Switching to a 100% remote follow-up of implantable cardiac electronic devices: Organizational model and results of a single center experience.

INTRODUCTION: During the SARS-CoV-2 COVID-19 pandemic, the global health system needed to review important processes involved in daily routines such as outpatient activities within the hospital, including follow-up visits of implantable cardiac electronic devices (CIEDs) carried out in office. The aim of this study is to describe our 3.5 years of real-world experience of a full remote CIED follow-up, evaluate the success rate of remote transmissions, and verify the adopted organizational model. METHODS: From April 2020 to November 2023, all patients with an activated and well-functioning remote monitoring (RM) system and automatic algorithms, like autocapture and autosensing, underwent exclusive RM follow-up. Unscheduled in-office visits were only prompted by remote yellow or red alerts. Patients were divided into two groups, based on available technology: Manual Transmission System (MTS) and Automatic Transmission System (ATS). The ATS group, in addition to ensuring a daily transmission of any yellow or red alerts, was checked at least every 15 days to ensure a valid connection. An automatic transmission was scheduled once a year, irrespective of alerts occurred. The MTS group provided a manual transmission every 6 months. RESULTS: One thousand nine hundred thirty-seven consecutive patients were included in the study. By the end of November 2023, a total of 1409 patients (1192 in the ATS and 217 in the MTS group) were still actively followed by our remote clinic (384 expired, 137 dismissed, 7 transferred). The overall success rate of transmissions with the adopted organizational model was 96.6% in the ATS group (connection index) and 87% in the MTS group. Conventional in-hospital follow-up visits decreased by 44%. Total clinic working time, resulting from the sum of the time spent during in-hospital and remote follow-up, after an initial increase, was progressively reduced to the actual -25%. Mortality rate for any cause was 7.5% per year in remote follow-up patients and 8.3% (p=NS) in in-office patients. In the ATS group, no device malfunctions were notified to our remote clinic, before we had already realized it through appropriate alerts. CONCLUSIONS: The available technology makes moving to a 100% remote clinic possible, without overwhelming clinic workflow, safely. Adopting an appropriate organizational model, it is possible to maintain high transmission success rates. The automatic transmissions allow a more frequent control of patients with CIED.

Device-detected atrial sensing amplitudes as a marker of increased risk for new onset and progression of atrial high-rate episodes.

BACKGROUND: Atrial high-rate episodes (AHREs) are frequent in patients with cardiac implantable electronic devices. A decrease in device-detected P-wave amplitude may be an indicator of periods of increased risk of AHRE. OBJECTIVE: The objective of this study was to assess the association between P-wave amplitude and AHRE incidence. METHODS: Remote monitoring data from 2579 patients with no history of atrial fibrillation (23% pacemakers and 77% implantable cardioverter-defibrillators, of which 40% provided cardiac resynchronization therapy) were used to calculate the mean P-wave amplitude during 1 month after implantation. The association with AHRE incidence according to 4 strata of daily burden duration (≥15 minutes, ≥6 hours, ≥24 hours, ≥7 days) was investigated by adjusting the hazard ratio with the CHA2DS2-VASc score. RESULTS: The adjusted hazard ratio for 1-mV lower mean P-wave amplitude during the first month increased from 1.10 (95% confidence interval [CI], 1.05-1.15; P < .001) to 1.18 (CI, 1.09-1.28; P < .001) with AHRE duration strata from ≥15 minutes to ≥7 days independent of the CHA2DS2-VASc score. Of 871 patients with AHREs, those with 1-month P-wave amplitude <2.45 mV had an adjusted hazard ratio of 1.51 (CI, 1.19-1.91; P = .001) for progression of AHREs from ≥15 minutes to ≥7 days compared with those with 1-month P-wave amplitude ≥2.45 mV. Device-detected P-wave amplitudes decreased linearly during the 1 year before the first AHRE by 7.3% (CI, 5.1%-9.5%; P < .001 vs patients without AHRE). CONCLUSION: Device-detected P-wave amplitudes <2.45 mV were associated with an increased risk of AHRE onset and progression to persistent forms of AHRE independent of the patient's risk profile.

Temporal association between drops in thoracic impedance and malignant ventricular arrhythmia: A longitudinal analysis of remote monitoring trends.

INTRODUCTION: Thoracic impedance (TI) drops measured by implantable cardioverter-defibrillators (ICDs) have been reported to correlate with ventricular tachycardia/fibrillation (VT/VF). The aim of our study was to assess the temporal association of decreasing TI trends with VT/VF episodes through a longitudinal analysis of daily remote monitoring data from ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds). METHODS AND RESULTS: Retrospective data from 2384 patients were randomized 1:1 into a derivation or validation cohort. The TI decrease rate was defined as the percentage of rolling weeks with a continuously decreasing TI trend. The derivation cohort was used to determine a TI decrease rate threshold for a ≥99% specificity of arrhythmia prediction. The associated risk of VT/VF episodes was estimated in the validation cohort by dividing the available follow-up into 60-day assessment intervals. Analyses were performed separately for 1354 ICD and 1030 CRT-D patients. During a median follow-up of 2.0 years, 727 patients (30.4%) experienced 3298 confirmed VT/VF episodes. In the ICD group, a TI decrease rate of >60% was associated with a higher risk of VT/VF episode in a 60-day assessment interval (stratified hazard ratio, 1.42; 95% confidence interval (CI), 1.05-1.92; p = .023). The TI decrease preceded (40.8%) or followed (59.2%) the VT/VF episodes. In the CRT-D group, no association between TI decrease and VT/VF episodes was observed (p = .84). CONCLUSION: In our longitudinal analysis, TI decrease was associated with VT/VF episodes only in ICD patients. Preventive interventions may be difficult since episodes can occur before or after TI decrease.

Cardiac resynchronization therapy defibrillators in patients with permanent atrial fibrillation.

AIMS: There are conflicting data on the benefit of cardiac resynchronization therapy (CRT) in heart failure (HF) patients with permanent atrial fibrillation (AF). We aimed to compare patient outcomes according to the presence or absence of permanent AF at device implantation. METHODS AND RESULTS: We retrospectively analysed remote monitoring data from 1141 CRT defibrillators. Propensity score with inverse-probability weighting method was used to balance AF and sinus rhythm (SR) groups. Analysis endpoints included total mortality, appropriate defibrillation shocks, and CRT percentage. There were 229 patients (20.1%) in the AF group and 912 patients (79.9%) in the SR group. Compared with SR patients, AF patients were older (median age, 77 vs. 72 years, P < 0.001), more frequently male (82.5% vs. 75.5%, P = 0.02), and had higher heart rate (75.7 vs. 71.0 b.p.m., P < 0.001). Of the 229 AF patients, 162 (70.7%) received suboptimal CRT (<98%) and 67 (29.3%) had adequate CRT (≥98%). During a median follow-up of 24 months, total mortality did not differ between AF and SR groups (propensity-score-weighted hazard ratio, HR 1.32 [95% confidence interval, 0.82-2.15], P = 0.25). The risk of appropriate shocks was significantly higher in the AF group with <98% CRT than in the SR group (weighted-HR, 1.99 [1.21-3.26], P = 0.006) and was similar in the AF group with ≥98% CRT versus the SR group (1.29 [0.66-2.53], P = 0.45). During follow-up, sinus rhythm was recovered in 23 patients in the AF group (10%) after a median time of 106 (42-256) days. The rate of sinus rhythm recovery in the AF group was 4.5 (95% CI, 2.8-6.7) per 100 patient-years; the rate of permanent AF occurrence in the SR group was 2.5 (95% CI, 1.9-3.3) per 100 patient-years. CONCLUSIONS: Although mortality was similar across patient groups, patients with permanent AF and suboptimal CRT had twofold higher risk of appropriate shocks than SR patients or AF patients with CRT ≥ 98%.

Stepwise approach for visualization and reconstruction of pulmonary valve with intracardiac echocardiography.

Ventricular tachycardia and premature ventricular complexes (PVCs) arising from right ventricular outflow tract (RVOT) are the most common type of ventricular arrhythmias (VAs) in patients without structural heart disease. Radiofrequency ablation is now the gold standard of treatment in this setting due to high efficacy rates and optimal safety profile. During the last few years, the pulmonary valve (PV) and the pulmonary artery (PA) have attracted much attention as reliable sites of origin of RVOT-type arrhythmias. In the mean while intracardiac echocardiogram (ICE) has undoubtedly improved our understanding of the cardiac anatomy. Aim of this paper is to provide an illustrated step-by-step guide on how to use ICE with the CARTOSOUND module to visualize and reconstruct 3D shell of the RV, the PV, as well of other contiguous anatomical structures (i.e., the aortic valve and coronary arteries) to perform aware and safe ablation in this region.

Mortality after cardioverter-defibrillator replacement: Results of the DECODE survival score index.

BACKGROUND: Device replacement is the ideal time to reassess health care goals regarding continuing implantable cardioverter-defibrillator (ICD) therapy. Only few data are available on the decision making at this time. OBJECTIVES: The goals of this study were to identify factors associated with poor prognosis at the time of ICD replacement and to develop a prognostic index able to stratify those patients at risk of dying early. METHODS: DEtect long-term COmplications after implantable cardioverter-DEfibrillator replacement (DECODE) was a prospective, single-arm, multicenter cohort study aimed at estimating long-term complications in a large population of patients who underwent ICD/cardiac resynchronization therapy - defibrillator replacement. Potential predictors of death were investigated, and all these factors were gathered into a survival score index (SUSCI). RESULTS: We included 983 consecutive patients (median age 71 years (63-78)); 750 (76%) were men, 537 (55%) had ischemic cardiomyopathy; 460 (47%) were implanted with cardiac resynchronization therapy - defibrillator. During a median follow-up period of 761 days (interquartile range 628-904 days), 114 patients (12%) died. In multivariate Cox regression analysis, New York Heart Association class III/IV, ischemic cardiomyopathy, body mass index < 26 kg/m2, insulin administration, age ≥ 75 years, history of atrial fibrillation, and hospitalization within 30 days before ICD replacement remained associated with death. The survival score index showed a good discriminatory power with a hazard ratio of 2.6 (95% confidence interval 2.2-3.1; P < .0001). The risk of death increased according to the severity of the risk profile ranging from 0% (low risk) to 47% (high risk). CONCLUSION: A simple score that includes a limited set of variables appears to be predictive of total mortality in an unselected real-world population undergoing ICD replacement. Evaluation of the patient's profile may assist in predicting vulnerability and should prompt individualized options, especially for high-risk patients.

Body mass index is related to unsuccessful puncture attempts and failure to axillary vein cannulation during ultrasound-guided cardiac electronic device implantation.

PURPOSE: Ultrasound (US)-guided axillary vein cannulation is effective and safe during cardiac implantable electronic devices (CIEDs). It is a reasonable alternative to other techniques in order to shorten procedural time and decrease perioperative complications. However, in this context, the short-axis (out-of-plane) visualization to guide the vein puncture is the most used technique. The aim of our study is to describe a single-center experience with the US long-axis (in-plane) technique defining predictors of unsuccessful puncture attempts and failure to axillary vein cannulation in a cohort of patients undergoing CIEDs procedures. METHODS: From November 2017 to June 2019, consecutive patients undergoing CIEDs procedures were enrolled in the study. US-guided long axis (in-plane) view to guide axillary vein cannulation was used in all subjects. Unsuccessful puncture attempts (UAs) and complete failures to cannulate the vein were collected for each procedure. All patients were evaluated on a daily basis until hospital discharge and at 1-month follow up visit. RESULTS: Among 119 subjects (M: F = 75:44), mean age was 79 ± 9 years, mean BMI 25.7 ± 4.3 kg/m2, and mean BSA 1.74 ± 0.4 m2. We placed 95 pacemakers (32 single-, 61 dual-, and 2 triple-chamber) and 20 ICDs (7 single, 6 dual, 7 triple chambers). An upgrade from dual-chamber to triple-chamber device was carried out with the addition of a new lead in 3 patients. During a system revision, one new electrode was implanted. The overall leads inserted were 204. There were 33 initial unsuccessful attempts in 22/119 patients. US-guided axillary access was finally successful in 94.9% of patients (113/119). In the other cases (6/119), cephalic vein was isolated or blinded subclavian puncture was performed. Interestingly, at univariate analysis, an increasing BMI and BSA, male sex, and anticoagulant therapy were predictors of unsuccessful attempts or failure to cannulate the vein with US. Among those subjects, the multivariate logistic regression showed significant correlations only between BMI and unsuccessful attempts: odds ratio (OR) = 1.16, p = 0.009 [95% CI = 1.04-1.31], and BMI with failure to cannulate the vein: OR = 1.21, p = 0.03 [95%CI = 1.01-1.45]. The receiver operating characteristic (ROC) curves individuated the best BMI value cutoff point at 27 kg/m2 (area under the curve [AUC]: 68.6%) having a sensitivity of 63.6% and a specificity of 66.5% for unsuccessful puncture attempts; a BMI value of 28 kg/m2 (AUC 74.9%) had a sensitivity of 66.7% and a specificity of 66.7% for failure to cannulate the vein with the US-guided approach. CONCLUSIONS: Axillary vein long-axis (in-plane) US-guided cannulation during CIEDs implantation is characterized by a high success rate (94.9%). An elevated BMI is significantly related to unsuccessful puncture attempts or failure to cannulation. The higher is the BMI, the more are the chances to have difficult vein puncture or cannulation failure and to switch from US-guided approach to another technique.

Thromboembolic Events Following Atrial Fibrillation Cardioversion and Ablation: What's the Culprit?

Stroke is a rare but possible complication after atrial fibrillation (AF) ablation. However, its etiopathogenesis is far from being completely characterized. Here we report a case of stroke, with recurrent peripheral embolism after AF ablation procedure. In our patient, an in situ femoral vein thrombosis and iatrogenic atrial septal defect were simultaneously detected. A comprehensive review of multiple pathophysiological mechanisms of stroke in this context is provided. The case underlines the importance of a global evaluation of patients undergoing AF ablation.

Predictors of Successful Ultrasound Guided Femoral Vein Cannulation in Electrophysiological Procedures.

BACKGROUND: Vascular complications are frequently reported after electrophysiological (EP) procedures. Ultrasound (US) guidance during femoral vein cannulation has shown to reduce vascular damage related to unsuccessful attempts.The aim of our study is to define, under ultrasound guidance,anatomical and technical predictors of successful femoral vein cannulation in a cohort of patients undergoing EP. MATERIAL AND METHODS: From December 2015 to January 2018, 192 patients (mean age 63,1±15,9 years, M:F=118:74) undergoing EP were enrolled in the study. US-guided approach to femoral vessels cannulation was used in all subjects by four untrained operators. Femoral vein and artery depths and diameters were measured in all patients. Unsuccessful attempts (UA) and time to successful cannulation (TSC) were also calculated. RESULTS: Vein and artery depths correlated with body weight (r=0.38 and 0.39, p=0.00), body mass index (r=0.53 and 0.50, p=0.00), and body surface area (r=0.25 and 0.28, p=0.00). Interestingly, the number of UA)positively correlated with vein depth (r=0.23, p=0.01 for the right side and r=0.33, p=0.00 for the left side). Linear regression analysis showed that both vein depth (ß=0.42, p=0.001) andoperator training(ß= -0.75,p=0.00)were independently associated with UA. CONCLUSION: Anthropometric features, namely BMI and BSA, may provide information about femoral vein/artery anatomy in patients undergoing EP procedures. Patients with high BMI have deeper and larger veins, however only vein depth is a determinant of successful cannulation. Numbers of UA and TSC significantly decrease with operators training.

Left Axillary Implantation of Loop Recorder versus the Traditional Left Chest Area: A Prospective Randomized Study.

BACKGROUND: Based upon the results of a previous small pilot study, we present the results of a prospective single-center randomized study comparing the performance of the implantable loop recorder (ILR) at two implanting sites. METHODS: A group of patients whose ILRs were implanted via a left axillary approach were compared with a group who received an ILR in the traditional left site of the chest. Follow-up (FU) was scheduled every 6 months or when symptoms occurred. All patients enrolled in the study had a complete FU from implantation to explantation. R- and P-wave amplitudes were measured at implantation and during FU. Explantation of the device was programmed at the end of service life or when ILR analysis resulted in a complete and exhaustive diagnosis. RESULTS: Sixty-three patients were enrolled (70 ± 12 years, range: 21-92, 59% male): 31 standard and 32 with axillary access. The R-wave amplitude obtained with the new technique was comparable with that obtained with the standard procedure. The diagnostic accuracy of the ILR was comparable in the two groups. The axillary implantation procedure was slightly longer but no complications were observed. CONCLUSION: This long-term randomized study confirmed that axillary access for ILR implantation is feasible, safe, well tolerated, and reliable in terms of device performance. Moreover, it is aesthetically superior to the standard approach and carries the potential of minimizing permanent scarring after ILR extraction.

Prevalence of auricular thrombosis before atrial flutter cardioversion: a 17-year transoesophageal echocardiographic study.

AIMS: Prevalence of left appendage thrombosis ranges from 6 to 18% in persistent atrial fibrillation (AF). Few and low sample size studies have assessed left and right atrial thrombosis in persistent atrial flutter (AFL) and a wide variety of frequencies, from 1 to 21%, has been reported. The aim of this study was to evaluate the prevalence of atrial appendage thrombosis in a large population of patients undergoing transoesophageal echocardiography (TEE)-guided cardioversion (CV) for recent AFL onset and compare it with AF. METHODS AND RESULTS: From 1999 to September 2014, we collected data of 1081 patients to CV: 877 affected by AF (81.1%) and 204 by AFL (18.9%). The presence of auricular thrombosis was evaluated by TEE in AF or AFL persisting for more than 48 h. The presence of appendage thrombosis, Doppler emptying velocities, and severe spontaneous echo contrast (SEC) was studied. The overall prevalence of atrial thrombosis was 9.62% (104/1081). Frequency of atrial thrombosis in AFL patients was 6.4% (13/204) vs. 10.5% among AF (92/877), P = 0.074. Comparing the two appendages, frequency of left atrial appendage thrombosis was in AFL 5.9% (12/204) vs. 9.9% (87/877) in the AF group, P = 0.07. Right atrial appendage thrombosis was present in 0.5% (1/204) in the AFL group vs. 0.8% (7/877) in the AF group, P = 0.64. Moderate to severe SEC (3+/4+) was present in 28% of AFL patients (57/204) vs. 35% of AF patients (307/877), P = 0.05. CONCLUSION: Auricular thrombosis is not an infrequent finding in AFL before CV. Our study suggests the use of TEE screening in AFL, as well as in AF, when patients arrive to clinical attention after more than 48 h from arrhythmia onset.

Pocket Hematoma: A Call for Definition.

Pocket hematoma is a common complication of cardiac implantable electronic device procedures and a potential risk factor for device infections, especially in patients on oral anticoagulation or antiplatelet treatment. There is a wide variability in the incidence of pocket hematoma and bleeding complications in the literature and the major cause for this seems to be the variability of the used definitions for hematomas. The lack of generally accepted definition for pocket hematoma renders the comparisons across the studies difficult. In this article, we briefly review the current literature on this issue and propose a uniform definition for pocket hematoma and criteria for grading the severity of hematoma in clinical practice and research.

Atrial Flutter In A Tetralogy Of Fallot Operated Patient: Importance Of A Rapid And Curative Treatment.

A 51 male, affected by Tetralogy of Fallot, underwent a left Blalock-Taussig anastomosis at the age of two years and an aorto - right pulmonary artery tube graft when 8 years old. Complete surgical correction was performed at age 21 with closure of the ventricular septal defect and a large patch over the right outflow tract, shunts were discontinued. Then it was well up to 51 years old when he began to suffer shortness of breath with minimal exertion. with ECG evidence of supraventricular tachycardia. Suggestive signs of a typical atrial flutter led to early electrophysiological assesment and successful cavo-tricuspid isthmus ablation was successfully performed. . Echocardiographic and magnetic resonance imaging and ergospirometry provided complete informations on anatomic and hemodynamic conditions but no other interventional procedure was necessary.

Frequency and significance of right atrial appendage thrombi in patients with persistent atrial fibrillation or atrial flutter.

BACKGROUND: Atrial fibrillation (AF) and atrial flutter (AFL) are strong atrial thrombosis (THR) risk factors. In recent-onset tachyarrhythmias, the incidence of left atrial appendage (LAA) THR, detected by transesophageal echocardiography (TEE), has been widely studied, ranging from 6% to 18% (AF) and 4% to 11% (AFL). On the contrary, few studies have assessed right atrial appendage (RAA) THR, and there is no information on the relation between the RAA flow characteristics and the presence of RAA THR. The aims of this study were to evaluate the incidence of RAA THR in a population of patients undergoing TEE-guided cardioversion for recent-onset atrial tachyarrhythmias and to analyze RAA Doppler flow and its relation to thrombus formation. METHODS: From 1998 to 2012, patients admitted to the emergency department for persistent, non-self-terminating atrial tachyarrhythmia lasting >2 days who gave informed consent for TEE-guided cardioversion were prospectively enrolled in the study. Among 1,042 patients, complete anatomic and functional studies of the LAA and RAA were feasible in 983 (AF, n = 810 [23%]; AFL, n = 173 [5%]). The presence of RAA and LAA THR, appendage emptying velocities, and the presence of severe spontaneous echocardiographic contrast were studied. RESULTS: The overall incidence of atrial THR was 9.7% (96 of 983). The incidence of THR was 9.3% (91 of 983) in the LAA and 0.73% (seven of 983) in the RAA (P < .01). In the AF and AFL groups, the incidence of LAA THR was 10.3% (83 of 805), compared with 0.75% (six of 805) for RAA THR (P < .01). Among patients with AFL, the incidence of LAA THR was 6% (10 of 178), compared with 0.6% (one of 178) for RAA THR (P < .01). The mean LAA peak emptying velocity was 24 cm/sec (range, 10-32 cm/sec) in patients with LAA THR, compared with 38 cm/sec (range, 20-59 cm/sec) in those without THR; the mean RAA peak emptying velocity was 17 ± 7 cm/sec in patients with RAA THR, compared with 34 ± 13 cm/sec in those without THR (P < .001). CONCLUSIONS: RAA thrombi are significantly less frequent than LAA thrombi but may reach large dimensions. Multiplane TEE allows RAA morphologic and functional assessment. Before TEE-guided cardioversion, both the LAA and the RAA must be routinely studied.