Pulmonary vascular disease & thromboembolism

Efficacy and Safety of the Aria Pulmonary Endovascular Device in Pulmonary Hypertension

Eur J Heart FailPublished Acute feasibility study

Authors' conclusion

Temporary implantation of the Aria endovascular device was feasible and safe. Device activation resulted in acute improvement of CPA and RV-PV coupling.

Study context

Population
Patients with pulmonary hypertension (PH) associated with left heart disease or chronic lung disease
Participants
8 vs 10
Comparison
Aria device on vs off
  • PH-LHDn = 8
  • PH-CLDn = 10
Outcome
Incidence of serious adverse events
Follow-up
30 days after the procedure
Methodological detailsDevice placed in main pulmonary artery via right femoral vein; haemodynamics assessed at baseline and with device off, on and off
  • Device placed in main pulmonary artery via right femoral vein; haemodynamics assessed at baseline and with device off, on and off

Main finding

As reported in the abstract

Serious adverse events · 30 days
  • No complications or investigational device-related serious adverse events

Further findings

OutcomePH-LHDPH-CLD
Change in pulmonary arterial pulse pressure with device activationDecrease, mmHg5.6 (SD 4.2)4.2 (SD 2.2)
Relative change−12%−11%
Pp = 0.003p < 0.001
Change in CPA with device activationIncrease, ml/mmHg0.4 (SD 0.2)0.4 (SD 0.3)
Relative change+23%+25%
Pp = 0.004p = 0.001
Change in RV-PV coupling with device activationIncrease0.24 (SD 0.18)0.11 (SD 0.07)
Relative change+40%+21%
Pp = 0.012p = 0.001

Safety

Complications and device-related serious adverse events · 30 days

No complications or investigational device-related serious adverse events occurred

Original publication

Efficacy and Safety of the Aria Pulmonary Endovascular Device in Pulmonary Hypertension. Eur J Heart Fail. Published 13 March 2024. doi:10.1002/ejhf.3187

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