
The Valiant Thoracic Stent Graft with the Captivia Delivery System is
contraindicated in:
• Patients who have a condition that threatens to infect the graft.
• Patients with known sensitivities or allergies to the device materials.
Warnings and Precautions
The long-term safety and efectiveness of the Valiant Thoracic Stent Graft with
the Captivia Delivery System has not been established. All patients should be
advised that endovascular treatment requires lifelong, regular follow-up to
assess the integrity and performance of the implanted endovascular stent
graft. Patients with specifc clinical fndings (for example, enlarging aneurysm,
endoleaks, migration, inadequate seal zone, or continued fow into the false
lumen in the case of a dissection) should receive enhanced follow-up. Specifc
follow-up guidelines are described in the Instructions for Use. The Valiant
true that there is no oversight or
ombudsman to protect the patient
in these outpatient facilities. Hospital-employed or university vascular
surgeons may correctly imply that
there is more oversight of procedures
performed in hospital facilities and
that this should limit unnecessary
procedures. Needless to say, that is
not the case in all institutions.
In our 600-bed municipal hospital,
there is limited peer review and the
few times when it has been applied
it has, on occasion, resulted in legal
suits against the reviewing medical
staf. Additionally, institutions that
reward practitioners based on relative value units may also induce a
perverse incentive to overuse procedures.
As Dr. Lawrence describes in
his article, site of service may not
be the only driving force behind
unnecessary interventions. In fact
the Clinical Council of the SVS has
seized upon appropriate care in offce-based centers and is working on
constructive suggestions to ensure
not only that site of service is convenient for patients, but also that it
provides appropriate high quality
care. For the time being the SVS
recognizes that we need improved
oversight and peer review in these
physician-owned centers, and that
Thoracic Stent Graft with the Captivia Delivery System is not recommended
in patients who cannot undergo, or who will not be compliant with, the
necessary preoperative and postoperative imaging and implantation
procedures as described in the Instructions for Use. Strict adherence to the
Valiant Thoracic Stent Graft sizing guidelines as described in the Instructions
for Use is expected when selecting the device size. Sizing outside of this range
can potentially result in endoleak, fracture, migration, infolding, or graft wear.
As cautioned in the Instructions for Use, a balloon should never be used when
treating a dissection. The safety and efectiveness of the Valiant Thoracic Stent
Graft with the Captivia Delivery 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 Valiant Thoracic Stent Graft is
MR Conditional. It can be scanned safely in both 1.5T and 3.0T MR systems
under specifc conditions as described in the product Instructions for Use.
For additional information regarding MRI please refer to the product
Instructions for Use.
Adverse Events
Potential adverse events include, but are not limited to access failure,
access site complications (e.g. spasm, trauma, bleeding, rupture, dissection),
adynamic ileus, allergic reaction (to contrast, antiplatelet therapy, stent
graft material), amputation, anaesthetic complications, aortic expansion
(e.g. aneurysm, false lumen), aneurysm rupture, angina, arrhythmia, arterial
stenosis, atelectasis, blindness, bowel ischemia/infarction, bowel necrosis,
bowel obstruction, branch vessel occlusion, buttock claudication, cardiac
tamponade, catheter breakage, cerebrovascular accident (CVA) / stroke,
change in mental status, coagulopathy, congestive heart failure, contrast
we should not simply abandon them
because of the abusive behavior of a
few unethical practitioners.
The New York Times article and
Dr. Lawrence’s article and letter to
the New York Times struck a chord
with our membership. It has provoked an outpouring of comments
and suggestions from our membership. Some of these are to be found
in this edition as letters to the editor.
It is apparent that many of us are
horrifed by what we are seeing, not
only in outpatient facilities but also in
hospitals.
I believe this is such an important
issue that I have requested our associate editors to write a brief comment on their views on the matter
and to specifcally identify methods
of rectifying the current overuse of
vascular procedures (see the following 2 pages).
I am hopeful that the NY Times
article and the responses we publish
will instigate vascular surgeons to
stand up for our profession and the
well-being of our patients. For if we
do not, we will continue to be marginalized by newspaper reporters
and government agencies. They will
continue to lump us together with
interventionalists who may not follow the same ethical road that most
of us travel.
toxicity, conversion to surgical repair, death, deployment difculties / failures,
dissection / perforation / rupture of the aortic vessel and/or surrounding
vasculature, embolism, endoleak(s), excessive or inappropriate radiation
exposure, extrusion / erosion, failure to deliver stent graft, femoral
neuropathy, fstula (including aortobronchial, aortoenteric, aortoesophageal,
arteriovenous, and lymph), gastrointestinal bleeding /complications,
genitourinary complications, hematoma, hemorrhage / bleeding,
hypotension / hypertension, infection or fever, insertion or removal
difculties, intercostal pain, intramural hematoma, leg /foot edema,
lymphocele, myocardial infarction, neuropathy, occlusion – venous or
arterial, pain / reaction at catheter insertion site, paralysis, paraparesis,
paraplegia, paresthesia, perfusion of the false lumen, peripheral ischemia,
peripheral nerve injury, pneumonia, post-implant syndrome, procedural /
post-procedural bleeding, prosthesis dilatation / infection / rupture /
thrombosis, pseudoaneurysm, pulmonary edema, pulmonary embolism,
reaction to anaesthesia, renal failure, renal insufciency, reoperation,
respiratory depression / failure, sepsis, seroma, shock, spinal neurological
defcit, stent graft material failure (including breakage of metal portion of
device) / migration / misplacement / occlusion / twisting / kinking, transient
ischemic attack (TIA), thrombosis, tissue necrosis, vascular ischemia, vascular
trauma, wound dehiscence, wound healing complications, wound infection.
Please reference product Instructions for Use for more information regarding
indications, warnings, precautions, contraindications and adverse events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order
of a physician.
www.medtronic.com
www.aortic.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
3
For distribution in the USA only.
FTSOP113326-22 Rev 1A © Medtronic, Inc. 2014. All Rights Reserved.
4
OPINION
MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T
FROM THE EDITORS
The associate editors weigh in
Editor’s Note: The associate editors of Vascular
Specialist were asked to provide their perspectives on
the stenting controversy. Here is a selection.
Dr. Frank J. Veith: The recent lead
article in the New York Times on
excessive implantation of lower
extremity stents highlights one key
point. Vascular
surgeons and all
vascular specialists who treat
lower extremity
occlusive disease
should always
clearly inform
patients with
intermittent
DR. VEITH
claudication that
one acceptable
treatment option is medical and
lipid-lowering therapy without any
invasive treatment of their arterial
blockage. They should be informed
that the condition almost never
leads to limb loss and that invasive
treatment can safely be delayed until such progression occurs. Given
such honest reassurance and the
option to choose their treatment,
most patients with claudication will
choose a conservative rather than an
invasive approach, and unnecessary
stent/angioplasty and other lower
extremity interventional procedures,
as described in the Times article,
will be minimized.
Dr. John F. Eidt: The truth is we all
bear responsibility. The treatment of
lower extremity peripheral artery disease (PAD) has largely defed prior efforts to defne appropriate care. Even
the SVS document recommending
risk factor modifcation in the initial
management
of intermittent
claudication
leaves substantial room for
individualized
judgment. The
appropriateness
of intervention is
largely in the eye
DR. EIDT
of the beholder.
“Lifestyle-limiting” claudication can be invoked as
justifcation for intervention in virtually anyone. But I do believe that
vascular surgeons are more wary of
the adverse consequences of vascular intervention for one important
reason – we do amputations. We are
unique among vascular specialists in
that we deal with the tragedies of
unwarranted vascular procedures.
For vascular surgeons, failure of intervention means more than binary
restenosis or increased target lesion
revascularization. Performing an amputation after failed intervention in
VASCULAR SPECIALIST Medical Editor Russell Samson, M.D.
Associate Editors
Mark A. Adelman M.D., O. William Brown, M.D., Elliot L. Chaikof,
M.D., Ph.D., Alan M. Dietzek, M.D., RPVI, FACS, Professor HansHenning Eckstein, M.D., John F. Eidt, M.D., Rob Fitridge, M.D.,
Larry Kraiss, M.D., Joann Lohr, M.D., James McKinsey, M.D.,
Erica L. Mitchell, M.D., M.Ed., FACS, Mark Morasch, M.D., Frank
Pomposelli, M.D., Luis A. Sanchez, M.D., FACS, Larry Scher, M.D.,
Murray L. Shames, M.D., Cynthia Shortell, M.D., Frank J. Veith,
M.D., Robert Eugene Zierler, M.D.
a claudicant leaves an indelible mark
on each of us and may underlie our
inherently conservative approach
to PAD. But we need to be fearless
in speaking the truth and serving
as advocates for exemplary patient
care. Continuing a relationship with
a source of carotid and aortic referrals while turning a blind eye to
meddlesome lower extremity intervention sends the wrong message.
Our silence constitutes tacit approval.
Too frequently I hear a patient say
“my cardiologist says there is nothing else he can do, go see a vascular
surgeon.” Despite years of branding
eforts by the SVS, surveys of primary care providers and the public alike
confrm that many remain uncertain
of our skills. We need to do a better
job of spreading the word that vascular surgeons are “leaders in the minimally invasive treatment of PAD.”
Not the last resort.
Dr. Frank Pomposelli: I could not
agree more with
Dr. Eidt. It’s easy
to indict the outpatient labs for
obvious reasons
but I personally
agree that the
root of the problem lies in the
overly aggressive
DR. POMPOSELLI
posture being
taken toward
treatment of claudication. It just so
happens that outpatient labs are flled
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with claudicants since they are most
likely to have the least complex disease – match made in heaven or hell,
depending on your perspective. One
cardiologist quoted in the N.Y. Times
piece said patients with claudication
have been “grossly under treated” – a
convenient posture to take when billing Medicare $4.5 million a year. The
other cardiologist who was the focus
of the investigation called the charges
“baseless and fction” and stated his
center had the lowest rate of amputation in the country. It gets back to
Dr. Eidt’s point how it’s easy for the
nonsurgeon to dismiss amputation as
an occasional unfortunate byproduct
of a busy practice when you never
have had to tell a patient they need
one and sufer with them through the
emotional and physical trauma that
always follows. I was taught like many
of you, I suspect, that any amputation
after treatment for claudication should
be considered not only an unacceptable complication but also a failure of
the trust the patient placed in me. My
mentor was a militant nihilist when it
came to surgery for claudication but
that concept is always in my mind
whenever I treat a patient and has always tempered my decision making.
I like to think our recently published
practice guidelines will help but am
skeptical that it will make a positive
impact where it is most needed; on
those who are primarily driven by fnancial gain. I’d also point out that Dr.
Darren B. Schneider was quoted as a
Continued on following page
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Managing Editor SVS Kay Severinsen
Vascular Specialist is the offcial newspaper of the Society for Vascular
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OPINION
VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5
Continued from previous page
member of the Society for Vascular
Medicine. I guess we need to work
harder on our branding.
Dr. Mark Morasch: Remember, all
politics are local, and any meaningful
change needs
to come from
the grass roots.
Experts can
write guidelines,
specialty societies can make
statements, and
newspapers can
print articles but
DR. MORASCH
the most infuential transaction
occurs in the exam room when we
are face to face with our patients. Remember, even though we are a small
group, we can have great infuence
when we always, always, always do
what we know is right.
Dr. Alan M. Dietzek: Dear Patient,
Let me introduce myself. I am a
Board-Certifed
Vascular Surgeon. My specialty is unique
in that I am well
versed and formally trained in
both the medical and surgical
management
DR. DIETZEK
of peripheral
vascular disease.
No other specialist can make this
claim. Most often, vascular problems
can be managed conservatively with
a combination of risk factor and
lifestyle modifcation, and occasionally prescription medications, all of
which I can outline and or prescribe
for you. When necessary, however,
I am prepared to treat your vascular
problem with either a minimally
invasive procedure or open surgery
depending on which treatment will
provide you with the best outcomes.
Again, only a vascular surgeon is
capable of ofering you these treatment options. I am dedicated to your
well-being. I am a Board-Certifed
Vascular Surgeon.
Dr. Murray L. Shames: The recent
New York Times article, “Medicare
payments surge for stents to unblock
blood vessels in limbs,” brings up
a critical issue in how we train our
residents to think and practice in the
future. Our current generation of
residents is faced with a tremendous
fnancial burden of medical school
debt, and they are being ofered highly competitive salaries after gradua-
tion. The motivation to join groups
with outpatient vascular centers is
certainly attractive: Why not have autonomy from the
hospital, control
your work environment, and increase efciency.
As educators we
must continue to
use clinical evidence and societal guidelines
DR. SHAMES
( J. Vasc. Surg.
2015:1-40) to
guide our clinical practice.
As vascular surgeons we have been
trained to manage asymptomatic
PAD and intermittent claudication
nonoperatively due to it’s relatively
benign natural history; endovascular interventions have dramatically
increased the treatment of claudication, even in our own hands. We
must continue to teach our residents
restraint and to consider the impact
of the interventions we perform.
That way we can maintain our status as the leaders in vascular disease
management and not just “interventionalists” that treat lesions.
Dr. Joann Lohr: The presence of
a stenotic lesion does not mandate
treatment either with a stent or surgical intervention but needs critical
assessment of
the impact on
the patient’s
quality of life.
Risk factor modifcation needs to
be undertaken
before any intervention and
will improve outDR. LOHR
comes and durability of repairs.
The only outcome that matters is the
patient’s. “How does treatment of
this lesion change my lifestyle?” is a
question that needs to be answered
for each patient. Treating physicians
need to establish long-term relationships. Never be afraid to tell patients
a procedure is not the frst line of
treatment. Thoughtful application of
new technology is needed in all areas
of medicine. Just because we can,
should we? Appropriate individualized treatment plans and goals need
to be established for each patient we
treat.
Dr. Larry Kraiss: Vascular surgeons
provide the full spectrum of care
for PAD from medical management
through intervention to the unfortunate situations when amputation
is necessary. The more sobering of
these experiences have imbued most
of us with a healthy respect for how
an intervention can go wrong. If
you haven’t had
to explain to a
patient or family
why an amputation is necessary,
you probably
don’t have the
same concern.
Thus, many of
us have a very
DR. KRAISS
conservative approach to PAD
intervention; primum non nocere is
the governing principle. This principle is supposed to guide the actions
of all physicians but I can’t help but
wonder if something happened to
primum non nocere on the way to
the outpatient endovascular center.
When physicians become fnancial
stakeholders in these enterprises, a
pernicious incentive is introduced
that is almost impossible to exclude
from daily clinical decision making.
Hospital-based physicians are also
subject to temptation to perform
unnecessary yet lucrative procedures
but at least these are being done
more in the open. I suspect that the
development of these centers has
allowed much activity to occur that
would rightly be condemned under
the scrutiny of one’s hospital peers.
Dr. Laura Drudi: It really comes
down to adequately informing the
patient. I always fnd it astounding
how many patients I encounter
asking me in a timid tone, “What
exactly did I have done on my leg?”
I question what patients actually
understand and
retain after being
overwhelmed
by the informed
consent we
have prior to an
intervention. I
see frst hand
the catastrophic
failures of interDR. DRUDI
vening on severe
claudication
leading to limb loss and worsening
of quality of life. It’s disheartening to
see adverse outcomes following vascular interventions either by vascular
surgeons or other interventionalists,
but I believe that if you are performing an intervention you should have
the expertise and technical skills to
deal with the complications.
The best interventionalists know
when not to intervene and that
should be the mantra we live by. We
should be advocates for our patients
at a local institutional level as well as
a public level. I believe that following
the New York Times article the pub-
5
lic will be more aware of the potential for inappropriate or unnecessary
interventions, many of which are
being performed by specialists other
than vascular surgeons.
The Society and individual vascular
surgeons should capitalize on this
opportunity to educate patients as to
the benefts of consulting with a vascular surgeon before undertaking any
endovascular procedure.
Dr. Elliot L. Chaikof: Both government and private payers have a vested interest in ensuring that patients
receive the highest quality care, while
reducing the unsustainable rate of
increase in health
care costs. In
Massachusetts
and elsewhere
in the United
States, this has
led to the introduction of new
risk contracting
models that feaDR. CHAIKOF
tures a global
payment with
incentives linked to efciency and
quality.
At our institution, approximately
60% of patients are now in such risk
contracts. Primary care physicians are
most directly incentivized and, along
with government and private payors,
are highly motivated to ensure that
our population of patients receives
the right care, at the right time, from
the right physician. The U.S. health
care system continues to be in a state
of fux with substantial regional
variations in the delivery of care and
how that care is fnanced.
Despite these challenges, the Society for Vascular Surgery can best
serve our patients through advocacy
and education, including promoting
the need for full transparency of
costs to our patients and their physicians. This would be most efective in
active partnership with primary care
providers, along with regional and
national payors.
Dr. Erica L. Mitchell: The line
separating a
business from a
profession is not
entirely clear
when professionals engage
in business practices that serve
to benefit the
individual finanDR. MITCHELL
cially.
One crucial
difference distinguishing the profession of medicine from other
Continued on following page
6
OPINION
MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T
LETTERS TO THE EDITOR
Editors note: The following letters are a selection of
responses from the SVS membership sent to Dr. Peter
Lawrence based upon his article in last month’s
Vascular Specialist (February 2015, p. 1) on the
topic of the abuse of peripheral artery disease
stenting in Medicare patients.
D
espite the unfortunate press,
we as a more global medical
vascular community are unable
to police our own. I have been involved in two specific instances in
which inappropriate and overuse
of endovascular therapy has been
addressed. Unfortunately, these
practitioners continue to perform
unindicated procedures while hospitals and state medical boards refuse to act.
What is Medicare to do when our
own medical regulatory bodies fail
to act on behalf of patients and the
payor? The two routes of targeting
practitioners through Medicare high
outliers and legal recourse for poor
outcome in unindicated procedures
will remain until our societies (this
includes SVIR and ACC) decide to
collaborate and ensure appropriate
practice. Simply stating that SVS has
guidelines in place will not solve the
problem.
Jason M. Johanning, M.D.
Omaha, Neb.
M
y ofce of fve vascular surgeons
actually has an in-ofce procedure suite. We have converted about
30%-40% of our minimally invasive
patient care to this setting. In review
of what we have done, we have actually decreased the cost of patient care
as there is no facility or hospital addon charge.
Our cost per patient is actually
about one-third of what is typically
Continued from previous page
professions is that physicians have a
fiduciary duty toward those whom
they serve. This means that we
have a legal duty to provide services to our patients that place the
patient’s interest above our own
financial interest.
This article highlights how legal
and ethical issues arise if health care
professionals forgo their fduciary
duties for personal gain. Unethical
physicians should be held account-
charged by the hospital, and our
quality based on our independent
QA is the same in our ofce setting
as it is in the hospital. These types
of settings can signifcantly reduce
health care costs if done in the proper fashion.
Dennis Fry, M.D.
West Des Moines, Iowa
T
he comments in the article that
hospitals confer a greater degree of oversight seems to come
right from the AHA. The problem
is not ofce-based procedures but
the ethics of fraudulent practices,
something that occurs in and among
hospitals as well. Hospitals can be
as much driven by case volume,
even at academic centers, as are the
practices of private outpatient procedures.
Paul Gagne, M.D.
Darien, Conn.
I
cannot help but wonder how our
specialty’s lack of identity – and
thus lack of appreciation of its
responsibility and role in public
awareness – has contributed to this
scenario. Our inclusion under the
umbrella of the American Heart
Association, again without any designation of our separate identity,
leads only to more confusion about
our specialty in the eyes of the
public.
The SVS must address its lack of
a public identity in a more forceful
able for unethical
practices.
Dr. Larry Scher:
The recent article by Julie
Creswell and
Reed Abelson in
the Jan. 29, 2015,
DR. SCHER
New York Times
highlights a recent problem in the care of patients
with peripheral vascular disease.
Vascular surgeons have been treating
manner. Unfortunately, it’s biggest
hurdle in this may well be the hospital-employed vascular surgeons
who cannot fght the administrators
marketing theme of “Heart and Vascular,” implying to the public that we
are all one, “like the cardiologists do”
as many patients state.
This is not to fault anyone, but it is
to awaken our leadership to the need
to establish a separate, independent
“awareness” vehicle to better craft
our identity as a separate specialty to
the entire nation.
It will take time but will be a
project which, when done properly,
we will never regret. It calls for a
board heavily weighted toward the
independent vascular surgeons, who
try daily, with limited resources, to
accomplish this.
Carlo Dall’Olmo, M.D.
Flint, Mich.
We have struggled locally with
the belief that we, as ethical and
well-reasoned providers, should
have some obligation to report
these providers to someone.
However, there are no acceptable
mechanisms with which to do so,
and there is a sense that this would
not be accepted well by our colleagues.
We also do not want to be written of as disgruntled competitors.
Physicians have never done a good
job of policing themselves. Maybe
articles like this can be a springboard
to discuss ways to reign in the outlier
providers in our communities.
Steven Merrell, M.D.
Murray, Utah
I
think most members of SVS have
intimate knowledge of a handful
of physicians in their communities
whose practices would be considered abusive, if not overtly suspect.
agree with Dr. Lawrence 100%.
We need the SVS to be a major
speaker in this debate. We have to
give patients the confidence that
they are being cared for by physicians who are not only capable to
diagnose the problem but are also
able to care for it in the most appropriate fashion.
We need to silence the naysayers
and the media hogs by developing
a method so that surgeons who
care for vascular patients in an offce-based vascular suite are certifed
by the Society in the form a Center
of Excellence designation. Initial
certifcation would be followed by
ongoing proactive reviews on a serial
basis.
I would ask that the leaders of our
society take a step toward developing the concept of this certifcation
body as soon as possible. We need to
police ourselves and this may be the
way to do it.
Thank you in advance for your attention and ongoing vigilance for the
vascular surgical community.
Khash Salartash, M.D.
Galloway, N.J.
peripheral arterial disease for over
50 years and have generally adopted
a conservative approach toward patients with claudication, emphasizing
risk factor modifcation and exercise.
This is based on an understanding
that the disease is benign, rarely progressive, and only occasionally disabling to the point that intervention
is indicated for symptom relief.
With new minimally invasive techniques available and specialists other
than vascular surgeons performing
peripheral catheter based procedures
we seem to have forgotten all that
vascular surgeons have learned over
the past 5 decades. Most patients
with claudication do not beneft from
and may be harmed by interventions
when long-term rather than shortterm outcomes are analyzed.
Although practitioners such as
those identifed in this article may
believe they are pioneers in the treatment of peripheral arterial disease
and specifcally claudication, I would
consider them cowboys who have
forgotten the lessons of the past.
W
hat the article misrepresents
is that this happens only in
outpatient labs. The same thing
occurs, albeit to a lesser degree, in
our hospitals. I am glad to see no
vascular surgeons were named. I
am also glad they are starting to
shine a light on the massive ongoing problems with EVLT and RF
ablation procedures. This is particularly bad in Florida.
I wonder if SVS can come up with
some response to suggest ways to
police this behavior. None of us want
more government oversight, but it
seems like something needs to be
done at the state board level to better
regulate these procedures.
Geofrey L. Risley, M.D.
Jacksonville, Fla.
I
VAS_7.indd 1
3/10/2015 10:43:22 AM
POINT/COUNTERPOINT
8
MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T
POINT/COUNTERPOINT
Renal artery occlusive disease – To treat or not to treat?
ASTRAL and CORAL trials show no indication
to treat percutaneously.
There are still indications to treat renal artery
occlusive disease.
when added to comprehensive,
multifactorial medical therapy, inercutaneous treatment of renal tervention yielded no beneft.
artery occlusive disease is unSo are there certain patient
necessary and should be abangroups who might beneft more
doned, except in pediatric cases.
from intervention? Among listed
This position is supported by
indications are high-grade stenosis
fndings from both the ASTRAL tri- (which doesn’t apply any longer);
al (N. Engl. J. Med. 2009;361:1953short history of progressive failure
62) and the CORAL trial (N. Engl.
(which is quite rare); ACE-induced
J. Med. 2013 Nov. 18 [doi:10.1056/
renal failure (which is also quite
NEJMoa1310753]).
rare); difcult-to-control hypertenThe ASTRAL trial, a prospective, sion (there really is no such thing
randomized comparison of best
now, except in a tiny percentage of
medical therapy with and without
patients); and – the least challenged
stent angioplasty in more than 800
indication – fash pulmonary edepatients, was the largest trial to
ma. These remaining indications
date when it began back
move our interventions
in the 1990s. The wellinto a very high-risk
known results showed
group of patients.
no diference in time
The current debate is
to frst renal event, frst
focused almost entirely
vascular and cardiovason endovascular intercular events, and overall
vention, but a systematic
survival. Furthermore,
review showed that there
there was no diference
is long-term beneft in
in these outcomes among
terms of renal function
DR. HAMILTON
patients with greater
and hypertension with
than 90% stenosis, with
open procedures. Althe exception of a possible diferthough overall there is increased
ence in mortality, which trended
mortality, this risk is minimized –
toward improvement among those
and not signifcantly diferent from
with high-grade stenosis.
endovascular procedures – in those
We concluded that revasculariza- having only renal revascularization
tion in the vast majority of patients vs. those having concomitant aortic
is unlikely to improve hypertension procedures. So open surgery recontrol or renal function, and that
mains a possible treatment option.
renal artery stenosis is not pathoindeed a recent level 1 study comphysiologically important. We also
paring stenting and open surgery;
concluded that there is no point in
showed better long-term results
screening for asymptomatic disease; with open surgery ( J. Vasc. Surg.
this was back when every patient
2009;49:667-75). The authors conwas getting screened, and treated
cluded that surgical reconstruction
primarily on the basis of fnding a
remains the gold standard in treatrenal arterial stenosis.
ing renal artery stenosis. Although
Finally, we concluded that propnational data suggest an overall
erly applied best medical therapy
mortality of about 10%, it is much
alone was an extremely good treat- lower at specialist, high-volume
ment.
centers with mortality rates similar
Several faws in the trial garnered
to those of stent angioplasty.
extensive criticism, however, and
Renal stenting is not a low-risk
the more rigidly designed CORAL
procedure. In all-comers the comtrial was expected to address them.
plication rates, serious complication
The fndings confrmed those of
rates, and mortality rates are signifthe ASTRAL trial. In more than 900 icant with short-term equivalence
patients from 88 centers, there was
between focused renal arterial
absolutely no beneft of intervention surgery and percutaneous intervenwith respect to primary and section.
ondary outcomes, including among
Returning to the debate, are eithose with high-grade stenosis.
ther methods of revascularization
We can now see on the basis
appropriate? Probably not.
HAMILTON continued on following page
of extensive level 1 evidence that
inclusion within a randomized trial
with change in renal function as its
lthough renal artery revasprimary outcome is problematic for
cularization has been grossly
the same reason.
overutilized and is not indicatASTRAL also had an additional,
ed in the majority of patients with
somewhat unorthodox inclusion
renal artery stenosis, I perform recriterion: uncertainty on the part of
nal artery revascularization as part
the treating physician that the patient
of my routine clinical practice and
“defnitely would have a worthbelieve that there are many instanc- while clinical beneft from revascues where revascularization should
larization.” Exclusion of patients
be considered, particularly when
considered likely to beneft from
patients have severe symptoms
revascularization would seem to endespite aggressive medical therapy.
sure a selection bias favoring the null
While neither ASTRAL nor CORhypothesis; this approach may also
AL observed any beneft associated explain the large proportion of particwith revascularization, both have
ipants with relatively mild occlusive
important limitations
disease (40% had stenotic
that should be kept in
lesions that were <70% in
mind when interpreting
severity).
the results of these trials.
A high rate of both
These limitations can
technical failure (12%)
be broadly categorized as
and adverse events (20%)
mismatch between indicaassociated with revascutions for revascularization
larization, asymmetric
and clinical endpoints,
crossover between treatselection biases favoring
ment groups (86 of the
DR. CORRIERE
enrollment of patients
110 patients who did not
with relatively mild sympreceive their randomized
toms, and inconsistencies between
intervention were in the revasstudy protocols and contemporary
cularization group), and lack of
decision-making strategies.
standardized protocol for medical
Given that ASTRAL’s primary
therapy further limit the concluoutcome was change in renal func- sions that can be drawn from the
tion (defned by a 20% or greater
ASTRAL results.
reduction in the mean slope of the
Although this trial does not proreciprocal of serum creatinine),
vide us with compelling evidence
it is important to remember that
that renal revascularization should
the inclusion criteria were renal
be abandoned for patients failartery stenosis with unexplained
ing appropriate medical therapy,
renal dysfunction or poorly conASTRAL demonstrated that no
trolled hypertension. Patients who
beneft should be expected from
had hypertension in the absence
nonselective use of revascularizaof signifcant renal dysfunction
tion, which can be associated with
were therefore eligible, and 40%
signifcant rates of both technical
of the randomized participants
failure and major adverse events.
had preserved baseline renal funcThe CORAL trial overcame many
tion (based on a serum creatinine
of the design limitations for which
of <150 micromol/liter). Unlike
ASTRAL drew criticism. CORAL’s
patients with baseline renal dysprimary endpoint (freedom from
function (which, in theory, might
major adverse cardiovascular or reimprove with revascularization),
nal events) allowed potential beneft
these patients with normal renal
for participants with either systolic
function who were treated with
hypertension or chronic kidney
revascularization risked decline in
disease as their indication for treatrenal function resulting from proce- ment. Although participants with
dure-related adverse events without systolic hypertension as their incluany real chance of renal function
sion criterion had to be on at least
improvement. It would certainly
two antihypertensive medications,
be difcult to justify revascularizait is important to acknowledge the
tion for the sake of renal function
growing number of indications for
CORRIERE continued on following page
salvage in these patients, and their
BY GEORGE HAMILTON, M.D.
P
BY MATTHEW A. CORRIERE, M.D.
A
VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5
HAMILTON continued from previous page
Even in fash pulmonary edema,
there is little evidence to support
revascularization. Few papers exist
suggesting a beneft of revascularization in reduction of fash
pulmonary edema, but the patient
numbers were small, and there
was no beneft in terms of preserCORRIERE continued from previous page
these medications related to cardiovascular risk reduction in the
setting of diabetes, heart disease,
and other diagnoses that may be
unrelated to any specifc blood
pressure target. Number of antihypertensive medications is therefore often a crude and potentially
invalid indicator of hypertension
severity or control.
In CORAL, the initial hypertension inclusion criterion of 155 mm
Hg was subsequently abandoned
during the trial, suggesting that
hypertension in many of these
patients may have been mild and/
or well controlled. Although medical therapy in CORAL was standardized, it also is notable that all
patients had their medical therapy
adjusted prior to randomization
during a roll-in phase to achieve
target blood pressure goals of
130/80 in patients with CKD and/
or diabetes or 140/90 otherwise.
I would suggest that achievement
of these blood pressure targets on
the study medications (candesartan ± hydrochlorothiazide plus
amlodipine-atorvastatin) might be
appropriately considered success of
medical therapy for patients with
hypertension in the absence of
renal dysfunction, making it challenging to defend proceeding with
revascularization in this scenario.
The study protocol, although
well designed from the perspective of attempting to isolate the
efect of renal artery angioplasty
and stenting, therefore did not
uniformly refect what would be
considered responsible utilization
of renal revascularization in a
real-world environment.
Patient enrollment in CORAL
was also very selective; only 947
of the 5,322 patients who were
screened went on to be enrolled
and randomized. It is likely that
at least some of those patients
who were not enrolled (especially
those who declined to participate
or were withdrawn by their physicians) were failing aggressive
POINT/COUNTERPOINT
vation of renal function.
The history of evolution and
evaluation of the role of renal
revascularization is remarkably
similar to that of renal denervation, initially and with considerable conviction thought to be a
cure for hypertension. However,
when properly assessed by prospective randomized comparison,
there was found to be absolutely no
beneft.
So, given the considerable objective
evidence from two major trials and
revisiting the basics of the pathophysiology of atherosclerotic renovascular disease, to expect beneft from
treating the osteal component of renal artery occlusive disease is at best
naive, in my opinion. There remains
little clinical evidence of beneft for
any indication, with the possible exceptions of ACE-induced renal failure
and possibly fash pulmonary edema
in the presence of bilateral renal arterial stenoses.
medical therapy and therefore
unwilling to being excluded from
angioplasty and stenting through
randomization. These limitations
aside, however, CORAL does
provide some very useful observations that should inform treatment
decisions. The results demonstrate
the efcacy of contemporary medical therapy for many patients, and
show that revascularization ofers
no additional beneft when medical therapy achieves an acceptable
clinical response (defned by stable
renal function and reasonable
blood pressure control). Additional
subgroup analyses of the CORAL
data are anticipated, but will likely
be underpowered to draw conclusions in the absence of identifed
revascularization efects.
So when should revascularization be considered for patients
with atherosclerotic renal artery
stenosis? In general, medical therapy is adequate for most patients
and should be implemented prior
to any consideration of procedural
intervention. Revascularization
should be considered only for patients who have failed appropriate,
aggressive medical therapy; the
medications used in CORAL can
certainly be regarded as adequate
initial therapy for symptomatic
renal artery stenosis, but many
providers (including myself )
would argue that additional agents
should be considered before proceeding with revascularization.
When decline in renal function
is the indication for considering
revascularization, alternative
causes (such as intrinsic renal disease) should diminish enthusiasm
for proceeding with angioplasty
and stenting, particularly when
the anatomic disease distribution
does not afect the entire renal
mass (as in patients with two
kidneys and unilateral stenosis).
Appropriate candidates for revascularization include patients with
severely impaired renal function
(particularly in the setting of a
precipitous functional decline) or
severe acute blood pressure ele-
vation associated with hypertensive
emergency (such as acute congestive
heart failure, encephalopathy, acute
coronary syndrome, or other signs
and symptoms of target organ damage resulting from hypertension and/
or volume overload). Continuation
of failed medical therapy is often
unacceptable to these “no-options”
patients as well as their providers,
both of whom presumably would be
unlikely to accept randomization to
ongoing medical management.
Other populations that are not represented within these trials include
patients with renal artery restenosis
and those with nonatherosclerotic
disease; it is therefore important to
exercise caution when generalizing
these study results to these distinct
groups of patients. Enrolling pa-
tients with severe symptoms who
have failed medical therapy will
likely remain challenging for future
randomized studies in the absence
of alternative treatment options.
Although the benefts of renal angioplasty and stenting for these
“no-options” patients remain to be
proved, the uncertainty of response
to revascularization is often easier to
accept than the ongoing morbidity
and mortality associated with staying
the course when medical therapy has
failed.
Dr. Hamilton is a professor at the Royal
Free London Hospital, University College
London.
Dr. Corriere is a vascular surgeon at
Wake Forest University School of Medicine, Winston-Salem, N.C.
This article developed from a debate held
at the 2014 Vascular Annual Meeting.
has not only a new look,
but new features, with the goal of providing you
the latest in vascular and medical
news beyond the print edition.
9
10
RESIDENTS’ FORUM
MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T
Private vs. academic salaries
PERSPECTIVE
Gap from page 1
Not just the money
the annual scientifc assembly of the
Eastern Association for the Surgery
of Trauma (EAST).
Every year a new class of surgeons
is faced with the question of academic practice or private practice,
The worse
fnancially you
make it to be
an academic
surgeon, the
more it risks our
mode of training.
DR. LOPEZ
but they are also struggling with increasing student loan debt and longer
training as more surgical residents
elect to enter fellowship rather than
general practice.
This growing fnancial liability
coupled with declining physician
reimbursement could rapidly shift
physician practices and thus threaten
the fscal viability of certain surgical
felds or academic surgical careers.
“The more fnancially irresponsible
you make it to become an academic
surgeon, the more we put at risk our
current mode of training,” Dr. Lopez
of Wake Forest University in Winston-Salem, N.C., said.
To account for additional factors
outside gross income, the investigators ran the numbers using a second
analysis, a net present value calculation, however, and came up with
roughly the same salary gap to contend with.
Net present value (NPV) calculations are commonly used in business
to calculate the proftability of an
investment and also have been used
in the medical feld to gauge return
on investment for various careers.
The NPV calculation accounts for
positive and negative cash fows over
the entire length of a career, using
in this case, a 5% discount rate and
adjusting for infation, Dr. Lopez
explained.
Both the lifetime gross income and
5% NPV calculation used data from
the Medical Group Management
Association’s 2012 physician salary report, the 2012 Association of American Medical Colleges physician salary
report, and the AAMC database for
residency and fellow salary.
The NPV assumed a career length
of 37-39 years, based on a retirement
age of 65 years for all specialties.
Positive cash fows included annual
salary less federal income tax. Negative cash fows included the average
principal for student loans, according
to the AAMC, and interest at 5%, the
average for the three largest student
loan lenders in 2014, he said. Student
loan repayment was calculated for
a fxed-rate loan to be paid over 25
years beginning after residency or
any required fellowship.
The average reduction in 5% NPV
across surgical specialties for an academic surgeon versus a privately
employed surgeon was 12.8% or
$246,499, Dr. Lopez said.
Once again, academic neurosurgeons had the largest reduction in 5%
NPV at 25.5% or a loss of $619,681,
followed closely by trauma surgeons
(23% or $381,179) and surgical oncologists (16.3% or $256,373). Academic
pediatric surgeons had the smallest
reduction in 5% NPV at 4.2% or
$88,827.
During a discussion of the provocative poster, attendees questioned
whether it was fair to say that private
surgeons make more money without
acknowledging the risk they face,
Market pressures
unaccounted
for in the model
can dramatically
infuence a
surgeon’s salary
over a lifetime.
DR. ZARZAUR
compared with surgeons employed in
an academic setting.
Dr. Lopez countered that, increasingly, even private surgeons are no
longer truly private surgeons.
“More and more surgical groups
are being bought up by hospitals, and
even the private surgical groups are
being bought up by hospitals, which
does stabilize your income to some
extent,” he said.
“We all still have [relative value
unit] goals to meet and RVU incentives that make it so you can get paid
a little more, but it’s something that’s
a consideration. It is a risk-reward
to be a private surgeon. Depending
on how your contract is structured
or how your group decides to pay
the partners, it may be that if you
don’t take very much call or take
that many cases, you’ll end up on the
short end of the stick.”
Dr. Ben L. Zarzaur, a general surgeon at Indiana University in Indianapolis who comoderated the poster
discussion, pointed out that market
pressures unaccounted for in the
model can dramatically infuence a
I
n the United States, academic
vascular surgeons earn 13.8%
or $1.7 million less than
private vascular surgeons.
This fnancial incentive
may infuence graduating
residents and fellows to
enter into private practice.
This article indicates that
this fnancial disparity may
cost academic institutions
the expertise needed to
train future physicians. Unfortunately, I believe this analysis
falls into one of the many myths
between academic and private
practice; that is, it’s not only about
making the most money possible.
The ongoing debate of academic versus private practice shouldn’t
surgeon’s salary over a lifetime.
Dr. Lopez agreed, citing how the
increasing number of stent placements by cardiologists, for example,
has impacted the bottom line of
cardiothoracic surgeons. The NPV
calculation was specifcally used,
however, because it gets at market
forces such as infation and return on
investment, not addressed by gross
income fgures alone.
Finally, Dr. Zarzaur turned and
asked the relatively young crowd
what they would do if ofered
$600,000 a year, but had to work 110
hours a week or could get $250,000
and work only 40 hours a week.
Most responded that they’d choose
the former to repay their student
loans and then switch to the lower-paying position.
Responders made much of job satisfaction, work-life balance, and the
really be a debate at all. It is all
about personal choices concerning research, education,
work-life balance, and
fnances to name a few.
In the end, anyone can
shape the ideal practice
they want to have. There
are many private practices that are involved in resident education, publish
extensively and present at
national and international meetings. No job is weaved perfectly,
but there will usually be a job that
fts an individual’s specifc goals
and desires.
Dr. Laura Drudi is the resident medical editor for Vascular Specialist.
ability of surgeons in academic practice to take time away from clinical
work to conduct research, their ready
access to continuing medical education, and their ability to educate the
next generation of surgeons.
“Any time we see this academic-private disparity, you have to think
about these secondary gains,” Dr.
Zarzaur said.
“This is really interesting work. It
gets into why we choose what we do,
why we’d take $600,000, work 110
hours a week, and get our rear ends
kicked. The fip side is, if I saw this,
why would you ever go into academics? But people still choose to do it.
I’m in academics so there’s a bias, but
we choose to do it anyway up to a
point. I don’t know where that point
is, but up to a point we do.”
pwendling@frontlinemedcom.com
PERSPECTIVE
Lifestyle choice important
T
he basic fnding of the disparity
is in fact true leaving aside the
fawed methodology of too many
assumptions by including all academic ranks, practitioners of diferent durations in practice, diference
in benefts, tuition assistance, and
assuming student loans for all surgeons plus a risk free rate that is
too high.
Our analysis of both vascular
and general surgeon compensation points to a larger disparity at
junior academic ranks over the
last decade. With our own studies
showing a shortage of vascular sur-
geons, retention of practitioners is
paramount for all health systems.
Academic centers rely on faculty
giving up a percentage of their
compensation for the pleasure of
teaching, research and intellectual
stimulation. The unanswered question is: How much of a disparity
will junior academic surgeons
tolerate, and how do they value
lifestyle against additional compensation? Time will tell.
Dr. Bhagwan Satiani is a professor of
vascular surgery at the Wexner Medical Center, Ohio State University.
VAS_11.indd 1
3/11/2015 9:09:59 AM
12
NEWS FROM SVS
MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T
ACA – What it takes for surgeons
to survive and succeed
E
ach year, one of the highlights of
the Vascular Annual Meeting is
the lively Crawford Critical Issues
Symposium, headed this year by Dr.
Bruce Perler of Johns Hopkins Hospital
Division of Vascular Surgery. His topic,
“How You Can Succeed Under the Affordable Care Act,” will be addressed by
stakeholders from all sides of the issue.
• Dr. Bruce Landon, professor of
health care policy, Harvard Medical
School, discussing how ACA may impact vascular surgeons
• Dr. Dan Clair, chair, Department of
Vascular Surgery, the Cleveland Clinic,
discussing how vascular surgeons can
succeed as hospital employees
DR. BRUCE PERLER
Vascular Specialist asked Dr. Perler
to tell us more about this event, scheduled for 10:30 a.m. to noon on Thursday, June 18.
VS: Why did you pick this topic?
Dr. Perler: There is no more important and overarching issue for all vascular surgeons today than the rapidly
changing contemporary health care
environment related to the AffordContinued on following page
Register now for the
Vascular Annual Meeting
R
egistration is now open for the
2015 Vascular Annual Meeting,
which is scheduled for June 17-20 in
Chicago, Ill.
Thanks in part to revised deadlines
for submissions, this year we received
a record 705 abstract and video submissions. This should ensure that you
will be attending invigorating sessions
with lively discussions. Registration
fees vary depending on your category,
from $650 for active members to $300
for candidates, international physicians, and non-member residents.
Early birds - This year, there will
be more to do on Wednesday, which
SVS ANNUAL
MEETING
705
Record-breaking total
submissions of VIDEOS
and ABSTRACTS.
HOTEL OPTIONS WITH SPECIAL RATES
Speakers will be –
• Dr. Stephen Ondra, senior vice
president and CMO of Health Care
Service Corporation, ofering the
viewpoint of the insurance industry
• Larry Boress, president and CEO,
Midwest Business Group on Health,
an agency that helps employers choose
and manage health care benefts for
employees
5
THINGS TO KNOW
ABOUT THE
features hands-on interactive workshops and lots of international events.
An excellent lineup of postgraduate
courses will be ofered, which are included in your registration fee.
Self-assessment credit – Credits will
be available for all plenary sessions
and attendees can claim credits online
following the meeting. You will need
to attend all seven plenary sessions to
apply for self-assessment credit.
Q. Who can beneft from attending
the SVS annual meeting?
A. Attendance can benefits active
Register continued on page 14
3
• Sheraton Chicago Hotel and Towers:
$279 single/$299double.
• Hyatt Regency McCormick Place:
$296 single/double.
• Holiday Inn Mart Plaza:
$189 single/double.
AMA PRA CATEGORY 1 CREDITS™
you can earn up to
30.75
5
PLAYERS ON THE TEXAS RANGERS who
have been diagnosed with THORACIC OUTLET
SYNDROME. The Chicago White Sox will play
the Rangers twice that weekend.
TICKETS: http://vsweb.org/Baseball
ATTENDEES in 2011,
the last time that VAM
was in Chicago.
3,020
NEWS FROM SVS
VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5
Continued from previous page
able Care Act. Quite honestly, for a
number of reasons and in large part
due to these changes, I believe the
lines of demarcation between private and academic practice are increasingly blurring. The pressures,
external threats, and challenges to
achieving a satisfying and economically viable practice are quite similar today irrespective of practice
type or location.
The increasing movement to
full-time hospital employment,
the increasing emphasis on quality
outcomes, impending changes in
reimbursement models, and the emergence of Accountable Care Organizations (ACOs) are factors afecting the
practices of all vascular surgeons. I
therefore believed that this was a most
appropriate topic to address at the
2015 Crawford Critical Issues Symposium. “How You Can Succeed Under
the Afordable Care Act” will provide
strategies that our members can follow to not only survive but thrive in
this new health care order.
VS: What takeaways do you hope
attendees will have at the end of
the session?
Dr. Perler: We will be bringing together in one forum a world class
group of nationally recognized experts and stakeholders in health care
to share their knowledge about, and
expectations for, the immediate and
mid-term future of health care economics. The panel includes individuals with diverse backgrounds and
interests including the perspectives
The lines of demarcation
between private and academic
practice are increasingly
blurring. The challenges
to achieving a satisfying
and economically viable
practice are quite similar.
of the employer, the payor, public
health policy-makers, and the practicing institution-employed vascular
surgeon. We believe these presentations and the opportunity for our
attendees to engage these leaders in
a question-and-answer session will
provide education about the expectations these stakeholders have of
clinicians and therefore allow our
members to develop strategies that
they might incorporate in their own
practices to continue professionally
satisfying and economically productive practices.
While all medical practitioners are
afected by these changes inherent in
the Afordable Care Act, because of
our relatively small numbers and the
increasing multispecialty completion
that vascular surgeons face, including
for many participation in multispecialty cardiovascular centers as well
as increasing hospital employment, I
believe that these issues are particularly relevant to our specialty.
VS: You have an interesting line-up
of panelists, what were your reasons for selecting each?
Dr. Perler: There are clearly multiple stakeholders or components in
our health care system with unique
backgrounds, interests, and agendas.
Each of them will bring to the Crawford Symposium a perspective from
his specifc component of the system,
the insurer, the employer, the hospital-employed surgeon, and someone
with specifc expertise in Accountable
Care Organizations and knowledge
of vascular surgical practice.
It was my expectation to bring
these experts together in one setting
to not only provide useful information for our attendees, but to allow
them to engage in a collective discourse that should provide an unparalleled educational experience for our
attendees.
13
VS: Where do you think their biggest
areas of agreement, and of disagreement, will be during the discussion?
Dr. Perler: That’s a great question and the short answer is I can’t
precisely predict. In general, I
would assume that there will be a
consensus that rising health care
costs must come under control and
physician reimbursement in the
future will be increasingly linked to
quality outcomes rather than pure
case volume. There also may be a
consensus on the importance of
longitudinal patient care.
Beyond the obvious, however, the
key question is whether or how the
health care system will align reimbursement to the distinctive competencies of vascular surgeons as the
only truly comprehensive vascular
specialists who provide the totality
of care including diagnosis as well as
medical, surgical, and endovascular
therapy. Will employers and insurers
recognize the value of the comprehensive care that only vascular surgeons provide? Will ACOs factor that
competency into specialty referral
patterns?
Further, will payors and hospitals
recognize the unique leadership that
vascular surgeons can provide in the
care of cardiovascular patients in the
hospital environment?
NEWS FROM SVS
14
MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T
Study: Surgery offers chance
to adjust vascular medications
P
atients who are treated at sites
with longer participation in the
VQI had better medical management and this was associated with
higher survival rates, according to a
new study reported
in the April 2015
issue of The Journal
of Vascular Surgery.
Further, surgery
at a VQI site may relate to optimized
medications with the goal to improve
survival rates.
Led by Dr. Randall R. De Martino,
a team of researchers studied medical
management for vascular surgery patients at sites participating in the Vascular Quality Initiative and associated
patient survival rates.
Two key outcomes were noted: Site
participation in VQI is associated with
improved use of antiplatelets and statin medication for that site’s patients
undergoing vascular procedures; and,
treatment with AP and statins is associated with a 14 percent survival
advantage for patients at fve years
postsurgery.
“Medical therapy for patients with
vascular disease remains important
for their long-term prevention of
cardiovascular events,” noted Dr. De
Martino. “The surgical encounter
provides an excellent opportunity to
ensure that appropriate medications are
prescribed. As our
data demonstrate,
many patients remain medically undertreated and this
is associated with worse long-term
survival. Importantly, participating in
a quality improvement initiative, like
the VQI, is associated with improvements in medical management. This
highlights how we can use a quality
improvement collaborative to improve care for our patients.”
Since up to 75 percent of patients
with peripheral arterial disease will
ultimately die of cardiovascular causes,
it seems that medical management is a
strong tool to ensure patient survival.
Additional authors are Drs. Andrew W. Hoel, Adam W. Beck, Jens
Eldrup-Jorgensen, John W. Hallett, Gilbert R. Upchurch, Jack L. Cronenwett,
and Philip P. Goodney.
Register
continued from page 12
members and non-members,
senior and retiree members, candidates, students, residents, and
fellows. Professionals in related
felds, such as podiatrists, allied
health professionals, PhDs and researchers, vascular nurses, international professionals, and exhibitors,
can also beneft.
Q. Can I still submit an abstract?
A. The deadline has passed, however there will be an opportunity
to submit late-breaking abstracts.
Visit vsweb.org/VAM15 for details.
from popular Navy Pier and
the shopping along Magnificent
Mile. Or enjoy the free concerts
offered at the nearby Jay Pritzker
Pavilion in Millennium Park on
Wednesday and Friday evenings.
Take a tour by Segway or trolley
or by boat along the Chicago River. Enjoy the city’s blues and jazz
night clubs and fabulous dining.
Sample local delicacies such as
Italian beef sandwiches or deep
dish pizza. Check out the free
Lincoln Park Zoo, or the lakeside
beaches.
Q. How do I get to McCormick
Place in Chicago?
A. See our travel page online at
http://vsweb.org/Travel.
Q. I’m not an active member yet.
Why should I come?
A. The Vascular Annual Meeting
has a vastly expanded program for
fellows, residents. Find out more at
http://vsweb.org/RSF. And you
get a big discount.
Q. Should I bring the family?
A. Sure, why not? June is one of
Chicago’s best weather months,
and the Sheraton is just blocks
Research and San Francisco? What’s not to like?
Sign up now for VriC...May 6, 2015 in the heart of San Francisco
There’s nothing abstract about the Vascular Research Initiatives Conference – it’s
specifcally designed to foster interaction and encourage new researchers. This year’s
translational session, “Biomarkers for Vascular Disease Prediction and Therapeutic
Screening,” will feature Drs. William R. Hiatt, Alberto Figueroa, and Lars Maegdefessel.
The one-day conference is scheduled the day before the AHA ATVB meeting at
the same location. MOC credits available.
regiStration iS now open
To register, visit: http://vsweb.org/VRICRegister
Pricing: Member: $275 / Non-Member: $300 / Resident: $125
aCCoMMoDationS
Hilton San Francisco Union Square, 333 O’Farrell St.
Special room rate: $229/night single/double occupancy;
frst come, frst serve.
Reservations: http://vsweb.org/VRIC15hotel or 800-HILTONS.
International guests may call: 415-771-1400.
®
Be sure to mention you are
attending the AHA ATVB meeting.
NEWS FROM SVS
VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5
15
Growing Medicare penalties start this year
A
long with the usual threat of
cuts to physician payment using
the Sustainable Growth Rate
(SGR) formula, which sets payment
rates through a formula based on
economic growth, physicians are also
facing other potential cuts.
Physician Quality Report System
(PQRS) – for eligible professionals (EPs), which include vascular
surgeons, who do not successfully
report nine quality measures:
1. 2015 – 1 percent payment adjustment
2. 2016 and beyond – 2 percent payment adjustment
3. According to the American Medical Association, only 35 percent of
EPs are participating in PQRS
Meaningful Use of Electronic
Health Record Incentive Program –
for EPs who fail to participate:
1. 2015 – 1 percent payment adjustment
2. 2016 – 2 percent payment adjustment
3. 2017 – 3 percent payment adjustment
4. Hardship exemptions – insufcient Internet access, new physician,
natural disaster or other unforeseeable barrier, lack of face-to-face or
telemedicine interaction or lack of
follow-up needed with patients and
lack of control over availability of
certifed EHR technology
5. According to a 2014 Medscape
Report, 22 percent of physicians are
opting out of Meaningful Use
Value-Based Payment Modifer –
for physicians who do not meet the
benchmark for both cost and quality data:
1. 2015 – 1 percent payment adjustment for physicians in group practices of 100 or more EPs under a single
tax identifcation number based on
2013 data
2. 2016 – 2 percent payment adjustment for physicians in group practices of 10 or more EPs based on 2014
data
3. 2017 – 4 percent for physicians in
group practices of 10 or more EPs/2
percent for physicians in group practices under 10 EPs based on 2015 data
Sequestration – 2 percent acrossthe-board cut on Medicare to reduce the defcit
The result – penalties go as high as 11
percent in 2017 for these programs
According to the Medical Group
Management Association survey conducted in October 2014 with 1,000
physician group practices in which
48,000 physicians practice:
1. 84 percent do not believe that
Medicare’s quality reporting programs enhance physicians’ ability to
provide high quality patient care
2. 71 percent rated the regulatory complexity
of the quality reporting programs as very or
extremely complex
3. 74 percent are concerned with
their practices’ ability to successfully
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participate in Medicare quality reporting programs in 2015
SVS supports replacing the three
programs with a Merit-Based Incentive Payment System, which was
included in last year’s SGR repeal
and reform bill. Even though there
is bipartisan, bicameral support for
this legislation, Congress will likely
enact another SGR “patch” for six
months before the current patch expires on March 31; otherwise, there
will be a 22 percent cut that would
take efect on April 1.
in presenters
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Drs. Sean Roddy, Robe
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Details: http://vsw
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16
ANEURYSMS
MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T
Managing infection
PERSPECTIVE
EVAR from page 1
T
rehydration. These tests are important because preoperative chronic obstructive pulmonary disease and renal
dysfunction correlate with worse
postoperative outcomes, he said.
Computed tomography angiography (CTA) is the most important
step of preoperative preparation,
with the sine qua non of infection
being air around the graft.
Unlike hand-sewn grafts where
infections can be localized, typically
there is total graft involvement in
these cases because the device is
left inside the aneurysm sac. Aneurysms or pseudoaneurysms also
have been seen above the infected
device, including at the top end of
suprarenal stents.
“This clearly has an impact on how
we approach patients, but what’s become very apparent to me is that CTA
often underestimates the amount of
periaortic infammation, especially at
the juxta- and pararenal locations.”
The Mayo group initially used
in situ antibiotic-soaked prosthetic
grafts for explanting EVAR devices,
which yielded “acceptable mortality
and reinfection rates, but primarily
outstanding patency rates.” However,
cryopreserved aortoiliac grafts have
now become their frst choice, he said.
An ABO match is not imperative, preparation takes roughly 45
minutes, branch closures done in
the lab are buttressed with sutures,
and the graft is turned over to
keep the lumbar arteries anterior,
which offers an easy fix if there is
bleeding, rather than having it on
the posterior wall. Cryopreserved
grafts, however, can dilate 40% and
lengthen 10% under pressure. “I’ve
been burned more than once where
the graft elongates more than I think,
and I end up having to cut a small
piece out to foreshorten it,” he said.
Surgeons should have several plans
for reconstruction, including routing a graft through a remote path,
remembering that CTA will underestimate the amount of periaortic
infammation. Separate bypasses of
the renal or visceral arteries are performed frst before the aortic clamp
is applied to reduce physiologic
stress. This requires knowledge of
the supraceliac and pararenal aorta
exposures, which really begins with
the correct choice of incisions, Dr.
Bower said. This is based on the aortic segment to be treated, position of
the new graft, the aortic clamp site,
and patient body habitus.
Most patients with EVAR infections
are approached with a midline ab-
dominal incision extended along the
xiphoid process, which is the linchpin for allowing upward and lateral
retraction of the abdominal wall, he
said. Choosing an incision that allows
a more vertical orientation to where
the new aortic anastomosis and
clamp site will be, rather than operating in a keyhole, is important.
The second step is to open up the
pararenal space by moving the viscera out of the way. This begins by
ligating the inferior mesenteric vein
and adjacent lymphatics, which allows incision of an avascular plane
along the base of the left transverse
colon. Retractor blades are set to
allow the upward and lateral retraction of the small bowel, the left
colon, and pancreas.
Exposure of the suprarenal or
supramesenteric aorta requires mobilization of the left renal vein after
ligation and division of its branches.
“If that vein is intensely involved
in infammation, don’t ligate the
branches in case you have to divide
that vein at the caval confuence.
Otherwise, you’ll run into some dysfunction of that left kidney.”
For a secure place for the aortic
cross clamp, the crura must be divided on either side of the diaphragm at
or above the supramesenteric aorta,
he added.
Key steps in total graft explantation
are to drain abscesses prior to surgery
to lower the bacterial burden and thus
reduce the postop infammatory response; bypass renal/visceral arteries
frst, if needed; remove the infected
graft; debride the aorta to healthy tissue; place the new graft and cover it
with omentum; and repair the bowel,
if needed. A piece of proximal aortic
wall should be sent to pathology to
ensure absence of bacteria or microabscesses. Organism-specifc antibiotics
are given intravenously for 6-8 weeks
followed by lifelong oral antibiotics.
An earlier report involving 24 patients with infected aortic endografts
showed potential contributors to
infection were endovascular reintervention in eight, aortoenteric fstula/
erosion in four, and various remote infections (J. Vasc. Surg. 2013;58:371-9).
Rifampin-soaked grafts were used in
15 patients, cryopreserved grafts in 4,
femoral vein in 2, and axillofemoral
grafts in 3. At 14 months follow-up,
patient survival, graft-related complications, and reinfection rates were
79%, 13%, and 4%, respectively.
Dr. Bower had disclosures.
pwendling@frontlinemedcom.com
he expert opinion from the
Northwestern Vascular Symposium regarding the management
of EVAR infections reminds us
of the importance of appropriate
patient selection, proper performance of the planned procedure,
and long-term follow-up. As EVAR
has become the treatment of
choice for more than 80% of patients with infrarenal AAAs in the
United States, the rate of patients
that return with EVAR
infections, although rare,
is increasing and their
management can be more
challenging than that of
a primary or aortic graft
infection as suggested by
Dr. Bower in this opinion.
The planning for these
cases is critical with multiple options for treatment currently
available and endorsed by a variety
of investigators. From an evaluation standpoint, CTA is critical for
diagnosis and case planning. Air
around the graft is considered the
“sine qua non” of infection but if
it presents in the frst month after
EVAR it can be due to trapped air
introduced into the sac during the
intervention.
Patients with air in the sac at the
initial postprocedure evaluation
should be considered for early follow-up to make sure this fnding
resolves. Further assessment that
will change the management of
the patient includes the type of
EVAR device, infra- or suprarenal,
since the entire removal of a suprarenal device usually requires
supraceliac cross-clamping with its
associated morbidity and mortality.
Drainage of the infected cavity, as
suggested by Dr. Bower, can help
lower the bacterial burden and
provide information regarding the
ofending organism. That information will help the vascular surgeon
decide if an in-line reconstruction
or an extra-anatomical one is more
appropriate in the patient’s situation, as more virulent organisms
tend to be associated with higher
reinfection and complication rates
when in-line reconstructions are
performed.
The diferent options for aortic
access need to be evaluated based
on the anatomy of the patient. A
transabdominal approach is best
for most patients as it allows access to the iliac arteries bilaterally
for removal of the entire graft,
debridement of the infected bed,
aortic and/or visceral reconstruc-
tion, and omental coverage of the
in-line graft or aortic stump if an
extra-anatomical reconstruction
is selected. The retroperitoneal
approach should be considered for
patients that will require extensive
perivisceral work, as may be necessary from suprarenal or fenestrated
devices, but limitations exist accessing the right iliac system and potentially intraabdominal targets for
visceral or renal reconstructions.
The best confguration to reconstruct these
patients remains largely
undetermined based on
the literature. The published experience from the
Mayo Clinic ( J. Vasc. Surg.
2013;58:371-9), in which
some of the opinions
of Dr. Bower are based,
suggested excellent results in 24
patients mostly treated with rifampin-soaked in-line reconstructions
with a periprocedural mortality of
4%. Cryopreserved aortic grafts
“have become the conduit of
choice for the group at this time,”
stated Dr. Bower, to try to further
decrease the reinfection rates in
their patient population. There are
limited data regarding the use of
cryopreserved aortoiliac segments
for aortic infections and less for
EVAR infections. The most recent
and largest series ( J. Vasc. Surg.
2014;59:669-74) included 220 patients with aortic infections with a
perioperative mortality of 9% and
cryopreserved graft complications
in another 12%-15% of patients.
In summary, aortic infections
associated with EVAR are challenging problems that should be
addressed in regional centers with
experience. Renal and visceral
reconstructions as well as supravisceral clamping are associated
with signifcantly higher periprocedural morbidity and mortality
based on the extensive experience
at the Cleveland Clinic with EVAR
explants ( J. Vasc. Surg. 2014;59:88693). The choice of the reconstruction and the material used should
be based on the ofending organism, type of EVAR device, extent
of the infectious process, and the
expertise of the treating physician.
Dr. Luis A. Sanchez is chief, section
of vascular surgery and Gregorio A.
Sicard Distinguished Professor of
Surgery and Radiology, Washington
University, St. Louis, and an associate
medical editor for Vascular Specialist.
He had no relevant disclosures.
TIPS & TRICKS
VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5
17
NEWS FROM WASHINGTON
Transcarotid angioplasty
device approved
The Food and Drug Administration
has approved a minimally invasive
angioplasty system that enters the
carotid artery adjacent to a blockage, and captures embolic debris by
extracorporeal filtration of blood
near the blockage.
The ENROUTE Transcarotid Neuroprotection System (ENROUTE
TNS) is inserted into the artery near
the stenotic region. As the stent is
deployed, the system draws blood
down the tube and away from the
brain under high pressure. An extracorporeal flter traps any emboli,
and the fltered blood is returned via
the femoral vein.
ENROUTE TNS was approved
on the basis of the successful
ROADSTER trial (Safety and Efficacy Study for Reverse Flow Used
During Carotid Artery Stenting
Procedure).
In this study, there was a 3.5%
rate of stroke, heart attack, and
death among patients treated with
the device – significantly lower
than the study’s primary outcome
goal of 11%.
The rate of adverse events was
about 14%; these included excessive
bleeding or injury at the device
insertion site, hypotension, and
thrombosis.
The system’s benefits include its
minimally invasive approach and
the ability to successfully navigate
severe carotid tortuosity. It also
may be more successful than traditional arterial angioplasty for patients with difficult anatomy of the
aortic arch, according to an FDA
statement.
Manufactured by Silk Road,
Sunnyvale, Calif., the ENROUTE
TNS device was approved through
a 510(k) submission, which provides
an approval pathway for low- to
moderate-risk devices that are substantially equivalent to a legally
marketed device.
According to the FDA statement,
ENROUTE TNS is equivalent to a
currently marketed flow-reversal
system that uses similar technology and has the same intended use,
but is designed to be introduced
through the groin.
–Michele G. Sullivan
Adhesive for varicose veins
The VenaSeal closure system,
which uses an adhesive directly
injected into the vein, has been approved as a permanent treatment
for symptomatic, superficial vari-
cose veins, the Food and Drug Administration announced on
February 20.
“This new system is the first to
permanently treat varicose veins
by sealing them with an adhesive,”
Dr. William Maisel, acting director
of the Office of Device Evaluation
in the FDA’s Center for Devices
and Radiological Health, said in
the FDA’s statement. Because the
system “does not incorporate heat
application or cutting, the in-office procedure can allow patients
to quickly return to their normal
activities, with less bruising,” he
added.
Continued on following page
18
TIPS & TRICKS
Continued from previous page
The VenaSeal system differs from
other procedures used to treat varicose veins, which use drugs, lasers,
radiofrequency, or incisions, the
FDA statement points out.
The complete sterile kit includes
the adhesive (n-butyl-2-cyanoacrylate), which solidifies when injected
directly into the target vein via a
catheter, under ultrasound guidance.
The additional system compo-
MA R C H 2 0 1 5 • VA S C ULA R S P EC IA LIS T
nents include the catheter, the adhesive, a guidewire, dispenser gun,
dispenser tips, and syringes.
Approval was based
on data from three clinical trials sponsored by
the manufacturer. In the
U.S. study that compared
results in 108 patients
treated with the VenaSeal
system and 114 patients treated
with radiofrequency ablation therapy, the device was shown “to be
safe and effective for vein closure
for the treatment of symptomatic
superficial varicose veins of the
legs,” according to the
FDA.
In the study, adverse
events associated with the
VenaSeal treatment included phlebitis and paresthesias in the treated areas,
which are “generally associated with treatments of this condition,” the FDA statement noted.
The agency reviewed the VenaSeal
System as a class III medical device,
considered the highest risk type of
medical devices that are subjected
to the highest level of regulatory
control, and which must be approved
before marketing.
VenaSeal is manufactured by Covidien, which acquired Sapheon,
the company that developed VenaSeal, in 2014. The system has
already been approved in Canada,
Europe, and Hong Kong, according
to a Covidien statement issued last
year.
–Elizabeth Mechcatie
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family elevates what is possible in therapy, now
afording minimally invasive treatment options to a
wider range of patients.
Longest Stent-Graft Available
The GORE® VIABAHN® Endoprosthesis is
the lowest profle, most fexible, self-expanding,
small-diameter endoprosthesis available. A result
of nearly two decades of continuing evolution, it
is the only stent-graft to receive approval for the
SFA (de novo, restenotic, and in-stent restenotic
disease), iliac artery, and arteriovenous access revision.
In October 2013, the GORE® VIABAHN®
Endoprosthesis became the longest stent-graft approved by the FDA, with a maximum length of 25
cm. The 25 cm endoprosthesis is designed to cover
long segment lesions in the SFA, reducing the need
for multiple devices. A multi-center European trial
supported the FDA’s approval of the 25 cm device.
Low Profle, Time-Proven Design
With more than 16 years and 190,000 devices distributed worldwide, the GORE® EXCLUDER®
AAA Endoprosthesis has elevated what is possible
in the treatment of abdominal aortic aneurysms
(AAAs), providing physicians with minimally invasive endovascular solutions for a wide range of
patient anatomies.
In 2014, Gore lowered the profle of the 23
mm and 26 mm trunk-ipsilateral leg devices and
the 23, 26, and 28.5 mm aortic extenders. The
profle reduction allows these ipsilateral legs and
aortic extenders to be used with a 16 Fr GORE®
DrySeal Sheath. No changes have been made to
the GORE® EXCLUDER® Device—instead, an
innovative process using ePTFE materials has been
used to constrain the device on the catheter. This
exemplifes Gore’s commitment to improving patient safety while maintaining ease-of-use for the
delivery of the GORE® EXCLUDER® Device.
Novel Solutions with Distinct Capabilities
Introduced in November 2013, the GORE® EXCLUDER® Iliac Branch Endoprosthesis is the frst
complete, fully engineered iliac system (iliac main
body device and internal iliac component) intended for endovascular treatment of common iliac
artery aneurysms or aortoiliac aneurysms.
The device—used in conjunction with GORE®
EXCLUDER® AAA Endoprosthesis components—
is built on Gore’s proven technology platform
and designed using the same durable, expanded
polytetrafuoroethylene (ePTFE) graft.
The GORE® EXCLUDER® Iliac Branch Endoprosthesis has CE mark and is in clinical study in the US:
Equipped for a Wider Range of Patient Anatomies
In September 2013, the Conformable GORE®
TAG® Thoracic Endoprosthesis received FDA approval for endovascular repair of acute and chronic
Type B dissections, making it the frst device to
receive FDA approval for this indication.
The Conformable GORE® TAG® Device ofers
conformability and ease of use, while accommodating tortuous and tapered anatomy. The device
resists compression and has a broad oversizing
window ranging from 6 to 33 percent. Physicians
are able to choose the appropriate oversizing for
the patient anatomy, which is particularly important in dissection patients due to the nature of the
disease.
As Gore continues to modify and add new treatment capabilities to its collection of devices, it
further demonstrates its commitment to providing
physicians with some of the most innovative devices available.
Lombard Medical Aorfx™
Endovascular Stent Graft
Lombard Medical Technologies Inc., located in
Irvine, CA, is global medical technology company focused on providing innovative endovascular
products. The Aorfx™ Endovascular Stent Graft
combines both an innovative design and technology that result in outstanding clinical performance
C ourtesy L ombard
Gore Vascular Devices
in EVAR patients with complex anatomy including
highly angulated necks and tortuous iliacs.
Aorfix is the only AAA graft with global
regulatory approvals for the treatment of aortic neck angulations from 0-90 degrees, and
is commercially available in the US, Europe,
Latin America, Canada, and Japan. Lombard
Medical recently received FDA approval for
Aorfix™Plus, an expansion of the Aorfix product line that treats aortic necks up to 32mm in
diameter.
For more information on Aorfix and Lombard Medical, visit www.lombardmedical.com.
Medtronic Endurant® II
Abdominal Stent Graft
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic Inc. ofers
the broadest range of innovative medical technology for the interventional and surgical treatment of
cardiovascular disease. One of these innovations,
the Endurant® II Stent Graft System, is built on
Medtronic’s 15 plus years of aortic stent graft
experience and is proven in more than 150,000 implants world-wide.1
In October 2014, Medtronic received approval
from the U.S. Food and Drug Administration for
Endurant IIs. Endurant IIs is part of Medtronic’s
innovation portfolio and extends its AAA product
line. This 3-piece system leverages the proven design of the market leading Endurant II Abdominal
Stent Graft, while having the same indications and
being designed to treat the same patient populaContinued on following page
ADVERTISING
VAS CULAR SPE CI AL I ST ONL I NE . COM • M ARC H 2 0 1 5
tion. The Endurant IIs Stent Graft System uses the
existing Endurant II delivery system allowing accurate placement and controlled deployment.2
The Endurant IIs Stent Graft System also
brings the unique benefit of expanding anatomical customization options.3 The system allows
physicians to utilize Medtronic’s full suite of
limb options on the patient’s ipsilateral and contralateral sides. Endurant IIs offers the ability
to have in-situ sizing on the ipsilateral side with
select limbs for adjustment during the case.3 Additionally, this new stent graft, Endurant IIs, provides up to a 20% reduction in distal diameter
compared to select Endurant II bifurs4 and may
provide simpler pre-case planning.3
Both the Endurant II and Endurant IIs systems
perform in a broad range of patients, including
those with short or angulated infrarenal aortic
necks, and those with tortuous iliacs. Physicians
can remain confdent in the clinical performance
of all of the Endurant® products, as evidenced in
the 3-year clinical results of the ENGAGE Registry
C ourtesy m edtroniC
Continued from previous page
ling and durable clinical results through 3 years
in both short (10 to <15mm) and standard (15 to
<20mm) necks: 0% and 0% rupture, 0% and 0%
conversion, 0% and 1.3% secondary endovascular
procedures to correct Type I/III endoleaks, and
0% and 0% migration, respectively . The Endurant II Stent Graft System delivers consistent
results in patients with both straightforward and
challenging anatomies,7 as the registry showed
no statistical diference between short and standard necks7, delivering compelling evidence that
the Endurant II product line is Durable, Consistent, and Proven.7
--------------------------------------
(the ENGAGE Registry evaluated the Endurant
Stent Graft System).5
The ENGAGE Registry represents clinical
data of a real-world patient population that is
unmatched in breadth, depth and quality. This
registry comprises over 1200 patients in 79 high
volume centers worldwide and is unprecedented
in size and scope with planned follow-up through
10 years.6 The registry recently delivered compel-
1. Medtronic Product Detail Report September 2014, data
on File at Medtronic
2. Medtronic FS156 QA Statement, data on fle at Medtronic
3. Endurant IIs Instructions for Use (IFU)
4. Data on fle at Medtronic
5. Verhagen, Hence. Device design and infuence on hostile
neck outcomes: how far can we go?, Charing Cross 2014.
6. VEITH Report 2013 – data on fle at Medtronic
7. Verhagen, Hence. Device design and infuence on hostile
neck outcomes: how far can we go?, Charing Cross 2014.
CLASSIFIEDS
Also available at MedJobNetwork.com
Vascular Surgeon
Southern, NJ (Philadelphia Suburbs)
* * * * *
Due to growth, Virtua Surgical Group in Southern, NJ, seeks a Vascular
Surgeon to join its well-respected and established surgical practice
located in the Moorestown/Medford, NJ area. You will be joining 4
very busy surgeons who enjoy a large referral base which will assist
you in rapid practice growth.
A competitive salary, production bonus, full benefits and retirement
plan are offered.
The practice is employed by Virtua, a comprehensive healthcare
system headquartered in Marlton, NJ. Virtua consists of four hospitals
(Berlin, Marlton, Mt. Holly, and Voorhees). This group performs its
surgery primarily at the Mt. Holly campus.
Southern New Jersey offers the culture and nightlife of Philadelphia,
as well as many of the country’s finest restaurants, intriguing
historical sites, fantastic shopping districts, exciting sports teams,
captivating music venues, beautiful theater productions, and worldclass museums.
Just a short drive away you can also find yourself in the glitter and
excitement of Atlantic City or the sun and sand of New Jersey’s many
wonderful shore resorts. South Jersey also has many charming towns
with unique shops, superb dining, recreational events, and community
celebrations. With the world-renowned Pine Barrens and many other
state parks, New Jersey has a wonderful array of places for camping,
boating, and hiking or any outdoor activity you desire.
For more information, please contact Ken Sammut at 800-261-2638;
email at ksammut@cejkasearch.com or visit our website at www.
cejkasearch.com
Disclaimer
19
VASCULAR SPECIALIST assumes the statements made in classified advertisements
are accurate, but cannot investigate the statements and assumes no responsibility or liability concerning
their content. The Publisher reserves the right to decline, withdraw, or edit advertisements. Every effort will
be made to avoid mistakes, but responsibility cannot be accepted for clerical or printer errors.
EXPLORE
NEW HORIZONS
Vascular Surgery Opportunity at the Beach
Imagine working where award-winning healthcare goes
hand-in-hand with an exceptional quality of life! Beebe
Healthcare is an expanding, progressive, not-for-proft
community health system with a 210-bed hospital and
numerous satellite facilities throughout southern Delaware.
Q Board certifed, experienced Vascular Surgeon
Q Well-established vascular program with reputation for excellence
Q Read all studies in Non-Invasive Vascular Lab
Q RPVI certifcation required
Exceptional location, with close proximity to Baltimore, DC, Philly, NYC. Family-oriented Southern
Delaware Beaches rank among Top 10 Beaches/Boardwalks (Parents Magazine, National Geographic,
Travel and Leisure, American Profles Magazine). Come discover Beebe, where you will make a diference!
424 Savannah Road l Lewes, DE 19958 l www.beebehealthcare.org
Email cover letter and CV to: mhill@beebehealthcare.org
Visit www.beebehealthcare.org to view additional physician opportunities.
FOR INFORMATION ON CLASSIFIEDS:
Contact: Linda Wilson
Call (973) 290-8243 or
Email ad to: lwilson@frontlinemedcom.com
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