Left Atrial Appendage Closure Device Research Articles

Management of peri-device leaks after left atrial appendage closure using endovascular coils and/or amplatzer plugs and radiofrequency ablation

Abstract Background Peri-device leaks (PDLs) after left atrial appendage closure (LAAC) portend a higher residual risk of thromboembolism in patients with Atrial Fibrillation (AF). Therefore, closure of PDLs has evolved as a procedural strategy to mitigate this residual thromboembolic risk. Objective To present our procedural experience and outcome data in patients who underwent PDL-closure after prior LAAC. Methods We performed a retrospective review of patients with follow-up imaging data (either transesophageal echocardiograms or Cardiac CT scans) performed at ∼1 year after LAAC between the time-period 5/2015 – 10/2022 to assess PDLs. Results We included a total of 532 patients with follow-up imaging data. At a mean follow up of 696±359 days post-LAAC, 63 of 532 (11.8%) patients underwent PDL closure. These PDL closure cohort was age 73.1±9.5 years, 41 of 62 (65%) had paroxysmal AF, and the CHA2DS2-Vasc was 3.7±1.5. In 42 of 62 (67.7%) patients, the initial LAAC device was Watchman, and in 21 (33.8%) patients, it was Watchman-FLX. Of the PDL closure cohort, 8 of 62 (12.9%) had a post-LAAC thromboembolic event (transient ischemic attack [TIA], stroke or systemic embolism). The PDL size was 3.8±2.0 mm. PDL closure was performed using endovascular coils alone in 23 (37.1%), plugs (Amplatzer devices, Abbott) alone in 18 (29%), and combinations of both in 13 (19.4%) patients. In 8 (14.5%) patients, radiofrequency ablation was used in concert with both coils and plugs (Figure). There was only 1 complication (pericardial effusion drained percutaneously) during the PDL closure procedure. During follow-up post-PDL closure, no patient sustained a stroke and only 1 patient had a TIA (Table). Conclusions Our data indicate that PDL closure after LAAC is feasible and safe, with a low risk of procedural complications. Such a strategy can be used in a subset of high-risk patients with PDL after LAAC who are at an elevated residual risk of thromboembolism.Table summarizing procedural strategies

Safety and feasibility of atrial fibrillation ablation after left atrial appendage closure: A single‐center experience of the left atrial appendage closure first strategy

AbstractBackgroundPatients with atrial fibrillation (AF) who are not suitable for long‐term anticoagulant therapy undergo percutaneous left atrial appendage closure (LAAC). The safety and feasibility of left atrial catheter ablation (CA) procedures after LAAC remain unclear. This study aimed to clarify the feasibility and safety of CA after LAAC, including in the early phase within 180 days.MethodsCharacteristics and clinical outcomes of 46 patients with AF who had undergone both CA and LAAC within 2 years (mean age, 72 years; 29 men) were compared between those who had undergone CA‐first (31 patients) and LAAC‐first (15 patients).ResultsThe mean CHA₂DS₂‐VASc and HAS‐BLED scores were 4.8 and 3.3 points, respectively. The LAAC‐first strategy was often used in patients with prior major bleeding and LAA thrombosis or sludge. In the LAAC‐first group, the mean duration between both procedures was 212 days, and all LAAC‐first patients, including seven patients in the early phase, could undergo CA without LAAC device‐related complications; moreover, no cardiovascular adverse events were reported after both procedures (mean periods: 420 days). After CA post‐LAAC, no device‐related adverse events (device‐related thrombosis, new peri‐device leak appearance, peri‐device leak increase, or device dislodgement) were observed, whereas, after LAAC post‐CA, 3 new peri‐device leak appearance events and 1 peri‐device leak increase event were observed, especially patients who underwent LAAC in the early phase post‐CA.ConclusionBased on single‐center experience, left atrial CA in the presence of an LAAC device implanted including the early phase was safe and feasible.

Pericardial Effusion After Left Atrial Appendage Closure: Timing, Predictors, and Clinical Impact

BackgroundPericardial effusion (PE) is the most common serious left atrial appendage closure (LAAC) complication, but its mechanisms, time course, and prognostic impact are poorly understood. ObjectivesThis study sought to assess the frequency, timing, predictors and clinical impact of PE after LAAC. MethodsData on consecutive patients undergoing percutaneous LAAC between 2009 and 2022 were prospectively collected including the 1-year follow-up. Both single (Watchman 2.5/FLX, Boston Scientific) and double (Amplatzer Cardiac Plug or Amulet, St. Jude Medical/Abbott) LAAC devices were used. An imaging core laboratory adjudicated the PEs and categorized them as early (≤7 days) and late (8-365 days). Logistic regression analysis was used to identify predictors of early and overall PE. ResultsOf 1,023 attempted LAAC procedures, PE was observed in 44 (4.3%) patients; PE was categorized as early in 34 (3.3%) and late in 10 (0.9%) patients. The majority of PEs occurred within 6 hours after LAAC (n = 25, 56.8%) and were clinically relevant (n = 28, 63.6%). Independent predictors of early PE were double-closure left atrial appendage devices (adjusted OR: 8.20; 95% CI: 1.09-61.69), female sex (adjusted OR: 3.41; 95% CI: 1.50-7.73), the use of oral anticoagulation (OAC) at baseline (adjusted OR: 2.60; 95% CI: 1.11-6.09), and advanced age (adjusted OR: 1.07; 95% CI: 1.01-1.23), whereas female sex and OAC at baseline remained independent predictors of overall PE. ConclusionsIn this large LAAC registry, PE was observed in <1 in 20 patients and usually occurred within 6 hours after procedure. The majority of early PEs were clinically relevant and occurred in the Amplatzer Cardiac Plug/Amulet procedures. Independent predictors included the use of double-closure devices, female sex, OAC at baseline, and advanced age. (LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure; NCT04628078)

Segmentation of the left atrial appendage based on fusion attention.

In clinical practice, the morphology of the left atrial appendage (LAA) plays an important role in the selection of LAA closure devices for LAA closure procedures. The morphology determination is influenced by the segmentation results. The LAA occupies only a small part of the entire 3D medical image, and the segmentation results are more likely to be biased towards the background region, making the segmentation of the LAA challenging. In this paper, we propose a lightweight attention mechanism called fusion attention, which imitates human visual behavior. We process the 3D image of the LAA using a method that involves overview observation followed by detailed observation. In the overview observation stage, the image features are pooled along the three dimensions of length, width, and height. The obtained features from the three dimensions are then separately input into the spatial attention and channel attention modules to learn the regions of interest. In the detailed observation stage, the attention results from the previous stage are fused using element-wise multiplication and combined with the original feature map to enhance feature learning. The fusion attention mechanism was evaluated on a left atrial appendage dataset provided by Liaoning Provincial People's Hospital, resulting in an average Dice coefficient of 0.8855. The results indicate that the fusion attention mechanism achieves better segmentation results on 3D images compared to existing lightweight attention mechanisms.

Pre-Clinical Evaluation of Left Atrial Appendage Closure Device in Mitigating Risk of Stroke in Patients with Atrial Fibrillation: Promising Results from Animal Trials with Future Prospects

Abstract: Atrial fibrillation (AF) is the most common clinical disorder of cardiac arrhythmia in geriatrics, characterized by the presence of disorganized and irregular electrical activity in atrial myocardium, which leads to worsening of the heart's systolic function. Left atrial appendage (LAA) is a tubular, tiny aperture construction, connecting the left atrium (LA) with separate structure from LA with distinctive mechanical, hormonal, and structural properties. AF and Mitral valve regurgitation disease elevate the chances of thrombus formation in LAA, these ultimately turns into stroke. Obstructing thrombus by using a Left Atrial Appendage Closure Device (LAAC) and preventing it from entering internal carotid arteries, the risk of LAA thrombosis can be decreased. This article serves as a comprehensive compilation detailing the successful development and implantation of Left Atrial Appendage Closure (LAAC) Device with its novel design and geometry in two pigs (pre-clinical evaluation), showcasing promising results that have future implications for addressing cardiovascular disease in humans.

Contrast-free left atrial appendage occlusion in patients using the LAMBRE™ device

BackgroundAdvances in imaging have led to procedural optimization of left atrial appendage closure (LAAC). Contrast-free approaches, guided merely by echocardiography, have been established, however data on this topic remains scarce. In this analysis, we assessed contrast-free procedural results with the LAMBRE LAAC device. MethodsThe multicenter retrospective BoBoMa (Bonn/Bordeaux/Mainz)-Registry included a total of 118 patients that underwent LAAC with LAMBRE devices omitting contrast-dye. Baseline and echocardiographic characteristics as well as intra- and postprocedural complications and outcomes were assessed. ResultsPatients were at a mean age of 77.5 ± 7.5 years with high thromboembolic and bleeding risk (CHADS-VASc-score 4.6 ± 1.4, HAS-BLED-score 3.7 ± 1.0, respectively). Renal function was impaired with a mean glomerular filtration rate (GFR) of 50 ± 22 ml/min. Mean procedural time was 47.2 ± 37.5 minutes with a mean radiation dose of 4.75 ± 5.25 Gy*cm2. Device success, defined as proper deployment in a correct position, was achieved in 97.5% (115/118) of cases with repositioning of the occluder in 7.6% (9/118) and resizing in 3.4% (4/118) of cases. No relevant peri-device leakage (>3 mm) was observed with 42% of occluders being implanted in an ostial position. Periprocedural complications occurred in 6.8% (8/118) of cases, including two cases of device embolization and one case of clinically-relevant pericardial effusion requiring surgical intervention. Other complications included pericardial effusion (2.5%, 3/118) and vascular access site complications (1.7%, 2/118). ConclusionEchocardiography-guided contrast-free LAAC using the LAMBRE device is safe and feasible. Further prospective studies including the direct comparison of devices as well as imaging techniques are warranted in contrast-free LAAC.

The use of percutaneous left atrial appendage occluder device in a patient with prior surgical ligation with incomplete exclusion: a case report

Abstract Background Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and the most common cause of cardioembolic stroke. The left atrial appendage (LAA) is the main source of thrombus formation in patients with AF. Therapies include use of percutaneous LAA closure devices, or surgical LAA occlusion (LAAO). Despite these options, complete closure of the LAA is not always achieved, and residual communication between the LAA and atrium may result in increased thrombus formation. Although studies have analysed the use of percutaneous measures such as coils, plugs, or second occluder device deployment in LAA with peri-device leak (PDL), use of percutaneous occlude devices in surgically occluded LAA is far less studied. Case summary We present a case of a 79-year-old female patient who underwent LAAO device deployment within a surgically occluded LAA with PDL. She underwent 27 mm LAAO device (WATCHMANTM) deployment and all the P.A.S.S. (Position, Anchor, Size, and Seal) criteria were satisfied. Only 1.4 mm PDL was present. She was continued on apixaban and aspirin post-operatively. Post-operative transoesophageal echocardiogram at 6 weeks demonstrated trivial PDL measuring 1.49 mm. Patient was continued on aspirin and clopidogrel, with discontinuation of apixaban. Discussion Percutaneous LAAO device deployment in previously surgically ligated LAA with incomplete exclusion is a potential therapeutic option for patients with AF and a high bleeding risk seeking a minimally invasive strategy, in an attempt to de-escalate anticoagulation therapy.

Left Atrial Appendage Closure: A Narrative Review.

Atrial fibrillation (AF) is the most commoncardiac arrhythmiaand the cause of thromboembolic events in elderly patients worldwide. AF is associated with a significantly increased risk of morbidity and mortality due to cardiac emboli, primarily from left atrial appendage (LAA) thrombus. Oralanticoagulation therapy is the standard treatment to effectively reduce the risk of thromboembolic events in patients with AF. However, anticoagulation treatment increases bleeding risk. LAA closure (LAAC) has recently been introduced as afeasible mechanical preventive intervention for thromboembolic events while minimizing the risk of bleeding. Transcatheter LAAC devices have evolved in the past decade, and several ongoing trials have demonstrated the improvements of safety and outcomes in newer generation devices. This review summarizes the current perspectives and outcomes regarding LAAC as an alternative to pharmacologic therapy.

Reactive atrial-based anti-tachycardia pacing algorithm in cardiovascular implantable electronic devices is safe and feasible without increase in thromboembolic events in patients with a left atrial appendage closure device

BackgroundReactive atrial-based anti-tachycardia pacing (rATP) in CIED (cardiovascular implantable electronic devices) is effective in atrial fibrillation (AF) suppression. Uninterrupted systemic anticoagulation is recommended when this algorithm is activated to avoid stroke, however, the use of a rATP algorithm in patients with a left atrial appendage (LAA) closure device has not been studied. We assessed the safety and feasibility of rATP algorithm to suppress AF in patients with a LAA closure device over an extended period.MethodsData from 55 consecutive patients who underwent a Watchman® implant at a tertiary care hospital between September 1, 2015, and January 30, 2020, who also had an in situ Medtronic® CIED (45 with and 10 without rATP capability) were retrospectively reviewed.ResultsThe 55-patient cohort was 60% male, 77 ± 8 years old, CHA2DS2-VASc score 5 (4–6), HAS-BLED score 3 (3–4), LVEF 53 ± 14%, LA size 4.4 ± 0.7 cm and ventricular pacing burden of 73 (1.4–98.3)%. The CIEDs (20 ICDs and 35 pacemakers) antedated Watchman® implants by 915 ± 725 days. Post-implant, all patients discontinued anticoagulation. Twenty patients in the rhythm-control group with active rATP algorithm displayed no increase in yearly AF burden and were less likely to develop permanent/long-standing persistent AF (p = 0.002) when compared to 35 patients in the rate-control group with CIEDs inactive/incapable of rATP over a ≤ 5-year follow-up. The longest AF episode in the rhythm-control group lasted 204 (19–2520) h. There was no increase in stroke/thromboembolism and a significant reduction in major bleeding noted over ≤ 5 years pre- versus post-implant in the whole cohort (p = 0.005).ConclusionrATP algorithm use is safe and feasible in patients with a Watchman® device. Patients should be forewarned of a surge in post-Watchman® implant AF burden.

Characterization of Left Atrial Appendage Closure Device Protrusion and Implications for Transcatheter Mitral Valve Replacement

Characterization of Left Atrial Appendage Closure Device Protrusion and Implications for Transcatheter Mitral Valve Replacement

Transcatheter mitral valve leak closure with left atrial appendage closure device: kill two birds with one stone.

Transcatheter mitral valve leak closure with left atrial appendage closure device: kill two birds with one stone.

Catheter based left atrial appendage closure in-hospital outcomes in Germany from 2016 to 2020.

New and refined catheter based left atrial appendage (LAA) closure devices have been introduced in the past decade. The procedure can be performed using either an endocardial occlusion device or an epicardial loop stitch. We aimed to analyzed recent procedural safety. Catheter based LAA closures were identified in a complete nationwide German dataset via ICD and OPS codes from 2016 to 2020. From 2016 to 2020, 28,039 endocardial and 213 epicardial occlusions were performed. Numbers of endocardial procedures increased from 5259 in 2016 to 5917 in 2020 (p = 0.020) in 387 centers with shifting of patients' characteristics towards older age (β = 0.29, p < 0.001), more heart failure (β = 1.01, p < 0.001) and renal disease (β = 0.67, p = 0.001) and without a significant trend for in-hospital safety except more bleeding (β = 0.12, p = 0.05). In-hospital major adverse cardiac and cerebrovascular events (MACCE) or pericardial puncture were independent on center procedure numbers. The loop stitch procedure was performed in 15 centers. Patients were younger (76.17 ± 8.16 vs. 73.16 ± 8.99, p < 0.001) and had a lower comorbidity index (2.29 ± 1.93 vs. 1.92 ± 1.64, p = 0.005). Adjusted risk difference for pericardial effusion (8.04%; 95% CI 3.01-13.08%; p = 0.002) and pericardial puncture (6.60%; 95% CI 3.85-9.35%; p < 0.001) was higher for the loop stitch procedure, while risk of bleeding (- 1.85%; 95% CI - 3.01 to - 0.69%; p = 0.002), intracerebral bleeding (- 0.37%; 95% CI - 0.59 to - 0.15%; p = 0.001) and shock (- 1.41%; 95% CI - 2.44 to - 0.39%; p = 0.007) was lower. No significant difference was observed for in-hospital MACCE. Endocardial occlusion was the major catheter based LAA closure procedure in Germany without improvements in in-hospital safety from 2016 to 2020. In-hospital MACCE was independent on endocardial LAAC center volumes. Conclusions on the comparison between the two procedure types must be made cautious as the LAA loop stitch occlusion was utilized limited in a minor number of centers. Catheter based left atrial appendage closure in-hospital outcomes in Germany from 2016 to 2020.

The Emerging Role of Intracardiac Echocardiography (ICE) in Left Atrial Appendage Closure (LAAC).

Intracardiac echocardiography (ICE) has emerged as a powerful imaging tool to guide percutaneous left atrial appendage closure (LAAC). Herein, we review an imaging protocol for ICE-guided LAAC and discuss the evidence for its use. Standardized imaging protocols have been proposed but have not been fully validated. ICE imaging yields similar procedural and clinical outcomes when compared to transesophageal echocardiography (TEE) to guide LAAC. Despite benefits of avoiding general anesthesia, TEE, and multiple physicians for LAAC procedures, ICE imaging remains under-utilized. Novel ICE catheters with 3D imaging capabilities may improve accuracy and efficiency of LAAC device implantation. ICE guidance is feasible, safe, and effective for LAAC. As the field evolves, further studies will be necessary to assess this technological advancement in imaging guidance.

Novel streamlined technique for left atrial appendage closure using a radiofrequency wire-based large access system.

Transseptal puncture (TSP) to allow for large delivery sheath left atrial (LA) access remains a challenging aspect of LA appendage closure (LAAC) in patients with prior history of TSP, thick or lipomatous septum, atrial septal aneurysms, or other complex cardiac anatomies. This study investigates the use of the VersaCross large access (VLA) system (Baylis Medical/Boston Scientific) to improve procedural efficiency of LAAC compared to the standard needle workflow. Fifty LAAC procedures using WATCHMAN FLX between November 2021 and September 2022 were retrospectively analyzed comparing the VLA workflow (n = 25) to the standard needle workflow (n = 25). Study primary endpoint was time to procedural efficiency, and secondary endpoints included TSP time, acute LAAC success, fluoroscopy use, device recaptures, and periprocedural complications. Acute LAAC was successfully completed in all cases with no intraprocedural complications. TSP time was faster, but not significant, using the VLA workflow compared to the standard RF needle workflow (2.6 ± 1.1 min vs. 3.0 ± 1.8 min, p = 0.38). Time to WATCHMAN sheath in LA from TSP was 27% faster (1.5 ± 0.8 min vs. 2.1 ± 0.9 min; p = 0.03), and time to WATCHMAN release from TSP was 19% faster (10.5. ± 2.5 min vs. 13.0 ± 3.7 min; p = 0.01) with the VLA workflow. Overall procedure time was 15% faster (30.4 ± 5.1 min vs. 36.0 ± 6.6 min; p = 0.003) using VLA. Fluoroscopy time was 25% lower (4.0 ± 2.2 min vs. 5.5 ± 2.3 min; p = 0.003) and fluoroscopy dose was 60% lower (97.0 ± 91.7 mGy vs. 241.8 ± 240.6 mGy; p = 0.01) and more consistent [F-test, p ˂ 0.0001] using the VLA workflow compared to the needle workflow. The VLA system streamlines LAAC procedures, improving LAAC efficiency and reducing fluoroscopy use by allowing for de novo dilation of the septum for large-bore delivery sheaths, and reducing device exchanges and delivery sheath manipulation.

Left Atrial Appendage Occlusion Strengths and Weaknesses of the Lobe-Only Occluder Concept in Theory and in Practice

Left atrial appendage closure aims to eliminate the stasis component of Virchow triad by eliminating a cul-de-sac that favors thrombosis, particularly when atrial contractility becomes inefficient, such as in atrial fibrillation. Left atrial appendage closure devices have a common objective of sealing the appendage completely, with device stability and avoidance of device thrombosis. Two main device designs have been used to perform left atrial appendage closure: those that use a pacifier design (lobe+disk) and those that use a plug (single lobe) design. This review highlights the potential features and benefits of the single-lobe devices.

MT45 Cost-Effectiveness Analysis of Left Atrial Appendage Closure (LAAC) Device Vesus Warfarin and New Oral Anticoagulants (NOACS) in Patients with Atrial Fibrillation (AF) - Large Brazilian Healthcare Payer Perspective

Atrial fibrillation (AF) is associated with increasing risk for stroke. Strokes are related to a large economic burden such as increased health expenditures, high and prolonged rates of hospitalization. Left atrial appendage closure (LAAC) emerged as viable treatment alternative for stroke risk reduction. The objective of the study was to evaluate the cost-effectiveness of LAAC with WATCHMAN device in the perspective of a large Brazilian healthcare payer with more than 18 million patients.

Intracardiac echocardiographic imaging with a cartosound module for guidance of left atrial appendage closure: a comparative study with transesophageal echocardiographic imaging.

In most clinical trials, intracardiac echocardiography (ICE) has provided fewer views than the four standard views provided by transesophageal echocardiography (TEE) when assessing left atrial appendage closure (LAAC) devices. This study aimed to determine if ICE guided by the CartoSound system achieve adequate high-quality views and similar clinical outcomes as TEE during LAAC. This study prospectively enrolled 202 patients who underwent LAAC using either ICE (n = 69), TEE (n = 121), or a combination of ICE and TEE (n = 12) as the procedural imaging under local anesthesia. A novel multi-angled "FLAVOR" approach was used for assessment in the ICE group. ICE allowed visualization of the implanted devices in all patients at all proposed angles with long-axis views while two-dimensional (2D) TEE showed short-axis views in 1 or 2 angles in 24.2% of cases, which was more prevalent when the pulmonary ridge was covered by the occluder. In the combined ICE-TEE cohort, 2D-TEE failed to detect peri-device leak in 1 patient. The complication rates were similar between the ICE and TEE groups. Shorter fluoroscopy time, lower radiation dose and contrast usage were founded in the ICE group. At first TEE follow-up, the rate and degree of peri-device leak were similar between the ICE and TEE groups. A systematic ICE protocol using a CartoSound module to guide LAAC was reliable for comprehensive long-axis imaging assessment compared with 2D/3D TEE under local anesthesia with a shorter fluoroscopy time, lower radiation dose, and less use of contrast.

Transcatheter Left Atrial Appendage Closure: Devices Available, Pitfalls, Advantages, and Future Directions

Transcatheter left atrial appendage closure has emerged as a non-pharmacological alternative to long-term anticoagulation for stroke prevention in appropriately selected patients with AF. In this concise review article, the Food and Drug Administration-approved and some other left atrial appendage closure devices that are under investigation are discussed. Currently, Watchman Flx and Amplatzer Amulet are the only two devices that have been approved for commercial use by the Food and Drug Administration. A brief overview of device designs, clinical data on efficacy and safety, major limitations of left atrial appendage closure devices, and perspectives on future direction are provided. The current generation of devices is effective; however, efforts should continue on innovations and refinement of device technology.

Enhanced Thromboresistance and Endothelialization of a Novel Fluoropolymer-Coated Left Atrial Appendage Closure Device

BackgroundDevice-related thrombus (DRT) after left atrial appendage closure (LAAC) procedures is a rare but potentially serious event. Thrombogenicity and delayed endothelialization play a role in the development of DRT. Fluorinated polymers are known to have thromboresistant properties that may favorably modulate the healing response to an LAAC device. ObjectivesThe goal of this study was to compare the thrombogenicity and endothelial coverage (EC) after LAAC between the conventional uncoated WATCHMAN FLX (WM) and a novel fluoropolymer-coated WATCHMAN FLX (FP-WM). MethodsCanines were randomized for implantation with WM or FP-WM devices and given no postimplant antithrombotic/antiplatelet agents. The presence of DRT was monitored by using transesophageal echocardiography and verified histologically. The biochemical mechanisms associated with coating were assessed by using flow loop experiments to quantify albumin adsorption, platelet adhesion, and porcine implants to quantify EC and the expression of markers of endothelial maturation (ie, vascular endothelial-cadherin/p120-catenin). ResultsCanines implanted with FP-WM exhibited significantly less DRT at 45 days than those implanted with WM (0% vs 50%; P < 0.05). In vitro experiments showed significantly greater albumin adsorption (52.8 [IQR: 41.0-58.3] mm2 vs 20.6 [IQR: 17.2-26.6] mm2; P = 0.03) and significantly less platelet adhesion (44.7% [IQR: 27.2%-60.2%] vs 60.9% [IQR: 39.9%-70.1%]; P < 0.01) on FP-WM. Porcine implants showed significantly greater EC by scanning electron microscopy (87.7% [IQR: 83.4%-92.3%] vs 68.2% [IQR: 47.6%-72.8%]; P = 0.03), and higher vascular endothelial-cadherin/p120-catenin expression after 3 months on FP-WM compared with WM. ConclusionsThe FP-WM device showed significantly less thrombus and reduced inflammation in a challenging canine model. Mechanistic studies indicated that the fluoropolymer-coated device binds more albumin, leading to reduced platelet binding, less inflammation, and greater EC.

PO-03-184 ASSESSMENT OF PRICE VARIATION IN PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE DEVICE PROCEDURES AT US HOSPITALS

Since their approval in the US in 2015, left atrial appendage closure (LAAC) devices have served as an alternative to oral anticoagulation in atrial fibrillation (AF) patients at increased risk of bleeding. However, few studies have explored the commercial cost footprint of LAAC procedures, despite the 2021 Hospital Price Transparency Final Rule mandating US hospitals publish their insurer-negotiated prices. This study sought to characterize and identify factors contributing to variation in LAAC procedure prices across the US. We queried a commercial database containing hospital-disclosed prices to characterize variation in LAAC procedure prices within and across US hospitals. We then linked this price data to hospital characteristics using Medicare Facility IDs. Univariate analysis was conducted to compare commercial prices across multiple factors. In total, 683 hospitals reported commercial prices for LAAC procedures. Among reporting hospitals, median prices were greater at major investor-owned vs. non-major investor-owned facilities ($10,991 vs. $7,227, p<0.01) and for-profit centers vs. not-for-profit and government centers ($10,991 vs. $7,417 vs. $5,051, p<0.01). Prices were also greater at non-teaching hospitals compared to minor and major teaching hospitals (p<0.01). The Pacific region exhibited the highest median price ($18,652), while the Middle Atlantic exhibited the lowest median price ($5191). There was no association between price and CMS hospital-wide mortality (p=0.21) or all-cause readmissions (p=0.29). Patient hospital ratings were correlated with price (p<0.01) but not CMS overall hospital ratings (p=0.62). Commercial and self-pay prices were 2.30- and 2.61-times higher than the Medicare price. Within hospitals, the 90th percentile payer-negotiated rate was 2.0 (IQR 1.00-4.06) times the 10th percentile rate (within-center ratio). Across hospitals within the same hospital referral region (HRR), the median price at the 90th percentile hospital was 1.54 (IQR 1.00-2.63) times that at the 10th percentile hospital (between-center ratio). Prices for LAAC procedures varied widely, with commercial and self-pay rates over double the Medicare price. Within-center variation in price was higher than between-center variation. Non-teaching, investor-owned, and for-profit hospitals had higher prices; however, there was no association between prices and hospital-wide mortality or readmission rates.Tabled 1Univariate Analysis of Factors Associated with Left Atrial Appendage Closure Device Procedures Commercial PriceCategorical Values (% Reporting)# ofHospitals (%)Median Price ($)Interquartile Range ($)P-ValueRegion (93.6)<0.01 New England (CT, MA, ME, NH, RI, VT)Middle Atlantic (NJ, NY, PA)South Atlantic (DC, DE, MD, VA, WV, C, SC, GA, FL))East North Central (OH, IN, IL, MI, WI)East South Central (KY, TN, AL, MS)West North Central (MN, IA, MO, ND, SD, NE, KS)West South Central (AR, LA, OK, TX)Mountain (MT, ID, WY, CO, NM, AZ, UT, NV)Pacific (WA, OR, CA, AK, HI)26 (4.1)59 (9.2)157 (24.6)119 (18.6)57 (8.9)78 (12.2)107 (16.7)26 (4.1)10 (1.6)90915191104657682113425900719911150186524865-125783839-94483652-145313562-113323005-152592780-124784030-114763094-122562891-26874Hospital Type (87.8)<0.01 For-ProfitNot-For-ProfitGovernment154 (25.7)407 (67.8)39 (6.5)10991741750516853-152603077-124772731-14581Major Investor Owned (96.8)<0.01 Major Investor OwnedNot Major Investor Owned173 (26.2)488 (73.8)1099172276997-152603050-12344Teaching Status (93.6)<0.01 Major TeachingMinor TeachingNon-Teaching84 (13.1)332 (52.0)223 (34.9)56488012106162475-91313340-123443840-15260Urban/Rural (100)0.06 UrbanRural620 (90.8)63 (9.2)823488373428-129183634-13784Disproportionate Share Hospital (82.3)0.63 Disproportionate Share Hospital (DSH)Sole Community Hospital (not DSH-eligible)Not DSH474 (84.3)14 (2.5)74 (13.2)81681073987693510-129885052-128633241-14189CMS Hospital-Wide Readmission Rate (82.6)0.26 Above National AverageSame as National AverageBelow National Average227 (40.2)80 (14.2)257 (45.6)8633863286493340-133264079-142673840-12579CMS Hospital-Wide Mortality (80.7)0.25 Above National AverageSame as National AverageBelow National Average99 (18.0)375 (68.1)77 (14.0)8819823789043486-119703544-132163473-15159HCAHPS Patient Overall Hospital Rating (81.1)<0.01 1234517 (3.1)96 (17.3)211 (38.1)209 (37.7)21 (3.8)10991875869649044136316295-205573635-128202856-112883844-146829078-18372CMS Overall Hospital Rating (83.1)0.62 1234526 (4.6)92 (16.2)160 (28.2)186 (32.7)104 (18.3)922490048620761886934492-120864918-126313632-130232864-132513803-13693Comparisons were done via the Kruskal-Wallis test. Open table in a new tab