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BLUHM CARDIOVASCULAR INSTITUTE
Clinical Activities and Outcomes Report 2010
U.S. News & World Report ranks
our Cardiology and Heart Surgery
program 16th in the nation.
2
To our Colleagues and Patients:
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
We are proud to share our 2010 annual Clinical Activities and Outcomes Report from Northwestern’s
Bluhm Cardiovascular Institute. Through stories about patient experiences and innovative programs, this
report illustrates how the work we do every day results in superior outcomes that meet and often exceed
national standards. Our hope is that physicians and patients alike find this report educational, informative
and useful when planning cardiovascular care.
Our clinical excellence, comprehensive programs and superior clinical outcomes have again been recognized
at the national level. In 2011, U.S. News & World Report ranked our Cardiology and Heart Surgery program
16th in the nation and ranked Northwestern Memorial as the No. 1 hospital in the Chicago metro region.
A new era has begun in the Division of Cardiology at Northwestern Memorial with the successful recruitment
of Clyde W. Yancy, MD, as the chief of Cardiology. As the immediate past president of the American Heart
Association, Dr. Yancy’s leadership and clinical expertise will greatly contribute to the growth of an already
thriving Bluhm Cardiovascular Institute.
Also, to meet the needs of patients, families and the community, services provided at the Bluhm
Cardiovascular Institute are now being offered at Northwestern Lake Forest Hospital, our affiliated hospital
located in the northern suburbs of Illinois where Ian D. Cohen, MD, is the medical director of Cardiology.
Through this affiliation, we work to provide a seamless integration of care between services provided at
Lake Forest and on the medical campus in downtown Chicago.
We are strong believers in providing outstanding patient care and in educating patients and referring
physicians on the importance of clinical outcomes in differentiating cardiovascular programs when
deciding where to seek and refer care. Our goal is to achieve superior clinical results for all of our patients
and to help them return to normal activities while improving their overall quality of life. The patient stories
and accompanying graphs in this report reflect our excellent outcomes and the individualized care that
patients receive at the Bluhm Cardiovascular Institute.
An extension of the patient experience is maintaining close cooperation and open communication
with referring physicians. This collaboration is a critical component of achieving high-quality care and
minimizing the challenges that come with performing complex cardiovascular procedures.
When you need advanced treatment, the nationally recognized experts at the Bluhm Cardiovascular
Institute are available to evaluate and respond to your medical needs.
Patrick M. McCarthy, MD
Chief
Division of Cardiac Surgery
Northwestern Memorial Hospital
Director
Bluhm Cardiovascular Institute
Heller-Sacks Professor of Surgery
Northwestern University
Feinberg School of Medicine
1
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
Northwestern’s Bluhm Cardiovascular Institute
At a Glance
World-Renowned Cardiovascular Care
in the Heart of Chicago
 In 2011, U.S. News & World Report ranked our Cardiology and
Heart Surgery program 16th in the nation.
 Immediate past president of the American Heart Association,
Clyde W. Yancy, MD, was named chief of Cardiology at
Northwestern Memorial and Magerstadt Professor of Medicine
at Northwestern University Feinberg School of Medicine.
 Ian D. Cohen, MD, assistant professor of Medicine-Cardiology
at Feinberg, was named medical director of Cardiology at
Northwestern Lake Forest Hospital, where, through an affiliation
with Northwestern Memorial, inpatient and outpatient cardiac
services through the Bluhm Cardiovascular Institute have expanded.
 Northwestern Memorial was the first in the nation to be granted
Accreditation for Carotid Stenting through the Intersocietal Commission
for the Accreditation of Carotid Stenting Facilities (ICACSF).
 We are the first hospital in North America to implant two
HeartWare® ventricular assist devices (VADs), two of the smallest
experimental VADs currently available for study, in both the left
and right ventricles of a single patient.
 Northwestern Memorial is one of only five hospitals in Illinois
offering a Medicare Destination Therapy Ventricular Assist Device
Program certified by The Joint Commission.
 Our Medicare-approved Heart Transplant program, a Blue Distinction®
Center for Transplants and an OptumHealthsm Transplant Center of
Excellence, ranks among the best in the country for one-year patient
survival at 96 percent.
 Northwestern’s Bluhm Cardiovascular Institute launched a first-
of-its-kind education and awareness campaign called “Hearts
a Bluhm,” a citywide art display of giant, painted acrylic hearts
“bluhming” on Michigan Avenue in Chicago during February,
National Heart Month.
TABLE OF CONTENTS
Heart Valve Disease
2
Heart Failure, Transplantation
and Mechanical Assist
Cardiovascular
Regenerative Medicine
18
4
Vascular Disease
6
Program for Limb
Preservation and Wound Care
19
Transcatheter Aortic
Valve Replacement
20
Clinical Trials and Research Highlights
21
The Patient Experience
24
Heart Rhythm Disorders
10
Coronary Disease
12
Cardiovascular Innovation
16
Preventive Medicine:
Cardiovascular Disease
17
Learn more about Northwestern’s world-class Bluhm Cardiovascular
Institute and how we are advancing cardiovascular medicine and
research by going to heart.nmh.org/cvoutcomes2010.
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CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
HEART VALVE DISEASE
Dr. Silverberg recommended
immediate surgery and arranged
a consultation with cardiac
surgeon Patrick M. McCarthy,
MD, chief of Cardiac Surgery at
Northwestern Memorial, director
of the Bluhm Cardiovascular
Institute and the Heller-Sacks
Professor of Surgery at Feinberg.
A referral from a colleague led Stefanie
Bader to the Bluhm Cardiovascular
Institute for valve replacement surgery.
COMMUNITY REFERRAL
Stefanie Bader was born with a bicuspid aortic valve and aortic
stenosis, which meant she had her first heart surgery at age 13 to
repair her aortic valve. Her life was restricted—she frequently came
down with fevers, went to many physician appointments and had to
sit on the sidelines when her schoolmates engaged in sports.
For those with this condition, the valve that connects the heart’s left
ventricle to the aorta has two leaflets, or cusps, instead of the usual
three and the space between the leaflets is narrowed. This prevents
the valve from opening fully and makes the heart work harder to pump
blood to the rest of the body.
Her condition was under control until the fall of 2009, when, at age
35, she suddenly began to again experience symptoms. She says she
felt “like a thousand needles were attacking my heart,” and knew
something wasn’t right.
After learning from her cardiologist that she likely needed surgery
to replace the bicuspid aortic valve that had been repaired when
she was a teenager, Mrs. Bader sought a second opinion. A mother
of a 5-year-old boy, she hoped to postpone surgery until after she
was able to get pregnant and have another child. A referral from
a colleague who had received care from specialists at the Bluhm
Cardiovascular Institute led her to see Robert A. Silverberg, MD,
cardiologist on the medical staff at Northwestern Memorial and
associate professor of Medicine at Feinberg.
“I’m so glad I had the surgery. My quality of life
has improved so much.” —Stefanie Bader
“At my first meeting with
Dr. McCarthy, he explained
the procedure for replacing
my aortic valve and discussed
the pros and cons of the
surgery,” Mrs. Bader says.
“I knew immediately that I would
be comfortable with him doing
my surgery.”
She underwent the procedure in April of 2010 and was able to
return to work just four weeks later at a Chicago law firm where
she oversees billing. On Dr. Silverberg’s recommendation to improve
her cardiovascular health, Mrs. Bader joined a health club and began
exercising, something she had never done before.
“When I first joined the health club, I went every day and I felt like I
was flying—I loved it,” says Mrs. Bader, who continues to exercise.
“I felt so cool running with everybody else.”
In the fall of 2010, Mrs. Bader received wonderful news: she was
pregnant with her second child. She delivered a healthy baby boy in
the summer of 2011. “I’m so glad I had the surgery,” Mrs. Bader says.
“My quality of life has improved so much.”
HEART VALVE DISEASE: FOR MORE INFORMATION PLEASE VISIT HEART.NMH.ORG · 866-662-8467
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DISTRIBUTION OF CARDIAC SURGERY PROCEDURES
IN-HOSPITAL MORTALITY FOR MITRAL VALVE PROCEDURES
CALENDAR YEAR 2010
CALENDAR YEARS 2006-2010
The distribution of cardiac procedures highlights the complexity of services performed
at the Bluhm Cardiovascular Institute. Overall, 62% of procedures performed were valve
operations, including both isolated and complex operations, such as valve operation +/coronary artery bypass graft (CABG) surgery or valve operation +/- Maze procedure.
The Bluhm Cardiovascular Institute demonstrated excellent outcomes for mitral valve
procedures with 0% in-hospital mortality in 2010. Cumulative five-year data shows
superior outcomes as compared to the national registry.
NORTHWESTERN MEMORIAL HOSPITAL
SOCIETY OF THORACIC SURGEONS
VALVE +/- OTHER
19%
OTHER COMPLEX PROCEDURES
19%
62%
ISOLATED CABG
Volume does not include laser lead
extractions, endostents, pericardial
windows or adult congenital cases.
MITRAL VALVE REPLACEMENT
MITRAL VALVE REPLACEMENT
+CABG
MITRAL VALVE REPAIR
MITRAL VALVE REPAIR
+CABG
HEART VALVE SELECTED INFORMATION
0
CALENDAR YEAR 2010
The Bluhm Cardiovascular Institute repaired mitral valves in 69% of all isolated mitral
valve cases. The repair of the mitral valve, especially for mitral valve prolapse, is
a complex procedure requiring advanced surgical skills. For patients at the Bluhm
Cardiovascular Institute with a preoperative diagnosis of mitral valve prolapse, the
repair rate was 96%.
Bioprosthetic valves were used in 95% of isolated mitral valve replacements and in 97%
of aortic valve replacements. This is considerably higher than national benchmarks.
2
4
6
8
10%
IN-HOSPITAL MORTALITY FOR AORTIC VALVE PROCEDURES
CALENDAR YEARS 2006-2010
The Bluhm Cardiovascular Institute has demonstrated excellent in-hospital mortality
rates for isolated aortic valve replacement and aortic valve replacement + CABG
procedures at 1.3% and 4.5%, respectively, over the last five years.
10%
ISOLATED
MITRAL VALVE
REPAIR VS.
REPLACEMENT
REPLACEMENT
CASES USING
BIOPROSTHETIC
VALVES
REPAIR
69%
NORTHWESTERN MEMORIAL
HOSPITAL
57%
8
REPLACE
31%
43%
ISOLATED
MITRAL VALVE
95%
66%
ISOLATED
AORTIC VALVE
97%
85%
SOCIETY OF THORACIC
SURGEONS
6
4
2
0
NORTHWESTERN
MEMORIAL
HOSPITAL
SOCIETY
OF THORACIC
SURGEONS
ISOLATED
AORTIC VALVE
REPLACEMENT
AORTIC VALVE
REPLACEMENT
+ CABG
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CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
HEART FAILURE, TRANSPLANTATION AND MECHANICAL ASSIST
James Armstrong receives life-saving
surgery after being diagnosed with acute
myocarditis. His surgery is the first of
its kind performed in North America.
ADVANCING PATIENT CARE THROUGH TECHNOLOGY
James “Jimmy” Armstrong had sailed the 333-mile boat race from
Chicago to Mackinac, Michigan, for 33 years. But when it was time
to prepare for the 2010 event, Armstrong was waiting for a heart
transplant in intensive care.
“I don’t remember much of what happened to me, a lot of it is a blur,”
says Mr. Armstrong, who at the age of 44 had endured a harrowing
experience spurred by a severe case of myocarditis, an inflammation of
the heart muscle. “I thought I had a bad cold or even food poisoning,
and then suddenly my health spiraled out of control.”
Mr. Armstrong, a local business owner and the father of three young
daughters, had no prior history of heart problems. However, persistent
bouts of dizziness and nausea sent him to Northwestern Lake Forest
Hospital’s Emergency Department in June of 2010. Cardiac imaging
confirmed acute myocarditis, which can be caused by many factors
including a viral, bacterial or fungal infection; drug or chemical
poisoning; or connective tissue diseases, such as lupus or rheumatoid
arthritis. While not always life threatening, myocarditis can lead to
heart failure or sudden cardiac death.
“Patients with myocarditis often have fever, aches and severe fatigue
similar to cold or flu-like symptoms,” says William G. Cotts, MD,
cardiologist on the medical staff at Northwestern Memorial, medical
director of Heart Transplantation and Mechanical Assistance at the
Bluhm Cardiovascular Institute and associate professor of Medicine
at Feinberg. “But Mr. Armstrong’s symptoms were more severe. When
he was referred to cardiac specialists at the Bluhm Cardiovascular
Institute, the myocarditis had resulted in such severe heart failure
that full-support VADs were his only hope,” says Dr. Cotts.
Mr. Armstrong underwent a procedure during which a HeartWare
VAD was implanted into each ventricle of his heart, known as
biventricular configuration or BiVAD, until a donor heart became
available. His surgery was the first time in North America when two
HeartWare VADs were implanted into a single heart.
Edwin C. McGee, Jr., MD, cardiac surgeon on the medical staff at
Northwestern Memorial, surgical director of Heart Transplantation
and Mechanical Assistance at the Bluhm Cardiovascular Institute and
associate professor of Surgery at Feinberg, performed the life-saving
intervention. The HeartWare VAD is the smallest full-support VAD
currently available for study in humans in the United States.
The BiVADs kept Mr. Armstrong alive for four months until October
of 2010, when a donor heart became available and he underwent a
heart transplant at Northwestern Memorial. Today, just one year later,
he has resumed an active lifestyle and is once again sailing.
“I may never know why or how I contracted the myocarditis that destroyed my heart, but I know I
wouldn’t be here if Northwestern Memorial’s team hadn’t acted as fast as they did to save my life.”
—James Armstrong
“I wouldn’t be here if Northwestern’s team hadn’t acted as fast as they
did to save my life,” Mr. Armstrong says.
HEART FAILURE, TRANSPLANTATION AND MECHANICAL ASSIST: FOR MORE INFORMATION PLEASE VISIT HEART.NMH.ORG · 866-662-8467
HEART TRANSPLANT SURVIVAL
CALENDAR YEARS 2005–2010
The Kaplan-Meier curve below demonstrated excellent survival for our heart transplant patients. The program has performed 122 heart transplants over the last six years.
NORTHWESTERN MEMORIAL HOSPITAL (NMH)
INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION (ISHLT) ADULT HEART
SURVIVAL PROBABILITY
100%
80
60
1-YEAR
SURVIVAL
2-YEAR
SURVIVAL
NMH 96%
ISHLT 86%
NMH 93%
ISHLT 82%
1
2
40
20
3-YEAR
SURVIVAL
4-YEAR
SURVIVAL
5-YEAR
SURVIVAL
NMH 90%
ISHLT 79%
NMH 90%
ISHLT 76%
NMH 87%
ISHLT 73%
3
4
5
0
YEARS
NMH Kaplan-Meier survival curve as of December 31, 2010. ISHLT transplants performed between 1/2002 and 6/2008 (J Heart Lung Transplant 2010 Oct; 29 (10): 1083-1141).
NMH survival curve includes two heart retransplants.
LEFT VENTRICULAR ASSIST DEVICE AS BRIDGE TO TRANSPLANT SURVIVAL
CALENDAR YEARS 2005–2010
The Kaplan-Meier curve below demonstrated excellent survival for our left ventricular assist device (LVAD) patients. The program has performed 113 VAD implants over
the last six years.
NORTHWESTERN MEMORIAL HOSPITAL (NMH)
HEARTMATE II (HMII) BRIDGE TO TRANSPLANT (BTT) CONTINUOUS LVAD TRIAL N=281
INTERMACS LVAD BTT N=1,092
SURVIVAL PROBABILITY
100%
80
60
1-YEAR
SURVIVAL
2-YEAR
SURVIVAL
3-YEAR
SURVIVAL
NMH 90%
NMH 90%
NMH 89%
2
3
40
20
0
1
YEARS
NMH Kaplan-Meier survival curve as of December 31, 2010. HMII Continuous LVAD Trial - Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device.
J Am Coll Cardiol. 2009; 54:312-321- patients enrolled between March 2005 and April 2008. Intermacs LVAD BTT - Second INTERMACS Annual Report. J Heart Lung Transplant 2010 29 (1):
1-10 - implants between June 23, 2006 and March 31, 2009.
5
6
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
VASCULAR DISEASE
Medical and surgical experts treat Muriel
Davis for a potentially life-threatening
thoracic aortic aneurysm, helping her
overcome nutritional challenges.
MULTIDISCIPLINARY TEAM APPROACH
Various medical conditions have caused Muriel Davis, 64, to spend a
great deal of time in physician offices, emergency rooms and hospitals.
A retired administrative assistant, she was diagnosed with lupus, a
chronic, inflammatory autoimmune disorder, in the late 1990s. Several
years later, in 2008, she began suffering from gastrointestinal issues
related to the lupus and struggled to keep her weight from falling too low.
“I was experiencing a lot of acid reflux and it was difficult for me to
swallow,” says Ms. Davis, who at her healthiest weighs little more
than 100 pounds. “I didn’t have a very good appetite.”
that the aneurysm was 4.3 centimeters at the time of diagnosis and
initially sought conservative options. But when the aneurysm grew,
he recommended surgery to prevent a life-threatening rupture.
Before Ms. Davis could tolerate surgery, her nutritional status had
to be addressed. With the help of a feeding tube, she gained enough
weight to have the surgery in September of 2010. During the complex
surgery, Dr. Morasch fixed the aneurysm, which had grown to a
dangerous size of nearly 6 centimeters.
He replaced the diseased aorta from the mid-chest to the pelvis with
a synthetic, tubular graft. Ms. Davis spent less than three weeks in the
hospital before moving to a rehabilitation facility for further recovery.
Eventually, she was able to go home without the feeding tube. Since
that time, she has gained 10 pounds.
Thanks to the surgery, Ms. Davis is enjoying a more active lifestyle.
For that, she’s thankful.
“The care that I’ve received has been marvelous,” she says. “The entire
team at Northwestern Memorial has been very concerned about my
health and well-being and supportive of all my needs.”
Ms. Davis sought treatment from John E. Pandolfino, MD, a
gastroenterologist on the medical staff at Northwestern Memorial
and associate professor of Medicine at Feinberg. He found that her
esophagus had collapsed and started her on drug therapy. But the
medications proved to be of little help and her symptoms became
so severe that she was admitted to Northwestern Memorial. More
testing revealed a condition unrelated to her lupus, a thoracic aortic
aneurysm, which is a bulging of part of the wall of the aorta, the
body’s main artery. Her aorta was compressing her esophagus against
her diaphragm’s muscle and tendon, making it difficult for food to
pass into her stomach.
Dr. Pandolfino consulted Mark D. Morasch, MD, vascular surgeon
on the medical staff at Northwestern Memorial, co-director of the
Bluhm Cardiovascular Institute’s Thoracic Aortic Surgery Program and
the John F. Marquardt, MD, Clinical Research Professor of Vascular
Surgery at Feinberg. Aneurysms continue to grow until they burst,
which is what makes the condition so dangerous. Dr. Morasch found
“The care that I’ve received has been marvelous. The entire team at Northwestern Memorial has been
very concerned about my health and well-being and supportive of all my needs.” —Muriel Davis
VASCULAR DISEASE: FOR MORE INFORMATION PLEASE VISIT HEART.NMH.ORG · 866-662-8467
VASCULAR SURGERY 30-DAY MORTALITY
THORACIC AORTIC ANEURYSM PROCEDURE VOLUME
CALENDAR YEARS 2006–2010
CALENDAR YEARS 2006–2010
The Bluhm Cardiovascular Institute demonstrated superior outcomes in comparison to
national academic medical centers as witnessed by a notably lower 30-day mortality
rate over the last five years.
The Bluhm Cardiovascular Institute has demonstrated an increase of 30% in thoracic
aortic procedure volume from 2006 to 2010.
10%
7
200
NORTHWESTERN MEMORIAL
HOSPITAL
8
6
NATIONAL SURGICAL
QUALITY IMPROVEMENT
PROGRAM ACADEMIC
MEDICAL CENTER COMPARISON
150
100
4
50
2
0
0
2006
2007
2008
2009
2010
OPEN AND ENDOVASCULAR THORACIC
AORTIC ANEURYSM REPAIR 30-DAY MORTALITY
MYOCARDIAL INFARCTION WITHIN 30 DAYS FOLLOWING
THORACIC AORTIC ANEURYSM PROCEDURES
CALENDAR YEARS 2006–2010
CALENDAR YEARS 2006–2010
The Bluhm Cardiovascular Institute has achieved noteworthy outcomes for thoracic
aortic aneurysm repairs, including both elective and ruptured repairs.
The Bluhm Cardiovascular Institute has witnessed a low incidence of myocardial
infarction (heart attack) following thoracic aortic aneurysm procedures over the
last five years.
10%
10%
NORTHWESTERN MEMORIAL
HOSPITAL
NORTHWESTERN MEMORIAL
HOSPITAL
8
6
NATIONAL SURGICAL
QUALITY IMPROVEMENT
PROGRAM ACADEMIC
MEDICAL CENTER COMPARISON
8
6
4
4
2
2
0
0
All National Surgical Quality Improvement Program case selections are based on sampling methodology.
NATIONAL SURGICAL
QUALITY IMPROVEMENT
PROGRAM ACADEMIC
MEDICAL CENTER COMPARISON
Northwestern Memorial Hospital
uses internal data compared to the
National Surgical Quality Improvement
Program Academic Medical Center
aggregate data.
8
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
VASCULAR DISEASE
William DeMarco travels 1,500 miles
for carotid artery surgery performed
by vascular specialists at the Bluhm
Cardiovascular Institute.
PHYSICIAN EXPERTISE
In the spring of 2010, William DeMarco and his wife, Mary, were
visiting the Chicago area. On their way to a party in the northern
suburbs, he began to feel lightheaded and unlike himself. His
wife was concerned and suggested they go to the hospital.
The nearest Emergency Department was at Northwestern
Lake Forest Hospital.
Tests revealed that both of his
carotid arteries—located on
either side of the neck that
provide the main blood supply
to the brain—were severely
blocked, a condition that
can lead to a life-threatening
stroke. He was admitted
and had a consultation with
Mark K. Eskandari, MD,
chief of Vascular Surgery
at Northwestern Memorial,
associate director of the Bluhm
“I came back to Northwestern Memorial
because I was so confident in Dr. Eskandari
Cardiovascular Institute and
and his entire staff.” —William DeMarco
the James S. T. Yao, MD, PhD,
Professor of Education in
Vascular Surgery at Feinberg. Dr. Eskandari told Mr. DeMarco that
he would need immediate surgery to open the blocked arteries.
An affiliation between Northwestern Lake Forest Hospital and
Northwestern Memorial benefits patients like Mr. DeMarco,
who was evaluated in the Northwestern Lake Forest Hospital
Emergency Department by a Bluhm Cardiovascular Institute expert
who spends time at both hospitals. Mr. DeMarco was transferred
to Northwestern Memorial where Dr. Eskandari performed the
procedure in a hybrid operating room suite that incorporates
elements of both a traditional operating room and cardiac
catheterization laboratory.
Dr. Eskandari tended to one carotid artery at a time, first placing
a stent into the right carotid artery to widen the blood vessel
and restore the blood flow. After one night in the hospital,
Mr. DeMarco returned home to Arizona to recuperate before
coming back to Northwestern Memorial for the second surgery
on his left carotid artery.
“After the first procedure, I would not have considered staying in
Phoenix and having someone else do the surgery,” says Mr. DeMarco,
68, who serves the Native American population as a part-time deacon
in his church. “I came back to Northwestern Memorial because I
was so confident in Dr. Eskandari and his entire staff. They explained
the procedure and its benefits. I had very positive feelings about
Dr. Eskandari’s expertise.”
Today he is watching his diet, visiting his physician for regular
checkups and will have an ultrasound of his carotid arteries
every year.
“It was kind of a wakeup call,” Mr. DeMarco says. “Fortunately,
because of Dr. Eskandari and the Bluhm Cardiovascular Institute,
the surgeries on my carotids did not cause me any grief.”
And that means he can get back to doing the work he loves:
ministering to the Native American population and working
with individuals on marriage preparation and the marriage
annulment process.
VASCULAR DISEASE: FOR MORE INFORMATION PLEASE VISIT HEART.NMH.ORG · 866-662-8467
9
CAROTID ENDARTERECTOMY AND STENTING 30-DAY MORTALITY
CALENDAR YEARS 2007–2010
The 30-day mortality outcomes for carotid endarterectomy and carotid artery stenting were better than national comparisons. Carotid endarterectomy and carotid artery stenting
demonstrated exemplary mortality outcomes at 0.4% and 0% respectively over the last four years.
CAROTID ENDARTERECTOMY
30-DAY MORTALITY
CAROTID ARTERY STENTING
30-DAY MORTALITY
5%
NORTHWESTERN MEMORIAL
HOSPITAL
4
SOCIETY FOR VASCULAR
SURGERY
5%
NORTHWESTERN MEMORIAL
HOSPITAL
4
3
3
2
2
1
1
0
0
SOCIETY FOR VASCULAR
SURGERY
CAROTID ENDARTERECTOMY AND STENTING 30-DAY STROKE OUTCOMES
CALENDAR YEARS 2007–2010
The 30-day stroke outcomes for carotid endarterectomy and carotid artery stenting were notably lower than national comparisons. Carotid endarterectomy and carotid artery stenting
demonstrated exemplary stroke outcomes at 0% and 1.9% respectively over the last four years.
CAROTID ENDARTERECTOMY
30-DAY STROKE OUTCOMES
CAROTID ARTERY STENTING
30-DAY STROKE OUTCOMES
5%
NORTHWESTERN MEMORIAL
HOSPITAL
4
SOCIETY FOR VASCULAR
SURGERY
5%
NORTHWESTERN MEMORIAL
HOSPITAL
4
3
3
2
2
1
1
0
0
SOCIETY FOR VASCULAR
SURGERY
Northwestern Memorial Hospital uses internal data compared to Society for Vascular Surgery (SVS) aggregate data. SVS benchmark contains all participants from 2002 through 2010 for carotid
endarterectomy procedures and from 2001 through 2010 for carotid artery stenting procedures.
10
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
HEART RHYTHM DISORDERS
A potentially lethal irregular heart rhythm
does not keep Carlos Ahon on the
sidelines, thanks to an implantable device.
RESTORING ACTIVE AND HEALTHY LIFESTYLES
Carlos Ahon has been playing soccer since he was a boy growing
up in Colombia. Even today, at the age of 35, he cannot imagine life
without watching and playing soccer.
So when severe fatigue and chest pain led him to an emergency
room in 2009 and later to a cardiologist who diagnosed dilated
cardiomyopathy, Mr. Ahon was worried that his soccer-playing days
might be numbered. In patients with dilated cardiomyopathy, the
heart’s ability to pump blood is decreased because its main pumping
chamber—the left ventricle—is enlarged, dilated and weak. With time,
the heart muscle walls weaken and are unable to pump as strongly,
leading to heart failure.
“I thought my life was going to change drastically,” he says. “I thought
it would interfere because I like to exercise a lot.”
Tests determined he had only 50 percent heart function and was at
increased risk of sudden cardiac death from ventricular fibrillation, a
potentially lethal irregular heart rhythm that causes the heart to beat
with rapid, erratic electrical impulses. This, in turn, can cause the
heart’s pumping chambers to quiver rather than pump blood.
To guard against ventricular fibrillation, patients like Mr. Ahon typically
receive an implantable cardioverter defibrillator (ICD) placed by
insertion through a vein, known as a transvenous ICD. The device
contains one or more electrical wires that are fed through the veins
and into the heart. When the ICD senses an irregular heart rhythm,
it sends an electrical shock to the heart to reset the normal rhythm.
However, his cardiologist thought he might benefit from a new
investigational device that implants the ICD device under the skin,
“I didn’t expect the results I got with this device—I had my doubts. I have been pleasantly surprised.
The device hasn’t interfered with my life at all.” —Carlos Ahon
with no wires touching the heart. Northwestern Memorial is among
30 healthcare institutions nationally that are participating in a Food
and Drug Administration (FDA) clinical trial of the new device, called
a subcutaneous (under the skin) cardioverter defibrillator (S-ICD).
Mr. Ahon was referred to electrophysiologist Bradley P. Knight, MD,
Northwestern’s principal investigator for S-ICD, director of Cardiac
Electrophysiology at the Bluhm Cardiovascular Institute and professor
of Medicine at Feinberg.
“Mr. Ahon was a good candidate because he is young and will have
the device for many years,” Dr. Knight says. “The potential advantages
are no wires touching the heart and fewer inappropriate shocks. We
can also retrieve data from the device to determine if the patient has
had an irregular rhythm leading to a shock.”
With the device, Mr. Ahon has found that he can enjoy an active
lifestyle, which includes his passion—playing soccer.
“I feel a lot more secure and I’m no longer afraid,” he says of living
with the implanted investigational device. “I have been pleasantly
surprised. The device hasn’t interfered with my life at all.”
HEART RHYTHM DISORDERS: FOR MORE INFORMATION PLEASE VISIT HEART.NMH.ORG · 866-662-8467
PERCENT OF PATIENTS WITH DIAGNOSIS OF ATRIAL
FIBRILLATION TREATED AT TIME OF ISOLATED MITRAL
VALVE SURGERY
CALENDAR YEAR 2010
Patients often present with an initial diagnosis of atrial fibrillation and, in the course of
the preliminary evaluation, mitral valve disease is found. At the Bluhm Cardiovascular
Institute, atrial fibrillation surgery was performed in 100% of isolated mitral valve
surgery patients with a previous history of atrial fibrillation. By comparison, the Society
of Thoracic Surgeons’ average was 51%. It is beneficial to patients to eliminate atrial
fibrillation and its risks during a single surgery.
100%
NORTHWESTERN MEMORIAL
HOSPITAL
80
SOCIETY OF
THORACIC SURGEONS
CARDIAC CATHETER ABLATION AND IMPLANTABLE
CARDIOVERTER DEFIBRILLATOR VOLUME
CALENDAR YEARS 2007–2010
The Bluhm Cardiovascular Institute has demonstrated consistent growth in ICD by
an average annual rate of 18% over the last four years. The Bluhm Cardiovascular
Institute has demonstrated an average annual growth rate of 17% in cardiac catheter
ablation volume from 2007-2010.
ICD VOLUME
500
250
0
2007
60
2008
2009
2010
2009
2010
ABLATION VOLUME
500
40
250
20
0
0
2007
2008
ATRIAL FIBRILLATION CATHETER ABLATION
30-DAY OUTCOMES
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
MAJOR IN-HOSPITAL ADVERSE EVENTS OR DEATH
CALENDAR YEAR 2010
CALENDAR YEAR 2010
The Bluhm Cardiovascular Institute has demonstrated excellent outcomes
following atrial fibrillation ablation as witnessed by a very low incidence of
major complications.
Over the last year, the Bluhm Cardiovascular Institute has demonstrated commendable
outcomes for ICD in both primary prevention and secondary prevention patients.
5%
NORTHWESTERN MEMORIAL
HOSPITAL
BLEEDING AND/OR
VASCULAR COMPLICATIONS
4
CARDIAC PERFORATION
THROMBOEMBOLIC EVENT
AMERICAN COLLEGE
OF CARDIOLOGY
NATIONAL CARDIOVASCULAR
DATA REGISTRY
3
ESOPHAGEAL FISTULA
2
PHRENIC NERVE INJURY
1
DEATH
0
0
1
2
3
4
5%
Data represents April-December 2010.
11
12
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
CORONARY DISEASE
A heart attack for Jorge Galdamez leads
to opening of a blocked coronary artery
and a stronger commitment to exercising.
EXERCISING FOR IMPROVED HEART HEALTH
Jorge Galdamez had always led an active life. Even at the age of
74, he was busy counseling growing businesses, playing golf and
exercising as part of his routine.
Then one night he woke with what he thought was a severe case
of heartburn, but realized it might be something else. Even so, he
was surprised to find himself being evaluated for heart problems in
Northwestern Memorial’s Emergency Department.
“I had never had the slightest bother in my body,” says Mr. Galdamez.
While in the Emergency Department, Mr. Galdamez was put
through a battery of tests to check for potential heart problems.
There were no suspicious readings from an ECG, chest X-ray or
blood work administered by a medical team led by James D.
Flaherty, MD, interventional cardiologist on the medical staff
at Northwestern Memorial and assistant professor of Medicine
at Feinberg.
But Dr. Flaherty remained skeptical that Mr. Galdamez was having a
heart attack and recommended that he have a cardiac catheterization,
a test to evaluate blood flow in the coronary arteries.
The next thing Mr. Galdamez says he remembers was waking up and
being told that the cardiac catheterization showed that one of his
coronary arteries was 100 percent blocked. Coronary arteries supply
blood to the heart and when plaque builds up in their walls, blood
flow becomes obstructed, reducing the heart’s supply of oxygen.
A heart attack can occur when the obstruction reaches a critical
point. Dr. Flaherty performed a percutaneous coronary intervention
(PCI), placing a stent in the artery to keep it open and restore blood
flow. Another coronary artery also was partially blocked, but not
significantly enough to require the procedure.
“I stayed in the hospital for three days,” says Mr. Galdamez. “I
didn’t feel anything during the procedure or after. There was no
discomfort, no pain.”
Since then, Mr. Galdamez has ramped up his exercise routine, first
as part of Northwestern Memorial’s Cardiac Rehabilitation program
and now in the gym of his condo building. Now that he is doing
better, he says he looks forward to spending more time on the golf
course than at his physician appointments.
“I feel very comfortable with Dr. Flaherty. He is very accessible and professional in the way he handles
my care.” —Jorge Galdamez
CORONARY DISEASE: FOR MORE INFORMATION PLEASE VISIT HEART.NMH.ORG · 866-662-8467
PERCUTANEOUS CORONARY INTERVENTION MORTALITY
CALENDAR YEARS 2007–2010
The mortality rate at the Bluhm Cardiovascular Institute following PCI has been
below national registry comparisons over the last four years.
3%
PERCUTANEOUS CORONARY INTERVENTION COMPLICATION:
MYOCARDIAL INFARCTION
CALENDAR YEARS 2007–2010
The Bluhm Cardiovascular Institute has demonstrated a low incidence of myocardial
infarction (heart attack), outperforming national registry comparisons.
3%
2
NORTHWESTERN MEMORIAL
HOSPITAL
NORTHWESTERN MEMORIAL
HOSPITAL
AMERICAN COLLEGE
OF CARDIOLOGY
NATIONAL CARDIOVASCULAR
DATA REGISTRY
AMERICAN COLLEGE
OF CARDIOLOGY
NATIONAL CARDIOVASCULAR
DATA REGISTRY
2
1
1
0
0
DIAGNOSTIC CARDIAC CATHETERIZATION AND PERCUTANEOUS CORONARY INTERVENTION INCIDENCE
OF VASCULAR COMPLICATIONS
CALENDAR YEARS 2007–2010
The Bluhm Cardiovascular Institute has exhibited a low incidence of vascular complications following diagnostic cardiac catheterization and PCI procedures.
DIAGNOSTIC CARDIAC CATHETERIZATION
INCIDENCE OF VASCULAR COMPLICATIONS
PERCUTANEOUS CORONARY INTERVENTION
INCIDENCE OF VASCULAR COMPLICATIONS
3%
2
13
3%
NORTHWESTERN MEMORIAL
HOSPITAL
NORTHWESTERN MEMORIAL
HOSPITAL
AMERICAN COLLEGE
OF CARDIOLOGY
NATIONAL CARDIOVASCULAR
DATA REGISTRY
AMERICAN COLLEGE
OF CARDIOLOGY
NATIONAL CARDIOVASCULAR
DATA REGISTRY
2
1
1
0
0
All Northwestern Memorial Hospital data is internal compared to American College of Cardiology National Cardiovascular Data Registry (NCDR) aggregate data. NCDR benchmark is from time period
January-December 2010.
14
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
TIME TAKEN FOR PATIENTS TO RECEIVE PERCUTANEOUS CORONARY INTERVENTION FROM HOSPITAL ARRIVAL
CALENDAR YEARS 2008–2010
National standards recommend a goal of 90 minutes or less from the patient’s arrival in an emergency department to the time the affected artery is opened via PCI. On average,
94% of patients at the Bluhm Cardiovascular Institute receive PCI in 90 minutes or less.
PRIMARY PCI RECEIVED WITHIN 90 MINUTES OF HOSPITAL ARRIVAL
100%
NORTHWESTERN MEMORIAL
HOSPITAL
80
AMERICAN COLLEGE
OF CARDIOLOGY NATIONAL
CARDIOVASCULAR DATA
REGISTRY
60
GOAL AREA
40
20
0
Q1
Q2
Q3
Q4
Q1
Q2
2008
Q3
Q4
Q1
Q2
2009
Q3
Q4
2010
MEDIAN TIME TO RECEIVE PCI FROM HOSPITAL ARRIVAL
MINUTES
100
NORTHWESTERN MEMORIAL
HOSPITAL
80
AMERICAN COLLEGE
OF CARDIOLOGY/AMERICAN
HEART ASSOCIATION GOAL
60
GOAL AREA
40
20
0
Q1
Q2
Q3
2008
Q4
Q1
Q2
Q3
2009
Q4
Q1
Q2
Q3
2010
Q4
CORONARY DISEASE: FOR MORE INFORMATION PLEASE VISIT HEART.NMH.ORG · 866-662-8467
OPERATIVE MORTALITY FOR CORONARY ARTERY
BYPASS GRAFT SURGERY
ISOLATED CORONARY ARTERY BYPASS GRAFT SURGERY:
PERCENT OF INTERNAL MAMMARY ARTERY GRAFTS USED
CALENDAR YEARS 2006–2010
CALENDAR YEARS 2006–2010
At the Bluhm Cardiovascular Institute, in-hospital mortality for CABG surgery has
been superior, outperforming national benchmark comparisons over the last
five years.
Bypassing a blocked coronary artery with arteries as opposed to veins is widely
accepted as beneficial. At the Bluhm Cardiovascular Institute, multiple arterial grafts
are routinely used for first-operative CABG surgery, exceeding national comparisons
over the last five years.
5%
98%
NORTHWESTERN MEMORIAL
HOSPITAL
4
NORTHWESTERN MEMORIAL
HOSPITAL
97
SOCIETY OF
THORACIC SURGEONS
SOCIETY OF
THORACIC SURGEONS
96
3
95
2
94
1
93
92
0
ISOLATED CORONARY ARTERY BYPASS GRAFT SURGERY:
PERCENT OF CASES WHERE ENDOVASCULAR VEIN
HARVEST TECHNIQUE WAS USED
MEAN INITIAL VENTILATION TIME AFTER CORONARY
ARTERY BYPASS GRAFT SURGERY
CALENDAR YEAR 2010
CALENDAR YEAR 2010
Patients at the Bluhm Cardiovascular Institute require less time on a ventilator after
CABG than the national average.
Harvesting the saphenous vein requires proficiency with the use of complex medical
equipment. The Bluhm Cardiovascular Institute offers this minimally invasive harvesting
technique, which can lead to smaller incisions, shorter recovery time and less pain.
80
60
40
20
0
20
NORTHWESTERN MEMORIAL
HOSPITAL
SOCIETY OF
THORACIC SURGEONS
15
HOURS
100%
10
5
0
NORTHWESTERN MEMORIAL
HOSPITAL
SOCIETY OF
THORACIC SURGEONS
15
16
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
CARDIOVASCULAR INNOVATION
To address ongoing gaps in heart disease care, the Center for
Cardiovascular Innovation was established at Feinberg in 2009.
The goal is to discover and disseminate knowledge through research
and participation in forums that will impact national clinical and
healthcare policy decisions and enhance care for all patients with
cardiovascular disease.
Ongoing research at the center focuses on developing innovative
therapies to improve outcomes for patients with heart failure;
understanding and reducing the high rates of readmission following
discharge from a heart failure hospitalization; patient-centered
outcomes in heart failure; influence of tort reform and reimbursement
legislation on physician use of diagnostic tests; effects of beta blocker
adherence and dose on outcomes of patients after heart attacks;
novel techniques to assess and treat stroke risk in patients with atrial
fibrillation; and virtual testing of the cardiac electrical system using
MRI to improve treatment for arrhythmias.
Members of the center collaborate with leading universities in the
United States, Europe and Asia on research studies and are participating
in healthcare quality initiatives in federal and private agencies including
the National Institutes of Health; the U.S. Agency for Healthcare
Research and Quality; the Center for Medicare and Medicaid Services;
the FDA; the National Quality Forum; The Joint Commission; the
National Center for Quality Assurance; the American Heart Association;
the American College of Cardiology; and the Physician Consortium for
Performance Improvement® of the American Medical Association.
The leaders of the center include:
 Robert O. Bonow, MD, a cardiologist on the medical staff at
Northwestern Memorial, director of the Center for Cardiovascular
Innovation, vice chair of Development and Innovation for
the Department of Medicine and the Max and Lilly Goldberg
Distinguished Professor of Cardiology at Feinberg
 Mihai Gheorghiade, MD, a cardiologist on the medical staff at
Northwestern Memorial, director of Experimental Therapeutics
at the Center for Cardiovascular Innovation and professor of
Medicine and Surgery at Feinberg
“Research conducted through the Center for Cardiovascular Innovation is impacting healthcare policy
and improving quality and patient outcomes.” —Robert O. Bonow, MD
 Jeffrey J. Goldberger, MD, a cardiologist and cardiac
electrophysiologist on the medical staff at Northwestern Memorial,
director of Arrhythmia Studies at the Center for Cardiovascular
Innovation and professor of Medicine at Feinberg
 Steven A. Farmer, MD, PhD, a cardiologist on the medical staff at
Northwestern Memorial, director of Healthcare Policy at the Center
for Cardiovascular Innovation and assistant professor of Medicine
at Feinberg and assistant professor of Management and Strategy at
Kellogg School of Management at Northwestern University
 Kathleen L. Grady, APN, PhD, administrative director of the Center
for Heart Failure at the Bluhm Cardiovascular Institute and associate
professor of Surgery at Feinberg
 Peter S. Pang, MD, an emergency medicine physician on the medical
staff at Northwestern Memorial, associate director of Experimental
Therapeutics at the Center for Cardiovascular Innovation and
associate professor of Emergency Medicine and Medicine at Feinberg
If you would like more information about the Center for
Cardiovascular Innovation, please call 312-695-1105 or visit
www.medicine.northwestern.edu/cvinnovation.
CLINICAL TRIALS: FOR MORE INFORMATION PLEASE VISIT HEART.NMH.ORG · 866-662-8467
17
PREVENTIVE MEDICINE: CARDIOVASCULAR DISEASE
Since its inception in 1972, the Department of Preventive Medicine
at Feinberg has been a leader in understanding the causes and
consequences of cardiovascular disease (CVD) for people of all ages,
and in finding new ways to prevent it. Donald M. Lloyd-Jones, MD,
is a cardiologist on the medical staff at Northwestern Memorial,
medical director of the Center for Preventive Cardiology at the Bluhm
Cardiovascular Institute and chair of the Department of Preventive
Medicine at Feinberg. The department participates in numerous
large-scale national studies that are expanding the boundaries of
our ability to detect and prevent CVD. One recent study from the
department showed the importance of healthy lifestyle beginning in
young adulthood for preserving long-term cardiovascular health.
“The results of the CARDIA study indicate that to maximize the benefit of low CVD risk profile in
middle age and later, more emphasis should be devoted to encourage a healthy lifestyle starting
at younger ages.” —Donald M. Lloyd-Jones, MD
Maintaining Low CVD Risk Profile from Young Adulthood
to Middle Age by Healthy Lifestyle: The CARDIA Study
CARDIA is a multi-center longitudinal study sponsored by the
National Heart, Lung, and Blood Institute to examine whether
maintaining a healthy lifestyle from young adulthood to middle
age can lead to a low CVD risk profile in middle age. Other
research from the department has indicated that the low CVD
risk profile—untreated cholesterol <200 mg/dl, untreated blood
pressure <120/80 mmHg, never smoking and no diabetes—in middleage adults is associated with greater longevity, dramatically lower
rates of CVD, higher quality of life and lower Medicare expenses in
older age.
The study followed 2,600 African-American and Caucasian participants,
ages 18 to 30 years at baseline, for a total of 20 years. Association of
healthy lifestyle factors through young adulthood with prevalence of
low CVD risk profile in middle age was assessed. The healthy lifestyle
factors examined were:
1. Body mass index (BMI) <25 (lean body weight)
2. Never smoking
3. No or low alcohol intake (<1 drink per day)
4. Higher amount of physical activity (top 40 percent for age and sex)
5. Healthier diet score indicating a diet rich in potassium, calcium
and fiber and low in saturated fats (top 40 percent for age
and sex)
The study concluded that a low CVD risk profile can be effectively
achieved in middle age by maintaining a healthy lifestyle through
young adulthood: almost 60 percent of those who followed all five
healthy lifestyle factors through young adulthood made it to middle
age with the low-risk profile, whereas only 5 percent of those who
followed zero healthy lifestyle factors achieved low-risk status in
middle age. “The results of the CARDIA study indicate that to maximize
the benefit of low CVD risk profile in middle age and later, more
emphasis should be devoted to encourage a healthy lifestyle starting
at younger ages,” says Dr. Lloyd-Jones.
If you would like more information about the Department
of Preventive Medicine, please call 312-908-7914 or visit
www.preventivemedicine.northwestern.edu.
18
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
CARDIOVASCULAR REGENERATIVE MEDICINE
Douglas W. Losordo, MD, interventional cardiologist on the medical
staff and director of the Program in Cardiovascular Regenerative
Medicine at Northwestern Memorial and director of the Feinberg
Cardiovascular Research Institute and the Eileen M. Foell Professor of
Heart Research at Feinberg, recently completed a clinical research trial
of patients suffering from chronic chest pain due to blocked arteries.
Stem cells collected from a patient’s blood are injected into the heart
and arteries through a catheter. Patients who received the stem cells
experienced reduced chest pain and a greater ability to exercise.
“One of the goals of cardiovascular regenerative medicine is to see if stem cell and gene therapy can
successfully improve heart function. If so, then these approaches may be able to help millions with
heart damage.” —Douglas W. Losordo, MD
Regenerative medicine seeks to help the body repair itself by
regenerating damaged tissue. While conventional medicine attempts
to improve the function of damaged tissue with medication or surgery,
regenerative medicine seeks to grow new cardiac and vascular tissue.
The Program in Cardiovascular Regenerative Medicine at
Northwestern Memorial is currently investigating approaches
including:
 Gene therapy, which attempts to increase the production of
naturally occurring proteins or nucleic acids. This approach relies
on the insertion of genes into diseased cells and tissues to help
repair tissue.
Greg Jodway, who is 44, has undergone multiple medical therapies
and procedures to treat his coronary artery disease and heart failure,
including medication management, angioplasty for stent placement
and ICD insertion. Hoping to improve his heart function, Mr. Jodway
began searching for additional treatment options and learned
about the Juventas SDF-1 gene therapy trial. The gene therapy trial,
conducted through the Program in Cardiovascular Regenerative
Medicine, led by principal investigator Dr. Losordo, involves
administration of DNA molecules that are taken up by cells to make
a therapeutic protein: stromal derived factor-1 (SDF-1). The protein
attracts stem cells from the circulation into the heart to stimulate repair
and regrowth of the blood vessels, resulting in improved blood flow
and better heart function. Since participating in this trial, Mr. Jodway
has noticed that he is less tired
and more active, giving him hope
that he will be able to return
to work, complete his degree
in computer networking and,
most importantly he says,
interact more with his children.
 Autologous stem cell therapy, which attempts to regenerate
and replenish tissue by increasing the supply of naturally occurring
reparative cells at sites of damage. This approach relies on the
phenomenon of plasticity, using autologous (the patient’s own)
stem cells from one tissue to generate specialized cells in another
tissue. An example would be to use bone marrow cells to build
blood vessels in the heart.
“After participating in the gene therapy trial, I
can now walk behind my three children as they
ride their bikes, and even ride my own bike.”
—Greg Jodway
If you would like more
information about the
Program in Cardiovascular
Regenerative Medicine, please
call 312-695-0072 or visit
fcvri.northwestern.edu.
CLINICAL TRIALS: FOR MORE INFORMATION PLEASE VISIT HEART.NMH.ORG · 866-662-8467
19
PROGRAM FOR LIMB PRESERVATION AND WOUND CARE
The Program for Limb Preservation and Wound Care at the Bluhm
Cardiovascular Institute provides corrective and preventive healthcare
services for the diagnosis, treatment and prevention of limb morbidity
caused by critical limb ischemia, a chronic condition caused by severe
cases of peripheral arterial disease. It results in pain in the leg or legs
while at rest or in ulcerations or wounds that will not heal and can
lead to gangrene, which is tissue death. If left untreated, critical limb
ischemia may lead to amputation of a foot or leg.
With a focus on patients first and clinical excellence and through
an academic partnership with Feinberg, the Program for Limb
Preservation and Wound Care individualizes treatment plans to
heal wounds, preserve limbs and lower the rate of amputations
by utilizing:
 State-of-the-art diagnostic tools to detect arterial disease and to
determine the oxygen levels in tissue and the severity of the disease.
 Advanced wound care technology including highly developed
biological dressings that expedite healing.
 Advanced minimally invasive techniques performed by nationally
recognized, board-certified surgeons from multiple specialties to
improve arterial circulation and to surgically reconstruct wounds.
The Program for Limb Preservation and Wound Care is led by
co-directors Heron E. Rodriguez, MD, and Robert D. Galiano,
MD. Dr. Rodriguez, a vascular surgeon on the medical staff at
Northwestern Memorial and assistant professor of Surgery at
Feinberg, specializes in restoring blood flow circulation to the
extremities using both traditional open bypass surgery and minimally
invasive techniques such as balloon angioplasty, stenting and laser
atherectomy. Dr. Galiano, a plastic surgeon on the medical staff at
Northwestern Memorial and assistant professor of Surgery at Feinberg,
specializes in complex reconstructive surgery to save limbs, including
the use of grafts, flaps and microsurgery. Drs. Rodriguez and Galiano
have extensive backgrounds in leading-edge research in the field of
limb preservation and have authored numerous papers and chapters
on wound care and arterial revascularization.
“The Program for Limb Preservation and Wound Care has experienced clinicians and advanced
treatment options for the most challenging non-healing wounds caused by peripheral arterial
disease.” —Heron E. Rodriguez, MD
Drs. Rodriguez and Galiano work with a multidisciplinary team of
physicians, surgeons and advanced practice nurses—all clinicians
who specialize in orthopaedics, endocrinology and rehabilitation
medicine who work together to preserve health, heal wounds, prevent
amputation and enhance the quality of life in patients with peripheral
artery disease and difficult-to-heal wounds.
If you would like more information about the Program for Limb
Preservation and Wound Care, please call 312-695-2714 or visit
nmh.org/nm/limbpreservation.
20
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
TRANSCATHETER AORTIC VALVE REPLACEMENT
Through The PARTNER Trials,
physicians and researchers
at the Bluhm Cardiovascular
Institute are investigating
transcatheter techniques, a
minimally invasive approach
for implanting a prosthetic
heart valve inside the stenotic
aortic valve.
The procedure uses an
expandable valve with a
stainless steel frame crimped
onto a balloon delivery catheter the width of a pencil. It is introduced
through an artery in the groin or a small incision between the ribs.
During the procedure, the prosthetic valve remains compressed until
SAPIEN valve image permission by Edwards
Lifesciences, LLC.
it reaches the aortic valve, at which time it is expanded with a balloon
and opened within the diseased aortic valve. The delivery catheter is
then removed and the transcatheter valve replaces the native valve
and functions in its place. The technology allows insertion of the
prosthetic valve while the heart is still beating, eliminating the need
for cardiopulmonary bypass and its associated risks.
The Edwards SAPIEN™ valve is intended to treat patients who are
considered high risk or who are not candidates for conventional
aortic valve replacement surgery. The implantation of the valve does
not require traditional open heart surgery and can be performed in
the cardiac catheterization lab.
 The PARTNER Trial: Placement of AoRtic TraNscathetER
Valves Trial
The purpose of the randomized PARTNER Trial is to evaluate the
safety and effectiveness of the Edwards SAPIEN transcatheter heart
valve and its transfemoral and transapical delivery systems.
 The PARTNER II Trial: Placement of AoRtic TraNscathetER
Valves Trial Edwards SAPIEN XT™ Transcatheter Heart Valve
Pivotal Trial #2010-12-US
The purpose of this randomized PARTNER II Trial is to evaluate the
safety and effectiveness of the Edwards SAPIEN Transcatheter Heart
Valve, Model 9000TFX and the lower-profile Edwards SAPIEN XT™,
Model 9300TFX Transcatheter Heart Valve and its transfemoral
delivery systems.
To date, surgeons at Northwestern Memorial have implanted the most
transcatheter aortic valves in patients throughout all of Illinois.
The prosthetic valves are investigational devices, which means they
are being studied and are not for sale commercially in the United
States. Data is being collected on the valves as the therapy is currently
under consideration for approval by the FDA for the treatment of
inoperable patients.
Due to declining health, Rose Spagnola, who is 86, underwent a successful transcatheter aortic valve
implantation via transfemoral approach.
If you would like more information about The PARTNER Trials at
Northwestern Memorial, please call 312-926-4000.
CLINICAL TRIALS AND RESEARCH HIGHLIGHTS: FOR MORE INFORMATION PLEASE VISIT HEART.NMH.ORG · 866-662-8467
21
CLINICAL TRIALS AND RESEARCH HIGHLIGHTS: CARDIAC SURGERY
Comparative Analysis of Aortic
Arch and Great Vessels Motion
in Humans
Principal Investigators:
S. Chris Malaisrie, MD, and
James Carr, MD
This is an investigator-initiated,
single-center project intended
to quantify great vessels
motion related to the aortic
arch in humans by using
four-dimensional computed
tomography (CT) and magnetic
resonance (MR) angiography to
predict the effect of the motion
on the stent-graft. An improved
understanding of motion of great
vessels related to the aortic arch
is vital in stent-graft development
and subsequent improved graft
durability and patient outcomes.
Clinical Evaluation of the size
23 mm Carpentier–Edwards®
PERIMOUNT® Magna Mitral
Bioprosthesis, Model 7000TFX
Principal Investigator:
S. Chris Malaisrie, MD
The purpose of this research
study is to collect information
on the safety and effectiveness
of an investigational device (not
yet approved by the FDA), the
Carpentier-Edwards PERIMOUNT
Magna Mitral Bioprosthesis (size
23 mm), model 7000/7000TFX,
in patients undergoing mitral
valve replacement. Subjects
will be evaluated at hospital
discharge and return for followup visits at six months and
annually through five years
post-treatment.
LAA Occlusion: Evaluation of
Surgical Techniques
Principal Investigator:
Richard Lee, MD
Most of the strokes in patients
with atrial fibrillation (AF) appear
to originate in the Left Atrial
Appendage (LAA). The surgical
treatment of AF eliminates the
LAA in an effort to reduce stroke.
The purpose of this randomized
study is to evaluate three surgical
techniques commonly used to
occlude the LAA: staple excision,
surgical excision and internal
ligation. Although these surgical
techniques are simple to apply
and all reduce the flow of blood
into the LAA, many times flow
into the LAA is noted following
the procedure. Residual flow may
not effectively reduce stroke. This
study will measure the success of
each technique.
A Prospective, Randomized,
Controlled, Un-blinded,
Multi-Center Clinical Trial
to Evaluate the HeartWare
Ventricular Assist System
for Destination Therapy of
Advanced Heart Failure
Principal Investigator:
Edwin C. McGee, Jr., MD
The purpose of this study is
to compare the safety and
effectiveness of the HeartWare
VAS device (investigational: not
yet approved by the FDA) versus
the HeartMate II® LVAD, which
has been approved by the FDA for
Destination Therapy. Destination
therapy is the approach used for
end-stage heart failure patients
who are not eligible for a heart
transplant due to age, additional
health problems or other
complications. These devices are
surgically implanted and help
maintain the pumping ability of
a heart that cannot effectively
work on its own due to advanced
heart failure.
Magna image permission by Edwards
Lifesciences, LLC.
Investigational device. Limited by U.S. law to
investigational use. VAS image permission by
HeartWare, Inc.
22
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
CLINICAL TRIALS AND RESEARCH HIGHLIGHTS: CARDIOLOGY
ALERTS (AngeLmed for Early
Recognition and Treatment of
STEMI) Study
Principal Investigator:
Dan J. Fintel, MD
This study is evaluating the
safety and effectiveness of
an investigational diagnostic
monitoring system (The Guardian
System), in comparison to the
standard of care in treating
patients with high-risk acute
coronary syndromes or multivessel CABG surgery as a result
of coronary artery disease. The
Guardian System (study device)
is intended to help reduce the
time it takes patients to seek
medical treatment when they
have a heart attack. The study
device is implanted under the
skin and continuously monitors
the heart’s electrical activity; if
the monitor detects an abnormal
electrical activity, it will alert the
subject to seek medical attention.
A Prospective, Single Blind,
Randomized Controlled Study
to Evaluate the Safety and
Effectiveness of the Tryton
Side Branch Stent™ used in
Conjunction with a DrugEluting Stent Compared to SideBranch Balloon Angioplasty
in Conjunction with a DrugEluting Stent in the Treatment
of de novo Bifurcation Lesions
Involving the Main Branch
and Side Branch within Native
Coronary Circulation
Principal Investigator:
Charles J. Davidson, MD
The purpose of this study is
to evaluate the safety and
effectiveness of the Tryton Side
Branch Stent (study device) in
treating stable, native coronary
artery bifurcation disease.
Subjects will be randomized
(1:1) to either the Tryton Side
Branch Stent with main branch
approved Drug-Eluting Stent
(DES) or side-branch balloon
angioplasty and main-branch
approved DES. The study device
does not have a drug coating
or filling. It is investigational,
meaning not FDA approved.
ALERTS image permission by Angel Medical
Systems, Inc.
Tryton Image permission by Tryton Medical, Inc.
Echocardiography Guided
Cardiac Resynchronization
Therapy Clinical Investigation
(Echo-CRT)
CRYptogenic STroke And
underLying AF (Atrial
Fibrillation) (CRYSTAL
AF Study)
Principal Investigator:
Robert A. Gordon, MD
Principal Investigator:
Rod S. Passman, MD
This study is recruiting subjects
who have heart failure and
require an ICD for the treatment
of fast, irregular heart rhythms
in the lower chambers of the
heart. For some cases of heart
failure, physicians may consider
an ICD that also provides pacing
therapy (small electrical impulses),
called Cardiac Resynchronization
Therapy (CRT), which may help
the heart contract in a more
efficient way. The purpose of
this study is to determine if CRT
can prevent death or reduce
heart failure hospitalizations in
a specific group of heart failure
patients who have left lower
heart chamber wall motion
differences (intraventricular
dyssynchrony) detected by
echocardiography that may affect
cardiac function. Although the
device and leads used in this
study are FDA-approved, this is
an investigational study because
CRT is being evaluated in a new
group of patients with heart
failure rather than those for
whom it is usually prescribed.
This study is enrolling subjects
who have had a cryptogenic
stroke, or stroke of undetermined
cause. Physicians believe an
irregular heart rhythm called
atrial fibrillation (AF) may be the
cause of stroke in many of these
cases. The purpose of the study
is to see if patients may benefit
from timely AF detection available
by use of the Medtronic Reveal®
XT insertable loop recorder. This
device continuously monitors
and records the heart’s electrical
activity for up to three years
and offers a new opportunity to
investigate the incidence of AF in
patients with cryptogenic stroke
or transient ischemic attack (TIA).
CRYSTAL AF image permission by Medtronic, Inc.
CLINICAL TRIALS AND RESEARCH HIGHLIGHTS: FOR MORE INFORMATION PLEASE VISIT HEART.NMH.ORG · 866-662-8467
23
CLINICAL TRIALS AND RESEARCH HIGHLIGHTS: VASCULAR SURGERY
Carotid Angioplasty and
Stenting vs. Endarterectomy
in Asymptomatic Subjects with
Significant Extracranial Carotid
Stenotic Disease (ACT I)
Evaluation of the Conformable
GORE TAG® Thoracic
Endoprosthesis for Treatment
of Acute Complicated Type B
Aortic Dissection (TAG 08-01)
A Pivotal Clinical Study
to Evaluate the Safety and
Effectiveness of the Ovation™
Abdominal Stent Graft System
(TriVascular AAA)
Principal Investigator:
Mark K. Eskandari, MD
Principal Investigator:
Heron E. Rodriguez, MD
Principal Investigator:
Mark K. Eskandari, MD
ACT I is sponsored by Abbott
Vascular Devices and is a
randomized, controlled, multicenter trial to demonstrate
the non-inferiority of carotid
artery stenting (CAS) using the
Emboshield Embolic Protection
System with the Xact® Carotid
Stent System when compared
to carotid endarterectomy
(CEA) for the treatment of
asymptomatic extracranial
carotid stenotic disease.
TAG 08-01 is sponsored by
W.L. Gore & Associates and is a
multi-center trial to demonstrate
the safety and efficacy of the
Conformable GORE TAG
Thoracic Endoprosthesis for
the treatment of acute
complicated Type B aortic
dissections. Subjects will be
evaluated through hospital
discharge and return for
follow-up visits at 30 days, six
months and annually through
five years post-treatment.
The purpose of this study
is to evaluate the Ovation
Abdominal Stent Graft System,
an investigational device (not
approved by the FDA for
general use) for the treatment
of abdominal aortic aneurysms.
An abdominal aortic aneurysm
is a bulge in the aorta caused
by a weakening in the artery
wall, which, if left untreated
can rupture, resulting in serious
internal bleeding.
The PEVAR Trial: Prospective,
Multi-Center, Randomized
Controlled Trial of
Endovascular Aneurysm Repair
Using a Bilateral Percutaneous
Approach (PEVAR) vs. Standard
Approach (SEVAR) Using the
IntuiTrak® Endovascular AAA
Delivery System and Prostar XL
or Perclose ProGlide SutureMediated Closure System
Principal Investigator:
Mark D. Morasch, MD
This study is sponsored by
Endologix, Inc. with collaboration
from Abbott Vascular and is
a multi-center, randomized,
controlled trial to compare a
bilateral percutaneous approach
and the standard cut-down
approach in the endovascular
treatment of abdominal aortic
aneurysms. Subjects will be
evaluated through hospital
discharge and at follow-up visits
at 30 days and six months.
Conformable GORE TAG image permission by
W.L. Gore & Associates, Inc.
ACT I image permission by Abbott
Laboratories, Inc.
Endologix PowerLink image permission
by Endologix, Inc.
24
CLINICAL ACTIVITIES AND OUTCOMES REPORT 2010
THE PATIENT EXPERIENCE
CARDIAC BEHAVIORAL MEDICINE
The S.M.A.R.T. Heart room
Treating cardiovascular disease is
most successful when the focus
is on the physical, emotional and
behavioral health of the patient.
To help achieve this, the Bluhm
Cardiovascular Institute’s Cardiac
Behavioral Medicine service offers
a new and innovative program
called Stress Management And
Recreational Therapy for Heart
Patients, or S.M.A.R.T. Heart.
The program launched at Northwestern Memorial in February of 2011
and is designed to help patients in the hospital manage stress and
reduce the heavy emotional burden that many experience following
surgery. Through structured and unstructured activities, S.M.A.R.T. Heart
teaches patients and members of their support network about coping
mechanisms such as relaxation and distraction techniques such as humor.
The program centers around a specially designed lounge where
patients and their families are encouraged to spend time together
relaxing, reading, using the Internet or watching television. In addition,
all patient rooms have been equipped with a clock radio/CD player/
MP3 docking station, which allows patients to listen to their own
music, relax and block out hospital noise. A mobile S.M.A.R.T. Heart
cart delivers books, movies and games to patient rooms.
“Cardiac surgery patients are often at greater risk of experiencing
depression and anxiety, which can hinder their recovery process,”
says Kim L. Feingold, PhD, director of Cardiac Behavioral Medicine
and assistant professor of Psychiatry and Surgery at Feinberg. The
goal of Cardiac Behavioral Medicine and S.M.A.R.T. Heart is to help
patients adjust to a diagnosis of cardiovascular disease and become
more resilient throughout the course of their treatment.
If you would like more information about Cardiac Behavioral Medicine,
please call 312-695-4965.
PATIENT SATISFACTION
CALENDAR YEAR 2010
Hospital Consumer Assessment of Healthcare Provider and Systems
(HCAHPS) is a national standardized survey of hospital patients
created to capture a patient’s experience during a given hospital stay.
The survey results are publicly reported on the Centers for Medicare
and Medicaid Services website for all participating hospitals. These
graphs highlight the results of patients with cardiovascular disease at
Northwestern Memorial compared to state and national averages for
all patient populations in 2010. For a complete list of results, refer to
hospitalcompare.hhs.gov.
The first set of data represents the percentage of Northwestern Memorial
cardiovascular patients who gave the hospital a rating of 9 or 10 on a scale
of 0 (lowest) to 10 (highest).
The second set of data represents the percentage of Northwestern Memorial
cardiovascular patients who would definitely recommend the hospital to others.
100%
NORTHWESTERN MEMORIAL
HOSPITAL
80
AVERAGE FOR ALL REPORTING
HOSPITALS IN THE UNITED STATES
AVERAGE FOR ALL REPORTING
HOSPITALS IN ILLINOIS
60
40
20
0
PATIENTS WHO
RATED THIS
HOSPITAL AS
A 9 OR 10
PATIENTS
WHO WOULD
DEFINITELY
RECOMMEND
THIS HOSPITAL
*State and national data is for all patient populations from October 2009 through September 2010.
Contact Us
LEADERSHIP OF NORTHWESTERN’S BLUHM CARDIOVASCULAR INSTITUTE
Patrick M. McCarthy, MD
Director
Bluhm Cardiovascular Institute
Charles J. Davidson, MD
Associate Director
Bluhm Cardiovascular Institute
Mark K. Eskandari, MD
Associate Director
Bluhm Cardiovascular Institute
Clyde W. Yancy, MD
Associate Director
Bluhm Cardiovascular Institute
Robert O. Bonow, MD
Vice Chair
Department of Medicine
Director
Center for Cardiovascular Innovation
Northwestern University
Feinberg School of Medicine
CENTER FOR CORONARY DISEASE
CENTER FOR HEART FAILURE
CENTER FOR HEART VALVE DISEASE
William G. Cotts, MD
Medical Director
Heart Transplantation
and Mechanical Assistance
Robert O. Bonow, MD
Medical Director
Center for Heart Valve Disease
Edwin C. McGee, Jr., MD
Surgical Director
Heart Transplantation
and Mechanical Assistance
Patrick M. McCarthy, MD
Surgical Director
Center for Heart Valve Disease
Bradley P. Knight, MD
Medical Director
Center for Heart Rhythm Disorders
Richard Lee, MD
Surgical Director
Center for Heart Rhythm Disorders
Rod S. Passman, MD
Medical Director
Program for Atrial Fibrillation
Donald M. Lloyd-Jones, MD
Medical Director
Center for Preventive Cardiology
Marla A. Mendelson, MD
Medical Director
Program for Women’s Cardiovascular Health
Vera H. Rigolin, MD
Associate Medical Director
Program for Women’s Cardiovascular Health
CENTER FOR VASCULAR DISEASE
Charles J. Davidson, MD
Medical Director
Center for Coronary Disease
Mark K. Eskandari, MD
Surgical Director
Center for Vascular Disease
Neil J. Stone, MD
Medical Director
Center for Vascular Disease
Heron E. Rodriguez, MD
Co-Director
Program for Limb Preservation
FOR MORE INFORMATION, PLEASE CONTACT THE BLUHM CARDIOVASCULAR INSTITUTE
Physician Access Line
866-662-8467
Physician to Physician Consults
800-638-3737
Outpatient Clinic
312-695-2714
Patient Appointments
312-NM-HEART (664-3278)
For additional copies of this report, please send requests to: [email protected].
Look for our expanded report online at heart.nmh.org/cvoutcomes2010.
S. Chris Malaisrie, MD
Co-Director
Thoracic Aortic Surgery Program
CLINICAL TRIALS UNIT OF NORTHWESTERN
CENTER FOR PREVENTIVE CARDIOLOGY
CENTER FOR HEART RHYTHM DISORDERS
Mark D. Morasch, MD
Co-Director
Thoracic Aortic Surgery Program
Clinical Trials Unit of Northwestern
312-926-4000
Donald M. Lloyd-Jones, MD
Acting Medical Director
Clinical Trials Unit of Northwestern
PROGRAM IN CARDIOVASCULAR
REGENERATIVE MEDICINE
Douglas W. Losordo, MD
Director
Feinberg Cardiovascular Research Institute
Northwestern University
Feinberg School of Medicine
Director
Program in Cardiovascular Regenerative
Medicine
For a complete list of physicians, clinical
staff and further information about the
Bluhm Cardiovascular Institute, please
visit heart.nmh.org.
251 East Huron Street
Chicago, Illinois 60611-2908
312.926.2000
nmh.org
For more information about the Bluhm Cardiovascular Institute, visit heart.nmh.org.
Learn more about the world-class Bluhm Cardiovascular Institute and how we are advancing cardiovascular medicine and research
by going to heart.nmh.org/cvoutcomes2010.
Para asistencia en español, por favor llamar al Departamento de Representantes para Pacientes al 312-926-3112.
Northwestern Memorial is committed to representing the communities we serve, fostering a culture of inclusion, delivering culturally competent care and access to
treatment and programs in a non-discriminatory manner, and eliminating healthcare disparities. For questions, please call the Patient Representative department at
312-926-3112, TDD/TTY number 312-944-2358.
© September 2011. Northwestern Memorial Hospital
Division of Public Relations, Marketing and Physician Services
For more information about Northwestern Memorial Hospital, please visit nmh.org
3166-11