it's complicated - cleveland clinic
TRANSCRIPT
CardiacConsult
Could Drug-coated Balloons Improve Care for SFA Disease? p3
Cardiac Magnetic Resonance for Treating HCM p4
Transcatheter Aortic Valve Replacement Update p6
Image of the Issue: Esophageal Perforation p13
Inside This Issue
Featured Article
It’s Complicatedp8
Heart and Vascular News from Cleveland Clinic | Fall 2011 | Vol. XXI No. 3
Dear Colleagues,
As we look at the future of cardiovascular medicine and cardiothoracic
and vascular surgery, it is clear that our specialties will be driven by innova-
tion. Many of the high-profile treatments that defined our practice in the
late 20th century are losing favor with patients and practitioners, even as
cost and quality considerations shape our decisions as never before. New
approaches like transcatheter aortic valve replacement (TAVR), SFA drug-
coated balloon angioplasty, and the use of MRI in the diagnosis of hypertro-
phic cardiomyopathy – all of them covered in this issue of Cardiac Consult
– not to mention minimally invasive, robotic and hybrid surgery, will
replace the older ways of doing things.
Our patients expect us to be conversant with the most advanced technologies
and techniques, many of which they read about on the Internet. That’s why
we’re looking forward to the upcoming Cleveland Clinic Medical Innovation
Summit, Oct. 3-5, 2011 – which will be focused on cardiovascular innovation
this year. This annual event gives us a high-level preview of the newest medi-
cal technologies and the financial drivers behind them. It offers real insight,
networking opportunities and actionable takeaway information. This year’s
event has a strong lineup of presenters, including top CEOs, innovators,
government officials and media figures.
This year’s Cleveland Clinic Medical Innovation Summit will be followed
by Shaping the Future of Cardiovascular Care: Progress and Controversies
(see p. 12) at the same venue, Oct. 5-7, 2011. We can’t recall when two
more fascinating events have been scheduled back-to-back in this way.
We hope to meet and speak with many of our readers there.
Fall 2011 marks the last quarter of Cleveland Clinic’s 90th anniversary year.
This has been a time for us to look back on the remarkable advances in cardiac
care that have enhanced the lives of millions of people since F. Mason Sones,
MD, developed the diagnostic coronary angiogram at Cleveland Clinic in 1958.
With the Cleveland Clinic Medical Innovation Summit and Shaping the Future
of Cardiovascular Care, we look forward to our next step in shaping the
“State of the Heart.”
Sincerely,
Christopher Bajzer, MD Sean Lyden, MDAssociate Director, Peripheral Intervention Staff Surgeon, Vascular SurgeryInterventional Cardiology Medical Director, Supply Chain Management
A. Marc Gillinov, MDThe Judith Dion Pyle Chair in Heart Valve ResearchThoracic and Cardiovascular Surgery
Page 2 | Cardiac Consult | Fall 11 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056
Cardiac Consult offers updates on state-of-the-art diagnostic and management techniques from Cleveland Clinic heart and vascular specialists. Please direct correspondence to:
Medical Editors
Christopher Bajzer, MDA. Marc Gillinov, MD Sean Lyden, MD [email protected]@[email protected]
Managing Editor
Ann Milanowski
Art Director
Michael Viars
Marketing Manager
Megan Frankel
Marketing Associate
Jason Lansdale
Photographers
Tom Merce Russell Lee
clevelandclinic.org/heart offers informa-tion on new procedures and services, clini-cal trials, and upcoming CME symposia, as well as recent issues of Cardiac Consult.
The Sydell and Arnold Miller Family Heart & Vascular Institute, ranked No. 1 in the nation for cardiac care by U.S.News & World Report every year since 1995, accommodates nearly 300,000 patient visits each year in world-class facilities. Staff are committed to researching and applying state-of-the-art diagnostic and management techniques. Cleveland Clinic is a not-for-profit, multispecialty academic medical center.
Cardiac Consult is written for physicians and should be relied upon for medical edu-cation purposes only. It does not provide a complete overview of the topics covered, and should not replace the independent judgment of a physician about the appro-priateness or risks of a procedure for a given patient.
© The Cleveland Clinic Foundation 2011
Visit clevelandclinic.org /heart | Cardiac Consult | Fall 11 | Page 3
Superficial Femoral Artery DiseasePivotal study on whether drug-coated angioplasty balloons improve treatment
When a patient experiences superficial femoral artery (SFA) disease, peripheral interventionalists
have a variety of tools to treat it, including angioplasty and stents. But these methods
sometimes fail. Now, Cleveland Clinic is among 55 sites across the globe enrolling patients
in the largest randomized peripheral drug-coated balloon trial to date, which aims to prove
these devices will improve outcomes in treating SFA disease in the future.
This study, called the LEVANT 2, is a FDA-approved IDE
trial of the Moxy™ drug-coated balloon (Lutonix, Minneap-
olis, Minn.). Cleveland Clinic vascular surgeon Sean Lyden,
MD, site Primary Investigator,
says this trial is exciting be-
cause of the many drawbacks
associated with angioplasty
and stenting.
“Many of the physicians at
Cleveland Clinic have not been
big fans of using stents in the
superficial femoral artery,”
Dr. Lyden says. “Once there is
restenosis, it is harder to treat.
We have favored angioplasty
because of the late failure due
to intimal hyperplasia in stents.
The ability to now apply an anti-
restenotic drug to a balloon may
offer an even better solution.”
Drug-coated balloons are
being watched very closely,
as they deliver anti-restenotic
drugs without leaving a device
behind in the artery. Early data
presented in Europe from three different drug-coated balloon
trials showed improved outcomes at six months.
The early results from Europe with the Moxy balloon in
the LEVANT I trial have been favorable. In the LEVANT I
trial, researchers found that with one 30-second inflation of
the balloon, the Moxy balloon can safely and substantially
inhibit restenosis. After the balloon deflates, the paclitaxel
infiltrates the layers of the artery over time. Earlier studies
indicate that the drug quickly becomes subtherapeutic in
the endothelial cells, bolstering
the growth of new endothelial
cells, which line the lumen.
The drug, however, slowly
reaches the deeper arterial
layers, producing a prolonged
effect in preventing the mecha-
nisms that cause restenosis.
The new LEVANT 2 study will
follow patients for five years,
expanding the follow-up time of
the European study, LEVANT I,
which examined patients for up
to two years.
LEVANT 2 is a multicenter,
single-blind, randomized,
controlled trial, comparing the
drug-coated balloon to a regular
angioplasty balloon in the
treatment of lesions in the SFA
or popliteal artery. The study
will include 467 patients at as
many as 55 centers. The trial is one of the largest studies
ever conducted to examine peripheral artery disease.
To refer a patient to Cleveland Clinic for the LEVANT
2 trial, call our research nurse, Jennifer Seaber, RN,
at 216.445.8063. Dr. Lyden can be contacted at
216.444.3581. ■
Levant II Enrollment Criteria
Eligible patients must:
• have stenosis in their SFA and popliteal
arteries
• have cramping or leg pain when walking
• be > 18 years of age
Page 4 | Cardiac Consult | Fall 11 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056
Hypertrophic cardiomyopathy (HCM) is a common genetic disorder affecting approximately one
in 500 and with an increased incidence of sudden cardiac death (SCD), even in asymptomatic
or mildly symptomatic patients. Traditional methods of diagnosing HCM, including clinical
assessment and transthoracic echocardiography (TTE), have known limitations that impact their
efficacy. Cardiac magnetic resonance (CMR) is emerging as a complementary technique with
the potential to assist clinicians in diagnosing and managing this condition. CMR imaging
is now routinely performed at Cleveland Clinic in patients with known or suspected HCM.
“CMR has an advantage over TTE in that its excellent resolution
offers increased potential to identify anatomic and pathological
characteristics associated with HCM. The information can be
invaluable in establishing or confirming a diagnosis, ascertain-
ing its severity, planning a procedure, in post-procedural evalu-
ation and in future prognostication. It can also be an effective
screening tool for at-risk individuals with a family history of
HCM,” says Milind Desai, MD, a Cleveland Clinic cardiologist
with specialty interests in clinical HCM and CMR.
Diagnostic utility of CMR
HCM patients have a wide and heterogeneous presentation,
creating a diagnostic challenge for clinicians. Compared with
TTE, CMR provides more precise identification of subtle
variations, including hypertrophy in isolated segments of the
left ventricle such as the lateral wall or apex. Such variations
may be difficult to visualize on TTE. Recently, apical aneu-
rysms, which are associated with a high annual event rate,
were shown to be well delineated on CMR, but were missed
on TTE in 40 percent of cases.
Additionally, CMR has been proven to be a useful adjunct to
TTE in the identification of papillary muscle abnormalities,
which have been demonstrated to be independently associated
with left ventricular outflow tract (LVOT) obstruction. LVOT ob-
struction is a characteristic finding in HCM patients that results
in significant symptomatology and is seen in about 70 percent
of symptomatic HCM patients. Cleveland Clinic recently
identified a subgroup of HCM patients with papillary muscle
and subvalvular abnormalities who have LVOT obstruction and
symptoms, without the characteristic LV thickening.
CMR has also demonstrated an increased ability to differenti-
ate HCM from such confounders as hypertensive heart disease,
aortic stenosis, athlete’s heart, noncompaction, amyloidosis and
infiltrative heart diseases, primarily through its sensitivity in
tissue characterization and identification of minor variations in
cardiac anatomy.
CMR in the treatment of HCM
When treatment with surgical myectomy is planned, preop-
erative CMR can be useful in measuring the degree and extent
of LV hypertrophy, particularly in the area of the septum. It
can also establish the relationship of the septum to the ante-
rior mitral valve leaflet, subvalvular apparatus and papillary
muscle morphology.
Increasing Value of Cardiac Magnetic Resonance in Diagnosing and Managing HCM
| Cardiac Consult | Fall 11 | Page 5Visit clevelandclinic.org /heart
“This helps in planning the procedure, especially in deciding
the amount of muscle to be removed during myectomy,”
says Dr. Desai. “It also helps us decide whether additional
procedures such as mitral valve repair or papillary muscle
reorientation are necessary.”
The complementary role of CMR enabled Dr. Desai and his team
to identify papillary muscle abnormalities, which led their
surgical colleagues to develop a new surgical technique for
papillary muscle reorientation.
Following surgery or alcohol ablation, CMR provides a noninva-
sive method of assessing improvement of LVOT obstruction and
the extent of scar formation.
CMR for risk stratification
CMR is excellent for delineating the presence of fibrosis within
the heart, a condition frequently seen in HCM patients. Fibro-
sis correlates with LV wall thickening and inversely correlates
with LV ejection fraction, as well as ventricular arrhythmia
and other markers of SCD. Recent studies have demonstrated
that the degree of fibrosis in the heart is associated with hard
outcomes, including death.
Although limitations on the use of CMR include cost and time,
and contraindications include pacemakers and defibrillators,
ongoing studies at Cleveland Clinic continue to uncover new
details that reinforce the role of CMR in therapeutic planning
and risk stratification.
“As our experience with CMR grows, our understanding
of the significance of subtle morphologic differences will help
us define new prognostic markers and improve current treat-
ment strategies,” says Dr. Desai.
Milind Desai, MD, is a Cleveland Clinic cardiologist with
specialty interests in clinical HCM and CMR. He can be
reached at 216.445.5250 or [email protected]. ■
(1)
(2)
(1)
A CMR image
in a young
adult with a
classic pattern
of HCM
(2)
Image reveals
extensive scar-
ring of the LV
myocardium
(arrow)
(3)
A CMR in a
patient with
an apical vari-
ant of HCM
(4)
Corresponding
image on the
right revealing
scar in the
apex (arrow)
(3)
(4)
Page 6 | Cardiac Consult | Fall 11 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056
C leveland Clinic interventional cardiologists
E. Murat Tuzcu, MD, and Samir Kapadia, MD,
and cardiothoracic surgeon Lars Svensson,
MD, have taken a leadership role in developing and
testing this technology through the Placement of Aortic
Transcatheter Valves (PARTNER) trial. Results of the
first arm, PARTNER B, were released in September
2010 and secured the value of TAVR as an effective
treatment for patients deemed inoperable due to their
comorbidities (see my.clevelandclinic.org/newsletters/
cardiac_consult). In this arm, patients treated with
TAVR had an absolute reduction in mortality of 20
percent, while those treated with the best medical therapy
had a mortality rate of 50 percent.
In June 2011, the results of PARTNER A were re-
leased. This arm compared TAVR to surgery in high-risk
patients. Dr. Tuzcu, who is Vice-Chairman of the Cardio-
vascular Medicine Department at the Sydell and Arnold
Miller Family Heart & Vascular Institute at Cleveland
Clinic, provides an update on this exciting treatment
option for patients with severe aortic stenosis.
How did TAVR fare in high-risk patients?
The second arm of PARTNER showed TAVR was not
inferior to aortic valve replacement surgery in terms of
survival and stroke-free survival among patients whose
predicted risk of mortality with standard open heart
surgery for aortic valve replacement was quite high.
That makes TAVR an acceptable alternative to surgery
in very high-risk patients. It does not mean all high-risk
patients should have TAVR.
Is the risk of stroke with TAVR a concern?
The risk of any serious complication is concerning, but we
have to put the risks in perspective. In the PARTNER A
trial, the rate of major stroke at one year was 5.1 percent
with TAVR and 2.4 percent with surgical valve replace-
ment. On the other hand, the one-year mortality rate
was 24 percent in the TAVR group, as compared with
27 percent in the surgical group. This means the risk of
major stroke was numerically higher with TAVR, whereas
the risk of dying was lower. However, neither of these dif-
ferences was statistically significant. Moreover, when we
look at the combined endpoint of risk of death or major
stroke, there was no difference between the two groups.
Physicians have long sought a method for treating life-limiting aortic stenosis in high-risk populations
and may have found a solution in transcatheter aortic valve replacement (TAVR). TAVR is a catheter-
based technique that involves transporting a synthetic valve to the heart through a tiny hole in the
groin or a small incision in the groin or chest.
At one year, the rate of mortality and rehospitalization was 29.1% lower in patients who received TAVR.
| Cardiac Consult | Fall 11 | Page 7Visit clevelandclinic.org /heart
How is evaluation of TAVR proceeding?
Major vascular complications were high in patients
who underwent TAVR, primarily due to the large catheters
required for this procedure. Edwards Lifesciences has since
developed a newer valve with a smaller delivery catheter.
The PARTNER IIB trial is now comparing the new valve
and delivery system with the already tested TAVR system
in inoperable patients. In this trial, there is no randomiza-
tion to medical therapy.
PARTNER IIA is in the planning stage. The purpose is
to test the new valve and delivery system in moderately
high-risk patients who are candidates for surgical AVR.
When is TAVR being used in patients at normal risk?
We must meticulously investigate this technique
step-by-step and test it in different risk groups. Right
now our focus is on patients at higher risk. Using
TAVR in normal-risk patients would require demon-
strating that it is as good as surgery, which is a safe,
effective and, most important, durable therapy for these
patients. If we have a 65-year-old patient with severe
aortic stenosis and no other health issues, his risk of
dying from standard aortic valve replacement surgery
at Cleveland Clinic is less than 1 percent. It will require
a lot of work before we can say that TAVR is as good
in such a patient.
What is Cleveland Clinic’s opinion of TAVR today?
TAVR is an exciting technology that is part of a com-
prehensive service we provide to patients with high-risk
aortic valve disease and complex comorbidities. It is one
of several options in our armamentarium for patients at
high risk for surgery, including optimization of clinical
status before treatment and ICU management.
Dr. Tuzcu can be reached at 216.444.8130
or [email protected]. ■
Breakthrough Technology for Aortic Valve ReplacementW H A T ’ S T H E L A T E S T T H I n k I n G F R o M C L I n I C A L T R I A L S ?
Page 8 | Cardiac Consult | Fall 11 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056
It’s ComplicatedAdults with congenital heart disease need lifelong attention from specialists who are comfortable with these complex conditions
| Cardiac Consult | Fall 11 | Page 9Visit clevelandclinic.org /heart
A dults with congenital heart
disease fall into two general
groups: those who are newly
diagnosed, and those who were diag-
nosed and treated as children,” says
Richard Krasuski, MD, Medical Direc-
tor of the Center for Adult Congenital
Heart Disease in the Miller Family
Heart & Vascular Institute. “The sec-
ond group is growing larger because of
improvements in pediatric congenital
heart disease treatment. These people
face unique challenges. Many mistake
the alleviation of symptoms as a result
of childhood treatment, for a cure. But
the defect often remains.
As they get older, they may outgrow re-
placed valves, and conduits and valves
may degenerate and become increas-
ingly leaky or stenotic, and the patients
are likely to experience problems
ranging from atrial fibrillation to heart
chamber enlargement and heart failure.”
Dr. Krasuski and cardiologist David
Majdalany, MD, collaborate with
pediatric and adult cardiologists,
electrophysiologists and cardiovascular
surgeons to care for the frequently
complex problems of adult congenital
heart disease patients. They treat more
than 1,200 patients a year. Among
the most frequent referrals are former
“blue babies” – born with tetralogy of
Fallot, the most common cyanotic
congenital heart disease.
often overlooked until it’s too late
Tetralogy of Fallot is a suite of con-
genital defects that includes ventricu-
lar septal defect, displacement of the
aorta, pulmonary stenosis and right
ventricular hypertrophy. Patients
who have this condition surgically
repaired as children should make
regular visits to a cardiologist for
the rest of their lives.
Unfortunately, since these conditions
are often asymptomatic in early adult-
hood, many patients fail to comply
with the needed follow-up, and do not
have their condition addressed when
it is most treatable. “The challenge
for primary care physicians,” says Dr.
Krasuski, “is to identify these patients
in their practice, to recognize the early
signs and symptoms of a worsening
condition, and to refer them for treat-
ment before the damage to their hearts
becomes irreversible.”
Tetralogy of Fallot is the second most
common condition treated by Dr. Kra-
suski and his team at the Miller Family
Heart & Vascular Institute. Most of
these patients have had previous repair
and are experiencing new issues related
to their original defect.
Many will develop pulmonary valve
insufficiency, which overloads the right
It’s ComplicatedAdults with congenital heart disease need lifelong attention from specialists who are comfortable with these complex conditions
In the old days, there wasn’t much demand for adult congenital heart disease care. Children who
were born with heart defects didn’t live very long. But the treatment of congenital heart defects
underwent drastic improvement in the latter half of the 20th century. Almost a million adults born
with congenital heart defects in the U.S. are alive today as a result. While some of these people
will go on to enjoy lives that are free from symptoms or further evidence of their disease, many
others will be vulnerable or subject to an array of consequences throughout adulthood and all
should be regularly monitored for potential complications of their congenital malformations.
“
Page 10 | Cardiac Consult | Fall 11 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056
ventricle, leading to enlargement and
further dysfunction. Pulmonary insuffi-
ciency can lead to atrial and ventricular
arrhythmias, possibly resulting from in-
creasing enlargement and stretching of
the right atrium and ventricle. The most
significant cause of illness and death in
these patients is arrhythmia, which can
result in sudden cardiac death.
“Drug therapy alone can’t slow the
progression of complications,” says
Dr. Krasuski. “Pulmonary valve
replacement is the only treatment
proven to improve right ventricular
function in the long term.”
The good news for patients is that
percutaneous procedures have been
developed for pulmonary valve replace-
ment. The Cleveland Clinic Children’s
Hospital was one of the first hospitals
to offer this procedure. Dr. Krasuski, in
collaboration with the pediatric heart
team, has been performing percutane-
ous pulmonary valve replacement in
adults for more than a year. “If percu-
taneous pulmonary valve replacement
proves to have reasonable long-term
durability,” says Dr. Krasuski, “it has
the potential to dramatically shift the
balance toward earlier intervention.”
The Center for Adult Congenital Heart
Disease is able to bring the full treat-
ment armamentarium of the Miller
Family Heart & Vascular Institute to
bear on aortic aneurysms, valve issues
and electrophysiological issues associ-
ated with adult congenital heart dis-
ease. This includes other experimental
percutaneous procedures, aortic stent-
ing and reconstruction.
Atrial fibrillation ablation is among the
treatments now being used for patients
with adult congenital heart disease.
Although the experience is still small,
results have shown success rates
that are nearly as good as for patients
without congenital anomalies.
There are rare cases of patients with
tetralogy of Fallot who survive into
adulthood without surgical treatment.
Adult surgery to correct tetralogy of
Fallot is highly complex.
Gösta Pettersson, MD, part of the
surgical team in the Center for Adult
Congenital Heart Disease, says, “Pa-
tients with more complex congenital
heart disease have often undergone
one or several operations in childhood
before presenting with new problems
as adults. So, therefore, it is important
to go to an experienced center with
these problems.”
To close or not to close
The most common congenital heart
problems are atrial septal defects.
About 25 percent of the population
has patent foramen ovale (PFO) –
improper closure of the atrial septum.
PFO is usually asymptomatic, but may
increase the risk of stroke. Because of
this, heart surgeons not infrequently
close a PFO if they discover one in
the midst of surgery for an unrelated
problem.
A recent study led by Dr. Krasuski,
however, found that closing PFOs
during surgery did not reduce the
patients’ long-term mortality, but more
than doubled their in-hospital stroke
risk. He believes that a surgeon should
talk with the patient before deciding to
close an incidentally discovered, non-
symptomatic PFO. “Each case needs
to be considered individually,” he says.
“PFO closure is a fairly controversial
topic at this time,” says Dr. Krasuski.
“In general, experts only agree that
patients with recurring stroke on
The Big TransitionMost patients with congenital heart disease develop strong relationships with their pediatric provider. However, these
patients often need lifelong care, leading to some uncertainty about the transition from pediatric to adult caregiving.
“Our specialty has been struggling with the mode of transition from pediatric to adult care for some time,” says Rich-
ard Krasuski, MD, Medical Director of the Center for Adult Congenital Heart Disease. “Both the timing of transition
and the people involved are difficult to coordinate. Typically, adult cardiologists, even those with specific training in
congenital heart disease, will not feel comfortable with patients under the age of 18. Pediatricians are usually more
comfortable and familiar with the patient-parent-physician dynamics in these cases. Ideally, during early adulthood
the patient will transition to an adult cardiologist who has experience and an interest in adult congenital heart dis-
ease. The complexity of the heart disease needs to be matched to the expertise of the potential physician.”
The kind of coordinated, specialized care offered through the Cleveland Clinic Center for Adult Congenital Heart
Disease is rare nationwide. “The care of most patients with congenital heart disease is still in the hands of general
cardiologists and even primary care physicians,” says Dr. Krasuski.
| Cardiac Consult | Fall 11 | Page 11Visit clevelandclinic.org /heart
medical therapy with PFO ought to
be considered for closure – surgical
or percutaneous.”
(Migraine headaches are also more
common in patients with PFO. While
closure of PFOs may improve migraine
symptoms, larger studies are currently
examining this effect).
Surgery for adult congenital
heart disease
Most congenital malformations of
the heart are surgically addressed in
childhood, but these corrections are
not necessarily permanent solutions.
Many patients require frequent reop-
erations over the course of their lives.
Subsequent procedures are increas-
ingly complex. Constantine Mavroudis,
MD, is the surgical director of the
Center for Adult Congenital Heart
Disease. He and his colleagues Robert
Stewart, MD, and Dr. Pettersson, have
unmatched experience with these
operations and reoperations.
Dr. Pettersson, who began his career
correcting congenital malformations as
a pediatric cardiac surgeon, special-
izes in some of the most complex
adult operations, including the Ross
procedure (which replaces the aortic
valve with a patient’s own pulmonary
valve, and replaces the pulmonary valve
with an allograft), and the reverse Ross
procedure (which corrects a deteriorat-
ing Ross procedure by repairing the
pulmonary valve and restoring it to its
old position, discarding the old allograft,
and replacing the aortic root with a new
allograft or valved conduit).
Mitral valve prolapse and bicuspid
aortic valve are also congenital heart
defects – although, as Dr. Pettersson
points out, “In spite of being con-
genital, many of these patients will not
require any operations before they are
adults, or even late in life.” Nonethe-
less, Cleveland Clinic does have one
of the nation’s largest valve practices,
with among the best outcomes for
when these patients do require surgery.
Hereditary or spontaneous?
Scientists continue to explore the
genesis of congenital heart disease –
whether it’s random or runs in families.
“A recent paper found that children of
patients with congenital heart defects
have approximately a 3 percent risk of
having congenital heart defects, which
are often different lesions,” Dr. Krasuski
noted in a recent webchat on cleve-
landclinic.org. “This is higher than the
reported 0.8 percent risk of congenital
heart disease in the general population.”
He noted, however, that not all – or
not even most – congenital heart dis-
ease runs in families. “We know this
because many don’t cluster in families
as hereditary problems should. Most
defects likely result from spontaneous
gene mutations during fetal develop-
ment. In some cases, toxic exposures
during pregnancy are responsible – the
best examples of this are rubella infec-
tion leading to patent ductus arterio-
sus and lithium exposure leading to
Ebstein anomaly [malformed tricuspid
valve leaflets]. A genetic defect in the
structural protein of the heart was
associated with ASD a few years ago,
but we still have little data about how
often this mutation is the cause of ASD
in the general population.” ■
Page 12 | Cardiac Consult | Fall 11 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056
Shaping the Future of Cardiovascular Care: Progress and ControversiesSome medical conferences are all about consensus and conventional wisdom. But not this one.
Shaping the Future of Cardiovascular Care: Progress and Controversies will tackle the toughest issues
in the diagnosis, treatment and prevention of heart and vascular disease. Shaping the Future (Oct. 5-7,
2011, Intercontinental Hotel and Conference Center, Cleveland Clinic) has assembled a distinguished
faculty from around the world to confront the most vexing cardiovascular questions of our time.
Hot Issues, Lively Discussion
Course directors Bruce W. Lytle, MD, Chair of the Miller Family Heart & Vascular Institute, Steven Nissen, MD, Chair of Cardiovascular Medicine; Stephen J. Nich-olls, MD, PhD, of Cardiovascular Medicine and Cell Biology; and Kathy Hoercher, RN, have crafted a vibrant program:
• Is the drug and device industry overregulated?• Prevention: promise or myth?• What’s to be made of the latest findings on HDL?• Are biomarkers worth looking at?• CRT: Who, what, when and what are the costs?• What’s the appropriate use of TAVR (transcatheter aortic valve replacement)?• Surgery for atrial fibrillation: Should we do more or less?• Is minimally invasive cardiovascular surgery overrated?• Medicine or surgery for coronary artery disease?• Endovascular vs. conventional surgery for aortic disease?• Is bariatric surgery “the ultimate cure for cardiovascular disease”?
These and many other questions will be discussed, analyzed and clarified by experts in presentations, panels, and open forums. With some of the best minds in cardiac and vascular care on hand, things are bound to get lively.
Back-to-Back Hits
Shaping the Future takes place hot on the heels of the Cleveland Clinic Medical Innovation Summit (Oct. 3-5, 2011) in the same venue.
“Cardiovascular Technologies” is the theme of this year’s Medical Inno- vation Summit – with presentations by leading biomedical CEOs, national media figures, former vice-president Dick Cheney and others.
As New York Times columnist David Brooks said of last year’s Summit, “You’ve got leaders in the healthcare industry. You’ve got the technology people, medical device people, and pharmaceutical people. You’ve obviously got physicians. You’ve got researchers. So pretty much if you’re into cutting edge technology, those people are here.”
It’s rare that two such high-powered cardiovascular meetings take place back-to-back – and many who have signed up for one are quickly registering for both. Visit clevelandclinic.org/cardiocare11 and clevelandclinic.org/innovations/summit.
| Cardiac Consult | Fall 11 | Page 13Visit clevelandclinic.org /heart
Endoscopic procedures for the treatment of gastro-
esophageal reflux disease have emerged as an
alternative to open or laparoscopic antireflux pro-
cedures. Early devices designed for endoscopic placement
failed to gain popularity because of serious adverse events
and limited efficacy. EsophyX® is an endoscopic plication
device (EndoGastric Solutions, Redwood City, Calif.) that
received FDA approval in 2007 after initial trials demon-
strated an acceptable safety and efficacy profile.
This patient, who underwent transoral incisionless fundo-
plication (TIF) with the EsophyX device, was transferred
to Cleveland Clinic from another facility after developing a
life-threatening esophageal perforation and esophagopul-
monary fistula (figure 1). The young woman underwent
thoracotomy with debridement and marsupialization of
the left lung abscess as well as ligation of the fistula,
with an unremarkable postoperative recovery.
Esophageal perforation is a known complication of the
EsophyX device; however, most of these are proximal and
related to device insertion. A distal esophageal perforation
after the EsophyX procedure leading to an esophagopul-
monary fistula is not previously described in the literature.
Although considered minimally invasive, endoscopic
procedures for the treatment of gastroesophageal reflux
disease do have significant complications. Early recogni-
tion is vital to limit the morbidity from these events.
Dr. Murthy is a thoracic and cardiovascular surgeon in
the Miller Family Heart & Vascular Institute. He can be
reached at 216.444.2820 or [email protected].
By Sudish Murthy, MDImage of the Issue
Figure 1
Page 14 | Cardiac Consult | Fall 11 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056
In
HeartMate II Has Excellent Continued Results
A prospective study by Randall Starling, MD, Section Head, Heart Failure & Cardiac Transplant Medicine, compared the outcomes of patients implanted with a HeartMate II (Thoratec) left ventricular assist device with similar patients treated with other LVADs and found that
“dissemination of this technology after approval has been associated with continued excellent results.”
The study, published in the May 10, 2011 issue of the Journal of the American College of Cardiology, evaluated the first 169 consecu-tive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April to August 2008 at 77 U.S. centers and followed for at least one year. A comparison group included all patients enrolled in the INTERMACS registry with other types of LVADs for the same bridge-to-transplant indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained from registry data.
Diastolic Dysfunction of the Heart Associated
with Increased Mortality Risk
A Cleveland Clinic study that appeared in the June 27 issue of Archives of Internal Medicine reports that diastolic dysfunction may be an independent risk factor for increased risk of death.
The study by Carmel M. Halley, MD, and colleagues in the Department of Cardiovascular Medicine reviewed clinical records and echocardiographic findings of consecutive patients who underwent an outpatient
echocardiogram that revealed normal systolic function (ejection fraction, 55%) from 1996 to 2005. Diastolic function was graded using echocardiographic Doppler variables designated as normal, mild (grade I, i.e., impaired relaxation pattern), moderate (grade II, i.e., pseudonormal pattern) or severe (grade III, i.e., restric-tive filling pattern) dysfunction. Propensity analysis was performed to compare outcomes among the groups.
The study concluded the presence of moderate or severe diastolic dysfunction was an independent predictor of mortality. Mild diastolic dysfunction,
although prevalent, did not affect survival rate.
nIH-Sponsored ATTRACT Trial for DVT
Cleveland Clinic is enrolling patients for the multicenter ATTRACT (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Throm-bolysis) trial. The purpose of the study,
led at Cleveland Clinic by Heather Gornik, MD, is to determine if cath-eter-directed pharmacomechanical thrombectomy/thrombolysis as a first-line treatment for deep vein thrombosis (DVT) promotes better
outcomes than the current stan-dard of care of anticoagulation and
graduated elastic compression stockings. The study is sponsored by the NIH’s National Heart,
Lung, and Blood Institute.
Participants are needed within two weeks of diagnosis of proximal lower extremity DVT. Qualified participants who enroll in the two-year trial will be randomly assigned to receive either conventional DVT therapy or conventional DVT therapy plus catheter-directed pharmacomechanical thrombectomy/thrombolysis.For more information or to refer a patient, call Jackie McCluskey, RN, at 216.444.4803 or Dr. Gornik at 214.445.3689 or [email protected].
Visit clevelandclinic.org /heart | Cardiac Consult | Fall 11 | Page 15
DrConnect Make Your Next Report Electronic
DrConnect is an Internet-based service developed to provide our community physician colleagues real-time electronic medical record information about the treatment their patients receive at Cleveland Clinic.
After establishing a DrConnect account with a secure log-in name and password, referring physicians may identify office personnel to receive security rights, allowing DrConnect patient updates to be immediately integrated into a busy medical practice’s daily activities and workflow.
A single daily email notification containing the DrConnect Web address (URL) gives you one-click access to all newly released patient-related information, which is presented in easy-to-navigate “What’s New” screens for quick access and effective case and time management.
Establishing your own DrConnect account is easy. 1) Log onto drconnect.clevelandclinic.org. 2) Click on the OnLine Signup button. 3) Simply fill out your physician participant information, including choosing a secure password, and submit.
Medical Concierge Complimentary assistance for out-of-state patients
and families 800.223.2273, ext. 55580, or email
Global Patient ServicesComplimentary assistance for national and international
patients and families 001.216.444.8184 or visit
clevelandclinic.org/ic
Critical Care Transport WorldwideCleveland Clinic’s critical care transport team, whose fleet
includes mobile ICU vehicles, helicopters and fixed-wing
aircraft, serves critically ill and highly complex patients
across the globe. Call 216.444.3202 or 800.553.5056
or visit clevelandclinic.org/criticalcaretransport
ReferralsTo refer patients to a Cleveland Clinic heart and vascular specialist please call:
Cardiovascular Medicine 216.444.6697
Thoracic and Cardiovascular Surgery 877.843.2781
Vascular Surgery216.444.4508
New patients, in most cases, can be seen within one week of calling for an appointment.
Same-day Visits Now AvailableThe Miller Family Heart & Vascular Institute has begun offering same-day appoint-
ments for new patients and follow-up visits. Patients who want or need to be seen
immediately will be scheduled with a HVI Cardiovascular Medicine staff member.
All same-day visits will be coordinated through our appointment office. To arrange a
same-day visit, call 216.444.6697 or 800.659.7822.
C l e V e l A N D C l I N I C A C C e S S G u I D e
The Cleveland Clinic Foundation9500 Euclid Avenue/AC311Cleveland, OH 44195
CardiacConsult
Shaping the Future of Cardiovascular Care: Progress and Controversies
Some medical conferences are all about
consensus and conventional wisdom.
But not this one.
Oct. 5-7, 2011Cleveland, Ohio
clevelandclinic.org/cardiocare11