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Effect of a Perioperative Intra-Aortic Balloon Pump in High-Risk Cardiac Surgery Patients

A Randomized Clinical Trial

Rocha Ferreira, Graziela Santos, MD, PhD1; de Almeida, Juliano Pinheiro, MD, PhD1; Landoni, Giovanni, MD2,3; Vincent, Jean Louis, MD, PhD4; Fominskiy, Evgeny, MD, PhD2; Gomes Galas, Filomena Regina Barbosa, MD, PhD1; Gaiotto, Fabio A., MD, PhD5; Dallan, Luís Oliveira, MD, PhD5; Franco, Rafael Alves, MD1; Lisboa, Luiz Augusto, MD, PhD5; Palma Dallan, Luis Roberto, MD5; Fukushima, Julia Tizue, MSc1; Rizk, Stephanie Itala, MD1; Park, Clarice Lee, MD1; Strabelli, Tânia Mara, MD, PhD6; Gelas Lage, Silvia Helena, MD, PhD7; Camara, Ligia, RN1; Zeferino, Suely, RN, PhD1; Jardim, Jaquelline, RN1; Calvo Arita, Elisandra Cristina Trevisan, RN1; Caldas Ribeiro, Juliana, MD, PhD1; Ayub-Ferreira, Silvia Moreira, MD, PhD7; Costa Auler, Jose Otavio Jr, MD, PhD1; Filho, Roberto Kalil, MD, PhD7; Jatene, Fabio Biscegli, MD, PhD5; Hajjar, Ludhmila Abrahao, MD, PhD7

doi: 10.1097/CCM.0000000000003185
Online Clinical Investigations

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.

1Surgical 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.

2Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.

3Faculty of Medicine and Surgery, Vita-Salute San Raffaele University of Milan, Milan, Italy.

4Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.

5Department of Cardiovascular Surgery, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

6Department of Infectious Diseases, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

7Department of Cardiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

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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.

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