This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
5.1 Failure of the delivery system and the need for a snare to remove it was reported in 1 patient in the RCT of 550 patients. Pressure sensor failure was reported in 1 patient in a case series of 40 patients at 6-month follow-up.
5.2 Cardiogenic shock was reported in 1 patient in the RCT of 550 patients, the timing of which was not reported. Exacerbation of pre-existing atrial arrhythmias during right-heart catheterisation was reported in less than 1% (2/550) of patients in the same study.
5.3 The specialist advisers listed anecdotal adverse events including excessive reduction in blood pressure and renal dysfunction caused by aggressive treatment of raised pulmonary artery pressure.
5.4 The specialist advisers listed theoretical adverse events including embolism of the device into the peripheral pulmonary tree, infection, pulmonary embolism, rupture of branch pulmonary artery, movement of the device, faulty communication of data, and errors in clinical decision-making based on measurements (even if the measurements are accurate).