Bipolar Sealer Research Articles

Bipolar Sealers and Tourniquet Use Have Similar Outcomes in Total Knee Arthroplasty.

The use of tourniquets and bipolar sealers are effective methods of hemostasis during total knee arthroplasty (TKA). However, their effect on perioperative patient outcomes is unknown. The purpose of this study is to compare the efficacy of tourniquet-less, tourniquet-less with use of a bipolar sealer, and tourniquet use on postoperative pain and surgical outcomes following TKA. A retrospective study of prospectively collected data of 120 primary TKA cases was conducted at an urban academic hospital. Primary outcomes were visual analog scale (VAS) scores and opioid consumption (in morphine milligram equivalents). Demographics, length of stay (LOS), perioperative complications, and change in Knee Injury and Osteoarthritis Outcome Score (ΔKOOS) were also collected. Patients were divided into cohorts based on the use of tourniquet-less with bipolar sealer (TRLB) (n = 40), tourniquet (TR) (n = 40), or tourniquet-less (TRL) (n = 40). There were no differences in demographic data between each cohort. TRLB, TR and TRL had similar LOS (2.68 ± 1.63 vs 2.29 ± 1.27 vs 2.36 ± 1.42days; p = 0.472) and VAS pain score on postoperative day 1 (4.68 vs 3.74 vs 3.63; p = 0.209). There were also no differences in opioid consumption at 2weeks (p = 0.903), 1month (p = 0.973), 3months (p = 0.983), or 5months (p = 0.983) post-operatively. TRLB and TR had comparable improvement in ΔKOOS from baseline to 12weeks post-operatively (Δ16.58 ± 8.47 vs Δ23.92 ± 14.60; p = 0.254). Compared to the ΔKOOS of TRL (Δ5.19 ± 2.59), TRLB and TR had clinically and statistically greater ΔKOOS improvements (p = 0.009; p = 0.001). The TRL cohort also had a higher readmission rate than TRLB and TR (15% vs 0% vs 5%, p = 0.025). Our findings demonstrate that both bipolar sealer and tourniquet use in TKA are associated with similar postoperative pain levels and LOS in comparison to tourniquet-less only TKA. However, bipolar sealer and tourniquet use may lead to better longer term improvement such as greater PRO score improvement and fewer readmissions.

P66: Does use of a saline-cooled bipolar sealer reduce re-operation rates for post-operative bleeding after cardiac surgery?

P66: Does use of a saline-cooled bipolar sealer reduce re-operation rates for post-operative bleeding after cardiac surgery?

Comparative Study to Evaluate the Effect of Using an Electro-Thermal Bipolar Sealing Device and Conventional Ligation on the Incidence of Post-Renal Transplant Lymphoceles in Recipients

Background: Lymphocele development is a well-established complication following kidney transplant. Some devices, such as electrothermal bipolar sealing devices, have been found to reduce lymphatic drain following kidney transplantation. The aim of the study: The purpose of the study is to compare the usage of conventional lymphatic ligation with the electrothermal bipolar sealing device and its influence on the formation of lymphoceles after kidney transplantation surgery. Patients and methods: A cohort retrospective and prospective study was conducted from May 2015 to November 2020 at the Basrah renal transplantation center in Al-Sader Teaching Hospital, Basrah. One hundred and thirty anonymized patients with end-stage renal diseases were involved in the present study. They were categorized into two groups: group 1 (conventional ligation group) with 70 patients and group 2 (electrothermal bipolar sealing device group) with 60 patients. The groups were compared and matched for possible risk factors. Patients were followed up for six weeks with full laboratory investigation (complet blood count, renal function tests, and liver function tests) and medical and surgical assessments. Statistical package of social siences version 25 was used for the statistical analysis of the data. Confidence intervals of 95% were applied as the dependent interval in statistics, and p-values < 0.05 were considered significant. Results: The mean age of the patients was parallel for both conventional ligation and electrothermal bipolar sealing device groups (34.69 ± 10.28 vs. 33.68 ± 10.35). The operative time (155.57 ± 17.9 vs. 140.33 ± 17.07), lymphocele development (12 (17.1%) vs. 4 (6.7%)), lymphatic drainage volume (974.57 ± 178.39 vs. 493.83 ± 163.65), and the days of drainage (8.28 ± 3.3 vs. 4.6 ± 1.4) showed statistically significant differences between the conventional ligation technique and the electrothermal bipolar sealing device technique (p < 0.05). Conclusion: The cautery of bipolar vessels is advantageous when compared to conventional ligation in kidney transplant lymphatic dissection, reducing the risk of lymphocele occurrence, in addition to its feasibility, safety, and easy performance

A rare cause of lower gastrointestinal bleeding treated with robotic colorectal surgery

BackgroundMetastatic melanoma to the colon is rarely diagnosed with an incidence of only 0.3% and more than 95% of cases identified post-mortem. Survival for patients with metastatic melanoma to the colon is poor, with 5-year survival rates of 26.5%. Nonetheless, surgical resection of the colonic metastatic melanoma lesions is recommended as it is associated with improved survival. Additionally, surgical resection is also indicated for palliative reasons, as symptom resolution is achieved in 90% of such patients. Use of the surgical robot has increased dramatically in the past decades, especially in the field of colorectal surgery. Furthermore, recent studies have demonstrated comparable outcomes between patients undergoing either laparoscopic or robotic-assisted colorectal surgery for cancer. Here, we describe the first case, to the authors knowledge, of a robot-assisted sigmoid colectomy for metastatic melanoma.Case presentationA 72-year-old male with a history of metastatic melanoma diagnosed in 2015 with a favorable response to immunotherapy presented to the emergency department with symptomatic lower gastrointestinal bleeding (LGIB). Endoscopy demonstrated a friable melanotic lesion of the sigmoid colon with biopsy demonstrating histopathologic evidence of metastatic melanoma. After further evaluation, the patient consented for an elective robot-assisted segmental colectomy for palliative intent. Diagnostic laparoscopy identified no evidence of further intra-abdominal metastatic disease. After identifying the metastatic lesion in the sigmoid colon, the mesentery of involved segment of sigmoid colon adjacent to the lesion was divided using the bipolar electrosurgical vessel sealer device. The colon was divided both proximal and distal to the lesion using a robotic stapler and a tension-free colo-colonic anastomosis was created intracorporeally. Postoperatively, the patient had an unremarkable course and was discharged home on post-operative day 3. On follow-up, the patient was doing well with resolution of preoperative LGIB.Conclusion This case highlights a rare presentation of metastatic melanoma to the colon in a patient presenting with LGIB. Furthermore, this case demonstrates the feasibility of the minimally invasive robotic-assisted approach for an uncommon pathology.

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.

A Combined Strategy of Vaginal Hysterectomy by Electrosurgery with Post Hysterectomy Check Laparoscopy in Benign Indications Associated with Known or Suspected Concomitant Pelvic Disease: A Retrospective Study

Purpose: A vaginal hysterectomy (VH) may be preferred when possible. However, VH is less than the ideal in benign cases with known or suspected concomitant pelvic disease and a laparoscopic approach of the hysterectomy may be favoured. The laparoscopic hysterectomy requires more surgical skills. The aim of the study is to demonstrate a combined strategy of vaginal hysterectomy by bipolar sealer -shear with post-hysterectomy check laparoscopy (VHPHCL) over lapa-roscopic assisted vaginal hysterectomy (LAVH) in cases with known or suspected concomitant pelvic disease.

In reply: Zenker's diverticulotomy with bipolar tissue sealer: Retrospective review of safety and short-term outcomes.

In reply: Zenker's diverticulotomy with bipolar tissue sealer: Retrospective review of safety and short-term outcomes.

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.

Hemostatic efficacy of an advanced bipolar sealer in open gynecologic, thoracic, and colectomy procedures: A prospective cohort study

BackgroundAn advanced bipolar (ABP) tissue sealer designed for division of major vessels in open procedures was evaluated in a prospective post-market study. The objective was to provide clinical data for assessment of vessel transection, hemostatic performance and ease of use of the ABP device during open colectomy, gynecologic, and thoracic operations. Materials and methodsThe ABP test device was used in colectomy (n = 36), gynecologic (n = 44), and thoracic (n = 21) procedure groups. Vessels transected with the ABP device were graded intraoperatively on a hemostasis scale of 1–4, defined as follows: Grade1, no bleeding; Grade 2, minor bleeding with no intervention; Grade 3, minor bleeding requiring touchup with the test device or monopolar cautery; and Grade 4, significant bleeding requiring intervention with any additional hemostatic product. The primary performance measure was the percentage of vessels that achieved hemostasis grades ≤3. The primary safety endpoint was the summarization of all ABP device-related adverse events (AEs). ResultsFor all three procedure groups together, 302 (96.2%) of 314 total vessel transections were scored as hemostasis grades ≤ 3, including 270 (86.0%) that were rated Grade 1. Twelve transections (3.8%) were Grade 4, which included 9 vessels transected in the gynecologic group and 3 in the thoracic group. Three subjects experienced a total of 4 device-related AEs, consisting of hematoma, hypotension, procedural pain, and superficial thermal burn. All 4 device-related AEs were mild in severity. ConclusionThe advanced bipolar device exhibited effective hemostasis, an acceptable safety profile, and ease of use during colectomy, thoracic, and gynecologic procedures. Trial registry numberClinicalTrials.gov, NCT034411.

Minimizing Blood Loss in Spine Surgery.

Study Design:Broad narrative review.Objective:To review and summarize the current literature on guidelines, outcomes, techniques and indications surrounding multiple modalities of minimizing blood loss in spine surgery.Methods:A thorough review of peer-reviewed literature was performed on the guidelines, outcomes, techniques, and indications for multiple modalities of minimizing blood loss in spine surgery.Results:There is a large body of literature that provides a consensus on guidelines regarding the appropriate timing of discontinuation of anticoagulation, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), and herbal supplements prior to surgery. Additionally, there is a more heterogenous discussion the utility of preoperative autologous blood donation facilitated by erythropoietin and iron supplementation for healthy patients slated for procedures with high anticipated blood loss and for whom allogeneic transfusion is likely. Intraoperative maneuvers available to minimize blood loss include positioning and maintaining normothermia. Tranexamic acid (TXA), bipolar sealer electrocautery, and topical hemostatic agents, and hypotensive anesthesia (mean arterial pressure (MAP) <65 mm Hg) should be strongly considered in cases with larger exposures and higher anticipated blood loss. There is strong level 1 evidence for the use of TXA in spine surgery as it reduces the overall blood loss and transfusion requirements.Conclusion:As the volume and complexity of spinal procedures rise, intraoperative blood loss management has become a pivotal topic of research within the field. There are many tools for minimizing blood loss in patients undergoing spine surgery. The current literature supports combining techniques to use a cost- effective multimodal approach to minimize blood loss in the perioperative period.

Is bipolar sealer superior than standard electrocautery for blood loss control after primary total knee arthroplasty: A meta-analysis.

Whether bipolar sealer (BS) is superior to standard electrocautery in patients with primary total knee arthroplasty (TKA) remains controversial. Thus, we conducted this meta-analysis involving comparative studies (S) to evaluate whether administration with BS (I) was associated with less blood loss (O) than standard electrocautery (C) after primary TKA (P). PubMed (1950-January 2017), EMBASE (1974-January 2017), the Cochrane Library (January 2017 Issue 3), and the Google database (1950-January 2017) were systematically searched. Studies were included in accordance with Population, Intervention, Comparison, Outcomes, and Setting including criteria. Only the patients prepared for primary TKA and administrated with BS as the intervention group and standard electrocautery as control group were included in this meta-analysis. Outcomes include need for transfusion, total blood loss, blood loss in drainage, hemoglobin at discharge, hemoglobin drop, and length of hospital stay. Continuous outcomes and discontinuous outcomes were expressed as weighted mean difference (WMD) and risk ratio (RR) with corresponding confidence intervals (CIs), respectively. Stata 13.0 software was used for relevant data calculation. A total of 7 clinical trials with 718 patients (398 patients in BS group and 320 in standard electrocautery group) were finally included in this meta-analysis. The pooled results indicated that administration with BS was associated with little reduction of total blood loss (WMD = -123.80, 95%CI -236.56 to -11.04, P = .031). There was no significant difference between the need for transfusion, blood loss in drainage, hemoglobin at discharge, hemoglobin drop, and length of hospital stay (P > .05). Based on the current meta-analysis, we found no evidence to support the routine use of bipolar sealer in the management of blood loss in primary TKA. Since the poor quality of the included studies, more randomized controlled trials are still needed to further identify the efficacy of BS after primary TKA.

Laparoscopic hepatic left lateral lobectomy using a combination of the harmonic scapel and the Aquamantys bipolar sealer: a case report

Introduction: There are so many tools and energy devices, used in liver parenchymal transection and hemostasis. No consensus statement is achieved on what kind of tools or energy devices are more efficient or reliable. Patient Concerns: A 40-year-old man presenting with epigastric discomfort was detected with a 6-cm sized mass at segment II/III with enhancement in the arterial phase with washout in the portal site or a delayed phase. Diagnosis: The clinical diagnosis was hepatocellular carcinoma. Interventions: We herein used a promising new tool, the Aquamantys bipolar sealer, combined with harmonic scalpel in liver parenchymal transection and hemostasis, and take laparoscopic left lateral lobectomy, for example. Outcomes: When we used the Aquamantys bipolar sealer to coagulate and push parenchymal apart gently, the vessels were exposed spontaneously. Conclusion: The coagulative and hemostatic effect was quite better than the previous tools. It is simple and practicable, and will help us to shorten the learning curve of laparoscopic hepatectomy.

Use of a novel bipolar sealer device in pocket infections: A case series.

Cardiac implantable electronic device pocket infections require complete system removal. However, postoperative bleeding and hematoma can occur after extensive debridement and an optimal management strategy has yet to be defined. Following system removal and debridement, all pockets were treated with the Aquamantys bipolar sealer until hemostasis of the underlying tissue was achieved. Clinical characteristics, sealer application time, and postoperative outcomes were analyzed. Thirteen consecutive patients were included with an average age of 61.6 years and 8/13 were male. One patient had both pocket infection and systemic bacteremia. Explanted devices included three pacemakers, nine transvenous implantable cardioverter-defibrillators (ICD), and one subcutaneous ICD. The average number of leads extracted was 2.08 ± 1.04 with a median lead dwell time of 75 months (range, 1-265). Pocket tissue culture yielded Streptococcus anginosus (1), Pseudomonas aeruginosa (2), Staphylococcus epidermidis (1), Staphylococcus aureus (1), and no growth (8). Average time using the Aquamantys was 5.6 ± 2.75 minutes per patient. Twelve out of thirteen pockets were closed by primary intention with one pocket packed and left to heal via secondary intention. A Jackson-Pratt drain was used in three patients and removed within 3 days. There were no hematomas noted during the acute hospitalization or during follow up and all of the wounds healed completely. Use of a novel bipolar sealing device in lieu of traditional electrocautery provided rapid and durable hemostasis with the ability to close almost all of the pockets via primary intention.

Efficacy of a Laparoscopic Saline-Coupled Bipolar Sealer in Minimally Invasive Hepatobiliary Surgery.

Hepatic resection presents unique surgical challenges to reduce blood loss during parenchymal division. The development of saline-coupled bipolar devices, in which hemostasis is achieved at lower temperatures than electrocautery or other bipolar sealing devices, have been employed for open hepatic resection. Saline-coupled bipolar devices have now become available for minimally invasive use. The goals of this study were to evaluate the feasibility and safety of a laparoscopic saline-coupled bipolar device for minimally invasive hepatectomy. Seventeen patients (median age 66 years, range 36-81) were consented for inclusion and enrolled. Patient demographics, intraoperative data, and surgeon feedback were collected. Seven robot-assisted partial hepatectomies, 9 laparoscopic partial hepatectomies, and 1 laparoscopic cholecystectomy with liver abscess resection were performed. Average operating time was 222 ± 33 minutes (median 188 minutes; range 61-564 minutes) with no difference between robotic versus laparoscopic time. Successful seals were achieved in all cases following application of 150 to 200 J energy (average 179 ± 3 J, average time to achieve a successful seal 9.3 ± 2.7 minutes). Estimated blood loss was 362 ± 74 mL (median 300 mL, range 5-1200 mL) and 3/17 patients received intraoperative blood transfusion. No bile leaks were detected in any of the patients. Median length of stay was 5 days (range 1-20 days), and there were no readmissions within 30 days. Postoperative morbidity occurred in 5/17 patients, all of which were Clavien Grade 1. There was no mortality within 90 days or complications requiring a return to the operating room, and there were no liver-specific morbidities. These data suggest the laparoscopic Aquamantys device represents a useful device for use in minimally invasive liver resection.

To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty

To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty

Cecal Resection with Bipolar Sealing Devices in a Rat Model

ABSTRACTBackground: Bipolar sealing devices are routinely used to seal blood vessels. The aim of the study is to evaluate the feasibility and safety of colonic sealing with the use of the bipolar energy devices in rats as model for experimental appendectomy. Methods: Seventy-five male Wistar rats underwent a cecal resection with four different bipolar sealing devices or a linear stapler. The harvesting procedure was performed immediately or at postoperative day (POD) 7. The sealing front bursting pressure (BP) was measured in both groups. At POD7, the resection line was clinically examined and the hydroxyproline (HDP) levels were determined. Hematoxylin and Eosin (H&E) staining was used for histopathological evaluation of the sealing front as well. Results: There was no mortality and no insufficiency. The BPs between the bipolar sealing devices showed no statistical differences. The early phase of the seal (POD 0) provides a low BP with an 30.8% increase until POD 7. The BPs in the stapler group showed significant better values. The hydroxyproline levels did not differ statistically between the groups. Histopathologically, there were more signs of ischemic necrosis in the stapler group than in the sealing devices groups. Conclusion: The resection and sealing of the cecum as an experimental appendectomy model with the use of bipolar energy devices proved feasible and safe in rats. The different energy devices in this study produce comparable results. To justify clinical practice in humans, several studies on the underlying mechanisms of early stage wound healing are needed.

Blood Loss Reduction with Tranexamic Acid and a Bipolar Sealer in Direct Anterior Total Hip Arthroplasty.

The purpose of this study is to determine the effectiveness of tranexamic acid (TXA) alone and in conjunction with a bipolar sealer in reducing postoperative transfusions during direct anterior (DA) total hip arthroplasty (THA).In this retrospective review, we analyzed 173 consecutive patients who underwent primary unilateral DA THA performed by 2 surgeons during a 1-year period. Subjects were divided into 3 groups based on TXA use: 63 patients received TXA alone (TXA group), 49 patients received TXA in addition to a bipolar sealer (TXA + bipolar sealer group), and 61 patients received neither TXA nor a bipolar sealer (control group). Primary end points were the transfusion rate and estimated blood loss. Secondary end points were length of stay, postoperative drop in hemoglobin, and postoperative drain output. Two patients in the TXA group and 10 patients in the control group were transfused (P = .02). In the TXA + bipolar sealer group, 1 patient was transfused (P = .02). No significant difference in the rate of transfusion was found between the TXA group and the TXA + bipolar sealer group (P = .99). Estimated blood loss was 310.3 mL ± 182.5 mL in the TXA group (P = .004), 292.9 mL ± 130.8 mL in the TXA + bipolar sealer group (P = .003), and 404.9 mL ± 201.2 mL in the control group. The use of TXA, with and without the concomitant use of a bipolar sealer, decreases intraoperative blood loss and postoperative transfusion requirements. The addition of a bipolar sealer, however, does not appear to provide any additional decrease in blood loss.

Bipolar Sealer Devices Used in Posterior Spinal Fusion for Neuromuscular Scoliosis Reduce Blood Loss and Transfusion Requirements

Reducing perioperative blood loss and the need for transfusions in patients undergoing spinal surgery is especially important for those with neuromuscular disorders. These patients require extensive spino-pelvic exposure and are often medically fragile. We have used Amicar to decrease blood loss since 2001. As an effort to further reduce blood loss and transfusions, we use a bipolar sealer device (Aquamantys) as an adjunct to electrocautery. We present the results of our first 64 neuromuscular patients to show the efficacy of the device. Using a prospectively maintained database we reviewed the operative time, estimated perioperative blood loss, cell saver use, and intraoperative and postoperative transfusion rate in patients who underwent posterior spinal fusion for neuromuscular scoliosis. Sixty-four patients were identified who fit these criteria since the use of the bipolar sealer device was instituted.We compared these patients with a control group of the preceding 65 patients in whom this device was not used for hemostasis. All patients, including those in the study group, received Amicar (infusion of 100 mg/kg over 15 to 20 min, then 10 mg/kg/h throughout the remainder of the procedure). The surgical technique did not differ between the 2 groups. Baseline characteristics between the 2 groups were similar except for the number of patients having an all-screw construct which was larger in the investigational group (25% vs. 8%, P=0.03). There were no significant differences in operative time or duration of hospital stay. Intraoperative blood loss was lower in the study group (741 mL) as compared with the control group (1052 mL, P=0.003). Total perioperative blood loss, however, showed no significant difference. Thirty-five (55%) patients in the study group and 50 (77%) patients in the control group required additional intraoperative or postoperative transfusions (P=0.01). The number of packed red cell units transfused per patient was 0.81 in the study group and 1.57 in the control group (P=0.001). Although the intraoperative cell saver transfusion was same, the total blood volume transfused, which includes cell saver and any other transfusions, was significantly lower in the study group, 425 mL versus 671 mL (P=0.002). Use of a bipolar sealer device in posterior spinal fusion for neuromuscular scoliosis significantly reduced intraoperative blood loss and transfusion rate when compared with a control group in this retrospective review. Level III-retrospective comparative study.

Total Pericystectomy in Liver Echynococcal Cysts Using Bipolar Sealing Coupled with Saline Device

Total Pericystectomy in Liver Echynococcal Cysts Using Bipolar Sealing Coupled with Saline Device

Estimating the Learning Curve of a Novel Medical Device: Bipolar Sealer Use in Unilateral Total Knee Arthroplasties

BackgroundThe use of cost-effectiveness analysis for medical devices has proven to be challenging because of the existence of the learning effects in the device-operator interactions. The need for the relevant analytical framework for assessing the economic value of such technologies has been recognized. ObjectivesTo present a modified difference-in-differences (DID) cost-effectiveness methodology that facilitates visualization of a new health technology’s learning curve. MethodsUsing the Premier Perspective database (Premier Inc., Charlotte, NC), we examined the impact of physicians adopting a bipolar sealer (BPS) to control blood loss in primary unilateral total knee arthroplasties on hospital lengths of stay and total hospitalization costs when compared with two control groups. In our DID approach, we substituted month-from-adoption for the calendar-month-of-adoption in both graphical representations and ordinary least-squares regression results to estimate the effect of the BPS. ResultsThe results clearly demonstrated a learning curve associated with the adoption of the BPS technology. Although the reductions in length of stay were immediate, the first postadoption year costs increased by $1335 (extrahospital controls) to $1565 (within-hospital controls). Importantly, and also consistent with a learning curve hypothesis, these initial higher costs were offset by subsequent cost savings in the second and third years postadoption. ConclusionsThe presented modified DID approach is a suitable and versatile analytical tool for economic evaluation of a slowly diffusing medical device or health technology. It provides a better understanding of the potential learning effects associated with relevant interventions.