Long‐term follow up of 3 T MRI‐detected brain lesions after percutaneous catheter‐based left atrial appendage closure

Bellmann, Barbara; Rillig, Andreas; Skurk, Carsten; Leistner, David M.; Hæusler, Karl Georg; Lin, Tina; Geran, Rohat; Koehler, Luzie; Guttmann, Selma; Tscholl, Verena; Roser, Mattias; Lenz, Klaus; Villringer, Kersten; Park, Jai Wun; Fiebach, Jochen B.; Landmesser, Ulf

doi:10.1002/ccd.27611

Cited by 8 publications

(10 citation statements)

References 17 publications

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“…Acute brain lesions detected by MRI occur in up to 48% after LAAC. 28 EPD might reduce the incidence of these lesions, as has been shown in transcatheter aortic valve replacement. 29 In the presence of LAA thrombus, the use of these devices may be particularly appropriate; however, in our study, EPD was used in only 34% of patients with LAA thrombus undergoing direct LAAC, a percentage slightly higher than previous reports.…”

Section: Discussionmentioning

confidence: 82%

Management and outcomes of patients with left atrial appendage thrombus prior to percutaneous closure

Marroquín

Tirado‐Conte

Streb

et al. 2021

Heart

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ObjectiveLeft atrial appendage (LAA) thrombus has heretofore been considered a contraindication to percutaneous LAA closure (LAAC). Data regarding its management are very limited. The aim of this study was to analyse the medical and invasive treatment of patients referred for LAAC in the presence of LAA thrombus.MethodsThis multicentre observational registry included 126 consecutive patients referred for LAAC with LAA thrombus on preprocedural imaging. Treatment strategies included intensification of antithrombotic therapy (IAT) or direct LAAC. The primary and secondary endpoints were a composite of bleeding, stroke and death at 18 months, and procedural success, respectively.ResultsIAT was the preferred strategy in 57.9% of patients, with total thrombus resolution observed in 60.3% and 75.3% after initial and subsequent IAT, respectively. Bleeding complications and stroke during IAT occurred in 9.6% and 2.9%, respectively, compared with 3.8% bleeding and no embolic events in the direct LAAC group before the procedure. Procedural success was 90.5% (96.2% vs 86.3% in direct LAAC and IAT group, respectively, p=0.072), without cases of in-hospital thromboembolic complications. The primary endpoint occurred in 29.3% and device-related thrombosis was found in 12.8%, without significant difference according to treatment strategy. Bleeding complications at 18 months occurred in 22.5% vs 10.5% in the IAT and direct LAAC group, respectively (p=0.102).ConclusionIn the presence of LAA thrombus, IAT was the initial management strategy in half of our cohort, with initial thrombus resolution in 60% of these, but with a relatively high bleeding rate (~10%). Direct LAAC was feasible, with high procedural success and absence of periprocedural embolic complications. However, a high rate of device-related thrombosis was detected during follow-up.

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Section: Discussionmentioning

confidence: 82%

Management and outcomes of patients with left atrial appendage thrombus prior to percutaneous closure

Marroquín

Tirado‐Conte

Streb

et al. 2021

Heart

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“…In one study analyzing ABLs also in LAmbre™ treated patients, ABLs were reported in 48% of the LAAC-patients. However, since no residual ABLs were detectable in 71% of these LAAC-treated patients at the 3-months-FUP examination, and since no significant neurocognitive alterations were discernable by the MoCA-test and the NIHSS-score, the clinical significance of these MRIdetected lesions is questionable [17,26].…”

Section: Discussionmentioning

confidence: 94%

“…Importantly, the follow-up (FUP) MRI which was performed in n = 7 ABL patients 3 months after the LAAC-implantation, no residual ABLs were detectable in 71% of these patients. There were no significant changes in neurocognitive function (MoCA-test and NIHSS-score) either after LAAC or at the 3-month FUP [17,26]. These publications included only 2 patients treated with a LAm-bre™ it was not designed to report success and complication rates, and was therefore not considered for the evaluation of the systematic review data.…”

Section: Resultsmentioning

confidence: 99%

Systematic review on left atrial appendage closure with the LAmbre device in patients with non-valvular atrial fibrillation

Ali

Rigopoulos

Mammadov

et al. 2020

BMC Cardiovasc Disord

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Background: Percutaneous closure (LAAC) of the left atrial appendage (LAA) is an efficacious preventive procedure for patients with non-valvular atrial fibrillation (NVAF) and considerable bleeding risk. We sought to systematically review the available LAAC data on the novel occluder device LAmbre™. Methods: For this systematic review, a search of the literature was conducted by 3 independent reviewers, reporting the safety and therapeutic success of LAAC in patients being treated with a LAmbre™. Publications reporting the safety and therapeutic success of LAAC using LAmbre™ in n > 5 patients were included. Results: The literature search retrieved n = 10 publications, encompassing n = 403 NVAF patients treated with a LAmbre™ LAAC, with relevant data regarding safety and therapeutic success of the procedure. The mean CHA 2 DS 2-VASc Score was 4.0 + 0.9, and the mean HAS-BLED score was 3.4 + 0.5. The implantation success was 99.7%, with a mean procedure time of 45.4 ± 18.7 min, and a fluoroscopy time of 9.6 ± 5.9 min, and a contrast agent volume of 96.7 ± 0.7 ml. The anticoagulation regimen was switched to DAPT post procedure in the majority of the patients (96.8%). Partial and full recapture were done in 45.5% and in 25.6%, respectively. Major complications were reported in 2.9%, with 0.3% mortality, 1.7% pericardial tamponade, 0.3% stroke, and 0.6% major bleeding complications; no device embolization was observed. During follow up at 6 or 12 months, major adverse cardiovascular events were reported in 3.3%: Stroke or TIA in 1.7%, thrombus formation on the device in 0.7%, and residual flow > 5 mm in 1.0%. In some publications, the favorable implantion properties of the LAmbre™ for difficult anatomies such as shallow or multilobular LAA anatomies were described. Conclusions: This systematic review on the LAmbre™ LAA-occluder including n = 403 NVAF patients demonstrates an excellent implantion success rate, promising follow-up clinical data, and favorable properties for also challenging LAA anatomies,. While its design seems to be helpful in preventing device embolization, pericardial tamponade may not be substantially reduced by the LAmbre™ as compared with other established LAAC devices. Further larger prospective multicenter registries and randomized trials are needed to scrutinize the value of the LAmbre™ compared with established LAAC devices.

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“…This analysis includes data derived from 2 prospective, observational, single‐center studies, including patients undergoing catheter‐based left atrial appendage closure (LAAC data set) 7 and percutaneous mitral valve repair (MVR) using the MitraClip System (MitraClip data set). 8 …”

Section: Methodsmentioning

confidence: 99%

New Cerebral Microbleeds After Catheter‐Based Structural Heart Interventions: An Exploratory Analysis

Braemswig

Kusserow

Bellmann

et al. 2023

JAHA

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Background Cerebral microbleeds (CMBs) are increasingly recognized as “covert” brain lesions indicating increased risk of future neurological events. However, data on CMBs in patients undergoing catheter‐based structural heart interventions are scarce. Therefore, we assessed occurrence and predictors of new CMBs in patients undergoing catheter‐based left atrial appendage closure and percutaneous mitral valve repair using the MitraClip System. Methods and Results We conducted an exploratory analysis using data derived from 2 prospective, observational studies. Eligible patients underwent cerebral magnetic resonance imaging (3 Tesla) examinations and cognitive tests (using the Montreal Cognitive Assessment) before and after catheter‐based left atrial appendage closure and percutaneous mitral valve repair. Forty‐seven patients (53% men; median age, 77 years) were included. New CMBs occurred in 17 of 47 patients (36%) following catheter‐based structural heart interventions. Occurrences of new CMBs did not differ significantly between patients undergoing catheter‐based left atrial appendage closure and percutaneous mitral valve repair (7/25 versus 10/22; P =0.348). In univariable analysis, longer procedure time was significantly associated with new CMBs. Adjustment for heparin attenuated this association (adjusted odds ratio [per 30 minutes]: 1.77 [95% CI, 0.92–3.83]; P =0.090). Conclusions New CMBs occur in approximately one‐third of patients after catheter‐based left atrial appendage closure and percutaneous mitral valve repair using the MitraClip System. Our data suggest that longer duration of the procedure may be a risk factor for new CMBs. Future studies in larger populations are needed to further investigate their clinical relevance. Clinical Trial Registration German Clinical Trials Register: DRKS00010300 ( https://drks.de/search/en/trial/DRKS00010300 ); ClinicalTrials.gov : NCT03104556 ( https://clinicaltrials.gov/ct2/show/NCT03104556?term=NCT03104556&draw=2&rank=1 ).

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Long‐term follow up of 3 T MRI‐detected brain lesions after percutaneous catheter‐based left atrial appendage closure

Abstract: While new MRI-detected brain lesions are commonly observed after percutaneous LAAC, ABLs were no longer detectable in 71% of the patients at the three-month follow-up. There were no significant changes in neurocognitive function after LAAC and at the three-month follow-up.

Cited by 8 publications

References 17 publications

Management and outcomes of patients with left atrial appendage thrombus prior to percutaneous closure

Management and outcomes of patients with left atrial appendage thrombus prior to percutaneous closure

Systematic review on left atrial appendage closure with the LAmbre device in patients with non-valvular atrial fibrillation

New Cerebral Microbleeds After Catheter‐Based Structural Heart Interventions: An Exploratory Analysis

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