5 Safety

5 Safety

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 interventional procedure overview.

5.1 In-hospital death was reported in 1 patient in the balloon pulmonary angioplasty (BPA) group in a non‑randomised retrospective comparative study of 53 patients treated by BPA (n=29) or pulmonary endarterectomy (PEA; n=24) for chronic thromboembolic pulmonary hypertension. This death was due to infection caused by a central venous catheter used to administer epoprostenol. In the same study, perioperative death was reported in 2 patients from the PEA group within 16 days of surgery. Both patients had severe pulmonary hypertension and low cardiac output, and needed constant cardiopulmonary support.

5.2 Death due to right heart failure was reported in 1 patient, 28 days after their third BPA session, in a case series of 68 patients. There was a severe reperfusion pulmonary injury during the BPA session, which exacerbated the patient's right heart failure.

5.3 Death due to right ventricular failure was reported in 1 patient, 7 days after BPA, in a case series of 18 patients. The patient developed segmental pulmonary oedema in all dilated areas and was receiving mechanical ventilation. In the same study, death due to recurrent aspiration pneumonia was reported in 1 patient, 16 months after their first BPA session. In a case series of 20 patients, death due to acute right ventricular failure was reported in 1 patient, within 2 hours of his first BPA session. In the same study, death due to acute pulmonary embolism was reported in 1 patient 9 days after his first BPA session. Also, death due to chronic right heart failure was reported in 1 patient 15 months after the last BPA session.

5.4 Wire perforation (blood vessels not specified) was reported after 5% (4/86) of BPAs but not after any PEAs in the non‑randomised retrospective comparative study of 53 patients. Pulmonary artery perforation was reported after 2% (5/255) of BPAs in the case series of 68 patients. Two of these patients were treated by emergency transcatheter coil embolisation. Perforation of the pulmonary artery in the right lower lobe was reported in 1 patient in the case series of 18 patients; this was treated by coil occlusion.

5.5 Femoral artery pseudoaneurysm was reported in 17% (3/18) of patients in the case series of 18 patients. These patients were obese and needed femoral arterial access for monitoring during BPA. All were successfully treated by surgical repair or mechanical compression.

5.6 Reperfusion pulmonary oedema was reported in 61% (11/18) of patients in the case series of 18 patients; 4 cases were identified at the time of catheterisation and 7 were identified up to 48 hours after surgery. The patients were treated with diuretics and oxygen, and 3 needed additional mechanical ventilation. Reperfusion pulmonary oedema was reported in 35% (7/20) of patients in the case series of 20 patients; they were treated by supplementary oxygen therapy and diuretics.

5.7 Severe haemoptysis was reported after 4% (3/86) of BPAs and 13% (3/24) of PEAs in the non‑randomised retrospective comparative study of 53 patients. Mild to moderate haemoptysis was reported in 50% (6/12) of patients in a case series of 12 patients.

5.8 Haemosputum or desaturation was reported after 28% (24/86) of BPAs and 13% (3/24) of PEAs in the non‑randomised retrospective comparative study of 53 patients. Breathlessness and desaturation were each reported in 3 patients in a case series of 8 patients. In the same study, atrial arrhythmia and subcutaneous haematoma were each reported in 1 patient.

5.9 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse events: acute kidney injury and anaphylactic shock, both caused by contrast medium, and exposure to high radiation in patients needing repeat procedures. They considered that cardiovascular collapse and cardiac tamponade were theoretical adverse events.

  • National Institute for Health and Care Excellence (NICE)