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OBJECTIVE: To assess the accuracy of "diabetes overtreatment" proxy definitions in predicting hypoglycemia in older adults with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: Inclusion of patients from HYPOAGE cohort with insulin-treated T2D, aged ≥75 years, and using a continuous glycemic monitoring (CGM) device for 28 days. "Diabetes overtreatment" was defined as HbA1c < 7.0% (fixed proxy definition) or as HbA1c < 7.0%, 7.5% and 8.0% according to patient's health status (individualized proxy definition). The primary outcome was time below range (TBR) ≥ 1%. RESULTS: Of the 134 patients included (81.6 ± 5.4 years, 59% male), 25 (19%) and 53 (40%) were overtreated, based on fixed and individualized proxy definitions, respectively. CGM data showed TBR >1% in nearly all patients regardless of overtreatment status. Both proxy definitions had low sensitivity (20% [14%; 29%] and 41% [32%; 50%]) and accuracy (27% [20%; 35%] and 44% [35%; 53%]) in predicting hypoglycemia. CONCLUSIONS: A revised definition of diabetes overtreatment is needed to better manage older insulin-treated patients and protect them from hypoglycemia.
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BACKGROUND: Arrhythmogenic left ventricular cardiomyopathy (ALVC) is characterized by fibrofatty myocardial replacement demonstrated on cardiac magnetic resonance by late gadolinium enhancement (LGE) mainly involving the subepicardium. The aims of this study were to describe the layer-specific strain (LSS) echocardiography phenotype of ALVC and to compare it with LGE features. METHODS: All consecutive ALVC pathogenic genetic variant carriers and noncarrier relatives were separated into four prespecified groups (overt ALVC [group 1], isolated LGE [group 2], pathogenic genetic variant carrier without ALVC phenotype [group 3], and no genetic variant carrier [group 4]) and studied accordingly using cardiac magnetic resonance and LSS echocardiography. RESULTS: Eighty-five individuals were included. Endocardial global longitudinal strain (GLS)-epicardial GLS (GLSepi) gradient was altered predominantly in group 1, illustrating transmural strain alteration in overt ALVC (3.8 ± 1.1 in group 1, 4.3 ± 2.2 in group 2, 5.2 ± 1.2 in group 3, and 5.4 ± 1.6 in group 4; P = .0017), whereas GLSepi was impaired predominantly in group 2 (endocardial GLS and GLSepi were 15.0 ± 4.1% and 11.2 ± 3.3%, respectively, in group 1; 20.5 ± 2.8% and 16.2 ± 5.5% in group 2; 23.4 ± 3.3% and 18.2 ± 2.7% in group 3; and 24.6 ± 2.8% and 19.2 ± 1.9% in group 4; P < .0001 for all). GLSepi was able to detect subepicardial LGE in genetic variant carriers without overt ALVC with an area under curve of 0.84 (95% CI, 0.73-0.95). However, segmental epicardial and endocardial strain behaved similarly and showed comparable diagnostic values for segmental LGE detection (areas under the curve, 0.72; [95% CI, 0.69-0.76] and 0.73 [95% CI, 0.70-0.76], respectively, P = .40). CONCLUSIONS: LSS alteration in ALVC progresses from the epicardium to the endocardium along with disease severity. Irrespective of LSS analysis, which did not provide incremental diagnostic value for the detection and localization of LGE, strain echocardiography was shown to be a potential surrogate marker of LGE, including in apparently healthy individuals with isolated LV fibrosis.
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BACKGROUND: More and more patients have obesity-hypoventilation syndrome (OHS) because of the increasing prevalence of obesity. The accuracy of transcutaneous PCO2 (PtcCO2 ) has recently been validated. However, no study evaluated the interest of measuring systematically nocturnal PtcCO2 in the follow-up of patients with OHS and home mechanical ventilation to detect residual nocturnal hypoventilation. We aimed to evaluate the contribution of nocturnal PtcCO2 to assess nocturnal hypoventilation compared with current routine examinations, that is, daytime arterial blood gases and nocturnal pulse oximetry. METHODS: A prospective monocentric pilot study was conducted from August 2018 to November 2019. Patients with stable OHS and who were treated with home noninvasive ventilation for at least 6 months were eligible to participate. After oral consent, we performed both diurnal arterial blood gases and combined home oximetry and capnography. The primary end point was the presence of residual nocturnal hypoventilation, defined as PaCO2 > 45 mm Hg or bicarbonate ≥ 27 mmol/L, SpO2 < 90% for ≥ 10% of the night, or PtcCO2 > 49 mm Hg for ≥ 10% of the night. RESULTS: A total of 32 subjects were included. Twenty-nine subjects with nocturnal PtcCO2 were analyzed. Eighteen of the 29 subjects showed residual nocturnal hypoventilation. The association of diurnal arterial blood gases and nocturnal pulse oximetry revealed nocturnal hypoventilation in only 9 subjects. Among the 19 subjects with both normal blood gases and normal nocturnal pulse oximetry, 11 had nocturnal hypoventilation with transcutaneous capnography. Only one subject presented with hypoventilation symptoms (asthenia). CONCLUSIONS: The assessment of PtcCO2 in comparison with nocturnal pulse oximetry and arterial blood gases provides important information for the diagnosis of residual nocturnal hypoventilation in the subjects with OHS who were ventilated at home.
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BACKGROUND: Long-term outcomes after acute type A aortic dissection (ATAAD) are related to remodelling of the descending thoracic aorta and aortic reinterventions. We compared the impact of an extensive repair at the index procedure using the Frozen Elephant Trunk (FET) technique, versus a conventional arch repair, on long-term remodelling of the descending thoracic and reintervention related to the aorta. METHODS: Consecutive patients who underwent conventional arch repair (conventional group) or FET repair (FET group) for an ATAAD from September 2018 to November 2021 were included. Patients who died before discharge or were lost to follow-up prior to the first appointment were excluded from the analysis. Preoperative and postoperative computed tomography angiography was reconstructed and diameter of the true/false lumen of the remaining aorta was compared up to 1 year. Negative (increased total diameter ≥ 5 mm) aortic remodelling was collected for each computed tomography angiography, as well as aortic reinterventions. Comparison of demographic, anatomical, and perioperative complications data were performed using Wilcoxon test for continuous variables or Chi-square test for categorical covariates. The Kaplan-Meier method estimator was used to assess survival rates. The Log rank test was used to compare survival curves between the 2 groups. RESULTS: Thirty nine patients were included, 22 in the conventional group and 17 in the FET group (82% males, mean age 60 ± 12 years). In the FET group, distal anastomosis was performed in zone 0 or 1 for 82% of patients using the simplified delivery technique. Median maximum preoperative descending aortic diameter was larger in the FET group (33 mm [30; 37] vs. 30 mm [28; 32] [P = 0.0172]). At 30 days, the rate of negative remodelling on the descending thoracic aorta was significantly higher in the conventional group (50%) than in the FET group (8%, P = 0.02). At 1 year, Kaplan-Meier analysis shown a freedom from descending aortic negative remodeling of 35.1% (95% confidence interval (CI) 18.7-66.1%) in conventional group and 44.9% (CI 95% 26.1-77.2%) in FET group with no significant difference. However, early negative remodelling was observed for the conventional group. Within a year, freedom from reintervention was observed for 74.4% (95% CI 57.1-97%) of patients in the conventional group and 75.5 (95% CI 57.1-99.7%) of patients in the FET group with no significant difference. CONCLUSIONS: Negative evolution of descending aorta remains a challenge after ATAAD. An extensive repair using the FET technique during the index procedure seems to be associated with satisfying short-term remodelling of descending aorta.
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Aneurisma da Aorta Torácica , Dissecção Aórtica , Implante de Prótese Vascular , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Feminino , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Resultado do Tratamento , Estudos Retrospectivos , Aorta/cirurgia , Dissecção Aórtica/diagnóstico por imagem , Dissecção Aórtica/cirurgiaRESUMO
BACKGROUND: There is a lack of real-life data regarding the frequency and predictive factors of hypoglycemia in older patients with type 2 diabetes (T2D). This study aimed to determine the frequency and predictors of hypoglycemia in older patients with insulin-treated T2D. METHODS: This prospective multicenter study included 155 insulin-treated T2D patients aged 75 years and older with ≥2 self-monitoring of blood glucose (SMBG) daily controls. Participants underwent a geriatric and diabetic assessment and received ambulatory blinded continuous glucose monitoring (CGM) for 28 consecutive days with FreeStyle Libre Pro® sensor. Study population (n = 141) has >70% CGM active time. Multivariable logistic regressions were used to identify factors associated with SMBG confirmed hypoglycemia (≥70 mg/dL) and with nocturnal level 2 time below range (glucose concentration <54 mg/dL during ≥15 consecutive min between 0.00 and 6.00 am). RESULTS: The mean age of the 141 analyzed patients was 81.5 ± 5.3 years and 56.7% were male. The mean baseline HbA1c was 7.9% ± 1.0%. After geriatric assessment, 102 participants (72.3%) were considered as complex and 39 (27.7%) as healthy. The primary endpoint (confirmed SMBG <70 mg/dL) occurred in 37.6% patients. In multivariable analysis, the risk of SMBG-confirmed hypoglycemia was positively associated with a longer duration of diabetes (OR (+1 year) =1.04, (1.00-1.08), p = 0.04) and glycemic variability assessed by CGM (CV %) (OR (+1%) = 1.12, [1.05-1.19], p = <0.001). Nighty-two patients (65.2%) experienced nocturnal time in hypoglycemia (i.e., <54 mg/dL during ≥15 consecutive min between midnight and 6 a.m.). In multivariable analyses, cognitive impairment (OR: 9.31 [2.59-33.4]), heart failure (OR: 4.81 [1;48-15.6]), and depressive disorder (OR: 0.19 [0.06-0.53]) were associated with nocturnal time in hypoglycemia. CONCLUSION: Nocturnal hypoglycemia is very common and largely underdiagnosed in older patients with insulin-treated T2D. CGM is a promising tool to better identify hypoglycemia and adapt diabetes management in this population.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Hipoglicemia , Humanos , Masculino , Idoso , Idoso de 80 Anos ou mais , Feminino , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Insulina/efeitos adversos , Glicemia/análise , Automonitorização da Glicemia , Estudos Prospectivos , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemiantes/efeitos adversosRESUMO
PURPOSE: Radiation exposure for vascular interventionalists is still a concern. The aim of this study was to assess the value of advanced imaging guidance on radiation exposure and iodinated contrast volume during endovascular treatment of lower extremity arterial disease (LEAD). MATERIALS AND METHODS: It was a prospective, randomized, monocentric, pilot, single-operator study, conducted from June 2018 to October 2019. Consecutive patients requiring a preoperative computed tomography angiography (CTA) for a symptomatic LEAD and scheduled for an iliac and/or femoropopliteal endovascular repair in a hybrid room were included. Patients were randomly assigned to the use of fusion imaging guidance (Vessel Navigator®, Philips) or not. The primary endpoint was the dose area product (DAP, Gy.cm²). Secondary endpoints were DAP for fluoroscopy, DAP for fluorography, Air Kerma, fluoroscopy time, volume of contrast, and number of digital subtraction angiography (DSA). Data were expressed in median [Q1-Q3]. RESULTS: In all, 64 of the 77 patients enrolled (34 in fusion group, 30 in control group, 82% men, 65.8 years [61-71]) were included. Groups were similar in terms of comorbidities, BMI (26 kg/cm2 [24-28]), but lesion location were not equally distributed (p=0.004). There was no significant difference between the groups regarding DAP (31.6 Gy.cm2 [23.4; 46.9] for fusion group vs 25.6[16.9; 34.0] Gy.cm2; p=0.07), Air Kerma (160 mGy [96;3365] vs 115 mGy [76;201]; p=0.12, fluoroscopy time (560 seconds [326;960] vs 454 seconds [228;1022]; p=0.44), contrast volume (60 ml [42;80] vs 50 ml [40;66]; p=0.10), or operative time (68 minutes [55;90] vs 46 minutes [30;80]; p=0.06). The median number of DSA was 14 [10-18] in the fusion group versus 11 [6-18]; p=0.049. CONCLUSION: Fusion imaging guidance does not affect radiation exposure and contrast volume during endovascular revascularisation of iliac and femoropopliteal occlusive disease in a hybrid room environment.
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Cardiomiopatias , Miocardite , Cardiomiopatias/diagnóstico por imagem , Cardiomiopatias/etiologia , Fluordesoxiglucose F18 , Humanos , Inflamação/diagnóstico por imagem , Miocardite/diagnóstico por imagem , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Tomografia por Emissão de Pósitrons/métodos , Compostos RadiofarmacêuticosRESUMO
OBJECTIVE: This study assessed the impact of a history of metabolic and bariatric surgery (MBS) on the clinical outcomes in patients with type 2 diabetes (T2D) and severe obesity hospitalized for COVID-19. METHODS: In this post hoc analysis from the nationwide observational CORONADO (Coronavirus SARS-CoV2 and Diabetes Outcomes) study, patients with T2D and a history of MBS were matched with patients without MBS for age, sex, and BMI either at the time of MBS or on admission for COVID-19. The composite primary outcome (CPO) combined invasive mechanical ventilation and/or death within 7 and 28 days following admission. RESULTS: Out of 2,398 CORONADO participants, 20 had a history of MBS. When matching for BMI at the time of MBS and after adjustment for diabetes duration, the CPO occurred less frequently within 7 days (3 vs. 17 events, OR: 0.15 [0.01 to 0.94], p = 0.03) and 28 days (3 vs. 19 events, OR: 0.11 [0.01 to 0.71], p = 0.02) in patients with MBS (n = 16) vs. controls (n = 44). There was no difference in CPO rate between patients with MBS and controls when matching for BMI on admission. CONCLUSIONS: These data are reassuring regarding COVID-19 prognosis in patients with diabetes and a history of MBS compared with those without MBS.
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Cirurgia Bariátrica , COVID-19 , Diabetes Mellitus Tipo 2 , Humanos , RNA Viral , Estudos Retrospectivos , SARS-CoV-2RESUMO
OBJECTIVE: Male sex is one of the determinants of severe coronavirus diseas-e-2019 (COVID-19). We aimed to characterize sex differences in severe outcomes in adults with diabetes hospitalized for COVID-19. METHODS: We performed a sex-stratified analysis of clinical and biological features and outcomes (i.e. invasive mechanical ventilation (IMV), death, intensive care unit (ICU) admission and home discharge at day 7 (D7) or day 28 (D28)) in 2380 patients with diabetes hospitalized for COVID-19 and included in the nationwide CORONADO observational study (NCT04324736). RESULTS: The study population was predominantly male (63.5%). After multiple adjustments, female sex was negatively associated with the primary outcome (IMV and/or death, OR: 0.66 (0.49-0.88)), death (OR: 0.49 (0.30-0.79)) and ICU admission (OR: 0.57 (0.43-0.77)) at D7 but only with ICU admission (OR: 0.58 (0.43-0.77)) at D28. Older age and a history of microvascular complications were predictors of death at D28 in both sexes, while chronic obstructive pulmonary disease (COPD) was predictive of death in women only. At admission, C-reactive protein (CRP), aspartate amino transferase (AST) and estimated glomerular filtration rate (eGFR), according to the CKD-EPI formula predicted death in both sexes. Lymphocytopenia was an independent predictor of death in women only, while thrombocytopenia and elevated plasma glucose concentration were predictors of death in men only. CONCLUSIONS: In patients with diabetes admitted for COVID-19, female sex was associated with lower incidence of early severe outcomes, but did not influence the overall in-hospital mortality, suggesting that diabetes mitigates the female protection from COVID-19 severity. Sex-associated biological determinants may be useful to optimize COVID-19 prevention and management in women and men.
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COVID-19/diagnóstico , COVID-19/epidemiologia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/epidemiologia , Caracteres Sexuais , Idoso , Idoso de 80 Anos ou mais , COVID-19/complicações , COVID-19/terapia , Complicações do Diabetes/diagnóstico , Complicações do Diabetes/epidemiologia , Feminino , França/epidemiologia , Mortalidade Hospitalar , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Pacientes Internados , Unidades de Terapia Intensiva/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Prognóstico , Respiração Artificial/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , SARS-CoV-2/fisiologia , Índice de Gravidade de DoençaRESUMO
BACKGROUND: Upper extremity venous thrombosis (UEVT) represents about 10% of venous thrombo-embolic disease. This is mainly explained by the increasing use of central venous line, for oncologic or nutritional care. The factors associated with venous recanalization are not known. OBJECTIVE: The aim of this study was to investigate prognosis factor associated with venous recanalization after UEVT. METHODS: This study included patients with UEVT diagnosed with duplex ultra-sonography (DUS) from January 2015 to December 2017 with DUS evaluations during follow-up. A multivariate Cox proportional-hazards-model analysis was performed to identify predictive factors of UEVT complete recanalization. RESULTS: This study included 494 UEVT, 304 proximal UEVT and 190 distal UEVT. The median age was 58 years, 39.5% were women. Clinical context was: hematological malignancy (40.7%), solid cancer (14.2%), infectious or inflammatory context (49.9%) and presence of venous catheters or pacemaker leads in 86.4%. The rate of recanalization without sequelae of UEVT was 38%. For all UEVT, in multivariate analysis, factors associated with complete vein recanalization were: thrombosis associated with central venous catheter (CVC) (HR:2.40, [1.45;3.95], p<0.001), UEVT limited to a venous segment (HR:1.94, [1.26;3.00], p = 0.003), occlusive thrombosis (HR:0.48 [0.34;0.67], p<0.0001), the presence of a PICC Line (HR:2.29, [1.48;3.52], p<0.001), a thrombosis of deep and distal topography (HR:1.70, [1.10;2.63], p = 0.02) or superficial thrombosis of the forearm (HR:2.79, [1.52;5.12], p<0.001). For deep and proximal UEVT, non-occlusive UEVT (HR:2.23, [1.49;3.33], p<0.0001), thrombosis associated with CVC (HR:1.58, [1.01;2.47], p = 0.04) and infectious or inflammatory context (HR:1.63, [1.10;2.41], p = 0.01) were factors associated with complete vein recanalization. CONCLUSION: In this study, factors associated with UEVT recanalization were UEVT limited to a venous segment, thrombosis associated with CVC, a thrombosis of deep and distal thrombosis topography and superficial thrombosis of the forearm. Occlusive thrombosis was associated with the absence of UEVT recanalization.
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Cateterismo Venoso Central/efeitos adversos , Extremidade Superior/irrigação sanguínea , Trombose Venosa/fisiopatologia , Adulto , Idoso , Cateterismo Venoso Central/métodos , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/métodos , Cateteres de Demora/efeitos adversos , Cateteres Venosos Centrais , Feminino , França , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Prognóstico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Trombose , Veias , Trombose Venosa/metabolismo , Trombose Venosa/terapiaRESUMO
BACKGROUND: Beta-blocker therapy is the cornerstone of treatment for patients with long QT syndrome (LQTS). Few details on the dose to be used are available. As the response is variable between patients, we systematically evaluated the effect of treatment by performing an exercise test. OBJECTIVE: The purpose of this study was to explore dose response to nadolol on exercise test in LQTS patients in order to propose a more personalized therapeutic approach. METHODS: LQTS patients followed at the Reference Centre for Hereditary Arrhythmic Diseases of Nantes with at least 1 exercise test under nadolol were included retrospectively between 1993 and 2017. All patients underwent gradual cycle exercise tests. Doses adjusted to weight and response to treatment were recorded and evaluated by the percentage of age-predicted maximum heart rate reached on exercise test. RESULTS: Ninety-five patients were included in the study, and 337 stress tests under nadolol were analyzed. No correlation existed between dose and percentage of age-predicted maximum heart rate on exercise tests. Twenty-one patients were overresponders, mostly LQTS1, and 20 were underresponders, mainly LQTS2 (P = .0229). Forty-two patients had at least 3 stress tests under nadolol. We found a negative correlation between dose change and percentage of age-predicted maximum heart rate change (P <.0001). We then proposed a table to adapt dose according to exercise test response. CONCLUSION: Our study demonstrated a major variability of dose response to nadolol in patients with LQTS, thus underlining the need for a tailored dosage for each patient. Intraindividual analysis showed a relatively constant dose-response relationship, allowing guided dose adaptation after the first exercise test.
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Adaptação Fisiológica/fisiologia , Eletrocardiografia/efeitos dos fármacos , Frequência Cardíaca/fisiologia , Síndrome do QT Longo/tratamento farmacológico , Nadolol/administração & dosagem , Adolescente , Adulto , Antiarrítmicos/administração & dosagem , Criança , Pré-Escolar , Relação Dose-Resposta a Droga , Teste de Esforço , Feminino , Seguimentos , Humanos , Lactente , Injeções Intravenosas , Síndrome do QT Longo/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto JovemRESUMO
BACKGROUND: Giant cell arteritis (GCA) is frequently associated with aortic involvement that is likely to cause life-threatening structural complications (aneurysm, dissection). Few studies have investigated the occurrence of these complications, and no predictive factor has been identified so far. The aim of this study was to investigate factors associated with the risk of aortic complications in a cohort of GCA aortitis. METHODS: Data of all patients managed with aortitis (CT or 18 FDG PET) at the diagnosis of GCA in five hospitals from May 1998 and April 2019 were retrospectively collected. Clinical features were compared according to the presence of aortitis symptoms. The predictive factors of occurrence or aggravation of aortic structural abnormalities were investigated. RESULTS: One hundred and seventy-one patients with GCA aortitis were included; 55 patients (32%) had symptoms of aortitis (dorsal/lumbar/abdominal pain, aortic insufficiency) at diagnosis. The median follow-up was 38 months. Aortic complications occurred after a median time of 32 months. There were 19 new aortic aneurysms or complications of aneurysm and 5 dissections. Survival without aortic complication was significantly different between the symptomatic and non-symptomatic groups (Log rank, p = 0.0003). In multivariate analysis the presence of aortitis symptoms at diagnosis (HR 6.64 [1.95, 22.6] p = 0.002) and GCA relapse (HR 3.62 [1.2, 10.9] p = 0.02) were factors associated with the occurrence of aortic complications. CONCLUSION: In this study, the presence of aortitis symptoms at the diagnosis of GCA aortitis and GCA relapse were independent predictive factors of occurrence of aortic complications during follow-up.
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Aortite , Arterite de Células Gigantes , Aorta , Aortite/diagnóstico por imagem , Aortite/epidemiologia , Arterite de Células Gigantes/complicações , Arterite de Células Gigantes/diagnóstico , Humanos , Prognóstico , Estudos RetrospectivosRESUMO
AIMS: Risk stratification of sudden cardiac arrest (SCA) in Brugada syndrome (Brs) remains the main challenge for physicians. Several scores have been suggested to improve risk stratification but never replicated. We aim to investigate the accuracy of the Brs risk scores. METHODS AND RESULTS: A total of 1613 patients [mean age 45 ± 15 years, 69% male, 323 (20%) symptomatic] were prospectively enrolled from 1993 to 2016 in a multicentric database. All data described in the risk score were double reviewed for the study. Among them, all patients were evaluated with Shanghai score and 461 (29%) with Sieira score. After a mean follow-up of 6.5 ± 4.7 years, an arrhythmic event occurred in 75 (5%) patients including 16 SCA, 11 symptomatic ventricular arrhythmia, and 48 appropriate therapies. Predictive capacity of the Shanghai score (n = 1613) and the Sieira (n = 461) score was, respectively, estimated by an area under the curve of 0.73 (0.67-0.79) and 0.71 (0.61-0.81). Considering Sieira score, the event rate at 10 years was significantly higher with a score of 5 (26.4%) than with a score of 0 (0.9%) or 1 (1.1%) (P < 0.01). No statistical difference was found in intermediate-risk patients (score 2-4). The Shanghai score does not allow to better stratify the risk of SCA. CONCLUSIONS: In the largest cohort of Brs patient ever described, risk scores do not allow stratifying the risk of arrhythmic event in intermediate-risk patient.
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Síndrome de Brugada , Desfibriladores Implantáveis , Adulto , Síndrome de Brugada/complicações , China , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Eletrocardiografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição de RiscoRESUMO
BACKGROUND: The recently recommended single lead-based criterion for the diagnosis of Brugada syndrome may lead to overdiagnosis of this disorder and overestimation of the risk of sudden cardiac death. AIM: To investigate the value of a single-lead diagnosis in patients with Brugada syndrome and a spontaneous type 1 electrocardiogram. METHODS: Consecutive patients with Brugada syndrome were included in a multicentre prospective registry; only those with a spontaneous type 1 electrocardiogram were enrolled. Clinical and electrocardiogram data were reviewed by two physicians blinded to the patients' clinical and genetic status. RESULTS: Among 1613 patients, 505 (31%) were enrolled (79% male; mean age 46±15 years). A spontaneous type 1 electrocardiogram pattern was found in one lead in 250 patients (group 1), in two leads in 227 patients (group 2) and in three leads in 27 patients (group 3). Groups were similar except for individuals in group 3, who presented more frequently a fragmented QRS complex, an early repolarization pattern and a prolonged Tpeak-Tend interval. After a mean follow-up of 6.4±4.7 years, ventricular arrhythmia, sudden cardiac death or implantable cardiac defibrillator shock occurred in 46 (9%) patients, without differences between groups. CONCLUSION: The prognosis of Brugada syndrome with a spontaneous type 1 electrocardiogram pattern does not appear to be affected by the number of leads required for the diagnosis.
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Síndrome de Brugada/diagnóstico , Eletrocardiografia/instrumentação , Frequência Cardíaca , Potenciais de Ação , Adulto , Idoso , Síndrome de Brugada/mortalidade , Síndrome de Brugada/fisiopatologia , Síndrome de Brugada/terapia , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Cardioversão Elétrica/instrumentação , Feminino , França , Frequência Cardíaca/genética , Humanos , Masculino , Pessoa de Meia-Idade , Mutação , Canal de Sódio Disparado por Voltagem NAV1.5/genética , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Sistema de Registros , Reprodutibilidade dos Testes , Fatores de Risco , Fatores de TempoRESUMO
BACKGROUND: Despite a strong genetic background, Brugada syndrome (BrS) mainly affects middle-age patients. Data are scarce in the youngest and oldest age groups. OBJECTIVE: The purpose of this study was to describe the clinical characteristics and variations in rhythmic risk in BrS patients according to age. METHODS: Consecutive BrS patients diagnosed in 15 French tertiary centers in France were enrolled from 1993 to 2016 and followed up prospectively. All of the clinical and ECG data were double reviewed. RESULTS: Among the 1613 patients enrolled (age 45 ± 15 years; 69% male), 3 groups were defined according to age (52 patients <17 years; 1285 between 17 and 59 years; and 276 >60 years). In the youngest patients, we identified more female gender (42%), diagnosis by familial screening (63%), previous sudden cardiac death (15%), SCN5A mutation (62%) sinus dysfunction (8%) and aVR sign (37%) (P <.001). The oldest patients had the same clinical characteristics except for gender (40% women; P <.001). During median follow-up of 5.5 [2.1, 10.0] years, 91 patients experienced an arrhythmic event, including 7 (13%) in the youngest patients, 80 (6%) in middle-age patients, and 4 (1%) in the oldest patients. Annual event rates were 2.1%, 1%, and 0.3%, respectively (P <.01). CONCLUSION: Age on diagnosis changes the clinical presentation of BrS. Although children are identified more during familial screening, they present the highest risk of sudden cardiac death, which is an argument for early and extensive familial screening. The oldest patients present the lowest risk of SCD.
Assuntos
Síndrome de Brugada/diagnóstico , Morte Súbita Cardíaca/epidemiologia , Desfibriladores Implantáveis , Eletrocardiografia/métodos , Medição de Risco/métodos , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Síndrome de Brugada/epidemiologia , Síndrome de Brugada/fisiopatologia , Morte Súbita Cardíaca/prevenção & controle , Feminino , Seguimentos , França/epidemiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Adulto JovemRESUMO
BACKGROUND: Vascular calcifications are associated with a high cardiovascular morbi-mortality in the coronary territory. In parallel, femoral arteries are more calcified and develop osteoid metaplasia (OM). This study was conducted to assess the predictive value of OM and local inflammation on the occurrence of mid- and long-term adverse cardiovascular events. METHOD: Between 2008 and 2015, 86 atheromatous samples were harvested during femoral endarterectomy on 81 patients and processed for histomorphological analyses of calcifications and inflammation (monocytes and B cells). Histological findings were compared with the long-term follow-up of patients, including major adverse cardiac event (MACE), major adverse limb event (MALE), and mortality. Frequencies were presented as percentage, and continuous data, as mean and standard deviation. A P-value < 0.05 was considered statistically significant. RESULTS: Median follow-up was 42.4 months (26.9-58.8). Twenty-eight percent of patients underwent a MACE; a MALE occurred in 18 (21%) limbs. Survival rate was 87.2% at 36 months. OM was found in 41 samples (51%), without any significant impact on the occurrence of MACE, MALE, or mortality. Preoperative white blood cell formulae revealed a higher rate of neutrophils associated with MACE (P = 0.04) and MALE (P = 0.0008), correlated with higher B cells counts in plaque samples. CONCLUSIONS: OM is part of femoral calcifications in almost 50% of the cases but does not seem to be an independent predictive variable for MACE or MALE. However, a higher rate of B cell infiltration of the plaque and preoperative neutrophil blood count may be predictive of adverse events during follow-up.
Assuntos
Artéria Femoral/patologia , Ossificação Heterotópica , Doença Arterial Periférica/patologia , Calcificação Vascular/patologia , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Linfócitos B/imunologia , Linfócitos B/patologia , Progressão da Doença , Endarterectomia , Feminino , Artéria Femoral/imunologia , Artéria Femoral/cirurgia , França/epidemiologia , Humanos , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Neutrófilos/imunologia , Neutrófilos/patologia , Doença Arterial Periférica/imunologia , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/cirurgia , Placa Aterosclerótica , Reoperação , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Calcificação Vascular/imunologia , Calcificação Vascular/mortalidade , Calcificação Vascular/cirurgiaRESUMO
AIMS: Percutaneous mitral valve repair has become an alternative to conventional surgery in patients suffering primary mitral regurgitation (MR) with a contraindication to surgery and could benefit patients at high surgical risk. The aim of the MITRA-HR study is to raise the level of evidence supporting the use of the MitraClip device in primary MR patients with a predefined high risk for surgery. METHODS AND RESULTS: MITRA-HR is a prospective, multicentre, randomised study designed to compare mitral valve repair using the MitraClip with conventional surgery in patients with severe primary mitral regurgitation at high risk for surgery. The surgical risk is defined by age, Society of Thoracic Surgeons (STS) risk estimate score, frailty, major organ system dysfunction, and procedure-specific impediments. The study will enrol 330 patients randomised between conventional surgery and MitraClip with a 1:1 ratio. The composite primary endpoint includes all-cause mortality, unplanned rehospitalisation for cardiovascular reasons, and mitral valve reintervention at 12 months. The main secondary safety endpoint is a major adverse event composite assessment evaluated 30 days after the procedure. CONCLUSIONS: The randomised MITRA-HR study is designed to provide additional supportive evidence of non-inferiority in efficacy and superiority in safety for percutaneous mitral valve repair using the MitraClip compared to conventional surgery in high surgical risk patients.
Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Valva Mitral , Insuficiência da Valva Mitral/cirurgia , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Although autogenous venous grafts are preferable for below-the-knee bypass surgery in patients with critical limb ischemia, some 20% of patients will have no suitable vein for grafting, compelling a resort to artificial graft materials. Retrospective subgroup analyses within published studies comparing heparin-bonded polytetrafluoroethylene (PTFE) with crude PFTE graft in below-the-knee bypass suggest that heparin-bonded graft offers superior long-term patency rates, but this has not been prospectively verified in patients with critical limb ischemia. METHODS: A single-blind randomized controlled trial in 20 French centers has been designed. Patients assessed as having no suitable autologous vein for bypass grafting for critical lower limb ischemia will be randomized to receive either a heparin-bonded PTFE graft or a crude PTFE graft. A literature review suggested expected 1-year patency rates of 53% for the crude ePTFE arm and 74% for the heparin-bonded PTFE arm. On analyzing 1-year patency rate as a binary variable, for a significance level α = 0.05 and a randomization ratio of 1:1, a total of 176 patients (88 in each arm) will be required to obtain approximately 80% power to reject the null hypothesis. Assuming 10% dropout at 1 year and 20% mortality, 228 patients will be randomized (114 patients in each arm). RESULTS: The primary outcome variable will be patency at 1 year assessed by duplex ultrasound color-flow scan. Any intervention to open up or prevent a graft occlusion before 1 year will be classified as loss of patency. Technical success, deaths, complications, major adverse cardiovascular and limb events, length of hospitalization, and quality of life will also be recorded and analyzed as secondary outcome variables. Cost-utility and cost-effectiveness analyses based on standard tariffs in the French health insurance system will be performed. CONCLUSIONS: The REPLACE trial is the first randomized controlled trial designed to determine if heparin-bonded PTFE graft is superior to crude PTFE graft in below-the-knee bypass surgery for critical limb ischemia.
Assuntos
Anticoagulantes/administração & dosagem , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Materiais Revestidos Biocompatíveis , Heparina/administração & dosagem , Isquemia/cirurgia , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/cirurgia , Politetrafluoretileno , Anticoagulantes/efeitos adversos , Implante de Prótese Vascular/efeitos adversos , França , Oclusão de Enxerto Vascular/diagnóstico por imagem , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/fisiopatologia , Heparina/efeitos adversos , Humanos , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Estudos Multicêntricos como Assunto , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
BACKGROUND: Studies in Brugada syndrome (BrS) have mainly consisted of men. OBJECTIVE: The purpose of this study was to describe the clinical characteristics and arrhythmic risk factors in BrS women. METHODS: Consecutive BrS patients were enrolled from 1993 and followed prospectively. RESULTS: Among 1613 patients, 494 were women (mean age 47 ± 16 years). Women were more frequently asymptomatic than men (423 [86%] vs 867 [77%], respectively; P = .001) and less frequently had a spontaneous ECG pattern (107 [22%] vs 398 [36%], respectively; P <.001). During median [25th, 75th percentile] follow-up of 57 [23, 118] vs 62 [22, 113] months (P = .65), arrhythmic events occurred in 12 women (2%) vs 79 men (7%) (P = .0005). Mean age at the first event was 48.6 ± 17.8 years for women vs 43 ± 14.2 years for men (P <.001). Gender was significantly related to cardiac events (hazard ratio [HR] 2.96; 95% confidence interval [CI] 1.6-5.4; P = .0005). In multivariate analysis, event predictors in women were index patient status (HR 10.15; 95% CI 1.7-61.4; P = .01), previous sudden cardiac death (HR 69.4; 95% CI 15-312.5; P <.0001), syncope (HR 6.8; 95% CI 1.4-34.5; P = .02), fragmented QRS (HR 20.2; 95% CI 1.8-228.9; P = .02), and QRS duration >120 ms (HR 4.7; 95% CI 1.2-19.5; P = .03). CONCLUSION: Women represent a lower-risk group than men among individuals with BrS. In asymptomatic women, fragmented QRS and QRS >120 ms seem to be the only event predictors.
Assuntos
Síndrome de Brugada/fisiopatologia , Morte Súbita Cardíaca/etiologia , Desfibriladores Implantáveis , Eletrocardiografia/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Síndrome de Brugada/complicações , Síndrome de Brugada/terapia , Criança , Pré-Escolar , Morte Súbita Cardíaca/epidemiologia , Feminino , Seguimentos , França/epidemiologia , Humanos , Incidência , Lactente , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo , Adulto JovemRESUMO
OBJECTIVES: The aim of this study was to describe and analyze data from patients treated in France with the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position. BACKGROUND: The Edwards SAPIEN valve has recently been introduced for percutaneous pulmonary valve implantation (PPVI). METHODS: From April 2011 to May 2017, 71 patients undergoing PPVI were consecutively included. RESULTS: The median age at PPVI was 26.8 years (range 12.8 to 70.1 years). Primary underlying diagnoses were conotruncal malformations (common arterial trunk, tetralogy of Fallot and variants; n = 45), Ross procedure (n = 18), and other diagnoses (n = 8). PPVI indication was pure stenosis in 33.8% of patients, pure regurgitation in 28.1%, and mixed lesions in 38.1%. PPVI was successfully implemented in 68 patients (95.8%). Pre-stenting of the right ventricular outflow tract was performed in 70 patients (98.6%). Early major complications occurred in 4 subjects (5.6%), including 1 death, 1 coronary compression, and 2 pulmonary valve embolizations. Three of the 4 major complications occurred in the first 15 operated patients. No significant regurgitation was recorded after the procedure. Transpulmonary gradient was significantly reduced from 34.5 to 10.5 mm Hg (p < 0.0001). No patient died during a 1-month follow-up period. At 1-year follow-up, the death rate was 2.9%, and 3 patients had undergone surgical reintervention (44%). CONCLUSIONS: Early results with the Edwards SAPIEN valve in the pulmonary position demonstrate an ongoing high rate of procedural success.