Covid-19 Vaccination Impact on Atrial Arrhythmias - Real-World Evidence from the Certitude Registry

Background: The COVID-19 vaccines were developed unprecedentedly and have proven safe and efficacious in reducing transmissibility and severe infection. The impact of mRNA-based COVID-19 vaccines on atrial arrhythmias (AA) incidence is unknown. Objective(s): To analyze the incidence of AA after COVID-19 vaccination in patients with a cardiac implantable electronic device (CIED). Method(s): BIOTRONIK Home Monitoring data and Medicare claims data from CERTITUDE patients implanted with a CIED between 2010-20 were utilized to identify recipients of one or more doses of the COVID-19 vaccine in 2021. Those who had influenza vaccination in 2020 were also identified in the same cohort as a control. From remote monitoring data, the number of atrial high rate events (AHR) and % burden of AA in the three months post-vaccination was compared to the preceding three months using Wilcoxon signed rank test. Kruskal-Wallis test was used for group difference comparisons. New AF diagnosis was determined from ICD-10 diagnosis codes in Medicare claims. Result(s): First and 2nd doses of COVID vaccine (50% Pfizer, 47% Moderna, and 3% J&J) were administered to 7757 and 6579 individuals with a CIED (age 76.2 (+/-9.0) y, 49% males), respectively. In the same cohort, 4723 (61%) individuals received the influenza vaccine. A statistically significant increase in the number of AHR episodes and % burden of AA was noted in the three months post-vaccination compared to the preceding three months after the 1st and 2nd doses of the COVID-19 vaccine (Figure). No such association was noted following influenza vaccination. In subgroup analysis, AHR episodes increased significantly in age groups >70 and men. Post-vaccination increase in AHR episodes was more significant in those without a pre-vaccination history of AHR episodes (mean increase of AHR 6.9+/-88.4, p<0.001) and was non-significant in those with a preceding history of AHR (p=0.8). Among the 764 patients with no AF diagnosis in claims preceding the first COVID-19 vaccine, 87 (11.4%) developed a new AF diagnosis or AHR event in the first three months post-vaccination. Conclusion(s): We report a small but significant increase in the number of CIED-detected atrial arrhythmias following vaccination for COVID-19 but not influenza, specifically in men and age >70 years. Acknowledging the immense public health benefit of COVID-19 vaccines, our results should prompt increased awareness of evaluating for AF in this high-risk group following vaccination. [Formula presented]Copyright © 2023

Safety of same-day discharge versus overnight stay strategy following cardiac device implantations: a high-volume single-centre experience.

BACKGROUND: The strategy of cardiac implantable electronic device (CIED) implantations performed as day-case admissions has gained a wider acceptance overtime; however, data on safety are still limited. This study aims to investigate the safety of a same-day discharge protocol introduced in our hospital for the postprocedural management of patients undergoing CIED implantation. METHODS: Α prospective, non-interventional, non-randomised study performed in a single high-volume implanting centre for a 16-month period (March 2020 to June 2021). At total of 821 of 965 (85.1%) patients scheduled for elective CIED implantation were considered to be eligible for inclusion in the Short-stay Device Management Protocol. These patients were compared with a historical group of 932 patients, meeting the same inclusion criteria. RESULTS: Procedure was successful in 812 patients (98.9%), committed to same-day discharge versus 921 of 932 patients (98.8%) admitted for overnight stay (p = 0.87). Overall, 90-day complication rate was comparable in both groups (4.14% vs 4.07%, p = 0.95), as was major (1.46% vs. 1.82%, p = 0.55) and minor (2.67% vs. 2.25%, p = 0.64) complication rates. The composite early post-procedural complication rates and late post-procedural complication rates were comparable among groups (0.97 vs 1.18%, p = 0.70 and 0.73% vs 0.64%, p = 0.83, respectively). Six hundred sixty-seven patients (84%) preferred the same-day discharge strategy. Finally, a reduction of 792 bed-days was recorded, resulting in possible financial Health System benefits. CONCLUSIONS: Same-day discharge is feasible and safe in the majority of patients referred for CIED implantation. Additionally, same-day discharge is preferred by patients and may reduce procedure-related costs due to significant bed-day reductions.

TELEMEDICINE IN POST-CIED CARE

Background: Previously, all patients post-CIED implant returned to the clinic to have wound assessment, reinforce device knowledge, and confirm remote connectivity. This did not offer any tailored options for patient follow-up. Narrative: At the onset of COVID-19, wound checks post-CIED implants were changed from in person visits to telemedicine. For the few patients who had wound healing/hematoma issues identified, the patient was asked to come to clinic for further assessment. The objective of the telemedicine visit was to assess incision healing post-CIED implant. The visit also allowed the provider to ensure remote connectivity and review expectations for establishing routine device follow up. Many patients preferred the convenience of the telemedicine as it reduced travel cost and hassle of getting to the clinic, making it a more time efficient visit. For those who scheduled for a telemedicine visit, expectations of the video visit is set at the time of discharge. We need to ask the patient if they are willing to take off the Steri-Strips at time of the telemedicine visit and send them home with the needed supplies for the telemedicine visit. If patient declined removing the Steri-Strips, they were instructed to let the bandage gradually come off. They were then instructed to notify clinic for any concerning signs/symptoms. Challenges with the video quality, at times, necessitated higher quality photos to be taken and sent in for better assessment of incision site. We identified specific patients, ie, patients taking anticoagulation medication or those who had a higher risk of infection, benefitted from an in clinic visit to allow a more accurate assessment of the pocket and incision line. Therefore, those patients were required to return to clinic. Conclusion: What started out as a pandemic necessity, expanded the opportunities for telemedicine assessments to evaluate wound healing and to provide education through a telemedicine format.

Realtime Remote Programming in Patients Carrying Cardiac Implantable Electronic Devices Requiring Emergent Reprogramming.

To protect cardiac implantable electronic device (CIED) patients with arrhythmia or possible device malfunction, it is important for health care professionals to provide emergent device evaluation and reprogramming. This case series illustrated the clinical application of realtime remote programming in CIED patients requiring emergent in-person evaluation and reprogramming (ChiCTR2100046883 chictr.org). All remote sessions were performed safely and efficiently by remote electrophysiologists without being in the physical presence of a patient. The implementation of realtime remote programming not only largely reduces the response time to urgent events but also greatly helps to minimize personnel exposure to COVID-19 infection.

Cloud Follow-Up in Patients With Cardiovascular Implantable Electronic Devices: A Single-Region Study in China.

Background: Due to seriously imbalanced distribution of follow-up clinics in China, routine in-office visits are erratically attended by many cardiovascular implantable electronic device (CIED) patients. Meanwhile, remote monitoring is significantly underutilized. Novel tools to address the current predicament of routine in-office visits in China is urgently needed. Objectives: To assess the reliability and feasibility of cloud follow-up in CIED patients. Methods: A total of 325 CIED patients from 13 hospitals in Sichuan Province, China, were enrolled. Information on patients' sociodemographic and basic clinical characteristics was collected. All devices were tested and programmed with 5G-cloud follow-up platform in a real-time manner. All patients were surveyed about their acceptance of and preferences regarding cloud follow-up compared to routine in-office visits. Results: Compliance with routine in-office visits in this region was 60.6%. None of the patients were enrolled in remote monitoring services. Clinically important predictors of non-compliance were elderly age (≥75 years old), odds ratio (OR) 2.392 (95% confidence interval, 1.111-5.150); needing notification from a follow-up clinic, OR 2.518 (1.179-5.376); and being beyond 15 months post-implantation, OR 5.440 (2.563-11.543). All cloud follow-up sessions were performed safely and efficiently, without any adverse events. 292 (89.8%) patients preferred cloud follow-up for future device management. Conclusion: Compliance with routine in-office visits in this region has much room for improvement. Cloud follow-up addresses the limitations of an imbalanced distribution of follow-up clinics and geographic barriers for in-office CIED evaluation. Thus, cloud follow-up provides a potential solution to the current predicament of routine in-office visits in China.

Idiopathic brachial plexopathy after pacemaker implant.

A middle-aged woman presented with symptomatic complete heart block and underwent an uneventful dual chamber pacemaker implantation. Three weeks post procedure, she developed left arm pain and weakness, with neurological localization to the lower trunk of left brachial plexus. Possibilities of traumatic compression by the device/leads or postoperative idiopathic brachial plexopathy were considered. After ruling out traumatic causes, she was started on oral steroids, to which she responded remarkably. This case highlights the importance of recognizing this rare cause of brachial plexopathy following pacemaker implantation, because not only does an expedited diagnosis and medical treatment lead to prompt recovery with minimal neurological deficits, but it also circumvents an unnecessary surgical re-exploration.

The influence of the 2020 COVID-19 pandemic on the implantation rates of cardiac implantable electronic devices in Germany: changes between 2020 Q1-Q3 and 2019 Q1-Q3.

AIMS: During the early phase of the COVID-19 pandemic, hospital admissions for several medical and surgical conditions declined. Few data are available with respect to elective cardiac implantable electronic device (CIED) implantation. The aim of the present study was to determine the impact of the COVID-19 pandemic on the monthly CIED implantation rates in Germany (January-September 2020 vs. 2019). METHODS AND RESULTS: The monthly rates of CIED implantation for the 2019 pre- and 2020 pandemic periods were retrieved from the Institute für das Entgeltsystem im Krankenhaus using German Operation and Procedure Classification codes to identify pacemakers (PMs), implantable cardioverter/defibrillators (ICDs), and cardiac resynchronization therapy (CRT) systems. Compared with 2019, the COVID-19 pandemic was associated with an overall decline of CIED implantation rates of -2.6%, reaching -22.9% in April 2020. Stratified by device type, the patterns of implantation were similar between PMs and ICDs, with maximal declines of -24.3% and -23.2% in April, respectively. Thereafter, the implantation rates gradually increased before stabilizing to rates similar to those observed in 2019. CRT implantation rates also declined in the early pandemic wave, but the overall 2020 rates increased by +4.3% likely driven by an increase of +16.5% (June-September). All the observed percentage differences of monthly device type related implantation rates demonstrated a statistical significance. CONCLUSION: The COVID-19 pandemic had a significant impact on the implantation of CIEDs in Germany. A differential pattern of resource utilization was observed with a catch-up effect for PMs and ICDs. The implantation rates of CRT systems also declined, but they increased rapidly and remained higher than those of 2019.

Physiologic changes of covid-19 infection detected by cardiac implantable electronic device data

Background: The trajectory of cardiac physiology throughout a COVID-19 infection remains poorly described. This study aimed to characterize physiologic changes associated with acute COVID-19 infection among patients with cardiac implantable electronic devices (CIEDs). Methods: The study population included 286 patients with a Boston Scientific CIED across a large health system. CIED sensor data from March 2020-February 2021 were linked to clinical data from electronic health records. Three cohorts were created: COVID-positive (n=20), COVID-negative (n=166), and an untested control (n=100) to account for testing bias as institutional protocols only allowed symptomatic patients to be tested in the early months of the study. The magnitude of sensor changes from baseline (30-60 days before a COVID-19 test) to event (15-day window around a test) was compared between cohorts using one-way ANOVA. A date during the study window was randomly selected to serve as the event for control cases. Results: Comparing COVID-positive vs. COVID-negative vs. control, there was a greater change from baseline to event in respiratory rate (15% vs. 2% vs. 0.6% [p<0.0001]), activity (-44% vs.-12% vs.-6% [p<0.0001]), temperature (1% vs. 0.1% vs.-0.3% [p<0.0001]), and HeartLogic Index, a composite index using multiple sensors (227% vs.-11% vs. 2% [p=0.004]). Average sensor changes show prominent differences surrounding a COVID-19 test for COVID-positive compared to COVIDnegative and control cases (Figure). Conclusions: Physiologic changes associated with COVID-19 infection are detectable using CIEDs. COVID-positive patients have significant increases in respiratory rate, temperature and HeartLogic index and significant decreases in activity compared to COVID-negative and untested patients. Future studies in a larger population will help characterize the utility of CIEDs in infection surveillance and physiologic worsening that should prompt medical attention.

No substantial excess all-cause mortality among cardiac implantable electronic device patients during the first COVID­19 lockdown in the Leiden area.

In the Netherlands, the coronavirus disease 2019 (COVID­19) pandemic has resulted in excess mortality nationwide. Chronic heart disease patients are at risk for a complicated COVID­19 course. The current study investigates all-cause mortality among cardiac implantable electronic device (CIED) patients during the first peak of the pandemic and compares the data to the statistics for the corresponding period in the two previous years. Data of adult CIED patients undergoing follow-up at the Leiden University Medical Centre were analysed. All-cause mortality between 1 March and 31 May 2020 was evaluated and compared to the data for the same period in 2019 and 2018. At the beginning of the first peak of the pandemic, 3,171 CIED patients (median age 70 years; 68% male; 41% ischaemic aetiology) were alive. Baseline characteristics of the 2019 (n = 3,216) and 2018 (n = 3,169) cohorts were comparable. All-cause mortality during the peak of the pandemic was 1.4% compared to 1.6% and 1.4% in the same period in 2019 and 2018, respectively (p = 0.84). During the first peak of the COVID­19 pandemic, there was no substantial excess mortality among CIED patients in the Leiden area, despite the fact that this is group at high risk for a complicated course of a COVID­19 infection. Strict adherence to the preventive measures may have prevented substantial excess mortality in these vulnerable patients.

Triage-HF plus: 12-month study of remote monitoring pathway for triage of heart failure risk initiated during the Covid-19 pandemic

Background: The Covid-19 pandemic necessitated rapid adoption of remote monitoring across cardiovascular patient cohorts. Most patients with cardiac implantable electronic devices (CIEDs) are now able to be remotely monitored using either scheduled, patient- or threshold-triggered transmissions. The validated Triage Heart Failure Risk Score (Triage-HFRS) is a medical algorithm within company-specific CIEDs that can risk-stratify patients as low-, medium- or high-risk of worsening heart failure (WHF) in the next 30 days based on integrated monitoring of physiological parameters. Building on a previous proof-of-concept of the Triage-HF Plus pathway, we integrated remote data with simple 5-question telephone triage within a clinical pathway to identify WHF during the first year of the Covid-19 pandemic. Purpose: Prospective evaluation of clinical remote monitoring pathway integrating Triage-HFRS with protocolised telephone triage (Triage-HF Plus pathway). Methods: Prospective, real-world evaluation of clinical pathway serving a large urban region over a 12-month period, using data from April 2020 to April 2021 (initiated during the first wave of Covid-19 pandemic in the UK). From a population of 435 patients with CIEDs, 87 high Triage-HFRS alerts were received and patients contacted for telephone triage assessment. Screening questions were designed to identify episodes of WHF and non-HF events. Intervention was at discretion of the clinical practitioner and in line with guideline-directed practice. A consecutive sample of 115 medium risk scores received the same triage. Results: Successful contact was made with 72 (82.8%) high-risk patients. Classification for high scoring patients confirmed on triage included isolated heart failure (18.3%), heart failure concurrent to medical problem (5.7%), alternative medical problem (10.3%), and recent hospital admission (8.0%);triage reassured absence of acute cause of high score in 40.2%. The sensitivity and specificity for detection of WHF was 87.9% (0.77-0.99) and 59.4% (0.50-0.69) respectively. Positive and negative predictive values were 40.3% and 94.0%, respectively. Overall accuracy was 66.2%. Conclusions: The Triage-HF Plus pathway served as a useful remote monitoring tool for identifying patients with WHF whose care had been otherwise disrupted by the Covid-19 pandemic, allowing timely intervention and cementing the longer-term role for such models of care delivery. Crucially, in this multimorbid, high-cost population, relevant non-HF issues were also identified. The high negative predictive value further highlights the potential of proactive surveillance over conventional, periodic follow up.

Implantation of cardiac electronic devices in active COVID-19 patients: Results from an international survey.

BACKGROUND: Cardiac implantable electronic device (CIED) implantation rates as well as the clinical and procedural characteristics and outcomes in patients with known active coronavirus disease 2019 (COVID-19) are unknown. OBJECTIVE: The purpose of this study was to gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey. METHODS: Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure. RESULTS: The CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (P <.001). Most devices were implanted due to high-degree/complete atrioventricular block (112 [67.5%]) or sick sinus syndrome (31 [18.7%]). Of the 166 patients in the study survey, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a fatal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs 66 years; P <.001) with a nonsignificant higher complication rate (16.5% vs 7.7%; P = .2) was observed in Europe vs North America, whereas higher rates of critically ill patients (33.3% vs 3.3%; P <.001) and mortality (26.9% vs 5%; P = .002) were observed in North America vs Europe. CONCLUSION: CIED procedure rates during known active COVID-19 disease varied greatly, from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take these risks into consideration before proceeding with CIED implantation in active COVID-19 patients.

Atrial fibrillation burden during the coronavirus disease 2019 pandemic.

AIMS: The aim of this study is to determine the association between the coronavirus disease 2019 (COVID-19) pandemic and atrial fibrillation (AF) occurrence in individuals with cardiac implantable electronic devices (CIEDs). METHOD AND RESULTS: Multi-centre, observational, cohort study over a 100-day period during the COVID-19 pandemic (COVID-19) in the USA. Remote monitoring was used to assess AF episodes in patients with a CIED (pacemaker or defibrillator; 20 centres, 13 states). For comparison, the identical 100-day period in 2019 was used (Control). The primary outcomes were the AF burden during the COVID-19 pandemic, and the association of the pandemic with AF occurrence, as compared with 1 year prior. The secondary outcome was the association of AF occurrence with per-state COVID-19 prevalence. During COVID-19, 10 346 CIEDs with an atrial lead were monitored. There were 16 570 AF episodes of ≥6 min transmitted (16 events per 1000 patient days) with a significant increase in proportion of patients with AF episodes in high COVID-19 prevalence states compared with low prevalence states [odds ratio 1.34, 95% confidence interval (CI) 1.21-1.48, P < 0.001]. There were significantly more AF episodes during COVID-19 compared with Control [incident rate ratio (IRR) 1.33, 95% CI 1.25-1.40, P < 0.001]. This relationship persisted for AF episodes ≥1 h (IRR 1.65, 95% CI 1.53-1.79, P < 0.001) and ≥6 h (IRR 1.54, 95% CI 1.38-1.73, P < 0.001). CONCLUSION: During the first 100 days of COVID-19, a 33% increase in AF episodes occurred with a 34% increase in the proportion of patients with AF episodes observed in states with higher COVID-19 prevalence. These findings suggest a possible association between pandemic-associated social disruptions and AF in patients with CIEDs. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry: ACTRN12620000692932.

Reduction in new cardiac electronic device implantations in Catalonia during COVID-19.

AIMS: During the COVID-19 pandemic, concern regarding its effect on the management of non-communicable diseases has been raised. However, there are no data on the impact on cardiac implantable electronic devices (CIED) implantation rates. We aimed to determine the impact of SARS-CoV2 on the monthly incidence rates and type of pacemaker (PM) and implantable cardiac defibrillator (ICD) implantations in Catalonia before and after the declaration of the state of alarm in Spain on 14 March 2020. METHODS AND RESULTS: Data on new CIED implantations for 2017-20 were prospectively collected by nine hospitals in Catalonia. A mixed model with random intercepts corrected for time was used to estimate the change in monthly CIED implantations. Compared to the pre-COVID-19 period, an absolute decrease of 56.5% was observed (54.7% in PM and 63.7% in ICD) in CIED implantation rates. Total CIED implantations for 2017-19 and January and February 2020 was 250/month (>195 PM and >55 ICD), decreasing to 207 (161 PM and 46 ICD) in March and 131 (108 PM and 23 ICD) in April 2020. In April 2020, there was a significant fall of 185.25 CIED implantations compared to 2018 [95% confidence interval (CI) 129.6-240.9; P < 0.001] and of 188 CIED compared to 2019 (95% CI 132.3-243.7; P < 0.001). No significant differences in the type of PM or ICD were observed, nor in the indication for primary or secondary prevention. CONCLUSIONS: During the first wave of the COVID-19 pandemic, a substantial decrease in CIED implantations was observed in Catalonia. Our findings call for measures to avoid long-term social impact.

Remote monitoring of cardiac implantable devices during COVID-19 outbreak: "keep people safe" and "focus only on health care needs".

BACKGROUND: The COVID-19 pandemic has challenged the ability of health care organisations to provide adequate care. We report the experience of a national tertiary electrophysiology centre in the management of patients with cardiac implantable electronic devices (CIEDs) through the use of a fully remote follow-up model. METHODS: We daily and prospectively collected remote monitoring (RM) relevant findings and following clinical actions performed from March 10th to April 3rd 2020, a period of suspension of routine ambulatory activity due to the national lockdown. RESULTS: During the study period (25 days), we received 2,215 transmissions from 2,955 devices. Among them, 129 patients reported potential clinically actionable RM observations (event rate: 12.0/1000 patient-week). In 77 patients (60%), RM events triggered a clinical action, but only 5 patients needed an urgent in-hospital access (4 urgent procedures and 1 device reprogramming). CONCLUSIONS: In the unprecedented COVID-19 pandemic, RM became an essential tool in healthcare delivery for CIED patients. We observed that RM was effective in "keep people safe" and "focus only on individuals with health care needs".

Cardiac electrophysiology consultative experience at the epicenter of the COVID-19 pandemic in the United States.

BACKGROUND: The COVID-19 pandemic has greatly altered the practice of cardiac electrophysiology around the world for the foreseeable future. Professional organizations have provided guidance for practitioners, but real-world examples of the consults and responsibilities cardiac electrophysiologists face during a surge of COVID-19 patients is lacking. METHODS: In this observational case series we report on 29 consecutive inpatient electrophysiology consultations at a major academic medical center in New York City, the epicenter of the pandemic in the United States, during a 2 week period from March 30-April 12, 2020, when 80% of hospital beds were occupied by COVID-19 patients, and the New York City metropolitan area accounted for 10% of COVID-19 cases worldwide. RESULTS: Reasons for consultation included: Atrial tachyarrhythmia (31%), cardiac implantable electronic device management (28%), bradycardia (14%), QTc prolongation (10%), ventricular arrhythmia (7%), post-transcatheter aortic valve replacement conduction abnormality (3.5%), ventricular pre-excitation (3.5%), and paroxysmal supraventricular tachycardia (3.5%). Twenty-four patients (86%) were positive for COVID-19 by nasopharyngeal swab. All elective procedures were canceled, and only one urgent device implantation was performed. Thirteen patients (45%) required in-person evaluation and the remainder were managed remotely. CONCLUSION: Our experience shows that the application of a massive alteration in workflow and personnel forced by the pandemic allowed our team to efficiently address the intersection of COVID-19 with a range of electrophysiology issues. This experience will prove useful as guidance for emerging hot spots or areas affected by future waves of the pandemic.