RESUMO
BACKGROUND: The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied. METHODS: We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding. On the basis of a hierarchical testing plan, the primary efficacy and safety outcomes were tested sequentially for noninferiority, with noninferiority of edoxaban established if the upper boundary of the 95% confidence interval for the hazard ratio did not exceed 1.38. Superiority testing of edoxaban for efficacy would follow if noninferiority and superiority were established for major bleeding. RESULTS: A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women. Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P = 0.01 for noninferiority). Rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P = 0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban. Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11). CONCLUSIONS: In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists. (Funded by Daiichi Sankyo; ENVISAGE-TAVI AF ClinicalTrials.gov number, NCT02943785.).
Assuntos
4-Hidroxicumarinas/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Inibidores do Fator Xa/uso terapêutico , Piridinas/uso terapêutico , Tiazóis/uso terapêutico , Substituição da Valva Aórtica Transcateter , Vitamina K/antagonistas & inibidores , 4-Hidroxicumarinas/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Mortalidade , Fenindiona/análogos & derivados , Fenindiona/uso terapêutico , Complicações Pós-Operatórias/prevenção & controle , Piridinas/efeitos adversos , Tiazóis/efeitos adversos , Tromboembolia/prevenção & controle , Substituição da Valva Aórtica Transcateter/efeitos adversosRESUMO
AIMS: Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors. METHODS AND RESULTS: The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan-Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0-18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03-1.08, per year increase], heart failure (HR 1.73, CI: 1.24-2.41), vascular disease (HR 1.47, CI: 1.05-2.05), valvular disease (HR 1.63, CI: 1.15-2.33), abnormal liver function (HR 1.80, CI: 1.02-3.17), and abnormal renal function (HR 1.58, CI: 1.10-2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors. CONCLUSION: One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO. CLINICAL TRIAL REGISTRATION: The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282.
Assuntos
Apêndice Atrial , Fibrilação Atrial , Sistema de Registros , Acidente Vascular Cerebral , Humanos , Apêndice Atrial/cirurgia , Masculino , Feminino , Fibrilação Atrial/mortalidade , Fibrilação Atrial/cirurgia , Idoso , Incidência , Fatores de Risco , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/etiologia , Idoso de 80 Anos ou mais , Cateterismo Cardíaco , Medição de Risco , Fatores de Tempo , Resultado do Tratamento , Causas de Morte , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Device-related thrombosis (DRT) is a common finding after left atrial appendage closure (LAAC) and is associated with worse outcomes. As women are underrepresented in clinical studies, further understanding of sex differences in DRT patients is warranted. METHODS AND RESULTS: This sub-analysis from the EUROC-DRT-registry compromises 176 patients with diagnosis of DRT after LAAC. Women, who accounted for 34.7% (61/176) of patients, were older (78.0 ± 6.7 vs. 74.9 ± 9.1 years, p = .06) with lower rates of comorbidities. While DRT was detected significantly later in women (173 ± 267 vs. 127 ± 192 days, p = .01), anticoagulation therapy was escalated similarly, mainly with initiation of novel oral anticoagulant (NOAC), vitamin K antagonist (VKA) or heparin. DRT resolution was achieved in 67.5% (27/40) of women and in 75.0% (54/72) of men (p = .40). In the remaining cases, an intensification/switch of anticoagulation was conducted in 50.% (9/18) of men and in 41.7% (5/12) of women. Final resolution was achieved in 72.5% (29/40) cases in women, and in 81.9% (59/72) cases in men (p = .24). Women were followed-up for a similar time as men (779 ± 520 vs. 908 ± 687 days, p = .51). Kaplan-Meier analysis revealed no difference in mortality rates in women (Hazard Ratio [HR]: 1.73, 95%-Confidence interval [95%-CI]: .68-4.37, p = .25) and no differences in stroke (HR: .83, 95%-CI: .30-2.32, p = .72) within 2 years after LAAC. CONCLUSION: Evaluation of risk factors and outcome revealed no differences between men and women, with DRT in women being diagnosed significantly later. Women should be monitored closely to assess for DRT formation/resolution. Treatment strategies appear to be equally effective.
Assuntos
Apêndice Atrial , Fibrilação Atrial , Sistema de Registros , Trombose , Humanos , Feminino , Masculino , Apêndice Atrial/cirurgia , Idoso , Trombose/etiologia , Fibrilação Atrial/cirurgia , Fatores Sexuais , Anticoagulantes/uso terapêutico , Fatores de Risco , Complicações Pós-Operatórias , Dispositivo para Oclusão Septal , Resultado do Tratamento , Ecocardiografia Transesofagiana/métodos , Europa (Continente)/epidemiologia , Oclusão do Apêndice Atrial EsquerdoRESUMO
BACKGROUND: Women with atrial fibrillation (AF) generally experience worse symptoms, poorer quality of life, and have a higher risk of stroke and death. There is limited availability of sex-related differences regarding left atrial appendage occlusion (LAAO). AIMS: The aim of this study was to evaluate the sex-related differences in patients undergoing LAAO in EWOLUTION. METHODS: A total of 1025 patients scheduled for elective LAAO therapy employing the WATCHMAN Gen 2.5 prospectively consented for participation; 1005 patients received a successful implant and were followed for 2 years. As we detected sex-related differences in baseline data we performed a propensity score matching. The primary endpoint is a combined endpoint of survival free from mortality, major bleeding, ischemic stroke, transitory ischemic attack (TIA) and systemic embolization (SE) up to 2-year clinical follow-up. Secondary Endpoints were periprocedural data and overall 2-year survival. RESULTS: Women were older but had less often vascular disease and hemorrhagic stroke. There was no sex-related significant difference after LAAO at 2 years in the combined endpoint of survival free from mortality, major bleeding, ischemic stroke, TIA, and SE (female vs. male: 79% vs.76%, p = 0.24) or in overall survival (female vs. male: 85% vs. 82%, p = 0.16). Procedural data showed a higher sealing rate after the implantation in women (complete sealing female 94% vs. male 90%, p = 0.033), significantly more pericardial effusions (female 1.2% vs. male 0.2%, p = 0.031) and a similar periprocedural risk profile. CONCLUSIONS: Females undergoing LAAO differ in various baseline variables, but after adjustment, we observed similar safety and efficacy of LAAO with no significant difference in long-term outcomes between women and men.
Assuntos
Apêndice Atrial , Fibrilação Atrial , Ataque Isquêmico Transitório , AVC Isquêmico , Acidente Vascular Cerebral , Humanos , Masculino , Feminino , Resultado do Tratamento , Apêndice Atrial/diagnóstico por imagem , Ataque Isquêmico Transitório/etiologia , Qualidade de Vida , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Europa (Continente) , Hemorragia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Fibrilação Atrial/complicações , Sistema de RegistrosRESUMO
BACKGROUND: Polymer-free and carrier-free drug-coated stents (DCS) represent a novel therapeutic option for the treatment of coronary artery disease. The objective of this pilot registry is to evaluate the safety and efficacy of DCS implantation in bifurcation lesions. METHODS: Overall, 23 consecutive patients with 24 lesions received a Biolimus A9-coated DCS for coronary bifurcation lesions. Patients were examined with quantitative coronary angiography (QCA) and optical coherence tomography (OCT) at 3-6 months of follow-up. RESULTS: A total of 23 patients with 24 bifurcation lesions were included in this study. Nine (33.3%) lesions of eight patients revealed angiographical target lesion failure due to in-stent restenosis (ISR). In total, 19 patients with 20 bifurcation lesions were suitable for OCT analysis. A total of 2936 struts were analyzed and 14 struts (0.47%) were classified as malapposed. The mean luminal area (mm2) was not different in lesions with ISR vs. lesions with no ISR (5.07⯱ 2.0 vs. 5.73⯱ 1.34, pâ¯= 0.39) at follow-up. Lesions with ISR showed higher mean neointimal burden (27.11⯱ 10.59 vs. 13.93⯱ 9.16%, respectively; pâ¯= 0.009). All of the patients who presented with significant ISR required percutaneous re-intervention. CONCLUSIONS: We observed a high rate of DCS ISR in bifurcation lesions, possibly related to increased inflammation and neoatherosclerosis. The small size of the study warrants careful interpretation of our results. Larger trials are necessary to expand knowledge of these findings.
Assuntos
Doença da Artéria Coronariana , Reestenose Coronária , Stents Farmacológicos , Intervenção Coronária Percutânea , Humanos , Tomografia de Coerência Óptica , Vasos Coronários , Resultado do Tratamento , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Angiografia Coronária , Sistema de Registros , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/terapiaRESUMO
BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.
Assuntos
Doenças das Valvas Cardíacas/cirurgia , Próteses Valvulares Cardíacas/normas , Valva Mitral/cirurgia , Sistema de Registros , Reoperação/normas , Substituição da Valva Aórtica Transcateter/normas , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Doenças das Valvas Cardíacas/diagnóstico por imagem , Próteses Valvulares Cardíacas/tendências , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/tendências , Humanos , Internacionalidade , Masculino , Pessoa de Meia-Idade , Valva Mitral/diagnóstico por imagem , Reoperação/tendências , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/tendênciasRESUMO
BACKGROUND: In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted. STUDY DESIGN: The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke. CONCLUSIONS: The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.
Assuntos
Oxigenação por Membrana Extracorpórea , Infarto do Miocárdio/terapia , Revascularização Miocárdica/métodos , Ponte de Artéria Coronária/métodos , Oxigenação por Membrana Extracorpórea/efeitos adversos , Oxigenação por Membrana Extracorpórea/métodos , Fibrinolíticos/uso terapêutico , Humanos , Infarto do Miocárdio/complicações , Infarto do Miocárdio/mortalidade , Prognóstico , Estudos Prospectivos , Qualidade de Vida , Tamanho da Amostra , Choque Cardiogênico/etiologia , Choque Cardiogênico/mortalidadeRESUMO
BACKGROUND: Presence of thrombus in the left atrial appendage (LAA) remains a severe contraindication to the percutaneous left atrial appendage closure procedure (LAAC), due to increased embolic risk. Recently, the experience developed in cerebral protection device in transcatheter aortic valve implantation (TAVI) procedure was translated in LAAC to address this issue. AIM: To evaluate efficacy and safety of Sentinel cerebral protection system (CPS) in supporting LAAC in real-world patient with persistent LAA thrombus. METHODS AND RESULTS: The study retrospectively enrolled consecutive patients with non-valvular atrial fibrillation (NVAF) and thrombus in LAA who underwent LAAC supported by Sentinel CPS in seven European high-volume centres. Twenty-seven patients were included with a median age of 69.1 ± 9.7 years old, with median CHA2 DS2 -VASc and HAS-BLEED scores 3 [2-5] and 3 [2.75-4], respectively. Technical and procedural success was achieved in all patients. No periprocedural TIA, stroke, or supra-aortic trunks dissection was recorded. CONCLUSIONS: In this multicenter registry, LAAC supported by Sentinel CPS in patients with LAA persistent thrombus seems to be a safe and efficacious treatment.
Assuntos
Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Trombose , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/diagnóstico por imagem , Humanos , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Trombose/diagnóstico por imagem , Trombose/etiologia , Resultado do TratamentoRESUMO
AIMS: Evidence regarding post-procedural antithrombotic regimen other than used in randomized trials assessing percutaneous left atrial appendage (LAA) closure is limited. The present work aimed to compare different antithrombotic strategies applied in the real-world EWOLUTION study. METHODS AND RESULTS: A total of 998 patients with successful WATCHMAN implantation were available for the present analysis. The composite ischaemic endpoint of stroke, transitory ischaemic attack, systemic embolism and device thrombus, and the bleeding endpoint defined as at least major bleeding were assessed during an initial period (from implant until first medication change) and long-term period (from first change up to 2 years). The antithrombotic medication chosen in the initial phase was dual antiplatelet therapy (DAPT) in 60%, oral anticoagulation (OAC) in 27%, single antiplatelet therapy (SAPT) in 7%, and no medication in 6%. In the second long-term phase, SAPT was used in 65%, DAPT in 23%, no therapy in 8%, and OAC in 4%. No significant differences were found between the groups regarding the ischaemic endpoint both in the initial period (Kaplan-Meier estimated rate 2.9% for DAPT vs. 4.3% for OAC vs. 3.9% for SAPT or no therapy) and in the second period (4.2% for SAPT vs. 1.8% for DAPT vs. 3.5% for no therapy). With respect to bleeding events, the only difference was found in the initial phase with a higher incidence in patients under SAPT or no therapy. CONCLUSIONS: Tailored antithrombotic treatment using even very reduced strategies such as SAPT or no therapy showed no significant differences regarding ischaemic complications after LAA closure.
Assuntos
Apêndice Atrial , Fibrilação Atrial , Fibrinolíticos , Anticoagulantes/uso terapêutico , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Fibrinolíticos/uso terapêutico , Humanos , Resultado do TratamentoRESUMO
INTRODUCTION: Pericardial effusion/tamponade (PE/PT) is a rare but serious complication following left atrial appendage closure (LAAC). It may be speculated that LAA contraction during sinus rhythm (SR) exerts mechanical force on the device that eventually leads to PE. We sought to determine the incidence and predictors of PE following LAAC using Watchman with special emphasis on the underlying heart rhythm during implant. METHODS AND RESULTS: From 47 centers in 13 European countries 1,020 patients underwent LAAC and data on baseline rhythm were available from 1,010 patients (mean age 73 ± 9 years, 60% male, median CHA2DS2-VASc = 4). Data were collected via electronic case report forms. A Cox proportional hazard model was calculated adjusting for multiple variables: age, gender, number of recaptures, and device oversizing. During implant, 41% and 59% of patients were in SR and atrial fibrillation (AF), respectively. PE/PT rate was significantly lower in patients implanted during AF at day 30 postimplant (n = 1; 0.2% vs. n = 6; 1.5%; P = 0.02). No PE requiring intervention occurred in the AF group compared to 5 events (1.2%) in the SR group (P = 0.01). While univariate analysis identified SR and gender as predictors for PE/tamponade, multivariate analysis only showed a statistical trend for both variables. CONCLUSION: The overall incidence of PE/PT was very low after LAAC using Watchman. Although SR was not identified as an independent predictor of PE/PT, all events requiring intervention occurred in patients with SR. It may be advisable to perform an extended echocardiographic follow-up in that patient population.
Assuntos
Apêndice Atrial/cirurgia , Procedimentos Endovasculares/efeitos adversos , Frequência Cardíaca/fisiologia , Derrame Pericárdico/epidemiologia , Derrame Pericárdico/fisiopatologia , Dispositivos de Oclusão Vascular/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Apêndice Atrial/diagnóstico por imagem , Procedimentos Endovasculares/tendências , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Derrame Pericárdico/diagnóstico por imagem , Sistema de Registros , Dispositivos de Oclusão Vascular/tendênciasRESUMO
AIMS: Aims of this case-series were to assess the feasibility of cerebral protection devices in interventional left atrial appendage occlusion (iLAAO) procedures and to yield insight into the pathomorphological correlate of early, procedural cerebral embolization during iLAAO. METHODS AND RESULTS: Five consecutive patients underwent iLLO flanked by the Sentinel CPS® (Claret Medical, Inc., Santa Rosa, CA) cerebral protection system. Placement and recapture of the Sentinel® device as well as the iLAAO were successful and safe in all cases. Histomorphometric analysis of the collected filters showed embolized debris in all patients. Acute thrombus was found in three patients, organizing thrombus in four. Interestingly, two patients had endocardial or myocardial tissue in their filters. CONCLUSIONS: Cerebral protection during iLAAO with the Sentinel CPS® device is feasible. Furthermore, this dataset identifies the formation and embolization of thrombus and cardiac tissue as emboligeneic sources and potential future targets to reduce procedural complications. © 2016 Wiley Periodicals, Inc.
Assuntos
Apêndice Atrial , Fibrilação Atrial/terapia , Cateterismo Cardíaco/instrumentação , Dispositivos de Proteção Embólica , Embolia Intracraniana/prevenção & controle , Acidente Vascular Cerebral/prevenção & controle , Trombose/prevenção & controle , Idoso , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Biópsia , Cateterismo Cardíaco/efeitos adversos , Estudos de Viabilidade , Humanos , Embolia Intracraniana/diagnóstico , Embolia Intracraniana/etiologia , Pessoa de Meia-Idade , Miocárdio/patologia , Projetos Piloto , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologia , Trombose/diagnóstico , Trombose/etiologia , Resultado do TratamentoRESUMO
OBJECTIVES: The feasibility and outcomes of 35 consecutive patients subjected to eCPR in the tertiary cardiology center were investigated. BACKGROUND: While conventional cardiopulmonary-resuscitation (cCPR) often times achieves only mediocre outcomes extracorporeal cardiopulmonary-resuscitation (eCPR) increasingly shifts into the focus of interest. However, the scientific evidence for eCPR is sparse, particularly in the cardiological setting. METHODS: Retrospective chart analysis of 35 patients treated with eCPR between 01/2014 and 10/2015. RESULTS: The duration of cCPR until initiation of eCPR was 73.8 ± 37.6 min and resulted in an initial pH of 6.9 ± 0.2 and serum lactate level of 14.5 ± 4.8 mmol/L. About 62% (n = 22) of the patients suffered from out of hospital cardiac arrest (OHCA), 85% (n = 30) of the overall events were witnessed and bystander-CPR performed in 77% (n = 27) of cases. Cause of arrest was dominated by acute myocardial infarction (AMI, 71%), initial rhythm to a lesser degree by ventricular fibrillation/tachycardia (VF/VT, 57%). Almost all patients (n = 33, 94%) experienced return of spontaneous circulation (ROSC) after establishing extracorporeal life support (ECLS). In all 57% patients were successfully weaned from ECLS. Survival to discharge was 31% with predominantly good cerebral performance category (CPC 1-2). Survivors were more likely to receive bystander-CPR (P = 0.03) and the duration of cCPR until initiation of eCPR was significantly shorter (P = 0.004). CONCLUSIONS: Our data proves the exceptional level of efficiency of eCPR particularly when Bystander-CPR has been initiated and there is a short duration of cCPR. © 2016 Wiley Periodicals, Inc.
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Reanimação Cardiopulmonar/métodos , Oxigenação por Membrana Extracorpórea/métodos , Parada Cardíaca Extra-Hospitalar/terapia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: There is accumulating evidence that up to 20% of the implanted devices after TAVI are associated with a significant degree of paravalvular leaks, which appear to be associated with a negative clinical outcome. METHODS: A total of 355 patients with severe aortic valvular stenosis (AVS) were treated by TAVI (Corevalve n = 222, Edwards Sapien n = 133). Survival, NT-proBNP and the grade of PVL were quantified up to 12 months after implantation. RESULTS: Technical success rate was 97.8%. Thirty-day mortality was 9.6%. Post-procedural transvalvular aortic regurgitation was seen only in a minority of cases (5%), whereas PVL were frequently observed (grade: <1+ in 58.2%, ≥1-<2 in 33.9%, and ≥2 in 7.9%). There was a clear relation-ship between PVL and adverse outcome (P < 0.001). After a transient increase, NT-proBNP showed a significant decline. Interestingly, a PVL ≥2+ was associated with a much higher rise in NT-proBNP compared to the other groups (P < 0.01), and a post-procedural increase in NT-proBNP by more than 1640 ng L(-1) within 5 days was associated with a significant increase in rate of death (P < 0.01). CONCLUSIONS: TAVI is an efficient treatment option for high-risk patients with severe AVS. The incidence of PVL is an inacceptable clinical problem. Serial measurement of NT-proBNP can be used for risk-stratification in patients with a significant PVL. In general, PVL graded ≥2+ is associated with a dramatically increased 6-month mortality. Therefore, any action to reduce paraprosthetical regurgitation is highly recommended.
Assuntos
Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/terapia , Cateterismo Cardíaco/instrumentação , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Falha de Prótese , Idoso , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/sangue , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Biomarcadores/sangue , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Feminino , Alemanha , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
The use of bioresorbable vascular scaffolds (BVS) in percutaneous coronary interventions holds great promise and the Absorb® BVS is increasingly used in clinical practice outside of controlled studies. However, questions have been raised concerning the delivery of the scaffold to complex lesions. We describe a case of successful delivery and implantation of two overlapping Absorb® BVS to a complex lesion in the left anterior descending artery. The crossing of the lesions was uneventful and after implantation a good acute result could be documented. A follow-up angiogram after 3 months proofed a stable midterm result. We thereby demonstrate the feasibility of delivering Absorb® BVS to more complex lesions than practiced so far in the setting of clinical trials.
Assuntos
Angioplastia Coronária com Balão/métodos , Stents Farmacológicos , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/terapia , Alicerces Teciduais , Implantes Absorvíveis , Angioplastia Coronária com Balão/instrumentação , Angiografia Coronária/métodos , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/terapia , Eletrocardiografia/métodos , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Desenho de Prótese , Resultado do TratamentoRESUMO
BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.
Assuntos
Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Tromboembolia , Trombose , Humanos , Feminino , Incidência , Apêndice Atrial/diagnóstico por imagem , Resultado do Tratamento , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/terapia , Fibrilação Atrial/complicações , Tromboembolia/diagnóstico por imagem , Tromboembolia/epidemiologia , Tromboembolia/etiologia , Trombose/diagnóstico por imagem , Trombose/epidemiologia , Trombose/etiologia , Acidente Vascular Cerebral/etiologiaRESUMO
BACKGROUND: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited. AIMS: This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed. METHODS: The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared. RESULTS: Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37-558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%). CONCLUSION: Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events.
Assuntos
Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Trombose , Humanos , Resultado do Tratamento , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Trombose/diagnóstico , Trombose/epidemiologia , Trombose/etiologia , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Sistema de Registros , Apêndice Atrial/diagnóstico por imagemRESUMO
BACKGROUND: The new-generation WATCHMAN FLX (Boston Scientific) device for left atrial appendage occlusion has been modified in various aspects to improve procedural results. No comparison of the WATCHMAN FLX device with the previous WATCHMAN device is available. OBJECTIVE: We aimed to compare procedural results with WATCHMAN FLX in patients on dual antiplatelet therapy at â¼3 months with data with WATCHMAN (EWOLUTION [Registry on WATCHMAN Outcomes in Real-Life Utilization]). METHODS: One hundred sixty-four consecutive patients receiving the WATCHMAN FLX device in 4 European centers were included in the retrospective ALSTER-FLX registry. As a control group for a matched-pair analysis, 1020 patients treated with the WATCHMAN device and data up to first follow-up (â¼3 months) from EWOLUTION were used. RESULTS: Implantation was successful in all ALSTER-FLX patients (100%) and similar to results in EWOLUTION (99%) (P = .2). We observed no stroke or device embolization in ALSTER-FLX similar to EWOLUTION (stroke 0.5%, device embolization 0.4%) at 3 months. Numerically less ALSTER-FLX patients (2.4%) developed a device-associated thrombus as compared with 3.7% EWOLUTION patients, yet without reaching statistical significance after matching (median [95% confidence interval] device-associated thrombus pairwise event difference 2 [0-6]; P = .1). WATCHMAN FLX implantation was associated with a significant higher sealing rate compared with EWOLUTION at 3 months (ALSTER-FLX 90% vs EWOLUTION 79.4%; P = .039 after matching). Major nonprocedural bleeding events and mortality were similar after matching (median event difference for bleeding 0 [-3 to 3]; P = .6 and death 1 [-2 to 4]; P = .3). CONCLUSION: Periprocedural, early 3-month outcomes with WATCHMAN FLX demonstrate a similar safety profile and an improved sealing rate compared to the WATCHMAN device.
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Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Trombose , Apêndice Atrial/cirurgia , Cateterismo Cardíaco , Humanos , Análise por Pareamento , Sistema de Registros , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia , Trombose/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: Left atrial appendage occlusion (LAAO) is recommended for patients with atrial fibrillation at increased stroke risk, where effective long-term oral anticoagulation (OAC) is not feasible. In order to assess long-term safety of LAAO with aspirin monotherapy or no therapy, we aimed to report on patients with the Watchman LAAO device (Boston Scientific) once postimplantation intensified antiplatelet or anticoagulation therapy is discontinued. METHODS: A total of 1025 patients scheduled for elective LAAO therapy prospectively consented for participation in the EWOLUTION registry; 1005 patients received a successful implant and were followed for 2 years. We identified 766 patients in EWOLUTION on single-antiplatelet therapy (SAPT; n = 639) or no therapy (n = 127) for ≥1 year following LAAO. RESULTS: Three to 6 months after LAAO, 766 patients were switched to SAPT or no therapy and were followed for at least 1 year until the study's conclusion or with events while on SAPT/ no therapy; mean time on SAPT/no therapy was 536.56 ± 177.59 days. Patients experienced 1.4 ischemic strokes per 100 patient years (PY) despite a CHA2DS2-VASC score of 4.3 ± 1.6. Major nonprocedural bleeding rates were low, with 1.3 major bleeds per 100 PY with a mean HAS-BLED score of 2.2 ± 1.2. Furthermore, the ischemic stroke rate in the SAPT/no-therapy subgroup was similar to the whole EWOLUTION collective and high-risk subgroups; the bleeding rate was even lower. When analyzed separately, strokes (2.1/100 PY) and bleedings (1.4/100 PY) of the no-therapy subgroup were similar to patients on SAPT (strokes 0.7/100 PY [P=.70]; bleedings 1.4/100 PY [P=.90]). CONCLUSIONS: Outcome data of patients on SAPT/no therapy for ≥1 year following Watchman implantation in the EWOLUTION registry suggest the efficacy and safety of LAAO.
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Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Anticoagulantes/efeitos adversos , Apêndice Atrial/cirurgia , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/prevenção & controle , Humanos , Sistema de Registros , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do TratamentoRESUMO
BACKGROUND: Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. METHODS: We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. RESULTS: Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88-9.49], p < 0.01). CONCLUSIONS: DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position.
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Apêndice Atrial , Fibrilação Atrial , Ataque Isquêmico Transitório , Acidente Vascular Cerebral , Trombose , Humanos , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/complicações , Fibrilação Atrial/cirurgia , Resultado do Tratamento , Trombose/diagnóstico , Trombose/epidemiologia , Trombose/etiologia , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Fatores de Risco , Ecocardiografia , Sistema de Registros , Anticoagulantes/uso terapêuticoRESUMO
Iatrogenic mitral stenosis following transcatheter mitral valve repair (TMVR) for relevant mitral regurgitation (MR) is a potential adverse side-effect, known to affect long-term outcome. However, only few determinants of an elevated mean transmitral pressure gradient (TMPG) have been described thus far. We sought to develop an integrative model for the prediction of TMPG following MitraClip (MC) therapy. From 01/2013 to 03/2017, a total of 175 consecutive patients were successfully (MR ≤ 2 + at discharge) treated with a MitraClip implantation at our centre. Of these, a total of 148 patients (54% male, 77.0 ± 6.0 years, 58% with secondary MR) had complete echocardiographic data sets comprising pre- and postinterventional two- and three-dimensional transthoracic (TTE) and transoesophageal (TOE) echocardiograms. Comprehensive studies of predefined parameters were performed. An expert-based prediction model including preprocedural variables (annular ellipticity, mitral valve commissure-to-commissure diameter, preprocedural transmitral pressure gradient and MR aetiology) was set up and validated with a total of 200 bootstrap samples. A nomogram was developed to predict the postprocedural TMPG based on selected echocardiographic variables. Introduction of nomogram-based guiding of MC therapy could help identify patients at risk for postprocedural mitral stenosis, have an influence on preprocedural patient selection and intraprocedural decision making.