Abstract

BackgroundThe cardiac diagnostic workup of stroke patients, especially the value of echocardiography and enhanced and prolonged Holter-ECG monitoring, is still a matter of debate. We aimed to analyse the impact of pathologies detected by echocardiography and ECG monitoring on therapeutic decisions and prognosis.MethodsFind-AFRANDOMISED was a prospective multicenter study which randomised 398 acute ischemic stroke patients ≥ 60 years to enhanced and prolonged Holter-ECG monitoring or usual stroke unit care. This substudy compared therapeutic consequences of echocardiography and routine Holter-ECG or enhanced and prolonged Holter-ECG monitoring, respectively, and prognosis of patients with or without pathologic findings in echocardiography or Holter-ECG monitoring.Results50.3% received enhanced and prolonged Holter-ECG monitoring and 49.7% routine ECG monitoring. 82.9% underwent transthoracic echocardiography (TTE), 38.9% transesophageal echocardiography (TEE) and 25.6% both procedures. 14/89 TEE pathologies and 1/90 TTE pathology led to a change in therapy, resulting in a number needed to change decision (NNCD) of 12 and 330 (p < 0.001), respectively. In comparison, enhanced and prolonged Holter-ECG monitoring found atrial fibrillation (AF) in 27 of 200 patients, and routine ECG monitoring in twelve of 198 patients, leading to therapeutic changes in all patients (NNCD 8 and 17, respectively, p < 0.001).ConclusionsMost changes in therapeutic decisions were triggered by enhanced and prolonged Holter-ECG monitoring, which should therefore play a more prominent role in future guidelines. Echocardiography identifies a patient group at high cardiovascular risk, but rarely result in therapeutic changes. Whether this patient group requires further cardiovascular workup remains unknown. This should be further investigated by interdisciplinary neurocardiologic teams and in appropriate future trials.Trial registrationClinicalTrials.gov NCT01855035

Highlights

  • Oral anticoagulation using Vitamin-K antagonists has been shown to decrease the risk of ischemic stroke by two thirds (Hart et al 2007) and newer drugs may be even more effective (Connolly et al 2009)

  • Registry data suggest that paroxysmal atrial fibrillation is largely underrepresented in anticoagulation trials and the risk of stroke and thromboembolism in paroxysmal Atrial fibrillation (AF) is less well defined (The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC) 2010)

  • Recent data suggest that the risk of stroke in paroxysmal atrial fibrillation is similar to persistent or permanent atrial fibrillation (Hohnloser et al 2007, Friberg et al 2010)

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Summary

Medical background

Atrial fibrillation (AF) is the most frequent arrhythmia and may be classified as paroxysmal, persistent and permanent. While persistent and permanent atrial fibrillation is diagnosed using a 12-lead ECG, the diagnosis of paroxysmal atrial fibrillation is more challenging. Registry data suggest that paroxysmal atrial fibrillation is largely underrepresented in anticoagulation trials and the risk of stroke and thromboembolism in paroxysmal AF is less well defined (The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC) 2010). Recent data suggest that the risk of stroke in paroxysmal atrial fibrillation is similar to persistent or permanent atrial fibrillation (Hohnloser et al 2007, Friberg et al 2010). Detection of paroxysmal atrial fibrillation is a major challenge in primary and secondary stroke prevention. Recent costeffectiveness analyses found that prolonged (7 day) Holter ECG after cerebral ischemia saves 1 quality adjusted life year (QALY) at the price of only $ 15.000 (Kamel et al 2010), or possibly even less (Wachter et al 2011)

Rationale
Risk-Benefit Consideration
Primary objectives
Secondary objectives
Premature termination
Inclusion criteria
Gender aspects
Enhanced and prolonged Holter monitoring
Patient information and informed consent
Withdrawal of informed consent
Only applicable for study site in Göttingen
Trial visits
Premature termination of trial participation
Adverse Events
Relevant Serious Adverse Events in the context of the Find-AFRANDOMISED-Trial
General Documentation and Reporting
Primary endpoint
Secondary endpoints
Sample Size Discussion
Statistical methods
Final Analysis
Submission
Protocol Amendments
10.2 Data Management
10.3 Archival storage
12.1 Direct access to source data
12.2 Monitoring
12.3 Audits
14.1 Adherence to the protocol
14.2 Funding and Insurance
14.3 Publication policy
Full Text
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