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Original Articles: Adult Cardiac

Preoperative Intraaortic Balloon Pumping Improves Outcomes for High-Risk Patients in Routine Coronary Artery Bypass Graft Surgery

^a Cardiac Surgery Unit, Magna Graecia University, Catanzaro, Italy
^b Anesthesiology Unit, Magna Graecia University, Catanzaro, Italy

Accepted for publication November 3, 2008.

^_* Address correspondence to Dr Onorati, Cardiac Surgery Unit, Magna Graecia University of Catanzaro, Viale Europa, Località Germaneto, Catanzaro, 88100, Italy (Email: frankono{at}libero.it).

	Abstract

Top Abstract Introduction Patients and Methods Results Comment References

 
Background: We evaluated the association between the preoperative use of intraaortic balloon pumping and in-hospital and long-term outcomes in high-risk patients undergoing coronary artery bypass grafting.

Methods: From 714 total patients undergoing coronary artery bypass grafting during a 4-year period, we compared the clinical, biochemical, and echocardiographic findings up to 1 year after surgery between 111 patients who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 12 or greater and received intraaortic balloon pumping preoperatively (group A) and 130 patients who had a EuroSCORE of 5 or less and received no preoperative intraaortic balloon pumping (group B).

Results: Group A patients were significantly older, had significantly more comorbid conditions, and had a significantly lower mean preoperative ejection fraction (all p < 0.001). Intraoperative data were comparable between groups, as were lactate and troponin I levels sampled from the coronary sinus. Lactate, troponin I, creatine kinase, and creatine kinase-MB mass showed comparable leakage at all postoperative times. The incidences of in-hospital mortality, perioperative myocardial damage, and acute myocardial infarction and duration of hospital stay were comparable. High-risk patients showed significant improvements in ejection fraction (p < 0.001) and wall-motion score index (p = 0.06) after surgery, but low-risk patients showed no significant change in these variables. The incidences of death, recurrent angina, myocardial infarction, and repeat coronary procedures did not differ significantly between groups.

Conclusions: The preoperative use of intraaortic balloon pumping appears to shift high-risk patients undergoing coronary artery bypass grafting into a lower-risk category and is associated with comparable perioperative troponin leakage and short-term and long-term outcomes similar to low-risk patients not receiving intraaortic balloon pumping.

	Introduction

Top Abstract Introduction Patients and Methods Results Comment References

 
The overall aging of the population and the widespread diffusion of interventional cardiology procedures have resulted in the phenomenon that patients referred for coronary artery bypass grafting (CABG) are older and have more extensive disease and poorer left ventricular function than in previous years [1]. Correspondingly, current CABG populations have poorer risk profiles as defined by scales such as the European System for Cardiac Operative Risk Evaluation (EuroSCORE) system [2, 3].

The evolution of myocardial protection techniques has yielded distinct benefits for the expanding population of high-risk candidates for CABG [4]. However, current methods do not invariably prevent against myocardial stunning or frank necrosis [4]. In this setting, the troponin I level represents the most sensitive biochemical marker to diagnose even minimal myocardial damage or necrosis, and it is now considered the gold standard for defining the quality of myocardial protection after CABG [5].

Since its first application, the intraaortic balloon pump (IABP) has rapidly become a reliable device that improves the outcomes of high-risk coronary patients, especially when used preoperatively [1]. Nonetheless, disagreement still exists worldwide about IABP use and the optimal timing of support; in fact, the need for IABP assistance is still sometimes considered to be an indicator of complications rather than a therapy [6]. The higher rates of IABP-related complications observed in the past have dissuaded some surgeons from its use [6]. The introduction of new IABP guidewires, together with technologic improvements in catheter size and software, have expanded the indications for preoperative IABP use [7]. For example, the transbrachial approach has now been performed successfully in patients with unsuitable femoral arteries [8]. Preoperative IABP has proved to be safe and effective in improving outcomes of open heart procedures, especially when such support is started preoperatively [9].

The aim of this study was to compare outcomes (ranging from perioperative troponin I leakage to 1-year clinical outcomes) of high-risk patients undergoing CABG who received preoperative IABP support with those of contemporaneous low-risk patients undergoing CABG who did not receive preoperative IABP support. To our knowledge, the literature lacks trials comparing clinical, biochemical, and echocardiographic findings between high-risk patients receiving IABP support before CABG and low-risk patients without the need for such preoperative IABP support.

	Patients and Methods

Top Abstract Introduction Patients and Methods Results Comment References

 
Patients
Between January 2003 and May 2007, 714 patients underwent CABG at our academic institution. The present study compares the clinical and biochemical findings of 111 of these patients who underwent isolated CABG, who had a EuroSCORE of 12 or greater, and who received IABP support preoperatively (high-risk, group A) with those of 130 of these patients who underwent elective CABG, who had a EuroSCORE of 5 less, and who did not receive IABP support preoperatively (low-risk, group B). Patients undergoing CABG who had a EuroSCORE between 6 and 11 were excluded from the study to better differentiate low-risk from high-risk patients. This EuroSCORE cutoff value was selected according to our previous experience and other clinical investigations [4, 10, 11]. Also, given that the EuroSCORE is calculated the day before surgery, preoperative IABP could be included in the risk calculation.

Our institution's ethical committee and institutional review board approved the study, and informed consent was obtained from each patient.

Intraaortic Balloon Pump Support
The preoperative use of IABP was indicated for patients with triple-vessel disease and at least two of the following: preoperative left ventricular ejection fraction equal to 0.30 or less, left main coronary artery stem stenosis greater than 90%, chronic occlusion of the three main coronary trunks (left anterior descending, right, and circumflex coronary arteries), tight stenosis (>99%) of the proximal left anterior descending coronary artery (before the first septal or diagonal branch), proximal tight stenosis (>99%) of a dominant right coronary artery with remote branches for the posterior wall of the left ventricle, unstable angina despite intravenous nitrates and heparin, acute ongoing angina or myocardial infarction, or acute failed percutaneous coronary intervention. It was institutional policy to start IABP assistance in case of high-risk patients; thus all patients with a EuroSCORE greater than 12 received IABP support before induction of anesthesia for CABG.

For patients in group A, it was institutional policy to insert an IABP (7F or 7.5F, 34 or 40 mL; Datascope Corp, Fairfield, NJ) percutaneously with the sheathless technique through the best femoral artery, before induction of anesthesia [8]. The IABP was connected to a Datascope pump (CS300; Datascope Corp). The correct placement of IABP was always assessed by postoperative chest roentgenography or transesophageal echocardiography. The IABP was withdrawn when hemodynamic stability was restored (ie, a cardiac index 2.0 L · m^–2 · min^–1 with only minimal pharmacologic inotropic support—dobutamine or enoximone at 5 µg · kg^–1 · min^–1). In 11 patients in group A (9.9%) and 4 patients in group B (3.1%), because of severe peripheral disease of the distal aorta, IABP was introduced percutaneously with the sheathless technique through the best brachial artery [8]. All IABP-related complications (peripheral ischemia, infection, hemorrhage, embolism, dissection) were recorded. Prolonged IABP support was defined as IABP assistance for greater than 72 hours postoperatively.

Surgical Technique
Surgery was performed in all cases through a median sternotomy.

As previously reported [12, 13], we prefer extensive arterial grafting whenever possible. In particular, the left internal mammary artery was always anastomosed to the left anterior descending. The gastroepiploic artery was used according to the surgeon's choice and always anastomosed to a severely stenosed (>80%) proximal posterior descending artery. The radial artery was anastomosed to a diagonal artery or obtuse marginal artery, in cases of proximal critical stenosis (>80%), and proximally anastomosed to the aorta or as a Y-conduit to the left internal mammary artery, in cases of calcified aorta difficult to clamp. Age was never considered as a contraindication to arterial revascularization.

The ascending aorta was always used as the arterial cannulation site. Venous return to the cardiopulmonary bypass machine was always accomplished through a double-stage cannula into the right atrium. Cardiopulmonary bypass was standardized, consisting of a Dideco (Mirandola, Modena, Italy) tubing set that included a 40-µm filter, a Stockert roller pump (Stockert Instruments, Munich, Germany), and a hollow-fiber membrane oxygenator (Monolyth; Sorin Biomedica, Saluggia, Italy). Heparin was given at a dose of 300 IU/kg to achieve a target activated clotting time of greater than 480 seconds. Total cardiopulmonary bypass flow was maintained at 2.6 L · min^–1 · m^–2. Systemic temperature was kept between 32° and 34°C. Myocardial protection on cardiopulmonary bypass was always achieved with intermittent antegrade and retrograde hyperkalemic warm-blood cardioplegia [4]. Proximal anastomoses were done after aortic cross-clamp removal when cardiopulmonary bypass was used, and before distal anastomoses when off-pump CABG was performed. For patients undergoing off-pump CABG (n = 54; 22.4% of the population), exposure and stabilization were achieved with the Octopus-IV tissue stabilizer (Medtronic Inc, Minneapolis, MN) and the Starfish system (Medtronic Inc). Intracoronary shunts were routinely used. In off-pump CABG, the first grafted vessel was always the left internal mammary artery to the left anterior descending coronary artery. Indications for off-pump CABG included isolated, severe, extracardiac comorbid conditions such as chronic obstructive pulmonary disease, renal insufficiency, and so forth. The heparinization protocol consisted of administration of 150 IU/kg to achieve an activated clotting time of greater than 300 seconds. All patients underwent blood recovery with an autotransfusion device (Autotrans Dideco; Mirandola).

Definitions of Perioperative Events
Hospital mortality was defined as death occurring during hospitalization or within 180 days after surgery. Perioperative myocardial damage was defined as a peak troponin I level of at least 3.1 µg/L at 12 hours after surgery without associated electrocardiographic or echocardiographic signs of myocardial infarction, as previously reported [5, 10]. Perioperative myocardial infarction was defined as new Q waves of greater than 0.04 milliseconds, reduction in R waves of greater than 25% in at least two leads, or both; new akinetic or dyskinetic segment on echocardiography; and a peak troponin I level of at least 3.1 µg/L at 12 hours [5]. Low-output syndrome was diagnosed if the patient showed hemodynamic compromise or a cardiac index less than 2.0 L · min^– · m^–2 in the intensive care unit despite IABP assistance and inotropic support, after correction of all electrolyte and blood gas abnormalities, and after adjusting the preload to its optimal value. Hospital morbidity was defined as any complication requiring specific therapy or causing a delay in hospital or intensive care unit discharge. Intensive care unit stay was defined as the time (hours) required for intensive care; hospital stay, as the time (days) required for hospitalization starting from the day of the surgery.

We have previously shown that phosphodiesterase inhibitors can reduce troponin I release and the need for further inotropic support in patients undergoing on-pump CABG [14]. Therefore it is now our institutional policy to start inotropic agents (enoximone, 5 µg · kg^–1 · min^–1) immediately after aortic cross-clamp removal [14]. Inotropic support was defined as low dose when 5 µg · kg^–1 · min^–1 or less of enoximone was given, medium dose when 6 to 10 µg · kg^–1 · min^–1 of enoximone was given or 5 to 10 µg · kg^–1 · min^–1 of dobutamine was added, and high dose when greater than 10 µg · kg^–1 · min^– of enoximone or dobutamine was given or any dose of epinephrine was added [14].

Biochemical and Echocardiographic Analysis
Blood samples to assess levels of troponin I, lactate, creatine kinase (CK), and CK-MB mass were obtained preoperatively (before anesthetic induction), at the end of cardiopulmonary bypass from the coronary sinus, and postoperatively at 12, 24, 48, and 72 hours [4]. Echocardiography was performed with a transthoracic VIVID 7 Pro ultrasound machine (GE Technologies, Milwaukee, WI) by the same two physicians at admission and before discharge. Left ventricular ejection fraction and wall motion score index were recorded.

Follow-Up
Clinical status was assessed at discharge, at 6 months, and at 1 year in the outpatient clinic. Follow-up was 100% complete at 1 year. Deaths, episodes of recurrent angina, myocardial infarctions, and repeat percutaneous or surgical coronary procedures during follow-up were recorded.

Statistical Analysis
Statistical analysis was performed with SPSS 13.0 statistical software (SPSS Inc, Chicago, IL). All continuous data were expressed as mean ± standard deviation. One-way or two-way analysis of variance for repeated measures was used to test the effects of group and time on the levels of troponin I, lactate, CK, and CK-MB mass. When analysis of variance indicated a significant effect of group or time (p < 0.05), the differences were specified with analysis of variance comparison. The unpaired Student's t test was used to compare other continuous variables. Categorical variables were expressed as numbers and percentages of patients, and these were analyzed using the ² test or Fisher's exact test when appropriate. Estimates of survival and freedom from recurrent angina, myocardial infarction, and repeat coronary procedures were determined with the Kaplan–Meier life-table analysis. The log-rank test was performed to ascertain differences between the groups. All comparisons were considered significant if the probability was less than 0.05.

	Results

Top Abstract Introduction Patients and Methods Results Comment References

 
The two groups showed significant differences in several demographic and clinical preoperative variables (Table 1), whereas intraoperative data and the release of lactate, troponin I, CK, and CK-MB mass from the coronary sinus were similar (Table 2). Accordingly, no differences were recorded in peripheral lactate, troponin I, CK, or CK-MB mass at all times. In particular, both high-risk and low-risk patients showed slight augmentation of postoperative enzymes, never reaching statistical significance between the two groups (Table 3).

Two additional patients in group B received IABP assistance immediately on intensive care unit arrival for unexpected ST-segment elevation on 12-lead electrocardiography. Neither of the patients had either myocardial damage or myocardial infarction.

There were no significant differences between the two groups in terms of postoperative myocardial damage or acute myocardial infarction (Table 4). Two patients in group A (1.8%) and 1 patient in group B (0.8%; p = 0.596) had transient acute renal failure treated with continuous venovenous hemofiltration, and 1 patient in group A showed transient cognitive dysfunction versus 0 in group B.

No major IABP-related complications were registered during the study period, except for 1 case of temporary limb ischemia in group A that resolved completely after prompt IABP withdrawal. Two minor complications occurred in group A (2 cases of bleeding at the balloon entry site that resolved with gentle manual compression alone; Table 5).

View larger version (19K): [in this window] [in a new window]   Fig 1. Ejection fraction (A) and wall motion score index (B) values for the two groups on preoperative (black bars) and postoperative (white bars) measurement.

	Comment

Top Abstract Introduction Patients and Methods Results Comment References

 
With the enormous growth of interventional cardiology in recent decades, patients coming to myocardial revascularization surgery are now more likely to have end-stage disease, with more-ischemic and energy-depleted hearts, compared with the era of coronary angioplasty and stenting [15]. Patients undergoing CABG are now older and sicker and have poorer ventricular function and more extensive disease [1, 2, 15]. Correspondingly, patients with failed angioplasty after myocardial infarction or unstable angina represent a surgical emergency [15].

There is growing evidence of the beneficial effects of preoperative IABP on hospital outcomes of high-risk patients, such that some have proposed a more liberal policy for IABP support for this critical population [6, 16–19]. We report here our 4-year experience of preoperative IABP support for patients considered at higher risk for perioperative cardiac complications and adverse outcome, in whom aortic counterpulsation was started before induction of anesthesia.

As already reported [6, 16–20], we observed low hospital mortality (3.6%) and a low incidence of perioperative acute myocardial infarction (5.4%) and low-output syndrome (5.4%). Our results contrast with both The Society of Thoracic Surgeons database (risk of mortality, 17.5% ± 4.3%) and logistic EuroSCORE (17.1% ± 6.6%), which predicted a higher mortality rate after high-risk CABG [2, 3, 20].

Crucial times for higher oxygen demand include when anesthesia is induced and conduits are harvested; thus any transitory hypotension during these phases may induce critical ischemia leading to acute myocardial damage or even infarction [21, 22]. In this setting, the troponin I level has recently been shown to be the most sensitive and specific marker of myocardial damage. It is therefore extensively used as an index of the quality of myocardial protection and revascularization, particularly as its levels have been shown to correlate with the amount of myocardium saved [21–25].

Lactate and troponin sampling from the coronary sinus reflect the metabolic aspects of myocardial protection techniques and are predictive for cardiac complications after cardiac revascularization [4]. We found similar lactate and troponin leakage from the coronary sinus blood in high-risk and low-risk groups undergoing CABG, suggesting there was no difference in terms of the efficacy of myocardial protection. We therefore confirm here our previous findings, given the comparable 1-year survival and comparable freedom from cumulative cardiovascular events and repeat coronary procedures between high- and low-risk patients [4].

Intraaortic balloon pump insertion can occasionally be cumbersome, risky, or even contraindicated because of severe and diffuse atherosclerosis of the descending aorta and peripheral arteries, or because of abdominal aortic aneurysms [26, 27]. In these cases, we routinely used the transbrachial approach when femoral access was unsuitable [8].

Preoperative IABP use proved to be beneficial in terms of long-term outcomes, although it does not carry a survival advantage compared with intraoperative or postoperative IABP use [20]. On the other hand, the Benchmark Registry showed that prophylactic IABP use was associated with reduced mortality in high-risk patients [28]. These data are confirmed by The Society of Thoracic Surgeons National Database, which also clearly showed a survival benefit with preoperative IABP assistance [20]. In our series, the beneficial outcomes among patients receiving preoperative IABP support persisted up to 1 year after CABG, given that no differences were noted between the two groups in terms of deaths, cardiac events, or repeat coronary procedures.

Moreover, despite the more liberal indications for preoperative IABP use, we did not register a higher incidence of IABP-related complications (0.9%) compared with the Benchmark Registry (7.0%) [29]. The low incidence of IABP-related complications reported in this study are likely explained by the effects of newer technologies (such as 7.5F or even 7F catheters, which are much smaller than the previous 8.5F or 9F versions), increased experience of the surgical teams, better education and surveillance of patients supported with IABP, and more focused attention to IABP-related complications.

In our series, only 1 patient had a loss of femoral pulse, which resolved immediately after IABP withdrawal. The 2 patients who had bleeding at the balloon entry site required no transfusion or surgical intervention, and the bleeding resolved with gentle manual compression alone. These latter 2 patients received IABP through the transbrachial approach; the smoother subcutaneous tissue in the elbow region compared with the inguinal region might have increased the risk of access-site bleeding in these patients.

Our results showed good myocardial preservation in high-risk patients, especially in those with "hot" coronary lesions and ongoing unstable angina. This confirms previous reports of the beneficial protective effects of IABP in the early phases of surgery [2].

We therefore conclude that the more liberal indications for preoperative IABP use in high-risk patients undergoing CABG resulted in significantly better short-term clinical, echocardiographic, and biochemical outcomes, similar to those of patients undergoing low-risk, elective CABG. Can preoperative IABP use shift "apples" to "oranges"? Certainly, meta-analyses of larger numbers of patients will be needed to validate these results.

This study lacked a true control group, which would have represented a cohort of high-risk patients not receiving preoperative IABP. This discrepancy reflects our policy that preoperative counterpulsation is indicated in such patients; therefore, a true control group does not exist. Moreover, this study design excluded a large group of patients with intermediate EuroSCOREs, whose potential benefit from preoperative IABP remains to be ascertained. We did not include these patients in the study design because we wished to discriminate among patients with significantly different classes of risk. Certainly, randomized studies are necessary to elucidate the role of preoperative IABP in various cohorts of patients.

We deliberately made a statistical mistake (comparing apples and oranges) to compare the outcomes of high-risk patients undergoing CABG with preoperative IABP support with those of low-risk patients undergoing CABG without preoperative IABP support (because such patients are generally considered to have a good prognosis). The literature lacks studies reporting such comparisons. Because of our good results in high-risk CABG and the reported benefit of preoperative IABP use in these patients, we believed that randomization to no IABP support could raise ethical issues. Another limitation of the study is the relatively small sample size of patients enrolled. This reflects the single-center design of the study, which, on the other hand, also guarantees uniformity in surgical technique and perioperative care.

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Giuseppe Santarpino Francesco Onorati Attilio Renzulli Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Santarpino, G. Articles by Renzulli, A. Search for Related Content PubMed PubMed Citation Articles by Santarpino, G. Articles by Renzulli, A. Related Collections Coronary disease Related Article