Pre-operative intra-aortic balloon counterpulsation in stable patients with left main coronary disease.

OBJECTIVE: To determine whether prophylactic, pre-operative, intra-aortic balloon counterpulsation (IABC) improves clinical outcome in stable patients with severe left main coronary artery disease. METHODS: A post-hoc analysis of 457 prospectively tracked, non-randomized patients undergoing coronary artery bypass graft surgery (CABG) for left main stenoses 50% and multivessel coronary disease, but without any hemodynamic compromise or ongoing angina, was conducted. Patients with heart failure, shock, ongoing ischemia or previous CABG were excluded. In 287 patients, pre-operative IABC was not used (Group 1), while IABC was initiated in 170 patients for "prophylaxis" (Group 2). RESULTS: Groups 1 and 2 were similar in age (67 +/- 10 years versus 67 +/- 11 years, respectively), sex (72% male versus 71% male, respectively), and body mass index (28 +/- 5.5 versus 27 +/- 5.1, respectively). However, more Group 1 patients had peripheral vascular disease (PVD) (25% versus 11%), but more Group 2 patients had diabetes (37% versus 29%), and a lower left ventricular ejection fraction. The unadjusted 30-day mortality was significantly higher in Group 1 [16 (5.6%) versus 2 (1.2%); p = 0.02]. Cardiopulmonary bypass time and post-operative length of stay did not differ between the two groups. After adjusting for PVD in the multivariate analysis, the p-value for the no IABP versus IABP comparison in the presence of PVD was 0.10, even though 0/18 patients with PVD and IABC died. CONCLUSION: While unadjusted mortality appears lower with prophylactic IABC, confounding variables such as PVD mandate a larger, randomized clinical trial in order to establish the role of IABC in stable patients with left main disease.

Cardiac tamponade in the "new device" era: evaluation of 6999 consecutive percutaneous coronary interventions.

BACKGROUND: The incidence of cardiac perforation and pericardial tamponade appears to be increasing in the era of new coronary interventional devices compared with coronary balloon angioplasty. METHODS AND RESULTS: We reviewed 6999 consecutive percutaneous coronary interventions performed during 1994 to 1996 in a single urban university hospital catheterization laboratory. Data had been collected prospectively as part of an ongoing quality assurance program. Fifteen patients had cardiac tamponade within 36 hours of the procedure. Only 6 of these occurred during the interventional procedure; the others occurred 2 to 36 hours later. The median patient age was 72 years. Nine (60%) patients were female. Three patients received abciximab. Five perforations were at the target coronary artery site, 3 were caused by a guide wire tip in the distal part of the target artery, and 7 represented right ventricular perforations caused by a temporary pacemaker wire. Five of the 7 right ventricular perforations occurred during rotational atherectomy procedures. Diagnosis was aided by immediate echocardiography. Treatment was medical, including pericardiocentesis, in 6 cases. The other 9 patients required surgical drainage and repair. All patients survived the index hospitalization. At 18-month follow-up, 1 patient had died, and all others were without apparent sequelae. CONCLUSIONS: Tamponade after percutaneous coronary intervention is not rare in the "new device" era (overall incidence 0.2%); tamponade after percutaneous coronary intervention is often delayed and may occur outside the catheterization suite; patients are more likely to be female and elderly; immediate echocardiography is an essential aid to diagnosis and prompt treatment; and the use of temporary right ventricular pacing catheters must be reexamined.

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 m(2)) 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(2), or body surface area <1.8 m(2)), 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.

Reduction in ischemic vascular complications with a hydrophilic-coated intra-aortic balloon catheter.

Hydrophilic coatings improve the handling characteristics of angioplasty equipment, but until recently this technology has not been available for intra-aortic balloon (IAB) catheters. To determine whether a new hydrophilic coating is associated with a reduction in IAB-related complications, we prospectively evaluated 188 patients undergoing insertion of this new IAB catheter. Complications related to IAB insertion were recorded and compared to data from 682 patients previously treated with an uncoated IAB catheter of the same shaft diameter and balloon size. By multivariate analysis the hydrophilic-coated IAB catheter was associated with a 72% reduction in ischemic vascular complications (relative risk 0.28, 95% CI 0.08-0.96, P= 0.04). There were also trends toward reductions in IAB rupture and the need for vascular surgical repair for bleeding or ischemia. While further investigation is warranted, hydrophilic coatings that reduce the coefficient of friction during IAB catheter insertion may also reduce subsequent ischemic vascular complications.

Prospective evaluation of factors associated with intraaortic balloon rupture.

The authors undertook a prospective analysis of all intraaortic balloon catheter (IAB) insertions at Hahnemann University Hospital during an 18 month period. Attention was directed to balloon rupture and factors associated with this complication. A total of 384 insertions were attempted in 363 patients: 19 patients (5.2%) experienced balloon rupture. The mean time to rupture was 2.1 +/- 3.3 days (range 0-15 days). All ruptured IAB catheters were removed percutaneously without subsequent complications. Ten balloons were subjected to leak testing and scanning electron microscopy. All but one rupture appeared to be the result of balloon abrasion against atherosclerotic plaque. The puncture site occurred at variable distances from the proximal end of the balloon at 9.4 +/- 8.3 cm. Comparison of patients with and without balloon rupture revealed several significant (p < 0.04) differences by univariate analysis (Table 1). No procedure related variables (IAB catheter size 9 versus 11 Fr, sheathless insertion, duration of counterpulsation) were associated with rupture. Stepwise logistic regression analysis revealed body surface area as the only independent predictor of balloon rupture (p = 0.007). Intraaortic balloon rupture with 40 cc balloons, is directly related to the size of the patient. Evaluation of smaller balloons in patients with body surface area < or = 1.8 m2 appears warranted to minimize IAB rupture.