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1.
Circulation ; 141(4): 243-259, 2020 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-31736356

RESUMO

BACKGROUND: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. METHODS: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. RESULTS: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; P<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; P<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; P=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; P=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. CONCLUSION: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.

2.
Aging Clin Exp Res ; 32(1): 133-140, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30903598

RESUMO

BACKGROUND: Clinical research is an essential step in the successful translation of knowledge from basic research into concrete clinical applications, yet many people are reluctant to provide consent when actually approached to actively participate in clinical trials. AIMS: We investigated the factors that influence older patient's (≥ 65 years) decisions to accept or refuse to participate in a prospective randomized clinical trial in secondary prevention after acute coronary syndrome. METHODS: Qualitative approach based on individual semi-structured interviews with patients who were approached for consent to participate in a currently ongoing clinical trial was adopted. Patients were interviewed after the consent process (8 accepted; 8 refused the trial). Interviews were analysed using grounded theory methodology. RESULTS: Sixteen patients aged ≥ 65 years participated. The main concept to emerge from these interviews is that the actual trial itself does not appear to be the primary determinant in the decision to participate in clinical research. Rather, patients' decisions to participate (or not) in clinical research appear to be primarily determined by their capacity to deal with the current health event that has disrupted their life, and by their available mental and physical resources. DISCUSSION AND CONCLUSION: Older patients display varying levels of engagement in their own health, ranging from low engagement with high trust in the medical profession, to high engagement mirrored by distrust of the medical profession. Structural conditions, such as personal benefit from trial participation, or logistic barriers to participation, seem to affect both accepters and refusers in the same manner.

4.
Rev Neurol (Paris) ; 2019 Nov 28.
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.

5.
Artigo em Inglês | MEDLINE | ID: mdl-31763775

RESUMO

OBJECTIVE: We sought to evaluate the correlations of pre-PCI QFR analysis with virtual PCI called residual QFR and post-PCI QFR compared to post-PCI FFR. BACKGROUND: Quantitative flow ratio (QFR) is a computation of fractional flow reserve (FFR) based on angiography without use of a pressure wire. The ability to evaluate post-PCI FFR using pre-PCI QFR analysis with a virtual PCI and the correlation between post-PCI QFR compared to post-PCI FFR remains unknown. METHODS: From the DOCTORS (Does Optical Coherence Tomography Optimize Results of Stenting) study population, we blindly analyzed residual QFR and post-PCI QFR from angiographies and compared them to post-PCI FFR. RESULTS: Ninety-three post-PCI QFR measurements and 84 pre-PCI residual QFR measurements were compared to post-PCI FFR measurements. No significant difference were observed between mean post-PCI FFR value (0.92 ± 0.05) compared to mean residual (0.93 ± 0.05) QFR and between mean post-PCI FFR value compared to mean post-PCI QFR values were (0.93 ± 0.05) (p > .05 for both). The correlation coefficient of residual QFR with post-PCI FFR was 0.68 (95% CI: 0.53-0.78) and the correlation coefficient of post-PCI-QFR with post-PCI FFR was 0.79 (95% CI: 0.70-0.86). CONCLUSIONS: Residual QFR corresponding to pre-PCI QFR analysis with virtual PCI, and post-PCI QFR analysis, correlated well with post-PCI FFR. Further studies are needed to prospectively validate a QFR-guided PCI strategy.

6.
Arch Cardiovasc Dis ; 2019 Nov 02.
Artigo em Inglês | MEDLINE | ID: mdl-31690519

RESUMO

BACKGROUND: Evidence-based clinical practice guidelines define initial management of acute pulmonary embolism (PE) according to risk stratification for early death. AIMS: The aims of the present study were to investigate patterns of non-compliance with guidelines for the acute PE treatment, and the associated risk of adverse events. METHODS: We performed an observational, multicentre, cohort study of acute PE. Inclusion criteria were all patients with pulmonary embolism admitted to the participating centres between January 2011 and April 2017. The measure of 100% compliance was used to allocate patients in the compliant or non-compliant groups. The primary outcome was all-cause death at 6 months. Secondary outcomes included recurrent venous thromboembolism and major bleeding. RESULTS: In total, 1285 patients were included. Treatment was not in compliance with the guidelines in 172 patients (13.4%). Four factors were identified to be related to non-compliance with the guidelines: shock or hypotension (relative risk [RR] 5.23, 95% confidence interval [CI] 2.64-10.30; P<0.001), renal insufficiency (RR 1.80, 95% CI 1.41-2.28; P<0.001), active cancer (RR 1.35, 95% CI 1.24-1.48; P<0.001) and right ventricular dysfunction at admission (RR 1.06, 95% CI 1.01-1.11; P=0.01). The primary endpoint of all-cause death at 6 months occurred in 62 of 172 patients (36.0%) in the non-compliant group and in 131 of 1113 patients (11.8%) in the compliant group (hazard ratio 2.02, 95% CI 1.45-2.81; P<0.001). The rates of recurrent venous thromboembolism (8.7% vs 1.1%; P<0.001) and major bleeding (13.4% vs 4.9%, P=0.04) from admission to 6-month follow-up were higher in the non-compliant group. CONCLUSION: Non-compliance with guidelines was independently associated with worse outcomes, including death, recurrent venous thromboembolism and bleeding.

8.
Eur Heart J Suppl ; 21(Suppl I): I23-I30, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31777454

RESUMO

Systemic thrombolysis for acute pulmonary embolism (PE) reduces the risk of death and cardiovascular collapse but is associated with an increased rate of bleeding. The desire to minimize the risk of bleeding events has driven the development of catheter-based strategies for pulmonary reperfusion in PE. These catheter-based strategies utilize lower-dose fibrinolytic regimens or purely mechanical techniques to expedite removal of the embolus. Several devices providing mechanical or suction embolectomy and catheter-directed thrombolysis, with or without facilitation by ultrasound, have been tested. Data are inconsistent regarding the efficacy and safety of mechanical and suction embolectomy. The most comprehensive data on catheter-based techniques stem from trials of ultrasound-facilitated catheter fibrinolysis. Ultrasound-facilitated catheter fibrinolysis relieves right ventricular pressure overload with a lower risk of major bleeding and intracranial haemorrhage than historical rates with systemic fibrinolysis. However, further research is required to determine the optimal application of ultrasound-facilitated catheter fibrinolysis and other catheter-based therapies in patients with acute PE.

9.
Int J Cardiol ; 297: 22-29, 2019 12 15.
Artigo em Inglês | MEDLINE | ID: mdl-31630816

RESUMO

AIMS: The impact of diabetes mellitus (DM) on clinical outcomes after transcatheter aortic valve replacement (TAVR) remains unclear. The aim of this study was to investigate the impact of DM on short-term clinical outcomes after TAVR in a large randomized trial population. METHODS AND RESULTS: BRAVO-3 trial randomized 802 patients undergoing trans-femoral TAVR to procedural anticoagulation with bivalirudin or unfractionated heparin. The study population was divided according to the presence of DM, and further stratified according to the use of insulin. Net adverse cardiovascular outcomes (NACE - death, myocardial infarction (MI), stroke or major bleeding by Bleeding Academic Research Consortium (BARC) type 3b or above) was the primary outcome in-hospital and at 30-days. Of the total 802 randomized patients, 239 (30%) had DM at baseline, with 87 (36%) being treated with insulin. At 30-days, DM patients experienced numerically higher rates of net adverse cardiovascular events (16.3% vs. 14.4%, p=0.48) and acute kidney injury (19.7% vs. 15.1%, p=0.11), while non-DM (NDM) patients had numerically higher rates of cerebrovascular accidents (3.6% vs. 1.7%, p=0.22). After multivariable adjustment, DM patients had higher odds of vascular complications at 30-days (OR 1.57, p=0.03) and life-threatening bleeding both in-hospital (OR 1.50, p=0.046) and at 30-days (OR 1.50, p=0.03) with the excess overall risk primarily attributed to the higher rates observed among non-insulin dependent DM patients. CONCLUSIONS: Patients with DM had higher adjusted odds of vascular and bleeding complications up to 30-days post-TAVR. Overall, there was no significant association between DM and early mortality following TAVR.

10.
Circulation ; 140(23): 1921-1932, 2019 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-31557056

RESUMO

BACKGROUND: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. METHODS: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI. RESULTS: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; Pinteraction=0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; Pinteraction=0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups (Pinteraction=0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; Pinteraction=0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization (Pinteraction=0.787) and death and ischemic events (Pinteraction=0.710). CONCLUSIONS: An antithrombotic regimen consisting of apixaban and a P2Y12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.

12.
Arch Cardiovasc Dis ; 112(8-9): 532-542, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31378692

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/prevenção & controle , Cateterismo Cardíaco/normas , Cardiologia/normas , Forame Oval Patente/terapia , Prevenção Secundária/normas , Acidente Vascular Cerebral/prevenção & controle , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/epidemiologia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Consenso , Feminino , Forame Oval Patente/diagnóstico , Forame Oval Patente/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Medição de Risco , Fatores de Risco , Dispositivo para Oclusão Septal/normas , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Resultado do Tratamento , Adulto Jovem
14.
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
15.
Clin Res Cardiol ; 108(7): 772-778, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30564950

RESUMO

INTRODUCTION: Symptoms and functional limitation are frequently reported by survivors of acute pulmonary embolism (PE). However, current guidelines provide no specific recommendations on which patients should be followed after acute PE, when follow-up should be performed, and which tests it should include. Definition and classification of late PE sequelae are evolving, and their predictors remain to be determined. METHODS: In a post hoc analysis of the Pulmonary Embolism Thrombolysis (PEITHO) trial, we focused on 219 survivors of acute intermediate-risk PE with clinical and echocardiographic follow-up 6 months after randomisation as well as over the long term (median, 3 years after acute PE). The primary outcome was a composite of (1) confirmed chronic thromboembolic pulmonary hypertension (CTEPH) or (2) 'post-PE impairment' (PPEI), defined by echocardiographic findings indicating an intermediate or high probability of pulmonary hypertension along with New York Heart Association functional class II-IV. RESULTS: Confirmed CTEPH or PPEI occurred in 29 (13.2%) patients, (6 with CTEPH and 23 with PPEI). A history of chronic heart failure at baseline and incomplete or absent recovery of echocardiographic parameters at 6 months predicted CTEPH or PPEI at long-term follow-up. CONCLUSIONS: CTEPH or PPEI occurs in almost one out of seven patients after acute intermediate-risk PE. Six-month echocardiographic follow-up may be useful for timely detection of late sequelae.


Assuntos
Ecocardiografia/métodos , Ventrículos do Coração/diagnóstico por imagem , Embolia Pulmonar/diagnóstico , Recuperação de Função Fisiológica , Tenecteplase/uso terapêutico , Terapia Trombolítica/métodos , Função Ventricular Direita/fisiologia , Doença Aguda , Progressão da Doença , Feminino , Fibrinolíticos/uso terapêutico , Seguimentos , Ventrículos do Coração/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
16.
Thromb Res ; 174: 27-33, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30553162

RESUMO

BACKGROUND: Data regarding the use of direct oral anticoagulants (DOACs) for the treatment of acute pulmonary embolism (PE) are sparse. We conducted a prospective multicentre registry study to describe patterns of DOAC prescription for the treatment of acute PE, and the associated risk of 6-month adverse events in daily practice. METHODS: We included all PE patients discharged since the availability of DOACs for the dedicated indication of acute PE treatment. Clinical data and 6-month outcomes, including death, recurrent venous thromboembolism (VTE), bleeding, and chronic thromboembolic pulmonary hypertension (CTEPH) were recorded prospectively. Temporal trends in DOAC prescription were tested. RESULTS: Between 09/2012 and 04/2017, 1082 patients were included: 60.6% (n = 656) were treated with DOACs and 39.4% (n = 426) with another anticoagulant. The prescription rate of DOACs increased sharply just after their release on the market to reach a plateau over time, between 56% and 72% of the total prescription per year in PE patients (p for trend = 0.33). Active malignancy and renal function impairment were factors independently associated with non-prescription of DOACs. Overall, prescription of DOACs was appropriate in 95.3% of patients. The rate of use of non-recommended DOAC doses was 4.2% (n = 28). The rate of death, recurrent VTE, bleeding and CTEPH were 2.4%, 1.2%, 7.2%, and 1.9%, respectively in the DOAC group. CONCLUSION: The choice to prescribe DOACs or not is related to patient characteristics. The overall appropriateness of prescription is high, while the rate of adverse events observed in patients treated with DOAC is low in our registry.


Assuntos
Anticoagulantes/uso terapêutico , Embolia Pulmonar/tratamento farmacológico , Administração Oral , Idoso , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros
17.
Circulation ; 138(23): 2597-2607, 2018 12 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.


Assuntos
Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Falha de Equipamento , Feminino , Seguimentos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Hemodinâmica , Humanos , Masculino , Modelos de Riscos Proporcionais , Sistema de Registros , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento
18.
BMC Palliat Care ; 17(1): 112, 2018 Oct 05.
Artigo em Inglês | MEDLINE | ID: mdl-30290818

RESUMO

BACKGROUND: Professional societies call for integration of end-of-life discussions early in the trajectory of heart failure, yet it remains unclear where current practices stand in relation to these recommendations. We sought to describe the perceptions and attitudes of caregivers in cardiology regarding end-of-life situations. METHODS: We performed a qualitative study using semi-directive interviews in the cardiology department of a university teaching hospital in France. Physicians, nurses and nurses' aides working full-time in the department at the time of the study were eligible. Participants were asked to describe how they experienced end-of-life situations. Interviews were recorded, transcribed and coded using thematic analysis to identify major and secondary themes. RESULTS: All physicians (N = 16)(average age 43.5 ± 13 years), 16 nurses (average age 38.5 ± 7.6 years) and 5 nurses' aides (average age 49 ± 7.8 years) participated. Interviews were held between 30 March and 17 July 2017. The main themes to emerge from the physicians' discourse were the concept of cardiology being a very active discipline, and a very curative frame of mind was prevalent. Communication (with paramedical staff, patients and families) was deemed to be important. Advance directives were thought to be rare, and not especially useful. Nurses also reported communication as a major issue, but their form of communication is bounded by several factors (physicians' prior discourse, legislation). They commonly engage in reconciling: between the approach (curative or palliative) and the reality of the treatment prescribed; performing curative interventions in patients they deem to be dying cases causes them distress. The emergency context prevents nurses from taking the time necessary to engage in end-of-life discussions. They engage in comfort-giving behaviors to maximize patient comfort. CONCLUSION: Current perceptions and practices vis-à-vis end-of-life situations in our department are individual, heterogeneous and not yet aligned with recommendations of professional societies.


Assuntos
Atitude do Pessoal de Saúde , Tomada de Decisão Clínica , Insuficiência Cardíaca , Médicos Hospitalares/psicologia , Recursos Humanos de Enfermagem no Hospital/psicologia , Cuidados Paliativos , Assistência Terminal , Adulto , Diretivas Antecipadas/psicologia , Serviço Hospitalar de Cardiologia , Tomada de Decisão Clínica/ética , Tomada de Decisão Clínica/métodos , Progressão da Doença , Feminino , França , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/psicologia , Insuficiência Cardíaca/terapia , Humanos , Comunicação Interdisciplinar , Masculino , Pessoa de Meia-Idade , Cuidados Paliativos/ética , Cuidados Paliativos/psicologia , Relações Profissional-Família , Relações Profissional-Paciente , Pesquisa Qualitativa , Assistência Terminal/ética , Assistência Terminal/métodos , Assistência Terminal/psicologia
19.
Presse Med ; 47(9): 784-791, 2018 Sep.
Artigo em Francês | MEDLINE | ID: mdl-30213470

RESUMO

The therapeutic strategy of acute pulmonary embolism (PE) is based on risk stratification of early mortality in the emergency department. Anticoagulant therapy should be given to all PE patients as early as possible, and direct oral anticoagulants are expected to replace vitamin K antagonists in the majority of cases. The use of a reperfusion strategy should always be considered in patients with high-risk PE defined as PE with clinical hemodynamic instability. Surgical or percutaneous embolectomy is an alternative in case of contraindication to thrombolytic therapy in these patients. Intermediate-risk PEs defined by a sPESI score of≥1 warrant hospitalization, and continuous care monitoring for patients presenting with elevated biomarkers and right ventricular dysfunction. Low risk PEs (sPESI=0) could be managed on an outpatient basis, provided that a care pathway had been defined beforehand.


Assuntos
Serviços Médicos de Emergência/normas , Serviço Hospitalar de Emergência , Guias de Prática Clínica como Assunto , Embolia Pulmonar/terapia , Doença Aguda , Serviço Hospitalar de Emergência/normas , Humanos , Padrões de Prática Médica/normas , Padrões de Prática Médica/estatística & dados numéricos , Embolia Pulmonar/epidemiologia , Embolia Pulmonar/patologia
20.
Exp Ther Med ; 16(2): 483-492, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30116307

RESUMO

The present study aimed to observe whether optical coherence tomography (OCT)-guided angioplasty is able to provide useful clinical information beyond that obtained by angiography as well as provide recommendations for physicians that may improve treatment selection. This prospective study included 83 patients with coronary artery disease (>18 years) undergoing coronary angiography (CAG) for ST-elevation myocardial infarction (n=13), non-ST-elevation myocardial infarction (n=19), stable angina (n=22), unstable angina (n=10), silent ischemia (n=11), or elective percutaneous coronary intervention (n=8). Following the initial CAG (CAG-pre), the patients underwent OCT before angioplasty (OCT-pre, 24 patients), after angioplasty (OCT-post, 22 patients), or both (37 patients). The thrombus burden, calcification and plaque dissection or rupture were compared between the OCT-pre and CAG-pre recordings. Following angioplasty, stent malapposition, suboptimal stent deployment, suboptimal stent lesion coverage, and edge dissection were compared between OCT-post and CAG-post alone. Among the 83 patients, 45.7% had single-vessel and 54.3% had multiple-vessel disease. OCT pre- and post-angioplasty revealed significantly more information on the procedure than CAG alone. This clinical information changed the clinical strategies in 41/83 (49.4%) patients, including 58 modifications of therapeutic strategy (69.9%, 58/83): Thrombus aspiration in 2 cases (2.4%), administration of glycoprotein IIb/IIIa inhibitors in 8 cases (9.6%), additional balloon inflation in 23 cases (27.7%), additional stent implantation in 17 cases (20.5%), avoiding stent implantation in 4 cases (4.8%), collateral intervention in 2 cases (2.4%), and guidewire reposition in 2 cases (2.4%). In conclusion, OCT-pre and OCT-post provided additional clinical information beyond that obtained by angiography alone, which resulted in modification of the treatment strategies in half of the included patients.

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