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 A large coronary perforation occurred (no further details of cause available) during optical coherence tomography (OCT) imaging in 1 patient presented in a case report, leading to reduced blood pressure and loss of consciousness. Surgical repair was done but the patient died of cardiac arrest after 7 days.
5.2 A minor type A coronary dissection occurred in 1 patient in the case series of 468 patients during time-domain OCT (TD OCT) imaging. Coronary blood flow was not impaired and further treatment was not needed.
5.3 Ventricular fibrillation occurred in 5 patients in a case series of 468 patients during TD OCT imaging, in 3 out of 256 during occlusive imaging and 2 out of 212 during non-occlusive imaging. In all cases, sinus rhythm was promptly restored after stopping OCT imaging and external defibrillation. Ventricular ectopic beats were noted in 3 patients in a case series of 90 patients undergoing 114 OCT image acquisitions.
5.4 Air embolism occurred in 3 patients in the case series of 468 patients during TD OCT imaging. All responded promptly to air aspiration, treatment with nitrates and, in 1 patient, nitroprusside administration.
5.5 Mechanical device failure occurred in 1 patient in the case series of 468 patients. The imaging wire became trapped within the struts of a stent and the tip fractured and remained within the stent. At 4 month follow-up there had been no clinical consequences and angiography showed no flow abnormalities.
5.6 Multiple thrombi were reported during OCT imaging in 3 patients presented in case reports. These formed during OCT imaging in the left anterior descending artery causing total occlusion in 1 patient and subtotal occlusion in 2 others. All resolved with appropriate management and all patients recovered uneventfully.
5.7 Vessel spasm during withdrawal of the OCT wire was reported in a single case report. This caused chest pain and ST elevation but resolved with an intracoronary injection of nitrate.
5.8 Self-limiting chest pain was reported by 48% of patients (225/468) during TD OCT imaging in the case series of 468 patients. This was significantly more common when the occlusive rather than the non-occlusive technique was used (70% [180/256] versus 21% [45/212], p<0.001).
5.9 Self-limiting QRS widening or ST depression and ST elevation occurred in 192 (46%) of 468 patients treated by occlusive or non-occlusive TD OCT. These were significantly more common when the occlusive rather than the non-occlusive technique was used (61% [139/256] versus 27% [53/212], p<0.001).
5.10 The specialist advisers described the possibility that emergency revascularisation might be needed as a result of some of the complications of OCT which were reported in the literature.