First Experience with EV-ICD Implantation under Deep Sedation with Non-invasive Ventilation

Introduction:

The extravascular implantable cardioverter-defibrillator (EV-ICD) is an innovative advancement in device-based arrhythmia management, offering effective defibrillation while sparing the cardiovascular system. Given its recent introduction and the relatively invasive retrosternal lead placement, the manufacturer recommends general anesthesia (GA) as the standard approach during implantation.

Methods:

We conducted a retrospective analysis of periprocedural and safety outcomes in patients who underwent EV-ICD implantation at our center focusing on the anesthetic approach.

Results:

A total of 11 patients underwent EV-ICD procedures, 7 under GA with anesthesiology support, and 4 under non-invasive ventilation with deep sedation (NIV-DS) using propofol and esketamine administered by cardiologists. Baseline characteristics were comparable between groups (Table 1). All procedures were completed without major complications. There were no significant differences in procedural and lab times. A detailed summary of procedural outcomes is provided in Table 2.

 

Conclusions:

EV-ICD implantation under NIV-DS administered by cardiologists appears feasible and safe. Further investigations in larger cohorts are needed to evaluate whether GA is necessary as the default anesthetic strategy in EV-ICD implantation.

 

Table 1: Baseline characteristics

	GA	NIV-DS	*p-value
N =	7	4
Age (years)	55 (53 – 65)	47 (45 – 51)	0,216
Gender			0,236
- male (%)	4 (57)	4 (100)
- females (%)	3 (43)	0 (0)
BMI (kg/m2)	28 (26 – 30)	29 (26 - 31)	0,924
LVEF (%)	30 (25 - 33)	25 (20 - 35)	0,773
Indication for ICD therapy			1
- primary prevention (%)	6 (86)	3 (75)
- secondary prevention (%)	1 (14)	1 (25)
Medical history
- OHCA	0 (0)	1 (25)	0,346
- Device infect (%)	1 (14)	0 (0)	1
- Heart failure (%)	6 (86)	4 (100)	1
- Hypertension (%)	6 (86)	3 (75)	1
- Diabetes (%)	2 (29)	2 (50)	0,576
- Smoking history (%)	4 (57)	3 (75)	1
- COPD (%)	0 (0)	0 (0)	1
Medication
- Antihypertensive drugs (%)	7 (100)	4 (100)	1
- Inhaled bronchodilators (%)	0 (0)	0 (0)	1

 

Table 2: periprocedural parameters:

	GA	NIV-DS	*p-value
N	7	4
Procedural parameters:
Total duration (min)	66 (63 - 73)	79 (76 - 81)	0,071
Wheels to incision time (min)	67 (44 - 74)	40 (33 - 43)	0,089
Fluoroscopy time (min)	4 (4 - 5)	5 (4 - 9)	0,345
DAP (Gy.cm²)	18 (13- 21)	22 (10 - 34)	0,850
Hospitalization duration (days)	2 (2 – 3)	2 (2 – 3)	0,575
Anesthesia:
Propofol induction dose (mg)	120 (103 - 145)	35 (30 - 40)	0,008
Propofol max. infusion rate (mg/h)	320 (290 – 350)	950 (825 - 1000)	0,008
Remifentanil induction dose (µg/kg)	0,5 (0,5 – 0,5)	-	-
Remifentanil infusion rate (µg/kg/min)	0,3 (0,2 – 0,3)	-	-
Esketamine cumulative dose (mg)	-	75 (69 – 78)	-
Use of vasopressors (%)	7 (100)	2 (50)	0,133
NA max. infusion rate (mg/h)	0,5 (0,3 – 0,7)	0,7 (0,6 – 0,8)	0,462
Major complications:	0 (0)	0 (0)	1
- Death (%)	0 (0)	0 (0)
- ICU admission (%)	0 (0)	0 (0)
- Respiratory emergency (%)	0 (0)	0 (0)
- Wound infection (%)	0 (0)	0 (0)
- Bleeding complication (%)	0 (0)	0 (0)

Abbreviations:
GA=general anesthesia, NIV-DS=non-invasive ventilation with deep sedation, BMI=body mass index, LVEF=left ventricular ejection fraction, OHCA= out of hospital cardiac arrest, COPD=chronic obstructive pulmonary disease, DAP= dose area product, NA= Noradrenaline, ICU=intensive care unit.

* Statistical tests: Mann-Whitney and Fischer Exact Tests. Continuous variables are presented as median (interquartile range), and categorical variables as counts (percentages).