Real-World Disparities in Remote Follow-Up of Cardiac Implantable Electronic Devices and Impact of the COVID-19 Pandemic: A Single-Center Experience.

Background Remote monitoring (RM) of cardiac implantable electronic devices has been shown to improve cardiovascular morbidity and mortality. To date, no studies have investigated disparities in use and delivery of RM. This study was performed to investigate if racial and socioeconomic disparities are present in cardiac implantable electronic device RM. Methods and Results This was a retrospective observational cohort study at a single tertiary care center in the United States. Patients who received a newly implanted cardiac implantable electronic device or device upgrade between January 2017 and December 2020 were included. Patients were classified as RM positive (RM+) when they underwent at least ≥2 remote interrogations per year during follow-up. Of all eligible patients, 2520 patients were included, and 34% were women. The mean follow-up was 25 months. Mean age was 71±14 years. Pacemakers constituted 66% of implanted devices, whereas 26% were implantable cardioverter-defibrillators, and 8% were cardiac resynchronization therapy with implantable cardioverter-defibrillators. Most patients (83%) were of European American ancestry. During follow-up, 66% of patients were classified as RM+. Patients who were younger, European American, college-educated, lived in a county with higher median household income, and were active on the hospital's patient portals were more frequently RM+. In an adjusted regression model, RM+ remained associated with the use of the online patient portal (odds ratio [OR], 2.889 [95% CI, 2.387-3.497]), presence of an implantable cardioverter-defibrillator (OR, 1.489 [95% CI, 1.207-1.835]), advanced college degree (OR, 1.244 [95% CI, 1.014-1.527]), and lastly with European American ancestry (P<0.05). During the years of the COVID-19 pandemic, the number of RM+ patients increased, whereas the association with ancestry and ethnicity decreased. Conclusions Despite being offered to all patients at implantation, significant disparities were present in cardiovascular implantable electronic device RM in this cohort. Disparities were partly reversed during COVID-19. Further studies are needed to examine health center- and patient-specific factors to overcome these barriers, and to facilitate equal opportunities to participate in RM.

Impact of remote monitoring in heart failure patients with cardiac implantable electronic devices during COVID-19 pandemic: a single center experience.

BACKGROUND: Coronavirus disease 2019 (COVID-19) had spread into a pandemic affecting healthcare providers worldwide. Heart failure patients with implanted cardiac devices require close follow-up in-spite of pandemic related healthcare restrictions. METHODS: Patients were retrospectively registered and clinical outcomes were compared of 61 remote monitored (RMG) versus 71 conventionally (in-office only) followed (CFG) cardiac device implanted, heart failure patients. Follow-up length was 12 months, during the COVID-19 pandemic related intermittent insitutional restrictions. We used a specified heart failure detection algorithm in RMG. This investigation compared worsening heart failure-, arrhythmia- and device related adverse events as primary outcome and heart failure hospitalization rates as secondary outcome in the two patient groups. RESULTS: No significant difference was observed in the primary composite end-point during the first 12 months of COVID-19 pandemic (p = 0.672). In RMG, patients who had worsening heart failure event had relative modest deterioration in heart failure functional class (p = 0.026), relative lower elevation of N terminal-pro BNP levels (p < 0.01) at in-office evaluation and were less hospitalized for worsening heart failure in the first 6 months of pandemic (p = 0.012) compared to CFG patients. CONCLUSIONS: Specified remote monitoring alert-based detection algorithm and workflow in device implanted heart failure patients may potentially indicate early worsening in heart failure status. Preemptive adequate intervention may prevent further progression of deteriorating heart failure and thus prevent heart failure hospitalizations.

Cardiac resynchronization therapy defibrillator: a de novo implant in a COVID-19 patient by an echo-guided axillary venous approach.

The COVID-19 pandemic has seriously revolutionized the management of patients who need an implanted cardiac implantable electronic device. We report, for the first time, a successful cardiac resynchronization therapy defibrillator implantation procedure in an 82-year-old man affected by COVID-19, recent myocardial infarction, second-degree 2:1 atrioventricular block and left bundle branch block.

CRT implantation after transvenous lead/device extraction (TLE) in a patient with COVID-19: Endocarditis triggered by syndrome coronavirus 2 (SARS-COV-2) infection? A case report.

In the era of coronavirus disease 2019 (COVID-19), the management of cardiac implantable electronic devices infections with concomitant viral infection has not been completely defined yet. In this explorable context, we report the first experience of a Cardiac resynchronization therapy with defibrillator (CRT-D) implantation after transvenous lead extraction for endocarditis in a COVID-19 patient. We describe both the measures and procedures implemented to reduce the cross-infection in the operating room and our clinical practice to improving procedure effectiveness on patient care.

Impact of lockdown during COVID-19 pandemic on physical activity and arrhythmia burden in heart failure patients.

BACKGROUND: Restricted outdoor activity during COVID-19 related lockdown may accelerate heart failure (HF) progression and thereby increase cardiac arrhythmias. We analyzed the impact of March/April 2020 lockdown on physical activity and arrhythmia burden in HF patients treated with cardiac resynchronization therapy (CRT) devices with daily, automatic remote monitoring (RM) function. METHODS: The study cohort included 405 HF patients enrolled in Observation of Clinical Routine Care for Heart Failure Patients Implanted with BIOTRONIK CRT Devices (BIO|STREAM.HF) registry in 16 countries, who had left ventricular ejection fraction (LVEF) ≤40% (mean 28.2 ± 6.6%) and NYHA class II/III/IV (47.9%/49.6%/2.5%) before CRT pacemaker/defibrillator implantation. The analyzed RM data comprised physical activity detected by accelerometer, mean heart rate and nocturnal rate, PP variability, percentage of biventricular pacing, atrial high rate episode (AHRE) burden, ventricular extrasystoles and tachyarrhythmias, defibrillator shocks, and number of implant interrogations (i.e., follow-ups). Intraindividual differences in RM parameters before (4-week period) versus during (4-week period) lockdown were tested for statistical significance and independent predictors were identified. RESULTS: There was a significant relative change in activity (mean -6.5%, p < .001), AHRE burden (+17%, p = .013), and follow-up rate (-75%, p < .001) during lockdown, with no significant changes in other RM parameters. Activity decreased by ≥8 min/day in 46.5% of patients; predictors were higher LVEF, lower NYHA class, no defibrillator indication, and more activity before lockdown. AHRE burden increased by ≥17 min/day in 4.7% of patients; predictors were history of atrial fibrillation, higher LVEF, higher body mass index, and activity decrease during lockdown. CONCLUSION: Unfavorable changes in physical activity, AHRE burden, and follow-up rate were observed during lockdown, but not in ventricular arrhythmia.

The usefulness of telemedicine devices in patients with severe heart failure with an implanted cardiac resynchronization therapy system during two years of observation.

BACKGROUND: Heart failure (HF) remains a disease with a poor prognosis. Telemonitoring is a medical service aimed at remote monitoring of patients. AIM: The study aimed to identify the clinical relevance of non-invasive telemonitoring devices in HF patients. METHODS: Sixty patients aged 66.1 (11) years, with left ventricular ejection fraction (LVEF) 26.3 (6.8)% underwent cardiac resynchronization therapy (CRT) implantation. They were randomly allocated to the control (standard medical care) or study (standard medical care + telemonitoring device) groups. During the follow-up (24 months), the patients in the study group provided body mass and blood pressure, along with electrocardiogram on a daily basis. The data were transferred to themonitoring center and consulted with a cardiologist. Transthoracic echocardiography and a 6-minute walk test were performed before and 24 months after CRT implantation. RESULTS: During the two-year observation, the composite endpoint (death or HF hospitalization) occurred in 21 patients, more often in the control group (46.8% vs. 21.4%; P = 0.026). Inunivariate analysis: the use of telemetry (hazard ratio [HR], 0.2; 95% confidence interval [CI], 0.07-0.7; P=0.004), thepresence of coronary heart disease (HR, 41.4; 95% CI, 3.1-567.7; P=0.005), hypertension (HR, 0.24; 95% CI, 0.07-0.90; P = 0.035), and patient's body mass (HR, 0.36; 95% CI, 0.14-0.92; P = 0.03) were related to the occurrence of the composite endpoint. CONCLUSIONS: The use of a telemonitoring device in CRT recipients improved theprognosis in2-year observation and contributed to the reduction of HF hospitalization.

Spanish Pacemaker Registry. 18th Official Report of the Cardiac Pacing Section of the Spanish Society of Cardiology (2020).

INTRODUCTION AND OBJECTIVES: This report describes the cardiac pacing activity performed in Spain in 2020, including the number and type of implanted devices, demographic and clinical factors, and data on remote monitoring. METHODS: Information consisted of the European Pacemaker Patient Card, data submitted to the cardiodispositivos.es online platform, the databases of participating centers, and supplier-reported data. RESULTS: A total of 14 662 procedures were registered from 102 hospitals, representing 39.2% of the estimated activity. The implantation rates of conventional and low-energy resynchronization pacemakers were 759 and 31 units per million population, respectively. In all, 520 leadless pacemakers were implanted, 70 with atrioventricular synchrony. The mean age at implantation was high (78.8 years), and the most frequent electrocardiographic change was atrioventricular block. There was a predominance of dual-chamber pacing mode but VVI/R single-chamber pacing was used in 19% of patients in sinus rhythm, depending on age and sex. Remote monitoring capability was present in 18.5% of implanted conventional pacemakers and 45.6% of low-energy resynchronization pacemakers, although registration in this system increased by 53% in 2020. CONCLUSIONS: In 2020, in the context of the SARS-CoV-2 pandemic, the number of implanted conventional pacemakers decreased by 8% and cardiac resynchronization therapy by 4.6%. The number of leadless pacemakers increased by 16.5%. Sequential pacing was predominant, influenced by age and sex. Home monitoring played a fundamental role as a mode of follow-up in this SARS-CoV-2 pandemic year.

Advances in cardiac resynchronization and implantable cardioverter/defibrillator therapy: Medtronic Cobalt and Crome.

Cardiovascular implantable electronic devices have revolutionized the management of heart failure with reduced ejection fraction. New device generations tend to be launched every few years, with incremental improvements in performance and safety and with an expectation that these will improve patient management and outcomes while remaining cost-effective. As a result, today's cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator devices are quite different from the pioneering but often bulky devices of the late 20th century. This review discusses new and improved features developed to target specific needs in managing heart failure patients, some of which are especially pertinent to the current worldwide healthcare situation, with focus on the latest generation of CRTs with defibrillator (CRT-Ds) and implantable cardioverter defibrillators from Medtronic.

Lay abstract Cardiac pacemaker devices, especially those that can retune the pumping function of the heart (known as resynchronization therapy) and those that provide shocks to restore a normal heart rhythm (known as implantable defibrillators) have revolutionized the management of heart failure over the last three decades and continue to improve in terms of their safety, effectiveness and battery life. This review discusses new and improved features developed to target specific needs in managing heart failure patients, specifically focusing on the latest generation of devices from Medtronic.

Cardiac Resynchronization Therapy Remote Monitoring - COVID-19 Pandemic Experiences and Future Perspectives.

Cardiac resynchronization therapy (CRT) is a well-established form of the treatment for heart failure (HF) in patients with left ventricle contraction dyssynchrony. Apart from typical in-office management, remote monitoring enables constant surveillance on both the patient's and the device's condition. This way, in case of any problems, clinical decisions could be made earlier leading to better outcome of CRT patients. COVID-19 pandemic with following lockdowns in many countries resulted in getting more attention on remote monitoring systems. The aim of this paper was to gather and summarize worldwide experiences from CRT remote monitoring during COVID-19 pandemic and point out future possibilities for HF patients treated with CRT. Already published experiences from remote monitoring of CRT devices during COVID-19 restrictions confirmed previous advantages of telemedical approach, however, more publications in this area would be helpful.

Impact of COVID-19 lockdown in patients with implantable cardioverter and cardiac resynchronization therapy defibrillators: insights from daily remote monitoring transmissions.

In Italy, a strict lockdown was imposed from 8 March 2020 to stop the spread of the coronavirus disease 2019 (COVID-19). We explored the effect of this lockdown on data transmitted by remote monitoring (RM) of implantable cardioverter and cardiac resynchronization therapy defibrillators (ICDs/CRT-Ds). RM daily transmissions from ICDs and CRT-Ds were analyzed and compared in two consecutive 1 month frames pre and post-lockdown: period I (7 February-7 March 2020) and period II (8 March-7 April 2020). The study cohort included 180 patients (81.1% male, 63.3% ICDs and 36.7% CRT-Ds) with a median age of 70 (interquartile range 62-78) years. The median value of physical activity provided by accelerometric sensors showed a significant reduction between period I and II [13.1% (8.2-18.1%) versus 9.4% (6.3-13.8%), p < 0.001]. Eighty nine % of patients decreased their activity, for 43.3% the relative reduction was ≥ 25%. The mean heart rate decreased significantly [69.2 (63.8-75.6) bpm vs 67.9 (62.7-75.3) bpm, p < 0.001], but with greater reduction (≈3 beats/minute) in patients aged < 70 years. Resting heart rate and thoracic impedance showed minor variations. No differences were observed in device pacing % and arrhythmias. In cardiac patients, the lockdown imposed to contain COVID-19 outbreak significantly reduced the amount of physical activity and the mean heart rate. These side effects of in-home confinement quarantine should be taken in consideration for frail patients.

Modified design of stimulation of the left ventricular endocardium for cardiac resynchronization therapy in nonresponders, previously untreatable and high-risk upgrade patients (SOLVE-CRT) trial.

The WiSE system is a novel, leadless endocardial system that can provide cardiac resynchronization therapy in patients who cannot be treated with a conventional epicardial left ventricular lead. Safety and efficacy were being evaluated in the pivotal, randomized, double-blind SOLVE-CRT Trial (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy.) The trial was initiated in 2018; however, patient enrollment was significantly impacted by the COVID-19 pandemic necessitating a change in design. This article describes the revised trial and the scientific rationale for the specific changes in the protocol.

Impact of COVID-19 pandemic on the clinical activities related to arrhythmias and electrophysiology in Italy: results of a survey promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

COVID-19 outbreak had a major impact on the organization of care in Italy, and a survey to evaluate provision of for arrhythmia during COVID-19 outbreak (March-April 2020) was launched. A total of 104 physicians from 84 Italian arrhythmia centres took part in the survey. The vast majority of participating centres (95.2%) reported a significant reduction in the number of elective pacemaker implantations during the outbreak period compared to the corresponding two months of year 2019 (50.0% of centres reported a reduction of > 50%). Similarly, 92.9% of participating centres reported a significant reduction in the number of implantable cardioverter-defibrillator (ICD) implantations for primary prevention, and 72.6% a significant reduction of ICD implantations for secondary prevention (> 50% in 65.5 and 44.0% of the centres, respectively). The majority of participating centres (77.4%) reported a significant reduction in the number of elective ablations (> 50% in 65.5% of the centres). Also the interventional procedures performed in an emergency setting, as well as acute management of atrial fibrillation had a marked reduction, thus leading to the conclusion that the impact of COVID-19 was disrupting the entire organization of health care, with a massive impact on the activities and procedures related to arrhythmia management in Italy.