Clinical use of topical thrombin as a surgical hemostat

When surgical ligation of bleeding fails, or is not possible, surgeons rely on a number of hemostatic aids, including thrombin. This review discusses the history, pharmacology and clinical application of thrombin as a surgical hemostat. The initial thrombin was bovine in origin, but its use has been complicated by the formation of antibodies that cross react with human coagulation factors. This has been associated with life threatening bleeding and in some circumstances anaphylaxis and death. Human thrombin, isolated from pooled plasma of donors, has been developed in an effort to minimize these risks, but its downside is the potential of transmitting blood-borne pathogens and limited availability. Recently a recombinant thrombin has been developed and approved for use by the FDA. It has the advantage of being minimally antigenic and devoid of the risk if viral transmission. Thrombin is often used in conjunction with other hemostatic aids, including absorbable agents (like gelfoam, collagen, and cellulose), and with fibrinogen in fibrin glues. The last part of this review will discuss these agents in detail, and review their clinical applications

Twilight an evening love song

https://digitalcommons.library.umaine.edu/mmb-vp/2608/thumbnail.jp

Limited B-mode venous imaging versus complete color-flow duplex venous scanning for detection of proximal deep venous thrombosis

AbstractPurpose: The purpose of this study was to compare the accuracy of a limited B-mode compression technique (BMCT) with a complete color-flow duplex venous examination (CDVE) for the detection of proximal deep vein thrombosis (DVT).Methods: We prospectively studied 72 patients (20 men and 52 women) for DVT. Two technologists blinded to each other performed either BMCT or CDVE independently. The BMCT is an abbreviated technique compressing two sites per limb. One site was the saphenofemoral junction including the superficial femoral and deep femoral vein confluence; the other was the saphenopopliteal junction including tibial vein confluence. Total limbs studied were 144. CDVE was considered the gold standard for purposes of sensitivity, specificity, and accuracy.Results: The technical failure rate of BMCT was three of 144. In all technically satisfactory examinations, the BMCT result was positive in 15 of 141 limbs, and the CDVE result was positive in 13. Sensitivity of BMCT was 100%, specificity was 98%, and overall accuracy was 99%. There were two false-positive results with BMCT; both were cases of popliteal veins deep to the artery leading to difficulty in compression. The BMCT was able to detect chronic thrombus, floating thrombus, and small thrombus behind femoral vein valve cusps.Conclusion: These data suggest that BMCT is a rapid, acceptable, alternative technique for detecting proximal DVT. In cases of equivocal or positive findings, the spectral and color-flow Doppler examination should be used to confirm the results. (J VASC SURG 1995;22:553-7.

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

ObjectivesRecombinant 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.MethodsData 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.ResultsPatients 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).ConclusionsrThrombin 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

Ultrasound-determined diameter measurements are more accurate than axial computed tomography after endovascular aortic aneurysm repair

ObjectiveThis study evaluated the correlation of ultrasound (US)-derived aortic aneurysm diameter measurements with centerline, three-dimensional (3-D) reconstruction computed tomography (CT) measurements after endovascular aortic aneurysm repair (EVAR).MethodsConcurrent CT and US examinations from 82 patients undergoing post-EVAR surveillance were reviewed. The aortic aneurysm diameter was defined as the major axis on the centerline images of 3-D CT reconstruction. This was compared with US-derived minor and major axis measurements, as well as with the minor axis measurement on the conventional axial CT images. Correlation was evaluated with linear regression analyses. Agreement between different imaging modalities and measurements was assessed with Bland-Altman plots.ResultsThe correlation coefficients from linear regression analyses were 0.92 between CT centerline major and US minor measurements, 0.94 between CT centerline major and US major measurements, and 0.93 between CT minor and centerline major measurements. Bland-Altman plots showed a mean difference of 0.11 mm between US major and CT centerline measurements compared with 5.38 mm between US minor and CT centerline measurements, and 4.25 mm between axial CT minor and centerline measurements. This suggested that, compared with axial CT and US minor axis measurements, US major axis measurements were in better agreement with CT centerline measurements. Variability between major and minor US and CT centerline diameter measurements was high (standard deviation of difference, 4.27-4.84 mm). However, high variability was also observed between axial CT measurements and centerline CT measurements (standard deviation of difference, 4.36 mm).ConclusionsThe major axis aneurysm diameter measurement obtained by US imaging for surveillance after EVAR correlates well and is in better agreement with centerline 3-D CT reconstruction diameters than axial CT

Primary stenting of the superficial femoral and popliteal artery

ObjectivesOver the last decade, the number of endovascular procedures performed on the superficial femoral (SFA) and popliteal arteries (PA) has significantly increased. There is no consensus on the optimal form of intervention used in this arterial segment. While some have advocated balloon angioplasty alone, others have championed either selective or primary stenting of these lesions. It is the purpose of this study to determine the efficacy and durability of primary stenting of the superficial femoral and popliteal artery.MethodsAll patients undergoing peripheral angioplasty by a single vascular surgeon were prospectively enrolled in an Institutional Review Board-approved, primary-stenting protocol. During a 44-month period, all patients undergoing percutaneous transluminal angioplasty of the SFA or PA also received primary arterial stenting with bare, self-expanding nitinol stents. Patient demographics and risk factors were identified. TransAtlantic InterSociety Consensus (TASC) classifications were determined for all lesions. Loss of primary patency was said to have occurred when an occlusion or a 50% or greater stenosis in any treated arterial segment was diagnosed by arterial duplex or angiography. Only time to loss of primary patency was recorded. Kaplan-Meier survival curves were plotted and differences between groups tested by log rank method.ResultsBetween January 16, 2004 and August 13, 2007, 201 angioplasties with primary stenting were performed on 161 patients. One hundred twenty-three stents were placed for claudication, and 78 for critical limb ischemia. Forty-six segments treated were TASC A, 82 were TASC B, 38 were TASC C, and 35 were TASC D. Patient follow-up ranged from three to 1329 days (mean: 426 days). Primary patency rates for TASC A and B lesions were 79%, 67%, and 57% at 12, 24, and 36 months. For TASC C and D lesions, primary patency rates were 52.7%, 36%, and 19% at the same time intervals. Primary patency rates for TASC A and B lesions were significantly higher than for C and D lesions (P < .001). The limb salvage rate was 88.5% in patients with critical limb ischemia. Distal runoff did not influence patency (P = .827).ConclusionsPrimary stenting of the SFA and PA provides durable results in patients with TASC A and B lesions and may be an effective treatment strategy. This approach is significantly less effective when used in treating those with TASC C and D disease. Based on the results in this series, the use of primary stenting does not extend the anatomic limits of the current treatment recommendations for catheter-based intervention in patients with infrainguinal occlusive disease

Renal revascularization in Takayasu arteritis–induced renal artery stenosis

AbstractPurposeThis study was undertaken to define the long-term effects of renal revascularization on blood pressure, and renal and cardiac function in patients with Takayasu arteritis–induced renal artery stenosis (TARAS).MethodsTwenty-seven patients (25 women; mean age, 27 years) with TARAS underwent intervention. Primary, primary assisted, and secondary patency rates were determined, and the late effects on blood pressure, renal and cardiac function, and survival were analyzed.ResultsAll patients had hypertension (mean blood pressure, 167/99 mm Hg; 2.5 antihypertensive medications per patient). Mean estimated glomerular filtration rate in patients not receiving hemodialysis was 76 mL/min, and in five patients serum creatinine concentration was greater than 1.5 mg/dL. Three patients were hemodialysis-dependent, and two had intractable congestive heart failure. Forty interventions were performed, including 32 aortorenal bypass procedures, two repeat implantations, four nephrectomies, and two transluminal angioplasty procedures. Postoperative morbidity was 19%. There were no deaths. During follow-up (mean, 68 months), three graft stenoses, all due to intimal hyperplasia, and three graft occlusions occurred. Two of three graft stenoses were successfully revised. At 1, 3, and 5 years of follow-up, primary patency was 87%, 79%, and 79%, respectively; primary assisted patency was 93%, 89%, 89%, respectively; and secondary patency was 93%, 89%, and 89%, respectively. Intervention resulted in a decrease in blood pressure to a mean of 132/79 mm Hg (P < .0001), and the need for antihypertensive medications was reduced to one per patient (P < .01). Mean glomerular filtration rate increased to 88 mL/min (P < .005), and two patients no longer required hemodialysis. Congestive heart failure resolved in both patients, and did not recur. There were three deaths during follow-up, with 5-year and 10-year actuarial survival of 96% and 80%, respectively.ConclusionsRenal revascularization to treat TARAS is durable, has a salutary effect on blood pressure, and enhances long-term renal and cardiac function. This response establishes renal revascularization as a successful and durable intervention for TARAS, and a benchmark to which other therapies should be compared

Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction

AbstractObjectivesThe objective of this clinical trial was to assess the safety and efficacy of carotid BAT in advanced HF.BackgroundIncreased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Baroreflex activation therapy (BAT) results in centrally mediated reduction of sympathetic outflow and increased parasympathetic activity.MethodsPatients with New York Heart Association (NYHA) functional class III HF and ejection fractions ≤35% on chronic stable guideline-directed medical therapy (GDMT) were enrolled at 45 centers in the United States, Canada, and Europe. They were randomly assigned to receive ongoing GDMT alone (control group) or ongoing GDMT plus BAT (treatment group) for 6 months. The primary safety end point was system- and procedure-related major adverse neurological and cardiovascular events. The primary efficacy end points were changes in NYHA functional class, quality-of-life score, and 6-minute hall walk distance.ResultsOne hundred forty-six patients were randomized, 70 to control and 76 to treatment. The major adverse neurological and cardiovascular event–free rate was 97.2% (lower 95% confidence bound 91.4%). Patients assigned to BAT, compared with control group patients, experienced improvements in the distance walked in 6 min (59.6 ± 14 m vs. 1.5 ± 13.2 m; p = 0.004), quality-of-life score (–17.4 ± 2.8 points vs. 2.1 ± 3.1 points; p < 0.001), and NYHA functional class ranking (p = 0.002 for change in distribution). BAT significantly reduced N-terminal pro–brain natriuretic peptide (p = 0.02) and was associated with a trend toward fewer days hospitalized for HF (p = 0.08).ConclusionsBAT is safe and improves functional status, quality of life, exercise capacity, N-terminal pro–brain natriuretic peptide, and possibly the burden of heart failure hospitalizations in patients with GDMT-treated NYHA functional class III HF. (Barostim Neo System in the Treatment of Heart Failure; NCT01471860; Barostim HOPE4HF [Hope for Heart Failure] Study; NCT01720160