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<title><string language="fre"><![CDATA[Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 4 : What endpoint for securing approval and reimbursement (Andrew FARB - Ileana PIÑA)]]></string></title>
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<string language="fre"><![CDATA[MODIGLIANI Debate Session 4 - Saturday December 1st, 2012:
HEART FAILURE REMOTE MONITORING TRIALS
Chairpersons: Stefan ANKER, Berlin, GER - Ileana PIÑA, New York, USA
Webcast: Daniela DOBRE, Nancy, FRA
Case studies and ultimate methodology for future trials
Remote monitoring remains an appealing option for following patients after a heart-failure hospitalization. Trials employing common strategies (simple phone calls with a nurse and Telemonitoring of vital signs) have in general not demonstrated improvement in survival and or reduction in risk of readmission; meta-analysis of telemonitoring trials using these common strategies, however, have shown improvements in survival and hospitalization rates. Recently, trials of more complex implanted remote monitoring devices that provide physiologic information have reported mixed results.
The 2 most recently published device remote monitoring trials are excellent case-studies that may serve for methodologically refining future trials:
• The CHAMPION trial was the first trial of a technology based (pulmonary artery pressure) telemonitoring (CardioMEMS), published in a major scientific journal (The Lancet) without standing positive results. The FDA advisory panel found the device to be safe (9-1 vote) but did not vote in favor of efficacy (4-6 vote) because of inability to distinguish the effect of the device from the support provided by the Sponsor to the investigators during the trial. The panel and the FDA were also concerned that this level of Sponsor support may not be practical in the commercial setting. The PIs and the Sponsor, however, pointed out that the device provides information only and to adequately test the trial hypothesis (management of pulmonary artery pressure in addition to routine HF care would reduce HF hospitalizations), there had to be a protocol compliance mechanism to ensure that physicians reviewed and responded to pulmonary artery pressures
per the protocol mandated guidelines. This trial poses interesting methodological questions regarding the evaluation of diagnostic devices; how do we design trials with therapeutic endpoints for purely diagnostic devices?
• The DOT-HF trial reported that Telemonitoring based on thoracic impedance was unexpectedly associated with more frequent hospital admissions in the Telemonitoring group. Then the question arises whether this trial failed because the technology - i.e. impedance - failed to deliver the right alerts at the right time or whether the strategy of care using the technology (beep alerts to the patient, no decisio support to the health care providers who managed patients according to a standardized intervention algorithm, on the basis of the available data and the clinical evaluation) was inadequate/ insufficient.
The aim of this workshop is by analyzing lessons from these 2 case-studies, to hopefully reach agreement on the ultimate methodology of future trials of remote monitoring.
Session program:
How to minimize bias? Trial design, control group, blinding and other methodological issues
Speaker: Stefan ANKER, Berlin, GER
Treatment optimization: Letting investigators decide vs. applying protocol defined algorithms (predefined, monitored, decision support systems)
Speaker: William T. ABRAHAM, Columbus, USA
What endpoint for securing approval (FDA, and in EU, beyond CE mark) and reimbursement
Debate led by regulatory agencies: Andrew FARB, FDA, USA - Ileana PIÑA, New York, USA]]></string></description>
<keyword><string language="fre"><![CDATA[Maladies cardiovasculaires]]></string></keyword>
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NOTE:Ileana PIÑA, New York, USA&lt;br&gt;Professor of Medicine &amp; Professor of Epidemiology/ Biostatistics. Case Western Reserve University. Graduated Quality Scholar. Louis Stokes Administration of Veteran’s Affairs. Dr. Piña, a cardiologist and heart failure/transplant expert received her MD at the University of Miami in 1976. She continued her education and received her Masters of Public Health in 2009 after completing a 3 year Fellowship in Quality at the Cleveland VA. She has served as Director of the Exercise Laboratory at the University of Miami, of Heart Failure and Cardiac Rehabilitation at Hahnemann University, of Cardiomyopathy at Temple University and Heart Failure/ Transplantation at University Hospitals Health System at Case Medical Center. Dr. Piña is the Principal Investigator of as well as has participated in many studies focused on improving heart failure and rehabilitation. She serves as an advisor/consultant to the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health and the Division of Epidemiology which allows her to assist in evaluation and review cardiovascular medical devices, epidemiologic research studies while working with the FDA staff. Dr. Piña is internationally recognized for her research in rehabilitation and recovery of heart failure patients. She has over 70 publications and is a world-renown speaker on this subject. She has been a recurrent presenter/speaker in the World Congress of Cardiology in Spain, Argentina, Berlin, and Beijing. She is also a National Spokesperson for Go Red for Women and the Heart Truth of Ohio in which she is dedicated to finding out why and coming up with solutions for women who suffer from Heart Disease, which will enable them to live healthier, longer, lives. In 1995, Dr. Piña established and initiated The National Heart Failure Training Program (N-Heft™) at Case Western Reserve University with Hector Ventura of Ochsner Medical Center in New Orleans, Louisiana which is a program that seeks to educate physicians and other healthcare professionals in best practices for treating heart failure. Dr. Piña is a recipient of many Outstanding Service Awards and Best Doctors recognition Awards 2010. She sits on numerous committees and chairs countless scientific sessions and meetings and is currently a member for the AHA (American Heart Association) Writing Group Women’s Cardiovascular Diseases Prevention Guidelines. She also representes the AHA at the Electronic Health Inititaive (eHI) and AHRQ Task Force on Workplace. 
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NOTE:Andrew FARB, FDA, USA 
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