[Cardiac monitoring with textile wearable Holter for atrial fibrillation detection after cryptogenic stroke]

Cárdaba Arranz M, González Enríquez J, García Carpintero E
Record ID 32018005210
Original Title: Monitorización cardíaca mediante dispositivos holter con electrodos textiles para detección de fibrilación auricular tras ictus criptogénico
Authors' objectives: To determine the effectiveness and safety of a prolonged monitoring strategy to detect atrial fibrillation after a cryptogenic stroke using a smart elastic fabric vest or Textile Wearable Holter, which is attached to the patient's body and monitors their cardiac activity
Authors' results and conclusions: RESULTS: The systematic review of the literature allowed the identification of 1.452 references (340 in Medline, 955 in EMBASE, 157 in Cochrane Library). After reading the title and abstract, 3 studies were included for full text reading. Finally, a study was included that met the inclusion criteria. The only study included is a pilot study conducted on a prospective, multicenter patient registry in four stroke units of Spanish hospitals. The study included 174 patients older than 55 years who had suffered a cryptogenic stroke. The study analyzed two ways of wearing the device: a cable model with a one-channel Holter and a vest model with a 3-channel Holter. The study began in December 2014, and in the patients included during the first 12 months the shape of the Nuubo® device called cable was evaluated and in the patients selected for the following 12 months the shape called vest was analyzed. A total of 146 patients completed the study. The rate of undiagnosed AF detected with this device was 21.9% (32/146), with a mean duration of episodes of 469 minutes (SD: 97 minutes). The detection rate of undiagnosed AF was higher in patients with cortical infarction 24.5% (24/98) compared to those without cortical infarction 5.9% (2/34) (p = 0.019). The authors also observed a higher percentage of AF detection in those patients with major vascular occlusion 31.8% (14/44) compared to patients without occlusion 14.1% (12/85) (p = 0.018). An increase in the incidence of detected AF was observed from 5.6% observed at 3 days, to 17.5% at 15 days and up to 20.9% at 28 days. Patient satisfaction was assessed by evaluating the degree of comfort with the device using a 5-point scale, where 5 indicated the highest degree of comfort and 1 the least. Globally, no significant differences were observed between day and night, with a mean of 3.7 and 3.89 points respectively. Neither were significant differences observed between the cable model and the vest. Regarding the safety of the device, the authors did not report any deaths during follow-up. The study does not collect information on cardiovascular or cerebrovascular morbidity. The authors reported that there were 5.6% reversible skin reactions that forced 8 patients (4 in each group) to abandon monitoring, with no statistically significant differences between the two device modalities analyzed. This study is a prospective pilot study with no comparator with a moderate risk of bias (assessed using the ROBINS-I scale). CONCLUSIONS: The evidence provided by this single study is considered insufficient to reach a conclusion on the efficacy and safety of this device in detecting atrial fibrillation in patients who have suffered a cryptogenic stroke, as well as on the potential clinical benefits of using this device, compared to other long term cardiac monitoring systems applicable in this clinical situation.
Authors' methods: A systematic review of the available scientific literature related to the efficacy, safety and efficiency of prolonged monitoring to detect atrial fibrillation after cryptogenic stroke in patients older than 18 years of age using the Nuubo® Wearable Holter Textile System has been carried out. Two reviewers independently selected the studies by reading the titles and abstracts located through the literature search, extracted data from the included studies, and assessed their quality by applying the scale ROBINSI risk of biases.
Project Status: Completed
Year Published: 2022
Requestor: Spanish Ministry of Health
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: Spain
MeSH Terms
  • Atrial Fibrillation
  • Intracranial Embolism
  • Intracranial Thrombosis
  • Stroke
  • Electrocardiography, Ambulatory
  • Wearable Electronic Devices
  • Monitoring, Physiologic
  • Arrhythmias, Cardiac
  • Atrial fibrillation
  • Holter
  • electrocardiography
  • cryptogenic stroke
Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias
Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;
Contact Name: Luis M. Sánchez Gómez
Contact Email: luism.sanchez@isciii.es
Copyright: <p>Agencia de Evaluacion</p>
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.