Medicare Ruling Concerns Hospital CEOs, but Better Reporting, New Antibiotic Technology Can Lower Cardiac Device Infection Rates

Medicare Ruling Concerns Hospital CEOs, but Better Reporting, New Antibiotic Technology Can Lower Cardiac Device Infection Rates

A new Medicare ruling that makes potentially avoidable surgical site infections (SSIs) following cardiac implantable electronic device (CIED) procedures non-reimbursable could have significant financial and quality rating impacts for hospitals, according to a new survey of hospital chief executive officers (CEOs). At the same time, a majority of the CEOs surveyed believed they could influence their electrophysiology/catheterization labs to reduce infection rates, thus managing the risk of higher non-reimbursed costs. Methods cited included leveraging internal reporting to heighten the visibility of CIED SSIs and through the use of antibiotic technologies such as prophylactic antibiotic usage and the AIGISRx® Antimicrobial Envelope, which is specifically designed to help reduce the risk of CIED infections.

On October 1, “Surgical Site Infection following CIED implantation” became an effective Hospital Acquired Condition (HAC) subject to the Hospital Inpatient Prospective Payment System (IPPS) of The Centers for Medicare and Medicaid Services (CMS). CMS considers such 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 CEOs at academic health centers and community hospitals across the United States to determine how hospital CEOs viewed HACs and their impact on hospital practices generally, and to understand how hospital practices might change specifically as a result of the new rule concerning CIED-related infections. Findings included:

• The top three concerns of CEOs surveyed about the inclusion of CIED-related infections as an HAC were: 1) financial impact; 2) impact on quality measures; and 3) infection rates outpacing CIED implant rates.
• Nearly two-thirds of CEOs surveyed said their institutions had increased use of antibiotic technology to reduce the incidence of previously designated HACs, such as infections associated with vascular catheter-associated infections or catheter-associated urinary tract infections.
• At least 70% percent of CEOs surveyed planned to introduce new technologies to reduce CIED infections, with over 50% citing adoption of the AIGISRx Antibacterial Envelope as an expected practice.
• Over 90% planned to use internal reporting to heighten visibility of CIED infections.
• Approximately 40% believed their institutions would implant fewer CIEDs in high-risk patients because of the new HAC.

Patients with SSIs 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 one-year mortality rates of 26.5–35.1%, depending on device type.

“Surgical site infections have a significant impact on hospitals, both financially and on their quality ratings, which heightened awareness of infection risks and use of preventive technologies can significantly mitigate,” stated Robert White, President and CEO of TYRX, Inc. “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. Two hundred and nine high-risk patients who received the AIGISRx Envelope had no infections in a recent study conducted by the Vanderbilt Heart and Vascular Institute. This compared to an infection rate of nearly 3% in 671 case matched control patients who did not receive the device.”

About TYRX, Inc.

TYRX, Inc. commercializes innovative, implantable combination drug+device products focused on infection control, including the AIGISRx® Antibacterial Envelope, designed to 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 pathogens responsible for the majority of CIED infections, including “superbugs” such as methicillin-resistant S. aureus (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.

Oscor Launches Destino Steerable Guiding Sheath

September 2012: Oscor receives FDA, Canada and CE Mark clearance on the next-generation steerable guiding sheath, the Destino. The Oscor Destino is the first and only steerable guiding sheath, which offers 180° bidirectional steering and is available in several curves (small, medium, large) and sheath length combinations (from 45 cm to 90 cm). Other features include a next-generation hemostatic valve with a side port and an ergonomically designed soft grip handle that provides more precise steering control. The Destino sheath is approved for use in procedures that involve the delivery of catheters and other therapeutic devices into the cardiovascular system, including transseptal access. Available in several sizes, from 8.5F to 12F shaft inner diameter, the Destino is an ideal tool that enables any catheter to become steerable, simply by inserting it into the Destino sheath and delivering it to the target location.

About Oscor, Inc.

Oscor, Inc. is a privately held company which develops medical technology and services that focus on providing physicians with the best tools to improve patient quality of life, while reducing risk, trauma, cost, procedure time and need for aftercare.
Oscor is headquartered in Palm Harbor, Florida, and has four major focus areas that include cardiac rhythm management, atrial fibrillation, cardiology and radiology.

BIOTRONIK Launches Implantable BioMonitor® - Highest Precision in Monitoring Arrhythmias

BIOTRONIK announced the European market release of BioMonitor®, a unique implantable cardiac device designed for the highly accurate and reliable monitoring and management of patients with atrial fibrillation (AF) or unexplained syncope.

BioMonitor® is a subcutaneous implantable leadless cardiac monitor for the long-term continuous remote monitoring of patients with arrhythmias such as AF, bradycardia, sudden rate drop, asystole, and tachycardia.

As sensitivity and specificity are essential in the detection of arrhythmias such as AF, BIOTRONIK has developed ClearSense Technology with a unique three-vector signal detection that produces highly precise and reliable arrhythmia monitoring.

The ClearSense Technology records three ECG channels converting them to one high-quality ECG input signal to clearly distinguish on a beat-to-beat basis between a genuine signal and other artifacts such as myopotentials due to body muscle contractions. This innovative technology allows for optimal arrhythmia detection independent of the device’s implant orientation within the body and provides a longevity of 6.4 years.

BioMonitor® is equipped with BIOTRONIK’s home monitoring system, which provides daily remote data transfer without patient interaction — leading to high patient compliance. Its traffic light system streamlines monitoring by highlighting the most relevant information and providing accurate data for physicians to monitor and manage their patients effectively.

“Only long-term continuous monitoring with reliable arrhythmia detection offers the type of vital information necessary for physicians to make the right therapy decisions when managing patients with AF or unexplained syncope,” commented Professor Gerhard Hindricks, director of the Department of Electrophysiology at the Leipzig University Heart Center in Germany.
Professor Hindricks together with Professor Wilhelm Haverkamp (Deputy of the Department of Cardiology at Charité Campus Virchow, Humboldt University Berlin), and Professor Dietmar Bänsch (Director of Cardiology Department and Rhythmology at the Rostock University Hospital) are the world’s first physicians to implant the BioMonitor® and take advantage of this new approach for monitoring AF in their patients.

“Effective management of AF and unexplained syncope starts with effective monitoring,” said Professor Haverkamp. “BioMonitor®, with its ClearSense technology, and BIOTRONIK Home Monitoring® offer the optimal combination of reliability and efficiency.”

The innovative BioMonitor® device marks a new product category in BIOTRONIK’s comprehensive device portfolio of pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy systems.

“BioMonitor® supports physicians in every step of arrhythmia management, from diagnosis via monitoring to individualized therapy offering high-quality solutions that benefit both physicians and patients,” explained Professor Bänsch.

Sites involved in the first implantations of the BioMonitor®:

Germany

• Prof. Gerhard Hindricks, Leipzig University Heart Center
• Prof. Wilhelm Haverkamp, Charité Campus Virchow, Humboldt University Berlin
• Prof. Dietmar Bänsch, Rostock University Hospital
• Prof. Dietrich Andresen, Vivantes Klinikum Am Urban/
• Im Friedrichshain, Berlin
• Dr. Dieter Bimmel, St-Marien-Hospital, Bonn

Italy

• Dr. Gaetano Senatore, Ospedale Civile di Cirie

Spain

• Dr. Jesús Rodríguez García, University Hospital Doce de Octubre, Madrid

Switzerland

• Dr. David Hürlimann, University Hospital of Zurich
• Dr. Jan Steffel, University Hospital of Zurich

France

• Dr. Arnaud Lazarus, Clinique Ambroise Paré, Paris

Denmark

• Dr. Jens Brock Johansen, Odense University Hospital

St. Jude Medical Announces Launch of its MediGuide Technology

St. Jude Medical, Inc. announced the launch of its MediGuide™ Technology, the first and only three-dimensional (3-D) navigation system intended for the evaluation of vascular and cardiac anatomy on a recorded fluoroscopic image instead of live fluoroscopy. The use of recorded images allows physicians to reduce the duration of radiation exposure during cardiovascular procedures, revolutionizing medical imaging procedures in the electrophysiology (EP) lab.
“The launch of MediGuide Technology is significant as it allows clinicians to perform cardiac procedures with less fluoroscopy and the corresponding exposure to harmful radiation,” said Dhanunjaya Lakkireddy, MD, cardiologist at the University of Kansas Hospital in Kansas City, KS, the first medical facility in the U.S. to use the MediGuide Technology system. “This revolutionary system reduces the need for live fluoroscopy, while providing unprecedented views inside the heart, improving complex cardiac resynchronization therapy and cardiac ablation image-guided procedures for physicians, patients and medical staff around the world.”

Similar to a global positioning system (GPS) that automobile drivers use to determine the location of their car on a map, MediGuide Technology allows physicians to see the precise location and orientation of MediGuide Enabled™ devices inside the heart. Using magnetic tracking to locate miniature sensors embedded in devices, such as the MediGuide Enabled™ Livewire™ Diagnostic Catheter and the CPS Excel™ MediGuide Enabled™ Guidewire, this technology applies 3-D visualization to previously recorded fluoroscopic images in real time. Automatic adjustments are made to the recorded images to maintain an accurate real-time clinical representation compensating for cardiac motion, respiratory changes and patient movements in order to minimize workflow delays.

“MediGuide Technology is the only real-time cardiac navigation and visualization platform that allows physicians to reduce fluoroscopy during cardiac procedures,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “St. Jude Medical continues to be committed to developing technologies that minimize radiation exposure in the EP lab, improve procedural repeatability and increase clinical and economic efficiency.”
Worldwide, physicians perform several billion radiation-based imaging studies annually, approximately one-third of which are in cardiovascular patients. According to the American Heart Association, the collective dose of ionizing radiation that patients annually received during medical tests increased among the general population an estimated 600 percent between 1980 and 2006. As a result, there has been a dramatic increase in human exposure to ionizing radiation.

MediGuide Technology integrates the Artis zee™ angiography systems, an innovative line of interventional radiology and cardiology imaging devices, from Siemens Healthcare. Combined, the technologies provide improved navigation during EP procedures.

Boston Scientific Receives FDA Approval of First-in-Class S-ICD® System for Patients at Risk of Sudden Cardiac Arrest

The U.S. Food and Drug Administration has granted Boston Scientific Corporation regulatory approval for its S-ICD® System, the first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). The S-ICD System sits entirely just below the skin without the need for leads to be placed into the heart. This leaves the heart and blood vessels untouched, offering patients an alternative to transvenous implantable cardioverter defibrillators (ICDs), which require leads to be placed in the heart itself.

“The S-ICD System establishes the first new category of cardiac rhythm management devices since the introduction of cardiac resynchronization therapy,” said Raul Weiss, MD, Associate Professor-Clinical, Cardiovascular Medicine at The Ohio State University. “Doctors now have a breakthrough treatment option that provides protection from sudden cardiac arrest without touching the heart.”

Approval of the S-ICD System was based on data from a 330-patient, prospective, non-randomized, multicenter clinical study, which evaluated the safety and effectiveness of the system in patients at risk of SCA. The S-ICD System met the primary endpoints of the study, and results were presented earlier this year at the Heart Rhythm Society 33rd Annual Scientific Sessions. The study results support that the S-ICD System is an important new treatment option for a wide range of primary and secondary prevention patients.

“With the addition of the S-ICD System, we believe Boston Scientific has a compelling and highly differentiated portfolio that will help fuel our growth strategy,” said Hank Kucheman, chief executive officer, Boston Scientific. “We are the only company to offer an FDA-approved subcutaneous implantable defibrillator and expect this to be the case for several years. The S-ICD System, coupled with our numerous recent regulatory approvals and our other innovative products, such as the WATCHMAN® Left Atrial Appendage Closure Device and Alair® Bronchial Thermoplasty System for the treatment of severe asthma, demonstrates our continued commitment to developing and bringing to market innovative products for physicians and their patients.”
Recent estimates show that approximately 850,000 people in the United States are at risk of SCA and indicated for an ICD device, but remain unprotected.

“Each year, thousands of patients indicated for an ICD are not referred to a specialist and remain untreated,” said William T. Abraham, MD, FACC, Director, Division of Cardiovascular Medicine at The Ohio State University Heart Center. “The S-ICD System is an important new treatment option that has the potential to improve patient acceptance of ICD therapy.”

The S-ICD System is designed to provide the same protection from sudden cardiac arrest as transvenous ICDs. The system has two main components: 1) the pulse generator, which powers the system, monitors heart activity, and delivers a shock if needed; and 2) the electrode, which enables the device to sense the cardiac rhythm and deliver shocks when necessary. Both components are implanted just under the skin — the generator at the side of the chest, and the electrode beside the breastbone. Unlike transvenous ICDs, the heart and blood vessels remain untouched. Implantation with the S-ICD System is straightforward using anatomical landmarks, without the need for fluoroscopy. Fluoroscopy is required for implanting the leads attached to transvenous ICD systems.

Boston Scientific expects to begin a phased launch of the S-ICD System that will expand over time as medical professionals are trained on the safe and effective use of the system. The company acquired the S-ICD System earlier this year when it completed the acquisition of Cameron Health, Inc. The S-ICD System received CE Mark in 2009 and is commercially available in many countries in Europe as well as in New Zealand. To date, more than 1,400 devices have been implanted in patients around the world.

The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

The WATCHMAN device is an investigational device in the United States. It is limited by applicable law to investigational use and not available for sale.

nContact Achieves IP Milestone: Solidifying its Pioneering Position in Epicardial-Endocardial Ablation for Cardiac Arrhythmias

nContact, Inc. reached a key intellectual property milestone. The United States Patent and Trademark Office recently issued four patents to the company covering essential components of the multidisciplinary epicardial-endocardial approach pioneered by the company and used by physicians to treat cardiac arrhythmias.

The issued U.S. Patents (U.S. Patents 8,241,273; 8,211,011; 8,235,990; and 8,267,951) specifically cover multidisciplinary approaches in which epicardial and endocardial cardiac ablation synergistically complete linear lesions, as well as devices and methods that enable creating consistent linear lesions under direct visualization without any chest incisions. The patented methodology and devices expand nContact’s intellectual property portfolio and augment its ownership of vacuum integrated epicardial ablation devices.
Co-inventor Sidney Fleischman commented, “These patents further demonstrate our focus on creating novel procedures and products that enable combining the best practices of endoscopic surgeons and electrophysiologists to provide new arrhythmia treatment options that benefit patients.”

About nContact, Inc.

nContact, Inc. is the leading innovator in epicardial ablation devices and techniques. Its mission is to transform the underserved arrhythmia market through the advancement of less invasive, more efficacious ablation alternatives for cardiac arrhythmias.

Its lead technologies, the EPi-Sense® and Numeris® Coagulation System with VisiTrax®, have CE Mark approval in Europe for the coagulation of cardiac tissue for the treatment of atrial fibrillation and atrial flutter.

The Numeris® Coagulation System with VisiTrax® is indicated for endoscopic coagulation of cardiac tissue in the United States. The EPi-Sense® device is not available in the United States. nContact was founded in 2005 and is headquartered in Morrisville, North Carolina.

Medtronic Announces Approval and Launch of Japan’s First MR-Conditional Pacemaker System

Medtronic, Inc. announced the Japanese regulatory approval and launch of the Advisa DR MRI™ SureScan™ pacing system. The Advisa MRI system is the first and only MR-Conditional pacemaker available to patients in Japan, the world’s second largest market for medical devices.
With the Advisa MRI system, pacemaker patients will have access to full body scans, without positioning limitations in the MRI scanner. MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray, ultrasound or CT scan, and critical for early detection, diagnosis and treatment. Advisa MRI was specifically tested and approved for use as labeled with MRI scanners in Japan. The system includes an Advisa MRI device and two CapSureFix MRI™ SureScan® leads, which must be used together.

“Until recently there was a significant unmet need for patients with pacemakers to have access to MRI technology,” said Ken Okumura MD, professor and chief, Department of Cardiology, Graduate School of Medicine, Hirosaki University and president of the Japanese Heart Rhythm Society. “Now physicians and patients have a choice of pacing systems that allow access to the invaluable benefits of MRI technology.”

The first SureScan pacemaker system was introduced in Europe in 2008 and its use in the MRI environment is supported by extensive computer modeling and clinical studies, as well as real-life data. To date, Medtronic has sold nearly 100,000 SureScan devices worldwide, and thousands of SureScan patients have been able to safely undergo an MRI that would have been denied to them with a standard pacemaker.

Approximately 400,000 people in Japan have implanted pacemakers. However, until the availability of Medtronic’s SureScan pacing systems, patients with pacemakers have been contraindicated in Japan from receiving MRI scans. There is the potential for pacemakers to interact with MRI machines in a manner that could negatively affect the device function or patient safety. According to estimates, 50 to 75 percent of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.¹

The Advisa DR MRI™ SureScan™ pacing system is not yet available in the U.S. The Revo MRI™ SureScan® pacing system was FDA approved in February 2011.

Advisa MRI – The Most Advanced Pacing System from Medtronic

Medtronic’s Advisa MRI pacing system provides patients with innovative exclusive technology, including the MVP™ (Managed Ventricular Pacing) algorithm, which is proven to reduce unnecessary ventricular pacing by 99 percent. Additional features include:

• Complete automaticity with Ventricular and Atrial Capture Management™ (VCM and ACM) and Anti-Tachycardia Pacing (ATP).
• Diagnostics such as the Cardiac Compass® Report, and tachyarrhythmia management tools that assist in the early detection of atrial fibrillation (AF).
• Remote follow-up via Medtronic’s CareLink® Network, which transmits comprehensive arrhythmia and diagnostic device data to a physician’s clinic.
• Rate Drop Response that identifies abrupt cardiac slowing and responds by pacing the heart at an elevated rate, which may reduce the frequency of syncopal episodes in patients with apparent cardio-inhibitory vasovagal syncope.

In collaboration with leading clinicians, researchers and scientists worldwide, 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 around the world.

1. Gillis AM, et al. Reducing Unnecessary Right Ventricular Pacing with the Managed Ventricular Pacing Mode in Patients with Sinus Node Disease and AV Block. PACE 2006;29:697-705.