Wearable Smartwatch Facilitated Remote Health Management for Patients Undergoing Transcatheter Aortic Valve Replacement
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Abstract
In the recent decades, the development of novel digital health technologies enables doctors to monitor ECG and vital signs remotely. But the data on applying the noninvasive wearable smartwatch on patients with transcatheter aortic valve replacement (TAVR) are unknown.
Methods and Results
We performed a prospective, observational cohort study to evaluate the feasibility of a novel, virtual, and remote health care strategy for patients with TAVR discharged to home with smart wearable devices. A total of 100 consecutive patients with severe aortic stenosis who underwent elective transfemoral TAVR were enrolled and received the Huawei smartwatch at least 1 day before TAVR. Vital signs, including heart rate, rhythm, oxygen saturation, and activity, were continuously recorded. Single‐lead ECG was recorded twice per day in the week following TAVR discharge and at least 2 days a week for the subsequent month after TAVR discharge. A designated heart team member provided remote health care with the data from the smartwatch when the patient had a need. Thirty‐eight cardiac events were reported in 34 patients after discharge, with most of the events (76.0%) detected and confirmed by the smartwatch. Six patients were advised and readmitted to the hospital for arrhythmia events detected by the smartwatch, of whom 4 patients received pacemaker implantation. The remaining 28 (82.4%) patients received telemedicine monitoring instead of face‐to‐face clinical visits, and 3 of them received new medication treatment under the online guidance of doctors. New‐onset left branch bundle block was found in 48 patients, with transient characteristics, and recovered spontaneously in 30 patients, and new‐onset atrial fibrillation was detected in 4 patients. There were no significant differences in the average weekly heart rates or the ratio of abnormal or low oxygen saturation when compared with the baseline. The average daily steps increased over time significantly (baseline, 870±1353 steps; first week, 1986±2406 steps; second week, 2707±2716 steps; third week, 3059±3036 steps; fourth week, 3678±3485 steps, P <0.001).
Conclusions
Smartwatches can facilitate remote health care for patients discharged to home after undergoing TAVR and enable a novel remote follow‐up strategy. The majority of cardiac clinical events that occurred within 30‐day follow‐up were detected by the smartwatch, mainly because of the record of conduction abnormality.
Registration
URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04454177.
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SciScore for 10.1101/2021.05.22.21256870: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study protocol was approved by the medical ethics committee of the Second Affiliated Hospital of Zhejiang University and was in accordance with the Declaration of Helsinki.
Consent: All participants provided informed consent to participating in the study before the procedure.Sex as a biological variable not detected. Randomization The major exclusion criteria were: 1) Severe complications of TAVR, such as death, and conversion to SAVR; 2) Life expectancy is less than 12 months due to non-heart disease (such as cancer, chronic liver disease, chronic kidney disease, or chronic end-stage lung disease, etc.); 3) Severe dementia (cannot sign research informed consent, cannot take care of … SciScore for 10.1101/2021.05.22.21256870: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study protocol was approved by the medical ethics committee of the Second Affiliated Hospital of Zhejiang University and was in accordance with the Declaration of Helsinki.
Consent: All participants provided informed consent to participating in the study before the procedure.Sex as a biological variable not detected. Randomization The major exclusion criteria were: 1) Severe complications of TAVR, such as death, and conversion to SAVR; 2) Life expectancy is less than 12 months due to non-heart disease (such as cancer, chronic liver disease, chronic kidney disease, or chronic end-stage lung disease, etc.); 3) Severe dementia (cannot sign research informed consent, cannot take care of themselves or cooperate in the study visit); 4) The investigator believes that the patient is not suitable to participate in the study or complete the follow-up prescribed by the protocol from other medical, social and psychological aspects; 5) The patient is currently participating in another randomized study. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical analysis: All statistical analyses were computed using SPSS 25 (IBM SPSS, USA). SPSSsuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Study limitations: This was a single-center study, and the valves used in this study were mainly first-generation ones, which may limit generalizability. Secondly, the current version of the Huawei Watch GT Pro has to be manually initiated to start recording a single lead ECG. However, with proper pre-discharge education, we found it could be handled properly by the elderly with good tolerance. Immediate alarm generation base on real-time blood oxygen saturation and heart rate monitoring will be upgraded in the next-generation software. Third, the follow-up duration of this study was 30 days, longer-term monitoring of our cohort may provide a better understanding of telemonitoring after TAVR.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04454177 Recruiting SMART Watch Facilitated Early Discharge in Patients Undergoi… Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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