St. Jude Medical is touting results of a recently published study that analyzed the clinical benefits of frequent and regular left atrial pressure (LAP) monitoring in patients with heart failure. In the study, patients wore a special device, called HeartPOD, that monitored their LAP and routed the data wirelessly to their cardiologist. The physician, in turn, was able to adjust the prescription drug dosage taken by the patient on a daily basis. The results show that this leads to better overall outcomes for patients and a greater understanding of the condition for the physicians involved.
The above picture was given to us by St. Jude Medical. And we think it has a clue as to the future of this technology. Imagine this kind of monitoring shows more and more positive outcomes in the future clinical studies, and it wins all needed regulatory approvals. One day we might be seeing these pressure monitoring sensors embedded into the electrodes of AICDs and pacemakers. Wouldn’t that be neat?
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 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, multi-center 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.
Abstract in Circulation: Physician-Directed Patient Self-Management of Left Atrial Pressure in Advanced Chronic Heart Failure
Press release: St. Jude Medical Announces Publication of Feasibility Results for Trial of Novel Heart Failure Management System …
Medgadget 2005 flashback: HeartPOD…