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DAIC Thought Leadership Series: The Importance of Inclusion in Clinical Trials

The Importance of Inclusion in Clinical Trials
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    As part of DAIC's continuing Thought Leadership Series, this month Editorial Director Melinda Taschetta-Millane sits down with Philip B. Adamson, MD, MSc, FACC, Chief Medical Officer of CVRx, to talk about health equity — starting at the beginning of clinical trials, and including how medical device manufacturers need a clear roadmap from the get-go to achieve success.

    As Chief Medical Officer of CVRx, Dr. Adamson will spearhead efforts to drive awareness and appropriate use of Barostim therapy among clinicians. He will guide comprehensive medical education, outreach and guideline integration initiatives to establish Barostim as the standard of care for patients with heart failure. Dr. Adamson previously was with Abbott Laboratories, where he served as Divisional Vice President and Chief Medical Officer of the Heart Failure division. A renowned expert in heart failure, he has nearly three decades of experience in academia as a professor and as a practicing cardiologist, during which time he authored over 150 manuscripts and book chapters. Dr. Adamson earned his MD with distinction from the University of Oklahoma College of Medicine and MSc in physiology from the University of Oklahoma.

    His clinical interests focus on developing more efficient and effective disease management systems for patients with chronic heart failure, specifically focusing on remote monitoring of physiologic signals from implanted devices. He has also served as the principal investigator on the steering committees of several large randomized clinical trials over the past decade.

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    Conference Coverage

    Cardiovascular Information Systems (CVIS) | December 18, 2014

    Sentara Health in Virginia is going through the process of choosing a new cardiovascular information system (CVIS) and implementing enterprise imaging. Sentara's IT leader shares information on what elements they are looking for and how they plan to wire their system to achieve a new level of interoperability for cardiology. They were at RSNA 2014 visiting with CVIS vendors as part of their selection process. Read the article "10 Questions to Ask When Purchasing a Cardiovascular Information System."
     

     

    Information Technology | December 18, 2014

    QICS is a unique, automated workflow management solution to help today's medical professionals enhance the delivery of care, reduce risks, optimize user productivity and meet regulatory requirements compliance. QICS can provide workflow efficiencies that help providers improve performance and satisfaction for both physicians and patients. Qualitative Intelligence and Communication System (QICS) solutions can help: Create records for accountability and analytics — Meet regulatory requirements — Reduce manual processes to streamline workflow — Optimize communication to help deliver better care

    Enterprise Imaging | December 18, 2014

    McKesson is committed to working with facilities to adapt to the new healthcare reality in both an effective and cost-efficient fashion. The vendor does this by providing a suite of enterprise solutions including: McKesson Enterprise Image Repository — Brings together all the scattered images from numerous isolated systems into the image repository (VNA) and helps provide a single view of the patient's imaging history, accessible from anywhere across the enterprise.  McKesson Clinical Data Exchange — Manage, share and access patient images and clinical documents anywhere in the enterprise or across a region from any common Web-enabled device or workstation by leveraging the IHE cross-enterprise document sharing (XDS) integration profile.

    RSNA | December 12, 2014

    Many of the key trends in radiology seen at the Radiological Society of North America (RSNA) 2014 meeting are discussed by ITN Contributing Editor Greg Freiherr and ITN Editor Dave Fornell.

    RSNA | December 12, 2014

    Here are ITN Editor Dave Fornell's choices for the most innovative new imaging technologies shown on the expo floor at the Radiological Society of North America (RSNA) 2014 annual meeting.

    Cardiovascular Ultrasound | October 17, 2014

    Siemens introduces True volume transesophageal echo (TEE) transducer — this 3-D/4-D 90°x90° TEE solution enables clinically meaningful echocardiography visualization of anatomy, volume color Doppler and function in one volume view, without compromises like stitching. Combined with eSieValves advanced cardioac ultrasound analysis package, it offers automated modeling and quantification in seconds allowing cardiologists to remove the guesswork from valve sizing. For more information: usa.healthcare.siemens.com/ultrasound/cardiovascular/acuson-sc2000-ultrasound-system/features

    Vascular Closure Devices | September 26, 2014

    Doug Drachman, M.D., Mass General Hospital Institute of Heart, Vascular and Stroke Care, explains how to prevent and manage access site complications, use of vascular closure devices and how to aid patient ambulation following PCI.

    Intravascular Imaging | September 26, 2014

    Ziad Ali, M.D., senior scientist at the Cardiovascular Research Foundation (CRF), discusses the current trials and future possibilities of intravascular near-infrared spectroscopy imaging to identify and pre-treat vulnerable plaque.

    Cath Lab | September 26, 2014

    DAIC Editor Dave Fornell offers his choices of the most innovative new cardiovascular technologies discussed in sessions and shown on the expo floor at the Transcatheter Cardiovascular Therapeutics (TCT) 2014 meeting.

    Stents Bioresorbable | September 24, 2014

    DAIC Editor, Dave Fornell, interviews  Jim Hermiller, M.D., FACC, director of interventional cardiology, St. Vincent Heart Center-Indiana, and a principle investigator in the Absorb III Trial. Read the article "FDA Approves First Totally Bioresorbable Stent."

    CT Angiography (CTA) | September 24, 2014

    John Stevens, chairman and CEO of HeartFlow, explains his company's computed tomography (CT)-based fractional flow reserve (FFR) assessment technology, which may eliminate the need for catheter-based FFR measurements.

    Cardiovascular Information Systems (CVIS) | September 12, 2014

    Centricity Cardio Enterprise Solution from GE Healthcare is designed to empower Cardiologists to enhance patient care through full clinical access, optimized productivity and enhanced revenue cycle efficiencies. Omar Sunna, global product manager for GE Healthcare IT, explains some of the highlights of the system at the American College of Cardiology (ACC) 2014 meeting.

    Advanced Visualization | July 30, 2014

    Toshiba launched its new myocardial perfusion software for computed tomography (CT) during the 2014 American College of College of Cardiology (ACC) annual meeting. Perfusion imaging is now available on both the Aquillion One and Aqullion One Vision CT systems.

    CT Angiography (CTA) | July 23, 2014

    Society of Cardiovascular Computed Tomography (SCCT) Past President Matthew Budoff, M.D., explains some of the new technology and latest trends seen in cardiac CT during the SCCT 2014 annual meeting in San Diego, Calif.

    Cardiovascular Ultrasound | July 18, 2014

    The Aplio 500 CV is the system of choice for all premium 2-D cardiac exams. Featuring Toshiba's 2-D Wall Motion Tracking technology, the system provides stunning visualization and quantitative analysis of myocardial wall motion with unrivaled accuracy and reproducibility. With on-board cardiac quantification measurements in all directions (radial, circumferential, 2D rotation and longitudinal), the Aplio 500 CV system is designed to get the most comprehensive information anytime and anywhere in the hospital, right at the patient's bedside. Additional cardiac-specific technologies include Tissue Enhancement, Advanced Dynamic Flow, Lateral Gain Controls, Tissue Doppler, Stress Echo, Flex-M Mode and Auto IMT. The system is easy to use, with superior ergonomics and a smaller footprint, making it easier to maneuver for greater patient access and improved workflow. For more information: http://medical.toshiba.com/products/ul/cardiovascular/index.php

    Cardiovascular Ultrasound | July 03, 2014

    DAIC Editor Dave Fornell highlights his choices for some of the most innovative new technology at the American Society of Echocardiography (ASE) 2014 meeting.

    Cardiovascular Ultrasound | July 02, 2014

    ASE Past President James Thomas, M.D., explains some of the hot topics in cardiovascular ultrasound at the 2014 meeting of the American Society Echocardiography (ASE).

    Nuclear Imaging | June 20, 2014

    DAIC Editor Dave Fornell shares his choices for the most innovative new technologies in nuclear imaging that were on display at the 2014 Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting.

    Nuclear Imaging | June 19, 2014

    Satoshi Minoshima, M.D., Ph.D., chairman of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Scientific Committee, discusses the new technologies and trends at the SNMMI 2014 meeting.

    ACC | April 08, 2014

    DAIC Editor Dave Fornell offers his choices of the most innovative new cardiovascular technologies shown on the expo floor at the American College of Cardiology (ACC) 2014 meeting.

    Stents Bioresorbable | April 03, 2014

    Bioresorbable stent technology was one of the big interventional technologies discussed at the American College of Cardiology (ACC) 2014 meeting. Doug Drachman, M.D., Mass General Hospital, explains where the technology is today and what we will likely see in the future. Read the article "FDA Approves First Totally Bioresorbable Stent."

    Heart Valve Technology | April 03, 2014

    The biggest late-breaking news to come out of the American College of Cardiology (ACC) 2014 meeting was from the CoreValve High-Risk pivotal trial, which showed a transcatheter valve offers a 26 percent survival benefit over surgical valve replacement. Co-Principal Investigator David Adams, M.D., explained the impact of the trial.

    Renal Denervation | April 03, 2014

    A major disappointment earlier this year was the announcement by Medtronic that its renal denervation system failed to meet its primary endpoint for efficacy in the U.S. SYMPLICITY HTN-3 trial. Michael Jaff , D.O., worked as part of the core lab for the trial and explains the trial outcomes and the future of renal denervation technology. He spoke to DAIC Editor Dave Fornell at the 2014 American College of Cardiology (ACC) meeting where the trial results were released.

     

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    VIDEO: Device Therapies to Treat Hypertension

    SPYRAL HTN-OFF MED Study Results Show Efficacy, Safety of Renal Denervation

    Medtronic Announces Spyral HTN Global Clinical Trial Program for Renal Denervation

    Medtronic Randomizes First Patients in Symplicity HTN-4

    Medtronic Says its U.S. Renal Denervation Pivotal Trial Fails to Meet Primary Efficacy Endpoint

    The Future of Renal Denervation Following the Failed SYMPLICITY HTN-3 Trial

     

    Information Technology | March 07, 2014

    A big trend in healthcare IT at HIMSS 2014 was the creation of enterprise-wide image access systems. With the introduction of vendor neutral archives (VNAs), enterprise imaging will increasingly be taken out of the hands of radiology and move to the responsibility of hospital IT directors. In this form, radiology may become just another department contributing images to the VNA. HIMSS also highlighted the proliferation of new, inexpensive home use patient monitors.

    Cath Lab | November 11, 2013

    DAIC Editor Dave Fornell offers his choices of the most innovative new cardiovascular technologies discussed in sessions and shown on the expo floor at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 meeting.

    Heart Valve Technology | November 07, 2013

    Scott Lim, M.D., director of the Heart Valve Center at the University of Virginia Medical Center, investigator in the EVEREST and COAPT trials, discusses the MitraClip transcatheter mitral valve repair system at TCT 2013. The device recieved FDA clearance a couple days before TCT.

    Read the article "FDA Clears First Transcatheter Mitral Valve Repair Device."
     

    November 07, 2013

    Herbert Aronow, M.D., MPH, St. Joseph Mercy Hospital, Ann Arbor, and an active member of ACC and SCAI, explains the top interventional cardiology highlights at TCT 2013.

    Cardiovascular Ultrasound | July 15, 2013

    American Society of Echocardiography (ASE) President Benjamin Byrd III, M.D., FASE, explains some of the recent trends and issues facing cardiac ultrasound. These trends include reimbursement issues, the rapid expansion of point-of-care ultrasound and the critical role played by the new sub-specialty of interventional ultrasound.

    Cardiovascular Ultrasound | July 15, 2013

    DAIC Editor Dave Fornell highlights some of the biggest trends and most innovative technology discussed during the American Society of Echocardiology (ASE) 2013 annual meeting.

    Cardiovascular Information Systems (CVIS) | April 19, 2013

    Agfa Healthcare introduced new functionality and workflow improvements for its completely revised cardiovascular information system (CVIS), introduced at the American College of Cardiology 2013 meeting. The CV12 system offers new solutions for echocardiography, nuclear perfusion imaging, cath lab reporting and ECG management and reporting. For more information, visit www.agfahealthcare.com

    Blood Pressure Monitor | March 26, 2013

    SunTech demonstrated its new Tango M2 cardiac stress test automated blood pressure monitoring system at the American College of Cardiology (ACC) 2013. The system eliminates the need to manually take blood pressure readings during a stress test, which can sometimes be difficult because of patient motion. It also allows clinicians to focus on the patient and the test instead of worrying about periodic blood pressure measurements. For more information, visit www.SunTechMed.com/TM2Info

    Cardiovascular Information Systems (CVIS) | March 22, 2013

    McKesson highlighted enhancements to its cardiovascular information system (CVIS) version 13. The system offers new modules for electrophysiology, inventory control and aids interoperability for better change capture and data mining. For more information, visit www.allaboutCVIS.com

    Cath Lab | March 19, 2013

    Ajay Kirtane, M.D., SD, chief academic officer at Columbia University Medical Center/New York Presbyterian Hospital, explains the key highlights regarding interventional cardiology at the American College of Cardiology (ACC) 2013. These included data on the use of cangrelor vs. clopidogrel during cath lab procedures, first U.S. reports on using the smaller Sapient XT transcatheter aortic valve, and the safety of using shorter duration dual-antiplatelet therapy with drug-eluting stents.

    ACC | March 19, 2013

    The American College of Cardiology (ACC) 2013 Scientific Session Committee Chairman Miguel Quinones, M.D., explains some of the key highlights from this year's meeting. Highlights included the impact of niacin on lowering cholesterol, new data on transcatheter aortic valve repair, and how mummies show atherosclerosis is not a modern disease.

    ACC | March 19, 2013

    DAIC Editor Dave Fornell explains his choices for the most innovative new technology on the expo floor at the American College of Cardiology (ACC) 2013. These include new angiography systems, dose monitoring software and technology integrations, an iPhone ECG monitoring device, ultrasound-aided CRT lead optimization, and new radiation protection aprons that are up to 50 percent lighter.

    Telecardiology | February 22, 2013

    The Iowa Heart Center created a telecardiology program that connects cardiologists in Des Moines with satellite facilities in rural towns around the state. With help from Esaote, patients can have their echo exams performed on a compact ultrasound system and delivered to Des Moines for review by experts. Iowa Heart will detail its program during sessions at ACC.2013, March 9-11, in San Francisco.

    Cardiac Imaging | December 20, 2012

    At RSNA 2012, Hitachi featured its Echelon Oval 1.5T MRI system, which features the widest bore on the market at 74 cm, a wide table and the ability to perform non-contrast MR angiography exams. Hitachi also highlighted new features for its Scenaria CT system, which is upgradeable to a 128-slice system, offers new, faster iterative reconstruction software and cardiac imaging packages.

    Cardiac Imaging | December 18, 2012

    DAIC Editor Dave Fornell highlights the latest advancements that will impact cardiovascular imaging from the 2012 Radiological Society of North America (RSNA) meeting. RSNA is the largest medical imaging show in the world and most advancements are shown here first.

    Cardiac Imaging | December 07, 2012

    Imaging Technology News experts discuss the trends and latest technology they saw on the show floor and in sessions at RSNA 2012. Their discussions include some of the most innovative new devices and software to solve issues facing radiology today.

    Antiplatelet and Anticoagulation Therapies | December 07, 2012

    One-year results from the ADAPT-DES Trial were presented during TCT 2012. It examined patient hyporesponsiveness to clopidogrel and aspirin in a large-scale, prospective, multicenter study.

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