Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry.

BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA2DS2-VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.

Safety and effectiveness of additional left atrial posterior wall ablation using pulsed field ablation for persistent and long-standing persistent atrial fibrillation patients.

INTRODUCTION: The unique safety profile of pulsed field ablation (PFA) has made pulmonary vein isolation (PVI) + left atrial posterior wall (LAPW) ablation promising for treating persistent atrial fibrillation (PerAF). The goal of this study was to assess long-term freedom from atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT), as well as the safety and feasibility of LAPW PFA using multipolar, pentaspline Farawave catheter. METHODS: Retrospective observational study at a single institution. Data for 94 patients were collected from a prespecified intraprocedural registry. The long-term AF/AFL/AT recurrence assessment was based on an analysis of medical history; 24-h Holter ECGs at 3, 6, and 12 months postablation; and 12-lead ECGs recorded during symptomatic episodes or visits. RESULTS: Half of the patients had ls-PerAF, and half had a history of catheter ablation-mostly RF PVI. The acute ablation success rate was 100%, and the primary safety outcome was observed in 2 patients. Fifty patients experienced AF/AFL/AT recurrence (54.3%). An increase in LAPW low-voltage areas and AF classification were associated with arrhythmia recurrence. After a median follow-up of 13 months, the Kaplan‒Meier estimated median time free of AF/AFL/AT after a single procedure was 14.7 months. CONCLUSION: PFA PVI + PWA had the best outcome in perAF patients without extensive LA fibrosis. AF recurrence was paroxysmal in significant part of the cohort. The addition of PWA to PVI using multipolar PFA was safe and did not significantly influence the transpired ablation time.

Pulsed field ablation using focal contact force-sensing catheters for treatment of atrial fibrillation: acute and 90-day invasive remapping results.

AIMS: Pulsed field ablation (PFA) has emerged as a promising alternative to thermal ablation for treatment of atrial fibrillation (AF). We report performance and safety using the CENTAURI™ System (Galvanize Therapeutics) with three commercial, focal ablation catheters. METHODS AND RESULTS: ECLIPSE AF (NCT04523545) was a prospective, single-arm, multi-centre study evaluating safety and acute and chronic pulmonary vein isolation (PVI) durability using the CENTAURI System in conjunction with the TactiCath SE, StablePoint, and ThermoCool ST ablation catheters. Patients with paroxysmal or persistent AF were treated at two centres. Patients were analysed in five cohorts based upon ablation settings, catheter, and mapping system. Pulsed field ablation was performed in 82 patients (74% male, 42 paroxysmal AF). Pulmonary vein isolation was achieved in 100% of pulmonary veins (322/322) with first-pass isolation in 92.2% (297/322). There were four serious adverse events of interest (three vascular access complications and one lacunar stroke). Eighty patients (98%) underwent invasive remapping. Pulsed field ablation development Cohorts 1 and 2 showed a per-patient isolation rate of 38% and 26% and a per-PV isolation rate of 47% and 53%, respectively. Optimized PFA Cohorts 3-5 showed a per-patient isolation rate of 60%, 73%, and 81% and a per-PV isolation rate of 84%, 90%, and 92%, respectively. CONCLUSION: ECLIPSE AF demonstrated that optimized PFA using the CENTAURI System with three commercial, contact force-sensing, solid-tip focal ablation catheters resulted in transmural lesion formation and high proportion of durable PVI with a favourable safety profile, thus providing a viable treatment option for AF that integrates with contemporary focal ablation workflows.

Diagnostic and therapeutic pathways for the malignant left atrial appendage: European Heart Rhythm Association physician survey.

AIMS: Patients with atrial fibrillation who despite taking oral anti-coagulant therapy (OAT) suffer a stroke or systemic embolism (SSE) without vascular cause or who develop left atrial appendage (LAA) thrombus (LAAT) should be considered as having malignant LAA. The optimal treatment strategy to reduce SSE risk in such patients is unknown. The aim of the study is to investigate the diagnostic and therapeutic pathways for malignant LAA practiced in European cardiac centres. METHODS AND RESULTS: An 18-item online questionnaire on malignant LAA was disseminated by the European Heart Rhythm Association (EHRA) Scientific Initiatives Committee. A total of 196 physicians participated in the survey. There seems to be high confidence in transoesophageal echocardiography (TEE) imaging, considering LAAT diagnosis. Switching to another direct oral anti-coagulant (DOAC) is the preferred initial step for the treatment of malignant LAA followed by a switch to vitamin K antagonist (VKA), low-molecular-weight heparin, or continued/optimized DOAC dosage, whereas LAA closure is the last option. Left atrial appendage closure is a viable option in patients with embolic stroke despite OAT and no evidence of thrombus at TEE (empty LAA) after comprehensive diagnostic measures to exclude other sources of embolism. CONCLUSION: This EHRA survey provides a snapshot of the contemporary management of patients diagnosed with malignant LAA. Currently, the majority of patients are treated on an outpatient basis with either shifting from VKA to DOAC or from one DOAC to another. Left atrial appendage closure in this population seems to be reserved for patients with higher bleeding risk or complications of malignant LAA, such as stroke.

Neurologic Biomarkers, Neuroimaging, and Cognitive Function in Persistent Atrial Fibrillation: A Cross-Sectional Study.

The aim of this study was to evaluate the specific neurologic biomarkers, neuroimaging findings, and cognitive function in patients with persistent atrial fibrillation (AF) undergoing electrical cardioversion, compared to control subjects. This cross-sectional study included 25 patients with persistent AF undergoing electrical cardioversion and 16 age- and sex-matched control subjects. Plasma levels of glial fibrillary acidic protein (GFAP), neurofilament light protein (NFL), and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), as well as parameters of neuroimaging and cognitive function, were compared between the groups. Neuroimaging was performed using the standard magnetic resonance imaging (MRI) protocol. Cognitive function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Index. Further analysis of neurologic biomarkers was performed based on the subsequent electrical cardioversion. There was no significant difference in GFAP (median of 24.7 vs. 28.7 pg/mL, p = 0.347), UCH-L1 (median of 112.8 vs. 117.7 pg/mL, p = 0.885), and NFL (median of 14.2 vs. 15.4 pg/mL, p = 0.886) levels between AF patients and control subjects. Similarly, neuroimaging showed no between-group difference in large cortical and non-cortical lesions (n = 2, 8.0% vs. n = 0, 0.0%, p = 0.246), small non-cortical lesions (n = 5, 20.0% vs. n = 5, 31.3%, p = 0.413), white matter hyperintensity (n = 23, 92.0% vs. n = 14, 87.5%, p = 0.636), and thromboembolic lesions (n = 0, 0.0% vs. n = 1, 6.3%, p = 0.206). Cognitive assessment did not show any between-group difference in the PROMIS index (52.2 ± 9.6 vs. 51.2 ± 6.2, p = 0.706). Finally, there were no significant dynamics in neurologic biomarkers following electrical cardioversion (p > 0.05). This hypothesis-generating study did not find a significant difference in neurologic biomarkers, neuroimaging findings, or cognitive function between patients with persistent AF and controls. The restoration of sinus rhythm was not significantly associated with a change in neurologic biomarkers. Further powered longitudinal studies are needed to re-assess these findings in an AF population.

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).

AIMS: Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications. METHODS AND RESULTS: This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). CONCLUSION: In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement.

Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: Insights from an initial multicenter experience.

INTRODUCTION: Recently a novel cryoballoon system (POLARx, Boston Scientific) became available for the treatment of atrial fibrillation. This cryoballoon is comparable with Arctic Front Advance Pro (AFA-Pro, Medtronic), however, it maintains a constant balloon pressure. We compared the procedural efficacy and biophysical characteristics of both systems. METHODS: One hundred and ten consecutive patients who underwent first-time cryoballoon ablation (POLARx: n = 57; AFA-Pro: n = 53) were included in this prospective cohort study. RESULTS: Acute isolation was achieved in 99.8% of all pulmonary veins (POLARx: 99.5% vs. AFA-Pro: 100%, p = 1.00). Total procedure time (81 vs. 67 min, p < .001) and balloon in body time (51 vs. 35 min, p < .001) were longer with POLARx. After a learning curve, these times were similar. Cryoablation with POLARx was associated with shorter time to balloon temperature -30°C (27 vs. 31 s, p < .001) and -40°C (32 vs. 54 s, p < .001), lower balloon nadir temperature (-55°C vs. -47°C, p < .001), and longer thawing time till 0°C (16 vs. 9 s, p < .001). There were no differences in time-to-isolation (TTI; POLARx: 45 s vs. AFA-Pro 43 s, p = .441), however, POLARx was associated with a lower balloon temperature at TTI (-46°C vs. -37°C, p < .001). Factors associated with acute isolation differed between groups. The incidence of phrenic nerve palsy was comparable (POLARx: 3.5% vs. AFA-Pro: 3.7%). CONCLUSION: The novel cryoballoon is comparable to AFA-Pro and requires only a short learning curve to get used to the slightly different handling. It was associated with faster cooling rates and lower balloon temperatures but TTI was similar to AFA-Pro.

COMPLETE ATRIOVENTRICULAR BLOCK AND ASYSTOLE DURING EPILEPTIC SEIZURE: A CASE REPORT.

Cardiac arrhythmias during or after epileptic seizures are one of the possible pathomechanisms of sudden unexpected death in epilepsy. These arrhythmogenic epilepsies are most commonly associated with sinus tachycardia, but atrioventricular block and asystole can also be seen. Although a rare occurrence, these arrhythmias can lead to significant morbidity and mortality, but also can be potentially preventable with pacemaker implantation. Here we describe a patient with recurrent epileptic seizures, diagnosed with ictal third-degree atrioventricular block and asystole during seizure, which required a permanent cardiac pacemaker.

MANAGEMENT OF PATIENTS WITH CARDIAC IMPLANTABLE ELECTRONIC DEVICES UNDERGOING MAGNETIC RESONANCE IMAGING - PROPOSAL FOR UNIFIED HOSPITAL PROTOCOL: CROATIAN WORKING GROUP ON ARRHYTHMIAS AND CARDIAC PACING.

For many years, magnetic resonance imaging (MRI) was contraindicated in patients with cardiac implantable electronic devices (CIED). Today, there is a growing amount of evidence that MRI can be performed safely in the majority of patients with CIEDs. Firstly, there are devices considered MRI conditional by manufacturers that are available on the market and secondly, there is clear evidence that even patients with MRI non-conditional devices can also undergo MRI safely. Protocols have been developed and recommendations from different cardiac and radiologic societies have been published in recent years. However, the majority of physicians are still reluctant to refer these patients to MRI. Therefore, this document is published as a joint statement of the Croatian Working Group on Arrhythmias and Cardiac Pacing and Department of Radiology, Sestre milosrdnice University Hospital Centre to guide and ease the management of patients with CIED undergoing MRI. Also, we propose a unified protocol and checklist that could be used in Croatian hospitals.

[LEFT VENTRICULAR NON-COMPACTION]. / NEKOMPAKTNA LIJEVA KLIJETKA.

Left ventricular non-compaction (LVNC) is a rare cardiomyopathy, which is today, due to modern ultrasound technology more frequently detected in clinical practice. It is caused by the failure of normal embryonic development of the myocardium from loosely arranged muscle fibers to the mature compacted form of myocardium. Morphologic presentation consists of unique two-layered structure, a thick noncompacted endocardial and a thin compact epicardial layer, in infero-lateral and apical segments. The endocardial layer contains loosely arranged muscle fibers, prominent trabeculations and deep perfused intertrabecular recesses. It could be diagnosed both as an infantile or adult type, appearing sporadically or among families where it is transferred x-linked or autosomal dominant. The recognition of the disease is mandatory because of its high mortality and morbidity due to the progressive heart failure, thromboembolic events and lethal arrhythmias. Echocardiography is the procedure of choice to confirm the diagnosis and in the follow-up of patients with LVNC. A literature review about LVNC pathogenesis, diagnostis, and treatment was discussed.

Recurrence of cardiac myxoma three decades after first extraction - never say never.

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Ablation of accessory pathways in different anatomic locations using focal pulsed field ablation.

BACKGROUND: Ablation of accessory pathways (APs) is the cornerstone for treatment of patients with Wolff-Parkinson-White syndrome and manifestation of atrioventricular reentrant tachycardia. Pulsed field ablation (PFA) is a new type of nonthermal energy source delivered to the underlying tissue via the ablation catheter and used for ablation of arrhythmic substrates. OBJECTIVE: The purpose of this study was to determine the efficiency and long-term outcome of ablation of APs of different localizations using a focal pulsed electrical field. METHODS: Electrophysiological study was performed in patients with indication for AP ablation. An ablation catheter was used to map the position of AP insertion. Pulsed electric field was delivered through a standard ablation catheter. In left-sided APs, the first ablation attempt was within the coronary sinus (CS). Patient follow-up was scheduled 1-3 months after the ablation. Additional check-up was performed after 6 and 12 months. RESULTS: Fourteen 14 patients (3 pediatric) were treated. Termination of AP conduction was achieved in all procedures. The cohort consisted of 3 right free wall, 3 posteroseptal, and 8 left-sided APs. Ablation through CS was successfully used in 7 of 8 patients with left-sided APs. No complications were reported. Median follow-up was 5.5 months. Conduction recurrence through AP was documented in 1 patient. CONCLUSION: Focal PFA for AP shows promising results in terms of efficacy and safety. A high rate of successful termination of left-sided APs by ablation within CS may represent a new standard approach. The safety and efficacy profile of PFA seems to be transferable to the pediatric population.

Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients with Heart Failure: A MANIFEST-PF Sub-analysis.

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: To assess the outcomes of pulsed-field ablation (PFA) in HF. METHODS: MANIFEST-PF is a multicenter patient-level registry of consecutive patients undergoing PFA for paroxysmal (PAF) or persistent AF (PerAF). In this sub-study, patients were stratified as: no history of HF (no-HF), HF with preserved EF (HFPEF; LVEF≥50%) or HF with reduced/mildly-reduced EF (HFMR/REF; LVEF<50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30s and major adverse events (MAEs), respectively. RESULTS: Of the 1,381 patients, 85% (n=1,174) were no-HF, 6.2% (n=87) were HFPEF, and 8.6% (n=120) were HFMR/REF. No-HF patients had less PerAF than patients with HF (p<0.001), with no difference between HF subtypes (p=1.00). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF than with HFPEF or HFMR/REF (79.9%, 71.3%, 67.5%, p<0.001), but similar between HFMR/REF and HFPEF (p=0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFPEF vs HFMR/REF for those with PAF (82.8%/82.4%/71.7%, p=0.09) and PerAF (73.3%, 64.2%, and 64.9%, p=0.14.MAE rates were similar between the no-HF, HFPEF and HFMR/REF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSION: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients With Heart Failure.

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: This study sought to assess the outcomes of pulsed field ablation (PFA) in HF. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively. RESULTS: Of the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P = >0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSIONS: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

Impact of Left Atrial Posterior Wall Ablation During Pulsed-Field Ablation for Persistent Atrial Fibrillation.

BACKGROUND: Pulmonary vein isolation (PVI) alone is insufficient to treat many patients with persistent atrial fibrillation (PersAF). Adjunctive left atrial posterior wall (LAPW) ablation with thermal technologies has revealed lack of efficacy, perhaps limited by the difficulty in achieving lesion durability amid concerns of esophageal injury. OBJECTIVES: This study aims to compare the safety and effectiveness of PVI + LAPW ablation vs PVI in patients with PersAF using pulsed-field ablation (PFA). METHODS: In a retrospective analysis of the MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-approval Clinical Use of Pulsed Field Ablation) registry, we studied consecutive PersAF patients undergoing post-approval treatment with a pentaspline PFA catheter. The primary effectiveness outcome was freedom from any atrial arrhythmia of ≥30 seconds. Safety outcomes included the composite of acute and chronic major adverse events. RESULTS: Of the 547 patients with PersAF who underwent PFA, 131 (24%) received adjunctive LAPW ablation. Compared to PVI-alone, patients receiving adjunctive LAPW ablation were younger (65 vs 67 years of age, P = 0.08), had a lower CHA2DS2-VASc score (2.3 ± 1.6 vs 2.6 ± 1.6, P = 0.08), and were more likely to receive electroanatomical mapping (48.1% vs 39.0%, P = 0.07) and intracardiac echocardiography imaging (46.1% vs 17.1%, P < 0.001). The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmias was not statistically different between groups in the full (PVI + LAPW: 66.4%; 95% CI: 57.6%-74.4% vs PVI: 73.1%; 95% CI: 68.5%-77.2%; P = 0.68) and propensity-matched cohorts (PVI + LAPW: 71.7% vs PVI: 68.5%; P = 0.34). There was also no significant difference in major adverse events between the groups (2.2% vs 1.4%, respectively, P = 0.51). CONCLUSIONS: In patients with PersAF undergoing PFA, as compared to PVI-alone, adjunctive LAPW ablation did not improve freedom from atrial arrhythmia at 12 months.

Relationship between interleukin-6 and cardiac involvement in systemic sclerosis.

OBJECTIVES: To explore the relationship between IL-6 levels and echocardiographic abnormalities, and N-terminal probrain natriuretic peptide (NT-proBNP) levels in SSc patients and to correlate tested parameters with European Scleroderma Activity (EUSTAR) score. METHODS: This case-control study included 31 SSc patients with preserved left ventricular ejection fraction (LVEF) and 32 matched healthy controls. Serum IL-6 and NT-proBNP levels were measured and subjects were evaluated by conventional and pulsed-wave tissue Doppler echocardiography. RESULTS: The level of IL-6 was significantly increased in patients with SSc (3.2 vs 2.2 pg/ml, P < 0.001). SSc patients had significantly lower values of LV systolic (7.7 vs 9.25 cm/s, P < 0.001) and early diastolic (8.7 vs 10.3 cm/s, P = 0.014) myocardial velocities and higher E/e' (9.04 vs 7.37, P = 0.001) ratio, although there was no between-group difference according to LVEF (68% vs 65%, P = 0.248). On evaluating the right ventricle there was no significant between-group difference in systolic tricuspid annular velocity (13 vs 13.9 cm/s, P = 0.105), but the peak early diastolic velocity was significantly lower (11.7 vs 13.6, P = 0.044) and E/e' was significantly higher (4.3 vs 3.38, P = 0.008) in SSc patients. IL-6 level showed correlation with LV mean e' (r = -0.57, P = 0.001), E/e' (r = 0.55, P = 0.001) and NT-proBNP (r = 0.52, P = 0.003). EUSTAR score correlated with LV E/e' (r = 0.48, P = 0.006), mean e' (r = -0.67, P < 0.001), mean s' (r = -0.51, P = 0.004), NT-proBNP (r = 0.60, P < 0.001) and IL-6 (r = 0.79, P < 0.001). CONCLUSION: IL-6 level is increased in patients with SSc and significantly correlates with LV diastolic dysfunction, NT-proBNP and EUSTAR score. These results support the role of IL-6 in the development of cardiac disease in SSc patients.

Association of Electrical Cardioversion with Brain Perfusion and Cognitive Function in Patients with Atrial Fibrillation.

BACKGROUND: The association of atrial fibrillation (AF) and brain perfusion (BP) has not been well-defined. This study aimed to determine the association of persistent AF with BP and cognition, in comparison to control subjects and with regards to electrical cardioversion (ECV). METHODS: This study compared 25 patients with persistent AF undergoing elective ECV with 16 age/sex-matched controls. We measured regional BP by using the magnetic resonance (MRI) arterial spin labelling technique. Cognitive function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) cognitive function index. Measurements were performed at baseline and 6 weeks after ECV. RESULTS: There was no significant difference in BP between AF patients and control subjects (p > 0.05). Following the ECV, there was a significant improvement in BP in 15 patients who maintained sinus rhythm, while there was no significant change in the recurrence group (297 ± 24 before vs. 328 ± 37 after ECV, p = 0.008, and 297 ± 22 before vs. 307 ± 24 after ECV, p = 0.45, respectively). There was no difference in the cognitive assessment between AF patients and control subjects, as well as before and after ECV within the AF group (52.2 ± 9.6 vs. 51.2 ± 6.2, p = 0.71 and 53 ± 10 vs. 54 ± 9, p = 0.46, respectively). CONCLUSIONS: This study did not show difference in BP between persistent AF patients and matched control subjects. Restoration of sinus rhythm was associated with significantly improved BP. There was no association of ECV and changes in cognitive function.

Serum Catestatin Concentrations Are Increased in Patients with Atrial Fibrillation.

The autonomic nervous system is crucial in initiating and maintaining atrial fibrillation (AF). Catestatin is a multipurpose peptide that regulates cardiovascular systems and reduces harmful, excessive activity of the sympathetic nervous system by blocking the release of catecholamines. We aimed to determine whether serum catestatin concentrations are associated with AF severity, duration indices, and various clinical and laboratory indicators in these individuals to better define the clinical value of catestatin in patients with AF. The present single center study enrolled 73 participants with AF and 72 healthy age-matched controls. Serum catestatin concentrations were markedly higher in AF patients than controls (14.11 (10.21-26.02) ng/mL vs. 10.93 (5.70-20.01) ng/mL, p = 0.013). Furthermore, patients with a more severe form of AF had significantly higher serum catestatin (17.56 (12.80-40.35) vs. 10.98 (8.38-20.91) ng/mL, p = 0.001). Patients with higher CHA2DS2-VASc scores (17.58 (11.89-37.87) vs. 13.02 (8.47-22.75) ng/mL, p = 0.034) and higher NT-proBNP levels (17.58 (IQR 13.91-34.62) vs. 13.23 (IQR 9.04-22.61), p = 0.036) had significantly higher serum catestatin concentrations. Finally, AF duration correlated negatively with serum catestatin levels (r = -0.348, p = 0.003). The results of the present study implicate the promising role of catestatin in the intricate pathophysiology of AF, which should be explored in future research.

COVID-19 pandemic: Impact on the cardiac implantable electronic devices' implantation rates in Croatia.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) pandemic has influenced health-care organization worldwide, including management of non-communicable diseases. The aim of this study was to determine the impact of COVID-19 pandemic on cardiac implantable electronic devices' (CIEDs) implantation rates in Croatia. METHODS: A retrospective, observational, national study was conducted. The data on CIEDs' implantation rates from 20 Croatian implantation centres, between January 2018 and June 2021, were extracted from the national Health Insurance Fund registry. Implantation rates before and after COVID-19 pandemic started, were compared. RESULTS: The overall numbers of CIED implantations in Croatia during COVID-19 pandemic were not different in comparison to 2 years pre-COVID-19 time (2618 vs. 2807, p = .081). The pacemaker implantation rates decreased significantly (by 45%) during April (122 vs. 223, p < .001) and May 2020 (135 vs. 244, p = .001), as well as during November 2020 (177 vs. 264, p = .003), but significantly increased during summer months 2020 comparing to 2018 and 2019 (737 vs. 497, p<0.001). The ICD implantation rates decreased significantly by 59% in April 2020 (26 vs. 64, p = .048). CONCLUSION: To the authors best knowledge this is a first study including complete national data on CIED implantation rates and COVID-19 pandemic impact. A significant reduction in number of both pacemaker and ICD implants during specific months of the COVID-19 pandemic was determined. However, afterwards compensation in implants resulted in similar total number when the complete year was evaluated.

Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation.

Importance: Previous studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile. Objective: To compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry. Design, Setting, and Participants: This was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF. Exposure: PFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator. Main Outcomes and Measures: The primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (<7 days postprocedure) and chronic (>7 days) major adverse events (MAEs). Results: Of 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P < .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P < .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P < .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19). Conclusion and Relevance: Results of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.