scholarly journals Impact of COVID-19 Pandemic on Remote Monitoring of Cardiac Implantable Electronic Devices in Italy: Results of a Survey Promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing)

2021 ◽  
Vol 10 (18) ◽  
pp. 4086
Author(s):  
Massimiliano Maines ◽  
Pietro Palmisano ◽  
Maurizio Del Greco ◽  
Donato Melissano ◽  
Silvana De Bonis ◽  
...  

The COVID-19 pandemic has had a profound impact on the organisation of health care in Italy, with an acceleration in the development of telemedicine. To assess the impact of the COVID-19 pandemic on the spread of remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) in Italy, a survey addressed to cardiologists operating in all Italian CIED-implanting centres was launched. A total of 127 cardiologists from 116 Italian arrhythmia centres took part in the survey, 41.0% of all 283 CIED-implanting centres operating in Italy in 2019. All participating centres declared to use RM of CIEDs. COVID-19 pandemic resulted in an increase in the use of RM in 83 (71.6%) participating centres. In a temporal perspective, an increase in the median number of patients per centre followed up by RM was found from 2012 to 2017, followed by an exponential increase from 2017 to 2020. In 36 participating centres (31.0%) a telehealth visits service was activated as a replacement for in-person outpatient visits (in patients with or without CIED) during the COVID-19 pandemic. COVID-19 pandemic has caused an acceleration in the use of RM of CIEDs and in the use of telemedicine in the clinical practice of cardiology.

EP Europace ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. 769-776 ◽  
Author(s):  
Mateusz Tajstra ◽  
Adam Sokal ◽  
Elżbieta Gadula-Gacek ◽  
Anna Kurek ◽  
Aleksandra Wozniak ◽  
...  

Abstract Aims The number of patients with heart failure (HF) and implantable cardiac electronic devices has been growing steadily. Remote monitoring care (RC) of cardiac implantable electronic devices can facilitate patient-healthcare clinical interactions and prompt preventive activities to improve HF outcomes. However, studies that have investigated the efficacy of remote monitoring have shown mixed findings, with better results for the system including daily verification of transmission. The purpose of the RESULT study was to analyse the impact of remote monitoring on clinical outcomes in HF patients with implantable cardioverter-defibrillator [ICD/cardiac resynchronization therapy-defibrillator (CRT-D)] in real-life conditions. Methods and results The RESULT is a prospective, single-centre, randomized trial. Patients with HF and de novo ICD or CRT-D implantation were randomized to undergo RC vs. in-office follow-ups (SC, standard care). The primary endpoint was a composite of all-cause death and hospitalization due to cardiovascular reasons within 12 months after randomization. We randomly assigned 600 eligible patients (299 in RC vs. 301 in SC). Baseline clinical and echocardiographic characteristics were well-balanced and similar in both arms. The incidence of the primary endpoint differed significantly between RC and SC and involved 39.5% and 48.5% of patients, respectively, (P = 0.048) within the 12-month follow-up. The rate of all-cause mortality was similar between the studied groups (6% vs. 6%, P = 0.9), whereas hospitalization rate due to cardiovascular reasons was higher in SC (37.1% vs. 45.5%, P = 0.045). Conclusion Remote monitoring of HF patients with implanted ICD or CRT-D significantly reduced the primary endpoint rate, mostly as a result of a lower hospitalization rate in the RC arm (ClinicalTrials.gov Identifier: NCT02409225).


2020 ◽  
Vol 9 (11) ◽  
pp. 3729
Author(s):  
Sławomir Pluta ◽  
Ewa Piotrowicz ◽  
Ryszard Piotrowicz ◽  
Ewa Lewicka ◽  
Wojciech Zaręba ◽  
...  

Background: The impact of cardiac rehabilitation on the number of alerts in patients with remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is unknown. We compared alerts in RM and outcomes in patients with CIEDs undergoing hybrid comprehensive telerehabilitation (HCTR) versus usual care (UC). Methods: Patients with heart failure (HF) after a hospitalization due to worsening HF within the last 6 months (New York Heart Association (NYHA) class I-III and left ventricular ejection fraction (LVEF) ≤40%) were enrolled in the TELEREH-HF study and randomised 1:1 to HCTR or UC. Patients with HCTR and CIEDs received RM (HCTR-RM). Patients with UC and CIEDs were offered RM optionally (UC-RM). Data from the initial 9 weeks of the study were analysed. Results: Of 850 enrolled patients, 208 were in the HCTR-RM group and 62 in the UC-RM group. The HCTR-RM group was less likely to have alerts of intrathoracic impedance (TI) decrease (p < 0.001), atrial fibrillation (AF) occurrence (p = 0.031) and lower mean number of alerts per patient associated with TI decrease (p < 0.0001) and AF (p = 0.019) than the UC-RM group. HCTR significantly decreased the occurrence of alerts in RM of CIEDs, 0.360 (95%CI, 0.189–0.686; p = 0.002), in multivariable regression analysis. There were two deaths in the HCTR-RM group (0.96%) and no deaths in the UC-RM group (p = 1.0). There were no differences in the number of hospitalised patients between the HCTR-RM and UC-RM group (p = 1.0). Conclusions: HCTR significantly reduced the number of patients with RM alerts of CIEDs related to TI decrease and AF occurrence. There were no differences in mortality or hospitalisation rates between HCTR-RM and UC-RM groups.


2018 ◽  
Vol 2 (47) ◽  
pp. 27-31
Author(s):  
Lidia Chmielewska-Michalak ◽  
Ewelina Konstanty ◽  
Przemysław Mitkowski

The number of patients with cardiac implantable electronic devices (CIED), who require oncological management including radiotherapy (RT) is still increasing. According to current knowledge the most frequent device dysfunction related to exposition to ionizing radiation is reprogramming to emergency mode (soft reset). There are uncommon cases of complete, irreversible device damage. CIED dysfunction during RT can be observed in approximately 3% of patients. In majority of cases they are asymptomatic, although in literature there are descriptions of deterioration of clinical status due to bradycardia or exacerbation of heart failure. The most important factor of device malfunction is radiotherapy with photons of energy >10 MV or protons despite energy used. So far there were no cases published with inadequate ICD therapies due to the presence of electromagnetic field interference during RT. Because patients with CIED undergoing RT need complex care to achieve high level of safety, experts of Heart Rhythm Society establish document, published in 2017 which summarized current knowledge about this group of patients. The document contains guidelines on peri-radiotherapy care of patients with CIED.


EP Europace ◽  
2021 ◽  
Author(s):  
Sharath Kumar ◽  
Jason Davis ◽  
Bernard Thibault ◽  
Iqwal Mangat ◽  
Benoit Coutu ◽  
...  

Abstract Aims Cardiac implantable electronic devices with device advisories have the potential of device malfunction. Remote monitoring (RM) of devices has been suggested to allow the identification of abnormal device performance and permit early intervention. We sought to describe the outcomes of patients with and without RM in devices subject to the Abbott Premature Battery Depletion (PBD) advisory with data from a Canadian registry. Methods and results Patients with an Abbott device subject to the PBD advisory from nine implantable cardioverter defibrillator (ICD) implanting centres in Canada were included in the registry. The use of RM was identified from baseline and follow-up data in the registry. The primary outcome was detection of PBD and all-cause mortality. A total of 2666 patients were identified with a device subject to the advisory. In all, 1687 patients (63.2%) had RM at baseline. There were 487 deaths during follow-up. At a mean follow-up of 5.7 ± 0.7 years, mortality was higher in those without a remote monitor compared with RM at baseline (24.7% vs. 14.5%; P &lt; 0.001). Pre-mature battery depletion was identified in 36 patients (2.1%) with RM vs. 7 (0.7%) without RM (P = 0.004). Time to battery replacement was significantly reduced in patients on RM (median 5 vs. 13 days, P = 0.001). Conclusion The use of RM in patients with ICD and cardiac resynchronization therapy under advisory improved detection of PBD, time to device replacement, and was associated with a reduction in all-cause mortality. The factors influencing the association with mortality are unknown and deserve further study.


2021 ◽  
Author(s):  
Giovanni Malanchini ◽  
Gabriele Ferrari ◽  
Cristina Leidi ◽  
Paola Ferrari ◽  
Michele Senni ◽  
...  

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
A Cueva-Parra ◽  
G Munoz-Benavides ◽  
W Ortiz-Solis ◽  
J Gomez-Flores ◽  
MF Marquez ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background - Introduction: The COVID-19 pandemic has generated serious repercussions on the health system, reducing the number of all cardiology procedures worldwide. Objectives Describe the impact of the COVID-19 pandemic on the procedures performed by the electrophysiology department in a national referral center.  Methods We made a retrospective review of our data base and we compared procedures made in the last 3 years since 2017 to 2019 with the procedures made in the 2020. We divide the procedures into two large groups: Cardiac Implantable Electronic Devices (CIED) related procedures (which included implants, revisions, changes, upgrades and extractions) and electrophysiological studies and ablations (which included conventional and complex procedures). Other types of procedures were no included. Results There was a significant reduction in all procedures, the average of procedures performed in the last 3 previous years was 467 (there were 479 in 2017, 411 in 2018 and 511 in 2019), while in 2020 we performed only 319 (p = 0.01); this represents a reduction of 33.4% in the total number of procedures performed in our center. There was no statistical difference regarding the CIED related procedures, the average of procedures of the last 3 previous years was 174 (there were 186 in 2017, 148 in 2018 and 188 in 2019), and in 2020 we performed 189 procedures, this value is near to the average of the last 3 previous years and very close to the value of the 2019 (p = 0.46). Regarding the electrophysiological studies and ablations, the average of procedures of the last 3 previous years was 293 (there were 293 in 2017, 263 in 2018 and 323 in 2019), while in 2020 we performed only 129 procedures, considerably decreasing compared to the previous years (p &lt; 0.01). The reduction in the electrophysiological studies and ablations was 55.97%. The most affected months were April, May and June. Conclusions The COVID-19 pandemic considerably affected the number of electrophysiological procedures in our center, reducing it by 33.4% compared to the previous years. The reduction of procedures fundamentally affected the electrophysiological studies and ablations, reducing them by 55.97%. The number of CIED related procedures were no affected. Electrophysiological procedures Procedures2017201820192017-2019 average2020CIED related procedures186148188174189Electrophysiological studies and ablations293263323293129Total479411511467319Comparative table of the electrophysiological procedures performed in our center in recent years.Abstract Figure. Comparison of the procedures.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Padmanabhan ◽  
M Farwati ◽  
A Izath ◽  
A Al-Masry ◽  
D Kella ◽  
...  

Abstract Recent guideline statements approve the performance of magnetic resonance imaging (MRI) in patients with non-conditional cardiac implantable electronic devices (CIEDs) under certain closely monitored conditions. Data from current registries may have lower power to discern changes that may occur in the CIED after the MRI. Objective We aimed to systematically review the literature to identify the adverse events and significance of changes in device function associated with performing MRI in patients with CIEDs Methods A comprehensive literature search of the databases was performed between 1980- 2017. Two independent reviewers selected studies and extracted data. A random-effects model was used for meta-analysis. Results A total of 7,422 patients underwent 8,865 MRI studies. No death occurred post MRI. Clinical adverse events were extremely rare (mostly less than 1%) and are summarized in Table 1. No significant changes in the pooled mean effect size estimate was noted for the changes in the lead parameters (pacing threshold, sensing and impedance) Binary outcomes post magnetic resonance imaging in patients with non-conditional cardiac implantable electronic devices Outcome Sample size Number of patients Rate SE LL of CI UL of CI Death 7401 0 0 0 0 0 Atrial arrhythmia 7173 10 0.001 0.0004 0.0007 0.0024 Ventricular arrhythmia 7371 9 0.0012 0.0004 0.0006 0.0022 Oversensing 4981 17 0.0034 0.0008 0.0020 0.0053 Inhibition of pacing 7371 6 0.0008 0.0003 0.0003 0.0016 Lead Failure/Generator Failure 7475/7475 2/8 0.0002/0.0011 0.0001/0.0004 0.0001/0.0005 0.0009/0.002 Power on Reset 1388 105 0.0131 0.0014 0.0107 0.0161 Did not complete scan 6851 13 0.0019 0.0005 0.0011 0.0031 Chest pain 7080 11 0.0021 0.0004 0.0008 0.0027. Lead threshold rise (>0.5v/>50%-A/V) 5076/6246 12/16 0.0024/0.0026 0.0007/0.0006 0.0013/0.0015 0.0040/0.0041 Change in Battery voltage >0.04V 7132 42 0.0061 0.0009 0.0043 0.0079 Sensing decrease >50%-A/V 5087/5834 17/9 0.0033/0.0015 0.0008/0.0005 0.0020/0.0008 0.0052/0.0028 Impedance changes >50ohms/>50% 5810 22 0.0038 0.0008 0.0024 0.0057 Rise in cardiac enzymes 1703 26 0.0152 0.0030 0.0102 0.0219 A, atrial; V, ventricular; SE, standard Error; LL, lower limit; UL, upper limit; CI, Confidence intervals. Conclusions MRI in patients with non-conditional CIEDs can be performed with high degree of safety and low rate of clinical events when performed under standardized protocols Acknowledgement/Funding None


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