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Usefulness of Intra-Aortic Balloon Pump Counterpulsation in Patients With Cardiogenic Shock from Acute Myocardial Infarction
Usefulness of Intra-Aortic Balloon Pump Counterpulsation in Patients With Cardiogenic Shock from Acute Myocardial Infarction Jin M. Cheng, MSca, Suzanne D.A. Valk, MDa, Corstiaan A. den Uil, MDa,*, Martin van der Ent, MD, PhDa, Wim K. Lagrand, MD, PhDb, Meike van de Sande, MDa, Ron T. van Domburg, PhDa, and Maarten L. Simoons, MD, PhDa Although intra-aortic balloon pump (IABP) counterpulsation is increasingly being used for the treatment of patients with cardiogenic shock from acute myocardial infarction, data on the long-term outcomes are lacking. The aim of the present study was to evaluate the 30-day and long-term mortality and to identify predictors for 30-day and long-term all-cause mortality of patients with acute myocardial infarction complicated by cardiogenic shock who were treated with IABP. From January 1990 to June 2004, 300 consecutive patients treated with IABP were included. The mean age of the study population was 61 ⴞ 11 years, and 79% of the patients were men. The survival rate until IABP removal after successful hemodynamic stabilization was 70% (n ⴝ 211). The overall cumulative 30-day survival rate was 58%. The 30-day mortality rate decreased over time from 52% in 1990 to 1994 to 36% in 2000 to 2004 (p for trend <0.05). Follow-up ranged from 0 to 15 years. In patients who survived until IABP removal, the cumulative 1-, 5-, and 10-year survival rate was 69%, 58%, and 36%, respectively. The adjusted predictors of long-term mortality were arrhythmias during the intensive cardiac care unit stay (hazard ratio [HR] 1.8, 95% confidence interval [CI] 1.2 to 2.9) and renal failure during the intensive cardiac care unit stay (HR 2.5, 95% CI 1.3 to 5.1). After adjustment, treatment with primary percutaneous coronary intervention (HR 0.5, 95% CI 0.3 to 0.9) and coronary artery bypass grafting (HR 0.4, 95% CI 0.2 to 0.8) were associated with lower long-term mortality. In conclusion, in patients with acute myocardial infarction complicated by cardiogenic shock treated with IABP, the 30-day survival improved with time and an encouraging number of patients survived in the long term. © 2009 Elsevier Inc. All rights reserved. (Am J Cardiol 2009;104:327–332) Cardiogenic shock is a state of inadequate tissue perfusion due to cardiac dysfunction.1 The incidence of cardiogenic shock complicating acute myocardial infarction (AMI) ranges from 5% to 10%.2 Even though the prognosis of patients with cardiogenic shock has improved over time because of aggressive reperfusion strategies, the in-hospital mortality rate from cardiogenic shock remains very high (i.e., 50%).2,3 The use of intra-aortic balloon pump (IABP) counterpulsation is associated with improved survival in patients with cardiogenic shock treated with thrombolysis.4 –7 Although IABP use in patients with cardiogenic shock adjunctive to primary percutaneous coronary intervention (PCI) was recently questioned,8 IABP is the method of first choice for mechanical assistance in patients with cardiogenic shock who do not respond adequately to standard pharmacologic treatment.9 Also, long-term follow-up data of these patients are lacking. Therefore, the aim of the a Thoraxcenter, Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands; bDepartment of Intensive Care Medicine, Academic Medical Center, Amsterdam, The Netherlands. Manuscript received January 28, 2009; revised manuscript received and accepted March 24, 2009. *Corresponding author: Tel: (⫹31) 10-703-5019; fax: (⫹31) 10-7032890. E-mail address: [email protected] (C.A. den Uil).
0002-9149/09/$ – see front matter © 2009 Elsevier Inc. All rights reserved. doi:10.1016/j.amjcard.2009.03.050
present study was to evaluate the 30-day and long-term outcomes and to identify predictors of 30-day mortality for patients with cardiogenic shock treated with IABP. In addition, we evaluated the predictors of long-term mortality in patients who survived until IABP removal after successful hemodynamic stabilization. Methods From January 1990 to June 2004, all consecutive patients (n ⫽ 300) with cardiogenic shock from AMI who were treated with IABP at Erasmus Medical Center in Rotterdam, The Netherlands, were included. Our center is a tertiary referral center for PCI, mechanical treatment of cardiogenic shock, and heart transplantation. From 1990 to 2000, about 175 patients with AMI were admitted to our center annually. From 2001 to 2004, the number of admitted patients with AMI increased to 350 annually, because primary PCI was implemented as a standard treatment of AMI, and our center was a referral center for primary PCI. The indication for IABP counterpulsation was cardiogenic shock in all cases. IABP insertion was withheld only when it was technically not feasible (e.g., because of severe atherosclerotic peripheral artery disease or aortic disease), or in patients judged to have a definite fatal prognosis because of concomitant disease, which concerned 21 patients during the inclusion www.AJConline.org
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period. The data were acquired retrospectively from the patient medical records and hospital database, for which a rate of missing data of ⬍5% was considered acceptable. We performed a subanalysis of those patients who survived until IABP removal after successful hemodynamic stabilization. The IABP was inserted either at the catheterization laboratory or at the intensive cardiac care unit. From 1990 to 1995, Datascope (Datascope, Fairfield, New Jersey) 9.5F and 10.5F catheters were used. From 1995 through 2000, Arrow (Arrow, Reading, Pennsylvania) 9F catheters were used, and from 2000 to 2004, Arrow 8F catheters were used. Recent AMI was defined as AMI at hospital admission. In addition to the clinical evidence of AMI (i.e., typical chest pain and electrocardiographic abnormalities), all patients had a diagnostic increase in cardiac markers during the hospitalization period. Cardiogenic shock was defined as low systolic blood pressure (⬍90 mm Hg) owing to cardiac insufficiency, with clinical signs of hypoperfusion (e.g., cold extremities, oliguria, altered mental state) not responsive to fluid resuscitation. Most patients had already received inotropic agents before the collection of baseline data. Blood pressure was measured just before IABP insertion (baseline). Left ventricular function (LVF) was assessed with echocardiography by trained cardiologists and categorized as normal (ejection fraction ⬎40%) or impaired (ejection fraction ⬍40%). The inotropic agents used in our hospital were catecholamines (i.e., dobutamine, dopamine, and/or norepinephrine) and phosphodiesterase inhibitors (enoximone). The antiarrhythmic agents used in our hospital were lidocaine, amiodarone, sotalol, and digoxin. The following complications of IABP counterpulsation were registered: limb ischemia requiring IABP removal, bleeding, embolic and thrombotic events, the need for vascular surgery, and IABP-related infection. Limb ischemia was defined as diminished or absent peripheral pulsation with a white coloration of the leg at the side of IABP catheter introduction. Major bleeding was defined as bleeding requiring red blood cell transfusion. Minor bleeding was defined as any access site bleeding not requiring red blood cell transfusion. Infection was defined as fever, combined with leukocytosis, increased C-reactive protein level (⬎5 mg/L), and signs of inflammation at the IABP insertion site, with or without positive blood and/or IABP-tip cultures. Follow-up started at the day of IABP insertion (baseline). In March 2006, vital status of all patients was acquired from municipal civil registries with a response rate of 100%. Ten patients (3%) were lost during follow-up. The median follow-up duration was 6.1 years (range 0 to 15). All data were analyzed using the Statistical Package for Social Sciences software, version 15.0 (SPSS, Chicago, Illinois). Continuous variables were compared using Student’s t test or 1-way analysis of variance and are presented as the mean ⫾ SD. Nonparametric continuous variables were compared using the Mann-Whitney U test or KruskalWallis test and are presented as the median and range. Categorical variables were compared using the chi-square test or Fisher’s exact test, as appropriate, and are presented as percentages. Patients lost to follow-up were considered at risk until the date of last contact, at which point they were censored. Cumulative survival was estimated according to
Table 1 Baseline and procedural characteristics (n ⫽ 300) Characteristic Age (yrs) Men Risk factors Diabetes mellitus Hypertension Smoking Hypercholesterolemia Peripheral vessel syndrome Renal insufficiency History Previous cerebral vascular accident Previous myocardial infarction Previous coronary artery bypass grafting Previous percutaneous coronary intervention Systolic blood pressure* (mm Hg) Diastolic blood pressure* (mm Hg) Heart rate (beats/min) Impaired LVF Three vessel/left main stem coronary disease ST-segment elevation and location Anterior/septal ST-elevation myocardial infarction Inferior/posterior ST-elevation myocardial infarction Non–ST-elevation myocardial infarction Mechanical complication after myocardial infarction Reperfusion therapy Primary PCI Thrombolysis CABG No reperfusion therapy Complications during ICCU stay Cardiopulmonary resuscitation Mechanical ventilation Arrhythmias requiring antiarrhythmic agents Renal failure requiring renal replacement therapy IABP running time (days) 1 2–5 ⱖ6
Value 61 ⫾ 11 79% 20% 35% 55% 27% 9% 3% 6% 45% 9% 7% 102 ⫾ 31 63 ⫾ 19 99 ⫾ 26 76% 42% 57% 35% 8% 12% 45% 27% 12% 20% 33% 56% 44% 6% 31% 49% 20%
Data are presented as mean ⫾ SD or percentages. * Blood pressure measured just before insertion of IABP. ICCU ⫽ intensive cardiac care unit.
the Kaplan-Meier method. Kaplan-Meier survival curves were compared using the log-rank test. Univariate and multivariate logistic regression analyses were performed to identify predictors of 30-day all-cause mortality. Multivariate Cox proportional hazards regression analyses were performed to identify predictors of long-term all-cause mortality in patients who survived until IABP removal. On multivariate analyses, the variables of age, gender, diabetes mellitus, hypercholesterolemia, history, LVF, blood pressure, heart rate, IABP running time, ST-elevation myocardial infarction, reperfusion therapy, and complications during intensive cardiac care unit stay were entered into the model in a stepwise fashion. The final results are presented as unadjusted and adjusted odds ratios (OR) and as unadjusted and adjusted hazard ratios (HR), both with the associated 95% confidence intervals (CIs). Subanalyses were performed stratified by IABP running time (1, 2 to 5, and
Coronary Artery Disease/Prognosis of Cardiogenic Shock With IABP
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Table 2 Baseline and procedural characteristics of patients who survived until removal of intra-aortic balloon pump (IABP) after successful hemodynamic stabilization Variable
Age (yrs) Men Risk factors Diabetes mellitus Hypertension Smoking Hypercholesterolemia Peripheral vessel disease Renal insufficiency History Previous cerebral vascular accident Previous myocardial infarction Previous CABG Previous PCI Systolic blood pressure* (mm Hg) Diastolic blood pressure* (mm Hg) Heart rate (beats/min) Impaired LVF Three vessel/left main stem coronary disease ST-segment elevation and location Anterior/septal ST-elevation myocardial infarction Inferior/posterior ST-elevation myocardial infarction Non–ST-elevation myocardial infarction Mechanical complication after myocardial infarction Reperfusion therapy Primary PCI Thrombolysis CABG No reperfusion therapy Complications during ICCU stay Cardiopulmonary resuscitation Mechanical ventilation Arrhythmias requiring antiarrhythmic agents Renal failure requiring renal replacement therapy
Total (n ⫽ 211)
IABP Running Time (days)
p Value
1 (n ⫽ 37)
2–5 (n ⫽ 123)
ⱖ6 (n ⫽ 51)
60 ⫾ 11 81%
61 ⫾ 12 84%
60 ⫾ 11 81%
59 ⫾ 12 80%
0.7 0.9
20% 35% 56% 28% 8% 4%
16% 44% 53% 35% 9% 3%
21% 33% 56% 25% 8% 2%
22% 34% 59% 31% 7% 8%
0.8 0.5 0.9 0.4 0.9 0.1
6% 43% 10% 8% 105 ⫾ 30 64 ⫾ 17 96 ⫾ 27 73% 38%
5% 41% 16% 14% 114 ⫾ 28 69 ⫾ 16 95 ⫾ 28 50% 41%
7% 38% 5% 7% 104 ⫾ 32 63 ⫾ 18 94 ⫾ 28 74% 38%
4% 55% 18% 6% 100 ⫾ 25 62 ⫾ 16 101 ⫾ 22 85% 35%
0.8 0.1 ⬍0.05 0.4 0.1 0.2 0.3 ⬍0.01 0.9 0.2
57% 36% 7% 11%
43% 46% 11% 11%
59% 37% 4% 13%
63% 27% 10% 8%
0.7
47% 30% 15% 13%
63% 23% 11% 6%
49% 30% 14% 11%
31% 37% 20% 22%
⬍0.05 0.4 0.4 0.1
26% 51% 48% 6%
24% 38% 19% 0%
24% 51% 46% 6%
29% 59% 73% 12%
0.8 0.1 ⬍0.001 0.1
Data are presented as mean ⫾ SD or percentages. * Blood pressure measured just before insertion of IABP. Abbreviation as in Table 1.
ⱖ6 days). All statistical tests were 2-tailed, and p ⬍0.05 was considered statistically significant. Results The baseline characteristics are listed in Table 1. The mean age of the study population was 61 ⫾ 11 years, and 79% of the patients were men. Most patients had an STsegment elevation myocardial infarction (92%). Reperfusion therapy was performed in 80% of the patients; 45% were treated with primary PCI, 27% were treated with thrombolysis, and 12% were treated with emergency coronary artery bypass grafting (CABG). Most patients had already received inotropic agents before IABP insertion (82%). Mechanical ventilation and cardiopulmonary resuscitation during the intensive cardiac care unit stay were needed in 56% and 33%, respectively. Arrhythmias requiring the use of antiarrhythmic agents and renal failure re-
quiring renal replacement therapy occurred in 44% and 6% of patients, respectively. The baseline characteristics of the patients who survived until IABP removal after successful hemodynamic stabilization (n ⫽ 211) are listed in Table 2. The IABP running time in this subgroup was 1 day for 18%, 2 to 5 days for 58%, and ⱖ6 days for 24%, with a median of 3 days (range 1 to 27). A history of CABG (p ⬍0.05), impaired LVF (p ⬍0.01), and arrhythmias (p ⬍0.001) was more frequent in patients with an IABP running time of ⱖ6 days than in patients with an IABP running time of 2 to 5 days. Fewer patients with an IABP running time of ⱖ6 days were treated with primary PCI (p ⬍0.05). The cumulative survival rate until IABP removal after successful hemodynamic stabilization was 70% (n ⫽ 211), and the overall cumulative 30-day survival rate was 58%. Patients who had an IABP for only 1 day had greater 30-day mortality than patients with an IABP running time of ⬎1
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The American Journal of Cardiology (www.AJConline.org) Table 3 Unadjusted predictors of 30-day and long-term mortality Variable
Figure 1. Cumulative long-term survival of patients with cardiogenic shock who survived until removal of IABP after successful hemodynamic stabilization, stratified by IABP running time. p Value obtained by comparing IABP running time of ⱖ6 days with IABP running time of 2 to 5 days.
day. Mortality was greatest in the first days after IABP insertion. The cumulative long-term survival rate was 48%, 41%, and 25% at 1, 5, and 10 years of follow-up, respectively. The 10-year estimated cumulative survival rate for the 30-day survivors was 41%. The cumulative long-term Kaplan-Meier survival estimates for the patients who survived until IABP removal after successful hemodynamic stabilization are shown in Figure 1. In these patients, the cumulative long-term survival rate was 69%, 58%, and 36% at 1, 5, and 10 years of follow-up, respectively. Patients with an IABP running time of ⱖ6 days had significantly greater long-term mortality compared with patients with an IABP running time of 2 to 5 days (p ⬍0.05). The unadjusted predictors of 30-day and long-term mortality are listed in Table 3. The adjusted predictors of 30-day mortality are presented in Figure 2. On multivariate analysis, the adjusted predictors of 30-day mortality were age (OR 1.04, 95% CI 1.01 to 1.07), impaired LVF (OR 2.5, 95% CI 1.1 to 5.5), need for cardiopulmonary resuscitation (OR 2.6, 95% CI 1.4 to 4.9), and need for mechanical ventilation (OR 2.4, 95% CI 1.3 to 4.5). After adjustment, treatment with primary PCI (OR 0.1, 95% CI 0.1 to 0.3), thrombolysis (OR 0.1, 95% CI 0.0 to 0.4), and emergency CABG (OR 0.1, 95% CI 0.0 to 0.4) were associated with improved 30-day survival. The adjusted predictors of longterm mortality in patients who survived until IABP removal after successful hemodynamic stabilization are presented in Figure 3. The adjusted predictors of long-term mortality were arrhythmias requiring the use of antiarrhythmic agents (HR 1.8, 95% CI 1.2 to 2.9) and renal failure requiring renal replacement therapy during the intensive cardiac care unit stay (HR 2.5, 95% CI 1.3 to 5.1). Treatment with primary PCI (HR 0.5, 95% CI 0.3 to 0.9) and CABG (HR 0.4, 95% CI 0.2 to 0.8) were associated with improved survival in the long term. The temporal trends of IABP use from 1990 to 2004 are listed in Table 4. The frequency of IABP insertion increased during the study period from 69 patients with cardiogenic
Age Men Risk factors Diabetes mellitus Hypertension Smoking Hypercholesterolemia History Previous cerebral vascular accident Previous myocardial infarction Previous CABG Previous PCI Impaired LVF Systolic blood pressure (units of 10 mm Hg) Diastolic blood pressure (units of 10 mm Hg) Heart rate (units of 10 beats/min) Hospital admission† 1995–1999 2000–2004 IABP running time‡ (days) 1 ⱖ6 ST-elevated myocardial infarction Reperfusion therapy Primary PCI Thrombolysis CABG Cardiopulmonary resuscitation Mechanical ventilation Arrhythmias requiring antiarrhythmic agents Renal failure requiring renal replacement therapy
30-Day Mortality
Long-Term Mortality*
OR
95% CI
HR
95% CI
1.03 0.7
1.01–1.05 0.4–1.2
1.02 1.1
1.00–1.04 0.7–1.7
1.1 1.0 0.7 0.7
0.6–1.9 0.6–1.8 0.4–1.1 0.4–1.2
1.2 1.1 0.7 0.9
0.8–1.9 0.7–1.7 0.5–1.1 0.6–1.4
1.3
0.5–3.4
1.8
0.9–3.5
1.5 0.8 0.5 2.8 0.9
0.9–2.4 0.4–1.8 0.2–1.4 1.5–5.2 0.8–1.0
1.5 1.8 1.1 1.8 1.0
1.0–2.2 1.0–3.1 0.5–2.3 1.2–2.7 1.0–1.1
0.9
0.8–1.0
1.0
0.9–1.1
1.1
1.0–1.2
1.0
1.0–1.1
0.6 0.5
0.3–1.2 0.3–0.9
0.7 0.7
0.4–1.1 0.4–1.1
2.7
1.6–2.3
0.8 1.6 1.3
0.5–1.5 1.0–2.4 0.6–2.9
0.4 0.2 0.2 2.5 2.0 0.9
0.2–0.7 0.1–1.0 0.1–0.5 1.5–4.1 1.3–3.2 0.6–1.4
0.7 0.7 0.5 1.2 1.4 1.7
0.4–1.2 0.3–2.2 0.2–0.9 0.8–1.8 0.9–2.0 1.2–2.6
1.3
0.5–3.4
2.7
1.5–5.1
* Only patients who survived until removal of IABP after successful hemodynamic stabilization were included in long-term Cox regression analysis. † Relative to hospital admission in 1990 –1994. ‡ Relative to IABP running time of 2–5 days.
shock in 1990 to 1994 to 132 patients in 2000 to 2004. The frequency of primary PCI increased from 22% in 1990 to 1994 to 65% in 2000 to 2004 (p ⬍0.001), and thrombolytic therapy was less frequently administered (p ⬍0.01). The 30-day mortality rate decreased from 52% in 1990 to 1994 to 36% in 2000 to 2004 (p for trend ⬍0.05). The overall incidence of IABP-related complications was 20%. Infection (9%), bleeding (6%), and limb ischemia (5%) were the most frequently observed complications. Limb ischemia was mostly transient, with either spontaneous recovery or recovery after IABP removal. However, vascular surgery was required in 2 patients. Five patients had a major bleeding at the access site requiring blood transfusion. Balloon rupture of the IABP occurred in 5 patients. The number of complications decreased from 32% in 1990 to 1994 to 10% in 2000 to 2004 (p ⬍0.001).
Coronary Artery Disease/Prognosis of Cardiogenic Shock With IABP
Figure 2. Adjusted predictors of 30-day mortality in patients with cardiogenic shock treated with IABP, presented as ORs with associated 95% CIs.
Figure 3. Adjusted predictors of long-term mortality in patients with cardiogenic shock treated with IABP, presented as HRs with associated 95% CIs. Only patients who could be successfully weaned from IABP were included in long-term Cox regression analysis. Variables age, gender, diabetes mellitus, hypercholesterolemia, history, LVF, blood pressure, heart rate, IABP running time, period of hospital admission, ST-elevation myocardial infarction, reperfusion therapy, and complications during ICCU stay were entered into model in stepwise fashion. ICCU ⫽ intensive cardiac care unit. Table 4 Temporal trends of intra-aortic balloon pump (IABP) use from 1990 to 2004 Variable Age (yrs) Men Reperfusion therapy Primary PCI Thrombolysis CABG No reperfusion therapy Median IABP running time (days) Any IABP-related complication 30-day Mortality
1990–1994 1995–1999 2000–2004 (n ⫽ 69) (n ⫽ 99) (n ⫽ 132)
p Value
61 ⫾ 10 81%
58 ⫾ 12 75%
63 ⫾ 11 81%
⬍0.01 0.8
22% 31% 19% 34% 3
34% 37% 13% 23% 3
65% 18% 7% 11% 2
⬍0.001 ⬍0.01 ⬍0.05 ⬍0.001 ⬍0.01
32%
26%
10%
⬍0.001
52%
41%
36%
⬍0.05
Data are expressed as mean ⫾ SD, median, or percentage.
Discussion To our knowledge, this is the first study presenting the long-term follow-up of a large cohort of patients with cardiogenic shock from AMI, all treated with IABP counterpulsation. Despite the high 30-day mortality, a considerable number of patients (36%) survived until 10 years after successful weaning of the IABP.
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The 30-day mortality rate in our study (42%) was comparable to those reported from other studies of patients with cardiogenic shock.2,4,10,11 The Global Utilization of Streptokinase and t-PA [tissue plasminogen activator] for Occluded coronary arteries (GUSTO)-I investigators presented the long-term outcomes of a general group of patients with AMI, of whom some had cardiogenic shock.12 That study found a 10-year survival rate of 54% in 30-day survivors of cardiogenic shock. In the present study, we found a lower 10-year survival rate (41%) in these patients. However, not all the patients with cardiogenic shock in the GUSTO-I study were treated with IABP. Therefore, our study population might have been a higher risk population compared with GUSTO-I patients. The 30-day mortality was greatest in patients who had an IABP inserted for ⬍1 day. This group mainly consisted of severely compromised patients who could not be stabilized despite hemodynamic support from the IABP and other treatment modalities and who did not survive the first day after IABP insertion. The mortality rate with the IABP in place in this group was 61% on the first day. In contrast, the remaining patients (39%) were in better hemodynamic condition compared with the patients with an IABP running time ⬎1 day, explaining their better 30-day outcome. Conversely, in patients who survived until IABP removal, those who were treated with an IABP for ⱖ6 days had greater long-term mortality than patients with an IABP running time of 2 to 5 days. However, the IABP running time was not an independent predictor of long-term mortality. The adjusted predictors of 30-day mortality were age, impaired LVF, the need for cardiopulmonary resuscitation, and the need for mechanical ventilation. Various reperfusion therapies (i.e., PCI, thrombolysis, and CABG) were associated with lower 30-day mortality after adjustment. The US National Registry of Myocardial Infarction 2 (NRMI2) investigators reported older age, female gender, diabetes mellitus, and a history of congestive heart failure as independent predictors of in-hospital mortality.11 The predictors of long-term outcomes of patients with cardiogenic shock treated with IABP counterpulsation have not been previously presented. For patients who could be successfully weaned from the IABP, we found a strong correlation between the occurrence of arrhythmias and renal failure during the intensive cardiac care unit stay and long-term mortality. In addition, treatment with primary PCI and CABG was beneficial in the long term. Although the admission period was not an independent predictor of outcome, the 30-day survival rate improved with time. This might have been related to the implementation of early revascularization with primary PCI in the routine treatment of AMI complicated by cardiogenic shock.13–15 Improving outcomes over time in patients with cardiogenic shock were also found in a recent study.2 The incidence of major complications was in line with the incidence reported by the Benchmark registry.16 In our study, severe bleeding, major limb ischemia, and balloon leak occurred in 2%, 1%, and 2%, respectively, compared with 0.8%, 0.9%, and 1.0%, respectively, as reported by the Benchmark registry. The number of vascular complications decreased during the study period, probably because of the use of improved IABP devices (especially, the introduction
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of smaller size catheters), as well as increased physician’s skills and experience, which has also been demonstrated in previous studies.17–19 We reported an IABP-related incidence of infection of 9%. However, this relatively high rate of infection might have been overestimated because of the robust definition of infection used in our study. However, in most cases, IABP-tip and/or blood cultures to definitely prove IABP-related infections were not available in our study. Additional limitations of our study included the retrospective nature and that we only included patients with cardiogenic shock who were treated with IABP. Thus, caution is urged in extrapolating these results to patients ineligible for IABP or those in cardiogenic shock who were not treated with IABP. The inclusion of a control group with cardiogenic shock without IABP treatment was not possible because IABP counterpulsation has been a part of the routine treatment of patients with AMI complicated by cardiogenic shock for years at our center. Hence, the benefit of IABP counterpulsation could not be proved by our study. Recently, a randomized controlled trial (clinical trials.gov identifier: NCT00491036; available from www.clinicaltrials. gov) has been initiated that will address the potential benefit of IABP counterpulsation adjunctive to medical treatment and primary PCI in patients with cardiogenic shock. 1. Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K, Vahanian A, Camm J, De Caterina R, Dean V, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J 2008;29:2388 –2442. 2. Goldberg RJ, Spencer FA, Gore JM, Lessard D, Yarzebski J. Thirtyyear trends (1975 to 2005) in the magnitude of, management of, and hospital death rates associated with cardiogenic shock in patients with acute myocardial infarction: a population-based perspective. Circulation 2009;119:1211–1219. 3. Bengtson JR, Kaplan AJ, Pieper KS, Wildermann NM, Mark DB, Pryor DB, Phillips HR, III, Califf RM. Prognosis in cardiogenic shock after acute myocardial infarction in the interventional era. J Am Coll Cardiol 1992;20:1482–1489. 4. Anderson RD, Ohman EM, Holmes DR Jr, Col I, Stebbins AL, Bates ER, Stomel RJ, Granger CB, Topol EJ, Califf RM. Use of intraaortic balloon counterpulsation in patients presenting with cardiogenic shock: observations from the GUSTO-I study: Global Utilization of Streptokinase and t-PA for Occluded coronary arteries. J Am Coll Cardiol 1997;30:708 –715. 5. Sanborn TA, Sleeper LA, Bates ER, Jacobs AK, Boland J, French JK, Dens J, Dzavik V, Palmeri ST, Webb JG, Goldberger M, Hochman JS. 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;36:1123–1129. 6. Barron HV, Every NR, Parsons LS, Angeja B, Goldberg RJ, Gore JM, Chou TM. The use of intra-aortic balloon counterpulsation in patients with cardiogenic shock complicating acute myocardial infarction: data
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from the National Registry of Myocardial Infarction 2. Am Heart J 2001;141:933–939. Ohman EM, Nanas J, Stomel RJ, Leesar MA, Nielsen DW, O’Dea D, Rogers FJ, Harber D, Hudson MP, Fraulo E, Shaw LK, Lee KL. Thrombolysis and counterpulsation to improve survival in myocardial infarction complicated by hypotension and suspected cardiogenic shock or heart failure: results of the TACTICS trial. J Thromb Thrombolysis 2005;19:33–39. Sjauw KD, Engstrom AE, Vis MM, van der Schaaf RJ, Baan J Jr, Koch KT, de Winter RJ, Piek JJ, Tijssen JG, Henriques JP. 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 – 468. Nieminen MS, Bohm M, Cowie MR, Drexler H, Filippatos GS, Jondeau G, Hasin Y, Lopez-Sendon J, Mebazaa A, Metra M, Rhodes A, Swedberg K, Priori SG, Garcia MA, Blanc JJ, Budaj A, Dean V, Deckers J, Burgos EF, Lekakis J, Lindahl B, Mazzotta G, Morais J, Oto A, Smiseth OA, Dickstein K, Albuquerque A, Conthe P, CrespoLeiro M, Ferrari R, Follath F, Gavazzi A, Janssens U, Komajda M, Moreno R, Singer M, Singh S, Tendera M, Thygesen K. Executive summary of the guidelines on the diagnosis and treatment of acute heart failure: the Task Force on Acute Heart Failure of the European Society of Cardiology. Eur Heart J 2005;26:384 – 416. Hochman JS, Buller CE, Sleeper LA, Boland J, Dzavik V, Sanborn TA, Godfrey E, White HD, Lim J, LeJemtel T. Cardiogenic shock complicating acute myocardial infarction— etiologies, management and outcome: a report from the SHOCK trial Registry: SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? J Am Coll Cardiol 2000;36:1063–1070. Chen EW, Canto JG, Parsons LS, Peterson ED, Littrell KA, Every NR, Gibson CM, Hochman JS, Ohman EM, Cheeks M, Barron HV. Relation between hospital intra-aortic balloon counterpulsation volume and mortality in acute myocardial infarction complicated by cardiogenic shock. Circulation 2003;108:951–957. Singh M, White J, Hasdai D, Hodgson PK, Berger PB, Topol EJ, Califf RM, Holmes DR Jr. Long-term outcome and its predictors among patients with ST-segment elevation myocardial infarction complicated by shock: insights from the GUSTO-I trial. J Am Coll Cardiol 2007; 50:1752–1758. Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK. N Engl J Med 1999;341:625– 634. Hochman JS, Sleeper LA, Webb JG, Dzavik V, Buller CE, Aylward P, Col J, White HD. Early revascularization and long-term survival in cardiogenic shock complicating acute myocardial infarction. JAMA 2006;295:2511–2515. Babaev A, Frederick PD, Pasta DJ, Every N, Sichrovsky T, Hochman JS. Trends in management and outcomes of patients with acute myocardial infarction complicated by cardiogenic shock. JAMA 2005;294: 448 – 454. Ferguson JJ III, Cohen M, Freedman RJ Jr, Stone GW, Miller MF, Joseph DL, Ohman EM. The current practice of intra-aortic balloon counterpulsation: results from the Benchmark Registry. J Am Coll Cardiol 2001;38:1456 –1462. Azeem T, Stephens-Lloyd A, Spyt T, Hartshorne R, Gershlick AH. Intra-aortic balloon counterpulsation: variations in use and complications. Int J Cardiol 2004;94:255–259. Eltchaninoff H, Dimas AP, Whitlow PL. Complications associated with percutaneous placement and use of intraaortic balloon counterpulsation. Am J Cardiol 1993;71:328 –332. Scholz KH, von Ragab S, von zur Muhlen F, Schroder T, Werner GS, Mindel L, Kreuzer H. 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 – 465.
0002-9149/09/$ – see front matter © 2009 Elsevier Inc. All rights reserved. doi:10.1016/j.amjcard.2009.03.050
present study was to evaluate the 30-day and long-term outcomes and to identify predictors of 30-day mortality for patients with cardiogenic shock treated with IABP. In addition, we evaluated the predictors of long-term mortality in patients who survived until IABP removal after successful hemodynamic stabilization. Methods From January 1990 to June 2004, all consecutive patients (n ⫽ 300) with cardiogenic shock from AMI who were treated with IABP at Erasmus Medical Center in Rotterdam, The Netherlands, were included. Our center is a tertiary referral center for PCI, mechanical treatment of cardiogenic shock, and heart transplantation. From 1990 to 2000, about 175 patients with AMI were admitted to our center annually. From 2001 to 2004, the number of admitted patients with AMI increased to 350 annually, because primary PCI was implemented as a standard treatment of AMI, and our center was a referral center for primary PCI. The indication for IABP counterpulsation was cardiogenic shock in all cases. IABP insertion was withheld only when it was technically not feasible (e.g., because of severe atherosclerotic peripheral artery disease or aortic disease), or in patients judged to have a definite fatal prognosis because of concomitant disease, which concerned 21 patients during the inclusion www.AJConline.org
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period. The data were acquired retrospectively from the patient medical records and hospital database, for which a rate of missing data of ⬍5% was considered acceptable. We performed a subanalysis of those patients who survived until IABP removal after successful hemodynamic stabilization. The IABP was inserted either at the catheterization laboratory or at the intensive cardiac care unit. From 1990 to 1995, Datascope (Datascope, Fairfield, New Jersey) 9.5F and 10.5F catheters were used. From 1995 through 2000, Arrow (Arrow, Reading, Pennsylvania) 9F catheters were used, and from 2000 to 2004, Arrow 8F catheters were used. Recent AMI was defined as AMI at hospital admission. In addition to the clinical evidence of AMI (i.e., typical chest pain and electrocardiographic abnormalities), all patients had a diagnostic increase in cardiac markers during the hospitalization period. Cardiogenic shock was defined as low systolic blood pressure (⬍90 mm Hg) owing to cardiac insufficiency, with clinical signs of hypoperfusion (e.g., cold extremities, oliguria, altered mental state) not responsive to fluid resuscitation. Most patients had already received inotropic agents before the collection of baseline data. Blood pressure was measured just before IABP insertion (baseline). Left ventricular function (LVF) was assessed with echocardiography by trained cardiologists and categorized as normal (ejection fraction ⬎40%) or impaired (ejection fraction ⬍40%). The inotropic agents used in our hospital were catecholamines (i.e., dobutamine, dopamine, and/or norepinephrine) and phosphodiesterase inhibitors (enoximone). The antiarrhythmic agents used in our hospital were lidocaine, amiodarone, sotalol, and digoxin. The following complications of IABP counterpulsation were registered: limb ischemia requiring IABP removal, bleeding, embolic and thrombotic events, the need for vascular surgery, and IABP-related infection. Limb ischemia was defined as diminished or absent peripheral pulsation with a white coloration of the leg at the side of IABP catheter introduction. Major bleeding was defined as bleeding requiring red blood cell transfusion. Minor bleeding was defined as any access site bleeding not requiring red blood cell transfusion. Infection was defined as fever, combined with leukocytosis, increased C-reactive protein level (⬎5 mg/L), and signs of inflammation at the IABP insertion site, with or without positive blood and/or IABP-tip cultures. Follow-up started at the day of IABP insertion (baseline). In March 2006, vital status of all patients was acquired from municipal civil registries with a response rate of 100%. Ten patients (3%) were lost during follow-up. The median follow-up duration was 6.1 years (range 0 to 15). All data were analyzed using the Statistical Package for Social Sciences software, version 15.0 (SPSS, Chicago, Illinois). Continuous variables were compared using Student’s t test or 1-way analysis of variance and are presented as the mean ⫾ SD. Nonparametric continuous variables were compared using the Mann-Whitney U test or KruskalWallis test and are presented as the median and range. Categorical variables were compared using the chi-square test or Fisher’s exact test, as appropriate, and are presented as percentages. Patients lost to follow-up were considered at risk until the date of last contact, at which point they were censored. Cumulative survival was estimated according to
Table 1 Baseline and procedural characteristics (n ⫽ 300) Characteristic Age (yrs) Men Risk factors Diabetes mellitus Hypertension Smoking Hypercholesterolemia Peripheral vessel syndrome Renal insufficiency History Previous cerebral vascular accident Previous myocardial infarction Previous coronary artery bypass grafting Previous percutaneous coronary intervention Systolic blood pressure* (mm Hg) Diastolic blood pressure* (mm Hg) Heart rate (beats/min) Impaired LVF Three vessel/left main stem coronary disease ST-segment elevation and location Anterior/septal ST-elevation myocardial infarction Inferior/posterior ST-elevation myocardial infarction Non–ST-elevation myocardial infarction Mechanical complication after myocardial infarction Reperfusion therapy Primary PCI Thrombolysis CABG No reperfusion therapy Complications during ICCU stay Cardiopulmonary resuscitation Mechanical ventilation Arrhythmias requiring antiarrhythmic agents Renal failure requiring renal replacement therapy IABP running time (days) 1 2–5 ⱖ6
Value 61 ⫾ 11 79% 20% 35% 55% 27% 9% 3% 6% 45% 9% 7% 102 ⫾ 31 63 ⫾ 19 99 ⫾ 26 76% 42% 57% 35% 8% 12% 45% 27% 12% 20% 33% 56% 44% 6% 31% 49% 20%
Data are presented as mean ⫾ SD or percentages. * Blood pressure measured just before insertion of IABP. ICCU ⫽ intensive cardiac care unit.
the Kaplan-Meier method. Kaplan-Meier survival curves were compared using the log-rank test. Univariate and multivariate logistic regression analyses were performed to identify predictors of 30-day all-cause mortality. Multivariate Cox proportional hazards regression analyses were performed to identify predictors of long-term all-cause mortality in patients who survived until IABP removal. On multivariate analyses, the variables of age, gender, diabetes mellitus, hypercholesterolemia, history, LVF, blood pressure, heart rate, IABP running time, ST-elevation myocardial infarction, reperfusion therapy, and complications during intensive cardiac care unit stay were entered into the model in a stepwise fashion. The final results are presented as unadjusted and adjusted odds ratios (OR) and as unadjusted and adjusted hazard ratios (HR), both with the associated 95% confidence intervals (CIs). Subanalyses were performed stratified by IABP running time (1, 2 to 5, and
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Table 2 Baseline and procedural characteristics of patients who survived until removal of intra-aortic balloon pump (IABP) after successful hemodynamic stabilization Variable
Age (yrs) Men Risk factors Diabetes mellitus Hypertension Smoking Hypercholesterolemia Peripheral vessel disease Renal insufficiency History Previous cerebral vascular accident Previous myocardial infarction Previous CABG Previous PCI Systolic blood pressure* (mm Hg) Diastolic blood pressure* (mm Hg) Heart rate (beats/min) Impaired LVF Three vessel/left main stem coronary disease ST-segment elevation and location Anterior/septal ST-elevation myocardial infarction Inferior/posterior ST-elevation myocardial infarction Non–ST-elevation myocardial infarction Mechanical complication after myocardial infarction Reperfusion therapy Primary PCI Thrombolysis CABG No reperfusion therapy Complications during ICCU stay Cardiopulmonary resuscitation Mechanical ventilation Arrhythmias requiring antiarrhythmic agents Renal failure requiring renal replacement therapy
Total (n ⫽ 211)
IABP Running Time (days)
p Value
1 (n ⫽ 37)
2–5 (n ⫽ 123)
ⱖ6 (n ⫽ 51)
60 ⫾ 11 81%
61 ⫾ 12 84%
60 ⫾ 11 81%
59 ⫾ 12 80%
0.7 0.9
20% 35% 56% 28% 8% 4%
16% 44% 53% 35% 9% 3%
21% 33% 56% 25% 8% 2%
22% 34% 59% 31% 7% 8%
0.8 0.5 0.9 0.4 0.9 0.1
6% 43% 10% 8% 105 ⫾ 30 64 ⫾ 17 96 ⫾ 27 73% 38%
5% 41% 16% 14% 114 ⫾ 28 69 ⫾ 16 95 ⫾ 28 50% 41%
7% 38% 5% 7% 104 ⫾ 32 63 ⫾ 18 94 ⫾ 28 74% 38%
4% 55% 18% 6% 100 ⫾ 25 62 ⫾ 16 101 ⫾ 22 85% 35%
0.8 0.1 ⬍0.05 0.4 0.1 0.2 0.3 ⬍0.01 0.9 0.2
57% 36% 7% 11%
43% 46% 11% 11%
59% 37% 4% 13%
63% 27% 10% 8%
0.7
47% 30% 15% 13%
63% 23% 11% 6%
49% 30% 14% 11%
31% 37% 20% 22%
⬍0.05 0.4 0.4 0.1
26% 51% 48% 6%
24% 38% 19% 0%
24% 51% 46% 6%
29% 59% 73% 12%
0.8 0.1 ⬍0.001 0.1
Data are presented as mean ⫾ SD or percentages. * Blood pressure measured just before insertion of IABP. Abbreviation as in Table 1.
ⱖ6 days). All statistical tests were 2-tailed, and p ⬍0.05 was considered statistically significant. Results The baseline characteristics are listed in Table 1. The mean age of the study population was 61 ⫾ 11 years, and 79% of the patients were men. Most patients had an STsegment elevation myocardial infarction (92%). Reperfusion therapy was performed in 80% of the patients; 45% were treated with primary PCI, 27% were treated with thrombolysis, and 12% were treated with emergency coronary artery bypass grafting (CABG). Most patients had already received inotropic agents before IABP insertion (82%). Mechanical ventilation and cardiopulmonary resuscitation during the intensive cardiac care unit stay were needed in 56% and 33%, respectively. Arrhythmias requiring the use of antiarrhythmic agents and renal failure re-
quiring renal replacement therapy occurred in 44% and 6% of patients, respectively. The baseline characteristics of the patients who survived until IABP removal after successful hemodynamic stabilization (n ⫽ 211) are listed in Table 2. The IABP running time in this subgroup was 1 day for 18%, 2 to 5 days for 58%, and ⱖ6 days for 24%, with a median of 3 days (range 1 to 27). A history of CABG (p ⬍0.05), impaired LVF (p ⬍0.01), and arrhythmias (p ⬍0.001) was more frequent in patients with an IABP running time of ⱖ6 days than in patients with an IABP running time of 2 to 5 days. Fewer patients with an IABP running time of ⱖ6 days were treated with primary PCI (p ⬍0.05). The cumulative survival rate until IABP removal after successful hemodynamic stabilization was 70% (n ⫽ 211), and the overall cumulative 30-day survival rate was 58%. Patients who had an IABP for only 1 day had greater 30-day mortality than patients with an IABP running time of ⬎1
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The American Journal of Cardiology (www.AJConline.org) Table 3 Unadjusted predictors of 30-day and long-term mortality Variable
Figure 1. Cumulative long-term survival of patients with cardiogenic shock who survived until removal of IABP after successful hemodynamic stabilization, stratified by IABP running time. p Value obtained by comparing IABP running time of ⱖ6 days with IABP running time of 2 to 5 days.
day. Mortality was greatest in the first days after IABP insertion. The cumulative long-term survival rate was 48%, 41%, and 25% at 1, 5, and 10 years of follow-up, respectively. The 10-year estimated cumulative survival rate for the 30-day survivors was 41%. The cumulative long-term Kaplan-Meier survival estimates for the patients who survived until IABP removal after successful hemodynamic stabilization are shown in Figure 1. In these patients, the cumulative long-term survival rate was 69%, 58%, and 36% at 1, 5, and 10 years of follow-up, respectively. Patients with an IABP running time of ⱖ6 days had significantly greater long-term mortality compared with patients with an IABP running time of 2 to 5 days (p ⬍0.05). The unadjusted predictors of 30-day and long-term mortality are listed in Table 3. The adjusted predictors of 30-day mortality are presented in Figure 2. On multivariate analysis, the adjusted predictors of 30-day mortality were age (OR 1.04, 95% CI 1.01 to 1.07), impaired LVF (OR 2.5, 95% CI 1.1 to 5.5), need for cardiopulmonary resuscitation (OR 2.6, 95% CI 1.4 to 4.9), and need for mechanical ventilation (OR 2.4, 95% CI 1.3 to 4.5). After adjustment, treatment with primary PCI (OR 0.1, 95% CI 0.1 to 0.3), thrombolysis (OR 0.1, 95% CI 0.0 to 0.4), and emergency CABG (OR 0.1, 95% CI 0.0 to 0.4) were associated with improved 30-day survival. The adjusted predictors of longterm mortality in patients who survived until IABP removal after successful hemodynamic stabilization are presented in Figure 3. The adjusted predictors of long-term mortality were arrhythmias requiring the use of antiarrhythmic agents (HR 1.8, 95% CI 1.2 to 2.9) and renal failure requiring renal replacement therapy during the intensive cardiac care unit stay (HR 2.5, 95% CI 1.3 to 5.1). Treatment with primary PCI (HR 0.5, 95% CI 0.3 to 0.9) and CABG (HR 0.4, 95% CI 0.2 to 0.8) were associated with improved survival in the long term. The temporal trends of IABP use from 1990 to 2004 are listed in Table 4. The frequency of IABP insertion increased during the study period from 69 patients with cardiogenic
Age Men Risk factors Diabetes mellitus Hypertension Smoking Hypercholesterolemia History Previous cerebral vascular accident Previous myocardial infarction Previous CABG Previous PCI Impaired LVF Systolic blood pressure (units of 10 mm Hg) Diastolic blood pressure (units of 10 mm Hg) Heart rate (units of 10 beats/min) Hospital admission† 1995–1999 2000–2004 IABP running time‡ (days) 1 ⱖ6 ST-elevated myocardial infarction Reperfusion therapy Primary PCI Thrombolysis CABG Cardiopulmonary resuscitation Mechanical ventilation Arrhythmias requiring antiarrhythmic agents Renal failure requiring renal replacement therapy
30-Day Mortality
Long-Term Mortality*
OR
95% CI
HR
95% CI
1.03 0.7
1.01–1.05 0.4–1.2
1.02 1.1
1.00–1.04 0.7–1.7
1.1 1.0 0.7 0.7
0.6–1.9 0.6–1.8 0.4–1.1 0.4–1.2
1.2 1.1 0.7 0.9
0.8–1.9 0.7–1.7 0.5–1.1 0.6–1.4
1.3
0.5–3.4
1.8
0.9–3.5
1.5 0.8 0.5 2.8 0.9
0.9–2.4 0.4–1.8 0.2–1.4 1.5–5.2 0.8–1.0
1.5 1.8 1.1 1.8 1.0
1.0–2.2 1.0–3.1 0.5–2.3 1.2–2.7 1.0–1.1
0.9
0.8–1.0
1.0
0.9–1.1
1.1
1.0–1.2
1.0
1.0–1.1
0.6 0.5
0.3–1.2 0.3–0.9
0.7 0.7
0.4–1.1 0.4–1.1
2.7
1.6–2.3
0.8 1.6 1.3
0.5–1.5 1.0–2.4 0.6–2.9
0.4 0.2 0.2 2.5 2.0 0.9
0.2–0.7 0.1–1.0 0.1–0.5 1.5–4.1 1.3–3.2 0.6–1.4
0.7 0.7 0.5 1.2 1.4 1.7
0.4–1.2 0.3–2.2 0.2–0.9 0.8–1.8 0.9–2.0 1.2–2.6
1.3
0.5–3.4
2.7
1.5–5.1
* Only patients who survived until removal of IABP after successful hemodynamic stabilization were included in long-term Cox regression analysis. † Relative to hospital admission in 1990 –1994. ‡ Relative to IABP running time of 2–5 days.
shock in 1990 to 1994 to 132 patients in 2000 to 2004. The frequency of primary PCI increased from 22% in 1990 to 1994 to 65% in 2000 to 2004 (p ⬍0.001), and thrombolytic therapy was less frequently administered (p ⬍0.01). The 30-day mortality rate decreased from 52% in 1990 to 1994 to 36% in 2000 to 2004 (p for trend ⬍0.05). The overall incidence of IABP-related complications was 20%. Infection (9%), bleeding (6%), and limb ischemia (5%) were the most frequently observed complications. Limb ischemia was mostly transient, with either spontaneous recovery or recovery after IABP removal. However, vascular surgery was required in 2 patients. Five patients had a major bleeding at the access site requiring blood transfusion. Balloon rupture of the IABP occurred in 5 patients. The number of complications decreased from 32% in 1990 to 1994 to 10% in 2000 to 2004 (p ⬍0.001).
Coronary Artery Disease/Prognosis of Cardiogenic Shock With IABP
Figure 2. Adjusted predictors of 30-day mortality in patients with cardiogenic shock treated with IABP, presented as ORs with associated 95% CIs.
Figure 3. Adjusted predictors of long-term mortality in patients with cardiogenic shock treated with IABP, presented as HRs with associated 95% CIs. Only patients who could be successfully weaned from IABP were included in long-term Cox regression analysis. Variables age, gender, diabetes mellitus, hypercholesterolemia, history, LVF, blood pressure, heart rate, IABP running time, period of hospital admission, ST-elevation myocardial infarction, reperfusion therapy, and complications during ICCU stay were entered into model in stepwise fashion. ICCU ⫽ intensive cardiac care unit. Table 4 Temporal trends of intra-aortic balloon pump (IABP) use from 1990 to 2004 Variable Age (yrs) Men Reperfusion therapy Primary PCI Thrombolysis CABG No reperfusion therapy Median IABP running time (days) Any IABP-related complication 30-day Mortality
1990–1994 1995–1999 2000–2004 (n ⫽ 69) (n ⫽ 99) (n ⫽ 132)
p Value
61 ⫾ 10 81%
58 ⫾ 12 75%
63 ⫾ 11 81%
⬍0.01 0.8
22% 31% 19% 34% 3
34% 37% 13% 23% 3
65% 18% 7% 11% 2
⬍0.001 ⬍0.01 ⬍0.05 ⬍0.001 ⬍0.01
32%
26%
10%
⬍0.001
52%
41%
36%
⬍0.05
Data are expressed as mean ⫾ SD, median, or percentage.
Discussion To our knowledge, this is the first study presenting the long-term follow-up of a large cohort of patients with cardiogenic shock from AMI, all treated with IABP counterpulsation. Despite the high 30-day mortality, a considerable number of patients (36%) survived until 10 years after successful weaning of the IABP.
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The 30-day mortality rate in our study (42%) was comparable to those reported from other studies of patients with cardiogenic shock.2,4,10,11 The Global Utilization of Streptokinase and t-PA [tissue plasminogen activator] for Occluded coronary arteries (GUSTO)-I investigators presented the long-term outcomes of a general group of patients with AMI, of whom some had cardiogenic shock.12 That study found a 10-year survival rate of 54% in 30-day survivors of cardiogenic shock. In the present study, we found a lower 10-year survival rate (41%) in these patients. However, not all the patients with cardiogenic shock in the GUSTO-I study were treated with IABP. Therefore, our study population might have been a higher risk population compared with GUSTO-I patients. The 30-day mortality was greatest in patients who had an IABP inserted for ⬍1 day. This group mainly consisted of severely compromised patients who could not be stabilized despite hemodynamic support from the IABP and other treatment modalities and who did not survive the first day after IABP insertion. The mortality rate with the IABP in place in this group was 61% on the first day. In contrast, the remaining patients (39%) were in better hemodynamic condition compared with the patients with an IABP running time ⬎1 day, explaining their better 30-day outcome. Conversely, in patients who survived until IABP removal, those who were treated with an IABP for ⱖ6 days had greater long-term mortality than patients with an IABP running time of 2 to 5 days. However, the IABP running time was not an independent predictor of long-term mortality. The adjusted predictors of 30-day mortality were age, impaired LVF, the need for cardiopulmonary resuscitation, and the need for mechanical ventilation. Various reperfusion therapies (i.e., PCI, thrombolysis, and CABG) were associated with lower 30-day mortality after adjustment. The US National Registry of Myocardial Infarction 2 (NRMI2) investigators reported older age, female gender, diabetes mellitus, and a history of congestive heart failure as independent predictors of in-hospital mortality.11 The predictors of long-term outcomes of patients with cardiogenic shock treated with IABP counterpulsation have not been previously presented. For patients who could be successfully weaned from the IABP, we found a strong correlation between the occurrence of arrhythmias and renal failure during the intensive cardiac care unit stay and long-term mortality. In addition, treatment with primary PCI and CABG was beneficial in the long term. Although the admission period was not an independent predictor of outcome, the 30-day survival rate improved with time. This might have been related to the implementation of early revascularization with primary PCI in the routine treatment of AMI complicated by cardiogenic shock.13–15 Improving outcomes over time in patients with cardiogenic shock were also found in a recent study.2 The incidence of major complications was in line with the incidence reported by the Benchmark registry.16 In our study, severe bleeding, major limb ischemia, and balloon leak occurred in 2%, 1%, and 2%, respectively, compared with 0.8%, 0.9%, and 1.0%, respectively, as reported by the Benchmark registry. The number of vascular complications decreased during the study period, probably because of the use of improved IABP devices (especially, the introduction
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of smaller size catheters), as well as increased physician’s skills and experience, which has also been demonstrated in previous studies.17–19 We reported an IABP-related incidence of infection of 9%. However, this relatively high rate of infection might have been overestimated because of the robust definition of infection used in our study. However, in most cases, IABP-tip and/or blood cultures to definitely prove IABP-related infections were not available in our study. Additional limitations of our study included the retrospective nature and that we only included patients with cardiogenic shock who were treated with IABP. Thus, caution is urged in extrapolating these results to patients ineligible for IABP or those in cardiogenic shock who were not treated with IABP. The inclusion of a control group with cardiogenic shock without IABP treatment was not possible because IABP counterpulsation has been a part of the routine treatment of patients with AMI complicated by cardiogenic shock for years at our center. Hence, the benefit of IABP counterpulsation could not be proved by our study. Recently, a randomized controlled trial (clinical trials.gov identifier: NCT00491036; available from www.clinicaltrials. gov) has been initiated that will address the potential benefit of IABP counterpulsation adjunctive to medical treatment and primary PCI in patients with cardiogenic shock. 1. Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K, Vahanian A, Camm J, De Caterina R, Dean V, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J 2008;29:2388 –2442. 2. Goldberg RJ, Spencer FA, Gore JM, Lessard D, Yarzebski J. Thirtyyear trends (1975 to 2005) in the magnitude of, management of, and hospital death rates associated with cardiogenic shock in patients with acute myocardial infarction: a population-based perspective. Circulation 2009;119:1211–1219. 3. Bengtson JR, Kaplan AJ, Pieper KS, Wildermann NM, Mark DB, Pryor DB, Phillips HR, III, Califf RM. Prognosis in cardiogenic shock after acute myocardial infarction in the interventional era. J Am Coll Cardiol 1992;20:1482–1489. 4. Anderson RD, Ohman EM, Holmes DR Jr, Col I, Stebbins AL, Bates ER, Stomel RJ, Granger CB, Topol EJ, Califf RM. Use of intraaortic balloon counterpulsation in patients presenting with cardiogenic shock: observations from the GUSTO-I study: Global Utilization of Streptokinase and t-PA for Occluded coronary arteries. J Am Coll Cardiol 1997;30:708 –715. 5. Sanborn TA, Sleeper LA, Bates ER, Jacobs AK, Boland J, French JK, Dens J, Dzavik V, Palmeri ST, Webb JG, Goldberger M, Hochman JS. 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;36:1123–1129. 6. Barron HV, Every NR, Parsons LS, Angeja B, Goldberg RJ, Gore JM, Chou TM. The use of intra-aortic balloon counterpulsation in patients with cardiogenic shock complicating acute myocardial infarction: data
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