Sex and Other Predictors of IABP Complications
Sex and Other Predictors of IABP Complications
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 m) 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/m, or body surface area <1.8 m), 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.
Technical advances such as percutaneous insertion, smaller diameter catheters, and sheathless insertion techniques have simplified the use of intra-aortic balloon counterpulsation (IABC), and made counterpulsation more available to practicing cardiologists outside tertiary care centers. In addition, results from recent clinical trials have expanded the indications for IABC. However, the complication rate associated with IABC remains high, ranging from 12% to 44%, with the majority of series reporting a frequency between 12% and 30%. Earlier studies identified peripheral vascular disease (PVD), sex, and diabetes as significant predictors of vascular complications after IABC. However, these studies were small and only one was prospective. Furthermore, no major reduction in complication rates has been demonstrated in high-risk patients, and retrospective studies evaluating catheter size or sheathless insertion have demonstrated either a modest reduction or no reduction in vascular complications.
To determine the current frequency of IABC-related complications, we prospectively analyzed a large, uniformly treated cohort of patients at one high-volume center. The size of our cohort allowed us to evaluate the independent predictors better and to assess the role of female sex on IABC-related complications.
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 m) 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/m, or body surface area <1.8 m), 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.
Technical advances such as percutaneous insertion, smaller diameter catheters, and sheathless insertion techniques have simplified the use of intra-aortic balloon counterpulsation (IABC), and made counterpulsation more available to practicing cardiologists outside tertiary care centers. In addition, results from recent clinical trials have expanded the indications for IABC. However, the complication rate associated with IABC remains high, ranging from 12% to 44%, with the majority of series reporting a frequency between 12% and 30%. Earlier studies identified peripheral vascular disease (PVD), sex, and diabetes as significant predictors of vascular complications after IABC. However, these studies were small and only one was prospective. Furthermore, no major reduction in complication rates has been demonstrated in high-risk patients, and retrospective studies evaluating catheter size or sheathless insertion have demonstrated either a modest reduction or no reduction in vascular complications.
To determine the current frequency of IABC-related complications, we prospectively analyzed a large, uniformly treated cohort of patients at one high-volume center. The size of our cohort allowed us to evaluate the independent predictors better and to assess the role of female sex on IABC-related complications.
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