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1.
Europace ; 22(6): 916-923, 2020 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-32003774

RESUMO

AIMS: This study compares clinical outcomes of Watchman vs. Amplatzer devices for left atrial appendage closure (LAAC). METHODS AND RESULTS: Of two real-world registries, the Watchman registry Lichtenfels, Germany, and the Amplatzer registry Bern-Zurich, Switzerland, 303 and 333 consecutive patients, respectively, were included. After a 1:1 propensity score matching, 266 vs. 266 patients were compared by use of the predefined primary efficacy endpoint of stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major peri-procedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards. Mean age was 75.3 ± 7.8 (Watchman) vs. 75.1 ± 9.9 (Amplatzer) years, CHA2DS2-VASc score 4.5 ± 1.7 vs. 4.5 ± 1.5, and HAS-BLED score 3.2 ± 1.0 vs. 3.2 ± 1.0. At a mean follow-up of 2.4 ± 1.3 vs. 2.5 ± 1.5 years and 1.322 patient-years, the primary endpoints of efficacy [40/646, 6.2% [Watchman] vs. 43/676, 6.4% [Amplatzer]; hazard ratio (HR), 1.02; 95% confidence interval (CI), 0.66-1.58; P = 0.92] and safety (33/646, 5.1% vs. 30/676, 4.4%; HR, 0.57; 95% CI, 0.29-1.11; P = 0.10), as well as the combined hazard endpoint (69/646, 10.7% vs. 66/676, 9.8%; HR, 0.80; 95% CI, 0.55-1.12; P = 0.26) were similar for both groups. CONCLUSION: This study suggests comparable efficacy and safety of the Watchman and Amplatzer devices.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral , Idoso , Idoso de 80 Anos ou mais , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Cateterismo Cardíaco , Alemanha/epidemiologia , Humanos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Suíça , Resultado do Tratamento
2.
Heart Vessels ; 34(8): 1360-1369, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30820642

RESUMO

This study aimed to estimate the incidence and risk factors of device-related thrombus (DRT) following percutaneous left atrial appendage closure (LAAC) in real-world practices. Between February 2012 and December 2016, 319 consecutive patients with atrial fibrillation underwent percutaneous LAAC using WATCHMAN, WATCHMAN Flx, Amplatzer cardiac plug, and Amulet devices. All patients underwent transesophageal echocardiography (TEE) at a minimum of three time points; periprocedurally, at 45 days, and at 6 months. Other clinical parameters were also evaluated, and a comparison between patients with DRT and those not suffering from DRT was done. The percutaneous LAAC was successfully performed in 97.8% of the patients. DRT was detected in 14 (4.49%) patients; of the 14 patients, DRT was detected in 3 patients at acute phase, 8 patients at subacute phase, 2 patients at late phase and 1 patient at very late phase. Most of the DRT originated from the central screw of device. In 6 out of 14 patients, DRT was successfully resolved by oral anticoagulation. Higher HAS-BLED score (4.1 ± 1.2 vs. 3.5 ± 1.1, p = 0.042) was more frequent in patients with DRT. Multivariable analysis showed that residual peri-device leak may result in a predisposition to DRT (p = 0.023). The incidence of DRT after percutaneous LAAC was acceptable, as a part of the DRT was resolved with oral anticoagulation. Residual peri-device leak was associated with DRT. Optimal implantation without peri-device gap, individual antithrombotic regimens, and careful monitoring with TEE follow-up could be conducive to the prevention of DRT.


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Dispositivo para Oclusão Septal/efeitos adversos , Trombose/diagnóstico por imagem , Trombose/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Ecocardiografia Transesofagiana , Feminino , Alemanha/epidemiologia , Humanos , Incidência , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento
3.
Heart Vessels ; 33(9): 1068-1075, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29564543

RESUMO

The prevalence of chronic kidney disease (CKD) is high in patients with atrial fibrillation (AF). Left atrial appendage closure (LAAC) has been recognized as an efficient alternative to oral anticoagulation for the prevention of thromboembolic events in patients with non-valvular AF (NVAF); however, the long-term safety and efficacy of LAAC in patients with CKD remain unclear. This study was designed to provide data regarding the safety and efficacy of LAAC in NVAF patients with CKD. A real-world analysis of the safety and efficacy of LAAC was performed on a cohort of 300 NVAF patients with or without CKD who underwent LAAC using the Watchman (WM) device at our center. The patients with CKD (n = 151) were significantly older (77.0 ± 7.2 vs. 73.2 ± 7.8 years, respectively, P < 0.0001) and had a higher CHA2DS2-VASc score (4.3 ± 1.5 vs. 3.4 ± 1.4, respectively, P < 0.0001) and HAS-BLED score (4.0 ± 1.0 vs. 3.0 ± 1.0, respectively, P < 0.0001) than the patients without CKD (n = 149). However, there were no differences between groups with respect to the device implant success rate (98.7 vs. 97.3%, respectively, P = 0.446) or severe periprocedural complications within 7 days. The patients were followed up for 637 ± 398 days, and all patients received repeat transesophageal echocardiography (TEE). Thirteen (4.3%) device-related thrombi, 3 (1.0%) ischemic strokes, and 19 (6.3%) non-procedural major bleeding cases were documented, and there were no differences in these complications between groups. The observed rate of all thromboembolic events by Kaplan-Meier analysis decreased by 68.8% (CKD) and 48.6% (non-CKD); moreover, the observed annual rate of bleeding was reduced by 57.5% (CKD) and 11.4% (non-CKD). Our results indicate that LAAC with the WM device is safe and effective in preventing stroke in NVAF patients with and without CKD.


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Taxa de Filtração Glomerular/fisiologia , Implantação de Prótese/métodos , Insuficiência Renal Crônica/complicações , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Idoso , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Ecocardiografia Transesofagiana , Feminino , Seguimentos , Humanos , Masculino , Insuficiência Renal Crônica/fisiopatologia , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento
4.
Int J Cardiol ; 265: 58-61, 2018 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-29754931

RESUMO

BACKGROUND: Left atrial appendage closure (LAAC) is an efficient alternative of oral anticoagulation to prevent stroke in patients with non-valvular atrial fibrillation (NVAF). Due to complexities of LAA anatomy, a complete closure may not always be obtained with a single device. The aim of this study was to evaluate the feasibility and safety of the staged 'kissing-Watchman' technology to occlude the LAA with complex anatomy. METHODS: In our center, among 300 cases underwent LAAC with Watchman device from February 2012 to December 2016, 7 complex LAAs were implanted double devices using the staged 'kissing-Watchman' technology. The anatomic morphology, procedure characteristics and safety were analyzed. RESULTS: Of the 7 LAAs, the anatomic morphology includes 6 cauliflowers and 1 chicken wings, each has 2 big lobes and a large common ostium. In the two-staged LAAC procedures, there were no differences in X-ray exposure time, but the total procedure time (p = 0.0634), contrast volume (p = 0.0802) and X-ray dose (p = 0.0803) in the first procedure showed a tendency over the second. All the procedures were successful, except for one case with a 2 mm of peri-device leakage, there were no severe complications or major adverse events including device dislocation, thrombosis, obvious peri-device leakage (≥5 mm), pericardial effusion/tamponade, stroke/transient ischemic attack/systemic embolism, death and major bleeding during the 7-day perioperative period and the 6-month follow-up. CONCLUSIONS: The staged 'kissing-Watchman' technology is feasible and safe, which might provide a strategy to occlude the LAA with complex anatomy when an incomplete closure is inevitable with a single device.


Assuntos
Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Desenho de Prótese , Implantação de Prótese/instrumentação , Dispositivos de Oclusão Vascular , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Implantação de Prótese/métodos , Resultado do Tratamento
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