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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

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

BACKGROUND: The 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. OBJECTIVES: To present a modified difference-in-differences (DID) cost-effectiveness methodology that facilitates visualization of a new health technology's learning curve. METHODS: Using 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. RESULTS: The 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. CONCLUSIONS: The 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.

Reduced blood loss and operation time in lumbar posterolateral fusion using a bipolar sealer.

PURPOSE: A bipolar sealer using Transcollation® technology, a combination of radiofrequency energy and saline, can provide hemostasis at 100 °C, which is lower than that used in standard electrocautery. Previous studies of joint arthroplasty have shown that use of the bipolar sealer reduces blood loss and tissue damage during the operation. However, it is unknown whether a bipolar sealer reduces blood loss and tissue damage in lumbar posterolateral fusion (PLF) surgery. The purpose of this study was to analyze the efficacy of this device in limiting blood loss during exposure of the lumbar spine in the treatment of PLF and postoperative pain. METHODS: Fifty patients who underwent PLF were prospectively enrolled between October 2011 and March 2013. Twenty-five patients were randomized to the bipolar sealer group (BS group) and 25 patients to the standard electrocautery group (control group). Operative time and blood loss during exposure of posterior bony elements including the transverse process for PLF, visual analog scale (VAS) to quantify postoperative pain, and the interval from the surgery to hospital discharge were compared. RESULTS: Operative time and blood loss expressed per level of exposure were significantly lower in the BS group than in the control group. There was a tendency toward a lower VAS at postoperative week 1 in the BS group. The duration of hospitalization was 15 and 26 days in the BS and control groups, respectively. CONCLUSIONS: A large randomized control trial adjusted for the number of fusion levels and body mass index is required to confirm the novelty value of this new bipolar sealers.

The efficacy of bipolar sealer on blood loss in spine surgery: a meta-analysis.

OBJECTIVE: The purpose of this meta-analysis of randomized controlled trials (RCTs) and non-RCTs was to gather data to evaluate the efficacy and safety of bipolar sealer versus standard electrocautery in the management of spinal disease. METHODS: The electronic databases including Embase, PubMed and Cochrane library were searched to identify relevant studies published from the time of the establishment of these databases up to January 2017. The primary outcomes were total blood loss, requirement of transfusion (rate and amount), and operation time. The secondary outcomes were length of hospital stay and postoperative wound infection. Data analysis was conducted with RevMan 5.3 software. RESULTS: A total of five studies involving 500 patients (261 patients in the BS group and 239 in the control group) were included in the meta-analysis. The pooled results revealed that application of bipolar sealer could decrease the total blood loss in spine surgery [WMD = -467.49, 95% CI (685.47 to -249.51); p < 0.05; I 2 = 91%]. Compared with standard electrocautery, bipolar sealer was associated with lower rates of need for transfusion [OR = 0.30, 95% CI (0.16-0.55), p < 0.05; I 2 = 0%]. In addition, patients in the BS group were likely to receive less amount of blood transfusion compared with patients in the control group[WMD = -0.73, 95% CI (-1.37 to -0.09), p < 0.05; I 2 = 76%]. The mean operative time was shorter in the BS groups compared with the control group [SMD = -0.36, 95% CI (-0.60 to -0.13), p < 0.05; I 2 = 0%]. There was no significant difference in terms of length of hospital stay [WMD = -0.73, 95% CI (-1.96 to 0.51), p = 0.25; I 2 = 67%] and postoperative wound infection [OR = 0.88, 95% CI (0.31-2.48), p = 0.81; I 2 = 0.0%] between both groups. CONCLUSIONS: The available evidence suggests that bipolar sealer is superior to standard electrocautery with less blood loss, shorter operation time and less transfusion requirement. There is no significant difference between both groups regarding length of hospitalization and wound infection. Hence, bipolar sealer is recommended in spine surgery. Because of the limitation of our study, more well-designed RCTs with large sample are required to provide further evidence of safety and efficacy between bipolar sealer and standard electrocautery in the treatment of spinal disease.

No Effect of a Bipolar Sealer on Total Blood Loss or Blood Transfusion in Nonseptic Revision Knee Arthroplasty-A Prospective Study With Matched Retrospective Controls.

BACKGROUND: Postoperative anemia is frequent after revision of total knee arthroplasty (TKA) with reported transfusion rates up to 83%. Despite increased efforts of reducing blood loss and enhancing fast recovery within the fast-track setup, a considerable transfusion rate is still evident. The aim of this study was therefore to evaluate the effect of a bipolar sealer on blood loss and transfusion in revision TKA. METHODS: In this single-center prospective cohort study with retrospective controls, 51 patients were enrolled in a fast-track setup for revision TKA without the use of a tourniquet. Twenty-five prospectively enrolled patients received treatment with both a bipolar sealer and electrocautery, whereas 26 patients had received treatment with a conventional electrocautery only in the retrospective group. RESULTS: No significant differences were found neither for calculated blood loss, with 1397 (standard deviation, ± 452) mL in the bipolar sealer group vs 1452 (SD, ± 530) mL in the control group (P = .66), nor for blood transfusion rates of 53% and 46% (P = .89), respectively. Four controls were readmitted within 90 days follow-up. CONCLUSION: The use of a bipolar sealer in a TKA revision setting without the use of a tourniquet did not reduce blood loss or blood transfusion rates.

The feasibility of bipolar tissue sealer for appendix stump closure.

BACKGROUND: Appendiceal stump closure is a highly important step in laparoscopic appendectomy, especially for post-operative complications. The aim of this study is to compare the effects of suture ligation and bipolar tissue sealer techniques on burst pressure using flesh appendectomy specimens. MATERIAL AND METHODS: Appendectomy specimens of 32 patients with grade I-II disease were included in the study. Perforated or necrotic appendices and specimens ineligible for pressure measurement were excluded from the study. Appendiceal stumps of 16 patients in group 1 were double-ligated with 2/0 polyglactin sutures, then appendectomy was performed between these sutures. In group 2, the management of the stump was performed through single ligation with polyglactin suture, followed by appendectomy using a bipolar tissue sealing device. Burst pressures were recorded for all specimens. RESULTS: There were no differences between groups in terms of age and sex. There was no significant difference between the two groups in terms of burst pressure (p = 0.92). Also, no significant difference was found between groups in terms of localization of the perforation (p > 0.05). CONCLUSION: Bipolar tissue sealer achieves safe stump closure with satisfactory burst pressure values. Based on this, using bipolar tissue sealer for appendiceal stump closure in appendicitis may be safe and reliable.

Comparison of the Unipolar Electrocautery and the Bipolar Sealer in Reducing Blood Loss in Total Knee Arthroplasty: A Prospective, Randomized, Noninferiority Study.

Background: This was a noninferiority trial to evaluate blood loss during total knee arthroplasty (TKA) when using the unipolar electrocautery system compared to the saline coupled bipolar sealer system in primary TKA. Methods: One hundred sixty-four patients were randomly assigned by a 1:1 ratio to either the unipolar electrocautery system (N = 82) or bipolar sealer system (N = 82). Inclusion criteria included patients scheduled for primary unilateral TKA, preoperative hemoglobin ≥11 mg/dL, preoperative platelet count ≥150,000, age >18 years, and patient willing to complete all study-related procedures. The primary efficacy outcome was estimated blood loss on morning of postoperative day. Secondary efficacy outcomes were comparison between the preoperative hemoglobin and postoperative day 1 hemoglobin, and allogeneic blood transfusions. Additionally, the study collected objective and functional outcomes using the postoperative 2011 Knee Society Score. Results: The unipolar electrocautery system was not found to be less efficacious than the bipolar sealer system. Mean blood loss for the unipolar electrocautery system was 1062.0 cubic centimeters (cc) (95% confidence limit for the mean: 985.2, 1138.7), and for the bipolar sealer system was 929.4 cc (95% confidence limit for the mean: 841.9, 1016.8). The mean difference in blood loss was 132.6 cc, below the margin of inferiority set at 200 cc. Additionally, there was no difference in patient outcomes as measured by the Knee Society Score. Conclusions: The safety, efficacy, and outcomes profile of the unipolar electrocautery system compared to the bipolar sealer system were similar. Use of the bipolar sealer system significantly increases surgical cost without any added benefits.

Randomized blinded study comparing a bipolar sealer and standard electrocautery in reducing transfusion requirements in anterior supine intermuscular total hip arthroplasty.

Managing blood loss in total hip arthroplasty (THA) minimizes complications and decreases cost. Tissue-sparing anterior supine intermuscular THA (ASI-THA) may offer a quicker recovery but increases blood loss and transfusion requirements. This double-blinded prospective study compared a bipolar sealer (Aquamantys 6.0 bipolar sealer) to standard monopolar electrocautery in reducing blood loss in ASI-THA. Differences in calculated actual blood loss (ABL), hemoglobin, and transfusion requirements were examined. One hundred hips were randomized to each group. Transfusion rates were similar, 6% and 4%, respectively (p>0.05). ABL and change in hemoglobin were identical (1.35 and 3.3g). No significant differences in transfusion, blood loss, or hemoglobin were seen with a bipolar sealer device. Routine use of this bipolar sealer device has been discontinued in ASI-THA.

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

Introduction: 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. Methods: 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). Results: 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 ± 1.42 days; 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 2 weeks (p = 0.903), 1 month (p = 0.973), 3 months (p = 0.983), or 5 months (p = 0.983) post-operatively. TRLB and TR had comparable improvement in ΔKOOS from baseline to 12 weeks 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). Conclusion: 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.

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.

The use of Transcollation Technology for Video-Assisted Thoracic Surgery lobectomy.

BACKGROUND: Video-Assisted Thoracic Surgery (VATS) lobectomy is now considered the preferred approach at many centers for early stage lung cancer. However, it needs an adequate learning curve, and it may be challenging in non-expert hands. The aim of this study was to evaluate the effectiveness of Transcollation Technology over Traditional Electrocautery to perform hilar and mediastinal dissection during VATS lobectomy. METHODS: This is a single-center retrospective study including consecutive patients undergoing VATS lobectomy for lung cancer. Patients were divided in two groups based on whether Transcollation Technology (TT Group) or Traditional Electrocautery (TE Group) was used for hilar and mediastinal lymphadenectomy. Operative time and surgical outcome, including number of transfusions, length of chest drainage, length of hospital stay, morbidity and mortality were registered, and the inter-group differences were statistically analyzed. RESULTS: 53 patients were included in the final analysis. The TT Group (n = 24) compared to the TE Group (n = 29) showed significant shorter operative time (75.2 ± 25.8 min versus 98.1 ± 33.3 min; p = 0.023), and reduction of length of chest tube stay (4.7 ± 0.8 days vs. 6.8 ± 1.1 days, p = 0.013) and length of hospital stay (5.3 ± 1.9 days vs. 6.8 ± 1.1 days, p = 0.007). No intraoperative or major postoperative complications were observed in either groups. CONCLUSIONS: Transcollation Technology represents a valid alternative to standard electrocautery instruments during VATS lobectomy. It contributes to reduce the operative time and length of hospital stay. Further larger prospective studies are required to confirm our data.

Stapleless laparoscopic sleeve gastrectomy. Preliminary report.

BACKGROUND: Laparoscopic sleeve gastrectomy (SG) as a single-stage procedure for the treatment of morbid obesity is becoming increasingly popular. In undeveloped countries, the linear staples required to create the sleeve are not always available because of their high cost. As an alternative to the staples, the bipolar vessel sealer device could be used in bariatric surgery to divide and temporarily seal the stomach. SETTINGS: Universidad Central de Venezuela, Caracas, Venezuela. METHODS: Between May 2015 and July 2016, 9 patients with a mean body mass index of 38.2 kg/m2 were submitted to a stapleless laparoscopic SG using the bipolar vessel sealer for the gastric division. The sleeve was performed over a 42 French bougie and closed with 2 layers of running sutures. Surgical time, morbidity, hospital stay, and excess weight loss were prospectively collected. RESULTS: Mean operative time and hospital stay were 117 min and 2.3 days. There was no major morbidity but 2 patients presented a basal atelectasis, which was solved by medical treatment without consequences. After a mean follow up of 6.8 months the mean excess weight loss was 78.4%. CONCLUSION: The technique of stapleless laparoscopic SG presented in this report is a valid alternative when these devices are not available. Large series with long-term follow-up are necessary to make definitive conclusions.

The efficacy and safety of using a bipolar sealer to prevent blood loss in spine surgery: A meta-analysis.

OBJECTIVE: The purpose of this systematic review and meta-analysis of randomized controlled trials (RCTs) and non-RCTs was to evaluate the effect of using a bipolar sealer to prevent surgical bleeding in spine surgery. METHODS: In June 2017, the PubMed, Embase, Cochrane controlled trials register, Web of Science, Google, and Chinese Wanfang databases were used to identify RCTs and non-RCTs comparing the effects of intraoperative placement of a bipolar sealer versus standard electrocautery with regard to blood loss and blood transfusion. Stata 12.0 software was used to perform the meta-analysis. Weighted mean differences with 95% confidential intervals (CIs) were used for continuous outcomes, and relative risks with 95% CIs were used for discontinuous outcomes. After testing for publication bias and heterogeneity across studies, the data were aggregated and assessed with a random effects model when necessary. RESULTS: In total, 6 clinical trials with 560 patients were included in this meta-analysis. The pooled results indicated that the use of a bipolar sealer decreased the estimated blood loss (MD = -165.06, 95% CI -236.73 to -93.40, P < 0.001), the need for a blood transfusion (RR = 0.46, 95% CI 0.31 to 0.68, P < 0.001), the transfusion units used (MD = -0.41, 95% CI -0.60 to -0.21, P < 0.001), the operative time (MD = -12.98, 95% CI -21.82 to -4.15, P = 0.004) and the length of hospital stay (MD = -2.77, 95% CI -5.45 to -0.10, P = 0.042). No significant difference was observed for the occurrence of infection (RR = 0.52, 95% CI 0.19 to 1.39, P = 0.192). CONCLUSION: Based on the current meta-analysis, the use of a bipolar sealer is superior to standard electrocautery for reducing intraoperative blood loss and is therefore recommend for use during spine surgery.

Hemostasis in endoscopic endonasal skull base surgery using the Aquamantys bipolar sealer: Technical note.

BACKGROUND: A major challenge during endoscopic transsphenoidal surgery is adequate intraoperative hemostasis. The Aquamantys® is a relatively new bipolar sealing device which uses radiofrequency energy and saline. This promotes hemostasis while decreasing charring and thermal spread. In this paper, we describe our experience with the Aquamantys® Mini EVS 3.4 Epidural Vein Sealer Bipolar Electrocautery System (Medtronic Advanced Energy, Portsmouth, NH, USA) during endoscopic surgery for tumors of the skull base with particular attention to ergonomic benefits and technical nuances. METHODS: We conducted a retrospective review of all patients undergoing endoscopic surgery for skull base tumors from September 2012 to June 2016 at our institution. All procedures used the Aquamantys® system. 45 cases were identified. RESULTS: Successful hemostasis was achieved in all cases with an average estimated blood loss (EBL) of 46mL (Range 10-250). There were no intraoperative complications. The single-shaft design allowed for excellent manipulation compared to pistol-grip bipolar forceps. The thermal energy provided excellent radial coverage without extensive penetration into viable pituitary tissue. CONCLUSION: To our knowledge, this is the largest series documenting the use of the Aquamantys® system in skull base surgery. The device is easily mobile and highly effective within the endonasal corridor and should be a tool in the repertoire of the endoneurosurgeon. Randomized control trials would be useful in comparing EBL between the Aquamantys® and standard bipolar electrocautery.

Secure, low-cost technique for laparoscopic hepatic resection using the crush-clamp method with a bipolar sealer.

INTRODUCTION: Laparoscopic hepatectomy is difficult because surgeons must perform the transection using many (four and more) energy devices and without direct manual maneuvers. Here we introduce hepatic transection by the classical method with a few (two or three) energy devices. MATERIALS AND SURGICAL TECHNIQUE: We performed laparoscopic hepatectomy for 40 patients with hepatic tumor and liver dysfunction. For parenchymal transection, we used bipolar radiofrequency coagulation forceps connected to a voltage-controlled electrosurgical generator and ultrasonic dissector. The demarcation of the liver surface was made by an ultrasonic dissector. Along the demarcation line, the blades of a BiClamp were opened slightly and inserted into the hepatic parenchyma. We clamped slowly, softly, and gradually, and a small amount of hepatic parenchyma was consequently coagulated and fractured. After the crush, the small vessels and intrahepatic bile duct that were sealed were left as atrophic strings, and the strings were divided by an ultrasonic dissector. Large vessels and Glisson's sheaths were left because of the small clamp. Large Glisson's sheaths and hepatic veins were ligated with a titanium clip or autosutures, and cut without bile leakage or bleeding. The mean operation time of the procedure was 196.9 min, mean blood loss was 69.9 mL, and mean postoperative hospitalization was 9.5 days. No blood transfusions were needed. Two cases had perioperative complications-one involving right shoulder pain and the other involving ascites due to liver dysfunction-but there were no serious postoperative complications. DISCUSSION: The present results appear to demonstrate that this simple and safe method helps decrease intraoperative bleeding and shorten hospital stay.

Effects of tranexamic acid and bipolar sealer alone or in combination in primary total knee arthroplasty: a prospective, randomized, controlled trial.

BACKGROUND: The purpose of this study was to compare 2 blood management interventions, tranexamic acid (TXA) and bipolar sealer system (BSS) used independently or in combination with a control group during primary total knee arthroplasty (TKA). METHODS: A total of 127 TKA patients were enrolled and randomized into 4 groups: Intravenous TXA plus the BSS (N = 29, group 1); TXA only (N = 29, group 2); BSS only (N = 31, group 3); and intravenous normal saline as a control group (N = 32, group 4). RESULTS: Changes in hemoglobin from baseline to postoperative follow-up were significantly lower among patients who received TXA plus BSS and those receiving TXA only when compared with the control. BSS only did not differ significantly when compared to the control group. In addition, TXA plus BSS was as efficacious as TXA only in preserving postoperative hemoglobin. CONCLUSIONS: In other terms, using bipolar sealer did not add to the effect of TXA in reducing the postoperative hemoglobin drop in primary TKA.