Left Atrial Appendage Occlusion Research Articles

The influence of epicardial adipose tissue on the prognosis of atrial fibrillation patients undergoing radiofrequency ablation combined with left atrial appendage occlusion.

Atrial fibrillation is the most common arrhythmia in adults. The interplay between epicardial adipose tissue and atrial fibrillation has garnered significant scientific interest. Recently, the combined approach of radiofrequency ablation and left atrial appendage occlusion has become a widely adopted strategy for managing non-valvular atrial fibrillation patients at high risk of thrombus formation. This study aims to assess the prognostic significance of epicardial adipose tissue volume in patients undergoing radiofrequency ablation in conjunction with left atrial appendage occlusion. This study results indicate that in patients undergoing the one-stop procedure, which comprises catheter radiofrequency ablation and percutaneous left atrial appendage occlusion, epicardial adipose tissue volume is significantly associated with AF recurrence post-strategy. Higher EATV predicts AF recurrence (HR = 1.17, 95%CI1.047-1.192, P = 0.001) and thromboembolism (P = 0.002) following the one-stop procedure. Epicardial adipose tissue volume serves as a significant predictor of atrial fibrillation recurrence following the one-stop procedure (area under the curve 0.648, 95%CI0.571-0.725, P = 0.002, sensitivity 0.88, specificity 0.50).

Intracerebral haemorrhage - mechanisms, diagnosis and prospects for treatment and prevention.

Intracerebral haemorrhage (ICH) is a devastating condition associated with high mortality and substantial residual disability among survivors. Effective treatments for the acute stages of ICH are limited. However, promising findings from randomized trials of therapeutic strategies, including acute care bundles that target anticoagulation therapies, blood pressure control and other physiological parameters, and trials of minimally invasive neurosurgical procedures have led to renewed optimism that patient outcomes can be improved. Currently ongoing areas of research for acute treatment include anti-inflammatory and haemostatic treatments. The implementation of effective secondary prevention strategies requires an understanding of the aetiology of ICH, which involves vascular and brain parenchymal imaging; the use of neuroimaging markers of cerebral small vessel disease improves classification with prognostic relevance. Other data underline the importance of preventing not only recurrent ICH but also ischaemic stroke and cardiovascular events in survivors of ICH. Ongoing and planned randomized controlled trials will assess the efficacy of prevention strategies, including antiplatelet agents, oral anticoagulants or left atrial appendage occlusion (in patients with concomitant atrial fibrillation), and optimal management of long-term blood pressure and statin use. Together, these advances herald a new era of improved understanding and effective interventions to reduce the burden of ICH.

Abstract 4138212: Efficacy of Left Atrial Appendage Occlusion in Reducing Mortality and Major Bleeding Events in Cancer Patients with Atrial Fibrillation

Introduction: Atrial fibrillation (AF) is a common comorbidity in cancer patients, increasing their risk of stroke and mortality. Cancer patients are often excluded from anticoagulation and AF intervention trials due to the nature of their disease, and risk scores such as HAS-BLED, CHADS2/CHADS2-VASc often underpredict the high risk of AF and related complications for these patients. Research Question: Does left atrial appendage occlusion (LAAO) reduce mortality, major bleeding events (MBE), and stroke in cancer patients with AF? Methods: Using TriNetX, an international health research network with data from over 100 million patients, cancer patients with AF, with and without LAAO were identified between 2015 and 2022. Equal cohorts of 147 patients were created after propensity score matching for demographics, diabetes, hypertension, and heart failure. Measures of Association and Survival Analysis were conducted between 3-months and 5-years. The primary outcome was mortality. The secondary outcomes were MBE and stroke. Results: The study included 294 cancer patients with AF, with 147 having received LAAO. The risk of mortality at 3 months was 6.8% in the LAAO+ group compared to 15% in the LAAO- group (p-value= 0.025). At 6 months, the mortality risk was 8.8% in the LAAO+ group and 18.4% in the LAAO- group (p-value= 0.017). At 1 year, the mortality risk was 12.2% in the LAAO+ group and 23.8% in the LAAO- group (p-value=0.010). At 5 years, the mortality risk was 28.6% in the LAAO+ group and 49.7% in the LAAO- group (p-value<0.0001). The MBE risk was 20.4% for the LAAO+ group and 32% for the LAAO- group at 3 months (p-value= 0.024). At 6 months, the MBE risk was 25.9% in the LAAO+ group and 40.1% in the LAAO- group (p-value=0.009). Although there was no significant difference in risk of MBE at 1 year and 5 years, survival was higher among the LAAO+ group than the LAAO- group (64.92% vs 52.76%; p-value= 0.038 at 1 year and 52.67% vs 39.23%; p-value=0.029 at 5 years). However, there was no difference between stroke risk or survival probability across all measured time points. Conclusion: LAAO in cancer patients with AF was associated with significantly reduced mortality and major bleeding events over a 5-year period compared to those without LAAO. These findings suggest that LAAO may be a beneficial intervention for improving survival and reducing bleeding complications in cancer patients with AF.

Abstract 4135286: Comparative Efficacy of Intracardiac and Transesophageal Echocardiography in Left Atrial Appendage Occlusion: A Meta-Analysis of Clinical Outcomes

Background: Left atrial appendage occlusion (LAAO) is essential for stroke prevention in patients with non-valvular atrial fibrillation where anticoagulation is contraindicated. Intracardiac Echocardiography (ICE) has been proven effective and safe for LAAO since 2011, yet adoption rates remain low, with only 2.2% of LAAOs guided by ICE between 2015 and 2019. Transesophageal Echocardiography (TEE), the current gold standard, and ICE differ significantly in operational dynamics and patient impacts, influencing procedural outcomes. Objective: This study aims to compare the efficacy and safety of ICE and TEE in facilitating LAAO, offering insights into their comparative clinical use. Methods: A systematic review and meta-analysis were conducted according to PRISMA guidelines. Searches were performed in MEDLINE/PubMed, OVID, and Scopus through December 2023, comparing ICE and TEE in LAAO. Inclusion criteria centered on studies reporting technical success, with secondary outcomes including length of stay (LOS), mortality, and adverse outcomes such as stroke, transient ischemic attacks (TIA), pericardial effusion, cardiac tamponade, device thrombosis, device embolization, and peri-device leaks. Data synthesis employed statistical methods utilizing R Studio. Results: Fourteen studies involving 4184 patients were included. The meta-analysis revealed no significant differences in technical success (OR 1.34, 95% CI: [0.76, 2.36]), LOS (OR 1.66, 95% CI: [0.80, 3.42]), or mortality (OR = 1.00, 95% CI: [0.50, 2.00]) between ICE and TEE. Similarly, non-significant differences were noted in stroke, TIA, pericardial effusion, and device leaks, with minimal heterogeneity (I 2 = 0%). Conclusion: ICE and TEE provide comparable clinical outcomes in LAAO, with no significant efficacy or safety differences. These results suggest that the choice between ICE and TEE should be based on procedural convenience, patient anatomy, and resource availability, rather than clinical outcomes alone. The equivalence in performance between these modalities allows for flexibility in clinical practice, ensuring that patient care can be customized to individual needs without compromising safety or effectiveness.

Abstract 4138242: Association of chronic kidney disease (CKD) and end-stage renal disease (ESRD) with procedural complications and in-hospital outcomes from left atrial appendage occlusion (LAAO) device implantation in elderly (>80 yrs) patients with atrial fibrillation (AF)

Background: LAAO has been used as an alternative strategy for stroke prevention in selected patients with AF, however there is very limited data about the outcomes in elderly patients with kidney disease. Methods: The National Inpatient Sample was queried for LAAO in the US between 2015–2020. Hospital outcomes were assessed for elderly patients undergoing LAAO in three cohorts; no CKD, CKD and ESRD. Results: A total of 31,360 elderly patients undergoing LAAO were identified in the study period; 23,250 (74.1%) had no CKD, 7,610 (24.2%) had CKD, and 500 (1.5%) had ESRD. CKD and ESRD were independently associated with higher odds of in-hospital mortality [aOR 3.06, 95 % CI (1.805-5.207), p <0.001)] & [ aOR 9.69 ,95% CI (3.52-26.64), p <0.001], cardiovascular complications [ aOR 1.43 ,95% CI (1.208-1.696), p <0.001] &[ aOR 3.41 ,95% CI (2.12-5.48), p <0.001], p <0.001], neurological complications [aOR 1.2 ,95% CI (1.05-1.36), p=0.006] &[aOR 1.58 ,95% CI (1.07-2.33), p=0.019], gastrointestinal and hematological complications [aOR 1.22 ,95% CI (1.06-1.39), p=0.003] &[ aOR 1.71 ,95% CI (1.16-2.52), p <0.001] respectively when compared to patients with no CKD. CKD was independently associated with higher odds of renal complications compared to patients with no CKD [aOR 5.34 ,95% CI (4.532-6.303), p <0.001]. In comparison to patients with ESRD, patients with CKD had significantly higher odds of renal complications [aOR 8.01 ,95% CI (3.28-19.57), p <0.001] with no significant difference in the odds of in-hospital mortality [aOR 0.4 ,95% CI (0.14-1.12), p=0.08]. In terms of resource utilization, length of stay didn’t differ with different kidney functions (1(1-1) for the three cohorts). However the ESRD cohort had the highest hospitalization costs compared to the CKD and no CKD cohorts ($26.113 ($19.728 -$34.362) vs. $25.799 ($20.231-$32.943) vs. $24.894 ($19.641-$31.373), p <0.001). Conclusion: The prevalence of CKD and ESRD was around 25.7% in elderly patients with AF undergoing LAOO. CKD and ESRD were independently associated with higher odds of in-hospital mortality compared to patients with no CKD while CKD was independently associated with higher odds of renal complications after LAAO.

Abstract 4119094: Claims-Based versus Registry-Reported Stroke Events in the NCDR Left Atrial Appendage Occlusion Registry

Background: Administrative claims data are increasingly used for post-marketing surveillance of drugs and medical devices, though data reliability remains uncertain. Given their associated morbidity and mortality, stroke events are particularly important to monitor for cardiovascular therapies such as transcatheter left atrial appendage occlusion (LAAO). However, there are limited data comparing stroke events in contemporary claims data to events reported in large nationwide registries with comprehensive data collection. Aim: To compare stroke events in Medicare claims data with adjudicated registry-reported events in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry. Methods: LAAO Registry data were linked with 2016-2022 Medicare inpatient claims. Primary diagnosis ICD-10 codes from inpatient hospitalizations were compared to adjudicated registry-reported ischemic and hemorrhagic stroke events occurring after discharge with up to two years of follow-up. In multiple secondary analyses, primary and secondary diagnosis codes were counted as events in claims data and patients with prior history of stroke were also excluded. Results: The cohort included 71,043 adults ≥65 years old in the LAAO Registry with inpatient Medicare data. Following LAAO hospitalization discharge, there were 1405 claims-based and 1308 registry-reported total stroke events. Sensitivity and positive predictive value (PPV) of claims for identifying registry-reported events were 60.8% and 50.5% for ischemic stroke (kappa statistic 0.55), 42.7% and 50.5% for hemorrhagic stroke (kappa 0.46), and 58.1% and 54.1% for all stroke (kappa 0.55), respectively. Inclusion of secondary diagnosis codes improved sensitivity of claims (70.3% for ischemic stroke, 53.9% for hemorrhagic stroke and 67.0% for all stroke), but PPV decreased (44.8% for ischemic stroke, 34.8% for hemorrhagic stroke and 47.8% for all stroke). Specificity and negative predictive values of claims data were >98% for all stroke types. Findings were similar after excluding patients with prior history of stroke ( Table ). Conclusions: Among Medicare patients in the LAAO Registry, administrative claims data had moderate agreement with adjudicated registry-reported stroke events. Claims data may not reliably capture all stroke events in real-world practice, and additional event ascertainment methods may be needed to ensure accurate assessment of stroke in post-marketing surveillance efforts.

Abstract 4131630: Comparative Outcomes of Left Atrial Appendage Occlusion Device Implantation in Atrial Fibrillation Patients with a Lower Stroke Risk

Introduction: Current guidelines recommend oral anticoagulation in atrial fibrillation (AF) patients with a CHA 2 DS 2 -VASc score ≥ 2 for stroke prevention. Left atrial appendage occlusion (LAAO) devices serve as alternatives to reduce stroke risk in select AF patients that are unable to tolerate long-term oral anticoagulation. However, Centers for Medicare&Medicaid Services reimburses left atrial appendage occlusion (LAAO) for patients with CHA 2 DS 2 -VASc score ≥ 3. Objective: To evaluate differences in outcomes and complications of LAAO therapy in AF patients with a CHA 2 DS 2 -VASc score of ≥ 3 versus < 3. Methods: National Inpatient Sample and International Classification of Diseases, 10th Revision codes were used to identify AF patients who underwent LAAO device implantation in the U.S. from 2016−2020. The study population was stratified by stroke risk into two groups, CHA 2 DS 2 -VASc ≥ 3 and < 3. Study endpoints assessed included procedural complications, inpatient outcomes and resource utilization. A multivariable logistic regression model was used to assess the independent association of CHA 2 DS 2 -VASc score with study outcomes. Results: A total of 73,795 and 15,500 LAAO devices were implanted in patients with CHA 2 DS 2 -VASc ≥ 3 and < 3, respectively. Compared to patients with CHA 2 DS 2 -VASc score of ≥ 3, patients with CHA 2 DS 2 -VASc < 3 had lower overall (6.9% vs 9.9%, P< 0.01) and major (4.5% vs 6.2%, P< 0.01) complications in the crude analysis. After multivariable adjustment for potential confounders, CHA 2 DS 2 -VASc < 3 was associated with lower overall complications (aOR 0.84, 95% CI 0.78 – 0.91), major complications (aOR 0.90, 95% CI 0.81-0.99) and cost of hospitalization (aOR 0.95, 95% CI 0.91-0.99). Conclusions: Patients with CHA 2 DS 2 -VASc < 3 had lower complications and hospitalization costs after LAAO device implantation than patients with CHA 2 DS 2 -VASc ≥ 3 . These data, if redemonstrated in a large randomized trial can have important clinical implications for stroke prevention in AF patients.

Abstract 4141461: Zonal Coating Application System for Left Atrial Appendage Occlusion Devices: A Novel Approach to Reduce Peri-Device Leakage and Device Related Thrombus.

Introduction: Left atrial appendage occlusion (LAAO) is an effective method of stroke prevention in patients with atrial fibrillation (AF). However, peri-device leakage (PDL) and device related thrombus (DRT) are common limitations of LAAO. Notably, PDL is associated with an increased risk of thromboembolic events. In order to minimize DRT, the Watchman FLX Pro is coated with PVDF-HFP. We aim to minimize both DRT and PDL with our novel zonal coating application system (ZCAS). ZCAS integrates a two-part thromboresistant and endothelialization promoting coating onto LAAO devices (Figure 1). In order to determine the optimal coating for the endothelialization promoting zone of ZCAS, we validated coating candidates in an in vitro model of LAAO device endothelialization (Figure 2). Hypothesis: We hypothesized that polyethylene terephthalate (PET) mesh coated with collagen type IV, fibronectin + VEGF, or poly-L-lysine would improve endothelial cell viability and proliferation. Methods: Human umbilical vein endothelial cells (HUVEC) were cultured in DMEM/F12 supplemented with ATCC’s Endothelial Cell Growth Kit and antibiotics. For the cell viability and proliferation assay, HUVEC cells were cultured in DMEM/F12 supplemented with 2% FBS, 10 mM L-glutamine, and antibiotics. A 96 well plate with PET inserts was coated with three coating candidates. Each coating was applied in three concentrations ([1x], [10x], and [100x]) with triplicates for each concentration. The coatings included collagen type IV ([1x]: 1 ug/cm2), fibronectin ([1x]: 1 ug/cm2) + VEGF ([1x]: 10 ng/cm2), and poly-L-lysine ([1x]: 4 ug/cm2). An MTS assay was performed at 48 hours after plating to assess cell viability and proliferation. Results: MTS absorbance relative to the uncoated control (MTS absorbance coated well/MTS absorbance uncoated well) for collagen type IV at [1x], [10x], and [100x] was 0.81, 1.29, and 0.84 respectively (Table 1). Fibronectin + VEGF at [1x], [10x], and [100x] was 1.31, 1.62, and 0.96. Finally, poly-L-lysine at [1x], [10x], and [100x] was 0.69, 0.90, and 0.91 respectively. Conclusion(s): Among the coating candidates, fibronectin (1 ug/cm2) + VEGF (100 ng/cm2) had the greatest increase in cell viability and proliferation compared to the uncoated PET control. The significance of this finding lies in the potential for ZCAS to improve the endothelial seal between the LAAO device and LAA orifice, which may significantly reduce PDL post-implantation.

Abstract 4129839: Successful Left Atrial Appendage Occlusion (LAAO) with WATCHMAN FLX via Transhepatic Approach

Left atrial appendage occlusion (LAAO) with the WATCHMAN FLX (Boston Scientific) has been proven to reduce stroke risk in patients with paroxysmal atrial fibrillation (PAF). Certain circumstances may preclude LAAO1. In this case, transhepatic vein access was used to successfully deploy a WATCHMAN FLX in a 72 year old male with PAF not on anticoagulation due to recent subdural hemorrhage and recurrent bilateral lower extremity deep venous thrombosis (DVT) post IVC filter placement. Recent attempt at LAAO was unsuccessful due to total occlusion of bilateral femoral veins (Figure 1 A-B) and inability to cross the IVC. Access to the inferior branch of the right hepatic vein was achieved by micropuncture technique at the right mid-axillary line at the level of the 12th rib, which was confirmed by venogram (Figure 2A). The 4F microsheath was upsized to 16F. Intraoperative TEE was used for device sizing and delivery (Figure 3A). The transseptal sheath and dilator were positioned in the right atrium at the level of the fossa ovalis (Figure 3B) before successfully crossing into the left atrium (Figure 2B). After confirming placement (Figure 3C), a pigtail catheter was positioned within the LAA (Figure 3D) and an angiogram was performed (Figure 2C). A 24 mm WATCHMAN FLX was partially unsheathed and positioned (Figure 3E). Repeat LAA angiogram was performed through the WATCHMAN delivery sheath (Figure 2D). A Tug test was performed. The device was released (Figure 3F). Repeat venogram was performed to confirm location (Figure 2E) of the access site, and coil embolization closure of the venotomy access site was performed (Figure 2F). The patient was discharged the following day on dual antiplatelet (aspirin, clopidogrel) without complication. Venous access via right hepatic vein is a viable option for LAAO using the WATCHMAN FLX device.

Abstract 4137278: Efficacy and Safety of Left Atrial Appendage Closure Devices in Patients Aged Above 80 Years: A Systematic Review and Meta-Analysis

Background: Limited single-center and observational studies suggest that left atrial appendage occlusion (LAAO) may be a safe alternative in selected elderly patients with AFib. Hypothesis: We hypothesize that patients aged over 80 will have similar rates of complications and the same level of efficacy in stroke prevention as young patients. Aims: This review aims to establish the safety and efficacy of LAAO in octogenarians and nonagenarian patients with AFib. Methods: A systematic search of PubMed, Science Direct, and CENTRAL was performed for studies that reported outcomes comparing octogenarian and nonagenarian patients who underwent LAAo with their younger counterparts. The Review Manager 5.4 software was utilized to conduct a meta-analysis of the outcomes. Results: Seven observational studies consisting of 6,126 patients were included, of whom 1,879 (31%) were ≥80 years old and 4247 (69%) <80 years old. The mean age of the octogenarian and older cohort ranged from 82.3 to 84.5 years, while that of the younger cohort ranged from 68.2 to 75.9 years. The mean follow-up across the studies ranged from one month to five years post-LAAO. Our pooled analysis showed no significant difference in the odds of mortality (OR 1.30; 95% CI [0.49, 3.47]; p = 0.60), all causes of stroke (OR 1.22; 95% CI [0.61, 2.43]; p= 0.57), vascular complications (OR 1.70; 95% CI [0.61,4.73]; p=0.31), and pericardial complications (OR 1.45; 95% CI [0.69, 3.05]; p = 0.33) but a significant difference in the odds of major bleeding events (OR 1.88; 95% CI [1.51, 2.34]; p<0.00001)occurred in patients aged >80 compared to their younger counterparts. Conclusion: This meta-analysis suggests that LAAO in patients aged 80 years and above demonstrates comparable mortality rates, post-procedural complications, and efficacy to those seen in younger patients. The findings support the safety and effectiveness of LAAO as a viable alternative for stroke prevention in very elderly patients, with additional consideration needed for those with increased susceptibility to bleeding events.

Abstract 4135279: The Watchman Device needs to be Watched: A Case of Device Related Thrombus

Introduction: Left atrial appendage (LAA) harbors approximately 90% of thrombi in non-valvular atrial fibrillation (AF) for which an anticoagulant (AC) is indicated to prevent cardio-embolic stroke. Alternatively, the benefits of LAA occlusion (LAAO) devices to those patients who encounter life-threating bleeding with AC are also well established. However, the LAAO device comes with the risk of device related thrombus (DRT), which is a real challenge. Case: A 68 year-old-male with history of chronic AF on apixaban and recurrent ischemic and hemorrhagic stroke was evaluated for LAAO device placement procedure. Initially, when the patient was not taking AC, he had an ischemic stroke likely cardio-embolic source, which necessitated the initiation of apixaban. Unfortunately, while he was taking apixaban, he had a right thalamic bleed causing persistent left sided paresis. Subsequently, AC was held for 6 months and he underwent watchman device placement. He remained on apixaban for 45 days post procedure and was continued on aspirin only. After 10 months, on routine cardiac computerized tomographic arteriography (CTA), a large filling defect measuring 1.7 x 1.4 cm on the left atrial side of the watchman device was seen (Figure 1A) which was confirmed with transesophageal echocardiogram. Then, he was re-started on apixaban for a short period of time, which culminated him to have a right temporal bleed. After holding AC for 3 months, repeat CTA showed persistent filling defect suggestive of DRT (Figure 1B). Therefore, AC was permanently discontinued and patient was evaluated for DRT removal procedure. Utilizing a shared decision model, the option of mechanical thrombectomy with cerebral protection device (CPD) was chosen to mitigate the risk of embolic stroke. Post procedure, he was continued on apixaban 2.5 mg twice daily for 3 months and then aspirin forever. Subsequent surveillance CTA did not show DRT (Figures 1C and D). Patient has remained asymptomatic thereafter. Conclusion: 3-7% of patients with Watchman device suffer from DRT. Life threatening bleeding from AC further complicates the management of such patients. Mechanical thrombectomy with CPD is an established procedure for the removal of intra-arterial or intravenous thrombus. However, the feasibility of the routine use of mechanical thrombectomy with CPD for persistent DRT in-patient like ours is yet to be studied in detail.

Abstract 4143224: Feasibility of Left Atrial Appendage Occlusion with Dual-Seal Technology without Pre-Procedural CT: Early Single-Center Experience

Background: Left Atrial Appendage (LAA) Occlusion with Amulet has shown promising results in achieving complete closure with minimal periprocedural leak. Amulet’s dual-sealed technology and numerous sizing options provide versatility for different LAA morphologies. Pre-procedural CT is routinely recommended for pre-procedural planning. However, this brings risks including use of contrast, risk of renal failure, radiation exposure, and patient inconvenience. Here, we share initial results of our Amulet implantation protocol without pre-procedural CT: 83 cases were reviewed; number of devices used, procedural time, periprocedural bleeding complications, success in coming off oral anticoagulation, and incidences of stroke and embolism were followed. Methods: We followed 83 AF patients who underwent LAA closure with Amulet, implanted with intraprocedural TEE, intracardiac left atrial echocardiography, and intraprocedural angiography. Pre-procedural CT was not used. Patients were followed to assess safety and efficacy of this protocol. Safety endpoints included rates of procedural and bleeding complications. Efficacy endpoints included rates of stroke and embolism, and number of devices used. Results: All 83 procedures were successfully completed with no perioperative procedural complications and no documented leaks on follow-up TEE. Patients had early ambulation with closure. On average, 1.14 devices were used per case: 88% of cases required 1 device, and nine cases required 2 devices; one case required 4 devices to fit as patient was noted to have an interrupted IVC, requiring implantation via right IJV. There were no cases of stroke or embolism following implantation, and all patients were safely able to come off oral anticoagulation. Conclusions: Results demonstrate that Amulet with its dual-sealed technology can be effectively and safely implanted without pre-procedural CT. No perioperative complications were observed. 88% of cases closed with single device usage. No post-procedure leaks were noted on follow-up TEE. Safety endpoints revealed minimal adverse events, with 2 cases of late pericardial effusion managed without long-term consequences. This protocol demonstrated high efficacy, as all patients were successfully able to come off oral anticoagulation with no reported strokes or embolic events. Intraprocedural TEE, intracardiac left atrial echocardiography, and intraprocedural angiography are typically appropriate for periprocedural sizing of the device.

Abstract 4122080: Outcomes of Left Atrial Appendage Occlusion With and Without Concurrent Catheter Ablation for Patients at High Bleeding Risk: A Systematic Review and Meta-analysis

Introduction: The prevalence of non-valvular atrial fibrillation (NVAF) and stroke-related morbidity is rising. First-line therapy remains rate or rhythm control with anticoagulation, with catheter ablation (CA) also considered in suitable candidates. Left atrial appendage closure (LAAC) is increasingly used due to mounting evidence of non-inferiority compared to anticoagulation. Despite improved pre-procedural planning and patient selection reducing complications, adverse outcomes such as pericardial effusion and device-related thrombus occur in about 5% of patients. This study evaluates the outcomes of LAAC with CA versus standalone LAAC in NVAF patients with contraindications to anticoagulation. Methods: We searched PubMed, EMBASE, and Cochrane databases for all cohort studies comparing LAAC with CA to LAAC alone in patients with NVAF. Case series, reviews, and non-English language studies were excluded. The assessed outcomes included device compression rate at implant, device-related thrombosis, pericardial effusion, need for pericardiocentesis, and peri-device leak at 6 weeks. Statistical analysis was performed using Review Manager 5.1.7. Heterogeneity was assessed with I 2 statistics. Results: We included 6 studies with 51,545 patients, of whom 1,221 (2.3%) underwent both procedures. LAAC with CA and standalone LAAC cohorts had similar baseline demographics including age (68, 69 years), percentage of women (48%, 46%), CHA2DS2-VASc score (3.6, 3.7), and HAS-BLED score (3.1, 3.2). LAAC with CA was associated with a reduced incidence of device-related thrombosis (OR=0.18; 95% CI= 0.04-0.89; p=0.04) without an increase in pericardial effusion rates (OR=0.85; 95% CI= 0.48-1.51; p=0.59). There were no significant differences in device compression rates at implant (MD=0.34; 95% CI= -0.77-1.45; p=0.55), the need for pericardiocentesis (OR=1.01; 95% CI= 0.30-3.48; p=0.98), or rates of peri-device leak at 6 weeks (OR=0.61; 95% CI= 0.21-1.78; p=0.37). Conclusion: Concomitant LAAC with CA may reduce rates of device-related thrombosis compared to standalone LAAC without increasing the risk of pericardial effusion or peri-device leak at 6 weeks. These findings support the consideration of combining these procedures in the management of high-risk NVAF patients unable to tolerate anticoagulation.

Abstract 4119189: Imaging practices prior to cardioversion in patients presenting post percutaneous left atrial appendage occlusion.

Background: Direct current cardioversion (DCCV) carries a risk for stroke in AF patients, for that reason there are guidelines for mitigating this risk in AF patients on oral anticoagulation (OAC). Meanwhile, no consensus on the best approach for cardioverting patients with an appendage occlusion device in situ. This led to a very wide variation in pre and post DCCV practices in these patients. Aims: We aim to explore different factors that might be associated with the variation seen in pre-DCCV imaging practices in patients presenting post- percutaneous LAAO. Methods: This was a multi-center retrospective cohort study of patients who received DCCV for AF or AFL during follow up after LAAO procedure within a single healthcare system from 2016-2024. Results: A total of 119 patients were included, there were more females 70 (59%), with more than half (64 (54%)) receiving a first-generation WATCHMAN™ 2.5, while the rest had WATCHMAN FLX™. Median age at presentation was 77 years (72,82), BMI of 31 kg/m 2 (26,37), average CHADSVASC score of 4.5 and HASBLED score of 3. A median duration of 10 months (3,21) between LAAO to presentation for DCCV . Forty-four (37%) patients had pre-DCCV imaging (imaging cohort). Number of males was significantly higher in the imaging cohort (24 (54.5%) vs 25 (33.3%), p=0.038), compared to those without imaging. There was a significant difference (p<0.001) between the two cohorts in the location (center) where DCCV was done. The site with the highest number of pre-DCCV imaging cases had an equal gender ratio of patients presenting for DCCV. Patients who received imaging presented earlier (11.2 months vs 15.8 months, p=0.068) compared to those without imaging, though the difference was not significant. Between the two groups, there was no significant difference in OAC (VKA-antagonist/DOAC) usage prior to presentation (8 (18.6%) vs 12 (16.4%), P=0.9). There was no significant difference in baseline CHADSVASC score, HASBLED score, age, LVEF. Higher percentage of patients were discharged on OAC post DCCV in the imaging arm (13 (30.2%) vs 14 (19.4%), p=0.27), but the difference was non-significant. No Device related thrombus nor significant PDL was detected on imaging. Conclusion: There was male preference in providing pre-DCCV imaging for ruling out DRT. Location of care was also associated with the variation in pre-DCCV protocols. Additional research is needed to understand other factors associated with variation seen in pre-DCCV practices.

Strategy Optimization for a Combined Procedure in Patients With Atrial Fibrillation: The COMBINATION Randomized Clinical Trial.

The optimal strategy of combining left atrial appendage occlusion (LAAO) with catheter ablation (CA) in patients with atrial fibrillation (AF) during a single procedure remains unclear. To determine the effects of ablation-first vs occlusion-first strategies on long-term clinical outcomes among patients with atrial fibrillation undergoing a combined LAAO and CA procedure. The prospective, multicenter COMBINATION randomized clinical trial was conducted in 14 high-volume centers in China. Enrollment of patients with nonvalvular AF referred for the combined procedure began on July 24, 2020, and concluded on January 20, 2022. Patients were randomly assigned to either the ablation-first group or the occlusion-first group. Outcomes of LAAO using an occlusion device and CA using a contact force-sensing catheter following different combination strategies during long-term follow-up were evaluated. The primary end point was a composite of thromboembolic events including stroke or transient ischemic attack, device-related thrombus (DRT), clinically relevant bleeding, and cardiovascular rehospitalization or death. Freedom from AF or atrial tachyarrhythmia (ATA) after a single procedure without antiarrhythmic drugs, at both 1 year and long-term follow-up, was also evaluated. Of the 202 patients enrolled, 194 (96.0%) completed the trial (97 in the ablation-first group and 97 in the occlusion-first group). The mean (SD) age of the cohort was 67.3 (9.2) years, and 110 patients (56.7%) were male. All procedures achieved acute successful LAAO and restoration of sinus rhythm, with similar incidences of periprocedural complications. Compared with the ablation-first group, the occlusion-first group exhibited significantly higher event-free survival of the primary end point (83.5% vs 71.1%; hazard ratio [HR], 0.53 [95% CI, 0.29-0.95]; log-rank P = .04) during the median 2.5 (IQR, 2.3-2.8) years of follow-up. Subgroup analysis indicated that male patients and those with higher CHA2DS2-VASc scores (a composite of factors associated with stroke risk; higher scores indicate higher risk) were at lower risk of thromboembolic events. Rates of long-term freedom from AF (77.3% vs 63.5%; HR, 0.58 [95% CI, 0.34-0.97]; log-rank P = .04) and from ATA (70.1% vs 55.7%; HR, 0.62 [95% CI, 0.39-0.99]; log-rank P = .04) were higher in the occlusion-first group vs the ablation-first group. Additionally, a higher incidence of chronic peridevice leak (15 [15.5%] vs 5 [5.2%]; P = .03) and DRT (8 [8.2%] vs 1 [1.0%]; P = .04) was observed in the ablation-first group vs the occlusion-first group. In this randomized clinical trial, the occlusion-first approach was superior due to its higher event-free survival of the primary end point and long-term freedom from ATA. These findings suggest that the occlusion-first approach should be recommended for combined procedures with plug-like device implantation. Chinese Clinical Trial Registry Identifier: ChiCTR2000031486.

Combined left atrial appendage occlusion and catheter ablation for atrial fibrillation versus isolated left atrial appendage occlusion: A systematic review and meta-analysis.

Data on the effects of combined left atrial appendage occlusion (LAAO) and catheter ablation (CA) for atrial fibrillation (AF) remain limited. We aimed to perform a systematic review and meta-analysis comparing LAAO and CA versus isolated LAAO. We systematically searched PubMed, Embase, and Cochrane Library for studies comparing combined LAAO and CA versus isolated LAAO in patients with atrial fibrillation. Statistical analyses were performed using R software version 4.3.1. We pooled odds ratios (OR) with 95% confidence intervals (CI) for binary outcomes. We included eight studies comprising 51,802 patients, of whom 1375 (2.6%) underwent combined LAAO and CA. There were no significant differences between combined LAAO and CA versus isolated LAAO in terms of major bleeding (OR 0.55; 95% CI 0.09, 3.41; p=0.52; I2=0%), major adverse cardiovascular events (OR 0.88; 95% CI 0.40, 1.93; p=0.74; I2=0%), stroke (OR 1.03; 95% CI 0.35, 3.00; p=0.96; I2=0%), thromboembolism (OR 0.60; 95% CI 0.18, 1.98; p=0.40; I2=0%), minor bleeding (OR 1.32; 95% CI 0.63, 2.80; p=0.46; I2=0%), or pericardial effusion (OR 1.18; 95% CI 0.60, 2.33; p=0.63; I2=24%). In this meta-analysis of observational studies, combined LAAO and CA for AF was similar to isolated LAAO in terms of efficacy and safety. Further large randomized controlled trials are needed to explore the long-term effects of combining these procedures.

Association of Chronic Kidney Disease and Kidney Failure with Replacement Therapy with Procedural and Long-Term Outcomes after First Generation Watchman Device: Insights from the NCDR LAAO Registry

BackgroundChronic kidney disease (CKD) and kidney failure with replacement therapy (KFRT) are prevalent in patients with atrial fibrillation (AF). ObjectiveTo analyze procedural and long-term outcomes in AF patients with underlying CKD and KFRT after left atrial appendage occlusion (LAAO) device implantation. MethodsData were extracted from the National Cardiovascular Data Registry LAAO Registry from January 2017 to December 2019 and linked to Centers for Medicare & Medicaid Services billing claims. Patients were stratified into three groups: no CKD, CKD, and KFRT. Multivariate analyses were utilized to assess the associations of CKD and KFRT with procedural and long-term outcomes, respectively. ResultsA total of 59,190 patients were enrolled in our study. CKD and KFRT were found to be independently associated with any complication from the procedure (OR 1.149, 95% CI 1.058-1.247 and OR 2.163, 95% CI 1.763-2.652) and in-hospital death (OR 1.603, 95% CI 1.054-2.437 and OR 5.488, 95% CI 2.686-11.213). At 1-year, CKD and KFRT were associated with a higher risk of any major adverse event (HR 1.402, 95% CI 1.333-1.474 and HR 2.506, 95% CI 2.236-2.809) and death (HR 1.662, 95% CI 1.553-1.779 and HR 3.422, 95% CI 2.989-3.919), but no difference in the competing risk of stroke (HR 0.972, 95% CI 0.819-1.152 and HR 0.794, 95% CI 0.434-1.451). ConclusionCKD and KFRT were associated with higher rates of procedural complications and 1-year adverse events and death, but no difference in the 1-year rate of stroke.

Morphology and Function Assessment of Left Atrial Appendage in Patients With Atrial Fibrillation.

Atrial fibrillation (AF) is among the most prevalent forms of clinically significant arrhythmia, and stroke incidence is among the most serious AF-related complications, causing high rates of morbidity and mortality among affected patients. The European Society of Cardiology guidelines recommend a thromboembolic event risk assessment based on the CHA2DS2-VASC score. However, stroke also occurs in some patients with a low CHA2DS2-VASC score. Therefore, it is necessary to improve thromboembolic risk stratification in AF patients. The left atrial appendage (LAA) is considered to be the most frequent site of thrombus formation. Approximately 47% of thrombi in valvular AF and 91% of thrombi in nonvalvular AF are localized in the LAA. Therefore, identification or exclusion of LAA thrombi is critical in many clinical situations. It is essential to assess LAA morphology and function using imaging modalities (particularly echocardiography) before, during, and after interventional procedures such as AF ablation and LAA occlusion. This review article describes the anatomical, physiological, and LAA assessment in daily practice.

5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

Incidence and predictors of 2-year mortality following percutaneous left atrial appendage occlusion in the EWOLUTION tria

Abstract Background and aims Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors. Methods The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were prespecified and death was categorized as cardiovascular, non-cardiovascular, or of unknown origin. Mortality rates were calculated from Kaplan-Meier estimates. Patient characteristics and event rates were compared between deceased and alive patients by unpaired T-tests or Chi-squared test, as appropriate. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Results 2-year mortality rate was 16.4% (CI: 14.0-18.7%), with 50% of patients dying from a noncardiovascular cause. Deceased patients had more comorbities and more often had a major bleeding after LAAO (20.6% vs 3.3%, p<0.001). Multivariate baseline predictors of 2-year mortality included age (HR 1.05, CI: 1.03-1.08, per year increase), heart failure (HR 1.73, CI: 1.24-2.41), vascular disease(HR 1.47, CI: 1.05-2.05), valvular disease (HR 1.63 CI: 1.15-2.33), abnormal liver function (HR 1.80 CI: 1.02-3.17) and abnormal renal function (HR 1.58, CI: 1.10-2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors. Conclusion One in six patients died within 2 years after LAAO. We were able to identify six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO.