Systematic review of hemostatic agents used in vascular surgery.

BACKGROUND: Hemostatic agents are routinely used in vascular surgery to complement proper suture techniques and decrease the risk of perioperative bleeding. A relative lack of comparative research studies have left surgeons with the option of choosing hemostatic agents based on their personal experience. The present review has highlighted the efficacy and safety of hemostatic agents and categorized them according to their primary mechanism of action and cost. METHODS: A systematic search strategy encompassing hemostatic agent products was deployed in the PubMed database. Single-center and multicenter, randomized, controlled trials with >10 patients were included in the present study. RESULTS: We reviewed 12 studies on the efficacy and safety of hemostatic agents compared with manual compression or other hemostatic agents. Using the time to hemostasis as the primary end point, all studies had found hemostatic agents to be significantly more efficient than manual compression. Likewise, adhesives (high pressure sealants) and dual agents (containing biologically active and absorbable components) were found to be more efficient, but costlier, than agents with either biologically active or absorbable components only. Agents with porcine or bovine constituents were found to trigger anaphylactic reactions in rare cases. Additionally, the absence of fibrin stabilizing factor XIII in a brand of fibrin sealant was speculated to reduce the affinity of the fibrin sealant for the expanded polytetrafluoroethylene graft. The cost of agents varied greatly depending on their active ingredient. CONCLUSIONS: Hemostatic agents appear to be highly effective at decreasing the risk of bleeding during surgical procedures. Although some hemostatic agents were demonstrated to achieve hemostasis faster than others, most are able to control bleeding within <10 minutes. Based on the limited data, the least expensive agents might suffice for limited suture lines used in routine procedures.

The Answer to "When to Clip" After Colorectal Endoscopic Mucosal Resection Based on a Cost-Effectiveness Analysis.

INTRODUCTION: Delayed bleeding (DB) is the most common major complication of endoscopic mucosal resection (EMR). Two randomized clinical trials recently demonstrated that clip closure after EMR of large nonpedunculated colorectal polyps (LNPCPs) reduces the risk of DB. We analyzed the cost-effectiveness of this prophylactic measure. METHODS: EMRs of LNCPCPs were consecutively registered in the ongoing prospective multicenter database of the Spanish EMR Group from May 2013 until July 2017. Patients were classified according to the Spanish Endoscopy Society EMR group (GSEED-RE2) DB risk score. Cost-effectiveness analysis was performed for both Spanish and US economic contexts. The average incremental cost-effectiveness ratio (ICER) thresholds were set at 54,000 € or $100,000 per quality-adjusted life year, respectively. RESULTS: We registered 2,263 EMRs in 2,130 patients. Applying their respective DB relative risk reductions after clip closure (51% and 59%), the DB rate decreased from 4.5% to 2.2% in the total cohort and from 13.7% to 5.7% in the high risk of the DB GSEED-RE2 subgroup. The ICERs for the universal clipping strategy in Spain and the United States, 469,706 € and $1,258,641, respectively, were not cost effective. By contrast, selective clipping in the high-risk of DB GSEED-RE2 subgroup was cost saving, with a negative ICER of -2,194 € in the Spanish context and cost effective with an ICER of $87,796 in the United States. DISCUSSION: Clip closure after EMR of large colorectal lesions is cost effective in patients with a high risk of bleeding. The GSEED-RE2 DB risk score may be a useful tool to identify that high-risk population.

Patient blood management interventions do not lead to important clinical benefits or cost-effectiveness for major surgery: a network meta-analysis.

BACKGROUND: Patient blood management (PBM) interventions aim to improve clinical outcomes by reducing bleeding and transfusion. We assessed whether existing evidence supports the routine use of combinations of these interventions during and after major surgery. METHODS: Five systematic reviews and a National Institute of Health and Care Excellence health economic review of trials of common PBM interventions enrolling participants of any age undergoing surgery were updated. The last search was on June 1, 2019. Studies in trauma, burns, gastrointestinal haemorrhage, gynaecology, dentistry, or critical care were excluded. The co-primary outcomes were: risk of receiving red cell transfusion and 30-day or hospital all-cause mortality. Treatment effects were estimated using random-effects models and risk ratios (RR) with 95% confidence intervals (CIs). Heterogeneity assessments used I2. Network meta-analyses used a frequentist approach. The protocol was registered prospectively (PROSPERO CRD42018085730). RESULTS: Searches identified 393 eligible randomised controlled trials enrolling 54 917 participants. PBM interventions resulted in a reduction in exposure to red cell transfusion (RR=0.60; 95% CI 0.57, 0.63; I2=77%), but had no statistically significant treatment effect on 30-day or hospital mortality (RR=0.93; 95% CI 0.81, 1.07; I2=0%). Treatment effects were consistent across multiple secondary outcomes, sub-groups and sensitivity analyses that considered clinical setting, type of intervention, and trial quality. Network meta-analysis did not demonstrate additive benefits from the use of multiple interventions. No trial demonstrated that PBM was cost-effective. CONCLUSIONS: In randomised trials, PBM interventions do not have important clinical benefits beyond reducing bleeding and transfusion in people undergoing major surgery.

Bleeding After Cardiac Surgery Is Associated With an Increase in the Total Cost of the Hospital Stay.

BACKGROUND: Cardiac surgery results in complications for some patients that lead to a longer hospital stay and higher costs. This study identified the presurgery characteristics of patients that were associated with the cost of their hospital stay and estimated how much of that cost could be attributed to a bleeding event, defined as requiring 3 units or more of packed red blood cells or returning to the operating room for bleeding. We also identified the presurgery characteristics that were associated with the bleeding event. METHODS: This prospective cohort of patients (n = 1459) underwent cardiac surgery at 3 tertiary referral hospitals in Australia during 2014 and 2015. Clinical data included the variables held by the Australian and New Zealand Society of Cardiac and Thoracic Surgeons registry. Cost data were collected as part of a state-level hospital data collection. RESULTS: Many of the baseline patient characteristics were associated with the total cost of cardiac surgery. After adjusting for these characteristics, the cost of cardiac surgery was 1.76 (confidence interval, 1.64-1.90) times higher for patients who had a bleeding event (P < .001), thus resulting in a median increase in costs (in Australian dollars) of $33,338 (confidence interval, $21,943-$38,415). Several baseline characteristics were strongly associated with a bleeding event. CONCLUSIONS: The impact of a bleeding event on the cost of cardiac surgery is substantial. This study identified a set of risk factors for bleeding that could be used to identify patients for discussion at the heart team level, where measures to minimize the risk of transfusion may be initiated.

Cost determinants in management of brain arteriovenous malformations.

INTRODUCTION: There is little data on the cost of treating brain arteriovenous malformations (AVMs). The goal of this study then is to identify cost determinants in multimodal management of brain AVMs. METHODS: One hundred forty patients with brain AVMs prospectively enrolled in the UCSF brain AVM registry and treated between 2012 and 2015 were included in the study. Patient and AVM characteristics, treatment type, and length of stay and radiographic evidence of obliteration were collected from the registry. We then calculated the cost of all inpatient and outpatient encounters, interventions, and imaging attributable to the AVM. We used generalized linear models to test whether there was an association between patient and AVM characteristics, treatment type, and cost and length of stay. We tested whether the proportion of patients with radiographic evidence of obliteration differed between treatment modalities using Fisher's exact test. RESULTS: The overall median cost of treatment and interquartile range was $77,865 (49,566-107,448). Surgery with preoperative embolization was the costliest treatment at $91,948 (79,914-140,600), while radiosurgery was the least at $20,917 (13,915-35,583). In multi-predictor analyses, hemorrhage, Spetzler-Martin grade, and treatment type were significant predictors of cost. Patients who had surgery had significantly higher rates of obliteration compared with radiosurgery patients. CONCLUSIONS: Hemorrhage, AVM grade, and treatment modality are significant cost determinants in AVM management. Surgery with preoperative embolization was the costliest treatment and radiosurgery the least; however, surgical cases had significantly higher rates of obliteration.

Target Population of Non-deferrable Surgery and Uncontrolled Severe Bleeding Related to Dabigatran.

PURPOSE: This observational study was aimed to identify patients who experienced non-deferrable surgery and/or uncontrolled severe bleeding following dabigatran administration and then are potentially eligible to the use of the specific antidote idarucizumab in a real-world setting. METHODS: From the big Italian real-world database ARCO, a cohort of adult patients treated with dabigatran and hospitalized due to diagnoses attributable to urgent interventions and/or major bleeding was selected in 2014. Baseline characteristics and all-cause hospitalizations, specialist/diagnostic outpatient services, and healthcare costs over the 1-year follow-up were described. RESULTS: Out of 16,756,843 Italian citizens, 271,540 (1.9%) were prescribed with oral anticoagulants, and specifically, 17,450 with dabigatran. Patients identified to be hospitalized for non-deferrable surgery (n = 106) and/or uncontrolled severe bleeding (n = 190) following dabigatran use were 289 (1.7%) [mean age (± SD) 79 ± 7, 50% of female sex]. On average, patients stayed in hospital 13.7 and 17.0 days, respectively. The per patient and per year cost to the Italian National Health System was on average 19,708€ (specifically 1487€ for drugs, of which 311€ for dabigatran, 17,353€ for all-cause hospitalizations, and 869€ for outpatient care), about four times more than the mean healthcare integrated cost of a single patient treated with dabigatran (4775€). CONCLUSIONS: This analysis of the ARCO database reliably describes the population potentially eligible to the dabigatran reversal agent, idarucizumab. These data may be useful for Healthcare Decision Makers to organize, define, and improve present and future emergency healthcare, mainly as starting point for cost-effectiveness analyses of new reversal agents.

Do complications following pancreatic resections impact hospital costs in France: Medico-economic study on 127 patients.

OBJECTIVE: To define the cost of pancreatectomies and to identify factors associated with increased hospital costs after pancreatic resection. METHODS: All patients undergoing pancreatic surgery in our department between January 2008 and December 2014 were included. All complications occurring during hospitalization or in the 90-day period after discharge were documented. The hospital costs were analyzed and predictive factors of increased hospital costs were determined. RESULTS: One hundred and twenty seven patients were identified. Most patients underwent pancreatectomy for malignant tumors (70%). Median hospital costs were 21,392 [15,998-29,667] euros. Age (P=0.011) and preoperative jaundice (P<0.001) were associated with higher hospital costs. Intraoperative surgical time and blood loss were correlated with increased costs (P=0.001 and P=0.002, respectively). Pancreatoduodenectomy was associated with statistically significantly higher costs compared to distal pancreatectomy (21,770 vs. 15,422 euros, P=0.001). Severe postoperative complications (Clavien-Dindo grade≥3) (P=0.001), septic complications (P=0.002) and hemorrhage (P=0.001) statistically significantly increased costs. In multivariate analysis, septic (P=0.003) and severe complications (P=0.01) were statistically significantly associated with increased hospital costs. CONCLUSION: Pancreatic surgery is associated with high hospital costs, essentially related to postoperative complications.

Successful percutaneous access for endovascular aneurysm repair is significantly cheaper than femoral cutdown in a prospective randomized trial.

OBJECTIVE: Because of its minimally invasive nature, percutaneous femoral access for endovascular aneurysm repair (pEVAR) is currently undergoing rapid popularization. Compared with surgical cutdown for femoral access (cEVAR), it offers the advantage of faster recovery after surgery as well as a reduction in wound complications. Despite proposed advantages, the method is largely considered uneconomical because of its reliance on costly closure devices. METHODS: There were 50 patients undergoing EVAR who were enrolled in this randomized prospective single-center trial. Each patient randomly received percutaneous access in one groin and surgical access in the other. The primary end points were access duration and cost. Secondary end points were wound complications and the postoperative pain levels. RESULTS: Surgery was performed per protocol in 44 patients. Mean access times for pEVAR and cEVAR were 11.5 ± 3.4 minutes and 24.8 ± 12.1 minutes (P < .001), respectively. Total access costs were €559.65 ± €112.69 for pEVAR and €674.85 ± €289.55 for cEVAR (P = .016). Eight complications in six patients were attributed to cutdown, none to pEVAR (P = .02). The percutaneously accessed groin was significantly less painful at day 1 and day 5 after surgery (P < .001). An intention-to-treat analysis (N = 50 patients) included six cases of pEVAR conversion due to technical failure in three patients (6%) and change of the operative strategy in another three patients (eg, aortouni-iliac stent graft followed by crossover bypass). The intention-to-treat analysis showed shorter mean overall access time for pEVAR (pEVAR, 14.65 ± 10.20 minutes; cEVAR, 25.12 ± 11.77 minutes; P < .001) and no cost difference between the two methods (pEVAR, €651.29 ± €313.49; cEVAR, €625.53 ± €238.29; P = .65). CONCLUSIONS: Our data confirm proposed potential benefits attributable to the minimally invasive nature of pEVAR while demonstrating cost-effectiveness despite the additional cost of closure devices. Taking into account pEVAR failures still does not increase pEVAR costs over cEVAR. Further considering reduced postoperative pain and wound complications, the technique deserves consideration in suitable patients.

Use of a flowable haemostat versus an oxidised regenerated cellulose agent in primary elective cardiac surgery: economic impact from a UK healthcare perspective.

BACKGROUND: Flowable haemostatic agents have been shown to be superior to non-flowable agents in terms of haemostatic control and need for transfusion products in patients undergoing cardiac surgery. We investigated the economic impact of the use of a flowable haemostatic agent (Floseal) compared with non-flowable oxidised regenerated cellulose (ORC) agent in primary elective cardiac surgery from the perspective of the UK National Health Service (NHS). METHODS: A cost-consequence framework based upon clinical data from a prospective trial and an observational trial and NHS-specific actual reference costs (2016) was developed to compare the economic impact of Floseal with that of ORC. The individual domains of care investigated comprised complications (major and minor) avoided, operating room time savings, surgical revisions for bleeding avoided and transfusions avoided. The cost impact of Floseal versus ORC on ICU days and extended bed days avoided was modelled separately. RESULTS: Compared with ORC, the use of Floseal would be associated with overall net savings to the NHS of £178,283 per 100 cardiac surgery patients who experience intraoperative bleeding requiring haemostatic therapy. Cost savings were apparent in all individual domains of care (complications avoided: £83,536; operating room time saved: £63,969; surgical revisions avoided: £34,038; and blood transfusions avoided: £22,317). Cost savings per 100 patients with Floseal over ORC in terms of ICU days avoided (n = 30) and extended bed days avoided (n = 51.7) were £57,960 and £21,965, respectively. A sensitivity analysis indicated that these findings remained robust when the model parameters representing the clinical benefit of Floseal over ORC were reduced by up to 20%. CONCLUSIONS: Despite higher initial acquisition costs, the use of flowable haemostatic agents achieves substantial cost savings over non-flowable agents in cardiac surgery. These cost savings commence during the operating theatre and appear to continue to be realised throughout the postoperative period.

Risks and benefits of opportunistic salpingectomy during vaginal hysterectomy: a decision analysis.

BACKGROUND: Fallopian tubes are commonly removed during laparoscopic and open hysterectomy to prevent ovarian and tubal cancer but are not routinely removed during vaginal hysterectomy because of perceptions of increased morbidity, difficulty, or inadequate surgical training. OBJECTIVE: We sought to quantify complications and costs associated with a strategy of planned salpingectomy during vaginal hysterectomy. STUDY DESIGN: We created a decision analysis model using TreeAgePro. Effectiveness outcomes included ovarian cancer incidence and mortality as well as major surgical complications. Modeled complications included transfusion, conversion to laparotomy or laparoscopy, abscess/hematoma requiring intervention, ileus, readmission, and reoperation within 30 days. We also modeled subsequent benign adnexal surgery beyond the postoperative window. Those whose procedures were converted from a vaginal route were assumed to undergo bilateral salpingectomy, regardless of treatment group, following American College of Obstetricians and Gynecologists guidelines. Costs were gathered from published literature and Medicare reimbursement data, with internal cost data from 892 hysterectomies at a single institution used to estimate costs when necessary. Complication rates were determined from published literature and from 13,397 vaginal hysterectomies recorded in the National Surgical Quality Improvement Program database from 2008 through 2013. RESULTS: Switching from a policy of vaginal hysterectomy alone to a policy of routine planned salpingectomy prevents a diagnosis of ovarian cancer in 1 of every 225 women having surgery and prevents death from ovarian cancer in 1 of every 450 women having surgery. Overall, salpingectomy was a less expensive strategy than not performing salpingectomy ($7350.62 vs $8113.45). Sensitivity analysis demonstrated the driving force behind increased costs was the increased risk of subsequent benign adnexal surgery among women retaining their tubes. Planned opportunistic salpingectomy had more major complications than hysterectomy alone (7.95% vs 7.68%). Major complications included transfusion, conversion to laparotomy or laparoscopy, abscess/hematoma requiring intervention, ileus, readmission, and reoperation within 30 days. Therefore, routine salpingectomy results in 0.61 additional complications per case of cancer prevented and 1.21 additional complications per death prevented. A surgeon therefore must withstand an additional ∼3 complications to prevent 5 cancer diagnoses and ∼6 additional complications to prevent 5 cancer deaths. CONCLUSION: Salpingectomy should routinely be performed with vaginal hysterectomy because it was the dominant and therefore cost-effective strategy. Complications are minimally increased, but the trade-off with cancer prevention is highly favorable.

Cell Saver for Adult Spinal Deformity Surgery Reduces Cost.

STUDY DESIGN: Retrospective cohort. OBJECTIVES: To determine if the use of cell saver reduces overall blood costs in adult spinal deformity (ASD) surgery. SUMMARY OF BACKGROUND DATA: Recent studies have questioned the clinical value of cell saver during spine procedures. METHODS: ASD patients enrolled in a prospective, multicenter surgical database who had complete preoperative and surgical data were identified. Patients were stratified into (1) cell saver available during surgery, but no intraoperative autologous infusion (No Infusion group), or (2) cell saver available and received autologous infusion (Infusion group). RESULTS: There were 427 patients in the Infusion group and 153 in the No infusion group. Patients in both groups had similar demographics. Mean autologous infusion volume was 698 mL. The Infusion group had a higher percentage of EBL relative to the estimated blood volume (42.2%) than the No Infusion group (19.6%, p < .000). Allogeneic transfusion was more common in the Infusion group (255/427, 60%) than the No Infusion group (67/153, 44%, p = .001). The number of allogeneic blood units transfused was also higher in the Infusion group (2.4) than the No Infusion group (1.7, p = .009). Total blood costs ranged from $396 to $2,146 in the No Infusion group and from $1,262 to $5,088 in the Infusion group. If the cost of cell saver blood was transformed into costs of allogeneic blood, total blood costs for the Infusion group would range from $840 to $5,418. Thus, cell saver use yielded a mean cost savings ranging from $330 to $422 (allogeneic blood averted). Linear regression showed that after an EBL of 614 mL, cell saver becomes cost-efficient. CONCLUSION: Compared to transfusing allogeneic blood, cell saver autologous infusion did not reduce the proportion or the volume of allogeneic transfusion for patients undergoing surgery for adult spinal deformity. The use of cell saver becomes cost-efficient above an EBL of 614 mL, producing a cost savings of $330 to $422. LEVEL OF EVIDENCE: Level III.

Mortality, Length of Stay, and Cost Implications of Procedural Bleeding After Percutaneous Interventions Using Large-Bore Catheters.

Importance: Bleeding complications after percutaneous transcatheter interventions that used large-bore catheters are frequent and associated with high mortality and morbidity. Objective: To describe the incidence of bleeding complications among patients undergoing contemporary endovascular interventions involving large-bore catheters and its association with in-hospital mortality, length of stay, and health care cost. Design, Setting, and Participants: This retrospective cohort study analyzed all 17 672 patients from the Healthcare Cost and Utilization Project's National Inpatient Sample database who were recorded as having undergone a transcatheter aortic valve replacement (n = 3223), an endovascular aneurysm repair (n = 12 633), or a percutaneous left ventricular assist device implant (n = 1816) between January 1, 2012, and December 31, 2013. Bleeding complication was defined as any transfusion, any hemorrhage or hematoma, or the need for percutaneous or surgical intervention to control the bleeding event. Health care costs were determined by multiplying the total charge for each visit by the cost to charge ratios reported for each hospital code in the database. Data were collected from the database on April 29, 2016. Main Outcomes and Measures: Adjusted association between bleeding complications and mortality was determined by multivariable logistic regression. Length of stay and total health care costs were compared using multivariable linear regression between patients who did and patients who did not have bleeding complications. Results: Bleeding complications occurred in 3128 patients (17.7%) (1984 men and 1144 women, with a mean [SD] age of 75.6 [11.9] years). Bleeding was associated with higher mortality (adjusted odds ratio, 2.70; 95% CI, 2.27-3.22; P < .001) and longer hospital stay (adjusted multiplicative difference, 2.14; 95% CI, 2.06-2.16; P < .001). Median (interquartile range) total health care costs were $48 663 ($32 620-$71 547) for patients with bleeding complications compared with $29 968 ($21 924-$43 287) for patients without a bleeding complication (adjusted multiplicative difference, 1.55; 95% CI, 1.52-1.59; P < .001). Conclusions and Relevance: Periprocedural bleeding was common among patients who underwent transcatheter intervention using large-bore catheters and was associated with a statistically significant increase in mortality, length of stay, and cost.

The impact of a multidisciplinary blood conservation protocol on patient outcomes and cost after cardiac surgery.

OBJECTIVE: Although associations between transfusion and inferior outcomes have been documented, there is a lack of blood transfusion standardization in cardiac surgery. At the Inova Heart and Vascular Institute, a multidisciplinary, criterion-driven algorithm for transfusion management was implemented. We examined the effect of our blood conservation protocol on transfusion rates and outcomes after cardiac surgery and on stability of transfusion over time. METHODS: Patients undergoing first-time cardiac surgery from 2006 (full year before protocol) were compared with those in 2009 (after protocol) and propensity score matched to improve balance. Data were prospectively collected. Stability of transfusion incidence also was compared (2005-2006 vs 2008-2014). RESULTS: After matching, 890 patients from each year were included. Use of blood products decreased from 54% in 2006 to 25% in 2009 (P < .001). Patients in 2009 had a lower incidence of postoperative renal failure (2.6% vs 4%, P = .04), reoperations for bleeding (2% vs 4%, P = .004), and readmissions at less than 30 days (6% vs 12%, P < .001). No differences were found for operative mortality, deep sternal wound infection, or permanent strokes. Patients in 2009 had greater improvement in physical (P = .001) and mental (P = .02) quality of life than patients in 2006. Reduction of blood products led to significant cost savings for packed erythrocytes (P < .001) and platelets (P < .001). After protocol implementation, transfusion incidence remained 30% or less, with less than 28% in most years. CONCLUSIONS: A multidisciplinary blood conservation program can significantly control blood transfusion rates, improve outcomes, and be sustained over time. Efforts are needed to implement evidence-based protocols to standardize and decrease blood use in cardiac surgery to improve outcomes and reduce cost.

Hospital costs of complications after esophagectomy for cancer.

OBJECTIVE: The purpose of this study was to estimate the economic burden of postoperative complications after esophagectomy for cancer, in order to optimally allocate resources for quality improvement initiatives in the future. METHODS: A retrospective analysis of prospectively collected clinical and financial outcomes after esophageal cancer surgery in a tertiary referral center in the Netherlands was performed. Data was extracted from consecutive patients registered in the Dutch Upper GI Cancer Audit between 2011 and 2014 (n = 201). Costs were measured up to 90-days after hospital discharge and based on Time-Driven Activity-Based Costing. The additional costs were estimated using multiple linear regression models. RESULTS: The average total cost for one patient after esophagectomy was €37,581 (±31,372). The estimated costs of an esophagectomy without complications were €23,476 (±6496). Mean costs after minor (47%) and severe complications (29%) were €31,529 (±23,359) and €59,167 (±42,615) (p < 0.001), respectively. The 5% most expensive patients were responsible for 20.3% of the total hospital costs assessed in this study. Patient characteristics associated with additional costs in multivariable analysis included, age >70 (+€2,922, p = 0.036), female gender (+€4,357, p = 0.005), COPD (+€5,415, p = 0.002), and a history of thromboembolic events (+€6,213, p = 0.028). Complications associated with a significant increase in costs in multivariable analysis included anastomotic leakage (+€4,123, p = 0.008), cardiac complications (+€5,711, p = 0.003), chyle leakage (+€6,188, p < 0.001) and postoperative bleeding (+€31,567, p < 0.001). CONCLUSIONS: Complications and severity of complications after esophageal surgery are associated with a substantial increase in costs. Although not all postoperative complications can be prevented, implementation of preventive measures to reduce complications could result in a considerable cost reduction and quality improvement.

Targeted Bleeding Management Reduces the Requirements for Blood Component Therapy in Lung Transplant Recipients.

OBJECTIVE: Lung transplantation is associated with high rates of bleeding and frequent blood transfusion. The authors aimed to determine if point-of-care coagulation testing (POCCT) reduced transfusion requirements. DESIGN, SETTINGS, AND PARTICIPANTS: A before-and-after cohort analysis conducted at a single tertiary referral center. Ninety-three sequential adult patients between January 2010 and January 2014 undergoing isolated lung transplant without preoperative extracorporeal support were analyzed. INTERVENTION: ROTEM and multi-plate POCCT were introduced on July 1, 2012, with an associated algorithm based on the results. MEASUREMENTS AND MAIN RESULTS: Statistically significant decreases in the proportion of patients receiving PRBCs (87% v 65%; p = 0.015), FFP (72% v 30%; p<0.0001) and platelets (70% v 37%; p = 0.002) were found after the intervention. There were small decreases in median chest tube blood loss at 2 hours (300 mLs v 215 mLs; p = 0.03) and 4 hours (440 mLs v 350 mLs; p = 0.050) but not at 12 hours postoperatively. There were no changes in reoperation for bleeding (9% v 4%; p = 0.158) or in-hospital mortality (6% v 2%; p = 0.617). The cost of blood products administered decreased from a median of $3,935.00 to $991.00 (p<0.001). CONCLUSIONS: Use of POCCT in lung-transplant surgery is associated with significant reductions in blood product use and cost. There were no detectable changes in outcome aside from a small decrease in early postoperative bleeding.

Postoperative outcomes and quality of life following hysterectomy by natural orifice transluminal endoscopic surgery (NOTES) compared to laparoscopy in women with a non-prolapsed uterus and benign gynaecological disease: a systematic review and meta-analysis.

OBJECTIVE: To critically appraise studies comparing benefits and harms in women with benign disease without prolapse undergoing hysterectomy by natural orifice transluminal endoscopic surgery (NOTES) versus laparoscopy. STUDY DESIGN: We followed the PRISMA guidelines. We searched MEDLINE, EMBASE and CENTRAL for randomised controlled trials (RCTs), controlled clinical trials (CCTs) and cohort studies comparing NOTES with laparoscopy assisted vaginal hysterectomy (LAVH) or total laparoscopic hysterectomy (TLH) in women bound to undergo removal of a non-prolapsed uterus for benign disease. Two authors searched and selected studies, extracted data and assessed the risk of bias independently. Any disagreement was resolved by discussion or arbitration. RESULTS: We did not find RCTs but retrieved two retrospective cohort studies comparing NOTES with LAVH. The study quality as assessed by the Newcastle-Ottawa scale was acceptable. Both studies reported no conversions. The operative time in women treated by NOTES was shorter compared to LAVH: the mean difference (MD) was -22.04min (95% CI -28.00min to -16.08min; 342 women; 2 studies). There were no differences for complications in women treated by NOTES compared to LAVH: the risk ratio (RR) was 0.57 (95% CI 0.17-1.91; 342 women; 2 studies). The length of stay was shorter in women treated by NOTES versus LAVH: the MD was -0.42days (95% CI -0.59days to -0.25days; 342 women; 2 studies). There were no differences for the median VAS scores at 12h between women treated by NOTES (median 2, range 0-6) or by LAVH (median 2, range 0-6) (48 women, 1 study). There were no differences in the median additional analgesic dose request in women treated by NOTES (median 0, range 0-6) or by LAVH (median 1, range 0-5) (48 women, 1 study). The hospital charges for treatment by NOTES were higher compared to LAVH: the mean difference was 137.00 € (95% CI 88.95-185.05 €; 294 women; 1 study). CONCLUSIONS: At the present NOTES should be considered as a technique under evaluation for use in gynaecological surgery. RCTs are needed to demonstrate its effectiveness.

Temporal Trends, Predictors, and Outcomes of In-Hospital Gastrointestinal Bleeding Associated With Percutaneous Coronary Intervention.

Since the introduction of new antiplatelet and anticoagulant agents in the last decade, large-scale data studying gastrointestinal bleeding (GIB) in patients undergoing percutaneous coronary intervention (PCI) are lacking. Using the Nationwide Inpatient Sample, we identified all hospitalizations from 2006 to 2012 that required PCI. Temporal trends in the incidence and multivariate predictors of GIB associated with PCI were analyzed. A total of 4,376,950 patients underwent PCI in the United States during the study period. The incidence of GIB was 1.1%. Mortality rate in the GIB group was significantly higher (9.71% vs 1.1%, p <0.0001). Although the incidence of GIB remained stable during the study period (0.97% in 2006 to 1.19% in 2012), in-hospital mortality rate increased significantly from 7.9% in 2006 to 10.78% in 2012, with a peak of 12% in 2010. The GIB group had a longer median length of stay (5.80 vs 1.57 days) and an increased median cost of hospitalization ($26,564 vs $16,879). The predictors of GIB included cardiovascular co-morbidities such as acute myocardial infarction, cardiogenic shock, atrial fibrillation, congestive heart failure, valvular heart diseases, and a history of transient ischemic attack/stroke. Gastrointestinal co-morbidities including diverticulosis, esophageal cancer, stomach cancer, small intestine cancer, large intestine cancer, rectosigmoid cancer, gastrointestinal ulcer, and liver disease were predictors of GIB. Interestingly, a lower risk of GIB was associated with obese patients and patients with private insurance. A higher risk of GIB was noted in urgent versus elective admissions and weekend versus weekday admissions. In conclusion, the incidence of GIB in patients who underwent PCI remained stable from 2006 to 2012; however, the in-hospital mortality increased significantly. Identifying patients at higher risk for GIB is critically important to develop preventive strategies to reduce morbidity and mortality.

Development of a risk prediction model for transfusion in carotid endarterectomy and demonstration of cost-saving potential by avoidance of "type and screen".

OBJECTIVE: Preoperative testing for carotid endarterectomy (CEA) often includes blood typing and antibody screen (T&S). In our institutional experience, however, transfusion for CEA is rare. We assessed transfusion rate and risk factors in a national clinical database to identify a cohort of patients in whom T&S can safely be avoided with the potential for substantial cost savings. METHODS: With use of the National Surgical Quality Improvement Program database, transfusion events and timing were established for all elective CEAs in 2012-2013. Comorbidities and other characteristics were compared for patients receiving intraoperative or postoperative transfusion and those who did not. After random assignment of the total data to either a training or validation set, a prediction model for transfusion risk was created and subsequently validated. RESULTS: Of 16,043 patients undergoing CEA in 2012-2013, 276 received at least one transfusion before discharge (1.7%); 42% of transfusions occurred on the day of surgery. Preoperative hematocrit <30% (odds ratio [OR], 57.4; 95% confidence interval [CI], 29.6-111.1), history of congestive heart failure (OR, 2.8; 95% CI, 1.1-7.1), dependent functional status (OR, 2.7; 95% CI, 1.5-5.1), coagulopathy (OR, 2.5; 95% CI, 1.7-3.6), creatinine concentration ≥1.2 mg/dL (OR, 2.3; 95% CI, 1.6-3.3), preoperative dyspnea (OR, 2.0; 95% CI, 1.4-3.1), and female gender (OR, 1.6; 95% CI, 1.1-2.3) predicted transfusion. A risk prediction model based on these data produced a C statistic of 0.85; application of this model to the validation set demonstrated a C statistic of 0.81. In the validation set, 93% of patients received a score of 6 or less, corresponding to an individual predicted transfusion risk of 5% or less. Omitting a T&S in these patients would generate a substantial annual cost saving for National Surgical Quality Improvement Program hospitals. CONCLUSIONS: Whereas T&S are commonly performed for patients undergoing CEA, transfusion after CEA is rare and well predicted by a transfusion risk score. Avoidance of T&S in this low-risk population provides a substantial cost-saving opportunity without compromise of patient care.

Impact on postoperative bleeding and cost of recombinant activated factor VII in patients undergoing heart transplantation.

BACKGROUND: Cardiac transplantation can be complicated by refractory hemorrhage particularly in cases where explantation of a ventricular assist device is necessary. Recombinant activated factor VII (rFVIIa) has been used to treat refractory bleeding in cardiac surgery patients, but little information is available on its efficacy or cost in heart transplant patients. METHODS: Patients who had orthotopic heart transplantation between January 2009 and December 2014 at a single center were reviewed. Postoperative bleeding and the total costs of hemostatic therapies were compared between patients who received rFVIIa and those who did not. Propensity scores were created and used to control for the likelihood of receiving rFVIIa in order to reduce bias in our risk estimates. RESULTS: Seventy-six patients underwent heart transplantation during the study period. Twenty-one patients (27.6%) received rFVIIa for refractory intraoperative bleeding. There was no difference in postoperative red blood cell transfusion, chest tube output, or surgical re-exploration between patients who received rFVIIa and those who did not, even after adjusting with the propensity score (P = 0.94, P = 0.60, and P = 0.10, respectively). The total cost for hemostatic therapies was significantly higher in the rFVIIa group (median $10,819 vs. $1,985; P < 0.0001). Subgroup analysis of patients who underwent redo-sternotomy with left ventricular assist device explantation did not show any benefit for rFVIIa either. CONCLUSIONS: In this relatively small cohort, rFVIIa use was not associated with decreased postoperative bleeding in patients undergoing heart transplantation; however, it led to significantly higher cost.