Author + information
- 1Rabin Medical Center, Petach Tikva, California, Israel
- 2Vectorious Medical Technologies, Tel Aviv, Israel
- 3Cardiovascular Center, OLV Hospital, Aalst, Belgium
- 4Vectorious Medical Technologies, Tel-Aviv, Israel
- 5Ohio State University, Columbus, Ohio, United States
- 6Shaare Zedek Medical Center, Jerusalem, Israel
Heart failure (HF) is a leading cause of hospital admissions. Advancements in monitoring of right-sided parameters have shown promise in reducing readmissions. To this date, a left-sided pressure monitoring system is not available. The Vectorious Medical Technologies V-LAPTM is a novel intracardiac HF monitoring system, based on a micro-computer sensory implant. It is the first fully digital, wireless left atrial pressure (LAP) sensor, which enables bi-directional communication with an external unit, as well as compensation for drift in pressure. The objective of this study was to assess the safety, the usability and the feasibility of the V-LAPTM to accurately measure LAP.
The V-LAPTM sensor was implanted at the interatrial septum using a trans-septal approach in 10 ovine subjects. LAP readouts were compared with invasive measurement of pulmonary capillary wedge pressure (PCWP) at index procedure and 1, 2 and 3-6 months after the implantation, at rest and after volume loading. Histopathology assessment (n=8) was performed at up to 50 weeks post procedure.
Procedural success was 100%. Measurements showed a mean difference between the V-LAPTM and PCWP of 0.19±2.51 mmHg. During this period, correlation of V-LAPTM with PCWP was excellent (R2=0.95, for 119 total measurements). There were no major adverse events related to the V-LAPTM system. Pathology showed intact tissue, with no mechanical or thrombotic complications.
In an animal model, the implantation of the novel wireless left atrial pressure sensor V-LAPTM was feasible, safe, and showed good accuracy and precision.
STRUCTURAL: Heart Failure