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A Unique Collaboration: The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital

Edward J. Schloss, MD, medical director of electrophysiology, The Christ Hospital, Vicki Placke, RN, BSN, clinical manager of electrophysiology, The Christ Hospital, and Karen Ibanez, RN, operational manager, The Carl and Edyth Lindner Center for Research and Education, Cincinnati, Ohio
The Christ Hospital recently purchased the Lindner Clinical Trial Center, becoming The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital. This new partnership will further expand clinical research and education in cardiac electrophysiology. Read more about their upcoming trials here. Physicians who want to include their patients in innovative therapy trials often find the process daunting. For example, the physicians and their support staff are often inundated with mountains of documentation. But for physicians who work at The Christ Hospital, the hospital and now hospital-owned Carl & Edyth Lindner Center for Research and Education at The Christ Hospital (The Lindner Research Center) provide organization and support for patient evaluation, documentation and review. In December of 2008, The Christ Hospital in Cincinnati, Ohio, finalized its purchase of The Lindner Research Center. The two are working together again after nearly a 10-year separation. The Lindner Research Center is now one of the few research centers associated with a private hospital, and The Christ Hospital is one of the few private hospitals associated with a top-ranking research center. This is the kind of unique synergy that is usually found only in university settings. The Christ Hospital, a 555-bed, not-for-profit acute care facility, has always been known for the quality of its cardiovascular care, but it extends its services to spine treatment, women’s health, major surgery, cancer, behavioral medicine, orthopedics, emergency care, kidney transplant and other specialties. Consistently recognized by U.S. News & World Report as one of the nation’s top hospitals, The Christ Hospital has been named Cincinnati’s Most Preferred Hospital for 13 consecutive years by the National Research Corporation. The Lindner Research Center will continue to operate under the leadership of Medical Director Dean Kereiakes, MD. The Lindner Research Center, a top enroller in the research arena, will retain the name of its non-profit component, The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital. Susan Croushore, President and CEO of The Christ Hospital, looks forward to a productive partnership. “This is a tremendous opportunity to build upon The Lindner Research Center’s international reputation for excellence in clinical research by extending its reach into new areas of specialty within the hospital. Having a central research arm with many facets will help us develop next-generation treatments and technologies that will benefit our patients, our physicians and our community.” The Lindner Research Center at The Christ Hospital now provides a firmer platform for physicians to focus on clinical work and create both a successful practice and a research environment. Working together, the physicians, the nurses and the data analysts can turn many homespun ideas into multi-center trials. Current Research Initiatives Historically, physicians at The Lindner Research Center have participated in more than 1,000 clinical trials, many in collaboration with The Christ Hospital. Together, they have performed multiple first-in-man or first-in the U.S. procedures, as well as innumerable first-in Cincinnati procedures. Currently, there are approximately 130 active trials, with 60 enrolling patients and about 70 in follow-up phase. Notable benchmarks include the hypothesis of the PROSPECT trial, which evaluated the use of echocardiograms as a predictive test for cardiac resynchronization therapy. Physicians at The Christ Hospital also led the MASTER trial, which examined the ability of microvolt T wave alternans testing to identify patients most at risk for cardiac arrest and therefore in need of implantable cardioverter-defibrillator (ICD) therapy. In the past, The Lindner Research Center was involved in trials of ibutilide and amiodarone, which are now both on the market. The Lindner Research Center was also involved in trials of the medication Betapace (sotalol), also out on the market. Working on the electrophysiology frontier, The Lindner Research Center and The Christ Hospital’s original research produced the first Chronicle ICD implant, a defibrillator that has the dual capability to prevent sudden cardiac arrest by regulating heart rate and monitoring congestive heart failure. Other firsts include the first Medtronic 4194 left ventricular pacing lead implantation. Eight other electrophysiology trials are currently in progress at The Christ Hospital, ranging from device trials to drug studies to anatomical research. For instance, The Lindner Center is running the ARISTOTLE trial (Bristol-Myers Squibb and Pfizer) to test an alternative medication to Coumadin that works through an entirely different pathway. The drug being tested may prevent blood clots that occur during atrial fibrillation. The hope is that agent will offer greater predictability and fewer side effects, along with a steady rate of blood pressure and less dosage fluctuation between patients. Another promising trial is called BLOCK HF (Medtronic), which has been ongoing since February of 2004. The aim of the BLOCK HF trial is to test the hypothesis that biventricular pacing is superior to right ventricular (RV) pacing in patients presenting with heart block. Patients in the trial are randomized to RV versus biventricular pacing and followed for the development of heart failure. A similar trial is also just getting underway — the Echo CRT (Biotronik) studying biventricular pacing in patients with narrow QRS intervals. The Venogram trial (Cardiac Concepts) was initiated in October of 2008. This device is concerned with the phrenic nerve and its role in hyperventilation episodes during central sleep apnea. The Venogram trial (Cardiac Concepts) was initiated in October of 2008. This device is concerned with the phrenic nerve and its role in hyperventilation episodes during central sleep apnea. The WATCHMAN trial (Atritech) has been going on for five years. As a left atrium appendage occlusion device, the WATCHMAN prevents stroke in patients with atrial fibrillation. This is accomplished through a fine-mesh, basket-like filter device that is placed over the opening of the left atrial appendage. In this way, blood clots are prevented from traveling outside the appendage. A few years ago, The Lindner Research Center physicians successfully piloted a trial called OPIS. Although that trial is now closed, the results led to the MendMI trial, which calculates biventricular pacing. This trial, through Boston Scientific, involves novel research on left ventricular pacing to prevent the heart from enlarging after a heart attack. The Lindner Research Center is testing still another biventricular pacing indication for Boston Scientific. Called MADIT-CRT, this trial is aimed at heart attack survivors with impaired heart function. Hopefully, the device can slow the progression of heart failure before the patient again becomes symptomatic to the point of debilitation. As in MendMI, the goal is to minimize remodeling. This trial is in the follow-up phase. Summary Now that The Christ Hospital and The Lindner Research Center have merged, one major advantage is the physicians’ relationship to their research. What is unique about this situation is that The Lindner Center has a dedicated staff. We see this when we go to meetings and talk to other centers. The dedicated staff can put a lot of time and focus on communication with the patients, sponsors and auditors in a way that frees up physicians to concentrate on patient care. We are then able to be effective investigators who can focus on the investigative clinical component. Ideas continue to spin off into the electrophysiology work that we do at The Christ Hospital every day in the EP lab. We are continually amazed by the developments in three-dimensional technology. When The Lindner Research Center physicians at The Christ Hospital share their visions for the future of electrophysiology research, they often involve the combination of device and pharmacological treatments. The future of The Lindner Research Center and The Christ Hospital seems bright and open to opportunity. For more information, please visit: www.thechristhospital.com.

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