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Background: The programing of subcutaneous implantable cardioverter‐defibrillators (S‐ICD) in clinical practice has been little studied, as the activation status of the SMART Pass filter, which was implemented to reduce inappropriate shocks. Purpose: We assessed device programing during follow‐up and the rate of detected arrhythmias in consecutive S‐ICD recipients. Methods: We analyzed data from 670 S‐ICD patients followed on the remote network at 17 Italian centers for a median of 31 months (25th–75th percentile: 16–51). The enhanced SMART Pass version, introduced in October 2022, was expected to reduce the unintentional deactivation rate. Results: At the latest remote data transmission, the median conditional zone cut‐off was set to 210 bpm (25th–75th percentile: 200–220), the shock zone cutoff was 250 bpm (25th–75th percentile: 240–250), and the SMART Pass was enabled in 586 (87%) patients. During follow‐up, 194 automatic deactivation events were reported in 118 (18%) patients. Shocks were delivered in 129 (19%) patients, and untreated arrhythmias were recorded in 136 (20%) patients. The rate of shocks was lower when SMART Pass was enabled ‐0.12/patient‐year (95% CI: 0.10–0.14) versus 0.20 (95% CI: 0.15–0.26) (p =.002), as it was the rate of untreated arrhythmias ‐0.12/patient‐year (95% CI: 0.11–0.14) versus 0.23 (95% CI: 0.18–0.30) (p =.001). The enhanced SMART Pass version was associated with a lower rate of deactivations ‐0.04/patient‐year (95% CI: 0.02–0.05) versus 0.14 (95% CI: 0.12–0.16) (p <.001), and with a reduction in treated and untreated arrhythmias (Incidence rate ratios: 0.40 (95% CI: 0.28–0.53) and 0.40 (95% CI: 0.30–0.55), respectively (p <.001)). Conclusions: Centers tend to program devices to detect high ventricular rates for arrhythmia detection, to minimize inappropriate shock occurrences. SMART Pass activation is associated with lower rates of detected and treated arrhythmias. The enhanced SMART Pass version seems associated with a lower deactivation rate and with a further decrease in treated arrhythmias. [ABSTRACT FROM AUTHOR]

Introduction: Patients with Brugada syndrome (BrS) face an increased risk of ventricular arrhythmias and sudden cardiac death. Implantable cardiac monitors (ICMs) have emerged as effective tools for detecting arrhythmias in BrS. Technological advancements, including temperature sensors and improved subcutaneous electrocardiogram (subECG) signal quality, hold promise for further enhancing their utility in this population. Methods and results: We present a case of a 40‐year‐old man exhibiting a BrS type 2 pattern on 12‐lead ECG, who underwent ICM insertion (BIOMONITOR IIIm, BIOTRONIK) due to drug‐induced BrS type 1 pattern and a history of syncope, with a negative response to programmed ventricular stimulation. The device contains an integrated temperature sensor and can transmit daily vital data, such as mean heart rate and physical activity. Several months later, remote alerts indicated a temperature increase, along with transmitted subECGs suggesting a fever‐induced BrS type 1 pattern. The patient was promptly advised to commence antipyretic therapy. Over the following days, remotely monitored parameters showed decreases in mean temperature, physical activity, and mean heart rate, without further recurrence of abnormal subECGs. Conclusion: ICMs offer valuable insights beyond arrhythmia detection in BrS. Early detection of fever using embedded temperature sensors may improve patient management, while continuous subECG morphological analysis has the potential to enhance risk stratification in BrS patients. [ABSTRACT FROM AUTHOR]

Introduction: Recently, a new cryoballoon (CB) technology (POLARx; Boston Scientific) has come onto the market. Preliminary data have shown that its acute safety and efficacy are similar to those of the first‐generation CB. The aim of this study was to assess the medium‐term outcome of pulmonary vein isolation (PVI) with the POLARxTM CB in a large multicenter registry. Methods: We prospectively collected data on 125 consecutive patients with paroxysmal atrial fibrillation (AF) who underwent PVI by means of a novel CB system. Two cases of transient phrenic nerve palsy occurred, with full recovery in the 48h post procedure; no major procedure‐related adverse events were reported. During the 90‐day blanking period, 4 (3.2%) patients experienced an early recurrence. After the blanking period, over a mean follow‐up of 411 ± 62 days, 19 patients (15.2%) suffered an AF/atrial tachycardia (AT) recurrence. The 1‐year freedom from AF/AT recurrence was 86.4% (n = 17): 10 (8%) patients had an AF recurrence, 6 (4.8%) had an AT occurrence and 1 (0.8%) suffered both events. Patients with AF/AT recurrences had both a shorter deflation time and total deflation time. Moreover, CB ablations with measured TTI < 90 s and TTI < 60 s were more frequent in patients without AF/AT recurrence (88.5% and 77.4%, respectively) than in those who experienced at least one AF/AT recurrence (67.5% and 55.0%, p =.001 and p =.005, respectively). Conclusion: The novel POLARx cryo‐balloon system is safe and effective for PV isolation, displaying a 1‐year freedom from atrial arrhythmia recurrence of 86.4%, which is in line to that reported with AFA‐Pro CB or RF ablation. Clinical trial registration: Catheter Ablation of Arrhythmias with a High‐Density Mapping System in Real‐World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998. Registration date: January 4, 2019. [ABSTRACT FROM AUTHOR]

Background: It has been observed that the fourth‐generation cryoballoon (CB4) ablation catheter increased the rate of acute real‐time recordings of pulmonary vein isolation (PVI) during the ablation for the treatment of atrial fibrillation (AF). The aim of this analysis was to compare the long‐term outcome results between patients treated with the CB4 and second‐generation cryoballoon (CB2). Methods: In total, 492 patients suffering from AF, underwent PVI ablation with either the CB2 or CB4 catheter within this examination of the 1STOP real‐world Italian project and were included in the analysis. Specifically, 246 consecutive patients treated by CB4 were compared to 246 propensity‐matched control patients who underwent PVI using CB2. Results: When comparing the patient cohorts treated with CB2 versus CB4, acute success rate (99.6 ± 4.7% vs. 99.7 ± 3.6%, p =.949) and peri‐procedural complications (3.7% vs.1.2%, p =.080) were similar in both groups, respectively. However, procedure time (100 vs.75 min, p <.001) and fluoroscopy duration (21 vs.17 min, p <.001) were all significantly lower in the CB4 treated patient cohort. At the 12‐month follow‐up, the freedom from AF recurrence after a 90‐day blanking period was significant higher in the CB4 as compared with the CB2 group (93.3% vs.81.3%, p <.001). Conclusions: In summary, usage of the CB4 ablation catheter increased the rate of acute PVI recording capability and resulted in a higher rate of long‐term PVI success, as demonstrated by the reduced rate of AF recurrence in comparison to the CB2 cohort at the 12‐month follow‐up period. [ABSTRACT FROM AUTHOR]

Background: Left atrial posterior wall isolation (LAPWI) is often performed in addition to pulmonary vein isolation (PVI) in the setting of persistent atrial fibrillation (AF) ablation. The aim of this study was to evaluate the feasibility and safety of a new cryoballoon ablation system in achieving PVI + LAPWI isolation. 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 left posterior wall isolation (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 both groups, except for lower temperatures during cryoenergy in the POLARx group, for both pulmonary vein isolation (PVI) and LAPWI. Conclusion: LAPWI + PVI with the novel POLARx™ Cryoballoon is feasible and safe; the results are comparable with the Arctic Front Advance PRO™ system. [ABSTRACT FROM AUTHOR]

Background: Pulmonary veins isolation (PVI) by cryoballoon (CB) ablation is marginally represented in clinical studies in obese patients. The aim of this analysis was to evaluate the safety and efficacy of CB‐PVI in a large cohort of overweight and obese patients from the 1STOP project. Methods: From 2012 to 2018, 2048 patients with atrial fibrillation (AF) (70% male, 59 ± 11 years; 75% paroxysmal AF) underwent index CB‐PVI. The patient data were separated into three cohorts for statistical evaluation, including: normal weight (body mass index [BMI] < 25 kg/m2), overweight (BMI = 25‐30 kg/m2), and obese patients (BMI > 30 kg/m2). Results: Out of 2048 patients, 693 (34%) patients had a BMI < 25 and were deemed as normal. There were 944 (46%) patients categorized as overweight (BMI = 25‐30) and 411 (20%) as obese (BMI > 30). Overweight or obese patients were more often in persistent AF, had more frequently hypertension and diabetes, had higher CHA2DS2‐VASc score, and had a number of failed antiarrhythmic drug (AAD). Periprocedural complication rates were similar among the three cohorts. The 12‐month freedom from AF recurrence was 76.4% in the normal BMI group as compared to 79.2% in the overweight and 73.5% in the obese group (p =.35). However, 48% of overweight patients were on AAD treatment during the follow‐up. By multivariate analysis, BMI was not a predictor for AF recurrence following the index CB‐PVI. Conclusion: CB‐PVI in obese patients is a safe procedure. Increased BMI (either moderate or severe) does not seem to be associated with a worse outcome or to a different rate of AAD discontinuation at 12 months. [ABSTRACT FROM AUTHOR]

Background: Which technique is better for repeat ablation in patients with atrial fibrillation (AF) remains unclear. The aim of the study was to compare long‐term efficacy of repeat ablation using the alternative technique for the first redo ablation procedure: (a) cryoballoon (CB) re‐ablation after a failed index pulmonary vein isolation (PVI) with radiofrequency (RF) ablation, RF‐then‐CB group or (b) RF repeat ablation following a failed CB ablation, CB‐then‐RF group. Methods: Within the 1STOP Italian Project, consecutive patients undergoing repeat ablation with a different technique from the index procedure were included. Results: We studied 474 patients, 349 in RF‐then‐CB and 125 in CB‐then‐RF group. Less women (21% vs 30%; P =.041), more persistent AF (33% vs 22%; P =.015), longer duration of AF (60 vs 31 months; P <.001), and more hypertension (50% vs 36%; P =.007) were observed in the RF‐then‐CB cohort as compared with the CB‐then‐RF group. The number of reconnected PVs was 3.7 ± 0.7 and 1.4 + 1.3 in RF‐then‐CB and CB‐then‐RF group, respectively (P <.001). During the follow‐up, significantly less AF recurrence occurred in the CB‐then‐RF group (22% vs 8%, HR = 0.46; 95% CI: 0.24‐0.92; P =.025). Cohort designation was the only independent predictor of AF recurrence. Conclusion: Alternation of energy source for repeat ablation was safe and effective, regardless the energy used first. However, patients initially treated with CB PVI undergoing repeat ablation with RF current had less AF recurrence at long‐term follow‐up as compared with those originally treated by RF ablation receiving a CB repeat ablation. [ABSTRACT FROM AUTHOR]

Aims: Leadless pacemaker (LDP) allows implantation using a femoral approach. This access could be utilized for conventional atrioventricular nodal ablation (AVNA). It could facilitate unifying the two procedural components. Data regarding its feasibility and long‐term outcomes remain lacking. We aim to evaluate the feasibility and long‐term outcomes of sequential LDP and AVNA. Methods: Prospective, observational multicenter study including consecutive patients with indication for single‐chamber pacemaker placement. In those with additional indication for AVNA, ablation was performed immediately after the LPD through the same sheath. Results: A total of 137 patients were included. Mean age was 77.9 ± 10.5 years; 74 (54%) were men. Immediately following LDP implantation, 27 patients (19.7%) underwent concurrent AVNA. There were six (5.5%) complications in patients referred for LDP procedures and three (11%) in those who underwent a combined approach. None of these complications were solely attributable to the added AVNA component. No mechanical dislodgement, electrical damage to any device, or electromagnetic interference ever took place. During a mean follow‐up period of 123 ± 48 days, three patients (3.6%) died of noncardiovascular causes. The remaining population stayed alive without significant arrhythmias. There were no relevant differences with regard to sensing and pacing thresholds between patients in the two groups. Conclusions: AVNA can safely be performed immediately following LDP. A combined approach obviates the need for additional vascular access and optimizes feasibility and comfort for patients and healthcare providers. It offers an acceptable safety and efficacy profile, both acutely and upon intermediate‐term follow‐up. [ABSTRACT FROM AUTHOR]

Background Catheter ablation (CA) is recommended for patients with drug refractory symptomatic atrial fibrillation (AF). 'One Shot' catheters have been introduced to simplify CA and cryoballoon ablation (CBA) is spreading rapidly. Few real-world data are available on standard clinical practice, mainly from single-center experience. We aimed to evaluate clinical settings, demographics, and acute procedural outcomes in a large cohort of patients treated with CBA. Methods A total of 903 patients (73% male, mean age 59 ± 11) underwent pulmonary vein CBA. Correlations between the patient's inclusion time and clinical characteristics, procedure duration, acute success rate, and intraprocedural complications were evaluated. Results Seventy-seven percent of patients were affected by paroxysmal AF and 23% by persistent AF. Overall, acute success rate was 97.9% and periprocedural complications were observed in 35 (3.9%) patients, 13 (1.4%) of which were classified as major complications. With respect to the patient's inclusion time analysis, an increase in treatment of persistent AF was observed, a significant decrease in CBA times (procedure, ablation, and fluoroscopy: 136.0 ± 46.5 minutes, 28.8 ± 19.6 minutes, and 34.3 ± 15.4 minutes, respectively) was observed, with comparable acute success rate and intraprocedural complications over time. The rate of major complications was extremely low (1.4%); no death, atrioesophageal fistula, stroke, or other major periinterventional or late complications occurred. Conclusion This series represents the largest experience of CBA in the treatment of AF that also describes the adoption curve of this relatively recent technology. CBA showed an excellent safety profile when performed in a large real-world clinical setting, with satisfactory acute success rate and, on average, short procedural times. Clinical Trial Registration (NCT01007474) [ABSTRACT FROM AUTHOR]

Purpose: Some implantable cardioverter-defibrillators (ICDs) are now able to monitor intrathoracic impedance. The aim of the study was to describe the use of such monitoring in clinical practice and to evaluate the clinical impact of the fluid accumulation alert feature of these ICDs. Methods and Results: Five hundred thirty-two heart failure (HF) patients implanted with these ICDs were followed up for 11 ± 7 months. A clinical event (CE) was deemed to have occurred if it resulted in hospitalization or milder manifestations of HF deterioration. Three hundred sixty-two acute decreases in intrathoracic impedance (Z events) occurred in 230 patients. Of these episodes, 171 (47%) were associated with a CE within 2 weeks of the Z event. In another 71 (20%) Z events, drug therapy was adjusted despite the absence of overt signs of clinical deterioration. The rate of unexplained Z events was 0.25 per patient-year and 25 hospitalizations were not associated with Z events. The audible alert was disabled in a group of 102 patients (OFF group). HF hospitalizations occurred in 29 (7%) patients in the ON group and 20 (20%, P < 0.001) patients in the OFF group. The rate of combined cardiac death and HF hospitalization was lower in patients with Alert ON (log-rank test, P = 0.007). Conclusions: The ICD reliably detected CE and yielded low rates of unexplained and undetected events. The alert capability seemed to reduce the number of HF hospitalizations by allowing timely detection and therapeutic intervention. [ABSTRACT FROM AUTHOR]