Implantation of the endovascular device Aria during right heart catheterization was found to improve pulmonary circulation in patients with pulmonary arterial hypertension (PAH), according to the results of an acute safety study published in the Journal of the American College of Cardiologists.
The Aria device system consists of the Aria balloon catheter, which is connected to a gas-filled reservoir which forms a closed system with a 14-F induction catheter that enters through the femoral vein. The balloon is a 15 mL Pellethane balloon on a 4-lumen catheter which accommodates the 0.35-inch guide wire, pressure wires placed proximally and distally to the balloon, and 1 lumen which allows for pulmonary artery (PA) pressure-responsive gas cycling to and from the reservoir. The reservoir is a 2-port glass container connecting the balloon catheter and allowing for pressure monitoring.
After the Aria device is implanted in the PA, gas flow from the balloon to the reservoir occurs during systole when the PA pressure is greater than the reservoir pressure. During diastole, the pressure is reversed, forcing gas to flow back into the balloon. As the balloon inflates, increased PA pressure restores diastolic pulmonary blood flow to lung capillary tissues.
After obtaining favorable results from computer-based modeling experiments and an in vivo experiment in calves, 10 patients with PAH (mean age, 52±17 years; 60% men) who were undergoing right heart catheterization were recruited for this study. All patients were stable on multidrug therapy. All procedures were performed using fluoroscopic monitoring and systemic heparinization. Patients were assessed with the device on or off at rest or during exercise. Cardiac output (CO) was assessed using the Fick method and right ventricular-to-PA coupling by the single-beat approach.
In this cohort, average PA pressure was 48.8±11.9 mmHg, average CO was 7.1±1.7 L/min, and average pulmonary vascular resistance was 6.0±2.6 Wood units (WU). The implantation procedures lasted a total of 59.8±29.5 minutes.
After the procedure, pulse pressure at rest was reduced (47.6±12.1 vs 44.1±11.6 mmHg, respectively; P <.01), and CO (6.8±1.7 vs 7.5±2.1 L/min, respectively; P <.01), pulmonary atrial compliance (CPA; 2.1±1.0 vs 2.5±1.2, respectively; P <.01), and end-systolic elastance/effective arterial elastance (Ees/Ea; 1.01±0.25 vs 1.27±0.21, respectively; P <.01) were increased compared with baseline when the device was on.
During exercise (n=6), similar, but more significant changes in vascular compliance were observed (CO: 8.5±2.9 vs 10.3±2.9 L/min, respectively; P <.05; CPA: 1.7±0.7 vs 2.3±1.0, respectively; P <.05; Ees/Ea: 1.01±0.37 vs 1.26±0.24, respectively; P <.05). When the device was turned off, CPA decreased by 20% during rest and by 40% during exercise (P =.003 and P =.028, respectively).
No adverse reactions were observed up to 30 days following the procedure.
This study was limited by its small sample size; however, the study purpose was to justify the safety for a larger trial.
These data indicated the Aria device improved vascular compliance following right heart catheterization among patients with PAH. Future studies are needed to assess long-term clinical outcomes and to confirm these preliminary findings in a larger cohort.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Gerges C, Vollmers K, Pritzker M R, et al. Pulmonary artery endovascular device compensates for loss of vascular compliance in pulmonary arterial hypertension. J Am Coll Cardiol. 2020;76(19):2284-2286. doi:10.1016/j.jacc.2020.08.080