ABSTRACT
OBJECTIVES: We report on real-world safety and performance outcomes of minimally invasive rapid-deployment aortic valve replacement using the EDWARDS INTUITY Elite aortic valve system. METHODS: The study valve system was used in a European, prospective, multicentre post-market study. Various procedural, haemodynamic and clinical outcomes were evaluated through 6 months of post-implant. RESULTS: A total of 276 patients out of 280 (98.6%) enrolments were successfully implanted with the study valve using a minimally invasive approach between February 2016 and April 2017. Of these 276 patients, 240 (87%) underwent partial sternotomy and 36 (13%) patients underwent right thoracotomy. Mean cross-clamp time was 51.9 [standard deviation (SD): 16.0] min. From baseline to 6 months, the mean effective orifice area increased from 0.8 (SD: 0.3) to 1.8 (SD: 0.6) cm2 and the mean systolic gradient decreased from 46.0 (SD: 14.1) to 8.8 (SD: 3.7) mmHg. After 6 months, 70.7% and 26.4% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major paravalvular leak, reoperation and device explant at 6 months were 96.0%, 98.5%, 98.8%, 99.2% and 99.2%, respectively. CONCLUSIONS: These results demonstrate that the study valve is a safe and effective choice for patients undergoing aortic valve replacement via minimally invasive surgery. NAME AND REGISTRATION OF REGISTRY: MISSION (Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve System in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry). clinicaltrials.gov ID #NCT02907463.
Subject(s)
Aortic Valve Stenosis , Bioprosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation/methods , Humans , Minimally Invasive Surgical Procedures/methods , Prospective Studies , Prosthesis Design , Treatment OutcomeABSTRACT
BACKGROUND: Transplacentally transferred antibodies induced by maternal pertussis vaccination interfere with infant immune responses to pertussis primary vaccination. We evaluated whether this interference remains in toddlers after booster vaccination. METHODS: In a prior phase IV, observer-blind, placebo-controlled, randomized study (NCT02377349), pregnant women in Australia, Canada and Europe received intramuscular tetanus-reduced-antigen-content diphtheria-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) at 270/7-366/7 weeks' gestation, with crossover immunization postpartum. Their infants were primed (study NCT02422264) and boosted (at 11-18 months; current study NCT02853929) with diphtheria-tetanus-three-component acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b vaccine (DTaP-HepB-IPV/Hib) and 13-valent pneumococcal conjugate vaccine. Immunogenicity before and after booster vaccination, and reactogenicity and safety of the booster were evaluated descriptively. RESULTS: 263 (Tdap group) and 277 (control group) toddlers received a DTaP-HepB-IPV/Hib booster. Pre-booster vaccination, observed geometric mean concentrations (GMCs) for the three pertussis antigens and diphtheria were 1.4-1.5-fold higher in controls than in the Tdap group. No differences were observed for the other DTaP-HepB-IPV/Hib antigens. One month post-booster vaccination, booster response rates for pertussis antigens were ≥ 92.1% and seroprotection rates for the other DTaP-HepB-IPV/Hib antigens were ≥ 99.2% in both groups (primary objective). Higher post-booster GMCs were observed in controls versus the Tdap group for anti-filamentous hemagglutinin (1.2-fold), anti-pertussis toxoid (1.5-fold) and anti-diphtheria (1.4-fold). GMCs for the other DTaP-HepB-IPV/Hib antigens were similar between groups. Serious adverse events were reported for three toddlers (controls, not vaccination-related). One death occurred pre-booster (Tdap group, not vaccination-related). CONCLUSIONS: As a consequence of interference of maternal pertussis antibodies with infant immune responses to pertussis primary vaccination, pertussis antibody concentrations were still lower in toddlers from Tdap-vaccinated mothers before DTaP-HepB-IPV/Hib booster vaccination. After the booster, antibody concentrations were lower for filamentous hemagglutinin and pertussis toxoid but not for pertactin. The clinical significance of this interference requires further evaluation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02853929.
Subject(s)
Diphtheria-Tetanus-acellular Pertussis Vaccines , Diphtheria , Haemophilus Vaccines , Tetanus , Whooping Cough , Antibodies, Bacterial , Australia , Canada , Child, Preschool , Diphtheria/prevention & control , Diphtheria-Tetanus-Pertussis Vaccine , Europe , Female , Follow-Up Studies , Humans , Immunity , Immunization, Secondary , Infant , Poliovirus Vaccine, Inactivated , Pregnancy , Tetanus/prevention & control , Vaccination , Vaccines, Combined , Whooping Cough/prevention & controlABSTRACT
BACKGROUND: Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization. METHODS: This phase IV, multi-country, open-label study assessed the immunogenicity and safety of infant primary vaccination with DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13). Enrolled infants (6-14â¯weeks old) were born to mothers who were randomized to receive reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) during pregnancy (270/7-366/7 weeks' gestation) with crossover immunization postpartum. All infants received 2 or 3 DTaP-HepB-IPV/Hib and PCV13 doses according to national schedules. Immunogenicity was assessed in infants pre- and 1â¯month post-primary vaccination. The primary objective was to assess seroprotection/vaccine response rates for DTaP-HepB-IPV/Hib antigens 1â¯month post-primary vaccination. RESULTS: 601 infants (Tdap group: 296; control group: 305) were vaccinated. One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups. Vaccine response rates for pertussis antigens were significantly lower in infants whose mothers received pregnancy Tdap (37.5-77.1%) versus placebo (90.0-99.2%). Solicited and unsolicited adverse event rates were similar between groups. Serious adverse events occurred in 2.4% (Tdap group) and 5.6% (control group) of infants, none were vaccination-related. CONCLUSIONS: Pertussis antibodies transferred during pregnancy may decrease the risk of pertussis infection in the first months of life but interfere with the infant's ability to produce pertussis antibodies, the clinical significance of which remains unknown. Safety and reactogenicity results were consistent with previous experience. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02422264.
Subject(s)
Antibodies, Bacterial/blood , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage , Haemophilus Vaccines/immunology , Hepatitis B Vaccines/immunology , Pneumococcal Vaccines/immunology , Poliovirus Vaccine, Inactivated/immunology , Female , Follow-Up Studies , Humans , Infant , Pregnancy , Vaccines, Combined/immunologyABSTRACT
Los programas de rehabilitación cardiaca y prevención secundaria han demostrado ser el método más eficaz para disminuir la morbimortalidad de las enfermedades cardiovasculares. A pesar de dichos beneficios, su desarrollo en los diferentes países es muy variable y, en la mayoría, insuficiente. En España existen pocas unidades de rehabilitación cardiaca multidisciplinarias, por lo que el número de pacientes que tienen acceso no supera el 5% de las indicaciones. En nuestro país, estos programas se realizan habitualmente en unidades hospitalarias; sin embargo, existen diferentes tipos de programas según las necesidades de cada paciente y el grado de supervisión que el riesgo de complicaciones requiera. Los pacientes considerados de bajo riesgo podrían realizar programas de rehabilitación cardiaca multidisciplinarios en los centros de salud, bajo la supervisión directa de los diferentes profesionales de atención primaria (AU)
Cardiac rehabilitation and secondary prevention programs have been shown to provide the most effective way of reducing the morbidity and mortality associated with cardiovascular disease. Despite the evidence of clinical benefits, program implementation has varied substantially between countries and is inadequate in the majority. In Spain, there are only a few multidisciplinary cardiac rehabilitation units, which means that less than 5% of patients with the appropriate indications have access to them. In the country, these programs are usually implemented in hospital departments. However, there are many different types of program, which vary according to the patients needs and to the level of supervision required to deal with the risk of complications in each individual. Patients regarded as being at a low risk could participate in multidisciplinary cardiac rehabilitation programs based in health centers, under the direct supervision of health-care professionals working in primary care (AU)
Subject(s)
Humans , Cardiovascular Diseases/rehabilitation , Exercise Therapy/methods , Cardiovascular Diseases/prevention & control , Exercise Tolerance , Primary Health Care , Secondary Prevention/methodsABSTRACT
Low-output syndrome is one of the leading causes of death following open-heart surgery or high-risk angioplasty. Ventricular assist devices have been used to treat patients who suffer from postoperative cardiogenic shock despite use of an intraaortic balloon pump and maximum inotropic support. The Impella pump (Impella Cardiosystems AG, Aachen, Germany) is a newly introduced left ventricular assist device that has been shown to reduce infarct size and to accelerate recovery of stunned myocardium. We report our initial experience using the Impella device for the treatment of cardiogenic shock following cardiopulmonary bypass and for maintaining hemodynamic stability in high-surgical-risk patients undergoing unprotected left coronary artery angioplasty.
Subject(s)
Cardiac Output, Low/surgery , Heart-Assist Devices , Shock, Cardiogenic/surgery , Stroke Volume , Aged , Aged, 80 and over , Angioplasty , Cardiac Surgical Procedures/adverse effects , Coronary Vessels/surgery , Female , Heart Ventricles , Humans , Male , Middle Aged , Myocardial Infarction/surgery , Prosthesis Design , Shock, Cardiogenic/etiologyABSTRACT
El síndrome de bajo gasto es una de las principales causas de muerte tras la cirugía cardiaca y la angioplastia de alto riesgo. Los dispositivos de asistencia ventricular se han utilizado para tratar a pacientes con bajo gasto postoperatorio a pesar del balón de contrapulsación intraaórtico y el apoyo inotrópico máximo. El Impella (Impella Cardiosystems AG, Aachen, Alemania) es un dispositivo de asistencia ventricular de reciente introducción que ha demostrado reducir el tamaño del infarto, así como acelerar la recuperación del miocardio aturdido. Describimos nuestra experiencia inicial con el Impella para el tratamiento del shock cardiogénico tras el bypass cardiopulmonar y para el mantenimiento de la estabilidad hemodinámica en pacientes con tronco coronario izquierdo no protegido de alto riesgo quirúrgico tratados con angioplastia (AU)
Low-output syndrome is one of the leading causes of death following open-heart surgery or high-risk angioplasty. Ventricular assist devices have been used to treat patients who suffer from postoperative cardiogenic shock despite use of an intraaortic balloon pump and maximum inotropic support. The Impella pump (Impella Cardiosystems AG, Aachen, Germany) is a newly introduced left ventricular assist device that has been shown to reduce infarct size and to accelerate recovery of stunned myocardium. We report our initial experience using the Impella device for the treatment of cardiogenic shock following cardiopulmonary bypass and for maintaining hemodynamic stability in high-surgical-risk patients undergoing unprotected left coronary artery angioplasty (AU)
Subject(s)
Male , Female , Middle Aged , Aged , Humans , Shock, Cardiogenic/therapy , Ventricular Dysfunction, Left/therapy , Angioplasty, Balloon, Coronary/methods , Intra-Aortic Balloon Pumping/methods , Coronary Angiography , Postoperative Complications/therapyABSTRACT
BACKGROUND: Pretreatment with statins reduces early ischemic events after percutaneous coronary interventions, primarily in patients with a high level of inflammation markers. We sought to examine the association between preoperative statin therapy, systemic inflammation, and myocardial ischemia with the occurrence of early cardiac complications after coronary artery bypass grafting surgery. METHODS: One hundred forty-one consecutive patients who underwent coronary artery bypass grafting surgery from two university tertiary hospitals were stratified according to their preoperative status of statin therapy (87 treated and 54 nontreated). Preoperative blood samples were collected for measurement of lipid parameters, C-reactive protein, interleukin-6, and troponin T. The evaluated primary endpoint was a composite of death and myocardial infarction at 30 days. RESULTS: Patients undergoing preoperative statin therapy showed a reduced incidence of death (2.3% versus 13.0%, p = 0.012), myocardial infarction (5.7% versus 18.5%, p = 0.017), and primary combined endpoint (8.0% versus 22.2%, p = 0.017). In the multivariate model, preoperative troponin T greater than 0.01 ng/mL (odds ratio 6.85, p = 0.001) and nonstatin therapy (odds ratio 4.2, p = 0.01) predicted a higher risk of primary endpoint. Statins showed a significant interaction with troponin T status and benefited primarily those patients with positive troponin T. Among 19 patients with troponin T greater than 0.01 ng/mL, the primary endpoint occurred in all 6 nonstatin-treated patients, but it occurred in only 1 of 13 statin-treated patients (p < 0.001). Neither C-reactive protein nor interleukin-6 predicted early complications, nor did they interact with statin therapy (p = not significant). CONCLUSIONS: Preoperative statin therapy reduces early complications and offers additional protection in patients with positive troponin T status, regardless of inflammatory markers.
Subject(s)
Coronary Artery Bypass/statistics & numerical data , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Postoperative Complications/epidemiology , Premedication , Troponin T/blood , Aged , Atorvastatin , Biomarkers , C-Reactive Protein/analysis , Comorbidity , Creatine Kinase, MB Form/blood , Female , Heptanoic Acids/therapeutic use , Hospital Mortality , Hospitals, University/statistics & numerical data , Humans , Hypercholesterolemia/complications , Hypercholesterolemia/drug therapy , Incidence , Interleukin-6/blood , Lipids/blood , Male , Middle Aged , Myocardial Infarction/blood , Myocardial Infarction/epidemiology , Myocardial Infarction/prevention & control , Postoperative Complications/blood , Postoperative Complications/prevention & control , Pravastatin/therapeutic use , Preoperative Care , Prospective Studies , Pyrroles/therapeutic use , Risk Assessment , Simvastatin/therapeutic use , Systemic Inflammatory Response Syndrome/epidemiology , Systemic Inflammatory Response Syndrome/prevention & controlABSTRACT
Echographically measured thicknesses of perirenal and subcutaneous fat, as well as serum metabolic and anthropometric parameters, were evaluated in 74 human immunodeficiency virus-infected patients receiving highly active antiretroviral therapy (HAART), 22 of whom were HAART-naive at baseline, who were followed-up for 27 months to detect predictive factors of lipodystrophy. Perirenal fat diameter (PRFD) at baseline differed in HAART-naive and HAART-experienced patients (P<.001), and it was the best predictor of lipodystrophy changes after 12 months of follow-up in the HAART-naive patients (hazard ratio, 7.34; 95% confidence interval, 1.18-45.49; P=.032). In addition, HAART-experienced patients in whom lipodystrophy improved had thinner baseline perirenal fat than those in whom lipodystrophy did not improve (P=.04). A PRFD of >2.6 mm at baseline or >4.9 mm during receipt of HAART suggested lipodystrophy predisposition. PRFD correlated significantly with other metabolic and anthropometric parameters. Echographically measured PRFD is associated with lipodystrophy and could be used as an early predictor of this syndrome in treatment-naive patients starting HAART.
Subject(s)
Adipose Tissue/diagnostic imaging , Anti-HIV Agents/therapeutic use , Antiretroviral Therapy, Highly Active/adverse effects , HIV-1 , HIV-Associated Lipodystrophy Syndrome/diagnostic imaging , HIV-Associated Lipodystrophy Syndrome/physiopathology , Adult , Anti-HIV Agents/adverse effects , Body Weights and Measures , Female , HIV Infections/drug therapy , HIV-Associated Lipodystrophy Syndrome/chemically induced , HIV-Associated Lipodystrophy Syndrome/metabolism , Humans , Kidney , Male , Middle Aged , Predictive Value of Tests , Prospective Studies , UltrasonographyABSTRACT
Q fever is characterized by its clinical polymorphism. Cardiac involvement in acute Q fever is rare. We report a case of pleuro-pericarditis that rapidly evolved to pericardial constriction during an acute episode of Coxiella burnetii infection. Constrictive pericarditis was confirmed by hemodynamic measurements, echocardiography, and magnetic resonance. Indirect immunofluorescence assay revealed positive serology for acute Q fever. The patient underwent a successful pericardiectomy and was given antibiotics. The histopathologic study of the excised pericardium showed C. burnetii in a large cluster of organisms. After a 6-month follow-up period, the individual was asymptomatic.
Subject(s)
Pericarditis, Constrictive/etiology , Q Fever/complications , Antibodies, Bacterial/analysis , Cardiac Catheterization , Combined Modality Therapy , Coxiella burnetii/immunology , Coxiella burnetii/isolation & purification , Doxycycline/therapeutic use , Humans , Immunoglobulin G/analysis , Immunoglobulin M/analysis , Magnetic Resonance Imaging , Male , Middle Aged , Pericardiectomy , Pericarditis, Constrictive/diagnostic imaging , Pericarditis, Constrictive/drug therapy , Pericarditis, Constrictive/pathology , Pericarditis, Constrictive/surgery , Pericardium/immunology , Pericardium/microbiology , Pleural Effusion/etiology , Pleural Effusion/immunology , Q Fever/diagnosis , Q Fever/drug therapy , UltrasonographyABSTRACT
PURPOSE: To report endovascular repair of dual aneurysms in a patient with Behçet's disease. CASE REPORT: A 37-year-old man diagnosed 6 months prior with Behçet's disease presented with a pulsating abdominal mass. Computed tomography revealed a 70-mm-diameter pseudoaneurysm in the abdominal aorta and another (20 mm) in the celiac trunk 5 mm from the aorta. Staged endovascular repair began with the aortic aneurysm, which was excluded with a bifurcated 23 x 140-mm Excluder stent-graft. Three days later, 2 Jostent stent-grafts were placed in the celiac trunk, successfully excluding the lesion. Fifteen days later, the patient was discharged on a regimen of clopidogrel, cyclosporine, and warfarin. At 6 months, the CT scan showed good perfusion of the stent-grafts. CONCLUSIONS: Aneurysmal involvement of the celiac trunk in a patient with Behçet's disease is a rare pathology that appears amenable to stent-graft repair.
Subject(s)
Aneurysm/surgery , Aortic Aneurysm, Abdominal/surgery , Behcet Syndrome/complications , Blood Vessel Prosthesis Implantation , Celiac Artery , Adult , Aneurysm/diagnostic imaging , Aneurysm/etiology , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/etiology , Celiac Artery/diagnostic imaging , Humans , Male , Stents , Tomography, X-Ray ComputedABSTRACT
We present a successful use of biventricular pneumatic assistance during seven days allowing the recovery from a severe primary graft failure that occurred in the operating room. Suboptimal donors are associated with higher rates of immediate graft failure; however proper use of mechanical assistance can help to recover graft function.
