Keeping you up to date on recent cardiovascular developments

IMPROVE HF study shows adherence to outpatient quality measures associated with improved survival in HF patients . . . Results from the largest U.S. outpatient heart failure clinical study, published yesterday in the journal Circulation and funded by Medtronic (Minneapolis), demonstrate that select guideline-based outpatient heart failure process measures positively impact patient survival and may be useful for assessing and improving overall patient quality of care. Findings from IMPROVE HF (The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting), showed that most of the class IA heart failure therapies measured, including implantable defibrillator therapy and cardiac resynchronization therapy, were linked to a lower risk of mortality. Specifically, compliance with the ICD process measure in eligible patients was associated with 38 percent lower odds of mortality over two years, and cardiac resynchronization therapy (CRT) process measure compliance was associated with 36% lower odds of mortality. "These findings are significant, as they offer the first real-world evidence suggesting that these process measures directly correlate with the quality of care provided to the millions of heart failure patients who are treated in the outpatient setting," said Gregg Fonarow, MD, co-chair of the IMPROVE HF Scientific Steering Committee and Professor of Cardiovascular Medicine at the University of California at Los Angeles. "In addition, results of this study suggest that successful efforts to improve conformity with these outpatient heart failure process measures, should be expected to translate into a favorable impact on clinical outcomes." Seven process quality measures were analyzed in the IMPROVE HF study, including use of drug therapy (ACE inhibitors or angiotensin receptor blockers, beta-blockers, aldosterone antagonists and anticoagulants for atrial fibrillation); use of implantable device treatments such as ICD, CRT with defibrillator, or CRT with pacemaker; and heart failure education. However, only four of the seven quality measures (ACE inhibitors, beta-blocker, HF education, and anticoagulation for atrial fibrillation) are currently recognized as standard heart failure performance measures. The study is the first to assess the link between current and emerging heart failure process measures and clinical outcomes. Study results revealed that every 10% improvement in the composite care process (percentage of the total number of indicated quality measures that were provided to a patient) was associated with a 13% decrease in the odds of mortality during the 24-month follow-up period. While there is a considerable gap in the integration of clinical trial evidence into professional guidelines and delivery of evidence-based care, professional and government-based organizations have worked to improve care among this patient population. As part of these efforts, standard, guideline-based process of care measures have been implemented in an effort to measure and improve overall quality of care among heart failure patients. IMPROVE HF is the first-of-its-kind, prospective study involving about 35,000 heart failure patients from 167 U.S. cardiology practices. Using a process improvement intervention and chart reviews at baseline, six, 12, 18 and 24 months, IMPROVE HF was designed to quantify and improve quality of care for heart failure patients by promoting the use of evidence-based, guideline-recommended therapies. All study data were collected and analyzed by an independent clinical research organization.

New study of 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 (Washington) 60th Annual Scientific Session by researchers from the Mayo Clinic, The Johns Hopkins School of Medicine, and TYRX (Monmouth Junction, New Jersey). "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, Minnesota), 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,CMO of TYRX. "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 healthcare costs. These findings further underscore the need for infection prevention as a key component of medical cost control." TYRX develops implantable combination drug/device products focused on infection control.

Biotronik enrolls final patient in IN-TIME study of home monitoring device . . . Biotronik (Berlin) said the last chronic heart failure patients enrolled in In-Time at the Schwabing Clinic (Munich, Germany), with principle investigator professor Stefan Sack, MD."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 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 home monitoring system, Biotronik said. "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," said 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."

– Compiled by Amanda Pedersen, MDD Senior Staff Writer

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