News | March 09, 2010

Hemodynamically Guided Home Self-Therapy May Aid Heart Failure Patients

March 9, 2010 — Initial clinical study results published in the journal Circulation indicates use of a physician-directed, patient self-management system guided by left atrial pressure can improve symptoms and outcomes in patients with heart failure (HF).

St. Jude Medical Inc. announced publication of clinical results in the Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS) trial. The left atrial pressure (LAP) management system featured in this study allows patients to adjust their HF medications daily, based on a physician-directed prescription plan and their current HF status, similar to the manner in which diabetes patients manage their insulin therapy.

Results of the HOMEOSTASIS study were published in the March 2010 issue of Circulation. This observational, first-in-human, feasibility study suggests that outpatient hemodynamic monitoring linked to a self-management therapeutic strategy could change current management of advanced HF and facilitate more optimal therapy and improved outcomes.

LAP is the gold standard in hemodynamic monitoring for HF, providing the most objective, direct measure of left-sided cardiac filling pressure, increases in which precede development of pulmonary congestion (fluid in the lungs) and other HF symptoms. Results from this study demonstrated that regular monitoring of LAP in combination with a dynamically adjusted prescription plan can be used to drive appropriate adjustment of HF treatments, and as a result, improved LAP control and reduction of HF events that may result in hospitalization or death.

Following implantation of an LAP sensor, all subjects in the study were free of major adverse cardiac and neurological events at six weeks, meeting the trial’s primary endpoint. Over a median follow-up of 25 months, LAP control was achieved for at least six consecutive months in 76 percent of patients, with a 67 percent reduction in the frequency of elevated LAP readings (over 25 mmHg).

Throughout this same period, there was a significant 84 percent average decrease in HF events including HF hospitalization and all-cause mortality once LAP-guided therapy was initiated. Over the course of treatment, patients also had significant improvements in HF symptoms and quality of life.

The report outlined results of the first 40 patients enrolled in the trial; 20 patients enrolled in three Australian or New Zealand sites and 20 patients enrolled in four U.S. sites. The trial was led by cardiologists Dr. Richard Troughton from Christchurch, New Zealand and William T. Abraham, M.D., from the Ohio State University.

“These results are significant in demonstrating for the first time that left atrial pressure monitoring, linked to a self-management strategy, can facilitate more optimal heart failure therapy and reduction of heart failure events,” said Mark Carlson, M.D., chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division. “St. Jude Medical will continue to focus on disease management technologies that will provide physicians more control in improving the lives of patients with heart failure.”

The early results of the HOMEOSTASIS trial led to the establishment of the LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) Study, a larger pivotal, randomized, controlled, prospective, multicenter clinical investigation. The LAPTOP-HF study will be conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) and is expected to begin in the first half of 2010.

More than five million Americans have HF with 550,000 new cases diagnosed each year. Heart failure occurs when the heart is unable to pump enough blood to meet the body’s demands. To compensate, the heart must pump at an elevated filling pressure. Progression of HF over a period of days is known as acute decompensation and results in substantially raising the left atrial pressure.

High levels of LAP directly force excess fluid into the lungs causing congestive symptoms, most commonly breathlessness. Approximately 90 percent of patients admitted to the hospital for HF have pulmonary congestion related to elevated LAP. Episodes of pulmonary congestion have a high associated mortality and result in a downward spiral of progressive cardiac deterioration.

For more information: sjm.com

Related Content

A 3-D rendering created from the chest CT scan of a 41-year-old coronavirus patient in China showing ground-glass opacities in several areas of the lungs from the coronavirus pneumonia. This was from one of the first medical imaging studies published on COVID-19 in the journal Radiology. #coronavirus #COVID2019 #COVID19 #2019nCoV

A 3-D rendering created from the chest CT scan of a 41-year-old coronavirus patient in China showing ground-glass opacities in several areas of the lungs from the coronavirus pneumonia. This was from one of the first medical imaging studies published on COVID-19 in the journal Radiology. 

Feature | Cardiovascular Clinical Studies | February 20, 2020 | Dave Fornell, Editor
February 20, 2020 — The American College of Cardiology (ACC) released a
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Overlay Init