advancing cardiovascular care 2012

2012 Cardiovascular Outcomes
advancing cardiovascular care
The Christ Hospital
Heart and Vascular Center
Dear Colleagues,
It is our pleasure to report the outcomes data for the Heart and Vascular Center
at The Christ Hospital from the past year. This publication is part of our continued
commitment to serve our community as the premier tertiary cardiovascular center
by fostering focused expertise, innovation and research.
This past year has witnessed the maturation of exciting initiatives into successful
clinical programs in percutaneous aortic valve replacement, ventricular assist device
and catheter ablation. These programs have required intense collaboration between
physicians, administration, and nursing, and have led to a cultural shift in which all
things are possible.
However, we are reminded daily that these advancements must be grounded in
personalized care. The Christ Hospital has a 100-year history of outstanding nursing
tradition, as reflected in our Magnet recognition.
We will strive to expand our reach and accessibility over the coming years as we
continue to improve outcomes and patient experience. We hope you find this
publication of value and look forward to further work with you and your patients.
Eugene S. Chung, MD
Medical Director, Outcomes
The Christ Hospital Heart & Vascular Center
Ian J. Sarembock, MD
Executive Medical Director, Cardiovascular Services
The Christ Hospital Heart & Vascular Center
2
2012 cardiovascular OUTCOMES
CONTENTS
3
Advanced Technologies
4
Clinical Service
6
Acute Coronary Syndrome
8
Heart Failure
12
Electrophysiology
14
Research
18
Cardiac Imaging
22
Vascular
24
Cardiac Surgery
26
Pulmonary Hypertension
28
Consumer Preference and Patient Satisfaction
30
Publications
32
Contacts
39
The Christ Hospital Heart & Vascular Center
Advanced Technologies
The Christ Hospital continues
to advance in three innovative
technologies: transcatheter aortic
valve replacement for aortic stenosis,
ventricular assist devices for advanced
heart failure and has introduced
to the region a third promising
intervention—radiofrequency ablation
of renal sympathetic nerves in resistant
hypertension.
Transcatheter Aortic Valve Replacement
Physicians at The Carl and Edyth Lindner Research Center at The Christ Hospital have treated the first
four patients in the United States with an investigational next-generation transcatheter aortic valve
replacement (TAVR ) therapy called the Edwards SAPIEN XT valve, as part of Cohort A in the PARTNER II
Trial. These high-risk patients who suffer from severe symptomatic aortic stenosis were treated with a
bovine pericardial tissue, aortic heart valve mounted in a balloon-expandable frame. To date, the Lindner
Research Center has enrolled more than 30 patients for this non-inferiority study, which will examine
clinical outcomes in a nationwide cohort (Cohort A) of up to 2,500 patients randomly assigned to receive
TAVR or surgical valve replacement.
Of note, 25 percent of patients who might benefit from TAVR have peripheral vasculature that is too
diseased or otherwise inadequate to allow use of the procedure’s customary femoral approach. For
this reason, investigators at The Christ Hospital use the transapical approach to the heart, through
a mini-thoracotomy.
TAVR also holds promise for those who are ineligible for surgery. In the earlier PARTNER Trial that studied
the first generation Edwards SAPIEN valve, the procedure demonstrated a 20 percentage point higher rate
of one-year survival among inoperable patients compared with standard medical treatment.
Ventricular Assist Device
Our Mechanical Heart Assist Device Program received The Joint Commission’s Gold Seal of Approval™, enabling us to
offer Medicare and select insurance coverage for destination therapy (DT) to eligible patients with end-stage heart failure
who are not candidates for transplantation. For these patients, DT is an option that gives them the chance for a longer
life span and improved quality of life. Other benefits of the VAD, relative to transplantation, include lower long-term
costs, no need for immunosuppressive medications, a shorter recovery period and less frequent follow-up care.
4
The Joint Commission’s approval, following its rigorous two-day onsite review, recognizes
our commitment to VAD patients and their families, infection prevention and control,
leadership, medication management and our work in educating emergency service
providers and others in the community who may care for patients after they return home.
We also continue to provide VAD implantation as a bridge-to-transplantation or bridgeto-decision for those who may qualify for transplantation.
Renal Sympathetic Nerve Ablation for Resistant Hypertension
For more than 12 percent of patients with hypertension, blood pressure remains
uncontrolled even with multiple medications. For every 20-point rise in systolic pressure,
the risk of heart attack or stroke doubles. The Christ Hospital is participating in a
nationwide pivotal phase III trial to evaluate use of the investigational SYMPLICITY™ Renal
Denervation System® in applying radiofrequency ablation to disrupt sympathetic nerves
adjacent to the renal arteries. These nerves stimulate the release of renin, which leads to
5
a reduction in blood flow to the kidneys and decreased excretion of sodium. They also
stimulate release of norepinephrine, which contributes to hypertension by stimulating
tachycardia and vasoconstriction.
In prior studies of this procedure outside the United States, the average blood pressure
of enrolled patients was 178/98 mm Hg despite being treated with five or more
antihypertensive medications. At six months following ablation, patients experienced
an average decline in systolic pressure of 32 mm Hg and 12 mm Hg in diastolic pressure,
compared with no change in control patients. Importantly, the procedure did not cause
unanticipated adverse device effects, serious procedure-related complications or evidence
of long-term adverse effects on kidney function.
The Christ Hospital Heart & Vascular Center
Clinical Service
Operating within The Christ
Hospital Heart and Vascular Center’s
environment of specialized acute
interventions is a team of physicians
and mid-level healthcare professionals
who provide inpatient clinical care.
Eight attending physicians rotate in
dedicated one-week periods, with no
other clinical or administrative duties, to
provide focused patient management
and enhance communication with
outpatient providers. The active
team onsite typically consists of two
attending physicians and four nurse
practitioners. In support of the clinical
service, imaging with echocardiography,
computerized tomography, magnetic
resonance imaging and stress testing
are available seven days a week. In
addition, a separate heart failure and
coronary care unit service is in place,
staffed by one of four dedicated heart
failure specialists and two nurse
practitioners.
6
Teaching and Multidisciplinary Team Interaction
We believe that physicians can provide optimal patient care when they have
the opportunity to discuss cases in multidisciplinary settings, with a spectrum
of available expertise. To that end, at Wednesday morning reviews, physicians
discuss interesting and difficult cases. On Friday mornings each week, a teaching
conference for medical residents takes place. In addition, morbidity and mortality
conferences occur monthly.
Cardiac Acute Care Admissions by Year
Data Source: The Christ Hospital Internal Reporting Software
Data Source: The Christ Hospital Internal Reporting Software
2011
3.89
2011
5289
2010
4.10
2010
5137
2009
4.53
2009
4830
2008
4.38
2008
5046
0
1
Year
Year
Cardiac Acute Care Average Length of Stay (LOS) by Year
2
3
4
Time (days)
7
5
6
0
1000
2000
3000
4000
Patient Volume
5000
6000
The Christ Hospital Heart & Vascular Center
Acute Coronary Syndrome
The Christ Hospital continues to receive
national and international recognition for
its work with leading-edge technologies
for treatment of acute coronary
syndrome (ACS). Consistent with our
tradition, we continue to introduce
state-of-the-art ACS interventions to the
Cincinnati region, including those made
available through multiple clinical trials,
for which we are consistently among the
top enrollers nationally.
Three notable “firsts” occurred this year at The Christ Hospital in the arena of ACS care.
1. We implanted the now commercially available Resolute Integrity™ Drug-Eluting Stent, yielding major
benefits while causing very few complications for several patients with coronary artery disease (CAD),
34 percent of whom also have diabetes.
2. As part of a pivotal trial for treatment of CAD, we were the first center in the United States to have
implanted the Tryton Side Branch Stent™, specially designed to improve clinical outcomes in treating
bifurcated lesions.
3. Patients who are not candidates for a drug-eluting stent may benefit from a new bare-metal stent in
clinical trial. We were the first in the United States to implant the OMEGA™ Platinum Chromium BareMetal Coronary Stent System, and we will assess its safety and efficacy as an alternative to
drug-eluting stents.
In addition to these achievements, The Christ Hospital has initiated a Chest Pain Network throughout
the Greater Cincinnati region, enabling participating hospitals and emergency medical service providers
to implement a standardized protocol for managing ACS patients. The Christ Hospital’s Level III Chest
Pain Center and all participating hospitals in the Tristate region are accredited by the Society of Chest
Pain Centers. The Christ Hospital—which serves as the tertiary center for myocardial infarction (MI) care
for this network of hospitals—increased MI referrals in 2010. These numbers remain consistent. We also
participate in the American Heart Association’s Mission: Lifeline, a program streamlining cardiovascular
treatment protocols in communities nationwide. In 2011, we received bronze-level recognition from the
American Heart Association for our performance in managing ST-segment elevation MI.
8
ST-Segment Elevated Myocardial Infarction Median
Door to Door to Balloon Times for Transfer Admits
ACC CathPCI Registry and The Christ Hospital Internal Reporting
Data Source: ACC CathPCI Registry
2011
229
314
2010
182
303
2009
173
297
2008
167
267
0
100
200
300
400
Emergency
Transfer
Year
Year
ST-Segment Elevated Myocardial Infarction Annual Volumes
(Emergency and Transfer Admit)
500
2011
111
2010
139
2009
137
0
600
50
100
Year
Acute Myocardial Infarction Core Measure
2010
60
2009
67
2008
59
0
20
90 minute
standard
40
60
Time (minutes)
9
80
100
Acute Myocardial Infarction Core Measure
All or None Bundle Compliance Data Source: Centers for Medicare and Medicaid Services
Acute Myocardial Infarction Core Measure
Year
ST-Segment Elevated Myocardial Infarction Average
Door to Balloon Time (D2B) Data Source: Centers for Medicare and Medicaid Services
55
200
Time (minutes)
Patient Volume
2011
150
2011
99.1%
2010
99.8%
2009
98.7%
2008
93.1%
0
20
40
60
% Compliance
80
100
The Christ Hospital Heart & Vascular Center
Acute Coronary Syndrome
continued
Non-ST Elevated Myocardial Infarction Annual Volumes
Year
Data Source: The Christ Hospital Internal Reporting Software
2011
408
2010
376
2009
366
2008
392
0
100
200
300
400
500
Patient Volume
Percutaneous Coronary Intervention (PCI) Annual Volumes
Year
Data Source: The Christ Hospital Internal Reporting Software
2011
1180
2010
1173
2009
1302
2008
1317
0
200
400
600
800 1000 1200 1400
Patient Volume
10
American College of Cardiology (ACC) CathPCI Registry PCI
Mortality Rates Data Source: ACC CathPCI Registry from January 2011 to December 2011
All
Participating
Hospitals
0.0
1.26
Expected
1.27
Observed
1.46
1.48
0.5
1.0
1.5
2.0
Mortality Rate
Year
2.2
2010
2.21
2009
2.23
2008
2.38
0
11
1
2
Time (days)
2011
3784
2010
3625
2009
3880
2008
3505
0
1000
2000
3000
Patient Volume
Percutaneous Coronary Intervention
Average Length of Stay Data Source: The Christ Hospital Internal Reporting Software
2011
Data Source: The Christ Hospital Internal Reporting Software
Year
The Christ
Hospital
Overall Diagnostic Catheterization Annual Volumes
3
4
4000
The Christ Hospital Heart & Vascular Center
Heart Failure
The Carl H. and Edyth Lindner Heart Failure Treatment Center is accredited by both
The Joint Commission (re-accredited in May) and the Healthcare Accreditation
Colloquium for heart failure care. Four advanced heart failure sub-specialty
physicians rotate in full-week assignments to provide consistent inpatient care
for patients. Sub-specialty midlevel providers, specialized registered nurses,
pharmacists, dieticians and physical therapists work collaboratively with the
physicians to implement current guidelines and the best clinical evidence
available. Through teamwork, we have significantly reduced our heart failure
readmission rate. Additionally, the team works on many clinical trials to improve
patient outcomes. Active clinical trials are listed in the research section.
Recognition by the American Heart Association (AHA)
Specialized Treatments
The Center offers two highly specialized treatments: ultrafiltration and ventricular
assist device implantation (see Advanced Technologies for the latter). Ultrafiltration
may effectively reduce fluid volume in patients for whom other treatment
options have proved insufficient. The Center manages one of the largest
ultrafiltration registries in existence, helping to refine treatment strategies and
tailor ultrafiltration use to individual patients.
Heart Link Program
When inpatients are ready to return home, the Center’s Heart Link program helps
ease the transition. Specially trained nurses follow up with patients after discharge
to review diet, exercise, medication and how to monitor for changes in health.
Primary Heart Failure Average Length of Stay (LOS) by Year
Data Source: The Christ Hospital Internal Reporting Software
Year
The Carl H. and Edyth Lindner Heart Failure Treatment Center has received the
AHA’s Gold Quality Achievement Award in recognition of the center’s compliance
with its Get With The Guidelines® quality improvement program. Over a
24-month period, the Center attained 85 percent compliance with core standard
levels of care outlined by the AHA and the American College of Cardiology in
their secondary prevention guidelines for heart failure patients.
2011
5.12
2010
5.06
2009
5.47
2008
5.21
0
25th
percentile
50th
percentile
75th
percentile
2
4
6
8
Time (days)
12
Secondary Heart Failure Admissions by Year
Data Source: The Christ Hospital Internal Reporting Software
Data Source: The Christ Hospital Internal Reporting Software
2011
1038
2011
3876
2010
1102
2010
3396
2009
1009
2009
3076
2008
884
2008
2853
0
200
Year
Year
Primary Heart Failure Admissions by Year
400
600
800
1000
1200
0
1000
2000
Patient Volume
Primary Heart Failure 30-day All Cause Readmission
Percent by Year Data Source: The Christ Hospital Internal Reporting Software
Data Source: The Christ Hospital Internal Reporting Software
Year
2010 1.63%
50th
percentile
2009 1.35%
75th
percentile
2008 0.92%
1.0
1.5
2.0
2.5
3.0
Incidence %
13
3.5
4.0
Year
25th
percentile
2011 1.64%
0.5
4000
Patient Volume
Primary Heart Failure Mortality Rate by Year
0.0
3000
2011
17.26
2010
17.33
2009
15.77
2008
16.69
0
5
25th
percentile
50th
percentile
75th
percentile
10
15
Readmission Rate
20
25
The Christ Hospital Heart & Vascular Center
Electrophysiology
The Christ Hospital provides a full scope
of state-of-the-art electrophysiology
services, including pacemaker and
defibrillator implants, lead extractions
and advanced ablation procedures
for rhythm disturbances such as atrial
fibrillation (AF), atrial flutter and
ventricular tachycardia (VT).
Pacemaker and Defibrillator Implants
MR conditional pacemakers
We implanted the first MR conditional pacemaker in Cincinnati in 2008, through a clinical trial of the
SureScan™ system. This technology has since become commercially available, although the U.S. Food
and Drug Administration (FDA) does not permit its use with scans near the chest. Additionally, The Christ
Hospital’s Heart and Vascular Center is the first in the country to have implanted the second generation of
this technology, the Advisa MRI™ SureScan® Pacing System, in a study to determine whether it is safe and
effective for use with MRI on any part of the body.
Novel defibrillators
Patients with implanted defibrillators to control irregular heartbeats often experience inappropriate
shocks. We were the first center in Ohio and in the Greater Cincinnati region to use a new cardiac rhythm
device in the FDA-approved Protecta™ line of defibrillators with SmartShock™ Technology designed to
minimize unwarranted shocks. Available devices with this technology include implantable cardioverterdefibrillators and resynchronization therapy-defibrillators. We are also the first center nationally to enroll
patients in Phase II of the multicenter, international PainFree SST Clinical Study, which will assess the longterm capacity of Protecta features to reduce inappropriate shocks.
Combined pacemaker/defibrillator devices in cardiac resynchronization
We are the first center worldwide to enroll patients in a new clinical study investigating the use of
combination pacemaker/defibrillator devices to prevent changes in the structure and function of the
heart following myocardial infarction. The Post-Myocardial Infarction Remodeling Prevention Therapy
(PRomPT) study is evaluating the effect of pacing the peri-scar region within 10 days of a large myocardial
infarction to attenuate left ventricular dilation and failure; this represents a Phase II trial of a concept that
has been initiated at The Christ Hospital, in partnership with device manufacturers.
14
Atrial Fibrillation Ablation Volumes by Year
Alternative to warfarin for stroke prevention
Patients with non-valvular atrial fibrillation (AF) tend to form thrombi in the left
atrial appendage, necessitating long-term anticoagulation therapy. The Christ
Hospital was the first center in Greater Cincinnati to implant an investigational
percutaneous technology—the WATCHMAN Left Atrial Appendage Closure
device—that could obviate the need for anticoagulants in patients with nonvalvular AF. The study underway follows a pivotal study completed in 2008, and
will provide additional safety and efficacy data for the FDA.
Year
Data Source: The Christ Hospital Internal Reporting Software
2011
189
2010
130
2009
92
2008
56
0
50
100
150
200
Advanced Ablation Procedures
Radiofrequency ablation
Patients with AF refractory to medical therapy can benefit from pulmonary vein
isolation (PVI) using high-frequency, low-voltage energy. PVI restores normal
sinus rhythm in approximately 70 percent of patients with paroxysmal AF after
one procedure, and in nearly 50 percent of patients with persistent AF. Some
patients may be able to remain free of anti-arrhythmic and anticoagulation
medications. Radiofrequency ablation may also be appropriate for atrial flutter.
Patient Volume
Ventricular Tachycardia Ablation Volumes by Year
Data Source: The Christ Hospital Internal Reporting Software
Year
For AF or ventricular tachycardia (VT) that fails to respond adequately to rateor rhythm-control medications, our center offers radiofrequency ablation and
cryoablation.
2011
15
2010
11
2009
10
2008
2
0
5
10
15
Patient Volume
15
20
The Christ Hospital Heart & Vascular Center
Electrophysiology
continued
Cryoablation
An alternative ablation procedure uses the Arctic Front® Cardiac Cryoablation Catheter. A balloon
positioned at the ostium of each pulmonary vein and inflated with coolant, freezes and fully ablates
the surrounding tissue. In a major trial, nearly 70 percent of 245 patients treated with cryoablation
remained symptom-free at one year, compared with just 7.3 percent of patients treated with medications
alone. Cryoablation was also associated with a decrease in the need for drug therapy and substantial
improvements in physical and mental quality-of-life indicators.
Ventricular Tachycardia (VT) ablation
For those with VT resistant to drug therapies (or in younger patients in whom long-term amiodarone
therapy is not desirable), ablation offers real potential for improved quality of life. Catheter ablation of VT
involves the use of a 3-D imaging system, sophisticated mapping techniques, a programmable stimulator
and modern, irrigated-tip ablation catheters. Following successful catheter ablation of VT, patients can
often stop taking amiodarone and other anti-arrhythmic agents.
Imaging technologies used to support ablation procedures
Low-radiation fluoroscopy minimizes patient and clinician exposure to ionizing radiation during ablation
procedures. Carto 3 and Ensite imaging systems use magnetic and electrical current-enabled processes
to provide precise visualization of cardiac anatomy, generating 3-D mapping to guide catheter placement
during complex arrhythmia ablations.
16
Other Ablation Volumes (Supraventricular Tachycardia,
Atrioventricular Nodal, Atrial Tachycardia)
Cardiac Resynchronization Therapy Device (CRT-D)
Volumes by Year Data Source: The Christ Hospital Internal Reporting Software
2011
105
2011
187
2010
95
2010
196
2009
94
2009
186
2008
113
2008
182
0
20
Year
Year
Data Source: The Christ Hospital Internal Reporting Software
40
60
80
100
120
0
50
Patient Volume
402
2010
420
2010
371
2009
383
2009
363
2008
405
2008
368
Year
Year
2011
300
Patient Volume
17
Data Source: The Christ Hospital Internal Reporting Software
428
200
200
Pacemaker Volumes by Year
2011
100
150
Patient Volume
Implantable Cardioverter Defibrillator (ICD) Volumes
by Year Data Source: The Christ Hospital Internal Reporting Software
0
100
400
500
0
100
200
300
Patient Volume
400
The Christ Hospital Heart & Vascular Center
Research
The Carl and Edyth Lindner
Center for Research and
Education at The Christ Hospital
has participated in more than
1,200 clinical research trials (130
active trials) and has introduced
most of the new techniques in
cardiovascular medicine over the
past 20 years. These studies have
included first-in-man as well as
first-in-the-U.S. experiences with
leading-edge techniques.
Trials listed here are open as of
print date: Aug. 1, 2012.
Acute coronary syndrome Pre-SERVE A prospective, randomized, double-blind, placebo
controlled phase II trial of intra-coronary infusion of AMR001, a bone marrow derived autologous CD34+ selected
cell product, in patients with acute myocardial infarction
Acute coronary syndrome PRomPTPost-myocardial infarction remodeling prevention
therapy
Acute coronary syndromeTOTALPilot Trial – A randomized trial of routine aspiration
ThrOmbecTomy with percutaneous coronary
intervention (PCI) versus PCI ALone in patients with
STEMI undergoing primary PCI
Advanced hypertensionSymplicity HTNSymplicity HTN-3 studies the safety and effectiveness
of renal denervation in subjects with uncontrolled
hypertension
Aortic valve stenosis
PARTNER II A & BPlacement of aortic transcatheter valves
Coronary artery disease
CANTOS A randomized, double-blind, placebo-controlled, eventdriven trial of quarterly subcutaneous canakinumab in the
prevention of recurrent cardiovascular events among stable
post-myocardial infarction patients with elevated hsCRP
Coronary artery diseaseEXACT Comparison of exercise magnetic resonance imaging
and exercise nuclear scintigraphy in patients with
suspected coronary artery disease
Coronary artery disease
PROMISEPROspective Multicenter Imaging Study for Evaluation
of chest pain
Coronary artery diseaseReduce-ItEvaluation of the effect of AMR101 on cardiovascular
health and mortality in hypertriglyceridemic
patients with cardiovascular disease or at high risk
for cardiovascular disease: REDUCE-IT (Reduction of
Cardiovascular Events With EPA - Intervention Trial)
Diabetes AlecardioStudy to evaluate the potential of aleglitazar to reduce
cardiovascular risk in patients with a recent acute coronary
syndrome event and Type 2 diabetes mellitus
18
Diabetes
CASCADECardiovascular outcome event trial in Type 2 diabetes mellitus patients
DiabetesELIXAEvaluation of cardiovascular outcomes in patients with Type 2 diabetes after acute
coronary syndrome diagnosis during treatment with AVE0010 (Lixisenatide)
DiabetesEXAMINE / TakedaCardiovascular outcomes study of alogliptin in subjects with Type 2 diabetes and acute
coronary syndrome Diabetes LEADERLiraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results A long-term evaluation
DiabetesMesoblastRandomized, placebo-controlled study to assess the safety of a single IV infusion of
mesenchymal precursor cells in patient with Type 2 diabetes controlled by Metformin
Electrophysiology ACUITY Longitudinal surveillance registry of the ACUITY spiral
Electrophysiology MultiSENSEMultisensor chronic evaluations in ambulatory heart failure patients
Electrophysiology PAIN FREE SST/ProtectaA prospective, multi-center clinical trial with two consecutive phases: “Phase I (Protecta
Clinical Study)” followed by “Phase II (PainFree SST Clinical Study).” Collectively, Phase I and
Phase II will provide data to support market release of the Protecta devices and evaluate
the SmartShock technology features in reducing inappropriate shock
Electrophysiology
PREVAIL / WatchmanProspective, randomized evaluation of warfarin therapy in atrial fibrillation patients versus
WATCHMAN left atrial appendage closure technology Electrophysiology Product PerformanceThe purpose of this post-market surveillance is to "enhance the public health by reducing Platform
the incidence of medical device adverse experiences"
ElectrophysiologyRAIDRanolazine implantable cardioverter-defibrillator trial: Late sodium current blockade in
high-risk implantable cardioverter defibrillator patients
ElectrophysiologySHIELD IIPhase III, randomized, placebo-controlled trial to evaluate Azimilide on incidence of
hospitalization or cardiovascular deaths in patients with implantable cardiac defibrillators
ElectrophysiologySureScan RegistryPost-approval study (PAS) to demonstrate the chronic performance of the SureScan™
pacing system when used in a magnetic resonance imaging environment according to
product labeling
19
Heart failureATOMIC /AMGEN 423A double-blind, randomized, placebo-controlled, multi-center study to evaluate the safety
and efficacy of intravenous infusion treatment with Omecamtiv Mecarbil in subjects with
left ventricular systolic dysfunction hospitalized for acute heart failure
Heart failure
CLOSE THE GAPMulti-center pilot evaluation to assess the effect of expanding the set of heart failure
performance measures to include implantable device evaluation as an additional
measure
Heart failureECHO CRTEchocardiography-guided cardiac resynchronization therapy (EchoCRT) clinical
investigation
Heart failureLAPTOPLeft Atrial Pressure monitoring To OPtimize heart failure therapy
Heart failureOPTIMUMOptivol in monitoring ultrafiltration and management of patients with acute
decompensated heart failure
Heart failure
ParadigmThis study will evaluate the efficacy and safety of LCZ696 compared to Enalapril on
morbidity and mortality of patients with chronic heart failure
Heart failure
JuventasPhase II, randomized, double-blind, placebo-controlled study to evaluate the safety
and efficacy of a single dose of JVS-100 (non-viral gene therapy) administered by
endomycardial infection in adults with ischemic heart failure
Heart failureAastromPhase IIB, randomized, double-blind, placebo controlled study to evaluate the efficacy
of transendocardial injection of ixmyelocel-T (obtained from bone marrow aspiration) in
subjects with ischemic dilated cardiomyopathy
Hypertension
NAC-MD-01Randomized eight-week study to evaluate the safety and efficacy of Nebird and Valsartan
in patients with essential hypertension
Interventional cardiology
BOSSEvaluation of sodium bicarbonate to reduce chronic kidney injury in subjects with
advanced chronic kidney disease who are undergoing angiography
Interventional cardiologyENGAGE PASEvaluation of Endurant stent graft for abdominal aortic aneurysm
Interventional cardiologyEXCELEvaluation of XIENCE PRIME™ stent versus coronary artery bypass surgery for effectiveness
of left main revascularization
Interventional cardiologyREDUCETesting of the GORE HELEX™ septal occluder for patent foramen ovale (PFO) closure in
stroke patients
Interventional cardiologyOMEGAA prospective, multi-center, single-arm trial to assess the OMEGA™ coronary stent system
for the treatment of a single de novo coronary artery lesion
20
Interventional cardiologyTRYTONA prospective, single blind, randomized controlled study to evaluate the safety and
effectiveness of the Tryton Side Branch Stent™ used in conjunction with a drug-eluting
stent compared to side branch balloon angioplasty in the treatment of de novo bifurcation
lesions involving the main branch and side branch within the native coronary circulation
Interventional cardiology
Baxter RenewPhase III, randomized, double-blind study to determine the efficacy and safety of
intramyocardial autologous CD34+ cells in subjects with refractory angina and chronic
myocardial ischemia
Interventional cardiologyEvolve IIA prospective trial to asses the safety and effectiveness of the SYNERGY Coronary Stent
System for the treatment of up to three atherosclerotic lesions in up to two native
coronary arteries. The SYNERGY stent is an everolimus-eluting platinum chromium device
with a polymer coating applied to the abluminal surface of the stent only and absorbable
within approximately four months.
Pulmonary hypertension AMBITIONA study of first-line Ambrisentan and Tadalafil combination therapy in subjects with
pulmonary arterial hypertension (PAH)
Pulmonary hypertension
COMPASS-2 Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on
morbidity and mortality in symptomatic patients with PAH –A multi-center, double-blind,
randomized, placebo-controlled, parallel group, prospective, event-driven Phase IV study
Pulmonary hypertension
GriphonA multicenter, double-blind, placebo-controlled phase III study to demonstrate the
efficacy and safety of ACT-293987 in patients with PAH
Pulmonary hypertension
Griphon OLLong-term single-arm open-label study, to assess the safety and tolerability of
ACT-293987 in patients with PAH Pulmonary hypertension
PhianoA phase II, open-label, dose-escalation study in subjects with PAH, (PAH, WHO Group 1),
and pulmonary hypertension secondary to idiopathic pulmonary fibrosis, (PH-IPF WHO
Group 3) using inhaled NITROsyl
VascularIN.PACT SFA IIRandomized trial evaluating Paclitaxel drug-eluting balloon vs. standard treatment for
atherosclerotic lesions in superficial/femoral and popliteal arteries 21
Vascular diseaseLEVANT - 2A prospective, multi-center, single blind, randomized, controlled trial comparing
the Moxy™ drug-coated balloon vs. standard balloon angioplasty for treatment of
femoropopliteal arteries
The Christ Hospital Heart & Vascular Center
Cardiac Imaging
At The Christ Hospital, physicians
who perform echocardiography,
computed tomography (CT) and
magnetic resonance imaging (MRI) are
Level III certified in accordance with
the American College of Cardiology
guidelines and recommendations.
Our laboratories are accredited in
echocardiography by the Intersocietal
Accreditation Commission.
Pivotal Role in Research
The transesophageal program, with extensive experience in 3-D imaging, provides support of advanced
procedures such as percutaneous aortic valve replacement, left atrial appendage exclusion and ablation.
Additionally, exercise MRI is a novel stress testing method we are studying, in conjunction with the
University of Pittsburgh Medical Center, The Ohio State University and Case Western Reserve University, in
the EXACT trial. The trial’s purpose is to study the diagnostic accuracy of treadmill stress cardiac MRI versus
single-photon emission computed tomography (SPECT), building on recent results from multi-center
studies in Europe that showed superior accuracy with pharmacologic stress cardiac MRI versus SPECT.
Technologic Advances
An example of newer technologies employed at The Christ Hospital is the Vital Enterprise Solution that
allows rapid access to images from any location, enabling direct online consultation between physicians
and expedited reporting of image findings.
Helping to Improve Cardiovascular Care Abroad
Physicians who are part of our Advanced Cardiac Imaging Program recently conducted a four-day course
in cardiac CT protocols and interpretations for 23 cardiologists and radiologists in Jeddah, Saudi Arabia.
They have similarly trained physicians in Australia, Canada, Egypt, India and the United Kingdom. The
course provided hands-on reviews of more than 50 real-time patient cases and one-on-one mentoring
in image interpretation. Underscoring the need for improved cardiovascular care in this region is the fact
that the live cases involved patients younger than those typically seen in the United States, evidence of
increasingly Westernized dietary and lifestyle habits. We look forward to return visits.
22
Overall Echocardiogram and Nuclear Diagnostic Testing
Annual Volumes (Main Hospital and All Outside Testing Centers)
Cardiac Computed Tomography Annual Volumes
Data Source: The Christ Hospital Internal Reporting Software
Data Source: The Christ Hospital Internal Reporting Software
2011
2011
304
2010
2010
322
2009
434
2008
382
Year
Electrocar- 17137
diography
15244
Nuclear 13601
Studies 14158
0
5,000
10,000
15,000
20,000
25,000
0
100
200
Procedure Volume
400
500
Procedure Volume
Transthoracic Echocardiography
Annual Volumes
Transesophageal Echocardiography
Annual Volumes
Data Source: The Christ Hospital Internal Reporting Software
Data Source: The Christ Hospital Internal Reporting Software
Data Source: The Christ Hospital Internal Reporting Software
182
2011
7364
2011
730
2010
187
2010
6835
2010
574
2009
156
2009
6850
2009
517
2008
115
2008
6554
2008
449
50
100
150
Procedure Volume
200
0
2000
Year
2011
Year
Year
Cardiac Magnetic Resonance
Imaging Annual Volumes
0
23
300
4000
6000
Procedure Volume
8000
0
200
400
600
Procedure Volume
800
The Christ Hospital Heart & Vascular Center
Vascular
The Christ Hospital’s Vascular Center program consists of a multidisciplinary
team of interventional radiologists and cardiologists, vascular surgeons and
cardiothoracic surgeons employing leading-edge techniques.
Peripheral Vascular Intervention Annual Volumes
Data Source: The Christ Hospital Internal Reporting Software
The Christ Hospital Vascular Center, through The Lindner Research Center, participates
in multiple clinical trials. Our center was the first in Ohio to study this treatment and
is participating in the LEVANT 2 trial, the first global, multi-center, randomized clinical
trial evaluating the safety and efficacy of the Moxy™ drug-coated balloon in treating
peripheral arterial disease. An anticipated total of 476 patients worldwide will be randomly
assigned to undergo either drug-coated or standard angioplasty to compare the
procedures’ effectiveness in unblocking femoral-popliteal arteries.
Also, through the Lindner Research Center, our vascular surgeons are participating in a
clinical trial for treatment of patients with acute, complicated type B aortic dissection with
either aortic rupture or branch vessel obstruction. Up to 67 patients will be enrolled at
one of the 30 global trial sites to evaluate the safety and efficacy of the Zenith Dissection
Endovascular System for treatment. The primary endpoints will be survival at 30 days and
freedom from major adverse events at 30 days.
Year
Trial Participation
Wound Healing
Patients with open wounds related to diabetes, lower extremity arterial disease or
immobilization that have not healed well can benefit from the unique expertise of our
physicians, nurses and therapists dedicated to wound treatment. Lesions of this sort are
often complex in nature. Our Wound Healing Center can apply the full range of medical
and surgical techniques available today—including hyperbaric treatment with 100
percent oxygen.
653
2010
1082
2009
964
2008
876
0
200
400
600
800
1000
1200
Procedure Volume
Vascular Surgery Lower Extremity Bypass Annual Volumes
Data Source: The Christ Hospital Internal Reporting Software
Year
Abdominal Aortic Aneurysm Management
The Heart and Vascular Center performs a high volume of procedures for abdominal aortic
aneurysm, particularly for minimally invasive endovascular placement of a stent graft to
prevent fatal rupture. We are also a market leader in performing open surgeries. Team
experience for both ascending and descending thoracic aneurysms, endovascular and
surgical, has increased steadily.
2011
2011
59
2010
73
2009
47
2008
50
0
20
40
60
80
Procedure Volume
24
2011
40
37
2010
20
51
Endovascular
AAA
2009
31
45
Open
AAA
2008
32
61
0
20
40
60
80
100
Carotid Duplex Annual Volumes
Data Source: The Christ Hospital Internal Reporting Software
Year
Year
Open and Endovascular Abdominal Aortic Aneurysm (AAA)
Repair Annual Volumes Data Source: The Christ Hospital Internal Reporting Software
2011
4493
2010
3686
2009
2893
2008
1247
0
1000
2000
Procedure Volume
29
13
2010
32
22
2009
37
13
2008
38
7
20
30
40
Procedure Volume
25
5000
50
Endovascular
TAA
Open
TAA
60
Overall Carotid Artery Procedure (Endartarectomy + Stent)
Annual Volumes Data Source: The Christ Hospital Internal Reporting Software
Year
Year
2011
10
4000
Procedure Volume
Open and Endovascular Thoracic Aortic Aneurysm (TAA)
Repair Annual Volumes Data Source: The Christ Hospital Internal Reporting Software
0
3000
2011
8
95
2010
9
66
Carotid
Endartarectomy
2009 11
79
Carotid
Stent
2008 15
83
0
20
40
60
80
Procedure Volume
100
120
The Christ Hospital Heart & Vascular Center
Cardiac Surgery
• Over the past year, The Christ Hospital has significantly expanded its ventricular assist device services
(see Advanced Technologies).
• For coronary artery bypass grafting, our venous harvest team collects saphenous veins endoscopically
through a small incision in the leg, sparing patients an ankle-to-thigh scar and aiding long-term graft
survival by reducing trauma to the vein.
• A new hybrid cardiac catheterization laboratory used for transcatheter aortic valve implantation is also
equipped for use as an operating room for open surgery, thereby permitting procedures without having
to move patients between suites to accommodate technology. The hospital plans to open a hybrid
operating room in 2013.
•P
ersonnel experienced specifically in the care of cardiac surgical intervention patients staff our 16-bed
cardiovascular intensive care unit (CVICU). In addition, we are currently in the process of staffing the
CVICU with three midlevel providers dedicated to helping the physicians caring for these patients as
well as providing continuing education for the staff nurses.
• For those families in need of lodging, the hospital may provide a room free of charge upon availability.
Overall Coronary Artery Bypass (CAB)Annual Volumes*
Data Source: Society of Thoracic Surgeons (STS) National Database
Year
The Christ Hospital’s cardiac surgery
program draws referrals from a
wide regional base of 14 counties
surrounding the Greater Cincinnati
area. The following highlights are
representative of our commitment to
achieve best possible outcomes.
2011
290
2010
282
2009
340
2008
357
0
100
200
300
400
Procedure Volume
*Procedure volumes include isolated CAB, aortic valve replacement + CAB, Mitral valve (MV) replacement + CAB, and MV repair + CAB
26
Society of Thoracic Surgeons (STS)
2011 Calendar Year Volumes
Isolated CAB Risk Adjusted (RA) Operative Mortality*
Data Source: Society of Thoracic Surgeons (STS) National Database
Data Source: Society of Thoracic Surgeons (STS) National Database
24
52
Valve*
49
114
CAB
0
STS
National
Average
TCH
Volume
143
242
50
100
150
200
250
Procedure Volume
1.7%
2010
1.5%
2009
0.0
2.3%
0.5
2010
107
2010
8.2
2009
133
2008
126
Year
8.8
2009
2008
Procedure Volume
*Procedure volumes include isolated valves and valves + CAB
2.0
2.5
3.0
Data Source: Society of Thoracic Surgeons (STS) National Database
2011
150
1.5
RA Operative Mortality Rate, %
154
100
1.0
*Operative mortality is defined as death during the same hospitalization as surgery or after discharge within 30 days of the procedure
2011
50
TCH
2.5%
The Christ Hospital (TCH) vs. Society of Thoracic Surgeons (STS) National Benchmark
Data Source: Society of Thoracic Surgeons (STS) National Database
0
STS
Benchmark
Isolated CAB Mean Length of Stay
Overall Valve Procedure Annual Volumes*
Year
2011
2008
*Any mitral, aortic, tricuspid or pulmonary valve surgery without concomitant CAB procedure.
**Any mitral, aortic, tricuspid or pulmonary valve surgery with concomitant CAB procedure.
27
Year
CAB +
Valve**
The Christ Hospital (TCH) vs. Society of Thoracic Surgeons (STS) National Benchmark
200
0
STS
Benchmark
TCH
9.0
8.7
2
4
6
8
Time (days)
10
12
The Christ Hospital Heart & Vascular Center
Pulmonary Hypertension
Pulmonary hypertension is a debilitating disease, once
largely overlooked because of the lack of effective
treatments. With the advent of medications in the last
few years that can change the course of the disease,
it is now imperative to identify these patients whose
unexplained dyspnea or hypoxia are often mistaken
for heart failure, lung disease or a consequence of
obesity or being out of shape. Pulmonary hypertension
specialists, which includes pulmonologists and
cardiologists, work closely with primary care physicians
to achieve optimal outcomes for patients.
28
Right Heart Catheterization Annual Volumes
Year
Data Source: The Christ Hospital Internal Reporting Software
2011
414
2010
354
2009
194
2008
123
0
100
200
300
Patient Volume
29
400
500
The Christ Hospital Heart & Vascular Center
Consumer Preference
Best Overall Quality
Most Preferred Hospital for Heart Care
Data Source: National Resource Corporation
Data Source: National Resource Corporation
Christ
20.1%
21.4%
19.9%
#2 Hospital
16.4%
12.8%
14.2%
2011
#3 Hospital
12.9%
11.8%
10.9%
2010
2009
#4 Hospital
10.0%
11.2%
9.5%
#4 Hospital
#5 Hospital
8.0%
10.8%
11.5%
#5 Hospital
#6 Hospital
6.6%
6.7%
6.3%
#6 Hospital
0
2
Christ
4
6
8 10 12 14 16 18 20 22
Percent Preference
#2 Hospital
#3 Hospital
#7 Hospital
Best Physicians
0
Data Source: National Resource Corporation
Christ
20.3%
21.9%
18.6%
#2 Hospital
15.1%
11.9%
12.7%
#3 Hospital
11.1%
10.8%
10.1%
#4 Hospital
17.3%
16.3%
16.0%
#5 Hospital
7.0%
8.6%
8.8%
#6 Hospital
5.7%
6.4%
6.4%
0
2
4
6
8 10 12 14 16 18 20 22
Percent Preference
2011
2010
2009
3
6
9 12 15 18 21 24 27 30 33 36 39 42
Percent Preference
2011
2010
2009
Data Source:
The National Research Corporation (www.nationalresearch.com) surveys the
region’s consumers regarding hospital preferences. Data is based on the following: The market is the Cincinnati-Middletown-OH-KY-IN CBSA (Core-Based
Statistical Area) counties of: Indiana: Dearborn, Franklin and Ohio; Kentucky:
Boone, Bracken, Campbell, Gallatin, Grant, Kenton and Pendleton; Ohio: Brown,
Butler, Clermont, Hamilton and Warren. The sample size is 1,571 households.
Range of error: ±2.5%.
30
The Christ Hospital Heart & Vascular Center
Patient Satisfaction
Inpatient Cardiac Surgery Patient Satisfaction
Data Source: Press Ganey patient satisfaction survey data
92
91.5
91
90.5
90
89.5
89
88.5
88
Apr. - June July - Sept. Oct. - Dec.
2011
2011
2011
Data Source: Press Ganey patient satisfaction survey data
Jan. - Mar.
2012
Inpatient Cardiology Patient Satisfaction
Data Source: Press Ganey patient satisfaction survey data
31
90.6
90.4
90.2
90
89.8
89.6
89.4
89.2
89
88.8
Apr. - June July - Sept. Oct. - Dec.
2011
2011
2011
Emergency Department Patient Satisfaction
Jan. - Mar.
2012
86.5
86
85.5
85
84.5
84
83.5
83
82.5
82
Apr. - June July - Sept. Oct. - Dec.
2011
2011
2011
Jan. - Mar.
2012
The Christ Hospital Lindner Research Center
Peer-Reviewed Scientific Publications
2011
Publications
Quyyumi AA, Waller EK, Murrow J, Esteves F, Galt J, Oshinski J, Lerakis S, Sher S, Vaughan D, Perin E, Willerson J, Kereiakes D, Gersh BJ,
Gregory D, Werner A, Moss T, Chan WS, Preti R, Percora AL. CD34+ cell infusion after ST elevation myocardial infarction is associated with
improved perfusion and is dose dependent. Am Heart J 2011;161:98-105.
Aronson D, Verbalis JG, Mueller M, Krum H on behalf of the DILIPO investigators. Short- and long-term treatment of dilutional
hyponatraemia with satavaptan, a selective arginine vasopressin V2-receptor antagonist: the DILIPO study. Eur J Heart Fail 2011
Jan 3 [Epub].
Mazur W, Hor KN, Germann JT, Fleck RJ, Al-Khalidi HR, Wansapura JP, Chung ES, Taylor MD, Jefferies JL, Benson DW, Gottliebson WM.
Patterns of left ventricular remodeling in patients with Duchenne muscular dystrophy: A cardiac MRI study of ventricular geometry, global
function, and strain. Int J Cardiovasc Imaging 2011 Jan 8 [Epub].
Hor KN, Wansapura JP, Al-Khalidi HR, Gottliebson WM, Taylor MD, Czosek RJ, Nagueh SF, Akula N, Chung ES, Benson DW, Mazur W. Presence
of mechanical dyssynchrony in Duchenne muscular dystrophy. J Cardiovasc Magn Reson. 2011;13:12-18.
Hor KN, Baumann R, Pedrizzetti G, Tonti F, Gottliebson WM, Taylor M, Benson W, Mazur W. Magnetic resonance derived myocardial strain
assessment using feature tracking. J Vis Exp. 2011;48:2356.
Szczeklik W, Miszalski-Jamka T, Mastalerz L, Sokolowska B, Dropinski J, Banys R, Hor KN, Mazur W, Musial J. Multimodality Assessment of
Cardiac Involvement in Churg-Strauss Syndrome Patients in Clinical Remission. Circ J. 2011;75:649-55.
Miszalski-Jamka T, Klimeczek P, Banys R, Krupinski M, Nycz K, Bury K, Lada M, Pelberg R, Kereiakes DJ, Mazur W. The composition and
extent of coronary artery plaque detected by multislice computed tomographic angiography provides incremental prognostic value in
patients with suspected coronary artery disease. Int J Cardiovasc Imaging. 2011 Mar 3 [Epub]
32
Cannon LA, Kereiakes DJ, Mann T, Popma JJ, Mooney MR, Mishkel GJ, Lee TC, Wilson BH, Stuckey TD, Orlow S, McGarry T, Ring ME,
Kellett MA, Underwood P, Dawkins KD. TAXUS PERSEUS Small Vessel: A Prospective Evaluation in a non-Randomized Trial of the Safety
and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery
Lesions in Small Vessels. EuroIntervention 2011;6:920-7.
Tantry U, Kereiakes DJ, Gurbel P. Clopidogrel and proton pump inhibitors: Influence of pharmacologic interactions on clinical outcomes
and mechanistic explanations. J Am Coll Cardiol Interventions 2011; 4:365-380.
Kereiakes DJ, Smits PC, Kedhi E, Parise H, Fahy M, Serruys PW, Stone GW. Predictors of death or myocardial infarction, ischaemic-driven
revascularisation, and major adverse cardiovascular events following everolimus-eluting or paclitaxel-eluting stent deployment: Pooled
analysis from the SPIRIT II, III, IV and COMPARE trials. EuroIntervention 2011;7:74-83.
Bhatti S, Hakeem A, Yousuf MA, Al-Khalidi HR, Mazur W, Shizukuda Y. Diagnostic performance of computed tomography angiography
for differentiating ischemic vs nonischemic cardiomyopathy. J Nuclear Cardiol. 2011; 18:407-20.
Stone GW, Rizvi A, Sudhir K, Newman W, Applegate RJ, Cannon LA, Maddux JT, Cutlip DE, Simonton CA, Sood P, Kereiakes DJ for the
SPIRIT IV investigators. Randomized comparison of everolimus- and paclitaxel-eluting stents: Two-year follow-up from the SPIRIT IV
(Clinical evaluation of the XIENCE V everolimus eluting coronary stent system) trial. J Am Coll. Cardiol. 2011;58:19-25.
Neutel J, Kereiakes DJ, Stoakes KA, Maa JF, Shojaee A, Waverczak WF. Blood pressure-lowering efficacy of an olmesartan medoxomil/
hydrochlorothiazide-based treatment algorithm in elderly patients (≥65 years) stratified by age, gender, and race. Drugs Aging
2011;28:477-90.
Kereiakes DJ. Novel drug-eluting coronary stents nearing approval in the United States. Cardiac Interventions Today 2011;5:29-34.
Stone GW, Kedhi E, Kereiakes DJ, Parise H, Fahy M, Serruys PW, Smits PC. Differential clinical responses to everolimus-eluting and
paclitaxel-eluting coronary stents in patients with and without diabetes mellitus. Circulation 2011;124:893-900.
33
Srivatsa SS, Taylor MD, Hor K, Collins DA, King-Strunk M, Pelberg RA, Mazur W. Liquefaction necrosis of mitral annular calcification
(LNMAC): review of pathology, prevalence, imaging and management: proposed diagnostic imaging criteria with detailed multi-modality
and MRI image characterization. Int J Cardiovasc Imaging 2011; Aug 24 [Epub]
Kereiakes DJ, Neutel JM. Seated cuff blood pressure-lowering efficacy of an olmesartan medoximil-based treatment regimen in patients
with type 2 diabetes mellitus. Drugs in Research & Development 2011:11;251-7.
Kereiakes DJ, Cannon LA, Ormiston JA, Turco MA, Wang H, Underwood P, Dawkins KD. Propensity-matched patient level comparison of
the TAXUS Liberté and TAXUS Element (ION) paclitaxel-eluting stents. Am J Cardiol 2011;108:828-37
Murrow J, Esteves F, Galt J, Chen J, Garcia E, Lin J. Lerakis S, Sher S, Khan Pohlel F, Waller EK, Vaughan D, Perin E, Willerson J,
Kereiakes DJ, Preti R, Percora AL, Quyyumi AA. Characterization of mechanical dyssychrony measured by gated photon emission
computed tomography phase analysis after acute ST-elevation myocardial infarction. J Nucl Cardiol 2011;18:912-9.
Tantry US, Kereiakes DJ, Gurbel PA. Role of ticagrelor in the treatment of coronary artery disease. Clinical Investigation 2011;1:429-437.
Povsic TJ, O’Connor CM, Henry T, Taussig A, Kereiakes DJ, Fortuin FD, Niederman A, Schatz R, Spencer III R, Owens D, Banks M, Joseph D,
Roberts R, Alexander JH, Sherman W. A double-blind, randomized controlled multicenter study to assess the safety and cardiovascular
effects of skeletal myoblast implantation by catheter delivery in patients with chronic heart failure following myocardial infarction. Am
Heart J 2011;162:654-662.e1.
Planer D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, Serruys PW, Stone GW. Comparison of everolimus-eluting and paclitaxel-eluting
stents in patients with acute and stable coronary syndromes: pooled results of the SPIRIT and COMPARE trials. J Am Coll Cardiol Intv
2011;4:1104-15.
Miszalski-Jamka T, Szczeklik W, Sokolowska B, Miszalki-Jamka K, Karwat K, Grządziel G, Mazur W, Kereiakes DJ, Musial J. Cardiac
involvement in Wegener’s granulomatosis resistant to induction therapy. Eur Radiol 2011; 21:2297-2304.
34
Cannon LA, Jones J, Cheong WF, Kusano H, Kereiakes DJ, Wang J, Zhang Z, Li X, Hattori K, Sood P, Simon D, Costa MA. The XIENCE nano™
everolimus eluting coronary stent system for the treatment of small coronary arteries: The SPIRIT small vessel trial. Catheterization and
Cardiovascular Interventions 2011 Nov 25; doi:10.1002/ccd.23397
Izzo JL Jr, Chrysant SG, Kereiakes DJ, Littlejohn III T, Oparil S, Melino M, Lee J, Fernandez V, Heyrman R. 24-hour efficacy and safety of triplecombination therapy with olmesartan, amlodipine, and hydrochlorothiazide: the TRINITY ambulatory blood pressure substudy. J Clin Hypertens
2011;13:873-80.
Szczeklik W, Miszalski-Jamka T, Mastalerz L, Sokolowska B, Dropinski J, Banys R, Hor KN, Mazur W, Musial J. Multimodality Assessment of Cardiac
Involvement in Churg-Strauss Syndrome Patients in Clinical Remission. Circ J. 2011;75:649-55.
Claessen B, Smits PC, Kereiakes DJ, Parise H, Fahy M, Kedhi E, Serruys PW, Lansky AJ, Cristea E, Sudhir K, Sood P, Simonton CA, Stone GW. Impact of
lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus-eluting vs. paclitaxel-eluting stents:
Pooled analysis from the SPIRIT and COMPARE randomized trials. J Am Coll Cardiol Intv 2011;4:1209-15.
Mega JL, Hochholzer W, Frelinger III AL, Kluk MJ, Angiolillo DJ, Kereiakes DJ, Isserman S, Rogers WJ, Ruff CT, Contant C, Pencina MJ, Scirica BM,
Longtine JA, Michelson AD, Sabatine MS. Dosing clopidogrel based on CYP2C19 genotype and the effect on platelet reactivity in patients with
stable cardiovascular disease. J Am Med Assn 2011;306:2221-8.
Pires LA, Ghio S, Chung ES, Tavazzi L, Abraham WT, Gerritse B. Relationship between acute improvement in left ventricular function to 6-month
outcomes after cardiac resynchronization therapy in patients with chronic heart failure. Congest Heart Fail 2011;17:65-70.
Hor KN, Mazur W, Taylor MD, Al-Khalidi HR, Cripe LH, Jefferies JL, Raman SV, Chung ES, Kinnett KJ, Williams K, Gottliebson WM, Benson DW. Effects
of steroids and angiotensin converting enzyme inhibition on circumferential strain in boys with Duchenne muscular dystrophy: a cross-sectional
and longitudinal study utilizing cardiovascular magnetic resonance. J Cardiovasc Magn Reson 2011;13:60-67.
35
Pelberg R, Budoff M, Goraya T, Keevil J, Lesser J, Litwin S, Newton C, Ridner M, Rumberger J, Teague S, Winkler M. Training, competency,
and certification in cardiac CT: A summary statement from the Society of Cardiovascular Computed Tomography. Journal of
Cardiovascular Computed Tomography 2011;5:279-285.
Pelberg R, Budoff M, Goraya T, Keevil J, Lesser J, Litwin S, Newton C, Ridner M, Rumberger J, Teague S, Winkler M. Training, competency,
and certification in cardiac CT: A summary statement from the Society of Cardiovascular Computed Tomography. Journal of
Cardiovascular Computed Tomography 2011;5:279-285.
Singh PP, Abbott JD, Lombardero MS, Sutton-Tyrrell K, Woodhead G, Venkitachalam L, Tsapatsaris NP, Piemonte TC, Lago RM, Rutter MK,
Nesto RW for Bypass Angioplasty Revascularization Investigation 2 Diabetes Study Group. The prevalence and predictors of an abnormal
ankle-brachial index in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Diabetes Care 2011;34:464-467.
Jessup M, Greenberg B, Mancini D, Cappola T, Pauly DF, Jaski B, Yaroshinsky A, Zsebo KM, Dittrich H, Hajjar RJ for Calcium Upregulation
by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID) Investigators. Calcium upregulation by percutaneous
administration of gene therapy in cardiac disease (CUPID): a Phase 2 trial of intracoronary gene therapy of sarcoplasmic reticulum
Ca2+-ATPase in patients with advanced heart failure. Circulation 2011;124:304-313.
Book Chapters / Books
Pelberg R, Mazur W. Vascular CT Angiography Manual. Springer-Verlag, London, Limited 2011. ISBN 978-1-84996-259-9.
Reginelli, JP. Renal Artery Intervention. In Yadav JS(ed) Practical Peripheral Vascular Intervention, Second Edition, Lippincott,
Williams & Wilkins, 2011.
36
2012
Publications
Chrysant SG, Izzo J, Kereiakes DJ, Littlejohn T, Oparil S, Melino M, Lee J, Fernandez V, Heyrman R. Efficacy and safety of triple-combination
therapy with olmesartan, amlodipine, and hydrochlorothiazide in study participants with hypertension and diabetes: a subpopulation
analysis of the TRINITY study. J Am Soc Hypertens 2012;6:132-41.
Marso SP, Teirstein P, Kereiakes DJ, Moses J, Lasala J, Grantham JA. Percutaneous coronary intervention use in the United States: defining
measures of appropriateness. J Am Coll Cardiol Intv 2012;5:229-35.
Kereiakes DJ, Chrysant SG, Izzo J, Littlejohn T, Oparil S, Melino M, Lee J, Fernandez V, Heyrman R. Long-term efficacy and safety of triplecombination therapy with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide for hypertension. J Clin Hypertens
2012;14:149-57.
Pervaiz HM, Sood P, Sudhir K, Hermiller JB, Hou L, Hattori K, Su X, Cao S, Wang J, Applegate RJ, Kereiakes DJ, Yaqub M, Stone GW, Cutlip DE.
Peri-procedural myocardial infarction in a randomized trial of everolimus-eluting and paclitaxel-eluting coronary stents: Frequency and
impact on mortality according to historical versus universal definitions. Circ Cardiovasc Interv. 2012;5:150-156.
McKenney JM, Koren MJ, Kereiakes DJ, Hanotin C, Ferrand AC, Stein EA. Safety and efficacy of a monoclonal antibody to proprotein
convertase subtilisin/kexin type 9 serine protease, SAR236553/REGN727, in patients with primary hypercholesterolemia receiving ongoing
stable atorvastatin therapy. J Am Coll Cardiol 2012;59:2344-53.
37
Kereiakes DJ, Popma JJ, Cannon LA, Kandzari DE, Kimmelstiel CD, Meredith IT, , Stone GW, Teirstein PS, Verheye S, Allocco DJ, Dawkins KD.
Longitudinal stent deformation: Quantitative coronary angiographic analysis from the PERSEUS and PLATINUM randomized controlled
clinical trials. Eurointervention 2012;8:196-204.
Miszalski-Jamka T, Klimeczek P, Banys R, Krupinski M, Nycz K, Bury K, Lada M, Pelberg R, Kereiakes DJ, Mazur W. The composition and
extent of coronary artery plaque detected by multislice computed tomographic angiography provides incremental prognostic value in
patients with suspected coronary artery disease. Int J Cardiovasc Imaging. 2012;28:621-31
Sarembock IJ, Kereiakes DJ. Risk stratification and timing of revascularization: Which patients benefit from early versus later
revascularization? Curr Cardiol Rep 2012 May 13 [Epub ahead of print].
O’Brien TM, Menon S, Stephens T, Mazur W, Chung ES. Algorithm-based assessment of target weight removal in acute decompensated
heart failure. Congest Heart Fail. 2012;18:43-6.
Mazur W, Hor KN, Germann JT, Fleck RJ, Al-Khalidi HR, Wansapura JP, Chung ES, Taylor MD, Jefferies JL, Benson DW, Gottliebson WM.
Patterns of left ventricular remodeling in patients with Duchenne muscular dystrophy: A cardiac MRI study of ventricular geometry, global
function, and strain. Int J Cardiovasc Imaging 2012;28:99-107.
Chung ES, Dye L, Feldmann A, Conley D, Bartone C, McDonald M. Effect of automated, point of care electronic medical record screening
for appropriate implantable device use in heart failure patients. Am J Med Qual. 2012 May 16.
Miszalski-Jamka T, Szczeklik W, Nycz K, Sokolowska B, Bury K, Zawadowski G, Noelting J, Mazur W, Musial J. The mechanics of left
ventricular dysfunction in patients with Churg-Strauss syndrome. Echocardiography 2012;29:568-78.
Galkina EV, Butcher M, Keller SR, Goff M, Bruce A, Pei H, Sarembock IJ, Sanders JM, Nagelin MH, Srinivasan S, Kulkarni RN, Hedrick CC,
Lattanzio FA, Dobrian AD, Nadler JL, Ley K. Accelerated atherosclerosis in Apoe-/ - mice heterozygous for the insulin receptor and the
insulin receptor substrate-1. Arterioscler Thromb Vasc Biol. 2012;32:247-256.
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Palmerini T, Kirtane AJ, Serruys PW, Smits PC, Kedhi E, Kereiakes DJ, Sangiorgi D, Bacchi Reggiani L, Kaiser C, Kim HS, De Waha A, Ribichini
F, Stone GW. Stent thrombosis with everolimus-eluting stents: Meta-analysis of comparative randomized controlled trials. Circ Cardiovasc
Interv 2012:5:357-64.
Book Chapters / Books
Kereiakes DJ, Henry TD. Regional Centers of Excellence for the Care of Patients With Acute Ischemic Heart Disease. In Topol EJ, Teirstein PS
(ed) Textbook of Interventional Cardiology, 6th edition, Elsevier Saunders, 2012.
Kereiakes DJ, Sarembock IJ. Stent thrombosis. In Serruys P (ed) Percutaneous Interventional Cardiovascular Medicine, 1st edition, PCR
publishing, 2012.
Gurbel PA, Kereiakes DJ, Tantry US. Coronary Heart Disease: Thrombosis, Haemostasis and Platelet Biology. In Myat A and Gershlick T (ed)
Landmark Papers in Cardiovascular Medicine. Oxford University Press, 2012.
The Christ Hospital Heart & Vascular Center
Contacts
39
Heart and Vascular Center
The Carl and Edyth Lindner Research Center
513-585-1613
513-585-1777
www.TheChristHospital.com/heart www.LindnerResearch.com
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