BACKGROUND: The presented study investigates the application of bi-arterial 3D printed models to guide transseptal puncture (TSP) in left atrial appendage closure (LAAC). AIMS: The objectives are to (1) test the feasibility of 3D printing (3DP) for TSP guidance, (2) analyse the distribution of the optimal TSP locations, and (3) define a CT-derived 2D parameter suitable for predicting the optimal TSP locations. METHODS: Preprocedural planning included multiplanar CT reconstruction, 3D segmentation, and 3DP. TSP was preprocedurally simulated in vitro at six defined sites. Based on the position of the sheath, TSP sites were classified as optimal, suboptimal, or nonoptimal. The aim was to target the TSP in the recommended position during the procedure. Procedure progress was assessed post hoc by the operator. RESULTS: Of 68 screened patients, 60 patients in five centers (mean age of 74.68 ± 7.64 years, 71.66% males) were prospectively analyzed (3DP failed in one case, and seven patients did not finally undergo the procedure). In 55 patients (91.66%), TSP was performed in the optimal location as recommended by the 3DP. The optimal locations for TSP were postero-inferior in 45.3%, mid-inferior in 45.3%, and antero-inferior in 37.7%, with a mean number of optimal segments of 1.34 ± 0.51 per patient. When the optimal TSP location was achieved, the procedure was considered difficult in only two (3.6%) patients (but in both due to complicated LAA anatomy). Comparing anterior versus posterior TSP in 2D CCT, two parameters differed significantly: (1) the angle supplementary to the LAA ostium and the interatrial septum angle (160.83° ± 9.42° vs. 146.49° ± 8.67°; p = 0.001), and (2) the angle between the LAA ostium and the mitral annulus (95.02° ± 3.73° vs. 107.38° ± 6.76°; p < 0.001), both in the sagittal plane. CONCLUSIONS: In vitro TSP simulation accurately determined the optimal TSP locations for LAAC and facilitated the procedure. More than one-third of the optimal TSP sites were anterior.
- Klíčová slova
- 3D printing, computed tomography, left atrial appendage closure, transseptal puncture,
- MeSH
- 3D tisk MeSH
- fibrilace síní * terapie chirurgie MeSH
- lidé MeSH
- počítačová rentgenová tomografie MeSH
- punkce metody MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- síňové ouško * diagnostické zobrazování chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
OBJECTIVE: The systemic immune inflammatory index (SII) has prognostic value in cardiovascular diseases. The aim of current study was to investigate whether or not left atrial appendage (LAA) thrombus could be predicted by SII in patients with non-valvular atrial fibrillation. METHOD: The study included 525 patients newly diagnosed with non-valvular atrial fibrillation, who had not previously had anticoagulant treatment (50.7% male, mean age 62.94±10.79 years). All patients underwent transoesophageal echocardiography. RESULTS: LAA thrombus was observed in 86 patients (16.4%). In the ROC curve SII had a good diagnostic power in predicting LAA thrombus (AUC: 0.760, 95% CI: 0.703-0.818, P<0.001). In the multivariate regression analysis, diabetes (Hazard ratio: 2.264, 95% CI: 1.169-4.389, P=0.015), LAA emptying rate of <20 cm/s (Hazard ratio: 59.347, 95% CI: 25.397-138.680, P<0.001), and SII value of >750 (Hazard ratio: 4.291, 95% CI: 2.144-8.586 P<0.001) were determined as independent predictors for LAA thrombus. A poor correlation was found between SII and the CHADS2 VASc score (r=0.239, P<0.001) Conclusion. The SII, a practical and easily obtained test, can be used as a predictor of LAA thrombus in patients with non-valvular atrial fibrillation, and to decide on the anticoagulant treatment.
- Klíčová slova
- atrial fibrillation, diabetes, left atrial appendage thrombus, systemic immune-inflammatory index,
- MeSH
- antikoagulancia terapeutické užití MeSH
- echokardiografie transezofageální MeSH
- fibrilace síní * MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- síňové ouško * diagnostické zobrazování MeSH
- trombóza * diagnostické zobrazování etiologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- antikoagulancia MeSH
OBJECTIVES: This is a first report of the safety and 1-year outcomes of left atrial appendage closure (LAAC) using a novel foam-based conformable device, guided by intracardiac echocardiography (ICE). BACKGROUND: Limitations of current transcatheter LAAC devices include the need for precise coaxial delivery into the left atrial appendage (LAA), potential for traumatic implantation, incomplete LAA seal, and device-related thrombus. METHODS: The device (Conformal Left Atrial Appendage Seal, Conformal Medical Inc) is a self-expanding occluder consisting of a cylindrical nitinol endoskeleton with low-profile anchor barbs around the midpoint, covered with a porous foam cup. In a prospective single-center series, under conscious sedation, the device was delivered under fluoroscopic and ICE guidance. After positioning, a transesophageal echocardiography probe was placed to confirm ICE findings before device release. After closure, dual antiplatelet therapy was administered for 6 months. Follow-up imaging was planned for 45 days and 6 and 12 months. RESULTS: A total of 15 patients (age 71.3 ± 10.8 years, 33% men, CHA2DS2-VASc 4.1 ± 1.7, HAS-BLED 3.4 ± 1.4) underwent LAAC, 100% successfully. There were no procedure/device-related complications requiring intervention. Asymptomatic pericardial effusion occurred in 2 patients. The 45-day, 6-month, and 12-month follow-up imaging in 11, 9, and 13 patients, respectively, revealed adequate LAA seal (leak ≤5 mm) in all patients; device-related thrombus was detected in 1 patient at 6 months. Over 1-year follow-up, there were no ischemic strokes and 1 minor bleed. Nonprocedure-/device-related death occurred in 2 patients. CONCLUSIONS: This first report indicates that LAAC with the conformable implant guided by ICE imaging is feasible with encouraging 1-year clinical outcomes. (The Conformal Prague Study; NCT04193826).
- Klíčová slova
- Watchman FLX, amulet, intracardiac echocardiography, left atrial appendage occlusion, stroke prevention,
- MeSH
- echokardiografie transezofageální MeSH
- fibrilace síní * MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- síňové ouško * diagnostické zobrazování chirurgie MeSH
- srdeční katetrizace metody MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
INTRODUCTION: The randomized PRAGUE-17 trial demonstrated noninferiority of left atrial appendage closure (LAAC) to non-vitamin K anticoagulants (NOACs) for the prevention of major cardiovascular or cerebrovascular events. However, the left atrial appendage is an important source of natriuretic peptides and plays a role in left atrial reservoir function. Changes of heart failure (HF) biomarkers after LAAC compared to NOAC has not been studied. The aim of the study was to compare the changes in concentrations of HF biomarkers between LAAC and NOAC patients. METHODS: Of 402 patients randomized in the PRAGUE-17 trial, biomarkers were analyzed in 144 patients (73 in the NOAC and 71 in the LAAC group). Both groups had similar baseline characteristics. Serum concentration of NT-proBNP, NT-proANP, Galectin-3, and GDF-15 were measured at baseline (before the procedure in the LAAC group), at the 6-month (and at 24-month for NT-proBNP) follow-up timepoint. RESULTS: There were no significant differences in baseline, 6 month, and delta (δ = baseline - 6 month) concentrations of NT-proANP between the groups (NOAC: baseline 2.6 [0.5; 4.9], 6-month 3.1 [1.8; 4.8], p = .068; LAAC: baseline 3.3 [1.1; 4.6], 6-month 2.6 [0.9; 5.3], p = .51; p value for δ in concentrations between groups = 0.42). Similarly, there were no significant differences in baseline, 6, 24 months, and delta concentrations of NT-proBNP between the groups (NOAC: baseline 461.0 [113.5; 1342.0], 6 month 440.0 [120.5; 1291.5], 24 month 798 [274; 2236], p = .39; LAAC: baseline 421.0 [100.0; 1320.0], 6 month 601.0 [145.0; 1230.0], 24 month 855 [410; 1367], p = .28; p value for δ in concentrations between groups = 0.73 at 6 months, and 0.58 at 24 months). Finally, no significant differences were present in baseline, 6 month, and δ concentrations of Galectin-3 and GDF-15 between the two groups. CONCLUSION: LAAC did not significantly influence the levels of HF biomarkers 6 months after the procedure.
- Klíčová slova
- atrial natriuretic peptide, biomarkers, brain natriuretic peptide, left atrial appendage, left atrial appendage closure,
- MeSH
- antikoagulancia terapeutické užití MeSH
- aplikace orální MeSH
- biologické markery MeSH
- cévní mozková příhoda * MeSH
- fibrilace síní * diagnóza farmakoterapie chirurgie MeSH
- lidé MeSH
- síňové ouško * diagnostické zobrazování chirurgie MeSH
- srdeční selhání * diagnóza farmakoterapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- antikoagulancia MeSH
- biologické markery MeSH
BACKGROUND: The next-generation Watchman FLX left atrial appendage closure (LAAC) device has: (1) an atraumatic closed distal end, (2) reduced height, (3) a recessed screw hub to decrease device-related thrombus (DRT), (4) two rows of J-shape anchors so redeployment is possible after full recapture, and (5) ability to treat a greater size range of LAA ostia. OBJECTIVE: To report, for the first time, the feasibility and safety of intracardiac echocardiography (ICE)-guided Watchman FLX implantation. METHODS: A single-center prospective registry of atrial fibrillation patients planned for LAAC with the FLX device underwent ICE-guided implantation with conscious sedation. Transesophageal echocardiography (TEE) imaging was done preprocedure (to assess LAA size and exclude thrombus) and at clinical follow-up at 6-12 weeks. Clinical outcomes were LAA closure success, complications, leak, or DRT on follow-up TEE and major safety events. RESULTS: The study included 30 patients: age 75 ± 8 years, 53% men, CHA2 DS2 -VASc 4.6 ± 1.6, and HAS-BLED 3.4 ± 1.1. The primary indication was prior bleeding in 60% (72% GI bleeding). The LAA orifice width and length were 22.7 ± 3.1 and 25.7 ± 5.7 mm, respectively. Technical success was 100% (the first-choice device was used in 28 of 30). Procedure time was less than 30 min in 27 of 30 cases, with 36 ± 15 ml contrast used. The final device size was 29.2 ± 4.7 mm with 21.6 ± 4.5% compression. There were no procedure-related complications. Follow-up TEE at a median 47 days follow-up showed 100% device success with no DRT or peridevice leak ≥5 mm. Major safety events occurred in 6.6% (2/30). CONCLUSION: The Watchman FLX device can be safely implanted with intraprocedural ICE imaging instead of TEE.
- Klíčová slova
- Watchman FLX, intracardiac echocardiography, left atrial appendage occlusion, stroke prevention,
- MeSH
- cévní mozková příhoda * MeSH
- echokardiografie transezofageální MeSH
- fibrilace síní * diagnostické zobrazování chirurgie MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- síňové ouško * diagnostické zobrazování chirurgie MeSH
- srdeční katetrizace škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- MeSH
- antikoagulancia MeSH
- cévní mozková příhoda * MeSH
- fibrilace síní * chirurgie MeSH
- kardiochirurgické výkony * MeSH
- lidé MeSH
- síňové ouško * diagnostické zobrazování chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- antikoagulancia MeSH
BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES: This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS: Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA2DS2-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS: A high-risk patient cohort (CHA2DS2-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS: Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944).
- Klíčová slova
- atrial fibrillation, cardioembolic event, direct oral anticoagulant, left atrial appendage, stroke,
- MeSH
- cévní mozková příhoda * etiologie prevence a kontrola MeSH
- fibrilace síní komplikace diagnóza farmakoterapie chirurgie MeSH
- implantace protézy * škodlivé účinky přístrojové vybavení metody MeSH
- inhibitory faktoru Xa * aplikace a dávkování škodlivé účinky MeSH
- kardiochirurgické výkony * škodlivé účinky přístrojové vybavení metody MeSH
- krvácení * chemicky indukované prevence a kontrola MeSH
- lidé MeSH
- senioři MeSH
- síňové ouško diagnostické zobrazování chirurgie MeSH
- výsledky a postupy - zhodnocení (zdravotní péče) MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- inhibitory faktoru Xa * MeSH
OBJECTIVES: This study sought to evaluate the safety and feasibility of percutaneous retrieval of left atrial appendage closure (LAAC) devices with an endoscopic grasping tool. BACKGROUND: Transcatheter LAAC is a mechanical stroke prevention strategy in patients with nonvalvular atrial fibrillation (AF) who are poor candidates for long-term oral anticoagulation. However, these LAAC devices can be inadvertently released into an unfavorable location, the device might migrate to a different (unfavorable) position within the left atrial appendage (LAA) or may embolize from the heart into the aorta. In such instances, it can be challenging to remove the LAAC device without open cardiac or vascular surgery. METHODS: This study reports on a series of 4 cases in which an endoscopic grasping tool (Raptor) designed for gastrointestinal applications was used to percutaneously (non-surgically) remove LAAC devices that were either malpositioned or embolized. RESULTS: LAAC devices were safely and non-surgically removed using the grasping device in all 4 cases (Amulet: 1, Watchman: 3). Devices were successfully retrieved from the left inferior pulmonary vein, descending aorta, aortic arch, and the edge of the LAA ostium. Time of device retrieval post-LAAC implantation ranged from 24 h to 1 year. Special precautionary measures, such as preemptive pericardial access, embolic protection devices, and intraprocedural imaging, were used in 2 cases. CONCLUSIONS: This case series demonstrated that the endoscopic grasping tool appeared to be safe and useful to percutaneously retrieve LAAC devices.
- Klíčová slova
- LAAC, Raptor, complications, device embolization, retrieval,
- MeSH
- cévní mozková příhoda * MeSH
- fibrilace síní * chirurgie MeSH
- kardiochirurgické výkony * MeSH
- lidé MeSH
- síňové ouško * diagnostické zobrazování chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Stroke is one of the most severe complications of atrial fibrillation. Oral anticoagulation is the first choice therapy in prevention of cardiac embolic events. Particularly in patients with the history of serious bleeding, oral anticoagulation may be contraindicated. Percutaneous left atrial appendage closure represents an alternative in prophylaxis of cardiac embolic events. This review article describes physiology and pathophysiology of the left auricle, the most frequently used devices and their indications and scientific rationale.
- Klíčová slova
- atrial fibrillation, left auricle, occlusion, stroke,
- MeSH
- antikoagulancia MeSH
- cévní mozková příhoda * etiologie prevence a kontrola MeSH
- fibrilace síní * komplikace MeSH
- krvácení MeSH
- lidé MeSH
- síňové ouško * diagnostické zobrazování chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Názvy látek
- antikoagulancia MeSH
BACKGROUND: We investigated whether the increase of plasma natriuretic peptides (NPs) in atrial fibrillation (AF) is independent of the effect of AF on the left atrial (LA) hemodynamics. METHODS: Hemodynamically stable patients scheduled for AF ablation underwent assessment of B-type natriuretic peptide (BNP) and mid-regional pro-atrial natriuretic peptide (MR-proANP), echocardiography, and direct measurement of left atrial (LA) pressure. Concentrations of the NPs were compared between patients in AF (n = 31) and controls in sinus rhythm (SR; n = 31) who were matched for age, gender, heart rate, left ventricular ejection fraction, LA volume index, and directly measured mean LA pressure. Eighteen patients underwent serial measurement of NPs and LA pressure during native SR and after 20 min of pacing-induced AF. RESULTS: Compared to the patients in SR, the patients in AF had 2.6 times higher unadjusted BNP [median (inter-quartile range), 101 (63, 129) vs. 38 (26, 79) ng/L] and two times higher unadjusted MR-proANP [183 (140, 230) vs. 91 (67, 135) pmol/L; both p < 0.001]. Concentrations of both NPs correlated with mean LA pressure in the patients in SR (r = 0.75 for BNP and 0.62 for MR-proANP, both p < 0.001) but not in the patients in AF (r = 0.18 and 0.04, respectively, both p > 0.3). Both NPs increased significantly during induced AF [adjusted median (IQR) relative change, BNP: 27 (22; 40)%, MR-proANP: 75 (64; 99)%, both p < 0.001] without a significant change in the LA pressure. CONCLUSIONS: The increase of NPs in AF was independent of its effect on the LA hemodynamics.
- Klíčová slova
- Atrial fibrillation, Atrial pressure, Heart failure with preserved ejection fraction, Natriuretic peptide,
- MeSH
- atriální natriuretický faktor krev MeSH
- biologické markery krev MeSH
- echokardiografie MeSH
- fibrilace síní krev diagnóza chirurgie MeSH
- funkce levé komory srdeční fyziologie MeSH
- katetrizační ablace metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- natriuretický peptid typu B krev MeSH
- prognóza MeSH
- progrese nemoci MeSH
- prospektivní studie MeSH
- síňové ouško diagnostické zobrazování MeSH
- síňový tlak fyziologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- atriální natriuretický faktor MeSH
- biologické markery MeSH
- midregional pro-atrial natriuretic peptide, human MeSH Prohlížeč
- natriuretický peptid typu B MeSH