Effect of a Perioperative Intra-Aortic Balloon Pump in High-Risk Cardiac Surgery Patients: A Randomized Clinical Trial

Objectives: The aim of this study was to evaluate the efficacy of perioperative intra-aortic balloon pump use in high-risk cardiac surgery patients. Design: A single-center randomized controlled trial and a meta-analysis of randomized controlled trials. Setting: Heart Institute of São Paulo University. Patients: High-risk patients undergoing elective coronary artery bypass surgery. Intervention: Patients were randomized to receive preskin incision intra-aortic balloon pump insertion after anesthesia induction versus no intra-aortic balloon pump use. Measurements and Main Results: The 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. Conclusions: In 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. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (https://ift.tt/29S62lw). Supported, in part, by the Heart Institute of the University of São Paulo, Brazil. Maquet Cardiopulmonary provided the intra-aortic balloon catheters at no cost and was also responsible for the costs of the neutrophil gelatinase-associated lipocalin and heart-type fatty acid binding protein measurements. Roche Diagnostics provided the material for N-terminal pro b-type natriuretic peptide “point-of-care” measurement. Drs. Gomes Galas, Gaiotto, Dallan, Lisboa, Fukushima, Rizk, Park, Gelas Lage, Ayub-Ferreira, Costa Auler, Filho, and Hajjar disclosed work for hire. Dr. Jatene disclosed government work. The remaining authors have disclosed that they do not have any potential conflicts of interest. For information regarding this article, E-mail: landoni.giovanni@hsr.it Copyright © by 2018 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

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