Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study

摘要: Aim To summarize the evidence on clinical effectiveness and safety of wearable cardioverter defibrillator (WCD) therapy for primary secondary prevention sudden cardiac arrest in patients at risk. Methods We performed a systematic literature search databases including MEDLINE via OVID, Embase, Cochrane Library, CRD (DARE, NHS-EED, HTA). The obtained was summarized according to GRADE methodology. A health technology assessment (HTA) conducted using HTA Core Model® rapid relative assessment. Primary outcomes domain were all-cause disease-specific mortality. Outcomes adverse events (AEs) serious (SAEs). focus group with disease evaluate ethical, organizational, patient, social, legal aspects WCD use. Results No randomized- or non-randomized controlled trials identified. Non-comparative studies (n=5) reported AEs skin rash/itching (6%), false alarms (14%), palpitations/light-headedness/fainting (9%) discontinuation due comfort/lifestyle issues (16-22%), SAEs inappropriate shocks (0-2%), unsuccessful (0-0.7%), death (0-0.3%). results that experiencing sense security is crucial not considered an option weeks even months expected restrictions living "normal" life. Conclusion appears be relatively safe short-to-medium term, but quality existing very low. need more appropriately order further device. High-quality comparative well-described groups are required assess determine which patient may benefit most from intervention.