Median Transfusion Requirement Research Articles

After 9,000 laparotomies for blunt trauma, resuscitation is becoming more balanced and time to intervention shorter: Evidence in action.

Several advancements in hemorrhage control have been advocated for in the past decade, including balanced transfusions and earlier times to intervention. The aim of this study was to examine the effect of these advancements on outcomes of blunt trauma patients undergoing emergency laparotomy. This is a 5-year (2013-2017) analysis of the Trauma Quality Improvement Program. Adult (18 years or older) blunt trauma patients with early (≤4 hours) packed red blood cell (PRBC) and fresh frozen plasma (FFP) transfusions and an emergency (≤4 hours) laparotomy for hemorrhage control were identified. Time-trend analysis of 24-hour mortality, PRBC/FFP ratio, and time to laparotomy was performed over the study period. The association between mortality and PRBC/FFP ratio, patient demographics, injury characteristics, transfusion volumes, and American College of Surgeons verification level was examined by hierarchical regression analysis adjusting for interyear variability. A total of 9,773 blunt trauma patients with emergency laparotomy were identified. The mean ± SD age was 44 ± 18 years, 67.5% were male, and median Injury Severity Score was 34 (range, 24-43). The mean ± SD systolic blood pressure at presentation was 73 ± 28 mm Hg, and the median transfusion requirements were PRBC 9 (range, 5-17) and FFP 6 (range, 3-12). During the 5-year analysis, time to laparotomy decreased from 1.87 hours to 1.37 hours ( p < 0.001), PRBC/FFP ratio at 4 hours decreased from 1.93 to 1.71 ( p < 0.001), and 24-hour mortality decreased from 23.0% to 19.3% ( p = 0.014). On multivariate analysis, decreased PRBC/FFP ratio was independently associated with decreased 24-hour mortality (odds ratio, 0.88; p < 0.001) and in-hospital mortality (odds ratio, 0.89; p < 0.001). Resuscitation is becoming more balanced and time to emergency laparotomy shorter in blunt trauma patients, with a significant improvement in mortality. Future efforts should be directed toward incorporating transfusion practices and timely surgical interventions as markers of trauma center quality. Therapeutic/care management, level III.

Preemptive VAE-An Important Tool for Managing Blood Loss in MVT Candidates With PMT.

Background.Explantation of native viscera in multivisceral transplant candidates, particularly in those with extensive portomesenteric thrombosis (PMT), carries considerable morbidity due to extensive vascularized adhesions. Preemptive visceral angioembolization has been previously described as a technique to minimize excessive blood loss during mobilization of the native viscera but is not well described specifically in patients with extensive PMT.Methods.In a series of 5 patients who underwent mutivisceral transplant for PMT from June 2015 to November 2018, we performed preoperative superior mesenteric, splenic, and hepatic artery embolization to reduce blood loss during explanation and evaluated the blood loss and blood product utilization, as well as 30-day rates of infectious complications.Results.Following preemptive embolization, median total blood loss was 6000 mL (range 800–7000 mL). The median transfusion requirements were as follows: 16 units packed red blood cells (range 2–47), 14 units fresh frozen plasma (range 0–29), 2 units cryoprecipitate (range 1–14), 4 units platelets (range 2–10), and 500 mL cell saver autotransfusion (range 0–1817). In the first 30 postoperative days, 2 out of 5 patients developed positive blood cultures and 3 out of 5 developed complex intra-abdominal infections. Two patients developed severe graft pancreatitis resulting in mycotic aneurysm of the aortic conduit; bleeding from the aneurysm led to 1 patient mortality.Conclusions.Preoperative embolization is an effective modality to mitigate exsanguinating blood loss during multivisceral transplant in patients with portomesenteric thrombosis; however, it is unclear if the resultant native organ ischemia during explant carries clinically relevant consequences.

Bevacizumab for treating Hereditary Hemorrhagic Telangiectasia patients with severe hepatic involvement or refractory anemia.

ObjectiveTo report our clinical experience with bevacizumab in a cohort of Hereditary Hemorrhagic Telangiectasia (HHT) patients with severe hepatic involvement and/or refractory anemia.MethodsObservational, ambispective study of the Institutional Registry of HHT at Hospital Italiano de Buenos Aires. Patients were treated with bevacizumab due to iron deficiency refractory anemia secondary to nasal/gastrointestinal bleeding and/or high output cardiac failure. We describe basal clinical data, bevacizumab schedules, efficacy outcomes and adverse events. Wilcoxon signed ranks test and longitudinal analysis were conducted.ResultsTwenty adult patients were included from July 2013 to June 2019. Clinical indications were: 13 for anemia, 4 for heart failure and 3 for both. In the anemia group, median pretreatment hemoglobin was 8.1 g/dl [IQR: 7.2–8.4] and median transfusion requirement was 4 units [2–6]. In heart failure group, pretreatment median cardiac index was 4.5 L/min/m2 [4.1–5.6] and cardiac output was 8.3 L/min [7.5–9.2]. Bevacizumab 5 mg/kg/dose every 2 weeks for 6 applications was scheduled. By the end of induction, median hemoglobin at 3 months was 10.9 g/dl [9.5–12.8] (p = 0.01) and median transfusion requirement 0 units [0–1] (p<0.01), and this effect was more or less sustained during a year. Regarding heart failure group, two patients had complete hemodynamic response and achieved liver transplantation and two had partial response. No serious adverse events were registered.ConclusionBevacizumab is a promising line of treatment for HHT patients with refractory anemia. For patients with high output cardiac failure, bevacizumab may be useful as bridge therapy awaiting for liver transplantation.

Incidence of Massive Transfusion and Overall Transfusion Requirements During Lung Transplantation Over a 25-Year Period

To establish the incidence of massive transfusion and overall transfusion requirements during lung transplantation, changes over time, and association with outcome in relation to patient complexity. Retrospective cohort study. University hospital. All 514 adult patients who underwent transplantation from 1990 until 2015. None. Patient records and transfusion data, divided into 5-year intervals, were analyzed. The incidence of massive transfusion (>10 units of red blood cells [RBCs] in 24 h) was 27% and did not change over time, whereas the median (interquartile range) transfusion requirement in the whole cohort decreased from 8 (5-12) to 3 (0-10) RBCs (p < 0.001). In patients transplanted from the intensive care unit, the incidence of massive transfusion increased over time from 25% to 54% (p = 0.04) and median transfusion requirements from 4.5 (3-8.5) units to 14.5 (5-26) units of RBCs (p = 0.03). Multivariable analysis showed that circulatory support, pulmonary hypertension, re-transplantation, cystic fibrosis, Eisenmenger syndrome, bilateral transplantation, and low body mass index were associated with massive transfusion. Patients with massive transfusion had more primary graft dysfunction grade III at 0, 24, 48, and 72 hours (p < 0.001), higher 30-day mortality (13% v 4%; p < 0.001), and lower 5-year survival (hazard ratio 3.67 [95% confidence interval 1.72-7.85]; p < 0.001). The incidence of massive transfusion did not change over time, whereas transfusion requirements in the whole cohort decreased. In patients transplanted from the intensive care unit, massive transfusion and transfusion requirements increased. Massive transfusion was associated with poor outcome.

Characteristics Associated With Mortality in 372 Patients Receiving Low-Dose Recombinant Factor VIIa (rFVIIa) for Cardiac Surgical Bleeding

Activated recombinant factor VII (rFVIIa) has been used to treat cardiac surgical bleeding in an off-label manner. This observational report analyzes the outcomes with use of a low dose and early administration of rFVIIa for cardiac surgical bleeding. A retrospective, observational study. Single-center, tertiary care cardiothoracic surgical setting. A total of 6,862 patients underwent cardiac surgery from January 2012 to January 2018. Of those, 372 patients received rFVIIa perioperatively. An institutional policy directed low-dose, incremental aliquots of intravenous rFVIIa (0.5-1 mg). Characteristics and outcomes were compared among patients who survived (n = 328) and patients who died (n = 44). The median dose of rFVIIa was low at 13.29 μg/kg. Higher doses were given to patients who died (15.79 μg/kg v 12.99 μg/kg; p = 0.0133). Patients who died received more blood and component transfusions (median 9 products in those who died v 6 products in survivors; p = 0.0022), although the median transfusion requirement for all patients was 6 units per patient. The rate of reoperation was not different in the 2 groups. Mortality was associated with emergent/urgent surgical procedures (p = 0.0282), type of surgical procedure with aortic procedures being highest risk (p = 0.0014), cardiogenic shock (p = 0.0028), postoperative renal failure (p = 0.0035), postoperative cardiac arrest (p = 0.0006), and ischemic stroke (p = 0.0084). Mortality after life-threatening cardiac surgical bleeding treated with rFVIIa was more common in aortic procedures and emergent and urgent surgeries. Lower doses of rFVIIa than previously reported may achieve bleeding cessation because overall blood component transfusions were low in this cohort.

Ferric carboxymaltose reduces the number of red blood cell units transfused and allows transfusion independence to be obtained in patients with iron deficiency anemia secondary to gastrointestinal chronic blood loss

The aim of this study was to evaluate the effectiveness of ferric carboxymaltose (FCM) in patients with iron deficiency anemia (IDA) secondary to gastrointestinal chronic blood loss (CBL), who received chronic transfusion support. We retrospectively evaluated 38 patients with IDA (hemoglobin [Hb] < 10 g/dL and ferritin < 12 ng/mL or transferrin saturation [TSAT] < 16%) refractory or intolerant to oral iron therapy that necessitated transfusion support in the previous 12 months. They were treated with FCM (500-2500 mg). The primary endpoint was to evaluate the reduction of transfusion requirements (red blood cell [RBC] units) after FCM treatment. The median age of the cohort was 78 years, with a male:female ratio of 22:16. Before FCM treatment a median of 6 RBC units had been transfused. At the treatment (T0) the median value of Hb was 8.7 g/dL, the TSAT 6%, and ferritin 12 ng/mL. The median FCM dose was 1000 mg. At 5 weeks from T0 the median Hb level was 11 g/dL, with a median increase of 2.4 g/dL. With a median follow-up of 326 days, the median transfusion requirement was 0 RBC units, significantly lower than before T0 (p < 0.001). Overall 17 patients still necessitated transfusion support. Twenty-three patients needed retreatment with FCM for recurrence of IDA: 10 of them obtained a response again. The percentage of transfusion-independent patients at median follow-up was equal to 52%. In patients with IDA secondary to CBL, FCM significantly reduces the need of transfusions and achieves transfusion independence in half of the cases.

Surgical Management and Oncologic Outcomes of Recurrent Venous Tumor Thrombus after Prior Nephrectomy for Renal Cell Carcinoma

BackgroundWhile the management of a venous tumor thrombus in renal cell carcinoma is well described, there is a paucity of evidence to guide care in patients who recur within the vena cava. ObjectiveTo report our experience with patients presenting with recurrent venous tumor thrombi after prior radical nephrectomy. Design, setting, and participantsA retrospective review of 16 patients from 1970 to 2013 with a history of renal cell carcinoma treated surgically for a recurrent tumor thrombus unrelated to a new renal tumor. InterventionRecurrent tumor thrombectomy. Outcome measurements and statistical analysisIntraoperative outcomes, recurrence-free survival, and cancer-specific survival following resection. Results and limitationsOf the 16 patients, three patients were diagnosed with synchronous widely metastatic disease, did not undergo recurrent tumor thrombectomy, and died within 6 mo. Among the remaining 13 repeat surgical patients, the median age was 67 (range: 48–76) yr with a median time from prior nephrectomy to diagnosis of 6 (range: 3–58) mo. Nine patients had known tumor thrombus at nephrectomy, all of whom were thought to have complete tumor thrombectomy at initial surgery. During exploration for recurrent thrombus, surgical resection was completed in 11, with a median blood loss of 2500 (range: 200–7000) ml, and a median transfusion requirement of four (range: 0–18) units. At a median follow-up of 12 mo all patients had recurred and died of disease. The median time to recurrence and death was 4 mo and 12 mo following repeat exploration, respectively. ConclusionsRecurrent tumor thrombectomy is a technically feasible yet challenging operation. Survival is poor in this population with metastatic progression appreciated in all patients in our series. Patient summaryIn this report we evaluated outcomes for patients presenting with vena cava tumor thrombus after prior nephrectomy for renal cell carcinoma. We found that surgical excision is complex yet feasible and that survival following resection was poor.

A decade of pelvic vascular injuries during the Global War on Terror

Pelvic vascular injuries (PVIs) rarely occur in isolation and are often associated with significant morbidity. The purpose of this study was to examine the incidence, trends, and early outcomes of PVIs sustained in combat. The Department of Defense Trauma Registry was queried to identify all patients treated with PVIs during the first 10years of Operation Enduring Freedom. Patient demographics, mechanism of injury, type of vascular injury, in-theater complications, and early clinical outcomes were examined. From 2003 to 2012, 143 patients (99% male) sustained a PVI in Afghanistan. During this period, there was a persistent increase in the percentage of patient visits (0.4% in 2003 to 2.0% in 2012). The mean Injury Severity Score (ISS) was 24. Sixty-six percent of patient injuries were secondary to explosions. Improvised explosive devices (IEDs) encountered by dismounted personnel accounted for 47% of all injuries and were associated with a significantly higher ISS (28) compared with all other mechanisms of injury (P< .01). There were 85 (43%) arterial and 112 (57%) venous PVIs. The most frequent arterial injury was the common iliac artery. Injury to the femoral vein was associated with a higher median transfusion requirement. One patient died in combat theater. Injuries from IEDs had higher rates of coagulopathy, acidosis, and hypothermia compared with other mechanisms of injury (P= .03). Forty-two patients (29%) sustained early infectious complications. Injuries from explosions were also associated with a significantly higher rate of infectious complications compared with other mechanisms of injury (P< .01). PVIs have occurred with increasing frequency during Operation Enduring Freedom. Despite a persistently low mortality, complication and infection rates remain high, particularly when injuries are secondary to explosions. IEDs are associated with higher ISS and complication rates. Future studies must continue to focus on the prevention and treatment of PVIs sustained in combat, particularly those caused by explosions.

PD35-07 EVALUATION AND MANAGEMENT OF RENAL FOSSA RECURRENCE FOLLOWING NEPHRECTOMY FOR RENAL CELL CARCINOMA

after surgical resection a flexible cystoscope is inserted into the vena cava for direct visual inspection of the caval lumen with high flow heparinized saline irrigation. Perioperative outcomes including estimated blood loss, transfusion requirements, residual tumor, changes in management due to findings at cavoscopy, and postoperative complications were analyzed. RESULTS: All patients underwent endoscopy of the vena caval lumen without complications. 8 of 32 patients were found to have residual tumor thrombus upon visualization of the lumen. Of these, six patients were noted to have tumor invasion of the intraluminal wall resulting in cavectomy. Residual intraluminal tumor was noted in 2 patients which was bluntly resected with no residual tumor visible on repeat endoscopy. Median estimated blood loss was 3L (0.5-16) with a median intraoperative transfusion requirement of 14 units (0-63 units). Median Pringle Maneuver time was 15 minutes (3-30 minutes). Median length of stay was 10 days (4-73 days). Postoperative lower extremity edema was noted in 5 patients (3 following cavectomy) with resolution in all patients and a median resolution time of 52 days (30-322 days). There were no complications associated with vena cavoscopy. CONCLUSIONS: Vena Cavoscopy using a flexible cystoscope is an expedient and feasible technique that may be utilized intra-operatively in order to ensure clearance of residual thrombus burden within the inferior vena cava or hepatic veins and to assess for caval wall invasion.

Activity of Lenalidomide in a Phase II Single Institution Study in Non-Del(5q) Transfusion Dependent, Patients with Low and Intermediate-1 Risklower-Risk, Non-Del(5q) Myelodysplastic Syndromes (MDS))): Results From a Single-Institution Phase II Study

Abstract 4929In a previous multi-center Phase II study, lenalidomide resulted in a 43% overall hematologic response with 26% of patients achieving transfusion independence (TI) among 214 non-del(5q) red blood cell (RBC) transfusion-dependent patients with International Prognostic Scoring System (IPSS) lower-risk MDS (Raza et al Blood. 2008). A single institution follow-up trial was conducted in patients with low or Int-1 risk non-del(5q) MDS, a platelet count of >50, 000 and requiredat least 2 units of blood required in 8 weeks. Fifty-six patients received lenalidomide at a starting dose of 10 mg qday. There were 41 males and 15 females, and the median age was 71 years. By IPSS, 27 had low-risk disease and 22 had Int-1-risk disease, while IPSS could not be assigned for 7 patients. By cytogenetics, 38 patients had a normal karyotype, 12 showed abnormalities, while data could not be obtained for 4 patients due to culture failure. Morphologic classification consisted of: RA=17, RCMD=16, RARS=4, RCMD-RS=7, RARS-T=1 and RAEB-1=11. Median duration of MDS was 12 months (range 1–120 months). Median transfusion requirement was 2 units in 8 weeks prior to starting therapy. Median duration of lenalidomide therapy was 4 months (range, 1–36+ months). Treatment was generally well tolerated. The most common Grade 3/4 toxicity was myelosuppression, with 17 (30%) experiencing thrombocytopenia, 12/(21%) neutropenia and 1 leukopenia (2%). Other Grade 3/4 toxicities included diarrhea (7%) rash (2%), and fatigue (2%). At least one dose reduction was required for 33 (59%) patients. Intent-to-treat analysis showed hematologic response (HI) by the IWG-R criteria in 23 (41%) patients, no response in 25(44%) patients, and other failure in 8 (14%) patients. Among the 23 responders, 18 (32%) achieved TI. Median time to response was 2 cycles (6 weeks), with 6 patients responding in cycle 1, 9 in cycle 2, 5 in cycle 3 and 1 each in cycles 4, 5, 6, respectively. Median duration of response was 294 days (approximately 10 months), with durations ranging from 44+ days to 936+ days (+ indicates continuing response). We confirm in this 56-patient, single institution phase II study that lenalidomide has substantial clinical activity in transfusion-dependent, lower-risk non-del(5q) MDS, with results comparable to those previously reported in the multi-center phase II study. Disclosures:No relevant conflicts of interest to declare.

Major liver resection without preoperative biliary drainage in jaundiced patients with hilar biliary obstruction

The need for routine use of preoperative biliary drainage (PBD) for major liver resection in jaundiced patients has recently been questioned. We present our experience of 22 consecutive patients with hilar biliary obstruction who underwent major liver resection without PBD between January 2007 and January 2011. Twenty-two patients with hilar biliary obstruction underwent major liver resection without PBD over a 4-year period; nineteen had malignant and 3 benign hilar strictures. Fifteen patients underwent right hepatectomy (7) or right trisectionectomy (8) and seven underwent left hepatectomy. Segment 4a was spared in all patients who underwent right trisectionectomy. Six patients had concomitant portal vein resection. Fourteen patients had varying degrees of lobar atrophy. The median preoperative bilirubin was 18 mg % (range 9.1 to 27 mg %). The median blood transfusion requirement was 2 units (range 1-6). There was one postoperative death from portal vein thrombosis. Three patients who underwent greater than 50 % resection developed postoperative ascites. Major liver resection leaving a liver remnant of 50 % is safe in jaundiced patients without PBD even when portal vein reconstruction is necessary. PBD should be used selectively.

Clinical significance of coagulation studies in predicting response to activated recombinant Factor VII in cardiac surgery patients

Clinical significance of coagulation studies in predicting response to activated recombinant Factor VII in cardiac surgery patients

Evaluation of Enteral Versus Parenteral Feeding As Nutritional Support In Allogeneic Hematopoietic Stem Cell Transplantation

Abstract 4576 IntroductionAllo-HSCT procedure is associated with a frequent and potentially severe malnutrition which could highly participate to the transplant-related morbidity (TRM). Optimal nutritional management is still poorly known while both enteral nutrition (EN) and parenteral nutrition (PN) are effective. We proposed to retrospectively evaluate the impact of EN versus PN as nutritional support on early outcome of allo-HSCT. Patients and methodsWe retrospectively analyzed all the successive patients who needed a nutritional support during their first allo-HSCT in our center from January 2009 to October 2010, excepting whose who had a progressive disease at time of transplant. Datas were compared in an intent to treat analysis according the EN or PN initial nutritional support strategy. ResultsWe analysed early outcome of 56 successive patients. Twenty of them received a myeloablative conditioning regimen and 36 a reduced intensity one. A total of 28 agreed to receive EN via a nasogastric feeding tube and the remaining 28 received PN. No significant difference in terms of age, diagnosis, disease status at transplant, conditioning regimens, stem cell source, GVHD nor antifungal secondary prophylaxis could be observed between the EN and PN groups. We found a lower median duration of fever in EN (2[0–8] vs. 5[0–17] (days); p=0.0026) and a lower need for antifungal therapy in EN group (7/28 vs. 17/28; p=0.0069), with a lower median duration of intravenous antifungal use (0 day [0–99] in EN vs. 7 days [0–93] in PN; p=0.00034) while incidence of bacteriemiae was not different. We observed a lower rate of replacement of central veinous catheter in EN group (3/28 in EN vs. 9/28 in PN; p=0.05) and a lower rate of transfer to ICU in the EN group (2/28 in EN vs. 8/28 in PN, p=0.036) but early death rate (<100 days) was the same in each group (4/28 vs. 4/28, p=NS). Median neutropenia and thrombopenia duration and median transfusion requirements were not significantly different. Fourteen patients in EN group and 18 in PN group presented a grade 3–4 oral mucositis (p=NS). Grade III-IV GVHD incidence was comparable in both groups (4/28 vs. 8/28; p=0.19). ConclusionCompared with PN, EN directly decreases the infectious risk, particularly the fungal risk, and its complications in allo-HSCT, without influencing hematopoietic toxicity nor GVHD incidence. Based on these encouraging results, we are now conducting a prospective, multicentric and randomized trial to confirm EN benefice in allo-HSCT. Disclosures:No relevant conflicts of interest to declare.

Clinical Significance of Coagulation Studies in Predicting Response to Recombinant Factor VIIa in Cardiac Surgery Patients

Abstract 4351 INTRODUCTION:While recombinant activated Factor VII (rFVIIa) is increasingly used for management of uncontrolled hemorrhage in a variety of clinical settings, its efficacy appears mixed. Few studies have examined the association between coagulation studies and rFVIIa efficacy in cardiac surgery. DESIGN/METHODS:We performed a retrospective study of all patients at Brigham and Women's Hospital (BWH) from February 2005 through March 2011 who received rFVIIa for uncontrolled hemorrhage during or after cardiac surgery. rFVIIa-mediated hemostasis was determined based on clinical descriptions in the medical record. Laboratory studies, clinical parameters, blood product transfusions, and chest tube output were compiled from the medical record. RESULTS AND DISCUSSION:Forty-seven patients were identified for this study. The median age was 65 years (range, 16–85). Thirty-one patients were male. Eleven had a perioperative left ventricular ejection fraction < 35%. Of 47 surgeries performed, 30 were emergent or urgent and 16 elective (data was missing in 1 case). Twelve required an intraaortic balloon pump, and 12 placement or removal of a ventricular assist device. Median cardiopulmonary bypass (CPB) time was 281.5 min (range, 104–744; n = 45). Over a median follow-up period of 52 days (range, 0–1673), 22 patients (46.8%) died, 10 within one day of receiving rFVIIa. Median survival was 443 days (90% confidence interval (CI) [30, not-yet-reached]). The median dose of rFVIIa was 40.2 mcg/Kg. rFVIIa-mediated hemostasis was achieved in 23 patients (48.9%), while continued bleeding was observed in 24 (51.1%). Thromboembolic complications attributed to rFVIIa developed in 9 patients (arterial, 5; venous, 4). Median transfusion requirements decreased after rFVIIa administration for the entire population, although the differences were not statistically significant. Survival status could not be reliably incorporated into models of transfusion requirements in this retrospective study, prohibiting further analysis.Mean coagulation studies before vs after rFVIIa were: PT, 24.9 sec +/− 18.3 (n = 44) vs 15.4 sec +/− 4.9 (n = 47); INR, 2.3 +/− 2.5 (n = 44) vs 1.2 +/− 0.5 (n = 47); and PTT, 57.3 sec +/− 27.2 (n = 40) vs 48.4 sec +/− 17.8 (n = 44), respectively. Plasma fibrinogen was excluded from the analysis, as levels were not measured in over one-third of cases. Univariate analyses identified several clinical or laboratory variables associated with rFVIIa-mediated hemostasis: PT after rFVIIa administration (p = 0.02 by Fisher's exact test), INR before rFVIIa (p = 0.05), INR after rFVIIa (p = 0.05), PTT after rFVIIa (p = 0.008), pH after rFVIIa (p = 0.04), and survival status (p = 0.008). In stepwise multivariable logistic regression analyses, only normalization of PTT after rFVIIa was significantly associated with rFVIIa-mediated hemostasis (odds ratio (OR) = 0.169, 95% CI [0.041,0.694], p = 0.01). Stepwise multivariable regression models of PT, INR, and PTT after rFVIIa showed a strong association of PTT and only a marginal association of PT with rFVIIa-mediated hemostasis (PTT: OR = 0.181, 95% CI [0.047,0.722], p = 0.02; PT: OR = 0.10, 95% CI [0.01,0.98], p = 0.05).Chest tube output was recorded for 14 patients who received rFVIIa in the CSICU rather than in an operating room. Of these, 8 (57.1%) had a reduction in chest tube output of ≥ 25% and 5 (21.4%) a reduction of ≥ 50%. While none of the variables examined showed a significant association with reduced chest tube output, concordance with rFVIIa-mediated hemostasis among this small subset of patients was poor (for ≥ 25% reduction: concordance 64.3%, 90% CI [39,84.7], p = 1.0 by McNemar's test; for ≥ 50% reduction: concordance 57.1%, 90% CI [32.5,79.4]), p = 0.2). CONCLUSION:In cardiac surgery patients who receive rFVIIa for uncontrolled hemorrhage, normalization of PTT after rFVIIa appears to be strongly correlated with rFVIIa-mediated hemostasis. This suggests that optimal hemostasis with rFVIIa occurs following concomitant repletion of other coagulation factors in both extrinsic and intrinsic pathways, although the possibility that normalization of coagulation studies in both pathways is a marker of rFVIIa-mediated hemostasis has not been ruled out. Prospective trials may help to determine whether correction of PTT and other coagulation parameters can improve rFVIIa efficacy in cardiac surgery. Disclosures:No relevant conflicts of interest to declare.

Predicting Patient Outcomes Utilizing a Novel Acute Upper Gastrointestinal Bleeding Risk Classification Rule: 2010 ACG/AstraZeneca Fellow Award

Purpose: The recently published International Consensus Recommendations on the Management of Patients with Nonvariceal Upper Gastrointestinal Bleeding recommends: “early risk stratification, by using validated prognostic scales” (Ann Intern Med 2010; 152: 101). Unfortunately, the existing risk stratification scores for upper GI bleeding can be difficult to calculate and some require endoscopic information. Preliminary data from our group examined predictors of mortality in over 30,000 patients with upper gastrointestinal bleeding. Five factors determined at the time of presentation provided the best discrimination: albumin<2.9, INR>1.5, altered mental status, systolic blood pressure <90 mmHg, and age >65 years (AIMS65). The current study evaluated the AIMS65 risk classification rule in a separate database to determine the effect of the score on the timing of endoscopy, blood transfusion requirement, and length of stay. Methods: Our hospital's research patient database was queried for ICD-9 codes related to upper GI bleeding, and the diagnosis was confirmed by examining the patients' discharge summaries. Over a 5-year period, 278 patients were identified who met the inclusion criteria and had adequate documentation to calculate the AIMS65 score. The outcomes of interest were timing of endoscopy, blood transfusion requirement and length of stay. Patients were defined as “low-risk” for the outcomes if the AIMS65 score was 0 or 1, and “high-risk” if it was greater than one. Statistical analyses were carried out using the non-parametric Wilcoxon rank-sum test. Results: The timing of endoscopy, blood transfusion requirements, and length of stay were all predicted by the AIMS65 score. Endoscopies occurred earlier for those patients in the high risk group compared to their low risk counterparts (mean 0.78 days vs. 1.01 days) [p=0.047]. Patients in the low-risk group were more likely to not require transfusions compared with those in the high-risk group (27% vs. 9%, p=0.001) and had a lower median transfusion requirement (2 versus 4 units, p<0.001). The AIMS65 criteria also predicted length of stay: the low-risk group had significantly shorter stays than did the high-risk group (median: 3 versus 4 days, p=0.0023). Conclusion: The AIMS65 bleeding risk score predicted the timing of endoscopy, blood transfusion requirement, and length of stay in patients presenting with upper GI bleeding. This easily derived risk score can be utilized early in the course of a patient with upper GI bleeding to prognosticate clinical outcomes.

Hemolysis, elevated liver enzymes, and low platelets syndrome: when is surgical help needed?

Background Life-threatening hemorrhage is a rare event in hemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome. Epidemiologic data are lacking to predict patients at risk for hemorrhage requiring surgical consultation. We sought to identify early clinical predictors of hemorrhagic complications in patients at risk for HELLP syndrome. Methods Patients at risk for HELLP syndrome from 1997 to 2007 were identified retrospectively. Variables evaluated in at-risk women were maternal age, gestational history, hepatic transaminase levels, and platelet count. Multiple logistic regression analysis was used to identify independent predictors of poor maternal outcomes, which were defined as hemorrhage requiring transfusion of blood products, need for surgical intervention, hepatic rupture, and death. Results A total of 109 at-risk women were identified. Adverse outcomes included transfusions (18%), hemorrhage interventions (8%), damage control laparotomy (2.8%), and hepatic rupture (2.8%). Maternal and perinatal mortality were .9% and 3.7%, respectively. Median transfusion requirements for women with hepatic rupture were 56 U of packed red blood cells, 26 U of fresh-frozen plasma, 18 U of platelets, and 6 U of cryoprecipitate. Multiple logistic regression analysis showed previous gestations ( P = .002), platelet count ( P = .01), and aspartate aminotransferase level increase ( P = .04) were independent predictors of life-threatening hemorrhage. Previous gestations increased the risk of adverse outcome 3-fold. Conclusions Identifiable risk factors predictive of major hemorrhage are thrombocytopenia (<100,000 cells/μL), increase of aspartate aminotransferase level greater than 70 IU/L, and previous gestations.

Treatment of Lower Risk MDS with Del 5q with Lenalidomide (LEN): Results of the French ATU Program.

Treatment of Lower Risk MDS with Del 5q with Lenalidomide (LEN): Results of the French ATU Program.

Treatment of Lower Risk MDS with Del 5q by Lenalidomide, with or without G-CSF: Current Results of the French Patient Named Program (ATU)

Background: LEN is very effective for the anemia of lower risk MDS with del 5q. A patient named program was launched by the French health agency (AFSSAPS) to use LEN in low and int 1 risk MDS with del 5q and transfusion dependence (> 2 RBC units/2 months).Methods: Patients received 10 mg of LEN/day, 3 weeks on, 1 week off. Hematological response (IWG 2006) was assessed after 8, 16 and 32 weeks of treatment. G-CSF use was recommended in case of grade 3 neutropenia, in order to avoid dose reduction, especially during the first 16 weeks of treatment.Results: 71 pts from 35 centers were evaluable for response as of Aug 1st, 2008. Median age was 75 [range 43–93], 68% females, median interval from diagnosis to LEN treatment 28.6 months (range 1–235). At inclusion, 32 pts had del 5q syndrome, 10 RA, 13 RARS, 2 RCMD-RS and 14 RAEB-1. IPSS was low in 43% and int-1 in 57%. Del 5q was isolated, with 1 additional and > 1 additional abn in 76%, 15% and 9% pts respectively. 23 pts were untreated, while 48 had previously received EPO. Median transfusion requirement was 4 units/2 months. 50/71 (69%) pts achieved erythroid response (IWG 2006), of whom 48 (67%) achieved transfusion independence (TI). Median time to TI was 12 weeks (range 8 – 32). TI was achieved in 76%, 62%, 68%, 70% and 50% pts with IPSS low, IPSS int 1, isolated del 5q, del 5q+1abn, del5q + >1abn, resp, and 70% and 65% of EPO pretreated and EPO naive pts (p=NS). Grade III-IV neutropenia and thrombocytopenia were seen in 86% and 26% pts resp, leading to transient discontinuation followed by reduction of LEN dosing in 55%pts. Of the 19 pts who received GCSF, 3 (16%) required transient LEN discontinuation due to neutropenia compared to 15 (28%) of the 52 who did not receive GCSF (p=0.3). Apart from neutropenia and thrombocytopenia, grade III–IV side effects were Lyell's syndrome (n=1), deep venous thrombosis (n=3) Quincke's oedema (n=1), No patient died from sepsis due to neutropenia or bleeding due to thrombocytopenia. With a still short median follow up on treatment (28 weeks), no relapse had occurred. 1 pt (RAEB 1 with 7% of blasts, isolated del 5q and IPSS INT-1 at inclusion who had achieved TI) progressed to AML at week 48.Conclusion: Our results confirm on a very multicenter basis the efficacy of LEN on the anemia of lower risk MDS with del 5q,. The use of G-CSF during the early treatment phase may somewhat reduce the proportion of early LEN discontinuation due to neutropenia.

Predictors of Blood Product Use in Orthotopic Liver Transplantation Using the Piggyback Hepatectomy Technique

Orthotopic liver transplantation (OLT) has historically been associated with massive blood loss and hemodynamic instability related to the coexistence of varices, coagulopathy, thrombocytopenia, and portal hypertension. Piggyback hepatectomy (PGB) is a technique increasingly utilized in OLT to avoid veno-venous bypass and vena cava clamping. This study evaluated the factors associated with blood loss and blood product requirement in PGB. Methods This study is a retrospective review of the anesthesia preoperative and operative notes and computerized lab values for all adult cadaveric liver transplants over a 42-month period. These data were combined with the liver transplant database for analysis. Approximately 98% of the transplants were performed using a standard piggyback approach with no use of veno-venous bypass. Results Data were included for all 526 transplants performed during this time period. Estimated blood loss (EBL) was 1000 cc. Median transfusion requirement was 3 units packed red blood cells, 7 units fresh frozen plasma, and 6 units platelets. Multivariate linear regression demonstrated that predictors of EBL were age, MELD score, preoperative hemoglobin, initial fibrinogen, initial central venous pressure, and total anesthesia time. Predictors of PRBC useage were age, MELD score, preoperative hemoglobin, initial fibrinogen, and anesthesia time. Postoperatively increased transfusion requirement was associated with increased length of hospital stay and lower 90-day and 1-year graft and patient survivals. Conclusion These results demonstrate that PGB can be safely accomplished in nearly all liver transplant patients without venovenous bypass or vena cava clamping and with less warm ischemia, which may ultimately be associated with less perioperative morbidity and improved outcomes.

Abdominocervical (transhiatal) oesophagectomy in the management of oesophageal carcinoma

Fifty-four patients have undergone abdominocervical oesophagectomy for oesophageal carcinoma as an alternative to a conventional transthoracic approach. Their median age was 69 years, with a range of 38-90 years, and 39 per cent of patients had chronic cardiorespiratory disease. Lymph node metastases were found in 80 per cent of patients and transmural tumour spread in 91 per cent. Median duration of operation was 2.2 h (range 1.75-6.0 h), and median transfusion requirement was 2.5 units (range 0-8 units). Respiratory complications were common (41 per cent) and caused all six postoperative deaths (11 per cent). Other complications were atrial fibrillation (26 per cent), transient recurrent laryngeal nerve palsy (11 per cent), cardiac failure (2 per cent), stroke (2 per cent), subphrenic abscess (2 per cent) and empyema (2 per cent). There were two anastomotic leaks (4 per cent), clinically manifest as temporary salivary fistulae. There have been 32 deaths from recurrent carcinoma, with a median duration of survival of 14 months (range 4-53 months). Fifteen patients are still alive, with a median survival of 16.5 months (range 3-49 months); the current 3-year survival rate is 10 per cent. All patients resumed normal swallowing after operation, but 11 of them developed anastomotic strictures requiring a median of three dilatations. Avoidance of formal thoracotomy by the abdominocervical approach may allow more rapid oesophagectomy without increasing the risk of postoperative death and gives a quality of palliation at least equivalent to that of conventional transthoracic oesophageal excision.