A randomized controlled trial of preoperative intra-aortic balloon pump in coronary patients with poor left ventricular function undergoing coronary artery bypass surgery*.
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.


METHODS
Single-center prospective randomized controlled trial.


METHODS
Tertiary cardiac surgery center, research hospital.


METHODS
One hundred ten subjects undergoing coronary operations, with a poor left ventricular ejection fraction (< 35%) and no hemodynamic instability.


METHODS
Patients randomized to receive preincision intra-aortic balloon pump or no intervention.


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.
Marco
M
Ranucci
Serenella
S
Castelvecchio
Andrea
A
Biondi
Carlo
C
de Vincentiis
Andrea
A
Ballotta
Alessandro
A
Varrica
Alessandro
A
Frigiola
Lorenzo
L
Menicanti
D000368:Aged; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D005260:Female; D006439:Hemodynamics; D006801:Humans; D007423:Intra-Aortic Balloon Pumping / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D057234:Preoperative Period; D011446:Prospective Studies; D018487:Ventricular Dysfunction, Left / Q000453:epidemiology*