Clinical Outcomes and Experience of a Multiyear Consecutive Case Series of Total Knee Arthroplasty Procedures Conducted with a Bipolar Sealer System for Hemostasis

Maximizing hemostasis during total knee replacement procedures remains a key challenge in current practice. Bipolar sealer technology achieves intraoperative hemostasis through tissue sealing and coagulation with adjustable radio frequency energy and a saline-irrigated tip. Optimal surgical site hemostasis is important to avoid potential complications such as hemarthrosis, wound drainage, increased pain, delayed discharge, and readmissions. The aim of this study is to evaluate the safety and effectiveness of the bipolar sealer device in primary knee replacement in the largest consecutive series to date. A consecutive, treatment-control series of subjects who underwent a primary total knee arthroplasty (TKA) utilizing a bipolar sealer for hemostasis, one subgroup with concomitant tranexamic acid (TXA) administration (n = 1599) and one subgroup without TXA administration (n = 3582), compared with a control group of primary TKA under tourniquet only (n = 667). Statistical analyses were performed through two-tailed unpaired t-tests. There was less total postoperative drain output and a lower overall transfusion rate in the bipolar sealer group (807ml ± 428) (2.5%) than the tourniquet only group (1290 ± 658, p = 0.001) (8.4%, p = 0.0001), respectively. Drainage output in bipolar sealer + TXA (450 ± 297 ml) was lower than the other two groups (bipolar sealer 807 ± 428 mL, p = 0.0001; tourniquet only 1290 ± 658 ml, p = 0.0001). The bipolar sealer group had a higher hematocrit at postoperative day 1 (POD1) (bipolar sealer: 33.1 ± 4.3 cc, tourniquet only: 32.5 ± 4.3 cc, p = 0.001) and at discharge (POD2, bipolar sealer: 31.5 ± 3.7 cc, tourniquet only: 30.2 ± 3.9 cc, p = 0.0001). There were zero reported serious adverse events related to hemostasis management in any group. The bipolar sealer system is a safe and effective instrument to achieve intraoperative hemostasis during primary TKA. The bipolar sealer group required significantly fewer postoperative blood product transfusions and maintained a higher hematocrit concentration at the time of discharge compared with subjects treated solely with tourniquet mediated hemostasis. Addition of TXA to local hemostasis methods may further reduce blood loss and transfusion requirements. Level of Evidence This is a Level III study.

Plasma Technology Reduces Blood Loss in Adolescent Idiopathic Scoliosis Surgery: A Prospective Randomized Clinical Trial

Study Design: Prospective randomized clinical trial. Objectives: To assess the effectiveness of PEAK Plasmablade (PPB), compared with bipolar sealer and standard electrocautery, in the posterior spinal instrumentation and fusion (PSF) surgery performed for adolescent idiopathic scoliosis (AIS). Methods: Ninety-three patients undergoing PSF surgery for AIS were randomized in 2 groups: group-A patients (n = 45) underwent PSF surgery using PPB; group-B patients (n = 48) were treated with bipolar sealer and standard electrocautery. Demographic and surgical data was recorded. All the patients underwent serial blood tests on the day before surgery (T0) and at 24 (T1), 48 (T2), 72 (T3), and 96 (T4) hours postoperatively. Visual analogue scale for pain (VAS) score, the percentage of paracetamol assumption, and the blood transfusion rate were recorded in the time-lapse T1 to T4. Intergroup variability was assessed. Pearson correlation test was performed. A P value <.05 was considered significant. Results: In group A, a significantly shorter total operative time ( P = .0087), a significantly lower total intraoperative blood loss (TBL) ( P = .001), and a higher postoperative hemoglobin (Hb) ( P = .01) were recorded. A significant higher mean Hb concentration and mean albumin value was recorded in group A at 24 and 48 hours postoperatively. A significant correlation between TBL and hospital stay was recorded in both groups (group A, P = .00 001; group B, P = .00 006); moreover, in both groups, a significant correlation was observed between TBL and mean VAS at 72 hours postoperatively (group A, P = .0009; group B, P = .0001) and at 96 hours postoperatively (group A, P = .000 044; group B, P = .00 001). Conclusions: PPB reduces the intraoperative blood loss in PSF performed for AIS, thus allowing a patient’s faster recovery.

Bipolar Sealers Do not Improve Blood Loss or Functional Outcomes of Primary Total Knee Arthroplasty

Several methods were introduced to limit perioperative blood loss in total knee arthroplasty (TKA). By transcollation of soft tissues below 100°C, bipolar sealers intend to reduce bleeding and tissue damage, compared with conventional electrocautery. Existing studies report contradictory findings about the performance of bipolar sealers. The purpose of this study was to evaluate the effect of a bipolar sealer on blood loss, transfusions, hospital length of stay (LOS), and functional scores in primary TKA. In this single-center prospective study, 101 patients, undergoing primary TKA in a fast-track setting without tourniquet use, were randomly assigned to either (1) the study group which was operated with a bipolar sealer or (2) the control group operated with conventional electrocautery. The study cohort comprised 49 men and 52 women, aged 71.1 ± 8.8 years. There was no significant difference between the bipolar sealer group and the control group in terms of blood loss at day 3 (1,240 ± 547.4 vs. 1,376 ± 584.4 mL; p = ns [not significant]), transfusion rate (10 vs. 4%; p = ns), surgery time (48.2 ± 10.8 vs. 46.6 ± 9.1 minute; p = ns) or LOS (4.1 ± 2.7 vs 4.3 ± 2.0 days; p = ns). At a mean follow-up of 63.3 ± 4.9 days, there was no significant difference between the bipolar sealer group and the control group in terms of net improvement of Knee Society Score (KSS) knee (26.0 ± 16.7 vs. 23.7 ± 12.3; p = ns) and KSS function (20.4 ± 19.3 vs. 20.8 ± 19.9; p = ns). Compared with the use of conventional electrocautery in primary TKA without tourniquet, we found no effect of bipolar sealer use on blood loss, transfusion rates, LOS, or functional recovery. This is a Level II, prospective cohort study.