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1.
Cureus ; 16(5): e61368, 2024 May.
Article in English | MEDLINE | ID: mdl-38947599

ABSTRACT

A 79-year-old female with chronic atrial fibrillation was being treated with dabigatran (Pradaxa). Pradaxa was discontinued after a significant bleeding episode. A WATCHMAN device was successfully implanted and Pradaxa was started. A transesophageal echocardiogram (TEE) 49 days later showed a 3.6×2.2 cm clot overlying the device. Pradaxa was switched to Coumadin. Subsequent TEEs showed the complete resolution of the thrombus after five months on Coumadin. Coumadin was discontinued. Six months later, TEE showed a large mobile thrombus attached to the left atrial appendage occlusion device (LAAOD). The patient's hypercoagulable workup was negative. Due to recurrent thrombotic events, she was started on apixaban (Eliquis) due to a prior history of bleeding on Coumadin. She is currently on Eliquis with no further episodes of bleeding or device thrombus.

2.
J Innov Card Rhythm Manag ; 15(6): 5917-5929, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38948665

ABSTRACT

Atrial fibrillation (AF) is a prevalent cardiac arrhythmia marked by irregular and frequent tachycardic rhythms in the atria, affecting 1%-2% of the general population. The WATCHMAN™ device from Boston Scientific (Marlborough, MA, USA) and the Amplatzer™ Amulet™ device from Abbott (Chicago, IL, USA) are two devices used globally for left atrial appendage closure (LAAC) in non-valvular AF. A systematic search was conducted in PubMed, the Cochrane Library, and Elsevier's ScienceDirect literature databases to identify studies comparing the WATCHMAN™ procedure with Amulet™ device implantation for LAAC in patients with AF. The analyses were conducted using the random-effects model. A total of 20 studies were identified, with 18 falling into the category of observational studies and 2 being randomized controlled trials. A total of 6310 participants were included in this meta-analysis, with 3198 individuals (50.68%) assigned to the WATCHMAN™ procedure group and 3112 individuals (49.32%) allocated to the Amplatzer™ Cardiac Plug (ACP) group. The analysis revealed a higher risk of stroke associated with the WATCHMAN™ technique (relative risk [RR], 1.14), albeit without statistical significance. Conversely, the WATCHMAN™ approach led to a significantly lower risk of cardiac death (RR, 0.44; P = .04). Notably, the risks of all-cause mortality (RR, 0.89; 95% confidence interval [CI], 0.73-1.08; I 2 = 0%; P = .25) and major bleeding (RR, 0.93; 95% CI, 0.65-1.33; I 2 = 31%; P = .70) were clinically reduced with the WATCHMAN™ procedure, although statistical significance was not achieved. Compared to Amulet™ device implantation, WATCHMAN™ device implantation decreased the risk of cardiac mortality, while the risks of stroke, systemic embolism, all-cause mortality, and major bleeding were not statistically significant.

3.
Article in English | MEDLINE | ID: mdl-38895767

ABSTRACT

BACKGROUND: Patients with nonvalvular atrial fibrillation (AF) not suitable for long-term anticoagulant therapy undergo percutaneous left atrial appendage closure (LAAC) using the WATCHMAN device. The safety and efficacy of WATCHMAN-FLX (WM-FLX) compared with WATCHMAN-2.5 (WM-2.5), particularly in Asian populations, is unknown. METHODS: We evaluated the background, procedure, and clinical outcomes of 199 patients who underwent LAAC between September 2019 and December 2022 and compared WM-2.5 (72 patients) with WM-FLX (127 patients). RESULTS: The mean age was 76 years, with 128 men, and 100 had nonparoxysmal AF (non-PAF). The mean CHA2DS2-VASc, and HAS-BLED were 5.1, and 3.2 points, respectively. WM-FLX group demonstrated a shorter procedure time than WM-2.5 group (50 vs. 42 min, p = 0.001). The WM-FLX group demonstrated no procedural-related acute cardiac tamponade, which was significantly low (5.6% vs. 0%, p = 0.02), and a significantly higher rate of complete seal at 45-day (63% vs. 80%, p = 0.04). WM-FLX group had a significantly higher cumulative 1-year incidence of device-related thrombosis (DRT) than WM-2.5 group (3.4% vs. 7.0%, Log-rank p = 0.01). Univariate analysis identified two DRT risk factors in the WM-FLX group: non-PAF (odds ratio [OR] 7.72; 95% confidence interval [CI] 1.20-48.7; p = 0.04), and 35-mm device (OR 5.13; 95% CI 1.31-19.8; p = 0.02). CONCLUSIONS: WM-FLX significantly improved the procedural quality and safety of LAAC. However, DRT remains an important issue even in the novel LAAC device, being a hazard for patients with high DRT risk, such as having non-PAF and using 35-mm devices.

4.
Circ Cardiovasc Interv ; 17(6): e013466, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38889251

ABSTRACT

BACKGROUND: Procedure volumes are associated with outcomes for many cardiovascular procedures, leading to guidelines on minimum volume thresholds for certain procedures; however, the volume-outcome relationship with left atrial appendage occlusion is poorly understood. As such, we sought to determine the relationship between hospital and physician volume and WATCHMAN left atrial appendage occlusion procedural success overall and with the new generation WATCHMAN FLX device. METHODS: We performed an analysis of WATCHMAN procedures (January 2019 to October 2021) from the National Cardiovascular Data Registry LAAO Registry. Three-level hierarchical generalized linear models were used to assess the adjusted relationship between procedure volume and procedural success (device released with peridevice leak <5 mm, no in-hospital major adverse events). RESULTS: Among 87 480 patients (76.2±8.0 years; 58.8% men; mean CHA2DS2-VASc score, 4.8±1.5) from 693 hospitals, the procedural success rate was 94.2%. With hospital volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (odds ratio [OR], 0.66 [CI, 0.57-0.77]) and Q2 (OR, 0.78 [CI, 0.69-0.90]) but not Q3 (OR, 0.95 [CI, 0.84-1.07]). With physician volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (OR, 0.72 [CI, 0.63-0.82]), Q2 (OR, 0.79 [CI, 0.71-0.89]), and Q3 (OR, 0.88 [CI, 0.79-0.97]). Among WATCHMAN FLX procedures, there was attenuation of the volume-outcome relationships, with statistically significant but modest absolute differences of only ≈1% across volume quartiles. CONCLUSIONS: In this contemporary national analysis, greater hospital and physician WATCHMAN volumes were associated with increased procedure success. The WATCHMAN FLX transition was associated with increased procedural success and less heterogeneity in outcomes across volume quartiles. These findings indicate the importance of understanding the volume-outcome relationship for individual left atrial appendage occlusion devices.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Hospitals, High-Volume , Hospitals, Low-Volume , Registries , Humans , Atrial Appendage/physiopathology , Female , Male , Aged , Treatment Outcome , Atrial Fibrillation/physiopathology , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Atrial Fibrillation/surgery , Aged, 80 and over , United States , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Risk Factors , Risk Assessment , Time Factors , Stroke/etiology , Stroke/prevention & control , Atrial Function, Left
5.
Front Cardiovasc Med ; 11: 1389811, 2024.
Article in English | MEDLINE | ID: mdl-38841258

ABSTRACT

Objective: 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. Methods: 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. Results: 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. Conclusions: 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.

6.
Article in English | MEDLINE | ID: mdl-38904848

ABSTRACT

Percutaneous closure of the left atrial appendage may be indicated in patients with contraindications to anticoagulation therapy, for example, after recurrent gastrointestinal bleeding. It is an effective and safe procedure but is not without complications. We present a patient who presented with severe aortic insufficiency due to migration of the left atrial appendage closure device, which required urgent cardiac surgery for its removal.

7.
Eur Heart J Case Rep ; 8(6): ytae286, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38938471

ABSTRACT

Background: Left atrial appendage (LAA) thrombus is a contraindication for LAA closure (LAAC). However, in selected cases, oral anticoagulants are strictly contraindicated because of a history of life-threatening bleeding, and LAAC remains the only possible therapy to avoid systemic and especially cerebral embolization. Case summary: We report a case of LAAC despite a massive proximal thrombus in a patient who had an absolute contraindication to anticoagulant therapy, with thorough pre-planning using CT scan, device modelling and thrombus trapping techniques to reduce the risk of systemic embolic events and perform LAAC safely. Discussion: Although LAAC remains at high risk in this setting, the use of cautious techniques and tools, from pre-procedure planning to systemic embolization prevention systems associated to a precise transoesopheageal echocardiography guiding throughout the procedure, allows it to be performed as safely as possible when no other option is available.

8.
J Arrhythm ; 40(3): 620-623, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38939787

ABSTRACT

We have seen ischemic stroke associated with a high-grade device-related pedunculated thrombosis after left atrial appendage closure (LAAC) after discontinuation of oral anticoagulations (OACs). Continuation of OACs, including half-dose direct oral anticoagulations after LAAC, may be a better option for patients at high risk of thromboembolism to prevent further thromboembolic events.

9.
J Cardiovasc Dev Dis ; 11(6)2024 May 21.
Article in English | MEDLINE | ID: mdl-38921657

ABSTRACT

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

10.
Heart Vessels ; 2024 Jun 05.
Article in English | MEDLINE | ID: mdl-38839649

ABSTRACT

Currently, no consensus has been established on the most effective antithrombotic therapy to prevent thromboembolic and bleeding events in patients undergoing percutaneous left atrial appendage closure (LAAC) with preprocedural thromboembolic or bleeding events under oral anticoagulation (OAC) therapy. We retrospectively investigated the incidence of device-related thrombosis (DRT), thromboembolic events, and bleeding events in patients who underwent LAAC from September 2019 to October 2022. After categorizing patients into three groups based on preprocedural thromboembolic or bleeding events under OAC therapy, we compared the incidence of DRT and prognosis according to the postprocedural antithrombotic therapy. In patients who received the conventional antithrombotic therapy (OAC with and without single antiplatelet therapy for 45 days after LAAC and dual-antiplatelet therapy from 45 days to 6 months followed by single antiplatelet therapy), preprocedural thromboembolic events despite OAC were independently associated with DRT or postprocedural thromboembolic events at the 3 year follow-up (hazard ratio [HR] 4.55; 95% confidence interval [CI] 1.32-15.6; P = 0.016), whereas preprocedural bleeding events were independently associated with postprocedural bleeding events (HR 8.01, 95% CI 1.45-58.3; P = 0.036). Continuation of OAC for 12 months among patients who developed preprocedural thromboembolic events during OAC significantly decreased the incidence of DRT or postoperative thromboembolic events (P = 0.002) with no increase in the bleeding events (P = 0.522). Preprocedural thromboembolic and bleeding events can predict adverse events after LAAC with the conventional antiplatelet-based antithrombotic therapy. Patients who develop thromboembolic events under continuous OAC may benefit from continuous OAC for 1 year after LAAC.

11.
Article in English | MEDLINE | ID: mdl-38841867

ABSTRACT

OBJECTIVES: The clinical efficacy and safety of a novel left atrial appendage (LAA) occluder of the SeaLA closure system in patients with nonvalvular atrial fibrillation (NVAF) were reported. BACKGROUND: Patients with NVAF are at a higher risk of stroke compared to healthy individuals. Left atrial appendage closure (LAAC) has emerged as a prominent strategy for reducing the risk of thrombosis in individuals with NVAF. METHODS: A prospective, multicenter study was conducted in NVAF patients with a high risk of stroke. RESULTS: The LAAC was successfully performed in 163 patients. The mean age was 66.93 ± 7.92 years, with a mean preoperative CHA2DS2-VASc score of 4.17 ± 1.48. One patient with residual flow >3 mm was observed at the 6-month follow-up, confirmed by TEE. During the follow-up, 2 severe pericardiac effusions were noted, and 2 ischemic strokes were observed. Four device-related thromboses were resolved after anticoagulation treatment. There was no device embolism. CONCLUSIONS: The LAAC with the SeaLA device demonstrates encouraging feasibility, safety, and efficacy outcomes.

12.
BMC Cardiovasc Disord ; 24(1): 293, 2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38844866

ABSTRACT

Patients with previous interatrial shunt device (IASD) implantation may face greater challenges during future left atrial interventional procedures. Herein, we report the first case of left atrial appendage closure (LAAC) in a patient with previous IASD implantation. The patient successfully underwent LAAC using the LAmbre device without complications.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Humans , Atrial Appendage/physiopathology , Atrial Appendage/diagnostic imaging , Atrial Fibrillation/physiopathology , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Treatment Outcome , Cardiac Catheterization/instrumentation , Male , Female , Echocardiography, Transesophageal , Aged , Atrial Function, Left , Foramen Ovale, Patent/diagnostic imaging , Foramen Ovale, Patent/therapy , Foramen Ovale, Patent/complications , Foramen Ovale, Patent/physiopathology , Foramen Ovale, Patent/surgery , Left Atrial Appendage Closure
14.
Heart Rhythm ; 2024 May 24.
Article in English | MEDLINE | ID: mdl-38797310

ABSTRACT

BACKGROUND: Peridevice leak (PDL) after left atrial appendage closure (LAAC) portends adverse outcomes. OBJECTIVE: The purpose of this study was to assess the incidence, predictors, clinical implications, and temporal evolution of PDL after LAAC. METHODS: This 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. RESULTS: Of the 355 patients who completed imaging at 47 days (interquartile range [IQR] 6 days), 139 (39%) had new PDL with a mean leak size of 3.2 ± 1.4 mm (median 3.0 mm; IQR 2.0 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%) and 33 (15%) patients with and without PDL, respectively (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 7 days) to 1.7 ± 2.0 mm at 189 days (IQR 127 days) (P < .001). The leak size regressed in 33 (77%), remained stable in 4 (9%), and progressed in 6 (14%) cases. CONCLUSION: Despite 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.

15.
Heart Rhythm ; 2024 May 13.
Article in English | MEDLINE | ID: mdl-38750910

ABSTRACT

BACKGROUND: Left atrial appendage closure (LAAC) is an alternative to reduce thrombotic risk in patients with nonvalvular atrial fibrillation. This procedure conventionally requires the use of a contrast agent. A significant proportion of patients who undergo this procedure have chronic kidney disease, with a high risk of contrast-induced nephropathy. OBJECTIVE: We aimed to systematically review existing literature regarding the feasibility and safety of a zero-contrast LAAC technique. METHODS: We searched the MEDLINE/PubMed, Embase, and Cochrane Central Register of Controlled Trials databases for studies comparing a zero-contrast LAAC technique with conventional LAAC up to April 2024. From each study, we extracted baseline characteristics, feasibility, and safety outcomes. A random model meta-analysis was used to compare outcomes between groups. RESULTS: Five studies reporting data from 367 patients were included. A 100% successful implantation rate was reported in all the zero-contrast groups. The mean number of recaptures reached no significant difference between the groups (mean difference, -0.15; CI, -0.67 to 0.37; I2 = 0%; P = .58). The zero-contrast group had a significantly shorter fluoroscopy time (mean difference, -4.03; CI, -7.72 to -0.34; I2 = 67%; P = .03). Complications related to the procedure, peridevice leak, and device-associated thrombus rates were not significantly different between the groups. CONCLUSION: Zero-contrast LAAC is a feasible alternative. The success and complication rates are consistent with those of conventional LAAC. Aside from the inherent benefit of zero-contrast exposure, this technique allows a reduction in fluoroscopy time.

16.
JACC Cardiovasc Interv ; 17(11): 1295-1307, 2024 Jun 10.
Article in English | MEDLINE | ID: mdl-38795087

ABSTRACT

BACKGROUND: Pericardial effusion (PE) is the most common serious left atrial appendage closure (LAAC) complication, but its mechanisms, time course, and prognostic impact are poorly understood. OBJECTIVES: This study sought to assess the frequency, timing, predictors and clinical impact of PE after LAAC. METHODS: Data 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. RESULTS: Of 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. CONCLUSIONS: In 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).


Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Pericardial Effusion , Humans , Female , Male , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Time Factors , Aged , Risk Factors , Pericardial Effusion/etiology , Pericardial Effusion/diagnostic imaging , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Atrial Fibrillation/complications , Atrial Fibrillation/physiopathology , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Treatment Outcome , Aged, 80 and over , Risk Assessment , Septal Occluder Device , Middle Aged , Prospective Studies , Sex Factors , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Left Atrial Appendage Closure
17.
Circ J ; 88(7): 1187-1197, 2024 Jun 25.
Article in English | MEDLINE | ID: mdl-38763735

ABSTRACT

BACKGROUND: Limited data are available regarding clinical outcomes after percutaneous left atrial appendage closure using WATCHMAN FLX (WM-FLX) and WATCHMAN-2.5 (WM2.5) devices in Asian patients.Methods and Results: Data of 1,464 consecutive patients (WM-FLX, n=909; WM2.5, n=555) were extracted from a Japanese multicenter registry, and clinical data were compared between the 2 groups. No in-hospital deaths, periprocedural stroke, or device embolization occurred. Procedural success was significantly higher in the WM-FLX than WM2.5 group (95.8% vs. 91.9%; P=0.002) owing to the lower incidence of periprocedural pericardial effusion (0.55% vs. 1.8%; P=0.021). No significant differences in all-cause death, postprocedural stroke, and device-related thrombus were observed between the 2 groups. However, the cumulative bleeding rate at 1 year was substantially lower in the WM-FLX group (7.8% vs. 16.4%; P<0.001). Landmark analysis of bleeding events highlighted lower bleeding rates in the WM-FLX than WM2.5 group within the first 6 months (6.4% vs. 14.8%; P<0.001), with comparable bleeding rates over the 6- to 12-month period (1.5% vs. 3.2%, respectively; P=0.065). CONCLUSIONS: This study demonstrated higher early safety and lower 1-year bleeding rates in the WM-FLX than WM2.5 group. The lower bleeding events with WM-FLX are likely due to multiple factors other than purely difference in devices, such as postprocedural drug regimen.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Registries , Humans , Aged , Atrial Appendage/surgery , Male , Female , Aged, 80 and over , Atrial Fibrillation/surgery , Japan , Stroke/etiology , Stroke/prevention & control , Treatment Outcome , Middle Aged , Left Atrial Appendage Closure
18.
Arch Med Sci ; 20(2): 420-427, 2024.
Article in English | MEDLINE | ID: mdl-38757034

ABSTRACT

Introduction: The catheter-based left atrial appendage closure (LAAC) has evolved as an alternative to oral anticoagulation (OAC) among non-valvular atrial fibrillation (AF) patients in whom long-term OAC is contraindicated. In daily practice, however, a sizeable number of patients who have been referred for an LAAC do not receive this intervention. This study aimed primarily to investigate the factors deterring the practice of an LAAC in referred AF patients, and secondarily to compare the complication rates of intervened patients with those who had refused the intervention within 1 year. Material and methods: This retrospective single-centre study includes 200 patients. After a thoroughly conducted clinical selection process, 161 of these patients (80.5%) were excluded from receiving an LAAC intervention. Results: An analysis comparing these patients to those receiving an LAAC reveales that a higher proportion of intervened patients had suffered a prior gastrointestinal bleeding (48.7 vs. 28.0%; p = 0.013) as well as a haemorrhagic stroke (12.8 vs. 2.5%; p = 0.015), and was not anticoagulated at the time of presentation (35.9 vs. 14.9%; p = 0.006). The main reason for not conducting the procedure was patient refusal (62.1%) followed by multimorbidity (16.8%). The annual rate of ischaemic strokes and bleedings among patients refusing the intervention was 2.1% and 29.5%, respectively, and this was not statistically different from the intervened patients (each p > 0.05). Conclusions: The reasons why patients did not undergo the catheter-based LAAC were mainly reluctance for the procedure and multimorbidity. Furthermore, it could be assumed that the potential benefit of the LAAC may not be realised within the first year.

19.
Clin Case Rep ; 12(5): e8906, 2024 May.
Article in English | MEDLINE | ID: mdl-38751959

ABSTRACT

Key Clinical Message: Atrial fibrillation ablation, including pulmonary vein isolation immediately after left atrial appendage closure (LAAC), is a rare and challenging issue. Intracardiac echocardiography guidance can help identify the LAAC device position for safe atrial fibrillation ablation without LAAC device-related adverse events even immediately after LAAC device implantation. Abstract: Early phase atrial fibrillation (AF) ablation after left atrial appendage closure (LAAC) is a rare and challenging issue. Here, we present a case illustrating the feasibility of AF ablation under intracardiac echocardiography guidance immediately after LAAC device implantation without LAAC device-related adverse events.

20.
Eur Radiol ; 2024 May 23.
Article in English | MEDLINE | ID: mdl-38780765

ABSTRACT

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSION: CCTA holds promise as an effective means of quantitatively assessing device endothelialization. Endothelialization advanced gradually over time, with PDL potentially impeding device endothelialization. CLINICAL RELEVANCE STATEMENT: 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. KEY POINTS: 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.

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