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.

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.

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.

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.

Rationale and study design of the Italian Registry in the setting of Atrial Fibrillation Ablation with Rivaroxaban - IRIS.

BACKGROUND: Catheter ablation (CA) of atrial fibrillation (AF) is used routinely to establish rhythm control. There is mounting evidence that CA procedures should be performed during continuous oral anticoagulation and direct oral anticoagulants (DOACs) are considered the first anticoagulation strategy. Few real-life data are now available and even less in the Italian panorama. METHODS: IRIS is an Italian multicenter, non-interventional, prospective study which will be enrolled consecutive AF patients eligible for CA and treated with Rivaroxaban; patients in treatment with Rivaroxaban proceeded directly to CA while Rivaroxaban-naive patients were scheduled for CA after 4 weeks of uninterrupted anticoagulation unless the exclusion of atrial thrombi. Rivaroxaban was uninterrupted or shortly uninterrupted (<24 hours) prior CA, in line with routinely practice of each operator. Patients will be followed on continuous anticoagulation for 1 month after the ablation. The primary efficacy outcome is the cumulative incidence of all-cause death and systemic embolism while the primary safety outcome is the incidence of major bleeding events. The secondary outcomes are represented by non-major bleeding events. All events must be occurred within the first 30 days after the procedure. RESULTS: Two hundred fifty patients are expected to be enrolled and the study is estimated to be completed by the end of 2022. Up to now 56 patients have been enrolled. CONCLUSIONS: This study is the first large Italian prospective study on the management of Rivaroxaban in patients undergoing CA of AF. It aims to depict a comprehensive view of anticoagulation strategy prior CA in several Italian electrophysiology labs.

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.

Left axillary implantation of loop recorder.

BACKGROUND: We compared the clinical course of 10 patients who received an implantable loop recorder (ILR) at a traditional site with 11 patients whose ILRs were implanted via a subpectoral site via a left axillary approach without complications. METHODS AND RESULTS: R-wave amplitude was determined at implantation and during follow-up. Each patient was followed after 7 days to optimize device setting and then at 1 and 3 months. The R-wave amplitude obtained with the new technique was significantly higher and more stable than that obtained with the standard procedure. Our preliminary experience suggests that axillary access for ILR implantation is feasible, safe, well tolerated, and reliable in terms of sensing function and device performance. Moreover, it is superior aesthetically to the standard approach and carries the potential of minimizing permanent scarring after ILR extraction.

Can right ventricular pacing be useful in the assessment of cavo-tricuspid isthumus block?

BACKGROUND: Cavo-tricuspid isthmus (CTI) block is currently assessed by coronary sinus (CS) pacing or low lateral and septal atrial pacing. Occasionally, CS catheterization through the femoral route can be difficult to perform or right atrial pacing can be problematic because of catheter instability or saturation of the atrial electrograms recorded near the catheter. OBJECTIVES: Our aim was to evaluate the feasibility of assessing cavo-tricuspid isthmus block by means of right ventricular (RV) pacing in patients with ventriculo-atrial conduction, comparing it with CS pacing. METHODS: Circumannular activation was analyzed during CS and RV pacing in consecutive patients in sinus rhythm undergoing CTI ablation for typical atrial flutter. Patients without ventriculo-atrial conduction were excluded from the study. The linear lesion was created during RV pacing and split atrial signals on the ablation line were analyzed. CTI block was confirmed by analyzing local electrograms on the line of block and circumannular activation during CS and RV pacing. RESULTS: Out of 31 patients, 20 displayed ventriculo-atrial conduction (64%) and were included in the study. Before ablation, during RV stimulation, the collision front of circumannular activation shifted counterclockwise in contrast with the pattern observed during CS pacing. After ablation, circumannular activation was similar during CS and RV pacing, showing fully descending lateral right atrium activation, even if double potentials registered on the ablation line were less widely split during RV pacing than CS pacing (111+/-26 ms vs 128+/-30 , p=0.0001). CONCLUSIONS: In patients with ventriculo-atrial conduction, tricuspid annulus activation during CS and RV pacing is similar, before and after CTI ablation. The occurrence of split atrial electrograms separated by an isoelectric interval registered on the line of block can be detected during CS or RV pacing. In patients with difficult CS catheterization via the femoral vein, before trying the subclavian or internal jugular route, if retrograde ventriculo-atrial conduction is present, RV pacing can be an easy trick to assess isthmus block.

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.

Initial energy for biphasic external electrical cardioversion of atrial fibrillation.

BACKGROUND: No international guidelines indicate the initial energy in biphasic external electrical cardioversion of atrial fibrillation (AF) actually. The aim of this study was to determine this value in order to find a reasonable compromise between the necessity of limiting tissue damage and of quickly restoring sinus rhythm as well. METHODS: Fifty-six consecutive patients with AF candidate to external electrical cardioversion were treated using adhesive anterior-posterior paddles and biphasic wave defibrillator Lifepack 12, with steps of 50 J. After 6 hours troponin I levels were measured. RESULTS: Thirty-four patients were cardioverted by 50 J (group A), 18 by 100 J (group B) and 3 by 150 J (group C). One patient was not cardioverted (success rate 98%). No significant differences were noted between groups A and B with regard to age, sex, weight, height, thoracic circumference, body mass index, body surface area, impedance, NYHA class, left ventricular ejection fraction, left atrial diameter, causes of heart disease, antiarrhythmic medications, and duration of current AF episode. No increase of troponin I levels occurred. CONCLUSIONS: An initial shock of 100 J in the biphasic external elective cardioversion of AF is a valid and highly effective option. An initial shock of 50 J was effective in 61% of our population, and it is probably appropriated in patients with a lower weight and body mass index.

Early mobilization after pacemaker implantation.

BACKGROUND: There are no international guidelines indicating how long a patient should stay strictly in bed after pacemaker implantation. In the present study, we tested a new protocol concerning the mobilization of patients 3 h after receiving a single or a dual-chamber pacemaker. METHODS: Consecutive patients who underwent single or dual-chamber pacemaker implantation were randomized to a 3 or 24 h immobilization protocol. Only bipolar passive fixation leads were computed. After the implant, an elastic bandage was put on the homolateral shoulder of all patients for 24 h. A complete clinical and electronic follow-up was performed before discharge and repeated 2 months later. End-points considered were the displacement of the lead, high pacing thresholds (> 3.5 V/0.4 ms at the discharge or > 2.5 V/0.4 ms at the 2-month follow-up), sensing defects not corrigible by programming and clinical complications of the pocket RESULTS: One hundred and thirty-four patients were included in the study: 57 in group A (mobilization after 3 h) and 77 in group B (24 h). In group A, one haematoma and two displacements occurred in three patients. In group B, we registered one haematoma, one subclavian vein thrombosis, three displacements and three high stimulation thresholds. No statistical differences were observed between the end-points of group A versus B. CONCLUSIONS: The present study shows that an early mobilization protocol is feasible because no statistical differences resulted from the two groups of study as regards clinical outcome, complications and electronic measurements of the implanted devices, which have been followed up for 2 months.