Conscious sedation for transcatheter implantation of atrial septal occluders with two- and three-dimensional transoesophageal echocardiography guidance - a feasibility and safety study.

ABSTRACT

BACKGROUND: General anaesthesia may have negative impact on patient mortality and morbidity, as well as overall procedure costs, in atrial septal occluder (ASO) implantation. AIM: We sought to evaluate the safety, efficacy, and feasibility of conscious sedation for transcatheter implantation of ASOs. METHODS: A total of 122 patients referred for transcatheter implantation of ASO were included. Mean patient age was 51 ± 15 years, and 43 (35%) patients were male. The initial dose of midazolam was 2 mg and fentanyl dose was 25 µg. Additional doses of midazolam and fentanyl were administered, if necessary. Patient responsiveness was assessed every 10 min, and the sedatives doses were titrated in order not to exceed grade 3 sedation in the Ramsey scale. RESULTS: Atrial septal occluders were successfully implanted in the majority of patients (98.4%). In two (1.6%) cases the proce-dure failed because of too small patent foramen ovale (PFO) diameter (n = 1, 0.8%) or device instability (n = 1, 0.8%). The mean duration of procedure was 47.6 ± 28.4 min and was similar for ASD and PFO closure (p = 0.522). The overall mean dose of midazolam was 4.7 ± 2.2 mg (63.9 ± 32.5 µg/kg) and fentanyl was 30.0 ± 11.9 µg (0.43 ± 0.17 µg/kg). Median entrance dose of radiation at the patient plane was 25 (interquartile range 16-57) mGy, and did not differ between ASD and PFO procedures (p = 0.614). The majority of patients were free of complications (91.0%). The following early complications were observed transient ischaemic attack (n = 2, 1.6%), supraventricular arrhythmias (n = 4, 3.3%), left atrial thrombus formation (n = 1, 0.8%), symptomatic bradycardia (n = 1, 0.8%), and femoral venous bleeding (n = 5, 4.1%). After mean follow-up of 386 days residual shunt was observed in eight (6.6%) patients. CONCLUSIONS: Conscious sedation for transcatheter implantation of ASO is a feasible, safe, and efficient technique, allowing successful PFO and ASD closure in the majority of patients.