Objective: Preoperative intra-aortic balloon pump use in high-risk patients undergoing surgical coronary revascularization is still a matter of debate. The objective of this study is to determine whether the preoperative use of an intra-aortic balloon pump improves the outcome after coronary operations in high-risk patients.
Design: Single-center prospective randomized controlled trial.
Setting: Tertiary cardiac surgery center, research hospital.
Patients: One hundred ten subjects undergoing coronary operations, with a poor left ventricular ejection fraction (< 35%) and no hemodynamic instability.
Interventions: Patients randomized to receive preincision intra-aortic balloon pump or no intervention.
Measurements and Main Results: The primary outcome measurement was postoperative major morbidity rate, defined as one of prolonged mechanical ventilation, stroke, acute kidney injury, surgical revision, mediastinitis, and operative mortality. There was no difference in major morbidity rate (40% in intra-aortic balloon pump group and 31% in control group; odds ratio, 1.49 [95% CI, 0.68–3.33]). No differences were observed for cardiac index before and after the operation; at the arrival in the ICU, patients in the intra-aortic balloon pump group had a significantly (p = 0.01) lower mean systemic arterial pressure (80.1 ± 15.1 mm Hg) versus control group patients (89.2 ± 17.9 mm Hg). Fewer patients in the intra-aortic balloon pump group (24%) than those in the control group (44%) required dopamine infusion (p = 0.043).
Conclusions: This study demonstrates that in patients undergoing nonemergent coronary operations, with a stable hemodynamic profile and a left ventricular ejection fraction less than 35%, the preincision insertion of intra-aortic balloon pump does not result in a better outcome. Given the possible complications of intra-aortic balloon pump insertion, and the additional cost of the procedure, this approach is not justified.
1Department of Cardiothoracic—Vascular Anesthesia and Intensive Care, IRCCS Policlinico San Donato, Milan, Italy.
2Department of Cardiac Surgery, IRCCS Policlinico San Donato, Milan, Italy.
* See also p. 2642.
Currently listed as ClinicalTrials.gov NCT00881192.
Supported, in part, by the IRCCS Policlinico San Donato with research funds.
Dr. Ranucci and Dr. de Vincentiis received honoraria from Arrow Intl for coauthoring a manual on intra-aortic balloon pump use. The remaining authors have disclosed that they do not have any potential conflicts of interest.
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