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1.
Eur J Heart Fail ; 2019 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-31476260

RESUMO

AIMS: The MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone. We report the 24-month outcome from this trial. METHODS AND RESULTS: At 37 centers, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm2 or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n=152) or medical treatment alone (control group, n=152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group (hazard ratio, 1.01; 95% confidence interval [CI], 0.77 to 1.34). All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (hazard ratio, 1.02; 95% CI, 0.70 to 1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (hazard ratio, 0.97; 95% CI 0.72 to 1.30). CONCLUSIONS: In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at two years compared with medical treatment alone.

3.
Artigo em Inglês | MEDLINE | ID: mdl-31365061

RESUMO

OBJECTIVES: The transcarotid (TC) approach for transcatheter aortic valve implantation (TAVI) is potentially an optimal alternative to the transfemoral (TF) approach. Our goal was to compare the safety and efficacy of TC- and TF-TAVI. METHODS: Patients who underwent TF-TAVI or TC-TAVI in the prospectively collected FRANCE TAVI registry between January 2013 and December 2015 were compared. Propensity score inverse probability weighting methods were employed to minimize the impact of bias related to non-random treatment assignment. RESULTS: Of the 11 033 patients included in the current study, 10 598 (96%) underwent a TF-TAVI and 435 (4.1%) had a TC-TAVI. Patients in the TC-TAVI access group presented with a higher risk profile but were significantly younger. There were no differences in the perioperative and 2-year mortality rates after adjustment [odds ratio (OR) 1.02, 95% confidence interval (CI) 0.62-1.68; P = 0.99 and hazard ratio 1.03, 95% CI 0.7-1.35; P = 0.83). TC-TAVI was associated with a significant risk of stroke (OR 2.42, 95% CI 2.01-2.92; P < 0.001), ST-elevation myocardial infarction (OR 7.32, 95% CI 3.87-13.87; P < 0.001), infections (OR 2.36, 95% CI 2.04-2.71; P < 0.001), bleeding (OR 2.01, 95% CI 1.76-2.29; P < 0.001), renal failure (OR 2.23, 95% CI 1.90-2.60; P < 0.001) and need for dialysis (OR 2.36, 95% CI 2.01-2.76, P < 0.001). Conversely, TC-TAVI was not confirmed as a risk factor for pacemaker implantation after adjustment (OR 1.05, 95% CI 0.96-1.15; P < 0.28) and was a protective factor for vascular complications (OR 0.37, 95% CI 0.32-0.43; P < 0.001). CONCLUSIONS: TC-TAVI is a safe procedure compared to TF-TAVI, although it holds an increased risk of perioperative complications. It should be considered in case of non-femoral peripheral access as the second access choice, to increase the overall safety of TAVI procedures.

4.
Cardiol J ; 2019 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-31106841

RESUMO

BACKGROUND: Left ventricular (LV) mechanics are impaired in patients with severe aortic stenosis (AS); however, transcatheter aortic valve implantation (TAVI) may positively affect LV mechanics. Assessed herein is the performance of the SAPIEN 3 transcatheter heart valve (THV) and the effect of TAVI on LV function recovery, as assessed by global longitudinal strain (GLS). METHODS: A subset of patients from the SOURCE 3 registry (n = 276) from 16 European centers received SAPIEN 3 balloon-expandable THV. Echocardiography was performed at baseline, post-procedure, and at 1 year, including assessment of GLS using standard two-dimensional images, and was analyzed in a core laboratory Paired analyses between baseline and discharge, baseline and at 1 year were conducted. RESULTS: Hemodynamic parameters were improved after TAVI and sustained to 1 year. At 1 year, the rate of moderate to severe paravalvular leaks (PVL), and moderate to severe mitral and tricuspid regurgitations were 1.8%, 1.7%, and 8.0%, respectively. The discharge GLS (-15.6 ± 5.1; p = 0.004; n = 149) improved significantly from baseline (-15.1 ± 4.8) following TAVI. This improvement was sustained at 1 year compared with baseline (-17.0 ± 4.6, p < 0.001; n = 100). Conversely, LV ejection fraction (LVEF) did not significantly change following TAVI (p = 0.47). CONCLUSIONS: Following TAVI with a third-generation THV, valve performances were good at 1 year with low PVL rate. The LV mechanics improved immediately after the procedure and were maintained at 1 year. These findings demonstrate the benefit of TAVI on LV mechanics, and suggests that GLS may be superior to LVEF in assessing this benefit. Clinicaltrial.gov number: NCT02698956.

5.
Clin J Am Soc Nephrol ; 14(6): 810-822, 2019 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-31010936

RESUMO

BACKGROUND AND OBJECTIVES: Whether prolonged dual antiplatelet therapy (DAPT) is more protective in patients with CKD and drug-eluting stents compared with shorter DAPT is uncertain. The purpose of this meta-analysis was to examine whether shorter DAPT in patients with drug-eluting stents and CKD is associated with lower mortality or major adverse cardiovascular event rates compared with longer DAPT. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A Medline literature research was conducted to identify randomized trials in patients with drug-eluting stents comparing different DAPT duration strategies. Inclusion of patients with CKD was also required. The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, or stent thrombosis (definite or probable). Major bleeding was the secondary outcome. The risk ratio (RR) was estimated using a random-effects model. RESULTS: Five randomized trials were included (1902 patients with CKD). Short DAPT (≤6 months) was associated with a similar incidence of the primary outcome, compared with 12-month DAPT among patients with CKD (48 versus 50 events; RR, 0.93; 95% confidence interval [95% CI], 0.64 to 1.36; P=0.72). Twelve-month DAPT was also associated with a similar incidence of the primary outcome compared with extended DAPT (≥30 months) in the CKD subgroup (35 versus 35 events; RR, 1.04; 95% CI, 0.67 to 1.62; P=0.87). Numerically lower major bleeding event rates were detected with shorter versus 12-month DAPT (9 versus 13 events; RR, 0.69; 95% CI, 0.30 to 1.60; P=0.39) and 12-month versus extended DAPT (9 versus 12 events; RR, 0.83; 95% CI, 0.35 to 1.93; P=0.66) in patients with CKD. CONCLUSIONS: Short DAPT does not appear to be inferior to longer DAPT in patients with CKD and drug-eluting stents. Because of imprecision in estimates (few events and wide confidence intervals), no definite conclusions can be drawn with respect to stent thrombosis.

7.
Circ Cardiovasc Interv ; 12(4): e007597, 2019 Apr.
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.

8.
Cardiovasc Diabetol ; 18(1): 27, 2019 03 11.
Artigo em Inglês | MEDLINE | ID: mdl-30857532

RESUMO

BACKGROUND: Glycemic variability is associated with worse outcomes after cardiac surgery, but the prognosis value of early glycemic variability after transcatheter aortic valve implantation is not known. This study was therefore designed to analyze the prognosis significance of post-procedural glycemic variability within 30 days after transcatheter aortic valve implantation. METHODS: A post hoc analysis of patients from our center included in the FRANCE and FRANCE-2 registries was conducted. Post-procedural glycemic variability was assessed by calculating the mean daily δ blood glucose during the first 2 days after transcatheter aortic valve implantation. Major complications within 30 days were death, stroke, myocardial infarction, acute heart failure, and life-threatening cardiac arrhythmias. RESULTS: We analyzed 160 patients (age (median [interquartile] = 84 [80-88] years; diabetes mellitus (n) = 41 (26%) patients; logistic Euroscore = 20 [12-32]). The median value of mean daily δ blood glucose was 4.3 mmol l-1. The rate of major complications within 30 days after procedure among patients with the lowest quartile of glycemic variability was 12%, increasing from 12 to 26%, and 39% in the second, third, and fourth quartiles, respectively. In multivariate analysis, glycemic variability was independently associated with an increased risk of major complications within 30 days after the procedure (odds ratio [95% CI] = 1.83 [1.19-2.83]; p = 0.006). CONCLUSIONS: This study showed that post-procedural glycemic variability was associated with an increased risk of major complications within 30 days after transcatheter aortic valve implantation. Trial registration Clinical trial registration number https://www.clinicaltrials.gov/ ; identifier: NCT02726958; date: April 4th, 2016.


Assuntos
Estenose da Valva Aórtica/cirurgia , Glicemia/metabolismo , Doenças Cardiovasculares/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Biomarcadores/sangue , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/mortalidade , Feminino , França , Humanos , Masculino , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
9.
Circ Cardiovasc Interv ; 12(3): e007541, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30871353

RESUMO

BACKGROUND: We sought to determine whether the risks and benefits of prolonging dual-antiplatelet therapy (DAPT) beyond 1 year after drug-eluting stent implantation depend on clinical presentation in a meta-analysis of randomized controlled trials. METHODS AND RESULTS: Randomized controlled trials comparing ≤1- versus >1-year DAPT after drug-eluting stent placement were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary efficacy end point was myocardial infarction, whereas the primary safety end point was major bleeding. Net clinical benefit was defined as the composite of myocardial infarction or major bleeding. Outcomes were analyzed according to patient presentation with stable ischemic heart disease versus acute coronary syndromes. The meta-analysis included 6 trials with a total of 21 457 patients, including 14 132 with stable ischemic heart disease and 7325 with acute coronary syndrome. After a median follow-up of 19.5 months, ≤1-year DAPT was associated with higher rates of myocardial infarction compared with >1-year DAPT (hazard ratio [HR], 1.63; 95% CI, 1.37-1.95), with no interaction apparent between treatment effect and clinical presentation. Shorter DAPT was associated with reduced rates of major bleeding compared with longer DAPT (HR, 0.64; 95% CI, 0.42-0.99) with no significant interaction between treatment effect and clinical presentation. However, a net clinical benefit of >1-year DAPT was present in patients with acute coronary syndrome (HR of shorter versus longer DAPT, 1.59; 95% CI, 1.24-2.02) but not in those with stable ischemic heart disease (HR, 1.15; 95% CI, 0.89-1.51; Pinteraction=0.04). Shorter DAPT was also associated with lower rates of noncardiac mortality compared with longer DAPT (HR, 0.71; 95% CI, 0.52-0.96), with no significant interaction between treatment effect and clinical presentation ( Pinteraction=0.12). CONCLUSIONS: Compared with ≤1-year DAPT, >1-year DAPT reduces the risk of myocardial infarction but increases the risk of major bleeding and noncardiac mortality. A net clinical benefit of extended DAPT was apparent for patients with acute coronary syndrome but not for those with stable ischemic heart disease.

10.
Catheter Cardiovasc Interv ; 94(2): 216-222, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-30719828

RESUMO

OBJECTIVES: The aim of this study was to determine the accuracy of DoseMap™ software as compared to gafchromic film in real clinical practices. BACKGROUND: The radiation exposure from cardiovascular procedures could expose patients to potential risk of cancer and/or skin injury. New tools like Dosemap software were developed to estimate the patient skin dose in the cardiac catheterization laboratory. However, little data are available to validate this estimation of patient radiation skin dose. METHODS: This is a prospective cross-sectional study comparing the peak skin dose (PSD) measured by gafchromic film used as reference with an estimated PSD given by Dosemap software, in patients with BMI > 30 kg/m2 undergoing elective diagnostic and/or therapeutic interventional cardiology procedures, from April 2016 to December 2016, at the Brest University Hospital Centre, France. RESULTS: After four exclusions of patients for poor quality of gafchromic films, 90 patients were included, with 58 angiography (67.4%), 14 percutaneous interventions (16.3%), and 14 both (16.3%). The median PSDDosemap and PSDFilm were similar with 157 mGy [IQR: 99; 273] versus 158 mGy [IQR: 101; 295] (P = 0.65), respectively, with an excellent correlation (r = 0.95). The comparison between cumulative air kerma and PSDFilm was different 366 mGy [IQR: 246; 575] versus 158 mGy [IQR: 101; 295] (P < 0.01) with moderate correlation (r = 0.79). No correlation was found between the dose area product and PSDFilm (r = 0.51). CONCLUSION: DoseMap is an effective and valid method as compared to gafchromic films to estimate PSDs during interventional cardiologic procedures.

11.
Thromb Haemost ; 119(1): 149-162, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30597509

RESUMO

BACKGROUND: Prolonged dual anti-platelet therapy (DAPT) is intended to reduce ischaemic events, at the cost of an increased bleeding risk in patients undergoing percutaneous coronary intervention (PCI). In this study, we evaluated whether race influences the ischaemia/bleeding risk trade-off. METHODS: We searched for randomized clinical trials (RCTs) comparing DAPT duration after PCI. To compare the benefit or harm between DAPT duration by race, individual patient-level landmark meta-analysis was performed after discontinuation of the shorter duration DAPT group in each RCT. The primary ischaemic endpoint was major adverse cardiac events (MACEs), and the primary bleeding endpoint was major bleeding events (clinicaltrials.gov NCT03338335). RESULTS: Seven RCTs including 16,518 patients (8,605 East Asians, 7,913 non-East Asians) were pooled. MACE occurred more frequently in non-East Asians (0.8% vs. 1.8%, p < 0.001), while major bleeding events occurred more frequently in East Asians (0.6% vs. 0.3%, p = 0.001). In Cox proportional hazards model, prolonged DAPT significantly increased the risk of major bleeding in East Asians (hazard ratio [HR], 2.843, 95% confidence interval [CI], 1.474-5.152, p = 0.002), but not in non-East Asians (HR, 1.375, 95% CI, 0.523-3.616, p = 0.523). East Asians had a higher median probability risk ratio of bleeding to ischaemia (0.66 vs. 0.15), and the proportion of patients with higher probability of bleeding than ischaemia was significantly higher in East Asians (32.3% vs. 0.4%, p < 0.001). CONCLUSION: We suggest that the ischaemia/bleeding trade-off may be different between East Asians and non-East Asians. In East Asians, prolonged DAPT may have no effect in reducing the ischaemic risk, while significantly increases the bleeding risk.


Assuntos
Hemorragia/tratamento farmacológico , Hemorragia/etnologia , Isquemia/tratamento farmacológico , Isquemia/etnologia , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação de Plaquetas/farmacologia , Grupo com Ancestrais do Continente Asiático , Plaquetas , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/etnologia , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Grupos Étnicos , Humanos , Infarto do Miocárdio/complicações , Infarto do Miocárdio/etnologia , Probabilidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Resultado do Tratamento
12.
Arch Cardiovasc Dis ; 112(4): 234-240, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30639198

RESUMO

BACKGROUND: France has a long history of successful cardiovascular research and scientific innovations, but its continued success cannot be taken for granted. AIMS: To identify current obstacles to cardiovascular research in France and to crystallize the analysis into recommendations for maintained and enhanced research excellence in the future. METHODS: The French Society of Cardiology set up seven Working Groups, each comprising four to eight cardiologists, covering a spectrum of research institutes, hospitals, specialties, ages and research experience. The Working Groups met regularly in person or by conference call to analyse experiences, refine situation assessments and formulate recommendations for improvements. Results and suggestions were presented to a Core Team, which worked to synthesize, prioritize and organize the findings into a consolidated situation assessment and generate a set of action-orientated recommendations. RESULTS: Four key areas of action were identified: stronger focus on the generation of high-quality data; facilitation of future cardiovascular research; greater promotion and support for research among young cardiologists; and increased focus and support for communications. Most recommendations targeted structural shortcomings and may be implemented at low additional financial cost. CONCLUSIONS: It is possible to maintain, and even increase, the quality of cardiovascular research in France and to boost the conversion of successful projects into high-impact publications, without major increases in funding. Intense collaboration between specialties and organizations is necessary to achieve sustainable results.


Assuntos
Pesquisa Biomédica/normas , Cardiologia/normas , Doenças Cardiovasculares , Publicações Periódicas como Assunto/normas , Controle de Qualidade , Projetos de Pesquisa/normas , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/fisiopatologia , Doenças Cardiovasculares/terapia , Consenso , Comportamento Cooperativo , Difusão de Inovações , Previsões , França , Humanos , Comunicação Interdisciplinar
13.
Clin Res Cardiol ; 108(7): 763-771, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30552511

RESUMO

BACKGROUND: Current trials and registries of transcatheter valve implantation (TAVI) mostly include patients older than 75 years. Little is known about younger patients who undergo this treatment. We investigated comorbidities among patients < 75 years old who underwent TAVI in the SAPIEN 3™ European post-approval SOURCE 3 Registry, and analysed outcomes at 30 days and 1 year. METHODS AND RESULTS: Three age groups of patients were analysed for outcomes and characteristics: < 75 (n = 235), 75-80 (n = 391) and ≥ 80 years (n = 1320). Overall, the mean age was 81.6 ± 6.7 years; transfemoral access was used in 87.1% of patients treated with SAPIEN 3 transcatheter heart valves. The mean logistic EuroSCORE increased according to age group (12.6%, 17.3% and 19.7%, respectively, p < 0.001). Younger patients had a higher incidence of comorbidities, particularly those not included in surgical risk score assessment tools, e.g., severe liver disease, previous radiation therapy, and porcelain aorta. Mortality rates were similar between age groups at 30 days (1.7%, 2.0% and 2.3%, respectively, p = 0.79) and 1 year (14.2%, 9.3% and 13.3%, respectively, p = 0.08). However, sudden cardiac death rates were higher in the < 75 years age group compared with the ≥ 85 years age group (20.7% vs. 4.8%, p = 0.010). CONCLUSIONS: In current TAVI practice, patients younger than 75 years are a minority (12%). Despite younger age and lower surgical risk scores, this cohort was characterized by comorbidities not accounted for by traditional surgical risk scores. More data are needed for this age group to guide the appropriate decision between surgery and TAVI. CLINICALTRIAL. GOV NUMBER: NCT02698956.

14.
JAMA Cardiol ; 4(1): 64-70, 2019 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-30566185

RESUMO

Importance: In low-flow, low-gradient aortic stenosis (LFLG AS), the severity of left ventricular dysfunction remains a key factor in the evaluation of aortic valve replacement. Objective: To evaluate the clinical outcomes and changes in left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR) in patients with LFLG AS and severe left ventricular dysfunction. Design, Setting, and Participants: This multicenter registry is a substudy of the True or Pseudo-Severe Aortic Stenosis-TAVI registry that included patients with classic LFLG AS, defined as a mean transvalvular gradient less than 35 mm Hg, an effective orifice area less than 1.0 cm2, and an LVEF of 40% or less. Patients were divided in groups with very low (<30%) LVEF and low (30%-40%) LVEF. Dobutamine stress echocardiography (DSE) was performed before TAVR in a subset with very low LVEF, and presence of contractile reserve was defined as an increase of 20% or more in stroke volume. Clinical outcomes were assessed at 1 and 12 months and yearly thereafter, and echocardiography was performed at 1-year follow-up. Retrospective data were collected from 2007 to 2013 and prospective data from January 2013 to March 2018. Data were analyzed from March to October 2018. Exposures: Transcatheter aortic valve replacement in patients with LFLG AS. Main Outcomes and Measures: Changes in LVEF over time; periprocedural and late mortality. Results: A total of 293 patients were included, including 128 (43.7%) with very low LVEF and 165 with low LVEF (56.3%). Their mean (SD) age was 80 (7) years, and most (214 [73.0%]) were men. The mean (SD) LVEF in the very low LVEF group was 22% (5%), compared with 37% (7%) in the low LVEF group (P < .001). There were no differences between groups in rates of periprocedural mortality and late mortality (median [interquartile range], 23 [6-38] months). Patients with very low LVEF displayed a greater increase in LVEF at the 1-year follow-up examination (mean absolute increase, 11.9% [95% CI, 8.8%-15.1%]), than the low LVEF group (3.6% [95% CI, 1.1%-6.1%]; P < .001). In 92 patients with very low LVEF who had preprocedural DSE, results showed a lack of contractile reserve in 45 (49%), but this had no effect on clinical outcomes or changes in LVEF over time. Conclusions and Relevance: In patients with LFLG AS and severe left ventricular dysfunction, TAVR was associated with similar clinical outcomes as in counterparts with milder left ventricular dysfunction. The TAVR procedure was associated with a significant increase in LVEF, irrespective of contractile reserve. These results support TAVR for LFLG AS, irrespective of the severity of left ventricular dysfunction and DSE results.

16.
Circulation ; 138(23): 2597-2607, 2018 Dec 04.
Artigo em Inglês | MEDLINE | ID: mdl-30571260

RESUMO

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.

17.
JACC Cardiovasc Interv ; 11(21): 2195-2203, 2018 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-30409276

RESUMO

OBJECTIVES: This study sought to compare outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) in a catheterization laboratory (cath lab) to those undergoing TAVR in a hybrid operating room (OR). BACKGROUND: TAVR can be performed in a cath lab or in a hybrid OR. Comparisons between these locations are scarce. METHODS: All TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. The primary endpoint of this study was all-cause mortality at 1 year. Secondary endpoints consisted of 30-day complications and 3-year mortality. All analyses were adjusted for baseline and procedural characteristics. RESULTS: A total of 12,121 patients were included in this study, 62% of which underwent TAVR in a cath lab versus 38% in a hybrid OR. Mean age was 82.9 ± 7.2 years, 48.9% of patients were men, and mean Logistic EuroScore was 17.9% ± 12.3%. Both procedure locations showed similar, below 2% rates of intraprocedural complications. After adjusting for baseline and procedural characteristics, major bleeding and infections were significantly higher in the hybrid OR group (bleeding, 6.3% vs. 4.8%; infection, 6.1% vs. 3.5%; p < 0.05). Adjusted mortality rates at 1 and 3 years did not differ significantly between groups (for cath lab vs. hybrid OR, respectively: 1 year: 16.2% vs. 15.8%; p = 0.91; 3 years: 38.4% vs. 36.4%; p = 0.49). CONCLUSIONS: Midterm mortality after TAVR was similar between the cath lab and the hybrid OR. These findings support the performance of TAVR in either location, which has important implications on health care organization and costs.

18.
Circ Cardiovasc Interv ; 11(9): e007241, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30354592

RESUMO

Background The optimal timing of administration of dual antiplatelet therapy (DAPT) in acute ST-segment-elevation myocardial infarction patients is debated. Clinical trials have failed to demonstrate the superiority of pretreatment with P2Y12 inhibitors in ST-segment-elevation myocardial infarction, but they were not designed to assess hard clinical end points. We used data from the FAST-MI (French Registry on Acute ST-Segment-Elevation or Non-ST-Segment-Elevation Myocardial Infarction) cohorts to determine 1-year survival and in-hospital outcomes in patients receiving DAPT, comparing prehospital versus in-hospital administration. Methods and Results The FAST-MI program collects extensive data on patients admitted in France for acute myocardial infarction over a 1-month period every 5 years since 2005. For the present analysis, 3548 patients with ST-segment-elevation myocardial infarction ≤12 hours from symptom onset, transported by physician-staffed emergency medical system ambulances, not treated with intravenous fibrinolysis, and receiving DAPT were included, of whom 44% received DAPT in the ambulance. The primary end point was 1-year survival as assessed by multivariate Cox analysis and propensity score analysis. In-hospital bleeding and ischemic complications were also analyzed. Adjusted in-hospital mortality was numerically but not significantly lower in patients with prehospital DAPT. There were no differences in in-hospital bleeding complications. Fully-adjusted hazard ratio for 1-year death in patients with prehospital versus in-hospital DAPT was 0.69 (95% CI, 0.51-0.92; P=0.011), and propensity score-adjusted hazard ratio was 0.55 (95% CI, 0.41-0.73; P=0.001) in the whole population. In the propensity score-matched cohorts (360 patients each), 1-year survival was 93.9% in patients with prehospital versus 90.3% in those with in-hospital DAPT (hazard ratio, 0.62; 95% CI, 0.36-1.05; P=0.077). Results were consistent in subgroups, including by year of survey, age, presence of out-of-hospital cardiac arrest, morphine use, and type of P2Y12 inhibitor used. Conclusions In these cohorts of ST-segment-elevation myocardial infarction patients considered for primary percutaneous coronary intervention, prehospital administration of DAPT was associated with higher 1-year survival and no increase in in-hospital bleeding complications. The magnitude of the decrease in 1-year mortality, however, may suggest the persistence of some degree of residual confounding. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifiers: NCT00673036, NCT01237418, and NCT02566200.

20.
JACC Cardiovasc Interv ; 11(19): 1956-1965, 2018 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-30219324

RESUMO

OBJECTIVES: This study sought to describe the current practices and compare outcomes according to the use of balloon aortic valvuloplasty (BAV) or not during transcatheter aortic valve replacement (TAVR). BACKGROUND: Since its development, aortic valve pre-dilatation has been an essential step of TAVR procedures. However, the feasibility of TAVR without systematic BAV has been described. METHODS: TAVR performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (Registry of Aortic Valve Bioprostheses Established by Catheter) registry. We compared outcomes according to BAV during the TAVR procedure. RESULTS: A total of 5,784 patients have been included in our analysis, corresponding to 2,579 (44.6%) with BAV avoidance and 3,205 (55.4%) patients with BAV performed. We observed a progressive decline in the use of BAV over time (78% of procedures in 2013 and 49% in the last trimester of 2015). Avoidance of BAV was associated with similar device implantation success (97.3% vs. 97.6%; p = 0.40). TAVR procedures without BAV were quicker (fluoroscopy 17.2 ± 9.1 vs. 18.5 ± 8.8 min; p < 0.01) and used lower amounts of contrast (131.5 ± 61.6 vs. 141.6 ± 61.5; p < 0.01) and radiation (608.9 ± 576.3 vs. 667.0 ± 631.3; p < 0.01). The rates of moderate to severe aortic regurgitation were lower with avoidance of BAV (8.3% vs. 12.2%; p < 0.01) and tamponade rates (1.5% vs. 2.3%; p = 0.04). CONCLUSIONS: We confirmed that TAVR without BAV is frequently performed in France with good procedural results. This procedure is associated with procedural simplification and lower rates of residual aortic regurgitation.

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