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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. 38 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