Cardiac Implantable Electrical Devices Research Articles

Cardiac arrhythmias during and after thoracic irradiation for malignancies.

Cardiac arrhythmia has been reported as a significant complication of thoracic radiotherapy. Both bradyarrhythmias and tachyarrhythmias have been reported, highlighting the arrhythmia-modulating potential of radiation in certain oncologic therapies. This study aimed to analyse the arrhythmic burden in patients with cardiac implantable electrical devices (CIEDs) undergoing thoracic irradiation, examining both immediate effects of radiotherapy and long-term sequelae post-therapy. A retrospective cohort study was conducted involving patients with CIEDs who received thoracic radiotherapy between January 2012 and December 2022. Two distinct analyses were performed involving (1) daily CIED follow-ups during radiotherapy and (2) long-term arrhythmic outcomes post-therapy. For long-term outcomes, Patients were matched in a 1:2 ratio with non-irradiated controls based on age, sex, cardiovascular risk factors, cardiac disease, and beta-blocker use. Statistical analyses included negative binomial regression and propensity score matching. A total of 186 patients underwent daily CIED monitoring during radiotherapy, with 79 receiving thoracic irradiation. Thoracic irradiation was negatively associated with atrial arrhythmia (OR 0.11 [0.02;0.70, 95% CI], adjusted p = 0.0498) and there was a tendency towards less ventricular events (OR 0.14 [0.02;1.41, 95% CI], adjusted p = 0.3572) during radiotherapy in a univariate regression analysis. This association was not significant in the multivariate (OR 0.44 [0.10;1.80, 95%-CI], p = 0.16) model including a history of atrial fibrillation, diabetes and beta-blocker use. Coronary artery disease was associated with an increase in atrial and ventricular arrhythmia. For the long-term analysis, 122 patients were followed up after thoracic (N = 33) and non-thoracic radiation (N = 89) and compared to 244 matched controls drawn from approximately 10.000 CIED-patients. There was no significant increase in arrhythmic events compared to controls over a median follow-up of 6.6months. A previous history of ventricular or atrial arrhythmic events was the strongest predictor for events during the follow-up. Thoracic radiotherapy can be safely administered in patients with CIEDs. However, patients with a history of arrhythmia are more prone to arrhythmic events during and after radiation. These findings highlight the need for personalized arrhythmia management strategies and further research to understand the mechanisms underlying the antiarrhythmic effects of thoracic radiation.

Abstract 4136884: Incidence and Characteristics of Peri-Procedural Complications of Cardiac Implantable Electrical Devices in Breast Cancer Survivors

Introduction: Breast cancer (BC) is the most common non-cutaneous cancer in women. Several BC treatments increase the risk of conduction abnormalities and heart failure, potentially requiring cardiac implantable electrical devices (CIEDs). Due to vascular access devices, surgical management, and chest wall radiation, these patients are subject to upper extremity vascular alterations. There is limited data regarding CIED use in this population. Research question: Do patients with BC and CIEDs have different procedural approaches or complications compared to the general population? Aims: This study aimed to evaluate CIED placement and periprocedural complications in patients with a history of BC. Methods: This was a retrospective study of CIEDs placed at our institution between 2005 and 2023. Patients with a diagnosis of BC prior to time of placement were included. Complications included those within 30 days of the procedure. Results: We analyzed 109 female patients (median age of 73 years, IQR 66-80) who received pacemaker (PPM, 58.7%), cardiac resynchronization therapy defibrillator (CRT-D, 22%), implantable cardioverter defibrillator (ICD, 16.5%), or cardiac resynchronization therapy pacemaker (CRT-P, 2.8%). The median time from cancer diagnosis to device placement was 13 years (IQR 7-21). Oncologic therapies are included in Figure 1. In patients with unilateral cancer, most devices (78.4%) were placed contralaterally, with 32% of all devices being right sided. Anatomy related to chemotherapy port altered intraoperative approach in 2 cases and bilateral lymph node dissection necessitated subcutaneous ICD in 1 case. Complications were noted in 12 patients (11%) and included hematoma, lead revision, upper extremity DVT, pericardial effusion, stress cardiomyopathy, perforation, site infection, and worsening of chronic lymphedema. Conclusions: BC survivors undergoing CIED placement appear to be at higher risk of periprocedural complications when compared to the general population. They are more likely to undergo right sided device placement to avoid vascular access ipsilateral to prior surgery or radiation. Further studies are required to understand the long-term outcomes of CIED placement in this cohort of patients.

Device-therapy in chronic heart failure: Cardiac contractility modulation versus cardiac resynchronization therapy.

Cardiac implantable electrical devices such as cardiac resynchronization therapy with defibrillator (CRT-Ds) or cardiac contractility modulation (CCMs) are therapy options for patients with symptomatic heart failure (HF) and reduced left ventricular ejection fraction (LVEF) despite optimal medical treatment. As yet, a comparison between both devices has not been performed. The Mannheim Cardiac Resynchronization Therapy Registry (MARACANA) and the Mannheim Cardiac Contractility Modulation Observational Study (MAINTAINED) included all patients who received CRTs or CCMs in our medical centre between 2012 and 2021. For the present analysis, we retrospectively compared patients provided with either CRT-Ds (n=220) or CCMs with additional defibrillators (n=105) regarding New York Heart Association classification (NYHA), LVEF, tricuspid annular plane systolic excursion (TAPSE), QRS-width and other HF modification aspects after 12months. Before implantation, CCM patients presented with lower LVEF (23.6±6.2 vs. 26.3±6.5%) and worse NYHA (3.03±0.47 vs. 2.81±0.48, both P<0.05), compared with CRT-D patients. Follow-up improvements in NYHA (2.43±0.67 vs. 2.28±0.72), LVEF (30.5±10.7 vs. 35.2±10.5%) and TAPSE (17.2±5.2 vs. 17.1±4.8 to 18.9±3.4 vs. 17.3±3.6mm, each P<0.05) were comparable. The intrinsic QRS-width was stable with CCM (109.1±18 vs. 111.7±19.7ms, P>0.05), while the paced QRS-width with CRT-D after 12months was lower than intrinsic values at baseline (157.5±16.5 vs. 139.2±16ms, P<0.05). HF hospitalizations occurred more often for CCM than CRT-D patients (45.7 vs. 16.8%/patient years, odds ratio 4.2, P<0.001). Chronic heart failure patients could experience comparable 12-month improvements in functional status and ventricular reverse remodelling, with appropriately implanted CCMs and CRT-Ds. Differences in HF hospitalization rates may be due to the more advanced HF of CCM patients at implantation.

Innovations in Imaging: 18F-Fluorodeoxyglucose PET/CT for Assessment of Cardiovascular Infection and Inflammation.

18F-Fluorodeoxyglucose positron emission tomography (PET) combined with computed tomography (CT), referred to as 18F-FDG PET/CT, plays a significant role in the diagnosis and management of patients with systemic infectious and inflammatory conditions. This review provides an overview of 18F-FDG PET/CT in systemic infectious and inflammatory conditions, including infective endocarditis (IE), cardiac implantable electrical device (CIED)/left ventricular assist device (LVAD) infection, sarcoidosis, and large-vessel vasculitis (LVV). This review highlights the past and present literature in the increasing role of 18F-FDG PET/CT in cardiovascular inflammation and infection, including diagnostic and prognostic findings. They key aspects of this paper are to highlight the importance of 18F-FDG PET/CT in cardiovascular infection and inflammation, and to provide illustrations of how it can contribute to patient diagnosis and management.

Long-Term Renal Function with Cardiac Contractility Modulation Therapy

Introduction: Cardiac implantable electrical devices are able to affect kidney function through hemodynamic improvements. The cardiac contractility modulation (CCM) is a device-based therapy option for patients with symptomatic chronic heart failure (HF) despite optimized medical treatment. The long-term cardiorenal interactions for CCM treated patients are yet to be described. Methods: CCM recipients (n = 187) from the Mannheim Cardiac Contractility Modulation Observational Study (MAINTAINED) were evaluated in the long-term (up to 60 months) for changes in serum creatinine, estimated glomerular filtration rate (eGFR), other surrogate markers of kidney function, and the chronic kidney disease (CKD) stage distribution. With regard to kidney function at baseline, the patients were furthermore grouped to either advanced CKD (aCKD, CKD stage ≥3, eGFR≤59 mL/min/1.73 m2, n = 107) or preserved kidney function and mild CKD (pCKD, CKD stages 1–2, eGFR≥60 mL/min/1.73 m2, n = 80). The groups were compared for differences regarding kidney function, New York Heart Association classification (NYHA), biventricular systolic function, HF hospitalizations and other parameters in the long-term (60 months). Results: CKD stage distribution remained stable during the entire follow-up (p = 0.65). An increase in serum creatinine (1.47 ± 1 vs. 1.6±1 mg/dL) with a corresponding decline of eGFR (58.2 ± 23.4 vs. 54.2 ± 24.4 mL/min/1.73 m2, both p < 0.05) were seen after 60 months but not before for the total cohort, which was only significant in pCKD patients in terms of group comparison. Mean survival (54.3 ± 1.3 vs. 55.3 ± 1.2 months, p = 0.53) was comparable in both groups. Improvements in NYHA (3.11 ± 0.46 vs. 2.94 ± 0.41–2.28 ± 0.8 vs. 1.94 ± 0.6) and LVEF (24.8 ± 7.1 vs. 22.9 ± 6.6–31.1 ± 11.4 vs. 35.5 ± 11.1%) were likewise similar after 60 months (both p < 0.05). The aCKD patients suffered from more HF hospitalizations and ventricular tachycardias during the entire follow-up period (both p < 0.05). Conclusions: The kidney function parameters and CKD stage distribution might remain stable in CCM treated HF patients in the long-term, who experience improvements in LVEF and functional status, regardless of their kidney function before. An impaired kidney function might be associated with further cardiovascular comorbidities and more advanced HF before CCM, and could be an additional risk factor of HF complications afterward.

Concerns on digital health from a cardiac implantable electrical device remote monitoring clinic perspective: results from an international survey

Concerns on digital health from a cardiac implantable electrical device remote monitoring clinic perspective: results from an international survey

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.

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

Despite near-global availability of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED), there is a high geographical variability in the uptake and use of RM. The underlying reasons for this geographic disparity remain largely unknown. To study the determinants of worldwide RM utilization and identify locoregional barriers of RM uptake. An international survey was administered to all CIED clinic personnel using the Heart Rhythm Society global network collecting demographic information, as well as information on the use of RM, the organization of the CIED clinic, and details on local reimbursement and clinic funding. The most complete response from each center was included in the current analysis. Stepwise forward multivariate linear regression was performed to identify determinants of the percentage of patients with a CIED on RM. A total of 302 responses from 47 different countries were included, 61.3% by physicians and 62.3% from hospital-based CIED clinics. The median percentage of CIED patients on RM was 80% (interquartile range, 40-90). Predictors of RM use were gross national income per capita (0.76% per US$1000, 95% CI 0.72-1.00, P < .001), office-based clinics (7.48%, 95% CI 1.53-13.44, P=.014), and presence of clinic funding (per-patient payment model 7.90% [95% CI 0.63-15.17, P = .033); global budget 3.56% (95% CI -6.14 to 13.25, P = .471]). The high variability in RM utilization can partly be explained by economic and structural barriers that may warrant specific efforts by all stakeholders to increase RM utilization.

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.

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&amp;lt;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 &amp;lt;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&amp;lt;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.

Severe 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). Data 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. Of 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. In 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.