A patient in Cincinnati has become the first in the USA to receive a system that enables remote monitoring of his heart and congestion status, as well as self-adjustment of diuretics.
Vectorious Medical Technologies developed a miniature pressure sensor that is implanted within the heart via standard minimally invasive transvenous catheterisation. The sensor measures left atrial pressure (LAP), the earliest and most accurate indicator of fluid overload and congestion status.
The system supports a scalable, physician-directed patient self-management approach, allowing heart failure (HF) patients to take an active role in managing their disease. By using the V-LAP system, patients can better understand their disease and adjust diuretics, daily activities, and fluid volume accordingly.
The first V-LAP implantation in the USA was performed by Sitaramesh Emani, director of heart failure clinical trials at The Christ Hospital (Cincinnati, USA). To date, 56 V-LAP implantations have been performed, resulting in more than 40,000 days of LAP monitoring. The study, together with the ongoing clinical programme in Europe and Israel, will further inform an upcoming US pivotal trial.
“The successful first US V-LAP implantation represents a pivotal moment in heart failure management,” Emani was quoted as saying in a press release issued by Vectorious. “By integrating real-time left atrial pressure monitoring into patient care, we are on the cusp of a transformative shift towards more proactive, personalised treatment strategies. This innovative approach aims to improve patient outcomes through a reduction in hospitalisations and enhancement of overall quality of life for heart failure patients, but will do so by empowering patients to actively manage their own care. The data collected from the VECTOR-HF IIb trial will be instrumental in moving our field forward.”
Initial studies of the V-LAP system, which were recently published in the European Journal of Heart Failure, have shown promising results, the company states. During 85% of the overall follow-up duration (26.98 patient-years, 9,593 LAP monitoring days), patient self-management alone, with no physician intervention, was sufficient to keep HF patients without congestion and within safe LAP ranges. This resulted in a significant decrease in the rate of HF-related hospitalisations and a notable improvement in quality of life, based on the 6-minute walk distance and the Kansas City Cardiomyopathy Questionnaire.
Eyal Orion, co-founder and CEO of Vectorious, said: “We look forward to expanding our clinical activities in the USA and work closely with physicians, nurses, the US Food and Drug Administration (FDA), and our partners towards a pivotal trial. Recent data published in JAMA Cardiology suggest recent plateaus or reversals after long-standing declines in cardiovascular mortality, particularly for HF related mortality in the USA between 1999 and 2021. I strongly believe that the technology and treatment paradigm we develop have the potential to reverse this concerning trend, and our team is fully committed to this mission.”
