Sex and other predictors of intra-aortic balloon counterpulsation—related complications: Prospective study of 1119 consecutive patients

Background and Objective Intra-aortic balloon counterpulsation (IABC) complication rates remain significant despite technical advances that have simplified and expanded its use. Previous reports implicated patient height, diabetes, or peripheral vascular disease as risk factors. However, these studies were small and not prospective. Therefore a prospective study at one high-volume center was conducted examining the complications associated with IABC and the role of sex and other risk factors in the current era. Methods The study prospectively evaluated 1174 consecutive percutaneous IAB insertions in 1119 patients between 1993 and 1997. Major complications were defined as embolism or limb ischemia requiring surgery; bleeding requiring transfusion or surgery; systemic infection; balloon rupture; or death from one of these causes. Minor complications were defined as limb ischemia or pulse loss resolving without surgery or after IAB removal or bleeding not requiring transfusion or surgical intervention. All variables were analyzed with univariate and stepwise multivariate analysis. Results Data were collected on 1119 patients (727 men and 392 women) with a mean age of 65 ± 11 years. The prevalence of diabetes, hypertension, and peripheral vascular disease was 27%, 52%, and 8%, respectively. Complications occurred in 166 patients (15%) and a major complication occurred in 126 (11%) of the 1119 patients. Multivariate logistic regression analysis was done with demographic, clinical, and procedural variables in a cohort of 1106 patients. The analysis identified peripheral vascular disease (relative risk [RR] 4.1), female sex [RR 2.3], and body surface area (RR 0.26 per m2) as independent predictors of a major complication. In addition, cardiac index [RR 0.7] was also identified as an independent predictor of any or major complications in a subset of 915 patients. In 754 high-risk patients (women or patients with peripheral vascular disease, diabetes, cardiac index <2.2 L/min/m2, or body surface area <1.8 m2), 114 major complications occurred (15%) compared with 8 (3%) among 278 non-high-risk patients (P < .0001). Conclusions The current complication rate associated with IABC remains significant. Advances in IAB technology need to focus on the high-risk subset of patients that includes women, smaller patients, and those with peripheral vascular disease.