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1.
J Am Coll Cardiol ; 74(18): 2267-2274, 2019 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-31672183

RESUMO

BACKGROUND: Direct current cardioversion (DCCV) is a common rhythm control strategy in patients with symptomatic atrial fibrillation or flutter. There is no long-term data regarding the safety of DCCV in patients with endocardial left atrial appendage occlusion (LAAO) devices. OBJECTIVES: The purpose of this study was to assess the feasibility and safety of DCCV in patients with an LAAO device. METHODS: This multicenter retrospective study included 148 patients with an LAAO device who underwent DCCV for symptomatic atrial fibrillation or atrial flutter. RESULTS: The average age of the included patients was 72 ± 7 years and 59% were men. All patients (100%) had a transesophageal echocardiogram prior to DCCV. Device-related thrombus was seen in 2.7%. They were all successfully treated with oral anticoagulation (OAC) and were able to undergo DCCV after 6 to 8 weeks. DCCV restored sinus rhythm in all patients. None of the patients had DCCV-related thromboembolic complications. A total of 22% of patients were newly started on OAC after DCCV. There was no difference in DCCV-related complications between patients treated with or without OAC post-DCCV. Patients receiving OAC post-DCCV were found to undergo cardioversion at an earlier time after implantation (3.6 months [interquartile range (IQR): 0.7 to 8.6 months] vs. 8.6 months [IQR: 2.5 to 13.3 months]; p = 0.003). Three transient ischemic attacks, unrelated to DCCV, were found during follow-up. During a median follow-up of 12.8 months (IQR: 11.8 to 14.2 months), no device or left atrial thrombosis, device dislodgement, or a new device leak were observed. One patient died during follow-up due to noncardiac cause. CONCLUSIONS: DCCV is feasible in high-risk AF patients with an LAAO device without the need for oral anticoagulation if pre-procedural transesophageal echocardiography shows good device position, absence of device-related thrombus, and peridevice leak of ≤5 mm. The preliminary results are encouraging, but further large studies are warranted to establish safety.

3.
Clin Res Cardiol ; 2019 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-31667622

RESUMO

Ischemic stroke is a feared complication associated with transcatheter aortic valve replacement (TAVR). Data on the late risk of ischemic stroke following TAVR are scarce. This study aimed to investigate the early (0-90 days) and late (90 days-5 years) risk of ischemic cerebrovascular events (CVE) in a large, unselected cohort of patients undergoing TAVR and to compare this risk with a matched background population. Therefore, all patients undergoing first-time TAVR in Denmark were matched to a background population (controls) in a 1:4 ratio based on age, sex, atrial fibrillation (AF), and the major stroke risk factors. A total of 2455 TAVR patients were matched with 9820 controls. TAVR was associated with a significantly higher ischemic CVE risk as compared with their controls in the early phase [hazard ratio (HR) 5.35 [95% CI 3.50-8.17]; p < 0.001) but not in the late phase (HR 1.17 [95% CI 0.94-1.46]; p = 0.15). In a predefined stratified analysis, no patient-related factors were associated with this higher CVE risk in the early phase. The cumulative 90-day ischemic CVE risk was the lowest in TAVR-patients with known AF receiving oral anticoagulant (OAC) therapy (1.3% [95% CI 0.6-2.5%] and was two-fold higher in OAC-naïve TAVR-patients (2.4% [95% CI 1.8-3.3%] in patients without AF and 2.5% [95% CI 0.9-5.3%] in patients with AF). In conclusion, TAVR was associated with an increased risk of ischemic CVE in the early phase, but not in the late phase, as compared to their matched controls-OAC therapy reduced this early risk of ischemic CVE by half.

4.
N Engl J Med ; 2019 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-31733180

RESUMO

BACKGROUND: Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear. METHODS: We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns. RESULTS: After a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P = 0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P = 0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53). CONCLUSIONS: In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.).

5.
N Engl J Med ; 2019 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-31733182

RESUMO

BACKGROUND: Subclinical leaflet thickening and reduced leaflet motion of bioprosthetic aortic valves have been documented by four-dimensional computed tomography (CT). Whether anticoagulation can reduce these phenomena after transcatheter aortic-valve replacement (TAVR) is not known. METHODS: In a substudy of a large randomized trial, we randomly assigned patients who had undergone successful TAVR and who did not have an indication for long-term anticoagulation to a rivaroxaban-based antithrombotic strategy (rivaroxaban [10 mg] plus aspirin [75 to 100 mg] once daily) or an antiplatelet-based strategy (clopidogrel [75 mg] plus aspirin [75 to 100 mg] once daily). Patients underwent evaluation by four-dimensional CT at a mean (±SD) of 90±15 days after randomization. The primary end point was the percentage of patients with at least one prosthetic valve leaflet with grade 3 or higher motion reduction (i.e., involving >50% of the leaflet). Leaflet thickening was also assessed. RESULTS: A total of 231 patients were enrolled. At least one prosthetic valve leaflet with grade 3 or higher motion reduction was found in 2 of 97 patients (2.1%) who had scans that could be evaluated in the rivaroxaban group, as compared with 11 of 101 (10.9%) in the antiplatelet group (difference, -8.8 percentage points; 95% confidence interval [CI], -16.5 to -1.9; P = 0.01). Thickening of at least one leaflet was observed in 12 of 97 patients (12.4%) in the rivaroxaban group and in 33 of 102 (32.4%) in the antiplatelet group (difference, -20.0 percentage points; 95% CI, -30.9 to -8.5). In the main trial, the risk of death or thromboembolic events and the risk of life-threatening, disabling, or major bleeding were higher with rivaroxaban (hazard ratios of 1.35 and 1.50, respectively). CONCLUSIONS: In a substudy of a trial involving patients without an indication for long-term anticoagulation who had undergone successful TAVR, a rivaroxaban-based antithrombotic strategy was more effective than an antiplatelet-based strategy in preventing subclinical leaflet-motion abnormalities. However, in the main trial, the rivaroxaban-based strategy was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than the antiplatelet-based strategy. (Funded by Bayer; GALILEO-4D ClinicalTrials.gov number, NCT02833948.).

6.
Artigo em Inglês | MEDLINE | ID: mdl-31587968

RESUMO

BACKGROUND: The use of transthoracic and transesophageal echocardiography may be challenging in patients suspected of having prosthetic valve endocarditis (PVE). Intracardiac echocardiography (ICE) provides a new diagnostic tool in the examination of patients with PVE, yet few data on its use have been published. METHODS: From January 2012 to December 2016, patients with suspected PVE and inconclusive findings on transthoracic and transesophageal echocardiography were further examined with ICE. Medical records were reviewed to assess clinical status, microbiologic etiology, echocardiography, antibiotic treatment, and surgical procedures. The modified Duke criteria were used to assess the diagnostic classification after ICE. RESULTS: A total of 38 patients suspected of having PVE were included, of whom 17 patients had undergone transcatheter aortic heart valve implantation, 19 had surgically prosthetic valves, and two had tetralogy of Fallot with transcatheter pulmonary valves. After ICE, 19 patients were classified with definite PVE, and four patients were treated as having PVE because of overall clinical presentation. Of the 15 patients not treated for endocarditis after ICE, one patient had a relapse. Regarding procedural safety, no vascular complications occurred, whereas six of the patients (16%) had groin hematomas, which did not require intervention and had no sequelae. CONCLUSIONS: Among patients with suspected PVE, ICE changed the diagnosis to definite PVE in half of the patients, with a low frequency of relapse among patients in whom PVE could not be confirmed by ICE. ICE may help guide clinicians in the duration of antibiotic treatment and surgical intervention in the treatment of patients with PVE.

7.
Circ Cardiovasc Imaging ; 12(10): e009178, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31594409

RESUMO

BACKGROUND: A patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) in tricuspid aortic valve has been developed, which can predict paravalvular regurgitation and conduction disturbance. We wished to validate a patient-specific computer simulation of TAVR in bicuspid aortic valve and to determine whether patient-specific transcatheter heart valve (THV) sizing and positioning might improve clinical outcomes. METHODS: A retrospective study was performed on TAVR in bicuspid aortic valve patients that had both pre- and postprocedural computed tomography imaging. Preprocedural computed tomography imaging was used to create finite element models of the aortic root. Finite element analysis and computational fluid dynamics was performed. The simulation output was compared with postprocedural computed tomography imaging, cineangiography, echocardiography, and electrocardiograms. For each patient, multiple simulations were performed, to identify an optimal THV size and position for the patient's specific anatomic characteristics. RESULTS: A total of 37 patients were included in the study. The simulations accurately predicted the THV frame deformation (minimum-diameter intraclass correlation coefficient, 0.84; maximum-diameter intraclass correlation coefficient, 0.88; perimeter intraclass correlation coefficient, 0.91; area intraclass correlation coefficient, 0.91), more than mild paravalvular regurgitation (area under the receiver operating characteristic curve, 0.86) and major conduction abnormalities (new left bundle branch block or high-degree atrioventricular block; area under the receiver operating characteristic curve, 0.88). When compared with the implanted THV size and implant depth, optimal patient-specific THV sizing and positioning reduced simulation-predicted paravalvular regurgitation and markers of conduction disturbance. CONCLUSIONS: Patient-specific computer simulation of TAVR in bicuspid aortic valve may predict the development of important clinical outcomes, such as paravalvular regurgitation and conduction abnormalities. Patient-specific THV sizing and positioning may improve clinical outcomes of TAVR in bicuspid aortic valve.

8.
EuroIntervention ; 2019 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-31607682

RESUMO

AIMS: We assessed the impact of implant depth on hydrodynamic function following valve-in-valve (VIV) intervention using the ALLEGRA (New Valve Technology, Hechingen, Germany) transcatheter heart valve (THV) in three different surgical valve designs. METHODS AND RESULTS: Multiple implantation depths (+2mm, -2mm and -6mm) were tested using a 23mm ALLEGRA THV for VIV intervention in 19mm, 21mm, 23mm, and 25mm Epic, Mitroflow and Magna Ease bioprosthetic valves. Multimodality imaging and hydrodynamic evaluation was performed at each implantation depth. The 23mm ALLEGRA valve had gradients <20mmHg in the Mitroflow and Epic valves sized ³21mm, and in all sizes of the Magna Ease valve. Gradients did not increase significantly at lower implantation depths. The 19mm Epic (+2mm: 20.1±0.6mmHg, -2mm: 18.8±0.5mmHg, -6mm: 22.8±0.3mmHg) and 19mm Mitroflow (+2mm: 24.1±0.2mmHg, -2mm: 31.5±0.3mmHg, -6mm: 25.6±0.2mmHg) valves, had elevated mean gradients. In larger sized surgical valves (³23mm) the regurgitant fraction was higher at low implantation depths. Pinwheeling was significantly worse in the smaller sized (£21mm) surgical valves and also at low (<-2mm) implantation depth. CONCLUSIONS: The 23mm ALLEGRA valve had favourable (<20mmHg) gradients in all surgical valves sized ³21mm, even when the THV was implanted low. In 19mm sized Mitroflow and Epic valves, gradients were elevated (>20mmHg). While there was no major difference in mean transvalvular gradients, leaflet pinwheeling was worse at lower implantation depths.

9.
Artigo em Inglês | MEDLINE | ID: mdl-31665260

RESUMO

AIM: To examine the risk of arterial thromboembolism, bleeding, and all-cause mortality in AF patients treated with direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: In this nationwide observational cohort study, 735 patients undergoing TAVI from January 1, 2012 to June 30, 2017 with a history of AF and who were treated with oral anticoagulants were identified using data from Danish nationwide registries. Of these, 219 (29.8%) and 516 (70.2%) patients were treated with DOACs and VKAs, respectively. The DOAC group was characterized by a higher prevalence of previous arterial thromboembolism and a lower prevalence of chronic kidney disease compared with the VKA group. The distribution of age, sex, CHA2DS2-VASc and HAS-BLED-score, and concomitant antiplatelet therapy was similar between groups. Compared with VKA, treatment with DOACs was not associated with a significantly different 3-year absolute risk of arterial thromboembolism (9.6% [95% confidence interval [CI], 4.7%-16.5%] versus 7.4% [95%CI, 4.9%-10.5%] in the DOAC and VKA group, respectively), bleeding (14.3% [95%CI, 7.6%-22.9%] versus 13.3% [95%CI, 9.9%-17.1%]), or all-cause mortality 32.7% [95%CI, 21.8%-44.0%] versus 32.0% [95%CI, 26.8%-37.3%]). In adjusted analyses, treatment with DOACs, as compared with VKAs, was not associated with a significantly different rate of arterial thromboembolism (hazard ratio [HR], 1.23 [95%CI, 0.58-2.59]), bleeding (HR, 1.14 [95%CI, 0.63-2.06]), or all-cause mortality (HR, 0.93 [95%CI, 0.61-1.40]). CONCLUSIONS: In patients with AF undergoing TAVI, treatment with DOACs was not associated with a significantly different risk of arterial thromboembolism, bleeding, or all-cause mortality compared with VKA.

11.
EuroIntervention ; 2019 Oct 29.
Artigo em Inglês | MEDLINE | ID: mdl-31659987

RESUMO

AIMS: A transfemoral transarterial approach is considered the preferable access route for transcatheter aortic valve implantation (TAVI), followed by a transaxillary/subclavian TAVI approach. However, these approaches may not be an option in all patients. This study aimed to report the initial European experience with transfemoral transcaval TAVI. METHODS AND RESULTS: Data on 50 patients treated by transcaval TAVI in five European centres were collected and analysed according to the Valve Academic Research Consortium (VARC)-2 definitions. The study population had a mean age of 78.7 ± 8.0 years and a high surgical risk profile (median STS risk score 6.1%, interquartile range 3.0%-11.2%). Transcaval access was successful in 49 of 50 patients and device success was obtained in 94% of cases. Closure of the caval-aortic puncture site with a nitinol cardiac occluder was successful in all cases without need for emergent surgery. One patient received additional sealing of the aortic puncture site with a covered stent one day post-TAVI due to a gradual haemoglobin drop of 3 g/dL. VARC-2-defined life-threatening bleeding and major vascular complications possibly related to transcaval access were 4% and 10%, respectively. There were no bleeding or vascular complications after discharge. At 30 days, the clinical efficacy endpoint was reached in 88% of patients. CONCLUSIONS: Transfemoral transcaval access proofs to be a feasible and safe TAVI approach for high-risk patients with severe aortic stenosis not suitable for transfemoral or transaxillary/subclavian transarterial access.

13.
Artigo em Inglês | MEDLINE | ID: mdl-31566873

RESUMO

OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP). BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations. METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator. RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons. CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.

15.
J Am Heart Assoc ; 8(21): e013491, 2019 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-31656122

RESUMO

Background We hypothesized that women with congenital heart disease (CHD) are at increased risk of giving birth preterm, including very and moderately preterm and giving birth to infants small for gestational age (SGA). We aimed to investigate this in a nation-wide study with focus on the potential modifying effect of socioeconomic status. Methods and Results We performed a cohort study using Danish nation-wide registers between 1997 and 2014. The exposure, maternal CHD, was subdivided into simple, moderate and complex based on severity of defects. Outcomes were preterm birth and SGA. Cox regression was used to estimate hazard ratios (HR). A total of 933 149 births including 3745 births among women with CHD were studied. The risk of giving birth preterm and SGA were higher among women with CHD as compared with women without CHD; for example, adjusted hazard ratios of preterm birth according to severity: simple 1.33 (95% CI, 1.11-1.59), moderate 1.45 (95% CI, 1.14-1.83) and complex 3.26 (95% CI, 2.41-4.40). Same pattern was seen for very and moderately preterm births and SGA. Education was a strong predictor of both preterm birth and SGA but did not modify the association between maternal congenital heart disease and preterm birth (P=0.38) or SGA (P=0.99). Conclusions Women with CHD were at increased risk of preterm birth both, moderately and very preterm, as well as giving birth to infants SGA. Education was a strong predictor of both preterm birth and SGA but the association between CHD and risk of preterm birth and SGA was independent of educational level.

16.
Artigo em Inglês | MEDLINE | ID: mdl-31647178

RESUMO

AIMS: The commonly used valve-in-valve (VIV) app recommends sizing based on dimensions of both the transcatheter heart valve (THV) and bioprosthetic surgical valve. The implications of hydrodynamic testing to guide VIV sizing are poorly understood. This bench study assessed the hydrodynamic performance of different sizes of self-expanding supra-annular THVs in three different surgical aortic bioprostheses at different implantation depths. METHODS: A small versus medium ACURATE neo (ACn), and a 26 mm versus 29 mm Evolut R were assessed after VIV implantation in 25 mm Mitroflow, Mosaic, and Magna Ease aortic surgical bioprostheses, at three implantation depths (+2 mm, -2 mm, and -6 mm). RESULTS: The medium-sized ACn had lower gradients compared to the small ACn when the THV was implanted high (+2 mm, or -2 mm). The 29 mm Evolut R had lower gradients compared to a 26 mm Evolut R for all implantation depths, except for a depth of -2 mm in the 25 mm Mitroflow. The medium ACn and 29 mm Evolut R had larger effective orifice areas compared to the small ACn and 26 mm Evolut R, respectively. Both Evolut R sizes had acceptable regurgitant fractions (<15%), while both ACn sizes were above the acceptable performance criteria (>15%), at all implantation depths. CONCLUSIONS: Use of a larger self-expanding THV was associated with superior hydrodynamic performance if the THV was implanted high. Hydrodynamic testing can provide additional information to the VIV app to help guide VIV sizing.

18.
EuroIntervention ; 15(7): 563-565, 2019 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-31538625
19.
Circulation ; 2019 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-31476897

RESUMO

BACKGROUND: For patients with severe aortic stenosis (AS) and coronary artery disease (CAD), the completely percutaneous approach to aortic valve replacement and revascularization has not been compared to the standard surgical approach. METHODS: The prospective SURTAVI trial enrolled intermediate-risk patients with severe AS from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score >22 was an exclusion criterion. Patients were stratified according to need for revascularization and then randomized to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention (PCI), while those in the SAVR group had coronary artery bypass grafting (CABG). The primary endpoint was the rate of all-cause mortality or disabling stroke at two years. RESULTS: Of 1,660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher STS risk score for mortality (4.8±1.7% vs 4.4±1.5%; p<0.01) and were more likely to be male (65.1% vs 54.2%; p<0.01) than the 1,328 patients not assigned to revascularization. After randomization to treatment, there were 169 TAVR and PCI patients, 163 SAVR and CABG patients, 695 TAVR patients, and 633 SAVR patients. No significant difference in the rate of the primary endpoint was found between TAVR and PCI and SAVR and CABG (16.0%; 95% CI 11.1 - 22.9 vs. 14.0%; 95% CI 9.2 - 21.1; p=0.62), or between TAVR and SAVR (11.9%; 95% CI 9.5 - 14.7 vs. 12.3%; 95% CI 9.8 - 15.4; p=0.76). CONCLUSIONS: For patients at intermediate surgical risk with severe AS and non-complex CAD (SYNTAX score ≤ 22), a complete percutaneous approach of TAVR and PCI is a reasonable alternative to SAVR and CABG. CLINICAL TRIAL REGISTRATION: URL: www.clinicaltrials.gov Unique Identifier: NCT01586910.

20.
BMC Cardiovasc Disord ; 19(1): 196, 2019 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-31412774

RESUMO

BACKGROUND: Left atrial appendage closure is increasingly used. LAA closure procedures can rarely be complicated by device embolization, typically towards the aorta. In this case report, we describe the successful percutaneous retrieval of an embolized Amulet device from the left atrium in a patient with previous MitraClips. CASE PRESENTATION: By guidance of intracardiac echocardiography (ICE) and under local anaesthesia, two guiding systems were introduced into the LA; one to stabilize the device against the lateral LA wall and one large system to retrieve the device. However, the LAA closure device was finally snared by a three-loop snare and pulled across the interatrial septum (IAS) without taking the device into a protective guiding sheath - and this without tearing the IAS. CONCLUSIONS: In conclusion, percutaneous retrieval of an embolized LAA closure device from the LA is feasible by transseptal approach under local anaesthesia and with ICE guidance.

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