Table 2 Definitions of safety outcomes

 Long term

Lead-related complications (i.e., dislodgement, lead malposition)

Presence of lead malfunction requiring reoperation [67]

 Short term or long term

Device infection

Hospitalization for proven CIED infection within 1 year of implantation. Infection is categorized into pocket infection, bloodstream infection, and endocarditis [68].

 Short term

Contrast-induced nephropath

Contrast nephropathy was defined as an increase in serum creatinine of 25% or greater within 48 h after contrast administration. Contrast nephropathy was defined as an increase in serum creatinine of 25% or greater within 48 h after contrast administration. Contrast nephropathy was defined as an increase in serum creatinine of 25% or greater within 48 h after contrast administration.

Contrast nephropathy was defined as an increase in serum creatinine of 25% or greater within 48 h after contrast administration which would lead to dialysis [69].

 Short term

Pneumothorax (related to venous access)

Complications while obtaining venous access during the index hospitalization including the absence of lung markings over the lung field ipsilateral to the PM pocket assessed from the predischarge X-ray [70].

 Short term

Pocket-related Hematoma

Hematoma requiring further surgery, resulting in prolongation of hospitalization, or requiring interruption of oral anticoagulation therapy. Prolongation of hospitalization was defined as extended hospitalization or rehospitalization for at least 24 h after the index surgical procedure, primarily due to the hematoma [71].

 Short term

Pericardial tamponade

Slow or rapid compression of the heart due to the pericardial accumulation of fluid, pus, blood, clots, or gas, as a result of effusion, trauma, or rupture of the heart [72].

 Short term

Phrenic nerve stimulation requiring reoperation

PS tested during follow-up of patients starting from maximum pacing system analyzer output, 10 V at 1.5 ms followed by a stepping down protocol. In the event of PS occurrence, its threshold is measured in all the possible pacing configurations and compared with LV pacing threshold to ensure the feasibility of biventricular stimulation.

PS disappearance was defined as absence of muscular stimulation over a 20-min observation period during respiratory changes (deep breath); LV threshold was defined as 100% stimulation during the same respiratory changes and requires reoperation [73].

 Short term

Death

Clinical death was considered to be when spontaneous respirations ceased, and pulse and blood pressure disappeared [74]..

Cause of death of patients before their first outpatient visit must be established by reviewing patient charts to identify relation to procedure [75].

 Short term

Electrical storm

Electric storm in patients with CRT-D is defined as ≥ 3 adequate detections of VT and/or VF in 24 h terminated with ATP or high-voltage therapy (HVT), or untreated sustained VT recorded in the monitoring zone over 1 week after the implantation [76,77,78,79].

 Short term

Pulmonary edema

NA

 Short term

Cardiogenic shock

Defined as hypotension (SBP, 90 mmHg) despite adequate filling status with signs of hypoperfusion [80].

 Short term

Hypotension requiring resuscitation

NA