Cardiac Implantable Electrical Devices Research Articles

Correction to "Infections of cardiac implantable electrical devices".

Correction to "Infections of cardiac implantable electrical devices".

Artificial intelligence to detect noise events in remote monitoring data

AbstractBackgroundRemote monitoring (RM) of cardiac implantable electrical devices (CIEDs) can detect various events early. However, the diagnostic ability of CIEDs has not been sufficient, especially for lead failure. The first notification of lead failure was almost noise events, which were detected as arrhythmia by the CIED. A human must analyze the intracardiac electrogram to accurately detect lead failure. However, the number of arrhythmic events is too large for human analysis. Artificial intelligence (AI) seems to be helpful in the early and accurate detection of lead failure before human analysis.ObjectiveTo test whether a neural network can be trained to precisely identify noise events in the intracardiac electrogram of RM data.MethodsWe analyzed 21 918 RM data consisting of 12 925 and 1884 Medtronic and Boston Scientific data, respectively. Among these, 153 and 52 Medtronic and Boston Scientific data, respectively, were diagnosed as noise events by human analysis. In Medtronic, 306 events, including 153 noise events and randomly selected 153 out of 12 692 nonnoise events, were analyzed in a five‐fold cross‐validation with a convolutional neural network. The Boston Scientific data were analyzed similarly.ResultsThe precision rate, recall rate, F1 score, accuracy rate, and the area under the curve were 85.8 ± 4.0%, 91.6 ± 6.7%, 88.4 ± 2.0%, 88.0 ± 2.0%, and 0.958 ± 0.021 in Medtronic and 88.4 ± 12.8%, 81.0 ± 9.3%, 84.1 ± 8.3%, 84.2 ± 8.3% and 0.928 ± 0.041 in Boston Scientific. Five‐fold cross‐validation with a weighted loss function could increase the recall rate.ConclusionsAI can accurately detect noise events. AI analysis may be helpful for detecting lead failure events early and accurately.

How we do it: Cardiac implantable devices are not a contraindication to MRI: time for a paradigm shift.

Magnetic resonance imaging (MRI) is now an indispensable diagnostic tool in medicine due to its outstanding contrast resolution and absence of radiation exposure, enabling detailed tissue characterization and three-dimensional anatomical representation. This is especially important when evaluating individuals with congenital heart disease (CHD) who frequently require cardiac implantable electrical devices (CIEDs). While MRI safety issues have previously limited its use in patients with CIEDs, new advances have called these limitations into question. However, difficulties persist in the pediatric population due to the continued lack of specific safety data both related to imaging young children and the specific CIED devices they often require. This paper discusses MRI safety considerations related to imaging patients with CIEDs, investigates pediatric-specific problems, and describes thorough methods for safe MRI access, highlighting the significance of specialized institutional guidelines.

Determinants of global cardiac implantable electrical device remote monitoring utilization – Results from an international survey

Determinants of global cardiac implantable electrical device remote monitoring utilization – Results from an international survey

The Use of Electrocardiogram Smartwatches in Patients with Cardiac Implantable Electrical Devices.

Unlimited access to ECGs using an over-the-counter smartwatch constitutes a real revolution for our discipline, and the application is rapidly expanding to include patients with cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs) and implantable cardioverter defibrillators (ICDs). CIEDs require periodic evaluation and adjustment by healthcare professionals. In addition, implanted patients often present with symptoms that may be related to their PMs or ICDs. An ECG smartwatch could reveal information about device functioning, confirm normal device function, or aid in the case of device troubleshooting. In this review, we delve into the available evidence surrounding smartwatches with ECG registration and their integration into the care of patients with implanted pacemakers and ICDs. We explore safety considerations and the benefits and limitations associated with these wearables, drawing on relevant studies and case series from our own experience. By analyzing the current landscape of this emerging technology, we aim to provide a comprehensive overview that facilitates informed decision-making for both healthcare professionals and patients.

The Contribution of Secondary Particles Following Carbon Ion Radiotherapy to Soft Errors in CIEDs.

Introduction: While carbon ion radiotherapy is highly effective in cancer treatment, it has a high risk of causing soft error, which leads to malfunctions in cardiac implantable electrical devices (CIEDs). To predict the risk of malfunction prior to treatment, it is necessary to measure the reaction cross-sections and contributions to the soft error of secondary particles generated during treatments. Methods: A field-programmable gate array was used instead of CIEDs to measure soft errors by varying the energy spectrum of secondary particles. Results and discussion: The reaction cross-sections measured for each secondary particle were 3.0 × 10-9, 2.0 × 10-9, 1.3 × 10-8, and 1.5 × 10-8 [cm2/Mb] for thermal neutrons, intermediate-energy neutrons, high-energy neutrons above 10 MeV, and protons, respectively. The contribution of high-energy neutrons was the largest among them. Our study indicates that to reduce the risk of soft errors, secure distance and appropriate irradiation directions are necessary.

Natural course and prognostic impact of lead-related tricuspid regurgitation

Abstract Aim Direct injury from Cardiac Implantable Electrical Device (CIED) leads is one of the most common causes of tricuspid regurgitation (TR), with a reported prevalence up to 40%. Little is known about the natural history of CIED-related TR and the prognostic impact of worsening TR detected at different time points after CIED implantation. Methods The CIED-IT registry retrospectively included patients who underwent CIED implantation in a tertiary referral center in Italy, as long as they had been performed repeated transthoracic echocardiograms (TTE) and at least one chest CT after the implantation. TR severity was graded using a pre-specified 4-class grading scheme: mild, moderate, severe and massive. The primary endpoint for outcome analysis was major adverse clinical events (MACE), defined as the composite of all-cause death or heart failure (HF) hospitalizations. Results 249 patients undergoing CIED implantation from January 2015 to December 2021 were included. Median time to last available TTE was 1593 days (IQR 857-2089). TR prevalence was 71.8% (178/248) at baseline and 88.7% (220/248, p<0.001) at last available TTE. Worsening TR was observed in 48.4% (120/248) of cases. Mean age was 74.5±10.1 years, 35% of patients were females, 45.6% had atrial fibrillation and 41.9% had a LVEF <40%. Baseline RV dysfunction was present in 23.8% of patients, while a worsening RV function was observed in 24.2% of patients with worsening TR and 10.1% of those without worsening TR (p=0.003). Median follow-up time was 4.2 years (IQR: 2.4-5.6). At Kaplan Maier analysis, the cumulative 5-year MACE incidence was 39.4% (95% CI: 30.4-50%) in patients with worsening TR and 18.9% (95% CI: 12.5-28.1%) in those with no worsening TR (Log-Rank p = 0.01). This difference was mainly driven by a higher rate of heart failure hospitalizations in the worsening TR group (36.5% vs, 10 at 5y, Log-Rank p<0.001), while the rate of all-cause death was comparable between the two groups (Log-Rank p=0.313). At multivariable stepwise Cox regression analysis, worsening TR was an independent predictor of both MACE (HR 1.89, 95% CI: 1.15-3.11, p=0.012) and HF hospitalizations (HR 2.77, 95% CI: 1.49-5.16, p=0.001). In a subgroup analysis including patients who also received a 1-year TTE (median time 182 days, IQR: 74-286), worsening TR at last available TTE was still an independent MACE predictor (HR 1.75, 95% CI: 1.0-3.1, p=0.05), while worsening TR at 1y was not (HR 1.66, 95% CI: 0.9-3.06). Conclusions CIED-related TR is a strong determinant of long-term adverse cardiovascular outcomes in patients undergoing CIED implantation. Lead-induced injury is sometimes not evident in the first months after the procedure and might require years to develop clinically significant TR. Serial echocardiographic assessments are therefore pivotal to implement risk stratification, while further knowledge of the pathophysiology of CIED-related TR is required to prevent its occurrence.Kaplan Maier Curves for MACEKaplan Maier curves for HHF

Long-term outcomes from upgrade to cardiac resynchronisation therapy in ischaemic versus non-ischaemic heart disease

Background Cardiac resynchronisation therapy (CRT) can be necessary in patients with chronic heart failure, who have already been provided with transvenous cardiac implantable electrical devices. Upgrade procedures revealed controversial results, while long-term outcomes regarding underlying Ischaemic- (ICM) or Non-Ischaemic heart disease (NICM) have yet to be described. Methods The Mannheim Cardiac Resynchronisation Therapy Registry (MARACANA) was designed as a retrospective observational single-centre registry, including all CRT implantations from 2013-2021 (n = 459). CRT upgrades (n = 136) were retrospectively grouped to either ICM (n = 84) or NICM (n = 52) and compared for New York Heart Association classification (NYHA), paced QRS-width, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE) and other heart failure modification aspects in the long-term (59.3 ± 5 months). Results Baseline-characteristics including paced QRS-width, upgrade indications or NYHA-classification were comparable for both groups (group comparison p>.05). The CRT upgrade improved NYHA (ICM: 2.98 ± 0.4 to 2.29 ± 0.7, NICM: 2.94 ± 0.5 to 2.08 ± 0.5) and the LVEF (ICM: 27.2 ± 6.6 to 38.25 ± 8.8, NICM: 30.2 ± 9.4 to 38.7 ± 13.8%) after five years, irrespective of underlying heart disease (each group p < .05, group comparison p>.05). Only ICM revealed significant improvements in TAPSE (15.9 ± 4.1 to 18.9 ± 4.1 mm) and narrowing of the paced QRS-width (185.4 ± 29 to 147.2 ± 16.3 ms) after five years (each p < .05). Conclusions Upgrade to CRT might improve heart failure symptoms and left-ventricular systolic function in the long-term, irrespective of underlying ischaemic or non-ischaemic heart disease.

Frame-rate reduction to reduce radiation dose for cardiac device implantation is safe.

Radiation exposure to patient and surgeon during cardiac implantable electrical device (CIED) procedures remains a substantial health hazard to date. Advanced technical options for radiation dose reduction often pose considerable financial hurdles. We propose a near-zero cost, low-effort modification to a clinical x-ray system significantly reducing radiation dose during CIED implantation. We aim to evaluate a reduced frame rate protocol in CIED implantation for complication rates and reduction in radiation exposure. Starting May 2019, the frame rate during CIED implantations at our hospital was halved from 7.5 frames/s to 3.8 frames/s, and no further technical changes were made. During the following year, 264 patients were operated using this protocol and retrospectively compared with 231 cases implanted in the year before the protocol change, totaling 495 cases. Of these, 17%, 63%, and 19% were single-chamber, dual-chamber, or resynchronization devices, respectively. Incidence of complication prior to hospital discharge was considered the primary endpoint of the analysis. Radiation dose and procedural parameters were secondary endpoints. There was no increase in complications with the reduced frame rate protocol. Regression analysis further supported that the reduced frame rate radiation protocol was not associated with complication rates. Radiation exposure measured as dose area product was significantly reduced by ∼62% (median 369 [interquartile range 154-1207] cGy·cm2 via the reduced frame rate protocol vs median 970 [interquartile range 400-1906] cGy·cm2 with the standard frame rate; P < 0.01). A reduction of frame rate during CIED implantation is safe in terms of complication incidence and effective in terms of reducing radiation exposure.

Predictors of Residual Severe Tricuspid Regurgitation After Transcatheter Mitral Valve Repair

BackgroundSevere tricuspid regurgitation (TR) may persist after a mitral transcatheter edge-to-edge repair (M-TEER) and is associated with worsened clinical outcomes and survival. It is unclear which patients with concomitant mitral regurgitation (MR) and TR will have TR reduction after M-TEER. The aim of this study was to identify the predictors of residual TR after transcatheter edge-to-edge repair (TEER).MethodsData were collected from the Northwell TEER registry, a prospectively maintained mandatory database including 4 high-volume transcatheter aortic valve replacement/TEER centers. Transthoracic echocardiograms, both pre-TEER and post-TEER, were evaluated. Univariate and multivariate logistic regression analyses were performed to identify predictors of severe TR after M-TEER. Significant TR reduction was defined as a reduction in TR grade by at least 1+ with moderate (2+) or less TR at 1 month.ResultsOf the 479 patients who underwent M-TEER, 107 patients with concomitant severe MR/TR were included. Successful MR reduction occurred in 89 patients (84%) and a significant TR reduction in 45 (42%). On the univariate analysis, the only predictors of severe residual TR were right atrial area and unsuccessful M-TEER. On the multivariate logistic regression model, the only predictor variable for patients with a reduction in TR was MR reduction of ≥3+ with M-TEER.ConclusionsIn patients with concomitant severe MR and TR, TR reduction after isolated M-TEER occurs in only ∼40% of patients. MR grade reduction ≥3+ was the only independent predictor for TR reduction. Other clinical and echocardiographic variables (including pulmonary hypertension, right ventricular function, tricuspid annular dilation, atrial fibrillation, and presence of a cardiac implantable electrical device) were not associated with residual TR. Inability to predict TR reduction after M-TEER highlights the importance of establishing transcatheter tricuspid valve therapies and should factor in heart-team discussions.

Impact of raising the upper extremity siding cardiac implantable electrical devices on postoperative safety.

The upper extremity siding cardiac implantable electrical device tends to have a limited range of motion during the perioperative period; however, the underlying reason lacks scientific evidence. This study aimed to investigate the safety of the two methods (stepwise or early) of postoperative early upper extremity rehabilitation. We retrospectively investigated 650 consecutive patients with a new implantable pacemaker (PM), implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT), or generator exchange between March 2017 and December 2020.The limitation program was conducted from March 2017 to March 2018. The intervention program started as a stepwise protocol in April 2018 and was switched to an early protocol in December 2019. This study analyzed 591 patients, excluding 59 who met the exclusion criteria. The mean age was 76.0 (69.0-82.0) years; 412 (69.7%) patients had a PM, 79 (13.4%) had an ICD, and 100 (16.9%) utilized CRT. There were 155 patients in the limitation protocol, 251 in the stepwise protocol, and 185 patients in the early protocol groups. Postoperative complications occurred in 53 (9.0%) patients. There was no significant difference in the incidence of all complications between the three groups (16 patients [10.3%] vs. 26 patients [10.4%] vs. 11 patients [5.9%]). Shoulder exercise-related complications were defined as hematoma (p = .94), lead dislodgement (p = .16), and increased pacing threshold (p = .23). General complications included wound infection (p = .51), pneumothorax (p = .27), tamponade (p = .07), and deep venous thrombosis (p = .26). Raising of the upper extremity siding cardiac implantable electrical devices above the head did not compromise postoperative safety.

Remote support during cardiac implantable electrical device follow-up: preliminary experience in clinical practice

Abstract Funding Acknowledgements Type of funding sources: None. Background Industry employed allied professionals (IEAPs) traditionally provide technical assistance to physicians during cardiac implantable electrical device (CIED) implantation, programming, troubleshooting, and follow-up, by operating the programmers under the supervision of the physician. The Heart Connect™ application is a data-sharing system intended to provide physicians with the means to establish an online meeting and share the display of the LATITUDE™ Programmer (Boston Scientific) with IEAPs in a remote location. Purpose We describe the preliminary experience of remote IEAP support during CIED follow-up in clinical practice. Methods The Heart Connect™ software was downloaded on the programmer and network connection was established and tested using both Wi-Fi and a 4G cellular adapter at 3 Italian medical centers. External headset and webcam have been connected to the programmer. After system setup, the staff was trained on how to use the application, and online meetings were established with IEAPs of the Remote Clinical Support team during consecutive CIED follow-up visits. Data and users’ feedback were collected on the training provided, the quality of the remote connection, the support at each meeting. Results All the professionals trained in the use of the system judged the information received to be clear and adequate, and felt confident in using the system. Online meetings were established during 34 follow-up visits (12 pacemakers and CRT-P, 13 single- or dual-chamber ICD, 9 CRT-D). The remote connection was successfully established in all cases. In all cases the communication remained stable for the entire duration of the visit, except for 2 cases (connected via 4G) in which a loss of connection occurred (not restored in 1 case). The sound and video quality during two-way communication were rated good or excellent in 31 (91%) cases. The mean duration of the online meeting was 7±3 minutes. Routine CIED checks were performed during the visits: battery status, pacing and sensing thresholds, impedances, current rhythm diagnosis, arrhythmias detected and therapies delivered, device counters and review of programmed parameters, alerts and clinical diagnostics. Programming changes were done during 7 (21%) visits: pacing and sensing parameters, tachycardia detection and therapies. The remote support allowed to successfully complete the visit in 33 (97%) cases, without requiring additional medical or technical support. In all these cases, the support was judged to be equally effective compared to the on-site support, without causing delays or organizational difficulties. Conclusions Remote support during CIED follow-up using Heart Connect™ seems feasible, effective and well accepted. Additional tests are ongoing to demonstrate the potential usefulness of this solution in standard clinical practice, and in the context of restrictions on access to healthcare facilities due to COVID-19 pandemic.

Superior vena cava isolation with pulsed field ablation in the presence of defibrillator leads.

Two patients with a history of dilated cardiomyopathy, dual chamber defibrillator implantation, and worsening heart failure because of persistent atrial fibrillation (AF) underwent catheter ablation of AF. Pulsed field ablation (PFA) was selected for the index procedure in these decompensated heart failure patients with enlarged atria.1 The 12-Fr over-the-wire pentaspline PFA catheter (Farawave) was advanced through a 13-Fr steerable sheath (Faradrive) to the ostium of each PV, and a total of eight PFA lesions were applied per vein. Phrenic nerve function was evaluated by direct phrenic capture and by observing diaphragmatic motion during inspiration. For posterior wall ablation, the catheter was placed into a flower configuration and positioned along the posterior left atrium to deliver overlapping sets of pulses at each location. As per institution protocol, superior vena cava (SVC), as a potential nonpulmonary trigger for AF, is isolated when active despite a risk of sinus node injury.2 Basket configuration (Figure 1) and two sets of two lesions at the trunk of the vessel (with rotation between each pair) were used for SVC isolation in the presence of atrial and defibrillator leads, without any impact on device and leads measurements or sinus node function (Figure 2). We observed incidence of phrenic capture during PFA, and no evidence of phrenic injury was detected after the procedure. Both patients were in AF and cardioverted into sinus rhythm post-SVC isolation. They remained at sinus rhythm at regular 3-month follow-up while device interrogation revealed intact sinus node function. Only 4.2% of operators in the MANIFEST-PF multinational survey (including 1758 consecutive unselected AF patients) performed SVC isolation by mean of PFA occasionally.3 This is the first report of off-label pulsed field ablation-mediated SVC isolation without device or lead malfunction. Human studies evaluating cardiac implantable electrical devices during ablation procedure remain limited. A recent study by a high-volume center indicated that PFA is a safe and feasible method in patients with devices in the terms of alterations in pacing, sensing, or impedance parameters, inappropriate anti-tachycardia pacing, and ICD shock and leads dislodgment.4 Indeed, our pilot procedures with PFA applications in the SVC of AF patients with implanted devices confirmed the previous results without apparent additional risk because of energy application adjacent to the electrodes. None declared. None. The authors declare no conflict of interests for this article. Approval of the research protocol: N/A. Informed Consent: Ν/Α. Registry and the Registration No. of the study/trial: N/A. Animal Studies: N/A. Data are available in the article.

A Universal Programmer for Cardiac Implantable Electrical Devices—Clinical, Technical, and Ethical Considerations

This Viewpoint explores the clinical, technical, and ethical considerations arguing in favor of a universal platform for cardiac implantable electrical device communication.

303 IMPACT OF LEAD POSITION IN THE TRICUSPID ANULUS ON THE DEVELOPMENT OF CARDIAC IMPLANTABLE ELECTRONIC DEVICES RELATED TRICUSPID REGURGITATION

Abstract Introduction Originally considered as the “forgotten valve disease”, tricuspid regurgitation (TR) has recently been shown to correlate with consistent morbidity and mortality, suggesting the need for a deeper understanding of its natural course. Direct injury from Cardiac Implantable Electrical Device (CIED) leads is one of the most common causes of primary TR, with a prevalence up to 40%. The aim of the present proof-of-concept study was to evaluate the effect of CIED right ventricular (RV) lead position within the tricuspid anulus on TR development. Methods Consecutive patients undergoing CIED implantation at our institution (Humanitas Research Horpital IRCCS, Milan, Italy) were included, as long as they had been performed pre- and post- transthoracic echocardiogram (TTE) and a chest CT scan after the implantation. TTE and CT images were retrospectively reviewed. TR severity was graded using a pre-specified 4-class grading scheme: mild, moderate, severe and massive. CIED RV lead position was defined as postero-septal, antero-septal or antero-posterior, based on the commissure in which the lead was observed on a cross-sectional view of the tricuspid anulus at CT scan. Results 64 patients undergoing CIED implantation from January 2015 to December 2021 were included. All CT scans were non-ECG gated. TR was detected in 42 patients (65.62%) at pre-implantation TTE. The RV lead was implanted across the postero-septal, antero-posterior and antero-septal commissures in 35 (54.7%), 16 (25%) and 13 (20.3%) patients respectively. After the implantation, 12 individuals (18.75%) had new-onset or worsening TR, with CIED lead contributing to TR in 46.88% of cases (30/64), and 26 (40.63%) had worse RV function. At logistic regression analysis, the absence of atrial fibrillation was the only independent predictor of new-onset or worsening TR (OR: 0.17, 95% CI: 0.03-0.86, p=0.032), while CIED RV lead in the postero-septal commissure was associated with a numerically lower risk as compared to other sites (OR: 0.34, 95% CI: 0.09-1.27, p=0.108). Consistently, the degree of increase in TR severity was numerically lower in patients with a lead in the postero-septal commissure (Δ = 0.38±0.10 vs. 0.63±0.13, p=0.07). Conclusions CIED implantation is associated with increasing TR severity and worsening RV function. Positioning a lead across the postero-septal commissure of the tricuspid anulus might have a lower impact on TR development and worsening, thus representing a feasible option to prevent CIED-related TR.

External cardioversion of atrial fibrillation and flutter in patients with cardiac implantable electrical devices.

Atrial fibrillation and flutter are often treated with external electrical cardioversion (ECV) in patients with potentially electrically sensitive cardiovascular implantable electronic devices (CIED). Long-term follow-up data on contemporary CIED undergoing ECV is sparse. The aim is to investigate shock-related complications and impact on CIEDs. All ECV procedures from 2010 to 2020 in patients with CIED performed at a tertiary university hospital were identified in the Danish National Patient Registry. Changes in device measurements after ECV were retrospectively studied and procedure-related complications were identified by review of medical records. We analyzed 763 ECV procedures in 372 patients, median device implant time 1.9years. The mean age of patients was 69.9±9.9years of which 73.4% were men. We identified two cases of device programming changes and four cases of premature battery depletion (≤3years after device implant). Minor changes in device measurements were found for impedances, sensing, and pacing thresholds. No patients died due to ECV-related device dysfunctions within the first 12 months after cardioversions. External cardioversion in patients with contemporary pacemakers and implantable cardioverter-defibrillators seems safe in the majority of patients. Clinically important changes in device function following cardioversion were rarely observed but may be critical for device function. In an observational study, causality between cardioversion and device dysfunction cannot be established. For patient safety, we suggest that routine device interrogation after cardioversion still should be part of standard care.

The impacts of preoperative frailty on readmission after cardiac implantable electrical device implantation.

Cardiac implantable electrical devices (CIED) such as pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapies are generally recommended for older patients and those with severe heart failure (HF). However, there is currently a lack of evidence on the relationship between frailty and readmission rates among patients with CIED. This study investigated whether preoperative frailty influenced readmission rates among patients with CIED over a one-year period following implantation. The study retrospectively analyzed 101 patients who underwent CIED implantations. To compare frailty-based differences in their characteristics and readmission rates, these participants were categorized into frailty and non-frailty groups via the modified frailty index (mFI). The frailty group had a significantly higher readmission rate than the non-frailty group (non-frailty group vs. frailty group = 1 vs. 8 patients: P < 0.05). Further, a multivariate analysis showed that frailty was a significant readmission factor. Based on individual analyses with/without histories of HF, the readmission rate also tended to be higher among individuals considered frail via the mFI (readmission rate in HF patients: non-frailty group vs. frailty group = 1 vs. 5 patients: P = 0.65; non-HF patients: non-frailty group vs. frailty group = 0 vs. 3 patients: P = 0.01). Participants with preoperative frailty showed higher readmission rates within a one-year period following implantation compared to those without preoperative frailty. This tendency was consistent regardless of HF history. The mFI may thus help predict readmission among patients with CIED.

Clinical utility of remote monitoring for patients with cardiac implantable electrical devices.

Remote monitoring of cardiac implantable electronic devices (CIEDs) offers practical and clinical benefits juxtaposed against burdens associated with high transmission volume. We identified patients receiving de novo pacemakers (PPMs) and implantable cardiac defibrillators (ICDs) at a single academic medical center (January 2016-December 2019) with at least 1year of follow-up device care. We collected patient- and device-specific data at time of implant and assessed all remote and in-person interrogation reports for clinically actionable findings based on pre-specified criteria. Among 963 patients (mean age of 71 (± 14) years, 37% female), 655 (68%) underwent PPM, and 308 (32%) underwent ICD implant. Median follow-up was 874 (627-1221) days, during which time patients underwent a mean of 13 (10-16) total interrogations; remote interrogations comprised 53% of all device evaluations; and of these, 96% were scheduled transmissions. Overall, 22% of all CIED interrogations yielded significant findings with a slightly higher rate in the PPM than in the ICD group (23% vs. 20%, p < 0.01). Only 8% of remote interrogations produced clinically meaningful results, compared with 38% of in-person ones. In adjusted models, routine, remote transmissions were least likely to be useful for both PPM and ICD patients (p < 0.001), whereas time from initial device implant was inversely associated with probability of obtaining a useful interrogation (p < 0.001). Routine remote interrogations constitute the majority of device evaluations performed, but uncommonly identify clinically actionable findings.

FDG PET/CT in Cardiac Infection: Does It Matter? A Narrative Review.

The limited performance of echocardiography in specific infectious processes involving the heart led to the search for additional diagnostic tools. Fluorodeoxyglucose positron emission tomography computed tomography (FDG PET/CT) has been proposed for its diagnostic abilities in several infectious diseases including cardiac infections. A literature review of studies evaluating FDG PET/CT in native valve infective endocarditis (IE), prosthetic valve IE, cardiac implantable electrical device (CIED) infection, and left ventricular assist device (LVAD) infection is presented, focusing on studies published in recent years. Overall, in prosthetic valve endocarditis (PVE), FDG PET/CT demonstrate high sensitivity (73-93%) and specificity (80-95%), while in native valve endocarditis (NVE) the sensitivity is very low (22-68%), with high specificity (97-100%) similar to PVE. For CIED, LVAD infection, and transcatheter aortic valve implantation associated endocarditis, data come from small studies and show good diagnostic performance of FDG PET/CT. International guidelines are increasingly recommending FDG PET/CT for the diagnosis of specific conditions of cardiac infections. Beyond the diagnostic performance ability, few studies have evaluated the added benefit of FDG PET/CT in terms of clinical outcomes of patients with suspected cardiac infection. This should be the focus in future studies.

Current status of reimbursement practices for remote monitoring of cardiac implantable electrical devices across Europe.

Remote monitoring (RM) of cardiac implantable electrical devices (CIEDs) is currently proposed as a standard of care for CIEDs follow-up, as recommended by major cardiology societies worldwide. By detecting a series of relevant device and patient-related parameters, RM is a valuable option for early detection of CIEDs' technical issues, as well as changes in parameters related to cardio-respiratory functions. Moreover, RM may allow longer spacing between in-office follow-ups and better organization of in-hospital resources. Despite these potential advantages, resulting in improved patient safety, we are still far from a widespread diffusion of RM across Europe. Reimbursement policies across Europe still show an important heterogeneity and have been considered as an important barrier to full implementation of RM as a standard for the follow-up of all the patients with pacemakers, defibrillators, devices for cardiac resynchronization, or implantable loop recorders. Indeed, in many countries, there are still inertia and unresponsiveness to the request for widespread implementation of RM for CIEDs, although an improvement was found in some countries as compared to years ago, related to the provision of some form of reimbursement. As a matter of fact, the COVID-19 pandemic has promoted an increased use of digital health for connecting physicians to patients, even if digital literacy may be a limit for the widespread implementation of telemedicine. CIEDs have the advantage of making possible RM with an already defined organization and reliable systems for data transmissions that can be easily implemented as a standard of care for present and future cardiology practice.