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.

Oesophageal safety in voltage-guided atrial fibrillation ablation using ablation index or contact force only: a prospective comparison.

AIMS: Left atrial ablation using radiofrequency (RF) is associated with endoscopically detected thermal oesophageal lesions (EDELs). The aim of this study was to compare EDEL occurrence after conventional contact force-guided (CFG) RF ablation vs. an ablation index-guided (AIG) approach in clinical routine of voltage-guided ablation (VGA). Predictors of EDEL were also assessed. METHODS AND RESULTS: This study compared CFG (n = 100) with AIG (n = 100) in consecutive atrial fibrillation ablation procedures, in which both pulmonary vein isolation and VGA were performed. In the AIG group, AI targets were ≥500 anteriorly and ≥350-400 posteriorly. Upper endoscopy was performed after ablation.The CFG and AIG groups had comparable baseline characteristics. The EDEL occurred in 6 and 5% (P = 0.86) in the CFG and AIG groups, respectively. Category 2 lesions occurred in 4 and 2% (P = 0.68), respectively. All EDEL healed under proton pump inhibitor therapy. The AI > 520 was the only predictor of EDEL [odds ratio (OR) 3.84; P = 0.039]. The more extensive Category 2 lesions were predicted by: AI max > 520 during posterior ablation (OR 7.05; P = 0.042), application of posterior or roof lines (OR 5.19; P = 0.039), existence of cardiomyopathy (OR 4.93; P = 0.047), and CHA2DS2-VASc score (OR 1.71; P = 0.044). The only Category 2 lesion with AI max < 520 (467) occurred in a patient with low body mass index. CONCLUSIONS: Both methods were comparable with respect to clinical complications and EDEL. In consideration of previous reconnection data and our study results regarding oesophageal safety, optimal AI target range might be between 400 and 450.

Catheter ablation of ventricular arrhythmias and in-hospital mortality: insights from the German-wide Helios hospital network of 5052 cases.

AIMS: Catheter ablation (CA) of ventricular arrhythmias is one of the most challenging electrophysiological interventions with an increasing use over the last years. Several benefits must be weighed against the risk of potentially life-threatening complications which necessitates a steady reevaluation of safety endpoints. Therefore, the aims of this study were (i) to investigate overall in-hospital mortality in patients undergoing such procedures and (ii) to identify variables associated with in-hospital mortality in a German-wide hospital network. METHODS AND RESULTS: Between January 2010 and September 2018, administrative data provided by 85 Helios hospitals were screened for patients with main or secondary discharge diagnosis of ventricular tachycardia (VT) or premature ventricular contractions (PVCs) in combination with an arrhythmia-related CA using ICD- and OPS codes. In 5052 cases (mean age 60.9 ± 14.3 years, 30.1% female) of 30 different hospitals, in-hospital mortality was 1.27% with a higher mortality in patients ablated for VT (1.99%, n = 2, 955) compared to PVC (0.24%, n = 2, 097, P < 0.01). Mortality rates were 2.06% in patients with ischaemic heart disease (IHD, n = 2, 137), 1.47% in patients with non-ischaemic structural heart disease (NIHD, n = 1, 224), and 0.12% in patients without structural heart disease (NSHD, n = 1, 691). Considering different types of hospital admission, mortality rates were 0.35% after elective (n = 2, 825), 1.60% after emergency admission/hospital transfer <24 h (n = 1, 314) and 3.72% following delayed hospital transfer >24 h after initial admission (n = 861, P < 0.01 vs. elective admission and emergency admission/hospital transfer <24 h). In multivariable analysis, a delayed hospital transfer >24 h [odds ratio (OR) 2.28, 95% confidence interval (CI) 1.59-3.28, P < 0.01], the occurrence of procedure-related major adverse events (OR 6.81, 95% CI 2.90-16.0, P < 0.01), Charlson Comorbidity Index (CCI, OR 2.39, 95% CI 1.56-3.66, P < 0.01) and its components congestive heart failure (OR 8.04, 95% CI 1.71-37.8, P < 0.01), and diabetes mellitus (OR 1.59, 95% CI 1.13-2.22, P < 0.01) were significantly associated with in-hospital death. CONCLUSIONS: We reported in-hospital mortality rates after CA of ventricular arrhythmias in the largest multicentre, administrative dataset in Germany which can be implemented in quality management programs. Aside from comorbidities, a delayed hospital transfer to a CA performing centre is associated with an increased in-hospital mortality. This deserves further studies to determine the optimal management strategy.

In-hospital mortality of patients with atrial arrhythmias: insights from the German-wide Helios hospital network of 161 502 patients and 34 025 arrhythmia-related procedures.

Aims: Atrial fibrillation (AFib) and atrial flutter (AFlut) are common arrhythmias with increased use of invasive procedures. A steady re-evaluation of relevant safety endpoints is recommended and both quality management and pay-for-performance programs are evolving. Therefore, the aims of this study were (i) to investigate and report overall in-hospital mortality and mortality of invasive arrhythmia-related procedures and (ii) to identify mortality predictors in a German-wide hospital network. Methods and results: Administrative data provided by 78 Helios hospitals between 2010 and 2017 were examined using International Statistical Classification of Diseases and Related Health Problems- and Operations and Procedures-codes to identify patients with AFib or AFlut as main discharge diagnosis or secondary diagnosis combined with invasive arrhythmia-related interventions. In 161 502 patients, in-hospital mortality was 0.6% with a significant decrease from 0.75% to 0.5% (P < 0.01) during the observational period. In multivariable analysis, age [odds ratio (OR) 2.69, 95% confidence interval (CI) 2.36-3.05; P < 0.01], high centre volume (OR 0.57, 95% CI 0.50-0.65; P < 0.01), emergency hospital admission (OR 1.57, 95% CI 1.38-1.79; P < 0.01), and Charlson Comorbidity Index (CCI, OR 4.95, 95% CI 4.50-5.44; P < 0.01) were found as independent predictors of in-hospital mortality. Mortality rates were 0.05% for left atrial catheter ablation (CA, n = 21 744), 0.3% for right atrial CA (n = 9972), and 0.56% for implantation of a left atrial appendage occluder (n = 2309), respectively. Conclusion: We analysed for the first time in-hospital mortality rates of patients with atrial arrhythmias in a German-wide, multi-centre administrative dataset. This allows feasible, comparable, and up-to-date performance measurement of clinically important endpoints in a real-world setting which may contribute to quality management programs and towards value-based healthcare.

Cardiac tamponade in catheter ablation of atrial fibrillation: German-wide analysis of 21 141 procedures in the Helios atrial fibrillation ablation registry (SAFER).

Aims: Catheter ablation is an established therapy in patients with symptomatic atrial fibrillation (AF) with increasing popularity. Pericardial effusion requiring intervention (PE) is one of the most threatening adverse outcomes. The aim of this study was to examine rates of PE after catheter ablation in a large 'real-world' data set in a German-wide hospital network. Methods and results: Using ICD and OPS codes, administrative data of 85 Helios hospitals from 2010 to 2017 was used to identify AF catheter ablation cases [Helios atrial fibrillation ablation registry (SAFER)]. PE occurred in 0.9% of 21 141 catheter ablation procedures. Patients with PE were significantly older, to a higher percentage female, had more frequently hypertension, mild liver disease, diabetes with chronic complications, and renal disease. Low hospital volume (<50 procedures per year) and radiofrequency ablation (vs. cryoablation) were significantly associated with PE. Using two logistic regression models, age, female gender, hypertension, mild liver disease, diabetes with chronic complications, renal disease, low hospital volume, and radiofrequency ablation remained independent predictors for PE. Conclusion: Overall PE rate was 0.9%. Predictors for PE occurrence involved factors ascribed to the patient (age, gender, comorbidities), the type of catheter ablation (radiofrequency), and the institution (low-volume centres).

Clinical Impact of the Microembolic Signal Burden During Catheter Ablation for Atrial Fibrillation: Just a Lot of Noise?

OBJECTIVES: Microembolic signal detection by transcranial Doppler ultrasonography may be considered a surrogate for cerebral events during invasive cardiac procedures. However, the impact of the microembolic signal count during pulmonary vein isolation on the clinical outcome is not well evaluated. We investigated the effect of the microembolic signal count on the occurrence of new silent cerebral embolism measured by diffusion-weighted imaging (DWI)-magnetic resonance imaging (MRI), changes in neuropsychological testing, and the occurrence of clinical events during long-term follow-up after pulmonary vein isolation. METHODS: Pulmonary vein isolation was performed in 41 patients. The total microembolic signal burden (classified into "solid," "gaseous," and "equivocal") and sustained thromboembolic showers of greater than 30 seconds were recorded. Diffusion-weighted imaging-MRI and neuropsychological testing were performed before and after pulmonary vein isolation to assess for silent cerebral embolism and neuropsychological sequelae. Long-term follow-up was performed by telephone to assess for stroke/transient ischemic attack. RESULTS: A total of 68,729 microembolic signals (14,893 solid, 11,909 gaseous, and 41,927 equivocal) with an average of 1676 signals per patient and 42 thromboembolic showers were recorded. No correlation between the microembolic signal/thromboembolic shower count and the occurrence of new DWI lesions or neuropsychological capability was found. After a mean follow-up ± SD of 49 ± 4 months, 1 patient had an overt transient ischemic event, which was not associated with a high microembolic signal count. CONCLUSIONS: In this multicenter study, we found no impact of the intraprocedural microembolic symbol/thromboembolic shower count on the occurrence of new DWI lesions, neuropsychological capability, or overt neurologic deficits after pulmonary vein isolation. Thus, not only the microembolic signal count but also procedural/individual factors may contribute to commensurable clinical damage, which may challenge this method as a valid biomarker during pulmonary vein isolation.

The Phospholipase Cγ2 Mutants R665W and L845F Identified in Ibrutinib-resistant Chronic Lymphocytic Leukemia Patients Are Hypersensitive to the Rho GTPase Rac2 Protein.

Mutations in the gene encoding phospholipase C-γ2 (PLCγ2) have been shown to be associated with resistance to targeted therapy of chronic lymphocytic leukemia (CLL) with the Bruton's tyrosine kinase inhibitor ibrutinib. The fact that two of these mutations, R665W and L845F, imparted upon PLCγ2 an ∼2-3-fold ibrutinib-insensitive increase in the concentration of cytosolic Ca2+ following ligation of the B cell antigen receptor (BCR) led to the assumption that the two mutants exhibit constitutively enhanced intrinsic activity. Here, we show that the two PLCγ2 mutants are strikingly hypersensitive to activation by Rac2 such that even wild-type Rac2 suffices to activate the mutant enzymes upon its introduction into intact cells. Enhanced "basal" activity of PLCγ2 in intact cells is shown using the pharmacologic Rac inhibitor EHT 1864 and the PLCγ2F897Q mutation mediating Rac resistance to be caused by Rac-stimulated rather than by constitutively enhanced PLCγ2 activity. We suggest that R665W and L845F be referred to as allomorphic rather than hypermorphic mutations of PLCG2 Rerouting of the transmembrane signals emanating from BCR and converging on PLCγ2 through Rac in ibrutinib-resistant CLL cells may provide novel drug treatment strategies to overcome ibrutinib resistance mediated by PLCG2 mutations or to prevent its development in ibrutinib-treated CLL patients.

Rac-mediated Stimulation of Phospholipase Cγ2 Amplifies B Cell Receptor-induced Calcium Signaling.

The Rho GTPase Rac is crucially involved in controlling multiple B cell functions, including those regulated by the B cell receptor (BCR) through increased cytosolic Ca(2+). The underlying molecular mechanisms and their relevance to the functions of intact B cells have thus far remained unknown. We have previously shown that the activity of phospholipase Cγ2 (PLCγ2), a key constituent of the BCR signalosome, is stimulated by activated Rac through direct protein-protein interaction. Here, we use a Rac-resistant mutant of PLCγ2 to functionally reconstitute cultured PLCγ2-deficient DT40 B cells and to examine the effects of the Rac-PLCγ2 interaction on BCR-mediated changes of intracellular Ca(2+) and regulation of Ca(2+)-regulated and nuclear-factor-of-activated-T-cell-regulated gene transcription at the level of single, intact B cells. The results show that the functional Rac-PLCγ2 interaction causes marked increases in the following: (i) sensitivity of B cells to BCR ligation; (ii) BCR-mediated Ca(2+) release from intracellular stores; (iii) Ca(2+) entry from the extracellular compartment; and (iv) nuclear translocation of the Ca(2+)-regulated nuclear factor of activated T cells. Hence, Rac-mediated stimulation of PLCγ2 activity serves to amplify B cell receptor-induced Ca(2+) signaling.

Spatial Relationship of Focal Impulses, Rotors and Low Voltage Zones in Patients With Persistent Atrial Fibrillation.

INTRODUCTION: Focal impulses (FI) and rotors are sources associated with the initiation and maintenance of atrial fibrillation (AF). Their ablation results in a lower recurrence rate. The aim of this study was to characterize for the first time the spatial relationship between such sources and atrial low voltage zones (LVZ) representing fibrosis. METHODS: Twenty-five consecutive patients undergoing their first ablation for persistent AF were included. Voltage mapping of both atria was done during AF. Endocardial mapping of FI and rotors (sources) was performed using a basket catheter and displayed using RhythmView(TM) (Topera Inc.) before ablation. Spatial relationship of LVZ and sources was analyzed. RESULTS: LVZs covered 13 ± 12% of right atrial (RA) endocardial surface and 33 ± 25% of left atrial (LA) endocardial surface. The median number of sources was 1 [1-3] in RA and 3 [1-4] in LA. Of LA sources, 18 (30%) were definitely not associated with LVZs or pulmonary vein (PV) antra. Of RA sources, 32 (84%) were remote from LVZ. During ablation of such sources substantial cycle length (CL) prolongation or AF conversion occurred in 11/23 patients (48%). Altogether, 8/11 (73%) of these pertinent sources were located remotely from LVZ and PV antra. CONCLUSIONS: There is a wide discrepancy in distribution of LVZ areas and sites of identified rotors. Site and incidence of FIRM sources appear to be unpredictable with atrial substrate mapping. Further prospective, randomized studies are necessary to elucidate the impact of additional ablation of such sources in patients with persistent or longstanding persistent AF.

Hemodynamic Improvement at Three Months after MitraClip® Treatment in End-Stage Heart Failure Patients with Functional Mitral Regurgitation.

BACKGROUND: Functional mitral regurgitation (FMR) is common in patients with advanced heart failure and impaired left ventricular function. The study aim was to examine functional and hemodynamic effects at three months after MitraClip® implantation in high-risk surgical patients with FMR. METHODS: A group of 93 patients was rejected for surgical treatment by heart-team decisions due to an inacceptable risk for conventional mitral valve surgery. Between October 2011 and May 2015, 89 of these patients (96%) were treated successfully with MitraClip implantation. A subsequent complete follow up was performed over three months in 32 patients with FMR, including pro-brain natriuretic peptide (pro-BNP) measurements, six-minute walk test, echocardiography, and right heart catheterization. RESULTS: The patients (mean age 73 ± 7 years) presented with a mean left ventricular ejection fraction (LVEF) of 32 ± 13%, and mitral regurgitation (MR) grade ≥3 in 30 of 32 cases (93%). All patients suffered from severe FMR and were highly symptomatic (NYHA functional class III or IV). The mean logistic EuroSCORE was 33%. MitraClip implantation resulted in a significant clinical improvement and reverse cardiac remodelling with a decrease in LV end-diastolic and LV endsystolic diameters, while LVEF was unchanged. In addition, a statistically relevant reduction of systolic, diastolic and mean pulmonary artery pressures (PAPsystolic -7.2 mmHg, p = 0.011; PAPdiastolic -4.5 mmHg, p = 0.003; and PAPmean -5.3 mmHg, p = 0.007) were measured, while the cardiac index (+0.3 l/min/m2, p <0.001) and cardiac output (+0.5 l/min, p <0.001) were increased significantly. The 30-day mortality was 8.6% (n = 8). CONCLUSIONS: Among the study population, MitraClip implantation led to clinical improvement, reverse cardiac remodeling, and a sustained hemodynamic benefit during the three-month follow up period.

Effect of Different Ablation Settings on Acute Complications Using the Novel Irrigated Multipolar Radiofrequency Ablation Catheter (nMARQ).

BACKGROUND: Single-shot ablation devices for pulmonary vein isolation (PVI) in patients with symptomatic atrial fibrillation (AF) have been increasingly used in clinical practice. OBJECTIVE: A novel mapping-system integrated irrigated multipolar circular ablation catheter (nMARQ) has been introduced for PVI but data on larger patient cohorts on acute safety and efficacy are lacking. METHODS: A total of 145 consecutive patients undergoing AF ablation treated with the nMARQ underwent endoscopic evaluation of esophageal thermal damage (EDEL) and brain MRI for detection of silent cerebral events (SCE). During the course of our experience different modifications of the ablation strategy, including energy delivery at the left atrial posterior wall, were evaluated. RESULTS: Effective PVI was achieved in 99% of all PVs during a mean procedure-duration of 115 (±36) minutes and ablation-duration of 18 (±8) minutes. Acute major complications occurred in 3 patients (2.1%) and asymptomatic complications like SCE in 26% and EDEL in 21%. There was a significant reduction in EDEL when not using a thermal esophageal probe (0% vs. 28%, P < 0.0001). Ablation under oral anticoagulation led to lower SCE incidences compared to interrupted anticoagulation regimen (15% vs. 31%, P = 0.7). Out of 65 patients with completed 12-month follow-up, 43 (66%) were in stable sinus rhythm. CONCLUSIONS: PVI using the nMARQ is safe and effective in patients with symptomatic AF. Not using an esophageal temperature probe during ablation has relevantly reduced the incidence of EDEL. Ablations under continued oral anticoagulation have reduced incidence of SCE. Further studies on long-term efficacy are needed.

Silent cerebral events/lesions related to atrial fibrillation ablation: a clinical review.

Brain magnetic resonance imaging (MRI) has identified a high incidence of cerebral ischemia in asymptomatic patients after atrial fibrillation (AF) ablation (silent). Detection of cerebral ischemic events on MRI is based on acute hyperintense lesions on diffusion-weighted imaging. In the literature, the incidence is related to specifications of MRI and depends on the definition applied. In comparative studies, silent cerebral events (SCE, diffusion-weighted MRI [DWI] positive only) appear to be approximately 3 times more common compared to using a definition of silent cerebral lesions (SCL; without fluid attenuated inverse recovery sequence [FLAIR] positivity). Whereas the FLAIR sequence may turn positive within days after the ischemic event, SCE definition is highly sensitive for early phases of ischemic brain damage. SCE/SCL appear to represent cerebral ischemic infarcts and determine the "embolic fingerprint" of a specific ablation technology and strategy used. The optimum time point for detecting SCE is early after AF ablation (24-72 hours), whereas detection of SCL can only be performed within the first 2-7 days (due to delay of FLAIR positivity). Different technology-, procedure-, and patient-related parameters have been identified to play a role in the multifactorial genesis of SCE/SCL. In recent years, evidence has been gathered that there may be differences of SCE/SCL rates depending upon the ablation technology used, but small patient numbers and a large number of potential confounders hamper all studies. As major findings of recent studies, mode of periprocedural and intraprocedural anticoagulation has been identified as a major predictor for incidences of SCE/SCL. Whereas procedural characteristics related to higher SCE/SCL-rates may be modified, unchangeable patient-related factors should be taken into account for future individualized risk assessment. Novel ablation devices introduced into the market should be tested for their potential embolic fingerprint and refinements of ablation procedures to reduce their embolic potential should be prompted. The knowledge of "best practice" in terms of low SCE/SCL rates has prompted changes in work-flow, which have been implemented into ablation procedures using novel ablation devices. So far, no study has linked SCE/SCL to neuropsychological decline and the low number of AF-ablation-associated events needs to be weighted against the multitude of preexisting asymptomatic MRI-detected brain lesions related to the course of AF itself. Future studies are needed to evaluate if more white matter hyperintensities due to AF may be prevented by AF ablation (producing only a small number of SCE/SCL).

Acute safety and efficacy of a novel multipolar irrigated radiofrequency ablation catheter for pulmonary vein isolation.

INTRODUCTION: "Single shot" ablation devices to treat symptomatic atrial fibrillation have been engineered over the last years. Safety and efficacy also includes subclinical complications only detected with esophageal endoscopy or cerebral MRI in asymptomatic patients. We studied the acute efficacy and safety profile of a novel multipolar irrigated RF ablation catheter (nMARQ™). METHODS AND RESULTS: Forty-three patients underwent pulmonary vein isolation (PVI) using the novel ablation device. Patient baseline and procedural characteristics were documented. Efficacy of PVI was identified using only the nMARQ™ catheter. All patients underwent postablation endoscopic evaluation of the esophagus to document thermal damage and cerebral MRI (diffusion weight imaging, attenuated diffusion coefficient-map) to document incidence and number of silent cerebral lesions (SCL). Effective PVI was achieved in 98% of targeted PVs in a mean procedure time of 133 minutes. A mean of 4.8, 60-second RF applications, per PV was needed for effective PVI. No clinical procedure-associated complications were noted. Esophageal temperature increase >40.5 °C was noted in 22 (51%) patients and 14 of these had thermal esophageal lesions on endoscopic evaluation. A total of 26 SCLs were noted in 14 patients (33%; 1.9/patient; mean diameter of 2.3 mm, 88% of lesions were ≤3 mm). CONCLUSIONS: PVI using the novel irrigated RF multipolar ablation device (nMARQ™) appears to be acutely effective. No clinical complications were identified. A high incidence of SCL (33%) and thermal esophageal lesions (33%) bears caution and further studies on long-term efficacy and safety are needed.

Exchanging Catheters Over a Single Transseptal Sheath During Left Atrial Ablation is Associated with a Higher Risk for Silent Cerebral Events.

BACKGROUND: Silent cerebral events (SCE) have been identified on magnetic resonance imaging (MRI) in asymptomatic patients after atrial fibrillation (AF) ablation. Procedural determinants influencing the risk for SCE still remain unclear. OBJECTIVE: Comparing the risk for SCE depending on exchanges of catheters (ExCath) over a single transseptal sheath. METHODS: 88 Patients undergoing pulmonary vein isolation (PVI) only ablation using either single-tip or balloon-based technique underwent pre- and post-ablation cerebral MRI. Ablations were either performed with double transseptal access and without exchanging catheters over the transseptal sheaths (group 1: no ExCath) or after a single transseptal access and exchanges of therapeutic and diagnostic catheters (group 2: ExCath). Differences in regard to SCE rates were analyzed. Multivariate analysis was performed to identify factors related to the risk for SCE. RESULTS: Included patients underwent PVI using single tip irrigated radiofrequency in 41, endoscopic laser balloon in 27 and cryoballoon in 20 cases. Overall SCE were identified in 23 (26%) patients. In group 1 (no ExCath; N=46) 6 patients (13%) and in group 2 (N=42) 17 patients (40%) had documented SCE (p=0.007). The applied ablation technology did not affect SCE rate. In multivariate analysis age (OR 1.1, p=0.03) and catheter exchanges over a single transseptal sheath (OR 12.1, p=0.007) were the only independent predictors of a higher risk for SCE. CONCLUSIONS: Exchanging catheters over a single transseptal access to perform left atrial ablation is associated with a significantly higher incidence of SCE compared to an ablation technique using different transseptal accesses for therapeutic and diagnostic catheters.

Incidence of silent cerebral thromboembolic lesions after atrial fibrillation ablation may change according to technology used: comparison of irrigated radiofrequency, multipolar nonirrigated catheter and cryoballoon.

INTRODUCTION: Silent cerebral ischemic lesions have recently emerged as the most frequent complications after pulmonary vein isolation (PVI). To reduce thromboembolic complications, new types of catheters and energy source have been introduced in clinical practice. The study purpose is to compare the incidence of new silent cerebral ischemic events in patients with paroxysmal atrial fibrillation (PAF) undergoing PVI with different ablation technologies. METHODS AND RESULTS: One hundred and eight patients (67% men; age 56 ± 9 years) with PAF were enrolled in a consecutive manner to undergo PVI performed with irrigated radiofrequency (RF) catheter (Group 1, 36 patients), multielectrode catheter (PVAC) associated with duty-cycled RF generator (Group 2, 36 patients) and cryoballoon (Group 3, 36 patients). The protocol included a cerebral magnetic resonance imaging before and after the procedure. After PVI, the following patients showed new silent cerebral ischemic lesions at postprocedural cerebral MRI: 3 patients in Group 1 (8.3%), 14 patients in Group 2 (38.9%), 2 patients in Group 3 (5.6%). PVAC related to higher incidence of silent cerebral ischemic events compared to irrigated RF (P = 0.002) and cryoballoon (P = 0.001), whereas no statistical differences were found between irrigated RF catheter and cryoballoon groups (8.3% vs 5.6%, P = 0.5). At the multivariate analysis, the only independent predictor of new ischemic asymptomatic cerebral lesions after PVI was ablation performed with PVAC (OR 1.48 95% CI 1.19-1.62, P < 0.001). CONCLUSION: The incidence of silent cerebral lesions after PVI is different depending on technologies used: PVAC increases the risk of 1.48 times compared to irrigated RF and cryoballoon ablation.

Voltage-guided ablation in persistent atrial fibrillation-favorable 1-year outcome and predictors.

INTRODUCTION: Pulmonary vein isolation (PVI) in persistent atrial fibrillation (AF) has a low success rate. A newer ablation concept targets left atrial (LA) low voltage zones (LVZ) which correlate with fibrosis and predict recurrence after PVI. We aimed to determine the success of combined PVI- and LVZ-guided ablation and to identify the predictors for LVZ and for ablation success. METHODS AND RESULTS: A total of 119 consecutive patients who underwent their first ablation procedure due to persistent AF were included. After acquisition of a high-resolution LA voltage map, PVI- and LVZ-guided ablation were performed. Mean age was 69 ± 8 years, 53% were men, and 8% had longstanding persistent AF. We found LVZ in 55% of patients. Twelve-month freedom from recurrences off drugs was 69%. The only independent predictor for recurrence was the existence of LVZ (OR 4.2, 95% CI 1.54-11.41, p = 0.005). Existence of LVZ was predicted positively by age ≥ 67 years (OR 4.4, 95% CI 1.4-13.7, p = 0.011), LA volume index ≥ 68 ml/m2 (OR 3.9, 95% CI 1.4-10.5, p = 0.008), and GFR ≤ 85 ml/min/1.73 m2 (OR 12.5, 95% CI 2.0-76.6, p = 0.006). BMI ≥ 26 kg/m2 (OR 0.06, 95% CI 0.01-0.30, p = 0.001) was a negative predictor of LVZ. CONCLUSION: LVZ-guided ablation in combination with PVI results in comparably high success rates. However, the existence of LVZ remains the strongest predictor of ablation success.

Pulmonary vein isolation using second-generation single-shot devices: not all the same?

INTRODUCTION: Single-shot devices have been developed to simplify pulmonary vein isolation (PVI). Randomized studies of the second-generation cryoballoon (CB 2nd) demonstrated excellent results. There are limited data comparing results of circular pulmonary vein ablation catheter (PVAC) with conventional RF ablation or CB for PVI. OBJECTIVE: Using a sequential registry cohort and a prospective randomized study, we aimed to compare the acute and long-term results of CB 2nd and PVAC Gold. METHODS: In the registry, consecutive patients with paroxysmal atrial fibrillation (AF) undergoing their first PVI were included. The preferred method used was PVAC Gold in 2014 and CB 2nd in 2015. Subsequently, a randomized study (PVAC vs. CB 2nd) was performed. Ablation success was measured as freedom of AF or atrial tachycardias (AT) off antiarrhythmic drugs. RESULTS: In the registry cohort, PVAC Gold was used in 60 patients and CB 2nd in 56 patients (age 66 ± 11 years, 52% male, LAD 43 ± 6). In the randomized study, 20 patients were treated with PVAC Gold and 22 with CB 2nd (age 67 ± 9; 43% men, LAD 40 ± 7 mm). During a mean follow up of 13.2 ± 3.6 months, success was 54% in PVAC Gold patients and 81% in CB 2nd cases (p = 0.001). In the randomized study 12 months success was 50% versus 86%, p < 0.05. Complications occurred rare in both groups. CONCLUSIONS: Our registry data and the randomized study both suggest superiority of PVI using CB 2nd as compared with PVI using PVAC Gold.

Sex differences of resource utilisation and outcomes in patients with atrial arrhythmias and heart failure.

OBJECTIVE: Atrial fibrillation or atrial flutter (AF) and heart failure (HF) often go hand in hand and, in combination, lead to an increased risk of death compared with patients with just one of both entities. Sex-specific differences in patients with AF and HF are under-reported. Therefore, the aim of this study was to investigate sex-specific catheter ablation (CA) use and acute in-hospital outcomes in patients with AF and concomitant HF in a retrospective cohort study. METHODS: Using International Statistical Classification of Diseases and Related Health Problems and Operations and Procedures codes, administrative data of 75 hospitals from 2010 to 2018 were analysed to identify cases with AF and HF. Sex differences were compared for baseline characteristics, right and left atrial CA use, procedure-related adverse outcomes and in-hospital mortality. RESULTS: Of 54 645 analysed cases with AF and HF, 46.2% were women. Women were significantly older (75.4±9.5 vs 68.7±11.1 years, p<0.001), had different comorbidities (more frequently: cerebrovascular disease (2.4% vs 1.8%, p<0.001), dementia (5.3% vs 2.2%, p<0.001), rheumatic disease (2.1% vs 0.8%, p<0.001), diabetes with chronic complications (9.7% vs 9.1%, p=0.033), hemiplegia or paraplegia (1.7% vs 1.2%, p<0.001) and chronic kidney disease (43.7% vs 33.5%, p<0.001); less frequently: myocardial infarction (5.4% vs 10.5%, p<0.001), peripheral vascular disease (6.9% vs 11.3%, p<0.001), mild liver disease (2.0% vs 2.3%, p=0.003) or any malignancy (1.0% vs 1.3%, p<0.001), underwent less often CA (12.0% vs 20.7%, p<0.001), had longer hospitalisations (6.6±5.8 vs 5.2±5.2 days, p<0.001) and higher in-hospital mortality (1.6% vs 0.9%, p<0.001). However, in the multivariable generalised linear mixed model for in-hospital mortality, sex did not remain an independent predictor (OR 0.96, 95% CI 0.82 to 1.12, p=0.579) when adjusted for age and comorbidities. Vascular access complications requiring interventions (4.8% vs 4.2%, p=0.001) and cardiac tamponade (0.3% vs 0.1%, p<0.001) occurred more frequently in women, whereas stroke (0.6% vs 0.5%, p=0.179) and death (0.3% vs 0.1%, p=0.101) showed no sex difference in patients undergoing CA. CONCLUSIONS: There are sex differences in patients with AF and HF with respect to demographics, resource utilisation and in-hospital outcomes. This needs to be considered when treating women with AF and HF, especially for a sufficient patient informed decision making in clinical practice.