Project description:BackgroundIn the recent ESC/EACTS guidelines, left atrial appendage (LAA) occlusion or exclusion in patients undergoing (thoracoscopic) atrial fibrillation (AF) ablation surgery is recommended. The Watchman device (WD, Boston Scientific, Minnesota) has proved to reduce the risk of thromboembolic events by closing of the LAA, yet no data exist on WD implantation during surgical AF ablation. The objective is to determine if WD implantation is safe and feasible in a hybrid AF ablation setting (i.e., combination of thoracoscopic epicardial surgical and endocardial catheter ablation) and could become subject of further testing to serve as a bail-out in cases in which surgical LAA occlusion methods cannot be applied, due to, for example, severe adhesions.MethodsIn this prospective, single center, pilot study, 10 consecutive patients undergoing a hybrid ablation qualifying for LAA exclusion (CHA2DS2-VASc ≥ 1) were included. At the end of the hybrid ablation, the LAA was occluded endocardially using the WD. The feasibility endpoint was successful implantation. The safety endpoint concerned major complications.ResultsOne patient was excluded and replaced because the LAA was insufficiently visible on transesophageal echocardiography. In 10/11 patients, device delivery was successful (mean time: 35 minutes). No major complications occurred. Transesophageal echocardiography after 6 weeks and 6 months showed successful occlusion of the LAA without significant peridevice flow.ConclusionImplantation of the WD seems to be feasible and safe in the setting of hybrid AF ablation and could be an alternative to epicardial occlusion in surgical AF ablation procedures. Larger studies are required to confirm these findings. This trial is registered with NCT02471131.
Project description:BackgroundIndigenous Australians experience a greater burden of AF. Whether this is in-part due to differences in arrhythmogenic structures that appear to contribute to AF differences amongst other ethnicities is not known.MethodsWe studied forty individuals matched for ethnicity and other AF risk factors. Computed tomography imaging was used to characterise left atrial (LA), pulmonary vein (PV), and left atrial appendage (LAA) anatomy.ResultsThere were no significant differences in LA diameters or volumes between Indigenous and non-Indigenous Australians. Similarly, we could not detect any consistent differences in PV number, morphology, diameters, or ostial characteristics according to ethnicity. LAA analyses suggested that Indigenous Australians may have a greater proportion of non chickenwing LAA type, and a tendency for eccentric, oval-shaped LAA ostia; however, there were no other differences seen with regards to LAA volume or depth. Indexed values for LA, PV and LAA anatomy corrected for body size were broadly similar.ConclusionsIn a cohort of individuals matched for AF risk factors, we could find no strong evidence of ethnic differences in LA, PV, and LAA characteristics that may explain a predisposition of Indigenous Australians for atrial arrhythmogenesis. These findings, in conjunction with our previous data showing highly prevalent cardiometabolic risk factors in Indigenous Australians with AF, suggest that it is these conditions that are more likely responsible for the AF substrate in these individuals. Continued efforts should therefore be directed towards risk factor management in an attempt to prevent and minimise the effects of AF in Indigenous Australians.
Project description:ObjectiveTo determine trends in real-world utilization and in-hospital adverse events from Watchman implantation since its approval by the Food and Drug Administration in 2015.BackgroundThe risk of embolic stroke caused by atrial fibrillation is reduced by oral anticoagulants, but not all patients can tolerate long-term anticoagulation. Left atrial appendage occlusion with the Watchman device has emerged as an alternative therapy.MethodsThis was a retrospective cohort study utilizing data from National Inpatient Sample for calendar years 2015-2017. The outcomes assessed in this study were associated complications, in-hospital mortality, and resource utilization trends after Watchman implantation. Trends analysis were performed using analysis of variance. Multivariable adjusted logistic regression analysis was performed to determine predictors of mortality.ResultsA total of 17 700 patients underwent Watchman implantation during the study period. There was a significantly increased trend in the number of Watchman procedures performed over the study years (from 1195 in 2015 to 11 165 devices in 2017, p < .01). A significant decline in the rate of complications (from 26.4% in 2015% to 7.9% in 2017, p < .01) and inpatient mortality (from 1.3% in 2015% to 0.1% in 2017, p < .01) were noted. Predictors of in-hospital mortality included a higher CHA2 DS2 -VASc score (odds ratio [OR]: 2.61 per 1-point increase, 95% confidence interval [CI]: 1.91-3.57), chronic blood loss anemia (OR: 3.63, 95% CI: 1.37-9.61) and coagulopathy (OR: 4.90, 95% CI: 2.32-10.35).ConclusionIn contemporary United States clinical practice, Watchman utilization has increased significantly since approval in 2015, while complications and in-patient mortality have declined.
Project description:BackgroundLeft atrial appendage closure is a non-pharmacological alternative for stroke prevention in high-risk non-valvular atrial fibrillation patients, but has not been widely studied in Asian patients. The prospective WASP registry assessed real-world outcomes for patients undergoing WATCHMAN implant in the Asia-Pacific region.MethodsData were collected from consecutive patients across 9 centres. Major endpoints included procedural success, safety and long-term outcomes including occurrence of bleeding, stroke/transient ischaemic attack/systemic embolism and all-cause mortality.ResultsSubjects (n = 201) had a mean age of 70.8 ± 9.4 years, high stroke risk (CHA2DS2-VASc: 3.9 ± 1.7), elevated bleeding risk (HAS-BLED: 2.1 ± 1.2) with 53% patients from Asian countries. Successful implantation occurred in 98.5% of patients; 7-day device/procedure-related SAE rate was 3.0%. After 2 years of follow-up, the rates of ischaemic stroke/TIA/SE and major bleeding were 1.9 and 2.2 per 100-PY, respectively, representing relative reductions of 77% and 49% versus expected rates per risk scores. The relative risk reductions versus expected rates were more pronounced in Asians vs. Non-Asians (89% vs 62%; 77% vs 14%). Other significant findings included larger mean LAA ostium diameter for Asians vs. Non-Asians (23.4 ± 4.1 mm vs. 21.2 ± 3.2 mm, p < 0.001) and hence requirement for larger median device size (27 mm for Asians, 24 mm for non-Asians [p < 0.0001]).ConclusionReal-world experience of left atrial appendage closure with WATCHMAN has demonstrated low peri-procedural risk, and long-term efficacy for stroke and bleeding prevention in a primarily Asian cohort.
Project description:BackgroundIn patients with non-valvular atrial fibrillation, the vast majority of thrombi originate in the left atrial appendage (LAA). Thus, occluding the LAA significantly reduces one's risk for developing an ischaemic stroke. To date, many different surgical methodologies in LAA occlusion (LAAO)/exclusion have been studied and utilized. Unfortunately, patients are often left with incomplete closure of their LAA, leaving behind residual lobes that continue to allow thrombus formations. With the recent rise in percutaneous approaches and devices such as the WATCHMAN FLX, there have been proven success rates in achieving total closure of the LAA. Reports and investigations regarding the utilization of WATCHMAN FLX devices in patients with surgically incomplete LAAO remain limited.Case summaryWe present three cases of patients who had previously undergone surgical exclusion of the LAA yet unfortunately were left with residual LAA that continued to place them at high risk for an ischaemic stroke. Percutaneous LAAO with the WATCHMAN FLX was utilized to successfully achieve complete sealing of the residual lobes in failed LAA surgical closures.DiscussionOur multicentre case series elucidates that an increased risk of stroke due to surgical LAAO failure is a real-world possibility that is likely to be encountered in clinical practice. We demonstrate in this series how the WATCHMAN FLX may provide a feasible and safe method to supplement a surgically incomplete LAAO to allow for improved ischaemic stroke and systemic embolization risk reduction.
Project description:Left atrial appendage closure (LAAC) is a promising site-directed therapy for stroke prevention in patients with non-valvular atrial fibrillation (AF) who are ineligible or contraindicated for long-term oral anticoagulation. A variety of LAAC modalities are available, including percutaneous endocardial occluder devices such as WATCHMANTM (Boston Scientific Corp., Marlborough, MA, USA), and an ever-increasing body of evidence is helping to define the optimal use of each technique. Similarly increased experience with LAAC has revealed challenges such as device-related thrombi and peri-device leaks for which the long-term significance and appropriate management are areas of active investigation. We review the evolution and long-term outcomes with the WATCHMANTM device with particular emphasis on the nuances of its use and its role in the broader landscape of appendageology.