Implantable defibrillator-detected heart failure status predicts ventricular tachyarrhythmias.

INTRODUCTION: The prediction of ventricular tachyarrhythmias among patients with implantable cardioverter defibrillators is difficult with available clinical tools. We sought to assess whether in patients with heart failure (HF) and reduced ejection fraction with defibrillators, physiological sensor-based HF status, as summarized by the HeartLogic index, could predict appropriate device therapies. METHODS: Five hundred and sixty-eight consecutive HF patients with defibrillators (n = 158, 28%) or cardiac resynchronization therapy-defibrillators (n = 410, 72%) were included in this prospective observational multicenter analysis. The association of both HeartLogic index and its physiological components with defibrillator shocks and overall appropriate therapies was assessed in regression and time-dependent Cox models. RESULTS: Over a follow-up of 25 (15-35) months, 122 (21%) patients received an appropriate device therapy (shock, n = 74, 13%), while the HeartLogic index crossed the threshold value (alert, HeartLogic ≥ 16) 1200 times (0.71 alerts/patient-year) in 370 (65%) subjects. The occurrence of ≥1 HeartLogic alert was significantly associated with both appropriate shocks (Hazard ratios [HR]: 2.44, 95% confidence interval [CI]: 1.49-3.97, p = .003), and any appropriate defibrillator therapies. In multivariable time-dependent Cox models, weekly IN-alert state was the strongest predictor of appropriate defibrillator shocks (HR: 2.94, 95% CI: 1.73-5.01, p < .001) and overall therapies. Compared with stable patients, patients with appropriate shocks had significantly higher values of HeartLogic index, third heart sound amplitude, and resting heart rate 30-60 days before device therapy. CONCLUSION: The HeartLogic index is an independent dynamic predictor of appropriate defibrillator therapies. The combined index and its individual physiological components change before the arrhythmic event occurs.

Pulmonary vein isolation by means of a novel cryoballoon technology in paroxysmal atrial fibrillation patients: 1-year outcome from a large Italian multicenter clinical registry.

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.

A reproducible sensor pattern to suspect COVID19 pulmonary infection with LATITUDE. Case report and literature review.

A 78 year-old patient with postischaemic dilated cardiomyopathy and severely reduced ejection fraction was implanted with a Boston Scientific RESONATE X4 CRT-D and followed by LATITUDE remote monitoring platform. From the end of January to the end of March 2021 he was hospitalized for COVID19 pneumonia followed by two episodes of acute heart decompensation with bilateral pleural effusion. We remotely followed the patient and identified a typical Heart Logic sensor pattern linked to the COVID19 pneumonia, different from the one linked to the heart failure (HF). We eventually made a literature review on the topic.

Minimal fluoroscopy approach for right-sided supraventricular tachycardia ablation with a novel ablation technology: Insights from the multicenter CHARISMA clinical registry.

BACKGROUND: No data exist on the ability of the novel Rhythmia 3-D mapping system to minimize fluoroscopy exposure during transcatheter ablation of arrhythmias. We report data on the feasibility and safety of a minimal fluoroscopic approach using this system in supraventricular tachycardia (SVT) procedures. METHODS: Consecutive patients were enrolled in the CHARISMA registry at 12 centers. All right-sided procedures performed with the Rhythmia mapping system were analyzed. The acquired electroanatomic information was used to reconstruct 3-D cardiac geometry; fluoroscopic confirmation was used whenever deemed necessary. RESULTS: Three hundred twenty-five patients (mean age = 56 ± 17 years, 57% male) were included: 152 atrioventricular nodal reentrant tachycardia, 116 atrial flutter, 41 and 16 right-sided accessory pathway and atrial tachycardia, respectively. Overall, 27 481 s of fluoroscopy were used (84.6 ± 224 s per procedure, equivalent effective dose = 1.1 ± 3.7 mSv per patient). One hundred ninety-two procedures (59.1%) were completed without the use of fluoroscopy (zero fluoroscopy, ZF). In multivariate analysis, the presence of a fellow in training (OR = 0.15, 95% CI: 0.05-0.46; p = .0008), radiofrequency application (0.99, 0.99-1.00; p = .0002), and mapping times (0.99, 0.99-1.00; p = .042) were all inversely associated with ZF approach. Acute procedural success was achieved in 97.8% of the cases (98.4 vs. 97% in the ZF vs. non-ZF group; p = .4503). During a mean of 290.7 ± 169.6 days follow-up, no major adverse events were reported, and recurrence of the primary arrhythmia was 2.5% (2.1 vs. 3% in the ZF vs. non-ZF group; p = .7206). CONCLUSIONS: The Rhythmia mapping system permits transcatheter ablation of right-sided SVT with minimal fluoroscopy exposure. Even more, in most cases, the system enables a ZF approach, without affecting safety and efficacy.

Pulmonary vein isolation in atrial fibrillation patients guided by a novel local impedance algorithm: 1-year outcome from the CHARISMA study.

BACKGROUND: Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have recently emerged as a viable real-time indicator of tissue characteristics and durability of the lesions created. We report the outcomes of acute and long-term clinical evaluation of the new DirectSense algorithm in AF ablation. METHODS: Consecutive patients undergoing AF ablation were included in the CHARISMA registry. RF delivery was guided by the DirectSense algorithm, which records the magnitude and time-course of the impedance drop. The ablation endpoint was pulmonary vein isolation (PVI), as assessed by the entrance and exit block. RESULTS: 3556 point-by-point first-pass RF applications of >10 s duration were analyzed in 153 patients (mean age=59 ± 10 years, 70% men, 61% paroxysmal AF, 39% persistent AF). The mean baseline LI was 105 ± 15 Ω before ablation and 92 ± 12 Ω after ablation (p < .0001). Both absolute drops in LI and the time to LI drop (LI drop/τ) were greater at successful ablation sites (n = 3122, 88%) than at ineffective ablation sites (n = 434, 12%) (14 ± 8 Ω vs 6 ± 4 Ω, p < .0001 for LI; 0.73 [0.41-1.25] Ω/s vs. 0.35[0.22-0.59 Ω/s, p < .0001 for LI drop/τ). No major complications occurred during or after the procedures. All PVs had been successfully isolated. During a mean follow-up of 366 ± 130 days, 18 patients (11.8%) suffered an AF/atrial tachycardia recurrence after the 90-day blanking period. CONCLUSION: The magnitude and time-course of the LI drop during RF delivery were associated with effective lesion formation. This ablation strategy for PVI guided by LI technology proved safe and effective and resulted in a very low rate of AF recurrence over 1-year follow-up.

Safety, efficacy, and reproducibility of cavotricuspid isthmus ablation guided by the ablation index: acute results of the FLAI study.

AIMS: Ablation index (AI) is a marker of lesion quality during catheter ablation that incorporates contact force, time, and power in a weighted formula. This index was originally developed for pulmonary vein isolation as well as other left atrial procedures. The aim of our study is to evaluate the feasibility and efficacy of the AI for the ablation of the cavotricuspid isthmus (CTI) in patients presenting with typical atrial flutter (AFL). METHODS AND RESULTS: This prospective multicentre non-randomized study enrolled 412 consecutive patients with typical AFL undergoing AI-guided cavotricuspid isthmus ablation. The procedure was performed targeting an AI of 500 and an inter-lesion distance measurement of ≤6 mm. The primary endpoints were CTI 'first-pass' block and persistent block after a 20-min waiting time. Secondary endpoints included procedural and radiofrequency duration and fluoroscopic time. A total of 412 consecutive patients were enrolled in 31 centres (mean age 64.9 ± 9.8; 72.1% males and 27.7% with structural heart disease). The CTI bidirectional 'first-pass' block was reached in 355 patients (88.3%), whereas CTI block at the end of the waiting time was achieved in 405 patients (98.3%). Mean procedural, radiofrequency, and fluoroscopic time were 56.5 ± 28.1, 7.8 ± 4.8, and 1.9 ± 4.8 min, respectively. There were no major procedural complications. There was no significant inter-operator variability in the ability to achieve any of the primary endpoints. CONCLUSION: AI-guided ablation with an inter-lesion distance ≤6 mm represents an effective, safe, and highly reproducible strategy to achieve bidirectional block in the treatment of typical AFL.

Early rhythm-control ablation therapy to prevent atrial fibrillation recurrences: Insights from the CHARISMA Registry.

BACKGROUND: An early, comprehensive rhythm-control therapy is needed in order to treat atrial fibrillation (AF) effectively and to improve ablation outcomes. METHODS: A total of 153 consecutive patients from the CHARISMA registry undergoing AF ablation at eight centers were included. Patients with de novo PVI were classified as having undergone early treatment (ET) if the procedure was performed within 6 months after the first AF episode, and as having undergone delayed treatment (DT) if ablation was performed over 6 months after the first AF episode. RESULTS: One-hundred fifty-three patients were enrolled (69.9% male, 59 ± 10 years, 61.4% paroxysmal AF, 38.6% persistent AF). The time from the first AF episode to the ablation procedure was 1034 ± 1483 days. The ET group comprised 36 patients (25.3%), the DT group 60 (39.2%) and Redo cases were 57 (37.3%). During a mean follow-up of 366 ± 130 days, 18 patients (11.8%) suffered an AF/AT recurrence. More DT patients than ET patients suffered recurrences (15.7% vs. 2.2%, p = 0.0452) and the time to AT/AF recurrence was shorter in the group of patients who received an ablation treatment after 6 months (HR = 6.19, 95% CI: 1.7 to 21.9; p = 0.0474). On multivariate Cox analysis, only hypertension (HR = 4.86, 95% CI: 1.6 to 14.98, p = 0.0062) was independently associated with recurrences. Beyond the hypertension risk factor, ET was associated with a low risk of recurrence; recurrence rate ranged from 0% (ET patients without hypertension) to 25.0% (DT patients with hypertension). CONCLUSIONS: An early rhythm-control ablation therapy in the absence of common risk factors was associated with the lowest rate of recurrences.

Catheter Ablation of Atrial Fibrillation in Heart Failure: from Evidences to Guidelines.

PURPOSE OF REVIEW: Catheter ablation of atrial fibrillation in heart failure seems to be the way to improve the quality of life, life expectance, and prognosis. In this review, we outline the growing role of this therapy and which patients can benefit from it. RECENT FINDINGS: While previous studies comparing rate control and rhythm control had not demonstrated the superiority of rhythm control in the prognosis of patients with atrial fibrillation and heart failure, recent findings seem to demonstrate that catheter ablation of atrial fibrillation reduces mortality and hospitalization for heart failure and improves the quality of life, when compared to medical therapy alone. An early rhythm-control strategy in atrial fibrillation may reduce cardiovascular death, stroke, hospitalization for HF, or acute coronary syndrome. Catheter ablation in heart failure is an effective and safe solution to obtain a rhythm control and, therefore, to improve outcomes. A better selection of the patients could help to avoid futile procedures and to identify patients requiring a closer follow-up, to redo procedures, or the addition of antiarrhythmic drugs.

Serratus anterior plane block in subcutaneous implantable cardioverter defibrillator implantation: A case-control analysis.

BACKGROUND: A two-incision technique, in association with inter-muscular positioning of the subcutaneous defibrillator (S-ICD), is now the most frequently adopted implantation approach in Europe. Ultrasound-guided serratus anterior plane block (SAPB) has been proposed to provide anesthesia/analgesia during S-ICD implantation. OBJECTIVE: We performed a case-control analysis in which a standardized SAPB approach was compared with the typical local anesthesia and sedation approach. METHODS: Ninety-one consecutive patients underwent implantation of an S-ICD with the SAPB approach for anesthesia/analgesia at 10 centers. The control group consisted of 55 consecutive patients who underwent S-ICD implantation with a standard local approach. RESULTS: The mean procedure duration was 59 ± 15 minutes in the SAPB group and 76 ± 23 minutes in the control group (P < .001). No operative complications were reported in either group. During the procedure, 79 (87%) patients in the SAPB group and 25 (46%) patients in the control group (P < .001) remained awake. Lower values of pain intensity at the device pocket (P = .005) and the lateral tunneling site (P = .046) were reported in the SAPB group. The difference in static (P = .002) and dynamic (P = .007) pain intensity between the groups persisted at 1 hour, while no differences were observed 6 hours after the end of the procedure. CONCLUSIONS: SAPB is feasible and effective in providing anesthesia/analgesia during S-ICD implantation. The procedures were successfully accomplished and no complications occurred in either group. However, SAPB was associated with lower pain levels, enabling the need for sedation to be reduced and more patients to remain awake. Moreover, it resulted in shorter procedure durations.

Reproducibility of pulmonary vein isolation guided by the ablation index: 1-year outcome of the AIR registry.

BACKGROUND: Ablation index (AI) is a new lesion quality marker that has been demonstrated to allow a high single-procedure arrhythmia-free survival in single-center studies. This prospective, multi-center study was designed to evaluate the reproducibility of pulmonary vein (PV) isolation guided by the AI. METHODS: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV isolation and were divided in four study groups according to operator's preference in choosing the ablation catheter (a contact force (ST) or contact force surround flow (STSF) catheter) and the AI setting (330-450 or 380-500 at anterior wall or posterior wall, respectively). RESULTS: At 12 months a high rate of freedom from AF recurrences was observed in patients with both paroxysmal and persistent AF (91% vs 83.3%; P = .039). There was no difference in the rate of AF recurrence among the four study groups (4.5% in group ST330-450, 12.2% in group ST 380-500, 14.9% in group STSF330-450, 9.4% in group STSF380-500; P = .083). Recurrence was also similar between patients treated with a ST (8%) or STSF catheter (12.1%; P = .2), and within patients targeting an AI settings of 330 to 450 (10.9%) or 380 to 500 (10.3%; P = .64). In patients with paroxysmal AF, there was no difference (P = .12) in the 1-year freedom from AF recurrence among 14 operators that performed ≥10 ablation procedure. CONCLUSIONS: An ablation protocol respecting strict criteria for contiguity and quality lesion resulted in high rate of 1-year freedom from AF recurrence, irrespective of the ablation catheters, AI settings, and operator.

Reproducibility of acute pulmonary vein isolation guided by the ablation index.

BACKGROUND: Atrial fibrillation (AF) ablation outcome is still operator dependent. Ablation Index (AI) is a new lesion quality marker that has been demonstrated to allow acute durable pulmonary vein (PV) isolation followed by a high single-procedure arrhythmia-free survival. This prospective, multicenter study was designed to evaluate the reproducibility of acute PV isolation guided by the AI. METHODS: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV encircling and were divided in four study groups according to operator preference in choosing the ablation catheter (a contact force [ST] or contact force surround flow [STSF] catheter) and the AI setting (330 at posterior and 450 at anterior wall or 380 at posterior and 500 at anterior wall). Radiofrequency was delivered targeting interlesion distance ≤6 mm. RESULTS: The rate of first-pass PV isolation (ST330 90 ± 16%, ST380 87 ± 19%, STSF330 90 ± 17%, STSF380 91 ± 15%, P = .585) was similar among the four study groups, whereas procedure (ST330 129 ± 44 minutes, ST380 144 ± 44 minutes, STSF330 120 ± 72 minutes, STSF380 125 ± 73 minutes, P < .001) and fluoroscopy time (ST330 542 ± 285 seconds, ST380 540 ± 416 seconds, STSF330 257 ± 356 seconds, STSF380 379 ± 454 seconds, P < 0.001) significantly differed. The difference in the rate of first-pass isolation was not statistical different (P = .06) among the 12 operators that performed at least 15 procedures. CONCLUSIONS: An ablation protocol respecting strict criteria for contiguity and quality lesion results in high and comparable rate of acute PV isolation among operator performing ablation with different catheters, AI settings, procedure, and fluoroscopy times.

Access to magnetic resonance imaging of patients with magnetic resonance-conditional pacemaker and implantable cardioverter-defibrillator systems: results from the Really ProMRI study.

Aims: The Really ProMRI study evaluates magnetic resonance imaging (MRI) access for patients with cardiac implantable electronic devices (CIEDs) as well as the performance of magnetic resonance (MR)-conditional leads when undergoing MRI. Methods and results: Patients either with an MR-conditional pacemaker or implantable defibrillator (ICD) system or with at least a component (device or one or more leads) from an MR-conditional system, were asked to fill in a questionnaire when they were referred to a MR scan. The rate of prescription, denial, or execution of MR examinations was evaluated in a 1-year follow-up visit. In total, 555 patients [median age (interquartile range) 72.2 (62.2-78.6); 72% male] were enrolled, 49% (270) with a pacemaker, 51% (285) with an ICD system. Five-hundred and ten patients completed the follow-up period. A total of 37 MRI referrals were reported in 35 patients, with a consequent event rate of 7.0/100 patient-years (CI, 4.9-9.7). Fourteen were denied, while 23 [66%; (CI, 48-81%)] were performed. The number of patients with MR referrals was not statistically different between pacemaker and ICD groups (21 vs. 14; P = 0.178). The rate of scans performed was higher in the pacemaker subjects (19/23 vs. 4/14, P = 0.003), while it was similar between patients with or without a complete MR-conditional system (19/30 vs. 4/7, P = 0.606). Conclusion: In this study, we reported a 7.0/100 patient-year's event rate of MR prescriptions in CIED patients. Many examinations were denied, despite MR-conditional systems, especially in ICD patients. Regulatory and cultural changes are needed to allow wider access to MR imaging in CIED patients with MR-conditional systems.

Stricter criteria for left bundle branch block diagnosis do not improve response to CRT.

BACKGROUND: Cardiac resynchronization therapy (CRT) has proved to be effective in patients with heart failure and left bundle branch block (LBBB). Recently, new electrocardiography criteria have been proposed for the diagnosis of LBBB. These criteria are stricter than the current American Heart Association (AHA) criteria. We assessed the rate of echocardiographic response to CRT in patients with traditional LBBB versus patients who met the new criteria (strict LBBB). METHODS: Consecutive patients undergoing CRT were enrolled in the CRT MORE registry. Patients with no-LBBB QRS morphology according to AHA criteria, atrial fibrillation, right bundle branch block, and right ventricular pacing were excluded. Strict LBBB was defined as: QRS ≥ 140 ms for men and ≥130 ms for women, QS or rS in V1-V2, mid-QRS notching or slurring in ≥2 contiguous leads. Patients showing a relative decrease of ≥15% in left ventricular end-systolic volume (LVESV) at 12 months were defined as responders. RESULTS: Among 335 patients with LBBB, 131 (39%) had strict LBBB. Patients with and without strict LBBB showed comparable baseline characteristics, except for QRS duration (166 ± 20 ms vs 152 ± 25 ms, P < 0.001). On 12-month evaluation, 205 patients (61%) were responders; 85 of 131 (65%) had strict LBBB and 120 of 204 (59%) had traditional LBBB (P = 0.267). On multivariate analysis, a history of atrial fibrillation, larger LVESV, and the presence of mid-QRS notching in ≥1 lead (odds ratio 2.099; 95% confidence interval 1.061-4.152, P = 0.033) were independently associated with echocardiographic response. CONCLUSION: Stricter definition of LBBB did not improve response to CRT in comparison to the current AHA definition.

Patient report outcomes in cryoballoon ablation of atrial fibrillation during the COVID Era: Insights from the 1STOP project.

BACKGROUND: Pulmonary vein isolation by cryoablation (PVI-C) is a standard therapy for the treatment of patients with symptomatic atrial fibrillation (AF). AF symptoms are highly subjective; however, they are important outcomes for the patient. The aim is to describe the use and impact of a web-based App to collect AF-related symptoms in a population of patients who underwent PVI-C in seven Italian centers. METHODS: A patient App to collect AF-related symptoms and general health status was proposed to all patients who underwent an index PVI-C. Patients were divided into two groups according to the utilization of the App or the non-usage. RESULTS: Out of 865 patients, 353 (41%) subjects composed the App group, and 512 (59%) composed the No-App group. Baseline characteristics were comparable between the two cohorts except for age, sex, type of AF, and body mass index. During a mean follow-up of 7.9±13.8 months, AF recurrence was found in 57/865 (7%) subjects with an annual rate of 7.36% (95% CI:5.67-9.55%) in the No-App versus 10.99% (95% CI:9.67-12.48%) in the App group, p=0.007. In total, 14,458 diaries were sent by the 353 subjects in the App group and 77.1% reported a good health status and no symptoms. In only 518 diaries (3.6%), the patients reported a bad health status, and bad health status was an independent parameter of AF recurrence during follow-up. CONCLUSIONS: The use of a web App to record AF-related symptoms was feasible and effective. Additionally, a bad health status reporting in the App was associated with AF recurrence during follow-up.

Association between amount of biventricular pacing and heart failure status measured by a multisensor implantable defibrillator algorithm.

Background: Achieving a high biventricular pacing percentage (BiV%) is crucial for optimizing outcomes in cardiac resynchronization therapy (CRT). The HeartLogic index, a multiparametric heart failure (HF) risk score, incorporates implantable cardioverter-defibrillator (ICD)-measured variables and has demonstrated its predictive ability for impending HF decompensation. Objective: This study aimed to investigate the relationship between daily BiV% in CRT ICD patients and their HF status, assessed using the HeartLogic algorithm. Methods: The HeartLogic algorithm was activated in 306 patients across 26 centers, with a median follow-up of 26 months (25th-75th percentile: 15-37). Results: During the follow-up period, 619 HeartLogic alerts were recorded in 186 patients. Overall, daily values associated with the best clinical status (highest first heart sound, intrathoracic impedance, patient activity; lowest combined index, third heart sound, respiration rate, night heart rate) were associated with a BiV% exceeding 99%. We identified 455 instances of BiV% dropping below 98% after consistent pacing periods. Longer episodes of reduced BiV% (hazard ratio: 2.68; 95% CI: 1.02-9.72; P = .045) and lower BiV% (hazard ratio: 3.97; 95% CI: 1.74-9.06; P=.001) were linked to a higher risk of HeartLogic alerts. BiV% drops exceeding 7 days predicted alerts with 90% sensitivity (95% CI [74%-98%]) and 55% specificity (95% CI [51%-60%]), while BiV% ≤96% predicted alerts with 74% sensitivity (95% CI [55%-88%]) and 81% specificity (95% CI [77%-85%]). Conclusion: A clear correlation was observed between reduced daily BiV% and worsening clinical conditions, as indicated by the HeartLogic index. Importantly, even minor reductions in pacing percentage and duration were associated with an increased risk of HF alerts.

Novel cryoballoon technology for atrial fibrillation ablation: Impact of pulmonary vein variant anatomy, cooling characteristics, and 1-year outcome from the CHARISMA registry.

BACKGROUND: No data have been reported on cooling characteristics and the impact of variant pulmonary vein (PV) anatomy on atrial fibrillation (AF) recurrences after POLARx cryoballoon (CB) ablation. OBJECTIVE: The purpose of this study was to analyze the impact of PV anatomy variants and cooling characteristics after CB ablation from a large multicenter prospective registry. METHODS: The primary end point was defined as 1-year absence of any atrial tachyarrhythmias (ATAs: AF/atrial flutter/atrial tachycardia). Correlation between ATA recurrences and anatomy variants/cooling characteristics were evaluated. The secondary outcome was the rate of major periprocedural complications. RESULTS: A total of 429 consecutive patients diagnosed with paroxysmal AF (83.4%) or persistent AF (peAF; 16.6%) were enrolled. Twenty-eight patients (6.6%) exhibited an anatomical variant (common ostium: 4.0%; adjunctive PV: 2.6%). Nadir temperature, thaw time, and total deflation time were different between standard PVs and PV variants. After the blanking period, over a mean of 431 ± 99 days of follow-up, 63 patients (14.7%) suffered an ATA recurrence. Patients with recurrences had both a shorter thaw time (18.5 ± 7 seconds vs 19.8 ± 7 seconds; P = .0012) and a shorter total deflation time, whereas time to isolation was longer (57.4 ± 42 seconds vs 49.1 ± 33 seconds; P = .04). Patients with anatomy variants showed a similar ATA recurrence rate (5 of 28 [17.9%]) to the standard PV anatomy group (58 of 401 [14.5%]) (P = .584), with a hazard ratio (HR) of 1.43 (95% confidence interval [CI] 0.49-4.13; log-rank, P = .4384). After adjusting for confounders, heart failure (HR 4.12; 95% CI 1.75-9.73; P = .0013) and peAF (HR 1.81; 95% CI 1.03-3.18; P = .0433) remained associated with ATA recurrence during follow-up. CONCLUSION: The POLARx CB system demonstrated long-term efficacy, along with a safe profile, in both patients with paroxysmal AF and those with peAF, regardless of the presence PV variants. Time to isolation was longer in patients with ATA recurrences during follow-up. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). CLINICALTRIALS: gov identifier: NCT03793998. Registration date: January 4, 2019.

Differentiating Sensor Changes in a Composite Heart Failure ICD Monitoring Index: Clinical Correlates and Implications.

BACKGROUND: The HeartLogic algorithm integrates data from implantable defibrillator(ICD) sensors to predict heart failure(HF) decompensation: first(S1) and third(S3) heart sounds, intrathoracic impedance, respiration rate, ratio of respiration rate to tidal volume(RSBI), and night heart rate. OBJECTIVE: This study assessed the relative changes in ICD sensors at the onset of HeartLogic alerts, their association with patient characteristics, and outcomes. METHODS: The study included 568 HF patients carrying ICDs(CRT-D,n=410) across 26 centers, with a median follow-up of 26 months. HeartLogic alerts triggered patient contact and potential treatment. RESULTS: A total of 1200 HeartLogic alerts were recorded in 370 patients. The sensor with the highest change at the alert's onset was S3 in 27% of alerts, followed by S3/S1(25%). Patients with atrial fibrillation(AF) and chronic kidney disease(CKD) at implantation had higher alert prevalence(AF,84% vs. no-AF,58%; CKD,72% vs. no-CKD,59%; p <0.05) and rate (AF,1.51/patient-year vs. no-AF,0.88/patient-year; CKD,1.30/patient-year vs. no-CKD,0.89/patient-year; p<0.05). During follow-up, 247 patients experienced more than one alert; in 85%, the sensor with the highest change varied between successive alerts. Of the 88(7%) alerts associated with HF hospitalization or death, respiration rate or RSBI(11%, p=0.007 vs. S3/S1) and night heart rate(11%, p=0.031 vs. S3/S1) were more commonly the sensors showing the highest change. Clinical events were more common with the first alert(12.6%) than subsequent alerts(5.2%,p <0.001). CONCLUSION: HeartLogic alerts are mostly triggered by changes in heart sounds, but clinical events are more linked to respiration rate, RSBI, and night heart rate. Recurrent alerts often involve different sensors, indicating diverse mechanisms of HF progression.

Microbial Air Contamination in a Dental Setting Environment and Ultrasonic Scaling in Periodontally Healthy Subjects: An Observational Study.

The risk of microbial air contamination in a dental setting, especially during aerosol-generating dental procedures (AGDPs), has long been recognized, becoming even more relevant during the COVID-19 pandemic. However, individual pathogens were rarely studied, and microbial loads were measured heterogeneously, often using low-sensitivity methods. Therefore, the present study aimed to assess microbial air contamination in the dental environment, identify the microorganisms involved, and determine their count by active air sampling at the beginning (T0), during (T1), and at the end (T2) of ultrasonic scaling in systemically and periodontally healthy subjects. Air microbial contamination was detected at T0 in all samples, regardless of whether the sample was collected from patients treated first or later; predominantly Gram-positive bacteria, including Staphylococcus and Bacillus spp. and a minority of fungi, were identified. The number of bacterial colonies at T1 was higher, although the species found were similar to that found during the T0 sampling, whereby Gram-positive bacteria, mainly Streptococcus spp., were identified. Air samples collected at T2 showed a decrease in bacterial load compared to the previous sampling. Further research should investigate the levels and patterns of the microbial contamination of air, people, and the environment in dental settings via ultrasonic scaling and other AGDPs and identify the microorganisms involved to perform the procedure- and patient-related risk assessment and provide appropriate recommendations for aerosol infection control.

"Shift and cover technique": conservative management of complications for the rescue of S-ICD subcutaneous implantable defibrillator systems.

BACKGROUND: The risk of complications has been shown to be lower with subcutaneous implantable defibrillator (S-ICD) than with conventional ICDs. Given the low frequency of complications, experience of how to manage them is limited. In this paper, we describe generator- and lead-related complications recorded in a series of S-ICD patients, and we propose our conservative approach to managing them. METHODS: The study cohort consisted of S-ICD patients who were referred to our institution owing to generator- or lead-related complications requiring surgical intervention. With our "shift and cover" approach, the system component involved is moved from its original position to an alternative, more protected location. In the case of the generator, this involves moving it to an intermuscular pocket. In the case of infections at the parasternal scar, the electrode sleeve is moved away from its original location, stitched, and then covered with the muscular fascia. RESULTS: Fourteen S-ICD patients were referred to our institution owing to system-related complications. Complications involved the generator in 7 cases (deep pocket infections with erosion, extrusion, or pain), the lead in 5 cases (parasternal infections at the xyphoid incision site), and both the generator and the lead in 2 cases. Complications were managed without completely removing the device and resolved in a single surgical session with no intraoperative complications. During defibrillation testing, the first shock at 65 J was effective in all patients. The shock impedance after revision was significantly lower than that measured during first implantation (59 ± 10 Ohm versus 86 ± 24 Ohm, P = 0.013). In all cases, the cosmetic result was satisfactory. No complications or recurrent infections were reported at the 12-month follow-up visit. CONCLUSIONS: The proposed conservative approach was successful in managing S-ICD complications. The revision procedure allowed to optimize the system configuration in terms of the defibrillation vector, resulting in lower shock impedance values and better device positioning.

Implantable defibrillator-detected heart failure status predicts atrial fibrillation occurrence.

BACKGROUND: In heart failure (HF) patients, atrial fibrillation (AF) is associated with a worse prognosis. Implantable cardioverter-defibrillator (ICD) diagnostics allow continuous monitoring of AF and are equipped with algorithms for HF monitoring. OBJECTIVE: We evaluated the association between the values of the multisensor HF HeartLogic index and the incidence of AF, and assessed the performance of the index in detecting follow-up periods of significantly increased AF risk. METHODS: The HeartLogic feature was activated in 568 ICD patients. Median follow-up was 25 months [25th-75th percentile (15-35)]. The HeartLogic algorithm calculates a daily HF index and identifies periods of IN-alert state on the basis of a configurable threshold. The endpoints were daily AF burden ≥5 minutes, ≥6 hours, and ≥23 hours. RESULTS: The HeartLogic index crossed the threshold value 1200 times. AF burden ≥5 minutes/day was documented in 183 patients (32%), ≥6 hours/day in 118 patients (21%), and ≥23 hours/day in 89 patients (16%). The weekly time of IN-alert state was independently associated with AF burden ≥5 minutes/day (hazard ratio [HR] 1.95; 95% confidence interval [CI] 1.22-3.13; P = .005), ≥6 hours/day (HR 2.66; 95% CI 1.60-4.44; P <.001), and ≥23 hours/day (HR 3.32; 95% CI 1.83-6.02; P <.001), after correction for baseline confounders. Comparison of the episode rates in the IN-alert state with those in the OUT-of-alert state yielded HR ranging from 1.57 to 3.11 for AF burden from ≥5 minutes to ≥23 hours. CONCLUSIONS: The HeartLogic alert state was independently associated with AF occurrence. The intervals of time defined by the algorithm as periods of increased risk of HF allow risk stratification of AF according to various thresholds of daily burden.