Abstract
Background: Heart failure is a huge health problem. The possibility of long-term monitoring heart function more accurately in these patients has gained increasing interest. The primary aim of this study was to see if a wireless pressure sensor can be safely implanted to give accurate and reproducible long-term intracardiac pressure recordings. Another aim was to see if there are any adverse effects connected with the implant. A control group was included for comparison of clinical data. Methods: Forty patients with heart failure, 31 scheduled for open heart surgery and 9 for transcatheter aortic valve replacement (TAVR) were included to test the safety and feasibility of the Titan™ pressure sensor. The patients were randomized to the implant or control group. Findings: Initial sensor measurements showed very good correlation with reference pressure values from a fluid-filled catheter, and there was no need for calibration of the sensor. At the 6-month follow-up 11 patients had been wearing the implant for >1 year with a median time of 560 days. Ten of these had adequate sensor function. Compared to the control group there was no difference in adverse clinical events and the overall number of complications was low. Conclusions: This first study in man on a new implantable wireless hemodynamic monitor showed favorable results regarding our primary endpoints; accuracy of recordings over time and safety profile. The technology has great potential for monitoring at home since it is easy to use in the out-patient setting.
Highlights
Heart failure is a huge health problem
All sensors were successfully implanted within 15 min regardless of left atrial (LA) or Left ventricular (LV) location
There was no need for calibration of the sensor in this patient or in any of the cases with LA or LV implants
Summary
Heart failure is a huge health problem. The disease often follows a similar course; stable in the initial stages but progressive deterioration develops with exacerbations that eventually lead to recurrent hospitalization. There are a few implantable cardiac hemodynamic monitors on the market, some already in use while others have gone through clinical studies with successful safety records These devices can be divided into two categories; those monitoring pressure of the left side of the heart, and those on the right. We did not focus on detailed surveillance of heart failure symptoms in this study, data so far obtained show the potential of home monitoring to detect early signs of increasing filling pressure and arrhythmias enabling therapeutic intervention before severe symptoms occur. The data suggest that LAP monitoring has the potential to improve hemodynamics, symptoms and outcomes in patients with advanced HF These promising results have been followed by the LAPTOP-HF study, the purpose of which is to investigate if LAP monitoring combined with a physician-directed self-management system will reduce episodes of HF exacerbation, decompensation and hospitalization. A control group was included for comparison of clinical data
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