Five waves of COVID-19 pandemic in Italy: results of a national survey evaluating the impact on activities related to arrhythmias, pacing, and electrophysiology promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

BACKGROUND: The subsequent waves of the COVID-19 pandemic in Italy had a major impact on cardiac care. METHODS: A survey to evaluate the dynamic changes in arrhythmia care during the first five waves of COVID-19 in Italy (first: March-May 2020; second: October 2020-January 2021; third: February-May 2021; fourth: June-October 2021; fifth: November 2021-February 2022) was launched. RESULTS: A total of 127 physicians from arrhythmia centers (34% of Italian centers) took part in the survey. As compared to 2019, a reduction in 40% of elective pacemaker (PM), defibrillators (ICD), and cardiac resynchronization devices (CRT) implantations, with a 70% reduction for ablations, was reported during the first wave, with a progressive and gradual return to pre-pandemic volumes, generally during the third-fourth waves, slower for ablations. For emergency procedures (PM, ICD, CRT, and ablations), recovery from the initial 10% decline occurred in most cases during the second wave, with some variability. However, acute care for atrial fibrillation, electrical cardioversions, and evaluations for syncope showed a prolonged reduction of activity. The number of patients with devices which started remote monitoring increased by 40% during the first wave, but then the adoption of remote monitoring declined. CONCLUSIONS: The dramatic and profound derangement in arrhythmia management that characterized the first wave of the COVID-19 pandemic was followed by a progressive return to the volume of activities of the pre-pandemic periods, even if with different temporal dynamics and some heterogeneity. Remote monitoring was largely implemented during the first wave, but full implementation is needed.

REPORTED DEVICE FAILURE AND THE CORONAVIRUS PANDEMIC: CARDIOVASCULAR INTERVENTIONS

Regular cardiology practices were interrupted by the COVID-19 pandemic. To better understand the pandemic's effects on cardiology practices, we investigated whether the pandemic affected reporting of cardiovascular medical device failure by examining whether adverse event reports per week attributed to different cardiovascular devices changed significantly during the pandemic. By using data from FDA's MAUDE database, we compared weekly rates of adverse event reports over the course of three years attributed to each of four devices: 'Implantable Cardioverter Defibrillator (Non-CRT)', 'Coronary Drug-Eluting Stent', 'Aortic Valve, Prosthesis, Percutaneously Delivered', and 'Heart Valve, Non-Allograft Tissue'. Specifically, we looked at trends per week for the adverse events 'Malfunction', 'Injury', and 'Death' for March 2018-March 2019, the pre-pandemic year of March 2019-March 2020, and the pandemic year March 2020-March 2021. We report a 46% decrease in reported deaths attributed to ICDs, a 27% decrease in reported injuries attributed to coronary DES, a 107% increase in reported deaths and a 45% increase in reported malfunctions attributed to percutaneous aortic valve prostheses, as well as a 27% decrease in reported injuries attributed to non-allograft tissue heart valves (all comparisons pandemic to pre-pandemic). That these four cardiovascular medical devices did not homogeneously increase or decrease suggests that changing care patterns that differently affected each device were the root of these trends, rather than a broader factor like underreporting which one would expect to affect the devices similarly. © 2022 by ASME

EXPLORATORY FACTOR ANALYSIS FOR IDENTIFYING CIEDS PATIENTS' CONCERNS DURING THE COVID-19 PANDEMIC IN EUROPE

The current COVID-19 pandemic affects healthcare worldwide. Patients living with cardiac implantable electronic devices (CIEDs) are at high-risk to experience emotional distress and severe COVID-19 symptoms. Assessing their mental and physical health condition during the pandemic is crucial. An online questionnaire consisting of 45 multiple-choice questions regarding the patients' emotional and physical status was completed by 210 CIEDs participants. On the eligible 184 responses, a principal axis factoring (PAF) multivariate analysis was performed, which is part of the Exploratory Factor Analysis (EFA) class, frequently used in healthcare research. The considered variables in the PAF were CIEDs patients' concerns related to: device functioning, having received a shock (if ICD), the possibility to receive a shock (if ICD), access to medical care, reaching physicians, access to medication, getting infected by SARS-CoV-2, the health of caretakers, the health of their loved ones. However, one of the most difficult tasks in PAF is the selection of an appropriate number of factors. We proposed three rules to be considered, the verification of: the Kaiser criterion, the Cattell's Scree test, and the cumulative variance (to explain at least 60-65 %). After the number of factors had been established, we proposed a final verification, the Monte Carlo Parallel Analysis. Two factors were identified, subsequently defined as "Healthcare -related concerns" and "Fear of COVID-19 disease", which explained 75.56% of the cumulative variance. The factors highlight the need for accurate medical information provision, patient education, and support to improve healthcare during the pandemic.

Findings of remote monitoring of implantable cardioverter defibrillators during the COVID-19 pandemic.

BACKGROUND: Monitoring of cardiac implantable electronic devices was highly impacted by the COVID-19 pandemic considering the high volume of in-person visits for regular follow-up. Recent recommendations highlight the important role of remote monitoring to prevent exposure to the virus. This study compared remote monitoring of implantable cardioverter defibrillators (ICDs) in patients whose in-person annual visit was substituted for a remote monitoring session with patients who were already scheduled for a remote monitoring session. METHODS: This was a cross-sectional observational study of 329 consecutive patients between 20 March and 24 April 2020. Group 1 included 131 patients whose in-person annual visit was substituted for a remote monitoring session. Group 2 included 198 patients who underwent a remote monitoring session as scheduled in their usual device follow-up. The time interval since the last in-person visit was 13.3 ± 3.2 months in group 1 and 5.9 ± 1.7 months in group 2 (P < .01). RESULTS: In group 1, 15 patients (11.5%) experienced a clinical event compared to 15 patients (7.6%) in group 2 (P = .25). Nineteen patients (14.5%) required a physician intervention in group 1 compared to 19 patients (9.6%) in group 2 (P = .22). Two patients (1.5%) in group 1 and four patients (2.0%) in group 2 required an early in-person follow-up visit during the pandemic (P > .99). CONCLUSION: Remote monitoring of ICDs is useful to identify clinical events and allows physicians to treat patients appropriately during the COVID-19 pandemic regardless of the time interval since their last in-person visit. It reduces significantly in-person visit for regular follow-up.

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.