Impact of gender in patients with device-related thrombosis after left atrial appendage closure - A sub-analysis from the multicenter EUROC-DRT-registry.

BACKGROUND: Device-related thrombosis (DRT) is a common finding after left atrial appendage closure (LAAC) and is associated with worse outcomes. As women are underrepresented in clinical studies, further understanding of sex differences in DRT patients is warranted. METHODS AND RESULTS: This sub-analysis from the EUROC-DRT-registry compromises 176 patients with diagnosis of DRT after LAAC. Women, who accounted for 34.7% (61/176) of patients, were older (78.0 ± 6.7 vs. 74.9 ± 9.1 years, p = .06) with lower rates of comorbidities. While DRT was detected significantly later in women (173 ± 267 vs. 127 ± 192 days, p = .01), anticoagulation therapy was escalated similarly, mainly with initiation of novel oral anticoagulant (NOAC), vitamin K antagonist (VKA) or heparin. DRT resolution was achieved in 67.5% (27/40) of women and in 75.0% (54/72) of men (p = .40). In the remaining cases, an intensification/switch of anticoagulation was conducted in 50.% (9/18) of men and in 41.7% (5/12) of women. Final resolution was achieved in 72.5% (29/40) cases in women, and in 81.9% (59/72) cases in men (p = .24). Women were followed-up for a similar time as men (779 ± 520 vs. 908 ± 687 days, p = .51). Kaplan-Meier analysis revealed no difference in mortality rates in women (Hazard Ratio [HR]: 1.73, 95%-Confidence interval [95%-CI]: .68-4.37, p = .25) and no differences in stroke (HR: .83, 95%-CI: .30-2.32, p = .72) within 2 years after LAAC. CONCLUSION: Evaluation of risk factors and outcome revealed no differences between men and women, with DRT in women being diagnosed significantly later. Women should be monitored closely to assess for DRT formation/resolution. Treatment strategies appear to be equally effective.

Symptomatic vs. non-symptomatic device-related thrombus after LAAC: a sub-analysis from the multicenter EUROC-DRT registry.

BACKGROUND: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited. AIMS: This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed. METHODS: The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared. RESULTS: Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37-558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%). CONCLUSION: Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events.

Clinical outcomes of subcutaneous vs. transvenous implantable defibrillator therapy in a polymorbid patient cohort.

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has been designed to overcome lead-related complications and device endocarditis. Lacking the ability for pacing or resynchronization therapy its usage is limited to selected patients at risk for sudden cardiac death (SCD). Objective: The aim of this single-center study was to assess clinical outcomes of S-ICD and single-chamber transvenous (TV)-ICD in an all-comers population. Methods: The study cohort comprised a total of 119 ICD patients who underwent either S-ICD (n = 35) or TV-ICD (n = 84) implantation at the University Hospital Frankfurt from 2009 to 2017. By applying an inverse probability-weighting (IPW) analysis based on the propensity score including the Charlson Comorbidity Index (CCI) to adjust for potential extracardiac comorbidities, we aimed for head-to-head comparison on the study composite endpoint: overall survival, hospitalization, and device-associated events (including appropriate and inappropriate shocks or system-related complications). Results: The median age of the study population was 66.0 years, 22.7% of the patients were female. The underlying heart disease was ischemic cardiomyopathy (61.4%) with a median LVEF of 30%. Only 52.9% had received an ICD for primary prevention, most of the patients (67.3%) had advanced heart failure (NYHA class II-III) and 16.8% were in atrial fibrillation. CCI was 5 points in TV-ICD patients vs. 4 points for patients with S-ICD (p = 0.209) indicating increased morbidity. The composite endpoint occurred in 38 patients (31.9 %), revealing no significant difference between patients implanted with an S-ICD or TV-ICD (unweighted HR 1.50, 95 % confidence interval (CI) 0.78-2.90; p = 0.229, weighted HR 0.94, 95% CI, 0.61-1.50, p = 0.777). Furthermore, we observed no difference in any single clinical endpoint or device-associated outcome, neither in the unweighted cohort nor following inverse probability-weighting. Conclusion: Clinical outcomes of the S-ICD and TV-ICD revealed no differences in the composite endpoint including survival, freedom of hospitalization and device-associated events, even after careful adjustment for potential confounders. Moreover, the CCI was evaluated in a S-ICD cohort demonstrating higher survival rates than predicted by the CCI in young, polymorbid (S-)ICD patients.

Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry.

BACKGROUND: Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. METHODS: We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. RESULTS: Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88-9.49], p < 0.01). CONCLUSIONS: DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position.

Laser balloon in pulmonary vein isolation for atrial fibrillation: current status and future prospects.

INTRODUCTION: Visually guided laser balloon (LB) catheter has been an established modality dedicated for pulmonary vein (PV) isolation in patients with atrial fibrillation. The newly updated version of this novel device has technically evolved recent years. AREAS COVERED: This review will summarize the contemporary technical evolution of LB catheter. Available efficacy outcomes and the historical change of ablation style will be evaluated. Furthermore, the future perspectives for clinical practice are discussed. EXPERT COMMENTARY: The initial LB ablation system provided comparable clinical results in PV isolation with other technologies, but with a unique strategical concept enabling the direct visualization of the tissue to cauterize. With multigenerational development, the LB catheter has been equipped with more compliant balloon for favorable PV occlusion and a robotically motor driven continuous ablation mode (RAPID mode). These technical innovations changed the concept of the ablation strategy using LB catheter as 'point-by-point' into 'single-shot' fashion. The remaining tasks are further improvements such as equipping with real-time recording system of intracardiac electrogram, durable structured balloon and the instrument for visualizing the cauterization area in a 360-degree panoramic view, which includes potential possibilities to develop this novel device to the more optimal device for PV isolation.

Single-sweep pulmonary vein isolation using the new third-generation laser balloon-Evolution in ablation style using endoscopic ablation system.

BACKGROUND: The endoscopic ablation system (EAS) is an established ablation device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). The novel X3 EAS is now equipped with a contiguous circumferential ablation mode (RAPID mode). AIM: To determine the feasibility of single-shot fashioned ablation using X3. METHODS: Consecutive patients who underwent AF ablation using X3 were enrolled. We assessed the acute procedural data focusing on "Single-sweep PVI" defined as successful PVI with a single RAPID mode energy application, and on "first-pass isolation" defined as successful PVI after initial circular lesion set. RESULTS: One hundred AF patients (56% male, age: 68 ± 10 years, 66% paroxysmal AF) were analyzed. A total of 379 of 383 PVs (99%) were isolated with X3. Single-sweep PVI and first-pass-isolation were achieved in 214 PVs (56%) and in 362 PVs (95%), respectively. Single-sweep PVI rates varied across PVs with higher rates at the superior PVs (61.2% vs. inferior PVs: 49.5%, p = .0239) and at PVs with maximal ostial diameter <24 mm (57.6% vs. >24 mm: 36.8%, p = .0151). The mean total procedure and fluoroscopy times were 43.0 ± 10 and 4.0 ± 2 min, respectively. In none of the patients an acute thromboembolic event (stroke or transient ischemic attack) or a pericardial effusion/tamponade occurred. A single transient phrenic nerve palsy was observed. CONCLUSION: The new X3 EAS allows for single-shot fashioned ablation in terms of single-sweep PVI in half or more of PVs. The new RAPID ablation mode leads to an improved rate of first-pass isolation associated with very short procedure times without compromising safety.

Validation of lesion durability following pulmonary vein isolation using the new third-generation laser balloon catheter in patients with recurrent atrial fibrillation.

BACKGROUND: The second- and third-generation endoscopic ablation systems (EAS2 and EAS3) have been launched in recent years. We aimed to assess the lesion durability as well as gap localization using the multigenerational novel technologies in patients with recurrent atrial fibrillation (AF). METHODS: Consecutive patients who underwent second ablation for recurrent AF following the initial pulmonary vein isolation (PVI) with EAS2 or EAS3 were retrospectively investigated. The persistent durability of PVI, gap localization at the second procedure, and procedural/anatomical features of durable PVI were analyzed. RESULTS: Among 225 patients treated with EAS3 (N = 125) and EAS2 (N = 100), 34 patients (EAS3: 13 patients, 50 PVs, EAS2: 21 patients, 82 PVs) underwent a second procedure because of recurrent AF mean 11.9 ± 9.3 months after the initial procedure. Persistent isolation of all four PVs was recorded in 6 (46.2%) patients in EAS3 group and 4 (19.1%) patients in EAS2 group (p = 0.130). Ninety-one out of 132 (68.9%) PVs were persistently isolated with a higher rate in EAS3 group (82.0% vs. EAS2 group: 61.0%, p = 0.0113). A total of 45 gaps were recorded in 41 PVs. Right superior PV (RSPV) was the predominantly common reconnected vein (15 gaps, 14 PVs) irrespective of generations (EAS3: 4 gaps in 3 PVs and EAS2: 12 gaps in 11 PVs). Logistic multivariate regression analysis revealed ablation without reduced energy dose (5.5-7 W) as an independent predictor of durable PVI [adjusted OR: 3.70, 95% CI (1.408-10.003)], p = 0.008]. CONCLUSION: The technical innovation resulted in a higher lesion durability in EAS3-guided PVI in patients with recurrent AF. The most common gap location was found at RSPV in successor EASs. Ablation without reduced energy was a predictor of durable PVI in successor EASs.

Device-Related Thrombus After Left Atrial Appendage Closure: Data on Thrombus Characteristics, Treatment Strategies, and Clinical Outcomes From the EUROC-DRT-Registry.

BACKGROUND: Left atrial appendage closure is an established therapy in patients with atrial fibrillation. Although device-related thrombosis (DRT) is relatively rare, it is potentially linked to adverse events. As data on DRT characteristics, outcome, and treatment regimen are scarce, we aimed to assess these questions in a multicenter approach. METHODS: One hundred fifty-six patients with the diagnosis of DRT after left atrial appendage closure were included in the multinational EUROC-DRT registry. Baseline characteristics included clinical and echocardiographic data. After inclusion, all patients underwent further clinical and echocardiographic follow-up to assess DRT dynamics, treatment success, and outcome. RESULTS: DRT was detected after a median of 93 days (interquartile range, 54­161 days) with 17.9% being detected >6 months after left atrial appendage closure. Patients with DRT were at high ischemic and bleeding risk (CHA2DS2-VASc 4.5±1.7, HAS-BLED 3.3±1.2) and had nonparoxysmal atrial fibrillation (67.3%), previous stroke (53.8%), and spontaneous echo contrast (50.6%). The initial treatment regimens showed comparable resolution rates (antiplatelet monotherapy: 57.1%, dual antiplatelet therapy: 85.7%, vitamin K antagonists: 80.0%, novel oral anticoagulants: 75.0%, and heparin: 68.6%). After intensification or switch of treatment, complete DRT resolution was achieved in 79.5% of patients. Two-year follow-up revealed a high risk of mortality (20.0%) and ischemic stroke (13.8%) in patients with DRT. Patients with incomplete DRT resolution showed numerically higher stroke rates and increased mortality rates (stroke: 17.6% versus 12.3%, P=0.29; mortality: 31.3% versus 13.1%, P=0.05). CONCLUSIONS: A substantial proportion of DRT is detected >6 months after left atrial appendage closure, highlighting the need for imaging follow-up. Patients with DRT appear to be at a high risk for stroke and mortality. While DRT resolution was achieved in most patients, incomplete DRT resolution appeared to identify patients at even higher risk. Optimal DRT diagnostic criteria and treatment regimens are warranted.