Vectorious Medical Technologies today announced interim results from a pilot study of its V-LAP sensor for heart failure management.
Tel Aviv, Israel-based Vectorious presented results from the left atrial pressure (LAP) guided patient self-management study at during an abstract session at THT 2023 in Boston.
The study has 13 enrolled patients to date. It includes New York Heart Association (NYHA) class II and III heart failure (HF) patients. These patients enrolled irrespective of left ventricular ejection fraction and received the V-LAP sensor in the left atrium.
Patients can see direct LAP readings captured by the sensor using a dedicated app and novel treatment paradigm. It allows self-management of diuretics and early intervention in cases of high LAP.
V-LAP allows patients to take a more active role in managing their disease. Using the system, patients can better understand the correlation between their daily medication routine, daily activities and their fluid volume status. Patients receive guidance to adjust diuretics when LA pressure falls out of the optimal range. When it remains in suboptimal ranges, medical teams receive notification and can add 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 Dr. Eyal Orion. “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. ”
The results from the study of the Vectorious V-LAP sensor
With an average follow-up of 278 days (9.14 months), patient adherence came in at 91.36%. Vectorious defined patient adherence as greater than or equal to five days of LAP measurements per week. During 89.1% of overall follow-up duration (9.6 patient years), patient self-management alone kept HF patients within the optimal LAP range. Meanwhile, in only 10.9% of overall follow-up time, patients required physician intervention to adjust medication dosage due to persistently high LAP.
Using the patient self-management approach, Vectorious observed a significant decrease in the annualized rate of HF-related hospitalizations. This compared to a similar period prior to self-management. The company saw zero admissions per patient under self-management compared to 0.69 prior to self-management.
Vectorious’ V-LAP patients demonstrated significant improvement in six-minute walk distance. They recorded a median of 187 meters at baseline, then a median of 325 meters at six months. The Kansas City Cardiomyopathy Questionnaire score also significantly improved from baseline to six months.
Dr. William Abraham, College of Medicine Distinguished Professor at The Ohio State University, presented the results at THT. He said the initial insights “represent the next frontier of hemodynamic monitoring.”
“Over the past decade, physician-directed hemodynamic management using pulmonary artery pressure sensors has demonstrated the benefits of pressure-guided HF care,” he said. “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.”