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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. 2 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 3 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 4 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