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.

Sex-related differences in outcome after left atrial appendage occlusion: Insights from Europe and the EWOLUTION registry.

BACKGROUND: Women with atrial fibrillation (AF) generally experience worse symptoms, poorer quality of life, and have a higher risk of stroke and death. There is limited availability of sex-related differences regarding left atrial appendage occlusion (LAAO). AIMS: The aim of this study was to evaluate the sex-related differences in patients undergoing LAAO in EWOLUTION. METHODS: A total of 1025 patients scheduled for elective LAAO therapy employing the WATCHMAN Gen 2.5 prospectively consented for participation; 1005 patients received a successful implant and were followed for 2 years. As we detected sex-related differences in baseline data we performed a propensity score matching. The primary endpoint is a combined endpoint of survival free from mortality, major bleeding, ischemic stroke, transitory ischemic attack (TIA) and systemic embolization (SE) up to 2-year clinical follow-up. Secondary Endpoints were periprocedural data and overall 2-year survival. RESULTS: Women were older but had less often vascular disease and hemorrhagic stroke. There was no sex-related significant difference after LAAO at 2 years in the combined endpoint of survival free from mortality, major bleeding, ischemic stroke, TIA, and SE (female vs. male: 79% vs.76%, p = 0.24) or in overall survival (female vs. male: 85% vs. 82%, p = 0.16). Procedural data showed a higher sealing rate after the implantation in women (complete sealing female 94% vs. male 90%, p = 0.033), significantly more pericardial effusions (female 1.2% vs. male 0.2%, p = 0.031) and a similar periprocedural risk profile. CONCLUSIONS: Females undergoing LAAO differ in various baseline variables, but after adjustment, we observed similar safety and efficacy of LAAO with no significant difference in long-term outcomes between women and men.

Impact of obesity on acute complications of catheter ablation for cardiac arrhythmia.

INTRODUCTION: The prevalence of obesity is increasing. However, data on the periprocedural complication rate of catheter ablation for arrhythmia in patients stratified by body mass index (BMI) are scarce. METHODS: This study included 1000 consecutive patients (age 62.0 ± 14.4 years) undergoing catheter ablation for cardiac arrhythmia. The primary study endpoint was any periprocedural major complication (cardiac tamponade, pseudoaneurysm, arteriovenous fistula, transient ischemic attack, stroke, valve damage, myocardial infarction, or death). RESULTS: The mean BMI was 27.6 ± 5.1 kg/m2 and the majority of patients were overweight (BMI 25.0-29.9 kg/m2 , 43.4%). A BMI of 30.0-34.9 kg/m2 (Class I obesity) was present in 177 (17.7%) of patients, a BMI of 35.0-39.9 kg/m2 (Class II obesity) in 67 (6.7%), and a BMI ≥ 40 kg/m2 (Class III obesity) in 16 (1.6%). There were 31 major complications (3.1%) and one fatality (0.1%) due to terminal heart failure in a patient undergoing palliative ventricular tachycardia ablation. There was no significant impact of the BMI on the rate of major complications (p = .495). Compared to normal weight patients, odds ratios for complications in overweight patients, as well as Class I, II, and III obesity were 1.1 (95% confidence interval (CI): 0.8, 1.7), 1.3 (CI: 0.6, 2.6), 1.4 (CI: 0.5, 4.1), and 1.6 (CI: 0.4, 6.3), respectively. Radiation exposure and procedure duration were significantly increased in obese patients (p < .001 and p = .001, respectively). CONCLUSION: In this study, obesity did not have a significant impact on the incidence of periprocedural complications after CA for cardiac arrhythmia.

Impact of a time-to-effect-guided ablation protocol in cryoballoon ablation on the durability of pulmonary vein isolation.

BACKGROUND: Cryoballoon (CB)-based pulmonary vein isolation (PVI) has proven to be as effective as radiofrequency-based ablation. Different ablation protocols took the individual time-to-isolation (TTI) into account aiming at shorter but equally or even more effective freeze cycles. The current study sought to assess the impact of the TTI on PVI durability in patients undergoing a repeat procedure for recurrence of atrial tachyarrhythmia (ATA). METHODS AND RESULTS: In 205 patients with ATA recurrence after previous CB-based PVI, a total of 806 pulmonary veins (PVs) were identified. A total of 126 out of 806 PVs (16%) were previously treated with a TTI-guided ablation (Protocol #1; TTI + 120 s), in 92/806 (11%) PVs TTI was only monitored (m) but fixed freeze cycles were applied (Protocol #2; mTTI) and in 588/806 (73%) a fixed freeze cycle was applied without mTTI. There was no difference in the PV-reconduction rate between the groups (p = .23). The right inferior pulmonary vein (RIPV) showed overall significantly higher reconduction rates compared to the other PVs (RIPV-left inferior PV p < .003, -left superior PV p < .001, -right superior PV p < .013). Twenty-one patients (10%) were demonstrated to have only electrical reconduction of the RIPV, while all other PVs were still electrically isolated. CONCLUSIONS: The TTI-based CB ablation protocol did not show significant differences regarding PV-reconduction rates compared to the other ablation protocols.

Acute and long-term success of left atrial anterior line and mitral isthmus line ablation in patients after mitral valve surgery.

BACKGROUND: Perimitral flutter and atrial fibrillation may occur in patients with prior surgical mitral valve (MV) repair or replacement and can be challenging for percutaneous catheter ablation. This study sought to determine the feasibility, acute success and durability of catheter ablation of atrial fibrillation or atrial tachycardia by way of a mitral isthmus line (MIL) or an anterior line (AL). METHODS: A total of 81 patients (49 males, mean age 62±11 years) with prior MV replacement (n = 30) or reconstruction (n = 51) underwent creation of a MIL (34) and/or an AL (72). RESULTS: Acute bidirectional block of the MIL was successfully achieved in 24/34 cases and of the AL in 64/72 patients. Patients of the control group without prior MV surgery were matched 1:1 with the valve group. In the AL control subgroup, acute bidirectional block was achieved in 65/72 patients. Acute blockage in the MIL control subgroup could be achieved in 31/34 patients. The MIL valve subgroup showed the worst results in terms of durability, whereas a similar trend emerged in the control group and the AL valve subgroup (probability of failure in MIL valve subgroup 2.224 vs. MIL control subgroup 0.605 [Hazard Ratio (HR) = 0.27, 95% confidence interval (CI), 0.11-0.65), P = .004]; probability of failure in AL valve subgroup 0.844 vs. AL control subgroup 1.03 [HR = 1.22 (95% CI, 0.66-2.26), P = .523]). CONCLUSIONS: Percutaneous creation of MIL and AL is feasible and safe in patients with prior MV replacement/repair and associated with moderate acute and long-term success rates to achieve bidirectional block.

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.

Bioprosthetic valve fracture: Predictors of outcome and follow-up. Results from a multicenter study.

OBJECTIVES: To evaluate outcome and its predictors of bioprosthetic valve fracture (BVF) in patients undergoing valve-in-valve transcatheter aortic valve replacement (VIV-TAVR). BACKGROUND: BVF is feasible and reduces transvalvular gradients in VIV-TAVR-procedures, but follow-up-data and information on factors influencing the outcome are missing. METHODS: The 81 cases of BVF-VIV-TAVR were collected from 14 international centers. RESULTS: Predominantly transcatheter heart valve (THV) was implanted first, followed by BVF. VARC-2 defined device success was 93%, most failures were attributed to residual high gradients. Mean gradients decreased from 37 ± 13 mmHg to 10.8 ± 5.9 mmHg (p < 0.001). BVF reduced the gradient by 16 mmHg. During follow-up (FU, 281 ± 164 days) mean gradient remained stable (10.8 ± 5.9 mmHg at discharge, 12.4 ± 6.3 mmHg at FU, p = ns). In-hospital major adverse events occurred in 3.7%. Event-free survival at 276 ± 237.6 days was 95.4%. The linear mixed model identified balloon-expandable valves (BEV), Mitroflow surgical valve, stenotic surgical bioprostheses and balloon only 1 mm larger than the true internal diameter of the surgical valve as predictors for higher gradients. CONCLUSIONS: BVF is safe and can significantly reduce gradients, which remain stable at FU. BEV, Mitroflow surgical valve, stenotic bioprostheses and balloon larger than the true internal diameter of the surgical valve of only 1 mm are predictors for higher final gradients.

Supervised Obesity Reduction Trial for AF ablation patients: results from the SORT-AF trial.

AIMS: Weight management seems to be beneficial for obese atrial fibrillation (AF) patients; however, randomized data are sparse. Thus, this study aimed to investigate the influence of weight reduction on AF ablation outcomes. METHODS AND RESULTS: SORT-AF is an investigator-sponsored, prospective, randomized, multicentre, and clinical trial. Patients with symptomatic AF (paroxysmal or persistent) and body mass index (BMI) 30-40 kg/m2 underwent AF ablation and were randomized to either weight-reduction (group 1) or usual care (group 2), after sleep-apnoea-screening and loop recorder (ILR) implantation. The primary endpoint was defined as AF burden between 3 and 12 months after AF ablation. Overall, 133 patients (60 ± 10 years, 57% persistent AF) were randomized to group 1 (n = 67) and group 2 (n = 66), respectively. Complications after AF-ablation were rare (one stroke and no tamponade). The intervention led to a significant reduction of BMI (34.9 ± 2.6-33.4 ± 3.6) in group 1 compared to a stable BMI in group 2 (P < 0.001). Atrial fibrillation burden after ablation decreased significantly (P < 0.001), with no significant difference regarding the primary endpoint between the groups (P = 0.815, odds ratio: 1.143, confidence interval: 0.369-3.613). Further analyses showed a significant correlation between BMI and AF recurrence for patients with persistent AF compared with paroxysmal AF patients (P = 0.032). CONCLUSION: The SORT-AF study shows that AF ablation is safe and successful in obese patients using continuous monitoring via ILR. Although the primary endpoint of AF burden after ablation did not differ between the two groups, the effects of weight loss and improvement of exercise activity were beneficial for obese patients with persistent AF demonstrating the relevance of life-style management as an important adjunct to AF ablation in this setting. TRIAL REGISTRATION NUMBER: NCT02064114.

Quantification of Left Atrial Fibrosis in Patients After Pulmonary Vein Isolation Using the Second-Generation Cryoballoon.

Left atrial (LA) fibrosis is associated with a poor outcome after atrial fibrillation (AF) ablation. This study examined the extent of low-voltage areas in patients with recurrence of atrial tachyarrhythmia (ATA) after CB-based pulmonary vein isolation (PVI).Sixty patients (mean age 67 ± 10 years, n = 32 female; n = 34 paroxysmal AF) who received radiofrequency redo-procedure due to recurrence of ATA within 6 months after CB-based PVI were included. A point-by point 3D-map was performed, and low-voltage sites were delineated based on bipolar voltage < 0.5 mV. The extent of fibrosis was categorized as stage A (0-10% of the LA wall), stage B (10-30%), stage C (30-50%), and stage D (> 50%).The median area of LA low-voltage sites was 28.9 (9; 50.3) cm2, corresponding to 17.4 (6; 30.6) % of the LA wall surface. 17/60 (28.3%) patients were categorized as fibrosis stage A, 21/60 (35%) as stage B, 18/60 (30%) as stage C, and 4/60 (6.7%) as stage D. Patient age and LA diameter were associated with more pronounced LA fibrosis; the extent of LA fibrosis was significantly higher in patients with LA tachycardia (LAT) during redo-procedures (P < 0.01), and ablation of linear lesions was more often performed (P < 0.01).In patients after CB2-based PVI, expanded LA tissue fibrosis was associated with the occurrence of LAT and more extensive LA ablation during redo-procedures.

Radiofrequency or cryoballoon ablation for index pulmonary vein isolation: What is the impact on long-term clinical outcomes after repeat ablation?

AIMS: The current study sought to assess the impact of the utilized energy source during index ablation on long-term clinical outcomes after repeat ablation of atrial fibrillation (AF). Index ablation procedures were either performed using radiofrequency current (RFC) (RFC group) or cryoballoon (CB) ablation (CB group). Repeat ablation was performed by the use of RFC. METHODS: A total of 195 patients (138 RFC group; 57 CB group) with paroxysmal AF were included. All patients had a recurrence of AF following the index ablation procedure. Freedom from AF was estimated with the Kaplan-Meier method. RESULTS: After a 3 years follow-up, the estimated arrhythmia-free survival did not differ between the two groups (RFC group 48% vs CB group 47%, P = .78). During index ablation, procedure times were significantly shorter in the CB group (95 [80, 140] vs 140 [115, 164] minutes, P ≤ .001), whereas fluoroscopy times (16 [11; 22] vs 19 [14; 25] minutes, P = .003), the dose area product (1862 [1203; 2922] vs 3148 [1756; 5888] cGycm2 , P ≤ .001) and the amount of contrast dye (92 ± 32 vs 123 ± 33 mL, P ≤ .001) were significantly lower in the RFC group. During repeat ablation, procedure times were significantly shorter in patients being initially treated with RFC (115 [85; 145] vs 125 [105; 150] minutes, P = .007). There was a trend towards a higher pulmonary vein reconnection rate in the RFC group without meeting statistical significance (P = .074). CONCLUSIONS: In patients with repeat ablation of AF, index RFC or CB ablation are equally effective in terms of freedom from AF. Although CB ablation results in shorter index procedures times, durations of repeat ablation are significantly longer.

Management of thrombus formation after electrical isolation of the left atrial appendage in patients with atrial fibrillation.

AIMS: Left atrial appendage (LAA) electrical isolation (LAAEI) in addition to pulmonary vein isolation is an emerging catheter-based therapy to treat symptomatic atrial fibrillation. Previous studies found high incidences of LAA thrombus formation after LAAEI. This study sought to analyse therapeutic strategies aiming at the resolution of LAA thrombi and prevention of thromboembolism. METHODS AND RESULTS: Left atrial appendage electrical isolation was conducted via creation of left atrial linear lesions or cryoballoon ablation. Follow-up including transoesophageal echocardiography was conducted. In patients with LAA thrombus, oral anticoagulation (OAC) was adjusted until thrombus resolution was documented. Percutaneous LAA closure (LAAC) under use of a cerebral protection device was conducted in case of medically refractory LAA thrombi. Left atrial appendage thrombus was documented in 54 of 239 analysed patients who had undergone LAAEI. Thrombus resolution was documented in 39/51 patients (72.2%) with available follow-up after adjustment of OAC. Twenty-nine patients underwent LAAC and 10 patients were kept on OAC after LAAEI. No thromboembolic events or further LAA thrombi were documented after 553 ± 443 days of follow-up in these patients. Persistent LAA thrombi despite adaption of OAC was documented in 12/51 patients. One patient remained on OAC until the end of follow-up, while LAAC with a cerebral protection device was performed in 11 patients in the presence of LAA thrombus without complications. CONCLUSION: Left atrial appendage thrombus formation is common after LAAEI. Adjustment of OAC leads to LAA thrombus resolution in most patients. Left atrial appendage closure in the presence of LAA thrombi might be a feasible option in case of failed medical treatment.

Outcome of cardiac tamponades in interventional electrophysiology.

AIMS: The aim of this study was to analyse tamponades following electrophysiological procedures regarding frequency and mortality in a high-volume centre and to identify independent predictors for severe tamponades. METHODS AND RESULTS: We performed a retrospective study on 34 982 consecutive patients undergoing diagnostic electrophysiological studies or catheter ablation of cardiac arrhythmias. The combined endpoint was defined as severe tamponade. Criteria for severe tamponade included surgical repair, repeat pericardiocentesis, cardiopulmonary resuscitation, intrahospital death or death during follow-up, and thrombo-embolic events or complications due to therapeutic management. Multivariate analysis was performed to identify independent predictors for severe tamponade. A total of 226 tamponades were identified. Overall frequency of tamponades was 0.6%. Procedures requiring epicardial approach had the highest rate of tamponades (9.4%). Twenty-nine patients with tamponade underwent surgery (12.8% of all tamponades and 21.4% of tamponades during epicardial procedures). Overall tamponade-related mortality was 0.03% (9 deaths). Fifty-six patients (24.8%) experienced severe tamponade. Independent risk factors for severe tamponades were endocardial ablation of ventricular tachycardia, epicardial approach, balloon device ablation, high aspiration volume during pericardiocentesis and structural heart disease. CONCLUSION: The frequency of tamponades is strongly dependent on the type of procedure performed. Overall tamponade-related mortality was low but significantly higher in patients undergoing epicardial procedures. Surgical backup should be considered for patients undergoing complex ventricular tachycardia ablation and left atrial ablation procedures.

Reconduction After Second-Generation Cryoballoon-Based Pulmonary Vein Isolation　- Impact of Different Ablation Strategies.

BACKGROUND: The second-generation cryoballoon (CB2) has demonstrated high procedural efficacy and convincing clinical success rates for pulmonary vein isolation (PVI). Nevertheless, data on the impact of different ablations protocols on durability are limited. The aim was to comparing the durability of PVI following 3 different ablation strategies in patients with recurrence of atrial fibrillation or atrial tachycardia undergoing repeat procedures.Methods and Results:In 192 patients, a total of 751 PVs were identified. All PVs were successfully isolated during index PVI. Thirty-one out of 192 (16%) patients were treated with a bonus-freeze protocol (group 1), 67/192 (35%) patients with a no bonus-freeze protocol (group 2), and 94/192 (49%) patients with a time-to-effect-guided protocol (group 3). Persistent PVI was documented in 419/751 (55.8%) PVs, and in 41/192 (21%) patients, all PVs were persistently isolated. The total rate of PV reconnection was not significantly different between the groups (P=0.134) and the comparison of individual PVs revealed no differences (P-values for RSPV: 0.424, RIPV: 0.541, LSPV: 0.788, LIPV: 0.346, LCPV: 0.865). The procedure times were significantly reduced by omitting the bonus-freeze and applying individualized application times (group 1: 123.4±31.5 min, group 2: 112.9±39.8 min, group 3: 86.67±28.4 min, P<0.001). CONCLUSIONS: Comparing 3 common ablation protocols, no differences for durable PVI were detected. Procedure times were significantly reduced by omitting the bonus-freeze cycle and by applying individualized application times.

The clip and the tip: Lessons learned from ablation of atrial fibrillation in patients postpercutaneous mitral valve repair.

BACKGROUND: Atrial fibrillation (AF) and higher grade mitral valve regurgitation are often associated. For both, there are interventional therapeutic options such as pulmonary vein isolation (PVI) and percutaneous mitral valve repair (PMVR) using MitraClip. OBJECTIVE: This study investigated the feasibility, safety and clinical outcome of AF ablation in patients with prior PMVR. METHODS: This study included patients with symptomatic AF who underwent PVI after prior PMVR at a tertiary care center (14 consecutive patients, group I). A propensity-score matched group of 42 patients (1:3 matching, group II) without prior valve repair acted as controls. RESULTS: Acute PVI was achieved in all patients. No difference was found regarding median procedure time (group I: 125.0 [Q1: 120.0; Q3: 176.3] vs group II: 135.0 [120.0; 177.5] minutes; P = 0.87) and median fluoroscopy duration (group I: 17.2 [12.9; 25.9] vs group II: 18.6 [12.3; 25.9] minutes; P = 0.95). In group I, one patient suffered a postprocedural transient ischemic attack. No further major complications occurred (P = 0.25). No periprocedural interference with the MitraClip was noted. The Kaplan-Meier estimate 18-month overall arrhythmia-free survival after the index procedure including a 3-month blanking period was 64.8% (95% confidence interval [CI] 42.1-99.8%) for the study group and 68.3% (95% CI, 54.6-85.6%) for the control group P = 0.35). A higher percentage of left atrial tachycardias was observed in the study group (67% vs 12% of patients with any arrhythmia recurrence; P = 0.01). CONCLUSION: Catheter ablation of AF in patients with prior PMVR is feasible and safe and results in satisfying clinical outcome.

Predictors of freedom from atrial arrhythmia recurrence after cryoballoon ablation for persistent atrial fibrillation: A multicenter study.

AIMS: We sought to assess (1) clinical outcomes of second-generation cryoballoon (CB) ablation for persistent atrial fibrillation (AF), and (2) the association of baseline and procedural covariates with atrial arrhythmia recurrence (AAR) after ablation. METHODS: A total of 135 patients (63 ± 11 years, 96 men [71%]) with persistent AF underwent CB ablation at three experienced electrophysiology centers. Freedom from AAR was estimated with the Kaplan-Meier method. A Cox proportional-hazards model was used to estimate the effects of baseline and procedural covariates on the likelihood of AAR. RESULTS: Freedom from AAR at 6, 12, and 18 months was estimated at 91% (95% confidence interval [CI] 86%-96%), 75% (95% CI, 67%-83%), and 53% (95% CI, 43%-65%), respectively. The presence of an implantable cardiac device (Hazard ratio [HR] 3.09; 95% CI, 1.37-7.00; P = .007), a left atrial (LA) diameter > 50 mm (HR 1.69; 95% CI, 1.02-2.79; P = .043), and absence of antiarrhythmic drug (AAD) therapy before the ablation procedure (HR 3.12; 95% CI, 1.72-5.64; P < .001) were associated with AAR. A trend toward an increased risk of AAR was revealed for women (HR 1.73; 95% CI, 0.96-3.11; P = .069). CONCLUSIONS: CB ablation for persistent AF resulted in freedom from AAR about that reported for RF ablation. The presence of an implantable cardiac device, LA size, and absence of AAD therapy at baseline were associated with the risk of AAR.

Efficacy and Safety of Cryoballoon Ablation in Patients With Heart Failure and Reduced Left Ventricular Ejection Fraction　- A Multicenter Study.

BACKGROUND: Second-generation cryoballoon (CB2)-based pulmonary vein isolation (PVI) has demonstrated encouraging results in the treatment of atrial fibrillation (AF). This study sought to assess data on the safety, efficacy and clinical success of CB2-based PVI in patients with heart failure (HF) and reduced ejection fraction (HFrEF).Methods and Results:CB2-based PVI was performed in 551 consecutive patients in 3 highly experienced EP centers. Patients with HF and LVEF ≤40% were included (HFrEF group, n=50/551, 9.1%). Data were compared with propensity score-matched patients without HF and preserved left ventricular EF (LVEF) (n=50, control group). The median LVEF was HFrEF: 37% (35, 40) and control: 55% (55, 55), P<0.0001. Major periprocedural complications were registered in 4/50 (8%, HFrEF group) and 3/50 (6%, control group), P=0.695. The 12-month freedom from AF recurrence was 73.1% (95% confidence interval (CI): 61-88, HFrEF group) and 72.6% (95% CI: 61-87, control group), P=0.25. NYHA class decreased from 2.4±0.8 (baseline) to 1.7±0.8 at 12-month follow-up (P<0.0001). LVEF improved from a median of 37% (35, 40) prior to ablation to a median of 55% (40, 55), P<0.0001. CONCLUSIONS: CB2-based PVI in patients with HFrEF appeared to be safe, was associated with comparable periprocedural complications and showed promising clinical success rates equal to those for patients with preserved LVEF. NYHA class and LVEF significantly improved at 12-month follow-up.

[Quality of life and disability after severe stroke and early neurological rehabilitation]. / Lebensqualität und Behinderung nach schwerem Schlaganfall und neurologischer Frührehabilitation.

BACKGROUND: Data on the long-term effects on quality of life of patients after severe stroke and discharge from early institutional rehabilitation are important for guiding the early rehabilitation phase and the further outpatient care. OBJECTIVE: Analysis of the outcome of patients following severe stroke 3 and 12 months after discharge from early neurological rehabilitation. METHODS: Analysis of the Asklepios Hamburg multicenter early stroke rehabilitation registry (ICD 10: I61, I60, I63 and OPS 8­552). Structured interviews with documentation of disabilities using the early rehabilitation Barthel index (ERBI), modified Rankin scale (mRS) and quality of life (12-item short form health survey, SF-12). Assessment of further treatment and complications 3 and 12 months after discharge from the early rehabilitation departments by telephone interviews. RESULTS: Out of 1045 treated stroke patients 270 were enrolled between October 2015 and November 2017 and 200 and 151 patients could be followed up after 3 and 12 months, respectively. There was a significant improvement (p < 0.001) in the median ERBI (151 patients at 12 months). Factors influencing a poorer functional outcome (higher mRS) at 12 months were a higher mRS at discharge (OR 5.43 [1.18, 25.09], p = 0.03) and age (per decade OR 1.5 [1.09, 2.02]; p = 0.01). Female sex reduced the risk for a poorer outcome after 12 months (OR 0.49 [0.25, 0.96]; p = 0.04). Quality of life (SF-12) was not different over time. The mental quality of life showed no differences (p = 0.32) compared to a historical, significantly less (p<0.001) handicapped stroke collective. CONCLUSION: The surviving severe stroke patients recovered significantly up to 12 months after discharge. The mental quality of life did not differ from that of a historical less handicapped collective.

Insights into ablation of persistent atrial fibrillation: Lessons from 6-year clinical outcomes.

INTRODUCTION: Ablation of persistent atrial fibrillation (AF) is a potential treatment option for symptomatic patients. We sought to evaluate the critical role of circumferential pulmonary vein isolation (CPVI) in the ablation of persistent AF. METHODS AND RESULTS: A total of 341 ablation procedures were performed in 174 consecutive patients with persistent AF. CPVI was performed in all patients, additional ablation was only performed if electrical cardioversion failed after CPVI. During a median follow-up (FU) of 89 (63; 89) months, stable sinus rhythm was documented in 42/170 (25%) patients after a single procedure and in 111/164 (68%) patients after 1.9 ± 1.1 procedures. Stable SR was achieved in 40/75 (53%) patients in whom only CPVI was performed during the index and repeat procedures and in 71/89 (79%) patients with CPVI plus additional ablation. The main predictor for ablation success was duration of persistent AF before the index procedure (P < 0.001, HR ± CI: 1.608 [1.034, 1.103]). Responders to CPVI during the initial procedure had a significantly better multiple-procedure outcome after 42 months of FU compared to CPVI nonresponders (P  =  0.0365). Conversion during the index procedure had no impact on clinical outcomes (P  =  0.0903). Persistent AF regressed to paroxysmal AF in 16% of patients. CONCLUSIONS: We demonstrate a 25% single- and 68% multiple-procedure success in patients with persistent AF, while stable SR was achieved in 53% of patients with pure CPVI during all procedures and in 79% of patients with CPVI plus additional ablation. Only duration of persistent AF before ablation had a statistically significant impact on ablation outcome.

Significant reduction of radiation exposure in cryoballoon-based pulmonary vein isolation.

Aims: Procedure times and left atrial dwell times of cryoballoon (CB)-based ablation strategies for atrial fibrillation (AF) are shorter as compared to radiofrequency ablation, yet fluoroscopy times are longer and result in a higher radiation exposure. The objective of this study is to evaluate a modified fluoroscopy protocol aiming at reduction of radiation exposure in CB ablation. Methods and results: A total of 120 patients with symptomatic AF underwent pulmonary vein isolation (PVI) using the second generation CB and an ablation strategy considering the individual time-to-isolation. The first 60 patients (Group 1) underwent CB-based PVI with conventional fluoroscopy settings. An optimized approach was applied in the following 60 patients (Group 2) by (i) using fluoroscopy instead of filming for verification of pulmonary vein (PV) occlusion after contrast injection, (ii) reducing the frame rate, and (iii) pursuing maximal collimation on the region of interest. A total of 475 PVs were identified and successfully isolated. Median dose area product and fluoroscopy time were significantly shorter in Group 2 as compared to Group 1 [389 (285; 550) cGycm2 vs. 2168 (1355; 3490) cGycm2 (P < 0.0001) and 10 (8; 12) min vs. 14 (11; 19) min (P < 0.0001)]. Additionally, median time-to-isolation of the PVs was significantly shorter in Group 2 [44 (30; 65) s vs. 33 (20; 46) s (P < 0.0001)]. Conclusions: The implementation of an optimized fluoroscopy protocol significantly reduces radiation exposure in CB-based PVI without compromising acute efficacy and safety.

Catheter ablation of atrial fibrillation in very young adults: a 5-year follow-up study.

Aims: Catheter ablation is an established therapy for symptomatic atrial fibrillation (AF). However, outcome data on catheter ablation for AF in young adults is scarce. Methods and results: From 2005-2014, 85 consecutive young adults (mean age 31 ± 4 years; 69% men) with symptomatic paroxysmal AF (PAF, n = 52) and persistent (Pers) AF (n = 33) underwent pulmonary vein isolation (PVI) [±ablation of complex fractionated atrial electrograms/linear lesions in PVI non-responders] at our centre. Follow-up was based on outpatient visits including 24-h Holter-ECG at 3, 6 and, 12 months post ablation, and every 12 months thereafter. Recurrence was defined as any AF/atrial tachycardia episode >30s following a 3-month blanking period. Follow-up was available for 74/85 (87%) patients. After a median follow-up of 4.6 years (Q1: 2.6; Q3: 6.6) and a mean of 1.5 ± 0.6 (median 1, range 1-3) ablation procedures 84% [including 13% on previously ineffective antiarrhythmic drugs (AAD)] of patients were in stable SR. Single-procedural 1-year/5-year arrhythmia-free survival was 66% [95% confidence interval (CI): 56-78%]/44% (95% CI: 33-59%), respectively. Structural heart disease [SHD; hazard ratio (HR) 2.79 (95% CI 1.52-5.12), P = 0.001] and obesity [HR 1.10 (95% CI 1.00-1.21) per unit increase in body mass index >27 kg/m2, P = 0.05] independently predicted AF recurrence. Major complications occurred in 6/122 (4.9%) procedures (PV stenosis in 3, cardiac tamponade in 1, stroke in 1, and arterial-venous fistula in 1). Conclusion: In the majority of very young adults catheter ablation for AF is effective, and associated with an acceptable complication rate. SHD and obesity are predictors for AF recurrence in this population.