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 An analysis of the Extracorporeal Life Support Organization (ELSO) register data (22 had arteriovenous extracorporeal carbon dioxide removal [AV‑ECCO2R] and 38 had venovenous [VV] ECCO2R) reported that 32% (19/60) of patients had complications. Of these 19 patients, 11 had a single complication and 8 had 2 or more complications. In a multicentre randomised controlled trial (RCT) of 79 patients treated by low ventilation (about 3 ml/kg) combined with AV‑ECCO2R (n=40) or an acute respiratory distress syndrome (ARDS) network strategy without ECCO2R (about 6 ml/kg; n=39), 8% (3/40) of patients had ECCO2R-related adverse reactions. In a meta‑analysis of 8 case series (n=225 patients treated by AV‑ECCO2R), the complication rate was 29%. In a case series of 90 patients treated by AV‑ECCO2R, serious complications were reported in 24% of patients (22/90).

5.2 Limb ischaemia was reported in 9% (21/225) of patients in the meta-analysis of 8 case series. ECCO2R-related ischaemia was reported in 1 patient in the RCT of 79 patients treated by low ventilation combined with AV‑ECCO2R (n=40) or an acute respiratory distress syndrome network strategy without ECCO2R (n=39). Lower limb ischaemia was reported in 8% (13/159) of patients in a case series of 159 patients treated by AV‑ECCO2R; in these patients, the arterial cannula was either exchanged with a smaller one or moved to the contralateral femoral artery.

5.3 Central nervous system haemorrhage was reported in 1 patient out of 60 in the analysis of UK cases in the ELSO register data. Intracerebral haemorrhage was reported in 1 patient in the case series of 90 patients. Intracranial haemorrhage was reported in 1 patient in each arm of an RCT of 40 patients treated by low frequency positive-pressure ventilation and VV‑ECCO2R (n=21) or continuous positive-pressure ventilation alone (n=19). In the same study, intrapulmonic haemorrhage was reported in 19% (4/21) of patients treated by ECCO2R. It was also reported that ECCO2R had to be stopped in 7 patients because of haemorrhage.

5.4 Bleeding at the site of cannulation was reported in 12% (7/60) of patients in the UK patients of the ELSO register, in 4% (8/225) of patients in the meta-analysis of 8 case series, and in 1 patient in the case series of 51 patients. Diffuse bleeding and shock during cannulation was reported in 1 patient in the case series of 90 patients (no further details provided).

5.5 Haematoma/aneurysm at the cannulation site was reported in 1 patient in the case series of 90 patients. 'False' aneurysm was reported in 5% (2/40) of patients treated by ECCO2R in the RCT of 79 patients treated by low ventilation combined with AV‑ECCO2R or ARDS Network strategy without ECCO2R. Pseudo aneurysm of the femoral artery was reported in 1 patient treated by pumpless extracorporeal lung assist (PECLA) in a multicentre retrospective matched comparison study of 42 patients treated by PECLA (n=21) or invasive mechanical ventilation (n=21).

5.6 Venous thrombosis was reported in 5% (1/21) of patients in the ECCO2R arm and in 11% (2/19) of patients in the control arm in the RCT of 40 patients. The meta-analysis of 8 case series reported arterial thrombus formation in 2% of patients (5/225), venous thrombus formation in 5% (11/225) and oxygenator thrombus formation in 3% (6/225). Thrombus formation was reported in 17% (27/159) of patients in the case series of 159 patients; the oxygenators were exchanged. In the same study, thrombosis of the entire system developed in 8 patients (4 were inadequately anticoagulated, 2 had heparin-induced thrombocytopenia type II and there were 2 device failures). ECCO2R circuit clotting was reported in 19% (4/21) of patients treated by VV‑ECCO2R in the RCT of 40 patients.

5.7 Infection was reported in 8% (5/60) of patients in the analysis of UK patients on the ELSO register. Infection was reported in 1 patient in the meta-analysis of 8 case series (n=225).

5.8 Compartment syndrome needing fasciotomy was reported in 3% (4/159) of patients in the case series of 159 patients; 1 of these patients needed lower leg amputation. Compartment syndrome was reported in 4% (4/90) of patients in the case series of 90 patients. Compartment syndrome was reported in 1 patient in the case series of 51 patients; this was surgically treated.

5.9 Renal complications were reported in 10% (6/60) of patients in the analysis of UK patients on the ELSO register.

5.10 Cardiovascular complications were reported in 10% (6/60) of patients in the analysis of UK patients on the ELSO register. Cardiac dysrhythmia was reported in 10% (2/21) of patients in the ECCO2R group and in 11% (2/19) of patients in the control group in the RCT of 40 patients; cardiac tamponade occurred in 5% (1/21) in the ECCO2R group and 0% (0/19) in the control group.

5.11 Haemolysis was reported in 1 patient in the case series of 90 patients.

5.12 Technical problems were reported in 21% (15/70) of patients in a case series of 70 patients treated by AV‑ECCO2R. Mechanical complications were reported on 7 occasions in the analysis of UK patients on the ELSO register: 1 oxygenator failure, 2 pump malfunctions, 1 oxygenator clot, 2 other clots and 1 cannula problem. Plasma leakage was reported in 4% (10/225) of patients in the meta-analysis of 8 case series.

5.13 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 did not list any anecdotal adverse events. They considered that allergic reaction was a theoretical adverse event.

  • National Institute for Health and Care Excellence (NICE)