RESUMO
AIM: To obtain a quantitative expression profile of the main genes involved in the cAMP-signaling cascade in human control atria and in different cardiac pathologies. METHODS AND RESULTS: Expression of 48 target genes playing a relevant role in the cAMP-signaling cascade was assessed by RT-qPCR. 113 samples were obtained from right atrial appendages (RAA) of patients in sinus rhythm (SR) with or without atrium dilation, paroxysmal atrial fibrillation (AF), persistent AF or heart failure (HF); and left atrial appendages (LAA) from patients in SR or with AF. Our results show that right and left atrial appendages in donor hearts or from SR patients have similar expression values except for AC7 and PDE2A. Despite the enormous chamber-dependent variability in the gene-expression changes between pathologies, several distinguishable patterns could be identified. PDE8A, PI3Kγ and EPAC2 were upregulated in AF. Different phosphodiesterase (PDE) families showed specific pathology-dependent changes. CONCLUSION: By comparing mRNA-expression patterns of the cAMP-signaling cascade related genes in right and left atrial appendages of human hearts and across different pathologies, we show that 1) gene expression is not significantly affected by cardioplegic solution content, 2) it is appropriate to use SR atrial samples as controls, and 3) many genes in the cAMP-signaling cascade are affected in AF and HF but only few of them appear to be chamber (right or left) specific. TOPIC: Genetic changes in human diseased atria. TRANSLATIONAL PERSPECTIVE: The cyclic AMP signaling pathway is important for atrial function. However, expression patterns of the genes involved in the atria of healthy and diseased hearts are still unclear. We give here a general overview of how different pathologies affect the expression of key genes in the cAMP signaling pathway in human right and left atria appendages. Our study may help identifying new genes of interest as potential therapeutic targets or clinical biomarkers for these pathologies and could serve as a guide in future gene therapy studies.
Assuntos
AMP Cíclico/metabolismo , Variação Genética , Átrios do Coração/metabolismo , Sistemas do Segundo Mensageiro/genética , Idoso , Alelos , Apêndice Atrial/metabolismo , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/genética , Fibrilação Atrial/fisiopatologia , Biomarcadores , Suscetibilidade a Doenças , Feminino , Perfilação da Expressão Gênica , Regulação da Expressão Gênica , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Proteoma , Proteômica/métodosRESUMO
BACKGROUND: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. METHODS: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. RESULTS: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). CONCLUSIONS: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.
Assuntos
Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Falha de Equipamento , Feminino , Seguimentos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Hemodinâmica , Humanos , Masculino , Modelos de Riscos Proporcionais , Sistema de Registros , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Análise de Sobrevida , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Significant postprocedural aortic regurgitation (AR) is observed in 10% to 20% of cases after transcatheter aortic valve replacement (TAVR). The prognostic value and the predictors of such a complication in balloon-expandable (BE) and self-expandable (SE) TAVR remain unclear. METHODS AND RESULTS: TAVR was performed in 3195 consecutive patients at 34 hospitals. Postprocedural transthoracic echocardiography was performed in 2769 (92%) patients of the eligible population, and these patients constituted the study group. Median follow-up was 306 days (Q1-Q3=178-490). BE and SE devices were implanted in 67.6% (n=1872) and 32.4% (n=897). Delivery was femoral (75.3%) or nonfemoral (24.7%). A postprocedural AR≥grade 2 was observed in 15.8% and was more frequent in SE (21.5%) than in BE-TAVR (13.0%, P=0.0001). Extensive multivariable analysis confirmed that the use of a SE device was one of the most powerful independent predictors of postprocedural AR≥grade 2. For BE-TAVR, 8 independent predictors of postprocedural AR≥grade 2 were identified including femoral delivery (P=0.04), larger aortic annulus (P=0.0004), and smaller prosthesis diameter (P=0.0001). For SE-TAVR, 2 independent predictors were identified including femoral delivery(P=0.0001). Aortic annulus and prosthesis diameter were not predictors of postprocedural AR for SE-TAVR. A postprocedural AR≥grade 2, but not a postprocedural AR=grade 1, was a strong independent predictor of 1-year mortality for BE (hazard ratio=2.50; P=0.0001) and SE-TAVR (hazard ratio=2.11; P=0.0001). Although postprocedural AR≥grade 2 was well tolerated in patients with AR≥grade 2 at baseline (1-year mortality=7%), it was associated with a very high mortality in other subgroups: renal failure (43%), ARAssuntos
Insuficiência da Valva Aórtica/epidemiologia
, Insuficiência da Valva Aórtica/mortalidade
, Valva Aórtica/cirurgia
, Valvuloplastia com Balão/métodos
, Implante de Prótese de Valva Cardíaca/métodos
, Complicações Pós-Operatórias/epidemiologia
, Complicações Pós-Operatórias/mortalidade
, Idoso
, Idoso de 80 Anos ou mais
, Insuficiência da Valva Aórtica/diagnóstico por imagem
, Insuficiência da Valva Aórtica/cirurgia
, Estenose da Valva Aórtica/diagnóstico por imagem
, Estenose da Valva Aórtica/cirurgia
, Ecocardiografia
, Feminino
, Seguimentos
, França
, Próteses Valvulares Cardíacas
, Humanos
, Incidência
, Estudos Longitudinais
, Masculino
, Valor Preditivo dos Testes
, Prognóstico
, Sistema de Registros
, Taxa de Sobrevida
, Fatores de Tempo
, Resultado do Tratamento
RESUMO
BACKGROUND: Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. METHODS: All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. RESULTS: A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. CONCLUSIONS: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).
Assuntos
Estenose da Valva Aórtica/terapia , Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca/métodos , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Cateterismo Cardíaco/métodos , Feminino , França/epidemiologia , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemorragia/epidemiologia , Hemorragia/etiologia , Humanos , Incidência , Masculino , Análise Multivariada , Estudos Prospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologiaRESUMO
BACKGROUND: Few data are available about postdilatation (PD) for the treatment of significant paravalvular aortic regurgitation (AR) after transcatheter aortic valve implantation of the Edwards valve. METHODS AND RESULTS: A total of 470 patients, aged 83.4 ± 6.4 yrs, with logistic European System for Cardiac Operative Risk Evaluation 21.9 ± 12.3, undergoing transcatheter aortic valve implantation with the Edwards valve were evaluated. PD was performed using the balloon delivery system when significant paravalvular AR was identified. The diameter of the valve was measured from cine acquisition at three different levels. PD was performed in 49 (10.4%) patients with grade 2, 3, or 4 AR as 42.1%, 55.3%, and 2.6%, respectively. After PD, a reduction of at least 1 degree of AR was achieved in 81.5% of cases. Residual AR grades 2, 3, and 4 were observed in 36.8%, 10.5%, and 0%, respectively. A significant increase in the prosthesis diameter was observed at the three valve levels (absolute Δ 3.5%-5.4%, P.< 0.01). For the 23 mm valve, mid level of valve increased from 23.0 ± 0.4 to 24.1 ± 0.5 mm (P < 0.01) and for the 26 mm, from 25.2 ± 0.9 to 26.6 ± 0.9 mm (P < 0.01). Occurrence of annulus rupture (4.1% vs. 1.7%, P = 0.24), cerebrovascular accidents (2.0% vs. 2.1%, P = 0.72), need for new pacemaker (8.2% vs. 5.5%, P = 0.31), and 30-day composite endpoint (24.5% vs. 20.2%, P = 0.48) were not significantly different between PD and non-PD groups. CONCLUSIONS: PD for the treatment of significant paravalvular leak proved to be a feasible treatment allowing a significant increase in valve size and decrease in PVL without increase in stroke rates. This promising approach needs further confirmation.
Assuntos
Insuficiência da Valva Aórtica/terapia , Estenose da Valva Aórtica/terapia , Valva Aórtica , Valvuloplastia com Balão , Cateterismo Cardíaco/instrumentação , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/fisiopatologia , Aortografia/métodos , Valvuloplastia com Balão/efeitos adversos , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Estudos de Viabilidade , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Retratamento , Fatores de Risco , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
BACKGROUND: Postprocedural paravalvular leak (PVL) ≥ 2 has been shown to be associated with worse outcomes after transcatheter aortic valve implantation (TAVI). This study sought to identify predictive factors of postprocedural PVL ≥ 2 after TAVI with the Edwards valve. METHODS AND RESULTS: A total of 176 patients with Edwards TAVI (aged 83.4 ± 7.4 years, Logistic EuroSCORE [the Logistic European System for Cardiac Operative Risk Evaluation] 18.8 ± 12.0, transfemoral 54.5%) who had preprocedural multidetector computed tomography (MDCT) were studied. A PVL ≥ 2 was observed in 12.5% of cases. By multivariate analysis, only the valve calcification index (VCI) defined as aortic root calcification volume/body surface area (odds ratio [OR] = 1.002, 95% confidence interval [CI] = 1.001-1.004, P = 0.006) and the valve diameter/the calculated average annulus diameter (CAAD) by MDCT (OR = 0.683, 95% CI = 0.474-0.984, P = 0.041) were identified as independent predictors of postprocedural PVL ≥ 2. A score predicting postprocedural PVL ≥ 2 (PVL score) was determined by allotting one point when the valve diameter/CAAD ratio was <1.055 and one point when VCI was >418.4 mm(3) /m(2) , and summing all points accrued. Area under receiver-operator characteristic curves of PVL score was 0.71 (95% CI = 0.59-0.83, P < 0.01). The incidence of PVL ≥ 2 was 5.3% in patients with a PVL score of 0, 11.8% for a PVL score of 1 and 37.5% for a PVL score of 2. CONCLUSIONS: The only predictors of PVL ≥ 2 after Edwards valve implantation are the valve diameter/CAAD and VCI. The PVL score could prove to be an excellent tool for predicting the risk of PVL.
Assuntos
Insuficiência da Valva Aórtica/diagnóstico , Complicações Pós-Operatórias/diagnóstico , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Ecocardiografia Transesofagiana , Feminino , Seguimentos , Humanos , Masculino , Tomografia Computadorizada Multidetectores , Complicações Pós-Operatórias/etiologia , Valor Preditivo dos Testes , Estudos RetrospectivosRESUMO
OBJECTIVES: The relationship between anemia, renal insufficiency, and the outcomes of TAVI patients has not been thoroughly studied. We aimed to evaluate the influence of pre- and post-procedural anemia on the incidence of renal insufficiency, especially AKI, and on the outcomes of TAVI. METHODS: Data from the French national TAVI registry were collected in 3,472 patients who underwent TAVI between January 2010 and December 2012. Of these 2,137 were in the no/mild anemia group, 748 were in the moderate anemia group, and 587 were in the severe anemia group before TAVI. Furthermore, we divided the 3,472 patients into three groups according to post-procedural anemia, measured as post-procedural hemoglobin (Hb) drop: <2 g/dl (n=1,633, group 1), 2 to <4 g/dl (n=1,458, group 2), and >4 g/dl (n = 381, group 3). Procedure and outcome variables were compared. RESULTS: Increased severity of anemia before TAVI was associated with significantly different rates of 1-year mortality (15%, 19%, and 24%, P<0.01), with similar differences in the incidence of AKI (5%, 8%, and 10%, P<0.01). Increased severity of Hb drop was associated with significantly different rates of 1-year mortality (16%, 18%, and 23%, P<0.01), and with similar differences in the incidence of AKI (6%, 7%, and 10%, P=0.04). Both pre- and post-procedural anemia were predictors of the incidence of AKI (OR 1.82, P<0.01; OR 1.82, P<0.01, respectively) and 1-year mortality (HR 1.44, P<0.01; HR 1.50, P<0.01, respectively). CONCLUSIONS: Both pre- and post-procedural anemia were significantly associated AKI and 1-year mortality.
Assuntos
Injúria Renal Aguda/epidemiologia , Anemia/epidemiologia , Estenose da Valva Aórtica/terapia , Valva Aórtica , Cateterismo Cardíaco/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Injúria Renal Aguda/diagnóstico , Injúria Renal Aguda/mortalidade , Idoso , Idoso de 80 Anos ou mais , Anemia/sangue , Anemia/diagnóstico , Anemia/mortalidade , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Biomarcadores/sangue , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Distribuição de Qui-Quadrado , Feminino , França/epidemiologia , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Hemoglobinas/metabolismo , Humanos , Incidência , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Análise Multivariada , Modelos de Riscos Proporcionais , Sistema de Registros , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Few data are available about whether aortic root calcification may impact the outcomes after transcatheter aortic valve implantation (TAVI). OBJECTIVES: This study sought to evaluate the impact of aortic root calcification volume on clinical outcome after TAVI with balloon expandable Edwards Sapien XT valve (Edwards Lifesciences, Irvine, California). METHODS: A total of 162 TAVI patients (aged 84.0 [Interquartile Range (IQR) 81.0-84.0] years, Logistic EuroSCORE 14.5 [IQR 9.8-25.1]) with preprocedural MDCT were studied. Aortic root calcification volume was measured by MDCT image and using the dedicated software for aortic valve assessment (the automated 3mensio™ Valves 5.1, sp1, 3mensio Pie Medical Imaging BV, Maastricht, the Netherlands). A valve calcification index (VCI) was defined as calcification volume (mm(3))/body surface area (mm(2)). RESULTS: VCI was significantly higher among patients with 30-day mortality. A VCI threshold of 517.4 (area under the curve 0.69, 95% CI 0.50-0.87, P = 0.03) predicted a higher incidence of annulus rupture (9.1 vs. 0.9%, P = 0.02) and cardiac tamponade (12.7 vs. 1.9%, P < 0.01), lower device success (83.6% vs. 95.3%, P < 0.01) and 30-day survival rate (80.0% vs. 97.2%, P < 0.01). Multivariate logistic regression analysis showed only ejection fraction and VCI were identified as independent predictors of 30-day mortality (Odds ratio 0.948 [95% confidence interval 0.909-0.988], P = 0.012, Odds ratio 1.003 [95% confidence interval 1.001-1.005], P = 0.013, respectively). CONCLUSIONS: Significantly worse acute clinical outcomes after Edwards valve implantation were observed in patients with large amount of aortic annulus calcifications quantitatively measured by dedicated MDCT software. Application of VCI may prove helpful in prediction of clinical outcomes after TAVI.
Assuntos
Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/terapia , Calcinose/diagnóstico , Causas de Morte , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/métodos , Idoso de 80 Anos ou mais , Análise de Variância , Valva Aórtica/patologia , Estenose da Valva Aórtica/diagnóstico , Calcinose/mortalidade , Estudos de Coortes , Ecocardiografia Transesofagiana/métodos , Feminino , Seguimentos , Humanos , Imageamento Tridimensional , Masculino , Tomografia Computadorizada Multidetectores/métodos , Análise Multivariada , Países Baixos , Análise de Regressão , Estudos Retrospectivos , Análise de Sobrevida , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
AIMS: The aim of this study was to evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) in patients of small body size (SB). METHODS AND RESULTS: Between October 2006 and November 2011, 424 patients undergoing TAVI were evaluated. Patients with a small body surface area (BSA; <1.75 m(2)) were defined as the "SB group" (n = 215) and the remaining large BSA patients as the "LB group" (n = 209). In the SB group, mean annulus diameter measured by CT and minimal femoral artery diameter were significantly smaller (23.1 ± 1.92 vs. 24.3 ± 1.91 mm, P < 0.01; 7.59 ± 1.06 vs. 8.29 ± 1.34 mm, P < 0.01, respectively). The logistic EuroSCORE was similar between groups (22.5 ± 10.4 vs. 23.4 ± 12.0; P = 0.43). Equivalent device success (91.2% vs. 91.4%; P = 0.94) and 30-day survival rates (85.1% vs. 87.6%; P = 0.46) were achieved in both groups. Vascular complications and the 30-day combined safety end point rate were significantly higher in the SB group (13.0% vs. 4.3%, P < 0.01; 27.4% vs. 18.3%, P = 0.03, respectively). Similar post-procedural mean pressure gradient was achieved in both groups (10.2 ± 4.3 vs. 11.0 ± 4.6 mmHg; P = 0.12). Multivariate analysis showed that BSA was one of the independent predictors of 30-day combined safety end point (Odds ratio: 0.20; 95% confidence interval (CI): 0.05-0.88; P = 0.03). However, Kaplan-Meier analysis revealed no significant difference in mid-term survival rate between groups (log-rank P = 0.64). CONCLUSIONS: TAVI in SB patients resulted in similar clinical outcomes with effective post-procedural hemodynamics compared with LB patients. Care should be taken to avoid vascular complications in SB patients.
Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica , Tamanho Corporal , Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Índice de Massa Corporal , Superfície Corporal , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Artéria Femoral/diagnóstico por imagem , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Hemodinâmica , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Análise Multivariada , Razão de Chances , Desenho de Prótese , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
Although annulus rupture is one of the most severe complications of transcatheter aortic valve implantation (TAVI), the incidence and mechanism of this complication remain unclear. Out of 387 consecutive TAVI cases in our institution, the incidence of annulus rupture was 1.0% (4/387). The first two patients died because of hemodynamic collapse due to tamponade on day 0. Both surviving patients had undergone preprocedural multidetector computed tomography which revealed large calcifications in the epicardial fat part of the aortic annulus. In both cases, annulus rupture occurred after deployment of a balloon expandable valve suggesting that mechanical compression of this "vulnerable area" by calcification may cause annulus rupture.
Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica/lesões , Valva Aórtica/patologia , Calcinose/terapia , Cateterismo Cardíaco/efeitos adversos , Ruptura Cardíaca/etiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico , Valvuloplastia com Balão/efeitos adversos , Calcinose/diagnóstico , Cateterismo Cardíaco/métodos , Tamponamento Cardíaco/etiologia , Evolução Fatal , Feminino , Ruptura Cardíaca/diagnóstico , Ruptura Cardíaca/fisiopatologia , Ruptura Cardíaca/terapia , Implante de Prótese de Valva Cardíaca/métodos , Hemodinâmica , Humanos , Masculino , Tomografia Computadorizada Multidetectores , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: The purpose of this study was to examine the performance of the European system for cardiac operative risk evaluation II (ESII) in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: The ESII was developed recently to improve the predictive value of the original logistic EuroSCORE (LES). METHODS: Between October 2006 and November 2011, 453 consecutive patients with severe aortic stenosis undergoing TAVI with either the Edwards valve or the Corevalve were included in the current analysis. The performance of the ESII, LES, and society of thoracic surgeons predicted risk of mortality score (STS) was evaluated. RESULTS: Mean age was 83.1 ± 6.4 years. The Edwards valve was used in 382 patients (84.3%) of the cohort, transfemoral approach (TF) in 55.0%, transapical approach (TA) in 25.2%, transaortic approach (TAo) 17.8%, transsubclabian approach (SC) 2.0%. The observed 30-day mortality was 12.6% (11.2, 18.4, 7.4, and 22.2% for TF, TA, TAo, SC, respectively). The mean LES, STS, and ESII were 22.4 ± 12.1, 8.1 ± 6.0, and 8.1 ± 5.2, respectively. The Hosmer-Lemeshow test showed ESII was inadequately calibrated for 30-day mortality compared with other risk scores (ESII P = 0.09, LES P = 0.84, STS P = 0.34). By using the area under the receiver operating characteristic curve (AUC), ESII better predicted 30-day mortality, albeit poorly, compared to LES and STS (AUC = 0.68, 0.65, and 0.60, respectively). In the TF cohort, ESII was better in predicting 30-day mortality compared to LES and STS (AUC = 0.74, 0.61, 0.60, respectively). CONCLUSIONS: Although the ESII demonstrated better predictive performance especially in the TF cohort, ESII is still inadequate in predicting mortality after TAVI as are LES and STS.
Assuntos
Estenose da Valva Aórtica/terapia , Cateterismo Cardíaco/mortalidade , Indicadores Básicos de Saúde , Implante de Prótese de Valva Cardíaca/mortalidade , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Área Sob a Curva , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Análise Multivariada , Razão de Chances , Desenho de Prótese , Curva ROC , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
AIMS: Transcatheter aortic valve implantation is a therapeutic alternative for high-surgical-risk patients with severe symptomatic aortic stenosis. Two models of prosthesis are currently commercialized in France, which can be implanted either via a transarterial or a transapical approach. The aim of the study was to evaluate in a national French registry the early safety and efficacy of transcatheter aortic valve replacement (AVR) using either the Edwards SAPIEN™ or CoreValve™ in high-surgical-risk patients with severe aortic stenosis. METHODS AND RESULTS: The multicentre national registry was conducted in 16 centres between February 2009 and June 2009, under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. The primary endpoint was mortality at 1 month. Two hundred and forty-four high-surgical-risk patients (logistic EuroSCORE ≥20%, STS ≥10%, or contra-indication to AVR) were enrolled. Mean age was 82 ± 7 years and 43.9% were female. Edwards SAPIEN and CoreValve were implanted in 68 and 32% of patients, respectively. The approaches used were transarterial (transfemoral: 66%; subclavian: 5%) or transapical in 29%. Device success rate was 98.3% and 30-day mortality was 12.7%. Severe complications included stroke (3.6%), tamponade (2%), acute coronary occlusion (1.2%), and vascular complications (7.3%). Pacemaker was required in 11.8%. At 1 month, 88% of patients were in NYHA class II or less. CONCLUSION: This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias/etiologia , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Resultado do TratamentoAssuntos
Insuficiência da Valva Aórtica/epidemiologia , Insuficiência da Valva Aórtica/mortalidade , Valva Aórtica/cirurgia , Valvuloplastia com Balão/métodos , Implante de Prótese de Valva Cardíaca/métodos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/mortalidade , Feminino , Humanos , MasculinoRESUMO
Mean Gradient (MG) elevation can be detected immediately after transcatheter aortic valve implantation (TAVI) or secondarily during follow-up. Comparisons and interactions between these two parameters and their impact on outcomes have not previously been investigated. This study aimed to identify incidence, influence on prognosis, and parameters associated with immediate high post-procedural mean transvalvular gradient (PPMG) and delayed mean gradient increase (6 to 12 months after TAVI, DMGI) in the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. The registry includes all consecutive symptomatic patients with severe aortic stenosis who have undergone TAVI. Three groups were analyzed: (1) PPMG < 20 mmHg without DMGI > 10 mmHg (control); (2) PPMG < 20 mmHg with DMGI > 10 mmHg (Group 1); and (3) PPMG ≥ 20 mmHg (Group 2). From January 2010 to January 2012, 4201 consecutive patients were prospectively enrolled in the registry. Controls comprised 2078 patients. In Group 1(n = 131 patients), DMGI exceeded 10 mmHg in 5.6%, and was not associated with greater 4-years mortality than in controls (32.6% vs. 40.1%, p = 0.27). In Group 2 (n = 144 patients), PPMG was at least 20 mmHg in 6.1% and was associated with higher 4-year mortality (48.7% versus 40.1%, p = 0.005). A total of two-thirds of the patients with PPMG ≥ 20 mmHg had MG < 20 mmHg at 1 year, with mortality similar to the controls (39.2% vs. 40.1%, p = 0.73). Patients with PPMG > 20 mmHg 1 year post-TAVI had higher 4-years mortality than the general population of the registry, unlike patients with MG normalization.
RESUMO
OBJECTIVES: Transcatheter aortic valve implantation with a transaortic approach (TAo-TAVI) is an alternative to transapical or femoral access. We studied the procedural and midterm efficacy and safety of TAo-TAVI with Edwards Sapien XT and Medtronic CoreValve devices. METHODS: Among 901 patients receiving TAVI since 2006, 265 consecutive patients underwent TAo-TAVI between January 2011 and September 2014. Procedural and midterm results were evaluated according to Valve Academic Research Consortium-2 criteria. RESULTS: The mean age was 83 ± 5 years. Sapien XT and CoreValve were used in 191 (72.1%) and 74 (27.9%) patients, respectively. Full sternotomy made elective concomitant off-pump coronary artery bypass grafting possible in 38 patients (14.3%) with severe coronary artery disease unsuitable for percutaneous coronary intervention. The device success rate was 95.5%. Postprocedural paravalvular leak ≥2/4 was observed in 16 patients (6.4%). Emergency open chest surgery was required in 10 patients (3.8%) (3 aortic dissections, 3 valve embolizations, 2 LMCA occlusions, 1 aortic annulus rupture and 1 aortic rupture). Cerebrovascular accidents occurred in 3 patients (1.1%). Transfusions ≥4 units were required in 36 patients (13.6%). New pacemakers were implanted in 26 patients (9.8%). Thirty-day and 1-year mortality were 8.7% and 16.2%, respectively. Mean follow-up duration was 24 ± 6 months. At 3 years, freedom from all-cause death was 80% ± 4%. New York Heart Association class Assuntos
Estenose da Valva Aórtica/cirurgia
, Substituição da Valva Aórtica Transcateter/métodos
, Idoso
, Idoso de 80 Anos ou mais
, Estenose da Valva Aórtica/complicações
, Estenose da Valva Aórtica/diagnóstico por imagem
, Estudos de Coortes
, Ponte de Artéria Coronária sem Circulação Extracorpórea
, Doença da Artéria Coronariana/complicações
, Doença da Artéria Coronariana/diagnóstico por imagem
, Doença da Artéria Coronariana/cirurgia
, Ecocardiografia
, Feminino
, Próteses Valvulares Cardíacas
, Humanos
, Masculino
, Esternotomia
, Substituição da Valva Aórtica Transcateter/instrumentação
, Resultado do Tratamento
RESUMO
Aims: Quantitative real-time RT-PCR (RT-qPCR) has become the method of choice for mRNA quantification, but requires an accurate normalization based on the use of reference genes showing invariant expression across various pathological conditions. Only few data exist on appropriate reference genes for the human heart. The objective of this study was to determine a set of suitable reference genes in human atrial and ventricular tissues, from right and left cavities in control and in cardiac diseases. Methods and results: We assessed the expression of 16 reference genes (ACTB, B2M, GAPDH, GUSB, HMBS, HPRT1, IPO8, PGK1, POLR2A, PPIA, RPLP0, TBP, TFRC, UBC, YWHAZ, 18S) in tissues from: right and left ventricles from healthy controls and heart failure (HF) patients; right-atrial tissue from patients in sinus rhythm with (SRd) or without (SRnd) atrial dilatation, patients with paroxysmal (pAF) or chronic (cAF) atrial fibrillation or with HF; and left-atrial tissue from patients in SR or cAF. Consensual analysis (by geNorm and Normfinder algorithms, BestKeeper software tool and comparative delta-Ct method) of the variability scores obtained for each reference gene expression shows that the most stably expressed genes are: GAPDH, GUSB, IPO8, POLR2A, and YWHAZ when comparing either right and left ventricle or ventricle from healthy controls and HF patients; GAPDH, IPO8, POLR2A, PPIA, and RPLP0 when comparing either right and left atrium or right atria from all pathological groups. ACTB, TBP, TFRC, and 18S genes were identified as the least stable. Conclusions: The overall most stable reference genes across different heart cavities and disease conditions were GAPDH, IPO8, POLR2A and PPIA. YWHAZ or GUSB could be added to this set for some specific experiments. This study should provide useful guidelines for reference gene selection in RT-qPCR studies in human heart.
Assuntos
Fibrilação Atrial/genética , Perfilação da Expressão Gênica/métodos , Genes Essenciais , Átrios do Coração/química , Cardiopatias/genética , Ventrículos do Coração/química , RNA Mensageiro/genética , Reação em Cadeia da Polimerase em Tempo Real , Transcriptoma , Proteínas 14-3-3/genética , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , RNA Polimerases Dirigidas por DNA/genética , Europa (Continente) , Feminino , Perfilação da Expressão Gênica/normas , Marcadores Genéticos , Glucuronidase/genética , Gliceraldeído-3-Fosfato Desidrogenases/genética , Humanos , Masculino , Pessoa de Meia-Idade , Peptidilprolil Isomerase/genética , Reação em Cadeia da Polimerase em Tempo Real/normas , Padrões de Referência , Reprodutibilidade dos Testes , beta Carioferinas/genéticaRESUMO
BACKGROUND: Some patients who are at high surgical risk because of multiple co-morbidities undergo balloon aortic valvuloplasty (BAV) as a bridge therapy towards transcatheter aortic-valve implantation (TAVI). AIM: The aim of this study was to compare the clinical course of patients with or without previous BAV who underwent TAVI and were included in the FRANCE 2 registry. METHODS: From January 2010 to December 2011, 3953 patients underwent TAVI. Survival analysis was done by multivariable regression and propensity-score analysis to adjust for confounders. RESULTS: Patients in the previous BAV group (n=664, 16.8%) were older than patients in the primary TAVI group. The logistic EuroSCORE I and the rates of co-morbidities and symptoms were higher in the previous BAV group. Procedural success was similar in both groups, as was postprocedural aortic regurgitation grade≥2/4. The 1-month mortality rates from all causes were 12.5 and 8.7%, respectively, in the previous BAV and primary TAVI groups (P=0.001). The 1-month to 1-year mortality rates were similar in both groups. Previous BAV was not an independent predictor of 1-month mortality (hazard ratio 1.44, 95% confidence interval 0.90-2.34; P=0.14) or 1-month to 1-year mortality. CONCLUSIONS: Crude 1-month mortality was higher in patients with previous BAV. Nevertheless, precarious preoperative status, but not previous BAV, was associated with mortality, and is the only marker that should be considered as detrimental at the time of preTAVI reassessment.
Assuntos
Valva Aórtica/cirurgia , Valvuloplastia com Balão , Doenças das Valvas Cardíacas/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Valvuloplastia com Balão/efeitos adversos , Valvuloplastia com Balão/mortalidade , Distribuição de Qui-Quadrado , Comorbidade , Feminino , França , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/mortalidade , Doenças das Valvas Cardíacas/fisiopatologia , Humanos , Modelos Logísticos , Masculino , Análise Multivariada , Pontuação de Propensão , Modelos de Riscos Proporcionais , Sistema de Registros , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do TratamentoRESUMO
BACKGROUND: Coronary artery disease (CAD) is common in patients undergoing transcatheter aortic valve replacement (TAVR). However, the impact of CAD distribution before TAVR on short- and long-term prognosis remains unclear. HYPOTHESIS: We hypothesized that the long-term clinical impact differs according to CAD distribution in patients undergoing TAVR using the FRench Aortic National CoreValve and Edwards (FRANCE-2) registry. METHODS: FRANCE-2 is a national French registry including all consecutive TAVR performed between 2010 and 2012 in 34 centers. Three-year mortality was assessed in relation to CAD status. CAD was defined as at least 1 coronary stenosis >50%. RESULTS: A total of 4201 patients were enrolled in the registry. For the present analysis, we excluded patients with a history of coronary artery bypass. CAD was reported in 1252 patients (30%). Half of the patients presented with coronary multivessel disease. CAD extent was associated with an increase in cardiovascular risk profile and in logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (from 19.3% ± 12.8% to 21.9% ± 13.5%, P < 0.001). Mortality at 30 days and 3 years was 9% and 44%, respectively, in the overall population. In multivariate analyses, neither the presence nor the extent of CAD was associated with mortality at 3 years (presence of CAD, hazard ratio [HR]: 0.90; 95% confidence interval [CI]: 0.78-1.07). A significant lesion of the left anterior descending (LAD) was associated with higher 3-year mortality (HR: 1.42; 95% CI: 1.10-1.87). CONCLUSIONS: CAD is not associated with decreased short- and long-term survival in patients undergoing TAVR. The potential deleterious effect of LAD disease on long-term survival and the need for revascularization before or at the time of TAVR should be validated in a randomized control trial.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Ponte de Artéria Coronária , Doença da Artéria Coronariana/complicações , Sistema de Registros , Medição de Risco/métodos , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/epidemiologia , Angiografia Coronária , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/cirurgia , Feminino , Seguimentos , França/epidemiologia , Humanos , Incidência , Masculino , Fatores de Risco , Índice de Gravidade de Doença , Taxa de Sobrevida/tendências , Resultado do TratamentoRESUMO
BACKGROUND: The development of new onset atrial fibrillation (NOAF) post-transcatheter aortic valve implantation (TAVI) is common and may be associated with an adverse prognosis. This study seeks to identify incidence, predictors, and impact of NOAF post-TAVI. METHODS: From the multicenter study of the French national transcatheter aortic valve implantation registry, FRANCE 2, a total of 1959 patients with sinus rhythm prior to TAVI were enrolled into this study. The incidence of post-TAVI NOAF, predictors of development of NOAF and impact on 30-day and 1-year-mortalities were assessed. RESULTS: Of the 1959 TAVI patients (mean-age: 82.6 ± 7.5 years, mean-logistic-EuroSCORE: 21.8 ± 14.3), 149 (7.6%) developed NOAF with the remaining 1810 (92.4%) control patients demonstrating no evidence of AF as defined by the Valve Academic Research Consortium (VARC). Advanced age and major and life-threatening bleeding were independent predictors of NOAF (95% CI: 0.93-0.99; p=0.006, 95% CI: 1.58-4.00; p<0.001, 95% CI: 1.09-3.75; p=0.025, respectively). A trend towards a higher incidence of major and life-threatening bleeding was observed in the patients undergoing TAVI via the transapical (TA)-approach compared with the transfemoral (TF)-approach. Both 30-day and cumulative 1-year-mortalities were significantly higher in patients with NOAF compared to patients without NOAF (3.0% vs. 7.4%; p=0.005, 9.1% vs. 20.8%; p<0.001, respectively). In addition, NOAF was an independent predictor of 30-day and 1-year-mortalities (HR: 2.16; 95% CI: 1.06-4.41; p=0.033, HR: 2.12; 95% CI: 1.42-3.15; p<0.001, respectively). CONCLUSION: Advanced age and major and life-threatening bleeding were independently associated with increased incidence of NOAF, which itself was an independent predictor of 30-day and 1-year-mortalities. With regards to the various transcatheter approaches, a trend towards a higher incidence of major and life-threatening bleeding was observed only with the TA-approach.
Assuntos
Fibrilação Atrial/diagnóstico , Complicações Pós-Operatórias/diagnóstico , Sistema de Registros , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/tendências , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/etiologia , Fibrilação Atrial/mortalidade , Feminino , Seguimentos , França/epidemiologia , Humanos , Masculino , Mortalidade/tendências , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Prognóstico , Estudos Prospectivos , Substituição da Valva Aórtica Transcateter/mortalidadeRESUMO
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. OBJECTIVES: This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. METHODS: The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. RESULTS: A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. CONCLUSIONS: The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.