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1.
Eur Heart J ; 45(11): 940-949, 2024 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-38243821

RESUMO

BACKGROUND AND AIMS: Mitral valve surgery and, more recently, mitral transcatheter edge-to-edge repair (TEER) are the two treatments of severe mitral regurgitation in eligible patients. Clinical comparison of both therapies remains limited by the number of patients analysed. The objective of this study was to analyse the outcomes of mitral TEER vs. isolated mitral valve surgery at a nationwide level in France. METHODS: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients treated for mitral regurgitation with isolated TEER or isolated mitral valve surgery between 2012 and 2022. Propensity score matching was used for the analysis of outcomes. RESULTS: A total of 57 030 patients were found in the database. After matching on baseline characteristics, 2160 patients were analysed in each arm. At 3-year follow-up, TEER was associated with significantly lower incidence of cardiovascular death (hazard ratio 0.685, 95% confidence interval 0.563-0.832; P = .0001), pacemaker implantation, and stroke. Non-cardiovascular death (hazard ratio 1.562, 95% confidence interval 1.238-1.971; P = .0002), recurrent pulmonary oedema, and cardiac arrest were more frequent after TEER. No significant differences between the two groups were observed regarding all-cause death (hazard ratio 0.967, 95% confidence interval 0.835-1.118; P = .65), endocarditis, major bleeding, atrial fibrillation, and myocardial infarction. CONCLUSIONS: Our results suggest that TEER for severe mitral regurgitation was associated with lower cardiovascular mortality than mitral surgery at long-term follow-up. Pacemaker implantation and stroke were less frequently observed after TEER.


Assuntos
Fibrilação Atrial , Endocardite , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Acidente Vascular Cerebral , Humanos , Insuficiência da Valva Mitral/epidemiologia , Insuficiência da Valva Mitral/cirurgia , Acidente Vascular Cerebral/epidemiologia , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/cirurgia , Bases de Dados Factuais , Resultado do Tratamento
2.
Eur Heart J ; 45(3): 198-210, 2024 Jan 14.
Artigo em Inglês | MEDLINE | ID: mdl-37874971

RESUMO

BACKGROUND AND AIMS: Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. METHODS: Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. RESULTS: Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. CONCLUSIONS: Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.


Assuntos
Endocardite Bacteriana , Endocardite , Cardiopatias Congênitas , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Pulmonar , Valva Pulmonar , Trombose , Adulto , Humanos , Cateterismo Cardíaco/efeitos adversos , Endocardite/epidemiologia , Endocardite Bacteriana/complicações , Cardiopatias Congênitas/complicações , Próteses Valvulares Cardíacas/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Desenho de Prótese , Valva Pulmonar/cirurgia , Insuficiência da Valva Pulmonar/epidemiologia , Insuficiência da Valva Pulmonar/cirurgia , Sistema de Registros , Estudos Retrospectivos , Trombose/etiologia , Resultado do Tratamento
3.
Eur J Epidemiol ; 38(7): 821-834, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37191831

RESUMO

Pediatric patients with congenital heart disease (CHD) often undergo low dose ionizing radiation (LDIR) from cardiac catheterization (CC) for the diagnosis and/or treatment of their disease. Although radiation doses from a single CC are usually low, less is known about the long-term radiation associated cancer risks. We aimed to assess the risk of lympho-hematopoietic malignancies in pediatric CHD patients diagnosed or treated with CC. A French cohort of 17,104 children free of cancer who had undergone a first CC from 01/01/2000 to 31/12/2013, before the age of 16 was set up. The follow-up started at the date of the first recorded CC until the exit date, i.e., the date of death, the date of first cancer diagnosis, the date of the 18th birthday, or the 31/12/2015, whichever occurred first. Poisson regression was used to estimate the LDIR associated cancer risk. The median follow-up was 5.9 years, with 110,335 person-years. There were 22,227 CC procedures, yielding an individual active bone marrow (ABM) mean cumulative dose of 3.0 milligray (mGy). Thirty-eight incident lympho-hematopoietic malignancies were observed. When adjusting for attained age, gender and predisposing factors to cancer status, no increased risk was observed for lympho-hematopoietic malignancies RR/mGy = 1.00 (95% CI: 0.88; 1.10). In summary, the risk of lympho-hematopoietic malignancies and lymphoma was not associated to LDIR in pediatric patients with CHD who undergo CC. Further epidemiological studies with greater statistical power are needed to improve the assessment of the dose-risk relationship.


Assuntos
Cardiopatias Congênitas , Neoplasias Hematológicas , Neoplasias Induzidas por Radiação , Humanos , Criança , Fatores de Risco , Neoplasias Induzidas por Radiação/epidemiologia , Neoplasias Induzidas por Radiação/etiologia , Radiação Ionizante , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/complicações , Cateterismo Cardíaco/efeitos adversos , Doses de Radiação
4.
Catheter Cardiovasc Interv ; 99(7): 2117-2124, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35395142

RESUMO

Rescue transcatheter aortic valve replacement (TAVR) in patients with cardiogenic shock is challenging, and there is limited literature on these critical patients. The aim of this study was to determine the characteristics and outcomes of patients undergoing TAVR, feasibility and safety of the procedure, and 1-year mortality factors. Thirty-eight patients with severe aortic disease and cardiogenic shock admitted to two French hospitals from 2015 to 2019 were included. The patients were critical, 78.9% of them had a left ventricular ejection fraction of <30%, and all of them received inotropic support. "Valve-in-valve" procedures were performed in 15.8% and 13.2% underwent balloon aortic valvuloplasty before TAVR. Edwards Sapien3® and Medtronic CoreValve EvolutR® were used. The survival probability remained reasonable for patients with cardiogenic shock who underwent rescue TAVR. The 30-day mortality rate was 7.9% and 21.1% at 1 year. No patient died during the intervention. The procedure was safe, with few complications except for acute kidney failure, the development of a left bundle branch block, and the need for pacemaker implantation. Both functional and echocardiographic results were good at 1 year, although 29% of the patients underwent rehospitalization within 1 year. The development of a left bundle branch block was found to be a mortality risk factor. This procedure is a safe and effective therapy with acceptable survivorship in critically ill patients. The benefits to their quality of life should be evaluated in future studies, and the need for providing early cardiac resynchronization therapy must be emphasized.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Arritmias Cardíacas , Bloqueio de Ramo/etiologia , Próteses Valvulares Cardíacas/efeitos adversos , Humanos , Qualidade de Vida , Estudos Retrospectivos , Fatores de Risco , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/etiologia , Choque Cardiogênico/terapia , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda
5.
Catheter Cardiovasc Interv ; 99(6): 1829-1838, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35324050

RESUMO

OBJECTIVES: Report contemporary outcomes in patients included in the Mitragister registry and treated with transcatheter mitral valve implantation for failed surgical annuloplasty rings or deteriorated bioprosthesis. BACKGROUND: Midterm survival rates have been reported, but little is known about contemporary morbimortality endpoints. METHODS: The primary safety outcome was the technical success rate. The primary efficacy composite endpoint was a composite of cardiovascular mortality and heart failure hospitalizations. RESULTS: From 2016 to 2021, 102 patients (median age: 81 [74;84] years, 61% female, Euroscore II 11.0% [7.8;16.0]) undergoing valve-in-valve (ViV; n = 89) or valve-in-ring (ViR; n = 13) procedures were consecutively included. At baseline, ViR group patients had worse left ventricular ejection fraction (50% vs. 60%; p = 0.004) and more frequently severe regurgitation (46% vs. 15%; p = 0.014). The primary safety outcome was 95%: 77% and 98% in the ViR and ViV populations, respectively, (p = 0.014). At intermediate follow-up (6-12 months) clinical improvement was notable, 88% of the patients were in NYHA class ≤ II (vs. 25% at baseline; p < 0.001). At a mean follow-up of 17.1 ± 11.0 months, the primary efficacy composite reached 27%. By multivariate analysis, paravalvular leak (PVL) was the only independent predictor (hazard ratio: 2.39, 95% confidence interval: 1.08-5.29; p = 0.031) while ViR was not found statistically associated (p = 0.456). CONCLUSIONS: This study confirms the safety and efficacy of the mitral ViV procedure. ViR patients appear at higher risk of procedural complications. The presence of PVL could be associated with markedly worse midterm prognosis. Whatever the intervention, procedural strategies to reduce PVL incidence remain to be assessed to prevent latter adverse outcomes.


Assuntos
Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Idoso de 80 Anos ou mais , Bioprótese/efeitos adversos , Cateterismo Cardíaco/métodos , Feminino , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Falha de Prótese , Sistema de Registros , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda
6.
J Card Surg ; 37(12): 5019-5026, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36378912

RESUMO

BACKGROUND AND AIM: The mortality rate of patients with post-myocardial infarction (MI) ventricular septal defects (VSDs) is high, and the benefit of surgery is unclear. We aimed to investigate the management and outcomes of post-MI VSD over a 10-year period in a large cohort. METHODS: Data of patients with post-MI VSD admitted in three French university hospitals from 2008 to 2019 were examined. The characteristics of those who underwent surgery were compared with those who received medical treatment. Mortality risk factors, survival curves, and outcomes at 30 days and 1 year after treatment were determined. RESULTS: Of the 92 patients whose data were examined, 50 underwent surgery and 42 received exclusive medical treatment. All patients were critically ill. Overall, 76.1% of patients received inotropic support, and 63% received mechanical ventilation. Circulatory assistance, mainly via intra-aortic balloon pump and extra-corporeal membrane oxygenation, was provided to 46.7% patients, with 14.1% requiring a second assistance. The median time to surgery was 4 days. At 1 year, mortality was 46% in those who underwent surgery and 83.3% in those treated medically (p < .001). Survival curves at 1 and 3 months showed major differences, and the survival rate showed little change 30 days after treatment. Cardiogenic shock and cardiac arrest emerged as risk factors for mortality. CONCLUSIONS: In our retrospective, multicenter study, the mortality resulting from post-MI VSD did not seem to improve over the last decade. Although surgery carried considerable risks, it improved survival.


Assuntos
Comunicação Interventricular , Infarto do Miocárdio , Humanos , Estudos Retrospectivos , Infarto do Miocárdio/complicações , Infarto do Miocárdio/cirurgia , Choque Cardiogênico/etiologia , Choque Cardiogênico/terapia , Comunicação Interventricular/etiologia , Fatores de Risco , Resultado do Tratamento
7.
N Engl J Med ; 379(24): 2297-2306, 2018 12 13.
Artigo em Inglês | MEDLINE | ID: mdl-30145927

RESUMO

BACKGROUND: In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown. METHODS: We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm2 or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months. RESULTS: At 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention group and 51.3% (78 of 152 patients) in the control group (odds ratio, 1.16; 95% confidence interval [CI], 0.73 to 1.84; P=0.53). The rate of death from any cause was 24.3% (37 of 152 patients) in the intervention group and 22.4% (34 of 152 patients) in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77). The rate of unplanned hospitalization for heart failure was 48.7% (74 of 152 patients) in the intervention group and 47.4% (72 of 152 patients) in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56). CONCLUSIONS: Among patients with severe secondary mitral regurgitation, the rate of death or unplanned hospitalization for heart failure at 1 year did not differ significantly between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone. (Funded by the French Ministry of Health and Research National Program and Abbott Vascular; MITRA-FR ClinicalTrials.gov number, NCT01920698 .).


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral/tratamento farmacológico , Insuficiência da Valva Mitral/cirurgia , Intervenção Coronária Percutânea , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Feminino , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Próteses Valvulares Cardíacas/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hospitalização/estatística & dados numéricos , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/mortalidade , Falha de Prótese , Volume Sistólico , Resultado do Tratamento , Disfunção Ventricular Esquerda/etiologia
8.
Catheter Cardiovasc Interv ; 98(1): E108-E114, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-33793055

RESUMO

A 48-year-old who underwent a Mustard operation in 1972 followed by a second cardiac intervention in 1996 for pulmonary venous baffle enlargement and residual baffle leak closure, complicated by recurrent atrial flutter, was admitted to our institution for severe systemic atrio-ventricular valve regurgitation (SAVVR) associated with severely impaired systemic right ventricular (RV) function. After careful preoperative anatomic assessment including three-dimensional transesophageal echocardiography (3DTEE) to define the clipping strategy and computed tomography to optimize the transvenous baffle puncture site, the intervention was performed under general anesthesia, fluoroscopic, and 3DTEE guidance. One XTR MitraClip was successfully implanted, achieving a significant reduction in regurgitation and immediate clinical improvement. The transbaffle puncture was closed using an 8 mm atrial septal defect (ASD) device without residual shunt or obstruction of the venous baffle. Post-operative clinical evaluation showed immediate improvement in the NYHA functional class (from III to II), but the patient presented with recurrent flutter at 1 week after the procedure, which was successfully treated by catheter ablation with another transbaffle approach next to the ASD device. Clinical improvement was maintained at 1- and 6-month follow-up with significant reduction in SAVVR, reduced systemic RV volumes and improved RV ejection fraction. This case demonstrates the feasibility of percutaneous treatment of systemic SAVV in patients with systemic RV after atrial redirection.


Assuntos
Transposição das Grandes Artérias , Ecocardiografia Tridimensional , Insuficiência da Valva Tricúspide , Ecocardiografia Transesofagiana , Humanos , Pessoa de Meia-Idade , Resultado do Tratamento , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/cirurgia
9.
Catheter Cardiovasc Interv ; 98(1): E9-E17, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-32966675

RESUMO

BACKGROUND: Bifurcation lesions in coronary arteries are complex to treat with coronary stents, which are not designed for that purpose and can be unproperly deployed. Moreover, devices are constantly evolving, and so are angioplasty techniques. OBJECTIVES: The aim of this study was to determine the performances of different stents in the treatment of bifurcation lesions using the re-proximal optimization technique (rePOT). METHODS: Eleven stent platforms were evaluated: Xience Sierra (Abbott), Xience Alpine (Abbott), Synergy (Boston), Coroflex Isar (Bbraun), Cobra PzF (Celonova), Ultimaster (Terumo), Resolute Integrity (Medtronic), Resolute Onyx (Medtronic), Optimax (Hexacath), Orsiro (Biotronik), and Absorb (Abbott). Stents were deployed in a silicone fractal bifurcation model using the rePOT. Micro-computed tomography was performed to assess side branch ostium coverage and strut malapposition, as well as the effect of rePOT on stent cell area. RESULTS: Our study showed significant differences between stent platforms regarding side branch ostium coverage (p = .002). The Synergy and Cobra PzF stents were the most performant devices to avoid ostium coverage. Strut malapposition varied significantly between devices (p = .008) but the percentage of malapposed struts was relatively low. Significant differences were observed between stents regarding the cell area before (p = .002) and also after rePOT (p = .003), and the increase in cell area caused by rePOT varied considerably between devices (p = .08). CONCLUSION: This study highlighted significant differences in the performances of stent platforms deployed in a fractal bifurcation model using rePOT, with a variable impact of the procedure on stent cell area.


Assuntos
Doença da Artéria Coronariana , Stents , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Fractais , Humanos , Desenho de Prótese , Tomografia de Coerência Óptica , Resultado do Tratamento , Microtomografia por Raio-X
10.
Catheter Cardiovasc Interv ; 98(5): 990-999, 2021 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-34227735

RESUMO

OBJECTIVES: This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve. BACKGROUND: The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported. METHODS: From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively. RESULTS: The primary efficacy outcome was met for 87.1% patients after a mean follow-up of 4.6 ± 1.8 years, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8-95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular regurgitation was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01-2.00%). At 5 years, freedom from infective endocarditis was 98.4% (95% CI 89.1-99.8%). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35. CONCLUSIONS: This study documents the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.


Assuntos
Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Valva Pulmonar , Obstrução do Fluxo Ventricular Externo , Cateterismo Cardíaco/efeitos adversos , Seguimentos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Desenho de Prótese , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/cirurgia , Sistema de Registros , Resultado do Tratamento , Obstrução do Fluxo Ventricular Externo/cirurgia
11.
J Card Surg ; 36(2): 442-448, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33319937

RESUMO

BACKGROUND: To evaluate the long-term results of implantation of homogeneous large size of pulmonary homograft (PH) for reconstruction of the right ventricular outflow tract (RVOT). METHODS: Between January 2000 and December 2017, 107 patients were implanted with PH for reconstruction of the RVOT. Data were collected retrospectively in this single-center study. PH failure was defined as a peak of gradient greater than 40 mmHg and/or as a pulmonary regurgitation greater than Grade 2. Primary endpoint was the reoperation of the RVOT during follow-up. Secondary endpoints were overall survival, occurrence of PH failure and the rate of reoperation for all cause. RESULTS: Mean age of the recipients was 26.1 ± 13.6 years. Median follow-up interval was 2.99 years (interquartile range [IQR]: 6.2). Mean size of PH was 24.9 ± 1.9 mm. Reoperation of the RVOT occurred in eight patients (7.8%). Time before reoperation was 2.74 years (IQR: 6.4). Freedom from reoperation for RVOT at 5 and 10 years was respectively 95.7% and 90.0%. Overall survival at 10 years was 95.2%. PH failure occurred in 13 patients (12.0%). Median time before PH failure was 6.7 years (IQR: 9.6). Freedom from PH failure at 10 years was 81.6%. Reoperation for PH failure occurred in four patients (3.9%). Concomitant tricuspid surgery (p = .01; 95% confidence interval [CI]: 1.9-319.6) and undersized PH (p = .01; 95% CI: 2.06-719.8) were independent risk factors of late reoperation. CONCLUSION: Implantation of large PH for RVOT reconstruction provides excellent midterm results in terms of reoperation.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Pulmonar , Obstrução do Fluxo Ventricular Externo , Adolescente , Adulto , Aloenxertos , Criança , Humanos , Lactente , Reoperação , Estudos Retrospectivos , Resultado do Tratamento , Obstrução do Fluxo Ventricular Externo/cirurgia , Adulto Jovem
12.
N Engl J Med ; 377(11): 1011-1021, 2017 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-28902593

RESUMO

BACKGROUND: Trials of patent foramen ovale (PFO) closure to prevent recurrent stroke have been inconclusive. We investigated whether patients with cryptogenic stroke and echocardiographic features representing risk of stroke would benefit from PFO closure or anticoagulation, as compared with antiplatelet therapy. METHODS: In a multicenter, randomized, open-label trial, we assigned, in a 1:1:1 ratio, patients 16 to 60 years of age who had had a recent stroke attributed to PFO, with an associated atrial septal aneurysm or large interatrial shunt, to transcatheter PFO closure plus long-term antiplatelet therapy (PFO closure group), antiplatelet therapy alone (antiplatelet-only group), or oral anticoagulation (anticoagulation group) (randomization group 1). Patients with contraindications to anticoagulants or to PFO closure were randomly assigned to the alternative noncontraindicated treatment or to antiplatelet therapy (randomization groups 2 and 3). The primary outcome was occurrence of stroke. The comparison of PFO closure plus antiplatelet therapy with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 2, and the comparison of oral anticoagulation with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 3. RESULTS: A total of 663 patients underwent randomization and were followed for a mean (±SD) of 5.3±2.0 years. In the analysis of randomization groups 1 and 2, no stroke occurred among the 238 patients in the PFO closure group, whereas stroke occurred in 14 of the 235 patients in the antiplatelet-only group (hazard ratio, 0.03; 95% confidence interval, 0 to 0.26; P<0.001). Procedural complications from PFO closure occurred in 14 patients (5.9%). The rate of atrial fibrillation was higher in the PFO closure group than in the antiplatelet-only group (4.6% vs. 0.9%, P=0.02). The number of serious adverse events did not differ significantly between the treatment groups (P=0.56). In the analysis of randomization groups 1 and 3, stroke occurred in 3 of 187 patients assigned to oral anticoagulants and in 7 of 174 patients assigned to antiplatelet therapy alone. CONCLUSIONS: Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. PFO closure was associated with an increased risk of atrial fibrillation. (Funded by the French Ministry of Health; CLOSE ClinicalTrials.gov number, NCT00562289 .).


Assuntos
Anticoagulantes/uso terapêutico , Forame Oval Patente/tratamento farmacológico , Forame Oval Patente/terapia , Inibidores da Agregação Plaquetária/uso terapêutico , Prevenção Secundária/métodos , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Adolescente , Adulto , Anticoagulantes/efeitos adversos , Fibrilação Atrial/etiologia , Terapia Combinada , Feminino , Seguimentos , Forame Oval Patente/complicações , Aneurisma Cardíaco/complicações , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/efeitos adversos , Recidiva , Dispositivo para Oclusão Septal/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Adulto Jovem
13.
Am Heart J ; 222: 131-138, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32059120

RESUMO

BACKGROUND: In adults, the most common cause of out-of-hospital cardiac arrests (OHCA) is acute coronary artery occlusion. If an immediate coronary angiogram (CAG) is recommended for survivors presenting a ST segment elevation on the electrocardiogram (ECG) performed after resuscitation, there is still a debate regarding the best strategy in patients without ST segment elevation. HYPOTHESIS: Performing an immediate CAG after an OHCA without ST segment elevation on the post-resuscitation ECG and no obvious non-cardiac cause of arrest could lead to a better 180-day survival rate with no or minimal neurological sequel as compared with a delayed CAG performed 48 to 96 hours after the arrest. DESIGN: The EMERGE trial is a prospective national, randomized, open and parallel group trial, in which 970 survivors of OHCA will be randomized (1:1) to either immediate (as soon as possible after return of spontaneous circulation) or delayed (48 to 96 h) CAG. Participants will be OHCA patients with no ST segment elevation on the post resuscitation ECG and no obvious non-cardiac cause of arrest. The primary endpoint of the study is the 180-day survival rate with no or minimal neurological sequel corresponding to Cerebral Performance Category (CPC) 1 or 2. The secondary endpoints are: occurrence of shock during the first 48 hours, ventricular tachycardia and/or fibrillation during the first 48 hours, change in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram, neurological status evaluated by the CPC score at intensive care unit (ICU) discharge and day 90 neurological status assessed by the Glasgow Outcome Scale Extended score (GOSE) at 90 and 180 days, overall survival rate, and hospital length of stay. SUMMARY: The EMERGE trial is a prospective, multicenter, randomized, controlled trial that will assess the 180-day survival rate with no or minimal neurologic sequel in patients resuscitated from an OHCA without ST segment elevation and who will be managed with either immediate or delayed CAG.


Assuntos
Angiografia Coronária/métodos , Oclusão Coronária/diagnóstico , Diagnóstico Tardio , Diagnóstico Precoce , Serviço Hospitalar de Emergência , Parada Cardíaca Extra-Hospitalar/diagnóstico , Sistema de Registros , Adulto , Idoso , Reanimação Cardiopulmonar/métodos , Oclusão Coronária/complicações , Oclusão Coronária/mortalidade , Eletrocardiografia , Feminino , Seguimentos , França/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Parada Cardíaca Extra-Hospitalar/etiologia , Parada Cardíaca Extra-Hospitalar/terapia , Estudos Prospectivos , Taxa de Sobrevida/tendências , Sobreviventes , Fatores de Tempo
14.
Heart Vessels ; 35(1): 132-135, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31250129

RESUMO

Coronary bifurcation revascularization needs to take account of the diameter differential between vessels and to limit side-branch obstruction (SBO). The self-apposing properties of the Xposition S™ stent (STENTYS, France) seem interesting in this regard. The present experimental fractal bench study determined the best provisional stenting technique using Xposition S™. Three sequential strategies were compared (n = 5/group): implantation alone, side-branch inflation (SBI), and re-POT (initial proximal optimization technique (POT) + SBI + final POT). 2D- and 3D-OCT analyses and micro-CT scan were performed to quantify the main mechanical results at each step. Of the three groups, SBI and re-POT provided better final results than implantation alone in terms of residual SBO (respectively, 24.6 ± 5.6% and 24.8 ± 5.0% vs. 46.5 ± 10.3%, p < 0.05) and malapposition (respectively, 0.9 ± 0.6% and 0.8 ± 0.4% vs. 3.8 ± 1.9%, p < 0.05). Unlike SBI, the two POTs of the re-POT sequence did not improve the final result. SBI, alone or as part of re-POT, systematically led to one connector breakage, whereas implantation alone maintained complete stent integrity (p < 0.05). In Xposition S™ implantation, SBI should be systematic, but not post-dilatation specifically dedicated to bifurcation stenting (i.e., POTs). However, global post-dilatation is still mandatory to prevent stent underexpansion due to untreated stenosis.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Fractais , Modelos Cardiovasculares , Stents , Teste de Materiais , Desenho de Prótese , Tomografia de Coerência Óptica , Microtomografia por Raio-X
15.
Eur Heart J Suppl ; 22(Suppl Pt t): P42-P46, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33390870

RESUMO

COVID-19 has put each and every one at test. Cardiological clinics are facing constrained resources, limiting timely treatment of patients as usual. Patients with valvular heart disease are one of the most time sensitive patient populations, with delayed therapy possible leading to increased morbidity and mortality. Identifying and allocating the available resources to the most vulnerable patients is crucial in providing optimal patient care with prioritization of essential surgical or percutaneous procedures for valvular heart disease. Implementing telemedicine approaches might help to minimize non-essential physician-to-patient contact to ensure safety, for both patients and lastly but not least the treating physicians.

17.
Rev Neurol (Paris) ; 176(1-2): 53-61, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31787326

RESUMO

BACKGROUND: Unlike previous randomized clinical trials (RCTs), recent trials and meta-analyses have shown that transcatheter closure of patent foramen ovale (PFO) reduces stroke recurrence risk in young and middle-aged adults with an otherwise unexplained PFO-associated ischaemic stroke. AIM: To produce an expert consensus on the role of transcatheter PFO closure and antithrombotic drugs for secondary stroke prevention in patients with PFO-associated ischaemic stroke. METHODS: Five neurologists and five cardiologists with extensive experience in the relevant field were nominated by the French Neurovascular Society and the French Society of Cardiology to make recommendations based on evidence from RCTs and meta-analyses. RESULTS: The experts recommend that any decision concerning treatment of patients with PFO-associated ischaemic stroke should be taken after neurological and cardiological evaluation, bringing together the necessary neurovascular, echocardiography and interventional cardiology expertise. Transcatheter PFO closure is recommended in patients fulfilling all the following criteria: age 16-60 years; recent (≤6 months) ischaemic stroke; PFO associated with atrial septal aneurysm (>10mm) or with a right-to-left shunt>20 microbubbles or with a diameter≥2mm; PFO felt to be the most likely cause of stroke after thorough aetiological evaluation by a stroke specialist. Long-term oral anticoagulation may be considered in the event of contraindication to or patient refusal of PFO closure, in the absence of a high bleeding risk. After PFO closure, dual anti-platelet therapy with aspirin (75mg/day) and clopidogrel (75mg/day) is recommended for 3 months, followed by monotherapy with aspirin or clopidogrel for≥5 years. CONCLUSIONS: Although a big step forward that will benefit many patients has been taken with recent trials, many questions remain unanswered. Pending results from further studies, decision-making regarding management of patients with PFO-associated ischaemic stroke should be based on a close coordination between neurologists/stroke specialists and cardiologists.


Assuntos
Isquemia Encefálica/cirurgia , Cateterismo Cardíaco/normas , Procedimentos Endovasculares/normas , Forame Oval Patente/cirurgia , Prevenção Secundária , Acidente Vascular Cerebral/prevenção & controle , Adolescente , Adulto , Isquemia Encefálica/complicações , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/métodos , Cardiologia/organização & administração , Cardiologia/normas , Consenso , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/métodos , Prova Pericial , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Neurologia/organização & administração , Neurologia/normas , Recidiva , Prevenção Secundária/métodos , Prevenção Secundária/normas , Sociedades Médicas/normas , Dispositivos de Acesso Vascular/normas , Técnicas de Fechamento de Ferimentos/instrumentação , Técnicas de Fechamento de Ferimentos/normas , Adulto Jovem
19.
N Engl J Med ; 373(11): 1021-31, 2015 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-26321103

RESUMO

BACKGROUND: Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size. We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling. METHODS: In a multicenter, double-blind, randomized trial, we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction (STEMI) who were undergoing percutaneous coronary intervention (PCI) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine (administered intravenously at a dose of 2.5 mg per kilogram of body weight) or matching placebo before coronary recanalization. The primary outcome was a composite of death from any cause, worsening of heart failure during the initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year. Adverse left ventricular remodeling was defined as an increase of 15% or more in the left ventricular end-diastolic volume. RESULTS: A total of 395 patients in the cyclosporine group and 396 in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at 1 year. The rate of the primary outcome was 59.0% in the cyclosporine group and 58.1% in the control group (odds ratio, 1.04; 95% confidence interval [CI], 0.78 to 1.39; P=0.77). Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events, including recurrent infarction, unstable angina, and stroke. No significant difference in the safety profile was observed between the two treatment groups. CONCLUSIONS: In patients with anterior STEMI who had been referred for primary PCI, intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at 1 year. (Funded by the French Ministry of Health and NeuroVive Pharmaceutical; CIRCUS ClinicalTrials.gov number, NCT01502774; EudraCT number, 2009-013713-99.).


Assuntos
Ciclofilinas/antagonistas & inibidores , Ciclosporina/administração & dosagem , Inibidores Enzimáticos/administração & dosagem , Infarto do Miocárdio/tratamento farmacológico , Intervenção Coronária Percutânea , Remodelação Ventricular/efeitos dos fármacos , Idoso , Terapia Combinada , Ciclosporina/efeitos adversos , Método Duplo-Cego , Eletrocardiografia , Inibidores Enzimáticos/efeitos adversos , Feminino , Insuficiência Cardíaca/epidemiologia , Humanos , Injeções Intravenosas , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Mortalidade , Infarto do Miocárdio/terapia
20.
Catheter Cardiovasc Interv ; 92(7): E465-E470, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-30269427

RESUMO

OBJECTIVES: The purpose of the study was to develop a standardized and global bench test protocol to evaluate the biomechanical characteristics of the most currently used drug-eluting coronary stents. BACKGROUND: The use of coronary stents has contributed to the reduction of cardiovascular mortality but can be associated with specific complications. Improving the biomechanical matching between the stents and the coronary anatomy may reduce these complications. METHODS: We assessed five commercially available drug-eluting stents: the Absorb, Orsiro, Resolute Onyx, Synergy, and Xience Alpine stents. Following stent deployment at nominal pressure in ambient air, radial elastic recoil and foreshortening were measured. Flexibility (crimped and deployed stents) and longitudinal and radial resistances were evaluated using a mechanical tester. RESULTS: Biomechanical characteristics were significantly different for all tested devices (ANOVA, P < 0.01). The Synergy, Orsiro, and Xience Alpine stents presented the lowest elastic recoil. The Synergy and Resolute Onyx stents were the most flexible devices. The Xience Alpine and Absorb stents had the highest longitudinal and radial resistances. CONCLUSIONS: Drug-eluting coronary stents used in current clinical practice have very different biomechanical characteristics, which should be taken into consideration to select the most appropriate device for each clinical situation.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Força Compressiva , Elasticidade , Teste de Materiais , Pressão , Desenho de Prótese , Falha de Prótese , Estresse Mecânico
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