Left Atrial Appendage Closure Research Articles

Percutaneous left atrial appendage closure for stroke prevention in hypertrophic cardiomyopathy patients with atrial fibrillation

BackgroundPercutaneous left atrial appendage closure (LAAC) is an effective alternative strategy for stroke prevention in patients with atrial fibrillation (AF) at high risk for bleeding with anticoagulation (AC). Efficacy of this strategy in hypertrophic cardiomyopathy (HCM) remains uncertain. ObjectiveThe study aimed to compare risk of stroke in HCM-AF patients treated with LAAC with those treated with AC. MethodsBy use of the TriNetX Global Research Network, HCM-AF patients from 2015 to 2024 were assigned to categories of treatment with LAAC and treatment solely with AC and observed for 3 years for ischemic stroke, systemic embolism, and all-cause mortality. Propensity score matching was used to limit confounders. ResultsOf 14,867 HCM-AF patients identified, 364 (2.5%) were treated with LAAC vs 14,503 (97.5%) treated with AC. HCM LAAC patients were older (72 vs 67 years; P < .001) and had more comorbidities and more prior bleeding events, including higher rate of prior gastrointestinal bleeding (68% vs 18%; P < .001), compared with HCM patients treated solely with AC. After propensity score matching, there was no baseline difference between groups including prior bleeding events (P > .05). During follow-up, HCM patients treated with LAAC had higher rates of ischemic stroke (13% vs 8%; hazard ratio, 1.9; P = .006) and systemic embolism (14% vs 9%; hazard ratio, 1.8; P = .006) but no difference in mortality compared with matched HCM patients receiving AC. ConclusionThese real-world data do not support percutaneous LAAC in HCM-AF patients as the primary treatment strategy during long-term AC to reduce stroke risk. However, LAAC may remain a reasonable option for HCM-AF patients who are unable to tolerate AC because of prohibitive bleeding risk.

Real-world experience utilizing the nuvision 4D intracardiac echocardiography catheter for left atrial appendage closure

Transesophageal echocardiography (TEE) has been the preferred imaging modality to help guide left atrial appendage closure. Newer technologies such as the Nuvision 4D Intracardiac echocardiography (ICE) catheter allow for real-time 3D imaging of cardiac anatomy. There are no direct comparison studies for procedural imaging between TEE and 4D ICE. To evaluate the performance and safety of left atrial appendage (LAA) closure procedures with the Watchman FLX and Amulet, guided by the Nuvision 4D ICE Catheter. This retrospective observational analysis was conducted on institutional LAAO National Cardiovascular Data Registry from January 2022 to March 2023. Patients had undergone LAA closure procedures with the Watchman FLX or Amulet device guided by TEE or a 4D ICE Catheter. The primary outcome evaluated was successful LAAO device placement. A total of 121 patients underwent LAAO device placement with 46 (38.0%) patients guided by 4D ICE during LAAO implantation. The 4D ICE group had a shorter procedural time compared with TEE guidance. Post procedural 45-day TEE post implant was also comparable for both groups with no patients in either group having incomplete closure of the left atrial appendage and peri-device leak > 5 mm. No device related complications (device related access, stroke, or pericardial effusion) occurred in either group at follow-up. There was no significant difference in device implant success or post procedural outcomes at 45 days in either the TEE or 4D ICE group. However, there was a noticeable improvement in procedural time with the 4D ICE catheter.

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

Left atrial appendage closure in patients with atrial fibrillation and haemodialysis: outcomes from an international, multicentric registry

Abstract Background Atrial fibrillation (AF) patients receiving haemodialysis (HD) face increased bleeding risks, so the net benefit of stroke prophylaxis by oral anticoagulation (OAC) is ill defined. Left atrial appendage closure (LAAC) might serve as a suitable alternative to OAC for stroke prevention in this high-risk cohort. Objective To determine the safety and clinical efficacy of LAAC in HD patients with AF. Methods In an international multi-center (n=9) registry, the clinical details were compiled from all HD+AF patients who underwent LAAC. Results The cohort included 147 patients: age 72.6 ± 10.4 yrs, 73% male, CHA2DS2-VASc 4.5 ± 1.5, HAS-BLED 4.7 ± 1.2, prior stroke/TIA 22,5%, prior major bleed 57,8%. The pre-LAAC anticoagulation regimen was heterogeneous with a wide array of at least 12 different combinations of medications utilized. A total of 149 procedures were performed and LAAC was successful in 98% (146 of 149), with a median procedure time of 43 (30-66) minutes. The most common device was Watchman (61%), followed by Amulet (23,3%). The rate of major complications was 5,4% (8), same as the rate of minor complications (5,4%), leading to an overall complication rate of 10,7% (16/149) including one fatal bleed the day after implantation, 4 (2.7%) cardiac tamponades of which 3 were treated with pericardiocentesis and one surgery, and 2 device dislodgements requiring percutaneous retrieval followed by successful reimplantation. Most patients were discharged on DAPT (61,6%). At a median of 61 days follow-up, imaging was performed in 83% of patients, revealing: only 2 (1.7%) peri-device leaks ≥5 mm, and no DRT. Subsequently, anticoagulation was shifted to SAPT so that SAPT emerged as the predominant anticoagulation regimen representing 165,9 patient years (py) of usage followed by DAPT (41,8 py). Over the follow-up of 222,9 py, the incidence of ischemic stroke was 0,9% per year (2 strokes in total), reflecting an 88% relative risk reduction (p&amp;lt;0,001) compared with the calculated stroke rate of 7,4% for patients with a similar CHA2DS2VASc score and no anticoagulation. Similarly, the rate of major bleeding events (defined as BARC score ≥3) was 4,5% per year, signifying a 55% relative risk reduction (p=0,023) compared to the expected rate of patients on VKA therapy, based on a comparable HAS-BLED score. Event tough time on SAPT was nearly four times longer than on DAPT, the number of major bleeding events was similar (SAPT: 5; DAPT: 4). Conclusion In light of these findings LAAO emerges as a promising solution for this unique patient cohort. By mitigating the risks of both bleeding complications associated with anticoagulation and the threat of stroke in the absence of anticoagulation, LAAO represents a well-balanced and effective therapeutic strategy for these individuals. However, the procedural complication rate was elevated compared to that observed in other LAAC cohorts, and requires further study.

Standalone transcatheter left atrial appendage closure or combined with cryoballoon pulmonary vein isolation

Abstract Background Head-to-head comparisons between stand-alone left atrial appendage closure (LAAC) and a same-procedure LACC + cryoballoon (CB) pulmonary vein isolation (PVI) (combined procedure) are currently lacking. Purpose To compare acute and long-term outcomes between stand-alone LAAC vs a LAAC+CB-PVI combined procedure. Methods All patients undergoing LAAC at our institution, having at least 2 years follow-up, were analyzed to assess the impact of additional CB-PVI. The primary efficacy and safety endpoints of our study were the acute procedural success rate and the peri-procedural complications rate. As secondary endpoints, major bleeding, and ischemic events, as well as sinus rhythm rate at 2 years follow-up were assessed. Results Among 126 LAAC patients meeting inclusion criteria (males=64.2%), n=55 (43.7%) underwent a combined procedure. LAAC-only patients were older (72.5±7.2 vs 68.9±8.6, p&amp;lt;0.05) and less frequently having paroxysmal AF (23.9% vs 47.3%, p&amp;lt;0.05). Baseline CHA2DS2-VASc was similar among groups (3.3±1.3 vs 2.9±1.1, p=0.07) while LAAC-only patients had higher HAS-BLED at enrollment (3.4±1.1 vs 3.0±1.0, p=0.04). Additional CB-PVI was not a risk factor for incomplete LAA occlusion (OR 0.24–3.78, p=0.96), presence of residual lateral flow (OR 0.26–4.05; p=0.96), intraprocedural need for occluder device resizing compared to pre-procedural assessment (OR 0.27–3.05; p=0.884), and peri-procedural complications (OR 0.25–6.74, p=0.749). At 3-month post-procedural trans-esophageal echocardiography, a combined procedure was not associated with higher risk of incomplete occlusion (OR 0.33–1.59, p = 0.432), nor larger peri-device leakages (coefficient k: -0.65–+0.20, p=0.291). Overall and by-group ischemic (red) and bleeding (blue) relative risk reduction from CHA2DS2-VASc and HAS-BLED predicted yearly rates during follow-up was reported in Figure1. Over a median follow-up of 40 [26–56] months, a combined procedure was not a risk factor for major bleeding (OR 0.31–5.48, p=0.715) or ischemic (OR 0.11–3.56, p=0.599) events. As expected, additional CB-PVI was strongly associated with a reduction of AF recurrences (OR 0.16–0.86, p&amp;lt;0.05), after excluding permanent AF patients from the analysis. Conclusion Combined LAAC + CB-PVI procedure does not appear to be a risk factor for worse LAAC-related outcomes, while reducing AF recurrences in non-permanent AF patients.Figure 1

Acute haemodynamic changes during left atrial appendage closure

Abstract Purpose Left atrial appendage closure (LAAC) presents an alternative treatment for stroke prevention in atrial fibrillation (AF) in patients with contraindication for long-term anticoagulation. However, even in patients in AF, left atrial appendage plays an important role in reservoir function of left atrium. The purpose of this study was to assess acute hemodynamic effects during LAAC. Methods Consecutive patients indicated for LAAC from January 2022 to October 2023 were enrolled. The invasive hemodynamic measurements were done at the beginning of the procedure after transseptal puncture, and at the end from the procedure after device deployment. Following parameters were measured: systolic, and diastolic blood pressure, and pressure in left atrium (LA), all measurements were done at rest and after 3 minute isometric exercise (handgrip). Results Thirty-two patients were included (age 76,2+7,1 yrs, 22 (69%) males, 23 (72%) permanent AF, left ventricular ejection fraction 52+11,8%). No patients experienced moderate/severe mitral insufficiency, the saline intake during procedure was 738 ml. Isometric exercise significantly increased the LA pressure: the LA pressures (rest/exercise) were 13.7+6.7 mmHg/16.7+8.8 mmHg (p=0.003) at the beginning of the procedure, and 17.0+7.3mmHg/20.0+7.3 mmHg (p=0.005) after device deployment. The LA pressure obtained after device deployment (both rest/exercise) were significantly higher compared to values obtained at the beginning of the procedure. (p=0.003). Conclusions LAAC is associated acute increase of both rest and exercise LA pressure. Whether its acute negative effect remains over time needs further investigation.

Characteristics and incidence of peri-device leaks after left atrial appendage closure in patients with prior electrical isolation of left atrial appendage during catheter ablation

Abstract Background Patients who undergo electrical isolation of left atrial appendage (eLAAi) during atrial fibrillation (AF) ablation have a higher subsequent risk of thromboembolism. In post-ablation patients with eLAAi who undergo mechanical LAA closure (LAAC), there are limited data on imaging and clinical outcomes during follow-up, particularly peri-device leaks (PDLs). Purpose We investigated imaging outcomes on ~1 year follow up transesophageal echocardiography (TEE) for PDL and clinical outcomes in patients who had undergone LAAc after sustaining eLAAi from catheter ablation. Methods We analyzed data from TEEs at ~1 year follow up in patients who had undergone LAAC with either the Watchman or Watchman-FLX device. The images were analyzed for evidence of any discernible PDL which also which also included the absence of thrombosis/obliteration of the distal LAA. "Severe" PDL was categorized as the leak size of &amp;gt;5 mm on follow up TEE imaging. Baseline characteristics, imaging and clinical outcomes were compared with univariate comparison using Fisher’s exact test, between the two subgroups of LAAC patients stratified according to prior h/o eLAAi. Results A total of 532 patients underwent LAAC at our center between 03/2015 and 10/2022, with data available on ~1 year follow-up TEE imaging. Of these, 21 (3.9%) had undergone eLAAi during AF ablation prior to LAAC. At ~1 year follow up TEE imaging, the patients with prior h/o eLAAi had a numerically higher incidence of any PDL (42.9% vs 26.5%, p = 0.09). The incidence of severe PDL was significantly higher in the subgroup of patients with prior eLAAi as compared to patients without prior eLAAi (14.3% vs 3.3%, p = 0.04; Figure). There was no statistically-significant difference in the subsequent risk of thromboembolism between the eLAAi and control subgroups (4.8% vs 6.1%, p = 1.0) over an average follow-up of 577±331 days post-LAAC. Conclusions A prior history of eLAAi during AF ablation was associated with a higher risk of severe PDLs (&amp;gt;5mm) on follow up imaging after LAAC. The finding of severe PDL in the eLAAi subgroup might be attributable to ostial fibrosis as a result of ablation which might affect the LAA endocardial surface interaction with the device fabric. The occurrence of a higher risk of severe PDL in patients with prior eLAAi after LAAC might necessitate PDL closure or resumption of anticoagulation in such patients to mitigate the risk of subsequent thromboembolism.igure showing our study schema and compa

Comparison of peri-device sealing and procedural outcome after LAA closure in patients with and without isolated left atrial appendage

Abstract Background Catheter-based electrical isolation of the left atrial appendage (LAA) is increasingly performed in patients with symptomatic atrial fibrillation (AF) not responding to pulmonary vein isolation (PVI). Since the electrically isolated LAA is known to be susceptible to thromboembolism, endovascular LAA occlusion (LAAO) is increasingly being used. Objective We performed a procedural and clinical outcome analysis over 12 months in patients receiving two different LAAO device systems and compared those with versus those without LAA isolation (LAAI). Methods Between 08/2021 and 10/2022 we enrolled 83 consecutive patients (median age 73.2 years; median CHA2DS2-VASc Score 3.0; 51 men [61%]) of whom 59 (71%) had LAAI and 24 (29%) no LAAI. All patients had a least one previous catheter ablation procedure of AF. LAAO was done 6 weeks after the last ablation procedure. The main indication for LAAO was the implementation of electrical LAAI. In the no-LAAI group, all patients had lost persistent LAAI. Implanted devices were Watchman FLXTM (n=30) and LAmbreTM (n=53). Pertinent procedural data, periprocedural complications, as well as peri-device leaks (PDL) at 45 days were assessed according to device type. The composite endpoints (death, TIA/stroke, device thrombus, bleeding) and the clinical impact after switch of anticoagulation therapy were assessed at 12 months follow-up. Results The distribution of LAAI/No LAAI were found in 21[70%]/9 patients treated with the Watchman device and in 38[72%]/15 patients treated with the LAmbre device (p=0.87). PDL on follow-up (f/u) TEE was observed in 13/54 LAAI patients (24%) and 10/23 No-LAAI patients (43%, p=0.089). Leak distribution (&amp;lt;3mm/3-5mm/&amp;gt;5mm/no leak) at f/u was different between LAAI groups (LAAI: 12/1/0/41; No LAAI: 5/4/1/13; p=0.027) but not between device types. The mechanisms of leaks according to device type are listed in Table 1. Procedural complications were observed in 6/59 LAAI patients and 0/24 No-LAAI patients (p=0.11). The composite endpoint of death, stroke, severe bleeding, device-related thrombus and thromboembolism was reached by a total of 2 patients (both LAAI with LAmbre device). In 9/13 LAAI-group patients (69%) with PDL (all &amp;lt;6 mm) the sealing effect was assumed to be incomplete with perfusion of the LAA. Post procedural anticoagulation therapy was switched after the control TEE from NOAC/VKA (8/1) to aspirin alone. None of these patients reached the composite endpoint after 12 months. Conclusions LAAO can be performed safely and efficaciously in patients with LAAI. Compared with patients without LAAI after LAAO, the occurrence of minor leaks, periprocedural complications, and composite endpoint events was not different between the two patient groups. Despite the presence of incomplete sealing with perfusion of LAA in the LAAI group, the switch in post-procedural anticoagulation seems to be safe regarding the composite endpoint after 12 months.Mechanism of PDL of the LAmbre DeviceMechanism of PDL between the LAAO types

Efficacy of catheter ablation in patients with persistent atrial fibrillation on chronic ibrutinib therapy

Abstract Background Ibrutinib represents a cornerstone in the management of B-Cells malignancies and chronic lymphatic leukaemia. This drug however was associated with a 5-fold increased risk of developing atrial fibrillation (AF). The consequences of AF in this category of frailty patients such as heart failure may lead to the need of Ibrutinib withdrawal, which is considered a disease modifying therapy. Purpose This study aims to evaluate the safety and efficacy of catheter ablation in managing AF in patients on chronic ibrutinib therapy. Methods this study evaluated 20 consecutive patients from two centres in Italy who developed persistent AF during chronic therapy with Ibrutinib for chronic lymphatic leukaemia or small lymphocytic lymphoma and underwent AF catheter ablation from 2016 to 2020. Antiarrhythmic drugs were withdrawn because of side effects and drug interaction. All receive pulmonary vein (PV) isolation + isolation of left atrial posterior wall (PW) and superior vena cava. A standardized protocol was performed to confirm persistent PVI and elicit any triggers originating from non-PV sites. Ablation of non-PV sites triggering runs of atrial tachyarrhythmias was left to operator's discretion. Exclusion criteria were age&amp;lt;18 years and history of AF before ibrutinib therapy. Patients were monitored for arrhythmia at quarterly office visits, ECGs, 7-day Holter monitoring and event recorders during the first year followed by biannual checkups during the remaining part of the follow-up period. Results 12 patients received PV+PW+SVC isolation plus ablation of non-PV trigger (Group 1) whereas 8 receive only PV+PW+SVC isolation (Group 2). 10 (83,3%) patients in group 1 remained arrhythmia-free without the need for additional antiarrhythmic drugs while only 3 (37,5%) in group 2 maintained sinus rhythms. Non pulmonary triggers were mostly found in left atrial appendage (5/12, 41,6%), coronary sinus (4/12, 33,3%) and crista terminalis (3/12 25%). More than one trigger was found in 4 (33.3) patients. After 22.3 ±3.6 months follow-up, patients with ablation of induced non-PV triggers had a significantly higher arrhythmia control than those whose triggers were not ablated (Chi – square p value: 0.035; Log rank p value: 0.014) (Fig.1). 5 patient that received left atrial appendage isolation underwent a left atrial appendage closure with Watchman device 3 months after atrial fibrillation ablation. Conclusion Catheter ablation in this category of patients seems to be a safe and effective tool for managing atrial fibrillation in patients with persistent AF on chronic ibrutinib therapy; an ablation strategy that includes as a first line therapy non pulmonary vein triggers appears to be an effective approach when compared to pulmonary vein plus posterior wall only. This approach will allow continuation of ibrutinib treatment, which markedly enhances the prognosis and diminishes the risk of adverse cardiovascular events in this patient population.Kaplan-Meier curve showing recurrence-fr

Efficacy of four different left atrial appendage closure techniques during cardiac surgery—A transesophageal echocardiography follow-up study

ObjectiveClosure of the left atrial appendage (LAA) is a routine part of atrial fibrillation ablation surgery and significantly reduces stroke rates. Different LAA-closure techniques are used in cardiac surgery with variable results reported. We therefore evaluated the efficacy of 4 different LAA-closure techniques in patients undergoing cardiac surgery. MethodsIn total, 149 patients who underwent concomitant LAA closure during cardiac surgery between 2015 and 2019 were included in this retrospective transesophageal echocardiography study. Four different LAA-closure techniques were evaluated: LAA clipping (n = 62), suture ligation (n = 28), stapler resection (n = 30), and surgical LAA excision (n = 29). Successful LAA closure was defined as absence of LAA perfusion and absence of a stump greater than 10 mm. ResultsThe mean patients age was 68.7 ± 9.4 years; 61.7% were male. No complications related to LAA closure were observed. Mean follow-up was 36.5 ± 8 months. Transesophageal echocardiography follow-up showed the following LAA closure success rates: LAA clip 98.4%, surgical excision 93.1%, stapler resection 76.6%, and suture ligation 39.2%. Suture ligation resulted in a high rate of recanalization (50%) and residual stumps (10.8%), whereas stapler resection resulted in a high rate of residual stumps (23.4%). Overall, 4 patients (2.7%) had a stroke during follow-up. In detail, 2 of 27 (7.4%) patients with unsuccessful LAA closure had a stroke, whereas 2 of the 122 (1.6%) patients with successful LAA closure had a stroke. ConclusionsIn our study, LAA clipping and surgical LAA excision proved to be both successful LAA-closure methods. External LAA ligation and stapler resection resulted in low rates of successful LAA closure and should be avoided.

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

Patients 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. Characteristics 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). The 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. Based on single-center experience, left atrial CA in the presence of an LAAC device implanted including the early phase was safe and feasible.

Peri-device leakage and delayed endothelialization of the Watchman device: a computed tomography study.

This study aimed to explore the endothelialization process and assess the potential association between endothelialization and peri-device leak (PDL) following Watchman implantation via a quantitative method. This is a single-center retrospective study of consecutive patients undergoing LAAO between December 2015 and November 2021. Device endothelialization, compared between PDL and non-PDL group, were quantitatively analyzed based on hypoattenuated thickening in cardiac computed tomography angiography (CCTA). Advancement in endothelialization over time were explored using the Cochran-Armitage test and generalized estimating equation approach. Potential risk factors of delayed endothelialization were analyzed using the Cox proportional-hazards model. A total of 172 patients (mean age, 68 years ± 10 [standard deviation], 114 men) were finally included. The average endothelialization ratio of the study population was 89.8 ± 7.2 percent. In the follow-up period of postprocedural 3 months to more than 12 months, an incremental trend of endothelialization over time was observed with the ratio of 85.8 ± 8.0, 89.6 ± 7.6, 92.2 ± 4.5, 94.3 ± 2.9 percent, respectively (p < 0.0001). Notably, patients without PDL exhibited a swifter advancement in endothelialization compared to those with PDL, irrespective of device size. The multivariable Cox regression model showed that PDL (HR = 2.113, 95%CI: 1.300-3.435, p = 0.003), DSP (HR = 1.717, 95%CI: 1.113-2.647, p = 0.014) were independent risk factors of delayed endothelialization. CCTA holds promise as an effective means of quantitatively assessing device endothelialization. Endothelialization advanced gradually over time, with PDL potentially impeding device endothelialization. A comprehensive understanding of the correlation between endothelialization ratio, time, and residual shunt can establish a more dependable foundation for determining the appropriate anticoagulation treatment following left atrial appendage closure. Current recommendations for postleft atrial appendage occlusion anti-platelet and anticoagulation therapy are based on animal studies. Cardiac computed tomography angiography (CCTA) combined with the UNet neural network model enables the quantitative assessment of device endothelialization. This technique will allow for additional studies to better understand device endothelialization to optimize treatments in this population.

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)

Left atrial appendage closure outcomes in relation to atrial fibrillation patterns: a comprehensive analysis.

The effect of atrial fibrillation (AF) patterns on outcomes remains controversial. This study aims to evaluate the influence of AF type on the risk of cardiocerebrovascular events after left atrial appendage closure (LAAC) at long-term follow-up. AF was categorized as paroxysmal AF (PAF) and non-PAF (NPAF). The baseline characteristics, procedural data, peri-procedural complications, and long-term outcomes between patients with PAF and NPAF after LAAC were compared. We analyzed 410 AF patients (mean age 74.8 ± 8.2 years; 271 male; 144 with PAF, 266 NPAF). The NPAF group tended to be older (≥75 years), male, and have chronic kidney disease (CKD) compared with the PAF group. The procedural data and peri-procedural complications were comparable. During 2.2 ± 1.5 years of follow-up, the incidences of thromboembolism, major bleeding, and device-related thrombus (DRT) did not differ between the two groups. The observed risk of thromboembolism and major bleeding was significantly lower than the estimated risk based on the CHA2DS2-VASc and HAS-BLED scores, respectively, in patients who underwent LAAC, regardless of the AF type. NPAF patients were associated with a higher risk of all-cause mortality, non-cardiovascular mortality, and combined efficacy endpoints. This association disappeared after propensity score matching (PSM) analysis. The risk of thromboembolism and major bleeding was lower in patients who underwent LAAC, regardless of the AF type. Although NPAF often coexists with multiple risk factors, it was not associated with worse long-term outcomes after LAAC when compared with PAF.

Comparative Assessment of Percutaneous Left-Atrial Appendage Occlusion (LAAO) Devices-A Single Center Cohort Study.

Percutaneous left-atrial appendage closure (LAAC) is an established method for preventing strokes in patients with atrial fibrillation, offering an alternative to oral anticoagulation. Various occluder devices have been developed to cater to individual anatomical needs and ensure a safe and effective procedure. In this retrospective, monocentric cohort study, we compare different LAAO devices with respect to clinical outcomes, LAA sealing properties, and device-related complications. We conducted a retrospective analysis of 270 patients who underwent percutaneous LAA closure in our center between 2009 and 2023. Patient data were extracted from medical records, including gender, age at implantation, indication, device type and size, laboratory values, LAA anatomy, periprocedural complications, ECG parameters, transthoracic and transesophageal echocardiography parameters (TTE and TEE), as well as medication at discharge. Moreover, fluoroscopy time and implantation duration, as well as post-implantation clinical events up to 1 year, were collected. Endpoints were bleeding events, recurrent stroke, thrombi on devices, and death. The implanted devices were the Watchman 2.5, Watchman FLX, Amplatzer Cardiac Plug (ACP), and Amulet. The procedural success rate was 95.7% (n = 265), with cactus anatomy posing the most challenges across all devices. The mean patient age was 75.5 ± 7.7 years, with 64.5% being male. The median CHA2DS2-VASc score was 4.8 ± 1.5 and the median HAS-BLED score was 3.8 ± 1.0. Indications for LAA closure included past bleeding events and elevated bleeding risk. Periprocedural complications were most commonly bleeding at the puncture site, particularly after ACP implantation (p = 0.014). Significant peridevice leaks (PDL) were observed in 21.4% of simple sealing mechanism devices versus 0% in double sealing mechanism devices (p = 0.004). Thrombi were detected on devices in six patients, with no subsequent ischemic stroke or thromboembolic event. Comparative analysis revealed no significant differences in the occurrence of stroke, transient ischemic attack (TIA), thromboembolic events, device-related thrombi, or mortality among different device types. A 62.3% relative risk reduction in thromboembolic events and 38.6% in major bleedings could be observed over 568.2 patient years. In summary, our study highlights the efficacy and safety of LAA closure using various occluder devices despite anatomical challenges. Our long-term follow-up findings support LAA closure as a promising option for stroke prevention in selected patient cohorts. Further research is needed to refine patient selection criteria and optimize outcomes in LAA closure procedures.

MID–TERM OUTCOMES OF ENDOSCOPIC MITRAL VALVE REPAIR VIA RIGHT ANTERIOR MINI–THORACOTOMY

Abstract The adoption of less–invasive mitral repair (MVr) surgery is increasing, backed by evidence of satisfactory short–term results and lower major morbidity. We assessed mid–term follow–up results of our experience, and compared two techniques: isolated leaflet resection and neochord implantation for posterior leaflet (PML) prolapse. Between 2012–2021, 700+ operations were performed with a video–assisted right mini–thoracotomy (RMT) approach. We report 309 consecutive patients who had endoscopic MVr, including those receiving concomitant tricuspid repair, ablation for atrial fibrillation, closure of patent foramen ovale and/or left atrial appendage. The early and mid–term follow–up results were ascertained. Primary outcome was the incidence of mortality and significant mitral regurgitation (MR) during follow–up which were summarized by Kaplan–Meier estimator and compared between treatment arms via log–rank test. Secondary outcomes were the early–postoperative results including 30–days mortality and major complications. All patients had endoscopic MVr via RMT at the 3rd/4th intercostal space (IS). A soft–tissue retractor is used, accompanied or not by a rib spreader, and two ports in the fourth and sixth IS are used for 3D thoracoscopy and carbon dioxide insufflation. Femoral vessels exposure through a right groin incision and echo–guided cannulation sec. Seldinger is achieved post–heparinization. Thoracic fascia bisection is performed during single–lung ventilation using a double–lumen endotracheal tube, integral to our anesthetic management, including percutaneous right internal jugular vein cannulation. The pericardium is opened and an aortic root cannula for cardioplegia delivery and venting is placed via working incision. After establishing cardiopulmonary bypass, a Chitwood clamp is passed through the second IS and cardioplegia is delivered. Endoaortic balloon clamping is primarily used in redo cases. With ring annuloplasty, 136 (44%) patients received PML resection (122 isolated) and 97 (31%) PML chords implantation (88 isolated). Forty–nine patients had annuloplasty alone. In–hospital mortality was 1.0%. Mean follow–up was 29±22 months (max 8.3 years). Kaplan–Meier 5–year survival was 97.3±1.0%. MR (3/4+) free–survival at 5 years was 94.5±2.3%. Subgroup time–to–event analysis for the indexed outcomes showed no statistical significance between techniques. In conclusion, endoscopic MVr is safe with excellent mid–term outcomes.

The left atrial appendage closure by surgery 2 trial: statistical analysis plan for a randomized multicenter trial exploring if the closure of the left atrial appendage during open-heart surgery reduces stroke irrespective of patients’ stroke risk and preoperative atrial fibrillation status

BackgroundSurgical left atrial appendage (LAA) closure concomitant to open-heart surgery prevents thromboembolism in high-risk patients. Nevertheless, high-level evidence does not exist for LAA closure performed in patients with any CHA2DS2-VASc score and preoperative atrial fibrillation or flutter (AF) status—the current trial attempts to provide such evidence.MethodsThe study is designed as a randomized, open-label, blinded outcome assessor, multicenter trial of adult patients undergoing first-time elective open-heart surgery. Patients with and without AF and any CHA2DS2-VASc score will be enrolled. The primary exclusion criteria are planned LAA closure, planned AF ablation, or ongoing endocarditis. Before randomization, a three-step stratification process will sort patients by site, surgery type, and preoperative or expected oral anticoagulation treatment. Patients will undergo balanced randomization (1:1) to LAA closure on top of the planned cardiac surgery or standard care. Block sizes vary from 8 to 16. Neurologists blinded to randomization will adjudicate the primary outcome of stroke, including transient ischemic attack (TIA). The secondary outcomes include a composite outcome of stroke, including TIA, and silent cerebral infarcts, an outcome of ischemic stroke, including TIA, and a composite outcome of stroke and all-cause mortality. LAA closure is expected to provide a 60% relative risk reduction. In total, 1500 patients will be randomized and followed for 2 years.DiscussionThe trial is expected to help form future guidelines within surgical LAA closure. This statistical analysis plan ensures transparency of analyses and limits potential reporting biases.Trial registrationClinicaltrials.gov, NCT03724318. Registered 26 October 2018, https://clinicaltrials.gov/study/NCT03724318.Protocol versionhttps://doi.org/10.1016/j.ahj.2023.06.003.

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.

Physicians' Perspective on Percutaneous Left Atrial Appendage Closure in Patients with Atrial Fibrillation and Chronic Kidney Disease in Pakistan.

This study, conducted in Pakistan, examines the perspectives of 1200 physicians across diverse specialties regarding Left Atrial Appendage Occlusion (LAAO) procedures for atrial fibrillation (AF) patients with chronic kidney disease (CKD). Using a random sampling approach, physicians participated in a survey that assessed their familiarity with LAAO, views on its effectiveness and safety, experience levels, and encountered challenges. The results unveil a spectrum of knowledge levels among physicians, reinforcing the need for tailored medical education and training programs. The majority of respondents were between 30 and 49 years old (59.8 %). A notable proportion, 33.3 %, had limited or no knowledge of LAAO, with 16.7 % having never heard of the procedure, and 16.7 % having limited knowledge but no experience. About 36.2 % of physicians believed LAAO was moderately to extremely effective in reducing stroke risk, with 23.3 % considering it very effective and 25.4 % believing it to be extremely effective. The most commonly cited clinical indications were a history of recurrent strokes despite anticoagulation (34.6 %) and a high CHA2DS2-VASc score (27.3 %). Renal considerations played a significant role, with 33.1 % considering LAAO for CKD stage 4 or 5 patients with elevated stroke risk. Patient preferences, such as a desire to avoid long-term anticoagulant use, were important for 28.7 % of physicians. Identified challenges encompass limited equipment access, training gaps, patient reluctance, and administrative complexities. Furthermore, the study underscores the pivotal role of shared decision-making in healthcare delivery. These findings lay essential groundwork for improving LAAO utilization and patient-centered care in Pakistan's healthcare system.

Incidence and temporal evolution of delayed peridevice leak after left atrial appendage closure

BackgroundPeridevice leak (PDL) after left atrial appendage closure (LAAC) portends adverse outcomes. ObjectiveThe purpose of this study was to assess the incidence, predictors, clinical implications, and temporal evolution of PDL after LAAC. MethodsThis single-center retrospective study included all patients who underwent LAAC with Watchman FLX and had no PDL detected at the time of implantation. The primary end point was the incidence of new PDL at initial imaging. The composite secondary end point included continued oral anticoagulation after initial imaging, device-related thrombus, stroke or transient ischemic attack, major bleeding, and need for PDL closure at longest follow-up. Temporal evolution of PDL was assessed in patients with available surveillance imaging. ResultsOf the 355 patients who completed imaging at 47 days (interquartile range [IQR] 44–50 days), 139 (39%) had new PDL with a mean leak size of 3.2 ± 1.4 mm (median 3.0 mm; IQR 2.0–4.0 mm; range 1.0–9.0 mm). Multiple deployment attempts and larger device size were positive predictors of PDL, while increased contrast volume administration was a negative predictor of PDL. The composite secondary end point occurred in 42 (30%) patients with PDL and 33 (15%) patients without PDL (P < .001). Of the 139 patients with PDL, 43 (31%) had surveillance imaging where the leak size regressed from 3.7 ± 1.8 mm at 46 days (IQR 44–51 days) to 1.7 ± 2.0 mm at 189 days (IQR 158–285 days) (P < .001). The leak size regressed in 33 (77%), remained stable in 4 (9%), and progressed in 6 (14%) cases. ConclusionDespite design improvements, LAAC with Watchman FLX demonstrates a significant incidence of PDL with meaningful clinical implications. Regardless of initial size, most leaks regressed over time.