Mortality and rehospitalization in patients with pre-existing implantable pacemakers undergoing catheter ablation are related to increased comorbidity burden-data from the German Ablation Registry.

BACKGROUND: Catheter ablation of atrial fibrillation and atrial flutter is routinely performed in patients with implantable devices. The aim of the present study was to assess success rates and potential complications in a large registry cohort of patients with cardiac pacemakers. METHODS AND RESULTS: The German Ablation Registry is a nationwide, prospective registry with a 1-year follow-up investigating patients who underwent catheter ablation of supraventricular arrhythmias in 51 German centers. The present analysis focussed on the presence of cardiac pacemakers in 591 patients undergoing catheter ablation of atrial fibrillation or atrial flutter. These were compared to 7393 patients without a pacemaker. Patients with pacemakers were significantly older and presented more comorbidities like diabetes, renal failure, cardiovascular disease, or previous stroke. One-year mortality (2.4% vs. 1.3%, p = 0.022) and a combined endpoint of death, myocardial infarction, and stroke (3.6% vs. 2.1%, p = 0.014) were significantly elevated in patients with pacemakers. Re-hospitalization was also more common in patients with a pacemaker (53.3% vs. 45.0%, p < 0.01). After adjustment for important comorbidities, pre-existing pacemaker systems did not show any negative effect. Procedural success was reported in 98.8% vs. 98.4% (p = 0.93). Device-related complications were only observed in 0.4% of patients with pacemakers. CONCLUSION: Patients with pacemaker systems undergoing catheter ablation of atrial fibrillation or atrial flutter demonstrate an increased risk of death, cardiovascular events, and re-hospitalization. This observation can be largely attributed to an older patient population and an increased rate of comorbidities.

LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry.

BACKGROUND: Interventional left atrial appendage occlusion (LAAO) mitigates the risk of thromboembolic events in nonvalvular atrial fibrillation (AF) patients with contraindication for long-term oral anticoagulation (OAC). Patients with prior stroke have a relevantly increased risk of recurrent stroke, so the effectiveness of LAAO could be reduced in this specific very high-risk patient group. AIM: This sub-study of the LAARGE registry investigates the effectiveness and safety of LAAO for secondary prevention in nonvalvular AF patients with a history of stroke. METHODS: LAARGE is a prospective, non-randomised registry on the clinical reality of LAAO. The current sub-study employs data from index procedure and 1-year follow-up. Effectiveness and safety were assessed by documentation of all-cause mortality, non-fatal thromboembolism, procedure-related complications, and bleeding events. RESULTS: A total of 638 patients were consecutively included from 38 hospitals in Germany and divided into two groups: 137 patients with a history of stroke (21.5%) and 501 patients without. Successful implantation was consistent between both groups (98.5% vs. 97.4%, p = NS), while peri-procedural MACCE and other complications were rare (0% vs. 0.6% and 4.4% vs. 4.0%, respectively; each p = NS). Kaplan-Meier estimate showed no significant difference in primary effectiveness outcome measure (freedom from all-cause death or non-fatal stroke) between both groups at follow-up (87.8% vs. 87.7%, p = NS). The incidence of transient ischemic attack or systemic embolism at follow-up was low (0% vs. 0.5% and 0.9% vs. 0%, respectively; each p = NS). Severe bleeding events after hospital discharge were rare (0% vs. 0.7%, p = NS). CONCLUSIONS: Patients with prior stroke demonstrated similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OAC for secondary stroke prevention in this selected group of nonvalvular AF patients. GOV IDENTIFIER: NCT02230748.

Is spontaneous echo contrast associated with device-related thrombus or embolic events after left atrial appendage occlusion? - Insights from the multicenter German LAARGE registry.

BACKGROUND: Interventional left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for prophylaxis of thromboembolic events (TEs) in nonvalvular atrial fibrillation patients, predominantly in those with high bleeding risk and contraindications for long-term OAC. Although spontaneous echo contrast (SEC) is a well-known risk factor for atrial thrombus formation, little is known about whether this means an increased risk of device-related thrombus (DRT) or TEs following LAAO. METHODS: This substudy of the prospective, multicenter German LAARGE registry assessed two groups according to absence (SEC -) or presence of SEC (SEC +) in preprocedural cardiac imaging. Clinical and echocardiographic parameters were registered up to 1 year after LAAO. RESULTS: Five hundred eighty-eight patients (SEC - 85.5 vs. SEC + 14.5%) were included. More SEC + patients were implanted for OAC non-compliance (11.8 vs. 4.6%, p = 0.008) and a higher proportion received only antiplatelet therapy without OAC at hospital discharge (96.5 vs. 86.0%, p = 0.007). The SEC + patients had larger LA diameters (50 (47; 54) vs. 47 (43; 51) mm, p < 0.001), wider LAA ostia (21 (19; 23) vs. 20 (17; 22) mm at 45°, p = 0.011), and lower left ventricular ejection fraction (50 (45; 60) vs. 60 (50; 60) %, p < 0.001) on admission. Procedural success was very high in both groups (98.1%, p = 1.00). Periprocedural major adverse cardiac and cerebrovascular events and other major complications were rare in both groups (3.8 vs. 4.7%, p = 0.76). At follow-up, DRT was only detected in the SEC - group (3.8 vs. 0%, p = 1.00). The rates of TEs (SEC - 1.2 vs. SEC + 0%, p = 1.00) after hospital discharge and 1-year mortality (SEC - 12.0 vs. SEC + 11.8%, p = 0.96) were not significantly different between the two groups. CONCLUSIONS: Presence of SEC at baseline was not associated with an increased rate of DRT or TEs at 1-year follow-up after LAAO in LAARGE.

Surgical ablation of long-standing persistent atrial fibrillation: 1-year outcomes from the CArdioSurgEry Atrial Fibrillation (CASE-AF) registry.

OBJECTIVES: The CArdioSurgEry Atrial Fibrillation (CASE-AF) registry is a prospective, multicentre study for collecting and analysing real-world data of surgical atrial fibrillation (AF) treatment. This study aimed to evaluate outcomes of surgery for long-standing persistent AF at 1 year. METHODS: In total, 17 centres consecutively include all eligible patients with continuous AF lasting for ≥1 year. Exclusion criteria are missing informed consent or age <18 years. For patient-reported outcomes measures, the European Heart Rhythm Association score was used. No presence of AF (based on ECG findings including Holter ECG and/or implanted devices), no re-ablation, no further cardioversion and no rehospitalization due to AF after a 3-month blanking period defined no AF recurrence at 1 year. RESULTS: From January 2017 to January 2020, a total of 1115 patients were enrolled in CASE-AF. Of them, 202 patients (mean age 69.7 ± 7.8 years, 27.2% female) underwent surgical ablation of long-standing persistent AF (study cohort), mostly accompanied by left atrial appendage closure (n = 180 [89%], resection n = 75 [42%]) and predominantly performed as concomitant (n = 174 [86%]) and left atrial only procedure (n = 144 [71%]). Early mortality (30 days) was 2.0% and morbidity was low. At follow-up (median 14.4 months, interquartile range, 12.7-17.6 months, 100% complete), 106 patients (56%) had no AF recurrence and 93% of them were asymptomatic. AF recurrence was accompanied by AF-related rehospitalization (n = 12, P = 0.003), direct current shock cardioversion (n = 23, P < 0.001), AF ablation (n = 7, P = 0.003) and stroke (n = 3, P = 0.059). Multivariable analysis identified cryoablation, predominantly performed endocardially including additional left atrial (74%) and biatrial (42%) lesions, as a significant factor for freedom from AF recurrence (odds ratio 2.7, 95% confidence interval 1.07-6.79, P = 0.035). CONCLUSIONS: According to CASE-AF, surgical ablation of long-standing persistent AF is most effective when concomitantly performed using endocardial cryoablation. Ongoing follow-up allows further elucidation of efficacious treatment strategies.

Prevention of cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation: the ODIn-AF trial.

BACKGROUND AND OBJECTIVES: Long-term oral anticoagulation (OAC) following successful catheter ablation of atrial fibrillation (AF) remains controversial. Prospective data are missing. The ODIn-AF study aimed to evaluate the effect of OAC on the incidence of silent cerebral embolic events and clinically relevant cardioembolic events in patients at intermediate to high risk for embolic events, free from AF after pulmonary vein isolation (PVI). METHODS: This prospective, randomized, multicenter, open-label, blinded endpoint interventional trial enrolled patients who were scheduled for PVI to treat paroxysmal or persistent AF. Six months after PVI, AF-free patients were randomized to receive either continued OAC with dabigatran or no OAC. The primary endpoint was the incidence of new silent micro- and macro-embolic lesions detected on brain MRI at 12 months of follow-up compared to baseline. Safety analysis included bleedings, clinically evident cardioembolic, and serious adverse events (SAE). RESULTS: Between 2015 and 2021, 200 patients were randomized into 2 study arms (on OAC: n = 99, off OAC: n = 101). There was no significant difference in the occurrence of new cerebral microlesions between the on OAC and off OAC arm [2 (2%) versus 0 (0%); P = 0.1517] after 12 months. MRI showed no new macro-embolic lesion, no clinical apparent strokes were present in both groups. SAE were more frequent in the OAC arm [on OAC n = 34 (31.8%), off OAC n = 18 (19.4%); P = 0.0460]; bleedings did not differ. CONCLUSION: Discontinuation of OAC after successful PVI was not found to be associated with an elevated risk of cerebral embolic events compared with continued OAC after a follow-up of 12 months.

[Isthmus-dependent right atrial flutter : Clinical course after isthmus ablation]. / Rechtsatriales isthmusabhängiges Vorhofflattern : Klinischer Verlauf nach Isthmusablation.

Ablation of the cavotricuspid isthmus (CTI) to create bidirectional isthmus blockade is the most effective way to achieve rhythm control in typical atrial flutter. Compared with drug therapy, ablation reduces cardiovascular mortality, all-cause mortality, stroke risk, and the risk of cardiac decompensation. Concomitant arrhythmia of atrial flutter is atrial fibrillation (AF); therefore the duration of oral anticoagulation should be adapted according to the risk of stroke and bleeding. A combined procedure of CTI ablation and pulmonary vein isolation (PVI) in patients with typical atrial flutter but without evidence of AF should be evaluated individually especially in patients aged > 54 years depending on (cardiac) comorbidities. The comprehensive diagnostic view should keep in mind not only arrhythmias but also possibly underlying coronary artery disease.

Electroanatomical Conduction Characteristics of Pig Myocardial Tissue Derived from High-Density Mapping.

BACKGROUND: Ultra-high-density mapping systems allow more precise measurement of the heart chambers at corresponding conduction velocities (CVs) and voltage amplitudes (VAs). Our aim for this study was to define and compare a basic value set for unipolar CV and VA in all four heart chambers and their separate walls in healthy, juvenile porcine hearts using ultra-high-density mapping. METHODS: We used the Rhythmia Mapping System to create electroanatomical maps of four pig hearts in sinus rhythm. CVs and VAs were calculated for chambers and wall segments with overlapping circular areas (radius of 5 mm). RESULTS: We analysed 21 maps with a resolution of 1.4 points/mm2. CVs were highest in the left atrium (LA), followed by the left ventricle (LV), right ventricle (RV), and right atrium (RA). As for VA, LV was highest, followed by RV, LA, and RA. The left chambers had a higher overall CV and VA than the right. Within the chambers, CV varied more in the right than in the left chambers, and VA varied in the ventricles but not in the atria. There was a slightly positive correlation between CVs and VAs at velocity values of <1.5 m/s. CONCLUSIONS: In healthy porcine hearts, the left chambers showed higher VAs and CVs than the right. CV differs mainly within the right chambers and VA differs only within the ventricles. A slightly positive linear correlation was found between slow CVs and low VAs.

Atrial Fibrillation can adversely impact Heart Failure with Preserved Ejection Fraction by its association with Heart Failure Progression and Mortality: A Post-Hoc Propensity Score-Matched Analysis of the TOPCAT Americas Trial.

AIMS: Prevalent atrial fibrillation (AF) is associated with excess cardiovascular (CV) death (D) and hospitalizations (H) in heart failure (HF) with preserved ejection fraction (pEF). We evaluated if it had an independent role in excess CVD in HFpEF and studied its impact on cause-specific mortality and HF morbidity. METHODS AND RESULTS: We used propensity score-matched (PSM) cohorts from the TOPCAT Americas trial to account for confounding by other co-morbidities. Two prevalent AF presentations at study entry were compared: (i) subjects with Any AF event by history or on electrocardiogram (ECG) with PSM subjects without an AF event and (ii) subjects in AF on ECG with PSM subjects in sinus rhythm. We analyzed cause-specific modes of death and HF morbidity during a mean follow-up period of 2.9 years. A total of 584 subjects with Any AF event and 418 subjects in AF on ECG were matched. Any AF was associated with increased CVH [hazard ratio (HR) 1.33, 95% confidence interval (CI) 1.11-1.61, P = 0.003], HFH (HR 1.44, 95% CI 1.12-1.86, P = 0.004), pump failure death (PFD) (HR 1.95, 95% CI 1.05-3.62, P = 0.035), and HF progression from New York Heart Association (NYHA) classes I/II to III/IV (HR 1.30, 95% CI 1.04-1.62, P = 0.02). Atrial fibrillation on ECG was associated with increased risk of CVD (HR 1.46, 95% CI 1.02-2.09, P = 0.039), PFD (HR 2.21, 95% CI 1.11-4.40, P = 0.024), and CVH and HFH (HR 1.37, 95% CI 1.09-1.72, P = 0.006 and HR 1.65, 95% CI 1.22-2.23, P = 0.001, respectively). Atrial fibrillation was not associated with risk of sudden death. Both Any AF and AF on ECG cohorts were associated with PFD in NYHA class III/IV HF. CONCLUSION: Prevalent AF can be an independent risk factor for adverse CV outcomes by its selective association with worsening HF, HFH, and PFD in HFpEF. Prevalent AF was not associated with excess sudden death risk in HFpEF. Atrial fibrillation was also associated with HF progression in early symptomatic HFpEF and PFD in advanced HFpEF. TRIAL REGISTRATION: TOPCAT trial is registered at www.clinicaltrials.gov:identifier NCT00094302.

The German CArdioSurgEry Atrial Fibrillation Registry: In-Hospital Outcomes.

BACKGROUND: The aim of this study was to describe outcomes of patients undergoing surgical ablation for atrial fibrillation (AF) as either stand-alone or concomitant cardiosurgical procedures in Germany. METHODS: Patients with AF undergoing concomitant or stand-alone surgical ablation were included in the registry. Cardiac surgery centers across Germany were invited to participate and sought to enroll 1,000 consecutive patients. Data was obtained through electronic case report forms. The protocol mandated follow-up interviews at 1 year. RESULTS: Between January 2017 and April 2020, 17 centers enrolled 1,000 consecutive patients. Among concomitant surgical patients (n = 899), paroxysmal AF was reported in 55.4% patients. Epicardial radio frequency (RF) bilateral pulmonary vein isolation (PVI) with excision of the left atrial appendage (LAA) was the most common operative strategy. In the stand-alone cohort (n = 101), persistent AF forms were reported in 84.1% of patients. Moderate-to-severe symptoms were reported in 85.1%. Sixty-seven patients had previously underwent at least two failed catheter ablative procedures. Thoracoscopic epicardial RF bilateral PVI and completion of a "box-lesion" with LAA closure were frequently preformed. Major cardiac and cerebrovascular complications occurred in 38 patients (4.3%) in the concomitant group. No deaths were reported in the stand-alone group. At discharge, sinus rhythm was achieved in 88.1% of stand-alone and 63.4% concomitant patients. CONCLUSION: The CArdioSurgEry Atrial Fibrillation registry provides insights into surgical strategies for AF ablation in a considerable cohort across Germany. This in-hospital data demonstrates that concomitant and stand-alone ablation during cardiac surgery is safe and effective with low complication rates.

Early diagnosis and better rhythm management to improve outcomes in patients with atrial fibrillation: the 8th AFNET/EHRA consensus conference.

Despite marked progress in the management of atrial fibrillation (AF), detecting AF remains difficult and AF-related complications cause unacceptable morbidity and mortality even on optimal current therapy. This document summarizes the key outcomes of the 8th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). Eighty-three international experts met in Hamburg for 2 days in October 2021. Results of the interdisciplinary, hybrid discussions in breakout groups and the plenary based on recently published and unpublished observations are summarized in this consensus paper to support improved care for patients with AF by guiding prevention, individualized management, and research strategies. The main outcomes are (i) new evidence supports a simple, scalable, and pragmatic population-based AF screening pathway; (ii) rhythm management is evolving from therapy aimed at improving symptoms to an integrated domain in the prevention of AF-related outcomes, especially in patients with recently diagnosed AF; (iii) improved characterization of atrial cardiomyopathy may help to identify patients in need for therapy; (iv) standardized assessment of cognitive function in patients with AF could lead to improvement in patient outcomes; and (v) artificial intelligence (AI) can support all of the above aims, but requires advanced interdisciplinary knowledge and collaboration as well as a better medico-legal framework. Implementation of new evidence-based approaches to AF screening and rhythm management can improve outcomes in patients with AF. Additional benefits are possible with further efforts to identify and target atrial cardiomyopathy and cognitive impairment, which can be facilitated by AI.

The German Cardiosurgery Atrial Fibrillation Registry: 1-Year Follow-up Outcomes.

OBJECTIVES: This study of German Cardiosurgery Atrial Fibrillation (CASE-AF) registry aims to describe the 1-year outcomes of patients undergoing ablative procedures for atrial fibrillation (AF) in a cardiosurgical setting. METHODS: Between January 2017 and April 2020, 17 German cardiosurgical units enrolled 1,000 consecutive patients undergoing concomitant or stand-alone ablation for AF. In-hospital and 1-year follow-up data were collected on web-based electronic case report forms. The protocol mandated telephone-based follow-up contact after 1 year. RESULTS: At 1-year follow-up (median, 14.5 months [12.6-18.2 months]), significant improvement (p < 0.0001) in baseline modified European Heart Rhythm Association Class I was reported in both concomitant and stand-alone patients. Follow-up examinations were completed in 97.9% of cases, and a sinus rhythm was reported in 60.2 and 63.6% of stand-alone and concomitant patients, respectively. Statistically significant factors determining late recurrence were female gender (p = 0.013), preoperative persistent AF (p < 0.0001), and presence of cardiac implantable electronic device (p = 0.011). All-cause mortality at 1 year was 1% (n = 1) in stand-alone patients and 6.7% (n = 58) in concomitant patients. CONCLUSION: Surgical ablation of AF is safe and provides satisfactory results at short-term follow-up, with significant improvement in patient symptoms. Adequate cardiac rhythm monitoring should be prioritized for higher quality data acquisition.

Adverse events and stroke prevention by interventional left atrial appendage occlusion in patients with low CHA2 DS2 -VASc score-results from the multicenter German LAARGE registry.

BACKGROUND: Interventional left atrial appendage occlusion (LAAO) is routinely performed in patients with nonvalvular atrial fibrillation and contraindications to standard anticoagulation. AIMS: We investigated its role in patients at low stroke risk, and compared the effectiveness and safety in patients with low versus high risk. METHODS: LAARGE is a prospective registry depicting the clinical reality of LAAO. LAAO was conducted with different standard commercial devices, and follow-up period was 1 year. Patients with started procedure and documented CHA2 DS2 -VASc score were selected from the whole database. RESULTS: A total of 638 patients from 38 centers were divided into CHA2 DS2 -VASc score ≤2, i.e., low-risk group (10.2%), and >2, i.e., high-risk group (89.8%). The latter had a pronounced cardiovascular risk profile and preceding strokes (0% vs. 23.9%; p < 0.001). Implantation success was consistently high (97.6%), frequencies of intrahospital major adverse cardiac and cerebrovascular events (0% vs. 0.5%) and other major complications (4.6% vs. 4.0%) were low (each p = not significant [NS]). Numerous moderate complications were also observed in the low-risk patients (12.3% vs. 9.4%; p = NS). Frequencies of nonfatal strokes (0% vs. 0.7%) and severe bleedings (0% vs. 0.7%) were low (each p = NS). In a specific analysis, patients at very high risk of stroke (i.e., CHA2 DS2 -VASc score >4) did not have increased rates of complications or nonfatal strokes in the first year after the procedure. CONCLUSIONS: Low-risk patients had no nonfatal strokes and major bleedings within 1 year after hospital discharge but had unexpectedly high rates of moderate procedural complications. The indication in these patients should be strictly defined based on an individual benefit-risk assessment.

Influence of severe anemia on procedural safety and one-year outcome after left atrial appendage closure: Insights from a very high-risk cohort.

INTRODUCTION: Patients undergoing left atrial appendage closure (LAAC) are often severly anemic and close to the transfusion threshold. The aim was to investigate the prevalence of severe anemia in this cohort and if procedural safety is compromised compared with non-anemic patients. METHODS AND RESULTS: Comparison of severly anemic patients (Hb < 80 g/l) vs. non-severly anemic patients in the prospective, multicentre observational LAARGE registry of patients undergoing LAAC. A total of 638 patients (anemia 22.3% vs non-anemic 77.7%) were included. Anemic patients were older (77.1 years ± 7.9 vs 75.6 years ± 7.9, p = 0.014), had more comorbidities, higher CHA2DS2-VASc (4.8 vs 4.4, p = 0.017) and higher HAS-BLED (4.3 vs 3.8, p < 0.001) scores. Implant success was not influenced by anemia (99.3% vs 97.2%). Severe in-hospital (0.7% vs 5.6%, p = 0.01) and overall complications (8.5% vs 13.7%, p = 0.11) were less common in patients with anemia, driven by fewer pericardial effusions. Mortality was higher in anemic patients and associated with an increased hazard ratio, albeit not significantly (16.0% vs 10.3%, HR 1.61 (95%-CI: 0.97-2.67), p = 0.06). In the one-year follow-up, composite outcome of death, stroke or systemic embolism occurred in 22/142 anemic and in 54/496 non-anemic patients with an adjusted HR of 1.04 (95%-CI 0.62-1.73, p = 0.89). CONCLUSION: Severe anemia close to the transfusion threshold is common in patients undergoing LAAC. However, this does not influence in-hospital complications or implant success. One-year mortality is higher in anemic patients, mainly driven by co-morbidities.

Anticoagulation versus antiplatelet therapy after percutaneous left atrial appendage closure-subanalysis from the multicenter LAARGE registry.

PURPOSE: Data regarding post-procedural antithrombotic therapy following percutaneous left atrial appendage (LAA) in real-world populations using various occluder systems is limited. In the present analysis, anticoagulation (AC) was compared against antiplatelet therapy (APT) using data from the real-world multi-center LAARGE study. METHODS: Patients following LAA closure enrolled in the LAARGE study were assigned to two groups depending on initial post-implantation antithrombotic regime consisting of either AC or APT. Selection of antithrombotic medication was at the discretion of the treating center and/or physician. RESULTS: From July 2014 until January 2016, a total of 627 patients at 38 centers were included. A total of 75 patients (12%) received AC and 552 patients (88%) received APT, respectively. No significant differences were found between the groups regarding the composite of death, stroke and systemic embolism 1 year after LAA closure (Kaplan-Meier estimated rate 9.4% for AC vs. 12.8% for APT; p log rank = 0.45). With respect to bleeding events also, no differences were observed 1 year after the procedure (major bleeding 4.0% vs. 2.0%, p = 0.23; moderate bleeding 4.0% vs. 4.9%, p = 1.00; any bleeding 8.0% vs. 6.9%, p = 0.73). CONCLUSIONS: Postprocedural antithrombotic treatment with AC and APT showed comparable results regarding the composite of death, stroke, and systemic embolism as well as regarding bleeding complications after LAA closure in a real-world all-comers population.

Potential of remote monitoring to prevent sensing and detection failures in implantable cardioverter defibrillators.

BACKGROUND: Sensing malfunction and misinterpretation of intracardiac electrograms (IEGMs) in patients with implantable cardioverter defibrillators (ICDs) may lead to inadequate device activity such as inappropriate shock delivery or unnecessary mode-switching. Remote monitoring has the potential for early detection of sensing malfunction or misclassification and may thus prevent adverse device activity. Therefore, the authors analyzed the amount, nature, and distribution of misclassification in current ICD and cardiac resynchronization therapy defibrillator technology using the device transmissions of the IN-TIME study population. METHODS: All transmitted tachyarrhythmic episodes in the 664 IN-TIME patients, comprising 2214 device-classified atrial fibrillation (DC-AF) episodes lasting ≥ 30 s and 1330 device-classified ventricular tachycardia or fibrillation (DC-VT/VF) episodes, were manually analyzed by two experienced cardiologists. RESULTS: After evaluation of all DC-VT/VF episodes, a total of 300 VT/VF events (23.1%) were false-positive, with supraventricular tachycardia being the most frequent cause (51.7%), followed by atrial fibrillation (21.3%) and T­wave oversensing (21.0%). A total of 15 patients with false-positive DC-VT/VF received inappropriate shocks. According to the inclusion criteria, 616 IEGMs with DC-AF were assessed. A total of 19.7% were false-positive AF episodes and R­wave oversensing was the most common reason (55.9%). CONCLUSIONS: Remote monitoring offers the opportunity of early detection of signal misclassification and thus early prevention of adverse device reaction, such as inappropriate shock delivery or mode-switching with intermittent loss of atrioventricular synchrony, by correcting the underlying causes.

Impact of atrial fibrillation pattern on outcomes after left atrial appendage closure: lessons from the prospective LAARGE registry.

BACKGROUND: Non-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death. METHODS: Comparison of procedural details and long-term outcomes in patients (pts) with paroxysmal AF (PAF) against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC (LAARGE). RESULTS: A total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The total CHA2DS2-VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), while HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was comparable. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77). In the three-month echo follow-up, LA thrombi (2.1% vs 7.3%, p = 0.12) and peridevice leak > 5 mm (0.0% vs 7.1%, p = 0.53) were numerically higher in the NPAF group. Overall, in-hospital complications occurred in 15.0% of the PAF cohort and 10.7% of the NPAF cohort (p = 0.12). In the one-year follow-up, unadjusted mortality (8.4% vs 14.0%, p = 0.039) and combined outcome of death, stroke and systemic embolism (8.8% vs 15.1%, p = 0.022) were significantly higher in the NPAF cohort. After adjusting for CHA2DS2-VASc and previous bleeding, NPAF was associated with increased death/stroke/systemic embolism (HR 1.67, 95% CI 1.02-2.72, p = 0.041). CONCLUSION: Atrial fibrillation type did not impair periprocedural safety or in-hospital MACE patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality.

Impact of HAS-BLED Score on outcome after percutaneous left atrial appendage closure: insights from the German Left Atrial Appendage Occluder Registry LAARGE.

AIM: Percutaneous left atrial appendage (LAA) closure has been established as alternative stroke prophylaxis in patients with non-valvular atrial fibrillation (AF) and high bleeding risk. However, little is known regarding the outcome after LAA closure depending on the HAS-BLED score. METHODS: A sub-analysis of the prospective, multicenter, Left-Atrium-Appendage Occluder Register-GErmany (LAARGE) registry was performed assessing three different groups with respect to the HAS-BLED score (0-2 [group 1] vs. 3-4 [group 2] vs. 5-7 [group 3]). RESULTS: A total of 633 patients at 38 centers were enrolled. Of them, 9% (n = 59) were in group 1, 63% (n = 400) in group 2 and 28% (n = 174) in group 3. The Kaplan-Meier estimated 1-year composite of death, stroke and systemic embolism was 3.4% in group 1 vs. 10.4% in group 2 vs. 20.1% in group 3, respectively (p log-rank < 0.001). The difference was driven by death since stroke and systemic embolism did not show a significant difference between the groups. The rate of major bleeding at 1 year was 0% vs. 0% vs. 2.4%, respectively (p = 0.016). CONCLUSION: The present data show that patients had similarly low rates of ischemic complications 1 year after LAA closure irrespective of the baseline bleeding risk. Higher HAS-BLED scores were associated with increased mortality due to higher age and more severe comorbidity of these patients.