RESUMO
BACKGROUND: Patients with hypertrophic cardiomyopathy (HCM) are at increased risk of sudden cardiac death (SCD) due to ventricular arrhythmias and other arrhythmias. Screening for arrhythmias is mandatory to assess the individual SCD risk, but long-term electrocardiography (ECG) is rarely performed in routine clinical practice. Intensified monitoring may increase the detection rate of ventricular arrhythmias and identify more patients with an increased SCD risk who are potential candidates for the primary prophylactic implantation of an implantable cardioverter-defibrillator. To date, reliable data on the clinical benefit of prolonged arrhythmia monitoring in patients with HCM are rare. OBJECTIVE: This prospective study aims to measure the prevalence of ventricular arrhythmias in patients with HCM observed by mobile health (mHealth)-based continuous rhythm monitoring over 14 days compared to standard practice (a 24- and 48-h long-term ECG). The frequency of ventricular arrhythmias in this 14-day period is compared with the frequency in the first 24 or 48 hours for the same patient (intraindividual comparison). METHODS: Following the sample size calculation, 34 patients with a low or intermediate risk for SCD, assessed by the HCM Risk-SCD calculator, will need to be recruited in this single-center cohort study between June 2023 and February 2024. All patients will receive an ECG patch that records their heart activity over 14 days. In addition, cardiac magnetic resonance imaging and genetic testing data will be integrated into risk stratification. All patients will be asked to complete questionnaires about their symptoms; previous therapy; family history; and, at the end of the study, their experience with the ECG patch-based monitoring. RESULTS: The Hypertrophic Cardiomyopathy: Clinical Impact of a Prolonged mHealth-Based Arrhythmia Monitoring by Single-Channel ECG (HCM-PATCH) study investigates the prevalence of nonsustained ventricular tachycardia (ie, ≥3 consecutive ventricular beats at a rate of 120 beats per minute, lasting for <30 seconds) in low- to intermediate-risk patients with HCM (according to the HCM Risk-SCD calculator) with additional mHealth-based prolonged rhythm monitoring. The study was funded by third-party funding from the Department of Cardiology and Intensive Care Medicine, University Hospital Ostwestfalen-Lippe of Bielefeld University in June 2023 and approved by the institutional review board in May 2023. Data collection began in June 2023, and we plan to end the study in February 2024. Of the 34 patients, 26 have been recruited. Data analysis has not yet taken place. Publication of the results is planned for the fall of 2024. CONCLUSIONS: Prolonged mHealth-based rhythm monitoring could lead to differences in the prevalence of arrhythmias compared to 24- and 48-hour long-term ECGs. This may lead to improved identification of patients at high risk and trigger therapeutic interventions that may provide better protection from SCD or atrial fibrillation-related complications such as embolic stroke. TRIAL REGISTRATION: Deutsches Register Klinischer Studien DRKS00032144; https://tinyurl.com/498bkrx8. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52035.
RESUMO
The advances in health care technologies over the last decade have led to improved capabilities in the use of digital health applications (DiHA) for the detection of atrial fibrillation (AFib). Thus, home-based remote heart rhythm monitoring is facilitated by smartphones or smartwatches alone or combined with external sensors. The available products differ in terms of type of application (wearable vs. handheld) and the technique used for rhythm detection (electrocardiography [ECG] vs. photoplethysmography [PPG]). While ECG-based algorithms often require additional sensors, PPG utilizes techniques integrated in smartphones or smartwatches. Algorithms based on artificial intelligence allow for the automated diagnosis of AFib, enabling high diagnostic accuracy for both ECG-based and PPG-based DiHA. Advantages for clinical use result from the widespread accessibility of rhythm monitoring, thereby permitting earlier diagnosis and higher AFib detection rates. DiHA are also useful for the follow-up of patients with known AFib by monitoring the success of therapeutic interventions to restore sinus rhythm, e.g. catheter ablation. Although some studies strongly suggest a potential benefit for the use of DiHA in the setting of AFib, the overall evidence for an improvement in hard, clinical endpoints and positive effects on clinical care is scarce. To enhance the acceptance of DiHA use in daily practice, more studies evaluating their clinical benefits for the detection of AFib are required. Moreover, most of the applications are still not reimbursable, although the German Digital Health Care Act (Digitale-Versorgung-Gesetz, DVG) made reimbursement possible in principle in 2019.
