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Eur J Cardiothorac Surg 2008;33:318. doi:10.1016/j.ejcts.2007.11.014
Copyright © 2008, European Association for Cardio-thoracic Surgery. Published by Elsevier. All rights reserved.
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Letters to the Editor

Reply to Nistor

Peter Lamm*, Bruno Reichart

Department of Cardiac Surgery, Ludwig-Maximilians-Universität München, Munich, Germany

Received 19 November 2007; accepted 21 November 2007.

* Corresponding author. Address: Department of Cardiac Surgery, Herzklinik der Universität München, Wolkerweg 16, 81375 München, Germany. Tel.: +49 89 7097 1844; fax: +49 89 7097 1848. (Email: lamm{at}lrz.uni-muenchen.de).

Key Words: Coronary disease • Revascularization • Fibrin sealant • Early graft occlusion • Myocardial infarction

We thank the Editor for giving us the opportunity to reply to Dr Nistor's letter to the Editor [1].

We are unaware that there are investigations performed by the Paul Ehrlich Institute (PEI) which conclude that the use of fibrin sealant is ‘a predictor and not the cause of increased mortality’. At the 2004 expert meeting the phrase, ‘predictor’ was used by Baxter and not by the PEI. A portion of the PEI investigation however, was the Hannover study, which yielded similar results to our study [2]. Contrary to Dr Nistor's statement, our study did show a significant difference between myocardial infarction (defined as CK-MB > 50 U/l, p < 0.001) between the treatment and control group [3].

The end-points of the cited randomized clinical trials [4,5] were local hemostasis within 5 min after application of fibrin sealant. In accordance with our observations, the sealants had a success rate of more than 80%. Interestingly, Rousou et al. [4] reported a mortality rate of approximately 13% for the fibrin sealant group. The historical non-matched controls showed a similar lethality. Unfortunately there is no information about the percentage of patients who received fibrin sealant within the controls [4]. Lowe et al. [5] had the same end-point. They compared Tisseel VH to a new generation sealant (Tisseel VH S/D). The authors report a difference of mortality: 1.6% for Tisseel VH S/D and 7.4% for Tisseel VH (p = 0.0366). Since they did not see a statistically significant difference in mortality in the ITT population, coupled with the lack of a difference in primary efficacy (hemostasis) and safety outcomes, they concluded that a clinically significant effect on mortality is unlikely [5]. From our experience however, we would in fact take this finding as another potential warning signal rather than an indicator for clinical safety.

As far as improper sealant thawing and potential misuse is concerned, we believe that according to the German product description (Fachinformation) from 2004, this is impossible. The description allows for the simultaneous application with the DUPLOJECT-System with and without use of the application needle, the simultaneous application using an application catheter or using a sprayer. It further allows the application in layers, separate application and local application by injection. It is obvious that every application technique produces different amounts of free thrombin. Since it is further known that the sealant is basically ineffective when used under deep hypothermia conditions, it is astounding that the description recommends, not requires, the use of the two components at 37 °C. In conclusion, we presently share Dr Nistor's opinion that the findings favor an increased vigilance and welcome the United Kingdom's revised ‘Summary of Product Characteristics’ from 2006 stating, ‘...In two retrospective, non-randomized studies in coronary artery bypass graft (CABG) surgery, patients that received fibrin sealant showed a statistically significant increased risk of mortality. While these studies could not provide a determination of a causal relationship the increased risk associated with the use of Tisseel in these patients cannot be excluded. Therefore, additional care should be taken to avoid inadvertent intravascular administration of this product ...’

References

  1. Nistor RF. Fibrin sealant in coronary artery bypass grafting surgery – reflection on risk and benefit. Eur J Cardiothorac Surg 2008;33(2):317.[Free Full Text]
  2. Goerler H, Oppelt P, Abel U, Haverich A. Safety of the use of Tissucol® Duo S in cardiovascular surgery: retrospective analysis of 2149 patients after coronary artery bypass grafting. Eur J Cardiothorac Surg 2007;32(4):560-566.[Abstract/Free Full Text]
  3. Lamm P, Adelhard K, Juchem G, Weitkunat R, Milz S, Kilger E, Goetz AE, Reichart B. Fibrin glue in coronary artery bypass grafting operations: casting out the Devil with Beelzebub?. Eur J Cardiothorac Surg 2007;32(4):567-572.[Abstract/Free Full Text]
  4. Rousou J, Levitsky S, Gonzales-Lavin L, Cosgrove D, Magillian D, Weldon C, Hiebert C, Hess P, Joyce L, Bergsland J, Gazzaniga A. Randomized clinical trial of fibrin sealant in patients undergoing resternotomy or reoperation after cardiac operations. A multicenter study. J Thorac Cardiovasc Surg 1989;97(2):194-203.[Abstract]
  5. Lowe J, Luber J, Levitsky S, Hantak E, Montgomery J, Schiestl N, Schofield N, Marra S. Evaluation of the topical hemostatic efficacy and safety of TISSEEL VH S/D fibrin sealant compared with currently licensed TISSEEL VH in patients undergoing cardiac surgery: a phase 3, randomized, double-blind clinical study. J Cardiovasc Surg (Torino) 2007;48(3):323-331.[Medline]




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