Abstract

Pediatric and adult congenital heart disease (ACHD) patients encounter physical and emotional barriers. Cardiac implantable electronic devices (CIEDs), including pacemakers and implantable cardiac defibrillators (ICD) often compound these issues. Damage to the CIED system may lead to urgent/emergent medical care and additional surgeries to resolve. Patient fear associated with damaging the CIED system can lead to avoidance of physical activity and reduced quality of life (QOL). CIED personal protective equipment (PPE) is a potential treatment for decreasing this fear. To determine the effects of CIED PPE use in the pediatric and ACHD population. Patients 5 years or older with a CIED at a single pediatric and ACHD heart rhythm center were prospectively enrolled. Demographic data and baseline assessments of self-reported physical activity and concerns regarding activity were obtained. QOL was assessed using the PedsQLTM 4.0 SF 15. Each participant received a Vital Beat (Tienhoven, The Netherlands) CIED protector and customized athletic shirt to support the device at the correct location. Repeat assessment after 6-12 months was completed. Statistical analysis with Wilcoxon signed-rank test was performed to compare pre/post-intervention responses. Of the 77 patients enrolled, 26 completed repeat assessment. The mean age at enrollment was 15.6 years (range 5 - 36) with a mean device age of 2.2 years (<1 - 10 years). Pacemakers were present in 77% and 23% had ICDs. Leads were epicardial with abdominal placement in 65% and transvenous with chest placement in 35%. There was structural heart disease in 77% and 31% were device dependent. The PPE was used in 92% and there were no reports of PPE malfunction. Fear associated with physical activity was significantly reduced, z = -4, p< .001, with a large effect size (r = .55). Increase in physical activity occurred in 23% though not statistically significant. Total quality of life scores improved, z = -2.771, P<.05, with a medium effect size (r = .4). Providing CIED PPE to pediatric and ACHD patients may decrease their fear of damaging their device system, increasing physical activity levels, and improving quality of life.

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