Percutaneous Left Atrial Appendage Occlusion Research Articles

Risk Stratification in Patients Who Underwent Percutaneous Left Atrial Appendage Occlusion

Left atrial appendage occlusion (LAAO) is effective in preventing thromboembolism. Risk stratification tools could help identify patients at risk for early mortality after LAAO. In this study, we validated and recalibrated a clinical risk score (CRS) to predict risk of all-cause mortality after LAAO. This study used data from patients who underwent LAAO in a single-center, tertiary hospital. A previously developed CRS using 5 variables (age, body mass index [BMI], diabetes, heart failure, and estimated glomerular filtration rate) was applied to each patient to assess risk of all-cause mortality at 1 and 2years. The CRS was recalibrated to the present study cohort and compared with established atrial fibrillation-specific (CHA2DS2-VASc and HAS-BLED) and generalized (Walter index) risk scores. Cox proportional hazard models were used to assess the risk of mortality and discrimination was assessed by Harrel C-index. Among 223 patients, the 1- and 2-year mortality rates were 6.7% and 11.2%, respectively. With the original CRS, only low BMI (<23kg/m2) was a significant predictor of all-cause mortality (hazard ratio [HR] [95% CI] 2.76 [1.03 to 7.35]; p=0.04). With recalibration, BMI <29kg/m2 and estimated glomerular filtration rate <60ml/min/1.73m2 were significantly associated with an increased risk of death (HR [95% CI] 3.24 [1.29 to 8.13] and 2.48 [1.07 to 5.74], respectively), with a trend toward significance noted for history of heart failure (HR [95% CI] 2.13 [0.97 to 4.67], p=0.06). Recalibration improved the discriminative ability of the CRS from 0.65 to 0.70 and significantly outperformed established risk scores (CHA2DS2-VASc=0.58, HAS-BLED=0.55, Walter index=0.62). In this single-center, observational study, the recalibrated CRS accurately risk stratified patients who underwent LAAO and significantly outperformed established atrial fibrillation-specific and generalized risk scores. In conclusion, clinical risk scores should be considered as an adjunct to standard of care when evaluating a patient's candidacy for LAAO.

Utilization and outcomes of protamine after percutaneous left atrial appendage occlusion.

The aim of this study was to describe the use pattern and outcomes of protamine administration for heparin reversal among sites performing percutaneous left atrial appendage occlusion (LAAO). We identified 45,135 patients who underwent LAAO at 243 hospitals participating in Vizient® Clinical Database between January 1, 2016 and December 31, 2021. Patients were stratified according to protamine administration after the procedure. Outcomes of interest included vascular complications, major bleeding, ischemic events, and same-day discharge. A total of 40,278 patients were included in the propensity-matched comparison, of whom 50% received protamine after the LAAO procedure. The use of protamine varied across hospitals, with 88 hospitals (36.2%) using protamine in >75% of cases and 32 hospitals (13.1%) not using protamine at all. Major bleeding occurred less frequently in the protamine group compared with the control group (2.4% vs. 2.8%, p = 0.03). Major vascular complications and pericardial tamponade were rare but slightly higher in the protamine group (0.8% vs. 0.6%, p = 0.04) and (1.0% vs. 0.8%, p = 0.01), respectively. There were no differences in the rates of ischemic or hemorrhagic stroke, all-cause mortality, or the rate of any major adverse event between the two groups. Same-day discharge was more frequent in the protamine group (12.3% vs 9.4%, p ≤ 0.001). Protamine is used in approximately 50% of LAAO procedures and is associated with lower bleeding events and higher rates of same-day discharge. The higher vascular complication and tamponade is likely due to its ad-hoc use as a reversal agent in these patients.

A comparable efficacy and safety between intracardiac echocardiography and transesophageal echocardiography for percutaneous left atrial appendage occlusion.

Accumulated clinical studies utilized intracardiac echocardiography (ICE) to guide percutaneous left atrial appendage occlusion (LAAO). However, its procedural success and safety compared to traditional transesophageal echocardiography (TEE) remained elusive. Therefore, we performed a meta-analysis to compare efficacy and safety of ICE and TEE for LAAO. We screened studies from four online databases (including the Cochrane Library, Embase, PubMed, and Web of Science) from their inception to 1 December 2022. We used a random or fixed-effect model to synthesize the clinical outcomes and conducted a subgroup analysis to identify the potential confounding factors. A total of twenty eligible studies with 3,610 atrial fibrillation (AF) patients (1,564 patients for ICE and 2,046 patients for TEE) were enrolled. Compared with TEE group, there was no significant difference in procedural success rate [risk ratio (RR) = 1.01; P = 0.171], total procedural time [weighted mean difference (WMD) = -5.58; P = 0.292], contrast volume (WMD = -2.61; P = 0.595), fluoroscopic time (WMD = -0.34; P = 0.705; I2 = 82.80%), procedural complications (RR = 0.82; P = 0.261), and long-term adverse events (RR = 0.86; P = 0.329) in the ICE group. Subgroup analysis revealed that ICE group might be associated with the reduction of contrast use and fluoroscopic time in the hypertension proportion <90 subgroup, with lower total procedure time, contrast volume, and the fluoroscopic time in device type subgroup with multi-seal mechanism, and with the lower contrast use in paroxysmal AF (PAF) proportion ≤50 subgroup. Whereas, ICE group might increase the total procedure time in PAF proportion >50 subgroup and contrast use in multi-center subgroup, respectively. Our study suggests that ICE may have comparable efficacy and safety compared to TEE for LAAO.

Acute kidney injury following percutaneous left atrial appendage occlusion: results from an international multicentre registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Acute kidney injury (AKI) is a serious complication after invasive cardiac procedures and has been associated with a higher incidence of periprocedural complications and increased mortality. Data on the occurrence of AKI associated with left atrial appendage occlusion (LAAO) are very limited. Purpose To report the incidence, predictors, and clinical implications of AKI following percutaneous LAAO. Methods This multicenter registry included 2124 patients with successful Watchman implantation. AKI was defined according to the AKI Network criteria as an increase in serum creatinine of ≥0.3 mg/dL or of ≥50% over the course of 48 hours post-procedure. Patients meeting this definition were further categorized in three stages: stage 1, increase in serum creatinine ≥ 0.3 mg/dl (≥ 26.4 μmol/l) or of 1.5 to 2 times compared to baseline; stage 2, increase in serum creatinine of 2 to 3 times compared to baseline; stage 3, increase in serum creatinine of &amp;gt; 3 times compared to baseline or serum creatinine ≥ 4.0 mg/dl [≥ 354 μmol/l] with an acute increase of at least 0.5 mg/dl [44 μmol/l]. Results Post-procedural AKI was documented in 68 (5.5%) of 1234 patients with creatinine determination between 24 and 48 hours post-LAAO. Among them, 63 (92.6%) patients had AKI stage 1, 4 (5.9%) had AKI stage 2, and 1 (1.5%) had AKI stage 3. AKI was associated with higher CHA2DS2-VASc (5.3 ± 1.4 vs. 4.8 ± 1.4; p=0.001) and HAS-BLED (3.8 ± 0.9 vs. 3.5 ± 1.0; p=0.01) scores at baseline, as well as a higher prevalence of diabetes mellitus (p=0.04) and CHF (p&amp;lt;0.001). At multivariate analysis (Table 1), independent predictors of AKI were CKD stage 4/5 (OR: 1.998; 95% CI: 1.018 – 3.923; p=0.04), and CHF (OR: 2.286; 95% CI: 1.328 – 3.934; p=0.01). The average follow-up was 13 ± 7 months. The annualized rates of cardiovascular mortality were 5.5% in AKI and 1.0% in non-AKI patients (p=0.01). The annualized rates of overall mortality were 15.1% in AKI and 3.4% in non-AKI patients (p&amp;lt;0.001). Conclusion AKI was an infrequent complication following percutaneous LAAO and a powerful predictor of cardiovascular and overall mortality during follow-up.

Zero-Contrast Left Atrial Appendage Occlusion Using a Hybrid Echocardiography-Fluoroscopy Technique Without Iodinated Contrast

Contrast exposure during left atrial appendage occlusion may be harmful in those with chronic kidney disease or allergy. This single-center registry (n=31) demonstrates the feasibility and safety of zero-contrast percutaneous left atrial appendage occlusion using echocardiography, fluoroscopy, and fusion imaging, with 100% procedural success and no device complications at 45days.

Outcomes of percutaneous left atrial appendage occlusion device implantation in patients with rheumatic atrial fibrillation

Outcomes of percutaneous left atrial appendage occlusion device implantation in patients with rheumatic atrial fibrillation

Left Atrial Appendage Occlusion: Transesophageal Echocardiography Versus Intracardiac Echocardiography—Pro: Intracardiac Echocardiography

OVER THE LAST 2 decades, intracardiac echocardiography (ICE) has emerged and challenges the use of transesophageal echocardiography (TEE) for imaging percutaneous left atrial appendage occlusion (LAAO).

PO-03-163 CONCOMITANT LAAO AND ATRIAL FIBRILLATION ABLATION VS. A STAGED APPROACH: INSIGHTS FROM THE NATIONWIDE READMISSIONS DATABASE

Percutaneous left atrial appendage occlusion (LAAO) is increasingly performed in patients with atrial fibrillation (AF). It is sometimes combined with catheter ablation (CA), either in a concomitant procedure or a staged approach. To compare the safety, efficacy, and costs of concomitant LAAO and CA versus a staged approach. The Nationwide Readmissions Database (NRD) is a nationally representative sample of all US hospitalizations, containing longitudinal patient data on almost half of all hospitalizations. The 2019 NRD was used to identify patients who underwent CA and LAAO from January to November 2019. Only patients who underwent CA and LAAO on the same date were included in the concomitant group; patients who underwent CA and LAAO on different dates or hospitalizations were included in the short-interval staged (SIS) group (within 6 months). In the SIS group, comorbidities were obtained from the first staged admission; outcomes were pooled from both procedures. Analysis accounted for the complex survey design of the NRD. Per NRD data reporting guidelines, any variable with n<10 was not reported. Out of the 25,392 patients who underwent LAAO during the study period, 191 patients underwent a concomitant procedure, and 392 patients underwent a SIS procedure. In the SIS group, mean time between the procedures was 92.4 ± 5.2 days, and LAAO was performed first in 52.3%. Patients in the concomitant group were significantly less likely to have heart failure (41.8% vs 56.5%, p=0.044), chronic obstructive pulmonary disease (11.1% vs 32.2%, p<0.01), fluid/electrolyte disorders, (<10 vs 17.5%, p=0.01), pulmonary circulation disorders (14.4% vs <10, p<0.01), and total Elixhauser comorbidities (4.1 ± 0.2 vs. 5.3 ± 0.2, p<0.01). Thirty-day readmissions (5.8% vs 4.3%, p<0.01), major bleeding (7.2% vs 19.3%, p=0.014), total length of stay (LOS) (1.8 ± 0.2 vs. 7.1± 0.6, p<0.01), and total charges ($184,566 ± $20,430 vs. $303,812± $18,308) were all significantly less in the concomitant group. After multivariate adjustment, 30-day readmissions, LOS, and total cost remained significantly different (Figure 1). Concomitant and SIS CA and LAAO procedures are performed infrequently. Patients undergoing concomitant procedures are healthier with less cardiopulmonary and overall comorbidities. After multivariate adjustment, concomitant procedures were associated with less 30-day readmissions, shorter LOS, and less total charges.

CE-452771-4 OUTCOMES WITH DIFFERENT POSTPROCEDURAL ANTITHROMBOTIC THERAPY REGIMENS FOLLOWING LEFT ATRIAL APPENDAGE OCCLUSION

Percutaneous left atrial appendage occlusion (LAAO) has emerged as an alternative to oral anticoagulation (OAC) to decrease the risk of thromboembolism in patients with nonvalvular atrial fibrillation. Short-term antithrombotic therapy is required after LAAO device implantation to prevent device related thrombus until endothelialization. Prescribing patterns continue to shift nationwide and the optimal antithrombotic therapy after LAAO is not clear. To investigate the prevalence and clinical impact of different antithrombotic regimens after LAAO with WATCHMAN FLX in real-world clinical practice. Patients who underwent LAAO with WATCHMAN FLX in the National Cardiovascular Data Registry LAAO Registry between August 5, 2020 and September 30, 2021 and who had discharge medication information were included in the analysis. Endpoints were evaluated between hospital discharge and 45 day follow-up visits in patients stratified by mutually exclusive discharge medication regimens. The risk of adverse events was compared in unadjusted and adjusted patient cohorts using a Cox proportional hazards model. A total of 40,626 patients were available to analyze (n=101 had missing discharge medication data). Mean age was 76.2 years and 41.0% were female. The most common discharge medication strategies were DOAC + aspirin (48.5%) and DOAC alone (22.0%), which was markedly different from earlier studies showing warfarin and aspirin were most common. Other regimens included: dual antiplatelet therapy (DAPT; 8.1%), warfarin + aspirin (8.0%), DOAC + P2Y12 inhibitor (4.9%), single antiplatelet therapy (SAPT; 2.7%), warfarin alone (2.6%), triple therapy (1.6%), warfarin + P2Y12 inhibitor (0.7%), none (0.7%), and other (0.1%). Differences in bleeding and thromboembolic risk were found between the medication groups (Table). The adjusted risk of major adverse events (MAE) was lower in patients receiving DOAC alone (HR 0.61 [0.52, 0.72]; Figure) and higher with triple therapy (1.73 [1.24, 2.42]) compared to DOAC + aspirin treated patients in a multivariable model. In this analysis, DOAC + aspirin was the predominant discharge medication regimen after LAAO in everyday clinical practice. DOAC alone had the lowest risk of major adverse events after LAAO.

PO-03-189 THROMBOEMBOLISM BEFORE VS AFTER PERCUTANEOUS CLOSURE OF PERI-DEVICE LEAKS RESULTING FROM PERCUTANEOUS LEFT ATRIAL APPENDAGE OCCLUSION

Recent studies have indicated that residual peri-device leaks after percutaneous left atrial appendage occlusion (LAAO) portend a higher risk of thromboembolic (TE) events. It is unknown whether eliminating these leaks via endovascular devices (e.g., coils, plugs) would improve clinical outcomes. To determine the TE risk in patients with incomplete LAAO before vs after leak closure with endovascular devices. This international, multicenter registry was designed as a retrospective review of individual prospective registries maintained at each participating center. All patients with peri-device leak≥3mm who underwent percutaneous closure were enrolled. A total of 238 LAAO patients with residual peri-device leak≥3mm were enrolled at 7 centers (age 74±9 years; 66.8% male; CHA2DS2-VASc 4.8±1.4; HAS-BLED 3.4 ± 1.1). The time between LAAO and leak closure was 11±9 months [221 patients-year (PY)]. Leaks were classified as moderate (3-4mm) in 174 patients (73.1%) or severe (≥5mm) in 64 (26.9%) patients. TE events occurred in 22 (9.2%) patients before leak closure, after a median of 8 months (IQR:6-21) post-LAAO (annualized rate: 9.9%). At the time of TE event, 13 (59.1%) patients were on ASA, 4 (18.2%) on warfarin, 4 (18.2%) on DAPT, and 1 (4.5%) on DOAC. Percutaneous leak closure was performed via endovascular coils or other vascular/septal occluders in 186 (78.1%) and 52 (21.9%) patients, respectively. Procedure time was 89±48 min; the mean volume of iodinated contrast medium used was 64±34mL. Major complications occurred in 2.5% (1 stroke, 1 air embolism, 4 pericardial effusions). Follow-up TEE after 3.4±1.9 months revealed complete LAA sealing or a negligible leak in 218 cases (91.6%); the remaining 20 patients had moderate (n=18) or severe (n=2) residual leak. During a mean follow-up after leak closure of 15±9 months (289PY); 9 (3.8%) patients developed TE events (annualized rate: 3.1%). Among them, 7 (77.8%) patients were on ASA, 1 (11.1%) on clopidogrel, and 1 (11.1%) on no antithrombotic therapy. TE incidence was significantly lower after leak closure (Hazard Ratio: 0.30; 95% Confidence Interval: 0.14-0.69; p=0.004). Kaplan Meier survival curves are reported in Figure 1 (log-rank p-value: 0.0023). Peri-device leaks≥3mm following percutaneous LAAO were associated with a high incidence of TE events. Percutaneous leak closure was safe and contributed to a significant thromboembolic risk reduction.

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

Two devices are currently available for percutaneous left atrial appendage occlusion (LAAO), Watchman FLX and Amplatzer Amulet. While in most cases LAAO is achieved by implanting the originally planned device, intra-procedural crossover from one type to the other might be necessary when LAAO is not satisfactory. To evaluate the rate and characteristics of intra-procedural device crossover in LAAO procedure. All successful LAAO procedures performed in our center since October 2021 (Amulet’s FDA approval) are included in the study. Of note, LAAO procedures are performed under fluoroscopic and ultrasound (TEE or ICE) guidance, without formal preprocedural imaging planning. 365 patients (74±9 years; 34% female) underwent LAAO over 12 months. LAAO was successful in all but 1 case, in which the LAA was too large for successful implantation of the originally planned device (Watchman) and crossover was not attempted. In almost all cases (361/364, 99%), the original planned device was implanted successfully achieving complete LAAO (Watchman in 325 patients, Amulet in 34 patients). Intra-procedural device crossover was observed in 4 (1%) patients, all from Watchman to Amulet. In 3 cases, the LAA ostium and proximal LAA were large, leading to deployment of an undercompressed, unstable 35 mm Watchman device: Amulet allowed positioning of the lobe in a more distal, stable location with the disc covering the ostium (Figure, left panel). In 1 case, the LAA was of adequate size, but a proximal ridge (s/p LAA isolation) lead to Watchman deformation (struts’ introversion on one side) once fully deployed, a behavior observed despite multiple recaptures and a device change: with Amulet, the lobe could be placed distally to the ridge with the disc covering the ostium (Figure, right panel). Mean procedural time was 107±3 min, with a mean contrast volume used of 203±70 mL and a mean fluoroscopy time of 15±4 min (yielding to a mean dose of 2070±3107 mGy). There were no procedural-related complications, and all patients were discharged home after overnight observation. Intraprocedural LAAO device crossover is a rare occurrence, usually secondary to unsatisfactory deployment of the originally planned device. To avoid unsuccessful LAAO, operators should be skilled in implantation of both type of devices and be able to switch from one to the other at the time of the index procedure.Tabled 1PatientLAA os max diameterOriginal deviceFinal device131 mm35 mm Watchman FLX31-mm Amplatzer Amulet229 mm35-mm Watchman FLX34-mm Amplatzer Amulet329 mm35-mm Watchman FLX34-mm Amplatzer Amulet421 mm27-mm Watchman FLX22-mm Amplatzer Amulet Open table in a new tab

Long-term outcomes of successful left atrial appendage occlusion with focus on stroke prevention: 10-year follow-up of a single-center registry.

Percutaneous left atrial appendage occlusion (LAAO) is an alternative to anticoagulation in the prevention of stroke in patients with nonvalvular atrial fibrillation, especially in patients with a contraindication for oral anticoagulation therapy (OAT). The study sought to obtain long-term patient outcomes after successful LAAO in everyday clinical practice. In this single-center registry spanning over 10 years, data of all consecutive patients that underwent percutaneous LAAO were collected. Observed thromboembolic and major bleeding event rates after successful LAAO during follow-up were compared with expected event rates based on CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) and HAS-BLED (hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores. Furthermore, anticoagulation and antiplatelet use during follow-up was evaluated. Of 230 patients scheduled for LAAO (38% women, 69.5 ± 8.2 years of age, CHA2DS2-VASc score 3.9 ± 1.6, HAS-BLED score 2.9 ± 1.0), 218 patients had a successful implantation (95%) with a follow-up duration of 5.2 ± 3.1 years. The procedure was combined with catheter ablation in 52% of the patients. Fifty thromboembolic complications (24 ischemic stroke, 26 transient ischemic attack) were observed during follow-up in 40 (18%) of 218 patients. Ischemic strokes occurred with a rate of 2.1 per 100 patient-years, accounting for a 66% relative risk reduction compared with the CHA2DS2-VASc predicted event rate. Device-related thrombus was observed in 5 (2%) patients. Sixty-five nonprocedural major bleeding complications occurred in 24 (11%) of 218 patients with a rate of 5.7 per 100-patient years, which is comparable to estimated HAS-BLED-bleeding rates under OAT use. At end of follow-up 71% of all patients were on single antiplatelet or no antiplatelet or anticoagulation treatment, while 29% were on OAT. Thromboembolic event rates during long-term follow-up after successful LAAO remained consistently lower than expected supporting the efficacy of LAAO.

PO-03-135 LEFT ATRIAL APPENDAGE OCCLUSION VERSUS STANDARD OF CARE IN PATIENTS WITH ATRIAL FIBRILLATION AND A PRIOR THROMBO-EMBOLIC EVENT DESPITE ORAL ANTICOAGULANT THERAPY: A PROPENSITY SCORE MATCHED COMPARISON

Patients with atrial fibrillation (AF) that suffer from ischemic stroke despite oral anticoagulant (OAC) therapy have a very high risk of recurrent stroke and better prevention strategies are needed. Left atrial appendage occlusion (LAAO) is a promising secondary prevention strategy that may provide mechanical protection. However, evidence showing effectiveness of LAAO in this population is scarce and the current international guidelines only consider LAAO in patients with a contra-indication for OAC. To compare percutaneous LAAO to standard-of-care including continuing/switching OAC therapy for secondary stroke prevention in patients with AF and a prior thrombo-embolic event and/or LAA thrombus under OAC therapy. The STR-OAC LAAO cohort is an international collaboration of multiple LAAO registries (21 participating centers). All patients that underwent percutaneous LAAO because of a thrombo-embolic event and/or LAA thrombus on OAC were included. Propensity score matching with a previously published multi-center dataset of patients continuing/switching OAC therapy after a thrombo-embolic event was performed to compare the occurence of ischemic stroke between groups.Time-to-event analysis was performed with Kaplan-Meier curves and Cox-proportional-hazard regression analyses. A total of 425 patients underwent LAAO between 2010-2021 and were included in the STR-OAC LAAO cohort. Mean age was 72±9 years; 45% was female and mean CHA2DS2-VASc and HAS-BLED score were 4.8±1.5 and 2.8±1.2, respectively. Oral anticoagulation was discontinued after LAAO at discharge or after confirmation of adequate LAA closure at 1-3 months follow-up in most patients, the remaining 30% of patients continued OAC after LAAO as an adjunctive strategy. All LAAO patients were propensity-score matched and included in the primary outcome analysis. During follow up including 1450 patient-years a total of 59 patients experienced ischemic stroke: 1.9% per patient-year in LAAO group versus 9.2% per patient-year in the control group. LAAO was associated with a significantly lower risk of ischemic stroke (HR 0.3, 95%CI [0.2-0.5], p<0.001) compared to standard-of-care. In this propensity-score matched study, LAAO was associated with a lower risk of ischemic stroke compared to standard-of-care in patients with a thrombo-embolic event and/or LAA thrombus despite OAC treatment. Randomized controlled trial data may further confirm the effectiveness of LAAO in this very high-risk population.

Impact of Frailty on In-Hospital Outcomes in Patients Who Underwent Percutaneous Left Atrial Appendage Occlusion

Impact of Frailty on In-Hospital Outcomes in Patients Who Underwent Percutaneous Left Atrial Appendage Occlusion

Impact of Psychosocial Risk Factors on Outcomes of Atrial Fibrillation Patients undergoing Left Atrial Appendage Occlusion Device Implantation.

The impact of psychosocial risk factors (PSRFs) on outcomes in patients undergoing percutaneous left atrial appendage occlusion (LAAO) device implantation is unclear. We aimed to analyze the association of psychosocial risk factors with outcomes in patients undergoing LAAO. Data were extracted from the Nationwide readmissions database for the calendar years 2016-2019. LAAO device implantations were identified using ICD-10-CM code 02L73DK. The outcomes of interest included procedural complications, inpatient mortality, resource utilization, and 30-day readmissions. Patients were divided into two cohorts based on the absence or presence of PSRFs. Our cohort included a total of 54,900 patients, of which, 19,984 (36.4%) had ≥ 1 PSRF as compared to 34,916 (63.6%) with no PSRFs. The prevalence of major complications (3.3% vs 2.8%, p=0.03) was significantly higher in patients with ≥ 1 PSRF as compared to no PSRFs. Furthermore, patients with ≥ 1 PSRF had a significantly higher 30-day readmission rate (6.9% vs 6.2%, p=0.02). In the multivariable model, the presence of ≥ 1 PSRF was associated with significantly higher odds of overall complications [adjusted odds ratio (aOR):1.11; 95% confidence interval (CI): 1.01-1.21; p=0.02]. Additionally, the presence of ≥ 1 PSRF was associated with higher odds of prolonged hospital stay for more than one day (aOR: 1.30; 95% CI: 1.21-1.40; p<0.01). The high prevalence of PSRFs may be associated with poorer outcomes in patients with AF patients undergoing LAAO device implantations. These data merit further study to help in the selection process of patients for LAAO for improved outcomes.

April 2023 Stroke Highlights.

April 2023 Stroke Highlights.

Outcomes of percutaneous left atrial appendage occlusion device implantation in atrial fibrillation patients based on underlying stroke risk.

To 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). Data 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). A 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.

Early Stroke and Mortality After Percutaneous Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation.

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.

Research Opportunities in Stroke Prevention for Atrial Fibrillation: A Report From a National Heart, Lung, and Blood Institute Virtual Workshop.

Atrial fibrillation (AF) is one of the strongest risk factors for ischemic stroke, which is a leading cause of disability and death. Given the aging population, increasing prevalence of AF risk factors, and improved survival in those with cardiovascular disease, the number of individuals affected by AF will continue increasing over time. While multiple proven stroke prevention therapies exist, important questions remain about the optimal approach to stroke prevention at the population and individual patient levels. Our report summarizes the National Heart, Lung, and Blood Institute virtual workshop focused on identifying key research opportunities related to stroke prevention in AF. The workshop reviewed major knowledge gaps and identified targeted research opportunities to advance stroke prevention in AF in the following areas: (1) improving risk stratification tools for stroke and intracranial hemorrhage; (2) addressing challenges with oral anticoagulants; and (3) delineating the optimal roles of percutaneous left atrial appendage occlusion and surgical left atrial appendage closure/excision. This report aims to promote innovative, impactful research that will lead to more personalized, effective use of stroke prevention strategies in people with AF.

Percutaneous left atrial appendage occlusion in patients with a cardiac implantable electronic device

BackgroundLeft atrial appendage occlusion (LAAO) may be a viable option for stroke prevention in patients with non-valvular atrial fibrillation and a contraindication for oral anticoagulation. No evidence evaluating the safety of this procedure in patients with a cardiac implantable electronic device (CIED) exists. The aim of this study was to evaluate whether CIED function is affected by LAAO and to explore LAAO procedural characteristics and complications in patients with a CIED.MethodsThis single-center cohort study included consecutive patients scheduled for percutaneous LAAO. Patients with a CIED prior to LAAO were selected and compared to the patients without CIED, concerning procedural characteristics and peri-procedural complications. In the group of patients with CIEDs, essential pacemaker integrity parameters were compared before and after the procedure to detect possible micro and macro lead displacements.ResultsThirty-one patients with CIED were scheduled for LAAO (age 73.7 ± 5.4 years, 65% males, CHA2DS2-VASc 4.3 ± 1.5, and HAS-BLED 3.3 ± 1.0). The 245 patients without CIED were younger, and HAS-BLED-score was slightly lower (69.4 ± 8.2 years, p < 0.001; 2.8 ± 1.0, p = 0.022). Patients without CIED more frequently underwent LAAO combined with catheter ablation (p = 0.002). All other procedural characteristics were comparable between both groups. No visible lead displacement was observed on chest X-ray after LAAO. Additionally, no differences in impedance, threshold, or intracardiac sensing in various CIED lead locations were found prior versus post LAAO.ConclusionThis study supports the feasibility and safety of LAAO in patients with a CIED.