News

New Study of Medicare Beneficiaries Reveals Significant Cost Burden, High Mortality Associated with Patient Infections Following Cardiac Device Implantation

Surgical infections associated with pacemakers and defibrillators led to 3-fold increases in hospital stay, 55–118% higher hospitalization costs, 8- to 11-fold increase in mortality rates, and double the mortality after 1 year compared to pacemaker and defibrillator implantations where no infection occurred. Surprisingly, more than one-third of the excess mortality occurred after hospital discharge. These findings, from a new study in Medicare beneficiaries of more than 200,000 pacemaker and defibrillator implantations with and without infection, were presented at a poster session at the American College of Cardiology 60th Annual Scientific Session by researchers from the Mayo Clinic, the Johns Hopkins School of Medicine, and TYRX, Inc.

“Rising health care costs are at the center of the political and economic debate this year,” said M. Rizwan Sohail, MD, Assistant Professor of Medicine, Mayo Clinic College of Medicine, Rochester, MN, lead author of the new study. “However, efforts at cost reduction must begin by identifying the major driving forces behind the cost of patient care. In this study, we have tried to do just that for patients with cardiac device infections.”

Key findings from the study included:

• The in-hospital mortality rate for pacemaker and defibrillator implantation admissions, with an infection, was 8- to 11-fold the rate for non-infected admissions, depending on the device type.
• The longer-term mortality rate (death during the admission quarter and following year) was 27–36%, about 2-fold the rate without infection, depending on the device type.
• The mean hospital length of stay (LOS) with infection was 3-fold the length of stay without infection. Moreover, it was substantially longer than the mean LOS for Medicare beneficiary admissions for the five leading principal diagnostic classifications: heart disease, pneumonia, malignant neoplasm, cerebrovascular disease, and fractures at all sites.
• Mean total hospitalization cost for pacemaker and defibrillator patients with infection was 55–118% higher than for those without infection, depending on the type of device. The incremental costs related to the treatment of the infection ranged from an average of $17,000 for pacemaker infections to $25,600 for certain types of defibrillators. The Medicare analysis revealed that the cost of managing the most extreme situations exceeded $1 million.

“The ‘2010 American Heart Association/Heart Rhythm Society Scientific Statement on Cardiac Implantable Electronic Device (CIED) Infections and their Management’ identified a need for more precise data on the impact and economic burden of pacemaker and defibrillator infections,” commented Daniel Lerner, MD, Chief Medical Officer of TYRX Inc. “This large population study in a broad spectrum of patients provides important information on the significant impact that cardiac device infections have on morbidity, mortality and health care costs. These findings further underscore the need for infection prevention as a key component of medical cost control.”

The new study was conducted with financial support from TYRX, Inc.

About TYRX, Inc.
TYRX, Inc. commercializes innovative, implantable combination drug/device products focused on infection control, including the AIGISRx® Antibacterial Envelope and AIGISRx® Flat Sheet products. AIGISRx products contain antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in implantable pacemaker and defibrillator related endocarditis, including “superbugs” or MRSA.* Following commercial release in 2008, the AIGISRx Envelope has been implanted in over 17,000 patients nationwide.

TYRX, Inc. is an ISO 13485:2003 certified medical device manufacturer and its products utilize technology licensed exclusively from Rutgers, Baylor College of Medicine, and The University of Texas M. D. Anderson Cancer Center.
* Based upon preclinical in vitro and in vivo data. Data on file at TYRX and published in PACE 2009;32(7):898–907.

IN-TIME Enrollment Completed: BIOTRONIK Home Monitoring® Clinical Study to Assess Improvement in Heart Failure Management

BIOTRONIK SE & Co. KG announced that the last chronic heart failure (HF) patient was enrolled in IN-TIME at the Schwabing Clinic in Munich, Germany, with principle investigator Professor Stefan Sack, MD.

IN-TIME is a prospective, multicenter, international clinical trial that randomized 720 patients to assess the influence of BIOTRONIK Home Monitoring® on the established Packer Score: a composite of all-cause mortality, unplanned hospitalization for worsening HF, New York Heart Association (NYHA) class status and patient global self-assessment. The study will contribute significantly to today’s evidence-based value proposition of BIOTRONIK Home Monitoring®.

“Death or hospitalizations due to worsening HF are often preceded by an onset of atrial or ventricular arrhythmia and/or distinct trends of parameters such as activity and heart rate variability,” commented Professor Gerhard Hindricks, MD, University Heart Center, Leipzig, Germany, and coordinating clinical investigator of IN-TIME. “BIOTRONIK Home Monitoring® is the only available solution that has the capability of facilitating such early detection for some of these trends in cardiac device patients and thus may offer physicians the possibility to intervene in time to prevent serious or even fatal events.”

“IN-TIME builds upon the existing substantial body of robust clinical evidence that has already demonstrated the unique abilities of BIOTRONIK Home Monitoring® to provide continuous patient monitoring, to minimize in-office follow-up visits and to detect health status changes and technical challenges early — while being associated with a very high degree of patient satisfaction and the potential to reduce costs for the healthcare system,” commented Marlou Janssen, Global Vice President of Marketing and Sales at BIOTRONIK.

Medicomp, Inc. Announces Company Purchase from United Therapeutics

Medicomp, Inc., previously a wholly-owned subsidiary of United Therapeutics Corporation, announced that it has been acquired by an investment group made up of current and past Medicomp management led by Dan Balda, MD, Medicomp’s President and CEO. The sale was finalized on March 31, 2011 and will allow the new Medicomp organization to focus on growing the Medicomp brand and business to become the medical monitoring center to the world. United Therapeutics retained a minority stake in the company as part of the sale.

“We are extremely excited about this opportunity to grow Medicomp and better assist physicians in diagnosing and treating cardiac disease. Our independence will enable increased focus so we can quickly add new technology partners, further increase the value we bring to patients, maximize clinically significant results to physicians, and seamlessly integrate into the medical community while injecting cost effectiveness into the healthcare system,” stated Dr. Balda.

Medicomp will maintain and grow the current management structure to ensure that Medicomp customers are not impacted in any way by this change.

About Medicomp, Inc.
Medicomp, Inc. develops and provides advanced cardiac monitoring products and services using the most sophisticated and reliable ambulatory heart-monitoring systems available. Medicomp’s diagnostic technologies are widely regarded as the most advanced in the industry, and they are therefore entrusted by physicians and scientists to provide cardiac monitoring services around the world in healthcare, research as well as space and aeronautical exploration.

Medicomp’s cardiac monitors use artificial intelligence operating in real-time. Their proprietary Diogenes algorithm employs rate, rhythm, morphology, and p-wave information for the most comprehensive ECG analysis available.

Medtronic Announces FDA Approval of Protecta™ Implantable Defibrillators That Reduce Inappropriate Shocks

Medtronic, Inc. announced U.S. Food and Drug Administration (FDA) approval of the Protecta™ portfolio of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds). The new family of implantable defibrillators features SmartShock™ Technology, which includes six new Medtronic-exclusive algorithms that recognize life-threatening arrhythmias and deliver therapeutic shocks only when appropriate,¹ therefore enhancing patient quality of life.² Findings from the Virtual ICD study, based on a statistical model, show that 98 percent of patients with SmartShock Technology will be free of inappropriate shocks one year after implant and 92 percent will be free of inappropriate shocks five years after implant.1 Shipments of the Protecta portfolio of products will begin immediately.

“With recent studies showing that up to one in five patients may experience inappropriate shocks, this new technology can significantly mitigate that concern and will have a real-world impact on my patients’ lives by improving quality of life,” said Kent Volosin, MD, cardiologist at the University of Pennsylvania in Philadelphia.

Implantable defibrillators are designed to provide lifesaving shocks or painless pacing to stop life-threatening ventricular arrhythmias, which can lead to sudden cardiac death. Sudden cardiac death kills more people each year than lung cancer, breast cancer and HIV/AIDS combined.^3,4 Medtronic estimates more than 70,000 lives have been saved worldwide by implantable defibrillators over the past five years.⁵

While the majority of shocks delivered are necessary to treat potentially fatal arrhythmias, studies estimate that up to 20 percent of patients with implantable defibrillators may experience inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device.^6–9 Additionally, data show that 61 percent of patients who received an inappropriate shock visited the hospital, clinic or emergency room at least once within three days of receiving therapy.¹⁰

“The Protecta family of devices addresses one of physicians’ top needs — allowing them to better serve patients by providing devices that are designed to deliver a shock only when needed to save a life,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic.

About SmartShock Technology
The Protecta implantable defibrillators include SmartShock Technology, six new Medtronic-exclusive solutions, five of which were not previously available. The algorithms are automatically on when implanted and address the industry-wide issue of inappropriate shocks. They include:

• Wavelet + PR Logic, SVT discrimination in the VF zone, and Confirmation + in Protecta devices are designed to detect non-lethal arrhythmias and deliver lifesaving shock therapy only when necessary.
• T-wave Discrimination and Lead Noise Discrimination distinguish oversensing from deadly arrhythmias and withhold shock therapy when appropriate.
• Lead Integrity Alert, first released in 2008, provides advanced warning of potential lead fractures so the patient can seek medical attention, and reduces the risk of receiving an inappropriate shock.

About Protecta
All Protecta XT devices have OptiVol® 2.0 Fluid Status Monitoring, a new update on the Medtronic-exclusive feature that measures changes in fluid build-up in heart failure patients to identify patients at risk of worsening heart failure.¹¹ Medtronic implantable defibrillators have Conexus® Wireless Telemetry that allows patients to transmit device data to a physician’s clinic from virtually anywhere via the industry’s largest remote monitoring system, the Medtronic CareLink® Network. CareLink serves more than 4,000 clinics and 500,000 patients in 30 countries.

1. Volosin, et al. Virtual ICD: A model to evaluate shock reduction strategies. Heart Rhythm Vol. 7, N. 5, May supplement 2010. (PO3-125).
2. Wathen MS, et al. Circulation 2004;110:2591–2596.
3. American Cancer Society. Cancer Facts and Figures. 2006.
4. CIA. The World Fact Book – Rank Order – HIV/AIDS – deaths. Available at https://www.cia.gov.
5. Medtronic data on file. 2010.
6. Kadish A, Dyer A, Daubert JP, et al., for the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 2004;350:2151–2158.
7. Daubert JP, Zareba W, Cannom DS, et al., for the MADIT II Investigators. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: Frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol 2008;51:1357–1365.
8. Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med 2008;359:1009–1017.
9. Mitka M. New study supports lifesaving benefits of implantable defibrillation devices. JAMA 2009;302:134–135.
10. Sweeney, et al. Differences in effects of electrical therapy type on health care utilization in the MVP ICD trial. Heart Rhythm Society May, 2010.
11. Whellan DJ, Ousdigian KT, Al-Khatib SM, et al. Combined heart failure diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: Results from PARTNERS HF study. J Am Coll Cardiol 2010;55:1803–1810.

St. Jude Medical Receives FDA Approval for New Bi-Directional Ablation Catheters

St. Jude Medical, Inc. announced that it has received U.S. Food and Drug Administration (FDA) approval of two new irrigated ablation catheters — the Safire BLU™ Bi-directional Irrigated Ablation Catheter and the Therapy™ Cool Path™ Bi-directional Ablation Catheter. These two new catheters have several key design features that offer physicians additional control, including bi-directional deflection, a new shaft with higher torque response, a lower fluid infusion rate when compared to other commercially available irrigated ablation systems, and a choice of handles.

Ablation catheters are thin flexible tubes that deliver radiofrequency (RF) energy to specific areas of cardiac tissue in order to create lesions that interrupt the abnormal electrical signals that contribute to irregular heart rhythms. Because the amount of energy required to create an effective cardiac lesion must be carefully balanced against tissue temperature, the Safire BLU and Therapy Cool Path ablation catheters were designed with an irrigated catheter tip. Irrigation can help to reduce some of the risk factors associated with the heat of the RF energy.

The Safire BLU and Therapy Cool Path irrigated ablation catheters feature a bi-directional deflection capability that provides enhanced maneuverability, which allows physicians to reach challenging anatomic locations. The bi-directional steering turns up to 180 degrees in both directions to allow physicians to better position the tip of the catheter during ablation procedures. This flexibility promotes efficiency and was designed to provide electrophysiologists with increased control over their delivery of ablation therapy.

The bi-directional steering in these catheters is complemented by a shaft that is designed to more efficiently transmit torque (or turning force) from the steering handle to the catheter tip. This improved capability enables the physician to position the catheter with greater precision.

“The new bi-directional irrigated ablation catheters from St. Jude Medical offer innovative features that provide additional control when treating cardiac arrhythmias. The torque response, catheter tip stability and ability to make very fine movements result in excellent catheter performance in complex ablations,” said Dr. Larry A. Chinitz, Director of Cardiac Electrophysiology and Invasive Cardiology at New York University School of Medicine.

The handles of the Safire BLU and Cool Path catheters were designed to be ergonomically appealing and provide physician comfort for both routine and complex ablation procedures. Physicians have the flexibility to choose the handle style that they prefer: the ComfortGrip™ for the Safire BLU catheter or push/pull style handle for the Therapy Cool Path catheter.

“The improved handling and catheter control of our new bi-directional catheters can assist physicians in accessing difficult-to-reach anatomic locations. This will allow for more predictable, repeatable and effective lesion formation so physicians can focus their attention on the patient,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. “St. Jude Medical is pleased to offer these two new catheters and provide physicians the unique benefits of bi-directional steering, along with the choice of handle that best suits their preference.”