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1.
Contemp Clin Trials Commun ; 19: 100617, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32695923

RESUMO

Anaemia and iron deficiency are frequent in patients scheduled for cardiac surgery. Perioperative patient blood management (PBM) is widely recommended in current practice guidelines. The aim of this protocol is to analyse the effect of a global perioperative PBM programme on the red blood cell (RBC) transfusion ratio, morbidities and rehabilitation score in elective cardiac surgery.This study is a prospective, single-centre trial with a 2-step protocol, A and B, as follows: A: non-drug intervention: the caregiver is given a blood management educational programme; B: drug intervention: systematic correction of perioperative iron, vitamin deficiencies, and anaemia. This study was designed to enrol 900 patients (500 in group A and 400 in group B) in a rolling period starting at anaesthesia consultation and ending 3 months after surgery. The primary objective was a 20% reduction in RBC transfusion after implementation of PBM programmes (protocol A + B) when compared to our previous transfusion ratio in the first half of 2018 (30.4% vs 38%). The secondary objectives were to evaluate the impact for each step of the study on the RBC transfusion rate, morbidity and the quality of postoperative rehabilitation.The strength of this study is its evaluation of the effect of a global PBM programme on RBC transfusion in cardiac surgery through a 2-step protocol. We aim to assess for the first time the impact of non-drug and drug interventions on RBC transfusion, comorbidities and delayed rehabilitation parameters. TRIALS REGISTRATIONS: ClinicalTrials.gov, NCT04040023: registered 29 July 2019.

2.
EuroIntervention ; 5(6): 659-65, 2010 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-20142215

RESUMO

AIMS: Transcatheter aortic valve implantation (TAVI) is performed through a transarterial approach with encouraging results in "one-type valve" registries. We report 30-day data from a mixed population of patients treated with either Medtronic CoreValve (MCV) or Edwards SAPIEN (ES) valves. METHODS AND RESULTS: Forty-five patients had TAVI via the transarterial approach (21 MCV and 24 ES). Mean age was 81.8+/-4.2 years, Logistic EuroSCORE was 25.2+/-8.4%. Procedural success rate was 97.8%. In-hospital death rate was 4.4%. Vascular complication rate was 8.9%. Of MCV patients, 28.6% had a permanent pacemaker vs. 4.2% of ES patients; p=0.02. No additional deaths were observed between discharge and 30 days. NYHA functional class was improved at 30-days: 2.07+/-0.4 vs. 3.09+/-0.05, p<0.0001. Mean transvalvular gradient was lower: 9.5+/-3.28 mmHg vs. 41.9+/-14 mmHg, p<0.0001. Overall 30-day MACE rate was 8.9%, similar between MCV and ES patients. CONCLUSION: A routine policy of TAVI using both MCV and ES valves is feasible without any worsening of procedural success rates and 30-day outcomes. A wider population of high risk patients with aortic stenosis can be offered a transarterial treatment. This could be the next standard of care for teams performing TAVI.


Assuntos
Estenose da Valva Aórtica/cirurgia , Bioprótese , Cateterismo Cardíaco/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Doenças Vasculares/etiologia , Idoso de 80 Anos ou mais , Angiografia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/epidemiologia , Cateterismo Cardíaco/métodos , Ecocardiografia Transesofagiana , Feminino , Seguimentos , França , Implante de Prótese de Valva Cardíaca/métodos , Mortalidade Hospitalar , Humanos , Incidência , Tempo de Internação , Masculino , Estudos Prospectivos , Desenho de Prótese , Fatores de Tempo , Resultado do Tratamento , Doenças Vasculares/epidemiologia
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