Introduction
Pulmonary Artery Pressure Monitoring has been shown to reduce rehospitalization in HF patients. Interatrial Shunting (IS) is in clinical studies for similar purposes. However, none of the currently available devices provide both at the same time.
Hypothesis
A novel implantable system has been developed to provide IS and LAP monitoring. It consists of an implant device, a delivery system, and an external Monitoring Unit (MU). The MU works with the device’s MEMS pressure sensor to provide the measured LAP. This study aims to assess the feasibility of the system and accuracy of measured LAP in a chronic canine study.
Methods
The device was implanted in 10 healthy dogs (Labrador, 30-35 Kg), with 4 observed for 1 month and 6 for 3 months. Procedure success, safety outcome, shunt patency (via TEE) and pressure accuracy were evaluated. To achieve various pressure levels, phenylephrine (0.05-2.00 mg) was injected during implant and at the end of each follow up (FU) before termination. Waveforms of PCWP from Swan Ganz and LAP from the device were recorded for more than 10 seconds by PowerLab (PLC01) and MU respectively. Correlation and agreement between LAP and PCWP were assessed with Pearson’s correlation analysis and Bland-Altman plots.
Results
The implant was successful in all dogs with shunt patent at 1 or 3 months. No device related adverse event was observed. Pressure points were obtained for each dog, with a total of 42 pairs of pressure measurements ranging from 0 to 22 mmHg from all dogs. Fig. 1a shows an example of the device encapsulation by a thin layer of endothelium at 3 months. Simultaneous pressure waveform recordings, correlation and Bland-Altman plot are shown in Fig.1b-d. The PCWP and LAP measurements correlated well (R2=0.87), with an average difference of 0.33±1.80 mmHg. In the Bland-Altman plot, 40 of 42 pairs fell inside the 95% limit of agreement, indicating good agreement between PCWP measured by Swan-Ganz and LAP by the device.
Conclusions
This preliminary chronic animal study demonstrated the feasibility of this implantable device and the accuracy of device-based LAP as compared to PCWP. Further studies are warranted. This novel device with interatrial shunting therapy and hemodynamic monitoring has the potential to provide clinicians with more options for managing HF patients.
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