Heart Update - Fall 2009

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I n This Issue: HEART CODE TEAM CUTTING DOOR-TO-BALLON TIMES • CARDIOVASCULAR SCREENINGS NOW AT WILMINGTON CAMPUS • STROKE ALERT PROTOCOL SAVES LIVES • CLOT-BUSTING TECHNIQUE IN CLINICAL TRIAL • NEW STENT FOR AAA REPAIRS • RESEARCH & SECTION UPDATES

Stereotaxis system offers advanced treatment for arrhythmias, other heart problems Electrophysiologists at Christiana Care now have the latest transcatheter ablation technology to treat complex heart rhythm disorders.

This month, physicians began treating patients with the newest generation Stereotaxis Niobe® Magnetic Navigation System in the Mr. and Mrs. Gerret and Tatiana Copeland Arrhythmia Center inside the Interventional Suite at the Center for Heart & Vascular Health. The stereotaxis system was made possible thanks to a generous gift from the Copelands.

“Introduction of the stereotaxis system places us at the forefront of current technology and significantly advances our ability to provide highly specialized cardiac care for our patients in Delaware and surrounding communities,” says Medical Director Timothy J. Gardner, M.D. “Few centers surpass our capabilities in this area.”

Easy to recognize, challenging to treat Atrial fibrillation is a common heart rhythm disorder that is easy to recognize but challenging to treat, prevent or cure.

Because of how complex the previously available ablation techniques were, only a few patients could be treated by a small number of highly trained and skilled physicians. continued on back page

From left: Sarah Drummonds, RN, Brian Sarter, M.D., Stacy Cruikshank, RN, Pat Watkins, LPN, Vanessa Sellars, RN, and Greg Bogush, RN, standing with the stereotaxis system.

“Stereotaxis technology allows us to manipulate catheters inside the heart more precisely and more consistently with a greater margin of safety and efficacy.”

Brian Sarter, M.D. Medical Director, Electrophysiology Lab

www.christianacare.org/heart

To our colleagues, Radiology Department, Dr. Pasquale and the radiologists also advanced our techniques for and clinical application of cardiac CT imaging.

t Christiana Care Health System’s Center for Heart & Vascular Health, we are transforming the way we deliver patient care. Through big breakthroughs and small, incremental achievements, we are striving to make each patient experience better, safer and more satisfying. This issue features some of our innovations and initiatives to meet this challenge:

Most recently, Dr. Pasquale and Gialloreto led the charge to transition from videotaped echocardiography studies to digital studies where sonographers capture moving clips of the heart for interpretation by cardiologists. They also helped all cardiologists transition from dictated reports to electronic reports, which provide real-time interpretations to hospital physicians and allow research data to be abstracted.

• Installing new technologies like the revolutionary Stereotaxis Remote Navigation System and new Neuro Bi-plane angiography equipment.

• Cutting door-to-treatment times for “heart code” patients and surpassing national benchmarks.

This past spring, Dr. Pasquale handed the reins of the Non-Invasive Cardiology Imaging Laboratory over to his colleague Eric Marshall, M.D., who he knew would continue to transform and enhance the service. We are grateful to Dr. Pasquale for his service to Christiana Care and our community. He will be missed. We thank all of our medical directors for their dedication and support.

• Raising the bar for stroke care with a dedicated Neuro ICU and a “stroke alert” protocol offering advanced neurointerventional procedures.

• Pioneering new treatments for deep vein thrombosis and the repair of complex abdominal aortic aneurysms.

• Improving patient safety and outcomes with fewer blood transfusions during cardiac surgery.

Future issues of Update will provide information about the growth and transformation of the Center for Heart & Vascular Health. 6

• Expanding our highly successful Cardiovascular Screening and Prevention Program on both the Christiana and Wilmington campuses.

In this issue, we also remember our colleague Michael J. Pasquale, M.D., who began transforming non-invasive cardiology services at Christiana Care as soon as he assumed the role of medical director. Working with Administrative Director Tony Gialloreto and others, he enhanced the facilities at both the Wilmington and Christiana campuses, upgraded technology to state-ofthe-art imaging including 3-D echo, achieved national certifications for echo and stress testing and instituted monthly echo teaching conferences. Working with the

In Memorium

PENNY VIGNEAU Vice President, Center for Heart & Vascular Health

TIMOTHY J. GARDNER, M.D. Medical Director, Center for Heart & Vascular Health

MICHAEL J. PASQUALE, M.D. Medical Director, Non-Invasive Cardiovascular Imaging Laboratory Partner, Cardiology Consultants, PA Exceptional doctor, champion of excellence, committed teacher, respected colleague THE MICHAEL J. PASQUALE NON-INVASIVE EDUCATIONAL FUND has been established to promote Dr. Pasquale’s passion for teaching our next generation of cardiologists, cardiac sonographers and nurses.

For more information, call the Center for Heart & Vascular Health at 302-733-1194. 6

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Heart code team strives to make door-to-balloon times well below national benchmarks hristiana Care’s Heart Code teams are cutting critical minutes from the time it takes to get an acute heart attack patient from the hospital door to the Cath Lab. The target “door-to-balloon time” at Christiana Hospital is now 60 minutes – a third less than the national benchmark of 90 minutes or less.

“Everyone is committed to streamlining the process,” says Ehsanur Rahman, M.D., associate chief of cardiology.

“Our goal is achievable.”

“More than a decade ago, Christiana Care led the way by establishing procedures to expedite lifesaving percutaneous reperfusion for patients with ST-segment elevated myocardial infarction,” says Timothy Gardner, M.D., medical director, Center for Heart & Vascular Health.

Interhospital transfers

“We’ve met and exceeded nationally recommended thresholds by continuously streamlining our ‘heart alert’ and ‘heart code’ pathways,” he says. “Now we have set ourselves an even higher standard to provide the absolute best care for our patients.”

Teamwork and cooperation

The team also expedites transfers to Christiana Hospital from Wilmington Hospital and other neighboring hospitals in Pennsylvania, New Jersey and Maryland. The goal is for acute heart attack patients to receive emergent cardiac catheterizations within 90 minutes of arriving at the first hospital. This goal is well below national recommended guidelines of 120 minutes or less.

“A rule of thumb is 30 minutes at the first hospital, and from there, 30 minutes for transportation to Christiana Hospital’s Cath Lab, then 30 minutes from arrival in the Cath Lab to first coronary intervention,” says Dr. Rahman.

The teamwork and cooperation of attending cardiologists and interventionalists, the Emergency Department and Cath Lab personnel have yielded outstanding accomplishments. A single call system activates a “heart alert” and initiates preparations for a potential emergency percutaneous coronary intervention in the Cath Lab. The Emergency Department sends a simultaneous page to all key hospital personnel and to the interventional cardiologist on call regardless of time of day. Affiliated cardiology practices modified their on-call procedures to facilitate this new process.

To achieve this goal, the team is addressing issues of transportation, technology, traffic and timelines.

“Collaboration with the other facilities is going smoothly,” says Dr. Rahman. “We are all working toward the same goal for the benefit of our patients.” 6

rule of thumb is 30 minutes at the first “ Ahospital, and from there, 30 minutes for transportation to Christiana Hospital’s Cath Lab, then 30 minutes from arrival in the Cath Lab to first coronary intervention.

”

EHSANUR RAHMAN, M.D.

Associate Chief of Cardiology

Cardiovascular screenings now offered at Wilmington campus he highly successful Center for Heart & Vascular Health’s Cardiovascular Screening and Prevention Program has helped more than 5,000 at-risk patients learn how to fight potential heart attacks, stroke and peripheral vascular disease. Appointments for in-person assessments are now available at the Roxana Cannon Arsht Surgicenter on the Wilmington campus.

Take the survey online at www.christianacare.org/hearttest to learn about and help prevent risk for stroke, heart disease and peripheral arterial disease. 6

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From left: Barbara Albani, M.D., Mark Garcia, M.D., Thomas Evans, M.D., Lisa Cluett, RTR, Kevin McCarraher, RN, Heather Swope, RTR, and Deborah Manley, RTR, in the new vascular interventional radiology suite.

Stroke alert protocol saves lives

t Christiana Care, a streamlined stroke alert protocol ensures patients who may benefit from powerful clot-dissolving therapy with tPA (tissue plasminogen activator) in the first three hours after a stroke are evaluated and rapidly identified.

says Neurologist Anthony Munson, M.D., medical director of the Stroke Program. Studies show that even within the treatment window, the earlier patients are treated, the better the response.

Prompt treatment is critical for people experiencing symptoms of stroke, the third leading cause of death among Americans.

Latest neurointerventional techniques Having Neurointerventional Radiologist Barbara Albani, M.D., on call extends the narrow treatment window for patients with acute (blocked artery) stroke, who historically could not benefit from acute therapy.

“Our primary focus is streamlining the procedure for inpatients showing signs of a new stroke, as well as increasing the response time for all elements of the alert to administer lifesaving therapy as early as possible,”

“One of the biggest hurdles we face with stroke care is that patients arrive at the emergency room too late,” she says. “With a combination of medicine and the latest intra-arterial technologies, we can mechanically extract blood clots, restoring blood flow to the brain and increasing patients’ chances for recovery.”

The ability to offer neurointerventional “procedures is one that few hospitals outside of large academic institutions possess. This underscores our commitment to providing cutting-edge treatments, positioning us as a leader in stroke care.

According to Dr. Munson, “The ability to offer neurointerventional procedures is one that few hospitals outside of large academic institutions possess. This underscores our commitment to providing cutting-edge treatments, positioning us as a leader in stroke care.” 6

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ANTHONY MUNSON, M.D.

Medical Director of the Stroke Program

New Neuro ICU opens

A new, six-bed unit on 2B at Christiana Hospital opens early in 2010, providing specialized care for patients with critical neurological conditions under the supervision of a full-time neurointensivist, who is being recruited. Nurses staffing the unit from Surgical Critical Care on 2A have advanced training in all facets of neuro-surgical critical care nursing.

“The Neuro ICU enhances our surgical critical care capability by focusing our neuro resources to best accommodate the increasing number of patients who present with intracranial hemorrhages and who are benefiting from the latest neurointerventional techniques we can now offer,” says Gerard J. Fulda, M.D., chief of Surgical Critical Care. The unit is one more step, he says, to ensuring Christiana Care offers excellent treatment of neurological disorders and stroke. 6 4

Pioneering clot-busting technique enters national clinical trial revolutionary way to treat large-volume acute clots in patients with deep vein thrombosis (DVT) is going national in a new clinical trial. It was developed by Mark J. Garcia, M.D., FSIR, and his Interventional Radiology colleagues at Christiana Care. thinners alone, up to 50 percent develop a chronic condition called Post Thrombotic Syndrome. Because blood thinners prevent clots from propagating and do not dissolve them, blood flow is still restricted, causing permanent vein damage. Patients experience debilitating pain, leg swelling, ulcers and other symptoms that restrict walking and compromise their ability to work or conduct daily activities.

Christiana Care is one of 28 U.S. hospitals selected to participate in ATTRACT (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombosis) to evaluate outcomes using the pharmacomechanical thrombolysis technique instead of standard therapy with blood thinners. The new study, sponsored by the National Institutes of Health, is set to enroll 692 patients.

Dr. Garcia, section chief of Vascular & Interventional Radiology and director of Christiana Care’s Vascular & Interventional Radiology Fellowship Program, and his colleagues previously have shown that their “Rapid Lysis” technique safely and effectively breaks up and removes acute blood clots in the veins faster and more efficiently without surgery. This reduces the chances of pulmonary embolism and long-term disability. Other members of the team are Randall Ryan, M.D.; George Kimbiris, M.D.; David Epstein, M.D.; Daniel Leung, M.D.; and Michael Dignazio, M.D.

The new study, sponsored by the National Institutes of Health, is set to enroll 692 patients.

“The most important thing we’ve learned so far is that doctors and these patients with significant symptoms should not give up hope, and that there may be some newer treatments that may help reduce their problems.

Some of these chronic clots can be successfully treated,” says Dr. Garcia. He and his partners have been using these newer techniques for nearly two years, successfully treating dozens of patients with difficult and chronic clots. Inquiries about the procedure have come from as far away as Dubai and England, while patients have come from California, Utah and Colorado for treatment.

Worldwide attention Dr. Garcia presents at national and international meetings, thanks to growing global interest. In September, he lectured on the treatment of acute blood clots at the CardioVascular Interventional Radiology Society of Europe (CIRSE) meeting in Portugal. In November, he will present to the Society of Vascular Surgeons in New York on using his technique to treat chronic blood clots.

Chronic clots treated successfully

He also has accepted an invitation to be a faculty member of the American Venous Forum, a brainstorming and planning meeting of world leaders in venous disease.

The forum aims to produce a plan of action to decrease the prevalence of venous ulcers in the United States by 50 percent in 10 years. 6

Building on years of experience and success in treating acute blood clots, Dr. Garcia and his team combined their technique with newer ultrasound-assisted devices, which recently showed success in breaking up and removing chronic clots that are harder and more intractable than standard thrombolysis.

There are estimates that among patients with extensive DVT treated with standard treatment using blood

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Fewer transfusions lead to shorter stays, better outcomes educing the use of blood transfusions during coronary artery bypass grafts (CABGs), valve replacements and other heart surgeries is producing better post-surgical outcomes for cardiac patients at Christiana Care.

“Our protocols help patients have safer surgeries and better outcomes,” says Dr. Banbury, co-author of a 2005 study showing that cardiac surgery patients who received transfusions had a higher risk of developing an infection following surgery.

A review of approximately 2,100 CABG patients treated between 2006 and 2008 confirms that new protocols instituted by Christiana Care’s cardiac surgery team, under the direction of Michael Banbury, M.D., chief of Cardiac Surgery, resulted in lower rates of mortality and infection.

Since the new protocols went into effect in 2006, Christiana Care has seen what Yong Zhao, M.D., medical director for Transfusion Services, calls a “significant decrease” in the number of transfusions during heart surgeries such as CABGs and valve replacements.

Better outcomes, safer procedures since 2006 CABG PROCEDURES WITH TRANSFUSION

From October 2007 to January 2008, just 21 percent of CABG patients received a transfusion of red blood cells, down from 65 percent during the same period in 2005-2006.

Average units of blood per procedure fell from 3.68 units to just 0.8 units during that same time.

65%

21%

The in-hospital mortality rate declined to 1.4 percent in 2008, down from 1.7 percent in 2006. The external wound infection rate fell to zero in 2008, compared with 0.5 percent in 2006.

CABG patients also spent less time in the hospital. In 2008, 67 percent of patients went home in fewer than six days, compared to 50 percent in 2006.

The number of transfusions during valve-replacement surgery also has declined dramatically.

In 2006, 96 percent of patients undergoing the procedure received a transfusion at an average of 5 units. In 2007, 46 percent of valve-replacement patients received a transfusion at an average of 1.5 units. 6

New one-piece stent facilitates complex abdominal aortic aneurysm repairs atients at Christiana Care who have an abdominal aneurysm but are not candidates for open surgery or commercially available endografts now have another option—a customized UNITE stent graft designed especially for them.

Unlike other commercially available Y-shaped endografts, the UNITE stent is designed specifically for each patient to accommodate individual anatomical differences. Once the stent is in place and the team ensures during a two-hour procedure that it is working properly, the patient returns home the next day. By contrast, abdominal aneurysm surgery takes at least three hours, and patients remain in the hospital for approximately a week after surgery.

“This is very exciting technology,” says Vascular Surgeon Ralph Ierardi, M.D. “It allows us to treat a whole category of critically ill patients who would otherwise be relegated to medical management and probable rupture.”

The UNITE stent, widely used in Europe, not only offers patients new options but also less time away from home and in rehab. Patients return for checkups every six months.

Christiana Care is one of only 21 research sites in the United States in Phase 2 trials of the UNITE stent, which is a single, flexible tube running from the aorta into only one of the iliac arteries. In the second year of the five-year study, Christiana Care has six patients enrolled and is second only to Emory University School of Medicine with eight.

Dr. Ierardi says that this technology is leading to more applications. Christiana Care is now involved in carotid stent trials and soon will move to thoracic stent trials. 6

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RESEARCH UPDATE Christiana Care authors publish and present nationally Results from major drug trials highlighted in Europe Cardiovascular Research participated in the following two major drug trials with positive results. These were highlighted at the European Society of Cardiology Congress in Barcelona.

PLATO (A Study of Platelet Inhibition and Patient Outcomes) demonstrated that ticagrelor (AZD6140), an investigational oral antiplatelet, achieved a statistically significant reduction in heart attack, stroke or cardiovascular death compared to clopidogrel.

RE-LY A randomized trial in patients with atrial fibrillation at high risk for stroke demonstrated that dabigatran, an oral direct thrombin inhibitor, was associated with lower rates of stroke and systemic embolism with no increase in major hemorrhaging compared to warfarin. 6

Cardiovascular clinical trials continue enrollment STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Darapladib inhibits Lp-PLA2, an enzyme that may contribute to instability of coronary artery plaques. The aim of the study is to determine whether darapladib (compared to placebo) can further reduce the risk of a major cardiovascular event when added to medications, including statins or antiplatelets, which study participants already are receiving. Total anticipated enrollment is 15,500 participants.

CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) People may qualify for the CORAL study if they have atherosclerotic renal artery blockage and are taking two or more anti-hypertensive medications to control high blood pressure. Participants are randomized to receive medication alone to control blood pressure and other risk factors or to be treated with medication and placement of a stent in the blocked kidney artery. The CORAL study will examine whether inserting a stent, or metal scaffold, to keep the artery open will lead to better outcomes overall for patients. Expected total enrollment is 1,000 at 100 recruiting sites across the United States.

To learn more about these and other clinical trials underway, call the Cardiovascular Research office at 302-733-2658. 6

SECTION UPDATES “Christiana Care Cardiac Rehabilitation Services does a remarkable job of caring for our patients after discharge following a cardiovascular event or major procedure,” says William Weintraub, M.D., the John H. Ammon chair of Cardiology and medical director of the Center for Outcomes Research at Christiana Care.” The integration of rehab data with clinical outcomes from the American College of Cardiology and the Society of Thoracic Surgeons registry data and beyond that into the medical center data warehouse is a remarkable achievement, serving patient care and offering an unparalleled opportunity for clinical research.” 6

Echo Lab upgrades The Echo Labs at Wilmington Hospital and The Health and Wellness Center at Smyrna completed Phase 2 ultrasound imaging technology upgrades. The Echo Lab at Christiana Hospital also installed two new transesophageal echo-imaging systems. 6

Cardiac Rehab Webinar describes integration of clinical data with outcomes “How Christiana Care Cardiac Rehab successfully aligned clinical goals with IT resources to deliver evidence-based, patient-centric care” was the subject of a Webinar on Sept.

24, 2009. According to Paula Stillman, M.D., president, Health Initiatives and vice president, Special Projects, “Because our integrated data collection system provides a comprehensive view of the patient—including outcomes, history and demographic data—we are able to deliver evidence-based care and document the success of our Cardiac Rehab Program.”

New Faces Bernadette Baker, RN, from Employee Health Services, joined the Cardiovascular Screening and Prevention Program.

Diana Reisenger is a new cardiac sonographer in the Echo Lab. 6 7

Non-Profit Org. US Postage

PAID Wilmington, DE Permit No. 357

4755 Ogletown-Stanton Road Newark, DE 19718 www.christianacare.org/heart

Christiana Care is a private not-for-profit regional health care system and relies in part on the generosity of individuals, foundations and corporations to fulfill its mission.

Timothy Gardner, M.D., receives leadership award Timothy J. Gardner, M.D., medical director of Christiana Care’s Center for Heart & Vascular Health and immediate past president of the American Heart Association, received a Distinguished National Leadership Award from the AHA. The National Heart, Lung and Blood Institute of the National Institutes of Health also named Dr. Gardner chair of the Steering Committee of the Cardiothoracic Surgery Clinical Research Network. ❖

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Stereotaxis system offers advanced treatment for arrhythmias, other heart problems According to Brian Sarter, M.D., medical director of the Electrophysiology Lab, the new system represents a major advancement in catheter-based interventional cardiology.

flexible and easily manipulated through the labyrinth of cardiac blood vessels.

“Stereotaxis technology allows us to manipulate catheters inside the heart more precisely and more consistently with a greater margin of safety and efficacy,” he says.

The electrophysiologist automatically controls the motion and targeting of the fully integrated catheter and digital fluoroscopy mapping by using a joystick, computer mouse or touch screen.

As a result, more patients could be eligible for catheter ablation of episodic and chronic atrial fibrillation, possibly even tripling the number of procedures performed in the next two to three years.

The new Electrophysiology Stereotaxis Lab initially will treat arrhythmias and guide left ventricular lead placements for cardiac resynchronization therapy. Future applications may include treating multi vessel and other complex coronary artery diseases.

Revolutionary technology What makes stereotaxis technology so revolutionary are magnetic fields that allow physicians direct control of the tip of soft catheters. Unlike other catheters used for radiofrequency ablation, stereotaxis catheters are more

The stereotaxis remote technology decreases the time required for digital fluoroscopy. As a result, it has the potential to significantly reduce X-ray exposure for patients and the electrophysiology team as well as to reduce the amount of time that physicians and staff must wear lead-protective clothing during the procedure.

Using stereotaxis along with Dr. Sarter are Christiana Care electrophysiologists Raymond Miller, M.D., associate director, Electrophysiology Lab; Piamsook Angkeow, M.D.; Stephen Blumberg, M.D.; John Hynes, M.D.; Roger Kerzner, M.D.; Joseph Pennington, M.D.; and Henry Weiner, M.D. ❖

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