It's Complicated - Cleveland Clinic

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


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)


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.


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 ?


It’s ComplicatedAdults with congenital heart disease need lifelong attention from specialists who are comfortable with these complex conditions


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.

“


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.


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.” ■


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.


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


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

[email protected]

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

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