Effective management of bleeding during tumor resection with a collagen-based hemostatic agent

In a prospective controlled trial hemostatic effectiveness of a novel collagen-based composite (CoStasis) was compared with a collagen sponge applied with manual pressure at diffusely bleeding sites after surgical tumor resection. The proportion of subjects achieving complete cessation of bleeding within 10 minutes (i.e., hemostatic success) and the time to "complete hemostasis" were determined at raw surgical sites after tumor resection among 23 experimental and 30 control subjects. There was a similar distribution in tumor types (e.g., benign vs malignant) evaluated between treatment groups. A significantly greater proportion of experimental subjects achieved complete hemostasis within 10 minutes of observation compared with controls [23 of 23 (100%) vs 21 of 30 (70%); P = 0.003]. The median time required to achieve complete hemostasis was more than three times longer for subjects treated with the collagen sponge compared with subjects treated with CoStasis (243 vs 78 seconds; P = 0.0001). Approximately 80 per cent of experimental subjects achieved complete hemostasis within 2 minutes compared with only 35 per cent of controls. There were no adverse events related to the experimental treatment in this study. These results support the use of this novel hemostatic agent to control diffuse surgical site bleeding after tumor resection at diverse anatomical locations.     

Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in children undergoing adenoidectomy.

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.     

Comparison of a new fibrin sealant with standard topical hemostatic agents

BACKGROUND: Bleeding following liver resection continues to be a significant morbidity of the procedure. Fibrin sealants represent an improvement over conventional topical hemostatic agents, because they contain components that actively form clot. However, most available agents contain nonhuman protein, which represents an immunologic risk. HYPOTHESIS: An investigational surgical fibrin sealant (Crosseal; American Red Cross, Washington, DC) composed of human clottable proteins and human thrombin is more effective than standard topical hemostatic agents in reducing the time required to achieve hemostasis after liver resection. DESIGN: Prospective, randomized, controlled trial. SETTING: Fifteen major referral centers in the United States and the United Kingdom. METHODS: After liver resection using standard surgical techniques, 121 patients seen between May 1999 and May 2000 were randomized to treatment with a 2-component fibrin sealant (n=58) or to standard topical hemostatic agents, used singly or in combination (n=63). Up to 10 mL of Crosseal was administered by a spray applicator, as recommended by the manufacturer, whereas agents used in the control group were applied according to their instructions for use. MAIN OUTCOME MEASURES: The primary outcome measured was time to hemostasis. Secondary outcomes measured included blood loss between application of the hemostatic agent and closure of the abdomen, duration of postoperative biliary drainage, and the occurrence of complications, defined a priori as reoperation for any reason, development of abdominal fluid collections, or bilious appearance of drained fluid for at least 1 day postoperatively. RESULTS: The mean time to hemostasis was 282 seconds with Crosseal, compared with 468 seconds with standard agents (2-sided; P =.06), for the 116 efficacy-evaluable patients. Hemostasis was achieved within 10 minutes in 53 patients (91.4%) treated with the study fibrin sealant and in 44 control patients (69.8%) (2-sided; P =.003). Intraoperative blood loss was similar in the 2 groups. In the Crosseal group, the percentage of patients developing postoperative complications was 17.2%, compared with 36.5% in the control group (2-sided; P =.02). CONCLUSIONS: Compared with the use of standard topical hemostatic agents, Crosseal fibrin sealant significantly reduced the time to achieve hemostasis following liver resection. Patients treated with the new fibrin sealant also experienced significantly fewer postoperative complications.     

Prospective, randomized, controlled trial of a hemostatic sealant in children undergoing adenotonsillectomy.

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.     

Advanced hemostatic dressing development program: animal model selection criteria and results of a study of nine hemostatic dressings in a model of severe large venous hemorrhage and hepatic injury in Swine

BACKGROUND: An advanced hemostatic dressing is needed to augment current methods for the control of life-threatening hemorrhage. A systematic approach to the study of dressings is described. We studied the effects of nine hemostatic dressings on blood loss using a model of severe venous hemorrhage and hepatic injury in swine. METHODS: Swine were treated using one of nine hemostatic dressings. Dressings used the following primary active ingredients: microfibrillar collagen, oxidized cellulose, thrombin, fibrinogen, propyl gallate, aluminum sulfate, and fully acetylated poly-N-acetyl glucosamine. Standardized liver injuries were induced, dressings were applied, and resuscitation was initiated. Blood loss, hemostasis, and 60-minute survival were quantified. RESULTS: The American Red Cross hemostatic dressing (fibrinogen and thrombin) reduced (p < 0.01) posttreatment blood loss (366 mL; 95% confidence interval, 175-762 mL) and increased (p < 0.05) the percentage of animals in which hemostasis was attained (73%), compared with gauze controls (2,973 mL; 95% confidence interval, 1,414-6,102 mL and 0%, respectively). No other dressing was effective. The number of vessels lacerated was positively related to pretreatment blood loss and negatively related to hemostasis. CONCLUSION: The hemorrhage model allowed differentiation among topical hemostatic agents for severe hemorrhage. The American Red Cross hemostatic dressing was effective and warrants further development.     

The management of peripheral vascular complications associated with the use of percutaneous suture-mediated closure devices

PURPOSE: The purpose of this study is to identify the peripheral vascular complications associated with the use of percutaneous suture-mediated closure (PSMC) devices and compare them with postcatheterization femoral artery complications not associated with PSMC devices. METHODS: This is a retrospective review of all patients admitted to the vascular surgery service at the Chattanooga Unit of the University of Tennessee Department of Surgery with a peripheral vascular complication after percutaneous femoral arteriotomy between July 1, 1998, and December 1, 1999. The complications followed the use of PSMC devices (group I, n = 11) and traditional compression therapy (group II, n = 14) to achieve arterial hemostasis. Group II was subdivided into patients who required operative intervention (group IIA, n = 8), and those who were treated without operation (group IIB, n = 6). RESULTS: No significant difference was found between groups I and II with regard to age (P =.227), time to vascular surgery consultation (P =.987), or diagnostic versus therapeutic catheterization (P =.897). A significant difference was found with regard to mean pseudoaneurysm size (group I = 5.9 cm, group II 2.9 cm; P =.003). Ultrasound compression was successfully performed in 66.6% of group II patients, but no (0.0%) patient in group I responded to this therapy (P =.016). Groups I and IIA had a significant difference for mean estimated blood loss (group I = 377.2 mL, group II = 121.8 mL; P =.017) and requirement for transfusion (P =.013). More patients in group I required extensive surgical treatment (P =.007), with six of these patients requiring vein patch angioplasty during their treatment. More patients in group I also had infectious complications (n = 3) compared with group IIA (n = 1). CONCLUSION: In comparison with complications that follow percutaneous arteriotomy when PSMC devices are not used for hemostasis: (1) pseudoaneurysms after the use of PSMC devices are larger and do not respond to ultrasound compression, (2) complications associated with PSMC devices result in more blood loss and increased need for transfusion and are more likely to require extensive operative procedures, and (3) arterial infections after the use of PSMC devices are more common and require aggressive surgical management.     

Patients with head and neck cancers and associated postirradiated carotid blowout syndrome: endovascular therapeutic methods and outcomes

PURPOSE: This study retrospectively evaluated the technical and hemostatic outcomes of reconstructive and deconstructive endovascular management in patients with head and neck cancers associated with carotid blowout syndrome (CBS). METHODS: Twenty-four patients with head and neck cancers with CBS involving the main trunk of carotid artery underwent endovascular therapy. This included reconstructive management with self-expandable stent grafts to preserve the diseased carotid artery in 11 patients and deconstructive management with balloons, coils, or acrylic adhesives to occlude the diseased carotid artery in 13 patients. Based on clinical severity and therapeutic priority, we classified CBS in our patients into two groups: acute or impending and threatened. The angiographic severity was graded from 0 to 3. Evaluation of technical outcome included technical success, initial and delayed complications, and patency of stent graft in the reconstructive group. The hemostatic outcome was evaluated by immediate hemostatic result, rebleeding, and duration of hemostasis. Sex, age, clinical and angiographic severities, local wound complications, and location of the pathologic lesion were examined as predictors of the technical and hemostatic outcomes of endovascular management by using Cox regression method. RESULTS: Technical success and immediate hemostasis were achieved in all patients of both groups. Initial complications during the procedures were encountered in four patients (36.4%) who underwent reconstructive management and in one patient (7.7%) who underwent deconstructive management (P = .142). Delayed complications during the follow-up were seen in one patient (9.1%) with reconstructive management and one patient (7.7%) with deconstructive management (P > .99). Rebleeding occurred in five patients (45.5%) in the reconstructive management group and in three patients (23.1%) in the deconstructive management group (P = .659). The mean duration of hemostasis after initial reconstructive and deconstructive management was 4.0 +/- 8.1 and 8.5 +/- 10.1 months, respectively (P = .249). Rebleeding was noted in 7 of 11 patients (63.6%) with acute CBS and in 1 of 13 patients (7.7%) with impending and threatened CBS (P = .008). CONCLUSION: There is no significant difference in technical and hemostatic outcomes between the reconstructive and deconstructive endovascular management methods. Hemostatic results were influenced by clinical severity. The rebleeding rate is higher in patients with advanced and acute clinical severity.     

Comparative study of the efficacy of the common topical hemostatic agents with fibrin sealant in a rabbit aortic anastomosis model

OBJECTIVE: The purpose of this study was to compare the hemostatic efficacy of the common surgical hemostatic agents with fibrin sealant (FS) and to assess their functional strength to secure hemostasis in lieu of placing additional sutures. METHODS: End-to-end anastomosis of transected abdominal aorta was performed in moderately anticoagulated rabbits using 4 or 6 interrupted sutures. The suture line was covered either with gauze alone ("untreated") or with gauze plus Gelfoam, Avitene, Surgicel, FloSeal, or FS, following which blood flow was restored. Blood loss was absorbed by gauze and measured. The surviving rabbits were recovered and the repaired vessel was examined histologically 4 weeks after operation. The investigators were blinded to the treatment groups. Aortic anastomoses using 8 or 12 sutures (untreated) were also performed. RESULTS: Untreated 4-suture anastomosis of aorta resulted in a profuse hemorrhage with an average 108.0 +/- 19.2 (mean +/- SD) ml blood loss and 100% mortality (n = 4). FS application sealed the anastomoses, prevented blood loss (P < 0.01 vs untreated) and exsanguination of the rabbits (n = 4). Other hemostatic agents reduced the bleeding to varying degrees compared to the untreated animals (Gelfoam 66.4 +/- 17.6, Avitene 80.6 +/- 34, Surgicel 66.7 +/- 16.7, FloSeal 44.2 +/- 8.5 ml blood loss, n = 4/group), but the changes were not statistically significant. One to three rabbits in each group survived the operation. Six-suture aortic anastomoses, untreated, resulted in 67.7 +/- 21.8 ml blood loss and 100% survival (n = 6). Application of FS produced immediate and sustained hemostasis in all the animals (P < 0.01 vs untreated). Other hemostatic agents also reduced the bleeding (Gelfoam 42.5 +/- 10, Avitene 50.9 +/- 12.4, Surgicel 32.1 +/- 14, FloSeal 33.9 +/- 5.4 ml blood loss, n = 6/group), but the changes were not statistically significant. The 8- and 12-suture aorta repairs resulted in a moderate blood loss (43.9 +/- 19 and 21.3 +/- 14.9 ml, respectively), followed by a stable hemostasis that precluded the need to use any hemostatic agent. The aortic cross-clamping time of the 12-suture and time to hemostasis for both the 8- and the 12-suture techniques were significantly longer than those of the 4-suture plus FS application (P < 0.01, P < 0.01 and P < 0.05, respectively). CONCLUSION: In a moderate coagulopathy, FS was proven to be the most efficacious hemostatic agent, producing immediate and sustained hemostasis at the arterial anastomotic site. This high efficacy is in part attributed to the strong tissue adhesive property of this agent. FS application may potentially ease the anastomosis and shorten the duration of timely critical vascular procedures.     

High-pressure fibrin sealant foam: an effective hemostatic agent for treating severe parenchymal hemorrhage

BACKGROUND: The majority of early trauma deaths are related to uncontrolled, noncompressible, parenchymal hemorrhage from truncal injuries. The purpose of this study was to formulate a fibrin sealant foam (FSF) able to control severe parenchymal bleeding without compression or vascular control. MATERIALS AND METHODS: FSF with high fibrinogen concentration (20 mg/mL) and low thrombin activity (5 U/mL) was prepared and pressurized by addition of liquid gas propellant. The efficacy of this foam was tested against a severe parenchymal hemorrhage, created by partial resection of liver lobes in anticoagulated rabbits (n = 7) and compared to untreated injury (n = 8) and placebo treatment (n = 7). The hemostatic efficacy of pressurized FSF (n = 8) was also compared to a commercially available liquid fibrin sealant (n = 8) and a developing dry powdered fibrin sealant product (n = 8) in the same model. RESULTS: The liver injury resulted in 122 +/- 11.5 mL blood loss and death of 75% of untreated rabbits (3.2-3.4 kg) within 1 h. Treatment with placebo foam had no effect on blood loss or mortality rate. Pressurized FSF significantly reduced bleeding, resulting in 56% (P < 0.05) and 66% (P < 0.01) reduction in blood loss as compared to untreated or placebo-treated animals, respectively, and 100% survival (P = 0.008). When pressurized FSF was compared with liquid and powdered forms of fibrin sealant, only foam significantly reduced blood loss (49%, P < 0.05) and mortality rate (54%, P < 0.05) of rabbits as compared to untreated control animals (n = 9). CONCLUSION: Biological nature, rapid preparation, coverage of large wound areas, and effective hemostatic properties make pressurized FSF an ideal candidate for treating nonoperable parenchymal injuries in damage control procedures.     

Operative time and other outcomes of the electrothermal bipolar vessel sealing system (LigaSure) versus other methods for surgical hemostasis: a meta-analysis

A meta-analysis was performed of 29 prospective, randomized trials (published January 1, 2000, to August 14, 2007) comparing an electrothermal bipolar vessel sealing system (EBVS-LigaSure, Covidien) (total n = 1107 patients) with either clamping with suture ligation/ electrocauterization (n = 1079 patients) or ultrasonic energy (eg, Harmonic Scalpel, Johnson & Johnson). Hemorrhoidectomy (12 articles), hysterectomy (4 articles), and thyroidectomy (3 articles) were the most common procedures. For 15 of 26 studies reporting standard deviations, the normalized mean operative time reduction for EBVS equaled 28% (95% confidence interval [CI] 18%-39%, P < .0001) compared with conventional surgical hemostasis. Operative time was reduced with EBVS in 24 of 26 studies (P < .0001). EBVS was associated with 43 mL (95% CI 14-73 mL, P = .0021) less blood loss, fewer complications (odds ratio 0.66, 95% CI 0.47-0.92, P = .02), and mean reduction in postoperative pain of 2.8 units (95% CI 1.5-4.1, P < .0001). Five studies used ultrasonic energy as the comparator, but none reported standard deviation so data could not be pooled.     

A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery

STUDY DESIGN: A prospective, randomized trial comparing Proceed, a gelatin-based hemostatic sealant (treatment), with Gelfoam-thrombin (control) in stopping intraoperative bleeding during spinal surgery. OBJECTIVES: To determine the effectiveness and safety of Proceed. SUMMARY OF BACKGROUND DATA: Proceed has been tested in animal models to determine its safety and effectiveness as a hemostatic agent. The current study was conducted under a Food and Drug Administration-approved Investigational Device Exemption to evaluate the effectiveness and safety of Proceed in humans. METHODS: For this study, 127 patients undergoing spinal surgery were randomized into either the treatment or control group after standard surgical means to control bleeding had failed. The bleeding site was evaluated at 1, 2, 3, 6, and 10 minutes after the hemostatic agent was applied. The application was considered successful if the bleeding stopped within 10 minutes. Follow-up evaluation was performed at 12 to 36 hours, then at 6 to 8 weeks after surgery. RESULTS: Proceed stopped bleeding in 98% of the patients (first bleeding site only) within 10 minutes, as compared with 90% of the control patients (P = 0.001). At 3 minutes, successful hemostasis had been achieved in 97% of the Proceed group, as compared with 71% of the control group (P = 0.0001). There was no difference in the adverse event profile between the two groups. CONCLUSIONS: A significantly larger number of bleeding sites had achieved hemostasis with Proceed than with Gelfoam-thrombin at 1, 2, and 3 minutes after application. Proceed was as safe as Gelfoam-thrombin when used for hemostasis during spinal surgery procedures.     

Chitosan hemostatic dressing for renal parenchymal wound sealing in a porcine model: implications for laparoscopic partial nephrectomy technique.

BACKGROUND AND OBJECTIVES: This study was to evaluate the feasibility of using a novel chitosan hemostatic dressing to control hemorrhage and urinary leakage by sealing off the parenchymal wound following LPN. METHODS: Nine heparinized domestic swine underwent bilateral laparoscopic partial nephrectomies involving either a polar or wedge resection. Estimated blood loss (EBL), hemostatic score, operative time, and adhesion score of the chitosan dressing were documented during LPN. Retrograde pyelography was performed to assess urinary leakage. RESULTS: Of 18 procedures, complete hemostasis after deployment of the chitosan dressing was successfully achieved in 17 of them. The hemostasis score improved significantly after the deployment in both polar (P<0.001) and wedge (P=0.017) resections. The rate of successful pyelocaliceal sealing was 85% (11/13) in polar and 60% (3/5) in wedge resections. Application of a bandage in wedge resections was fraught with greater difficulties in terms of number of applications required and prolonged operative time. However, the differences between this group and polar resection were not statistically significant. CONCLUSIONS: The chitosan hemostatic dressing is capable of being used in LPN procedures as a primary or supplemental material for controlling parenchymal hemorrhage and sealing the renal collecting system in the animal model.     

A comparison of recombinant thrombin to bovine thrombin as a hemostatic ancillary in patients undergoing peripheral arterial bypass and arteriovenous graft procedures

OBJECTIVES: Recombinant thrombin (rThrombin) is a potential hemostatic alternative to bovine and human plasma-derived thrombin. This report examines the clinical results for the vascular surgery subgroup of patients enrolled in a larger double-blind, randomized, multicenter trial, which evaluated the comparative safety and efficacy of rThrombin and bovine plasma-derived thrombin (bThrombin) when used as adjuncts to surgical hemostasis. METHODS: Data from the 164 vascular patients who underwent either a peripheral arterial bypass (PAB) or arteriovenous graft (AV) procedure are included in this analysis. Time to hemostasis at proximal and distal anastomotic sites at 1.5-, 3-, 6-, and 10-minute intervals was determined by procedure (PAB or AV) and overall (PAB + AV). Baseline and day 29 immunologic sera were analyzed. The incidences of postoperative adverse events were compared between treatment groups. Categorical adverse events were evaluated in relation to thrombin product antibody formation. RESULTS: Patients were randomized to either bThrombin (n = 82) or rThrombin (n = 82). Procedures included PAB (n = 88) and AV (n = 76). The bThrombin and rThrombin groups were well matched for demographics and baseline characteristics. A comparable incidence of anastomotic hemostasis was observed in both treatment groups at 10 minutes (94% bThrombin, 91% rThrombin). The incidence of hemostasis was lower at all time points for PAB procedures compared with AV procedures. In the PAB group, a significantly greater proportion of patients receiving rThrombin (55%) achieved hemostasis at 3 minutes compared with bThrombin (39%; P < .05). Adverse event profiles and laboratory findings were similar between groups. No patients in the rThrombin group developed anti-rThrombin product antibodies at day 29, whereas 27% of patients in the bThrombin group developed antibodies to bThrombin product (P < .0001). CONCLUSIONS: rThrombin or bThrombin used as a hemostatic ancillary for anastomotic bleeding was equally effective at 10 minutes; however, rThrombin compared with bThrombin may provide a more rapid onset of hemostasis at 3 minutes in PAB procedures. Adverse events were similar between the two thrombins. In patients undergoing vascular surgery, both treatments were similarly well tolerated, although rThrombin demonstrated a superior immunogenicity profile.     

High-dose aprotinin in cardiac surgery: three years' experience in 1,784 patients.

The effect of the proteinase-inhibitor aprotinin on blood loss and homologous blood requirement in cardiac surgery was investigated. In a prospective study, 902 adult patients were treated with high-dose aprotinin (total greater than 5 x 10(6) kallikrein inactivator units [KIU]; group A), while 882 patients without aprotinin administration served as the controls (group C). Both groups were operated on between January 1987 and October 1989, and included patients with primary coronary artery bypass grafting (n = 525 group C, n = 560 group A), valve replacement (n = 292 group C, n = 264 group A), or combined procedures (n = 65 group C, n = 78 group A), as well as cardiac reoperations (n = 91 group C, n = 110 group A). The average blood loss 36 hours postoperatively in the aprotinin group was 679 +/- 419 mL, compared with 1,038 +/- 671 mL in the control group (P less than 0.05). Total homologous blood requirement was also significantly less in group A (942 +/- 1,630 mL) compared with group C (1,999 +/- 2,283 mL) (P less than 0.05), a reduction of 53%. Serum creatinine concentrations did not show intergroup differences on the first postoperative day (group A, 1.2 +/- 0.7; group C, 1.3 +/- 0.5 mg/dL) or on discharge from the intensive care unit (ICU). Thus, impairment of renal function as a consequence of aprotinin treatment was not observed. Three patients developed signs of mild circulatory depression after injection of aprotinin, which responded promptly to vasopressor therapy.(ABSTRACT TRUNCATED AT 250 WORDS)     

The effect of preoperative biliary stenting on postoperative complications after pancreaticoduodenectomy

BACKGROUND: Preoperative biliary drainage (PBD) in jaundiced patients undergoing pancreaticoduodenectomy remains controversial. METHODS: Patients presenting with obstructive jaundice who subsequently underwent pancreaticoduodenectomy from January 1996 to June 2002 were included in the study (n = 212). Patients with preoperative biliary stents (n = 154) were compared with patients without preoperative drainage (n = 58). RESULTS: Patients in the stented group required a longer operative time (mean 6.8 hours versus 6.5 hours) and had greater intraoperative blood loss (mean 1207 mL versus 1122 mL) compared with the unstented group, (P = 0.046 and 0.018). No differences were found with respect to operative mortality (2%), incidence of pancreatic fistula (10% versus 14%), or intraabdominal abscess (7% versus 5%). Wound infection occurred more often in the stented group (8% versus 0%, P = 0.039). CONCLUSIONS: PBD was associated with increased operative time, intraoperative blood loss, and incidence of wound infection. Although PBD did not increase major postoperative morbidity and mortality, it should be used selectively in patients undergoing pancreaticoduodenectomy.     

Defining the pediatric spinal thoracoscopy learning curve: sixty-five consecutive cases

STUDY DESIGN: Consecutive case prospective chart and radiographic review. OBJECTIVES: The purpose of this study was to define the learning curve of spinal thoracoscopy. SUMMARY OF BACKGROUND DATA: Thoracoscopy is an alternative to open thoracotomy in the treatment of pediatric spinal deformity. The learning curve for spinal thoracoscopy has not been described. METHODS: In this prospective study 65 consecutive cases of thoracoscopic anterior release with discectomy and fusion performed by one surgeon for the treatment of pediatric spinal deformity were reviewed. The patients were, on average, 14 +/- 3 years old and had the following diagnoses: idiopathic scoliosis (n = 13), Scheuermann's kyphosis (n = 9), neuromuscular spinal deformity (n = 35), congenital scoliosis (n = 4), and tumor/syrinx (n = 4). RESULTS: The average operative time for the thoracoscopic procedure was 161 +/- 41 minutes (range, 50-240 minutes). There was a slight decrease in the average operative time as the series progressed. The average number of discs excised was 6.5 +/- 1.5 (range, 3-10), and the number increased as the series progressed. The average operative time per disc was 29.3 +/- 7.7 minutes in the first 30 patients compared with 22.3 +/- 4.7 minutes in the next 35 patients (P < 0.01). The average blood loss during the thoracoscopic procedure was 301 +/- 322 mL (range, 25-2000 mL) and did not decrease as the series progressed. Initial postoperative scoliosis and kyphosis corrections were 59% +/- 17% and 92% +/- 12%, respectively. Complications occurred in six patients (cases 4, 8, 17, 31, 39, and 46) and were evenly distributed throughout the series. CONCLUSIONS: The learning curve for thoracoscopy is substantial, but not prohibitive. This technique provides a safe and effective alternative to thoracotomy in the treatment of pediatric spinal deformity.     

Damage control management of experimental grade 5 renal injuries: further evaluation of FloSeal gelatin matrix

BACKGROUND: We developed a porcine grade 5 renal laceration damage control model to evaluate the hemostatic efficacy of FloSeal gelatin matrix (Baxter Healthcare, Corp., Deerfield, Ill). METHODS: Ten commercial swine underwent celiotomy, contralateral nephrectomy, and cooling to 32 degrees C after a well-established hypothermia protocol to simulate a damage control scenario. Following prospective randomization, a complex grade 5 renal injury was uniformly produced on the remaining kidney. Control animals (group 1, n = 5) were treated with direct manual compression with a gelatin sponge. Experimental animals (group 2, n = 5) were treated by application of FloSeal gelatin matrix followed by direct compression with a gelatin sponge. Operative blood loss and efficacy of hemostasis were compared. Creatinine levels were obtained daily until postoperative day 7. Abdominal computed tomography was performed at 10 days. RESULTS: Use of FloSeal gelatin matrix hemostatic sealant resulted in significantly less mean blood loss than gelatin sponge bolster compression alone (202.4 mL vs. 540.4 mL, respectively, p = 0.016). Hemostasis was complete in 60% (three out of five) of experimental animals after 2 minutes, but was incomplete in all control animals. After an initial increase, serum creatinine approached baseline by postoperative day 7 in all animals. Axial imaging 10 days postoperatively revealed no evidence of significant delayed perirenal hemorrhage. CONCLUSIONS: FloSeal gelatin matrix performed well as a rapidly deployable, effective hemostatic agent in a hypothermic grade 5 renal injury damage control model. The absence of delayed bleeding and nephrotoxicity suggests a possible increased role for FloSeal in the treatment of devastating renal injuries in damage control surgery.     

Safely increasing the efficiency of thyroidectomy using a new bipolar electrosealing device (LigaSure) versus conventional clamp-and-tie technique

Operative time in thyroid surgery can be safely reduced through use of a new bipolar electrosealing device (LigaSure). We evaluated consecutive patients undergoing thyroid surgery from January 2003 through January 2005 (n=155). During the first half of the study, hemostasis was obtained using silk ties (conventional group, n=70). During the second half of the study period, hemostasis was obtained with a bipolar electrosealing device (LigaSure group, n=85). The mean operative time was 130 +/- 37 minutes in the conventional group and 110 +/- 33 minutes (P < 0.001) in the LigaSure group. EBL in the LigaSure group was statistically significantly less (43 +/- 53 vs 33 +/- 33 mL; P < 0.05). Postoperative calcium level was statistically significantly higher in the LigaSure group (8.2 +/- 0.5 vs 8.4 +/- 0.6 mg/dL, P < 0.05). Hospital length of stay (LOS) did not differ significantly. One patient in each group developed neck hematoma requiring reoperation. One permanent recurrent nerve injury occurred in the conventional group and one transient bilateral recurrent nerve injury occurred in the LigaSure group. The occurrence of symptomatic hypocalcemia was similar between the two groups. The training level of the surgical resident had no significant impact on the operative time, estimated blood loss (EBL), LOS, or complication rate. LigaSure bipolar electrosealer as the primary means of hemostasis during thyroidectomy significantly reduces mean operative times. Rates of operative complications were unchanged. LigaSure use in thyroid surgery can safely increase efficiency.     

Packing in endoscopic sinus surgery: is it really required?

OBJECTIVE: The aim of this study was to evaluate the routine use of packing or local hemostatic agents in endoscopic sinus surgery (ESS). METHODS: Packing and/or hemostatic agents were used only when necessary in 100 consecutive adult ESS patients in a tertiary academic hospital. Necessity for packing the nose after excessive bleeding was analyzed in relation to demographic characteristics, medical history, previous surgeries, current surgical procedure, type of anesthesia, and amount of intraoperative bleeding. RESULTS: Three patients who required packing because of other reasons (such as bolstering of mucosa) were excluded from the study. The remaining 97 patients included 61 males and 36 females between the ages of 16 to 86 (mean 44). Forty-nine patients underwent only ESS, 40 ESSs associated with nasal polypectomy, and 8 underwent other endoscopic procedures. Fifty-four underwent the operation under general anesthesia and 43 under local anesthesia. Intraoperative blood loss was less than 30 mL in 82 patients (85%), 30 to 50 mL in 11 (11%), and more than 50 mL in 4 (4%). In 89 patients (92%), packing or a hemostatic agent was not used. No patient had bleeding complications postoperatively. A comparison between patients who required packing to those who did not showed that the only statistically significant associations related to general anesthesia (P = 0.0082) and to the amount of intraoperative bleeding (P < 0.001). CONCLUSIONS: Most ESS procedures can be managed without packing or any other hemostatic measures. Local anesthesia, use of local vasoconstrictors, and careful operative technique minimize the need for nose packing, thus reducing patient's discomfort, postoperative complications, and cost of surgery.     

Prospective randomized evaluation of a collagen/thrombin and autologous platelet hemostatic agent during total knee arthroplasty

The purpose of this study was to evaluate the effectiveness of a collagen/thrombin and autologous platelet hemostatic agent in preventing blood loss during primary total knee arthroplasty. This prospective, double-blinded, randomized study was designed to enroll a total of 100 patients. Patients were randomized 1:1 to either the treatment arm (standard hemostasis plus study product) or the control arm (standard hemostasis alone). Transfusion requirements, as determined by a blinded investigator using standardized criteria, were significantly lower in the treatment group (no blood transfusions) compared with the control group (5 transfusions; P = .007). These data support the addition of the study product to prevent blood transfusions after primary total knee arthroplasty.