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Historical data from 1000 patients with ICD implants showed significantly shorter procedural times for patients with subcutaneous device pockets. No significant differences with regard to pocket haematomas were found. There were no significant differences in the cumulative percentages of patients free from complication during follow-up.682 Pocket irrigation at the end of the procedure with normal saline leads to dilution of possible contaminants and eliminates debris from the wound before closure.683,684 Addition of antibiotics to the rinsing solution does not reduce the risk of device infections.683 The World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT study) investigated the effect of an absorbable antibiotic-eluting envelope on the development of postoperative CIED infections. A total of 6983 patients undergoing a CIED pocket revision, generator replacement, or system upgrade, or initial implantation of a CRT-D were randomly assigned, in a 1:1 ratio, to receive the antibiotic envelope or not. The rate of CIED infection in patients who had the antibacterial envelope was 0.7% vs. 1.2% in the control group (HR 0.6, 95% CI 0.360.98; P = 0.04).685 No effect on infection rate was observed in the subgroup with pacemakers.685 Considering cost-effectiveness aspects, the use of an antibiotic envelope may be considered in pacemaker patients at high risk for CIED infections. Risk factors to be considered in this context are end-stage renal disease, chronic obstructive pulmonary disease, diabetes mellitus, and device replacement, revision, or upgrade procedures.638 10 Complications of cardiac

pacing and cardiac resynchronization therapy

10.1 General complications

Cardiac pacing and CRT are associated with a substantial risk of complications (Table 12), most of which occur in the perioperative phase,429,690 but a sizable risk remains during long-term follow-up.691 Complication rates after dual-chamber pacemaker implantation in the MOST trial were 4.8% at 30 days, 5.5% at 90 days, and 7.5% at 3 years.692 However, ‘real-life’ data indicate a higher risk.690,693 In a recent study of >81 000 patients receiving de novo CIED implantations, major complications occurred in 8.2% within 90 days of hospital discharge.694 Mortality in hospital (0.5%) and within 30 days (0.8%) was low. Complication risks generally increase with the complexity of the device and are more common in the context of a device upgrade or lead revisions compared with de novo implantation. In a Danish population-based cohort study, complications were observed in 9.9% of patients at first device implantation and in 14.8% upon upgrade or lead revision.354 Procedures limited to replacement of the generator had a lower complication risk (5.9%). In the prospective REPLACE registry, a similar proportion (4%) of complication risks in the setting of generator replacement was reported, but much higher risks were found in those with one or more additional lead insertions (up to 15.3%).695 Accordingly, major complications were particularly more common with CRT upgrade procedures, a finding that was corroborated in a large US inpatient cohort339 and a prospective Italian observational study.696 The rate of procedural complications also increases with comorbidity burden.697 Thus, careful shared decision-making is warranted when considering upgrades to more complex systems. This also applies to prophylactic replacement of recalled CIED generators and leads, a scenario in which procedural risks should be carefully weighed against the risks associated with device or lead failure.698 Overall, complication rates are closely linked to individual and centre implantation volumes.429,658,693 Complications were increased by 60% in inexperienced operators who had performed fewer than

Recommendations regarding device implantations and peri-operative management

Recommendations Classa Levelb

Administration of pre-operative antibiotic prophylaxis within 1 h of skin incision is recommended to reduce risk of CIED infection.641,643.686 I A Chlorhexidinealcohol instead of povidoneiodinealcohol should be considered for skin antisepsis.647,648 IIa B For venous access, the cephalic or axillary vein should be considered as first choice.658,659 IIa B To confirm target ventricular lead position, use of multiple fluoroscopic views should be considered. IIa C For implantation of coronary sinus leads, quadripolar leads should be considered as first choice.665,666,687 IIa C Rinsing the device pocket with normal saline solution before wound closure should be considered.683,684 IIa C In patients undergoing a reintervention CIED procedure, the use of an antibiotic-eluting envelope may be considered.685,688 IIb B Pacing of the mid-ventricular septum may be considered in patients at high risk of perforation (e.g. elderly, previous perforation, low body mass index, women).420,674 IIb C

Continued In pacemaker implantations in patients with pos-

sible pocket issues such as increased risk of erosion due to low body mass index, Twiddler’s syndrome, or for aesthetic reasons, a submuscular device pocket may be considered. IIb C Heparin bridging of anticoagulated patients is not recommended.650,689 III A Permanent pacemaker implantation is not recommended in patients with fever. Pacemaker implantation should be delayed until the patient has been afebrile for at least 24 h.638,639 III B

CIED = cardiovascular implantable electronic device. aClass of recommendation. bLevel of evidence. ESC 2021

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