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Experts Praise McKesson Cardiology’s Single Database Architecture, Call for it to Become
Industry Standard

McKesson announced the release of McKesson Cardiology 13.0, with enhancements acclaimed by customers and technology experts alike for its groundbreaking innovation. With this new release, McKesson becomes the only company to offer a single database solution for cardiac and peripheral catheterization, hemodynamics monitoring, electrophysiology (EP), echocardiography, vascular ultrasound, nuclear cardiology, and ECG/stress/Holter management. Data entered at any point of care flows into the electronic health record (EHR) without the need for potentially cumbersome interfaces or redundant documentation. This latest release further emphasizes McKesson’s commitment to help healthcare providers improve patient outcomes, boost clinical efficiencies and reduce operational costs.

In the October 2011 KLAS Cardiology 2011 report, providers ranked the McKesson cardiology solution to be the most complete solution in the study.1 The solution becomes even more comprehensive with the addition of EP, stress, Holter and inventory management modules.

“The McKesson Cardiology EP is a one-of-a-kind, complete, patient-centric solution,” said Andrea Russo, MD, Director of Cardiac Electrophysiology and Arrhythmia Services, Cooper University Hospital and professor, Cooper Medical School at Rowan University. “Generally, cardiology department electrophysiology documentation is spread across at least four databases, as well as paper records. This solution integrates all essential cardiovascular information, which will ultimately lead to increased lab efficiency, improved data accuracy and improved efficiencies for cardiology staff.”

With McKesson Cardiology 13.0, all data — from pre-procedure and intra-procedure information to physician reporting to American College of Cardiology’s National Cardiac Data Registry (NCDR) — is integrated and immediately available to physicians to review or share with other caregivers. “The more information we can acquire from one source, the less data entry required and the less chance of inaccuracy,” added Russo. She also noted the benefit of customizable reporting capabilities, an ACC ICD data capture and overall ease of use as unique benefits.

As part of its research and development effort, McKesson teams worked closely with physician members of the Heart Rhythm Society (HRS), whose mission is to improve patient care through the advancement of healthcare policies and standards. The electrophysiologists from HRS praise the new McKesson release, calling for its design to become the industry standard.

“Until now, hospitals across the country have been using various vendor solutions with adequate functionality, but poor usability at the point of service,” said Michael Mirro, MD, a nationally noted member of the HRS and the American College of Cardiology, as well as Clinical Professor of Medicine at Indiana University and Medical Director, Parkview Research Center and electrophysiologist, Parkview Physician Group-Cardiology. “Staff typically had to enter the same data in multiple places, and the available systems didn’t support real-world workflows. By harmonizing all data fields, McKesson Cardiology 13.0 simplifies the data entry, including physician reporting and ICD registry workflow. In doing so, the solution helps to save staff time and reduce operational costs. This is why the HRS is now working with other professional societies to use this solution as the foundation of new healthcare IT standards.”

In addition to newly added EP and stress/Holter management capabilities, the 13.0 release includes a new inventory management module. Tightly integrated with the McKesson Point of Use Supply™, the new solution is designed to provide documentation, billing and management for inventory in the cardiovascular department. With a single barcode scan into McKesson Cardiology, for example, the system will automatically update clinical documentation, generate charges, adjust stock levels and electronically send orders to the hospital materials management system.

“McKesson has always been an active partner with professional organizations, like the HRS and our customers, to identify and develop cutting-edge solutions,” said Kevan Torgerson, president, Enterprise Medical Imaging, McKesson Provider Technologies. “The new release supports McKesson’s Better Health 2020 initiative through the availability of more accurate, timely clinical data, which leads to faster decision making and improved staff efficiencies, all at a competitive cost of ownership.”

Dr. Mirro agreed and called for greater collaboration between technology providers and clinicians. “This level of collaboration between the healthcare technology community and physician leaders is exactly what it takes to create the most advanced technology solutions,” he said. “With 13.0, McKesson has done a great thing for the entire cardiology community.”

About the Heart Rhythm Society

The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders.

About Cooper University Hospital

Cooper University Hospital is the leading provider of comprehensive health services, medical education and clinical research in Southern New Jersey and the Delaware Valley. With more than 700 physicians in over 75 specialties, Cooper is uniquely equipped to provide an almost unlimited number of medical services. As the clinical campus of the University of Medicine and Dentistry of New Jersey – Robert Wood Johnson Medical School at Camden, and now the Cooper Medical School of Rowan University, the hospital is committed to excellence in medical education, patient care and research. Cooper offers training programs for medical students, residents, fellows, nurses and allied health professionals in a variety of specialties.

About McKesson

McKesson Corporation, currently ranked 14th on the FORTUNE 500, is a healthcare services and information technology company dedicated to making the business of healthcare run better. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting. McKesson helps its customers improve their financial, operational, and clinical performance with solutions that include pharmaceutical and medical-surgical supply management, healthcare information technology, and business and clinical services. For more information, visit http://www.mckesson.com.

  1. Source: Cardiology 2011: Will the Complete CVIS Please Stand Up? report, October 2011, www.KLASresearch.com, © 2011 KLAS Enterprises, LLC. All rights reserved.

Cardiovascular Credentialing International Announces Changes to Qualification Pathways

Cardiovascular Credentialing International (CCI) announced changes to its qualification pathways for five of its credentialing programs. The effective date of these changes will be July 1, 2013. The affected credentialing programs include the following:

  • Registered Cardiovascular Invasive Specialist (RCIS)
  • Registered Cardiac Sonographer (RCS)
  • Registered Vascular Specialist (RVS)
  • Registered Cardiac Electrophysiology Specialist (RCES)
  • Registered Congenital Cardiac Sonographer (RCCS)

The eligibility changes include the following:

  1. Applicants applying under a pathway requiring on-the-job training for the RCS, RVS, and RCCS registry level credentials are required to perform a minimum of 600 studies in the corresponding specialty.
  2. Candidates who graduated with a diploma, associate, or baccalaureate degree from an academic program in health science, which is not programmatically accredited in the specialty for which they are applying, will not be eligible to sit for the certification exams until they have completed the required work experience/on-the job training (one year).
  3. For the RCIS credentialing program, the RCIS1 qualification pathway will be discontinued. This pathway, which is also referred to as the Two Year On-the-Job Training qualification pathway, allowed applicants to qualify by ONLY having been employed for two years or more (full-time or full-time equivalent) in Invasive Cardiovascular Technology.

For details, please visit www.cci-online.org/new-examination-qualifications

About CCI

CCI is a not-for-profit corporation established for the purpose of administering credentialing examinations as an independent credentialing agency. CCI began credentialing cardiovascular professionals in 1968. CCI is governed by a Board of Trustees and a Board of Advisors. The CCI Board of Advisors is comprised of representatives nominated by the following organizations to represent their cardiovascular specialty field: American College of Cardiology (ACC), American College of Phlebology (ACP), American Society of Echocardiography (ASE), Heart Rhythm Society (HRS), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Diagnostic Medical Sonography (SDMS), Society of Invasive Cardiovascular Professionals (SICP), and the Society for Vascular Ultrasound (SVU).

Over 50% of Hospital CFOs Plan to Adopt New Technology in Response to Medicare Cuts for Cardiac Device Infections

Medicare’s decision to stop reimbursing hospitals for the treatment of potentially avoidable surgical site infections following cardiac implantable electronic device (CIED) procedures, including pacemaker and defibrillator implants, will significantly impact hospital practices according to a new national survey of hospital chief financial officers (CFOs).

The Centers for Medicare and Medicaid Services (CMS) recently released its Hospital Inpatient Prospective Payment System (IPPS) Final Rule for Fiscal Year 2013, which adds Surgical Site Infection following CIED implantation as a condition subject to the Hospital Acquired Condition (HAC) payment provision. CMS considers these infections to be reasonably preventable and has classified them as complicating conditions that would otherwise result in higher payment to the hospital. Under the new policy, CMS will pay for the original implantation surgery, but will not reimburse hospitals at a higher rate for treating the infection.

The survey polled 50 hospital CFOs at academic health centers and community hospitals across the United States to determine how hospital practices are likely to change as the result of the new CMS rule. Findings included:

  • 62% of CFOs consider the financial impact of the HAC on their hospital’s operations to be “very important.”
  • Nearly all CFOs had adopted or plan to adopt new technologies to help reduce the risk of CIED infections; half those surveyed specifically cited increased use of the AIGISRx® Antibacterial Envelope.
  • 82% of CFOs plan to use internal reporting measures to reduce the incidence of the CIED infections.
  • 74% of CFOs believe their facilities may reduce the use of CIEDs when alternative therapies are available.
  • Only 6% of hospital CFOs said their organization had not taken any actions to reduce the incidence of existing HACs.

Patients with surgical site infections following CIED procedures spend an average of two extra weeks in the hospital, undergo repeat surgical procedures to treat the infection, and cost the facility an average of $72,485. Additionally, such patients experience significant increases in morbidity and mortality, with 1-year mortality rates of 26.5–35.1%, depending on device type.

“Surgical site infections are expensive to treat and have a significant financial impact on hospitals as well as on patients’ health and wellbeing,” stated Robert White, Chief Executive Officer of TYRX, Inc., the leader in the commercialization of implantable medical devices intended to help reduce surgical site infections (SSIs). “New technologies, such as the AIGISRx® Antibacterial Envelope, can play an important role in reducing the incidence of such infections and thus lowering hospital costs.”

The survey, conducted by Epocrates, was sponsored by TYRX, Inc.

About TYRX, Inc.

TYRX, Inc., headquartered in Monmouth Junction, New Jersey, is a pioneer in the development, manufacture, and distribution of innovative, implantable combination drug-device products including the AIGISRx® Antibacterial Envelope. The AIGISRx Envelope is specifically designed to aid in the stabilization of CIED placement as well as to help reduce surgical-site infections associated with Cardiac Implantable Electronic Devices (CIEDs). AIGISRx products contain the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection by organisms representing the majority of the infections reported in CIED-related endocarditis, including “superbugs” or MRSA.*

For more information, please visit www.TYRX.com or www.HeartDeviceInfection.com.

* Data on file at TYRX and published in PACE 2009;32(7):898-907.

Medtronic Launches CareLink Express Service

In line with the company’s commitment to provide superior economic value to customers, Medtronic, Inc. announced the U.S. launch of the CareLink Express Service. This service is a remote monitoring system that enables clinicians in healthcare facilities to quickly obtain data regarding the status of Medtronic implanted cardiac devices, facilitating faster treatment decisions. An industry-first, the service sets a new industry standard in connectivity by enabling a device expert to remotely review device data and send the information to the hospital within minutes.

“In line with Medtronic’s stated goal of offering products and services that provide enhanced economic value to hospitals and clinicians, our data shows that CareLink Express reduces burdens on physicians and hospitals by increasing workflow efficiency and reducing operating costs,” said Pat Mackin, senior vice president and president of the Cardiac Rhythm Disease Management business at Medtronic. “These efficiencies demonstrate that quality of care and cost reduction can work hand-in-hand; it’s not necessary to diminish patient care in order to reduce healthcare costs.”1

The new service was evaluated in a 55-site pilot program over the past six months. In the pilot, hospitals using CareLink Express were able to reduce patient wait times from an average of 84 minutes to less than 15 minutes.2 The reduced wait times are intended to expedite clinical decision making so that patients receive needed care sooner, and to reduce bottlenecks in expensive care settings such as the emergency room.

“Incorporating CareLink Express into our hospital has enabled us to provide better service to our cardiac device patients by providing them faster access to care, while improving our patient flow and decreasing costs related to delays that occur while waiting for device checks to be completed,” said Tina Santos, vice president of patient care and chief nursing officer at Heywood Hospital in Gardner, MA, which participated in the CareLink Express pilot program. “This new technology has the potential to significantly impact our efforts to reduce costs in our emergency departments and operating rooms.”3

Prior to CareLink Express, when cardiac device patients visited emergency departments or operating rooms for any reason – including accidents or illnesses unrelated to their implanted cardiac device – they often had to wait to have their implanted devices checked in-person by a qualified device expert. Especially in rural areas, this process could require multiple phone calls, extended stints in hospital waiting rooms and unnecessary trips for clinicians.4 With CareLink Express, physicians no longer have to wait for a cardiac device expert to arrive to perform device checks; instead, physicians and device representatives remotely evaluate a patient’s device status.

How CareLink Express Works

Medtronic provides healthcare facilities with a CareLink Express monitor, which is compatible with almost all Medtronic ICDs, CRT devices, ICMs and pacemakers. The one-touch monitor is used to check or “interrogate” the implanted Medtronic cardiac device.

When a patient with an implanted Medtronic cardiac device arrives at the healthcare facility, the facility staff uses the CareLink Express monitor to check the implanted device and the device data is transmitted to the CareLink® Network.

When the data is transmitted to the CareLink Network, a device expert receives an automatic notification via page or email indicating that new information is available.

The device expert reviews the information remotely and provides an assessment of the device status to the hospital.

Based on the device assessment, the healthcare facility staff determines the appropriate treatment for the patient.

The device data from CareLink Express can be automatically exported to the facility’s electronic health records (EHR). In addition, the implanted device data is automatically sent via the CareLink Network to the patient’s device-following physician, for immediate access.5

The Medtronic CareLink Network

CareLink provides health care providers and patients the convenience of telemedicine by remotely monitoring patients implanted with Medtronic cardiac devices and providing comprehensive data received from the implanted cardiac devices to their physicians. The CareLink Network currently serves more than 6,600 clinics and 720,000 patients in 33 countries.6

More than three million Americans have implantable cardiac devices, including pacemakers, implantable cardioverter defibrillators (ICD), and implantable cardiac monitors (ICMs).7

In collaborating with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

  1. CareLink Express Pilot Data (Medtronic CareLink Network, 2012)
  2. CareLink Express Pilot Data (Medtronic CareLink Network, 2012)
  3. CareLink Express Pilot Data (Medtronic CareLink Network, 2012)
  4. CareLink Express Field Evaluation (November 2011).
  5. CareLink Express Service Concept Description, Human Factors Engineering Intended Use, Human Factors Engineering Task Analysis.
  6. Medtronic CareLink Metrics Database, May 2012.
  7. Medtronic Finance Metrics, May 2012.

Catheter Robotics Receives 510(k) Clearance of Its Amigo Remote Catheter System

Catheter Robotics, Inc. is pleased to announce 510(k) clearance of Amigo by the U.S. Food and Drug Administration (FDA). Catheter Robotics will enter the U.S. market with right-sided diagnostic approval with the Blazer® DX 20 catheter (Boston Scientific).

Amigo is a remote catheter system that allows physicians to operate a catheter some distance from the radiation field, up to 100 feet. It is designed to be compatible with third party catheters and to easily integrate into a hospital’s existing electrophysiology lab. When placed on the Amigo system, the catheter is navigated by a remote controller that mimics catheter handles, reducing the time needed for physicians to learn and feel comfortable using a robotic catheter system.

David Jenkins, President and CEO, believes that the approval of Amigo is not only beneficial for Catheter Robotics, but also for the advancement of robotics in the electrophysiology field. “We have a product that will benefit physicians and hospitals, and we are excited to have it available to the marketplace. Amigo meets the performance expectations of physicians while meeting the cost expectations of hospitals, and creates a solution to the unmet needs of current robotic systems. Catheter Robotics continues to be dedicated to meeting the needs of patients, physicians and hospitals within the electrophysiology lab.”

Amigo was evaluated at 13 centers worldwide which enrolled more than 200 patients. Jennifer Englund, Vice President of Clinical and Regulatory Affairs, feels very positive about the results of the clinical trial. “The clinical trial was a great success and resulted in data that exceeded our safety and efficacy objectives.  The trial data demonstrated effective catheter navigation with Amigo (sufficient tissue contact, ability to navigate the catheter to multiple pre-determined points in the right heart, and ease of use) and a strong safety profile (no major complications related to Amigo).  We are truly excited to have 510(k) clearance of Amigo by the FDA, which allows us to market the device in the U.S.”

About Catheter Robotics, Inc.

Catheter Robotics, Inc. (www.CatheterRobotics.com), headquartered in Mount Olive, New Jersey, is dedicated to transforming robotics into an intuitive, user-friendly technology that benefits patients, physicians and hospitals around the world.

Biosense Webster Announces Launch of the Carto® 3 MEM Base Version

Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the launch of the new Carto® 3 MEM (Multi-Electrode Mapping) Version in the United States.

New Multi-Electrode Mapping Technology

The Carto® MEM Version is the latest advancement on the Carto® 3 System platform. Based on market–leading electromagnetic technology, the new Carto® 3 MEM Version provides a fast method for mapping and diagnosing arrhythmias, while using sensor-based MEM-enabled catheters to maintain a high degree of anatomical accuracy. The new PentaRay® Nav Catheter is equipped with the electromagnetic sensor, allowing for accurate visualization of electrode position on the Carto® 3 System and higher resolution signals.

“Multi-electrode mapping represents a significant advancement in mapping technology, allowing physicians to acquire multiple mapping points simultaneously with a high level of detail and Carto® 3 System accuracy,” said Dr. Vivek Reddy, Mount Sinai School of Medicine. “Combined with the new PentaRay® Nav Catheter, you can reduce the number of required catheter maneuvers to quickly diagnose any arrhythmia. This further supports the safety, effectiveness and efficiency of cardiac ablation procedures for patients.”

About AF and cardiac ablation

Atrial fibrillation (AF) is the most prevalent arrhythmia, and is a leading cause of stroke among people 65 years and older. Worldwide, it is estimated that 20 million people have AF, yet only ~130,000 are treated with ablation every year. The public health implications of AF are a growing concern because those with AF are at an increased risk of morbidity and mortality as well as a reduced quality of life. Today, most patients with AF are treated with anti-arrhythmic drugs, even though about half of them are refractory to these drugs.

Cardiac ablation offers a safe and efficacious alternative to treat cardiac arrhythmias. During cardiac ablation, energy is delivered through the catheter to those areas of the heart muscle causing the abnormal heart rhythm. This energy “disconnects” the pathway of the abnormal rhythm. Cardiac ablation is commonly used for “simple” arrhythmias, like Wolff-Parkinson-White syndrome and atrioventricular nodal re-entry tachycardia, and is increasingly being used for more complex arrhythmias like ventricular tachycardia and atrial fibrillation. ThermoCool® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with Carto® Systems (excluding the NaviStar® RMT ThermoCool® Catheter).

Dr. Reddy is compensated for his services as a member of the company’s scientific advisory board and provides other consulting services.

To see more EP news, please visit: http://eplabdigest.com/articles/EP-News-4