Outcomes and predictors of readmission after implantation of a percutaneous left atrial appendage occlusion device in the United States: A propensity score-matched analysis from The National Readmission Database.

Key Findings▪Percutaneous left atrial appendage (LAA) occlusion has emerged as an alternative strategy to oral anticoagulants in selected patients with atrial fibrillation.▪The landmark trials comparing LAA occlusion to an oral anticoagulation strategy enrolled patients with no apparent contraindications to the use of warfarin.▪LAA occlusion has limited head-to-head comparison against the direct-acting oral anticoagulants.▪Observational data to date have generally shown specific adverse events after LAA occlusion in specific subgroups of patients (women, patients with kidney disease and heart failure, patients belonging to racial/ethnic subgroups and with advanced age), but further large-scale studies are necessary to elucidate reasons for increased adverse events associated with LAA occlusion in these subgroups of patients before recommending this modality as first-line therapy in all patient groups. ▪Percutaneous left atrial appendage (LAA) occlusion has emerged as an alternative strategy to oral anticoagulants in selected patients with atrial fibrillation.▪The landmark trials comparing LAA occlusion to an oral anticoagulation strategy enrolled patients with no apparent contraindications to the use of warfarin.▪LAA occlusion has limited head-to-head comparison against the direct-acting oral anticoagulants.▪Observational data to date have generally shown specific adverse events after LAA occlusion in specific subgroups of patients (women, patients with kidney disease and heart failure, patients belonging to racial/ethnic subgroups and with advanced age), but further large-scale studies are necessary to elucidate reasons for increased adverse events associated with LAA occlusion in these subgroups of patients before recommending this modality as first-line therapy in all patient groups.

Atrial fibrillation (AF) is associated with profound morbidity and mortality, including a fivefold increase in stroke risk. Left atrial appendage occlusion (LAAO) devices have emerged as an alternative approach to anticoagulation in patients with elevated bleeding risk and/or have contraindications to anticoagulation. However, females have been underrepresented in PROTECT & PREVAIL landmark trials supporting LAAO use. We aim to compare gender differences in outcomes of LAAO occlusive devices. The national readmission database (2016-2020) was utilized to identify hospitalizations for LAAO placement. Cohorts were stratified by gender as males and females. A propensity score matching (PSM) model matched both cohorts. Pearson's x2 test was applied to the matched cohorts to compare outcomes. Among 89,552 hospitalizations for LAAO placement, 41.3% of procedures were performed in females. Females were found to have a lower prevalence of co-morbidities such as diabetes, hypertension, hyperlipidemia and CKD [p < 0.001]. After propensity matching (N = 20,627), females had higher adverse events, including mortality (0.23%vs. 0.15%, p: 0.041), sudden cardiac arrest (1.77%vs. 1.37%, p: 0.001), pericardial complications (1.46%vs. 0.86%, p < 0.001), cardiac tamponade (0.94%vs. 0.54%, p < 0.001), post-procedural bleeding (0.69%vs. 0.53%, p: 0.032) & net adverse events (4.73%vs. 4.24%, p < 0.001). At six-month follow-up post-procedure, females had higher readmission rates at 30 days (9.42%vs. 8.07%, p < 0.001), 90-day and 180-day intervals (p < 0.001). In patients with hospitalizations for LAAO device placement, we observed a higher risk of net adverse events and mortality in females following the procedure compared to males. Prospective trials are warranted to identify and stratify the at-risk population with extensive preprocedural evaluation and determine ways to mitigate the sex-related disparities in clinical outcomes following the LAAO procedure.

Transfabric Leaks After Percutaneous Left Atrial Appendage Occlusion Procedures with the WATCHMAN FLX Device

Percutaneous left atrial appendage (LAA) occlusion (LAAO) is a procedure dominated by cardiologists. The aim of our study was to present the results of percutaneous LAAO performed solely by cardiac surgeons. Two hundred twenty-three consecutive patients with nonvalvular atrial fibrillation underwent percutaneous LAAO in two cardiac surgery sites. In the first center, all 84 LAAO procedures were performed with the endocardial LAA occluders: 60 cases with the Amulet and 24 cases with the LAmbre. In the second center, all 139 LAAO procedures were performed with the LARIAT epicardial device. The mean CHA2 DS2 -VASc-score was 3.7 ± 1.8 points, and mean HAS-BLED score was 3.6 ± 1.2 points. The procedure was successful in 97.3% of cases. Procedural or device-related adverse events were noted in 4.4% (n = 10) of cases: one periprocedural cardiac arrest, one aortic injury, one gastrointestinal bleeding, three cases of vascular access complications, and four cardiac tamponades. After a follow-up of 40.3 ± 17.3 months, 78.4% of patients were alive, with the annual mortality rate of 5.3%. Compared to the predicted risk, the observed incidence of thromboembolism was lower by 71%, and the bleeding incidence was lower by 69%. Percutaneous LAAO procedures can be safely performed by cardiac surgeons, with no cardiological assistance. LAAO done by surgeons is safe and effective, and periprocedural and long-term outcomes are excellent. Cardiac surgeons should be trained in both types of LAAO: endocardial and epicardial.

PO-03-161 INTRA-PROCEDURAL CROSSOVER OF LEFT ATRIAL APPENDAGE OCCLUSION DEVICES, A SINGLE CENTER EXPERIENCE

Percutaneous left atrial appendage occlusion: A review of current devices, clinical evidence, patient selection, and post procedural antithrombotic management

Background: The safety of concomitant percutaneous left atrial appendage occlusion procedure (LAAO) among patients undergoing catheter ablation (CA) for atrial fibrillation (AF) is unclear. This study aimed to evaluate the association between concomitant LAAO vs non-receipt LAAO with the risk of in-hospital complications and 30-day all-cause readmission among patients undergoing CA for AF. Methods: We performed a retrospective study using the Nationwide Readmission Database of the United States. The primary outcome was the in-hospital composite complications, which was defined as a composite of death, tamponade, hematoma, pneumothorax, and blood transfusion. The secondary outcome was the 30-day all-cause readmission. We performed a 1:10 propensity score (PS) matching analysis to compare the safety of performing and not performing LAAO on the same day of CA for AF. Logistic regression analysis was performed to evaluate the association between performing LAAO and the endpoints in the PS-matched cohort. Results: Among 25,834 patients (median age 70 years [62-78], 45% female) who underwent CA for AF between 2017 and 2019, 146 patients (0.6%) underwent LAAO on the same day. After the PS matching, a total of 1,515 patients (145 in the LAAO group and 1,370 in the non-LAAO group) were included in the comparative analysis. Concomitant LAAO procedure was not associated with higher risk of in-hospital complications (LAAO vs. non-LAAO; 10% vs. 7.9%; odds ratio [OR]; 1.35, 95% confidence interval [CI]; 0.76-2.38) and 30-day all-cause readmission following discharge (10% vs. 14%; OR; 0.71, 95% CI; 0.41-1.24). Conclusions: There was no significant difference in the in-hospital complications and 30-day all-cause readmission rates following LAAO and CA for AF compared to that of those who underwent CA for AF without LAAO.

Objective To evaluate the role of real-time three-dimensional transesophageal echocardiography(RT-3D TEE) in left atrial appendage (LAA) occlusion. Methods Consecutive 10 atrial fibrillation (AF) patients (CHADS2≥2) with high risk bleeding underwent LAA occlusion under the guidance of TEE. The LAA orifice shape and characteristics of lobes were assessed, the size of LAA with RT-3D TEE wee measured before closer implanation, and the position of the LAA occlusion device were evaluated by RT-3D TEE.The correlational analysis between LAA diameter and occluder size was conducted. Results Among 10 patients, the test results revealed 8 cases with complete LAA occlusion and 1 case with incomplete occlusion, and 1 case with failed occlusion. Five cases showed approximate round LAA ostium, and the other 5 showed approximate oval ostium. The average number of LAA lobes were 2.2±0.7. LAA ostium long diameter were larger by 3D TEE compared with 2D TEE[(21.8±5.1)mm vs (20.8±4.1)mm], and ostium short diameter were smaller by 3D TEE compared with 2D TEE[(16.1±3.0)mm vs (17.0±2.6)mm], however there were no significant differences between 2D and 3D TEE measurements, and the mean ostium diameter and LAA depth were comparable between two methods. LAA ostium long diameter, short diameter, average diameter and LAA depth assessed by 3D TEE and 2D TEE showed good correlation with occluder diameter (3D TEE: r=0.719, 0.690, 0.791, 0.711, and P=0.029, 0.040, 0.011, 0.032, respectively; 2D TEE: r=0.887, 0.894, 0.932, 0.896, and P=0.001, 0.001, 0.000, 0.000, respectively). LAA occlusion device position assessed by RT-3D: 6 cases with appropriate position, acceptable position with 2 cases, and 1 case with malposition. Conclusions RT-3D TEE can play important role in evaluating the morphology of LAA, accurately judging LAA ostium shape and size and position of the occlusion device. Key words: Echocardiography, transesophageal; Echocardiography, real-time three-dimensional; Left atrial appendage; Occlusion

AimsThe safety and feasibility of combining percutaneous catheter ablation (CA) for atrial fibrillation with left atrial appendage occlusion (LAAO) as a single procedure in the USA have not been investigated. We analyzed the US National Readmission Database (NRD) to investigate the incidence of combined LAAO + CA and compare major adverse cardiovascular events (MACEs) with matched LAAO-only and CA-only patients.Methods and resultsIn this retrospective study from NRD data, we identified patients undergoing combined LAAO and CA procedures on the same day in the USA from 2016 to 2019. A 1:1 propensity score match was performed to identify patients undergoing LAAO-only and CA-only procedures. The number of LAAO + CA procedures increased from 28 (2016) to 119 (2019). LAAO + CA patients (n = 375, mean age 74 ± 9.2 years, 53.4% were males) had non-significant higher MACE (8.1%) when compared with LAAO-only (n = 407, 5.3%) or CA-only patients (n = 406, 7.4%), which was primarily driven by higher rate of pericardial effusion (4.3%). All-cause 30-day readmission rates among LAAO + CA patients (10.7%) were similar when compared with LAAO-only (12.7%) or CA-only (17.5%) patients. The most frequent primary reason for readmissions among LAAO + CA and LAAO-only cohorts was heart failure (24.6 and 31.5%, respectively), while among the CA-only cohort, it was paroxysmal atrial fibrillation (25.7%).ConclusionWe report an 63% annual growth (from 28 procedures) in combined LAAO and CA procedures in the USA. There were no significant difference in MACE and all-cause 30-day readmission rates among LAAO + CA patients compared with matched LAAO-only or CA-only patients.

Background: Maze procedure and left atrial appendage occlusion (LAAO) are often done as adjunctive procedures during mitral valve surgery in patients with atrial fibrillation (AF). We examined the effect of the Maze procedure and LAAO on AF-related clinical outcomes. Methods: We identified patients with AF from the Nationwide Readmission Database who underwent mitral valve surgery in the years 2016-2019 using ICD 10 codes. Patients were grouped by procedure type (Maze+/LAAO+, Maze+/LAAO-, Maze-/LAAO+, Maze-/LAAO- (control)). Outcomes were in-hospital and 180-day readmission rate for stroke and mortality, and 180-day AF/atrial flutter readmission. Multivariate regression analysis was conducted adjusting for demographics, hospital characteristics, comorbidities, and cardiac surgery type. Results: Of 14,979 patients with AF who underwent mitral valve surgery, adjunctive procedures were performed as follows: 2427 Maze+/LAAO+, 997 Maze+/LAAO-, 4052 Maze-/LAAO+, and 7503 Maze-/LAAO-. Stroke during the index admission and within 180 days occurred less frequently in the adjunctive procedure groups than in control group (2.5%, 2.3%, 3.4%, and 4.9% respectively, P&lt;0.001). Similar results were observed for in-hospital and 180-day mortality (3.9%, 7.6%, 4.8%, and 6.8% respectively, P&lt;0.001). However, readmission within 180 days for AF/atrial flutter was higher in the adjunctive procedure groups than the control group (5.6% vs 4.2% vs 5.4% vs 3.8%, P&lt;0.001). On multivariate analysis, patients who had either Maze or LAAO procedures (Maze+/LAAO+, Maze+/LAAO-, Maze-/LAAO+) had a lower 180-day stroke risk when compared to the control group (hazard ratio (HR) 0.7, P=0.01; HR 0.66, P=0.55; and HR 0.79, P=0.01 respectively). Similarly, 180-day mortality was lower in patients who underwent LAAO compared to the control group (HR 0.71, P=0.002; HR 1.27, P=0.05; and HR 0.78, P=0.004 respectively). Conclusion: Patients with AF who underwent Maze and/or LAAO procedures during mitral valve surgery had lower 180-day stroke and mortality rates. There was a higher rate of readmission for AF/atrial flutter, which may be a short-term proarrhythmic effect of these procedures or may reflect differences in AF type and rhythm control goals in the control group.

Aortic Stenosis and Atrial Fibrillation Left Atrial Appendage Occlusion—Could We? If So, How and When?

Percutaneous endocardial left atrial appendage occlusion (LAAO) is an alternative therapy for stroke prevention in patients with atrial fibrillation who are poor candidates for oral anticoagulants. Oral anticoagulation is generally discontinued 45 days following successful LAAO. Real-world data on early stroke and mortality following LAAO are lacking. Using International Classification of Diseases, Tenth Revision, Clinical-Modification codes, we performed a retrospective observational registry analysis to examine the rates and predictors of stroke, mortality, and procedural complications during index hospitalization and 90-day readmission among 42 114 admissions in the Nationwide Readmissions Database for LAAO between 2016 and 2019. Early stroke and mortality were defined as events occurring during index admission or 90-day readmission. Data on timing of early strokes post-LAAO were collected. Multivariable logistic regression modeling was used to ascertain predictors of early stroke and major adverse events. LAAO was associated with low rates of early stroke (0.63%), early mortality (0.53%), and procedural complications (2.59%). Among patients who had readmissions with strokes after LAAO, the median time from implant to readmission was 35 days (interquartile range, 9-57 days); 67% of readmissions with strokes occurred <45 days postimplant. Between 2016 and 2019, the rates of early stroke after LAAO significantly decreased (0.64% versus 0.46% P-for-trend <0.001), while early mortality and major adverse event rates were unchanged. Peripheral vascular disease and a history of prior stroke were independently associated with early stroke after LAAO. Early post-LAAO stroke rates were similar between low, medium, and high LAAO volume tertile centers. In this contemporary real-world analysis, the early stroke rate after LAAO was low, with the majority occurring within 45 days of device implantation. Despite an increase in LAAO procedures between 2016 and 2019, there with a significant decline in early strokes after LAAO during that period.

AimsTo determine outcomes in atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion (LAAO) based on the underlying stroke risk (defined by the CHA2DS2-VASc score).Methods and resultsData were extracted from the National Inpatient Sample for calendar years 2016–20. Left atrial appendage occlusion implantations were identified on the basis of the International Classification of Diseases, 10th Revision, Clinical Modification code of 02L73DK. The study sample was stratified on the basis of the CHA2DS2-VASc score into three groups (scores of 3, 4, and ≥5). The outcomes assessed in our study included complications and resource utilization. A total of 73 795 LAAO device implantations were studied. Approximately 63% of LAAO device implantations occurred in patients with CHA2DS2-VASc scores of 4 and ≥5. The crude prevalence of pericardial effusion requiring intervention was higher with increased CHA2DS2-VASc score (1.4% in patients with a score of ≥5 vs. 1.1% in patients with a score of 4 vs. 0.8% in patients with a score of 3, P < 0.01). In the multivariable model adjusted for potential confounders, CHA2DS2-VASc scores of 4 and ≥5 were found to be independently associated with overall complications [adjusted odds ratio (aOR) 1.26, 95% confidence interval (CI) 1.18–1.35, and aOR 1.88, 95% CI 1.73–2.04, respectively] and prolonged length of stay (aOR 1.18, 95% CI 1.11–1.25, and aOR 1.54, 95% CI 1.44–1.66, respectively).ConclusionA higher CHA2DS2-VASc score was associated with an increased risk of peri-procedural complications and resource utilization after LAAO. These findings highlight the importance of patient selection for the LAAO procedure and need validation in future studies.

Catheter ablation for atrial fibrillation in patients with left atrial appendage closure devices.

We studied the impact of the use of three-dimensional multidetector computed tomography (3D-MDCT) and fluoroscopy fusion on percutaneous left atrial appendage occlusion (LAAO) procedures in relation to procedure time, contrast volume, fluoroscopy time, and total radiation. This was a single-center, prospective, single-blinded, randomized control trial. Patients meeting criteria for LAAO were randomized to undergo LAAO with the WATCHMAN FLXTM device with and without 3D-MDCT-fluoroscopy fusion guidance using a prespecified protocol using computed tomography angiography for WATCHMAN FLXTM sizing, moderate sedation, and intracardiac echocardiography for procedural guidance. Overall, 59 participants were randomly assigned to the fusion (n = 33) or no fusion (n = 26) groups. The median (interquartile range) age was 79 (75-83) years, 24 (41%) were female, and 55 (93%) were Caucasian. The median CHA2 DS2 VASc and HASBLED scores were 5 (4-6) and 3 (3-4), respectively. At the time of the study, 51 (53%) patients were on a direct acting oral anticoagulant. There were no significant differences between the fusion and no fusion groups in procedure time (52.4 ± 15.4 vs. 56.8 ± 19.5 min, p = .36), mean contrast volume used (33.8 ± 12.0 vs. 29.6 ± 11.5 mls, p = .19), mean fluoroscopy time (31.3 ± 9.9 vs. 28.9 ± 8.7 min, p = .32), mean radiation dose (1177 ± 969 vs. 1091 ± 692 mGy, p = .70), and radiation dose product curve (23.9 ± 20.5 vs. 35.0 ± 49.1 Gy cm2 , p = .29). There was no periprosthetic leak in the two groups in the immediate 1-month postprocedure follow-up periods. There was no significant difference with and without 3D-MDCT-fluoroscopy fusion in procedure time, contrast volume use, radiation dose, and radiation dose product.