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1.
Am Heart J ; 222: 1-7, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32000067

RESUMO

BACKGROUND: In ST-elevation myocardial infarction (STEMI) patients presenting with multivessel disease (MVD), recent studies have demonstrated the superiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) for non-culprit lesions compared to culprit lesion treatment-only therapy. FFR- and angio-guided PCI have however never been compared in STEMI patients. TRIAL DESIGN: FLOWER-MI is an open-label multicenter national randomized clinical trial. The aim is to investigate FFR-guided complete revascularization in comparison to angio-guided complete revascularization in STEMI patients with successful PCI of the culprit lesion and ≥50% stenosis in at least one additional non-culprit lesion requiring PCI. Eligible patients will be randomized after successful primary PCI in a 1:1 fashion to either FFR-guided or angio-guided complete revascularization during the index procedure or a staged procedure before discharge (≤5 days). Patients assigned to FFR guidance first have FFR measured in each non-culprit vessel and only undergo PCI if FFR is ≤0.80. The primary end point of the study is a composite of major adverse cardiac events, including all-cause death, non-fatal MI, and unplanned hospitalization leading to urgent revascularization at 1 year. Secondary end points will include the individual adverse events, cost-effectiveness, quality of life, and 30-day, 6-month, and 3-year outcomes. Based on estimated event rates, a sample size of 1170 patients is needed to show superiority of the FFR-guided revascularization with 80% power. CONCLUSION: The aim of FLOWER-MI trial is to assess whether FFR-guided complete revascularization in the acute setting is superior angio-guided complete revascularization.


Assuntos
Angiografia Coronária/métodos , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Cirurgia Assistida por Computador/métodos , Feminino , Seguimentos , Humanos , Masculino , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Resultado do Tratamento
2.
J Am Coll Cardiol ; 74(22): 2728-2739, 2019 12 03.
Artigo em Inglês | MEDLINE | ID: mdl-31779788

RESUMO

BACKGROUND: Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral accesses exist, although they have not been accurately compared with femoral access. OBJECTIVES: This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR. METHODS: Using the data from the national prospective French registry (FRANCE TAVI [French Transcatheter Aortic Valve Implantation]), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score-based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed. RESULTS: Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers. CONCLUSIONS: n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Cateterismo Periférico/métodos , Complicações Pós-Operatórias/epidemiologia , Pontuação de Propensão , Sistema de Registros , Substituição da Valva Aórtica Transcateter/métodos , Idoso de 80 Anos ou mais , Feminino , Artéria Femoral , Seguimentos , França/epidemiologia , Humanos , Incidência , Masculino , Estudos Prospectivos , Índice de Gravidade de Doença , Taxa de Sobrevida/tendências , Fatores de Tempo
3.
Circ Cardiovasc Interv ; 12(4): e007597, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30998397

RESUMO

BACKGROUND: The durability of transcatheter aortic bioprosthetic valves is a crucial issue, but data are scarce, especially beyond 5 years of follow-up. We aimed to assess long-term (7 years) structural valve deterioration (SVD) and bioprosthetic valve failure of transcatheter aortic bioprosthetic valves. METHODS AND RESULTS: Consecutive patients with at least 5-year follow-up available undergoing transcatheter aortic valve implantation from April 2002 to December 2011 in 5 French centers were included. Incidence of SVD and bioprosthetic valve failure were defined according to newly standardized criteria of the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery and reported as cumulative incidence function to account for the competing risk of death. One thousand four hundred three consecutive patients were included with a mean age of 82.6±7.5 years and with a mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 21.3±7.5%. A balloon-expandable valve was used in 83.7% of cases. Survival rates were 83.5% (95% CI, 81.4%-85.5%) and 18.6% (95% CI, 15.3%-21.8%) at 1 and 7 years, respectively. Median duration of follow-up was 3.9 years. Bioprosthetic valve failure occurred in 19 patients with a 7-year cumulative incidence of 1.9% (95% CI, 1.4%-2.4%). SVD occurred in 49 patients (moderate, n=32; severe, n=17) with a 7-year cumulative incidence of moderate and severe SVD of 7.0% (95% CI, 5.6%-8.4%) and 4.2% (95% CI, 2.9%-5.5%), respectively. Five patients had aortic valve reintervention (1.0%; 95% CI, 0.4%-1.6%) including 1 case of surgical aortic valve replacement and 4 redo-transcatheter aortic valve implantation. The incidences of SVD and bioprosthetic valve failure were not significantly different between balloon and self-expandable prostheses. CONCLUSIONS: The long-term assessment of transcatheter aortic bioprosthetic valves durability is limited by the poor survival of our population beyond 5 years. Further studies are warranted, particularly in younger and lower-risk patients.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias/epidemiologia , Falha de Prótese , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Valvuloplastia com Balão , Feminino , França/epidemiologia , Humanos , Incidência , Masculino , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/cirurgia , Desenho de Prótese , Reoperação , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
4.
Circ Cardiovasc Interv ; 11(11): e006388, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30571205

RESUMO

Background The optimal access for patients undergoing transcatheter aortic valve replacement (TAVR) who are not candidates for a transfemoral approach has not been elucidated. The purpose of this study was to compare the safety, feasibility, and early clinical outcomes of transcarotid TAVR compared with thoracic approaches. Methods and Results From a multicenter consecutive cohort of 329 alternative-access TAVR patients (2012-2017), we identified 101 patients who underwent transcarotid TAVR and 228 patients who underwent a transapical or transaortic TAVR. Preprocedural success and 30-day clinical outcomes were compared using multivariable propensity score analysis to account for between-group differences in baseline characteristics. All transcarotid cases were performed under general anesthesia, mainly using the left common carotid artery (97%). Propensity-matched groups had similar rates of 30-day all-cause mortality (2.1% versus 4.6%; P=0.37), stroke (2.1% versus 3.5%; P=0.67; transcarotid versus transapical/transaortic, respectively), new pacemaker implantation, and major vascular complications. Transcarotid TAVR was associated with significantly less new-onset atrial fibrillation (3.2% versus 19.0%; P=0.002), major or life-threatening bleeding (4.3% versus 19.9%; P=0.002), acute kidney injury (none versus 12.1%; P=0.002), and shorter median length of hospital stay (6 versus 8 days; P<0.001). Conclusions Transcarotid vascular access for TAVR is safe and feasible and is associated with encouraging short-term clinical outcomes. Our data suggest a clinical benefit of transcarotid TAVR with respect to atrial fibrillation, major bleeding, acute kidney injury, and length of stay compared with the more invasive transapical or transaortic strategies. Randomized studies are required to ascertain whether transcarotid TAVR yields equivalent results to other alternative vascular access routes.


Assuntos
Aorta , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/patologia , Valva Aórtica/cirurgia , Calcinose/cirurgia , Artéria Carótida Primitiva , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Aorta/diagnóstico por imagem , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Calcinose/diagnóstico por imagem , Calcinose/mortalidade , Canadá/epidemiologia , Artéria Carótida Primitiva/diagnóstico por imagem , Feminino , França/epidemiologia , Humanos , Masculino , Complicações Pós-Operatórias/mortalidade , Sistema de Registros , Estudos Retrospectivos , 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 Tratamento
5.
Clin Cardiol ; 40(12): 1316-1322, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29247516

RESUMO

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 Tratamento
7.
Int J Cardiol ; 220: 7-13, 2016 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-27372037

RESUMO

BACKGROUND: Although the trans-radial approach (TR) has been applied to various subsets of patients in percutaneous coronary intervention, the feasibility, efficacy, acute procedural and long-term outcomes of TR versus trans-femoral approach (TF) for alcohol septal ablation (ASA) have not yet been determined. OBJECTIVES: The aim of this study was to compare the short and long-term outcomes of ASA with the TR approach compared to the TF approach. METHODS: We retrospectively analyzed 240 patients who underwent an ASA procedure at our institution from November 1999 to November 2015. The TR approach was performed in 172 cases and the TF approach in the remaining 68 cases. RESULTS: The use of TR approach progressively increased from 62% in 1999-2005 to 91% in 2011-2015 (p=0.0001). The TF and TR group had similar age, baseline NYHA class (NYHA 3 or 4) and mean left ventricular outflow tract peak gradient before ASA. Total contrast used (TR: 73.2±47.2ml; TF: 88.7±49.3ml, p=0.11), total radiation Air kerma area product (TR: 43.7±48.0Gycm(-2); TF: 55.9±48.2Gycm(-2); p=0.39) and peak left ventricular outflow tract gradient immediately after ASA (TR: 19.1±19.6mmHg; TF: 20.4±18.0mmHg, p=0.63) were similar in both groups. Procedural success was 91.9% and 91.2% in the TR and TF groups, respectively (p=0.53). At 30days, there was 2 intra-hospital death (1 in TF and 1 in TR), 1 major stroke in the TF group and 1 coronary artery dissection in the TR group. Vascular complications were less frequent in the TR group (0.58% vs. 7.3%; p=0.002). The mean length of follow-up was 4.56±4.34years (IQR 0.69-8.2; median 2.92years; maximum: 15.5years). By Kaplan-Meier estimate, the observed survival in the overall cohort was comparable to the expected survival for a sex and age-matched comparable general French population at 10years (86.9 vs. 83.6%, p=0.88). Survival was similar between the TR and TF group (92.1% vs. 89.7% at 6years, respectively; p=0.71). CONCLUSIONS: Alcohol septal ablation from the radial approach can be performed with similar acute and long-term success, but with lower vascular complications compared to the femoral approach.


Assuntos
Cardiomiopatia Hipertrófica/cirurgia , Ablação por Cateter/métodos , Etanol/administração & dosagem , Artéria Femoral/cirurgia , Septos Cardíacos/cirurgia , Artéria Radial/cirurgia , Adulto , Idoso , Cateterismo Cardíaco/métodos , Cardiomiopatia Hipertrófica/diagnóstico , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
8.
Catheter Cardiovasc Interv ; 86(2): E58-65, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25810163

RESUMO

OBJECTIVES: To assess the impact of gender on myocardial revascularization using data collected in a French nationwide registry: the national observational study of diagnostic and interventional cardiac catheterization (ONACI). BACKGROUND: Gender differences in management of patients with acute coronary syndromes (ACS) have been reported. METHODS: We analysed data from a nationwide French prospective multicentre registry including 64,932 suspected ACS patients recruited in 99 centres from 2004 to 2008. RESULTS: Overall, women were older (70.7 ± 12.7 vs. 63.8 ± 12.9 years), had a higher cardiovascular risk profile, and were more frequently admitted with non ST-elevation myocardial infarction or unstable angina (NSTEMI/UA) compared to men (73% vs. 68%). Women had significantly more angiographically normal coronary arteries or non-significant coronary artery disease (CAD) in both STEMI (6% vs. 3%) and NSTEMI/UA (21% vs. 11%) while men had more severe CAD. After adjusting for age, cardiovascular risk factors, and extent of disease, myocardial revascularization (defined as the use of percutaneous coronary intervention (PCI) or coronary artery bypass grafting) was less frequently used in women (adjusted OR = 0.78; 95% CI: 0.77-0.83). For those receiving PCI, in-hospital mortality within 24 hr of intervention was higher in women (3.6% vs. 1.2%; adjusted OR = 1.51; 95% CI: 1.22-1.87). CONCLUSIONS: In the present study, despite having a higher cardiovascular risk profile, women more frequently had normal vessel/non-significant angiographic coronary artery disease. In patients with significant coronary artery disease, myocardial revascularization was less frequently used in women whatever the type of ACS.


Assuntos
Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Cateterismo Cardíaco/estatística & dados numéricos , Ponte de Artéria Coronária/estatística & dados numéricos , Disparidades em Assistência à Saúde , Intervenção Coronária Percutânea/estatística & dados numéricos , Avaliação de Processos em Cuidados de Saúde/estatística & dados numéricos , Síndrome Coronariana Aguda/mortalidade , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Distribuição de Qui-Quadrado , Angiografia Coronária/estatística & dados numéricos , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Feminino , França , Disparidades nos Níveis de Saúde , Mortalidade Hospitalar , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Valor Preditivo dos Testes , Pontuação de Propensão , Sistema de Registros , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores Sexuais , Resultado do Tratamento
10.
JAMA ; 308(10): 998-1006, 2012 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-22928184

RESUMO

CONTEXT: The contemporary decline in mortality reported in patients with ST-segment elevation myocardial infarction (STEMI) has been attributed mainly to improved use of reperfusion therapy. OBJECTIVE: To determine potential factors-beyond reperfusion therapy-associated with improved survival in patients with STEMI over a 15-year period. DESIGN, SETTING, AND PATIENTS: Four 1-month French nationwide registries, conducted 5 years apart (between 1995, 2000, 2005, 2010), including a total of 6707 STEMI patients admitted to intensive care or coronary care units. MAIN OUTCOME MEASURES: Changes over time in crude 30-day mortality, and mortality standardized to the 2010 population characteristics. RESULTS: Mean (SD) age decreased from 66.2 (14.0) to 63.3 (14.5) years, with a concomitant decline in history of cardiovascular events and comorbidities. The proportion of younger patients increased, particularly in women younger than 60 years (from 11.8% to 25.5%), in whom prevalence of current smoking (37.3% to 73.1%) and obesity (17.6% to 27.1%) increased. Time from symptom onset to hospital admission decreased, with a shorter time from onset to first call, and broader use of mobile intensive care units. Reperfusion therapy increased from 49.4% to 74.7%, driven by primary percutaneous coronary intervention (11.9% to 60.8%). Early use of recommended medications increased, particularly low-molecular-weight heparins and statins. Crude 30-day mortality decreased from 13.7% (95% CI, 12.0-15.4) to 4.4% (95% CI, 3.5-5.4), whereas standardized mortality decreased from 11.3% (95% CI, 9.5-13.2) to 4.4% (95% CI, 3.5-5.4). Multivariable analysis showed a consistent reduction in mortality from 1995 to 2010 after controlling for clinical characteristics in addition to the initial population risk score and use of reperfusion therapy, with odds mortality ratios of 0.39 (95%, 0.29-0.53, P <.001) in 2010 compared with 1995. CONCLUSION: In France, the overall rate of cardiovascular mortality among patients with STEMI decreased from 1995 to 2010, accompanied by an increase in the proportion of women younger than 60 years with STEMI, changes in other population characteristics, and greater use of reperfusion therapy and recommended medications.


Assuntos
Infarto do Miocárdio/mortalidade , Reperfusão Miocárdica/estatística & dados numéricos , Fatores Etários , Idoso , Demografia , Feminino , França/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Mortalidade/tendências , Infarto do Miocárdio/terapia , Sistema de Registros/estatística & dados numéricos , Estudos Retrospectivos , Fatores Sexuais , Análise de Sobrevida
11.
Eur Heart J ; 33(20): 2535-43, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22927559

RESUMO

AIM: The historical evolution of incidence and outcome of cardiogenic shock (CS) in acute myocardial infarction (AMI) patients is debated. This study compared outcomes in AMI patients from 1995 to 2005, according to the presence of CS. METHOD AND RESULTS: Three nationwide French registries were conducted 5 years apart, using a similar methodology in consecutive patients admitted over a 1-month period. All 7531 AMI patients presenting ≤48 h of symptom onset were included. The evolution of mortality was compared in the 486 patients with CS vs. those without CS. The incidence of CS tended to decrease over time (6.9% in 1995; 5.7% in 2005, P = 0.07). Thirty-day mortality was considerably higher in CS patients (60.9 vs. 5.2%). Over the 10-year period, mortality decreased for both patients with (70-51%, P = 0.003) and without CS (9-4%, P < 0.001). In CS patients, the use of percutaneous coronary intervention (PCI) increased from 20 to 50% (P < 0.001). Time period was an independent predictor of early mortality in CS patients (OR for death, 2005 vs. 1995 = 0.45; 95% CI: 0.27-0.75, P = 0.005), along with age, diabetes, and smoking status. When added to the multivariate model, PCI was associated with decreased mortality (OR = 0.38; 95% CI: 0.24-0.58, P < 0.001). In propensity-score-matched cohorts, CS patients with PCI had a significantly higher survival. CONCLUSIONS: Cardiogenic shock remains a clinical concern, although early mortality has decreased. Improved survival is concomitant with a broader use of PCI and recommended medications at the acute stage. Beyond the acute stage, however, 1-year survival has remained unchanged.


Assuntos
Choque Cardiogênico/mortalidade , Adolescente , Adulto , Idoso , Métodos Epidemiológicos , Feminino , França/epidemiologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Choque Cardiogênico/complicações , Choque Cardiogênico/terapia , Adulto Jovem
12.
J Heart Valve Dis ; 21(6): 764-6, 2012 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23409359

RESUMO

Transcatheter aortic valve implantation (TAVI) has been shown as an effective procedure in patients considered at high risk for surgery. Aortic valve bicuspidy, as encountered in up of 50% of patients with severe aortic stenosis, has been considered a contraindication to TAVI. One reason for this is that stent deformation is likely to occur after prosthesis deployment, but this has been refuted by recent observations with the SAPIEN prosthesis. Herein is reported the first case of a severely deformed SAPIEN XT prosthesis after TAVI in a patient with severe symptomatic aortic stenosis, and known to have a bicuspid native aortic valve.


Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica , Cateterismo Cardíaco/instrumentação , Cardiopatias Congênitas/complicações , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Idoso de 80 Anos ou mais , Valva Aórtica/anormalidades , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Cateterismo Cardíaco/efeitos adversos , Feminino , Cardiopatias Congênitas/diagnóstico por imagem , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Tomografia Computadorizada Multidetectores , Desenho de Prótese , Índice de Gravidade de Doença , Resultado do Tratamento
13.
Ann Vasc Surg ; 25(6): 752-7, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21621377

RESUMO

BACKGROUND: Aortic valve implantation (AVI) is a booming therapeutic option in high-risk patients with calcific aortic stenosis. Retrograde femoral approach drawbacks include vascular complications owing to the size of the introduction system (22- and 24-F).The aim of this study was to retrospectively analyze the incidence and the treatment of vascular complications in the first 2 years of transfemoral AVI experience with the first generation of Edwards SAPIEN transcatheter heart valves. METHODS: Since December 2007, AVI has been performed in 71 patients, 21 times by the transapical route and 50 times by the transfemoral route through an inguinal approach with the first generation of Edwards SAPIEN transcatheter heart valves (23 and 26 mm). The incidence and the treatment of vascular complications were evaluated as main criteria for transfemoral AVI. RESULTS: All the procedures could be successfully performed by a femoral route, except for three cases when the introducing device could not be fixed on the thoracic aorta because of vascular access problems. Vascular access-related complications occurred in nine patients (18%), including three iliac dissections, two aortic dissections, three femoral lesions, and one thoracic aorta rupture. These complications were treated either in a conservative way (n = 2), or in an endovascular way using a contralateral approach (n = 3), or surgically through an inguinal approach (n = 3). A traumatic rupture of the thoracic aorta resulted in the death of a female patient. CONCLUSION: In our experience, transfemoral AVI gives a satisfying technical success rate in the selected patients. The incidence of complications involving the vascular access remains an important limitation of this new technique. Although a conservative or endovascular treatment can be applied in most cases, improving the introduction devices is highly expected because it would reduce the complications rate of vascular access.


Assuntos
Estenose da Valva Aórtica/terapia , Cateterismo Cardíaco/efeitos adversos , Artéria Femoral , Implante de Prótese de Valva Cardíaca/efeitos adversos , Doenças Vasculares/etiologia , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Procedimentos Endovasculares , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Paris , Desenho de Prótese , Radiografia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Doenças Vasculares/diagnóstico por imagem , Doenças Vasculares/terapia , Procedimentos Cirúrgicos Vasculares
14.
Circulation ; 123(5): 474-82, 2011 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-21262992

RESUMO

BACKGROUND: Clopidogrel requires metabolic activation by cytochrome P450 2C19 (CYP2C19). Proton pump inhibitors (PPIs) that inhibit CYP2C19 are commonly coadministered with clopidogrel to reduce the risk of gastrointestinal bleeding. This analysis compares treatment outcomes for patients in the French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) who did or did not receive clopidogrel and/or PPIs. METHODS AND RESULTS: The FAST-MI registry included 3670 patients (2744 clopidogrel- and PPI-naïve patients) presenting with definite MI. Patients were categorized according to use of clopidogrel and/or PPI within 48 hours after hospital admission. PPI use was not associated with an increased risk for any of the main in-hospital events (in-hospital survival, reinfarction, stroke, bleeding, and transfusion). Likewise, PPI treatment was not an independent predictor of 1-year survival (hazard ratio, 0.97; 95% confidence interval [CI], 0.87 to 1.08; P=0.57) or 1-year MI, stroke, or death (hazard ratio, 0.98; 95% CI, 0.90 to 1.08; P=0.72). No differences were seen when the type of PPI or CYP2C19 genotype was taken into account. In the propensity-matched cohorts, the odds ratios for major in-hospital events in PPI versus no PPI were 0.29 (95% CI, 0.06 to 1.44) and 1.70 (95% CI, 0.10 to 30.3) for patients with 1 and 2 variant alleles, respectively. Similarly, the hazard ratio for 1-year events in hospital survivors was 0.68 (95% CI, 0.26 to 1.79) and 0.55 (95% CI, 0.06 to 5.30), respectively. CONCLUSION: PPI use was not associated with an increased risk of cardiovascular events or mortality in patients administered clopidogrel for recent MI, whatever the CYP2C19 genotype, although harm could not be formally excluded in patients with 2 loss-of-function alleles.


Assuntos
Hidrocarboneto de Aril Hidroxilases/genética , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/epidemiologia , Inibidores da Bomba de Prótons/uso terapêutico , Ticlopidina/análogos & derivados , Idoso , Idoso de 80 Anos ou mais , Clopidogrel , Estudos de Coortes , Citocromo P-450 CYP2C19 , Quimioterapia Combinada , Feminino , França/epidemiologia , Genótipo , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/mortalidade , Inibidores da Agregação Plaquetária/uso terapêutico , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Sistema de Registros , Ticlopidina/uso terapêutico , Resultado do Tratamento
15.
Eur Heart J ; 32(2): 191-7, 2011 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-20843959

RESUMO

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 Tratamento
16.
Eur J Cardiothorac Surg ; 40(1): 257-9, 2011 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-21167732

RESUMO

It has been suggested that valved stent deployment during transcatheter aortic valve implantation may be responsible for traumatic injury to pericardial leaflets, especially with balloon expandable valved stents. However, such an injury has not been described nor reported so far. We here report the microscopic analysis of 4 Sapien-Edwards prostheses, 2 of which have been implanted in humans. There was no macroscopic evidence of traumatic injury to the pericardial leaflets of the percutaneous valves. However, pathological microscopic findings were observed in all of them. These mainly consisted of collagen fibers fragmentation and disruption. Areas of non- or mildly affected tissue were adjacent to areas of severely damaged tissue. The entire thickness of the leaflets might be involved. The severity of the lesions also differed among leaflets from a same prosthesis. Areas of plasmatic insudation were identified in one case. The disruption index was significantly higher in the Sapien group in comparison to the control group: 42.4% (14-63.5%) versus 17.5% (9.2-31%) (p < 0.001). Although of limited size sample, this study does prove that traumatic injury to leaflets occurs during percutaneous valves implantation. This should prompt physicians to wait for the long-term results of this new technology before extending the indications to low-risk patients.


Assuntos
Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Próteses Valvulares Cardíacas , Bioprótese , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Pericárdio/patologia , Pericárdio/transplante , Desenho de Prótese , Falha de Prótese , Stents
18.
Arch Cardiovasc Dis ; 102(10): 677-83, 2009 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-19913769

RESUMO

BACKGROUND: The use of the internal thoracic artery for coronary artery bypass has improved the results of such surgery. However, bypass using only the internal thoracic arteries sometimes requires a T-graft. This purely internal thoracic artery T-graft technique has progressively become part of our surgical protocol for coronary artery bypass surgery. AIMS: The aim of the study was to analyse the impact of this surgical technique on the degree and quality of coronary revascularization using early postoperative angiography. METHODS: Between January 2004 and December 2006, 148 patients underwent coronary artery bypass surgery exclusively using both internal thoracic arteries in a T-graft configuration. Systematic postoperative angiography was offered to all 148 patients; it was accepted by 108 patients and refused by 40 patients. RESULTS: There were no statistically significant differences between the two groups. In-patient mortality was 2.02% (n=3) for the whole population studied, and 1.49% (n=2) for the 134 patients who received only coronary artery bypass grafts. The revascularization rate was 89% and 3.46 coronary anastomoses were constructed per patient (range 2-6). Angiography was performed on 108 right internal thoracic artery to left internal thoracic artery anastomoses, 374 anastomoses of internal thoracic arteries to coronary arteries and 382 inter-anastomosis segments: 98% of the anastomoses and segments were patent. CONCLUSION: The exclusive recourse to the purely internal thoracic artery T-graft technique meant that it has been possible to dispense with other types of graft while achieving complete and effective revascularization of the coronary artery.


Assuntos
Angiografia Coronária , Ponte de Artéria Coronária/métodos , Estenose Coronária/cirurgia , Oclusão de Enxerto Vascular/diagnóstico por imagem , Artéria Torácica Interna/cirurgia , Grau de Desobstrução Vascular , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Estenose Coronária/fisiopatologia , Feminino , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/fisiopatologia , Humanos , Masculino , Artéria Torácica Interna/diagnóstico por imagem , Artéria Torácica Interna/fisiopatologia , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
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