Acute Cardiac Care, June 2014; 16(2): 74–77 Copyright © 2014 Informa UK, Ltd ISSN 1748-2941 print/ISSN 1748-295X online DOI: 10.3109/17482941.2014.889311
ORIGINAL ARTICLE
Duration of intra-aortic balloon pump use and related complications Konstantinos Dean Boudoulas, Theodore Bowen, Andrew Pederzolli, Kyle Pfahl, Vincent J Pompili & Ernest L. Mazzaferri Jr Division of Cardiovascular Medicine, Section of Interventional Cardiology, The Ohio State University Medical Center, Columbus, Ohio, USA
often used in conjunction with an IABP may further increase bleeding. In addition, we have shown previously that gastrointestinal bleeding is not uncommon in these cases (11). The risk for complications potentially increases with longer duration of IABP use (12,13). Several studies in STEMI with or without cardiogenic shock have shown that use of an IABP does not decrease mortality (10,14–18). In certain individual patients, however, the use of an IABP may become necessary. When an IABP is placed, attempts should be made to minimize the incidence of complications related to its use. The present study was undertaken to define the vascular complications and the incidence of bleeding in relation to the duration of IABP use in patients with STEMI that have undergone PCI.
Background: Intra-aortic balloon pump (IABP) use may be associated with complications; however, in certain patients with ST-elevation myocardial infarction (STEMI) with hemodynamic instability refractory to medical management its use may become necessary. Methods: 36 STEMI patients with IABP placement for hemodynamic instability after percutaneous coronary intervention were studied. IABP duration ranged from one to seven days (median two days). Based on median time, patients were divided into two groups: IABP duration ⱕ 2 days (n ⴝ 27) or ⬎ 2 days (n ⴝ 9). Vascular complications and incidence of bleeding were compared. Results: Mean IABP duration was 1.4 ⴞ 0.5 and 4.1 ⴞ 1.3 days in ⱕ 2 day and ⬎ 2 day groups, respectively (P ⬍ 0.01). Glycoprotein IIb/IIIa inhibitor and anti-coagulation use was not significantly different between groups. Mean duration of anti-coagulation was 1.9 ⴞ 1.2 and 4.5 ⴞ 1.3 days in ⱕ 2 day and ⬎ 2 day groups, respectively (P ⬍ 0.05). Complications (vascular, access site bleeding, gastrointestinal bleeding) were significantly greater in ⬎ 2 day group (66%) compared to ⱕ 2 day group (18%; P ⬍ 0.05). Conclusions: When an IABP was used for more than two days complications significantly increased. The clinical implications of the study will be strengthened if the findings are confirmed in a prospective study with a larger number of patients.
Methods Study population Patients with an acute STEMI where an IABP was used after PCI due to hemodynamic instability refractory to medical management who were hospitalized at the Richard M. Ross Heart Hospital at The Ohio State University Medical Center (Columbus, Ohio, USA) from October 2008 to November 2010 were retrospectively analyzed. A total of 36 patients were identified where an IABP was used. In these patients, the range in time of IABP use was one to seven days with a median duration of two days. The median value was used to divide the patients into two groups: patients with IABP duration of ⱕ 2 days (n ⫽ 27) and those with ⬎ 2 days (n ⫽ 9). All vascular complications and incidence of bleeding were recorded and differences were compared between groups. The IABP was inserted through an 8F femoral artery sheath and then advanced to the descending aorta using fluoroscopy
Keywords: Intra-aortic balloon pump, complication
Introduction Intra-aortic balloon pump (IABP) has been used in hemodynamic unstable patients with ST-elevation myocardial infarction (STEMI) along with percutaneous coronary intervention (PCI) (1–6). The larger sheath required for IABP insertion increases the risk for vascular complications and the incidence of bleeding (6–10). Anti-coagulation that is
Correspondence: Konstantinos Dean Boudoulas, Assistant Professor of Medicine/Cardiology, Department of Medicine, Division of Cardiovascular Medicine, The Ohio State University, 473 W. 12th Avenue, Suite 200, Columbus, Ohio 43210, USA. Tel: ⫹ 1 614 293 7885. E-mail: kdboudoulas@ osumc.edu (Received 26 July 2013; accepted 14 January 2014)
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Intra-aortic balloon pump use and complications guidance in standard fashion (19,20). Removal of IABP was based on hemodynamic recovery of the patient. Manual pressure was used to achieve hemostasis upon IABP and sheath removal. Complications The incidence of vascular complications including formation of arteriovenous fistula, pseudoaneurysm, leg ischemia, mesenteric ischemia and/or aortic dissection/rupture during IABP use was determined. Bleeding was defined as a patient requiring at least one unit of packed red blood cell (PRBC) transfusion during IABP use resulting from access site/ hematoma, retroperitoneal, gastrointestinal and/or genitourinary bleeding; anti-coagulation that is used along with an IABP may exacerbate gastrointestinal and genitourinary bleeding, as previously described (11). Statistical analysis Descriptive data are presented as mean ⫾ standard deviation and categorical data as a total number and percent of total number of patients. To determine statistical significance between groups a Fisher's exact test for categorical data or a Student's t-test were performed where appropriate. A P-value ⬍ 0.05 was considered as statistically significant.
Results Baseline characteristics are shown in Table I. The incidence of diabetes mellitus was 33% in each group. There was no significant difference in previous history of gastrointestinal bleeding between the two groups. Likewise, there was no significant difference in the mean left ventricular systolic function and frequency of left anterior descending coronary artery PCI between the two groups. Mean duration of IABP was 1.4 ⫾ 0.5 days and 4.1 ⫾ 1.3 days in the ⱕ 2 day and ⬎ 2 day groups, respectively; by definition the difference in the duration of IABP was statistically significant (P ⬍ 0.01).
All patients were receiving aspirin and clopidogrel therapy. Glycoprotein IIb/IIIa inhibitor and anti-coagulation use was not statistically significant between the two groups. Heparin infusion was used in almost all patients except for 1 patient in the ⬎ 2 day group who received heparin for four days followed by argatroban infusion for three days. Mean duration of anti-coagulation was 1.9 ⫾ 1.2 days and 4.5 ⫾ 1.3 days in the ⱕ 2 day and ⬎ 2 day groups, respectively (P ⬍ 0.05). Histamine-2 receptor antagonist or proton pump inhibitor administration during IABP use tended to be utilized more in the ⬎ 2 day group, however, this difference did not reach statistical significance (P ⫽ 0.07). Overall for both groups vascular complications were 5.5% and incidence of bleeding was 27.7%. Vascular complications and incidence of bleeding were significantly greater when the IABP was in use for ⬎ 2 days compared to ⱕ 2 days, 66% versus 18%, respectively (Fisher’s exact test P ⫽ 0.012; Table II). There were no episodes of bacteremia related to IABP in either group. Overall mortality was 30% with no statistical difference between the two groups. In the ⱕ 2 day group vascular complications included mesenteric ischemia (one event) and leg ischemia (one event); bleeding occurred from access site (two events) and gastrointestinal (two events). One individual in the ⱕ 2 day group had both a bleeding and vascular complication; however, this subject was only accounted for once during statistical analysis. The average unit of PRBC transfused in this group was 2.7 ⫾ 1.2 units. In the ⬎ 2 day group there were no vascular complications, while bleeding was all related to access site (six events). The average unit of PRBC transfused in this group was 2.1 ⫾ 1.1 units.
Discussion The use of an IABP is associated with a decrease in afterload and an increase in myocardial blood flow (20–23). For this reason, IABP has been used during STEMI to provide
Table I. Study population: demographics and clinical parameters. Duration of IABP Use
Age (mean ⫾ SD) Gender Male, n (%) Female, n (%) LVEF, % (mean ⫾ SD) Left anterior descending artery PCI, n (%) History of GI bleed, n (%) GP IIb/IIIa inhibitor use, n (%) PPI/H2 antagonist use, n (%) Anti-coagulation post-PCI, days (mean ⫾ SD) Duration of IABP, days (mean ⫾ SD)
ⱕ 2 days (n ⫽ 27)
⬎ 2 days (n ⫽ 9)
60 ⫾ 10
56 ⫾ 7
17 (63) 10 (37) 29 ⫾ 16 17 (62.9) 2 (7.4) 21 (77.7) 18 (66.6) 1.9 ⫾ 1.2 1.4 ⫾ 0.5
7 (78) 2 (22) 22 ⫾ 8 8 (88.8) 1 (11.1) 6 (66.6) 9 (100) 4.5 ⫾ 1.3 4.1 ⫾ 1.3
P-value 0.25 0.68 0.68 0.86 0.22 1.0 0.66 0.07 ⬍ 0.005 ⬍ 0.0005
GI, gastrointestinal; GP IIb/IIIa, glycoprotein IIb/IIIa; H2, histamine-2 receptor; IABP, intra-aortic balloon pump; LVEF, left ventricular ejection fraction; PCI, percutaneous coronary intervention; PPI, proton pump inhibitor; SD, standard deviation. © 2014 Informa UK, Ltd.
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Table II. Duration of intra-aortic balloon pump use in ST-elevation myocardial infarction and related complications.
ⱕ 2 days ⬎ 2 days
Complicationsa
No complication
18% (n ⫽ 5) 66% (n ⫽ 6)
81% (n ⫽ 22) 33% (n ⫽ 3)
aComplications
include vascular and bleeding. One subject had both a vascular and bleeding complication in the ⱕ 2 day group; however, this subject was only accounted for once during statistical analysis. Fisher’s Exact Test P ⫽ 0.012; n, number of patients.
hemodynamic support; however, the efficacy of this procedure has been recently debated (10,14–18). This may be related to complications related to IABP use that may offset its beneficial effects (6–10). Therefore, it is important to define patients at higher risk for developing complications in order to prevent or treat appropriately. The present study addresses these important points. Femoral artery access with a larger sheath required for IABP insertion increases the risk for vascular complications and the incidence of bleeding, which may be further exacerbated when anti-coagulation is used and the device is maintained for a prolonged time period. Studies have shown that bleeding associated with IABP use at the time of PCI ranges from 3–40% (6,8–10), which was consistent with our study that demonstrated an overall incidence of bleeding of 27%. It has also been shown in a metaanalysis of randomized trials that IABP use during STEMI was associated with increased bleeding by 6% compared to not using the device (14). Leg ischemia associated with the use of IABP has been shown to range from 0–14% (7,8,10); our study demonstrated overall vascular complications of 5%. Increasing the duration of IABP use may potentially result in a greater risk in the development of vascular or bleeding complications. In this study, complications were significantly greater when the IABP was in use for ⬎ 2 days compared to ⱕ 2 days by at least three-fold. Complications in the ⬎ 2 day group were all due to access site bleeding most likely exacerbated by prolonged use of anti-coagulation, which was more prevalent compared to when the IABP was used for ⬍ 2 days. This increase in access site bleeding with prolonged IABP use warrants careful patient follow-up for bleeding when the IABP is in use and/or limiting the duration of use if possible. There were no episodes of gastrointestinal bleeding in the ⬎ 2 day group while there were 2 patients in the ⱕ 2 day group that had gastrointestinal bleeding; all patients in the ⬎ 2 day group were taking a histamine-2 receptor antagonist or proton pump inhibitor during IABP use compared to 66% of the patients in the ⱕ 2 day group, however, this did not reach statistical significance (P ⫽ 0.07) most likely due to the small number of patients in this study. Thus, bleeding may not be directly related to access site, as we have shown previously (11). The incidence of gastrointestinal bleeding is not uncommon in acutely ill patients and the use of anti-coagulation will exacerbate this complication (24–26); however, even if patients with gastrointestinal bleeding were excluded
in the analysis, the difference in complications becomes more obvious. When continuously using an IABP, the administration of histamine-2 receptor antagonist or proton pump inhibitor should be considered regardless of duration of IABP use. The ⱕ 2 day group had two vascular complications that included 1 patient with mesenteric ischemia and one with leg ischemia. Thus, vascular complications may manifest early from obstruction of blood flow due to the IABP and/ or from the larger femoral artery sheath required for IABP insertion. Mesenteric ischemia in 1 patient most likely was related to counterpulsation in the descending aorta and/or to the embolization of atheroma resulting in compromise of blood flow. Leg ischemia in 1 patient most likely was due to occlusion of the femoral artery or its branches from the sheath. Awareness of potential vascular complications that may arise in certain patient populations (peripheral vascular disease, abdominal aortic aneurysm, aortic atheroma, other) should be carefully evaluated prior to the consideration of IABP placement. This study has a few limitations. This was a retrospective study and patients were not randomized for the duration of IABP use. In addition, the study consisted of a small number of patients. Despite these limitations, however, the study suggests that complications increase when an IABP is used for greater than two days. Therefore, it is suggested that if an IABP is placed to limit its use to two days or less if possible. Further, an IABP should not be used in patients with significant peripheral vascular disease or aortic atherosclerosis.
Conclusion Complications from IABP use were significantly greater when used for ⬎ 2 days compared to ⱕ 2 days by at least three-fold, which suggests limiting the duration of IABP use if possible to two days or less. Complications in the ⬎ 2 day group were all due to bleeding from the access site most likely exacerbated by prolonged anti-coagulation therapy. Gastrointestinal bleeding was also seen and may be exacerbated by anti-coagulation use, thus the administration of histamine-2 receptor antagonists or proton pump inhibitor should be considered in all patients regardless of the duration of IABP use. All vascular complications were seen in the ⱕ 2 day group suggesting that vascular complications, which are due to obstruction of blood flow from IABP and/ or from the femoral artery sheath, may occur early. Awareness of potential vascular complications that may arise in certain patient populations should be carefully evaluated prior to the consideration of IABP placement. The clinical implications of the study will be strengthened if the findings are confirmed in a prospective study with a larger number of patients. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper. Acute Cardiac Care
Intra-aortic balloon pump use and complications
References 1. Saia F, Grigioni F, Marzocchi A, Branzi A. Management of acute left ventricular dysfunction after primary percutaneous coronary intervention for ST elevation acute myocardial infarction. Am Heart J. 2010;160:S16–S21. 2. Bahekar A, Singh M, Singh S, Bhuriya R, Ahmad K, Khosla S, et al. Cardiovascular outcomes using intra-aortic balloon pump in high-risk acute myocardial infarction with or without cardiogenic shock: a meta-analysis. J Cardiovasc Pharmacol Ther. 2012;17:44–56. 3. Gu J, Hu W, Xiao H, Feng X, Chen Y, Zhang D. Intra-aortic balloon pump improves clinical prognosis and attenuates C-reactive protein level in acute STEMI complicated by cardiogenic shock. Cardiology 2010;117:75–80. 4. Sanborn TA, Sleeper LA, Bates ER, Jacobs AK, Boland J, French JK, et al. Impact of thrombolysis, intra-aortic balloon pump counterpulsation, and their combination in cardiogenic shock complicating acute myocardial infarction: A report from the shock trial registry. Should we emergently revascularize occluded coronaries for cardiogenic shock? J Am Coll Cardiol. 2000;36(Suppl. A):1123–9. 5. Brodie BR, Stuckey TD, Hansen C, Muncy D. Intraaortic balloon counterpulsation before primary percutaneous transluminal coronary angioplasty reduces catheterization laboratory events in high-risk patients with acute myocardial infarction. Am J Cardiol. 1999;84:18–23. 6. Thiele H, Sick P, Boudriot E, Diederich KW, Hambrecht R, Niebauer J. Randomized comparison of intra-aortic balloon support with a percutaneous left ventricular assist device in patients with revascularized acute myocardial infarction complicated by cardiogenic shock. Eur Heart J. 2005;26:1276–83. 7. Seyfarth M, Sibbing D, Bauer I, Fröhlich G, Bott-Flügel L, Byrne R, et al. A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. J Am Coll Cardiol. 2008; 52:1584–8. 8. Cheng JM, den Uil CA, van der Ent M, Jewbali LS, van Domburg RT, et al. Percutaneous left ventricular assist devices vs. intra-aortic balloon pump counterpulsation for treatment of cardiogenic shock: a Ameta-analysis of controlled trials. Eur Heart J. 2009;30:2102–8. 9. Perera D, Stables R, Thomas M, Booth J, Pitt M, Blackman D, et al; BCIS-1 Investigators. Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention a randomized controlled trial. JAMA. 2010;304:867–74. 10. Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, et al. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012;367: 1287–96. 11. Boudoulas KD, Pederzolli A, Saini U, Gumina RJ, Mazzaferri EL Jr, Davis M, et al. Comparison of Impella and intra-aortic balloon pump in high-risk percutaneous coronary intervention: Vascular complications and incidence of bleeding. Acute Card Care. 2012;14:120–4. 12. Parissis H, Soo A, Al-Alao B. Intraaortic balloon pump: Literature review of risk factors related to complications of the intraaortic balloon pump. J Cardiothorac Surg. 2011;6:147.
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13. Valente S, Lazzeri C, Crudeli E, Chiostri M, Giglioli C, Bernardo P, et al. Intraaortic balloon pump: Incidence and predictors of complications in the Florence registry. Clin Cardiol. 2012;35:200–4. 14. Sjauw KD, Engström AE, Vis MM, van der Schaaf RJ, Baan J Jr, Koch KT, et al. A systematic review and meta-analysis of intra-aortic balloon pump therapy in ST-elevation myocardial infarction: Should we change the guidelines? Eur Heart J. 2009;30:459–68. 15. Mahmoudi M, Hauville C, Gaglia MA Jr, Sardi G, Torguson R, Xue Z, et al. The impact of intra-aortic balloon counter-pulsation on in-hospital mortality in patients presenting with anterior ST-elevation myocardial infarction without cardiogenic shock. Cardiovasc Revasc Med. 2012;13:328–30. 16. Ohman EM, George BS, White CJ, Kern MJ, Gurbel PA, Freedman RJ, et al. Use of aortic counterpulsation to improve sustained coronary artery patency during acute myocardial infarction. Results of a randomized trial. The randomized IABP study group. Circulation 1994;90:792–9. 17. Stone GW, Marsalese D, Brodie BR, Griffin JJ, Donohue B, Costantini C, et al. A prospective, randomized evaluation of prophylactic intraaortic balloon counterpulsation in high risk patients with acute myocardial infarction treated with primary angioplasty. Second primary angioplasty in myocardial infarction (PAMI-II) trial investigators. J Am Coll Cardiol. 1997;29:1459–67. 18. van’t Hof AW, Liem AL, de Boer MJ, Hoorntje JC, Suryapranata H, Zijlstra F. A randomized comparison of intraaortic balloon pumping after primary coronary angioplasty in high risk patients with acute myocardial infarction. Eur Heart J. 1999;20:659–65. 19. Mejia VM, Naidu SS, Hermann H. Support devices for high-risk percutaneous coronary interventions. In: Topol EJ, editor. Textbook of interventional cardiology 5th edition. Philadelphia, PA: Saunders Elsevier; 2008. pp. 643–4. 20. Trost JC, Hillis LD. Intra-aortic balloon counterpulsation. Am J Cardiol. 2006;97:1391–8. 21. Williams DO, Korr KS, Gewirtz H, Most AS. The effect of intraaortic balloon counterpulsation on regional myocardial blood flow and oxygen consumption in the presence of coronary artery stenosis in patients with unstable angina. Circulation 1982;66:593–7. 22. Kern MJ, Aguirre F, Bach R, Donohue T, Siegel R, Segal J. Augmentation of coronary blood flow by intraaortic balloon pumping in patients after coronary angioplasty. Circulation 1993;87:500–11. 23. Prondzinsky R, Unverzagt S, Russ M, Lemm H, Swyter M, Wegener N, et al. Hemodynamic effects of intra-aortic balloon counterpulsation in patients with acute myocardial infarction complicated by cardiogenic shock: The prospective, randomized IABP shock trial. Shock 2012;37:378–84. 24. Cook DJ, Reeve BK, Guyatt GH, Heyland DK, Griffith LE, Buckingham L, et al. Stress ulcer prophylaxis in critically ill patients. Resolving discordant meta-analyses. JAMA. 1996;275: 308–14. 25. Cook DJ, Witt LG, Cook RJ, Guyatt GH. Stress ulcer prophylaxis in the critically ill: A meta-analysis. Am J Med. 1991;91:519–27. 26. Alhazzani W, Alenezi F, Jaeschke RZ, Moayyedi P, Cook DJ. Proton pump inhibitors versus histamine 2 receptor antagonists for stress ulcer prophylaxis in critically ill patients: A systematic review and meta-analysis. Crit Care Med. 2013;41:693–705.
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ORIGINAL ARTICLE
Duration of intra-aortic balloon pump use and related complications Konstantinos Dean Boudoulas, Theodore Bowen, Andrew Pederzolli, Kyle Pfahl, Vincent J Pompili & Ernest L. Mazzaferri Jr Division of Cardiovascular Medicine, Section of Interventional Cardiology, The Ohio State University Medical Center, Columbus, Ohio, USA
often used in conjunction with an IABP may further increase bleeding. In addition, we have shown previously that gastrointestinal bleeding is not uncommon in these cases (11). The risk for complications potentially increases with longer duration of IABP use (12,13). Several studies in STEMI with or without cardiogenic shock have shown that use of an IABP does not decrease mortality (10,14–18). In certain individual patients, however, the use of an IABP may become necessary. When an IABP is placed, attempts should be made to minimize the incidence of complications related to its use. The present study was undertaken to define the vascular complications and the incidence of bleeding in relation to the duration of IABP use in patients with STEMI that have undergone PCI.
Background: Intra-aortic balloon pump (IABP) use may be associated with complications; however, in certain patients with ST-elevation myocardial infarction (STEMI) with hemodynamic instability refractory to medical management its use may become necessary. Methods: 36 STEMI patients with IABP placement for hemodynamic instability after percutaneous coronary intervention were studied. IABP duration ranged from one to seven days (median two days). Based on median time, patients were divided into two groups: IABP duration ⱕ 2 days (n ⴝ 27) or ⬎ 2 days (n ⴝ 9). Vascular complications and incidence of bleeding were compared. Results: Mean IABP duration was 1.4 ⴞ 0.5 and 4.1 ⴞ 1.3 days in ⱕ 2 day and ⬎ 2 day groups, respectively (P ⬍ 0.01). Glycoprotein IIb/IIIa inhibitor and anti-coagulation use was not significantly different between groups. Mean duration of anti-coagulation was 1.9 ⴞ 1.2 and 4.5 ⴞ 1.3 days in ⱕ 2 day and ⬎ 2 day groups, respectively (P ⬍ 0.05). Complications (vascular, access site bleeding, gastrointestinal bleeding) were significantly greater in ⬎ 2 day group (66%) compared to ⱕ 2 day group (18%; P ⬍ 0.05). Conclusions: When an IABP was used for more than two days complications significantly increased. The clinical implications of the study will be strengthened if the findings are confirmed in a prospective study with a larger number of patients.
Methods Study population Patients with an acute STEMI where an IABP was used after PCI due to hemodynamic instability refractory to medical management who were hospitalized at the Richard M. Ross Heart Hospital at The Ohio State University Medical Center (Columbus, Ohio, USA) from October 2008 to November 2010 were retrospectively analyzed. A total of 36 patients were identified where an IABP was used. In these patients, the range in time of IABP use was one to seven days with a median duration of two days. The median value was used to divide the patients into two groups: patients with IABP duration of ⱕ 2 days (n ⫽ 27) and those with ⬎ 2 days (n ⫽ 9). All vascular complications and incidence of bleeding were recorded and differences were compared between groups. The IABP was inserted through an 8F femoral artery sheath and then advanced to the descending aorta using fluoroscopy
Keywords: Intra-aortic balloon pump, complication
Introduction Intra-aortic balloon pump (IABP) has been used in hemodynamic unstable patients with ST-elevation myocardial infarction (STEMI) along with percutaneous coronary intervention (PCI) (1–6). The larger sheath required for IABP insertion increases the risk for vascular complications and the incidence of bleeding (6–10). Anti-coagulation that is
Correspondence: Konstantinos Dean Boudoulas, Assistant Professor of Medicine/Cardiology, Department of Medicine, Division of Cardiovascular Medicine, The Ohio State University, 473 W. 12th Avenue, Suite 200, Columbus, Ohio 43210, USA. Tel: ⫹ 1 614 293 7885. E-mail: kdboudoulas@ osumc.edu (Received 26 July 2013; accepted 14 January 2014)
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Intra-aortic balloon pump use and complications guidance in standard fashion (19,20). Removal of IABP was based on hemodynamic recovery of the patient. Manual pressure was used to achieve hemostasis upon IABP and sheath removal. Complications The incidence of vascular complications including formation of arteriovenous fistula, pseudoaneurysm, leg ischemia, mesenteric ischemia and/or aortic dissection/rupture during IABP use was determined. Bleeding was defined as a patient requiring at least one unit of packed red blood cell (PRBC) transfusion during IABP use resulting from access site/ hematoma, retroperitoneal, gastrointestinal and/or genitourinary bleeding; anti-coagulation that is used along with an IABP may exacerbate gastrointestinal and genitourinary bleeding, as previously described (11). Statistical analysis Descriptive data are presented as mean ⫾ standard deviation and categorical data as a total number and percent of total number of patients. To determine statistical significance between groups a Fisher's exact test for categorical data or a Student's t-test were performed where appropriate. A P-value ⬍ 0.05 was considered as statistically significant.
Results Baseline characteristics are shown in Table I. The incidence of diabetes mellitus was 33% in each group. There was no significant difference in previous history of gastrointestinal bleeding between the two groups. Likewise, there was no significant difference in the mean left ventricular systolic function and frequency of left anterior descending coronary artery PCI between the two groups. Mean duration of IABP was 1.4 ⫾ 0.5 days and 4.1 ⫾ 1.3 days in the ⱕ 2 day and ⬎ 2 day groups, respectively; by definition the difference in the duration of IABP was statistically significant (P ⬍ 0.01).
All patients were receiving aspirin and clopidogrel therapy. Glycoprotein IIb/IIIa inhibitor and anti-coagulation use was not statistically significant between the two groups. Heparin infusion was used in almost all patients except for 1 patient in the ⬎ 2 day group who received heparin for four days followed by argatroban infusion for three days. Mean duration of anti-coagulation was 1.9 ⫾ 1.2 days and 4.5 ⫾ 1.3 days in the ⱕ 2 day and ⬎ 2 day groups, respectively (P ⬍ 0.05). Histamine-2 receptor antagonist or proton pump inhibitor administration during IABP use tended to be utilized more in the ⬎ 2 day group, however, this difference did not reach statistical significance (P ⫽ 0.07). Overall for both groups vascular complications were 5.5% and incidence of bleeding was 27.7%. Vascular complications and incidence of bleeding were significantly greater when the IABP was in use for ⬎ 2 days compared to ⱕ 2 days, 66% versus 18%, respectively (Fisher’s exact test P ⫽ 0.012; Table II). There were no episodes of bacteremia related to IABP in either group. Overall mortality was 30% with no statistical difference between the two groups. In the ⱕ 2 day group vascular complications included mesenteric ischemia (one event) and leg ischemia (one event); bleeding occurred from access site (two events) and gastrointestinal (two events). One individual in the ⱕ 2 day group had both a bleeding and vascular complication; however, this subject was only accounted for once during statistical analysis. The average unit of PRBC transfused in this group was 2.7 ⫾ 1.2 units. In the ⬎ 2 day group there were no vascular complications, while bleeding was all related to access site (six events). The average unit of PRBC transfused in this group was 2.1 ⫾ 1.1 units.
Discussion The use of an IABP is associated with a decrease in afterload and an increase in myocardial blood flow (20–23). For this reason, IABP has been used during STEMI to provide
Table I. Study population: demographics and clinical parameters. Duration of IABP Use
Age (mean ⫾ SD) Gender Male, n (%) Female, n (%) LVEF, % (mean ⫾ SD) Left anterior descending artery PCI, n (%) History of GI bleed, n (%) GP IIb/IIIa inhibitor use, n (%) PPI/H2 antagonist use, n (%) Anti-coagulation post-PCI, days (mean ⫾ SD) Duration of IABP, days (mean ⫾ SD)
ⱕ 2 days (n ⫽ 27)
⬎ 2 days (n ⫽ 9)
60 ⫾ 10
56 ⫾ 7
17 (63) 10 (37) 29 ⫾ 16 17 (62.9) 2 (7.4) 21 (77.7) 18 (66.6) 1.9 ⫾ 1.2 1.4 ⫾ 0.5
7 (78) 2 (22) 22 ⫾ 8 8 (88.8) 1 (11.1) 6 (66.6) 9 (100) 4.5 ⫾ 1.3 4.1 ⫾ 1.3
P-value 0.25 0.68 0.68 0.86 0.22 1.0 0.66 0.07 ⬍ 0.005 ⬍ 0.0005
GI, gastrointestinal; GP IIb/IIIa, glycoprotein IIb/IIIa; H2, histamine-2 receptor; IABP, intra-aortic balloon pump; LVEF, left ventricular ejection fraction; PCI, percutaneous coronary intervention; PPI, proton pump inhibitor; SD, standard deviation. © 2014 Informa UK, Ltd.
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Table II. Duration of intra-aortic balloon pump use in ST-elevation myocardial infarction and related complications.
ⱕ 2 days ⬎ 2 days
Complicationsa
No complication
18% (n ⫽ 5) 66% (n ⫽ 6)
81% (n ⫽ 22) 33% (n ⫽ 3)
aComplications
include vascular and bleeding. One subject had both a vascular and bleeding complication in the ⱕ 2 day group; however, this subject was only accounted for once during statistical analysis. Fisher’s Exact Test P ⫽ 0.012; n, number of patients.
hemodynamic support; however, the efficacy of this procedure has been recently debated (10,14–18). This may be related to complications related to IABP use that may offset its beneficial effects (6–10). Therefore, it is important to define patients at higher risk for developing complications in order to prevent or treat appropriately. The present study addresses these important points. Femoral artery access with a larger sheath required for IABP insertion increases the risk for vascular complications and the incidence of bleeding, which may be further exacerbated when anti-coagulation is used and the device is maintained for a prolonged time period. Studies have shown that bleeding associated with IABP use at the time of PCI ranges from 3–40% (6,8–10), which was consistent with our study that demonstrated an overall incidence of bleeding of 27%. It has also been shown in a metaanalysis of randomized trials that IABP use during STEMI was associated with increased bleeding by 6% compared to not using the device (14). Leg ischemia associated with the use of IABP has been shown to range from 0–14% (7,8,10); our study demonstrated overall vascular complications of 5%. Increasing the duration of IABP use may potentially result in a greater risk in the development of vascular or bleeding complications. In this study, complications were significantly greater when the IABP was in use for ⬎ 2 days compared to ⱕ 2 days by at least three-fold. Complications in the ⬎ 2 day group were all due to access site bleeding most likely exacerbated by prolonged use of anti-coagulation, which was more prevalent compared to when the IABP was used for ⬍ 2 days. This increase in access site bleeding with prolonged IABP use warrants careful patient follow-up for bleeding when the IABP is in use and/or limiting the duration of use if possible. There were no episodes of gastrointestinal bleeding in the ⬎ 2 day group while there were 2 patients in the ⱕ 2 day group that had gastrointestinal bleeding; all patients in the ⬎ 2 day group were taking a histamine-2 receptor antagonist or proton pump inhibitor during IABP use compared to 66% of the patients in the ⱕ 2 day group, however, this did not reach statistical significance (P ⫽ 0.07) most likely due to the small number of patients in this study. Thus, bleeding may not be directly related to access site, as we have shown previously (11). The incidence of gastrointestinal bleeding is not uncommon in acutely ill patients and the use of anti-coagulation will exacerbate this complication (24–26); however, even if patients with gastrointestinal bleeding were excluded
in the analysis, the difference in complications becomes more obvious. When continuously using an IABP, the administration of histamine-2 receptor antagonist or proton pump inhibitor should be considered regardless of duration of IABP use. The ⱕ 2 day group had two vascular complications that included 1 patient with mesenteric ischemia and one with leg ischemia. Thus, vascular complications may manifest early from obstruction of blood flow due to the IABP and/ or from the larger femoral artery sheath required for IABP insertion. Mesenteric ischemia in 1 patient most likely was related to counterpulsation in the descending aorta and/or to the embolization of atheroma resulting in compromise of blood flow. Leg ischemia in 1 patient most likely was due to occlusion of the femoral artery or its branches from the sheath. Awareness of potential vascular complications that may arise in certain patient populations (peripheral vascular disease, abdominal aortic aneurysm, aortic atheroma, other) should be carefully evaluated prior to the consideration of IABP placement. This study has a few limitations. This was a retrospective study and patients were not randomized for the duration of IABP use. In addition, the study consisted of a small number of patients. Despite these limitations, however, the study suggests that complications increase when an IABP is used for greater than two days. Therefore, it is suggested that if an IABP is placed to limit its use to two days or less if possible. Further, an IABP should not be used in patients with significant peripheral vascular disease or aortic atherosclerosis.
Conclusion Complications from IABP use were significantly greater when used for ⬎ 2 days compared to ⱕ 2 days by at least three-fold, which suggests limiting the duration of IABP use if possible to two days or less. Complications in the ⬎ 2 day group were all due to bleeding from the access site most likely exacerbated by prolonged anti-coagulation therapy. Gastrointestinal bleeding was also seen and may be exacerbated by anti-coagulation use, thus the administration of histamine-2 receptor antagonists or proton pump inhibitor should be considered in all patients regardless of the duration of IABP use. All vascular complications were seen in the ⱕ 2 day group suggesting that vascular complications, which are due to obstruction of blood flow from IABP and/ or from the femoral artery sheath, may occur early. Awareness of potential vascular complications that may arise in certain patient populations should be carefully evaluated prior to the consideration of IABP placement. The clinical implications of the study will be strengthened if the findings are confirmed in a prospective study with a larger number of patients. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper. Acute Cardiac Care
Intra-aortic balloon pump use and complications
References 1. Saia F, Grigioni F, Marzocchi A, Branzi A. Management of acute left ventricular dysfunction after primary percutaneous coronary intervention for ST elevation acute myocardial infarction. Am Heart J. 2010;160:S16–S21. 2. Bahekar A, Singh M, Singh S, Bhuriya R, Ahmad K, Khosla S, et al. Cardiovascular outcomes using intra-aortic balloon pump in high-risk acute myocardial infarction with or without cardiogenic shock: a meta-analysis. J Cardiovasc Pharmacol Ther. 2012;17:44–56. 3. Gu J, Hu W, Xiao H, Feng X, Chen Y, Zhang D. Intra-aortic balloon pump improves clinical prognosis and attenuates C-reactive protein level in acute STEMI complicated by cardiogenic shock. Cardiology 2010;117:75–80. 4. Sanborn TA, Sleeper LA, Bates ER, Jacobs AK, Boland J, French JK, et al. Impact of thrombolysis, intra-aortic balloon pump counterpulsation, and their combination in cardiogenic shock complicating acute myocardial infarction: A report from the shock trial registry. Should we emergently revascularize occluded coronaries for cardiogenic shock? J Am Coll Cardiol. 2000;36(Suppl. A):1123–9. 5. Brodie BR, Stuckey TD, Hansen C, Muncy D. Intraaortic balloon counterpulsation before primary percutaneous transluminal coronary angioplasty reduces catheterization laboratory events in high-risk patients with acute myocardial infarction. Am J Cardiol. 1999;84:18–23. 6. Thiele H, Sick P, Boudriot E, Diederich KW, Hambrecht R, Niebauer J. Randomized comparison of intra-aortic balloon support with a percutaneous left ventricular assist device in patients with revascularized acute myocardial infarction complicated by cardiogenic shock. Eur Heart J. 2005;26:1276–83. 7. Seyfarth M, Sibbing D, Bauer I, Fröhlich G, Bott-Flügel L, Byrne R, et al. A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. J Am Coll Cardiol. 2008; 52:1584–8. 8. Cheng JM, den Uil CA, van der Ent M, Jewbali LS, van Domburg RT, et al. Percutaneous left ventricular assist devices vs. intra-aortic balloon pump counterpulsation for treatment of cardiogenic shock: a Ameta-analysis of controlled trials. Eur Heart J. 2009;30:2102–8. 9. Perera D, Stables R, Thomas M, Booth J, Pitt M, Blackman D, et al; BCIS-1 Investigators. Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention a randomized controlled trial. JAMA. 2010;304:867–74. 10. Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, et al. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012;367: 1287–96. 11. Boudoulas KD, Pederzolli A, Saini U, Gumina RJ, Mazzaferri EL Jr, Davis M, et al. Comparison of Impella and intra-aortic balloon pump in high-risk percutaneous coronary intervention: Vascular complications and incidence of bleeding. Acute Card Care. 2012;14:120–4. 12. Parissis H, Soo A, Al-Alao B. Intraaortic balloon pump: Literature review of risk factors related to complications of the intraaortic balloon pump. J Cardiothorac Surg. 2011;6:147.
© 2014 Informa UK, Ltd.
77
13. Valente S, Lazzeri C, Crudeli E, Chiostri M, Giglioli C, Bernardo P, et al. Intraaortic balloon pump: Incidence and predictors of complications in the Florence registry. Clin Cardiol. 2012;35:200–4. 14. Sjauw KD, Engström AE, Vis MM, van der Schaaf RJ, Baan J Jr, Koch KT, et al. A systematic review and meta-analysis of intra-aortic balloon pump therapy in ST-elevation myocardial infarction: Should we change the guidelines? Eur Heart J. 2009;30:459–68. 15. Mahmoudi M, Hauville C, Gaglia MA Jr, Sardi G, Torguson R, Xue Z, et al. The impact of intra-aortic balloon counter-pulsation on in-hospital mortality in patients presenting with anterior ST-elevation myocardial infarction without cardiogenic shock. Cardiovasc Revasc Med. 2012;13:328–30. 16. Ohman EM, George BS, White CJ, Kern MJ, Gurbel PA, Freedman RJ, et al. Use of aortic counterpulsation to improve sustained coronary artery patency during acute myocardial infarction. Results of a randomized trial. The randomized IABP study group. Circulation 1994;90:792–9. 17. Stone GW, Marsalese D, Brodie BR, Griffin JJ, Donohue B, Costantini C, et al. A prospective, randomized evaluation of prophylactic intraaortic balloon counterpulsation in high risk patients with acute myocardial infarction treated with primary angioplasty. Second primary angioplasty in myocardial infarction (PAMI-II) trial investigators. J Am Coll Cardiol. 1997;29:1459–67. 18. van’t Hof AW, Liem AL, de Boer MJ, Hoorntje JC, Suryapranata H, Zijlstra F. A randomized comparison of intraaortic balloon pumping after primary coronary angioplasty in high risk patients with acute myocardial infarction. Eur Heart J. 1999;20:659–65. 19. Mejia VM, Naidu SS, Hermann H. Support devices for high-risk percutaneous coronary interventions. In: Topol EJ, editor. Textbook of interventional cardiology 5th edition. Philadelphia, PA: Saunders Elsevier; 2008. pp. 643–4. 20. Trost JC, Hillis LD. Intra-aortic balloon counterpulsation. Am J Cardiol. 2006;97:1391–8. 21. Williams DO, Korr KS, Gewirtz H, Most AS. The effect of intraaortic balloon counterpulsation on regional myocardial blood flow and oxygen consumption in the presence of coronary artery stenosis in patients with unstable angina. Circulation 1982;66:593–7. 22. Kern MJ, Aguirre F, Bach R, Donohue T, Siegel R, Segal J. Augmentation of coronary blood flow by intraaortic balloon pumping in patients after coronary angioplasty. Circulation 1993;87:500–11. 23. Prondzinsky R, Unverzagt S, Russ M, Lemm H, Swyter M, Wegener N, et al. Hemodynamic effects of intra-aortic balloon counterpulsation in patients with acute myocardial infarction complicated by cardiogenic shock: The prospective, randomized IABP shock trial. Shock 2012;37:378–84. 24. Cook DJ, Reeve BK, Guyatt GH, Heyland DK, Griffith LE, Buckingham L, et al. Stress ulcer prophylaxis in critically ill patients. Resolving discordant meta-analyses. JAMA. 1996;275: 308–14. 25. Cook DJ, Witt LG, Cook RJ, Guyatt GH. Stress ulcer prophylaxis in the critically ill: A meta-analysis. Am J Med. 1991;91:519–27. 26. Alhazzani W, Alenezi F, Jaeschke RZ, Moayyedi P, Cook DJ. Proton pump inhibitors versus histamine 2 receptor antagonists for stress ulcer prophylaxis in critically ill patients: A systematic review and meta-analysis. Crit Care Med. 2013;41:693–705.
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