RESUMO
Despite advances in syncope evaluation strategies and risk stratification, the high cost of syncope is largely driven by extensive and often repetitive testing. This analysis of a large deidentified US claims database compared the use of diagnostic tests, therapeutic procedures, and the recurrence rate of acute syncope events before and after placement of an insertable cardiac monitor (ICM) in syncope patients. The patients had a minimum of 1 year of continuous enrollment before and 2 years after ICM placement. Among 2140 patients identified, a statistically significant reduction in the use of 14 out of 18 tests was observed during follow-up compared with pre-ICM testing. During the 2-year follow-up, 28.3% of patients underwent cardiac therapeutic interventions after a median of 127 days. Significantly fewer patients experienced acute syncope events during the 1st and 2nd years of ICM follow-up compared with the 1-year pre-ICM period, and the frequency of events per patient also decreased. In conclusion, reductions in diagnostic testing and acute syncope events were observed after ICM placement in a large real-world cohort of unexplained syncope patients. Further studies are needed to prospectively assess the impact of ICM vs. short-term monitoring on patient outcomes and healthcare utilization.
RESUMO
Importance: Patients with ischemic stroke attributed to large- or small-vessel disease are not considered at high risk for atrial fibrillation (AF), and the AF incidence rate in this population is unknown. Objectives: To determine whether long-term cardiac monitoring is more effective than usual care for AF detection in patients with stroke attributed to large- or small-vessel disease through 12 months of follow-up. Design, Setting, and Participants: The STROKE-AF trial was a randomized (1:1), multicenter (33 sites in the US) clinical trial that enrolled 496 patients between April 2016 and July 2019, with primary end point follow-up through August 2020. Eligible patients were aged 60 years or older or aged 50 to 59 years with at least 1 additional stroke risk factor and had an index stroke attributed to large- or small-vessel disease within 10 days prior to insertable cardiac monitor (ICM) insertion. Interventions: Patients randomized to the intervention group (n = 242) received ICM insertion within 10 days of the index stroke; patients in the control group (n = 250) received site-specific usual care consisting of external cardiac monitoring, such as 12-lead electrocardiograms, Holter monitoring, telemetry, or event recorders. Main Outcomes and Measures: Incident AF lasting more than 30 seconds through 12 months. Results: Among 492 patients who were randomized (mean [SD] age, 67.1 [9.4] years; 185 [37.6%] women), 417 (84.8%) completed 12 months of follow-up. The median (interquartile range) CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score was 5 (4-6). AF detection at 12 months was significantly higher in the ICM group vs the control group (27 patients [12.1%] vs 4 patients [1.8%]; hazard ratio, 7.4 [95% CI, 2.6-21.3]; P < .001). Among the 221 patients in the ICM group who received an ICM, 4 (1.8%) had ICM procedure-related adverse events (1 site infection, 2 incision site hemorrhages, and 1 implant site pain). Conclusions and Relevance: Among patients with stroke attributed to large- or small-vessel disease, monitoring with an ICM compared with usual care detected significantly more AF over 12 months. However, further research is needed to understand whether identifying AF in these patients is of clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT02700945.
