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Ann Thorac Surg 1999;67:645-651
© 1999 The Society of Thoracic Surgeons
a Department of Surgery, Rikshospitalet, Oslo, Norway
Accepted for publication July 31, 1998.
Address reprint requests to Dr Arafa, Department of Surgery A, Rikshospitalet, 0027 Oslo, Norway
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Abstract |
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 Top Abstract IntroductionPatients and methodsResultsCommentReferences |
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Methods. Five hundred nine patients who underwent open heart operations at our institution and who were treated with the IABP from January 1980 through December 1994 were studied retrospectively to assess IABP-related vascular complications and their independent preoperative predictors and the implications of IABP-related vascular complications on the patients’ mortality, morbidity (clinical sepsis and organ failure), and long-term survival.
Results. Early vascular complications occurred in 56 patients (11%) and major complications occurred in 41 patients (8%). The latter consisted of aortic perforation in 1 patient, aortoiliac dissection in 2 patients, and limb ischemia in 38 patients. Logistic regression analysis identified concomitant peripheral vascular disease (p < 0.001), elevated preoperative end-diastolic pressure, small body surface area, and large catheter size (p < 0.05) as independent risk factors for IABP-related major vascular complications in patients who survived the day of operation. Late IABP-related sequelae occurred in 10 patients, 9 of whom had had early vascular complications. The presence of vascular complications per se was not a significant independent factor among other risk factors for mortality, morbidity, or long-term survival.
Conclusions. Careful clinical assessment of the aortofemoral vascular tree is a cornerstone of early diagnosis and early intervention and usually prevents limb loss. The significant decrease in major vascular complications that has occurred over the last 5 years can be explained by the increased use of catheters with smaller diameters. The timing of IABP insertion in relation to operation and the duration of IABP use were the only device-related risk factors identified for morbidity and survival.
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Introduction |
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TopAbstractIntroductionPatients and methodsResultsCommentReferences |
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As experience with the IABP continues to evolve, indications for its use may be expanded. The prophylactic preoperative insertion of an IABP in high-risk patients undergoing open heart operations or percutaneous transluminal coronary angioplasty has been proposed. However, there are severe complications associated with the use of the IABP [5–9]. We assessed the incidence of and predictors for IABP-related vascular complications in patients who underwent open heart operations at our institution. In addition, we attempted to determine the implications of IABP-related vascular complications on the patients’ short- and long-term prognosis.
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Patients and methods |
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TopAbstractIntroductionPatients and methodsResultsCommentReferences |
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Vascular complications of IABP use were classified as major and minor. Major complications included aortic dissection or perforation and limb ischemia that was treated with thromboembolectomy, vascular repair, bypass operation, fasciotomy, or amputation. Minor complications included limb ischemia that was relieved by removal of the IABP without further surgical intervention, infection at the balloon site, and hemorrhage at the balloon entry point necessitating its removal. Residual IABP-related deficits such as pseudoaneurysm, neuralgia, and foot drop also were reviewed.
Early mortality data included all patients who died during the first 30 postoperative days, and late mortality was defined as any death that occurred after 30 days. Mortality data were verified using the Norwegian civil registry.
Recorded demographic factors and clinical parameters included age; sex; body surface area; hypercholesterolemia; smoking habits (>10 cigarettes per day); diabetes mellitus; hypertension; preoperative New York Heart Association class; nonsinus rhythm; family history of cardiac disease or cardiac-related death; history of previous myocardial infarction; acute myocardial infarction (diagnosed before IABP insertion); preoperative creatinine level; presence of or operation for peripheral vascular disease (defined as claudication or pulse deficit on physical examination, angiographic diagnosis of significant stenosis of a peripheral vessel, or operation for peripheral vascular disease); preoperative use of acetylsalicylic acid, warfarin, or corticosteroids; history of previous cardiac operation; urgent or emergency operation; preoperative cardiac function (ejection fraction and end-diastolic pressure); relative heart volume; type of cardiac operation (valvular, ischemic, combined, or other); year of IABP insertion; indication for IABP insertion; duration of cardiopulmonary bypass; duration of aortic cross-clamping; and IABP-related variables such as timing of insertion, type and volume of balloon, diameter of balloon catheter, technique of balloon insertion, site of balloon insertion, and duration of use. All patients were operated on in moderate hypothermia (28° to 32°C). Topical iced Ringer’s lactate solution and cold crystalloid potassium cardioplegia were used for myocardial protection. The mean age of the patients was 59.8 years (range, 7 to 91 years), and men comprised 66.8% of the series; 32.8% of the patients underwent operation on a nonelective basis and 20% underwent redo operations (Table 1).
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The technique used for IABP insertion was primarily transfemoral; early in the study by cutdown and puncture or cutdown with Dacron graft sewn to the common femoral artery were used. Whereas late in the study, mostly the percutaneous Seldinger technique was used. When femoral insertion failed, transthoracic insertion was performed through a graft sewn to the ascending aorta; the catheter was passed transpleurally to emerge subcutaneously. Heparin or, when contraindicated, low–molecular–weight dextran was used for anticoagulation. Antibiotics were used prophylactically in all patients while the IABP was in place.
The indication for IABP insertion was perioperative heart failure or hypotension refractory to volume loading and pharmacologic support optimized by hemodynamic monitoring. Two hundred sixty-two patients (51.5%) received an IABP because of inability to wean from cardiopulmonary bypass, whereas 247 patients (48.5%) received an IABP because of refractory cardiogenic shock or hypotension. The volume of the balloons varied. Early in the series, an IABP was inserted in 9 children (age < 14 years) using small balloons of < 20 mL; balloons of 30 to 34 mL were inserted in patients with small body surface areas. The remaining patients received 40-mL balloons. Parameters related to the IABP are shown in Table 2.
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2 test or Fisher’s exact test was used to determine statistical significance for discrete variables. Continuous variables were analyzed with the two-tailed Student’s t-test. BMDP 7 software (BMDP Statistical Software Inc, Cork Technology Park, Cork, Ireland) [11] was used for multivariate analysis and for survival analysis with covariates (ie, Cox analysis). All the variables that demonstrated statistical significance (p < 0.05) or marginal significance (p < 0.1) in the univariate analysis or that were considered to be clinically important (ie, age, sex, smoking, diabetes mellitus, nonelective operation, redo operation, balloon-related variables) were forced into a multiple logistic regression. Logistic regression analysis was performed on the total patient population and then on the patients who survived the day of IABP insertion. Independent risk factors were determined, and their relative risk and 95% confidence intervals were estimated. Multivariate risk analysis was performed for all vascular complications (major and minor) and then for only major vascular complications to determine their risk factors. The same strategy was used to determine risk factors for morbidity (ie, sepsis and multiorgan failure), with the IABP-related vascular complications introduced as covariates in the analysis.
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Results |
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TopAbstractIntroductionPatients and methodsResultsCommentReferences |
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Minor vascular complications in 15 patients included a local hematoma in 7 that required wound exploration and hemostasis without vascular repair. Hemorrhage around the balloon catheter in 4 patients and ipsilateral ischemia in 3 patients was relieved by removal of the IABP. Local infection that caused skin loss in 1 patient was treated with a skin graft.
Late IABP-related complications (Table 3) occurred in 10 patients (3.9% of hospital survivors); 5 had been treated for early major vascular complications, 4 had been treated for early minor vascular complications, and 1 had not had early vascular complications. Limb ischemia occurred in 2 patients; 1 was treated with above-the-knee amputation and the other was treated with aortobifemoral bypass for aortoiliac dissection 1 year after IABP insertion. A femoral pseudoaneurysm was repaired in 3 patients. Five patients had weakness of ankle flexion (foot drop) and underwent physical therapy.
Technical complications (recorded prospectively only between 1990 and 1994) included balloon rupture in 5 (3%) of 165 patients and kinking of the introducer sheath resulting in a continuous alarm signal in 2 patients. All the technical complications were discovered early and managed by change (4 patients) or removal (3 patients) of the balloon catheter.
Univariate risk analysis of early vascular complications (both major and minor) showed that the presence of peripheral vascular disease, the use of antiplatelet drugs, and the duration of IABP use were significant risk factors (p < 0.05), and that the preoperative serum creatinine level and the technique of IABP insertion had marginal statistical significance (p < 0.1). Logistic regression analysis of all early IABP-related vascular complications (both major and minor) revealed the presence of peripheral vascular disease to be the most significant independent predictor (p < 0.001). Other independent (p < 0.05) risk factors were the timing of IABP insertion (there was an increased risk of vascular complications in patients who were treated with an IABP preoperatively) and catheter size (there was a decreased risk with a small catheter diameter). The results did not change when we excluded the patients who died of intractable cardiac failure on the day of IABP insertion.
Logistic regression analysis of major vascular complications identified the following independent risk factors: the presence of peripheral vascular disease, the year of IABP insertion (there was a significant decrease in the risk in the last 5 years of the study compared with the first 5 years), an elevated end-diastolic pressure, and the timing of IABP insertion (preoperative insertion was associated with a higher risk). When we repeated the analysis but excluded the year of IABP insertion, catheter diameter became an independent risk factor. This indicates that the main reason for the decrease in the risk of major vascular complications over the last 5 years could be the use of smaller catheters. When we repeated the analysis on patients who survived the day of IABP insertion but excluded the year of operation (Table 4), body surface area appeared to be a significant risk factor (the risk of major vascular complications decreased with increasing body surface area).
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The result of Cox analysis showed no significant correlation between IABP-related vascular complications and survival (p > 0.2), whereas factors such as age, preoperative creatinine level, preoperative ejection fraction, preoperative myocardial infarction, and timing of IABP insertion were significant predictors. The development of vascular complications was not a significant independent risk factor for either early or late death, regardless of whether patients who died on the day of IABP insertion were excluded from the analysis.
The only IABP-related parameter associated with clinical sepsis was the duration of IABP use (89 ± 75 hours in the nonseptic group versus 144 ± 89 hours in the septic group, p < 0.001). Other variables that demonstrated statistical significance were revision for postoperative bleeding, history of smoking, type of operation (there was an increased risk of sepsis with valve operations compared with operations for ischemic lesions), and male gender (Table 5). When we excluded the duration of IABP use from the analysis, the year of operation appeared to be significant.
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Comment |
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TopAbstractIntroductionPatients and methodsResultsCommentReferences |
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The overall 11% incidence of IABP-related vascular complications in our series is comparable to the range of 8.7% to 29% reported in the literature [5, 6, 8, 12–15]. Isner and coworkers [7] noted that clinical studies may underestimate the true frequency of IABP-related complications. Injury related to the use of the IABP may be unrecognized unless it has relatively catastrophic clinical consequences, and the time required for the complications to evolve into clinical significance may be insufficient because of the high early mortality rate. However, the incidence of IABP-related vascular complications in our series only increased to 13% when we excluded from the analysis patients who died on the day of IABP insertion.
The risk analysis identified factors that may predict the development of major vascular complications. In agreement with other reports [11, 13–15], the presence of peripheral vascular disease was the most significant predictor of IABP-related vascular complications. Careful vascular assessment both before and after IABP insertion may be essential for both prevention and early management of IABP-related vascular complications.
The year of operation was another independent risk predictor, with a significant decrease in vascular complications occurring during the last 5 years of the study. Over the entire 15-year study period, the technique used for IABP insertion changed from femoral cutdown to percutaneous insertion, and the diameter of the balloon catheter used decreased. When the year of operation was excluded from the logistic regression model of risk analysis for vascular complications, reduction of the catheter size to a 9.5-French catheter appeared to be a significant independent factor in reducing vascular complications, especially major ones. This finding is in agreement with other reports [14, 15].
The third independent risk factor, the preoperative end-diastolic pressure, reflected to a great extent the degree of cardiac dysfunction. This suggests that the development of vascular complications is enhanced by a depressed preoperative cardiac function.
The final independent risk factor identified was the timing of IABP insertion. There was a significantly increased incidence of vascular complications associated with preoperative insertion of the IABP. Severe hemodynamic instability of some duration may predispose patients to the development of vascular complications. However, uncontrolled confounders such as the place of IABP insertion or less than ideal circumstances for insertion may be important. When we analyzed only those patients who survived the day of IABP insertion for major vascular complications, body surface area was independently significant; the risk was higher for patients who had a smaller body surface area, which may reflect a smaller arterial diameter.
We did not identify age, female gender, hypertension, diabetes, or a percutaneous IABP insertion technique to be significant risk factors for IABP-related vascular complications, in contrast to other reports [6, 8, 9, 15–17]. Late IABP-related vascular sequelae were few and occurred almost exclusively in patients who had experienced early complications. In agreement with Barnett and colleagues [8], we did not find IABP-related vascular complications to be significant risk factors for early or late mortality, regardless of whether patients who died on the day of IABP insertion were included in the analysis. The occurrence of vascular complications did not significantly affect the long-term survival of our patients. This in contrast to a recent report by Busch and associates [9], who found that the mortality rate was significantly higher for patients with ischemic vascular complications (59.6%) than for patients with no vascular complications (30.1%). Risk analysis of postoperative morbidity, represented by organ failure and clinical sepsis, showed factors other than the development of vascular complications to be significant independent risk factors.
This study confirms that the use of the IABP is associated with numerous vascular complications. The presence of peripheral vascular disease is the most significant independent risk factor for the development of vascular complications in patients who are treated with the IABP. Careful vascular assessment before and after IABP insertion is important for early diagnosis and management of these events. Early removal of the balloon, whenever possible, accompanied by bidirectional thromboembolectomy, usually saves the limb. The significant decrease in the risk of major vascular complications that has occurred over the few years appears to be due to a decrease in the size of the catheters used to 9.5-French catheters. Late IABP-related morbidity was rare in this study and most often related to early complications.
Vascular complications associated with IABP insertion did not influence short- or long-term survival among the high-risk patients in this study. However, the timing of IABP insertion and the duration of its use significantly affected patient prognosis.
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References |
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TopAbstractIntroductionPatients and methodsResultsCommentReferences |
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