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      Management of cardiac implantable electronic device follow‐up in COVID‐19 pandemic: Lessons learned during Italian lockdown

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          Abstract

          Introduction

          Remote monitoring (RM) has significantly transformed the standard of care for patients with cardiac electronic implantable devices. It provides easy access to valuable information, such as arrhythmic events, acute decompensation manifestations and device‐related issues, without the need of in‐person visits.

          Methods

          Starting March 1st, 332 patients were introduced to an RM program during the Italian lockdown to limit the risk of in‐hospital exposure to severe acute respiratory syndrome‐coronavirus‐2. Patients were categorized into two groups based on the modality of RM delivery (home [ n = 229] vs. office [ n = 103] delivered). The study aimed at assessing the efficacy of the new follow‐up protocol, assessed as mean RM activation time (AT), and the need for technical support. In addition, patients' acceptance and anxiety status were quantified via the Home Monitoring Acceptance and Satisfaction Questionnaire and the Generalized Anxiety Disorder 7‐item scale.

          Results

          AT time was less than 48 h in 93% of patients and 7% of them required further technical support. Despite a higher number of trans‐telephonic technical support in the home‐delivered RM group, mean AT was similar between groups (1.33 ± 0.83 days in home‐delivered vs 1.28 ± 0.81 days in office‐delivered patients; p = .60). A total of 28 (2.5%) urgent/emergent in‐person examinations were required. A high degree of patient satisfaction was reached in both groups whereas anxiety status was higher in the office‐delivered group.

          Conclusions

          The adoption of RM resulted in high patient satisfaction, regardless of the modality of modem delivery; nonetheless, in‐office modem delivery was associated with a higher prevalence of anxiety symptoms.

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          Most cited references18

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          A brief measure for assessing generalized anxiety disorder: the GAD-7.

          Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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            Reduced Rate of Hospital Admissions for ACS during Covid-19 Outbreak in Northern Italy

            To the Editor: To address the coronavirus (Covid-19) pandemic, 1 strict social containment measures have been adopted worldwide, and health care systems have been reorganized to cope with the enormous increase in the numbers of acutely ill patients. 2,3 During this same period, some changes in the pattern of hospital admissions for other conditions have been noted. The aim of the present analysis is to investigate the rate of hospital admissions for acute coronary syndrome (ACS) during the early days of the Covid-19 outbreak. In this study, we performed a retrospective analysis of clinical and angiographic characteristics of consecutive patients who were admitted for ACS at 15 hospitals in northern Italy. All the hospitals were hubs of local networks for treatment involving primary percutaneous coronary intervention. The study period was defined as the time between the first confirmed case of Covid-19 in Italy (February 20, 2020) and March 31, 2020. We compared hospitalization rates between the study period and two control periods: a corresponding period during the previous year (February 20 to March 31, 2019) and an earlier period during the same year (January 1 to February 19, 2020). The primary outcome was the overall rate of hospital admissions for ACS. We calculated incidence rates for the primary outcome by dividing the number of cumulative admissions by the number of days for each time period. Incidence rate ratios comparing the study period with each of the control periods were calculated with the use of Poisson regression. (Details regarding the study methods are provided in the Supplementary Appendix, available with the full text of this letter at NEJM.org.) Of the 547 patients who were hospitalized for ACS during the study period, 420 (76.8%) were males; the mean (±SD) age was 68±12 years. Of these patients, 248 (45.3%) presented with ST-segment elevation myocardial infarction (STEMI). The mean admission rate for ACS during the study period was 13.3 admissions per day. This rate was significantly lower than either the rate during the earlier period in the same year (total number of admissions, 899; 18.0 admissions per day; incidence rate ratio, 0.74; 95% confidence interval [CI], 0.66 to 0.82; P<0.001) or the rate during the previous year (total number of admissions, 756; 18.9 admissions per day; incidence rate ratio, 0.70; 95% CI, 0.63 to 0.78; P<0.001). The incidence rate ratios for individual ACS subtypes are presented in Table 1. After the national lockdown was implemented on March 8, 2020, 4 a further reduction in ACS admissions was reported. (Details regarding the full secondary analyses are provided in the Supplementary Appendix.) This report shows a significant decrease in ACS-related hospitalization rates across several cardiovascular centers in northern Italy during the early days of the Covid-19 outbreak. Recent data suggest a significant increase in mortality during this period that was not fully explained by Covid-19 cases alone. 5 This observation and data from our study raise the question of whether some patients have died from ACS without seeking medical attention during the Covid-19 pandemic.
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              Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial.

              An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial.
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                Author and article information

                Contributors
                carlo.lavalle@uniroma1.it
                Journal
                J Cardiovasc Electrophysiol
                J Cardiovasc Electrophysiol
                10.1111/(ISSN)1540-8167
                JCE
                Journal of Cardiovascular Electrophysiology
                John Wiley and Sons Inc. (Hoboken )
                1045-3873
                1540-8167
                30 September 2020
                November 2020
                : 31
                : 11 ( doiID: 10.1111/jce.v31.11 )
                : 2814-2823
                Affiliations
                [ 1 ] Department of Cardiovascular, Respiratory, Nephrology, Anaesthesiology and Geriatric Sciences “Sapienza” University of Rome Rome Italy
                [ 2 ] Texas Cardiac Arrhythmia Institute St David's Medical Center Austin Texas USA
                [ 3 ] Department of Translational and Precision Medicine Sapienza University of Rome Rome Italy
                [ 4 ] Interventional Electrophysiology Scripps Clinic La Jolla California USA
                [ 5 ] Department of Cardiology, MetroHealth Medical Center Case Western Reserve University School of Medicine Cleveland Ohio USA
                [ 6 ] Division of Cardiology Stanford University Stanford California USA
                [ 7 ] Dell Medical School University of Texas Austin Texas USA
                Author notes
                [*] [* ] Correspondence Carlo Lavalle, MD, Department of Clinical, Internal, Anesthesiology and Cardiovascular Sciences, Sapienza University of Rome, Viale del Policlinico, 155,00161 Rome, Italy.

                Email: carlo.lavalle@ 123456uniroma1.it

                Author information
                https://orcid.org/0000-0002-5995-4963
                http://orcid.org/0000-0003-3837-3462
                http://orcid.org/0000-0002-5487-0728
                https://orcid.org/0000-0002-9480-1209
                Article
                JCE14755
                10.1111/jce.14755
                7646650
                32954600
                781977d1-555b-4290-84c2-42581983945e
                © 2020 Wiley Periodicals LLC

                This article is being made freely available through PubMed Central as part of the COVID-19 public health emergency response. It can be used for unrestricted research re-use and analysis in any form or by any means with acknowledgement of the original source, for the duration of the public health emergency.

                History
                : 22 June 2020
                : 03 September 2020
                : 08 September 2020
                Page count
                Figures: 3, Tables: 5, Pages: 10, Words: 6057
                Categories
                Original ‐ Devices
                Original ‐ Devices
                Custom metadata
                2.0
                November 2020
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.9.3 mode:remove_FC converted:06.11.2020

                Cardiovascular Medicine
                cardiac implantable electronic device,cied,covid‐19,gad‐7,remote monitoring

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