Endovascular treatment of carotid blowout syndrome: who and how to treat

Carotid blowout syndrome (CBS) is a high-risk condition associated with significant morbidity and mortality that may result from invasion and destruction of the cervical carotid vasculature from head and neck squamous cell carcinoma. Endovascular approaches offer multiple modalities for treatment to prevent morbidity and death. In this paper we review our experience in addressing CBS and present an up-to-date algorithm of endovascular management. 16 lesions were identified in 8 patients treated with 9 procedures over the past year. Pseudoaneurysm and/or active extravasation were documented in at least one vessel in all 8 cases presenting with acute CBS. There were 13 pseudoaneurysms in external carotid artery (ECA) trunk (5), ECA branches (4), internal carotid artery (ICA) (1) and common carotid artery (CCA) (3). There were 3 additional ICA lesions due to tumor infiltration, resulting in ICA occlusion (2) and long segment stenosis (1). Permanent vessel occlusion was performed in 11 lesions of the ECA trunk (4), ECA branches (4) and ICA (3). Stent-grafts were placed in 5 lesions in the CCA (3), ICA (1) and ECA trunk (1). Technical success and immediate hemostasis were achieved in all patients. There were no procedural deaths or immediate complications. With a median follow-up of 2 months (range, 1-13 months), three patients died: one from recurrent CBS, one from global brain ischemia after a cardiac arrest event unrelated to CBS and one from systemic disease. There was no other recurrence of bleeding or neurological complication. Endovascular techniques offer an armamentarium to effectively address CBS, significantly affecting the care and outcome in this particular oncologic population. These techniques should be offered as early as possible in the context of a multidisciplinary approach.     

Efficacy of Endoscopic Pure Ethanol Injection Method for Gastrointestinal Ulcer Bleeding

We reviewed endoscopic hemostatic effects of the pure ethanol injection (PEI) method for reducting emergency operations and deaths due to gastroduodenal ulcer bleeding. During 17 years beginning in June 1979 in Tohoku University Hospital, 331 patients underwent endoscopic hemostasis by the PEI method. Initial hemostasis was successfully obtained in all cases. Rebleeding occurred in about 4% of the patients, and rehemostasis was obtained successfully in all of them. Complete hemostasis was obtained in 330 of 331 patients (99.7%) using the PEI method; there were no deaths. Only one patient required emergency operation after hemostasis because of repeated neogenetic bleeding complicated with a perforation and another because of an unidentifiable neogenetic ulcer bleeding located just above the Vater papilla. None required other endoscopic hemostasis or interventional radiology. Moreover, after introduction of “second-look” endoscopy, the rebleeding rate decreased to about 1% with PEI hemostasis. Based on these excellent hemostatic effects of the PEI method, we believe that a comparative study with other hemostatic methods is not needed.     

Intraoperative hemostasis during spinal reconstructive procedures

In a consecutive sample of patients undergoing similar spinal reconstructive procedures in the thoracolumbar region, hemostatic effectiveness of a collagen-based composite (CoStasis; Cohesion Technologies, Palo Alto, Calif) n = 10) was compared with standard hemostatic methods (manual compression) (n = 9). All patients treated with CoStasis at the operative site(s) demonstrated immediate hemostasis,whereas all cases treated with gauze and sponges showed protracted bleeding (P < .01). The average perioperative blood loss was approximately twice as great among control patients compared to CoStasis patients (1322 mL versus 685 mL; P = .02). Total transfusion requirements and operative duration also were less among CoStasis patients. These findings suggest CoStasis may provide effective hemostasis in spinal reconstructive procedures such as instrumented fusion where blood loss is excessive.     

The management of vertebral artery injury in anterior cervical spine operation: a systematic review of published cases

Purpose

Anterior cervical spine operations (ACSO) are generally considered to be safe and effective, but the vertebral artery (VA) is at risk during the procedure. Because the consequences of VA injury can be catastrophic, properly managing a VA injury is very important. However, due to the rarity of these injuries, there is no agreed upon treatment strategy.

Methods

Studies were identified for inclusion in the review via sensitive searches of electronic databases through 31 December 2011. All cases included in the review were qualitatively analyzed to explore the relationship between type of VA injury management and neurological complications.

Results

Seventeen articles describing 39 cases of VA injury during ACSO were included in this study. Seven patients (17.9 %) had neurological complications followed by VA insufficiency. Two patients (5.1 %) had root damage due to ligation. One case (2.6 %) resulted in intraoperative death due to fatal bleeding. Delayed vascular complications were identified in nine (45.0 %) of the 20 patients that underwent only tamponade or hemostatic agent during the operation. Four patients underwent intraoperative endovascular treatment, and three of these patients had a cerebral infarction. All three patients who underwent clipping also had neurological complications. The five patients treated by direct repair did not have any complications.

Conclusion

Our review suggests the management of VA injury should be considered in order listed: (1) performing tamponade with a hemostatic agent, (2) direct repair, (3) postoperative endovascular procedures to prevent delayed complications. If tamponade fails to achieve proper hemostasis, additional procedures as endovascular embolization, clipping and ligation should be considered but carry the risk of neurological complications. Because of the limitations of this review, further studies are recommended with larger sample sizes.     

Tissue glues and nonsuturing techniques

PURPOSE OF REVIEW: This article details the diverse urologic applications of tissue glues and hemostatic agents over the past 3 years in the management of genitourinary injuries, surgical wounds, and complications. RECENT FINDINGS: Biosurgical agents designed to promote tissue adhesion and hemostasis are being increasingly employed across all surgical disciplines. Fibrin sealant is the most widely utilized biosurgical product. Gelatin matrix thrombin has proven to be an efficacious hemostatic agent. Bovine serum albumin-gluataraldehyde is a new, promising tissue glue. Complex reconstructive, oncologic and laparoscopic procedures are those most appropriate for sealant use in urology. SUMMARY: Tissue glues and hemostatic agents are effective, safe, and their use is increasing. All urologists should have a working knowledge of these adjuncts.     

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.     

In-stent Restenosis After Carotid Angioplasty and Stenting: A Challenge for the Vascular Surgeon

PURPOSE: This study aims to review the incidence of in-stent restenosis (ISR), the factors which determine restenosis, and to evaluate the use of various endovascular techniques for the management of ISR following carotid artery stenting (CAS). METHODS: Four hundred and seven patients (334 men, mean age 63 years, range 46-86, median 65 years) were treated with CAS between December 2000 and March 2004. Three hundred and seventy-two (89%) patients had at least one ultrasound evaluation performed 6 months after procedure (range 6-40). Recurrent stenosis >80% detected with duplex ultrasound scans were further evaluated by angiography and treated with repeat endovascular procedure. RESULTS: CAS was performed successfully in all cases with a Carotid WallStent (Boston Scientific) using a cerebral protection device (filter). Perioperative complications included four (0.9%) minor and two (0.4%) major strokes these latter two patients died at 5 and 12 days after the operation. No other deaths occurred. A total of 15 carotid arteries (3.6%) in 14 patients had ISR. All ISR were treated with a repeat endovascular procedure: three balloon angioplasty alone, eight angioplasty and secondary stenting, four angioplasty with cutting balloon. Postsurgical restenosis was confirmed to be the only predictive factor for the development of in-stent restenosis (OR 14.5, 95% CI 2.3-113.4, p=0.005). Endovascular treatment of ISR achieved technical success without periprocedurale complications and the absence of significant restenosis over a median follow up time of 12.4 months (range 3.5-30.7). CONCLUSION: Our experience with a large cohort of CAS showed an encouragingly low incidence of ISR (3.6%) and successful treatment by repeat endovascular intervention. We recommend attempting all endovascular possibilities before performing stent removal.     

Adjunctive endovascular techniques in the management of postoperative carotid artery pseudoaneurysms--useful armamentarium for vascular surgeons--three case reports

Postoperative carotid artery pseudoaneurysms are rare. The traditional treatment of choice has been operative repair, which can present a significant technical challenge owing to the reoperative neck inflammation and potential cranial nerve injuries. The authors report 3 cases of postoperative carotid pseudoaneurysms that were successfully managed by use of various adjunctive endovascular techniques. The adjunctive endovascular maneuvers included the following: 1) endoluminal balloon placement for preoperative test occlusion and intraoperative proximal control to facilitate operative dissection in the first patient with a carotid pseudoaneurysm; 2) endoluminal stent-graft placement to exclude a large expanding carotid pseudoaneurysm in the second patient; and 3) endoluminal coil placement along with balloon occlusion to achieve complete hemostasis in the third patient, who presented with a hemorrhaging carotid pseudoaneurysm. Successful outcomes were achieved in all 3 patients by use of adjunctive endovascular techniques. These cases underscore the role of adjunctive endovascular treatment as an armamentarium for vascular surgeons in the treatment of complex carotid pseudoaneurysms.     

Evidence based coagulation monitors: heparin monitoring, thromboelastography, and platelet function

The hemostatic management of patients undergoing cardiac surgery is a unique challenge. Since its inception, cardiopulmonary bypass (CPB) has required meticulous attention to maintaining adequate anticoagulation. New anticoagulants and alternative monitoring techniques present an opportunity to investigate potential advances in the area of anticoagulation for CPB. Hemostasis after CPB is still a vexing problem, and the addition of antiplatelet medication to the platelet defect already incurred during CPB has led to hemorrhagic complications in cardiac surgery. The two opposing processes of anticoagulation and hemostasis must be managed carefully and modified with respect to the patient's hematologic status and desired hemostatic outcome. Cardiac surgical patients consume a much larger fraction of perioperative blood transfusions than the percentage of the surgical population they represent. Thus, during CPB, careful attention must be paid to optimal anticoagulation, platelet quiescence, biocompatible circuitry and interventions, and to monitoring hemostasis. The multifactorial etiology of the CPB-induced hemostatic defect requires a multimodal approach to blood conservation and hemostasis monitoring, including heparin maintenance and sophisticated point-of-care hemostasis monitoring. Each technology has its own attributes and each may be suitable for different populations based upon the expected defects being measured. This article reviews the evidence supporting the use of point-of-care monitors in coagulation and hemostasis management in cardiac surgical patients.     

Percutaneous arterial closure in peripheral vascular disease: a prospective randomized evaluation of the Perclose device

BACKGROUND: Patients with peripheral vascular disease have been excluded from initial studies of percutaneous suture-mediated closure devices (SMCD) despite representing a significant proportion of those requiring endovascular intervention. We sought to determine whether these devices could be safely used in patients with peripheral vascular disease. METHODS: Patients were stratified into two groups and five subgroups on the basis of indication for arteriography, and they were prospectively randomized at the end of the procedure to receive either the SMCD or manual compression. Ankle-brachial index was determined and duplex ultrasound scanning of the accessed femoral artery was performed, before and after the procedure. Ultrasound data included peak systolic velocity, minimum intraluminal vessel diameter, and presence or absence of calcified plaque. Time to hemostasis, ambulation, and discharge were recorded, and major or minor complications were noted. RESULTS: Of 102 patients included in the study, 52 patients were randomized to receive the SMCD. There was no difference in ankle-brachial index, minimum intraluminal vessel diameter, or peak systolic velocity in the accessed vessel after closure with SMCD or manual compression. Time to hemostasis, ambulation, and discharge was significantly less in the SMCD group (P =.001). Presence of calcified plaque was not associated with complications (P =.146). In the SMCD group, hemostasis was achieved with 49 of 52 devices (94.2%). There were six complications (5.9%), two of which were major and required operative intervention. All complications were hemorrhagic and not occlusive. There was no difference in overall complication rate between SMCD (7.7%) and manual compression (4.0%) groups (P =.678). No infection was noted in any of the 102 patients. CONCLUSIONS: Suture-mediated percutaneous arterial closure can be safely performed in patients with peripheral vascular disease, even in the presence of calcified plaque. This closure technique enables shorter time to hemostasis, ambulation, and hospital discharge. There are observed differences in minor, but not major, complication rates for MC versus percutaneous arterial closure in patients with peripheral vascular disease, but these differences did not achieve statistical significance in this small series.     

Endovascular treatment of carotid blowout syndrome

Background

Carotid blowout syndrome (CBS) is a life-threatening complication of head and neck cancer and radiation therapy. Endovascular techniques have emerged as preferable alternatives to surgical ligation for treatment of CBS. We performed a systematic review and meta-analysis to study periprocedural complications and outcomes of CBS patients treated with coil embolization and covered stents.

Measurement and impact of proximal and distal tortuosity in carotid stenting procedures

BACKGROUND: Proximal and distal carotid tortuosity is considered of paramount importance in carotid artery stenting (CAS) procedures. Specifically, distal internal carotid coiling or kinking is thought to interfere with proper distal protection devices, thus contraindicating CAS. The type of the aortic arch is also considered a key factor in CAS success; however, no standardized method of evaluation of these indicators is available in the literature. We have evaluated the impact of arch angulation and proximal and distal tortuosity in a series of CAS procedures. METHODS: In patients undergoing CAS, arch angulation and tortuosity of both common and distal internal carotid arteries were evaluated prospectively by calculating the sum of all angles diverging from the ideal straight axis, considering a 90 degrees ideal angle for the origin from the arch (tortuosity index, TI). All procedures were through a transfemoral approach and with distal protection. Results were correlated with technical procedural success (residual stenosis <30%) and neurologic complication by Student t test. Multivariate logistic regression analysis was conducted to identify independent predictors of results. RESULTS: In a group of 298 CAS procedures, the mean proximal TI was 111.9 degrees +/- 96.77 degrees and the mean distal TI was 123.4 degrees +/- 117.47 degrees . Technical success was obtained in 272 patients (91.2%). Causes for the 26 technical failures were incapacity to obtain stable proximal access in 25 (96.1%), and uncrossable stenosis in one (3.9%). Neurologic protection was achieved with distal filters in all cases. Neurologic complications occurred in 23 patients (7.7%), consisting of 16 transient ischemic attacks and seven minor strokes. The proximal TI was significantly greater in the 26 cases of technical failure (158.4 degrees +/- 102.2 degrees vs 107.6 degrees +/- 95.3 degrees , P = .01). The distal TI was not different in the two groups (89 degrees +/- 99.1 degrees vs 126.5 degrees +/- 118.6 degrees , P = .11). Similarly, the proximal TI was significantly greater in neurologic complications (162.8 degrees +/- 111.8 degrees vs 107.6 degrees +/- 18.2 degrees , P = .03); the distal TI was not different in the two groups (112.6 degrees +/- 110.1 degrees vs 124.3 degrees +/- 96.1 degrees , P = .5) By logistic regression analysis, a proximal TI >150 was an independent predictor of both neurologic complications and technical failure. Age was also independently associated with technical failure. Appropriate distal filter placement was possible in all cases with a crossable stenosis, irrespective of the internal carotid TI. CONCLUSIONS: The proximal TI is significantly associated with both technical success and neurologic complications after CAS, whereas the distal TI did not influence either outcome. The presence of distal kinking or coiling should not be considered a contraindication to CAS.     

Carotid artery stenting with neuroprotection: assessing the learning curve and treatment outcome

PURPOSE: Carotid artery stenting (CAS) has emerged as an acceptable treatment alternative in high-risk patients with carotid stenosis. The purpose of this study was to assess the effect of the learning curve on treatment complications and the clinical outcomes of CAS. METHODS: Clinical variables and treatment outcomes of 200 consecutive CAS procedures in 182 patients (mean age 72 years) with carotid stenosis > or = 70% during a 40-month period were analyzed. Four sequential groups (groups I, II, III, and IV) of 50 consecutive interventions were compared with regard to technical success, periprocedural complications, and treatment outcomes. RESULTS: Treatment indications and relevant risk factors were similar among the 4 groups. The overall technical success and combined 30-day stroke and death rates were 98% and 2.5%, respectively. An increase in the technical success rate was noted in the latter 3 groups compared with group I (P < .05). Total procedural time and contrast volume were significantly higher in group I compared with the latter 3 groups (P < .05). The intraoperative anticoagulation regimen was changed from intravenous heparin combination to bivalirudin after the first 54 patients, which resulted in decreased bleeding complications in groups III and IV (P = 0.03) compared with the first group. The 30-day stroke and death rate in groups I and II were 8% and 2%, respectively, and was decreased significantly in groups III and IV (0% and 0%, respectively, P < .05). A Cox regression model identified procedural volume (P = .03) as a predictor of decreased complication rate. CONCLUSIONS: CAS with neuroprotection can provide excellent treatment outcomes. Our experience demonstrates a procedure-associated learning curve as evidenced by decreased procedure-related complications, fluoroscopic time, and contrast volume occurring with increased physician experience. Procedural success was also enhanced partly by endovascular device refinement and an improved anticoagulation regimen. Successful CAS outcomes can be achieved once physicians overcome the initial procedure-related learning curve.     

Nd:YAG laser bipolar dissector--preliminary results.

We have developed a laser bipolar dissector (LBD) which uses the 1,064 nm Nd:YAG wavelength. The laser emits from the inner surface of the distal 7 mm of each probe made of synthetic sapphire. With low laser power (15-25 W), the bipolar provides hemostatic cutting of larger blood vessels. Animal experiments were carried out using New Zealand white rabbits. The LBD hemostatically cut through veins up to 5 mm and arteries up to 2 mm in diameter. Rebleeding did not occur. Transection of parenchymal organs such as liver and lung was easily performed with complete hemostasis. In chronic experiments a partial hepatectomy with splenectomy and left nephrectomy was performed using the LBD alone without any ligation. Up to 3 weeks postoperatively there were no direct complications related to using the LBD. In conclusion the LBD could perform a hemostatic transection of large vessels and might have clinical application in the dissection of vascular parenchymal organs.     

Surgical complications from hemostatic puncture closure devices

BACKGROUND: For securing immediate hemostasis following percutaneous arterial catheterization, the Food and Drug Administration has approved three hemostatic puncture closure devices. We reviewed our institutional experience with one device (Angio-Seal). METHODS: A retrospective, single-center, nonrandomized observational study was made of all vascular complications following femoral cardiac catheterization. RESULTS: An immediate mechanical failure of the device was experienced in 34 (8%) patients. Surgical repair was required in 1.6% (7 of 425) of patients following Angio-Seal versus 0.3% (5 of 1662) following routine manual compression (P = 0.004). In 5 patients, the device caused either complete occlusion or stenosis of the femoral artery. The polymer anchor embolized in 1 patient and was retrieved with a balloon catheter at surgery. CONCLUSION: During the first year of utilization of a percutaneous hemostatic closure device following cardiac catheterization, we observed a marked increase in arterial occlusive complications requiring surgical repair. Surgeons must be familiar with the design of these devices to achieve precise repair of surgical complications.     

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.     

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.     

Various local hemostatic agents with different modes of action; an in vivo comparative randomized vascular surgical experimental study.

OBJECTIVES: To evaluate the effects of different local hemostatic agents in a new high flow vascular experimental bleeding model. DESIGN: Bovine thrombin combined with collagen matrix (bTcM), microporous polysaccharide hemospheres (MPH), freeze-dried rFVIIa with and without the combination of MPH were compared to a control group (solely compression) in a randomized fashion (20 animals/group). Primary endpoint was hemostasis, and secondary endpoints were time to hemostasis, blood loss, and blood pressure at hemostasis. METHODS: The common carotid artery of heparinized rats was ligated proximally and transected. Compression was applied for one minute followed by application of the topical hemostatic agent. Compression was maintained for another two minutes followed by re-evaluation of hemostasis: if bleeding continued additional compression was applied and thereafter bleeding was checked every minute until hemostasis. RESULTS: All animals in the bTcM group obtained hemostasis compared to 20% in the control group (p<0.0001). The combination of MPH and rFVIIa (70% hemostasis) also showed a significant hemostatic capacity compared to control group (p<0.001). None of the other active treatment groups differed compared to control group. Animals treated with bTcM had a significantly shorter time to hemostasis compared to animals in the other active treatment groups. No significant difference in blood loss and blood pressure at hemostasis was detected. CONCLUSIONS: The most effective hemostatic agent was bTcM, followed by the combination of rFVIIa and MPH, while neither MPH nor rFVIIa alone displayed any hemostatic capacity compared to compression only.     

Prospective randomized trial of ACUSEAL (Gore-Tex) versus Hemashield-Finesse patching during carotid endarterectomy: early results

BACKGROUND/PURPOSE: Several studies have reported that carotid endarterectomy (CEA) with patch angioplasty produces superior results compared with primary closure. Conventional polytetrafluoroethylene (PTFE) patching has been shown to have results comparable to autogenous vein patching; however, it requires a prolonged hemostasis time. Therefore, many surgeons use collagen-impregnated Dacron patching (Hemashield [HP]). Recently, we reported a satisfactory hemostasis time using the new hemostatic PTFE patch (ACUSEAL by Gore). This study is the first prospective randomized trial comparing the ACUSEAL patch with the HP Finesse patch. METHODS: 200 CEAs were 1:1 randomized into two patch closure groups (ACUSEAL or Finesse). All patients underwent immediate and 1 month postoperative duplex ultrasound studies. Demographic and clinical characteristics were similar in both groups, including the mean operative diameter of the internal carotid artery and length of arteriotomy. RESULTS: The overall perioperative ipsilateral stroke rate was 2% (2% ACUSEAL, 2% Finesse; P = 1.0). The perioperative ipsilateral TIA rates were 0% for the ACUSEAL and 2% for the Finesse patch (P = .5). The combined perioperative neurological event (TIA + stroke) rates were 2% for ACUSEAL and 4% for the Finesse (P = .68). The early >or=50% restenosis rate was 0% for ACUSEAL vs 4% for Finesse patching. Two perioperative carotid thromboses were noted with Finesse patching vs none with ACUSEAL patching (P = .50). The combined early morbidity rate (TIA, stroke, and >or=50% restenosis or thrombosis) was 2% for the ACUSEAL patch vs 8% for the Finesse patch (P = .10). The mean hemostasis time for the ACUSEAL and Finesse patches was 5.1 vs 3.7 minutes (P = .01), however, the mean operative times were similar for both groups (P = .61). CONCLUSION: The perioperative neurological events and overall short-term morbidity associated with CEA when using ACUSEAL or Finesse patches were similar. Both patches have short hemostasis times.     

Control of bone bleeding at the sternum and iliac crest donor sites using a collagen-based composite combined with autologous plasma: results of a randomized controlled trial

In a randomized controlled trial, hemostatic effectiveness of a collagen-based composite (experimental group) was compared with standard hemostatic methods (ie, electrocautery and collagen sponge) (control group) at two bone sites. Hemostatic success, time to "controlled bleeding," and time to "complete hemostasis" were determined at the sternal edge following median sternotomy (n=64) and at the iliac crest following bone graft harvest (n=19). Almost twice the percentage of sternal edge patients (83% versus 44%, P=.002) and nearly three times the percentage of iliac crest patients (83% versus 29%, P<.05) achieved complete hemostasis in the experimental group compared to controls. Time to controlled bleeding and complete hemostasis for all bone sites also favored the experimental group over the control group at highly significant levels (P<.0001 for most comparisons). There were no adverse events related to experimental treatment use. The results support the use of this investigational hemostatic agent to control cancellous bone bleeding.