Left atrial appendage closure in end-stage renal disease and hemodialysis: Data from a German multicenter registry.

BACKGROUND: Left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). OAC treatment has been proven feasible in mild-to-moderate chronic kidney disease (CKD). In contrast, the optimal antithrombotic management of AF patients with end-stage renal disease (ESRD) is unknown and LAAC has not been proven in these patients in prospective randomized clinical trials. OBJECTIVES: The objective of this study is to evaluate safety and efficacy of LAAC in patients with ESRD. METHODS: Patients undergoing LAAC were collected in a German multicenter real-world observational registry. A composite endpoint consisting of the occurrence of ischemic stroke/transient ischemic attack, systemic embolism, and/or major clinical bleeding was assessed. Patients with ESRD were compared with propensity score-matched patients without severe CKD. ESRD was defined as a glomerular filtration rate < 15 ml/min/1.73 m2 or chronic hemodialysis treatment. RESULTS: A total of 604 patients were analyzed, including 57 with ESRD and 57 propensity-matched patients. Overall, 596 endocardial and 8 epicardial LAAC procedures were performed. Frequency of major complications was 7.0% (42/604 patients) in the overall cohort, 8.8% (5/57 patients) in patients with ESRD, and 10.5% (6/57 patients) in matched controls (p = 0.75). The estimated event-free survival of the combined endpoint after 500 days was 90.7 ± 4.5% in patients with ESRD and 90.2 ± 5.5% in matched controls (p = 0.33). CONCLUSIONS: LAAC had comparable procedural safety and clinical efficacy in patients with ESRD and patients without severe CKD.

Individualized or fixed approach to pulmonary vein isolation utilizing the fourth-generation cryoballoon in patients with paroxysmal atrial fibrillation: the randomized INDI-FREEZE trial.

AIMS: Cryoballoon (CB) based pulmonary vein isolation (PVI) is a widely used technique for treatment of atrial fibrillation (AF); however the ideal energy dosing has not yet been standardized. This was a single-centre randomized clinical trial aiming at assessing the safety, acute efficacy, and clinical outcome of an individualized vs. a fixed CB ablation protocol using the fourth-generation CB (CB4) guided by pulmonary vein (PV) potential recordings and CB temperature. METHODS AND RESULTS: Patients were randomized in a 1:1 fashion to two different dosing protocols: INDI-FREEZE group (individualized protocol): freeze-cycle duration of time to effect plus 90 s or interruption of the freeze-cycle and repositioning CB if a CB temperature of -30°C was not within 40 s. Control group (fixed protocol): freeze-cycle duration of 180 s. No-bonus freeze-cycle was applied in either patient group. The primary endpoint was freedom from atrial tachyarrhythmia at 12 months. Secondary end points included procedural parameters and complications. A total of 100 patients with paroxysmal AF were prospectively enrolled. No difference was seen in the primary endpoint [INDI-FREEZE group: 38/47 (81%) vs. control group: 40/47, (85%), P = 0.583]. The total freezing time was significantly shorter in the INDI-FREEZE group (157 ± 56 s vs. 212 ± 83 s, P < 0.001), while procedure duration (57.9 ± 17.9 min vs. 63.2 ± 20.2 min, P = 0.172) was similar. No differences were seen in the minimum CB and oesophageal temperatures as well as in periprocedural complications. CONCLUSION: Compared to the fixed protocol, the individualized approach provides a similar safety profile and clinical outcome, while reducing the total freezing time.

[ESC guidelines 2021 on cardiac pacing and cardiac resynchronization therapy : What's new?] / ESC-Leitlinien 2021 zur Schrittmacher- und Resynchronisationstherapie : Was gibt es Neues?

The new European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy were presented together with the new ESC heart failure guidelines at the ESC congress in September. The new document includes detailed sections on patient evaluation and clinical assessment, implantation, minimizing complications and patient follow-up. The guidelines have been updated and expanded particularly on the approach to reflex syncope, the indications after transcatheter aortic valve implantation (TAVI) and the perioperative management. The indications for cardiac resynchronization therapy (CRT) are now in line with the simultaneously published ESC heart failure guidelines. New physiological forms of stimulation and leadless pacing are now included in the guidelines.

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.

Percutaneous Left Atrial Appendage Closure with the LAmbre Device Protected by a Cerebral Protection System in a 76-Year-Old Man with Persistent Left Atrial Appendage Thrombus.

BACKGROUND Despite use of optimal oral anticoagulation regimens, left atrial appendage (LAA) thrombus may develop and persist in patients with atrial fibrillation (AF). The therapeutic options in this population are limited. Percutaneous LAA closure (LAAC) is performed to reduce thrombus formation and the risk of thromboembolism. However, this approach is prohibited in patients with LAA thrombus. We report the case of a 76-year-old man with AF and persistent LAA thrombus who underwent percutaneous LAAC with the LAmbre device protected by the SENTINEL Cerebral Protection System (CPS). CASE REPORT A 76-year-old man with history of persistent AF treated with pulmonary veins and LAA isolation developed LAA thrombus resistant to different anticoagulation therapies, including apixaban and Phenprocoumon, with a target international normalized ratio (INR) of 3-3,5. Repeated follow-up transesophageal echocardiography showed a persistent LAA thrombus despite optimal INR values. Thus, we performed a percutaneous LAAC using a double-umbrella-designed appendage occluder and a CPS to minimize the risk of intraprocedural cerebral embolization. The procedure was guided by transesophageal echocardiography and fluoroscopy. No signs of systemic thromboembolism were noted, and the CPS filters showed no evidence of thrombotic material. CONCLUSIONS This report shows that the use of a CPS during percutaneous LAAC may reduce the risk of procedural cerebral embolization and could be used as an alternative therapy for patients with contraindication or lack of effectiveness of oral anticoagulation.

Safety and Feasibility of Catheter Ablation Procedures in Patients with Bleeding Disorders.

Aims/Objectives: Patients with bleeding disorders are a rare and complex population in catheter ablation (CA) procedures. The most common types of bleeding disorders are von Willebrand disease (VWD) and hemophilia A (HA). Patients with VWD or HA tend to have a higher risk of bleeding complications compared to other patients. There is a lack of data concerning peri- and postinterventional coagulation treatment. We sought to assess the optimal management of patients with VWD and HA referred for catheter ablation procedures. Methods and Results: In this study, we analyzed patients with VWD or HA undergoing CA procedures at two centers in Germany and Switzerland between 2016 and 2021. Clotting factors were administered in conjunction with hemostaseological recommendations. CA was performed as per the institutional standard. During the procedure, unfractionated heparin (UFH) was given intravenously with respect to the activated clotting time (ACT). Primary endpoints included the feasibility of the procedure, bleeding complications, and thromboembolic events during the procedure. Secondary endpoints included bleeding complications and thromboembolic events up to one year after catheter ablation. A total of seven patients (three VWD Type I, one VWD Type IIa, three HA) underwent 10 catheter ablation procedures (pulmonary vein isolation (PVI): two × radiofrequency (RF), one × laser balloon (LB), one × cryoballoon (CB); PVI + cavotricuspid isthmus (CTI): one × RF; PVI + left atrial appendage isolation (LAAI): one × RF; Premature ventricular contraction (PVC): three × RF; Atrioventricular nodal reentrant tachycardia (AVNRT): one × RF). VWD patients received 2000−3000 IE Wilate i.v. 30 to 45 min prior to ablation. Patients with HA received 2000−3000 IE factor VIII before the procedure. All patients undergoing PVI received UFH (cumulative dose 9000−18,000 IE) with a target ACT of >300 s. All patients after PVI were started on oral anticoagulation (OAC) 12 h after ablation. Two patients received aspirin (acetylsalicylic acid; ASA) for 4 weeks after the ablation of left-sided PVCs. No anticoagulation was prescribed after slow pathway modulation in a case with AVNRT. No bleeding complications or thromboembolic events were reported. During a follow-up of one year, one case of gastrointestinal bleeding occurred following OAC withdrawal after LAA occlusion. Conclusions: After the substitution of clotting factors, catheter ablation in patients with VWD and HA seems to be safe and feasible.

Very-high-power short-duration ablation for treatment of premature ventricular contractions - The FAST-AND-FURIOUS PVC study.

Objectives: We sought to assess the efficacy, safety and short-term clinical outcome of very high-power short-duration (vHP-SD) radiofrequency (RF) catheter ablation for the treatment of idiopathic PVCs originating from the cardiac outflow tract (OT). Background: Power-controlled RF ablation is a widely used technique for the treatment of premature ventricular contractions (PVCs). A novel ablation catheter offers three microelectrodes and six thermocouples at its tip and provides temperature-controlled vHP-SD (90 Watts/4 s,) with the opportunity to switch to moderate-power mode. Methods: In this pilot study, twenty-four consecutive, prospectively enrolled patients underwent PVC ablation utilizing the vHP-SD ablation (study group) and were compared with 24 consecutive patients previously treated with power-controlled ablation (control group). Each group included 12 patients with PVCs originating from the right ventricular OT (RVOT) and 12 patients with PVCs originating from the left ventricular OT (LVOT). The acute endpoint was PVC elimination and was achieved in all patients. Results: In 16/24 (67%) patients (study group) it was achieved by using vHP-SD only. The median RF delivery time was 52 (interquartile range [IQR] 16, 156) seconds (study group) and 350 (IQR 240, 442) seconds (control group, p < 0.0001). No difference was observed regarding procedure duration (p = 0.489) as well as 6-months follow-up (p = 0.712). One (4%, study group) and 2 (8%, control group) severe adverse events occured (p = 0.551). Conclusion: In this study, vHP-SD PVC ablation was similarly effective and safe as compared to conventional power-controlled ablation. The RF time was significantly shorter.

Atrial appendage closure in patients with heart failure and atrial fibrillation: industry-independent single-centre study.

AIMS: To evaluate outcomes of percutaneous left atrial appendage closure (LAAC) in patients with congestive heart failure (CHF) and non-valvular atrial fibrillation (AF) in a consecutive, industry-independent registry associated with periprocedural success and complications during long-term follow-up. METHODS AND RESULTS: For this analysis, we included patients who underwent transcatheter LAAC from January 2014 to December 2019 at the University Heart Center in Lübeck, Germany, and compared patients with presence of CHF defined as patients with a reduced left ventricular ejection fraction (LVEF ≤ 40%), patients with a mid-range LVEF (LVEF 41-49%), patients with diastolic dysfunction and preserved LVEF (LVEF ≥ 50%), and patients with right-sided heart failure and impaired right ventricular function (tricuspid annular plane systolic excursion < 17) to patients undergoing LAAC with no CHF. Primary endpoints were defined as periprocedural complications, and complications during long-term follow-up presented as major adverse cardiac and cerebrovascular events (MACCE). A total of 300 consecutive patients underwent LAAC. Of these, 96 patients in the CHF group were compared with 204 patients in the non-CHF group. Implantation success was lower in CHF group in comparison with non-CHF group (99.5% vs. 96%, P = 0.038); otherwise, there were no differences in periprocedural complications between groups. Patients with CHF showed a significantly higher incidence of MACCE rate (31.9% vs. 15.1%, P = 0.002) and more deaths (24.2% vs. 7%, P ≤ 0.001) during long-term follow-up. In Cox multivariable regression analysis, CHF was an independent predictor of mortality after LAAC implantation at long-term follow-up (hazard ratio 3.23, 95% confidence intervals 1.52-6.86, P = 0.002). CONCLUSIONS: Implantation of LAAC devices in patients with non-valvular AF and CHF is safe. The increased mortality in patients with CHF compared with patients without CHF during the long-term follow-up is mainly attributed to comorbidities associated with CHF.

[Hypotension after catheter ablation]. / Hypotonie nach Katheterablation.

A 80-year-old female patient with symptomatic atrial tachycardia develops cold sweat and hypotension in the recovery room after pulmonary vein isolation. The procedure included an anterior line and an endo- and epicardial mitral isthmus line. Echocardiography excluded a hemodynamically relevant pericardial effusion. The patient's symptoms deteriorated over time. A rare cause was found.

Safety and Efficacy of Cryoballoon Based Pulmonary Vein Isolation in Patients with Atrial Fibrillation and a History of Cancer.

INTRODUCTION: A growing body of evidence suggests a strong association between atrial fibrillation (AF) and cancer. A relevant number of patients with a present or former malignant disease with highly symptomatic drug-refractory AF are in need of interventional therapy. Data on the safety and efficacy of catheter ablation in these patients are sparse. The present study aims to analyze the safety and efficacy of cryoballoon-based pulmonary vein isolation (CB-PVI) for symptomatic AF in patients with past or present cancer disease. METHODS AND RESULTS: Consecutive patients undergoing CB-PVI for symptomatic AF at University Hospital Lübeck, Germany between July 2015 and January 2019 were included in this study. Propensity-score based matching was performed to identify comparable patients with and without cancer disease and further analyze clinical characteristics, periprocedural complications and arrhythmia-free survival. A total of 70 patients with a history of cancer undergoing CB-PVI were matched to 70 patients without a history of cancer. The frequency of complications was similar between patients with and without a history of cancer (p = 0.11), with four phrenic nerve palsies occurring in patients with a history of cancer (5.6% of the cohort) vs. one phrenic nerve palsy in patients without cancer (p = 0.36). Arrhythmia free survival after 12 months did not differ significantly in patients with and without a history of cancer (67.1 ± 5.8% vs. 77.8% ± 5.1%, p = 0.16). CONCLUSION: This study indicates that CB-PVI for symptomatic AF is equally safe and effective in patients with and without a history of cancer and cancer treatment.

Evaluation of predictive scores for late and very late recurrence after cryoballoon-based ablation of atrial fibrillation.

PURPOSE: Studies on predictive scores for very late recurrence (VLR) (recurrence later than 12 months) after second-generation cryoballoon-based pulmonary vein isolation (CB2-PVI) are sparse. We aimed to evaluate the frequency of late recurrence (LR) (later than 3 months) and VLR, and to validate predictive scores for LR and VLR after initial CB2-PVI. METHODS: A total of 288 patients undergoing initial CB2-PVI (66 ± 11 years, 46% paroxysmal) were retrospectively enrolled in the LR cohort. In the VLR cohort, 83 patients with recurrence within 3-12 months or with < 12-month follow-up were excluded. The predictive scores of arrhythmia recurrence were assessed, including the APPLE, DR-FLASH, PLAAF, BASE-AF2, ATLAS, SCALE-CryoAF, and MB-LATER scores. RESULTS: During a mean follow-up of 15.3 ± 7.1 months, 188 of 288 (65.2%) patients remained in sinus rhythm without any recurrences. Thirty-two of 205 (15.6%) patients experienced VLR after a mean of 16.6 ± 5.6 months. Comparing the predictive values of these specific scores, the MB-LATER score showed a reliable trend toward greater risk of both LR and VLR (area under the curve in LR; 0.632, 0.637, 0.632, 0.637, 0.604, 0.725, and 0.691 (p = ns), VLR; 0.612, 0.636, 0.644, 0.586, 0.541, 0.633, and 0.680 (p = 0.038, vs. BASE-AF2, respectively)). Kaplan-Meier analysis estimated patients with higher MB-LATER scores which had favorable outcomes (24-month freedom from LR; 26.0% vs. 56.7%, p < 0.0001, VLR; 53.4% vs. 82.1%, p = 0.013). CONCLUSION: The MB-LATER score provided more reliable predictive value for both LR and VLR. Patients with higher MB-LATER scores may benefit from more intensive long-term follow-up.

Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience.

BACKGROUND: Data reporting a head-to-head comparison between Amulet and Watchman devices are scarce. The aim of this study was to compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry. METHODS: Patients who underwent LAAC using Watchman or Amulet devices from January 2014 to December 2019 at the University Heart Center Lübeck, Lübeck, Germany were included in the present analysis. Primary endpoints included periprocedural complications (in-hospital death, pericardial tamponade, device embolization, stroke, major bleeding and vascular access complications), and complications during long-term follow-up (ischemic stroke, hemorrhagic stroke, thromboembolism, device thrombus, bleeding and death). RESULTS: After matching the patients for age (±5 years), gender, CHA2DS2Vasc score (±1) and HASBLED score (±1), each of the Watchman and the Amulet groups included 113 patients. Patients in the Amulet group had significantly more periprocedural complications (2.7% vs 10.6%, p = 0.029; respectively) and more major bleeding complications (0% vs 5.3%, p = 0.029; respectively). During long-term follow-up, the rate of events was comparable between the Watchman and Amulet groups (18.3% versus 20.8%, p = 0.729; respectively). CONCLUSION: Amulet LAAC device was associated with increased periprocedural complications as compared to Watchman LAAC device. On long-term follow-up, both devices showed comparable efficacy and safety.

Impact of Left Atrial Appendage Closure on LAA Thrombus Formation and Thromboembolism After LAA Isolation.

OBJECTIVES: This study sought to evaluate the safety and effectiveness of electrical isolation of the left atrial appendage (LAAEI) as well as the status of left atrial appendage closure (LAAC) in these patients. BACKGROUND: Catheter-based LAAEI is increasingly performed for treatment of symptomatic atrial fibrillation and pulmonary vein isolation nonresponders. Previous studies indicate an increased incidence of thromboembolic events after LAAEI despite effective oral anticoagulation. Interventional LAAC may prevent cardioembolic events after LAAEI but data regarding safety, feasibility, and efficacy of LAAC in this clinical setting are scarce. METHODS: Consecutive patients who underwent LAAEI at 2 German tertiary care hospitals were analyzed. RESULTS: A total of 270 patients underwent LAAEI by radiofrequency ablation in 255 (94.4%), cryoballoon ablation in 12 (4.4%), and by a combination of both techniques in 3 cases (1.1%). Stroke or transient ischemic attack occurred in 24 of 244 (9.8%) individuals with available follow-up. LAA thrombus formation was found in 53 patients (19.6%). A total of 150 patients underwent LAAC after LAAEI. No LAA thrombus was documented in any patient who underwent LAAC. Of the patients who underwent LAAEI, 67.6% were in sinus rhythm after a mean of 682.7 ± 61.7 days. LAA flow after LAAEI but not arrhythmia recurrence was identified as an independent predictor of stroke and/or transient ischemic attack or LAA thrombus (p < 0.0001). CONCLUSIONS: Sinus rhythm was documented in about two-third of patients undergoing LAAEI as treatment of therapy refractory atrial arrhythmias. LAAC potentially prevents LAA thrombus formation and thromboembolism.