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Table

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General considerations

Statement	Class	Evidence
Device indication should be based upon current guidelines and take into account the patient’s specific needs.		E
The operation room/catheterization or electrophysiology laboratory must meet aseptic standards for foreign body implants and be ventilated with >15 air changes/h (ideally 20–25 changes/h).¹³^,¹⁴		O
The procedure should be performed or supervised by a proficient physician, with EHRA level 2 or national certification, or equivalent expertise.		E
At least one unscrubbed allied professional or nurse should assist the implanter with the procedure.		E
Anaesthesia standby should be readily available.		E
The operator, or another physician present on site, should be able to perform emergency pericardiocentesis.		E
Exposure to irradiation should be minimized.		E

Statement	Class	Evidence
Device indication should be based upon current guidelines and take into account the patient’s specific needs.		E
The operation room/catheterization or electrophysiology laboratory must meet aseptic standards for foreign body implants and be ventilated with >15 air changes/h (ideally 20–25 changes/h).¹³^,¹⁴		O
The procedure should be performed or supervised by a proficient physician, with EHRA level 2 or national certification, or equivalent expertise.		E
At least one unscrubbed allied professional or nurse should assist the implanter with the procedure.		E
Anaesthesia standby should be readily available.		E
The operator, or another physician present on site, should be able to perform emergency pericardiocentesis.		E
Exposure to irradiation should be minimized.		E

E, evidence and expert opinion; M, meta-analysis; O, observational studies; R, randomized trials.

Table

Open in new tab

General considerations

Statement	Class	Evidence
Device indication should be based upon current guidelines and take into account the patient’s specific needs.		E
The operation room/catheterization or electrophysiology laboratory must meet aseptic standards for foreign body implants and be ventilated with >15 air changes/h (ideally 20–25 changes/h).¹³^,¹⁴		O
The procedure should be performed or supervised by a proficient physician, with EHRA level 2 or national certification, or equivalent expertise.		E
At least one unscrubbed allied professional or nurse should assist the implanter with the procedure.		E
Anaesthesia standby should be readily available.		E
The operator, or another physician present on site, should be able to perform emergency pericardiocentesis.		E
Exposure to irradiation should be minimized.		E

Statement	Class	Evidence
Device indication should be based upon current guidelines and take into account the patient’s specific needs.		E
The operation room/catheterization or electrophysiology laboratory must meet aseptic standards for foreign body implants and be ventilated with >15 air changes/h (ideally 20–25 changes/h).¹³^,¹⁴		O
The procedure should be performed or supervised by a proficient physician, with EHRA level 2 or national certification, or equivalent expertise.		E
At least one unscrubbed allied professional or nurse should assist the implanter with the procedure.		E
Anaesthesia standby should be readily available.		E
The operator, or another physician present on site, should be able to perform emergency pericardiocentesis.		E
Exposure to irradiation should be minimized.		E

E, evidence and expert opinion; M, meta-analysis; O, observational studies; R, randomized trials.