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Ann Thorac Surg 1999;68:1321-1325
© 1999 The Society of Thoracic Surgeons
a Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
b Optima Health: Catholic Medical Center, Manchester, New Hampshire, USA
c Eastern Maine Medical Center, Bangor, Maine, USA
d Beth Israel-Deaconess Medical Center, Boston, Massachusetts, USA
e Fletcher-Allen Health Care, Burlington, Vermont, USA
f Maine Medical Center, Portland, Maine, USA
Address reprint requests to Dr Munoz, VA Outcomes Group (111B), Department of Veterans Affairs Hospital, White River Junction, VT 05009
e-mail: john.j.munoz{at}hitchcock.org
| Abstract |
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Methods. We performed a regional observational study of all of the 12,555 consecutive patients undergoing isolated CABG surgery in northern New England between 1992 and 1997. The rates of reexploration and patient characteristics were examined between two time intervals: period I (January 1, 1992 to June 1, 1994) and period II (June 1, 1995 to March 31, 1997). All of the regions 23 practicing surgeons responsible for these patients were surveyed to assess changes in practice patterns potentially related to bleeding risks.
Results. The adjusted rates of reexploration for bleeding declined 46% between periods I and II (3.6% versus 2.0%, p < 0.001). All of the five cardiac centers in northern New England showed similar trends with adjusted risk reductions ranging from 32% to 48% between the two time periods. This decline occurred despite the patients in period II having higher percentages of risk factors for reexploration for bleeding compared to patients in period I. From the surgeon survey, the number of surgeons using antifibrinolytics markedly increased from period I to period II. More surgeons were also using preoperative aspirin and heparin up until the time of surgery in period II.
Conclusions. Similar to the rates of mortality, the rates of reexploration for bleeding following CABG surgery are substantially declining. This decrease in the reexploration rates occurred despite higher patient risks.
| Introduction |
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Unfortunately, it is not known if there have been similar improvements in the rates of morbidity associated with CABG surgery. One of the serious complications associated with CABG surgery is reexploration for hemorrhage. Prior rates of reexploration have ranged from 4% to 6% [5, 6]. Reexploration for bleeding has been associated with increased rates of mortality (~10%), morbidity, and hospital resource utilization including increased blood product use and longer lengths of stay [7]. However, with changes in practice patterns, new blood conservation techniques, and the introduction of antifibrinolytics for hemorrhage prophylaxis, recent trends in the rates of reexploration have not been fully investigated.
The goal of this study is to evaluate the trends in reexploration rates for hemorrhage following isolated CABG surgery in northern New England from 1992 to 1997. We also explore potential changes in patient characteristics and/or surgeon practice patterns potentially related to bleeding risks.
| Patients and methods |
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Data collection
Data collection, methods and definitions, and patient characteristics of these groups of patients have been described previously in detail [8, 9]. The following data were recorded prospectively for all patients: age, gender, body surface area (BSA), cardiac catheterization results (degree of left main coronary artery stenosis, total number of significantly diseased vessels, left ventricular end-diastolic pressure [LVEDP], ejection fraction [EF]), prior CABG, priority of surgery (emergent, urgent, or elective), thrombolytic therapy within 48 hours, use of an intraaortic balloon pump (IABP), total time of cardiopulmonary bypass, number of distal anastomoses, and use of internal mammary arteries. The EF results were scored using the method described by Pierpont and associates [10]. CABG was defined as emergent when medical factors relating to the patients cardiac disease dictated that surgery be performed within hours to prevent morbidity or death. Urgent CABG was defined by the presence of clinical factors requiring that the patient remain in the hospital to have the operation before discharge. The remaining cases were defined as elective.
Postoperative hemorrhage was defined as bleeding which resulted in return to the operating room. The decision to re-explore a patient was at the discretion of the individual surgeon. We did not attempt to categorize the specific indication for reoperation, such as excessive chest tube drainage, collection of blood within the chest, or cardiac tamponade. Data on those patients with high chest tube output who did not require reexploration and their outcomes were not collected.
After adjusting for patient characteristics, which included age, body surface area, cardiopulmonary bypass time, and number of distal anastomoses, the rate of reexploration was calculated for every 3-month interval during the 5-year study period. Also, the adjusted mean reexploration rates were calculated for periods I and II for comparison.
A questionnaire was completed by each of the 23 cardiac surgeons contributing information to the NNECVDSG data set during the study period. Questions regarding the use of prophylactic antifibrinolytic therapy with
-aminocaproic acid and/or aprotinin and the use of preoperative aspirin and heparin were asked to identify any changes in practice patterns between periods I and II.
Statistical analysis
Standard statistical methods (
2 for categorical data and Students t-tests for continuous variables) were used to compare the characteristics of patients between the two time periods. Multivariate logistic regression analysis was used to explore the association between hemorrhage and potential risk factors and to adjust for potentially confounding variables [11]. The multivariate model was developed by incrementally testing variables found in univariate analysis to be significant at the p < 0.10 level. Analysis was performed using STATA software (Stata Corporation, College Station, TX) [12].
| Results |
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-aminocaproic acid (ie, in all or in many patients undergoing CABG surgery) increased from 4% to 78% (p < 0.001). Although no surgeon used aprotinin routinely, its use in selected patients increased from 30% to 91% (p < 0.001). In contrast to the prior hemorrhage prevention methods, there was an inease in preoperative aspirin and heparin use. Practices in period II showed 78% of surgeons continued aspirin use up until the time of surgery. During period I, only 22% of surgeons continued preoperative aspirin (p < 0.001). Surgeons also reported increased continuation of preoperative heparin between periods I and II, increasing from 43% to 74% (p = 0.036).
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| Comment |
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-aminocaproic acid and the selected use of aprotinin in patients undergoing CABG surgery substantially increased in this region. Few studies have focused on the trends in reexploration rates for hemorrhage following CABG surgery. A retrospective investigation of the incidence of reexploration following CABG surgery in a single institution in Sweden revealed a 5.1% rate of reexploration for 19901994 compared to a 3.9% rate for 19701989 [5]. The increased rates of reexploration were associated with patients who were older, sicker, and had longer, more complex procedures. Process of care factors was not considered. In our study, despite similar "worsening" in patient risk profile, a marked decrease in the rates of reexploration for hemorrhage was observed.
Several studies have attempted to identify patient-specific and procedure-related risk factors for reexploration for hemorrhage following CABG surgery. Increased age, smaller body surface area, dialysis-dependent renal failure, longer time on cardiopulmonary bypass, higher numbers of distal anastomoses, and utilization of internal mammary artery grafting have all been shown to be predictors for increased risk of reexploration for bleeding [5, 7, 13]. In our study, the patients in period II were older, had longer mean cardiopulmonary bypass times, higher numbers of distal anastomoses, and increased internal mammary artery graft utilization than the patients in period I. Yet, as discussed above, the adjusted mean of the rates of reexploration for period II were substantially lower than period I. Therefore, other factors, presumably changes in processes of care, appear to be contributing to this declining trend.
Antifibrinolytic use has become an increasingly popular form of postoperative hemorrhage prophylaxis, and may have contributed to the recent decline in the rates of reexploration in northern New England. Their ability to reduce postoperative hemorrhage in patients undergoing cardiac surgery has been well established in multiple randomized controlled trials and several meta-analyses. In a recent meta-analysis comparing aprotinin and
-aminocaproic acid to placebo/control groups in cardiac surgery, patients receiving high-dose aprotinin were 61% less likely to be re-explored than control patients [14]. While
-aminocaproic acid seems similarly efficacious in reducing postoperative bleeding, the results of meta-analyses have been statistically insignificant due to relatively few trials that have included this drug. It seems plausible that the 46% reduction in the rates of reexploration found in our study may be related to the increased use of these agents.
It is important to consider this studys strengths and limitations. Given the large sample size, this study possessed sufficient power to detect most differences in patient characteristics between the two time periods. The data in this observational study were collected prospectively. This limited the potential for bias in the ascertainment of the outcomes and patient variables. Also, because this regional study was population-based, our results should be generalizable. Finally, we were able to obtain 100% response rate with our surgeon questionnaire, thus eliminating the systematic bias associated with nonresponse.
Among the limitations, we did not consider all potentially important variables that may have influenced the rates of postoperative bleeding. While we did not have sufficient data to assess the trends in preoperative aspirin and heparin use, other studies have not identified these variables as risk factors for clinically important bleeding after CABG [15, 16]. Data on the trends in preoperative laboratory findings, including bleeding times, were also lacking in our study. However, they have not been shown to be associated with increased reexploration rates in other studies [13]. Furthermore, we did not investigate other potential changes in processes of care that may have influenced the outcome of study: for example, changes in platelet transfusions or differing cardiopulmonary bypass techniques. As a further limitation, this study focused on the trends in the rates of postoperative bleeding sufficient to require reexploration. Other less dramatic, but clinically important indicators of postoperative bleeding, such as the trends in the rates of transfusion, were not examined.
Though our study can provide evidence against many of the possible explanations for the observed reductions in bleeding in our region during this time period, including chance, bias, and confounding, its main limitation is its inability to prove what did cause this to occur. Our survey of time-related use of antifibrinolytics can provide some evidence of a temporal relationship between the use of these drugs and bleeding rates, but can not prove a cause-and-effect relationship. This is because of the correlational nature of this part of our study, which makes it impossible to link use of antifibrinolytics to risks of bleeding in individuals.
Similar to the rates of mortality, the rates of reexploration after CABG surgery are declining. This decline in the reexploration rates is occurring despite the increase in older and sicker patients who have longer, more complex procedures. This decrease is temporally related to trends toward routine use of antifibrinolytics.
| Footnotes |
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* The members of the study group are listed in the Appendix 1. ![]()
| Appendix 1. Northern New England Cardiovascular Disease Study Group |
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Dartmouth Hitchcock Medical Center, Hanover, NH
Virginia Beggs, MS, John D. Birkmeyer, MD, Nancy J. O. Birkmeyer, PhD, William Burke, RCVT, Edward Catherwood, MD, Mike Chamberlain, RN, Lawrence J. Dacey, MD, Gordon Defoe, CCP, Kenneth Dixon-Vestal, RN, Thomas Dodds, MD, Mary Fillinger, MD, Bruce Friedman, MD, Christine Heins, RN, Bruce Hettleman, MD, Karen A. Jean, RN, Pamela Jenkins, MD, Joseph Kasper, ScD, Lori Key, RN, Terry Kneeland, MPH, Judith Kobe, RN, Elizabeth Maislen, ARNP, David Malenka, MD, Charles A.S. Marrin, MB, BS, Mary Menduni, RN, Nathaniel Niles, MD, William C. Nugent, MD, Gerald T. OConnor, DSc, Elaine M. Olmstead, Daniel ORourke, MD, Stephen K. Plume, MD, Hebe B. Quinton, MS, John Robb, MD, Cathy S. Ross, John Sanders, MD, William Schults, MS, William F. Sullivan, MS, Jon Wahrenberger, MD, Beth Wolf.
Eastern Maine Medical Center, Bangor, ME
Robert Allen MD, Jim Blum, MS, Chae C. Choi, MD, Deborah Carey-Johnson, RN, Tina Closson, RN, Robert Clough, MD, Cynthia M. Downs, RN, Glen D. Garson MD, Felix Hernandez, Jr, MD, Joseph J. Hessel, MD, Robert M. Hoffman, MD, John H. Jentzer MD,Edward R. Johnson, MD, Peter Marshall, MD, Helen McKinnon, RN, Cathy Mingo, RN, Craig Pedersen, PA, Wendy Perkins, LPN, Robert Rosenthal, MD, Matthew L. Rowe, MD, Katrina Sargent, M. Theodore Silver, MD, Wolfgang J.T. Spyra, MD, Laurie True, RN, Peter Ver Lee, MD, Paul vom Eigen, MD, Craig Warren, CCP, William Witmer, MD.
Fletcher Allen Health Care, Burlington, VT
Richard G. Brandenburg, PhD, Pamela Brown, Steve Colmanaro, PA, Steve Crumb, RN, Jan Faucett, RN, Sue Geoffrey, RN, Walter D. Gundel, MD, Richard S. Jackson, MD, David Johnson, MD, Charlie Krumholz, CCP, Ann Laramee, RN, Bruce J. Leavitt, MD, Karen McKenny, RN, Madeline Norse, RN, William C. Paganelli, MD, Ph.D., Diane Pappalardo, MHSA, Daniel S. Raabe, MD, Melinda Rabideau, RN, Martha Root, RN, Janice Smith, RN, Christopher M. Terrien Jr, MD, Edward Terrien, MD, Matthew Watkins, MD.
Maine Medical Assessment Foundation
Robert B. Keller, MD, David C. Soule, David Wennberg, MD.
Maine Medical Center, Portland, ME
Lawrence Adrian, PA, Warren D. Alpern, MD, Eric Anderson, Richard A. Anderson, MD, Linda Banister, RN, Claire Berg, RN, Seth Blank, MD, John Braxton, MD, Carl E. Bredenberg, MD, Michael Brennan, PA, David Burkey, MD, Rita Cassetari, RN, Cantwell Clark, MD, Jane Cleaves, RN, Deborah Courtney, RN, MS, Joshua Cutler, MD, Desmond Donegan, MD, Pat Fallo, RN, Rick Forest, CCP, Robert Groom, CCP, Daniel Hanley, MD, Jane Kane, RN, Saul Katz, MD, Mirle A. Kellett, Jr, MD, Robert Kramer, MD, Costas T. Lambrew, MD, F. Stephen Larned, MD, Lee Lucas, Chris A. Lutes, MD, Paul D. McGrath, MD, Jeremy R. Morton, MD, Edward R. Nowicki, MD, John R. OMeara, MD, Harold Osher, MD, Sheilia Parker, RN, Patricia Peasley, RN, Cathy Prouty, RN, Reed D. Quinn, MD, Dennis Redfield, RN, Karen Reynolds, MPH, Thomas Ryan, Jr., MD, Jean Saunders, MSN, Alyce Schultz, PhD, Susan Seekins, RN, Russell Stogsdill, PA, Paul W. Sweeny, MD, Karen Tolan, RN, Nancy Tooker, RN, Joan F. Tryzelaar, MD, Marie Turcotte, RN, Kathy Viger, RN, Paul T. Vaitkus, MD, Cynthia Westlund, RN, Richard L White, MD, Wanda Whittet, RN.
Optima Health Care: Catholic Medical Center, Manchester, NH
Yvon Baribeau, MD, Ann Becker, RN, Craig C. Berry, MD, Kevin Berry, MD, William A. Bradley, MD, David C. Charlesworth, MD, Susan Cuddy, RN, Robert C. Dewey, MD, Frank Fedele, MD, Louis I. Fink, MD, Erik J. Funk, MD, Alan E. Garstka, MD, Karen Grafton RN, Dan Halstead, CCP, Michael J. Hearne, MD, J. Beatty Hunter, MD, Alan D. Kaplan, MD, Dennis Kelly, MD, Mark A. Klinker, MD, Peggy Lambert, RN, Patrick M Lawrence, MD, Jeffery Lockhart, MD, Christopher T. Maloney, MD, Kathy McNeil, RN, Venkatram Nethala, MD, Edward Palank, MD, John Pieroni, CCP, M. Judith Porelle, RN, Donna Pulsifer, RN, Joanne Robichaud, RN, Mary Sanford, RN, James Schnitz, MD, Benjamin M. Westbrook, MD, Thomas P. Wharton, MD, Kirke W. Wheeler, MD, Diane White, RN.
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