Left Atrial Appendage Closure Research Articles

Abstract 15986: Very Rare Case of a Interatrial Thrombus Following Watchman Device Placement

Introduction: Device related thrombus (DRT) is a known complication of left atrial appendage closure (LAAC). We present a case of a thrombus at the interatrial septum following LAAC detected eight months after the procedure. Case: Eighty-six years old woman with a history of coronary artery disease s/p percutaneous coronary intervention with drug eluting stent to right coronary artery in 2016, heart failure with preserved ejection fraction, atrial fibrillation (AF) s/p 27mm Watchman device placement (on aspirin only) due to recurrent episodes of hematuria, hypertension, hyperlipidemia, chronic kidney disease presented to the hospital with complaints of right flank pain. Initial labs were unremarkable except for anemia, hemoglobin of 10g/dl. Computed tomography (CT) abdomen and pelvis showed an incidental finding of new mass like filling defect within the left atrium. Transthoracic echocardiogram (TTE) showed mobile mass 1.7 x 1.6 cm attached to the interatrial septum on the left atrial side.(Figure 1.A) Low dose apixaban was started. Follow up transesophageal echocardiogram (TEE) in four months interval showed the thrombus attached to the interatrial septum had slightly reduced in size to 1.5 x 0.9 cm, but an additional large thrombus measuring 2.5 x 1.3 cm was seen on top of the Watchman device (Figure 1.B) and Apixaban was increased to full dose. Discussion: Incidence of DRT after LAAC is 3.74% with most cases occurring in the first year after LAAC. Exposed and incompletely endothelialized device are foci for DRT. Iatrogenic pericardial effusion, hypercoagulable state, deep implant, renal insufficiency, non-paroxysmal AF are some of the factors increasing the risk of device related thrombus. Most cases of DRT described are attached to the device. In our case, a large interatrial thrombus was identified incidentally which likely formed at the site of septal puncture during device insertion which highlights the importance of follow up echocardiogram at intervals.

Abstract 14299: Low Left Atrial Motion Automatically Calculated is Indicator of Atrial Cardiomyopathy and High Risk of Cardioembolic Stroke

Background: Atrial cardiomyopathy is considered to be an important risk factor for cardioembolic stroke. However, little is known how to evaluate the degree of atrial cardiomyopathy. Hypothesis: Left atrial ejection fractions (LAEF) are useful and more sensitive predictors of cardioembolic stroke. Aim; To identify the relationship between LAEF and clinical events such as cardioembolic stroke. Methods: The left atrial appendage closure (LAAC) database of our institution from February 2020 to April 2023 was retrospectively analyzed. The LAEF was calculated from cardiovascular computed tomography (CT) imaging data using the automatic 3-dimensional chamber analysis software. We examined the relationship between the risk of cardioembolic stroke and LAEF. Results: We enrolled 52 consecutive patients who underwent cardiovascular CT before LAAC (age, 75.3±1.1 years; female gender, 26.9%; BMI, 23.3±0.5 kg/m 2 ; CHA 2 DS 2 -VASc score, 4.8±0.2; HAS-BLED score, 3.3±0.1). Of those, 22 (42.3%) patients had histories of cardioembolic stroke. Comparison between patients with and without cardioembolic stroke were shown in Table1. Receiver-operating characteristic curve analysis confirmed that 16.32% was the best cut-off value of LAEF for the history of cardioembolic stroke (AUC = 0.81). In the multivariate analysis, LAEF ≤ 16.32% is the independent predictor for cardioembolic stroke (p-value = 0.0362, respectively) (Table2). Conclusions: Low left atrial motion was potential risk factor for cardioembolic stroke in this population. This result could have a relevant impact on the antithrombotic management of patients and, moreover, LAAC could be the best option for these patients.

Abstract 17596: Association of Racial-Ethnic Disparities and Frailty on Adverse Outcomes in Geriatric Patients Undergoing Elective Percutaneous Left Atrial Appendage Closure With Watchman Device

Introduction: Use of left atrial appendage closure (LAAC) has become more widespread in the geriatric population. Frailty, a geriatric syndrome, is associated with significant morbidity and mortality. Hypothesis: Race/Ethnicity influences frailty status and may differentially impact adverse outcomes in elective LAAC procedure. Methods: Patients aged ≥65 years who underwent elective LAAC were identified using ICD-10 procedure code 02L73DK from 2016-2018 HCUP-NIS Database. Hospital Frailty Risk Score (HFRS) was calculated for each patient based on 109 ICD-10 diagnosis codes and classified into non-frail (HFRS < 5) and frail (HFRS score ≥ 5) groups. Charlson comorbidity index (CCI) was used to assess comorbidity burden. In-hospital major adverse event (MAE) was defined as the composite of mortality, stroke (ischemic or hemorrhagic) or TIA, bleeding or transfusion, vascular complications, myocardial infarction, systemic embolization, and pericardial effusion or tamponade requiring pericardiocentesis or surgery. Outcome was in-hospital MAE. Multivariate regression analysis was used to assess the association of race/ethnicity and frailty on MAE. Results: 27,155 patients (Age = 77.3 ± 6.4 years; Female = 42.4%, White: 88%, Black: 3.4%, Hispanic:5.2%, Other: 3.4%) were included. Overall, the prevalence of frailty was 12.5% (White:12.4%, Black: 13.7%, Hispanic: 11.8%, Other: 13%). Overall, in-hospital MAE was 4.7%, with increased rates in frail patients (4% vs.9.6%; p<0.001). Rates of in-hospital MAE were frail-White: 9.3%, frail-Black: 8%, frail-Hispanic:20.6%, and frail-Other: 4.2% (p<0.001). On multivariate analysis, frail-White and frail-Hispanic patients were at increased risk of in-hospital MAE compared to non-frail patients (Figure). Conclusion: Further research is needed to highlight disparities by race/ethnicity and to identify potentially modifiable factors to mitigate adverse events in frail geriatric population undergoing LAAC.

Abstract 13662: Novel Morphological Classification of Left Atrial Appendage Using 3-Dimensional Printer -Rock, Paper and Scissors-

Background: Left atrial appendage (LAA) of Asians is generally larger and more complicated than that of non-Asians. Whereas the four classifications from previous reports are widely used in the world, different physicians have different point of views in the real-world practice. Purpose: To identify the relationship between morphological features of LAA and cardioembolic stroke in Japanese patients. Methods: All left atrial appendage closure (LAAC) cases in our institution performed between February 2020 and April 2023 were retrospectively analyzed. The three-dimensional printing of LAA was generated from cardiovascular computed tomography imaging data. The shapes of the LAA were classified into 3 morphological types: (1) The LAA with bi lobe was defined as “Scissors” type; (2) The one with complicated peripheral branches was “Paper” type; (3) The simple one was “Rock” type. We examined the relationship between the risk of cardioembolic stroke and the morphological features of the LAA. Results: The cohort consisted of 93 consecutive patients (age, 75±1 years; male gender, 72%; the size of WATCHMAN device, 29±0 mm). There were 41 (44%) patients who had a history of cardioembolic stroke (27% vs. 41% vs. 58%; Rock vs. Scissors vs. Paper types, p-value = 0.0466). In the multivariate analysis, the Paper type is the potential risk factor of cardioembolic stroke (p-value < 0.01) (Table1.2). Conclusions: The morphological features of LAA by three-dimensional printing was significantly related to cardioembolic stroke in this population. Physicians should pay attention to anticoagulant therapy management and proactively consider LAAC in LAA with complicated peripheral branches.

Abstract 14558: Causes and Predictors of Short-Term Readmissions Following Percutaneous Left Atrial Appendage Closure Procedure in Patients With and Without Rheumatic Mitral Valve Disease

Introduction: Atrial fibrillation (AF) is the most common cardiac arrhythmia, characterized by erratic heart beats. AF increases the risk of thromboembolic events particularly stroke. Percutaneous left atrial appendage closure (LAAC) is an alternative option to prevent embolic stroke in patients with AF who have contraindication to anticoagulants. Up to our knowledge, this is the first National Readmission Database (NRD) study to elucidate the difference in readmission rates between rheumatic vs non-rheumatic AF patients who underwent LAAC. Methods: We utilized the Nationwide Readmissions Database (NRD) between the years 2016-2020. The study involved hospitalizations with rheumatic mitral valve disease (R-MVD) and non-rheumatic mitral valve disease (NR-MVD) who underwent LAAC using ICD-10 diagnostic codes. We deemed this as the index admission. We excluded patients less than 18 years old and October-December hospitalizations from 90-day readmission analysis, due to lack of adjoining period to assess readmission. Results: Among 9,150 patients with mitral valve disease who underwent LAAC in their index hospitalizations, 9,122 were discharged alive. 4,200 patients (45.8%) were readmitted in 90-days. R-MVD 90-day readmission rate compared to NR-MVD (52.3% vs 40.7% respectively, p<0.001). The most common cause of readmission in both groups was atrial fibrillation, 96% of total readmissions in R-MVD and 97% of total readmissions in NR-MVD group. This was followed by “accidental puncture and laceration of a digestive system organ or structure” in 0.3% of R-MVD group vs “mitral valve insufficiency” in 0.7% of NR-MVD readmission causes. Figure 1 shows the Forest plot of multivariate analysis of independent factors associated with readmissions. Conclusion: Among AF patients who underwent LAAC with or without history of mitral valve rheumatic heart disease, those with history of R-MVD had significantly higher 90-day readmission rate.

Abstract 13650: Trends in Women Cardiac Operators of Structural and Interventional Procedures in the United States

Background: Women have historically been underrepresented in cardiology workforces. Throughout the United States, there is a major underrepresentation of women in cardiology as operators within structural proceduralists and interventional cardiology (IC). Methods: We extracted data from the Medicare Provider Utilization and Payment Database (MPUPD) from 2013 to 2020. The MPUPD is an administrative database of services rendered to Medicare patients enrolled in a fee-for-service program. We sought operators who performed >10 procedures using procedure codes for percutaneous transcatheter closure of congenital atrial septal defect (ASD) with implant and percutaneous coronary intervention, transcatheter mitral valve replacement via transcutaneous edge to edge repairs (TEER), and percutaneous left atrial appendage closure (PLAAO) using relevant CPT codes. The proportion of women operators was analyzed across the 8-year period. Results: Between 2013 and 2020, women on average represented 3.02% of the 1,260 cardiac operators identified. Despite the number of total structural operators performing 10 or more procedures increasing from 9 to 871 over the 8-year period, the proportion of women remained unchanged at less than 4.5% (P = 0.712) (Figure 1). By procedure, the total ASD, TEER, and PLAAO operators have increased, though the proportion of women operators remained constant over time (P = .913, .725 and .891). Over the studied period, there were no women operators identified with over 10 operations in 28 states (56%) for any structural procedures, 49 states (98%) for ASD procedures, 39 states (78%) for TEER, and 33 states (66%) of PLAAO. Conclusion: Women continue to represent an overwhelming minority of structural cardiac operators. Despite a rapid rise in the total number of operators, the proportion of female operators has not increased. Prospective studies are needed to investigate the underlying factors contributing to these sex-related differences.

Abstract 16630: Economic Impact of Frailty in Patients Undergoing Elective Percutaneous Left Atrial Appendage Closure (LAAC) With WATCHMAN Device

Introduction: Frailty is associated with significant morbidity and mortality in older adults. Currently, standard practice after percutaneous left atrial appendage closure involves monitoring patients overnight and discharging them the following day. Hypothesis: Frailty predicts increased hospital cost and length of stay (LOS) in patients undergoing elective LAAC with WATCHMAN device. Methods: Patients aged ≥65 years who underwent elective LAAC with WATCHMAN device were identified using ICD-10 procedure code 02L73DK from 2016-2018 HCUP-NIS Database. In-hospital major adverse event (MAE) was defined as the composite of mortality, stroke (ischemic or hemorrhagic) or TIA, bleeding or transfusion, vascular complications, myocardial infarction, systemic embolization, and pericardial effusion or tamponade requiring pericardiocentesis or surgery. Hospital Frailty Risk Score (HFRS) was calculated for each patient based on 109 ICD-10 diagnosis codes and classified into non-frail (HFRS < 5) and frail (HFRS score ≥ 5) groups. Multivariate regression analysis was used to assess the relationship between the HFRS and hospital cost hospitalization (≥90 centile) and prolonged LOS (>72 hours). Results: 28,050 patients (Age = 77.3 ± 6.4 years; Female = 42.6%) were included. Median hospitalization cost was $24,500 (inter-decile range: $14,000-37,100) and median LOS was 1 day (inter-decile range: 1-2 days) and 4.7% experienced in-hospital MAE. Frail patients (HFRS score ≥ 5) constituted 12.5% of the cohort. Increasing Hospital Frailty Risk Score was associated with a greater risk of high-cost hospitalization and LOS > 72 hours (Figure). Conclusions: Increasing frailty is a significant predictor of increased hospital cost and LOS in elective LAAC. This effect is independent of age and in-hospital MAE.

Application of three-dimensional printing in cardiovascular diseases: a bibliometric analysis.

This paper aimed to explore the application of three-dimensional (3D) printing in cardiovascular diseases, to reach an insight in this field and prospect the future trend. The articles were selected from the Web of Science Core Collection database. Excel 2019, VOSviewer 1.6.16, and CiteSpace 6.1.R6 were used to analyze the information. A total of 467 papers of 3D printing in cardiovascular diseases were identified, and the first included literature appeared in 2000. A total of 692 institutions from 52 countries participated in the relevant research, while the United States of America contributed to 160 articles and were in a leading position. The most productive institution was Curtin University , and Zhonghua Sun who has posted the most articles ( n =8) was also from there. The Frontiers in Cardiovascular Medicine published most papers ( n =25). The Journal of Thoracic and Cardiovascular Surgery coveted the most citations ( n =520). Related topics of frontiers will still focus on congenital heart disease, valvular heart disease, and left atrial appendage closure. The authors summarized the publication information of the application of 3D printing in cardiovascular diseases related literature from 2000 to 2023, including country and institution of origin, authors, and publication journal. This study can reflect the current hotspots and novel directions for the application of 3D printing in cardiovascular diseases.

Atrial Fibrillation Patients with Immune Thrombocytopenia: A Review of Management Options and Bleeding Risks

Aim : The objective of this research is to review the bleeding risks in patients with atrial fibrillation (Afib) and immune thrombocytopenia (ITP) and explore various management strategies to formulate an optimal therapeutic approach that improves the prognosis of these patients. Methods: In this study, we devised our search approach by utilizing PubMed's Medical Subject Headings (MeSH) terms and incorporating pertinent keywords extracted from article titles and abstracts. To ensure a comprehensive scope, we integrated terms associated with immune thrombocytopenia purpura, such as “Immune Thrombocytopenia,” and similar expressions. Additionally, terms related to atrial fibrillation, including “atrial fibrillation,” were included to identify articles discussing atrial fibrillation in the context of immune thrombocytopenia. To adapt the initial search strategy for Embase, Web of Science, and Scopus databases, we employed a polyglot translator. All identified studies resulting from the search strategy were imported into EndNote, where duplicate articles were meticulously removed. The remaining studies were then transferred to Rayyan for further duplicate elimination and to initiate the screening process. The study incorporates full-text articles, submitted abstracts, and conference abstracts. Excluded from this analysis were studies falling into the following categories: (1) animal studies, (2) reviews or non-original articles, and (3) non-English articles. Results: A total of 1891 articles were retrieved from four databases, and after careful selection, 14 relevant full-text articles were analyzed. Among these, 12 studies investigated the efficacy of anticoagulants in managing cases of concurrent Afib and ITP as well as their bleeding risks. Comparing bleeding risk between groups was usually done through measuring by CHA 2DS 2 VASc or HAS BLED scoring systems and survival was also compared by using Kaplan-Meier curves A few of them also compared the efficacy and safety of warfarin against Non-Vitamin K Antagonists which has shown that Non-Vitamin K Antagonists have a lower event rate of major bleeding, lower hazard ration of systemic embolism and higher survival rate compared to warfarin The remaining two papers explored the efficacy and safety of surgical interventions, specifically left atrial appendage closure. Many studies reported that anticoagulant therapies were associated with reduced bleeding risk and have shown promising outcomes in managing patients with Afib and ITP. Additionally, percutaneous left atrial appendage closure has been reported to be a potentially safe management option for atrial fibrillation in patients with primary hemostatic disorders, including thrombocytopenia. Conclusion: In essence, this review focused on investigating the bleeding risk associated with atrial fibrillation (Afib) in patients with immune thrombocytopenia (ITP) and examining available management strategies. While the precise pathophysiological mechanisms linking atrial fibrillation and ITP remain incompletely understood, the review emphasized the intricate interplay between thromboembolic risk and bleeding complications in this specific patient group. The findings suggest that certain anticoagulation regimens and also left atrial appendage closure have shown promising safety and effectiveness in Afib patients with thrombocytopenia. Nevertheless, further research with larger sample sizes and diverse populations is needed to enhance our understanding of the Afib-ITP relationship. Such studies will yield more definitive conclusions and valuable insights into optimal anticoagulation approaches and alternative therapies for patients with both Afib and ITP.

Comparison of intracardiac vs. transesophageal echocardiography for "one-stop" procedures of combined radiofrequency catheter ablation and left atrial appendage closure with the Watchman device in the treatment of atrial fibrillation.

This study aimed to assess the efficacy and safety of "one-stop" procedures that combined radiofrequency catheter ablation and left atrial appendage closure (LAAC) with the Watchman device under the guidance of intracardiac echocardiography (ICE) vs. transesophageal echocardiography (TEE) in patients with atrial fibrillation. In this study, we prospectively enrolled patients who underwent "one-stop" procedures under the guidance of ICE (n = 193, 109 men, 65.02 ± 8.47 years) or TEE (n = 109, 69 men, 64.23 ± 7.75 years) between January 2021 and October 2022. Intraprocedural thrombus formation in the left atrial appendage (LAA) was observed in 3 (1.46%) patients in the ICE group and 15 (11.63%) patients in the TEE group (P < 0.05) before LAAC. Total fluoroscopy time and dose in the ICE group were less than those in the TEE group. The total "one-stop" turnaround time and LAAC procedure time in the ICE group were significantly shorter than those in the TEE group (P < 0.05). Postoperative esophagus discomfort, nausea and vomiting, and hypotension were more often seen in the TEE group (P < 0.001). There was no significant difference in matched cases between ICE and fluoroscopy measurements (P = 0.082). The TEE results related to LAAC and clinical events were similar between the two groups during the follow-up (P > 0.05). The ICE-guided "one-stop" procedure was safe and feasible with less radiation exposure, shorter turnaround time, and fewer complications and intraoperative thrombus formations than the TEE group. ICE offered accurate measurements in the LAA dimension during LAAC. Echocardiography during the "one-stop" procedures was necessary to rule out the intraoperative thrombus.

Gender Specified In-Hospital Outcome after Left Atrial Appendage Closure with a Dual Occlusive Mechanism Device

Background: Recent studies have suggested an increased rate of adverse events in women following left atrial appendage occlusion (LAAO), particularly with dual occlusive mechanism devices. Objectives: This study aimed to investigate gender disparities in in-hospital adverse events and short-term device-related outcomes in an experienced center using dual occlusive mechanism devices exclusively. Methods: In a single-center retrospective study, patients who received dual occlusive mechanism devices (Amplatzer cardiac plug and Amulet) were analyzed. We assessed gender differences in patient characteristics, LAAO indications, procedural data, in-hospital complications, and short-term device-related outcomes in the form of one-month follow-up transesophageal echocardiography. Results: Among 474 patients, 211 (45%) were women. At device implantation, women were significantly older (77.45±6.98 years vs. 75.89±7.26; p = 0.01), with higher CHA2DS2Vasc scores (5.03±1.46 vs. 4.28±1.51; p &lt; 0.01) and lower HASBLED scores (3.78±1.06 vs. 4.03±1.12; p = 0.01) compared to men. Men had a higher prevalence of coronary artery disease (52% vs. 32%; p &lt; 0.01). LAAO indications did not significantly differ. Device success was 99% in men and 98% in women (p = 0.75). In-hospital complications, including deaths, major bleedings, and pericardial effusion, did not significantly vary by gender. Rates of device-related thrombus and device closure with a residual jet ≤ 5 mm were similar. Conclusions: In a large cohort of consecutive LAAO patients at an experienced center, gender was not linked to higher in-hospital complications.

Efficacy and safety of patients with chronic kidney disease undergoing left atrial appendage closure for atrial fibrillation.

The relative safety and efficacy of left atrial appendage closure (LAAC) for atrial fibrillation (AF) in patients with chronic kidney disease (CKD) have not been well defined. To evaluate the results in this cohort, we conducted a systematic review and meta-analysis of observational studies. We searched the PubMed, EMBASE, Web of Science, and Cochrane Library databases from inception to January 2023 for all relevant studies. Our inclusion criteria were met by twelve observational studies that included 61324 patients altogether. Compared with no CKD group, in-hospital mortality (OR: 2.84, 95% CI: 2.12-3.81, p<0.01, I2 = 0%), acute kidney injury (AKI) (OR: 4.39,95% CI:4.00-4.83, P<0.01, I2 = 3%), major bleeding events (OR: 1.44, 95% CI: 1.29-1.60, p<0.01 I2 = 0%), and pericardial effusion/tamponade (OR 1.30; 95% CI 1.13-1.51, p < 0.01; I2 = 0%) were more common in the CKD group, especially in patients with end-stage renal disease (ESRD). No significant difference was observed in the occurrence of stroke (OR: 1.24, 95% CI: 0.86-1.78, P = 0.25, I2 = 0%), LAAC success rates (OR: 1.02, 95% CI: 0.33-3.16, p = 0.97, I2 = 58%) and vascular access complications (OR: 1.13, 95% CI: 0.91-1.39, p = 0.28, I2 = 0%) between the two groups. During the follow-up, there was no difference in the risk of stroke between the two groups. CKD patients who receive LAAC have a greater risk of in-hospital mortality, AKI, pericardial effusion/tamponade, and major bleeding events than those without CKD, especially in patients with ESRD. No significant difference in the risk of stroke was found in the long-term follow-up after LAAC between the two groups, demonstrating a similar efficacy of LAAC to prevent stroke in CKD patients.

Combined Radiofrequency Ablation and Left Atrial Appendage Closure in Atrial Fibrillation and Systolic Heart Failure.

Managing patients with atrial fibrillation (AF) and comorbid heart failure (HF) with reduced (HFrEF) or mildly reduced ejection fraction (HFmrEF) is of clinical importance but a great challenge. This study aimed to evaluate the clinical benefit of the combined radiofrequency catheter ablation (RFCA) and left atrial appendage closure (LAAC) procedure in AF patients complicated with systolic HF. AF patients with HFrEF or HFmrEF who underwent the combined RFCA and LAAC procedure were prospectively enrolled in the LAACablation registry. The procedural complications and long-term outcomes were evaluated. Another cohort of AF patients with systolic HF who did not undergo either RFCA or LAAC were used for prognosis comparison. Among 802 AF patients who underwent the combined procedure, 65 patients were comorbid with systolic HF (25 with HFrEF and 40 with HFmrEF). The overall procedural complication rate was 9.2%, which was mainly attributed to acute decompensated HF (6.2%). Accompanied with markedly reduced AF burden (from median [25th, 75th percentile]: 100 [100, 100] to 0 [0, 1.2]%, p < 0.001), upward trajectories of cardiac function were observed in 51 (78.4%) patients, showing improvement in New York Heart Classification (p < 0.01), natriuretic peptide levels (from 1492 [809, 3259] to 413 [163, 880] pg/mL, p < 0.001) and left ventricular EF (from 42.6 ± 5.3 to 53.8 ± 8.2%, p < 0.001). During the 27-month follow-up period, death, thromboembolism, major bleeding, and HF rehospitalization were observed in three, one, one, and four patients, respectively. The observed event rates showed a significant reduction compared with the non-procedure AF-HF cohort (n = 138; for composite endpoint: hazard ratio: 2.509, 95% confidence interval: 1.415-4.449, p = 0.002) and with the respective rates predicted by risk scores. Combining RFCA and LAAC achieves acceptable safety and credible long-term efficacy in AF patients with systolic HF. Further randomized studies are warranted in a larger patient cohort.

Anticoagulation Status and Left Atrial Appendage Occlusion Indications in Hospitalized Cardiology Patients with Atrial Fibrillation: A Hellenic Cardiorenal Morbidity Snapshot (HECMOS) Sub-Study.

Background and Objectives: The proper use of oral anticoagulants is crucial in the management of non-valvular atrial fibrillation (AF) patients. Left atrial appendage closure (LAAC) may be considered for stroke prevention in patients with AF and contraindications for long-term anticoagulant treatment. We aimed to assess anticoagulation status and LAAC indications in patients with AF from the HECMOS (Hellenic Cardiorenal Morbidity Snapshot) survey. Materials and Methods: The HECMOS was a nationwide snapshot survey of cardiorenal morbidity in hospitalized cardiology patients. HECMOS used an electronic platform to collect demographic and clinically relevant information from all patients hospitalized on 3 March 2022 in 55 different cardiology departments. In this substudy, we included patients with known AF without mechanical prosthetic valves or moderate-to-severe mitral valve stenosis. Patients with prior stroke, previous major bleeding, poor adherence to anticoagulants, and end-stage renal disease were considered candidates for LAAC. Results: Two hundred fifty-six patients (mean age 76.6 ± 11.7, 148 males) were included in our analysis. Most of them (n = 159; 62%) suffered from persistent AF. The mean CHA2DS2-VASc score was 4.28 ± 1.7, while the mean HAS-BLED score was 1.47 ± 0.9. Three out of three patients with a a CHA2DS2-VASc score of 0 or 1 (female) were inappropriately anticoagulated. Sixteen out of eighteen patients with a CHA2DS2-VASc score 1 or 2 (if female) received anticoagulants. Thirty-one out of two hundred thirty-five patients with a CHA2DS2-VASc score > 1 or 2 (if female) were inappropriately not anticoagulated. Relative indications for LAAC were present in 68 patients with NVAF (63 had only one risk factor and 5 had two concurrent risk factors). In detail, 36 had a prior stroke, 17 patients had a history of major bleeding, 15 patients reported poor or no adherence to the anticoagulant therapy and 5 had an eGFR value < 15 mL/min/1.73 m2 for a total of 73 risk factors. Moreover, 33 had a HAS-BLED score ≥ 3. No LAAC treatment was recorded. Conclusions: Anticoagulation status was nearly optimal in a high-thromboembolic-risk population of cardiology patients who were mainly treated using NOACs. One out of four AF patients should be screened for LAAC.

Single antiplatelet therapy after left atrial appendage closure in patients with AF: safety and effectiveness

Introduction and objectivesThe optimal antithrombotic strategy following left atrial appendage closure (LAAC) is poorly defined in patients with nonvalvular atrial fibrillation. We assessed the safety and effectiveness of a single antiplatelet treatment (SAPT) strategy after LAAC in a population at high risk of ischemic and bleeding events. MethodsThis single-center, observational, prospective study included a consecutive cohort of patients who underwent LAAC using the LAmbre device (Lifetech Scientific, China) and who were discharged with SAPT. The primary outcome was a composite of stroke, systemic embolism, and device-related thrombosis during follow-up. Secondary endpoints were cardiovascular mortality and major bleeding events (BARC ≥3a). Clinical follow-up was performed at 1, 6, and 12 months and subsequently on an annual basis. Transesophageal echocardiography was performed at 1 and 12 months of follow-up. ResultsThe study comprised 74 patients. The median age was 77 [72-83] years and 43% were women. The cohort exhibited a high prevalence of comorbidities and cardiovascular risk factors. The median CHA2DS2-VASc and HAS-BLED scores were 4 [3-6] and 4 [4-5], respectively. The median length of follow-up was 2.5 years (188 patients-year). During follow-up, device-related thrombosis occurred in 3 patients (4%). Ischemic stroke occurred in 1 patient (1.3%, rate 0.5%/y), representing a 90.9% relative risk reduction compared with the risk predicted by CHA2DS2-VASc. Major bleeding events occurred in 12 patients (16%, 6.4%/y), with a relative risk reduction of 26.4% of that predicted by HAS-BLED. Cardiovascular-related mortality was observed in 2 patients (2.7%). ConclusionsSAPT appears to be a safe and effective treatment following LAAC in patients at high ischemic and hemorrhagic risk. Further studies are needed to confirm our findings.

Cost-effectiveness of left atrial appendage closure for stroke prevention in atrial fibrillation: a systematic review appraising the methodological quality

BackgroundThe increasing global prevalence of atrial fibrillation (AF) has led to a growing demand for stroke prevention strategies, resulting in higher healthcare costs. High-quality economic evaluations of stroke prevention strategies can play a crucial role in maximising efficient allocation of resources. In this systematic review, we assessed the methodological quality of such economic evaluations.MethodsWe searched electronic databases of PubMed, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, and Econ Lit to identify model-based economic evaluations comparing the left atrial appendage closure procedure (LAAC) and oral anticoagulants published in English since 2000. Data on study characteristics, model-based details, and analyses were collected. The methodological quality was evaluated using the modified Economic Evaluations Bias (ECOBIAS) checklist. For each of the 22 biases listed in this checklist, studies were categorised into one of four groups: low risk, partial risk, high risk due to inadequate reporting, or high risk. To gauge the overall quality of each study, we computed a composite score by assigning + 2, 0, − 1 and − 2 to each risk category, respectively.ResultsIn our analysis of 12 studies, majority adopted a healthcare provider or payer perspective and employed Markov Models with the number of health states varying from 6 to 16. Cost-effectiveness results varied across studies. LAAC displayed a probability exceeding 50% of being the cost-effective option in six out of nine evaluations compared to warfarin, six out of eight evaluations when compared to dabigatran, in three out of five evaluations against apixaban, and in two out of three studies compared to rivaroxaban. The methodological quality scores for individual studies ranged from 10 to − 12 out of a possible 24. Most high-risk ratings were due to inadequate reporting, which was prevalent across various biases, including those related to data identification, baseline data, treatment effects, and data incorporation. Cost measurement omission bias and inefficient comparator bias were also common.ConclusionsWhile most studies concluded LAAC to be the cost-effective strategy for stroke prevention in AF, shortcomings in methodological quality raise concerns about reliability and validity of results. Future evaluations, free of these shortcomings, can yield stronger policy evidence.

Transseptal puncture in left atrial appendage closure guided by 3D printing and multiplanar CT reconstruction.

The presented study investigates the application of bi-arterial 3D printed models to guide transseptal puncture (TSP) in left atrial appendage closure (LAAC). The objectives are to (1) test the feasibility of 3D printing (3DP) for TSP guidance, (2) analyse the distribution of the optimal TSP locations, and (3) define a CT-derived 2D parameter suitable for predicting the optimal TSP locations. Preprocedural planning included multiplanar CT reconstruction, 3D segmentation, and 3DP. TSP was preprocedurally simulated in vitro at six defined sites. Based on the position of the sheath, TSP sites were classified as optimal, suboptimal, or nonoptimal. The aim was to target the TSP in the recommended position during the procedure. Procedure progress was assessed post hoc by the operator. Of 68 screened patients, 60 patients in five centers (mean age of 74.68 ± 7.64 years, 71.66% males) were prospectively analyzed (3DP failed in one case, and seven patients did not finally undergo the procedure). In 55 patients (91.66%), TSP was performed in the optimal location as recommended by the 3DP. The optimal locations for TSP were postero-inferior in 45.3%, mid-inferior in 45.3%, and antero-inferior in 37.7%, with a mean number of optimal segments of 1.34 ± 0.51 per patient. When the optimal TSP location was achieved, the procedure was considered difficult in only two (3.6%) patients (but in both due to complicated LAA anatomy). Comparing anterior versus posterior TSP in 2D CCT, two parameters differed significantly: (1) the angle supplementary to the LAA ostium and the interatrial septum angle (160.83° ± 9.42° vs. 146.49° ± 8.67°; p = 0.001), and (2) the angle between the LAA ostium and the mitral annulus (95.02° ± 3.73° vs. 107.38° ± 6.76°; p < 0.001), both in the sagittal plane. In vitro TSP simulation accurately determined the optimal TSP locations for LAAC and facilitated the procedure. More than one-third of the optimal TSP sites were anterior.

Cost-effectiveness of left atrial appendage closure with Watchman for non-valvular atrial fibrillation patients in Japan

AimsLeft atrial appendage closure (LAAC) has been demonstrated to be cost-saving relative to oral anticoagulants for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF) in the United States and Europe. This study assessed the cost-effectiveness of LAAC with the Watchman device relative to warfarin and direct oral anticoagulants (DOACs) for stroke risk reduction in NVAF from a Japanese public healthcare payer perspective.MethodsA Markov model was developed with 70-year-old patients using a lifetime time horizon. LAAC clinical inputs were from pooled, 5-year PROTECT AF and PREVAIL trials; warfarin and DOAC inputs were from published meta-analyses. Baseline stroke and bleeding risks were from the SALUTE trial on LAAC. Cost inputs were from the Japanese Medical Data Vision database. Probabilistic and one-way sensitivity analyses were performed.ResultsOver the lifetime time horizon, LAAC was less costly than warfarin (savings of JPY 1,878,335, equivalent to US $17,600) and DOACs (savings of JPY 1,198,096, equivalent to US $11,226). LAAC also provided 1.500 more incremental quality-adjusted life years (QALYs) than warfarin and 0.996 more than DOACs. In probabilistic sensitivity analysis, LAAC was cost-effective relative to warfarin and DOACs in 99.98% and 99.73% of simulations, respectively. LAAC dominated (had higher cumulative QALYs and was less costly than) warfarin and DOACs in 89.94% and 83.35% of simulations, respectively.ConclusionsOver a lifetime time horizon, LAAC is cost-saving relative to warfarin and DOACs for stroke risk reduction in NVAF patients in Japan and is associated with improved quality-of-life.

Combination of percutaneous left appendage epicardial ligation and endo-epicardial atrial fibrillation ablation.

Atrial fibrillation (AF) is the main cause of cardioembolic stroke. In high-bleeding-risk patients, long-life anticoagulation therapy is not permitted, and left atrial appendage (LAA) closure may be considered. LAA is also a critical substrate for AF. Epicardial LAA occlusion has several advantages: LAA ligation results in a favorable electrical and structural atrial remodeling, which decreases AF recurrence. Endocardial ablation alone is not efficient for all patients, and new evidence shows better outcomes in patients affected by persistent AF after a combined hybrid endo-epicardial ablation. Considering the synergic potential of these techniques, in this case series, they were both combined in a single procedure. We describe the treatment of 5 patients referred for refractory AF ablation and LAA closure. All patients had high thrombotic and previous major hemorrhage, with relative contraindication to life-long therapy with anticoagulation. A combined procedure of LAA ligation and endo-epicardial ablation was scheduled with short-term anticoagulation. LAA closure was performed with an epicardial approach using the LARIAT system. Then, LA mapping and ablation were performed, endocardially and then epicardially.All procedures were concluded without complications.At follow-up, in all patients, transesophageal echocardiography showed the complete occlusion of the LAA; therefore, anticoagulation therapy was interrupted. All patients were asymptomatic, and in the sinus rhythm, no hemorrhage or ischemic events occurred. The combination of percutaneous LAA ligation and endo-epicardial ablation was revealed to be feasible and safe and might represent a new approach for the treatment of refractory AF in patients with indication of LAA occlusion.

Left atrial appendage closure in very elderly patients in the French National Registry

ObjectiveLeft atrial appendage closure (LAAC) is recommended to decrease the stroke risk in patients with atrial fibrillation and contraindications to anticoagulation. However, age-stratified data are scarce. The aim of this...