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Postcardiotomy mechanical support: risk factors and outcomes Nicholas G. Smedira and Eugene H.

Blackstone Ann Thorac Surg 2001;71:60-66

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The Annals of Thoracic Surgery is the official journal of The Society of Thoracic Surgeons and the Southern Thoracic Surgical Association. Copyright 2001 by The Society of Thoracic Surgeons. Print ISSN: 0003-4975; eISSN: 1552-6259.

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Postcardiotomy Mechanical Support: Risk Factors and Outcomes

Nicholas G. Smedira, MD, and Eugene H. Blackstone, MD
Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio

Background. The need for postcardiotomy mechanical support is uncommon, with an incidence of 0.5%. Methods. Multivariable logistic regression analysis of factors associated with postcardiotomy extracorporeal membrane oxygenation (ECMO) support was investigated in 19,985 patients, of whom, 97 required ECMO. Results. Younger age, number of reoperations, emergency operation, higher creatinine, greater left ventricular dysfunction, and history of myocardial infarction were signicant predictors. Overall survival was 35%, but signicantly better (72%) in the subgroup converted

to an implantable system and then bridged to transplantation. Conclusions. Patients at increased risk for mechanical support can be identied preoperatively and patient management modied as indicated. Improvement in postcardiotomy survival has been realized by bridging to transplantation. In nontransplant candidates, permanent support may be the only option for increasing survival. (Ann Thorac Surg 2001;71:S60 6) 2001 by The Society of Thoracic Surgeons

ortunately, the need for postcardiotomy mechanical circulatory support is uncommon and likely declining in incidence. Postcardiotomy support in the form of intraaortic balloon pump (IABP) counterpulsation is reported to occur in 4%, and more advanced support is necessary in 0.2% to 1.2% [1]. At the Cleveland Clinic Foundation between 1992 and 1999, 19,985 patients have undergone cardiac procedures, with 107 (0.5%) requiring postcardiotomy support. The preoperative predictors, intraoperative management, and results of postcardiotomy support with extracorporeal membrane oxygenation (ECMO) at the Cleveland Clinic Foundation, as well as published experiences with the ABIOMED BVS 5000 (ABIOMED Cardiovascular, Danvers, MA) and the Thoratec VAD (Thoratec Laboratories Corporation, Berkeley, CA), will be described below.

Material and Methods Predictors of Postcardiotomy Pump Failure and ECMO Support
Most reports of postcardiotomy mechanical support have included small numbers of patients and have focused on patient outcomes after support. There are little data detailing the patients preoperative characteristics, which may help identify patients at increased risk for mechanical support after cardiovascular procedures. The best information about postoperative myocardial dysfunction comes from a careful review by Rao and associates of 4,558 consecutive patients who underwent
Presented at the Fifth International Conference on Circulatory Support Devices for Severe Cardiac Failure, New York, NY, Sept 1517, 2000. Address reprint requests to Dr Smedira, Department of Thoracic and Cardiovascular Surgery, 9500 Euclid Ave, Desk F25, Cleveland, OH 44195; e-mail:

coronary revascularization at the Toronto Hospital [2]. Although they did not look directly at postcardiotomy mechanical support, low output syndrome (LOS) as dened by the requirement for intraaortic balloon counterpulsation or inotropic support for longer that 30 minutes after arrival in the intensive care unit to maintain a systolic blood pressure greater than 90 mm Hg and the cardiac index greater than 2.2 L/min/m2 is a useful surrogate for the potential need for advanced support. Multivariate analysis identied reduced ejection fraction ( 20%), reoperation, emergency surgery, and female gender as strong predictors of low output syndrome after CABG (Table 1). The likelihood of developing LOS for various combinations of predictors is shown in Figure 1. Additionally, there was a greater incidence of LOS after incomplete revascularization, 14.6% versus 8.1% with complete revascularization and after a perioperative myocardial infarction, 14.3% compared with 1.8% without a myocardial infarction. To see if similar factors were related to the need for postcardiotomy mechanical support, we compared patients undergoing cardiovascular procedures who did and did not need ECMO support postcardiotomy. Between September 1, 1992, and January 2000, 233 adults were supported with ECMO at the Cleveland Clinic Foundation. Of these, 107 patients had ECMO instituted for circulatory support after cardiovascular surgery. The majority of these patients had undergone coronary artery bypass grafting or valve surgery (Table 2). The patients ranged from 18 to 82 years of age; 72% were men, and 54% were undergoing a reoperative procedure.

From the Cardiovascular Information Registry (CVIR), a registry of all cardiovascular

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2001 by The Society of Thoracic Surgeons Published by Elsevier Science Inc

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Table 1. Multivariable Analysis of Low Cardiac Output Syndrome

Variable EF 20% Reoperation Emergency Female gender Diabetes Age 70 years Recent MI Odds Ratio 5.7 4.4 3.7 2.5 1.6 1.4 1.4 Percent With Variable Developing LOS 27 25 27 16 13 12 16

Table 2. Procedure Leading to Extracorporeal Membrane Oxygenation

Procedure CABG Valve surgery Combined CABG and valve surgery Congenital heart surgery Descending thoracic aorta surgery Post-left ventriculectomy Total

No. 60 15 19 8 4 1 107

Percent of 107 56 14 18 7 4 1 100

Modied from Rao and associates [2]. EF ejection fraction; cardial infarction. LOS low output syndrome; MI myo-

coronary artery bypass grafting.

operations with data entered prospectively and concurrently with care, all patients undergoing coronary artery bypass grafting, valve operations, combined valve and coronary operations, and thoracic aorta operations were selected between September 1, 1992 and January 1, 1999, the last date for which complete information was available. This yielded 19,985 patients, of whom, 97 were among the 107 ECMO patients. The remaining patients were either those after congenital heart surgery or having an operation in 1999.

when they were approximately normally distributed, and as range. Categorical variables are expressed as percentages. Complications during ECMO that were examined included infection, dialysis, neurologic events (encephalopathy, intracranial bleeding, stroke), pump thrombus, and limb complications. The highest values for BUN, creatinine, AST, and total bilirubin were recorded. We recorded whether the patient was bridged with the intent of transplantation, was weaned with the intent for survival, or withdrawn from support.

Conduct of ECMO
All 107 patients received veno-arterial ECMO. Peripheral cannulation (common femoral artery and vein) was used in 67% of the patients, and central cannulation (ascending aorta and right atrium or common femoral vein) in 33%. The ECMO circuit and cannulation protocols have been described in detail previously [3, 4].

Method of Data Analysis

DESCRIPTIVE. Descriptive statistics are summarized as the mean and standard deviation for continuous variables

The question of what factors were associated with the decision to use ECMO after cardiovascular surgery was investigated by multivariable logistic regression. Initial screening of variables possibly related to survival utilized contingency table methods and simple t testing. Continuous and ordinal variables were assessed univariably by decile analysis to suggest transformation of scale to incorporate these into the multivariable analysis in a way that ensured that the relation of these variables to outcome was well calibrated with respect to model assumptions. Variables were identied using a directed technique of entry of variables into the multivariable models [5]. The p value criterion for retention of variables in the nal model was 0.05. This directed technique of entry of variables into the model was veried by bootstrap resampling variable selection [6, 7]. All variables found by ordinary multivariable regression composed a complete set of variables appearing in at least 50% of the 500 resamplings.

Fig 1. Probability of developing low output syndrome after coronary artery bypass grafting. Left ventricular grade (LV Grade) scored 1 to 4. (ACB Redo reoperation; timing: E elective; S semi-elective; U urgent; TVD triple vessel disease.) (Tabular material from Rao and colleagues [2]; reprinted with permission from Mosby/Harcourt Brace, Inc.)

PRESENTATION. Tables of risk factors are presented with their coefcients and standard deviations rather than as odds ratios because of the use of data transformation that makes these derived statistics difcult to interpret. All condence limits are equivalent to 1 SE for consistency with the presentation of mean values.

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Ann Thorac Surg 2001;71:S60 6

Table 3. Risk Factors for Extracorporeal Membrane Oxygenation

Logistic Coefcient SD 0.81 1.82 2.4 0.197 0.78 0.044 0.56 0.36 0.190 0.22 0.24 0.050 0.24 0.0157 0.23 0.140 6.33 0.83 Reliabilitya (%) 98 99.8 100 66 75 66 54 89

Factor Demography Young ageb Clinical status More cardiac reoperationsc Emergency operation Higher creatinine Cardiac comorbidity Left main disease ( 50% diameter stenosis) Greater LV dysfunctiond History of previous MI Experience More recent date of operatione Intercept Goodness-of-t (c)

p 0.0001 0.0001 0.0001 0.0001 0.001 0.005 0.02 0.009

b c Percent of times that variable appeared in 500 bootstrap resamplings. [age/50]2 squared transformation. In[surgery number d logarithmic transformation. exp[LV dysfunction grade (1 none, 2 mild, 3 moderate, 4 severe)] exponential transformation. since September 1, 1992] natural logarithmic transformation.

1 e

]natural ln[years


left ventricular;


myocardial infarction.

Results Variables Associated With Need for ECMO

Patients who required ECMO after cardiovascular surgery differed in a number of respects from patients who did not require ECMO (Appendix Table). They were older, they were in more advanced clinical status, they often had come to operation on an emergent basis, they had more severe left ventricular dysfunction, two-thirds had a history of myocardial infarction, they were more likely to have had a reoperation, they were more likely to be in renal failure, they were more likely to have left main disease and three-system disease, and they were less likely to have received an internal thoracic artery graft. By both multivariable and bootstrap reliability analysis, eight factors were found to be the common denominators for ECMO: younger age, more cardiac reoperations, emergency operation, higher creatinine, left main disease, greater left ventricular dysfunction, a history of previous myocardial infarction (MI), and a more recent date of operation (Table 3, Figs 2, 3). The correspondence between actual use of ECMO and that predicted on the basis of the above variables was strong and in the predictive range (C 0.83). It is noteworthy that this analysis and the Rao investigation found almost identical risk factors and that the multivariable tables can be used in a prospective fashion to estimate the likelihood that a patient would require mechanical support after cardiovascular surgery.

were pneumonia, line-related bacteremia, and surgical wound infections and not related to the ECMO system or cannulation site. Distal limb ischemia was seen early in our experience and has been eliminated by inserting a 10 French pediatric aortic cannula into the supercial femoral artery [4]. The median number of transfused units of

Complications occurring while patients were on ECMO included infections in 48%, requirement for dialysis in 39%, neurologic events in 29%, pump thrombus in 5%, and limb complications in 27% (Table 4). The infections

Fig 2. ECMO use after cardiac surgery according to age of patients and clinical conditions. This is a so-called nomogram of the multivariable logistic regression equation shown in Table 3. It has been solved for patients with a median preoperative serum creatinine level of 1.3 mg/dL. Three different patient proles are shown. The lowest curve relates to patients undergoing elective operations, without prior MI, normal ventricular function, and no left main (LM) disease, but undergoing a rst reoperation. The other 2 patients are also undergoing rst reoperations, but in an emergency setting with poor left ventricular function from a history of prior myocardial infarction. One of these patient proles includes left main disease and the other does not.

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Fig 3. ECMO use after cardiac surgery according to level of preoperative serum creatinine (mg/dL). The depictions represent patients 60 years of age (median). The patient proles are otherwise the same as in Figure 2.

packed red blood cells was 18 (25th percentile, 11; 75th percentile, 28; minimum, 0; maximum, 99). All measures of renal and hepatic function were elevated during ECMO compared with pre-ECMO placement. Similar complication rates after postcardiotomy support have been reported by Golding and associates with centrifugal devices, McBride and associates with their use of the Thoratec VAD, and Korfer and Guyton and associates with the ABIOMED system [8 11].

Fig 4. Survival after ECMO following cardiac surgery. Two groups of patients are depicted, those bridged from ECMO with intent of heart transplantation, and those weaned from ECMO with intent of surviving without assistance. Patients who were bridged are represented by circles and those weaned are represented by squares. The symbols are nonparametric survival estimates, and the vertical bars represent condence limits equivalent to 1 SE. The numbers in parentheses are the number of patients still being traced at the various time intervals. The solid lines are parametric survival estimates and are accompanied by condence limits equivalent to 1

Wean and Survival Rates


Eighteen of the patients supported with ECMO were bridged to transplantation, and 42 were weaned with intent for survival. ECMO support was withdrawn from 47 patients. This yielded an overall survival to discharge of 35%. The ABIOMED BVS 5000 is a simple, easy-to-use extracorporeal pulsatile pump capable of

biventricular support. Its ease of use is reected by the fact that it is available in over 450 centers in the US, with the majority being utilized in nontransplant centers. From the postmarket data recorded on 78 patients averaging 57.5 years of age, overall wean and discharge rates were 55% and 31%, respectively. Samuels and associates found similar wean and discharge rates and noted a substantial survival benet, 40% versus 0% in patients whom the device was placed less than 3 hours of the rst wean attempt from cardiopulmonary bypass, compared with patients support after 3 hours [12].


Table 4. Complications During Extracorporeal Membrane Oxygenation

Complication Infection (pneumonia and bacteremias) Dialysis Neurologic events Encephalopathy Intracranial bleeding Stroke Pump thrombus Limb complicationsa Ischemia Fasciotomy Vascular repair Amputation

The Thoratec VAD is a versatile paracorporeal device capable of biventricular and both shortand long-term support. Wean rates of 43% with survival of 27% have been reported [9].

No. 51 42 31 22 3 6 5 29 20 4 3 2

Percent of 107 48 39 29 21 3 6 5 27 19 4 3 2

Increasing Survival With Transplantation and Advanced Support

Overall survival and wean rates after postcardiotomy support have remained static over the past decade. The most signicant improvement has been seen at transplant and assist centers, where appropriate transplant candidates are bridged to transplantation using an implantable system or the ABIOMED and Thoratec VADS. ECMO support was converted to an implantable left ventricular assist device (LVAD) in 18 patients at the Cleveland Clinic. Of these, 72% survived to transplant, with 92% 1-year survival (Fig 4). The successful use of an implantable LVAD for postcardiotomy support has been described by DeRose and associates from Columbia Presbyterian Medical Center [13]. In their series, 12 patients after elective or emergency coronary artery grafting requiring IABP, Biomedicus, or ABIOMED

Documentation not available in one case.

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Ann Thorac Surg 2001;71:S60 6

LVAD support were converted to the TCI Heartmate (ThermoCardio Systems, Inc, Woburn, MA) at a mean of 3.5 days. Of these, 8 were transplanted, 1 was explanted, and all discharged for an overall survival of 75%. Similar results have been described by Korfer and associates [10]. In their experience with 68 patients supported with the ABIOMED BVS 5000, the majority with postcardiotomy failure, 32 were weaned and 13 patients transplanted, with an overall survival of 47%. Thoratec VADs were used in another 17 patients at their institution for postcardiotomy support, with 8 survivors (47%): 7 patients transplanted and 1 successfully weaned (Farrar DJ, Personal communication, 2000).

Risk analysis and careful review of patients developing LOS and needing ECMO support postcardiotomy reveal a consistent patient prole. In general, the patient at risk has a long history of coronary atherosclerosis with previous myocardial infarctions resulting in reduced cardiac reserve, had one or more coronary revascularizations, and is unstable, requiring an emergency operation. Incomplete revascularization and perioperative myocardial infarctions are common. In fact, McBride and Golding and associates found that over two-thirds of patients dying after postcardiotomy support and undergoing an autopsy had evidence of extensive MI [9, 10]. This information is important as it allows for perioperative identication of a high-risk patient and can be used to select a device intraoperatively. At the Cleveland Clinic Foundation, a patient identied as being at increased risk for postcardiotomy support is admitted to the Heart Failure Service and is assessed and managed by a heart failure cardiologist. This expertise is utilized to prepare the patient for surgery by improving hemodynamics and functional class and reducing myocardial ischemia. In the appropriate patient, transplant screening is begun and discussions are initiated with the patient and the family about transplantation and use of assist devices. This approach reduces the difculties of transplantation assessment in a patient already committed to an assist device. With the knowledge that myocardial ischemia and damage, often irreversible, account for the majority of cases requiring postcardiotomy support, technical steps such as complete revascularization, meticulous myocardial protection, and avoiding vein graft atheroembolization will likely minimize its occurrence. In the patient at high risk, with baseline severe limitation in cardiac function, the development of postcardiotomy low output favors the use of a long-term device such as the Thoratec VAD or an implantable system at the initial operation. The Thoratec VADs versatility is particularly useful in this setting, as the patient can be supported for prolonged periods, bridged to transplant, or weaned. However, it is not possible to discharge the patients supported on the Thoratec while awaiting transplant. At the Cleveland Clinic Foundation, our approach to device selection has evolved over the

past few years. In patients with acute MIs with cardiogenic shock or postcardiotomy pump failure who have been cleared for transplantation, we utilize an implantable LVAD as the rst choice and the ABIOMED or Thoratec devices if biventricular support is needed or for smaller patients. We believe this avoids the blood trauma of ECMO support and may promote myocardial recovery through direct apical cannulation. At this time, there is no evidence to directly support this contention. For the remainder of patients requiring postcardiotomy support, ECMO and IABP support remain our initial choices. Overall, postcardiotomy survival has only recently begun to improve. From the literature, postcardiotomy survival averages between 25% and 30%. By utilizing VADs and transplantation more frequently, survival has improved to approximately 50%. At the Cleveland Clinic Foundation, patients are supported for 48 to 72 hours with ECMO and then converted to an implantable device if they are an appropriate candidate for transplantation and if myocardial function has not improved. This approach avoids the high-risk emergency heart transplantation and provides the time necessary for improvement in organ function and patient status. Samuels, Korfer, DeRose, and Pagani and associ ates have published similar guidelines [10, 1214]. With the knowledge that extensive myocardial injury is present in the majority of nonsurvivors of postcardiotomy support, it is unlikely that a specic device or mode of support will improve outcome. In the nontransplant candidate, consideration of permanent device support, when available, may offer a life-saving alternative.
The authors thank Colleen Vahcic for her help with manuscript preparation and Lucinda Mitchin for her invaluable advice and technical assistance.

1. Torchiana DF, Hirsch G, Buckley MJ, et al. Intraaortic balloon pumping for cardiac support: trends in practice and outcome, 1968 to 1995. J Thorac Cardiovasc Surg 1997;113: 758 69. 2. Rao V, Ivanov J, Weisel RD, Ikonomidis JS, Christakis GT, David TE. Surgery for acquired heart disease: predictors of low cardiac output syndrome after coronary artery bypass. J Thorac Cardiovasc Surg 1996;112:3851. 3. Magovern GJ Jr, Simpson KA. Extracorporeal membrane oxygenation for adult cardiac support: the Allegheny experience. Ann Thorac Surg 1999;68:655 61. 4. McDonald M, Smedira NG. Adult extracorporeal life support. In: Franco KL, Verrier ED, eds. Advanced therapy in cardiac surgery. Hamilton, Ontario: BC Decker; 1999;326 34. 5. Baskerville JC, Toogood JH. Guided regression modeling for prediction and exploration of structure with many explanatory variables. Technometrics 1982;24:917. 6. Efron B, Tibshirani R. Bootstrap methods for standard errors, condence intervals, and other measures of statistical accuracy. Stat Sci 1986;1:5477. 7. Altran DG, Andersen PK. Bootstrap investigation of the stability of a Cox regression model. Stat Med 1989;8:771 83. 8. Golding LAR, Crouch RD, Stewart RW, et al. Postcardiotomy centrifugal mechanical ventricular support. Ann Thorac Surg 1992;54:1059 644. 9. McBride LR, Naunheim KS, Fiore AC, Moroney DA, Swartz

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10. 11. 12.



MT. Clinical experience with 111 Thoratec Ventricular Assist Devices. Ann Thorac Surg 1999;67:12339. Korfer R, El-Banayosy A, Arusoglu L, et al. Temporary pulsatile ventricular assist devices and biventricular assist devices. Ann Thorac Surg 1999;68:678 83. Guyton RA, Schonberger JPAM, Everts PAM, et al. Postcardiotomy shock clinical evaluation of the BVS 5000 Biventricular System. Ann Thorac Surg 1993;56:34656. Samuels LE, Kaufman MS, Thomas MP, Holmes EC, Brockman SK, Wechsler AS. Pharmacological criteria for ventricular assist device insertion following postcardiotomy shock: experience with the ABIOMED BVS system. J Card Surg 1999;14:28893. DeRose JJ, Umana JP, Argenziano M, et al. Improved results for postcardiotomy cardiogenic shock with the use of implantable left ventricular assist devices. Ann Thorac Surg 1997;64:1757 63. Pagani FD, Lynch W, Swaniker F, et al. Extracorporeal life support to left ventricular assist device bridge to heart transplant: a strategy to optimize survival and resource utilization. Circulation 1999;100(Suppl II):II206 10.


New York Heart Association functional class, emergency surgery.

CARDIAC COMORBIDITY. Atrial brillation, previous percutaneous coronary intervention, number of cardiac operations/reoperations. NONCARDIAC COMORBIDITY.

Diabetes, insulin-treated diabetes, orally treated diabetes, smoker, lipid levels (cholesterol, LDL and HDL cholesterol, triglycerides), peripheral vascular disease, COPD, hypertension, chronic renal failure, BUN, creatinine.

CORONARY ANATOMY. Left main, left anterior descending, circumex, and right coronary artery disease (percent diameter reduction, 50%, 70%, 100%, and any obstruction 0). OPERATION. Coronary artery bypass grafting (CABG) alone, valve surgery (with or without CABG), thoracic aorta operation, use of CABG, aortic valve repair or replacement, mitral valve repair or replacement, use of internal thoracic artery (ITA) conduit, date of operation (years since September 1, 1992).

Appendix Variables Examined as Potential Predictors of Need for ECMO

DEMOGRAPHY. Gender, age (years), weight (kg), height (cm), body surface area (m2), body mass index (kg/m2).

Appendix Table. Comparison of Patients Receiving or Not Receiving ECMO

No ECMO Variable Demography Women Age (years, mean SD) Weight (kg, mean SD) BSA BMI Clinical condition NYHA class I II III IV Emergency operation LV dysfunction None Mild Moderate Severe History of MI Prior cardiac operation 0 1 2 3 4 or more Noncardiac comorbidity Diabetes Smoker Peripheral vascular disease COPD Hypertension Renal failure N 19,888 19,888 19,807 19,753 19,753 19,875 3,270 9,225 3,132 4,248 628 11,137 3,832 2,563 1,562 9,156 15,224 3,763 734 135 32 18,902 19,760 19,886 19,886 18,661 19,886 4,281 11,980 5,360 3,329 11,953 1,115 16 46 16 21 3.2 58 20 13 8 46 77 34 3.7 0.7 0.2 23 61 27 17 64 5.6 91 92 97 97 88 97 n 5795 63 12 81 17 1.97 0.25 28 7.5 % 29 N 97 97 97 95 95 97 20 26 17 34 25 40 13 14 17 64 41 33 14 7 2 23 59 27 11 52 15 21 27 18 35 26 48 15 17 20 66 42 34 14.4 7.2 2.1 25 64 28 11 59 15 0.6 0.5 0.8 0.16 0.3 0.0001 ECMO n 28 59 81 1.95 28 11 19 0.21 4.7 % 29 p 0.95 0.0009 0.9 0.4 0.4 0.0005

19,888 19,094

97 84

0.0001 0.0005

19,886 19,888

97 97

0.0001 0.0001

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Appendix Table. Comparison of Patients Receiving or Not Receiving ECMO (Continued)

No ECMO Variable Coronary disease Left main 50% LAD 50% LCx 50% RCA 50% Three-system disease Operative category CABG only Valve CABG Thoracic aorta Operative procedures CABG Use of ITA Aortic procedure Mitral procedure N 17,145 19,115 19,115 19,115 19,115 19,888 n 3,061 13,629 11,618 12,352 9,214 11,911 7,245 732 19,888 14,778 10,425 4,185 4,177 74 52 21 21 % 18 71 61 65 48 60 36 3.7 97 77 32 22 20 79 33 23 21 0.3 0.0001 0.7 0.93 N 78 84 84 84 84 97 ECMO n 29 66 58 65 50 57 35 5 % 37 79 69 77 60 59 36 5.2 p 0.0001 0.14 0.12 0.01 0.04 0.8 0.94 0.4

BSA body surface area; BMI body mass index; CABG coronary artery bypass grafting; COPD chronic obstructive pulmonary disease; ECMO extracorporeal membrane oxygenation; ITA internal thoracic artery; LAD left anterior descending coronary artery; LCx left circumex coronary artery; LV left ventricle; MI myocardial infarction; NYHA New York Heart Association; RCA right coronary artery.

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Postcardiotomy mechanical support: risk factors and outcomes Nicholas G. Smedira and Eugene H. Blackstone Ann Thorac Surg 2001;71:60-66
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