Asian Cardiovasc Thorac Ann 2007;15:408-412
© 2007 Asia Publishing EXchange Ltd
Long Intraaortic Balloon Treatment Time Leads to More Vascular Complications
Jan T Christenson, MD,
Jorge Sierra, MD,
Jacques-André Romand, MD1,
Marc Licker, MD1,
Afksendyios Kalangos, MD
Department of Cardiovascular Surgery
1 Department of Anesthesiology, Pharmacology and Surgical Intensive Care, University Hospital of Geneva, Geneva, Switzerland
For reprint information contact: Jan T Christenson, MD, Tel: 41 22 372 7872, Fax: 41 22 372 7634, Email: jan.christenson{at}hcuge.ch, Department of Cardiovascular Surgery, University Hospital of Geneva, 24 rue Micheli-du-Crest, CH-1211 Geneva 14, Switzerland.
 |
ABSTRACT
|
|---|
Intraaortic balloon counterpulsation is an established and efficient therapy. Limb ischemia is the most common complication. The impact of treatment duration on balloon-related complications was analyzed retrospectively in 135 patients who underwent balloon counterpulsation between 1998 and 2004. Thirty high-risk coronary patients required preoperative intraaortic balloon therapy, 41 were in preoperative cardiogenic shock, and 64 needed support for difficulties in weaning from cardiopulmonary bypass. No balloon-related mortality occurred. The overall balloon-related complication rate was 20/135 (14.8%); 18 had limb ischemia, of whom 6 (4.4%) required vascular interventions. Intraaortic balloon treatment time was significantly longer in patients who developed limb ischemia (99.8 ± 54.1 h) compared to those who did not (34.4 ± 30.4 h). Preoperative therapy had short treatment times and few complications. Intraaortic balloon pumping provides effective circulatory support with a low complication rate. A clear relationship was established between duration of treatment and balloon-related complications. Independent risk factors for balloon-related complications were long treatment time, acute myocardial infarction, age over 65 years, and ejection fraction less than 0.30.
|
INTRODUCTION
|
|---|
The intraaortic balloon pump (IABP) is the most investigated and simplest of all circulatory assist devices available. It was introduced in the 1960s to support the failing heart by increasing coronary perfusion, thus lowering the oxygen demand of the myocardium.1 There have been numerous reports of the positive effects of IABP support, and recent data suggest a steadily increasing utilization rate of IABP both in cardiology and cardiac surgery.2–4 New indications for IABP use have emerged, such as proactive, preventive and/or pre-interventional therapy in high-risk patients, where its efficacy has improved outcomes.5–10 Technical advances in both the balloon catheter (e.g., smaller size) and the control console, as well as the percutaneous catheter insertion technique have made balloon pumping more reliable.11 As with all invasive technologies, the IABP is not free from therapy-related complications, and these have dissuaded many physicians from its use, which is reflected in the large variations in use between institutions and continents.2,12–14 However, some recent studies have demonstrated a much lower incidence of IABP-related complications, most likely due to increased experience by operators as well as the technical improvements.2,11,15 Vascular complications (limb ischemia) following femoral insertion of the balloon catheter remain the most frequently observed problems.15,16 Earlier attempts to determine the reasons for these vascular complications failed due to lack of accurate information and small series;17 with the exception of a recent study by Cohen and colleagues.11 A retrospective analysis was undertaken with the specific aim of defining whether a relationship between duration of therapy and balloon-related complications does indeed exist, and also to identify other factors that might predispose to IABP-related complications.
|
PATIENTS AND METHODS
|
|---|
The study endpoints were clinical outcome of IABP treatment (mortality and morbidity) in relation to indications for use, IABP-related complications (bleeding, limb ischemia including arterial injury and peripheral embolization, infection, thrombocytopenia, and neurological deficits), need for postoperative inotropic support, and relationship between IABP-related complications and duration of treatment. All 135 patients receiving an IABP and admitted to the department of surgery or the surgical intensive care unit between January 1998 and December 2004 were included in this retrospective analysis of files stored in our computer database. The study was approved by the Central Ethical Commission of the University Hospital of Geneva (project no: 02-202R), according to the laws and regulations applying in Switzerland regarding retrospective studies involving patients. Patient demographics, indications for IABP use, insertion time, total treatment time, and IABP-related complications were analyzed. Data sets were complete for all patients enrolled in the study. There were no exclusion criteria set for this study. Demographic data for the entire series as well as the 3 subgroups studied is presented in Table 1
. Peripheral arterial pulses were present in all limbs used for IABP catheter insertion.
High-risk coronary patients were defined as those presenting with at least 2 of the following criteria: left ventricular ejection fraction (LVEF) 
0.30, unstable angina despite optimal pharmacological therapy, main stem coronary artery stenosis > 70%, redo cardiac surgery, or diffuse coronary artery disease requiring > 4 distal anastomosis. Cardiogenic shock was defined as: hemodynamic instability refractory to volume optimization and inotropic support, systolic arterial blood pressure < 90 mm Hg, cardiac index < 2 L·min–1·m–2, and pulmonary capillary wedge pressure > 18 mm Hg. Peripheral vascular disease was history and/or physical examination showing Fontaine class 2 or higher, or previous vascular surgery for arterial insufficiency. Peri-/postoperative IABP therapy was initiated when the cardiac index could not be maintained at > 2 L·min–1·m–2 postoperatively despite pharmacological support (dopamine 15 µg·kg–1·min–1, dobutamine 5 to 10 µg·kg–1·min–1, amrinone 0.5 mg·kg–1 bolus dose, or a combination of drugs). Minimal postoperative pharmacological support was defined as single-drug therapy: dopamine < 5 µg·kg–1·min–1. Massive inotropic support was defined as dopamine at least 15 µg·kg–1·min–1, dobutamine 5–10 µg·kg–1·min–1, amrinone 0.5 mg·kg–1 bolus dose, or a combination of these drugs.
Student’s t test, the Mann-Whitney U test, and Fisher’s exact test were employed to assess differences between groups, where appropriate. A probability level of p < 0.05 was regarded significant. All data are presented as mean ± standard deviation. A stepwise multivariate logistic regression analysis was performed to identify independent predictors of IABP-related complications. A potential risk factor had to have an odds ratio with a 95% confidence interval with a lower limit of at least 1. Potential co-variables considered were: age (> 65 years), sex (female), peripheral vascular disease, diabetes mellitus, cardiogenic shock, size of catheter (9.5F and 8F), time of insertion (preoperative or postoperative), preoperative LVEF < 0.30, and acute myocardial infarction (AMI).
|
RESULTS
|
|---|
The IABP was inserted using sheathless percutaneous insertion techniques in all patients, and there was no failure to place the balloon. All patients received anticoagulation therapy with intravenous heparin infusion during IABP treatment, with a target partial thromboplastin time > 40 sec, and prophylactic antibiotics (cefazolin 1g x 4 for 24 hours). Thyroid hormones were not given to any patient before starting postoperative IABP support. A 9.5F balloon catheter was used in 41 patients in the early part of the study; during the later period, all 94 patients had 8F catheters (Datascope, Inc., Fairfield, NJ, USA). A Datascope console unit was used in all cases. Table 2 indicates when and where IABP therapy started.
In 28 of the 39 patients who died, the IABP was in place (Table 3). There was no IABP-related mortality. There was a lower hospital mortality rate in patients given an IABP preoperatively compared to those requiring postoperative IABP insertion: 3.3% (1/30) vs 26.6% (17/64), p = 0.043. For patients admitted in cardiogenic shock, the hospital mortality was significantly lower when IABP therapy was started early, well prior to surgery, compared to when it was started in the postoperative phase: 44.1% (15/34) vs 85.7% (6/7); however, these differences did not reach statistical significance. Significantly fewer patients required massive postoperative pharmacological support in the group given preoperative IABP therapy (p < 0.0001) compared to the other 2 groups. The overall IABP treatment time for surviving patients ranged from 8 to 199 hours, and the overall IABP-related complication rate was 14.8% (Table 4). Peripheral circulation was restored after removal of the IABP in the 12 (8.9%) patients who had minor limb ischemia, but 6 (4.4%) required a vascular surgical intervention: thrombectomy in 1, and vascular repair or reconstruction in 5. One patient suffered partial limb paralysis, and another with known peripheral vascular disease developed severe limb ischemia during IABP treatment and required a femorodistal graft, which occluded 4 months later. This patient had a lower limb amputation due to persistent ischemia 1 month later. The IABP treatment time was significantly longer for those who developed ischemic symptoms (p < 0.001). Complication rates observed for different length of IABP treatment are shown in Figure 1. There was no significant difference in IABP treatment time between patients who developed major or minor limb ischemia, nor between patients who had postoperative IABP insertion and those who were in cardiogenic shock, but preoperative IABP therapy resulted in a significantly shorter IABP treatment time (p < 0.001).
Four variables were found to be independent predictors of IABP-related complications: longer duration of IABP treatment (odds ratio 3.8), AMI (odds ratio 2.4), age > 65 years (odds ratio 1.4), and LVEF < 0.30 (odds ratio 1.2). Other potential risk factors for IABP-related complications evaluated, such as smaller catheter size, diabetes mellitus, female sex, and presence of peripheral vascular disease, did not emerge as statistically significant independent risk factors.
|
DISCUSSION
|
|---|
The IABP is routinely used in serious cardiovascular conditions ranging from hemodynamic stabilization in complications of AMI or cardiogenic shock, to very high-risk patients undergoing angioplasty or coronary bypass grafting.4,11 Intraaortic balloon pump use has continued to increase with the expansion of interventional cardiology and the increase in age and critical status of cardiac surgical patients.5,6 Despite the current era of ventricular assist devices and artificial hearts, the IABP remains the mainstay of therapy in acute coronary syndromes or postcardiotomy heart failure, although high IABP-related complication rates have deterred some from its routine use.2,4,17,18 Most reports on IABP complications have been retrospective and covered extended periods during which the overall care of these severely sick patients has improved. Intraaortic balloon pump-catheter size, peripheral arterial disease, and cardiogenic shock have been identified as independent predictors of IABP-related complications using multivariate regression analysis.19 Smaller catheters, increased experience, and better surveillance has led to a marked decrease in complication rates, with major complications occurring in only 2.7%.4,11,15 However, these multicenter studies, although including large populations, were based on registry data that may not be representative of the entire spectrum of clinical practice. This study was undertaken to demonstrate the IABP experience from a single institution. In this series, vascular complications, particularly limb ischemia, remained the most frequently observed complication, with hemorrhage, embolic events, and infection occurring less frequently.13,4,15 Our incidence of vascular complications agrees with recent reports.12,13,16
Whether a relationship exists between duration of IABP therapy and vascular complications is still debated. Some studies were unable to demonstrate a relationship between treatment duration and vascular complications, while others suggested but did not prove that duration of therapy may be a predictor of IABP-related complications.17,20 In agreement with earlier studies, hospital mortality in this series differed significantly between groups, as did the need for inotropic and vasoactive pharmacological support.2,4,15 Massive doses of vasoactive substances may contribute to vascular complications due to severe vasoconstriction, but more important is IABP-catheter insertion where the arterial lumen is already partly obstructed. Treatment time also differed between groups, with a shorter duration of treatment in the preoperative IABP group. Shorter IABP therapy was associated with a lower IABP-related complication rate. Preoperative therapy in high-risk coronary patients results in improved cardiac function immediately after myocardial revascularization.20 This is reflected in shorter IABP treatment times and diminished requirement for inotropics. Four independent predictors of IABP-related complications were identified (duration of IABP therapy, AMI, age > 65 years, and LVEF < 0.30). Other potential risk factors were not confirmed, although there was a trend towards more complications with larger catheter size and female sex, which agrees with earlier reports.4,15,19
It was concluded that intraaortic counterpulsation is an effective method of circulatory support for high-risk cardiac surgery patients, with a low IABP-related complication rate. Limb ischemia was the most frequently observed complication. Preoperative IABP therapy in patients with high operative risk was associated with a significantly lower hospital mortality, less need for massive pharmacological support, and significantly shorter IABP treatment times compared to postoperative IABP insertion. A relationship between duration of IABP treatment and IABP-related complications was established. Independent risk factors for IABP-related complications were prolonged treatment time, AMI, age > 65 years, and LVEF < 0.30. In patients presenting in cardiogenic shock, hospital mortality remains high despite IABP therapy in addition to medical treatment.
|
REFERENCES
|
|---|
- Kantrowitz A, Tjonneland S, Freed PS, Phillips SJ, Butner AN, Sherman JL Jr. Initial clinical experience with intraaortic balloon pumping in cardiogenic shock. JAMA 1968;203:113–8.[Abstract/Free Full Text]
- Baskett RJ, Ghali WA, Maitland A, Hirsch GM. The intraaortic balloon pump in cardiac surgery [Review]. Ann Thorac Surg 2002;74:1276–87.[Abstract/Free Full Text]
- Ferguson JJ 3rd, Cohen M, Freedman RJ Jr, Stone GW, Miller MF, Joseph DL, et al. The current practice of intra-aortic balloon counterpulsation: results from the Benchmark Registry. J Am Coll Cardiol 2001;38:1456–62.[Abstract/Free Full Text]
- Stone GW, Ohman EM, Miller MF, Joseph DL, Christenson JT, Cohen M, et al. Contemporary utilization and outcomes of intra-aortic balloon counterpulsation in acute myocardial infarction. J Am Coll Cardiol 2003;41:1940–5.[Abstract/Free Full Text]
- Gutfinger DE, Ott RA, Miller M. Aggressive preoperative use of intraaortic balloon pump in elderly patients undergoing coronary artery bypass grafting. Ann Thorac Surg 1999;67:610–3.[Abstract/Free Full Text]
- Christenson JT, Badel P, Simonet F, Schmuziger M. Preoperative intraaortic balloon pump enhances cardiac performance and improves outcome of redo CABG. Ann Thorac Surg 1997;64:1237–44.[Abstract/Free Full Text]
- Craver JM, Murrah CP. Elective intraaortic counterpulsation for high-risk off-pump coronary artery bypass operations. Ann Thorac Surg 2001;71:1220–3.[Abstract/Free Full Text]
- Fasseas P, Cohen M, Kopistansky C, Bowers B, McCormick DJ, Kasper K, et al. Pre-operative intra-aortic balloon counterpulsation in stable patients with left main coronary disease. J Invasive Cardiol 2001;13:679–83.[Medline]
- Christenson JT, Schmuziger M, Simonet F. Effective surgical management of high-risk coronary patients using preoperative intra-aortic balloon counterpulsation therapy. Cardiovasc Surg 2001:9:383–90.[Medline]
- Holman WL, Li Q, Kiefe CI, McGriffin DC, Peterson ED, Allman RM, et al. Prophylactic value of preincision intra-aortic balloon pump: analysis of a statewide experience. J Thorac Cardiovasc Surg 2000;120:1112–9.[Abstract/Free Full Text]
- Cohen M, Ferguson JJ, Freedman RJ, Miller MF, Reddy RC, Ohman EM, et al. Comparison of outcomes after 8 vs. 9.5 French size intra-aortic balloon counterpulsation catheters based on 9,332 patients in the Benchmark registry. Catheter Cardiovasc Interv 2002;56:200–6.[Medline]
- Mand’ak J, Lonsky, Dominik J, Zacek P. Vascular complications of the intra-aortic balloon counterpulsation. Angiology 2005;56:69–74.[Abstract/Free Full Text]
- Elahi MM, Chetty GK, Kirke R, Azeem T, Hartshorne R, Spyt TJ. Complications related to intra-aortic balloon pump in cardiac surgery: a decade later. Eur J Vasc Endovasc Surg 2005;29:591–4.[Medline]
- Cohen M, Dawson MS, Kopistansky C, McBride R. Sex and other predictors of intra-aortic balloon counterpulsation-related complications: prospective study of 1119 consecutive patients. Am Heart J 2000;139:282–7.[Medline]
- Christenson JT, Cohen M, Ferguson JJ 3rd, Freedman RJ, Miller MF, Ohman EM, et al. Trends in IABP complications and outcomes in cardiac surgery. Ann Thorac Surg 2002:74:1086–91.[Abstract/Free Full Text]
- Erdogan HB, Goksedef D, Erentug V, Polat A, Bozbuga N, Mansuroglu D, et al. In which patients should sheathless IABP be used? An analysis of vascular complications in 1211 cases. J Card Surg 2006;21:342–6.[Medline]
- Manord JD, Garrard CL, Mehra MR, Sternbergh WC 3rd, Ballinger B, Ventura HO, et al. Implications for the vascular surgeon with prolonged (3 to 89 days) intraaortic balloon pump counterpulsation. J Vasc Surg 1997;26:511–6.[Medline]
- Christenson JT, Simonet F, Schmuziger M. Economic impact of preoperative intraaortic balloon pump therapy in high-risk coronary patients. Ann Thorac Surg 2000;70:510–5.[Abstract/Free Full Text]
- Scholz KH, Ragab S, von zur Muhlen F, Schroder T, Werner GS, Mindel L, et al. Complications of intra-aortic balloon counterpulsation. The role of catheter size and duration of support in a multivariate analysis of risk. Eur Heart J 1998;19:458–65.[Abstract/Free Full Text]
- Meharwal ZS, Trehan N. Vascular complications of intra-aortic balloon insertion in patients undergoing coronary revascularization: analysis of 911 cases. Eur J Cardiothorac Surg 2002;21:741–7.[Abstract/Free Full Text]
TOP
ABSTRACT
INTRODUCTION
