RESUMO
Randomized trials inform the use of implantable cardioverter-defibrillators (ICDs) for prevention of sudden cardiac death, yet management of patients considering ICD generator replacement procedures remains largely dependent on clinical judgment. Thus, we performed a systematic review of all studies evaluating outcomes associated with ICD generator replacement. We queried PubMed, Embase, Web of Science, and the Cochrane Database of Systematic Reviews for relevant studies with a prespecified search and adjudication strategy (PROSPERO registration number CRD42018100818) to evaluate outcomes including (1) survival; (2) clinical complications (eg, infection, hematoma); or (3) incidence of ICD therapy. From 1607 unique titles, 37 studies met inclusion criteria, describing outcomes for 238,949 patients. Procedural mortality was rare, but complications including reoperation (median 4.57%; range 0.38%-10.31%), infections (median 2.01%; range 0.03%-9.27%), and hematoma (median 1.22%, range 0.17%-2.53%) were observed in a small fraction of patients. Appropriate ICD therapy after generator replacement was common (median rate 23.03%; range 10.9%-31.4%), with an overall annualized event rate of 8.52% at median duration of follow-up of 32.4 months. Appropriate ICD therapy continued to occur at a significant annual rate even in patients who no longer met implantation criteria (5.27%) and in patients who never previously received ICD therapy (4.87%). This analysis of published observational data regarding ICD generator replacement procedures identifies relatively low risks of procedural complications and clinically meaningful rates of appropriate ICD therapies. These estimates may guide clinical decisions and inform the design of definitive trials.
Assuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Prevenção Primária/métodos , Volume Sistólico/fisiologia , Função Ventricular Esquerda/fisiologia , Humanos , Fatores de RiscoRESUMO
Shared decision making (SDM), a collaborative process whereby patients and professionals make health care decisions together, is a cornerstone of ethical patient care. The patient-clinician communication necessary to achieve SDM depends on many factors, not the least of which is a shared language (sometimes with the aid of a medical interpreter). However, even when a patient and clinician are speaking the same mother tongue, the use of medical jargon can pose a large and unnecessary barrier. This article discusses how health care professionals can use "universal health literacy precautions" as a legal, practical, and ethical means to enhance SDM and improve health care outcomes.
