In Vitro Evaluation of a Novel Image Processing Device to Estimate Surgical Blood Loss in Suction Canisters.

BACKGROUND: Clinicians are tasked with monitoring surgical blood loss. Unfortunately, there is no reliable method available to assure an accurate result. Most blood lost during surgery ends up on surgical sponges and within suction canisters. A novel Food and Drug Administration-cleared device (Triton system; Gauss Surgical, Inc, Los Altos, CA) to measure the amount of blood present on sponges using computer image analysis has been previously described. This study reports on performance of a complementary Food and Drug Administration-cleared device (Triton Canister System; Gauss Surgical, Inc, Los Altos, CA) that uses similar image analysis to measure the amount of blood in suction canisters. METHODS: Known quantities of expired donated whole blood, packed red blood cells, and plasma, in conjunction with various amounts of normal saline, were used to create 207 samples representing a wide range of blood dilutions commonly seen in suction canisters. Each sample was measured by the Triton device under 3 operating room lighting conditions (bright, medium, and dark) meant to represent a reasonable range, resulting in a total of 621 measurements. Using the Bland-Altman method, the measured hemoglobin (Hb) mass in each sample was compared to the results obtained using a standard laboratory assay as a reference value. The analysis was performed separately for samples measured under each lighting condition. It was expected that under each separate lighting condition, the device would measure the various samples within a prespecified clinically significant Hb mass range (±30 g per canister). RESULTS: The limits of agreement (LOA) between the device and the reference method for dark (bias: 4.7 g [95% confidence interval {CI}, 3.8-5.6 g]; LOA: -8.1 g [95% CI, -9.7 to -6.6 g] to 17.6 g [95% CI, 16.0-19.1 g]), medium (bias: 3.4 g [95% CI, 2.6-4.1 g]; LOA: -7.4 g [95% CI, -8.7 to -6.1 g] to 14.2 g [95% CI, 12.9-15.5 g]), and bright lighting conditions (bias: 4.1 g [95% CI, 3.2-4.9 g]; LOA: -7.6 g [95% CI, -9.0 to -6.2 g] to 15.7 g [95% CI, 14.3-17.1 g]) fell well within the predetermined clinically significant limits of ±30 g. Repeated measurements of the samples under the various lighting conditions were highly correlated with intraclass correlation coefficient of 0.995 (95% CI, 0.993-0.996; P < .001), showing that lighting conditions did not have a significant impact on measurements. Hb mass bias was significantly associated with hemolysis level (Spearman ρ correlation coefficient, -0.137; P = .001) and total canister volume (Spearman ρ correlation coefficient, 0.135; P = .001), but not ambient illuminance. CONCLUSIONS: The Triton Canister System was able to measure the Hb mass reliably with clinically acceptable accuracy in reconstituted blood samples representing a wide range of Hb concentrations, dilutions, hemolysis, and ambient lighting settings.

Real-time evaluation of an image analysis system for monitoring surgical hemoglobin loss.

Monitoring blood loss is important for management of surgical patients. This study reviews a device (Triton) that uses computer analysis of a photograph to estimate hemoglobin (Hb) mass present on surgical sponges. The device essentially does what a clinician does when trying to make a visual estimation of blood loss by looking at a sponge, albeit with less subjective variation. The performance of the Triton system is reported upon in during real-time use in surgical procedures. The cumulative Hb losses estimated using the Triton system for 50 enrolled patients were compared with reference Hb measurements during the first quarter, half, three-quarters and full duration of the surgery. Additionally, the estimated blood loss (EBL) was calculated using the Triton measured Hb loss and compared with values obtained from both visual estimation and gravimetric measurements. Hb loss measured by Triton correlated with the reference method across the four measurement intervals. Bias remained low and increased from 0.1 g in the first quarter to 3.7 g at case completion. The limits of agreement remained narrow and increased proportionally from the beginning to the end of the cases, reaching a maximum range of -15.3 to 22.7 g. The median (IQR) difference of EBL derived from the Triton system, gravimetric method and visual estimation versus the reference value were 13 (74), 389 (287), and 4 (230) mL, respectively. Use of the Triton system to measure Hb loss in real-time during surgery is feasible and accurate.

In vitro evaluation of a novel system for monitoring surgical hemoglobin loss.

BACKGROUND: Accurate measurement of intraoperative blood loss is an important clinical variable in managing fluid resuscitation and avoiding unnecessary transfusion of blood products. In this study, we measured surgical blood loss using a tablet computer programmed with a unique algorithm modeled after facial recognition technology. The aim of the study was to assess the accuracy and performance of the system on surgical laparotomy sponges in vitro. METHODS: Whole blood samples of premeasured hemoglobin (Hb) and volume were reconstituted from units of human packed red blood cells and plasma and distributed across surgical laparotomy sponges. Normal saline was added to simulate the presence of varying levels of hemodilution and/or irrigation use. Soaked sponges from 4 different manufacturers were scanned using the Triton System with Feature Extraction Technology (Gauss Surgical, Inc., Palo Alto, CA) under 3 different ambient light conditions in an operating room. Accuracy of Hb loss measurement was evaluated relative to the premeasured values using linear regression and Bland-Altman analysis. Correlations between studied variables and measurement bias were analyzed using nonparametric tests. RESULTS: The overall mean percent error for measure of Hb loss for the Triton System was 12.3% (95% confidence interval [CI], 8.2%-16.4%). A strong positive linear correlation between the premeasured and actual Hb masses was noted across the full range of intraoperative lighting conditions, including (A) high (r = 0.95 [95% CI, 0.93-0.96]), (B) medium (r = 0.94 [95% CI, 0.93-0.96]), and (C) low (r = 0.90 [95% CI, 0.87-0.93]) mean ambient light intensity. Bland-Altman analysis revealed a bias of 0.01 g [95% CI, -0.03 to 0.06 g] of Hb per sponge between the 2 measures. The corresponding lower and upper limits of agreement were -1.16 g (95% CI, -1.21 to -1.12 g) per sponge and 1.19 g (95% CI, 1.15-1.24 g) per sponge, respectively. Measurement bias of estimated blood loss and Hb mass using the new system were not associated with the volume of saline used to reconstitute the samples (P = 0.506 and P = 0.469, respectively), suggesting that the system is robust under a wide range of sponge saturation conditions. CONCLUSIONS: Mobile blood loss monitoring using the Triton system is accurate in assessing Hb mass on surgical sponges across a range of ambient light conditions, sponge saturation, saline contamination, and initial blood Hb. Utilization of this tool could significantly improve the accuracy of blood loss estimates.

Clinical evaluation of a novel system for monitoring surgical hemoglobin loss.

BACKGROUND: Accurate measurement of intraoperative blood loss is an important clinical variable in managing fluid resuscitation and avoiding unnecessary transfusion of blood products. In this study, blood lost onto laparotomy sponges during surgical cases was measured using a tablet computer programmed with a unique algorithm modeled after facial recognition technology. In this study, we assessed the accuracy and performance of the system in surgical cases. METHODS: In this prospective, multicenter study, 46 patients undergoing surgery with anticipated significant blood loss contributed laparotomy sponges for hemoglobin (Hb) loss measurement using the Triton System with Feature Extraction Technology (Gauss Surgical, Inc., Los Altos, CA). The Hb loss measured by the new system was compared with that measured by manual rinsing of the sponges. Accuracy was evaluated using linear regression and Bland-Altman analysis. In addition, the new system's calculation of blood volume loss was compared with the gravimetric method of estimating blood loss from intraoperative sponge weights. RESULTS: A significant positive linear correlation was noted between the new system's measurements and the rinsed Hb mass (r = 0.93, P < 0.0001). Bland-Altman analysis revealed a bias of 9.0 g and narrow limits of agreement (-7.5 to 25.5 g) between the new system's measures and the rinsed Hb mass. These limits were within the clinically relevant difference of ±30 g, which is approximately half of the Hb content of a unit of allogeneic whole blood. Bland-Altman analysis of the estimated blood loss on sponges using the gravimetric method demonstrated a bias of 466 mL (overestimation) with limits of agreement of -171 and 1103 mL, due to the presence of contaminants other than blood on the laparotomy sponges. CONCLUSIONS: The novel mobile monitoring system provides an accurate measurement of Hb mass on surgical sponges as compared with that of manual rinsing measurements and is significantly more accurate than the gravimetric method. Further study is warranted to assess the clinical use of the technology.

Stationary versus agitated storage of whole blood during acute normovolemic hemodilution.

BACKGROUND: Acute normovolemic hemodilution is an intraoperative technique to reduce the number of red blood cells lost in shed blood during surgery. Standard guidelines for storage of platelets recommend constant gentle agitation to maintain gas exchange for the metabolically active platelets. The collected whole blood (WB) for acute normovolemic hemodilution remains stationary for as long as 8 hours before reinfusion. We hypothesized that gentle agitation of WB throughout storage would improve the coagulation properties of the WB at the time of reinfusion. METHODS: WB was collected from 10 volunteer donors and control samples taken. The units were split in 2 storage groups: agitated (rocked) and stationary (unrocked). Cell counts and fibrinogen levels, as well as thromboelastography (TEG®) measurements, including TEG® PlateletMapping® assays, were performed on the control sample and the test samples after 8 hours of rocked or unrocked storage at room temperature. RESULTS: Nine units WB from 9 different healthy volunteers were tested. There were no significant differences in hematocrit, hemoglobin, red blood cells counts, platelet counts, or fibrinogen levels between the control samples and the rocked and unrocked WB samples. WB coagulation as measured by TEG® was preserved during the 8-hour storage period in both the rocked and unrocked samples. There were no significant differences between the control, rocked, and unrocked samples in time to initiate clotting, time of clot formation, rate of clot formation, or maximum strength of clot values. There were also no significant differences in the fibrin contribution to clot strength between the control, rocked, and unrocked samples, and no significant difference between the platelet activation from adenosine diphosphate or arachidonic acid among any of the 3 groups. CONCLUSIONS: Given the small sample size, there is no statistical evidence on which to reject the null hypothesis of there being no difference in the changes from the baseline between coagulation function as measured by TEG® between WB that is either agitated or kept stationary for 8 hours. These findings need to be confirmed in a larger study.

The effect of salvaged blood on coagulation function as measured by thromboelastography.

BACKGROUND: There is concern that salvaged blood has the potential to activate the coagulation system, which might place patients at risk of thrombotic complications. The aim of this study was to determine whether transfusion of salvaged blood after total knee arthroplasty (TKA) would lead to procoagulopathic changes as measured by thromboelastography (TEG) and furthermore if washing would reduce this risk. STUDY DESIGN AND METHODS: Twenty-two patients undergoing TKA were enrolled. Control samples were venous blood samples taken before surgery. Test samples were created by mixing the control samples with postoperatively salvaged blood, either washed or unwashed. TEG profiles were measured, noting the time to initiate clotting (R), the time of clot formation (K), the angle of clot formation (α-angle), and the maximum amplitude (clot strength [MA]). RESULTS: The changes in the coagulation profile from control samples to test samples were consistent for both the washed and the unwashed groups: R time decreased, MA decreased, and K and α-angle remained the same. However, the changes were more pronounced in the unwashed group than the washed group, with a 61% decrease in R time compared with 14%, and a 26% decrease in MA compared with 6%. CONCLUSION: The addition of salvaged blood to the patient's preoperative blood resulted in decreased MA as well as decreased R time. This suggests that the reinfusion of postoperatively salvaged washed or unwashed blood after TKA favors a change toward a more hypocoagulable state, and washing appears to reduce this effect.

Human tissue-engineered blood vessels for adult arterial revascularization.

There is a crucial need for alternatives to native vein or artery for vascular surgery. The clinical efficacy of synthetic, allogeneic or xenogeneic vessels has been limited by thrombosis, rejection, chronic inflammation and poor mechanical properties. Using adult human fibroblasts extracted from skin biopsies harvested from individuals with advanced cardiovascular disease, we constructed tissue-engineered blood vessels (TEBVs) that serve as arterial bypass grafts in long-term animal models. These TEBVs have mechanical properties similar to human blood vessels, without relying upon synthetic or exogenous scaffolding. The TEBVs are antithrombogenic and mechanically stable for 8 months in vivo. Histological analysis showed complete tissue integration and formation of vasa vasorum. The endothelium was confluent and positive for von Willebrand factor. A smooth muscle-specific alpha-actin-positive cell population developed within the TEBV, suggesting regeneration of a vascular media. Electron microscopy showed an endothelial basement membrane, elastogenesis and a complex collagen network. These results indicate that a completely biological and clinically relevant TEBV can be assembled exclusively from an individual's own cells.

Stored platelet functionality is not decreased after warming with a fluid warmer.

BACKGROUND: Warming of IV-administered fluids and blood products is routinely performed in the operating room to help maintain normothermia. Current guidelines recommend against the warming of platelets (PLTs), although there is no evidence for this prohibition in the literature. Our goal in this pilot study was to determine whether the warming of stored PLTs had any effect on their function. METHODS: Ten units of 3-day-old, PLT-rich plasma-derived whole blood PLTs were acquired from the transfusion service. A 5-mL aliquot was taken from each unit before warming (control samples). The remainder of the unit was then passed into a blood-warming device and held there for 2 minutes. Postwarming (warmed) PLT samples were then collected from the effluent end of the warming device. PLT aggregometry assays with adenosine diphosphate, collagen, and arachidonic acid as agonists were performed on the control and warmed samples. Thromboelastography tests were also performed on the control and warmed samples from 6 of the 10 PLT units. RESULTS: The mean temperature of the control and warmed samples was 22.4°C ± 0.5°C and 37.8°C ± 2.3°C, respectively. There was no significant difference (all P ≥ 0.13) in any of the PLT aggregometry assays or in the maximum amplitude of the thromboelastography test between the control and the warmed samples. The observed mean of only 1 parameter decreased (PLT aggregometry with 5 µM adenosine diphosphate) by 5% (95% confidence interval, -115% to 105%). The maximum change observed was PLT aggregometry with arachidonic acid as agonist, which increased by 116% (95% confidence interval, -91% to 323%). CONCLUSION: Although small in size, the results of this study do not support the prohibition against mechanical PLT warming. Studies of PLT activation after warming are also warranted.

Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty.

The objective of this study was to determine if tranexamic acid (TXA) applied topically reduced postoperative bleeding and transfusion rates after primary total hip arthroplasty (THA) and primary total knee arthroplasty (TKA). Two hundred and ninety consecutive patients from a single surgeon were enrolled. In TKA, TXA solution was injected into the knee after closure of the arthrotomy. In THA, the joint was bathed in TXA solution at three points during the procedure. In both THA and TKA the TXA solution was at a concentration of 3 g TXA per 100 mL saline. The mean blood loss was significantly higher in the non-TXA patients in both TKA and THA groups. Postoperative transfusions decreased dramatically with TXA, dropping from 10% to 0%, and from 15% to 1%, in the TKA and THA groups, respectively. Topical application of TXA significantly reduces postoperative blood loss and transfusion risk in TKA and THA.

Treatment strategies of arterial steal after arteriovenous access.

INTRODUCTION: Ischemic steal syndrome (ISS) associated with arteriovenous (AV) access is rare but can result in severe complications. Multiple techniques have been described to treat ISS with varying degrees of success. This study compares the management and success associated with these techniques. METHODS: Patients with ISS between June 2003 and June of 2008 at the University of Pittsburgh Medical Center were retrospectively reviewed. Demographics, type of AV access, management technique, and success of intervention were recorded. Success was defined as resolution of ISS symptoms while preserving access function. One hundred consecutive AV access procedures were reviewed for comparison. Data were analyzed using χ(2) test, Fisher's exact test, and Student's t test. The study was approved by our institutional review board. RESULTS: A total of 114 patients with ISS had a mean age of 65 years (range, 20-90 years), were predominantly female (66%), diabetic (61%), and with a brachial origin fistula (69%). Risk factors for ISS included coronary artery disease (CAD; P < .001), hypertension (P < .001), and tobacco use (P = .048). Women were noted to have a brachial origin access more frequently than men (odds ratio [OR], 3.1; P = .009). Forty-four patients with mild steal were observed. Seventy patients underwent 87 procedures. Procedures performed included ligation (n = 27), banding (n = 22), distal revascularization and interval ligation (DRIL; n = 21), improvement of proximal inflow (n = 9), revision using distal inflow (RUDI; n = 4), and proximalization of arterial inflow (PAI; n = 3). Early procedures (<30 days from the index fistula) were mostly ligation (50%) or banding (38%), while DRIL was the most frequent choice for late interventions (41%). Banding had a high failure rate (62%) and was the most common reason for reintervention (8 of 11, 73%) and DRIL had a better success rate than banding (P ≤ .05). In our current practice, 18% of patients had an AV fistula with the proximal radial artery (PRA) as the inflow source, while this type of fistula accounted for only 2% of all ISS patients. Ligation resolved symptoms in all patients, but the AV access was lost. CONCLUSIONS: Risk factors for development of ISS include CAD, diabetes, female gender, hypertension, and tobacco use. Among various options to treat ISS, banding has a low success rate and high likelihood for reintervention, while DRIL is particularly effective although not uniformly. Less invasive treatment options such as RUDI and PAI may be quite effective in treating ISS. Use of the PRA as the inflow source may decrease the incidence of ISS.

Case Report of Remifentanil Labor Analgesia for a Pregnant Patient With Congenital Methemoglobinemia Type 1.

Congenital methemoglobinemia is a rare disease characterized by cyanosis and a left shifting of the oxyhemoglobin dissociation curve. The disease necessitates avoidance of certain medications commonly used in obstetrics, making labor analgesia and anesthesia challenging. We present a case report of peripartum anesthetic management of a pregnant patient with congenital methemoglobinemia type 1 who received remifentanil labor analgesia and continuous methemoglobin monitoring. Continuous real-time monitoring of methemoglobin concentrations may prove to be a useful monitor in future care settings. A review of literature encompassing various perioperative and obstetric anesthesia and analgesia management considerations is presented.

Clinical Utility of Autologous Salvaged Blood: a Review.

INTRODUCTION: Autologous salvaged blood, commonly referred to as "cell saver" or "cell salvage" blood, is an important method of blood conservation. Understanding the mechanism of action and summarizing the existing evidence regarding the safety, efficiency, and the relative costs of cell salvage may help educate clinicians on how and when to best utilize autotransfusion. METHODS: This review focuses on issues concerning the quality of red blood cells (RBC), efficiency, and the cost effectiveness relative to autotransfusion. The key considerations of safe use and clinical applicability are described along with the challenges for wider dissemination. RESULTS: Cell salvage can reduce requirements for allogeneic transfusions, along with the associated risks and costs. Autologous salvaged RBCs provide high-quality transfusion, since the cells have not been subjected to the adverse effects of storage as occurs with banked blood. The risks for RBC alloimmunization and transfusion-related infectious diseases are also avoided. With a careful selection of cases, salvaged blood can be more cost effective than donor blood. Cell salvage may have a role in cardiac, major vascular, orthopedic, transplant, and trauma surgeries. However, there remain theoretical safety concerns in cases with bacterial contamination or in cancer surgery. CONCLUSION: In addition to other methods of blood conservation used in patient blood management programs, autologous salvaged blood adds value and is cost effective for appropriate surgical cases. Evidence suggests that autologous salvaged blood may be of higher quality and confer a cost reduction compared with the allogeneic banked blood, when used appropriately.

Pharmacomechanical thrombectomy for iliofemoral deep vein thrombosis: an alternative in patients with contraindications to thrombolysis.

OBJECTIVE: Venous lysis is usually reserved for symptomatic patients with acute deep vein thrombosis (DVT) and low risk for bleeding. This study reports the use of pharmacomechanical thrombectomy (PMT) in patients with contraindications to thrombolysis. METHODS: A retrospective review of all patients with symptomatic DVT treated between 2007 and 2008 with PMT was performed. All patients were treated by a combination of local tissue plasminogen activator (tPA) with the Angiojet (Possis Medical, Minneapolis, Minn) or Trellis device (Bacchus Vascular, Santa Clara, Calif). Catheter-directed lysis was used sparingly. RESULTS: Forty-three patients (mean age, 48.4 +/- 16.6 years) presented with symptoms averaging 13.6 +/- 9.6 days in duration. Nineteen (44%) had symptoms for >14 days, and 15 (35%) had a high risk for bleeding. Symptomatic subclavian thrombosis occurred in eight (19%), and 35 (81%) presented with disabling lower extremity DVT (4 phlegmasia) despite anticoagulation. Fifteen patients had a thrombosed indwelling permanent filter. Sixty-three percent were treated in one session, but 16 patients required a lytic infusion after suboptimal PMT. Iliac stenting was required in 35% of limbs treated. Successful lysis (>50%) was achieved in 95% of patients and symptom resolution in 93%. All patients became ambulatory with no or minimal limitation. There were no major systemic bleeding complications, but access site hematoma occurred in two patients and worsening of pre-existing rectus sheath hematoma requiring transfusion occurred in another two. Limb salvage was maintained in 100% of patients who presented with phlegmasia. Mean follow-up was 5.0 +/- 4.8 months. Freedom from DVT recurrence and reintervention was 95% at 9 months by life-table analysis. CONCLUSIONS: PMT can be safely and effectively used for subacute iliocaval and iliofemoral DVT and in patients with contraindications for lytic therapy, resulting in improved functional outcomes relative to their debilitated state before the procedure.

Mechanical properties of completely autologous human tissue engineered blood vessels compared to human saphenous vein and mammary artery.

We have previously reported the initial clinical feasibility with our small diameter tissue engineered blood vessel (TEBV). Here we present in vitro results of the mechanical properties of the TEBVs of the first 25 patients enrolled in an arterio-venous (A-V) shunt safety trial, and compare these properties with those of risk-matched human vein and artery. TEBV average burst pressures (3490+/-892 mmHg, n=230) were higher than native saphenous vein (SV) (1599+/-877 mmHg, n=7), and not significantly different from native internal mammary artery (IMA) (3196+/-1264 mmHg, n=16). Suture retention strength for the TEBVs (152+/-50 gmf) was also not significantly different than IMA (138+/-50 gmf). Compliance for the TEBVs prior to implantation (3.4+/-1.6%/100 mmHg) was lower than IMA (11.5+/-3.9%/100 mmHg). By 6 months post-implant, the TEBV compliance (8.8+/-4.2%/100 mmHg, n=5) had increased to values comparable to IMA, and showed no evidence of dilation or aneurysm formation. With clinical time points beyond 21 months as an A-V shunt without intervention, the mechanical tests and subsequent lot release criteria reported here would seem appropriate minimum standards for clinical use of tissue engineered vessels.