Massimo Miscusi (Department of Medico-Surgical Sciences Biotechnologies, Sapienza University of Rome, Latina, Italy) and others report in the European Spine Journal that BioGlue (CryoLife) has comparable safety and efficacy to Tissucol (Baxter) when used as an adjunct to immediate repair of a dural tear.
Miscusi et al state that a dural tear is the most frequent complication of spinal surgery and is associated with cerebrospinal fluid leakage and an increased risk of infection-related complications. However, they add that if a dural tear is successfully repaired during surgery, it is not associated with increased morbidity. The aim of their study was to compare the success of dural repair with two different surgical sealants (BioGlue vs. Tissucol) and also evaluate the short- and long-term complications associated with those sealants.
The authors reviewed outcomes of 321 patients who underwent non-instrumented spinal surgery at their department between January 2005 and August 2011. Of these, 23 incurred a dural tear during surgery. Primary repair was performed with 5–0 silk sutures (16 patients) or with a small dural patch (Tissudura, Baxter) placed over the dural tear and partially sutured with 5–0 silk sutures (seven patients). The sutures were reinforced with either a thick layer of Tissucol (11 patients) or a thin layer of BioGlue (12 patients). Miscusi et al comment: “To test the integrity of the dural tear repairs and the absence of any intraoperative cerebrospinal fluid leakage, the Valsalva manoeuver was performed in triplicate in all cases.”
The dural tear was repaired effectively in all 23 patients, but two patients in the Tissucol group had to receive a second application of the fibrin glue after the Valsalva manoeuver resulted in sealant dislodgement. Also in the postoperative period, three of the Tissucol patients experienced cerebrospinal fluid leakage (at the second, sixth, and 10th postoperative day, respectively) and a fourth experienced deep vein thrombosis. There were no cases of cerebrospinal fluid leakage (either intraoperatively or postoperatively) or neurological complications in the BioGlue group.
At three months and at one year, there were no reported cases of neurological complications in either group. However, five patients (three who received Tissucol and two who received BioGlue) reported having persistent low back pain with a mean Visual Analogue Scale score of 45 at three months and four patients continued to have low back pain at one year (mean VAS score 26).
The authors note that the dural sealants have different characteristics and therefore, should be used in different manners. They write: “When Tissucol is applied, a dense fibrin network is formed which facilitates dural tear repair via its haemostatic properties. In contrast, BioGlue forms covalent bonds with cell surface proteins once in contact with the tissue. Because of the difference between Tissucol and BioGlue in mechanism of action, a thin layer of BioGlue is sufficient to achieve repair of the dural tear without complications.”
Miscusi et al comment that although their study did not identify any significant differences between the two sealants, they speculate that BioGlue’s strong bonding properties make it “more resistant soon after the application to internal cerebrospinal fluid pressure and pulses, which could consequently force the suture open, dislodge the applied sealant, and reopen the tear.” They add that they therefore have “increasingly moved towards” using BioGlue for dural tear repair at their institution because they view it as a “faster and more confident” technique for controlling cerebrospinal fluid leakage during surgery.
Concluding, the authors claim that when used appropriately, BioGlue could potentially reduce the incidence of the short- and long-term complications of dural tear repair. “Further studies to evaluate the effects of BioGlue use on the incidence of complications with the repair of dural tears are warranted,” they state.
Miscusi told Spinal News International: “BioGlue needs to be used in an informed manner to obtain the best results and minimise the risk of complications; in fact, becauseof its unique chemicophysical characteristics, BioGlue has to be applied only as a very thin layer on the suture or on the patch. I am very confident of BioGlue—especially when used in the more difficult cases.”