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.

Contemporary catheter ablation of complex atrial tachycardias after prior atrial fibrillation ablation: pulsed field vs. radiofrequency current energy ablation guided by high-density mapping.

AIMS: Catheter ablation (CA) of post-ablation left atrial tachycardias (LATs) can be challenging. So far, pulsed field ablation (PFA) has not been compared to standard point-by-point radiofrequency current (RFC) energy for LAT ablation. To compare efficacy of PFA vs. RFC in patients undergoing CA for LAT. METHODS AND RESULTS: Consecutive patients undergoing LAT-CA were prospectively enrolled (09/2021-02/2023). After electro-anatomical high-density mapping, ablation with either a pentaspline PFA catheter or RFC was performed. Patients were matched 1:1. Ablation was performed at the assumed critical isthmus site with additional ablation, if necessary. Right atrial tachycardia (RAT) was ablated with RFC. Acute and chronic success were assessed. Fifty-six patients (n = 28 each group, age 70 ± 9 years, 75% male) were enrolled.A total of 77 AT (n = 67 LAT, n = 10 RAT; 77% macroreentries) occurred with n = 32 LAT in the PFA group and n = 35 LAT in the RFC group. Of all LAT, 94% (PFA group) vs. 91% (RFC group) successfully terminated to sinus rhythm or another AT during ablation (P = 1.0). Procedure times were shorter (PFA: 121 ± 41 vs. RFC: 190 ± 44 min, P < 0.0001) and fluoroscopy times longer in the PFA group (PFA: 15 ± 9 vs. RFC: 11 ± 6 min, P = 0.04). There were no major complications. After one-year follow-up, estimated arrhythmia free survival was 63% (PFA group) and 87% (RFC group), [hazard ratio 2.91 (95% CI: 1.11-7.65), P = 0.0473]. CONCLUSION: Pulsed field ablation of post-ablation LAT using a pentaspline catheter is feasible, safe, and faster but less effective compared to standard RFC ablation after one year of follow-up. Future catheter designs and optimization of the electrical field may further improve practicability and efficacy of PFA for LAT.

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.

Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study.

AIMS: Pulmonary vein isolation (PVI) is a well-established strategy for the treatment of paroxysmal atrial fibrillation (PAF). Despite randomized controlled trials and real-world data showing the promise of pulsed-field ablation (PFA) for this treatment, long-term efficacy and safety data demonstrating single-procedure outcomes off antiarrhythmic drugs remain limited. The aim of the FARA-Freedom Study was to evaluate the long-term efficacy and safety of PFA using the pentaspline catheter for PAF. METHODS AND RESULTS: FARA-Freedom, a prospective, non-randomized, multicentre study, enrolled patients with PAF undergoing de novo PVI with PFA, who were followed for 12 months with weekly transtelephonic monitoring and a 72-h Holter ECG at 6 and 12 months. The primary safety endpoint was a composite of device- or procedure-related serious adverse events out to 7 days post-ablation and PV stenosis or atrioesophageal (AE) fistula out to 12 months. Treatment success is a composite of acute PVI and chronic success, which includes freedom from any documented atrial tachyarrhythmia longer than 30 s, use of antiarrhythmic drugs or cardioversion after a 3-month blanking period, or use of amiodarone or repeat ablation at any time. The study enrolled 179 PAF patients (62 ± 10 years, 39% female) at 13 centres. At the index procedure, all PVs were successfully isolated with the pentaspline PFA catheter. Procedure and left atrial dwell times, with a 20-min waiting period, were 71.9 ± 17.6 and 41.0 ± 13.3 min, respectively. Fluoroscopy time was 11.5 ± 7.4 min. Notably, monitoring compliance was high, with 88.4 and 90.3% with weekly events and 72-h Holter monitors, respectively. Freedom from the composite primary effectiveness endpoint was 66.6%, and 41 patients had atrial tachyarrhythmia recurrence, mostly recurrent atrial fibrillation (31 patients). The composite safety endpoint occurred in two patients (1.1%), one tamponade and one transient ischaemic attack. There was no coronary spasm, PV stenosis, or AE fistula. There were four cases of transient phrenic nerve palsy, but all resolved during the index procedure. CONCLUSION: In this prospective, non-randomized, multicentre study, PVI using a pentaspline PFA catheter was effective in treating PAF patients despite rigourous endpoint definitions and high monitoring compliance and demonstrated favourable safety. REGISTRATION: Clinical Trials.gov Identifier: NCT05072964 (sponsor: Boston Scientific Corporation).

Pulsed-field versus cryoballoon ablation for atrial fibrillation-Impact of energy source on sedation and analgesia requirement.

INTRODUCTION: Pulsed field ablation (PFA) represents a novel, nonthermal energy modality that can be applied for single-shot pulmonary vein isolation (PVI) in atrial fibrillation (AF). Comparative data with regard to deep sedation to established single-shot modalities such as cryoballoon (CB) ablation are scarce. The aim of this study was to compare a deep sedation protocol in patients receiving PVI with either PFA or CB. METHODS: Prospective, consecutive AF patients undergoing PVI with a pentaspline PFA catheter were compared to a retrospective CB-PVI cohort of the same timeframe. Study endpoints were the requirements of analgesics, cardiorespiratory stability, and sedation-associated complications. RESULTS: A total of 100 PVI patients were included (PFA n = 50, CB n = 50, mean age 66 ± 10.6, 61% male patients, 65% paroxysmal AF). Requirement of propofol, midazolam, and sufentanyl was significantly higher in the PFA group compared to CB [propofol 0.14 ± 0.04 mg/kg/min in PFA vs. 0.11 ± 0.04 mg/kg/min in CB (p = .001); midazolam 0.00086 ± 0.0004 mg/kg/min in PFA vs. 0.0006295 ± 0.0003 mg/kg/min in CB (p = .002) and sufentanyl 0.0013 ± 0.0007 µg/kg/min in PFA vs. 0.0008 ± 0.0004 µg/kg/min in CB (p < .0001)]. Sedation-associated complications did not differ between both groups (PFA n = 1/50 mild aspiration pneumonia, CB n = 0/50, p > .99). Nonsedation-associated complications (PFA: n = 2/50, 4%, CB: n = 1/50, 2%, p > .99) and procedure times (PFA 75 ± 31, CB 84 ± 32 min, p = .18) did not differ between groups. CONCLUSIONS: PFA is associated with higher sedation and especially analgesia requirements. However, the safety of deep sedation does not differ to CB ablation.

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.

Left Atrial Posterior Wall Isolation with Pulsed Field Ablation in Persistent Atrial Fibrillation.

BACKGROUND: Left atrial posterior wall isolation (LAPWI) may improve rhythm control in addition to pulmonary vein isolation (PVI) in persistent atrial fibrillation (persAF) patients undergoing catheter ablation (CA). However, LAPWI may be challenging when using thermal energy sources. OBJECTIVE: This study aimed to investigate the efficacy and safety of LAPWI performed by non-thermal pulsed field ablation (PFA) in CA for persAF. METHODS: Consecutive persAF patients from two German centers were prospectively enrolled. There were two study cohorts: (1) the LAPWI cohort, which included PFA-guided (re-)PVI with LAPWI for first-time and/or repeat ablation procedures; and (2) a comparative persAF cohort with a PFA PVI-only approach without LAPWI for first-time ablation within the same timeframe. Patients were followed up by routine Holter ECGs. RESULTS: In total, 79 persistent AF patients were included in the study: 59/79 patients were enrolled in the LAPWI cohort, including 16/59 index (27%) and 43/59 repeat ablation procedures (73%). Sixteen patients (16/79; 21%) were in the PVI-only cohort without LAPWI. Of the patients treated with LAPWI, procedure time and fluoroscopy time was 91 ± 30 min and 15 ± 7 min, respectively. The acute PVI rate was 100% in all first-time ablation patients (32 patients (16 PVI only, 16 PVI plus LAPWI), 196/196 PVs). Of the 43 re-do patients in the LAPWI cohort, re-PVI was necessary in 33% (14/43) of patients (27 PVs; 1.9 PV per-patient); in 67% (29/43), all PVs were isolated, and antral ablation of the PV ostia was performed in 48% (14/29). LAPWI was performed successfully in all 59 (100%) patients of the LAPWI cohort. Two minor complications occurred. No esophageal lesion was detected in the LAPWI cohort (n = 33/59 (56%) patients underwent endoscopy). After 354 ± 197 days of follow-up, freedom from atrial arrhythmias was 79.3% (95-CI: 62-95%) in the complete LAPWI cohort (n = 14/59 (24%) on AAD: class Ic n = 9, class III n = 5). There was no difference regarding acute procedural and clinical outcome compared to the PVI-only cohort. CONCLUSION: LAPWI guided by PFA is feasible and safe in patients undergoing CA for persAF and shows favorable outcomes. In the context of durable PVI, PFA-guided LAPWI may be an effective adjunctive treatment option.

Higher in-hospital mortality in SARS-CoV-2 omicron variant infection compared to influenza infection-Insights from the CORONA Germany study.

BACKGROUND: With the emergence of new subvariants, the disease severity of Severe Acute Respiratory Syndrome Coronavirus-2 has attenuated. This study aimed to compare the disease severity in patients hospitalized with omicron variant infection to those with influenza infection. METHODS: We compared data from the multicenter observational, prospective, epidemiological "CORONA Germany" (Clinical Outcome and Risk in hospitalized COVID-19 patients) study on patients infected with Severe Acute Respiratory Syndrome Coronavirus-2 to retrospective data on influenza infection cases from November 2016 to August 2022. Severe Acute Respiratory Syndrome Coronavirus-2 cases were classified as wild-type/delta variant before January 2022, or omicron variant from January 2022 onward. The primary outcome was in-hospital mortality, adjusted for age, gender, and comorbidities. RESULTS: The study included 35,806 patients from 53 hospitals in Germany, including 4,916 patients (13.7%) with influenza infection, 16,654 patients (46.5%) with wild-type/delta variant infection, and 14,236 patients (39.8%) with omicron variant infection. In-hospital mortality was highest in patients with wild-type/delta variant infection (16.8%), followed by patients with omicron variant infection (8.4%) and patients with influenza infection (4.7%). In the adjusted analysis, higher age was the strongest predictor for in-hospital mortality (age 80 years vs. age 50 years: OR 4.25, 95% CI 3.10-5.83). Both, patients with wild-type/delta variant infection (OR 3.54, 95% CI 3.02-4.15) and patients with omicron variant infection (OR 1.56, 95% CI 1.32-1.84) had a higher risk for in-hospital mortality than patients with influenza infection. CONCLUSION: After adjusting for age, gender and comorbidities, patients with wild-type/delta variant infection had the highest risk for in-hospital mortality compared to patients with influenza infection. Even for patients with omicron variant infection, the adjusted risk for in-hospital mortality was higher than for patients with influenza infection. The adjusted risk for in-hospital mortality showed a strong age dependency across all virus types and variants. TRIAL REGISTRATION NUMBER: NCT04659187.

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.

A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: the POTTER-AF study.

AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.

[Asymptomatic atrial fibrillation : Screening and therapy]. / Asymptomatisches Vorhofflimmern : Screening und Therapie.

Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting millions of people worldwide and poses a significant burden to the health care system. AF screening of the general population or of a specific higher-risk population could not only lead to earlier detection of AF but also to a prompt initiation of an adequate therapy to prevent complications such as stroke or death and consecutively to a potential reduction of health care costs, especially in asymptomatic AF patients. To conduct screening programs, accessible new technology devices such as "wearables", smartwatches, and implantable event recorders provide an innovative solution. However, as data regarding screening are inconclusive, routine AF screening of the population is currently not recommended by the European Society of Cardiology. Recently published studies have indicated that anticoagulation and early rhythm control of asymptomatic AF could avoid occurrence of clinical endpoints. This article reports on the scientific results of the current literature as well as gaps of evidence and discusses possible treatment options of asymptomatic AF.

High In-Hospital Mortality in SARS-CoV-2-Infected Patients with Active Cancer Disease during Omicron Phase of the Pandemic: Insights from the CORONA Germany Study.

INTRODUCTION: SARS-CoV-2 infected patients with cancer have a worse outcome including a significant higher mortality, compared to non-cancer patients. However, limited data are available regarding in-hospital mortality during the Omicron phase of the pandemic. Therefore, the aim of the study was the comparison of mortality in patients with history of cancer and patients with active cancer disease during the different phases of the COVID-19 pandemic, focusing on the current Omicron variant of concern. METHODS: We conducted a multicenter, observational, epidemiological cohort study at 45 hospitals in Germany. Until July 20, 2022, all adult hospitalized SARS-CoV-2 positive patients were included. The primary endpoint was in-hospital mortality regarding cancer status (history of cancer and active cancer disease) and SARS-CoV-2 virus type. RESULTS: From March 11, 2020, to July 20, 2022, a total of 27,490 adult SARS-CoV-2 positive patients were included in the study. 2,578 patients (9.4%) had diagnosis of cancer, of whom 1,065 (41.3%) had history of cancer, whereas 1,513 (58.7%) had active cancer disease. Overall 3,749 out of the total of 27,490 patients (13.6%) died during the hospital stay. Patients with active cancer disease had a significantly higher mortality compared to patients without cancer diagnosis, in both phases of the pandemic (wild-type to Delta: OR 1.940 [1.646-2.285]); Omicron: 2.864 [2.354-3.486]). After adjustment to co-variables, SARS-CoV-2 infected patients with active cancer disease had the highest risk for in-hospital mortality compared to the other groups, in both phases of the pandemic. CONCLUSION: The CORONA Germany study indicates that hospitalized patients with active cancer disease are at high risk of death during a SARS-CoV-2 infection. Mortality of patients with history of cancer improved to nearly the level of non-cancer patients during Omicron phase.

Is there an association between depression, anxiety disorders and COVID-19 severity and mortality? A multicenter retrospective cohort study conducted in 50 hospitals in Germany.

BACKGROUND: The aim of this retrospective cohort study was to investigate associations between depression and anxiety disorder and the risk of COVID-19 severity and mortality in patients treated in large hospitals in Germany. METHODS: This retrospective study was based on anonymized electronic medical data from 50 public healthcare service hospitals across Germany. Multivariable logistic regression models were used to study associations between depression, anxiety and mechanical ventilation and mortality due to COVID adjusted for age, sex, time of COVID-19 diagnosis, and pre-defined co-diagnoses. RESULTS: Of 28,311 patients diagnosed with COVID-19, 1970 (6.9%) had a diagnosis of depression and 369 (1.3%) had a diagnosis of anxiety disorder prior to contracting COVID-19. While multivariable logistic regression models did not indicate any association between depression diagnosis and the risk of mechanical ventilation, depression was associated with a decreased risk of mortality (OR: 0.71; 95% CI: 0.53-0.94). There was no association between anxiety disorders and risk of mortality, but there was a strong positive association between anxiety disorders and the risk of mechanical ventilation (OR: 2.04; 95% CI: 1.35-3.10). CONCLUSION: In the present study, depression and anxiety disorder diagnoses were not associated with increased COVID-19 mortality. Anxiety disorder was strongly associated with an increased risk of mechanical ventilation. Further studies are needed to clarify how depression and anxiety disorders may influence COVID-19 severity and mortality.

A Simplified Approach to Pulmonary Vein Visualization during Cryoballoon Ablation of Atrial Fibrillation.

Background and Objectives: Selective pulmonary vein (PV) angiography has been established as the gold standard for PV visualization in cryoballoon (CB)-based pulmonary vein isolation (PVI). We sought to simplify this approach to reduce procedural complexity and radiation exposure. Materials and Methods: Patients with paroxysmal and recently diagnosed persistent AF undergoing CB-based PVI from January 2015 to December 2017 were retrospectively analyzed. Patients underwent either selective PV angiography or conventional left atrial (LA) angiography for PV visualization. Results: A total of 336 patients were analyzed. A total of 87 patients (26%) received PV angiography and 249 (74%) LA angiography. LA angiography required fewer cine-sequences for PV visualization, translating into a significant reduction in procedure duration, fluoroscopy time and dose area product. Additionally, less contrast medium was utilized. PV occlusion by the CB, CB temperature and time to isolation showed no significant differences. The number of CB applications and total application time (LA angiography: 1.4 ± 0.02 vs. PV Angiography: 1.6 ± 0.05; p < 0.0001; LA angiography: 297.9 ± 4.62 vs. PV-Angiography: 348.9 ± 11.03; p < 0.001, respectively) per vein were slightly but significantly higher in the PV angiography group. We observed no difference in late AF recurrence (24.7% LA angiography vs. 21.3% PV angiography; p = 0.2657). Conclusions: A simplified protocol, using LA angiography for PV visualization, entails a reduction in procedure time and radiation exposure while equally maintaining procedural efficiency and safety in both groups.

[Focal atrial tachycardias: diagnostics and therapy]. / Fokale atriale Tachykardien: Diagnostik und Therapie.

In this article, typical characteristics of focal atrial tachycardias are described and a systematic approach regarding diagnostics and treatment options in the field of invasive cardiac electrophysiology (EP) is presented. Subjects of this article include the definition of focal atrial tachycardias, knowledge about localizing the origin of such, and guidance on how to approach an invasive EP study (e.g., administration of medication during the EP study to provoke tachycardias). Further, descriptions will be found on how to localize the origin of focal atrial tachycardias with the help of the 12-lead ECG and invasive three-dimensional mapping to successfully treat focal atrial tachycardias with catheter ablation.

Comparison of machine learning methods with logistic regression analysis in creating predictive models for risk of critical in-hospital events in COVID-19 patients on hospital admission.

BACKGROUND: Machine learning (ML) algorithms have been trained to early predict critical in-hospital events from COVID-19 using patient data at admission, but little is known on how their performance compares with each other and/or with statistical logistic regression (LR). This prospective multicentre cohort study compares the performance of a LR and five ML models on the contribution of influencing predictors and predictor-to-event relationships on prediction model´s performance. METHODS: We used 25 baseline variables of 490 COVID-19 patients admitted to 8 hospitals in Germany (March-November 2020) to develop and validate (75/25 random-split) 3 linear (L1 and L2 penalty, elastic net [EN]) and 2 non-linear (support vector machine [SVM] with radial kernel, random forest [RF]) ML approaches for predicting critical events defined by intensive care unit transfer, invasive ventilation and/or death (composite end-point: 181 patients). Models were compared for performance (area-under-the-receiver-operating characteristic-curve [AUC], Brier score) and predictor importance (performance-loss metrics, partial-dependence profiles). RESULTS: Models performed close with a small benefit for LR (utilizing restricted cubic splines for non-linearity) and RF (AUC means: 0.763-0.731 [RF-L1]); Brier scores: 0.184-0.197 [LR-L1]). Top ranked predictor variables (consistently highest importance: C-reactive protein) were largely identical across models, except creatinine, which exhibited marginal (L1, L2, EN, SVM) or high/non-linear effects (LR, RF) on events. CONCLUSIONS: Although the LR and ML models analysed showed no strong differences in performance and the most influencing predictors for COVID-19-related event prediction, our results indicate a predictive benefit from taking account for non-linear predictor-to-event relationships and effects. Future efforts should focus on leveraging data-driven ML technologies from static towards dynamic modelling solutions that continuously learn and adapt to changes in data environments during the evolving pandemic. TRIAL REGISTRATION NUMBER: NCT04659187.

Pulsed field ablation in patients with complex consecutive atrial tachycardia in conjunction with ultra-high density mapping: Proof of concept.

INTRODUCTION: Catheter-ablation (CA) of consecutive left atrial tachycardias (LAT) can be challenging. Pulsed field ablation (PFA) yields a novel nonthermal CA technology for treatment of atrial fibrillation (AF). There is no data regarding PFA of LAT. This study sought to investigate PFA of consecutive LAT following prior CA of AF. METHODS: Consecutive patients with LAT underwent ultrahigh-density (UHDx) mapping. Subsequent to identification of the AT mechanism, PFA was performed at the assumed critical sites for LAT maintenance. Continuous ablation lines were performed if required and evaluated with pre- and post-PFA HDx-mapping. RESULTS: Fifteen patients (age 70 ± 10, male 73%) who underwent 3.6 ± 2 prior AF-CA procedures were included. The total mean procedure and fluoroscopy times were 141 ± 43 and 18 ± 10 min, respectively. All 19 of 19 (100%) LAT were successfully ablated with PFA. Two AT located at the right atria required RF-ablation. LAT were identified as localized reentry (n = 1) and macro-reentry LAT (n = 18) and targeted with PFA. All LAT terminated with PFA either to sinus rhythm (9/15) or a secondary AT (6/15 and subsequently to SR); 63% (12/19) terminated with the first PFA-application. All lines (13 roof, 11 anterior, 1 mitral) were blocked. LA-posterior-wall isolation (LAPWI) was successfully achieved when performed (10/10). AF/AT free survival was 80% (12/15) after 153 [88-207] days of follow-up. No procedure-related complications occurred. CONCLUSION: PFA of consecutive LAT is feasible and safe. Successful creation of ablation lines and LAPWI can be achieved in a short time. PFA may offer the opportunity for effective ablation of atrial arrhythmias beyond AF.

A novel wide-band dielectric imaging system to guide radiofrequency ablation for pulmonary vein isolation.

INTRODUCTION: Recently, the wide-band dielectric mapping system Kodex-EPD was introduced. This study reports the first clinical experience using a novel system to guide pulmonary vein isolation (PVI) with radiofrequency (RF) ablation. METHODS AND RESULTS: The study included 20 consecutive patients undergoing de-novo PVI for symptomatic paroxysmal or persistent atrial fibrillation guided by Kodex-EPD. The primary efficacy endpoint was successful PVI. Secondary endpoints included procedural parameters and complications. In all 20 patients (mean age 68 ± 8 years, 12 male patients, paroxysmal fibrillation in 14/20 [70%] patients), PVI was successfully completed. One patient underwent additional cavo-tricuspid isthmus ablation for concomitant typical atrial flutter and one patient required additional ablation of a focal atrial tachycardia. A conventional three-dimensional image of the left atrium as well as the innovative endocardial panoramic view were used to guide catheter manipulation and ablation. Median procedure time was 115 [1st; 3rd quartile 93,75; 140] min and median total fluoroscopy time was 9.9 [9.7; 11.2] min, of which a median of 0.8 [0.6; 0.9] min was required to create left atrial maps. Complete left atrial imaging using Kodex-EPD was achieved within a median of 7.1 [5.7; 8.3] min. Median RF ablation time was 45.1 [34.6; 58.7] min. No major complications were observed. CONCLUSION: RF ablation PVI guided by Kodex-EPD seems safe and feasible. The system provides effective three-dimensional guidance for PVI.

Sleep apnea predicts cardiovascular death in patients with Marfan syndrome: a cohort study.

Background: Surgical replacement of the aortic root is the only intervention that can prevent aortic dissection and cardiovascular death in Marfan syndrome (MFS). However, in some individuals, MFS also causes sleep apnea. If sleep apnea predicts cardiovascular death, a new target for predictive, preventive, and personalized medicine (PPPM) may emerge for those individuals with MFS who have sleep apnea. Methods: This is an investigator-initiated study with long-term follow-up data of 105 individuals with MFS. All individuals were screened for sleep apnea regardless of symptoms. Cardiovascular death served as a primary endpoint, and aortic events as a secondary outcome. Results: Sleep apnea with an apnea-hypopnea index (AHI) > 5/h was observed in 21.0% (22/105) with mild sleep apnea in 13% (14/105) and moderate to severe sleep apnea in 7.6% (8/105). After a median follow-up of 7.76 years (interquartile range: 6.84, 8.41), 10% (10/105) had died, with cardiovascular cause of death in 80% (8/10). After adjusting for age and body mass index (BMI), the AHI score emerged as an independent risk factor for cardiovascular death (hazard ratio 1.712, 95% confidence interval [1.061-2.761], p = 0.0276). The secondary outcome of aortic events occurred in 33% (35/105). There was no effect of the AHI score on aortic events after adjusting for age and BMI (hazard ratio 0.965, 95% confidence interval [0.617-1.509]), possibly due to a high number of patients with prior aortic surgery. Interpretation: Sleep apnea is emerging as an independent predictor of cardiovascular death in MFS. It seems mandatory to screen all individuals with MFS for sleep apnea and to include these individuals, with both MFS and sleep apnea, in further studies to evaluate the impact of preventive measures with regard to cardiovascular death. Supplementary Information: The online version contains supplementary material available at 10.1007/s13167-022-00291-4.