Clinical Outcomes for Spine Surgery

During posterior spinal fusion surgery for deformity, this study showed a significant decrease in estimated blood loss in the bipolar sealer group whether measured in total (435 ± 192mL, compared with 1009 ± 392 mL in the control group; p < 0.001) or per level fused (39 ± 17 mL, compared with 95 ± 33 mL in the control group; p < 0.001). In turn, this decreased blood loss resulted in a significantly reduced risk of transfusion (p = 0.014).

This 70-patient study in severe neuromuscular scoliosis demonstrated a reduced operative blood loss, a decrease in the amount of blood transfused, and reduction in overall operative time when the bipolar sealer was used as an adjunct to the author’s conventional blood management strategy.

In a study of 60 patients undergoing multi-level (2-5 level) spine surgery from a posterior approach, the researchers demonstrated that Transcollation^® technology resulted in a 35% reduction in intra-operative hemoglobin loss (66.2 g hemoglobin loss in the treatment arm vs. 102.4 g in the control arm).

In this retrospective study of 100 patients undergoing posterior spinal fusion for idiopathic scoliosis, baseline characteristics between groups were similar except for the number of levels fused, which was larger in the bipolar sealer group. The results showed that bipolar sealer patients experienced statistically significantly lower total peri-operative blood loss including post-op drain output, intra-operative cell saver transfusion, intra-operative or post-operative transfusions, and total blood volume transfused.

Journal Articles

• Mankin KP, Moore CA, Miller LE et al. Hemostasis with a bipolar sealer during surgical correction of adolescent idiopathic scoliosis. J Spinal Disorders & Techniques, October 2011; doi:10.1097/BSD.0b013e3182334ec5.

White Papers

• Santiago P. Controlling epidural bleeding and improving visibility during spinal surgery with a novel bipolar sealing technology. Medtronic White Paper, 2009.

• Snyder BD, Hedequist D, Shannon E. Hemostatic Efficacy of Bipolar Wound Sealer as Adjunct to Wound Management in Children with Neuromuscular Scoliosis. Annual Meeting of the Pediatric Orthopaedic Society of North America 2007; Hollywood, FL.

• Small HN, Chisholm SD. Use of a new bipolar sealing technology to reduce blood loss during instrumented lumbar fusion surgery. Medtronic White Paper, 2007.

Published Abstracts

• Mankin, KP. Use of bipolar sealing technology in spinal deformity surgery can dramatically reduce blood loss and transfusion rates. SABM Abstracts: Transfusion, Vol. 49, September 2009.

   - Society for the Advancement of Blood Management 2009, Kansas City, MO.

• Diesen DL, Sabesan V, Broomer B et al. Preliminary results from a prospective, randomized, double-blinded study of Tissuelink versus traditional electrocautery and sealants for intraoperative haemostasis during spinal surgery. SABM Abstracts: Transfusion, Vol. 48, September 2008.

   - Society for the Advancement of Blood Management 2009; Baltimore, MD

Podium Presentations

• Gordon Z, Poe-Kochert C, Son-Hing J et al. Use of bipolar sealer device reduces blood loss and transfusions in posterior spinal fusion. Poster presentation at American Academy of Orthopaedic Surgeons Annual Meeting 2012; San Francisco, CA; paper number 339.

• Snyder BD, Shannon E. Bipolar sealing technology to control bleeding in spine surgery: a retrospective study.

   - American Association of Orthopedic Surgeons 2007; San Diego, CA

   - Pediatric Orthopaedic Society of North America 2007; Hollywood, FL 

   - National Association of Orthopaedic Nurses 2007; St. Louis, MO