Search

The Hem-o-lok Weck clip is part of a polymer locking ligation system often employed for hemostasis in surgical practices. Its use is routine in a wide array of surgical subspecialties. Surgeons have limited options in removing these clips when they are aberrantly positioned. Herein, we describe a novel, cost-effective approach for removing a Hem-o-lok clip using standard robotic instruments. This simple approach will allow surgeons to remove a Hem-o-lok clip precisely and quickly if it is not adequately placed. During a routine robotic-assisted laparoscopic prostatectomy a Hem-o-lok Weck clip was noted to be in juxtaposition to the rectal wall, and it was deemed appropriate to remove it. Ultimately, the indwelling Prograsp forceps was moved from the right fourth arm position to the left arm position. This allowed the Prograsp forceps to compress the scissors in the right hand port, which was insufficient in cutting the hinge of the clip. This provided sufficient force to cut through the clip at its hinge with ease. The Hem-o-lok Weck clip is used in various surgical specialties. It is occasionally placed suboptimally and requires removal. Given the challenge of finding and using the clip removal device, surgeons should be aware of this simple and cost-effective way of removing a Hem-o-lok clip if desired.

Objective: The primary training in any surgical practice starts with tissue handling and effective hemostasis. Neurosurgical procedures start with an incision in the scalp and require summative use of mechanical hemostats and bipolar coagulation to achieve hemostasis. Though Raney clips are the most popular and effective in maintaining hemostasis, their high cost and nonreusability become deterrents for routine use in resource-stricken environments., Methods: We have compared stationery binder clips of different sizes with Raney clips on the parameters of effectiveness, availability, and cost. Binder clips were also used in intraoperative settings for scalp hemostasis. The comparative efficacy, additional usage of cautery, and need for sterilization are also discussed., Results: We describe our experience with simple stationery metal binder clips in maintaining effective hemostasis in a cost-effective manner. The 25-mm size binder clip exerts same force as a Raney clip without any tissue injury. Practical application revealed effective scalp hemostasis up to blood pressure of 150 mm Hg., Conclusions: Stationery binder clips are a cost-effective, ready-to-use alternative for standard Raney clips., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to evaluate the efficacy and safety of the harmonic scalpel compared to the conventional technique in patients submitted to total thyroidectomy., Method: This is a systematic review with inclusion of randomized controlled trials (RCTs) that compared both techniques. An electronic search was carried out in the Medline and Lilacs databases until June 2017. The outcomes analysed were operation time, intraoperative bleeding, surgical morbidity, and costs., Results: Data from 31 primary studies were included. The use of the harmonic scalpel correlates to a shorter operation time (p <0.001) and a lower volume of intraoperative bleeding (p <0.001). There were no differences in the risk of transient (p = 0.53) and permanent (p = 0.70) hypocalcaemia, transient (p = 0.61) and permanent (p = 0.50) dysfunctions of the inferior laryngeal nerve and hematoma (p = 0.14)., Conclusion: Total thyroidectomy using a harmonic scalpel is effective and safe compared to the conventional technique.

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., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background: Flowable haemostatic agents have been shown to be superior to non-flowable agents in terms of haemostatic control and need for transfusion products in patients undergoing cardiac surgery. We investigated the economic impact of the use of a flowable haemostatic agent (Floseal) compared with non-flowable oxidised regenerated cellulose (ORC) agent in primary elective cardiac surgery from the perspective of the UK National Health Service (NHS)., Methods: A cost-consequence framework based upon clinical data from a prospective trial and an observational trial and NHS-specific actual reference costs (2016) was developed to compare the economic impact of Floseal with that of ORC. The individual domains of care investigated comprised complications (major and minor) avoided, operating room time savings, surgical revisions for bleeding avoided and transfusions avoided. The cost impact of Floseal versus ORC on ICU days and extended bed days avoided was modelled separately., Results: Compared with ORC, the use of Floseal would be associated with overall net savings to the NHS of £178,283 per 100 cardiac surgery patients who experience intraoperative bleeding requiring haemostatic therapy. Cost savings were apparent in all individual domains of care (complications avoided: £83,536; operating room time saved: £63,969; surgical revisions avoided: £34,038; and blood transfusions avoided: £22,317). Cost savings per 100 patients with Floseal over ORC in terms of ICU days avoided (n = 30) and extended bed days avoided (n = 51.7) were £57,960 and £21,965, respectively. A sensitivity analysis indicated that these findings remained robust when the model parameters representing the clinical benefit of Floseal over ORC were reduced by up to 20%., Conclusions: Despite higher initial acquisition costs, the use of flowable haemostatic agents achieves substantial cost savings over non-flowable agents in cardiac surgery. These cost savings commence during the operating theatre and appear to continue to be realised throughout the postoperative period.

Introduction: The aim of this clinical control trial is to analyze the cost-effectiveness and to understand the efficacy of the HARMONIC FOCUS®+ (Ethicon Inc., Somerville, New Jersey) scalpel as the only system to cut and coagulate in thyroidectomy., Materials and Methods: One hundered patients of the thyroid clinic of the Mexico City General Hospital were included. All patients underwent surgery and were divided into two randomized groups. In Group 1, the HARMONIC scalpel was the only device used for cut and coagulate (50 patients), and in Group 2 clamp, tie, and electrocautery (50 patients) were used. Surgical bleeding, operative time, complications, diagnosis, thyroid size, and hospital stay were evaluated in both groups. The statistical analysis was done using central trend measurements, Student's t-, chi-squared, and Fisher's exact test, with a significance level of p < 0.05. The cost-effectiveness analysis was completed by determining the total cost of the surgical procedure per hour in US dollars, and the evolution to compare efficacy will be the number of re-interventions due to postoperative bleeding., Results: The use of the HARMONIC scalpel in thyroid surgery had the same results as the traditional method when comparing complications, reoperation, hospital stay, and hypoparathyroidism. In total thyroidectomy patients, the bleeding in Group 1 was 55.16ml ( ± 32.97) and 85.4ml ( ± 69.41) in Group 2 , p=0.034. Operative time in Group 1 was 74.6 minutes (± 23.39) and 104.09 minutes (± 34.66) in Group 2, p= 0.0001. In both groups, there were no statistical differences in lobectomy. Cost-effectiveness analysis implies an adequate hemostasis if we are using a hemostatic device, and above all, the avoidance of a re-intervention due to hematoma, and the cost-effectiveness with regard to the re-intervention as a result of a hematoma implies that $161 US more is spent for each re-intervention., Conclusion: The utilization of the HARMONIC scalpel device is similar to the traditional technique of ligature and knots as far as cost-effectiveness is concerned, due to the fact that the greater expense of the device is compensated by the lower expense in time and surgical re-intervention.

Background: In recent years, several publications have shown that new adhesives and sealants, like Tissucol(®), applied in thyroid space reduce local complications after thyroidectomies., Study Aims: To demonstrate the effectiveness of fibrin glue Tissucol(®) in reducing the post-operative hospital stay of patients operated on for differentiated thyroid carcinoma in which total thyroidectomy with central and unilateral node neck dissection was performed (due to the debit drains decrease), with consequent cost savings., Material and Methods: A prospective randomised study was conducted during the period between May 2009 and October 2013 on patients with differentiated thyroid carcinoma with cervical nodal metastases, and subjected to elective surgery. Two groups were formed: one in which Tissucol(®) was used (case group) and another where it was not used (control group). Patients were operated on by surgeons specifically dedicated to endocrine surgical pathology, using the same surgical technique in all cases., Results: A total of 60 total thyroidectomies with lymph node dissection were performed, with 30 patients in the case group, and 30 patients in control group. No statistically significant differences were observed in most of the studied variables. However, the case group had a shorter hospital stay than the control group with a statistically significant difference (p<0.05)., Conclusion: Implementation of Tissucol(®) has statistically and significantly reduced the hospital stay of patients undergoing total thyroidectomy with neck dissection, which represents a significant reduction in hospital costs. This decrease in hospital stay has no influence on the occurrence of major complications related to the intervention., (Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.)

Background: Reduction of blood transfusion in cardiac surgery is an important target. The aim of this study was to investigate the cost-effectiveness of the use of CryoSeal®, an allogeneic single-donor fibrin sealant, in patients undergoing coronary artery bypass grafting (CABG)., Methods: This randomized clinical study involved seven cardiac surgery centres in the Netherlands. Patients undergoing elective isolated CABG with the use of at least one internal thoracic artery (ITA) graft were assigned randomly to receive either CryoSeal® (5 ml per ITA bed) or no CryoSeal®. Primary efficacy endpoints were units of transfused red blood cells, fresh frozen plasma and platelet concentrates, and duration of intensive care unit stay. Secondary efficacy endpoints were 48-h blood loss, reoperation for bleeding, mediastinitis, 30-day mortality and duration of hospital stay., Results: Between March 2009 and January 2012, 1445 patients were randomized. The intention-to-treat (ITT) population comprised 1436 patients; the per-protocol (PP) population 1292. In both the ITT and the PP analysis, no significant difference between the treatment groups was observed for any of the primary and secondary efficacy endpoints. In addition, no significant difference between the groups was seen in the proportion of transfused patients. Estimated CryoSeal® costs were €822 (95 per cent c.i. €808 to €836) per patient, which translated to €72,000 per avoided transfusion (unbounded 95 per cent c.i.)., Conclusion: The use of the fibrin sealant CryoSeal® did not result in health benefits. Combined with the high cost per avoided transfusion, this study does not support the implementation of routine CryoSeal® use in elective isolated CABG., Registration Number: NTR1386 ( http://www.trialregister.nl)., (© 2015 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Purpose: Trauma and complex cardiac surgery are associated with a high risk of bleeding complications. The difference in costs between patients who require bleeding control measures and those who do not is poorly understood. Our goal was to assess the cost of care and outcomes for patients in these settings., Methods: Patients >18 years of age, who were discharged between January 2010 and December 2012, were retrospectively identified in the Premier Hospital Database based on International Classification of Disease, Ninth Revision codes. These patients were categorized as having received blood products ("bleeding patients") or not ("nonbleeding patients"). Patients with costs and length of stay (LOS) of zero were excluded. Differences in treatment costs and outcomes were assessed using univariate analysis and multivariate modeling., Findings: Bleeding trauma patients (n = 8800) had a 150% higher total cost of care (P < 0.001; 146% after excluding costs of agents used for bleeding control, P < 0.001), an 81.3% longer hospital LOS (P < 0.001), and a 65.2% longer intensive care unit (ICU) LOS (P < 0.001) than nonbleeding patients (n = 53,727). Bleeding complex cardiac surgery patients (n = 82,832) had a 133.2% higher total cost of care (P < 0.001; 128.7% after excluding costs of agents used for bleeding control, P < 0.001), a 155.6% longer hospital LOS (P < 0.001), and an 89.3% longer ICU LOS (P < 0.001) than nonbleeding patients (n = 380,902)., Implications: Trauma and cardiac surgery patients who experienced bleeding and received allogeneic blood product transfusions had significantly worse outcomes, including longer LOS, greater inpatient mortality, and higher costs of care (even when excluding costs of agents used for bleeding control) than those who did not., (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Thyroidectomy is the most frequently performed endocrine surgery, and in recent years, the surgical instruments and techniques used in this surgery have greatly evolved. New devices are created to facilitate dissection, haemostasis increasing the intraoperative cost., Material and Method: We prospectively examined patients undergoing to traditional thyroidectomy using reusable vs disposable devices (BiClamp 150, ERBE ® - group A vs. Harmonic Focus, ETHICON® - group B). The patients were treated for benign and malignant diseases from two experienced surgeons. The two groups were separated based on age, sex, skin-to-skin operative time, the number of parathyroid glands identified by the surgeon during the operation, preand post-operative serum calcium levels evaluated with PTH until 24 hours after surgery, the mean hospital stay, the evaluation of the content of the drainages at 6 hours and 24 hours, and the thyroid gland volume calculated via ultrasound preoperatively. The patients were asked to complete a form at 24 hours post-op to self-evaluate dysphagia to liquids and pain on a scale from 0 to 10., Results: The patients analysed were 80 pts. Analysis of the data showed no significant differences between the groups with respect to age, (p = 0:48), or gender, 9 males and 31 females in group A and 8 males and 32 females in group B.The thyroid volume (in ml), calculated on the basis of preoperative ultrasonography, was 43.89 ± 37.10 in group A vs. 54.54 ± 51.92 in group B (p = 0.35). The skin-to-skin operative time was equal to 50.16 ± 10.43 min.vs. 52.39 ± 11:54 min.(p = 0.36) in groups A and B, respectively. No statistically significant differences in pre e postoperative calcium levels. The amount of drainage at 6 hours after surgery was 16.63 ± 15.24ml. in group A and 23.72 ± 21.93ml. in group B (p = 0.07). At 24 hours after surgery, the amount was 57.84 ± 32.56ml. in group A and 66.79 ± 39.94ml. in group B (p = 0.28). For group A and group B, we analysed dysphagia for liquids on a scale from 0 to 10 (4.5 ± 2.35 vs. 4.18 ± 2.4, p = 0.48, respectively), alterations in patients' tone of voice (1.97 ± 2.51 vs. 1.43 ± 0:48, p = 0.29, respectively), and postoperative pain at 24 hours after surgery (2.76 ± 1.99 vs. 2.68 ± 2.12, p = 0.87, respectively). The average cost for group A was equal to € 25 × 40 = 1000 vs. € 450 × 40 = 18000 for Group B. The hospital stay in days was equal to 1.70 ± 0.46 (Group A) vs. 1.66 ± 0.53 (Group B) (p = 0.69)., Conclusions: One limitation of the current study is its small sample size. Both devices are effective and safe for total thyroidectomy because they have similar effects on the operative time, postoperative bleeding and patient outcomes in endocrine experienced surgical team. On the other hand, in a time of the spending review and the standardisation of surgical techniques to ensure the highest quality of services offered, the BiClamp is a viable alternative tool with a high security standard and low cost that offers significant savings to the health care system., Key Words: Energy devices, Health care, Thyroidectomy.

Aim: The aim of this study was to evaluate the efficacy and cost-effectiveness of fibrinogen/thrombin-coated collagen patch (FTCCP)(TachoSil®) during intraoperative hemostasis in patients with congenital heart disease, who required a reoperation during childhood., Methods: We reviewed data on the intraoperative blood product requirements and hospital costs of children (age <16 years) who underwent a reoperation for treating their congenital heart disease between January 2009 and December 2011., Results: One-hundred and seventeen patients were included. Median age at surgery was 2.1 years (range 3 days-14.1 years). Main causes of intraoperative bleeding were: 1) reinforcement of suture lines (106 patients, 90.6%); 2) lung lesions (5 patients, 4.2%); 3) epicardial lesions (3 patients, 2.6%); and 4) chest wall lesions (3 patients, 2.6%). At logistic regression the amount of packed red blood cells (PRBC) requirement was significantly higher in patients with preoperative cyanosis (P=0.008, OR=3.85) and in patients who required the use of cardiopulmonary bypass (P=0.005, OR=21.19). The use of FTCCP (N.=90 patients) as first line treatment was significantly associated with a lower PRBC requirement (P=0.0003, OR=0.1) which in addition to the avoidance of other hemostatic/sealant agents, leads to lower hospital cost., Conclusion: FTCCP is an effective hemostatic agent which can be safely used during the hemostasis of children requiring reoperations for their congenital heart malformations. When used as first line treatment, with specific indications, FTCCP limited the intraoperative PRBC requirement and the use of other hemostatic/sealant agents thus reducing hospital costs.

Pancreatoduodenectomy is an exceptional procedure that requires an extensive dissection of the supramesocolic region extended to the first jejunal limb. Lymphadenectomy, required for cancer, increases the dissection surface. The extensive preparation of the area is traditionally conducted with bipolar ormonopolar instruments, while clips, ligatures, and sutures are used for haemostasis. LigaSure™ vessel sealing(LSVS; Valleylab, Boulder, CO) is a technology that obtains vessel closure by using the body's own collagen and elastin to create a permanent fusion zone. This is obtained by a combination of forceps pressure and radio frequency. This effect has been improved by the introduction of the Force Triad™ (Valleylab, Boulder,CO) energy platform, controlled by TissueFect™ (Valleylab, Boulder, CO) sensing technology. With this device, the surgeon is able to fuse vessels up to 7 mm, lymphatics, tissue bundles, and pulmonary vasculature in a fast-seal cycle of almost 4 seconds. In our daily practice of open surgery we observe a rapid improvement of abdominal drainage output with a drastic reduction of protein loss. Its practical significance is, in our opinion, that we obtain a rapid recovery of normal serum protein levels with a low number of blood/plasmasac transfusions and a real improvement of anastomosis healing. Moreover, the efficacy and the speed of work of the device allow us to reduce the operating time significantly but safely. We performed a retrospective analysis of the data of 20 pancreatic resections conducted both with traditional dissection and with the Liga-Sure Impact device with Force Triad platform in order to verify whether observed data were real. Our clinical results show that the use of the LigaSure Impact device with Force Triad energy platform is really useful in open surgery to save operating time, number of postoperative days, and hemoderivate administration.

Blood conservation with saline-coupled bipolar sealing devices in primary total knee arthroplasty (TKA) has had mixed results. Moreover, investigators have not studied these devices in infected TKA cases in which conventional methods of blood management cannot be used. We conducted a single-surgeon, case-control study to evaluate how the choice of an electrocautery device affects total blood loss, transfusion requirements, and total cost in revision TKA for infection. Each of the 80 patients in the study had an infected TKA and underwent surgery that involved the use of a saline-coupled bipolar sealing device at our institution. Results were compared with those of a control group of 40 patients immediately predating use of this device. Groups were matched for age, body mass index, American Society of Anesthesiologists (ASA) classification, and surgery type. We then compared the groups on multiple variables, including total blood loss, transfusion requirements, operative time, and hemoglobin decrease. The groups did not differ with respect to blood loss or transfusion requirements. However, operative time was significantly lower in the bipolar sealer group. This difference translated to an average net additional cost of about $70 per case. Given the results of this study, use of a saline-coupled bipolar sealing device in patients with infected TKAs is not clinically or economically justified.

Conventional hemostatic technologies utilized in thyroid surgery include clamp-and-tie, clips and monopolar and bipolar diathermy. Over the last decade, there has been a major shift towards utilizing newer hemostatic technologies, most notably the electrothermal bipolar vessel sealing systems (EBVS) and the Harmonic Scalpel (Ethicon Endosurgery, OH, USA), for thyroid surgery. Since the first report of EBVS thyroidectomy in 2003, more than 50 studies have been published evaluating EBVS utilization for thyroid surgery. In addition to providing a historical perspective and exploring the principles of EBVS technology, this review aims to evaluate the current published data regarding EBVS utilization for thyroid surgery. In particular, a focus is given to LigaSure (Covidien, Dublin, Ireland) technology because it has been studied most thoroughly in the literature. This review will also evaluate studies comparing the EBVS with Harmonic Scalpel technology for thyroid surgery.

Background: Perioperative hemorrhage and postoperative bile leakage are severe complications of liver surgery. They may be related to the techniques used to divide the tissue. We designed a randomized clinical trial to compare the cavitron ultrasonic surgical aspirator (CUSA) and an endoscopic stapler device applied in routine clinical hepatic surgical practice., Methods: All consecutive patients admitted for elective hepatic resective surgery--at least bisegmentectomy of the liver--were assessed for enrollment in the study. A total of 100 patients were subsequently randomized. There was a good balance between the study groups concerning issues that may be of relevance for the perioperative and postoperative courses. The primary objective of the study was to achieve an approximately 25 % reduction in perioperative blood loss and postoperative bile leakage. Secondary outcome variables were operating time, general postoperative morbidity, length of hospital stay, and direct medical costs., Results: The amount of perioperative or postoperative blood loss did not differ significantly between the two groups. We observed a trend toward shorter transection and operating time for patients in whom staplers were used, but the difference did not reach statistical significance. The postoperative courses were close to identical in the respective study arms with no difference in bile leakage rates or in the total morbidity profiles. The direct medical costs were nonsignificantly lower in the group where staplers were used for liver transection., Conclusions: The results show that the use of endoscopic vascular staplers in liver surgery is feasible and safe. It offers an attractive alternative for division of the liver parenchyma during routine hepatic surgery, being comparable to the use of CUSA without adding extra costs.

Finger tourniquets are used in a variety of operative procedures in both the trauma and elective setting. A wide range of methods are used in clinical practise as there is no standardised method. Many of the methods in use have significant drawbacks such as the inability to exsanguinate the digit or the more concerning problem of inadvertently leaving the tourniquet on the digit on completion of the procedure. We discuss two techniques that are quick, cheap and easy that do not have these drawbacks. There is a brief discussion of the literature assessing the various attributes of published methods. We feel that the adoption of these methods could result in easier and safer finger exsanguination and haemostasis.

Background: Adequate hemostatic techniques are essential for optimal intra- and postoperative results. A number of different hemostatic techniques and devices have been developed over the past few years, but which device should be preferred during laparoscopic and open abdominal procedures?, Methods: We conducted a systematic search for randomized controlled trials (RCTs) that compared the effectiveness and costs of vessel-sealing devices with those of other electrothermal or ultrasonic devices in abdominal surgical procedures., Results: Seven RCTs that included 554 patients met the inclusion criteria. Various procedures that used a vessel-sealing device (LigaSure™) (n = 264) were compared to ultrasonic devices (n = 139) and mono- (n = 20) or bipolar devices (n = 130). LigaSure was favored in two studies with respect to less blood loss, shorter operating time, and lower costs. However, no differences were observed in the other studies. Considering the relatively low number of complications, all hemostatic devices used may be considered relatively safe. None of the studies reported on quality of life or cost effectiveness., Conclusions: Vessel-sealing devices may be considered safe and their use may reduce costs due to reduced blood loss and shorter operating time in some abdominal surgical procedures compared to mono- or bipolar electrothermal devices. Wider-ranging RCTs of sufficient quality that assess (cost) effectiveness are required to make firm conclusions.

Background: The aim of the study was to evaluate the potential advantages of the ultrasonic scalpel compared with the conventional technique in gastric cancer surgery., Methods: Patients with resectable adenocarcinoma of the stomach were randomly assigned to ultrasonic scalpel or conventional technique. We used the HARMONIC FOCUS (Ethicon Endo-Surgery, Inc.) as ultrasonic scalpel., Results: Between February 2010 and December 2010, 60 patients with resectable gastric cancer were enrolled into the study. Operative time was significantly shorter with the ultrasonic arm than with the conventional arm (median 238.5 vs. 300.5 min; P = 0.0004). Blood loss was also significantly lower in the ultrasonic arm than in the conventional arm (median 351.0 vs. 569.5 ml; P = 0.016). Clavien-Dindo grades of postoperative complications were similar in the two groups. From a questionnaire survey of operators, the ultrasonic scalpel significantly reduced the stress of lymph node dissection (3.67 vs. 2.87; P = 0.0006). However, in assisting surgeons, the contributions to surgery, study, and technical improvement of the ultrasonic group were lower than in the conventional group., Conclusions: This study shows that the ultrasonic scalpel is a reliable and safe tool for open gastric cancer surgery.

Background: Numerous studies have supported the effectiveness of recombinant activated factor VII (rFVIIa) for the control of bleeding after cardiac procedures; however safety concerns persist. Here we report the novel use of intraoperative low-dose rFVIIa in thoracic aortic operations, a strategy intended to improve safety by minimizing rFVIIa exposure., Methods: Between July 2005 and December 2010, 425 consecutive patients at a single referral center underwent thoracic aortic operations with cardiopulmonary bypass (CPB); 77 of these patients received intraoperative low-dose rFVIIa (≤60 μg/kg) for severe coagulopathy after CPB. Propensity matching produced a cohort of 88 patients (44 received intraoperative low-dose rFVIIa and 44 controls) for comparison., Results: Matched patients receiving intraoperative low-dose rFVIIa got an initial median dose of 32 μg/kg (interquartile range [IQR], 16-43 μg/kg) rFVIIa given 51 minutes (42-67 minutes) after separation from CPB. Patients receiving intraoperative low-dose rFVIIa demonstrated improved postoperative coagulation measurements (partial thromboplastin time 28.6 versus 31.5 seconds; p=0.05; international normalized ratio, 0.8 versus 1.2; p<0.0001) and received 50% fewer postoperative blood product transfusions (2.5 versus 5.0 units; p=0.05) compared with control patients. No patient receiving intraoperative low-dose rFVIIa required postoperative rFVIIa administration or reexploration for bleeding. Rates of stroke, thromboembolism, myocardial infarction, and other adverse events were equivalent between groups., Conclusions: Intraoperative low-dose rFVIIa led to improved postoperative hemostasis with no apparent increase in adverse events. Intraoperative rFVIIa administration in appropriately selected patients may correct coagulopathy early in the course of refractory blood loss and lead to improved safety through the use of smaller rFVIIa doses. Appropriately powered randomized studies are necessary to confirm the safety and efficacy of this approach., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Re-exploration for bleeding after cardiac surgery is an indicator of substantial haemorrhage and is associated with increased hospital resource utilization. This study aimed to analyse the costs of re-exploration and estimate the costs of haemostatic prophylaxis., Methods: A total of 4232 patients underwent isolated, first-time, coronary artery bypass graft (CABG) surgery during 2005-8. Each patient re-explored for bleeding (n=127) was matched with two controls not requiring re-exploration (n=254). Cost analysis was based on resource utilization from completion of CABG until discharge. A mean cost per patient for re-exploration was calculated. Based on this, the net cost of prophylactic treatment with haemostatic drugs for preventing re-exploration was calculated., Results: Patients undergoing re-exploration had higher exposure to clopidogrel before operation, prolonged stays in the intensive care unit, and more blood transfusions than controls. The mean incremental cost for re-exploration was €6290 [95% confidence interval (CI) €3408-€9173] per patient, of which 48% [€3001 (95% CI €249-€2147)] was due to prolonged stay, 31% [€1928 (95% CI €1710-€2147)] to the cost of surgery/anaesthesia, 20% [€1261 (95% CI €1145-€1378)] to the increased number of blood transfusions, and <2% [€100 (95% CI €39-€161)] to the cost of haemostatic drugs. A cost model, at an estimated 50% efficacy for recombinant activated clotting factor VIIa and a 50% expected risk for re-exploration without prophylaxis, demonstrated that to be cost neutral, prophylaxis of four patients needed to result in one avoided re-exploration., Conclusions: The resource utilization costs were substantially higher in patients requiring re-exploration for bleeding. From a strict cost-effectiveness perspective, clinical interventions to prevent haemorrhage might be underutilized.

Background: Advanced vessel sealing devices provide an alternative to conventional ligation techniques for thyroidectomy. To date, most studies have been inadequately powered to explore differences in the infrequent post-operative complications following thyroidectomy. This study is designed to compare the outcomes of sutureless thyroidectomy and conventional thyroidectomy for recurrent laryngeal nerve (RLN) injury, permanent hypoparathyroidism, and haematoma formation., Methods: A cohort study of consecutive patients undergoing total thyroidectomy using conventional versus sutureless techniques was performed. Sutureless thyroidectomy was performed using either Ligasure Precise (Covidien) or Harmonic Focus (Johnson and Johnson) devices. The primary outcome measures were post-operative haemorrhage, permanent RLN injury and hypoparathyroidism. Secondary outcome measures were operative time, temporary hypoparathyroidism and vocal cord dysfunction. A cost minimization analysis comparing the two techniques was performed., Result: From January 2006 to July 2009, 1935 consecutive patients underwent total thyroidectomy. Of these, 772 underwent conventional thyroidectomy and 1163 were performed using a sutureless technique. The mean operative time was significantly lower in the sutureless group (71 versus 86 min, P = 0.02). There was no difference in the post-operative complications of haematoma (0.78% conventional versus 1.12% sutureless, P = 0.46), permanent hypoparathyroidism (1.30% conventional versus 0.52% sutureless, P = 0.06) or permanent RLN injury (0.26% conventional versus 0.52% sutureless, P = 0.39). There was an overall cost saving of AUD$14,300 per 100 total thyroidectomy cases performed using the sutureless technique., Conclusions: Sutureless thyroidectomy is a safe and efficient way of performing total thyroidectomy and has the potential to reduce operating room costs.

Background: Two surgical devices have become popular in thyroid surgery: a bipolar energy sealing system (B) and ultrasonic coagulation (UC). Retrospective and prospective studies have demonstrated that the use of these surgical devices for thyroidectomy compared with conventional thyroidectomy (clamp-and-tie) techniques reduces operative time and cost. We conducted a prospective randomized clinical trial to determine if there is any difference in operative time and cost between B and UC., Materials and Methods: A single-blinded prospective randomized controlled trial was conducted at a tertiary referral center. A total of 90 patients who required a thyroidectomy for thyroid cancer, thyroid nodules, or hyperthyroidism were randomized to either B or UC during thyroidectomy. The operative time and cost of thyroidectomy were compared between the two groups., Results: There was no statistically significant difference in patient age, gender, body mass index, indication for thyroidectomy and thyroid gland weight between the two groups. There was no statistically significant difference in operating room cost or total cost for thyroidectomy between the B and UC groups. There was also no statistically significant difference in the operative time between the B and UC groups (187.6 vs. 184.2 min, P = 0.48) or in postoperative complication rates. The only statistically significant difference in total cost was between surgeons independent of the device used (P < 0.01)., Conclusions: In thyroid surgery, total cost and operative time were similar between the two surgical devices used.

Introduction: One of the keystones in surgery of the thyroid gland is accurate hemostasis. This can be achieved by conventional ligations or new instruments as harmonic scissors or bipolar devices. In the present study, we report our experience with a new bipolar thermofusion vessel sealing system (TVS) compared to conventional vessel ligation (CVL)., Methods: This prospective non-randomized study included 186 patients operated on by two surgeons between April and November 2007. Age, gender, preoperative diagnosis, type of surgery, operative time, and complications were prospectively collected. TVS was used in 93 patients (29 M, 64 F; mean age 50+/-14 years, range 11-83) and CVL in 93 patients (27 M, 66 F; mean age 49+/-14 years, range 16-82). Results and postoperative complications were registered., Results: Postoperative complications included two cases of transient hypocalcaemia in both groups 1 (TVS group) and 2 (CVL group) hemorrhages requiring reoperation (p = ns). No recurrent laryngeal nerve palsy was observed in both groups. A drain was used in 25 cases in the TVS group and in 47 patients in the CVL group (p<0.008). Mean operative time for total thyroidectomy was significantly shorter in the TVS group (73+/-18 min, range=35-110) than in the CVL group (18+/-20 min, range = 40 -130; p<0.01). No differences were found for lobectomies or subtotal thyroidectomies., Conclusion: TVS is safe with a similar complication rate as CVL. Mean operative time for total thyroidectomy is shortened with TVS.

Objective: The aim of the study was to compare the efficiency, safety, and cost of the different methods of hemostasis (conventional hemostasis versus LigaSure vessel sealing system [LVSS] versus harmonic scalpel) currently available for thyroid surgery., Study Design: Randomized, controlled trial., Setting: The study was conducted from September 2007 to December 2008 in a university hospital., Patients and Methods: Sixty patients (48 females and 12 males) underwent a total thyroidectomy for multinodular goiter. They were randomly assigned into three groups: group one (n = 20), conventional hemostasis; group two (n = 20), LigaSure; and group three (n = 20), harmonic scalpel., Results: For group three, the mean operative time was 37 minutes shorter than group one (P < 0.001) and eight minutes shorter than group two (P = 0.04). The complications rate was similar among the three groups. The mean postoperative paracetamol consummation in group one was 1.4 g greater than in group two (P = 0.016) and 1.3 g greater than in group three (P = 0.02). The overall average operative cost was 11 and 85 dollars cheaper for groups two and three than for group one, respectively (P < 0.001)., Conclusion: Total thyroidectomy using the harmonic scalpel was the fastest procedure because it was bloodless, and hemostasis and sectioning were controlled with a single instrument; it was, therefore, the most inexpensive procedure because of the reduction of operative time and staff cost. The operative safety was similar for all three procedures. In our series, the harmonic scalpel and the LVSS caused less pain than the conventional hemostasis.

Study Design: : Randomized, placebo-controlled trial., Objective: : To evaluate the efficacy of epsilon aminocaproic acid (EACA) to reduce the number of red-cell (RBC) transfusions in adult patients undergoing major spinal surgery., Summary of Background Data: : Reconstructive spinal surgery is associated with significant blood loss. The number of studies evaluating the efficacy of EACA in adult patients undergoing spinal surgery remains scarce and limited., Methods: : EACA (100 mg/kg) or placebo was administered to 182 adult patients after the induction of anesthesia followed by an infusion that was continued for 8 hours after surgery. Primary end points included total allogeneic RBC transfusions through postoperative day 8 and postoperative allogeneic plus autologus RBC transfusions through postoperative day 8., Results: : Mean total allogeneic RBC transfusions were not statistically different between the groups (5.9 units EACA vs. 6.9 units placebo; P = 0.17). Mean postoperative RBC transfusions in the EACA group was less (2.0 units vs. 2.8 units placebo; P = 0.03). There was no significantdifference in mean estimated intraoperative estimated-blood loss (2938 cc EACA vs. 3273 cc placebo; P = 0.32). Mean intensive care unit length of stay was decreased (EACA: 1.8 days vs. 2.8 days placebo; P = 0.04). The incidence of thromboembolic complications was similar (2.2% EACA vs. 6.6% placebo; P = 0.15)., Conclusion: : The difference in total allogeneic RBC transfusions between the groups was not statistically significant. EACA was associated with a 30% (0.8 units) reduction in postoperative RBC transfusions and a 1-day reduction in ICU LOS, without an increased incidence of thromboembolic events. EACA may be considered for patients undergoing major spinal surgery. Larger studies are needed to evaluate the relationship between EACA and total RBC requirements.

Thrombin has demonstrated utility in aiding surgical hemostasis since its introduction more than 60 years ago. It is used across a wide variety of surgical procedures by virtually every specialty. Only recently have new equally effective and safe products entered the market, causing decision makers to evaluate formulary selection among products with otherwise modest differences. This evaluation includes identifying costs beyond those of acquisition and storage, as well as indirect factors such as monitoring or specialized distribution requirements. One factor to consider specifically in selection of topical thrombin products is the potential for patients to develop an immune-mediated coagulopathy (IMC) after exposure to bovine-derived thrombin. Costs due to adverse drug events fall into the category of indirect costs and, in some instances, can be substantial if bleeding due to IMC occurs.

Reduction of blood transfusions in patients with neuromuscular scoliosis can decrease potential complications such as immune suppression, infection, hemolytic reaction and viral transmission. Aprotinin (Trasylol), Bayer), an antifibrinolytic, has proven to be effective in reducing blood loss in cardiac and liver surgery, but little data exists in patients undergoing spinal fusion for neuromuscular scoliosis. The purpose of this study was to evaluate the safety and efficacy of aprotinin in pediatric neuromuscular scoliosis patients undergoing spinal fusion. The medical records of all patients undergoing initial spinal fusions for neuromuscular scoliosis between January 1999 and March 2003 were reviewed to determine demographic data, perioperative data, wound drainage and number of transfusion required. Cases were compared to a matched group of historical controls. We had 14 patients in the aprotinin group and 17 in the control group. Total blood loss in the aprotinin group was significantly lower compared to the control group (715 vs. 2,110 ml; P = 0.007). Significantly less blood loss occurred in the aprotinin group when blood loss per kilogram was evaluated as well (23 vs. 60 ml/kg, respectively; P = 0.002). Intra-operative packed red blood cell (PRBC) transfusions were also significantly lower in the aprotinin group (1.25 vs. 3.16 units; P = 0.001). No clinical evidence of anaphylaxis, deep vein thrombosis (DVT) or renal failure was observed in the aprotinin group. After considering the price of drug therapy, operating room time, and the cost of blood products, the use of aprotinin saved an average of $8,577 per patient. In our series, the use of aprotinin resulted in decreased blood loss and a decreased rate of transfusions in children with neuromuscular scoliosis undergoing extensive spinal fusion. At out institution, the use of aprotinin is safe and cost effective for patients with neuromuscular scoliosis.

Introduction: Thyrotoxicosis is often considered to be the most difficult thyroid operation because of the high vascularisation and the risk of bleeding. The conventional haemostatic technique in thyroidectomy today include knot tying and electrocoagulation. The introduction of the harmonic scalpel (HS) has led to further research if the use of the HS has any benefits in thyroid surgery. To our knowledge, no previous study has evaluated the HS dissection technique in a homogenous group of patients with Graves' disease undergoing total thyroidectomy., Materials and Methods: Fifty-one patients (39 women and 12 men) with the pre-operative diagnosis of Graves' disease treated at two endocrine centers were randomised to total thyroidectomy with the use of the HS or with conventional haemostatic techniques., Results: Twenty-seven patients were randomised to the harmonic group and 24 to the conventional group. The operating time was shorter in the HS group (median, 121 min; range, 84-213 min) compared to the conventional group (median, 172 min; range, 66-268 min; p = 0.011)., Conclusion: The use of the HS was associated with a significant reduction in operating time compared to the use of the conventional haemostatic techniques in patients with Graves' disease undergoing total thyroidectomy.

Objectives: To evaluate the efficacy of Floseal as a hemostatic sealant compared to traditional electrocautery hemostasis after cold knife adenotonsillectomy., Study Design: Prospective, randomized, controlled trial of 68 consecutive patients undergoing cold steel adenotonsillectomy. Patients were randomized to receive either Floseal (FS) or electrocautery (EC) for hemostasis., Results: FS patients had shorter operative times than EC patients (16 min vs 31.2 min, P < 0.0001) and less blood loss (49.2 mL vs 70.8 mL, P < 0.05). Four EC patients were crossed over to Floseal when adequate hemostasis could not be achieved in the adenoid bed. No Floseal patients were crossed over. FS patients had significantly less pain on postoperative days two through 11 (P < 0.05) and less use of narcotic pain medications over the first 10 postoperative days (P < 0.05). FS patients also had a faster return to regular diet (5.5 days vs 7.9 days, P < 0.01) and activity (5.3 days vs 7.8 days, P < 0.01) as compared to the EC patients. There were no significant complications in either group., Conclusions: Floseal is safe and efficacious, and decreases postoperative morbidity as compared to electrocautery hemostasis after cold steel adenotonsillectomy., Significance: This study demonstrates the safety and efficacy of Floseal as a hemostatic method in children undergoing adenotonsillectomy.

Aims: The aims of this study was to determine whether an active policy of cost curtailment would impact on the theater cost of laparoscopic surgery in a pediatric setting; to document the extent of cost changes over time and to identify factors that adversely influence expenditure; and to investigate whether the surgeon is a significant factor in the price of the procedure., Materials and Methods: A prospective audit of laparoscopic procedures was performed in a single unit over a 36-month period. Detailed costs of theater inventory for all procedures were compiled on a case-by-case basis and recorded on a database. The cost of six index procedures were collated and changes over the period of the study analyzed. The factors responsible for increased expenditure were flagged and appraised to enable the implementation of cost-saving measures. The prices of the laparoscopic equipment were based on invoiced figures provided by hospital managers, and no long-term outcome measures were taken into account., Results: A total of 179 cases were performed by six surgeons over a 3-year period between January 1, 2003 and December 31, 2005, with no adverse intraoperative events. The procedures studied in further detail were appendicectomy (n = 50), fundoplication (n = 25), cholecystectomy (n = 12), nephrectomy (n = 10), Fowler Stevens for undescended testes (n = 10), and modified Palomo operations for varicocoele (n = 7). The mean cost of these procedures fell year by year over the period of study but was significant only in appendicectomy (P = 0.017). For this procedure, there was a significant difference in costs between the various surgeons (P = 0.007), but this trend was not noted with the other procedures. There were no major intraoperative events, although 2 patients required conversion owing to technical difficulties posed by the cases. Among the factors that influenced costs were the use of disposables, particularly for hemostasis and suctioning, and an inability to procure reuseable instruments., Conclusions: The costs of commonly performed laparoscopic procedures are falling year by year. The surgeon is a factor in the costs of some procedures. A cost-saving strategy has not been compromised of patient safety; however, some cost-saving measures, though attractive, are labor intensive and are not practical. An overall commitment to the sensible use of health care resources translates into savings for hospitals, thereby strengthening the case for laparoscopic surgery.

Objective: Percutaneous access during endovascular aneurysm repair has been difficult owing to the large size of the delivery catheters. This study reports a single-center experience of totally percutaneous access during endovascular abdominal and thoracic aortic repairs using the Preclose Proglide device (Abbott Vascular, Redwood City, Calif)., Methods: Between December 2004 and August 2006, 262 endovascular aortic aneurysm repairs were performed. Percutaneous access was used for the introduction of 12F to 24F sheaths (4.4-mm to 8.6-mm outer diameter). The technique involved deployment of two Proglide devices before insertion of the sheath ("Preclose" technique) with the sutures left extracorporeally for closure after conclusion of the procedure. A prospectively maintained endovascular database and medical records were retrospectively reviewed. Rates of technical success, failure modes, and the overall duration of the endovascular repair compared with a similar cohort using open femoral exposures were examined., Results: A total of 559 Proglide devices were used to close 279 femoral arteries, and 175 (63%) required the insertion of 18F to 24F sheaths. There were 16 failures, mainly due to obesity, device malfunction, severe calcific disease, and faulty arterial punctures, for a technical success rate of 94.3%. The success rates for 12F to 16F size sheaths were significantly higher than for the larger 18F to 24F sheaths (99.0% vs 91.4%, P<.01). For both endovascular abdominal (EVAR) and thoracic (TEVAR) aortic repairs, the Preclose technique resulted in shorter overall procedure times compared with a similar cohort in which open femoral exposures were used (EVAR, 115 vs 128 min, P<.001; TEVAR, 80 vs 112, P=.019). Despite this reduction of procedure time, the savings on the cost of operating room time was negated by the cost of the Proglide devices ($295 per device)., Conclusions: Percutaneous access for endovascular aortic repair is safe and feasible using the Proglide device. Although the success rates are higher for smaller size sheaths, successful closures may be obtained for up to 24F sheaths. Percutaneous access may result in shorter overall procedure times and potentially lower operating room costs, but this appears to be offset by the cost of the closure devices.

Unlabelled: Introduction. The techniques used for axillary node dissection are constantly evolving. The advent of the grip Ligasure Precise raise the question of its cost-effectiveness compared with surgical clips., Objective: To compare the effectiveness of Ligasure compared with surgical clips for simple axillary node dissection or Patey procedure in terms of duration of drainage, cost of hospitalization and complications., Material: and method. Retrospective study extending from January 1, 2003 to December 31, 2004, concerning 187 patients who underwent simple axillary dissection (100) or Patey procedure (87), with use of surgical clips or Ligasure followed by drainage., Results: The use of Ligasure increased the operative cost because its price is higher than that of a clip grip with a refill. Ligasure significantly decreased the duration of drainage in the two groups but there was significantly more abundant fluid loss in the dissection group. The cost of hospitalization related to the choice of the technique of hemostasis (cost of the material + lasted of drainage X price of the day of hospitalization), was not significantly favor of Ligasure. Taking into account the choice of the hemostasis technique and the total duration of hospitalization (material cost + duration of hospitalization X price of the day of hospitalization), there is no significant difference between the two groups., Conclusion: This study compares grip Ligasure Precise with surgical clips for axillary dissection. The duration of drainage was significantly shorter with Ligasure Precise but its benefit in terms of fluid loss remains to be shown. The use of Ligasure does not significantly reduce the cost of hospitalization.

Aim: We designed a study to estimate the economic impact of CoSeal Surgical Sealant for the prevention of anastomotic bleeding in cardiac and vascular surgery. We also explored the potential economic value of CoSeal as a means of inhibiting the formation of pericardial tissue adhesions., Methods: A Delphi panel of 6 expert vascular and cardiac surgeons provided the assumptions and estimates needed to develop a decision analysis model to assess the impact of sealant on the costs associated with low- and high-risk forms of cardiac (valve replacement/reconstruction) and vascular (abdominal aortic aneurysm [AAA] repair, femoral bypass grafting) surgery. The primary outcome was incremental cost per patient., Results: For valve repair/replacement surgery, sealant was expected to confer cost-savings in high-risk but not low-risk procedures. Predicted cost savings for high-risk AAA repairs were substantial, but minimal in the overall AAA group. Cost-savings were predicted for sealant use in all femoral-popliteal ePTFE bypass grafts, but in high-risk femoral-femoral ePTFE bypass grafts only., Conclusions: According to our decision analysis model, routine use of surgical sealant in select subgroups may confer considerable economic benefits to health service budgets. Future research should aim at testing this model in a real-world hospital setting. Assessment of the value of CoSeal in the prevention of postsurgical adhesions showed that expert surgeons see a need for effective prophylaxis. Further research into the clinical and economic benefit of this intervention is required.

Different methods to reduce blood loss during spinal surgery have been described already. Although the use of the harmonic scalpel (HS), an ultrasonically activated coagulator, has been described in endoscopic spinal surgery, its efficacy in posterior instrumentation of the spine remains unclear. The aim of this study was to determine if blood loss was lower using the HS than electrocauterization (EC) and to evaluate the cost effectiveness of the HS in reducing the need for transfusion in patients undergoing posterior instrumentation of the spine. The two groups were matched in a blinded manner, without knowledge of blood loss and were similar with respect to mean age, diagnosis and operation data. All instrumentations were done by the same surgeon. After matching was completed (HS group n = 50, EC group n = 50) blood loss and overall costs for blood products were analyzed by independent observers. The following were significantly lower with the HS than with EC: (1) blood loss (1106+/-985 ml vs 2176+/-1764 ml, P < 0.001), (2) frequency of cell saver use (13 vs 28 patients, P = 0.001), (3) average cost of blood products (Euro 72 vs Euro 219, P < 0.001), (4) predonation of autologous fresh frozen plasma (2.58+/-2.78 vs 4.5+/-2.2 U, P = 0.002) and red blood cells (0.38+/-0.75 vs 0.88+/-1.1 U, P = 0.009). The overall costs, including the costs for the HS, remained neutral. The use of the HS in posterior spinal surgery leads to significantly lower blood loss, and less need for and cost of blood products, compared to EC in cases with major anticipated blood loss.

Haemophilia is a rare, inherited blood disorder in which blood clotting is impaired such that patients suffer from excessive internal and external bleeding. At present there is no cure for haemophilia A and patients require expensive, life-long treatment involving clotting factor replacement therapy. Treatment costs are perceived to be higher for patients who have developed inhibitory antibodies to factor VIII, the standard therapy for haemophilia A. However, initial cost analyses suggest that clotting factor therapy with alternative haemostatic agents, such as recombinant activated factor VII or activated prothrombin complex concentrate, is no more expensive for the majority of haemophilia A patients with inhibitors than for those without inhibitors. With the availability of effective alternative haemostatic agents, orthopaedic surgery for haemophilia A patients with inhibitors is now a clinical option, and initial cost analyses suggest this may be a cost-effective treatment strategy for patients with inhibitors whose quality of life (QoL) is severely impaired by joint arthropathy. In an era of finite healthcare resourcing it is important to determine whether new treatments justify higher unit costs compared with standard therapies and whether such higher costs are justified from an individual perspective in terms of improved QoL, and from a societal perspective in terms of improved productivity and reduced overall healthcare costs. This paper examines current data on the health economics of treating haemophilia A patients with inhibitors, focusing on the overall costs of clotting factor replacement therapy and the cost consequences of joint replacement.

In the present study the Authors tried and assess the advantages of the standard sutureless thyroidectomy performed by the Ligasure Vessel Sealing System, thanks to the use of the dedicated Precise handle. The Authors compared the efficacy of haemostasis and the economical impact of the device, in terms of drug administration and costs. The Authors comparatively analyzed 120 total extracapsular thyroidectomies (TET) performed by the standard operative technique (Group A, control) and 70 TET achieved by the "sutureless technique" (Group B, case). There was a statistically significant decrease of transient postoperative hypocalcemia (5.71% vs 7.5%) and also of mean operative time (about 20 minutes) in patients of the group B. Non significant decrease of other kind of complications (postoperative hemorrhage, transient and permanent inferior laryngeal palsy, stupor of the superior laryngeal nerve, seromas) were also observed. The use of the Ligasure Precise resulted easy, safe and efficient in the Authors' experience. It allowed the decrease of postoperative haemorrhages and mean operative time.

Problem Addressed: Floseal is a novel matrix hemostatic sealant composed of collagen-derived particles and topical bovine-derived thrombin. It is applied as a high-viscosity gel for hemostasis and has been clinically proven to control bleeding. This study is a prospective, randomized, controlled clinical trial of Floseal sealant compared to traditional suction cautery hemostasis in children undergoing adenoidectomy., Methods and Measures: Seventy patients (mean age 7.0 yrs, 45.7% male) with obstructive sleep apnea underwent traditional cold steel adenoidectomy with an adenoid curette and were then randomized to receive the hemostatic sealant (Floseal) or cautery to obtain hemostasis. Patients were crossed over to the other hemostatic technique if hemostasis was not achieved after more than 100 mL of blood loss or 15 minutes elapsed time. Objective data collected included time to hemostasis and blood loss during hemostasis. Visual analog scales (VAS) were used to record subjective data by the operating surgeon including bleeding following adenoid pack removal (0 = none, 3 = brisk) and ease of operation (1 = extremely easy, 6 = extremely difficult). Parents recorded diet on a journal and were contacted by phone at postoperative day 7 and questioned with regard to return to regular diet and use of narcotics., Results: Compared to patients in the cautery group (n = 35), Floseal patients (n = 35) had significantly shorter times to hemostasis (0.6 +/- 1.3 minutes vs 9.5 +/- 5.4 minutes [mean +/- SD], P < 0.001), less blood loss (2.5 +/- 9.2 mL vs 29.4 +/- 27.1 mL, P < 0.001), less subjective bleeding (0.0 +/- 0.6 vs 2.0 +/- 0.7, [median 4-point VAS +/- SD], P < 0.001), and subjectively easier operations (2.6 +/- 1.0 vs 5.2 +/- 1.0 [mean 6-point VAS +/- SD], P < 0.001). Furthermore, Floseal patients returned to regular diet earlier (2.7 +/- 0.7 vs 4.1 +/- 0.5 days [mean +/- SD], P < 0.001) and had less use of narcotics at 7 days postoperatively (40% vs 69%, P < 0.05). Lastly, three patients in the cautery group were crossed over to the Floseal group, but no Floseal subjects were crossed over to the cautery group. The retail cost of Floseal is US 85 dollars. Operating room costs are estimated at US 12 dollars/minute. Reducing the operative length by 8.9 minutes on average produces a cost savings of US 106.80 dollars per operation. There were no complications in either experimental group including postoperative hemorrhage, hospitalization, blood transfusion, or aspiration., Conclusions: Floseal matrix hemostatic sealant is a safe, efficacious, easy, and cost-effective technique for obtaining hemostasis in children undergoing adenoidectomy. Limitations of the study include the fact that it is nonblinded, which does allow for some bias in the subjective data recorded. However, utilizing 4 different operating surgeons, 3 of whom were not affiliated with the study, minimized this. CLINICAL SIGNIFICANCE OF STUDY: This study demonstrates the safety and efficacy of a novel hemostatic sealant in children undergoing adenoidectomy. Floseal matrix hemostatic sealant can be used as a first-line hemostatic agent, and it is a good tool in the armamentarium of otolaryngologists who encounter significant bleeding following adenoidectomy.

The pharmacological methods used to achieve systemic hemostasis have generated much discussion due to concerns of serious adverse effects (e.g., thromboembolic complications) and costs of therapy in addition to efficacy considerations. There are a limited number of well-controlled trials involving pharmacological hemostasis for spine surgery. In the largest double-blinded randomized controlled trial to date involving spine surgery, there was a trend toward reduced homologous transfusion in patients receiving aprotinin, but the only statistically significant result ( p<0.001) was a reduction in autologous red cell donations. The findings of this trial are important, since the investigators used a number of restrictive transfusion strategies (e.g., autologous donation, low hematocrit trigger for transfusion, blood-salvaging procedures with the exception of no cell saver) that were not always employed in earlier trials involving hemostatic agents. Smaller studies involving antifibrinolytic agents other than aprotinin have demonstrated reductions in blood loss and transfusion requirements in patients undergoing spine surgery, although the results were not always statistically significant. A very large randomized trial would be required to address comparative medication- and transfusion-related adverse events; such a trial involving patients undergoing cardiac surgery is currently being performed. Additionally, cost-effectiveness analyses are needed to help define the role of these agents based on the data that is available.

The femoral approach is the most commonly used route for diagnostic cardiac catheterization and coronary interventions today. Manual compression and pressure bandages usually lead to immobilisation of the patient for several hours and may result in significant discomfort. Since the introduction of the first femoral closure device in 1991, many devices have proven their efficacy in significantly reducing time to hemostasis while simultaneously improving patient comfort. Twenty four closure device systems with different concepts are on the market, e. g. pure collagen, collagen + thrombin, collagen + anchor, vascular suture, hemostatic patches and pads, staples and more. The four predominantly used are Angio-Seal (46 %), Perclose (32 %), VasoSeal (14 %) and Duett (3 %). The effectiveness of all four systems has been proven in a prospective, randomized, controlled multicenter trial each. Efficacy and safety were analyzed using data from ten comparative studies in 8832 predominantly or exclusively interventional patients, however none of the closure systems proved to be superior. Fortunately, recent years have shown a trend toward a reduction in local complications by vascular closure devices compared to manual compression. Closure devices are thus becoming increasingly cost effective. Vascular closure systems should be preferred when the prolonged supine position is not tolerated, a protein IIb/IIIa-inhibitor was used during the procedure, or early discharge of patient is anticipated. In the presence of peripheral vascular disease, small diameter of the femoral vessels or stenotic lesions in the femoral artery, closure devices should be used with caution. Closure systems for immediate femoral puncture site hemostasis are now an important tool of invasive cardiology today.

The aim of this study was to assess costs and safety of immediate femoral sheath removal and closure with a suture-mediated closure device (Perclose, Menlo Park, CA) in patients undergoing elective (PCI). A total of 193 patients was prospectively randomized to immediate arterial sheath removal and access site closure with a suture-mediated closure device (SMC; n = 96) or sheath removal 4 hr after PCI followed by manual compression (MC; n = 97). In the SMC group, patients were ambulated 4 hr after elective PCI if hemostasis was achieved. In the MC group, patients were ambulated the day after the procedure. In addition to safety, total direct costs including physician and nursing time, infrastructure, and the device were assessed in both groups. Total direct costs were significantly (all P < 0.001) lower in the SMC group. Successful hemostasis without major complication was achieved in all patients. The time to achieve hemostasis was significantly shorter in the SMC group (7.1 +/- 3.4 vs. 22.9 +/- 14.0 min; P < 0.01) and 85% of SMC patients were ambulated on the day of intervention. Suture-mediated closure allows a reduction in hospitalization time, leading to significant cost savings due to decreased personnel and infrastructural demands. In addition, the use of SMC is safe and convenient to the patients., (Copyright 2002 Wiley-Liss, Inc.)

The purpose of this study was to determine if closure of the femoral artery access site using a percutaneous arterial suture device (Perclose, Menlo Park, CA) in patients undergoing coronary stenting can result in the same benefits as seen with radial artery access. A total of 218 consecutive patients underwent coronary stenting (109 femoral, 109 radial) by investigators experienced with each technique. The two groups were matched in terms of sex, age, clinical presentation (50% acute), number of vessels and lesions stented, and lesion morphology. The relative costs of the femoral and radial procedures were examined using a decision analytic model and sensitivity analysis. The suture device was not used in 20/109 patients (18%) for anatomic reasons and failed to obtain hemostasis in 9/89 patients (10%). One radial patient had an occluded radial artery postprocedure, but this was recanalized at follow-up a month later. Primary success, procedural complications, postprocedure length of stay, and the percentage of patients discharged the same day were the same in both groups. Because of the added time to deploy Perclose, total procedure time was significantly longer in the femoral group (57 +/- 22 min femoral vs. 44 +/- 22 min radial, P < 0.01). Access site complications occurred only in the femoral group. More patients were ambulatory the same day of the procedure in the radial group (95% radial vs. 56% femoral, P < 0.01). The cost of the radial approach was substantially less than the femoral approach because of lower supply costs and fewer access complications. The transradial approach is a dominant strategy for coronary stenting, offering better outcomes at lower cost. Cathet. Cardiovasc. Intervent. 49:150-156, 2000., (Copyright 2000 Wiley-Liss, Inc.)

Blood loss in patients undergoing radical prostatectomy may be substantial. In a randomized, prospective study, we assessed two methods of reducing the need for allogeneic blood transfusion with regard to efficacy and costs. Sixty patients undergoing retropubic radical prostatectomy were allocated randomly to one of three groups. In group 1 (n = 20), acute normovolaemic haemodilution (ANH) was initiated after induction of anaesthesia; autologous blood 15 ml kg-1 was withdrawn and replaced by colloid solutions (gelatin) to maintain haemodynamic stability. In group 2 (n = 20), controlled hypotension was established using sodium nitroprusside (target mean arterial pressure (MAP) approximately 50 mm Hg). Group 3 (n = 20), without manipulations, served as a control group. Troponin T (TnT), a sensitive marker for myocardial ischaemia, and various coagulation variables were measured in the perioperative period. Packed red blood cells (PRBC) were given when haemoglobin concentration was less than 7 g dl-1. Cost calculations did not include hospital overhead costs or staff costs. In the ANH group, mean 1278 (SD 150) ml of autologous blood were withdrawn. Significantly more volume was infused in the ANH patients (gelatin 2450 (550) ml) than in the two other groups. Coagulation data (platelet count, activated partial thromboplastin time (aPTT), fibrinogen, antithrombin III (AT III), D-dimers) did not differ significantly between the three groups. The hypotension group had significantly lower blood loss (1260 (570) ml), whereas the ANH (1820 (680) ml) and control group (1920 (590) ml) did not differ significantly. Patients in the hypotension group needed significantly less PRBC (total 14 units; 75% of patients did not need PRBC) than the ANH (total 21 units; 55% of patients did not need PRBC) or control patients (total 28 units; 40% of patients did not need PRBC). Total costs were lowest in the hypotension group (41% less than in the control patients) (P < 0.05). We conclude that the use of hypotension during radical prostatectomy resulted in approximately 40% reduction in total transfusion costs. ANH was less effective and more costly than controlled hypotension.

There are numerous ways to achieve hemostasis. With the abundance of hemostatic agents available and with the introduction of new products, one has to make an objective decision. A good agent achieves hemostasis within a short period of time, is easy to manipulate, is biocompatible, does not impair or retard healing, must be relatively inexpensive, is reliable, and works best for the particular surgical procedure. With these purposes in mind, the following sequence is recommended to achieve hemostasis during endodontic microsurgery. I. Presurgical: Give 2 to 3 Carpules of 1:50,000 epinephrine local anesthetic with multiple infiltration sites throughout the entire surgical field. II. Surgical: A. Remove all granulation tissue. B. Place an epinephrine pellet into the bony crypt followed by dry sterile cotton pellets. Apply pressure for 2 minutes. Remove all the cotton pellets except the first epinephrine pellet. Continue with the surgical procedure and remove the epinephrine pellet before final irrigation and closure. C. Alternatively, calcium sulfate can be mixed into a thick putty and packed against the bone cavity. Because it is a biodegradable material, calcium sulfate can be left in situ. In fact, in large bone defects and through-and-through lesions, additional calcium sulfate can be placed to fill the entire bone cavity as a barrier material. Healing is more predictable with little chance of scar tissue formation. Calcium sulfate resorbs in 2 to 4 weeks. D. Small bleeding sites in the bone can be brushed with ferric sulfate solution. III. Postsurgical: Tissue compression before and after suturing cuts down on postsurgical bleeding and swelling. Hemostasis is imperative in endodontic microsurgery for better visualization, a good environment for placement of retrograde filling material, and a more efficient surgical procedure with less blood loss.