Cerebral embolisation during transcatheter edge-to-edge repair of the mitral valve with the MitraClip system: a prospective, observational study

Braemswig, Tim Bastian; Kusserow, Madeleine; Kruppa, Jochen; Reinthaler, Markus; Erdur, Hebun; Fritsch, Merve; Curio, Jonathan; Alushi, Brunilda; Villringer, Kersten; Galinović, Ivana; Berger, Christian; Leistner, David M.; Audebert, Heinrich J.; Endres, Matthias; Landmesser, Ulf; Fiebach, Jochen B.; Nolte, Christian H.; Beckhoff, Frederik; Lauten, Alexander

doi:10.4244/eij-d-21-00646

Cited by 13 publications

(12 citation statements)

References 26 publications

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“…Baseline characteristics were extracted from the medical records (including sex, age, vascular risk factors, laboratory data, and medication on admission). As previously reported, 8 the severity of mitral regurgitation was graded as mild (I), moderate (II), or severe (III). Cognitive tests were performed before and after the catheter‐based structural heart interventions using the Montreal Cognitive Assessment.…”

Section: Methodsmentioning

confidence: 97%

“…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%

“… 7 Patients undergoing percutaneous MVR using the MitraClip System had heart failure and moderate/severe mitral regurgitation. 8 To unequivocally detect new CMBs after these procedures, eligible patients for this exploratory analysis had to receive 2 cerebral MRI examinations—before and after the catheter‐based structural heart intervention—on the same MRI scanner (Figure 1 ).…”

Section: Methodsmentioning

confidence: 99%

“…Recruitment was performed at the Charité—Universitätsmedizin Berlin, Campus Benjamin Franklin, between May 2016 and May 2017 (LAAC data set; German Clinical Trials Register: DRKS00010300) 7 and between June 2017 and September 2019 (MitraClip data set; ClinicalTrials.gov : NCT03104556). 8 Both prospective, observational studies were approved by the local Ethics Committee of the Charité—Universitätsmedizin Berlin, Germany (LAAC data set: EA/084/15; MitraClip data set: EA2/005/17). All patients gave written informed consent.…”

Section: Methodsmentioning

confidence: 99%

“…Catheter‐based LAAC and percutaneous MVR using the MitraClip System were performed in standard fashion as described previously. 7 , 8 During both procedures, repeated boluses of unfractionated heparin were administered aiming at an activated clotting time >250 seconds. LAAC (using the Amulet [Abbott, Menlo Park, CA], Occlutech [Occlutech, Jena, Germany], or Lambre [Lifetech Scientific, Shenzhen, China] devices) was performed under conscious sedation, MVR using the MitraClip System (Abbott) was performed under conscious sedation (n=4) or general anesthesia (n=18).…”

Section: Methodsmentioning

confidence: 99%

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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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Section: Methodsmentioning

confidence: 97%

Section: Methodsmentioning

confidence: 99%