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One patient in this registry died after placement of a PTC drain. However, this event was not
related to the sedation procedure.
The most critical AEs that were recorded were two patients with cardiac arrest and two
patients with haemodynamic collapse. These AEs were related to the performed procedure
rather than related to sedation. However, these AEs does emphasise the need for a well-
trained SP to promptly and effectively initiate management in case of such events.
Procedures that carry the highest risk for significant sedation related events are
bronchoscopies, EBUS and PVI, either alone or in combination with other procedures (Table
2). EBUS has a risk of a sedation related AE of 29.9%with a sentinel severity rate in 1⁄3 of these
cases. Bronchoscopy carries a risk of a sedation related AE of 26.5% with a sentinel severity
of 19.4%. PVI and PVI combined with transoesophageal echocardiography (TOE) carry a risk
of 27.5% and 45.5% of sedation related AEs, respectively. Moreover 10% and 40% of these
sedation related AEs are rated with sentinel severity. It is well known that catheter ablation
for atrial fibrillation is a high-risk procedure, with a reported mortality of 1:1000 procedures.
8
Four patients needed admission to the hospital after PVI, two of them to a critical care unit.
PVI was the procedure most complicated by hospital admission and yielded 2 of the 4 most
critical events and 1 poor outcome. One after a cardiac arrest, secondary to a sheath-related
air embolus, the other after a catheter-related cardiac perforation and tamponade resulting
in cardiovascular collapse.
On the basis of this study the authors can’t discourage PSA for PVI, EBUS or bronchoscopy.
A factor to take into consideration whether PVI should be performed under PSA is the
duration of the procedure. Median time for the procedure in this series was 120 minutes
(IQR 100-180 minutes) with a maximum duration of 640 minutes. It might not be feasible for
all patients to be comfortable lying still for this period of time. Consequently, the patients
would have to be sedated quite deep for a long time, exposing them to an increased risk
of sedation related AEs.
Novice SP should have sufficient experience in effectively managing critical emergencies
before they can perform sedation for these procedures.
Furthermore, these are high-risk interventions and careful periprocedural planning (e.g.
patient selection, preprocedural optimisation of patients, experienced operator and
SPs providing PSA and the possibility of direct supervision of an anaesthesiologist) is
recommended. With increasing complexity of both, the procedures and the comorbidity
of the patients, thorough preprocedural-assessment, procedural planning and high
quality postoperative care to identify deterioration early are becoming more and more
important. Hospitals with sedation programs should have standard operation procedures
for unexpected emergencies, and optimal postprocedural care for high-risk patients or
high-risk procedures.