Safety and feasibility of same-day discharge following uncomplicated transvenous lead extraction.

INTRODUCTION: Transvenous lead extraction (TLE), while mostly a safe procedure, has risk of serious periprocedural complications. As such, overnight hospitalization remains a routine practice. In our center, we routinely discharge patients on the same day following an uncomplicated TLE. METHODS: This is a retrospective study of 265 consecutive patients who underwent uncomplicated TLE in our center between 2019 and 2021. Same-day discharge (SDD) patients are compared with those who stayed at least overnight for observation after the TLE procedure (non-SDD group). To assess the safety of an SDD strategy after uncomplicated TLE, the main study endpoint was to compare the rate of major procedure-related complications at 1-, 7-, and 30-days. To identify the factors influencing the operator's decision to discharge the patient on the same day, the secondary endpoint was to analyze clinical and procedural predictors of SDD. RESULTS: A total of 153 patients were discharged the same day after uncomplicated TLE (SDD), while 112 stayed at least overnight after the procedure (non-SDD). There was no significant difference in major procedure-related complications at 1-day (SDD 0% vs. non-SDD 1.8%, p value = ns), while patients in the SDD group had a lower rate of 7- and 30-day complications when compared with those in the non-SDD group (2.1% vs. 8.2%, p value = .0308; and 3.5% vs. 16%, p value = .0049, respectively). Noninfectious indication for TLE (OR 16.1, 95% confidence interval [CI] 4.29-77.6) and procedure end time before 12:00 (OR 2.82, 95% CI 1.11-7.27) were the only independent predictors of SDD. CONCLUSION: SDD discharge following uncomplicated TLE in selected patients (i.e., those without device infection and when the TLE procedure is completed in the morning) is feasible and safe.

Best anticoagulation strategy with and without appendage occlusion for stroke-prophylaxis in postablation atrial fibrillation patients with cardiac amyloidosis.

INTRODUCTION: Both atrial fibrillation (AF) and amyloidosis increase stroke risk. We evaluated the best anticoagulation strategy in AF patients with coexistent amyloidosis. METHODS: Consecutive AF patients with concomitant amyloidosis were divided into two groups based on the postablation stroke-prophylaxis approach; group 1: left atrial appendage occlusion (LAAO) in eligible patients and group 2: oral anticoagulation (OAC). Group 1 patients were further divided into Gr. 1A: LAAO + half-does NOAC (HD-NOAC) for 6 months followed by aspirin 81 mg/day and Gr. 1B: LAAO + HD-NOAC. In group 1 patients, with complete occlusion at the 45-day transesophageal echocardiogram, patients were switched to aspirin, 81 mg/day at 6 months. In case of leak, or dense "smoke" in the left atrium (LA) or enlarged LA, they were placed on long-term half-dose (HD) NOAC. Group 2 patients remained on full-dose NOAC during the whole study period. RESULTS: A total of 92 patients were included in the analysis; group 1: 56 and group 2: 36. After the 45-day TEE, 31 patients from group 1 remained on baby-aspirin and 25 on HD NOAC. At 1-year follow-up, four stroke, one TIA and six device-thrombus were reported in group 1A, compared to none in patients in group 1B (5/31 vs. 0/25, p = .03). No bleeding events were reported in group 1, whereas group 2 had five bleeding events (one subdural hematoma, one retinal hemorrhage, and four GI bleedings). Additionally, one stroke was reported in group 2 that happened during brief discontinuation of OAC. CONCLUSION: In patients with coexistent AF and amyloidosis, half-dose NOAC following LAAO was observed to be the safest stroke-prophylaxis strategy.

Application Repetition and Electrode-Tissue-Contact Results in Deeper Lesions Using a Pulsed-Field Ablation Circular Variable Loop Catheter.

BACKGROUND: Pulsed field ablation (PFA) is a novel, myocardial-selective, non-thermal ablation modality used to target cardiac arrhythmias. Although prompt EGM signal disappearance is observed immediately after PFA application in the pulmonary veins, whether this finding results in adequate transmural lesions is unknown. STUDY AIM: If application repetition and catheter-tissue contact impact on lesion formation during PFA. METHODS: A circular loop PFA catheter was used to deliver repeated energy applications with various levels of contact-force. A benchtop vegetal potato model and a beating heart ventricular myocardial model were utilized to evaluate the impact of application repetition, contact force, and catheter repositioning on contiguity and lesion depth. Lesion development occurred over 18 hours in the vegetal model and over 6 hours in the porcine model. RESULTS: Lesion formation was found to be dependent on application repetition and contact. In porcine ventricles, single and multiple stacked applications led to a lesion depth of 3.5 ± 0.7 mm and 4.4 ± 1.3 mm, respectively (p =0.002). Furthermore, the greater the catheter-tissue contact, the more contiguous and deeper the lesions in the vegetal model (1.0±0.9 mm with no contact Vs. 5.4±1.4 mm with 30 g of force; p=.0001). CONCLUSION: PFA delivered via a circular catheter showed that both repetition and catheter contact led independently to deeper lesion formation. These findings indicate that endpoints for effective PFA ablation are more related to PFA biophysics than mere EGM attenuation.

Inherited Arrhythmias in the Pediatric Population: An Updated Overview.

Pediatric cardiomyopathies (CMs) and electrical diseases constitute a heterogeneous spectrum of disorders distinguished by structural and electrical abnormalities in the heart muscle, attributed to a genetic variant. They rank among the main causes of morbidity and mortality in the pediatric population, with an annual incidence of 1.1-1.5 per 100,000 in children under the age of 18. The most common conditions are dilated cardiomyopathy (DCM) and hypertrophic cardiomyopathy (HCM). Despite great enthusiasm for research in this field, studies in this population are still limited, and the management and treatment often follow adult recommendations, which have significantly more data on treatment benefits. Although adult and pediatric cardiac diseases share similar morphological and clinical manifestations, their outcomes significantly differ. This review summarizes the latest evidence on genetics, clinical characteristics, management, and updated outcomes of primary pediatric CMs and electrical diseases, including DCM, HCM, arrhythmogenic right ventricular cardiomyopathy (ARVC), Brugada syndrome (BrS), catecholaminergic polymorphic ventricular tachycardia (CPVT), long QT syndrome (LQTS), and short QT syndrome (SQTS).

Catheter ablation approach and outcome in HIV+ patients with recurrent atrial fibrillation.

INTRODUCTION: Earlier studies have shown a clear association between severity of human immunodeficiency virus (HIV) infection and incident atrial fibrillation (AF). We present the long-term outcome of catheter ablation (CA) and electrophysiological characteristics in HIV+ AF patients. METHODS: This study evaluated 1438 consecutive AF patients [31 (2.15%) with HIV and 1407 (97.8%) without HIV diagnosis] undergoing their first CA at our center. A total of 31 HIV patients and 31 controls were generated by propensity matching, based on calculated risk factor scores, using a logistic model. During first procedure, all received isolation of pulmonary vein (PV) + posterior wall and superior vena cava. Non-PV triggers, defined as ectopic triggers originating from sites other than PVs, were identified at the redo ablation with high-dose isoproterenol challenge. RESULTS: Clinical characteristics were not different between the groups. When compared to the control, by the end of 5 years after the first procedure, recurrence was significantly greater in HIV group [100% vs. 54%, p < .001]. Among patients that underwent redo ablation non-PV triggers were higher in HIV group [93.5% vs. 54%, p < .001], and most frequently originated from the coronary sinus [67.7% vs. 45.2%, p < .001] and left atrial appendage [41.9% vs. 25.8%, p < .001]. After focal ablation of non-PV trigger, no difference in arrhythmia recurrence between two groups [80.6% vs. 87.1%, p = .753] at 1-year follow up was found. CONCLUSION: Our findings suggest that non-PV triggers are highly prevalent in HIV+ AF patients resulting in higher rate of the mid- and long-term arrhythmia recurrence.

Three-dimensional intracardiac echocardiography for left atrial appendage sizing and percutaneous occlusion guidance.

AIMS: Left atrial appendage (LAA) imaging is critical during percutaneous occlusion procedures. 3D-intracardiac echocardiography (ICE) features direct visualization of LAA from multiple cross-sectional planes at a time. We aimed at reporting procedural success of 3D-ICE-guided LAA occlusion and the correlation between pre-procedural transoesophageal echocardiography (TEE) and intraprocedural 3D-ICE for LAA sizing. METHODS AND RESULTS: Among 274 patients undergoing left atrial appendage occlusion (LAAO) with a Watchman FLX, periprocedural ICE guidance was achieved via a commercially available 2D-ICE catheter (220 patients) or a novel (NUVISION™) 3D-ICE one (54 patients). Primary endpoint was a composite of procedural success and LAA sealing at follow-up TEE. Secondary endpoint was a composite of periprocedural device recapture/resizing plus presence of leaks ≥ 3 mm at follow-up TEE. 3D-ICE measurements of maximum landing zone correlated highly with pre-procedural TEE reference values [Pearson's: 0.94; P < 0.001; bias: -0.06 (-2.39, 2.27)]. The agreement between 3D-ICE-based device selection and final device size was 96.3% vs. 79.1% with 2D-ICE (P = 0.005). The incidence of the primary endpoint was 98.1% with 3D-ICE and 97.3% with 2D-ICE (P = 0.99). 2D-ICE patients had a trend towards a higher incidence of periprocedural device recapture/redeployment (31.5% vs. 44.5%; P = 0.09). The secondary endpoint occurred in 31.5% of 3D-ICE patients vs. 45.9% of 2D-ICE ones (P = 0.065). CONCLUSION: Intracardiac echocardiography-guided LAAO showed a very high success, with no major adverse events. A very high level of agreement for LAA sizing was found between pre-procedural TEE and periprocedural 3D-ICE. 3D-ICE performed significantly better than 2D-ICE for FLX size selection and may provide better guidance during device deployment.

Intra- and Extra-Hospitalization Monitoring of Vital Signs-Two Sides of the Same Coin: Perspectives from LIMS and Greenline-HT Study Operators.

BACKGROUND: In recent years, due to the epidemiological transition, the burden of very complex patients in hospital wards has increased. Telemedicine usage appears to be a potential high-impact factor in helping with patient management, allowing hospital personnel to assess conditions in out-of-hospital scenarios. METHODS: To investigate the management of chronic patients during both hospitalization for disease and discharge, randomized studies (LIMS and Greenline-HT) are ongoing in the Internal Medicine Unit at ASL Roma 6 Castelli Hospital. The study endpoints are clinical outcomes (from a patient's perspective). In this perspective paper, the main findings of these studies, from the operators' point of view, are reported. Operator opinions were collected from structured and unstructured surveys conducted among the staff involved, and their main themes are reported in a narrative manner. RESULTS: Telemonitoring appears to be linked to a reduction in side-events and side-effects, which represent some of most commons risk factors for re-hospitalization and for delayed discharge during hospitalization. The main perceived advantages are increased patient safety and the quick response in case of emergency. The main disadvantages are believed to be related to low patient compliance and an infrastructural lack of optimization. CONCLUSIONS: The evidence of wireless monitoring studies, combined with the analysis of activity data, suggests the need for a model of patient management that envisages an increase in the territory of structures capable of offering patients subacute care (the possibility of antibiotic treatments, blood transfusions, infusion support, and pain therapy) for the timely management of chronic patients in the terminal phase, for which treatment in acute wards must be guaranteed only for a limited time for the management of the acute phase of their diseases.

Bipolar Ablation for an Intramural Septal Atrial Tachycardia.

A 70-year-old man with recurrent atrial fibrillation (AF) underwent transcatheter radiofrequency ablation after an earlier unsuccessful attempt. Although typical AF triggers were ablated, the patient's condition persisted, leading to the identification of the interatrial septum (IAS) as the probable source of the tachycardia trigger. Given the depth and thickness of the IAS, traditional radiofrequency ablation proved ineffective. However, using the alternative method of bipolar radiofrequency catheter ablation (B-RFCA), the atrial tachycardia was successfully terminated. B-RFCA demonstrates potential for effectively terminating tachycardias originating from deep intramural locations, suggesting its potential as a pivotal technique for complex cases with septal atrial tachycardia.

Antiarrhythmic Drug Use in Pregnancy: Considerations and Safety Profiles.

Pregnancy entails notable physiological alterations and hormonal fluctuations that affect the well-being of both the fetus and the mother. Cardiovascular events and arrhythmias are a major concern during pregnancy, especially in women with comorbidities or a history of arrhythmias. This paper provides an overview of the prevalence, therapies, and prognoses of different types of arrhythmias during pregnancy. The administration of antiarrhythmic drugs (AADs) during pregnancy demands careful consideration because of their possible effect on the mother and fetus. AADs can cross the placenta or be present in breast milk, potentially leading to adverse effects such as teratogenicity, growth restriction, or premature birth. The safety profiles of different classes of AADs are discussed. Individualized treatment approaches and close monitoring of pregnant women prescribed AADs are essential to ensure optimal maternal and fetal outcomes.

Pulsed Field Energy in Atrial Fibrillation Ablation: From Physical Principles to Clinical Applications.

Atrial fibrillation, representing the most prevalent sustained cardiac arrhythmia, significantly impacts stroke risk and cardiovascular mortality. Historically managed with antiarrhythmic drugs with limited efficacy, and more recently, catheter ablation, the interventional approach field is still evolving with technological advances. This review highlights pulsed field ablation (PFA), a revolutionary technique gaining prominence in interventional electrophysiology because of its efficacy and safety. PFA employs non-thermal electric fields to create irreversible electroporation, disrupting cell membranes selectively within myocardial tissue, thus preventing the non-selective damage associated with traditional thermal ablation methods like radiofrequency or cryoablation. Clinical studies have consistently shown PFA's ability to achieve pulmonary vein isolation-a cornerstone of AF treatment-rapidly and with minimal complications. Notably, PFA reduces procedure times and has shown a lower incidence of esophageal and phrenic nerve damage, two common concerns with thermal techniques. Emerging from oncological applications, the principles of electroporation provide a unique tissue-selective ablation method that minimizes collateral damage. This review synthesizes findings from foundational animal studies through to recent clinical trials, such as the MANIFEST-PF and ADVENT trials, demonstrating PFA's effectiveness and safety. Future perspectives point towards expanding indications and refinement of techniques that promise to improve AF management outcomes further. PFA represents a paradigm shift in AF ablation, offering a safer, faster, and equally effective alternative to conventional methods. This synthesis of its development and clinical application outlines its potential to become the new standard in AF treatment protocols.

Pulsed-Field Ablation Does Not Worsen Baseline Pulmonary Hypertension Following Prior Radiofrequency Ablations.

BACKGROUND: Studies have reported development of pulmonary hypertension (PH) secondary to reduced LA compliance following AF ablation. OBJECTIVES: This study aimed to compare the risk of worsening of baseline PH between non-paroxysmal AF patients undergoing pulsed-field ablation (PFA) and standard radiofrequency ablation (RFA). METHODS: This multicenter study included 28 nonparoxysmal AF patients with PH undergoing a PFA-based ablation procedure after >1 failed RFA. A cohort of 28 AF patients with PH, scheduled for repeat RFA, 1:1 propensity-score matched using a multivariable logistic model, were used as the comparator group. Right heart catheterization and echocardiography were performed before and after the procedure to assess the pulmonary artery pressure (PAP). PH was defined as resting mean PAP of >20 mm Hg. RESULTS: The baseline characteristics of the PFA and propensity-matched RFA groups were comparable. The mean PAP assessments at baseline, follow-up, and change from baseline were analyzed. The groups had comparable baseline mean pulmonary artery pressures (mPAP) (P = 0.177). After adjustment for baseline mPAP in an analysis of covariance model, the least-squares means change at 3 months after ablation was -1.71 ± 1.03 mm Hg and 19.67 ± 1.03 mm Hg in PFA and RFA, respectively (P <0.001). CONCLUSIONS: In this propensity-matched population, no worsening of mPAP was detected following pulsed-field ablation in patients with pre-existing PH undergoing a repeat procedure for recurrence.

Substrate Characterization and Outcomes of Ventricular Tachycardia Ablation in Amyloid Cardiomyopathy: A Multicenter Study.

BACKGROUND: Sustained ventricular tachycardia (VT) in cardiac amyloidosis is uncommon, and the substrate and outcomes of catheter ablation are not defined. METHODS: We included 22 consecutive patients (mean age, 68±10 years; male sex, 91%) with cardiac amyloidosis (ATTR [transthyretin], n=16; light chain, n=6) undergoing catheter ablation for VT/ventricular fibrillation (VF) between 2013 and 2023 in a retrospective, observational, international study. The primary efficacy outcome was recurrent VT/VF during follow-up, while the primary safety end point included major procedure-related adverse events. RESULTS: The indication for ablation was drug-refractory VT in 17 patients (77%), and premature ventricular complex-initiated polymorphic VT/VF in 5 patients (23%). Catheter ablation was performed using endocardial (n=17.77%) or endo-epicardial approaches (n=5.23%). Complete endocardial electroanatomical voltage maps of the left and right ventricles were obtained in 17 (77%) and 10 (45%) patients, respectively. Each patient had evidence of low-voltage areas, most commonly involving the interventricular septum (n=16); late potentials were recorded in 16 patients (73%). A median of 1 (1-2) VT was inducible per patient; 12 of the 26 mappable VTs (46%) originated from the interventricular septum. Complete procedural success was achieved in 16 patients (73%), with 4 (18%) major procedure-related adverse events. After a median follow-up of 32 (14-42) months, sustained VT/VF recurrence was observed in 9 patients (41%); survival free from VT/VF recurrence was 56% (95% CI, 36%-86%) at 36-month follow-up, and most patients remained on antiarrhythmic drugs. A significant reduction in per patient implantable cardioverter defibrillator therapies was noted in the 6-month period after ablation (before: 6 [4-9] versus after: 0 [0-0]; P<0.001). In multivariable analysis, complete procedural success was associated with reduced risk of recurrent VT/VF (hazard ratio, 0.002; P=0.034). CONCLUSIONS: Catheter ablation can achieve control of recurrent VT/VF in more than half of patients with cardiac amyloidosis, and the reduction in VT/VF burden post-ablation may be relevant for quality of life. Septal substrate and risk of procedure-related complications challenge successful management of patients with cardiac amyloidosis and VT/VF.

Redefining the blanking period following pulsed-field ablation in patients with atrial fibrillation.

BACKGROUND: Recurrence during the 3-month blanking period following radiofrequency ablation of atrial fibrillation (AF) is typically not considered as a predictor for late recurrence. OBJECTIVE: We investigated the significance of early recurrence as a risk factor for late recurrence in AF patients receiving pulsed-field ablation (PFA). METHODS: Consecutive patients undergoing PFA were prospectively followed-up for 1 year. All patients received isolation of pulmonary veins. Additional ablations were performed per operator's discretion. Following the procedure all remained on their previously ineffective antiarrhythmic drugs (AAD) during the 2-month blanking period after which the AADs were discontinued. Early recurrence was defined as atrial arrhythmia of > 30 second duration during the 3-mo blanking period and any recurrence beyond 3-mo was considered as late recurrence. RESULTS: A total of 337 patients undergoing PFA for AF were included. Early recurrence was recorded in 53 (15.7%) patients; 10 in the 1st month, 12 in the 2nd month and 31 in the 3rd month. Of the 10 patients having recurrence during the 1st month, 7 (70%) remained in sinus rhythm after cardioversion whereas 3 (30%) underwent redo because of late-recurrence. At 1 year, all patients with recurrence during the 2nd and 3rd month, experienced late-recurrence of which 10/12 and 27/31 underwent redo and the remaining 6 patients were in sinus on-AAD. CONCLUSION: In this consecutive series of AF patients, early-recurrence in the 2nd or 3rd month following the PFA procedure was associated with high risk of late-recurrence. Thus, blanking period could be redefined as 1-month following PFA.

Acute Kidney Injury Resulting From Hemoglobinuria After Pulsed-Field Ablation in Atrial Fibrillation: Is it Preventable?

BACKGROUND: High-voltage pulses can cause hemolysis. OBJECTIVES: The authors evaluated the occurrence of hemoglobinuria after pulsed-field ablation (PFA) and its impact on renal function in patients with atrial fibrillation (AF). METHODS: A consecutive series of patients with AF undergoing PFA were included in this analysis. The initial patients who did not receive postablation hydration immediately after the procedure were classified as group 1 (n = 28), and the rest of the study patients who received planned fluid infusion (0.9% sodium chloride ≥2 L) after the procedure were categorized as group 2 (n = 75). RESULTS: Of the 28 patients in group 1, 21 (75%) experienced hemoglobinuria during the 24 hours after catheter ablation. The mean postablation serum creatinine (S-Cr) was significantly higher than the baseline value in those 21 patients (1.46 ± 0.28 mg/dL vs 0.86 ± 0.24 mg/dL, P < 0.001). Of those 21 patients, 4 (19%) had S-Cr. >2.5 mg/dL (mean: 2.95 ± 0.21 mg/dL). The mean number of PF applications was significantly higher in those 4 patients than in the other 17 patients experiencing hemoglobinuria (94.63 ± 3.20 vs 46.75 ± 9.10, P < 0.001). In group 2 patients, no significant changes in S-Cr were noted. The group 2 patients received significantly higher amounts of fluid infusion after catheter ablation than did those in group 1 (2,082.50 ± 258.08 mL vs 494.01 ± 71.65 mL, P < 0.001). In multivariable analysis, both hydration (R2 = 0.63, P < 0.01) and number of PFA applications (R2 = 0.33, P < 0.01) were independent predictors of postprocedure acute kidney injury. CONCLUSIONS: On the basis of our findings, both the number of PFA applications and postablation hydration were independent predictors of renal insult that could be prevented using planned fluid infusion immediately after the procedure.

Contrast-induced nephropathy after cardiac resynchronization therapy implant impairs the recovery of ejection fraction in responders.

AIMS: Data regarding contrast-induced nephropathy (CIN) after cardiac resynchronization therapy (CRT) implant are limited. We aimed to investigate the incidence and determinants of CIN and its impact on CRT response and outcomes. METHODS AND RESULTS: Patients who underwent CRT implant were retrospectively analysed, and CIN was defined as an increase of serum creatinine ≥0.3 mg/dL or ≥1.5 times the baseline value. Response to CRT was defined as a reduction of left ventricle end-systolic volume (LVESV) of 15% or the increase of five percentage points in ejection fraction (EF) as assessed by echocardiography at 6 months. Follow-up visits were scheduled at 3, 6, and 12 months. Contrast-induced nephropathy occurred in 13/107 patients (12%). Among baseline clinical, echocardiographic, and laboratory characteristics, only a high baseline serum creatinine was associated with the occurrence of CIN. Symptoms, EF, and LVESV at 6 months improved in both CIN and non-CIN patients, and the rate of responders to CRT was similar. Among responders, at 6 months, those with CIN had significantly lower EF (28.5% vs. 35.7% P = 0.003). At a median follow-up of 112 weeks, 43% of patients experienced a clinical event with similar incidence in CIN and non-CIN patients, and likewise survival was similar. Non-responders to CRT had worse survival while among responders those with CIN had worse survival than non-CIN patients (71% vs. 90%, P = 0.0035). CONCLUSIONS: The incidence of CIN is rather high. Although CIN does not influence response to CRT overall, however among responders impairs the recovery of EF and survival.