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Ann Thorac Surg 1999;67:994-1000
© 1999 The Society of Thoracic Surgeons

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Original Articles

Heparin-coated circuits for high-risk patients: a multicenter, prospective, randomized trial

^a San Donato Hospital, Milan, Italy
^b University Hospital, Verona, Italy
^c Policlinico Sant’Orsola, Bologna, Italy
^d San Raffaele Hospital, Milan, Italy
^e S. Maria della Misericordia Hospital, Udine, Italy
^f Ospedale di Circolo, Varese, Italy
^g Hesperia Hospital, Modena, Italy
^h San Bortolo Hospital, Vicenza, Italy
ⁱ Sant’ Ambrogio Hospital, Milan, Italy
^j Policlinico Le Scotte, Siena, Italy
^k Ospedale Civili, Brescia, Italy
^l S. Maria della Misericordia Hospital, Perugia, Italy

Accepted for publication September 23, 1998.

Address reprint requests to Dr Ranucci, Cardiovascular Center E. Malan, San Donato Hospital, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy

	Abstract

Top Footnotes Abstract Introduction Material and methods Results Comment References

 
Background. Heparin-coated circuits (HCCs) in low-risk cardiac patients who have coronary revascularization have a limited impact on postoperative outcome. In this prospective, randomized investigation, we studied high-risk patients who had cardiac operations with or without HCCs.

Methods. A total of 886 patients who had cardiac operations with cardiopulmonary bypass and at least one patient-related or procedure-related risk factor were enrolled in a multicenter study. They were randomly allocated to have cardiopulmonary bypass with Duraflo II HCCs (HCC group, n = 442) or conventional circuits (control group, n = 444). Postoperative outcome was investigated with respect to the occurrence of organ dysfunction.

Results. HCCs are associated with a shorter intensive care unit and postoperative hospital stay and with a lower rate of patients having a severely impaired clinical outcome (stay in intensive care unit for more than 5 days or death) (relative risk 0.66, p = 0.045). Lung dysfunction rate was significantly lower for the patients in HCC group affected by chronic obstructive pulmonary disease or who had mitral procedure (relative risk, respectively, 0.31, p = 0.018 and 0.05, p = 0.02). Renal dysfunction rate was significantly (p = 0.05) lower for diabetics in the HCC group (relative risk 0.28).

Conclusions. When HCCs were used postoperative times decreased and they had a protective effect on lung and kidney function in high-risk patients.

	Introduction

Top Footnotes Abstract Introduction Material and methods Results Comment References

 
Heparin-coated circuits (HCCs) have a well-defined biochemical effect on blood reaction to cardiopulmonary bypass (CPB). This effect includes inhibition of thrombin generation [1], reduction of complement activation [2–4], and granulocyte activation [5, 6]; this last action seems to be more pronounced in the presence of reduced levels of systemic heparin [7]. Both complement and granulocyte activations are considered major steps in the systemic inflammatory response which, in turn, contributes to morbidity and mortality after cardiac operations with CPB [8, 9]. Limiting these reactions should result in the improved clinical outcome of patients who had open heart operations. Despite this apparently logical sequence, no clear evidence of postoperative clinical improvement has been demonstrated in patients treated with HCCs [1, 4, 6]. So far, clinical studies of HCCs without reduction of systemic heparinization have demonstrated only a preservation of lung function after CPB [10] and a significantly improved clinical outcome in patients treated with HCCs and aprotinin [11]. A recent multicenter trial [12] enrolled 805 low-risk patients who were randomly assigned to receive HCCs or conventional oxygenators and circuits during elective coronary artery bypass graft (CABG) operations. That study failed to demonstrate a significant impact of HCCs on the postoperative clinical outcome of the whole population, but significant differences were seen in transfusion rate for female patients and intensive care unit (ICU) stay for patients who had prolonged CPB.

On the basis of this previous experience, we drew the following conclusions: (1) In a population of patients at low risk for cardiac operation, the rate of adverse events and death is so low as to require not fewer than 5,000 patients to find significant differences related to the use of HCCs. (2) Increasing the sensitivity of the study, through a selection of medium-risk patient subgroups, resulted in a significant beneficial effect of HCCs regarding need for transfusions, ICU stay, and need for intraaortic balloon pump. We decided that a second study, focused on medium- to high-risk patients, was needed. The aims of the present study, therefore, were to determine whether HCCs exert a beneficial effect on the postoperative outcome of these subgroups of patients and, specifically, to determine the risk circumstances, either patient related or procedure related, in which HCCs are able to induce a positive influence on postoperative results.

	Material and methods

Top Footnotes Abstract Introduction Material and methods Results Comment References

 
Patients
Twelve Italian centers for cardiac surgery were involved in the study. From September 1995 to September 1997 a total of 886 patients were enrolled, with a contribution of 40 to 100 patients per center. Entry criteria included one or more of the following patient-related or procedure-related risk factors: age 75 years or more; weight 65 kg or less; body mass index (weight in kg/[height in m]²) at least 30; anemia (hematocrit 34%); severe left ventricular dysfunction (ejection fraction 0.3); New York Heart Association functional class III or higher; recent ( 6 hours and 7 days preoperatively) myocardial infarction; cardiogenic shock; congestive heart failure (pulmonary edema, peripheral edema, x-ray evidence of increased extravascular lung water); preoperative intraaortic balloon pump; preoperative mechanical ventilation; serum creatinine at least 2 mg/dL; preoperative dialysis dependency; chronic obstructive pulmonary disease (COPD) previously diagnosed; cerebrovascular disease (previous transitory ischemic attack, stroke, cerebrovascular operation); previous vascular operation; diabetes requiring medication; anticoagulant therapy not interrupted; redo operation; combined operation (valve plus CABG operation, double or triple valve, carotid artery plus cardiac operation, CABG plus left ventricle aneurysmectomy); urgent or emergent operation. The choice of these factors was based on the current literature [13–15] and our clinical experience.

The patients were randomly assigned to the HCC group or the control group, the only difference between groups being the use of HCCs or conventional oxygenators and tubings. Informed consent was obtained from each patient, and Ethics Committee approval was obtained according to the local policy of each center.

Intraoperative procedure
The extracorporeal circulation circuit consisted of an hard-shell venous reservoir, roller pump, membrane oxygenator (Univox, Baxter Healthcare, Irvine, CA), cardiotomy reservoir, and silicone or polyvinyl tubing system. For patients in the HCC group, this equipment was pretreated with immobilized heparin (Duraflo II, Bentley/Baxter, Uden, the Netherlands), whereas for patients in the control group the same circuit was untreated. Local policies were respected with regard to administration of anesthesia, surgical procedures, and perfusion techniques (temperature, alpha/pH stat, pressures, and flows). Systemic heparinization was accomplished with 300 IU/kg heparin and further boluses of 5,000 IU to maintain the activated clotting time greater than 480 seconds. At the end of CPB heparin was neutralized with protamine at a 1:1 ratio.

Data collection and statistical analysis
Preoperative data collection included the presence of risk factors, demographic information, and type of surgical procedure. Intraoperative data collection included the following variables: priming volume (mL), total heparin dose (IU), total protamine dose (mg), lowest core temperature reached while on CPB, lowest hematocrit reached while on CPB, CPB duration (minutes), aortic cross-clamping duration (minutes), number of anastomoses and arterial grafts for CABG operations, use of aprotinin, and need for transfusions. Postoperative data collected included blood loss during the first 6 hours, need for transfusions, mechanical ventilation duration (hours), ICU stay (days), and postoperative hospital stay (days). Morbidity and mortality were defined according to the criteria listed in Table 1.

Postoperative outcome variables were investigated using a two-sided t test and Mann-Whitney U-test. Binary variables were investigated by estimating relative risk (with 95% confidence interval). Variables significantly correlated with treatment by that univariate analysis were tested with multivariate analysis: a multiple logistic regression [16] was performed to compare both groups as to the outcome variables that were affected significantly by the treatment at the univariate step. Because the result of a multiple logistic regression analysis is an odds ratio, it is presented with a 95% confidence interval and can be interpreted as an approximation for relative risk.

This statistical approach was applied to the totality of the patients and to 13 subgroups that were identified when designing the study. The subgroups included patients with the following characteristics: female, age 75 years or more, ejection fraction 0.3 or less, previous neurologic injury, COPD, diabetes, currently on anticoagulant therapy, redo operations, combined operations, urgent CABG, mitral valve procedures, aortic valve procedures, and high-risk CABG (with a clinical severity score greater than 7) [14].

	Results

Top Footnotes Abstract Introduction Material and methods Results Comment References

 
Of the 886 patients enrolled, 444 had CPB with untreated circuits (controls) and 442 with HCCs. No intergroup differences were seen with respect to preoperative and intraoperative variables (Table 2).

Patients aged 75 years or more had a shorter ICU stay (HCC group, median 2 days, range 1 to 5 days; control group, median 3 days, range 1 to 8 days, p = 0.007, dead patients excluded) and postoperative hospital stay (HCC group, median 8 days, range 6 to 21 days; control group, median 10 days, range 6 to 45 days, p = 0.001, dead patients excluded) when treated with HCCs. These differences are more pronounced than in the totality of the patients. The same happened for patients who had an ICU stay because of a mitral valve procedure (HCC group, median 2 days, range 1 to 5 days; control group, median 2 days, range 1 to 18 days, p = 0.044, dead patients excluded) and postoperative hospital stay (HCC group, median 8 days, range 6 to 25 days; control group, median 11 days, range 6 to 58 days, p = 0.002, dead patients excluded).

In three subgroups adverse events occurred at significantly different rates in the HCC and control groups, by univariate analysis (Table 5). Patients affected by COPD demonstrated a significantly lower rate of total lung dysfunction in the HCC group; diabetics had significantly lower rates of minor and total renal dysfunction in the HCC group; and patients who had a mitral valve procedure had lower rates of major and total lung dysfunction and a lower rate of severely impaired clinical outcome in the HCC group. In the latter subgroup, the rate of total renal dysfunction was almost significantly lower in the HCC group (2.3% versus 17%, relative risk 0.13, 95% confidence interval, 0.017 to 1.06, p = 0.07).

	Comment

Top Footnotes Abstract Introduction Material and methods Results Comment References

If not associated with reduced systemic heparinization, HCCs cannot be considered a blood-saving tool in cardiac operations. There was no difference in blood loss and transfusion rate between the two experimental groups. This observation agrees with the results of most other studies, including the previous multicenter European study [12] and the studies by Gu and coworkers [1] and Wagner and coworkers [17]. Weerwind and coworkers [18] failed to demonstrate blood-saving effect of HCCs with normal systemic heparinization in low-risk patients. Even in the experimental setting with patients who are at high risk for bleeding (under anticoagulant therapy; diabetics; combined procedures), this finding did not change this basic information, that nowadays relies on about 2,000 randomly studied low- and high-risk patients.

Whether reduction in systemic heparinization, as allowed by the use of HCCs, is able to reduce blood loss and the need for blood products has not been definitively determined. The results of the studies by Øvrum and coworkers [19] and Aldea and coworkers [20] concur.

Intensive care unit stay, postoperative stay, and number of patients who have a severely impaired clinical outcome are indices of the overall quality of the postoperative outcome. These indices were significantly better in HCC group when we considered either the totality of patients or the subgroup of patients who had a mitral valve procedure; ICU stay and postoperative stay were shorter in the HCC group in older patients (75 years old or more). This result indicates that high-risk patients might benefit, in general terms, from the use of HCCs. Previous studies failed to demonstrate significant differences in these indices as a result of HCC use [1, 12, 18, 19]. In those studies only low-risk patients scheduled for elective coronary revascularization were enrolled. The median ICU stay in those experimental settings ranged from 1 to 2 days, whereas it was 3 days in our study. Increasing the number of patients requiring a prolonged ICU and hospital stay results in increased statistical impact of techniques able to improve the outcome.

Subgroup analysis showed that HCCs are associated with a decreased rate of lung and renal dysfunction. Lung dysfunction rate was significantly lower in COPD patients and patients who had mitral valve procedures. Of course, both groups are to be considered at risk for postoperative lung dysfunction because of the preoperative deterioration of the lung; therefore, it is not surprising that the impact of HCCs was significant. Even after correction for other events that influence postoperative lung dysfunction (CPB time and congestive heart failure), HCCs still protected lung function.

HCCs are associated with a limited increase in intrapulmonary shunt after CPB in humans [10]. Redmond and coworkers [21] demonstrated in an animal model that HCCs are associated with a lesser decrease of thoracopulmonary static compliance than conventional oxygenators and tubings. Postperfusion pulmonary damage is related directly to complement and leukocyte activation. Because several studies found that HCCs had a limiting effect on both these mechanisms, it is not surprising that their use is able to limit postperfusion lung dysfunction. Our observation of a clinically relevant decrease in lung complications is important because it was not observed in a population of low-risk patients [10, 12]. It is possible that the higher sensitivity of patients with COPD and mitral valve disease is probably the reason that the already observed pathophysiologic benefits became clinical relevant.

Renal dysfunction was reduced significantly by HCCs in diabetic patients, who are at high risk for renal dysfunction due to the diabetes-related micro-macroangiopathy. HCCs maintained their protective role after correction for other explanatory variables (low output syndrome, preoperative creatinine and ejection fraction, cardiogenic shock). Further investigations are required to understand the possible chain of events linking complement and leukocyte activation, renal function, and HCCs. The finding that diabetics, patients with COPD, and patients who had mitral valve procedures are the subgroups of patients that demonstrated a beneficial effect of HCCs can be seen from two points of view. One could be encouraged to use these circuits and oxygenators in every patient belonging to these categories. In our opinion, however, our results simply demonstrate that lung and kidney appear to react positively to this treatment, and this appeared in the three subgroups that were preoperatively at high risk for lung and renal dysfunction, because the rate of adverse lung and renal events was so high as to be suitable for reaching statistical significance when modulated by treatment.

In conclusion, HCCs are able to reduce the risks associated with CPB in selected patients, especially those at risk for lung and renal dysfunction. Because HCCs appear not to be responsible for any adverse reaction, together with other recently developed biocompatibility treatments, they will probably eventually replace conventional oxygenators, as happened for hollow-fiber and bubble oxygenators. Although they will cost more than conventional equipment, their use could be recommended mainly for preserving lung and kidney function in particular subgroups of patients. (Appendix 1).

	Footnotes

Top Footnotes Abstract Introduction Material and methods Results Comment References

 
This study was supported by a grant from the Baxter Cardiovascular Group Italy and the Bentley Division, Baxter Cardiovascular Group Europe, Baxter Healthcare.

	Appendix

 
The Italian working group on biocompatibility in cardiac surgery
San Donato Hospital, Milan, Italy Anna Angelini, Alessandra Boncilli, CCP, Anna Cazzaniga, MD, Antonio Ditta, CCP, Giuseppe Isgrò, MD, and Giorgio Soro, MD University Hospital, Verona, Italy Giuseppe Faggian, MD, Edoardo Gasparotto, CCP, and Michela Salionti, CCP Policlinico Sant’Orsola, Bologna, Italy Iolter Cattabriga, MD San Raffaele Hospital, Milan, Italy Ferdinando Bellotti, MD, Marta Bizzarri, MD, Davide Guzzon, MD, Giovanni Marino, MD, Maria Muratore, CCP, Michele Oppizzi, MD, Gabriella Piazza, CCP, and Antonella Vescovo, CCP S. Maria della Misericordia Hospital, Udine, Italy Ospedale di Circolo, Varese, Italy Patrizia Doria, CCP, Eugenio Gandini, CCP, Claudio Grossi, MD, Diego Ornaghi, MD, Andrea Sala, MD, Claudio Salis, CCP, Giuseppe Tarelli, MD, and Enrico Ucussich, MD Hesperia Hospital, Modena, Italy Fausto Carlin, CCP and Ivic Nenad, CCP San Bortolo Hospital, Vicenza, Italy Sant’Ambrogio Hospital, Milan, Italy Bruna Borghetti, CCP and Elena Conti, MD Policlinico Le Scotte, Siena, Italy Luca Marchetti, MD and Felicetta Simeone, MD Ospedale Civili, Brescia, Italy Giulio Pavan, MD and Mario Zogno, MD S. Maria della Misericordia Hospital, Perugia, Italy Stefano Bartoccioni, MD, Daniela Di Lazzaro, MD, and Giorgio Lanzillo, MD

	References

Top Footnotes Abstract Introduction Material and methods Results Comment References

 

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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): Alessandro Mazzucco Lorenzo Porreca Roberto Lorusso Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Ranucci, M. Articles by de Jong, A. Search for Related Content PubMed PubMed Citation Articles by Ranucci, M. Articles by de Jong, A. Related Collections Related Article