COVID-19 pandemic: Impact on the cardiac implantable electronic devices' implantation rates in Croatia.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) pandemic has influenced health-care organization worldwide, including management of non-communicable diseases. The aim of this study was to determine the impact of COVID-19 pandemic on cardiac implantable electronic devices' (CIEDs) implantation rates in Croatia. METHODS: A retrospective, observational, national study was conducted. The data on CIEDs' implantation rates from 20 Croatian implantation centres, between January 2018 and June 2021, were extracted from the national Health Insurance Fund registry. Implantation rates before and after COVID-19 pandemic started, were compared. RESULTS: The overall numbers of CIED implantations in Croatia during COVID-19 pandemic were not different in comparison to 2 years pre-COVID-19 time (2618 vs. 2807, p = .081). The pacemaker implantation rates decreased significantly (by 45%) during April (122 vs. 223, p < .001) and May 2020 (135 vs. 244, p = .001), as well as during November 2020 (177 vs. 264, p = .003), but significantly increased during summer months 2020 comparing to 2018 and 2019 (737 vs. 497, p<0.001). The ICD implantation rates decreased significantly by 59% in April 2020 (26 vs. 64, p = .048). CONCLUSION: To the authors best knowledge this is a first study including complete national data on CIED implantation rates and COVID-19 pandemic impact. A significant reduction in number of both pacemaker and ICD implants during specific months of the COVID-19 pandemic was determined. However, afterwards compensation in implants resulted in similar total number when the complete year was evaluated.

Impact of Nationwide COVID-19 Lockdowns on the Implantation Rate of Cardiac Implantable Electronic Devices.

AIM: The COVID-19 pandemic resulted in a significant decrease in the number of hospital admissions for severe emergent cardiovascular diseases during lockdowns worldwide. This study aimed to determine the impact of both the first and the second Danish nationwide lockdown on the implantation rate of cardiac implantable electronic devices (CIEDs). METHODS: We retrospectively analysed the number of CIED implantations performed in Denmark and stratified them into 3-week intervals. RESULTS: The total number of de novo CIED implantations decreased during the first lockdown by 15.5% and during the second by 5.1%. Comparing each 3-week interval using rate ratios, a significant decrease in the daily rates of the total number of de novo and replacement CIEDs (0.82, 95% CI [0.70, 0.96]), de novo CIEDs only (0.82, 95% CI [0.69, 0.98]), and non-acute pacemaker implantations (0.80, 95% CI [0.63, 0.99]) was observed during the first interval of the first lockdown. During the second lockdown (third interval), a significant decrease was seen in the daily rates of de novo CIEDs (0.73, 95% CI [0.55, 0.97]), and of pacemakers in total during both the second (0.78, 95% CI [0.62, 0.97]) and the third (0.60, 95% CI [0.42, 0.85]) intervals. Additionally, the daily rates of acute pacemaker implantation decreased during the second interval (0.47, 95% CI [0.27, 0.79]) and of non-acute implantation during the third interval (0.57, 95% CI [0.38, 0.84]). A significant increase was observed in the number of replacement procedures during the first interval of the second lockdown (1.70, 95% CI [1.04, 2.85]). CONCLUSIONS: Our study found only modest changes in CIED implantations in Denmark during two national lockdowns.

Quality of life of children and young adults with and without cardiovascular implantable electronic devices during the COVID-19 pandemic.

BACKGROUND: Children with cardiovascular implantable electronic devices (CIEDs) have a lower quality of life (QoL) compared to the general pediatric population. The combined effect of COVID-19 and CIEDs on the QoL and physical activity (PA) both within and between each population is unknown. METHODS: Individuals 8-25-year-old with and without CIED's were recruited to complete a phone survey. Data collection included demographics, the Pediatric Quality of Life Inventory (PedsQL), and the (PAQ). PedsQL and PAQ scores range from 0-100 and 1-5, respectively, with higher scores indicating a higher QoL and PA. RESULTS: Of the 190 individuals contacted, 148 participated (CIED n = 76, non-CIED n = 72), for an 81% response rate. Participants with and without CIEDs were similar in age (15.5 vs. 16 years, p = .57), gender (male = 57% vs. 42%, p = .07), and self-identified race (white = 79% vs. 81%, p = .44). CIED participants had a lower QoL (70.8 vs. 83.3, p < .001). Lower total scores were noted in CIED participants with structural heart disease compared to those without (71.6 vs. 83.6, p = .035) and those with a history of non-CIED heart or chest surgery compared to those without (71.3 vs. 83.3, p = .035). PAQ scores were similarly lower for CIED participants (2.17 vs. 2.73, p < .001). CONCLUSION: The presence of a CIED negatively impacts the QoL and PA of the pediatric population in the setting of the COVID-19 pandemic. Further research is needed to better understand and address the drivers of decreased QoL and PA in the pediatric CIED population in the setting of the COVID-19 Pandemic.

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.

Complete atrioventricular block due to multisystem inflammatory syndrome in children: a case report.

BACKGROUND: Cardiac manifestations in multisystem inflammatory syndrome in children (MIS-C) may involve the conduction system. The incidence and publication is still very limited. CASE: We report the case of a 2-year-old girl who presented with complete atrioventricular (AV) block with a current infection of SARS-CoV-2 and fulfilled the criteria of MIS-C. After observation for 2 weeks of the SARS-CoV-2 convalescence phase and temporary pacemaker insertion, the complete AV block was not resolved. The intrinsic junctional escape beat was only 40 beats/minute. We decided to implant a dual-chamber epicardial permanent pacemaker to maintain synchrony between atrium and ventricle and furthermore provide hemodynamic stability. We observed persistent complete AV block 9 months after SARS-CoV-2 infection in long-term follow up of this patient. CONCLUSIONS: Complete AV block in MIS-C could persist months after its onset. Our case could give additional knowledge regarding the natural history of cardiac involvement after SARS-CoV-2 infection.

Symptomatic Bradycardia in Covid-19 Hospitalized Patients: A Case Series.

SARS COV-2 infection has become a global threat. Cardiovascular manifestations associated with Covid-19 have been noted in several publications, and bradycardia related to Covid-19 is a commonly reported complication. This study reports six serial cases of bradycardia attributable to Covid-19; four of them developed complete atrioventricular block. These patients experienced clinical symptoms related to bradycardia and initially required permanent pacemaker implantation. However, one patient did not require permanent pacing later on due to spontaneous conversion to sinus rhythm. In comparison, the other two patients who developed transient sinus bradycardia experienced a self-limiting condition during their hospitalization period without requiring any cardiac pacing device or medication to increase heart rate. Complete atrioventricular block and transient sinus bradycardia in these patients, despite not having any history of bradycardia, might be due to complex processes in the systemic inflammatory response in Covid-19. Cardiac monitoring, hemodynamic evaluation, and strategy for permanent pacemaker in these patients should be treated on a case-by-case basis.

Sudden Occurrence of Pacemaker Capture Failure during Irreversible Electroporation Ablation for Prostate Cancer in Post-COVID-19 Patient: A Case Report.

Irreversible electroporation (IRE) ablation is a novel treatment option for localized prostate cancer. Here, we present a case of an abrupt and fatal arrhythmia during the IRE procedure in a prostate cancer patient with an implanted permanent pacemaker. A 78-year-old male patient with a pacemaker due to sick sinus syndrome and syncope was scheduled for IRE prostate ablation surgery under general anesthesia. He had a history of recovering from coronavirus disease 2019 (COVID-19) after having been vaccinated against it and recovered without sequalae. Pacemaker interrogation and reprogramming to asynchronous AOO mode was carried out before surgery, however, sinus pause occurred repeatedly during ablation pulse delivery. After the first sinus pause of 2.25 s there was a decrease in continuous arterial blood pressure (ABP). During the delivery of the second and third pulses, identical sinus pauses were observed due to failure to capture. However, the atrial-paced rhythm recovered instantly, and vital signs became acceptable. Although sinus pause recovered gradually, the duration thereof was increased by the delivery of more IRE pulses, with a subsequent abrupt decrease seen in blood pressure. The pacemaker was urgently reprogrammed to DOO mode, after which there were no further pacing failures and no hemodynamic adverse events. For patients with pacemakers, close cardiac monitoring in addition to the interrogation of the pacemaker during the electromagnetic interference (EMI) procedure is recommended, especially in the case of having a disease that may aggravate cardiac vulnerability, such as COVID-19.

Usefulness of Temporary Pacing in Patients With New Left Bundle Branch Block During Transcatheter Aortic Valve Implantation.

New-onset left bundle branch block (NLBBB) is the most common complication after transcatheter aortic valve implantation (TAVI). Expert consensus recommends temporary transvenous pacemaker (TTVP) support for 24 hours in these patients. To date, no study has examined TTVP use during the index hospitalization in detail. Therefore, we aimed to assess TTVP use in patients with TAVI who developed NLBBB. In this prospective observational study, we performed a detailed analysis of 24-hour telemetry in patients who developed NLBBB during TAVI. Baseline characteristics and procedural and postprocedural data were recorded. The primary outcome was pacing by the TTVP. We evaluated inappropriate TTVP use, electrophysiology study findings, permanent pacemaker (PPM) implantation, and NLBBB resolution. A total of 83 patients (74.4 ± 8.7 years, 41% female) developed NLBBB during TAVI. During index hospitalization, 1 patient (1%) required TTVP because of complete heart block and received a PPM. Five of the 83 (6%) patients were inappropriately paced, and 1 patient (1%) had ventricular fibrillation, likely secondary to TTVP. A total of 34 patients (41%) underwent electrophysiology study during hospitalization, with 4 of 83 (5%) subsequently receiving a PPM. One (1%) patient died during hospitalization, and 9 patients were lost to follow-up because of the COVID-19 pandemic. Of the remaining 73 patients with a 30-day follow-up, NLBBB had resolved in 36 (49%) at 30 days, and 2 (3%) were readmitted with complete heart block and received PPM. In conclusion, in patients with TAVI who develop NLBBB, temporary pacing is rarely necessary, may carry additional risks to the patient, and prolong hospitalization time.

COVID-19 pandemic and elderly: is the curtain dropped for urgent pacemaker implantations?

BACKGROUND: Permanent cardiac pacing is the therapy of choice for treating severe and/or symptomatic bradyarrhythmia. During the COVID-19 outbreak, it has been reported a decrease in the incidence of acute coronary syndrome, but few data are available about pacemaker implantation rates. This study aimed to analyze patients referred to our center with permanent cardiac pacing indication during the COVID-19 outbreak. METHODS: We compared the number, the characteristics and the outcomes of patients who underwent urgent pacemaker implantation between March and April 2019 (Group I) with those performed in the corresponding 2020 period (Group II). RESULTS: A total of 27 patients (Group I) were implanted in March-April 2019 and 34 patients (Group II) in the corresponding 2020 period. In both groups, about half of the patients received a dual-chamber pacemaker. No significant differences in baseline patients' characteristics were observed. The most frequent indication was advanced atrio-ventricular block with a prevalence of 78% and 62% in Group I and II, respectively. The rate of procedural complications, the in-hospital and 1-month mortality were also similar between the two groups. CONCLUSIONS: In our regional referral center, we observed a routine activity in terms of urgent pacemaker implantations for the treatment of symptomatic bradyarrhythmia during the COVID-19 outbreak.

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.

Assessment of pacemaker lead-related infective endocarditis with three-dimensional echocardiography and cardiac computed tomography.

Pacemaker endocarditis is rare and symptoms may be misleading. If missed, it carries significant morbidity and mortality, particularly in the elderly. Advances in multi-modality imaging in recent years have emphasised its role in clinical decision making. This case highlights the ability of multi-modality imaging techniques to individualise diagnosis, management and prognosis in patients with suspected cardiovascular implantable electronic device (CIED) endocarditis.

[Changes in cardiac implantable electronic device follow-up induced by the COVID-19 pandemic in 2020: report of a single-centre experience]. / Variazioni del follow-up dei dispositivi elettronici cardiaci impiantabili indotte dalla pandemia COVID-19 nel 2020: esperienza di un singolo centro.

BACKGROUND: The COVID-19 pandemic caused by SARS-CoV-2 has greatly modified outpatient follow-ups. The aim of this retrospective study was to evaluate the organizational modalities and clinical effects of rearrangements of pacemaker (PM) and implantable cardioverter-defibrillator (ICD) outpatient visits performed in our centers at Ravenna and Lugo Hospitals, Italy, during the pandemic outbreak in 2020. METHODS: All scheduled in-person device follow-up visits in March-December 2020 have been considered. On the basis of documented past functioning of each device and of remote monitoring (RM) capabilities, in-person visits were either performed or postponed at variable times. The characteristics of the follow-ups and the device-related clinically relevant events were analyzed, the latter being further divided into serious malfunction and problems to be corrected by device reprogramming. RESULTS: Overall, 27% of in-person visits were postponed (n = 576) (36% of ICDs and 25% of PMs), peaking 62% in March-May 2020. RM compensated nearly all hold-ups in ICDs and just 63% of postponements in PMs. The postponement-caused delay between in-person visits was 5.6 ± 1.1 months for ICDs and 4.7 ± 1.2 months for PMs; in 24% of ICDs the time interval between in-person visits was ≥18 months. Clinically relevant events were 56 (18 [4.4%] in ICDs, 38 [2.1%] in PMs), with no deaths and 21 serious malfunctions (4 [1%] in ICDs, 15 [0.8%] in PMs). RM identified all ICD malfunctions, while it was not available in the affected PMs. In comparison with the year 2019, serious malfunctions increased, though the difference was not significant. Monthly RM transmissions increased by 2.3 fold. CONCLUSIONS: In our single-center experience during the COVID-19 pandemic, numerous in-person PM/ICD follow-up visits were postponed, and delays were well beyond the previously recommended time limits. However, device-related malfunctions did not increase, notably, when RM capabilities were used.

Complete heart block, severe right ventricular dysfunction in a child with COVID-19 infection.

A young child presented with hepatomegaly, ascites and bradycardia in the setting of COVID-19. Permanent complete atrioventricular block and severe right heart failure were diagnosed. He was treated with surgical epicardial pacemaker implantation. This report is the first description of COVID-19-induced permanent complete atrioventricular block in a child.

Clinical use of real-time remote programming in pacemakers during the COVID-19 pandemic: A case report.

We report a case in which real-time remote interrogation and reprogramming of the parameters of a dual-chamber pacemaker was performed during the COVID-19 pandemic. The described case demonstrated the safety and effectiveness of CIED remote programming based on the 5G cloud technology support platform (5G-CTP), and showed that the application of real-time remote programming would help in reducing the risk of cross-infection between doctors and patients.

Activity During the COVID-19 Pandemic in Children with Cardiac Rhythm Management Devices.

Decreased physical activity is associated with cardiovascular, metabolic and mental health disease. While decreases in physical activity during the COVID-19 pandemic have been described in the general population, there is a paucity of data regarding children with underlying cardiovascular disease. We hypothesized there would be a decrease in physical activity at the onset of the COVID-19 pandemic. Performed a single-center, retrospective cohort study of children aged < 19 years with cardiac rhythm management devices. Patients were included if they had device-measured physical activity data from > 80% of dates from February 3, 2020 through June 30, 2020. Patients with significant neurologic/neuromuscular disease were excluded. We identified 144 patients with a median age of 15.4 years. 47% were female. 34% had congenital heart disease, 20% had cardiomyopathy, 19% had an inherited arrhythmia syndrome and 5% had atrioventricular block without congenital heart disease. 47% of patients had an implantable loop recorder, 29% had a permanent pacemaker and 24% had an implantable cardioverter-defibrillator. We observed a significant decrease in device-measured physical activity from baseline (February 3-March 9), with up to a 21% decrease in physical activity during mid-March through early May. Activity levels returned to pre-pandemic levels in June. Physical activity sharply declined in children with cardiac rhythm management devices at the onset of the COVID-19 pandemic. These data highlight the importance of finding strategies to maintain physical activity during the current pandemic and future public health crises.

Knowledge Update on the Economic Evaluation of Pacemaker Telemonitoring Systems.

(1) Introduction: In the last two decades, telemedicine has been increasingly applied to telemonitoring (TM) of patients with pacemakers; however, presently, its growth has significantly accelerated because of the COVID-19 pandemic, which has pushed patients and healthcare workers alike to seek new ways to stay healthy with minimal physical contact. Therefore, the main objective of this study was to update the current knowledge on the differences in the medium-and long-term effectiveness of TM and conventional monitoring (CM) in relation to costs and health outcomes. (2) Methods: Three databases and one scientific registry were searched (PubMed, EMBASE, Scopus, and Google Scholar), with no restrictions on language or year of publication. Studies published until July 2021 were included. The inclusion criteria were: (a) experimental or observational design, (b) complete economic evaluation, (c) patients with implanted pacemakers, and (d) comparison of TM with CM. Measurements of study characteristics (author, study duration, sample size, age, sex, major indication for implantation, and pacemaker used), analysis, significant results of the variables (analysis performed, primary endpoints, secondary endpoints, health outcomes, and cost outcomes), and further miscellaneous measurements (methodological quality, variables coded, instrument development, coder training, and intercoder reliability, etc.) were included. (3) Results: 11 studies met the inclusion criteria, consisting of 3372 enrolled patients; 1773 (52.58%) of them were part of randomized clinical trials. The mean age was 72 years, and the atrioventricular block was established as the main indication for device implantation. TM was significantly effective in detecting the presence or absence of pacemaker problems, leading to a reduction in the number of unscheduled hospital visits (8.34-55.55%). The cost of TM was up to 87% lower than that of CM. There were no significant differences in health-related quality of life (HRQoL) and the number of cardiovascular events. (4) Conclusions: Most of the studies included in this systematic review confirm that in the TM group of patients with pacemakers, cardiovascular events are detected and treated earlier, and the number of unscheduled visits to the hospital is significantly reduced, without affecting the HRQoL of patients. In addition, with TM modality, both formal and informal costs are significantly reduced in the medium and long term.

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.

Impact of COVID-19 Pandemic on Cardiac Electronic Device Management and Role of Remote Monitoring.

During the coronavirus disease 2019 (COVID-19) worldwide pandemic, patients with cardiac implantable electronic device (CIED) refused scheduled follow-up visits because of the risk of infection. In this scenario, different telemedicine strategies have been implemented to ensure continuity of care to CIED patients. Patients can be monitored through dedicated applications, telephone calls, or virtual visits providing easy access to valuable information, such as arrhythmic events, acute decompensation manifestations, and device-related issues, without the need for in-person visits. This review provides a comprehensive description of the many possible applications of telemedicine for CIED patients during the COVID-19 period.