V o l u m e T e n O c t o b e r 2 0 0 9

In This Issue:

w w w . c h r i s t i a n a c a r e . o r g / h e a r t

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

Electrophysiologists at Christiana Care now have the latesttranscatheter ablation technology to treat complex heart rhythmdisorders.

This month, physicians began treating patients with the newestgeneration Stereotaxis Niobe® Magnetic Navigation System inthe Mr. and Mrs. Gerret and Tatiana Copeland ArrhythmiaCenter 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 ourability to provide highly specialized cardiac care for ourpatients in Delaware and surrounding communities,” saysMedical Director Timothy J. Gardner, M.D. “Few centers surpass our capabilities in this area.”

Easy to recognize, challenging to treatAtrial fibrillation is a common heart rhythm disorder that iseasy 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.

Stereotaxis system offers advanced treatmentfor arrhythmias, other heart problems

continued on back page

“Stereotaxis technology allows usto manipulate catheters inside theheart more precisely and more

consistently with a greater marginof safety and efficacy.”

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

From left: Sarah Drummonds, RN, Brian Sarter, M.D., StacyCruikshank, RN, Pat Watkins, LPN, Vanessa Sellars, RN, andGreg Bogush, RN, standing with the stereotaxis system.

PENNY VIGNEAUVice President, Center forHeart & Vascular Health

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

To our colleagues,

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

In Memorium

2

t Christiana Care Health System’s Center forHeart & Vascular Health, we are transformingthe way we deliver patient care. Through big

breakthroughs and small, incremental achievements, weare striving to make each patient experience better, saferand more satisfying. This issue features some of our innovations and initiatives to meet this challenge:

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

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

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

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

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

• Expanding our highly successful CardiovascularScreening and Prevention Program on both theChristiana and Wilmington campuses.

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

Radiology Department, Dr. Pasquale and the radiologistsalso advanced our techniques for and clinical applicationof cardiac CT imaging.

Most recently, Dr. Pasquale and Gialloreto led the chargeto transition from videotaped echocardiography studies todigital studies where sonographers capture moving clipsof the heart for interpretation by cardiologists. They alsohelped all cardiologists transition from dictated reports toelectronic reports, which provide real-time interpretationsto hospital physicians and allow research data to beabstracted.

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

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

hristiana Care’s Heart Code teams are cutting critical minutes from the time it takes to get an acute heartattack patient from the hospital door to the Cath Lab. The target “door-to-balloon time” at ChristianaHospital is now 60 minutes – a third less than the national benchmark of 90 minutes or less.

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

“We’ve met and exceeded nationally recommendedthresholds by continuously streamlining our ‘heart alert’and ‘heart code’ pathways,” he says. “Now we have setourselves an even higher standard to provide the absolutebest care for our patients.”

Teamwork and cooperationThe teamwork and cooperation of attending cardiologistsand interventionalists, the Emergency Department andCath Lab personnel have yielded outstanding accom-plishments. 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 pageto all key hospital personnel and to the interventional car-diologist on call regardless of time of day. Affiliatedcardiology practices modified their on-call procedures tofacilitate this new process.

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

Interhospital transfersThe team also expedites transfers to Christiana Hospitalfrom Wilmington Hospital and other neighboring hospi-tals in Pennsylvania, New Jersey and Maryland. The goalis 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, andfrom there, 30 minutes for transportation to ChristianaHospital’s Cath Lab, then 30 minutes from arrival in the Cath Lab to first coronary intervention,” says Dr. Rahman.

To achieve this goal, the team is addressing issues of transportation, technology, traffic and timelines.“Collaboration with the other facilities is going smooth-ly,” says Dr. Rahman. “We are all working toward thesame goal for the benefit of our patients.” 6

Heart code team strives to make door-to-balloon timeswell below national benchmarks

“ A rule of thumb is 30 minutes at the firsthospital, and from there, 30 minutes for

transportation to Christiana Hospital’s CathLab, then 30 minutes from arrival in the

Cath Lab to first coronary intervention. ”EHSANUR RAHMAN, M.D.Associate Chief of Cardiology

3

Cardiovascular screenings now offered at Wilmington campus

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

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

4

t Christiana Care, a streamlined stroke alertprotocol ensures patients who may benefitfrom powerful clot-dissolving therapy with

tPA (tissue plasminogen activator) in the first three hoursafter a stroke are evaluated and rapidly identified.

Prompt treatment is critical for people experiencingsymptoms of stroke, the third leading cause of deathamong Americans.

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

says Neurologist Anthony Munson, M.D., medicaldirector of the Stroke Program. Studies show that evenwithin the treatment window, the earlier patients aretreated, the better the response.

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

“One of the biggest hurdles we face with stroke care isthat patients arrive at the emergency room too late,” shesays. “With a combination of medicine and the latestintra-arterial technologies, we can mechanically extractblood clots, restoring blood flow to the brain andincreasing patients’ chances for recovery.”

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

Stroke alert protocol saves lives

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

ANTHONY MUNSON, M.D.Medical Director of the Stroke Program

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

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 supervi-sion 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 excellenttreatment of neurological disorders and stroke.6

New Neuro ICU opens

5

Pioneering clot-busting technique enters national clinical trial

revolutionary way to treat large-volume acute clots in patients with deep vein thrombosis (DVT) is goingnational in a new clinical trial. It was developed by Mark J. Garcia, M.D., FSIR, and his InterventionalRadiology colleagues at Christiana Care.

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

Dr. Garcia, section chief of Vascular & InterventionalRadiology and director of Christiana Care’s Vascular &Interventional Radiology Fellowship Program, and hiscolleagues previously have shown that their “RapidLysis” technique safely and effectively breaks up andremoves acute blood clots in the veins faster and moreefficiently without surgery. This reduces the chances ofpulmonary embolism and long-term disability. Othermembers of the team are Randall Ryan, M.D.; GeorgeKimbiris, M.D.; David Epstein, M.D.; Daniel Leung,M.D.; and Michael Dignazio, M.D.

Chronic clots treated successfullyBuilding on years of experience and success in treatingacute blood clots, Dr. Garcia and his team combined theirtechnique with newer ultrasound-assisted devices, whichrecently showed success in breaking up and removingchronic clots that are harder and more intractable thanstandard thrombolysis.

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

thinners alone, up to 50 percent develop a chronic condition called Post Thrombotic Syndrome. Becauseblood thinners prevent clots from propagating and do not dissolve them, blood flow is still restricted, causingpermanent vein damage. Patients experience debilitatingpain, leg swelling, ulcers and other symptoms thatrestrict walking and compromise their ability to work orconduct daily activities.

“The most important thing we’ve learned so far is thatdoctors and these patients with significant symptomsshould not give up hope, and that there may be somenewer 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 usingthese newer techniques for nearly two years, successfullytreating dozens of patients with difficult and chronicclots. Inquiries about the procedure have come from asfar away as Dubai and England, while patients havecome from California, Utah and Colorado for treatment.

Worldwide attention Dr. Garcia presents at national and international meet-ings, thanks to growing global interest. In September, helectured on the treatment of acute blood clots at theCardioVascular Interventional Radiology Society ofEurope (CIRSE) meeting in Portugal. In November, hewill present to the Society of Vascular Surgeons in NewYork on using his technique to treat chronic blood clots.

He also has accepted an invitation to be a faculty memberof the American Venous Forum, a brainstorming andplanning meeting of world leaders in venous disease. The forum aims to produce a plan of action to decreasethe prevalence of venous ulcers in the United States by 50 percent in 10 years.6

The new study, sponsored by theNational Institutes of Health, is set toenroll 692 patients.

From October 2007 to January 2008, just21 percent of CABG patients received atransfusion of red blood cells, down from65 percent during the same period in2005-2006.

Average units of blood per procedure fellfrom 3.68 units to just 0.8 units duringthat same time.

The in-hospital mortality rate declined to 1.4 percent in 2008, down from 1.7percent in 2006. The external woundinfection 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 ofpatients went home in fewer than sixdays, compared to 50 percent in 2006.

The number of transfusions duringvalve-replacement surgery also hasdeclined dramatically.

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

6

Fewer transfusions lead to shorter stays, better outcomes

educing the use of blood transfusions duringcoronary artery bypass grafts (CABGs), valvereplacements and other heart surgeries is produc-

ing better post-surgical outcomes for cardiac patients atChristiana Care.

A review of approximately 2,100 CABG patients treatedbetween 2006 and 2008 confirms that new protocols insti-tuted by Christiana Care’s cardiac surgery team, under thedirection of Michael Banbury, M.D., chief of CardiacSurgery, resulted in lower rates of mortality and infection.

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

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

atients at Christiana Care whohave an abdominal aneurysmbut are not candidates for open surgery or commercially

available endografts now have anotheroption—a customized UNITE stent graftdesigned especially for them.

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

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

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

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

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

CABG PROCEDURES WITH TRANSFUSION

65%21%

Better outcomes, safer proceduressince 2006

New one-piece stent facilitates complex abdominalaortic aneurysm repairs

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

Cardiac Rehab Webinar describes integration ofclinical data with outcomes“How Christiana Care Cardiac Rehab successfully alignedclinical 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 acomprehensive view of the patient—including outcomes,history and demographic data—we are able to deliver evidence-based care and document the success of ourCardiac Rehab Program.”

“Christiana Care Cardiac Rehabilitation Services does aremarkable job of caring for our patients after dischargefollowing a cardiovascular event or major procedure,”says William Weintraub, M.D., the John H. Ammon chairof Cardiology and medical director of the Center forOutcomes Research at Christiana Care.” The integration of rehab data with clinical outcomes from the AmericanCollege of Cardiology and the Society of ThoracicSurgeons registry data and beyond that into the medicalcenter data warehouse is a remarkable achievement, serving patient care and offering an unparalleled opportunity for clinical research.” 6

New FacesBernadette Baker, RN, from Employee Health Services,joined the Cardiovascular Screening and PreventionProgram.

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

S E C T I O N U P D A T E S

7

R E S E A R C H U P D A T E

Christiana Care authors publish and present nationally

Results from major drug trialshighlighted in EuropeCardiovascular Research participated inthe following two major drug trials withpositive results. These were highlighted at the European Society of CardiologyCongress in Barcelona.

PLATO (A Study of PlateletInhibition and Patient Outcomes)demonstrated that ticagrelor(AZD6140), an investigational oralantiplatelet, achieved a statisticallysignificant reduction in heart attack,stroke or cardiovascular death compared to clopidogrel.

RE-LY A randomized trial in patientswith atrial fibrillation at high risk forstroke demonstrated that dabigatran,an oral direct thrombin inhibitor, wasassociated with lower rates of strokeand systemic embolism with noincrease in major hemorrhaging compared to warfarin. 6

Cardiovascular clinical trials continue enrollment

STABILITY (Stabilization of Atherosclerotic Plaque by Initiation ofDarapladib Therapy)

Darapladib inhibits Lp-PLA2, an enzyme that may contribute to instabilityof coronary artery plaques. The aim of the study is to determine whetherdarapladib (compared to placebo) can further reduce the risk of a majorcardiovascular event when added to medications, including statins or antiplatelets, which study participants already are receiving. Totalanticipated enrollment is 15,500 participants.

CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions)

People may qualify for the CORAL study if they have atherosclerotic renalartery blockage and are taking two or more anti-hypertensive medicationsto control high blood pressure. Participants are randomized to receivemedication alone to control blood pressure and other risk factors or to betreated with medication and placement of a stent in the blocked kidneyartery. The CORAL study will examine whether inserting a stent, or metalscaffold, to keep the artery open will lead to better outcomes overall forpatients. Expected total enrollment is 1,000 at 100 recruiting sites acrossthe United States.

To learn more about these and other clinical trials underway, call theCardiovascular Research office at 302-733-2658.6

4755 Ogletown-Stanton RoadNewark, DE 19718

www.christianacare.org/heart

Non-Profit Org.US Postage

PAIDWilmington, DEPermit No. 357

10HRTC22

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.

According to Brian Sarter, M.D., medical director of theElectrophysiology Lab, the new system represents a majoradvancement in catheter-based interventional cardiology.

“Stereotaxis technology allows us to manipulate cathetersinside the heart more precisely and more consistently witha greater margin of safety and efficacy,” he says.

As a result, more patients could be eligible for catheterablation of episodic and chronic atrial fibrillation, possiblyeven tripling the number of procedures performed in thenext two to three years.

The new Electrophysiology Stereotaxis Lab initially willtreat arrhythmias and guide left ventricular lead place-ments for cardiac resynchronization therapy. Future applications may include treating multi vessel and othercomplex coronary artery diseases.

Revolutionary technologyWhat makes stereotaxis technology so revolutionary aremagnetic fields that allow physicians direct control of thetip of soft catheters. Unlike other catheters used forradiofrequency ablation, stereotaxis catheters are more

flexible and easily manipulatedthrough the labyrinth of cardiacblood vessels.

The electrophysiologist automati-cally controls the motion and targeting of the fully integratedcatheter and digital fluoroscopymapping by using a joystick, computer mouse or touchscreen.

The stereotaxis remote technology decreases the timerequired for digital fluoroscopy. As a result, it has thepotential to significantly reduce X-ray exposure forpatients and the electrophysiology team as well as toreduce the amount of time that physicians and staff mustwear lead-protective clothing during the procedure.

Using stereotaxis along with Dr. Sarter are Christiana Careelectrophysiologists Raymond Miller, M.D., associatedirector, Electrophysiology Lab; Piamsook Angkeow,M.D.; Stephen Blumberg, M.D.; John Hynes, M.D.;Roger Kerzner, M.D.; Joseph Pennington, M.D.; andHenry Weiner, M.D. �

continued from cover

Stereotaxis system offers advanced treatment for arrhythmias,other heart problems

Timothy Gardner, M.D., receives leadership awardTimothy J. Gardner, M.D., medical director of Christiana Care’s Center for Heart & Vascular Health and immediatepast 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 theSteering Committee of the Cardiothoracic Surgery Clinical Research Network. �