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Critical care medicine · Aug 2018
Randomized Controlled TrialEffect of a Perioperative Intra-Aortic Balloon Pump in High-Risk Cardiac Surgery Patients: A Randomized Clinical Trial.
- Graziela Santos Rocha Ferreira, de Almeida Juliano Pinheiro JP Surgical Intensive Care Unit and Department of Anesthesiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da U, Giovanni Landoni, Jean Louis Vincent, Evgeny Fominskiy, Gomes Galas Filomena Regina Barbosa FRB Surgical Intensive Care Unit and Department of Anesthesiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medi, Fabio A Gaiotto, Luís Oliveira Dallan, Rafael Alves Franco, Luiz Augusto Lisboa, Luis Roberto Palma Dallan, Julia Tizue Fukushima, Stephanie Itala Rizk, Park Clarice Lee CL Surgical Intensive Care Unit and Department of Anesthesiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade, Tânia Mara Strabelli, Silvia Helena Gelas Lage, Ligia Camara, Suely Zeferino, Jaquelline Jardim, Elisandra Cristina Trevisan Calvo Arita, Juliana Caldas Ribeiro, Silvia Moreira Ayub-Ferreira, Costa Auler Jose Otavio JO Jr Surgical Intensive Care Unit and Department of Anesthesiology, Heart Institute (InCor), Hospital das Clinicas da Faculda, Filho Roberto Kalil RK Department of Cardiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil., Fabio Biscegli Jatene, and Ludhmila Abrahao Hajjar.
- Surgical Intensive Care Unit and Department of Anesthesiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
- Crit. Care Med. 2018 Aug 1; 46 (8): e742-e750.
ObjectivesThe aim of this study was to evaluate the efficacy of perioperative intra-aortic balloon pump use in high-risk cardiac surgery patients.DesignA single-center randomized controlled trial and a meta-analysis of randomized controlled trials.SettingHeart Institute of São Paulo University.PatientsHigh-risk patients undergoing elective coronary artery bypass surgery.InterventionPatients were randomized to receive preskin incision intra-aortic balloon pump insertion after anesthesia induction versus no intra-aortic balloon pump use.Measurements And Main ResultsThe primary outcome was a composite endpoint of 30-day mortality and major morbidity (cardiogenic shock, stroke, acute renal failure, mediastinitis, prolonged mechanical ventilation, and a need for reoperation). A total of 181 patients (mean [SD] age 65.4 [9.4] yr; 32% female) were randomized. The primary outcome was observed in 43 patients (47.8%) in the intra-aortic balloon pump group and 42 patients (46.2%) in the control group (p = 0.46). The median duration of inotrope use (51 hr [interquartile range, 32-94 hr] vs 39 hr [interquartile range, 25-66 hr]; p = 0.007) and the ICU length of stay (5 d [interquartile range, 3-8 d] vs 4 d [interquartile range, 3-6 d]; p = 0.035) were longer in the intra-aortic balloon pump group than in the control group. A meta-analysis of 11 randomized controlled trials confirmed a lack of survival improvement in high-risk cardiac surgery patients with perioperative intra-aortic balloon pump use.ConclusionsIn high-risk patients undergoing cardiac surgery, the perioperative use of an intra-aortic balloon pump did not reduce the occurrence of a composite outcome of 30-day mortality and major complications compared with usual care alone.
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