V-LAP Left Atrial Monitoring systEm for Patients with Chronic sysTOlic and Diastolic Congestive Heart FailuRe First-in-Human

Abstract

Despite advancements in diagnostic and therapeutic modalities, the rate of HF hospitalizations (HFH) has not changed substantially in recent years. While non-invasive monitoring approaches have generally failed to reduce the risk of HFH, management guided by intracardiac or pulmonary artery pressure has. Purpose: To present the initial experience with a novel battery-less and wireless left-sided pressure system, directly assessing left-atrial pressure (LAP) in ambulatory HF patients, from the V-LAP monitoring systEm for patients with Chronic sysTOlic and diastolic congestive heart failuRe first-in-human (VECTOR) study. Methods: The V-LAP™ sensor is able to directly measure absolute pressures in the LA in high resolution, compensate for pressure drift, transmit daily hemodynamic feedback, and detect common comorbidities such as Afib and MR. It is implanted using a TS approach, under angiographic and echocardiographic guidance. The V-LAP™ system includes an external unit, which powers the implant remotely and collects data via RF communication on a daily basis. The system is undergoing initial clinical evaluation in the VECTOR-HF Trial, in order to assess the safety, performance and usability of the system in patients with HF. Results: In pre-clinical studies, the device was shown to enable accurate and safe LAP measurement. Currently, two patients have been successfully implanted with the device. In the first case the patient has great variability in LAP on a daily basis, likely due to rapid changes in preload due to variability in venous capacitance and possibly volume status, accompanied by preload-dependent changes in the severity of functional MR, which was well observed during both TTE and LAP waveform morphology. This patient might be at high-risk for HFH. In the second case the LAP is well-controlled with little variability. During the conference we will describe and discuss the first 8 cases, and discuss the potential role of the V-LAP™ wireless sensor in the management of patients with HF in the future. Conclusions: The VECTOR-HF trial currently enrolled the first two patients, who were safely implanted with the V-LAP™ wireless sensor. Clinical trials will demonstrate whether the system enables optimal therapy for HF patients, reduces readmissions and detects co-morbidities in a personalized manner. Daily hemodynamic feedback from the heart opens a new era in the management of HF patients and scientific outcomes based on LAP data.