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• W4377016321 abstract "Extravascular devices (EVD), such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP), were developed to circumvent pocket- and lead-related device complications. Knowledge on the complications of these devices is mainly derived from selected populations or industry-initiated studies. To assess the real-world nationwide (trends in) short-term complications of EVDs in the Netherlands. Using real-world data registered at the Netherlands Heart Registration, consecutive patients were included with an EVD or single-chamber conventional ICD or pacemaker implantation (de novo or replacement) from 2018-2020. Major complications included tamponade requiring reintervention up to 30 days, and perforation, arterial dissection, bleeding, device or lead dislocation, device or lead defect and infection requiring reintervention up to 90 days. The overall major complication rate and complication types were compared between S-ICDs and single-chamber conventional ICDs, and between LPs and single-chamber conventional pacemakers (Fisher’s exact test). Trends in major complication rate over time were estimated. In 41 Dutch device-implanting hospitals, there were 960 S-ICD, 3407 single-chamber transvenous ICD, 338 LP and 2795 single-chamber conventional pacemaker implantations. The major complication rates were equal for S-ICDs and single-chamber conventional ICDs (15/960 [1.6%] vs. 49/3407 [1.4%]; p=0.76), and for LPs and single-chamber conventional pacemakers (5/338 [1.5%] vs. 36/2841 [1.3%], p=0.80). S-ICDs were associated with significantly more infections (0.7% vs. 0.2%; p=0.01) (Fig. 1). LPs were associated with significantly more tamponades (0.6% vs. 0.04%; p=0.03). Of all patients with a tamponade/perforation, one (due to a conventional ICD) died within 7 days post-implantation. Major complication rates did not change significantly over time, but a non-significant decrease was seen for S-ICDs (Fig. 2). In this national cohort, short-term major complication rates did not differ significantly between EVDs and conventional ICDs or pacemakers. Though, in line with previous studies, different complication types for EVDs and non-EVDs were observed, including an increased rate of perforations at LP implantation." @default.
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• W4377016321 date "2023-05-01" @default.
• W4377016321 modified "2023-10-18" @default.
• W4377016321 title "PO-02-084 3-MONTH MAJOR COMPLICATION RATE OF EXTRAVASCULAR DEVICES COMPARED TO CONVENTIONAL TRANSVENOUS DEVICES: REAL-WORLD DATA FROM THE NETHERLANDS HEART REGISTRATION" @default.
• W4377016321 doi "https://doi.org/10.1016/j.hrthm.2023.03.862" @default.
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