RESUMO
OBJECTIVE: The study in patients with percutaneous left atrial appendage (LAA) occlusion investigates clinical outcomes according to the position of the Amplatzer Cardiac Plug (ACP) disc. BACKGROUND: The ACP consists of a disc and an anchoring lobe. The disc is meant to cover the ostium of the LAA, but frequently retracts partially or completely into the neck of the LAA. It is not known whether a retracted disc affects outcome. METHODS: Outcomes of 169 consecutive patients (age 73.1 ± 10.4 years; 76% male) with successful LAA closure were analyzed according to the position of the ACP disc: group A had complete coverage of the LAA ostium; in group B the disc prolapsed partially or completely into the LAA-neck. Transesophageal echocardiography was performed 1-6 months after ACP implantation. The safety endpoint was the composite of clinically significant pericardial effusion, device embolization, procedure-related stroke/transient ischemic attack (TIA), major bleeding, or device thrombus. The efficacy endpoint was the composite of death, neurological events (ischemic and hemorrhagic stroke, TIA), or systemic embolism during follow-up. RESULTS: Group A comprised 76 patients (age 73.0 ± 9.9 years; 74% male) and group B 93 patients (age 73.3 ± 10.9 years; 79% male). Mean CHA2 DS2 -Vasc score and HASBLED score were 4.2 ± 1.7 (group A 4.3 ± 1.6; group B 4.2 ± 1.8) and 2.9 ± 1.1 (group A 2.9 ± 1.0; group B 3.0 ± 1.2), respectively. Mean follow-up of the study population was 13.0 ± 10.4 months. Overall, the composite safety and efficacy endpoints occurred in 20 (12%) and 6 patients (4%), respectively. There was no significant difference between groups A and B in the occurrence of the safety endpoint (13% vs. 11%, P = 0.64), or the efficacy endpoint (4% vs. 3%, P = 1.0). CONCLUSIONS: No evidence for a difference in the occurrence of the safety and efficacy endpoint was found between patients with complete vs. incomplete ACP disc coverage of the LAA ostium. The risk of repositioning attempts in case of incomplete coverage does not seem to be warranted. Current findings need further confirmation in a larger scale clinical trial. © 2016 Wiley Periodicals, Inc.
Assuntos
Apêndice Atrial , Fibrilação Atrial/terapia , Cateterismo Cardíaco/instrumentação , Idoso , Idoso de 80 Anos ou mais , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico por imagem , Cateterismo Cardíaco/efeitos adversos , Intervalo Livre de Doença , Ecocardiografia Doppler em Cores , Ecocardiografia Transesofagiana , Desenho de Equipamento , Feminino , Humanos , Embolia Intracraniana/etiologia , Embolia Intracraniana/prevenção & controle , Ataque Isquêmico Transitório/etiologia , Ataque Isquêmico Transitório/prevenção & controle , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: To assess feasibility and outcomes of left atrial appendage (LAA) closure when using a patent foramen ovale (PFO) for left atrial access. BACKGROUND: Because of the fear of entering the left atrium too high, using a PFO for left atrial access during LAA occlusion (LAAO) is generally discouraged. We report our single-center experience using a concomitant PFO for LAAO, thereby avoiding transseptal puncture. METHODS: LAAO was performed with local anesthesia and fluoroscopic guidance only (no echocardiography). The Amplatzer Cardiac Plug (ACP) was used in all patients. After LAAO, the PFO was closed at the same sitting, using an Amplatzer occluder through the ACP delivery sheath. Patients were discharged the same or the following day on dual antiplatelet therapy for 1-6 months, at which time a follow-up transesophageal echocardiogram (TEE) was performed. RESULTS: In 49 (96%) of 51 patients (35 males, age 70.9 ± 11.9 years), LAAO was successful using the PFO for left atrial access. In one patient, a long tunnel PFO precluded LAAO, which was performed via a more caudal transseptal puncture. In a second patient, a previously inserted ASD occluder precluded LAAO, which was abandoned because of pericardial bleeding. PFO closure was successful in all patients. Follow-up TEE was performed in 43 patients 138 ± 34 days after the procedure. It showed proper sitting of both devices in all patients. CONCLUSIONS: Using a PFO for LAAO had a high success rate and could be the default access in all patients with a PFO, potentially reducing procedural complications arising from transseptal puncture.
Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Cateterismo Cardíaco/métodos , Forame Oval Patente/complicações , Dispositivo para Oclusão Septal , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/etiologia , Ecocardiografia Transesofagiana , Feminino , Fluoroscopia , Seguimentos , Forame Oval Patente/diagnóstico , Humanos , Masculino , Resultado do TratamentoRESUMO
OBJECTIVES: To report a 10-year single center experience with Amplatzer devices for left atrial appendage (LAA) occlusion. BACKGROUND: Intermediate-term outcome data following LAA occlusion are scarce. METHODS: Short- and intermediate-term outcomes of patients who underwent LAA occlusion were assessed. All procedures were performed under local aesthesia without transesophageal echocardiography. Patients were discharged on acetylsalicylic acid and clopidogrel for 1-6 months. RESULTS: LAA occlusion was attempted in 152 patients (105 males, age 72 ± 10 years, CHA2 DS2 -Vasc-score 3.4 ± 1.7, HAS-BLED-score 2.4 ± 1.2). Nondedicated devices were used in 32 patients (21%, ND group) and dedicated Amplatzer Cardiac Plugs were used in 120 patients (79%, ACP group). A patent foramen ovale or atrial septal defect was used for left atrial access and closed at the end of LAA occlusion in 40 patients. The short-term safety endpoints (procedural complications, bleeds) occurred in 15 (9.8%) and the efficacy endpoints (death, stroke, systemic embolization) in 0 patients. Device embolization occurred more frequently in the ND as compared to the ACP group (5 patients or 12% vs. 2 patients or 2%). Mean intermediate-term follow up of the study population was 32 months (range 1-120). Late deaths occurred in 15 patients (5 cardiovascular, 7 noncardiac, 3 unexplained). Neurologic events occurred in 2, peripheral embolism in 1, and major bleeding in 4 patients. The composite efficacy and safety endpoint occurred in 7% and 12% of patients. CONCLUSION: LAA closure may be a good alternative to oral anticoagulation. This hypothesis needs to be tested in a randomized clinical trial to ensure that all potential biases of this observational study are accounted for.
Assuntos
Apêndice Atrial/fisiopatologia , Fibrilação Atrial/terapia , Cateterismo Cardíaco/instrumentação , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Anestesia Local , Aspirina/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Cateterismo Cardíaco/efeitos adversos , Clopidogrel , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/uso terapêutico , Radiografia Intervencionista , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia , Suíça , Ticlopidina/análogos & derivados , Ticlopidina/uso terapêutico , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION AND OBJECTIVES: Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment. METHODS: We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO. Patientes with previous stroke on OAC therapy as indication for LAAO were identified and compared with patients with other indications. RESULTS: A total of 115 patients (11%) with RS were identified. The CHA2DS2-VASc and the HAS-BLED score were significantly higher in the RS group (respectively 5.5±1.5 vs 4.3±1.6; P <.001; 3.9±1.3 vs 3.1±1.2; P <.001). No significant differences were observed in periprocedural major safety events (7.8 vs 4.5%; P=.1). With a mean clinical follow-up of 16.2±12.2 months, the observed annual stroke/transient ischemic attack rate for the RS group was 2.6% (65% risk reduction) and the observed annual major bleeding rate was 0% (100% risk reduction). CONCLUSIONS: Patients with RS undergoing LAAO showed similar safety outcomes to patients without RS, with a significant reduction in stroke/transient ischemic attack and major bleeding events during follow-up. Adequately powered controlled trials are needed to further investigate the use of LAAO in RS patients.
Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/terapia , Sistema de Registros , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Idoso , Fibrilação Atrial/complicações , Cateterismo Cardíaco/métodos , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Incidência , Masculino , Estudos Retrospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: Routine device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. METHODS: Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-device leak, device-associated thrombus, device embolization, device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. RESULTS: Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients' mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither device-associated thrombus nor peri-device leak was associated with an increased risk for cardiovascular events. Independent predictors of device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). CONCLUSIONS: Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-device leak was relatively low, and device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.
Assuntos
Apêndice Atrial , Fibrilação Atrial/terapia , Cateterismo Cardíaco/instrumentação , Falha de Equipamento , Trombose/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Apêndice Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Canadá , Cateterismo Cardíaco/efeitos adversos , Distribuição de Qui-Quadrado , Bases de Dados Factuais , Ecocardiografia Doppler em Cores , Ecocardiografia Transesofagiana , Europa (Continente) , Feminino , Humanos , Incidência , Modelos Logísticos , Masculino , Análise Multivariada , Razão de Chances , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Trombose/diagnóstico por imagem , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: In patients with non-valvular atrial fibrillation (NVAF), intracranial bleeding (ICB) constitutes a very challenging situation in which the rate of both ischemic and hemorrhagic events is increased. In these patients, left atrial appendage occlusion (LAAO) might represent a very valid alternative. OBJECTIVES: To investigate the procedural safety and long-term outcome of patients undergoing LAAO therapy due to previous ICB. METHODS: Data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients were analyzed. Patients with previous ICB as indication for LAAO were compared to patients with other indications. RESULTS: A total of 198 patients (18.9%) with previous ICB were identified. The CHA2DS2-VASc score was similar (4.5±1.5 vs. 4.4±1.6, p=0.687) and the HAS-BLED score was higher in patients with previous ICB compared to those without (3.5±1.1 vs. 3.1±1.2, p<0.001). No significant differences in peri-procedural major adverse events were observed (2.5 vs 5.4%, p=0.1). Patients with previous ICB were more frequently on single acetylsalicylic acid therapy after LAAO (42.4% vs. 28.3%; p<0.001). With an average follow-up of 1.3years, the observed annual stroke/TIA rate (procedure and follow-up) for patients with previous ICB was 1.4% (75% relative risk reduction). The observed annual major bleeding rate (procedure and follow-up) for patients with previous ICB was 0.7% (89% relative risk reduction). CONCLUSIONS: In patients with NVAF and previous ICB, LAAO seemed to be a safe procedure and was associated with a significant reduction in stroke/TIA and a remarkably low frequency of major bleeding during follow-up.
Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Hemorragias Intracranianas/cirurgia , Sistema de Registros , Dispositivo para Oclusão Septal/tendências , Idoso , Idoso de 80 Anos ou mais , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Hemorragias Intracranianas/diagnóstico por imagem , Masculino , Estudos Prospectivos , Estudos RetrospectivosRESUMO
History of major gastrointestinal (GI) bleeding may represent a frequent clinical indication for left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). This study aims to investigate the procedural safety and long-term outcome of patients with previous major GI bleeding (MGIB) who underwent LAAO. Data from the Amplatzer Cardiac Plug multicenter registry on 1,047 patients were analyzed. Patients with previous MGIB as indication for LAAO were compared with patients without previous MGIB. A total of 151 patients (14.4%) with previous MGIB were identified. Periprocedural major bleeding events were more frequent in patients with previous MGIB (4.0% vs 0.8%, p = 0.001). With an average follow-up of 1.3 years, the observed annual rate of stroke/transient ischemic attack and major bleeding for patients with previous MGIB were 2.1% (61.4% relative reduction according to the Congestive Heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, Age 65-74, and Sex (female) [CHA2DS2-VASc] score) and 4.6% (20.1% relative reduction according to the expected rate based on the Hypertension, Abnormal renal/liver function (1 point each), Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs/alcohol concomitantly (1 point each) [HAS-BLED] score), respectively. In conclusion, in patients with non-valvular atrial fibrillation and previous MGIB, LAAO was associated with a low annual rate of stroke/transient ischemic attack. Periprocedural major bleeding events were more frequent in this specific population although the annual major bleeding rate showed a 20.1% relative risk reduction according to the HAS-BLED score.
Assuntos
Anticoagulantes/efeitos adversos , Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Procedimentos Cirúrgicos Cardíacos/métodos , Hemorragia Gastrointestinal/induzido quimicamente , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Idoso , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Feminino , Seguimentos , Humanos , Masculino , Sistema de Registros , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to investigate the safety and efficacy of combining transcatheter valve replacement (TAVR) and left atrial appendage occlusion (LAAO) versus TAVR alone. BACKGROUND: Patients with severe aortic stenosis and atrial fibrillation undergoing TAVR are at increased risk for stroke and bleeding complications. METHODS: A cohort of 52 patients undergoing concomitant TAVR and LAAO were compared with 52 patients undergoing isolated TAVR. A primary safety endpoint at 30 days, a clinical efficacy endpoint from day 30 to last follow-up, and an LAAO efficacy endpoint from the first post-interventional day to the last follow-up were chosen. RESULTS: The mean age of the study population was 85 ± 5 years. The mean CHA2DS2-VASc score and HAS-BLED score were 3.9 ± 1.1 and 2.6 ± 0.9, respectively. The mean Society of Thoracic Surgeons score was 7.8 ± 5.5. The median follow-up duration of the study population was 9.4 months (range 0 to 48 months). The primary safety endpoint occurred in 10 patients in the concomitant group and in 7 patients in the isolated TAVR group (19% vs. 14%; 95% confidence interval: 0.59 to 4.06). The clinical and LAAO efficacy endpoints were achieved in 81 (79%) (75% vs. 82%; 95% confidence interval: 0.49 to 2.92) and 75 (73%) patients (69% vs. 76%; 95% confidence interval: 0.54 to 2.51), respectively. CONCLUSIONS: This pilot study shows that concomitant TAVR and LAAO is feasible and seems to be safe among patients with severe aortic stenosis and atrial fibrillation. Larger trials and longer follow-up are needed to confirm the safety and efficacy of such an approach.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Apêndice Atrial , Fibrilação Atrial/terapia , Cateterismo Cardíaco , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Apêndice Atrial/fisiopatologia , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Cateterismo Cardíaco/instrumentação , Intervalo Livre de Doença , Estudos de Viabilidade , Feminino , Próteses Valvulares Cardíacas , Humanos , Estimativa de Kaplan-Meier , Masculino , Projetos Piloto , Complicações Pós-Operatórias/etiologia , Fatores de Risco , Índice de Gravidade de Doença , Suíça , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/instrumentação , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to assess predictors of adverse 1-week outcomes and determine the effect of left atrial appendage (LAA) morphology following LAA closure (LAAC) with Amplatzer devices. BACKGROUND: Percutaneous LAAC is a valuable treatment option for stroke prevention in patients with atrial fibrillation. Determinants of procedural safety events with Amplatzer occluders are not well established, and the possibly interrelating effect of LAA anatomy is unknown. METHODS: Between 2009 and 2014, 500 consecutive patients with atrial fibrillation ineligible or at high risk for oral anticoagulation underwent LAAC using Amplatzer devices. Procedure- and device-related major adverse events (MAEs) were defined as the composite of death, stroke, major or life-threatening bleeding, serious pericardial effusion, device embolization, major access-site vascular complication, or need for cardiovascular surgery within 7 days following the intervention. RESULTS: Patients (mean age 73.9 ± 10.1 years) were treated with Amplatzer Cardiac Plug (n = 408 [82%]) or Amulet (n = 92 [18%]) devices. Early procedural success was 97.8%, and MAEs occurred in 29 patients (5.8%). Independent predictors of MAEs included device repositioning (odds ratio: 9.13; 95% confidence interval: 2.85 to 33.54; p < 0.001) and left ventricular ejection fraction <30% (odds ratio: 4.08; 95% confidence interval: 1.49 to 11.20; p = 0.006), with no effect of device type or size. Angiographic LAA morphology, characterized as cauliflower (33%), cactus (32%), windsock (20%), or chicken wing (15%), was not associated with procedural success (p = 0.51) or the occurrence of MAEs (p = 0.78). CONCLUSIONS: In this nonrandomized study, procedural success of LAAC using Amplatzer devices was high. MAEs within 7 days were predicted by patient- and procedure-related factors. Although LAA morphology displayed substantial heterogeneity, outcomes were comparable across the spectrum of LAA anatomies.
Assuntos
Apêndice Atrial , Fibrilação Atrial/terapia , Cateterismo Cardíaco/instrumentação , Dispositivo para Oclusão Septal , Idoso , Idoso de 80 Anos ou mais , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Função do Átrio Esquerdo , Cateterismo Cardíaco/efeitos adversos , Distribuição de Qui-Quadrado , Angiografia Coronária , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Volume Sistólico , Suíça , Fatores de Tempo , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
AIMS: To investigate the safety, feasibility, and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) for stroke prevention in patients with atrial fibrillation (AF). METHODS AND RESULTS: Data from consecutive patients treated in 22 centres were collected. A total of 1,047 patients were included in the study. Procedural success was 97.3%. There were 52 (4.97%) periprocedural major adverse events. Follow-up was complete in 1,001/1,019 (98.2%) of successfully implanted patients (average 13 months, total 1,349 patient-years). One-year all-cause mortality was 4.2%. No death at follow-up was reported as device-related. There were nine strokes (0.9%) and nine transient ischaemic attacks (0.9%) during follow-up. The annual rate of systemic thromboembolism was 2.3% (31/1,349 patient-years), which is a 59% risk reduction. There were 15 major bleedings (1.5%) during follow-up. The annual rate of major bleeding was 2.1% (28/1,349 patient-years), which is a 61% risk reduction. Patients with single LAAO on aspirin monotherapy or no therapy and longer follow-up had fewer cerebral and fewer bleeding events. CONCLUSIONS: In this multicentre study, LAAO with the ACP showed high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Modification in antithrombotic therapy after LAAO may result in reduction of bleeding events.
Assuntos
Anticoagulantes/uso terapêutico , Apêndice Atrial/cirurgia , Fibrilação Atrial/terapia , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/métodos , Ecocardiografia Transesofagiana/métodos , Feminino , Humanos , Masculino , Dispositivo para Oclusão Septal/efeitos adversos , Tromboembolia/etiologia , Tromboembolia/prevenção & controle , Resultado do TratamentoRESUMO
Left atrial appendage occlusion (LAAO) is emerging as a promising alternative to oral anticoagulation. Because aged patients present a greater risk of not only cardioembolic events but also major bleeding, LAAO might represent a valid alternative as this would allow oral anticoagulation cessation while keeping cardioembolic protection. The objective of the study was to explore the safety and efficacy of LAAO in elderly patients. Data from the AMPLATZER Cardiac Plug multicenter registry were analyzed. The cohort was categorized in 2 groups (<75 vs ≥ 75 years). A total of 1,053 subjects were included in the registry. Of them, 219 were excluded because of combined procedures. As a result, 828 subjects were included (54.6% ≥ 75 years). Procedural success was high and similar in both groups (97.3%). Acute procedural major adverse events were not statistically different among groups (3.2% in <75 years vs 5.1%; p = 0.17) although stratified analysis showed a higher incidence of cardiac tamponade in elderly patients (0.5% vs 2.2%; p = 0.04). With a median follow-up of 16.8 months, no significant differences in stroke/TIA (1.9% vs 2.3%; p = 0.89) and major bleeding (1.7% vs 2.6%; p = 0.54) were observed. In conclusion, LAAO was associated with similar procedural success in patients aged <75 and ≥ 75 years although older patients had a higher incidence of cardiac tamponade. At follow-up, stroke and major bleeding rates were similar among groups.
Assuntos
Fibrilação Atrial/complicações , Cateterismo Cardíaco/métodos , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Apêndice Atrial , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Ecocardiografia Transesofagiana , Feminino , Seguimentos , Humanos , Masculino , Estudos Retrospectivos , Segurança , Acidente Vascular Cerebral/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Left atrial appendage occlusion (LAAO) using the Amplatzer cardiac plug (ACP) is a preventive treatment of atrial fibrillation related thromboembolism. AIM: To assess the safety and efficacy of LAAO in patients with chronic kidney disease (CKD). METHODS: Among the ACP multicentre registry, 1014 patients (75±8yrs) with available renal function were included. RESULTS: Patients with CKD (N=375, CHA2DS2-VASc: 4.9±1.5, HASBLED: 3.4±1.3) were at higher risk than patients without CKD (N=639, CHA2DS2-VASc: 4.2±1.6, HASBLED: 2.9±1.2; p<0.001 for both). Procedural (97%) and occlusion (99%) success were similarly high in all stages of CKD. Peri-procedural major adverse events (MAE) were observed in 5.1% of patients, 0.8% of death, with no difference between patients with and those without CKD (6.1 vs 4.5%, p=0.47). In patients with complete follow-up (1319 patients years), the annual stroke+transient ischaemic attack (TIA) rate was 2.3% and the observed bleeding rate was 2.1% (62 and 60% less than expected, similarly among patients with and those without CKD). Kaplan-Meier analysis showed a lower overall survival (84 vs 96% and 84 vs 93% at 1 and 2yrs. respectively; p<0.001) among patients with an eGFR <30ml/min/1.73m(2). CONCLUSION: LAAO using the ACP has a similar procedural safety among CKD patients compared to patients with normal renal function. LAAO with ACP offers a dramatic reduction of stroke+TIA rate and of bleeding rate persistent in all stages of CKD, as compared to the expected annual risk.
Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Átrios do Coração/cirurgia , Insuficiência Renal Crônica/cirurgia , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/epidemiologia , Estudos de Coortes , Feminino , Seguimentos , Hemorragia/epidemiologia , Hemorragia/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Insuficiência Renal Crônica/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Resultado do TratamentoRESUMO
Cardioembolic strokes are generally more lethal and disabling than other source of strokes. Data from PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) suggest that strokes after left atrial appendage occlusion (LAAO) with the Watchman device are less disabling than those in the warfarin group. No data assessing the severity of strokes after LAAO with the AMPLATZER Cardiac Plug (ACP) are available. The objective of the study was to evaluate the severity of cerebrovascular events after LAAO with the ACP in a population mostly characterized by an absolute or relative contraindication to oral anticoagulation. Data from the ACP multicenter registry were analyzed. Disabling strokes were defined as those with a modified Rankin score of 3 to 6 at 90 days after the event. A total of 1,047 subjects were included. The mean age and CHADS2 score were 75 ± 8 years and 2.8 ± 1.3, respectively. Procedural success was achieved in 97.3% and 4.9% of the patients presented procedural major adverse events. Clinical follow-up was complete in 98.2% of patients with a median of 13 months. There were 9 strokes (0.9%), 9 transient ischemic attacks (0.9%), and no intracranial hemorrhages (0%) at follow-up. After excluding 2 patients with pre-LAAO disability, functional assessment showed disabling events in 3 (19%) of the remaining 16 patients. The median time of presentation was 420 days (interquartile range 234 to 671) after LAAO, and 17 patients (94%) were on single-antiplatelet therapy when the event occurred. According to our results, cerebrovascular events after LAAO with the ACP system were infrequent and mostly nondisabling.
Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/terapia , Hemorragias Intracranianas/prevenção & controle , Ataque Isquêmico Transitório/prevenção & controle , Sistema de Registros , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/complicações , Estudos de Coortes , Gerenciamento Clínico , Feminino , Humanos , Hemorragias Intracranianas/etiologia , Ataque Isquêmico Transitório/etiologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: Transcatheter left atrial appendage (LAA) occlusion has been proven to be an effective treatment for stroke prophylaxis in patients with atrial fibrillation. For this purpose, the Amplatzer cardiac plug (ACP) was introduced. Its second generation, the Amulet, was developed for easier delivery, better coverage, and reduction of complications. AIM: To investigate the safety and efficacy of first generation versus second generation Amplatzer occluders for LAA occlusion. METHODS: Retrospective analysis of prospectively collected data from the LAA occlusion registries of the Bern and Zurich university hospitals. Comparison of the last consecutive 50 ACP cases versus the first consecutive 50 Amulet cases in patients with non-valvular atrial fibrillation. For safety, a periprocedural combined endpoint, which is composed of death, stroke, cardiac tamponade, and bailout by surgery was predefined. For efficacy, the endpoint was procedural success. RESULTS: There were no differences between the two groups in baseline characteristics. The percentage of associated interventions during LAA occlusion was high in (78% with ACP vs. 70% with Amulet p = ns). Procedural success was similar in both groups (98 vs. 94%, p = 0.61). The combined safety endpoint for severe adverse events was reached by a similar rate of patients in both groups (6 vs. 8%, p = 0.7). Overall complication rate was insignificantly higher in the ACP group, which was mainly driven by clinically irrelevant pericardial effusions (24 vs. 14%, p = 0.31). Death, stroke, or tamponade were similar between the groups (0 vs. 2%, 0 vs. 0%, or 6 vs. 6%, p = ns). CONCLUSION: Transcatheter LAA occlusion for stroke prophylaxis in patients with atrial fibrillation can be performed with similarly high success rates with first and second generations of Amplatzer occluders. According to this early experience, the Amulet has failed to improve results of LAA occlusion. The risk for major procedural adverse events is acceptable but has to be taken into account when selecting patients for LAA occlusion, a preventive procedure.
Assuntos
Apêndice Atrial/fisiopatologia , Fibrilação Atrial/terapia , Cateterismo Cardíaco/instrumentação , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Fibrilação Atrial/fisiopatologia , Cateterismo Cardíaco/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/fisiopatologia , Suíça , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Concurrent cardiac diseases are frequent among elderly patients and invite simultaneous treatment to ensure an overall favourable patient outcome. AIM: To investigate the feasibility of combined single-session percutaneous cardiac interventions in the era of transcatheter aortic valve implantation (TAVI). METHODS: This prospective, case-control study included 10 consecutive patients treated with TAVI, left atrial appendage occlusion and percutaneous coronary interventions. Some in addition had patent foramen ovale or atrial septal defect closure in the same session. The patients were matched in a 1:10 manner with TAVI-only cases treated within the same time period at the same institution regarding their baseline factors. The outcome was validated according to the Valve Academic Research Consortium (VARC) criteria. RESULTS: Procedural time (126±42 vs 83±40â min, p=0.0016), radiation time (34±8 vs 22±12â min, p=0.0001) and contrast dye (397±89 vs 250±105â mL, p<0.0001) were higher in the combined intervention group than in the TAVI-only group. Despite these drawbacks, no difference in the VARC endpoints was evident during the in-hospital period and after 30â days (VARC combined safety endpoint 32% for TAVI only and 20% for combined intervention, p=1.0). CONCLUSIONS: Transcatheter treatment of combined cardiac diseases is feasible even in a single session in a high-volume centre with experienced operators.
Assuntos
Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Intervenção Coronária Percutânea/métodos , Tomografia Computadorizada por Raios X/métodos , Dispositivos de Oclusão Vascular , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Dispositivos de Oclusão Vascular/estatística & dados numéricosAssuntos
Apêndice Atrial , Fibrilação Atrial/terapia , Flutter Atrial/terapia , Cateterismo Cardíaco/métodos , Dispositivo para Oclusão Septal , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/fisiopatologia , Flutter Atrial/diagnóstico por imagem , Flutter Atrial/fisiopatologia , Ecocardiografia Transesofagiana , Feminino , Humanos , Pessoa de Meia-Idade , Desenho de Prótese , Punções , Radiografia Intervencionista , Resultado do TratamentoRESUMO
INTRODUCCIÓN Y OBJETIVOS: A pesar de la eficacia de los anticoagulantes orales (ACO), algunos pacientes mantienen una alto riesgo residual y presentan ictus aun estando en tratamiento con ACO, y falta evidencia sobre el tratamiento de estos pacientes. El objetivo del estudio es analizar la seguridad y la eficacia del cierre percutáneo de la orejuela izquierda (OI) como prevención secundaria para pacientes con fibrilación auricular no valvular que han experimentado un ictus/accidente isquémico transitorio a pesar de los ACO (ictus resistente [IR]). MÉTODOS: Se estudió a 1.047 pacientes consecutivos con fibrilación auricular no valvular sometidos a cierre percutáneo de la OI incluidos en el registro multicéntrico Amplatzer Cardiac Plug. Se seleccionó a los pacientes con IR como indicación para el cierre de la OI, y se los comparó con pacientes con otras indicaciones. RESULTADOS: En un total de 115 pacientes (11%) se produjo un IR. Las escalas CHA2DS2-VASc y HAS-BLED eran significativamente más altas en el grupo de IR (5,5+/-1,5 frente a 4,3+/-1,6; p <0,001 y 3,9+/-1,3 frente a 3,1+/-1,2; p <0,001). No hubo diferencias significativas en los eventos mayores de seguridad periprocedimiento (el 7,8 frente al 4,5%; p = 0,1). Tras 16,2+/-12,2 meses de seguimiento medio, la tasa anual de ictus/accidente isquémico transitorio observada fue del 2,6% (el 65% de reducción del riesgo) y la tasa anual de hemorragia mayor observada fue del 0% (el 100% de reducción del riesgo) en los pacientes con IR. CONCLUSIONES: Los pacientes con IR sometidos a cierre percutáneo de la OI presentaron resultados de seguridad similares que los pacientes sin IR, con una reducción significativa de los eventos de ictus/accidente isquémico transitorio y hemorragia mayor durante el seguimiento
INTRODUCTION AND OBJECTIVES: Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment. METHODS: We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO. Patientes with previous stroke on OAC therapy as indication for LAAO were identified and compared with patients with other indications. RESULTS: A total of 115 patients (11%) with RS were identified. The CHA2DS2-VASc and the HAS-BLED score were significantly higher in the RS group (respectively 5.5+/-1.5 vs 4.3+/-1.6; P <.001; 3.9+/-1.3 vs 3.1+/-1.2; P <.001). No significant differences were observed in periprocedural major safety events (7.8 vs 4.5%; P=.1). With a mean clinical follow-up of 16.2+/-12.2 months, the observed annual stroke/transient ischemic attack rate for the RS group was 2.6% (65% risk reduction) and the observed annual major bleeding rate was 0% (100% risk reduction). CONCLUSIONS: Patients with RS undergoing LAAO showed similar safety outcomes to patients without RS, with a significant reduction in stroke/transient ischemic attack and major bleeding events during follow-up. Adequately powered controlled trials are needed to further investigate the use of LAAO in RS patients