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Eur J Cardiothorac Surg 2001;19:949-950
© 2001 Elsevier Science NL
Letter to the Editor |
a Department of Cardiac Surgery & Anesthesiology, Karolinska Institute, Huddinge University Hospital, Stockholm, Sweden
b Department of Clinical Physiology, Karolinska Institute, Huddinge University Hospital, Stockholm, Sweden
c Department of Diagnostic Radiology, Uppsala University Hospital, Uppsala, Sweden
Received 9 October 2000; received in revised form 20 March 2001; accepted 21 March 2001.
Corresponding author. Department of Cardiothoracic Surgery & Anesthesiology, Karolinska Institute, Huddinge University Hospital, SE-14186 Stockholm, Sweden. Tel.: +46-8-585856296; fax: +46-8-58586740
e-mail: jan.vanderlinden{at}thsurg.hs.sll.se
Adhesions between the sternum and the heart complicate and prolong cardiac re-operations. Hyaluronic bio-absorbable acid membranes (HAM) have been shown to reduce postoperative abdominal adhesions [1]. Recent animal studies with HAM have shown a reduction of adhesions in the pericardial cavity following sternotomy [2–4]. Computerized tomography (CT) may detect retrosternal adhesions by determining the presence or absence of fat in the retrosternal area [5].
We set to investigate if treatment with hyaluronate solution and HAM reduces postoperative retrosternal adhesions in coronary artery bypass surgery (CABG).
We studied 20 consecutive patients undergoing routine CABG. The Hospital Ethical Committee approved the study and informed written consent was obtained from all patients. They all had stable 2–3 coronary vessel disease and normal ejection fraction (>50%). Operations were performed by senior surgeons. Postoperative autotransfusion of shed blood was avoided. The patients were randomized into two groups. In the study group (S-group) the pericardial cavity was irrigated with 50 ml of 0.4% hyalurononate solution (Sepracoat®, Genzyme Corp., Boston, MA, USA) every 20 min during the operation. The irrigation was allowed to act for 2 min. In the control group (C-group) the pericardial cavity was irrigated with 50 ml of Ringer's acetate in the same manner. Additionally, patients in S-group had the anterior part the heart covered with two films (12.7x15.2 cm) of Seprafilm® (chemically modified sodium hyaluronate and carboxymethycellulose) before closing of the sternum. All patients underwent CT examinations 6–8 months after the operation. The scans were performed at breathhold with 5 mm thick slices from the diaphragm to the bifurcation of the pulmonary artery. The presence of fat interposed between the sternum and the anterior surface of the heart was interpreted as absence of retrosternal adhesions [5]. Two experienced independent observers blind to the study evaluated the scans. The percentage of retrosternal adhesions between the two groups was compared with Mann–Whitney U-test.
There were nine patients (median age 64.0 years, range 47–77 years) in the S-group and ten patients (median age 62.5 years, range 48–81 years) in the C-group. An additional 10th patient randomized to S-group was excluded from the study due to re-operation for postoperative bleeding. No patient in the study had retrosternal or pericardial adhesions before the operation. All patients had an uneventful postoperative course and were discharged from the hospital within 10 days. None of the patients had clinical, ECG or enzymatic evidence of peri-operative myocardial infarction. Also, no patient was re-operated before the CT-follow-up. The median percentage of retrosternal adhesions in the S-group was 53% (range 27–88%) versus 71% (range 18–90%) in the H group (P=0.45).
We conclude that the intraoperative topical use of hyaluronate solution combined with application of hyaluronate films do not significantly reduce postoperative formation of retrosternal adhesions in adults undergoing surgery for coronary artery disease. However, because of small numbers, we cannot definitely rule out a type II error i.e. a larger number might have shown a clinically insignificant but statistically significant difference between the groups. There were no adverse events.
Footnotes
Presented at the 14th Annual Meeting of the European Association for Cardio-thoracic Surgery, Frankfurt, Germany, October 7–11, 2000.
Appendix A. Conference discussion
Dr O. Alfieri (Milan, Italy): Is the CT scan reliable in predicting the difficulty of the dissection?
Dr van der Linden: Yes. Studies with hyaluronate in abdominal surgery have shown clinically a decrease from 85 to 15% of adhesions, so it is a wide or huge decrease in adhesions. We were just looking for the presence or absence of adhesions, not if the adhesions were very thick or very thin.
Dr Alfieri: There are many other problems related to reoperations, like the visualization of the coronary arteries.
Dr van der Linden: I agree fully, but we were just looking for retrosternal adhesions as a way to possibly prevent the most dreaded, feared complication, that is, rupture of the right heart during the reoperation.
Dr O.H. Frazier (Houston, TX): Has this been studied in LVAD patients?
Dr van der Linden: I don't know.
Dr Frazier: LVAD patients would be a good group for study because the device is implanted, then removed, a few months later at the time of the transplant.
Dr van der Linden: That is a good point.
Dr Frazier: We used it in one patient. The patient nearly bled to death when we took it out, so we never used it again, but that's an N of one. I think if somebody wanted to do that study, it would yield good information.
Dr T. Kuhme (Linkoeping, Sweden): Did you follow these patients with ultrasounds and was there any difference?
Dr van der Linden: Actually we did an ultrasonic study as well on these patients, and unfortunately we lost data in some patients. We only compared eight versus eight, and the differences in various parameters were almost but not significant, and that might be a type II error.
References
., Larsson S.G., Hansson H-E. CT and MR evaluation of pericardial and retrosternal adhesions after cardiac surgery. J Comput Assist Tomogr 1991;15:555-560.[Medline]
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