Left Atrial Appendage Occlusion Devices Research Articles

Percutaneous left atrial appendage occlusion: impact on left atrial deformation indices.

Percutaneous left atrial appendage occlusion (LAAO) is an accepted alternative to thromboprophylaxis in patients with atrial fibrillation (AF) who are: (i) intolerant to oral anticoagulation (OAC) (e.g. life-threatening haemorrhage), (ii) non-adherent to OAC, or (iii) at a high bleeding risk with OAC. Improvement in LA mechanics was shown post-LAAO in the LAFIT-LARIAT study, using the Lariat device. No significant change was seen in LA mechanics after LAAO with the Watchman device in the LAFIT-Watchman study. The impact of LAAO with the Amplatzer or Amulet device on LA deformation mechanics has not been investigated. To evaluate the impact of LAAO with the Amplatzer or Amulet device on echocardiographic LA deformation indices. All patients undergoing percutaneous LAAO from 2013 to 2021 at a single centre were included from an ongoing clinical registry. LA reservoir (εreservoir), conduit (εconduit) and contractile strain (εcontractile) and strain rate (SRreservoir, SRconduit, SRcontractile) were assessed with two-dimensional speckle tracking echocardiography from an apical four-chamber view. Conduit and contractile strain and strain rates were only recorded for patients without AF at the time of echocardiography. Changes in LA deformation indices over time were compared with a linear mixed model. 28 LAAO recipients (mean age 73 ± 12 years, 68% male) were analysed. 5 (18%) patients had AF pre- or post-procedure. After a mean follow-up of 1.6 ± 1.4 months, the mean LA εreservoir increased from 10.15 ± 6.44% to 10.18 ± 8.72% (p = 0.985), the mean LA εconduit increased from 5.12 ± 5.48% to 5.31 ± 6.11% (p = 0.891) and the mean LA εcontractile decreased from 5.14 ± 4.32% to 4.95 ± 5.30% (p = 0.898). During the same time interval, the mean LA SRreservoir decreased from + 0.54 ± 0.23.s- 1 to + 0.48 ± 0.43.s- 1 (p = 0.566), the mean LA SRconduit remained stable: -0.47 ± 0.41.s- 1 to -0.47 ± 0.32.s- 1 (p = 0.997) and the mean LA SRcontractile decreased from - 0.66 ± 0.50.s- 1 to -0.55 ± 0.46.s- 1 (p = 0.660). No significant improvement in LA mechanical function was seen after LAAO with the Amplatzer or Amulet device. Different LAAO devices therefore appear to have divergent effects on LA deformation, the clinical implications of which may warrant further study.

Anterior Pathway for Epicardial Left Atrial Appendage Clip Occlusion During Minimally Invasive Atrioventricular Valve Surgery.

The left atrial appendage occlusion (LAAO) by endocardial suture is sometimes inadequate and thrombogenic with uncertain electrical competence. Moreover, epicardial LAAO clip placement through the transverse sinus can be technically challenging during minimally invasive atrioventricular valve surgery. Here, we describe our new endoscopic technique via an anterior access pathway in 5 patients with concomitant atrial fibrillation using an epicardial clip device (AtriClip Pro 1 or AtriClip Pro 2, AtriCure, Mason, OH, USA) for LAAO. The LAAO was successful in all patients without residual perfusion and surgical complications. Epicardial LAAO by clip via the anterior access pathway represents a novel and feasible endoscopic technique for minimally invasive atrioventricular valve surgery.

High rates of oral anticoagulation in atrial fibrillation patients observed in a large multi-specialty health system in the Northeast.

Anticoagulation is a cornerstone in atrial fibrillation (AF) management for stroke prevention. Studies showed that oral anticoagulants (OAC), previously limited to warfarin, were underused. Recently, non-vitamin K oral anticoagulants (NOACs) have seen widespread adoption, but it has not been well studied whether there has been a subsequent increase in OAC usage in AF patients. We quantified OAC rates in AF patients in a large multispecialty health system in the Northeast United States. A total of 351,795 patients seen in the network over the preceding 18months were reviewed. Of these patients, 8727 (2.5%) carried a diagnosis of AF, and, of the 6933 patients with a CHA2DS2-VASc score of 2 or higher, 5576 (80.4%) had an OAC listed as an active medication or had received a left atrial appendage occlusion device. Of the 6605 patients treated with an OAC, 5308 (80.4%) were treated with a NOAC and 1295 (19.6%) were prescribed warfarin. A higher percentage of patients with CHA2DS2-VASc ≥ 2 who had seen a cardiologist were treated with an OAC vs. those who had not seen a cardiologist in the prior 18months (83.95% vs. 67.43%, p < 0.01). We show dramatically increased OAC usage among patients with AF and that NOACs comprise the large majority of OACs compared with previous studies. This suggests an association between widespread adoption of NOACs and increased oral anticoagulation rates. Future directions include assessing barriers to oral anticoagulation and developing interventions to reduce disparity in OAC use between clinics.

Intracardiac echocardiography-guided left atrial appendage occlusion: descriptive analysis

Abstract Introduction Oral anticoagulants are the standard treatment for prevention of stroke in patients with atrial fibrillation (AF). However, some patients still have stroke despite anticoagulation or have contraindications to anticoagulation. The left atrial appendage occlusion (LAAO) is an option for those patients. The use of intracardiac echocardiography (ICE) instead of Transesophageal echocardiography guiding LAAO procedures has increased, allowing to reduce the use of general anesthesia. Objectives The aim of this study is to describe data regarding safety and efficacy in patients submitted to ICE-guided LAAO. Methods In a tertiary center, patients submitted to ICE-guided LAAO were identified. Information regarding baseline characteristics, procedure technical success, complications, hospitalization and follow-up data was noted retrospectively. The registered stroke and bleeding rates were compared with predicted rates using CHA2DS2-VASc and HAS-BLED scores, respectively. Results 45 patients underwent ICE-guided LAAO, mean age 75.5±9.6 years old, 71.1% male (detailed characteristics in table 1). Permanent AF was present in 68.9% (n=31), with average CHA2DS2-VASc and HAS-BLED scores of 4.0±1.4 and 3.6±1.1, respectively (predicting a stroke risk of 4.0% per year and a major bleeding risk of 8.7% per year). The LAAO indication was previous major bleeding in 64.4% (n=29), high bleeding risk in 24.4% (n=11) and embolic events despite therapeutic anticoagulation in 11.1% (n=5). The LAAO devices were implanted successfully in 96% of the patients (n=43). It was noted a complication rate of 8.8% (n=4), perforation in 4.4% (n=2), device embolization in 4.4% (n=2, one of them leading to cardiac arrest and death) and no major vascular complications occurred. No other procedure-related deaths occurred. The average duration of hospitalization after the procedure was 5.7 days. All patients were followed-up for a mean period of 19.0 months. During that period, another death (2.2%) occurred with a non-cardiac cause and the re-hospitalization rate was 26.7% (n=12), 11.1% (n=5) for cardiac causes. During the same period, 1 stroke (2.2%) and 6 major bleeding (13.3%) occurred – yearly rates of 1.4% and 8.4%, respectively. The stroke rate is markedly inferior to predicted by the score and the major bleeding is slightly inferior to predicted. Conclusions This study provides data about the safety and mainly about the efficacy of the LAAO guided by ICE in a cohort of patients with high hemorrhagic and embolic risk. Funding Acknowledgement Type of funding sources: None.

Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion.

Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF. The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort. At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and rate of LAA occlusion at 45 days. A total of 201 roll-in patients were enrolled. Device success occurred in 99% of patients, and device closure (residual jet ≤5 mm) was observed in 98.9% of patients at 45 days. The safety endpoint rate was numerically higher (worse) in the roll-in cohort compared to the randomized Amulet occluder cohort (18.4% vs 14.5%). Six patients (3.1%) experienced an ischemic stroke and 0 patients with a systemic embolism within 18 months, which was similar to the primary effectiveness endpoint rate in the randomized Amulet occluder cohort (2.8%). Despite lack of experience of the operators with the Amulet occluder in the roll-in phase, device implant success was high, a high rate of device closure was achieved, and low stroke rates were observed in patients with NVAF.

Feasibility and safety of laser balloon pulmonary vein isolation in patients with prior left atrial appendage occlusion device implantation.

With the increasing adoption of left atrial appendage occlusion (LAAO) procedures and the eligibility of patients for pulmonary vein isolation (PVI) post device placement, we examined the feasibility and safety of laser balloon (LB) for PVIin patients with prior LAAO. We retrospectively examined consecutive patients with paroxysmal or persistent, drug-resistant atrial fibrillation(AF) who underwent LB PVI, after Watchman FLX device implantation at Rush University Medical Center between January 2020 and December 2021. Seven patients (four persistent and three paroxysmal) with a mean age of 64 ± 11 years, predominantly male sex (86%), were included in the study. Two (29%) patients had prior cryoablation PVI with recurrence of AF. The mean CHA2 DS2 VASc is 2.6 ± 0.5 and the mean HAS-BLED score is 3.4 ± 0.8. The mean follow-up duration was 10 ± 7 months. The mean duration between Watchman FLX device implantation and LB PVI was 592 days. Acute first pass left pulmonary vein (PV) isolation was achieved in 100% of the procedures. There were no periprocedural complications such as death, pericardial tamponade or effusion, phrenic nerve injury, PV stenosis, device perforation or embolization, or worsening peri-device leak in any of the patients. None of the patients had AF recurrence after the blanking period. LB PVI was safe and effective with 100% acute isolation of left-sided veins in patients with prior LAAO device.

TCT-546 Stroke and Safety Outcomes With Left Atrial Appendage Occlusion Device Implantation in Chronic Kidney Disease: A Systemic Review and Meta-Analysis

TCT-546 Stroke and Safety Outcomes With Left Atrial Appendage Occlusion Device Implantation in Chronic Kidney Disease: A Systemic Review and Meta-Analysis

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Occluding morphologically complicated left atrial appendage using the small-umbrella LAmbre device

BackgroundPercutaneous left atrial appendage (LAA) occlusion is effective for stroke prevention in patients with atrial fibrillation. LAA can have a complex anatomy, such as multiple lobes or a large orifice, which may render it unsuitable for occlusion using regular devices. We aimed to investigate the feasibility, safety, and short-term efficacy of the small-umbrella LAmbre device for morphologically complicated LAA.MethodsWe retrospectively enrolled 129 consecutive patients who underwent LAA occlusion using the LAmbre device; the small-umbrella LAmbre device was used in 30 of these patients. We analyzed patients’ characteristics, procedural details, and outcomes.ResultsTwenty-two patients (73.3%) had multilobed (≥ 2) LAA. The umbrella of the occluder was anchored in the branch in 9 patients and in the common trunks of branches in 13 patients. The landing zone and orifice diameters were 19.0 ± 4.39 mm and 27.4 ± 3.95 mm, respectively. The sizes of the umbrella and occluder cover were 22.0 ± 3.42 mm and 34.3 ± 2.75 mm, respectively. At 3-month follow-up transesophageal echocardiography in 24 patients, no peri-device residual flow was reported. Device thrombosis was detected in one patient at 3 months and disappeared after 3 months of anticoagulation. Ischemic stroke occurred in one patient; no other adverse events were reported.ConclusionsOcclusion of morphologically complicated LAA using the small-umbrella LAmbre device was feasible, safe, and effective in patients with atrial fibrillation in this study. This occluder provides an alternative for patients who cannot be treated with regular-sized LAA occlusion devices.

418 An Australian Experience Of Starting A Program To Use Computed Tomography Assessment Of The Left Atrial Appendage To Avoid Trans-oesophageal Echocardiography In The Covid-19 Pandemic

Introduction: Trans-oesophageal echocardiography (TOE) has long been the gold standard for assessment of the left atrial appendage (LAA). In the COVID-19 pandemic Australian and international guidelines recommend avoiding aerosol generating procedures (AGP). Computed tomography left atrial appendage (CTLAA) is not an AGP and has a negative predictive value for LAA thrombus of 99% in meta-analyses. CTLAA has been endorsed by the Society of Cardiac Computed Tomography to exclude LAA thrombus but is not used widely in Australia outside of pulmonary vein isolation and LAA occlusion device insertion planning.

Association of advanced age with procedural complications and in-hospital outcomes from left atrial appendage occlusion device implantation in patients with atrial fibrillation: insights from the National Inpatient Sample of 36,065 procedures

BackgroundAge-stratified analyses of atrial fibrillation (AF) patients undergoing percutaneous left atrial appendage occlusion (LAAO) are limited. The purpose of current study was to compare in-hospital outcomes in elderly AF patients (age > 80 years) to a relatively younger cohort (age £ 80 years) after LAAO.MethodsData were extracted from National Inpatient Sample for calendar years 2015–2018. LAAO device implantations were identified on the basis of International Classification of Diseases, 9th and 10th Revision, Clinical Modification codes of 37.90 and 02L73DK. The outcomes assessed in our study included complications, inpatient mortality, and resource utilization with LAAO.ResultsA total of 36,065 LAAO recipients were included in the final analysis, of which 34.6% (n=12,475) were performed on elderly AF patients. Elderly AF patients had a higher prevalence of major complications (6.7% vs. 5.7%, p < 0.01) and mortality (0.4% vs. 0.1%, p < 0.01) after LAAO device implantation in the crude analysis. After multivariate adjustment of potential confounders, age > 80 years was associated with increased risk of inpatient mortality (adjusted odds ratio [aOR] 4.439, 95% confidence interval [CI] 2.391–8.239) but not major complications (aOR 1.084, 95% CI 0.971–1.211), prolonged length of stay (aOR 0.943, 95% CI 0.88–1.101), or increased hospitalization costs (aOR 0.909, 95% CI 0.865–0.955).ConclusionOver 1 in 3 LAAO device implantations occurred in elderly AF patients. After adjusting for potential confounding variables, advanced age was associated with inpatient mortality, but not with other LAAO procedural–related outcomes including major complications, prolonged length of stay, or increased hospitalization costs.

Seize the day, …s(e)ize the device: The emerging imaging modality to improve left atrial appendage device sizing.

There is still uncertainity about the use of computed tomography-scan for left atrial appendage occlusion (LAAO) device sizing. The main reason for this disappointing position is likely to relate to the scarcity of robust data, since there is still difference among institutions with regards how to perform measurement of the devices. Dallan et al. report their own experience on the use of a novel computed tomography angiography-based (CTA) for sizing the Watchman Flex device for LAAO. The authors through the TruPlan software package that a preprocedural CTA sizing protocol can be applied successfully with intracardiac echocardiography guidance and provide excellent procedural outcomes. The applied CTA protocol is safe and can provide high success rates with the WatchmanTM FLX device reducing the number of deployment attempts and reducing the risk of complications.

Safety and Efficacy of Left Atrial Catheter Ablation in Patients with Left Atrial Appendage Occlusion Devices.

Background: Left atrial appendage occlusion (LAAO) is an alternative to oral anticoagulation for thromboembolic prevention in patients with atrial fibrillation (AF). Left atrial (LA) catheter ablation (CA) in patients with LAAO devices has not been well investigated. Here, we report on the safety and efficacy of LA CA in patients with nitinol cage or plug LAAO devices. Methods: A total of 18 patients (aged 67 ± 11 years; 14 males; 5 paroxysmal AF) with LAAO devices (nitinol cage, n = 10; nitinol plug, n = 8) and symptomatic LA tachyarrhythmias were included. Periprocedural and follow-up data were assessed. Results: A total of 20 LA CA procedures were performed at a median of 130 (63, 338) days after LAAO. The strategy of CA consisted of circumferential pulmonary vein isolation (n = 16), linear lesions (n = 14) and complex fractionated atrial electrogram ablation (n = 6). No major adverse events occurred periprocedurally. Repeated transesophageal echocardiography showed no device-related thrombus, newly developed peridevice leakage or device dislodgement. After a median follow-up period of 793 (376, 1090) days, four patients (22%) experienced LA tachyarrhythmias recurrence and two received redo LA CA. No patients suffered stroke or major bleeding events during follow-up. Conclusions: LA CA in patients with LAAO devices (either nitinol cages or nitinol plugs) seems to be safe and efficient in our single-center experience.

Periprocedural Outcomes Associated With Use of a Left Atrial Appendage Occlusion Device in China

Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation for patients with atrial fibrillation. However, the performance of LAAO among East Asian patients is unknown. To document the procedural success rate and configurations, major adverse event rates, and antithrombotic medication regimens during and after LAAO procedures among patients in China. In this cohort study, consecutive patients from 39 Chinese centers undergoing LAAO were prospectively enrolled between April 1, 2019, and October 31, 2020. Periprocedural and intraprocedural techniques and postprocedural medications were left to the surgeon's discretion. Data were analyzed from July 1 to November 1, 2021. LAAO for patients with atrial fibrillation. The main outcomes were procedural success and complication rates periprocedure and major adverse event rates of death, stroke, systemic embolism, and bleeding events at 30 days postprocedure; the composite end point of death, stroke, and systemic embolism was also analyzed. Unadjusted and multivariable-adjusted logistic regression analyses were performed to assess the associations of periprocedural techniques (types of anesthesia, intraprocedural imaging modalities, and combined ablation procedure) with 30-day adverse events. Among 3096 enrolled participants, 1782 participants (57.6%) were men, and the mean (SD) age was 69 (9) years. Participants had a high risk of stroke (mean [SD] cardiovascular risk score, 4.0 [1.8]) and a moderate-to-high risk of bleeding (mean [SD] bleeding risk score, 2.4 [1.2]). A total of 1287 procedures (41.6%) were performed under local anesthesia, while 493 procedures (15.9%) used only fluoroscopy guidance. In 1297 procedures (41.9%), LAAO implantation was combined with radiofrequency ablation or cryoablation for atrial fibrillation. Procedural success was achieved in 3032 patients (97.9%). At 30-day follow-up, the rate of the composite end point of death, stroke, or systemic embolism was 0.52% (95% CI, 0.32%-0.84%), and the rate of any life-threatening or major bleeding was 1.23% (95% CI, 0.90%-1.68%). No significant associations were observed between the procedural success or 30-day adverse events and the types of anesthesia (general or local), intraprocedural imaging (transesophageal echocardiography, fluoroscopy, or intracardiac echocardiography), or whether a combined ablation procedure was performed or not. In centers performing at least 40 procedures per year, compared with those performing fewer than 40 procedures per year, procedural success was significantly higher (adjusted odd ratio [aOR], 1.97; 95% CI, 1.01-3.53; P = .02) and risk of life-threatening or major bleeding was significantly lower (aOR, 0.42; 95% CI, 0.21-0.87; P = .02). These findings suggest that patients with a high risk of stroke and moderate to high risk of bleeding who underwent implantation of a LAAO device in Chinese centers had high rates of procedural success and low rates of short-term ischemic and bleeding events.

Association of heart failure with procedural complications and in-hospital outcomes from left atrial appendage occlusion device implantation in patients with atrial fibrillation: insights from the national inpatient sample of 62 980 procedures.

To determine outcomes in atrial fibrillation (AF) patients undergoing percutaneous left atrial appendage occlusion (LAAO) with concomitant heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF). Data were extracted from National Inpatient Sample for calendar years 2015-2019. LAAO device implantations were identified on the basis of ICD-10-CM code of 02L73DK. The outcomes assessed in our study included complications, in-patient mortality, and resource utilization. A total of 62 980 LAAO device implantations were studied. HFpEF (14.4%, n = 9040) and HFrEF (11.2%, n = 7100) were associated with a higher prevalence of major complications and in-patient mortality in crude analysis. In the multivariate model adjusted for potential confounders, HFpEF and HFrEF were not associated with major complications [adjusted odds ratio (aOR) 1.04, 95% confidence interval (CI) 0.93-1.16 and aOR 1.07, 95% CI 0.95-1.21] or in-patient mortality (aOR 1.48, 95% CI 0.85-2.55 and aOR 1.26, 95% CI 0.67-2.38). HFpEF and HFrEF were associated with prolonged length of stay (LOS) > 1 day (aOR 1.41, 95% CI 1.31-1.53 and aOR 1.66, 95% CI 1.53-1.80) and increased hospitalization costs > median cost 24 752$ (aOR 1.26, 95% CI 1.19-1.34 and aOR 1.21, 95% CI 1.13-1.29). The prevalence of HF in AF patients undergoing percutaneous LAAO was approximately 26%. HF was not independently associated with major complications and in-patient mortality but was associated with prolonged LOS and higher hospitalization costs.

P88 LEFT ATRIAL APPENDAGE CLOSURE DEVICE COMPLICATED BY LATE ONSET PERICARDIAL EFFUSION AND TAMPONADE: A CASE REPORT

Abstract Background Late onset complications of left atrial appendage occlusion (LAAO) device procedure are anecdotal and there are no such complications reported in literature using Cardia Ultraseal (Cardia, USA). Case Summary We report the case of a 74–year–old Caucasian man affected by paroxysmal atrial fibrillation with significant bleeding risk (familiar thrombocytopenia, macroscopic hematuria episodes during therapy with direct oral anticoagulants, HAS–BLED risk score: 4) and ischemic risk as well (CHADSVASC score: 3). The patient was treated with LAAO device implantation for high bleeding risk. Subsequently, after 26 days from LAAO procedure, he was admitted to the emergency department for hematic cardiac tamponade. The patient was successfully treated with subxyphoidal pericardiocentesis in the acute phase, unfortunately cardiac arrest occurred during the transfer to the referral hospital for urgent cardiac surgery. Permanent neurological damage was reported and the patient died on day 28. Discussion There are several clinical and radiological aspects that may suggest a cause–effect relationship with the occurrence of hematic pericardial effusion and LAA occlusion device implantation: firstly the pericardial effusion was hematic and its occurrence was preceded by acute interscapular pain suggesting an acute pericardial irritation caused by the hematic effusion and secondly, the CT scan played an “indirect key role” excluding several causes of hematic pericardial effusion (such as aortic dissection and solid tumors that could infiltrate the pericardial membrane), thirdly there are no other anamnestic events that may be associated with this clinical manifestation (such as trauma). The low flexibility of the Cardia Ultraseal (Cardia, Inc., Eagan, MN, USA) nitinol mesh structure, as previously reported in others settings, may be associated to increased torque of the device by the beating heart. A bench test showed that the Ultrasept, a large–mashed device for interatrial defect closure, very similar to Ultraseal, needs a high compression force during implantation as a result of its low radial strength. In addition, compared to other devices, the bulb part is much larger. Consequently, when the device is deeply inserted in LAA, a higher surface area within the appendage wall is directly overlapped, having more chance of causing friction.All these aspects could be responsible of wall erosion.

PO-671-07 SAFETY OF AMULET LAA OCCLUDER AND WATCHMAN DEVICE FOR LEFT ATRIAL APPENDAGE CLOSURE IN PATIENTS WITH ATRIAL FIBRILLATION

Left atrial appendage (LAA) closure is an alternative to chronic anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation. Multiple devices were used for LAA closure with Amplatzer Amulet LAA Occluder and Watchman Device being the most used in clinical practice. In August 2021, the FDA approved the use of the Amplatzer Amulet LAA Occluder. There is still a knowledge gap in in the safety profile of the Amplatzer Amulet LAA occluder device in comparison to Watchman device. The aim of this study was to assess and compare the safety profile peri-procedure and post-procedure between the Amplatzer Amulet LAA occluder and Watchman device. Patients who underwent LAA closure using Watchman or Amulet devices from July 2015 to August 2020 at the American University of Beirut Medical Center were included in the analysis. Primary endpoints included peri-operative and post procedural complications (thromboembolic events, bleeding complications, vascular access complications, pericardial effusion/tamponade, device positional complications and in-hospital death). The study included 37 patients (21 had Watchman devices, 16 had Amplatzer Amulet LAA occluder devices, 28 were men, mean age 76.57 +/- 9.3 years).Seven patients who developed post-procedural iatrogenic atrial septal defects (4 in the Watchman group vs 3 in the Amulet group, p-value= 0.982).Three patients developed pericardial effusion (1 in the Watchman vs 2 in the Amulet group, p- value = 0.394). Only one patient developed peri-device leak (1 in the Watchman group vs none in the Amulet group, p-value =0.283).One device could not be deployed (1 in the Amulet group vs none in the Watchman group, p-value= 0.191).None of the patients developed in-hospital death, cardiac tamponade, device embolism, device thrombosis, stroke/TIA, cranial bleeding, or arrhythmias after the procedure. The rate of peri-operative complications was similar between both groups.Both groups displayed low rates of adverse events in the peri-operative and post-operative period. There was no significant difference in the safety profile of Amplatzer Amulet LAA occluders and Watchman devices. There was a low incidence of peri-operative and post-operative adverse events with the implanted devices.

PO-614-05 A COMMUNITY HOSPITAL REVIEW OF WATCHMAN OUTCOMES TO DETERMINE SAFE DISCHARGE PROTOCOLS

Left atrial appendage occlusion (LAAO) devices are increasingly used to decrease the risk of stroke in atrial fibrillation patients with contraindication to oral anticoagulation. Discharge protocols after this procedure are variable, and same day discharge (SDD) may improve inpatient bed utilization.

True Efficacy of LAA Closure: Patient Outcomes on Long-term Single-Antiplatelet or No Therapy: Insights From the EWOLUTION Registry.

Left atrial appendage occlusion (LAAO) is recommended for patients with atrial fibrillation at increased stroke risk, where effective long-term oral anticoagulation (OAC) is not feasible. In order to assess long-term safety of LAAO with aspirin monotherapy or no therapy, we aimed to report on patients with the Watchman LAAO device (Boston Scientific) once postimplantation intensified antiplatelet or anticoagulation therapy is discontinued. A total of 1025 patients scheduled for elective LAAO therapy prospectively consented for participation in the EWOLUTION registry; 1005 patients received a successful implant and were followed for 2 years. We identified 766 patients in EWOLUTION on single-antiplatelet therapy (SAPT; n = 639) or no therapy (n = 127) for ≥1 year following LAAO. Three to 6 months after LAAO, 766 patients were switched to SAPT or no therapy and were followed for at least 1 year until the study's conclusion or with events while on SAPT/ no therapy; mean time on SAPT/no therapy was 536.56 ± 177.59 days. Patients experienced 1.4 ischemic strokes per 100 patient years (PY) despite a CHA2DS2-VASC score of 4.3 ± 1.6. Major nonprocedural bleeding rates were low, with 1.3 major bleeds per 100 PY with a mean HAS-BLED score of 2.2 ± 1.2. Furthermore, the ischemic stroke rate in the SAPT/no-therapy subgroup was similar to the whole EWOLUTION collective and high-risk subgroups; the bleeding rate was even lower. When analyzed separately, strokes (2.1/100 PY) and bleedings (1.4/100 PY) of the no-therapy subgroup were similar to patients on SAPT (strokes 0.7/100 PY [P=.70]; bleedings 1.4/100 PY [P=.90]). Outcome data of patients on SAPT/no therapy for ≥1 year following Watchman implantation in the EWOLUTION registry suggest the efficacy and safety of LAAO.

Risk of Stroke With Mitral Stenosis: The Underlying Mechanism, Treatment, and Prevention.

Mitral stenosis (MS), a valvular heart disease, is defined by the narrowing of the mitral valve orifice. The common risk factors for stroke include mitral annular calcification (MAC), diabetes mellitus (DM), male gender, hypertension (HTN), hyperlipidemia, and obesity. Endothelial damage, hypercoagulability, and blood stasis in the left atrium promote the development of the thrombus. Among all the risk factors described, MAC is the independent predictor of stroke. The complicated mechanisms responsible for thromboembolism, predisposing factors for thromboembolism, the risk of cerebrovascular accident (CVA) in MS patients, advanced standardized assessment models for identifying those at risk for stroke, and the possible advantages and disadvantages of available therapies have all been discussed in this review article. We have also discussed newer oral anticoagulants (NOACs) like dabigatran, edoxaban, apixaban, and rivaroxaban. Non-pharmacological therapies are also highlighted such as left atrial appendage ligation and occlusion devices. We also conducted a thorough review of the literature on the efficacy and safety of various NOACs in reducing the risk of stroke.