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Ann Thorac Surg 2002;73:1394-1401
© 2002 The Society of Thoracic Surgeons
a Division of Cardiovascular Surgery, St. Vincent Mercy Medical Center, Toledo, Ohio, USA
b Medical College of Ohio, Toledo, Ohio, USA
Accepted for publication January 11, 2002.
* Address reprint requests to Dr Habib, Cardiopulmonary Research, St Vincent Mercy Medical Center, 2213 Cherry St, ACC Bldg, Suite 309, Toledo, OH 43608 USA
e-mail: robert_habib{at}mhsnr.org
| Abstract |
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Methods. Safety of the implemented selective PAC use was assessed by comparisons to contemporaneous coronary artery bypass grafting outcome reported by The Society of Thoracic Surgeons national data. Continuous relations describing PAC use in terms of continuous univariate predictors were obtained using overlapping-range patient cohorts. Next, independent predictors of PAC use were derived by multivariate regression to best fit the categorical variable PAC (Yes = 1, No = 0). Model estimates were a continuous variable (PAC score) with values between 0 and 1.
Results. Planned use of PAC was based on collective consideration of preoperative patient variables, and was not limited to low-risk or preserved ejection fraction patients. Planned and unplanned use of PAC was limited to 176 (planned, 6.6%) and 66 (unplanned, 2.4%) patients, respectively, whereas no PAC was used in 2,443 (91%). Overall patient characteristics and risk factors in this series were comparable to contemporaneous Society of Thoracic Surgeons data, and the incidence of operative deaths was 2.31% (n = 61; observed-to-expected [Society of Thoracic Surgeons risk] mortality = 0.73). Independent predictors of PAC use were ejection fraction, Society of Thoracic Surgeons risk, intraaortic balloon pump, congestive heart failure, reoperative surgery, and New York Heart Association class IV. Expectedly, PAC scores were substantially different for PAC (mean ± standard deviation, 0.37 ± 0.20; median, 0.38) and no PAC (0.14 ± 0.11; median, 0.10) patients (p < 0.001). Area under the receiver operating characteristic curve derived for PAC score was relatively high (area, 0.85). Moreover, the corresponding summed sensitivity (0.68 to 0.91) and specificity (0.85 to 0.62) was maximized at 1.53 for PAC score between 0.15 and 0.31.
Conclusions. Our results indicate that highly selective use of PAC in coronary artery bypass grafting can be accomplished safely, and it need not be limited to patients with preserved ejection fractions or low operative risk. Indeed, coronary artery bypass grafting without PAC may be preferable in the vast majority of patients as it reduces catheter-associated risks and resource utilization without incurring an increased operative risk. Also, pending further prospective confirmation, our analysis suggests that collective consideration of PAC use predictors to derive a PAC score provides an objective criterion to minimize unnecessary use of PAC with an acceptably low probability of error.
| Introduction |
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A large fraction of PAC utilization occurs in cardiac operations. In late 1998, we surveyed 48 large-volume cardiac surgery programs in the United States, and obtained 30 responses from institutions that performed between 725 and 3,000 cardiac operations in 1997 (data available upon request). The survey results showed that 20 of 30 (67%) programs used PACs routinely (
80%) in isolated coronary artery bypass grafting (CABG) compared with only 4 programs (13%) using it selectively (
20%).
Importantly, routine planned use of PAC occurs despite the fact that the large majority of CABG patients do not experience significant postoperative hemodynamic instability, are extubated expeditiously, and are transferred from intensive care within 24 hours of operation. In such patients, a PAC provides little or no clinical benefit, is arguably an unjustified resource utilization, and may represent additional unnecessary risk of catheter-related complications. Moreover, patients who develop late hemodynamic or cardiopulmonary complications will most likely have a new PAC inserted as the original catheters are typically removed during the first postoperative day unless clinical events dictate otherwise. We contend that optimal use of PAC in CABG should be limited to either patients with ongoing hemodynamic instability or those who are highly likely to develop such symptoms intraoperatively or early during the postoperative period. However, no objective method is currently available for identifying this subset of patients with a low probability of error.
For nearly two decades, we have adhered to a practice of highly selective PAC use in CABG that is not limited to low-risk patients or to those with preserved left ventricular function. Instead, planned use of PAC was based on a collective consideration of preoperative patient variables. In this study, we evaluate the safety of the above long-implemented approach by means of CABG outcome comparisons to contemporaneous Society of Thoracic Surgeons (STS) national data [9]. A second goal of this investigation was to develop objective criteria for PAC use patient selection. We thus derived a multivariate model that provides a preoperative PAC score that potentially represents a quantitative means for selecting patients in whom CABG can proceed without a PAC and in which the likelihood of unplanned postoperative PAC use is low. A prospective trial validating this model is underway.
| Material and methods |
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Utilization of pulmonary artery catheters
The decision to use a PAC during CABG, rather than standard central venous pressure (CVP) monitoring, was always made by the surgeon on the basis of a comprehensive consideration of preoperative variables. A single factor was rarely sufficient to cause use of PAC. Preoperative factors considered in selecting patients included whether the procedure was a reoperation, emergency, severity of left ventricular (LV) dysfunction (percent ejection fraction [EF]), left main coronary artery disease, unstable angina, recent myocardial infarction, renal failure, congestive heart failure, intraaortic balloon pump, and chronic obstructive pulmonary disease. Patients in whom intraoperative circumstances dictated placement of a PAC in the immediate postoperative period were considered as unplanned.
Pulmonary artery catheter subgroups
In this study, CABG patients who received a PAC during their admission were categorized to various study subgroups according to the flow chart in Figure 1.
Briefly, patients selected to receive a PAC were categorized as planned PAC patients (PACP), whereas those with unplanned use of PAC were categorized as PACU. All remaining patients were categorized as No PAC. Unplanned PAC patients were further divided to (1) PACU (Early), or those in whom a PAC was inserted either on arrival to the cardiovascular intensive care unit (CVICU) or during the first postoperative day 1; and (2) PACU (Late), or those with PAC insertions during or after postoperative day 2. Alternatively, to ascertain the efficacy of PAC use selection, PACP patients were further categorized to those who likely benefited from this monitoring [PACP (Benefit)] versus those who did not [PACP (No Benefit)]. Note the latter group consisted of all PACP patients who had an unremarkable postoperative course, ie, free of complications, hemodynamic instability or hospital death, expeditious extubation, and timely CVICU (
1 day) and hospital (
8 days) discharge. Accordingly, optimal PAC use should be limited to the PACP (Benefit) and PACU (Early) subgroups [PAC (Needed)].
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2 or Fischers exact test for categorical variables and either the unpaired Students t test or the nonparametric Mann-Whitney rank sum test for continuous variables, depending on applicability. A probability value less than 0.05 was always used to indicate significance (SigmaStat; Jandel Scientific, San Raphael, CA). Multivariate regression was used in the 2,302 patients (212 had a PAC used) in whom EF data were available to derive a model of PAC use in CABG. Here, we first determined the patient variables that predicted use of PAC by appropriate univariate statistical methods. The role of continuous preoperative variables (age, preoperative hematocrit, EF, STS risk) in PAC use was investigated using overlapping-range cohorts as recently described by us [10]. This approach allowed the derivation of PAC use-continuous variable relations by nonlinear regression analysis. Second, we determined the independent predictors of PAC use by means of multiple linear regression analysis in which all univariate predictors were covaried to obtain a best fit of the categorical variable PAC (Yes = 1, No = 0). This multivariate model used a single coefficient for each variable, but coefficients of continuous predictors multiplied prederived PAC use-variable relation (eg, PAC versus EF) as opposed to the variable itself (or EF).
The multivariate model estimates represent a continuous variable that varies in terms of the independent predictors of PAC use. These estimates then effectively constitute a PAC score that varies between 0 and 1, and the greater the PAC score, the more is the likelihood of PAC use. Sensitivity, specificity, positive predictive value, negative predictive value, and area under the corresponding receiver operating characteristic curve were used to ascertain whether and how PAC score may be used to guide patient selection for PAC use.
| Results |
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Use of pulmonary artery catheter in coronary artery bypass grafting
A total of 242 patients received a PAC (9.0%) during their admission (Fig 1) compared with 2,443 patients (91%) who did not. Use of PAC was planned in 176 patients [PACP; 6.55%], whereas in 66 patients PAC use was unplanned [PACU; 2.46%]. In the latter group, PAC was inserted early after operation in 40 patients [PACU (Early); 1.5%] owing to unexpected intraoperative complications affecting ventricular function. Also, not infrequently, PAC was inserted early postoperatively as a result of hemorrhagic complications. Pulmonary artery catheter insertion was relatively late in 26 patients [PACU (Late); 1.0%], mostly as a consequence of single or multiorgan failure. Of the PACP group, 49 (1.8%) patients had an uncomplicated postoperative course with no hemodynamic instability [PACU (No Benefit)], whereas PAC was potentially useful in 127 (4.7%) patients whose clinical course was complicated or who experienced a slow postoperative recovery [PACU (Benefit)].
Predictors of pulmonary artery catheter use
Consideration of preoperative risk factors resulted in a total of 15 univariate (11 categorical, 4 continuous) predictors of PAC use. The incidence of each of these factors for PAC versus No PAC patients, the corresponding odds ratio (for categorical variables), and statistical significance are summarized in Table 2. The preoperative continuous PAC use predictors (hematocrit, age, EF, and STS risk) are shown in Figure 2.
Briefly, PAC use was systematically decreased as preoperative hematocrit (%) and EF (%) are increased. Conversely, PAC use was systematically greater with increasing age and operative risk. Note, the roles of age and EF in PAC use are partly reflected in the STS risk-PAC use relations. The independent predictors of PAC use by multivariate analysis were EF, STS risk, intraaortic balloon pump, congestive heart failure, redo operation, and New York Heart Association class IV (Table 3).
These variables, combined, determined a PAC score that is increased as the likelihood of PAC is increased.
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| Comment |
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In this study, we present a series of 2,685 consecutive CABG patients in whom overall use of PAC was limited to 9% (6.6% planned), and in whom selective use was attempted irrespective of the degree of LV dysfunction (Fig 2). Surgical outcomes in this series were quite favorable (Table 1). Comparing these outcomes to the contemporaneous national data provided by the STS in which PAC use is more routine supports our contention that highly selective use of PAC in CABG is indeed safe. Additionally, selective PAC use on the basis of clinical judgment by the attending surgeon even in patient cohorts with significant LV dysfunction or high operative risk did not adversely affect outcomes (Fig 5).
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Our data concur with others that CABG without PAC is more likely in patients with normal or near normal EF. However, the same data show that less than 40% of patients with severe LV dysfunction (EF
30%) actually require a PAC. Indeed, use of PAC was systematically lower as EF increased (Fig 2), and patients with normal LV function (EF
50%) had a PAC inserted very rarely (3.1%). Given the favorable surgical outcomes in this population irrespective of EF and operative risk (Fig 5), we believe that neither EF nor STS risk should be used alone to determine when a PAC is used.
A pertinent question in this patient series is whether patient selection for PAC use was too selective and hence resulting in too many unplanned insertions. Unplanned catheter insertions occurred in 66 of 2,865 patients (PACU, 2.5%) overall, and of these, 40 occurred early during the postoperative period (PACU [Early], 1.5%). This incidence is perhaps within acceptable limits of postoperative PAC insertions, and the relatively good surgical outcomes in this series suggest that the used PAC selection did not lead to adverse results. Nonetheless, roughly one in four PAC patients (66 of 242) were unplanned, and minimizing this rate of unplanned insertions by objective means may be of clinical benefit.
Selection of patients for planned use of PAC in this patient series was based on collective consideration, by the attending surgeon, of each patients preoperative data with the general aim of predicting those likely to develop hemodynamic instability. By retrospective analysis, a total of 15 patient variables were distinctly different between PAC and No PAC patients (Table 2), and of these, six risk factors (EF, STS risk, congestive heart failure, intraaortic balloon pump, reoperation, and New York Heart Association class IV) independently predicted PAC use by multivariate regression model analysis (Table 3). This model provided a PAC score in each patient, and the obtained distribution of PAC score values for the various patient subgroups potentially provides a basis for an objective patient selection criterion.
Inspecting the cumulative distribution of PAC scores (Fig 3, bottom) one notes (1) nearly 50% of all CABG patients had a PAC score less than or equal to 0.1 with essentially none of these patients receiving a PAC (planned or unplanned); and (2) 76.9% of patients had a PAC score less than or equal to 0.2 of whom only 2.3% received a PAC. Of these PAC patients, perioperative data indicated that additional monitoring was perhaps needed in 1.8% (Fig 3, bottom [insert]). These results suggest that PAC score as determined from the multivariate model described in Table 3 may be used to indicate CABG without PAC with a low probability of error. Indeed, this contention is supported by (1) the high area (0.851) under the corresponding receiver operating characteristic curve and (2) relatively high specificity and sensitivity of PAC score to PAC use for values ranging between 0.15 and 0.30 (Fig 4).
In summary, favorable outcomes obtained in a large CABG series in which PAC use was limited to 9% of all patients indicate that selective use of PAC in CABG is safe. Moreover, selective use is perhaps more efficacious in a large majority of CABG cases inasmuch as in these patients, the possibility of catheter-associated complications, unnecessary use of vasoactive drugs, and resource utilization are decreased. Another implication of our data are that preset limits for EF or operative risk for when to use PACs should be avoided, and that these variables should be two of several factors considered in selecting patients. Finally, when collectively considered in the form of a multivariate model (Table 3), predictors of PAC use provided an objective quantitative criterion (PAC score) that may be used to avoid unnecessary use of PAC in a large fraction of CABG patients with reasonably high sensitivity and specificity. Prospective confirmation of the safety and efficacy of limited PAC use based on a priori PAC score as suggested by our retrospective analysis is warranted.
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