Search

BACKGROUND: Limited data on the real-world safety and efficacy of leadless pacemakers (LPMs) post-transvenous lead extraction (TLE) are available. OBJECTIVE: The purpose of this study was to assess the long-term safety and effectiveness of LPMs following TLE in comparison with LPMs de novo implantation. METHODS: Consecutive patients who underwent LPM implantation in 12 European centers joining the International LEAdless PacemakEr Registry were enrolled. The primary end point was the comparison of LPM-related complication rate at implantation and during follow-up (FU) between groups. Differences in electrical performance were deemed secondary outcomes. RESULTS: Of the 1179 patients enrolled, 15.6% underwent a previous TLE. During a median FU of 33 (interquartile range 24-47) months, LPM-related major complications and all-cause mortality did not differ between groups (TLE group: 1.6% and 5.4% vs de novo group: 2.2% and 7.8%; P = .785 and P = .288, respectively). Pacing threshold (PT) was higher in the TLE group at implantation and during FU, with very high PT (>2 V@0.24 ms) patients being more represented than in the de novo implantation group (5.4% vs 1.6 %; P = .004). When the LPM was deployed at a different right ventricular (RV) location than the one where the previous transvenous RV lead was extracted, a lower proportion of high PT (>1-2 V@0.24 ms) patients at implantation, 1-month FU, and 12-month FU (5.9% vs 18.2%, P = .012; 3.4% vs 12.9%, P = .026; and 4.3% vs 14.5%, P = .037, respectively) was found. CONCLUSION: LPMs showed a satisfactory safety and efficacy profile after TLE. Better electrical parameters were obtained when LPMs were implanted at a different RV location than the one where the previous transvenous RV lead was extracted.

Aims The multielectrode radiofrequency balloon catheter (RFB) has been developed to achieve safe and effective pulmonary vein isolation (PVI) for atrial fibrillation (AF) ablation. This single-centre study aimed to evaluate the midterm clinical outcome and predictors of single-shot PVI with the novel RFB. Methods and results All consecutive patients with symptomatic paroxysmal or persistent AF undergoing first-time PVI with the RFB were prospectively included. Clinical and procedural parameters were systematically collected. The primary safety endpoint was defined as any major periprocedural complications. The primary efficacy endpoint consisted of freedom from any atrial tachyarrhythmias (ATas) lasting >30 s during the follow-up after a 3-month blanking period. Persistent single-shot PVI was defined as PVI achieved with a single RFB application without acute reconnection. A total of 104 consecutive patients (mean age 64.3 ± 11.4 years, 56.7% males) were included. 15 patients (14.4%) presented with persistent AF. The procedure time was 59.0 min with a dwell time of 20.0 min. One major complication occurred in one patient. At a mean follow-up of 10.1 ± 5.3 months, freedom from ATas was 82.9%. ATas occurred in 14 patients, 11/69 patients (15.9%) with paroxysmal AF and 3/13 (23.1%) with persistent AF. The best cut-offs to predict persistent single-shot PVI were impedance drop >19.2 Ω [area under the receiver operator characteristic curve (AUC) 0.74] and temperature rise >11.1° C (AUC 0.77). Conclusion In a large cohort of patients undergoing PVI with the RFB, the complication rate was 1%. At a mid-term follow-up of 10.1 ± 5.3 months, freedom from ATas was 82.9%. Specific cut-offs of impedance drop and temperature rise may be useful to predict persistent single-shot isolation.

Background: Age-related differences on leadless pacemaker (LP) are poorly described. Aim of this study was to compare clinical indications, periprocedural and mid-term device-associated outcomes in a large real-world cohort of LP patients, stratified by age at implantation. Methods: Two cohorts of younger and older patients (≤50 and > 50 years old) were retrieved from the iLEAPER registry. The primary outcome was to compare the underlying indication why a LP was preferred over a transvenous PM across the two cohorts. Rates of peri-procedural and mid-term follow-up major complications as well as LP electrical performance were deemed secondary outcomes. Results: 1154 patients were enrolled, with younger patients representing 6.2% of the entire cohort. Infective and vascular concerns were the most frequent characteristics that led to a LP implantation in the older cohort (45.8% vs 67.7%, p < 0.001; 4.2% vs 16.4%, p = 0.006), while patient preference was the leading cause to choose a LP in the younger (47.2% vs 5.6%, p < 0.001). Median overall procedural (52 [40–70] vs 50 [40–65] mins) and fluoroscopy time were similar in both groups. 4.3% of patients experienced periprocedural complications, without differences among groups. Threshold values were higher in the younger, both at discharge and at last follow-up (0.63 [0.5–0.9] vs 0.5 [0.38–0-7] V, p = 0.004). Conclusion: When considering LP indications, patient preference was more common in younger, while infective and vascular concerns were more frequent in the older cohort. Rates of device-related complications did not differ significantly. Younger patients tended to have a slightly higher pacing threshold at mid-term follow-up.

N/A

BACKGROUND: The second-generation cryoballoon (CB) has proven to be a highly effective ablative strategy in patients with symptomatic atrial fibrillation (AF). This study sought to investigate the anatomical characteristics of pulmonary veins (PVs) and the relationship between their size, ovality, and late reconnections in a large cohort of patients undergoing repeat ablation for recurrence of atrial arrhythmias. METHODS AND RESULTS: A total of 152 consecutive patients (98 males, 64.5%; mean age 64.9 ± 9.6 years) underwent a repeat ablation for recurrent atrial tachyarrhythmias after a median time of 6.5 months [IQR 11] from the index CB ablation. All repeat ablations were performed using a 3-dimensional electro-anatomical mapping system. Among all 593 PVs, 134 (22.6%) showed a late PV reconnection in 95 patients (0.88 per patient), at the time of repeat ablation procedure. There was a significant difference in ovality between left- and right-sided PVs (p

Atrial fibrillation (AF) is a commonly encountered chronic and progressive heart rhythm disorder, characterized by exacerbations and remissions. Contemporary clinical practice guidelines recommend a trial of antiarrhythmic drugs (AADs) as the initial therapy for sinus rhythm maintenance; however, these medications have modest efficacy and are associated with significant adverse effects. Recently, several trials have demonstrated that an initial treatment strategy of cryoballoon catheter ablation significantly improves arrhythmia outcomes (e.g. freedom atrial tachyarrhythmia and reduction in arrhythmia burden), produces clinically meaningful improvements in patient-reported outcomes (e.g. symptoms and quality of life), and significantly reduces subsequent healthcare resource utilization (e.g. hospitalization), without increasing the risk of serious or any adverse events. These findings are relevant to patients, providers, and healthcare systems, helping inform the decision regarding the initial choice of rhythm-control therapy in patients with treatment-naïve AF.

Background: Brugada syndrome (BrS) is caused by mutations in SCN5A gene in 15%-20% of cases. Previous studies showed worse prognosis in SCN5A mutation carriers (SCN5A+). To date, there are no data on genotype–phenotype correlation with electrocardiographic (ECG) imaging (ECGI) and high-density epicardial electroanatomic map. Objective: This study aimed to correlate SCN5A mutation with substrate severity in BrS assessed by ECGI and high-density electroanatomic map. Methods: All consecutive BrS patients undergoing ECGI and high-density epicardial electroanatomic map with HD Grid Mapping Catheter were retrospectively analyzed. On ECGI, the following parameters were analyzed before and after ajmaline administration: right ventricular outflow tract (RVOT) activation time (RVOT-AT) and RVOT recovery time (RVOT-RT). On electroanatomic map, the parameters analyzed before and after ajmaline were high-frequency potential activation time (HFPat), high-frequency potential duration (HFPd), high-frequency potential amplitude (HFPa), low-frequency potential activation time (LFPat), low-frequency potential duration (LFPd), and low-frequency potential amplitude (LFPa). Results: Thirty-nine BrS patients with ECGI were included. Eight patients (20.5%) were SCN5A+. At baseline ECGI map, mean RVOT-RT was longer in SCN5A+ (P = .024). After ajmaline administration, SCN5A+ patients showed longer RVOT-AT (125.6 vs 100.8 ms; P = .045) and longer RVOT-RT (426.4 vs 397 ms; P = .033). After ajmaline administration, SCN5A+ showed longer HFPat (164.1 vs 119.5 ms; P = .041); longer LFPat (272.7 vs 200.5 ms; P = .018); and longer LFPd (211.9 vs 151.2 ms; P = .033). Conclusion: In BrS, SCN5A+ patients compared with SCN5A– patients exhibit marked depolarization and repolarization abnormalities as assessed by ECGI and epicardial high-density electroanatomic map.

Introduction: Left atrial posterior wall isolation (LAPWI) is often performed in addition to pulmonary vein isolation (PVI) to improve outcome in patients with persistent atrial fibrillation (AF). In this setting, LAPWI + PVI using cryoballoon ablation had comparable results with radiofrequency ablation (RFA). The aim of the study is to evaluate the feasibility and safety of a new cryoballoon ablation system in PVI + LAPWI isolation, comparing it with the historical platform. Methods: The study was a prospective, non-randomized, single center study. Forty consecutive patients, undergoing PVI + LAPWI with the novel POLARx™, were compared to 40 consecutive patients who underwent the same procedure with the established Arctic Front Advance PRO™. Results: Acute isolation was achieved in all PVs in both groups and LAPWI was achieved in 38 patients (95%) in the POLARx group and in 36 patients (90%) in Arctic Front group. Procedural outcomes were similar between the two groups, except for lower temperatures during cryoapplications in the POLARx group, for both PVI and LAPWI. The complication rate was low and similar between groups. Conclusion: LAPWI+PVI with the novel POLARx™ Cryoballoon is feasible and safe; the results are comparable with the Arctic Front Advance PRO™ system.

Aims Hybrid atrial fibrillation (AF) ablation is a promising approach in non-paroxysmal AF. The aim of this study is to assess the long-term outcomes of hybrid ablation in a large cohort of patients after both an initial and as a redo procedure. Methods and results All consecutive patients undergoing hybrid AF ablation at UZ Brussel from 2010 to 2020 were retrospectively evaluated. Hybrid AF ablation was performed in a one-step procedure: (i) thoracoscopic ablation followed by (ii) endocardial mapping and eventual ablation. All patients received PVI and posterior wall isolation. Additional lesions were performed based on clinical indication and physician judgement. Primary endpoint was freedom from atrial tachyarrhythmias (ATas). A total of 120 consecutive patients were included, 85 patients (70.8%) underwent hybrid AF ablation as first procedure (non-paroxysmal AF 100%), 20 patients (16.7%) as second procedure (non-paroxysmal AF 30%), and 15 patients (12.5%) as third procedure (non-paroxysmal AF 33.3%). After a mean follow-up of 62.3 months ± 20.3, a total of 63 patients (52.5%) experienced ATas recurrence. Complications occurred in 12.5% of patients. There was no difference in ATas between patients undergoing hybrid as first vs. redo procedure (P = 0.53). Left atrial volume index and recurrence during blanking period were independent predictors of ATas recurrence. Conclusion In a large cohort of patients undergoing hybrid AF ablation, the survival from ATas recurrence was 47.5% at ≈5 years follow-up. There was no difference in clinical outcomes between patients undergoing hybrid AF ablation as first procedure or as a redo.

BACKGROUND: Inappropriate sinus tachycardia (IST) is defined as resting heart rate >100 beats/min and average 24-hour heart rate >90 beats/min. It is associated with distressing symptoms and significant loss of quality of life. Drugs are not effective in symptom control of IST in up to 30% of patients. Catheter ablation of the sinus node has a high recurrence rate, and the complications are significant. Recently, a novel hybrid sinus node-sparing ablation approach for IST was described. OBJECTIVE: The objective of the Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia (HEAL-IST) investigational device exemption trial (NCT05280093) is to evaluate safety and effectiveness of the hybrid sinus node-sparing ablation procedure for the treatment of symptomatic, drug-refractory or drug-intolerant IST. METHODS: The HEAL-IST trial is a prospective, multicenter, pivotal, single-arm trial. Up to 142 subjects in up to 40 centers will be treated in the trial with a Bayesian adaptive design. RESULTS: Subjects will be assessed for primary safety through 30 days post-hybrid ablation procedure. The primary effectiveness endpoint will be freedom from IST at 12 months. Freedom from IST will be defined as mean heart rate of ≤90 beats/min or at least a 15% reduction in mean heart rate as compared with baseline, in the absence of new or higher dosage of previously failed medications at a 24-month follow-up assessment. CONCLUSION: The HEAL-IST trial is the first multicenter trial evaluating hybrid IST ablation in patients with symptomatic IST and refractory or intolerant to drugs. The results of this study will help guide decision making regarding the best management in this population.

BACKGROUND: Medical treatment of inappropriate sinus tachycardia (IST) remains suboptimal. Radiofrequency sinus node (RF-SN) ablation has poor success and higher complication rates. OBJECTIVE: We aimed to compare clinical outcomes of the novel SN sparing hybrid ablation technique with those of RF-SN modification for IST management. METHODS: This is a multicenter prospective registry comparing the SN sparing hybrid ablation strategy with RF-SN modification. The hybrid procedure was performed using an RF bipolar clamp, isolating superior vena cava/inferior vena cava with the creation of a lateral line across the crista terminalis while sparing the SN region (identified by endocardial 3-dimensional mapping). RF-SN modification was performed by endocardial and/or epicardial mapping and ablation at the site of earliest atrial activation. RESULTS: Of the 100 patients (hybrid ablation group, n = 50; RF-SN group, n = 50), 82% were women, and the mean age was 22.8 years. Normal sinus rhythm and rate were restored in all patients in the hybrid group (vs 84% in the RF-SN group; P = .006). Hybrid ablation was associated with significantly better improvement in mean daily heart rate and peak 6-minute walk heart rate compared with RF-SN ablation. The RF-SN group had a significantly higher rate of redo procedures (100% vs 8%; P < .001), phrenic nerve injury (14% vs 0%; P = .012), lower acute pericarditis (48% vs 92%; P < .0001), permanent pacemaker implantation (50% vs 4%; P < .0001) than did the hybrid ablation group. CONCLUSION: The novel sinus node sparing hybrid ablation procedure appears to be more efficacious and safer in patients with symptomatic drug-resistant IST with long-term durability than RF-SN ablation.

Background: The lack of thermally and mechanically performant biomaterials represents the major limit for 3D-printed surgical guides, aimed at facilitating complex surgery and ablations. Methods: Cryosurgery is a treatment for cardiac arrhythmias. It consists of obtaining cryolesions, by freezing the target tissue, resulting in selective and irreversible damage. MED625FLX and TPU95A are two biocompatible materials for surgical guides; however, there are no data on their response to cryoenergy delivery. The study purpose is to evaluate the biomaterials' thermal properties, examining the temperature changes on the porcine muscle samples (PMS) when the biomaterials are in place during the cryoablation. Two biomaterials were selected, MED625FLX and TPU95A, with two thicknesses (1.0 and 2.5 mm). To analyze the biomaterials' behavior, the PMS temperatures were measured during cryoablation, firstly without biomaterials (control) and after with the biomaterials in place. To verify the biomaterials' suitability, the temperatures under the biomaterial samples should not exceed a limit of -30.0 °C. Furthermore, the biomaterials' geometry after cryoablation was evaluated using the grid paper test. Results: TPU95A (1.0 and 2.5 mm) successfully passed all tests, making this material suitable for cryoablation treatment. MED625FLX of 1.0 mm did not retain its shape, losing its function according to the grid paper test. Further, MED625FLX of 2.5 mm is also suitable for use with a cryoenergy source. Conclusions: TPU95A (1.0 and 2.5 mm) and MED625FLX of 2.5 mm could be used in the design of surgical guides for cryoablation treatment, because of their mechanical, geometrical, and thermal properties. The positive results from the thermal tests on these materials and their thickness prompt further clinical investigation. ispartof: JOURNAL OF CLINICAL MEDICINE vol:12 issue:3 ispartof: location:Switzerland status: published

Purpose: Drug-induced type I Brugada syndrome (BrS) is associated with a ventricular arrhythmia (VA) rate of 1 case per 100 person-years. This study aims to evaluate changes in electrocardiographic (ECG) parameters such as microvolt T wave alternans (mTWA) and heart rate variability (HRV) at baseline and during ajmaline testing for BrS diagnosis. Methods: Consecutive patients diagnosed with BrS during ajmaline testing with 5-year follow-up were included in this study. For comparison, a negative ajmaline control group and an isoproterenol control group were also included. ECG recordings during ajmaline or isoproterenol test were divided in two timeframes from which ECG parameters were calculated: a 5-min baseline timeframe and a 5-min drug timeframe. Results: A total of 308 patients with BrS were included, 22 (0.7%) of which suffered VAs during follow-up. One hundred patients were included in both isoproterenol and negative ajmaline control groups. At baseline, there was no difference in ECG parameters betweencontrol groups and patients with BrS, nor between BrS with and without VAs. During ajmaline testing, BrS with VAs presented longer QRS duration [159 ± 34 ms versus 138 (122–155) ms, p = 0.006], higher maximum mTWA [33.8 (14.0–114) µV versus 8.00 (3.67–28.2) µV, p = 0.001], and lower power in low frequency band [25.6 (5.8–53.8) ms 2 versus 129.5 (52.7–286) ms 2, p < 0.0001] when compared to BrS without VAs. Conclusions: Ajmaline induced important HRV changes similar to those observed during isoproterenol. Increased mTWA was observed only in patients with BrS. BrS with VAs during follow-up presented worse changes during ajmaline test, including lower LF power and higher maximum mTWA which were independent predictors of events.

We present the case of a 55-year-old patient with paroxysmal atrial fibrillation referred for pulmonary vein isolation (PVI) by means of pulsed-field ablation (PFA). Based on preprocedural imaging (computed tomography) showing a bilateral common ostium (CO) as PV variant, the larger penta-spline PFA catheter measuring 35 mm was selected for ablation. Bilaterally, acute PVI was observed during the first applications at the CO wiring the superior branches. Overall, eight application pairs were delivered with four pairs per CO (two pairs wiring superior and inferior branches, respectively, ‘basket’ and ‘flower petal’ deployment pose per pair). Pre- and post-ablation 3D ultra-high-density voltage map of the left atrium was acquired with a 64-pole basket mapping catheter (Orion). The post-ablation map confirmed acute PVI, but showed unexpected fused lesions on the lower posterior wall (PW) in addition (Panel B). Although the PFA applications were intentionally delivered for PVI, the finding of extended PW lesions may be explained by the larger sized PFA catheter, the relatively shorter posterior inter-venal distance (although still 39 mm), but clearly also by the unique property of PF technology to obtain tissue lesions not necessarily through high catheter contact, but also in the proximity of the tissue–electrodes interface.

BACKGROUND: Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. METHODS: Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary. RESULTS: Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P

Aims To identify predictors of individual late pulmonary vein (PV) reconnection after second-generation cryoballoon (CB2) ablation. Anatomic indicators of late pulmonary vein reconnection (LPVR) post-CB2 ablation have not yet been studied on an individual PV level, nor weighed against clinical and procedural factors. Methods and results Clinical, procedural, and PV anatomic data from 125 patients with a repeat procedure for arrhythmia recurrence after index CB2 ablation were analyzed. Preprocedural computed tomography (CT) evaluated 486 PVs for measurement of size; shape (ovality index); carina width; and orientation angle in frontal (superior/inferior) and transversal (anterior/posterior) plane (with horizontal line 0° as reference and upper/lower half circle as positive/negative value, respectively). Durable isolation in all PVs was demonstrated in 50/125 (40%) patients. Late reconnection rates at the different PVs were as follows: 16% left superior (LS), 12% left inferior (LI), 17% right superior (RS), and 31% right inferior (RI) PV. Multivariable analysis performed per vein showed following independent determinants predicting LPVR: ovality index [odds ratio (OR) 1.61, 95% confidence interval (CI) 1.07–2.41, P = 0.022] and carina width (OR 0.75, CI 0.59–0.96, P = 0.024) for LSPV; carina width (OR 0.71, CI 0.53–0.95, P = 0.020) for LIPV; frontal angle (OR 0.91, CI 0.87–0.95, P < 0.001) for RIPV; and transversal angle (OR 1.15, CI 1.03–1.31, P = 0.032) for RSPV. Conclusion Cardiac CT-based evaluation of anatomic PV characteristics presented higher predictive value compared to clinical and procedural variables for individual LPVR after CB2 ablation. Pre-procedural identification of unfavourable PV anatomy might be important to tailor the ablation approach.

Background Catheter ablation has become an established treatment option for premature ventricular complexes (PVCs). It is well known that the use of fluoroscopy exposes patients and medical staff to potentially harmful stochastic and deterministic effects of ionising radiations. We sought to analyse procedural outcomes in terms of safety and efficacy using a “zero” or “near zero” X rays approach for treatment of PVCs. Methods The present retrospective, multicentre, observational study included 131 patients having undergone catheter ablation of PVCs using zero or “near zero” (less than 2 minutes) fluoroscopy between 2016 and 2020 in 4 high-volume centres. Baseline characteristics of the population, acute success and complications derived from the procedure were evaluated, as well as recurrence rate during follow-up. Results Median age was 51.0 years old [38-63], males were 77 (58.8%). Most often cause of ablation were palpitations (90.0%), followed by reduced left ventricular ejection fraction (4.6%) and pre-syncope (14.5%). Among the study population, 26 (19.8%) had a cardiopathy. The median PVC burden before ablation was 15.1% [6%-22.4%]. The most frequent PVC origin was right ventricular outflow tract (n=72; 55.0%) followed by the left ventricle (n=21; 16.0%), LVOT and cusps (n=18; 13.7%),aortomitral continuity (n=7; 5.3%). A 3D electro-anatomical mapping system was used in all cases as well as a contact force catheter for mapping and ablation. The mean maximum radiofrequency power applied was 32.9 ± 4.1 W (median time: 370 sec). Median number of applications was 4.5 and mean total procedural time was 117.3 ± 47.5 minutes. Median best prematurity was 31.5 msec. We used isoprenaline in order to induce PVCs in 42% of cases and suppression of PVC was achieved in 127 patients (96.9%). There was only 2 complication (femoral hematoma and arteriovenous fistula conservatively treated). At 12 months, a complete success was documented in 109 patients (83.2%), a reduction in PVC burden was achieved in other 18 patients (13.7%) and a failure was recorded in 4 patients (3.1%). Conclusion The PVC ablation with “zero” or “near-zero” fluoroscopy is a safe procedure with no major complications and good rates of success and recurrence in our multicentre experience.

Introduction Atrial fibrillation (AF) is the most common sustained arrhythmia and an important risk factor for stroke and heart. Recent technology advances have allowed for heart rhythm monitoring using smart gadgets/wearable devices which can be used for early AF diagnosis. Hypothesis We performed a systemic review and meta-analysis to assess the accuracy of AF diagnosis by smart gadgets/wearable devices. Methods We systematically searched Medline, Embase and Cochrane electronic databases up to April 15th, 2022 for observational studies of the diagnostic accuracy of smartphone application, wrist-worn wearables and external devices in detecting AF. We calculated the area under the curve (AUC) of the summary receiver operating characteristic curves (SROC) and pooled sensitivities and specificities. Results A total of 79 studies were included enrolling 36903 patients, 66.3% male with average age of 68.3±8 years. In the overall analysis of all devices, the AUC was 0.99 (95% CI: 0.98-1.00), the sensitivity 95%(95% CI: 94–96%), the specificity 96%(95% CI: 96–97%). Wrist-worn wearables had AUC of 0.99 (95% CI: 0.98-1.00), the sensitivity 95%(9% CI: 92–97%), the specificity 97%(95% CI: 96–98%)(Figure 1A). Smartphone applications had AUC of 0.98 (95% CI: 0.96-0.99), the sensitivity 96%(9% CI: 94–97%), the specificity 96%(95% CI: 93–98%)(Figure 1B). External devices had AUC of 0.99 (95% CI: 0.98-1.00), the sensitivity 95%(9% CI: 93–97%), the specificity 96%(95% CI: 95–97%)(Figure 1C). Single-lead ECG had AUC of 0.99 (95% CI: 0.98- 1.00), the sensitivity 95%(9% CI: 92–96%), the specificity 96%(95% CI: 95–97%). PPG had AUC of 0.99 (95% CI: 0.98-1.00), the sensitivity 96%(9% CI: 95–97%), the specificity 97%(95% CI: 95–98%). Conclusions Smartphone application, wrist-worn devices and external devices with PPG and single-lead ECG have excellent diagnostic accuracy in atrial fibrillation diagnosis. Figure 1. Summary Receiver Operating Characteristic curves and Areas Under The Curve of Wrist-worn wearables (A), Smartphone applications (B) and External devices (C).

Background Atrial fibrillation (AF) and heart failure (HF) often coexist and syner-gistically contribute to an increased risk of hospitalization, stroke, and mortality. Objective: To compare the efficacy of catheter ablation (CA) versus medical therapy (MT) in HF patients with AF. Methods Electronic databases were queried for randomized controlled trials (RCTs) of CA versus MT of AF in patients with HF. Risk ratios (RRs), mean differences (MDs), and 95% confidence in-tervals (CIs) were measured using the Mantel–Haenszel method. Results A total of nine RCTs enrolling 2155 patients met the inclusion criteria. Compared to MT, CA led to a significant reduction in the composite of all-cause mortality and HF hospitalization (24.6% vs. 37.1%; RR: 0.65 (95% CI: 0.53–0.80); p < 0.0001) (Figure 1), all-cause mortality (8.8% vs. 13.6%; RR: 0.65 (95% CI: 0.51–0.82); p = 0.0005), HF hospitalization (15.4% vs. 22.4%; (RR: 0.67 (95% CI: 0.54–0.82); p = 0.0001), AF re-currence (31.8% vs. 77.0%; RR: 0.36 (95% CI: 0.24–0.54); p < 0.0001), and cardiovascular (CV) death (4.9% vs. 8.4%; RR: 0.58 (95% CI: 0.39–0.86); p = 0.007). CA improved the left ventricular ejection fraction (MD:4.76% (95% CI: 2.35–7.18); p = 0.0001), 6 min walk test (MD: 20.48 m (95% CI: 10.83–30.14); p < 0.0001), peak oxygen consumption (MD: 3.1 2mL/kg/min (95% CI: 1.01–5.22); p = 0.004), Minnesota Living with Heart Failure Questionnaire score (MD: −6.98 (95% CI: −12–03, −1.93); p = 0.007), and brain natriuretic peptide levels (MD:−133.94 pg/mL (95% CI: −197.33, −70.55); p < 0.0001). Conclusions In HF patients, AF catheter ablation was superior to MT in re-ducing CV and all-cause mortality. Further significant benefits occurred within the ablation group in terms of HF hospitalizations, AF recurrences, the systolic function, exercise capacity, and quality of life. Figure 1: Forest plot displaying a decrease in the composite endpoint in patients with AF and HF undergoing CA versus MT.

Introduction The Implantable Cardioverter Defibrillator (ICD) has been demonstrated to successfully prevent sudden cardiac death in children and young adults. A wide range of device-related complications/malfunctions have been described, which depend on the intrinsic design of the defibrillation system [Transvenous (TV-ICD) vs Subcutaneous (S-ICD)]. Objective To compare the device-related complications and inappropriate shocks with TV-ICD vs S-ICD. Methods Electronic databases were queried for studies focusing on the prevention of SCD in children and young adults with TV-ICD or S-ICD. The effect size was estimated using a random-effect model as Odds Ratio (OR) and relative 95% Confidence Interval (CI). The primary endpoint was a composite of any device-related complications and inappropriate shocks. Results We identified a total of 5 studied including 236 patients (Group S-ICD: 76 patients; Group TV-ICD: 160 patients) with a mean follow-up time of 54.2 ± 24.9 months. S-ICD implantation contributed to a significant reduction in the risk of the primary endpoint of any device-related complications and inappropriate shock (OR:0.18; 95% CI: 0.05 - 0.73; p=0.02)(Figure 1). S-ICD was also associated with a significantly lower incidence of inappropriate shocks (OR:0.28; 95% CI: 0.11 - 0.74; p=0.01) and lead-related complications (OR:0.18; 95% IC: 0.05 - 0.66; p=0.01). Otherwise, a trend towards a higher risk of pocket complications (OR:5.91; 95% CI: 0.98 - 35.63; p=0.05) was recorded in patients with S-ICD. Conclusion Children and young adults undergoing S-ICD implantation may have a lower risk of a composite of device-related complications and inappropriate shocks, compared to TV-ICD patients.

BACKGROUND: This study aimed to evaluate the feasibility and safety of an innovative "all in one" integrated transseptal crossing device to achieve transseptal puncture (TSP). METHODS: Twenty patients (10 males, mean age 65.65 ± 9.25 years), indicated to supraventricular left side tachyarrhythmia ablation, underwent TSP using a new-generation integrated crossing device, and a control cohort of twenty patients (10 males, mean age 65.5 ± 10.12 years) underwent TSP using the traditional TSP system. RESULTS: In all the study patients, the novel TSP device led to a successful and safe access to the left atrium (LA). The mean transseptal time, defined as the time occurring between the groin puncture and the advancing of the guidewire into the left superior pulmonary vein (PV), was 3 min 33 s ± 44 s, 7 min 5 s ± 36 s in the control cohort. Additionally, we compared the cost of the two systems. No acute complications related to the TSP were noted in both cohorts. CONCLUSIONS: TSP performed with the new integrated transseptal system is feasible and safe.

INTRODUCTION: The implantable cardioverter defibrillator (ICD) has been demonstrated to successfully prevent sudden cardiac death (SCD) in children and young adults. A wide range of device-related complications/malfunctions have been described, which depend on the intrinsic design of the defibrillation system (transvenous-implantable cardioverter defibrillator [TV-ICD] vs. subcutaneous-implantable cardioverter defibrillator [S-ICD]). OBJECTIVE: To compare the device-related complications and inappropriate shocks with TV-ICD versus S-ICD. METHODS AND RESULTS: Electronic databases were queried for studies focusing on the prevention of SCD in children and young adults with TV-ICD or S-ICD. The effect size was estimated using a random-effect model as odds ratio (OR) and relative 95% confidence interval (CI). The primary endpoint was a composite of any device-related complications and inappropriate shocks. We identified a total of five studies including 236 patients (Group S-ICD: 76 patients; Group TV-ICD: 160 patients) with a mean follow-up time of 54.2 ± 24.9 months. S-ICD implantation contributed to a significant reduction in the risk of the primary endpoint of any device-related complications and inappropriate shocks (OR: 0.18; 95% CI: 0.05-0.73; p = .02). S-ICD was also associated with a significantly lower incidence of inappropriate shocks (OR: 0.28; 95% CI: 0.11-0.74; p = .01) and lead-related complications (OR: 0.18; 95% CI: 0.05-0.66; p = .01). A trend toward a higher risk of pocket complications (OR: 5.91; 95% CI: 0.98-35.63; p = .05) was recorded in patients with S-ICD. CONCLUSION: Children and young adults undergoing S-ICD implantation may have a lower risk of a composite of device-related complications and inappropriate shocks, compared to TV-ICD patients.

To evaluate coronary artery disease (CAD) with computed tomography coronary angiography (CTCA)-derived fractional flow reserve (FFR) in patients with atrial fibrillation (AF) requiring ablation. The study population consisted of 151 patients who underwent CTCA before AF ablation (AF group), and a control group of 151 patients from the outpatient clinic who underwent CTCA without any history of AF (non-AF group), matched for age, sex, BMI, and angina symptomatology. All study patients underwent CTCA with subdivision of coronary lesion type into severe (≥ 70% luminal narrowing), moderate (50% ≤ luminal narrowing < 70%), and mild stenosis (< 50% luminal narrowing). In patients with ≥ 1 moderate or severe stenosis, non-invasive FFR was calculated from CTCA (FFR CT). Baseline characteristics and CAD risk factors were similar between the 2 groups. During CTCA, 38% of the patients in the AF group were in ongoing atrial arrhythmia (either AF or regular atrial tachycardia). The number of patients with severe (10 (6.6%) vs 10 (6.6%), P = 1.00), moderate (14 (9.5%) vs 10 (6.7%), P = 0.4), and mild stenosis (43 (28.5%) vs 56 (37.1%), P = 0.11) was not significantly different between the 2 groups. Performance of FFR CT was feasible in 32/44 patients (73%), and failed in 27% of the patients (7 and 5 patients in the AF and non-AF group, respectively, P = 0.74). No difference was observed in the prevalence of hemodynamically significant stenosis (FFR CT ≤ 0.80) (15 (9.9%) vs 12 (7.9%), P = 0.85). Our study showed technical feasibility of CTCA in all patients of both groups, including the patients with AF as presenting rhythm. The FFR CT add-on analysis failed equally frequent in patients of the AF versus non-AF group. An equal rate of CAD was observed in the AF group and non-AF group, favoring the concept of shared associated risk factors for CAD and AF.