V-LAP Allows Heart Failure Patients to Self-Adjust Medication: Vectorious Reports Promising Findings From its Pilot Study at the THT Meeting
During 89.1% of the overall follow up duration (3504 days), Patient Self-Management (PSM) alone was sufficient to stabilize HF patients within the optimal LAP thresholds, while only 10.9% of follow up time, physician intervention was required to adjust medication
TEL AVIV, ISRAEL – Yesterday, Vectorious Medical Technologies Ltd. presented interim results from its Left Atrial Pressure (LAP) Guided, Patient Self-Management (PSM) pilot study during a featured abstract session at THT 2023 in Boston.
The study, which has enrolled 13 patients to date, includes New York Heart Association (NYHA) class II and III HF patients, irrespective of left ventricular ejection fraction, who are implanted with the V-LAP sensor in the left atrium. Direct LAP readings captured by the sensor are visible to patients who use a dedicated app and novel treatment paradigm for self-management of diuretics and early intervention in cases of high LAP.
Over an average follow-up of 9.14 months (278 days; range 93-412 days), patient adherence (defined as ≥ 5 days of LAP measurements per week) was 91.36%. During 89.1% of overall follow-up duration (9.6 patient years, 3504 total days), PSM alone was used to keep HF patients within the optimal LAP range, while in only 10.9% of overall follow-up time, physician intervention was required to further adjust medication dosage due to persistently high LAP. Using the PSM approach, a significant decrease in the annualized rate of HF-related hospitalizations was observed compared to a similar period prior to PSM utilization (0 admissions per patient under PSM versus 0.69 admissions per patient prior to PSM, P=0.004). PSM patients demonstrated significant improvement in 6-minute walk distance from a median of 187.00m (IQR 178.00-325.00m) at baseline to 325.00m (IQR 235.00-425.00m) at 6 months, P=0.047. The Kansas City Cardiomyopathy Questionnaire score was also significantly improved from baseline to 6 months. (median 49.22, IQR 36.4-52.08, to 68.75, IQR 53.91–86.46, P=0.031).
“These initial insights represent the next frontier of hemodynamic monitoring by enabling patients to self-manage their LAP under the direction of their physician’s prescribed guidelines” said Dr. William T. Abraham M.D., College of Medicine Distinguished Professor at The Ohio State University, who presented the results at the THT meeting. “Over the past decade, physician directed hemodynamic management using pulmonary artery pressure sensors has demonstrated the benefits of pressure-guided HF care. Based on randomized controlled trials, these devices are now indicated for NYHA class II and III HF patients for prevention of re-admissions due to HF exacerbations. Next generation LA sensors enable this paradigm to further evolve to physician directed, patient self-management. While larger randomized controlled studies are required to confirm the effectiveness of this approach, it has the potential to revolutionize the field and have clinical impact on millions of HF patients.”
The V-LAP System also allows HF patients to take a more active role in managing their disease. Using the V-LAP System, patients can better understand the correlation between their daily medication routine, daily life activities and their fluid volume status. When LA pressure is out of the optimal range, patients are guided to adjust diuretics based on the predefined treatment plan. If the LA pressure is in suboptimal ranges, the medical team is notified and can provide additional instructions to prevent further deterioration.
“We strongly believe that the unique data from the LA, coupled with our technological platform will enable millions of HF patients to take ownership of their disease” said Vectorious CEO and co-founder Eyal Orion, MD. “Using the insights we get from the left atrium, we continue to learn about the disease and optimize our treatment paradigm to tailor personalized treatment to the individual patient. We believe that implantable sensors, that can provide long term accurate physiological information, will play major role in treatment of patients with chronic diseases and development of novel therapeutic approaches.”
About Vectorious Medical Technologies Ltd.
Vectorious is a Tel Aviv-based company, founded in 2011. The company’s V-LAP System enables heart failure patients to better control their disease and live fuller, longer lives by remotely monitoring the heart’s Left Atrial Pressure (LAP) to detect fluid accumulation in the earliest stages of disease, prior to physiological symptoms. A patient app further empowers the patient to self-titrate medication in real time based on data extracted from the heart. For more information, please visit the company website.
Contact:
Lili Arbely-Elbaz
Vectorious Medical Technologies
+972-(0)525909192
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SOURCE Vectorious Medical Technologies Ltd.
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