Objectives: To study the impact of curfews during the COVID-19 pandemic, on the physical activity in patients of heart failure implanted withcardiac implantable electronic devices (CIEDs). Methods: This was a retrospective single-center study of heart failure patients inserted with remote monitoring (RM)-capable CIED. We analyzed the transmitted data of physical activity and fluid volume status of all patients, before, and during the lockdown periods between February and April 2020. The clinical status of the patients was also evaluated. Results: Device data from 429 patients implanted with CIED capable of RM were initially evaluated. Patients with an implantable loop recorder, Brugada or Long QT syndromes, and patients with incomplete transmissions were excluded. Eighty-two patients with heart failure were included. The median age was 65 years (58-72), and 53 (64.6%) subjects were men. There was a 27.1% decline in physical activity, and the median physical activity of patients significantly declined from 2.4 to 1.8 hours/day ( p =0.000010). Conclusion: Data obtained by remotely monitored CIED in heart failure patients suggests a significant decline in physical activity during the country lockdown due to the pandemic. Awareness of the future potential hazards in this group of patients is warranted.
This is the first randomized clinical study of an ICD system designed for full-body MRI at 1.5-T. These data support that the system is safe and the MRI scan does not adversely affect electrical performance or efficacy. (Confirmatory Clinical Trial of the Evera MRI System for Conditionally-Safe MRI Access; NCT02117414).
C ardiac magnetic resonance imaging (MRI) is generally accepted as a valuable diagnostic tool to detect and monitor a large variety of cardiac diseases; it has both excellent tissue characterization capabilities and high image quality in most cases. In a large population of >9900 patients cardiac image quality was shown to be diagnostic in 98.2%. 1 Even in the presence of a pacemaker system, the diagnostic quality of cardiac MRI (CMR) of the left (LV) and right (RV) ventricles is preserved. 2 Thus, the high reliability and robustness of CMR is known for patients implanted with a pacemaker system. It is estimated that >60% of patients implanted with an ICD will require an MRI within 10 years post implant, 3 and recently an MR-conditional ICD system was shown to be safe and effective when scanned at 1.5 Tesla (T). 4 In comparison with pacemakers, the larger size of the ICD pulse generator Background-Recently, magnetic resonance (MR)-conditional implantable cardioverter defibrillator (ICD) systems have become available. However, associated cardiac MR image (MRI) quality is unknown. The goal was to evaluate the image quality performance of various cardiac MR sequences in a multicenter trial of patients implanted with an MR-conditional ICD system. Methods and Results-The Evera-MRI trial enrolled 275 patients in 42 centers worldwide. There were 263 patients implanted with an Evera-MRI single-or dual-chamber ICD and randomized to controls (n=88) and MRI (n=175), 156 of whom underwent a protocol-required MRI (9-12 weeks post implant). Steady-state-free-precession (SSFP) and fast-gradient-echo (FGE) sequences were acquired in short-axis and horizontal long-axis orientations. Qualitative and quantitative assessment of image quality was performed by using a 7-point scale (grades 1-3: good quality, grades 6-7: nondiagnostic) and measuring ICD-and lead-related artifact size. Good to moderate image quality (grades 1-5) was obtained in 53% and 74% of SSFP and FGE acquisitions, respectively, covering the left ventricle, and in 69% and 84%, respectively, covering the right ventricle. Odds for better image quality were greater for right ventricle versus left ventricle (odds ratio, 1.8; 95% confidence interval, 1.5-2.2; P<0.0001) and greater for FGE versus SSFP (odds ratio, 3.5; 95% confidence interval, 2.5-4.8; P<0.0001). Compared with SSFP, ICD-related artifacts on FGE were smaller (141±65 versus 75±57 mm, respectively; P<0.0001). Lead artifacts were much smaller than ICD artifacts (P<0.0001). Conclusions-FGE yields good to moderate quality in 74% of left ventricle and 84% of right ventricle acquisitions and performs better than SSFP in patients with an MRI-conditional ICD system. In these patients, cardiac MRI can offer diagnostic information in most cases. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02117414.(Circ Cardiovasc Imaging. 2016;9:e004025.
MRI scans can be performed safely without positioning restrictions in patients with Medtronic CapSureFix Novus 5076 leads connected to an MR-conditional pacemaker.
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