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Objective To examine whether prospective bleeding risk estimates for patients undergoing percutaneous coronary intervention could improve the use of bleeding avoidance strategies and reduce bleeding.Design Prospective cohort study comparing the use of bleeding avoidance strategies and bleeding rates before and after implementation of prospective risk stratification for peri-procedural bleeding.Setting Nine hospitals in the United States.Participants All patients undergoing percutaneous coronary intervention for indications other than primary reperfusion for ST elevation myocardial infarction.Main outcome measures Use of bleeding avoidance strategies, including bivalirudin, radial approach, and vascular closure devices, and peri-procedural bleeding rates, stratified by bleeding risk. Observed changes were adjusted for changes observed in a pool of 1135 hospitals without access to pre-procedural risk stratification. Hospital level and physician level variability in use of bleeding avoidance strategies was examined. Results In a comparison of 7408 pre-intervention procedures with 3529 post-intervention procedures, use of bleeding avoidance strategies within intervention sites increased with pre-procedural risk stratification (odds ratio 1.81, 95% confidence interval 1.44 to 2.27), particularly among higher risk patients (2.03, 1.58 to 2.61; 1.41, 1.09 to 1.83 in low risk patients, after adjustment for control sites; P for interaction=0.05). Bleeding rates within intervention sites were significantly lower after implementation of risk stratification (1.0% v 1.7%; odds ratio 0.56, 0.40 to 0.78; 0.62, 0.44 to 0.87, after adjustment); the reduction in bleeding was greatest in high risk patients. Marked variability in use of bleeding avoidance strategies was observed across sites and physicians, both before and after implementation.Conclusions Prospective provision of individualized bleeding risk estimates was associated with increased use of bleeding avoidance strategies and lower bleeding rates. Marked variability between providers highlights an important opportunity to improve the consistency, safety, and quality of care.Study registration Clinicaltrials.gov NCT01383382.

Identify high risk patients likely to benefit from bleeding avoidance strategies

The role of wound drainage in total knee arthroplasty (TKA) is controversial. The use of drainage was believed to be effective in decreasing hematoma formation, but it inevitably increases bleeding because the tamponade effect of a closed and undrained wound is eliminated. Clamping the drain tube in the first 4 hours after TKA can temporarily recreate a tamponade effect for bleeding control. Previous studies compared the clamping drainage with the conventional drainage method but not with non-drainage. Some current studies have shown that drainage in TKA is not necessary. Thus, we conducted a study to compare the outcomes between the patients with temporarily clamping drainage and without drainage. One hundred consecutive patients undergoing primary TKA were included. Change of hemoglobin, blood transfusion, use of narcotics, postoperative wound dressing, length of hospital stay, and range of motion were recorded. The drain-clamping group demonstrated more postoperative hemoglobin loss and a longer hospital stay, and gained no benefit compared with the non-drain group. Therefore, we concluded that despite clamping for 4 hours after TKA, the drain was still of no use. We would not recommend using a draining system routinely after TKA.

Surgical staplers are essential tools in minimally invasive surgery (MIS), enabling tissue division, hemostasis, and secure anastomoses. With the growth of robotic-assisted surgery, robotic staplers such as SureForm have recently become available. These staplers offer precise articulation and real-time tissue compression monitoring. However, the clinical advantages of robotic staplers over bedside staplers remain uncertain. Studies show mixed results across specialties, mainly due to small sample sizes, outdated data, and data heterogeneity. This study protocol proposes a series of future analyses that will evaluate the clinical outcomes and resource utilization of robotic versus bedside staplers in robotic-assisted surgeries across multiple specialties using recent real-world data. This retrospective cohort study will use data from the Premier Healthcare Database (PHD), a large hospital-based database covering patients with varied payers across the United States. Adult patients (≥18 years) who underwent elective, fully robotic-assisted lung, colorectal, gastric, or bariatric surgeries from 2019 to 2023 will be included. Each surgical specialty will be analyzed in a separate paper. Patients will be categorized into two groups based on the type of surgical stapler used: robotic staplers (SureForm) and bedside staplers (manual or powered). The primary outcome will be postoperative leak (air leak for lung resection; anastomotic leak for colorectal, gastrectomy, and bariatric). Key secondary outcomes are other complications, conversion to open surgery, operative time, transfusion requirements, length of stay (LOS), and cost. Overlap weighting will be applied to minimize bias. Results will be disseminated through peer-reviewed surgical journals and presentations at relevant surgical meetings.

To evaluate the safety and effectiveness of radiofrequency dissection in conventional 'open' total thyroidectomy. Thirty-nine patients scheduled for conventional total thyroidectomy were included in a prospective randomised study. Patients were randomly assigned to one of two groups: a radiofrequency dissection method was used in one group, and a knot tying technique was used in the other. Significantly fewer surgical instruments and materials were required for the radiofrequency dissection group than the knot tying group (p < 0.01). There were no significant differences between the two groups in mean operative time, blood loss, post-operative drainage and pain, recurrent palsy, and hypocalcaemia (p > 0.05). Radiofrequency dissection is a safe alternative to the knot tying technique, and enables a significant reduction in the number of surgical instruments required for the operation.

One view of value in medicine is outcome relative to cost of care provided. With respect to operative care, increased attention has been placed on evaluation and optimization of patients prior to undergoing an elective surgery. We examined more than 2 million patients having elective, non-cardiac surgery to assess the incidence and utility of pre-operative hemostatic screening, compared with a composite of history variables that may indicate a propensity for bleeding, to assess several important outcomes of surgery. We queried the NSQIP database to identify 2,020,533 patients and compared hemostatic tests (PT, aPTT, platelet count) and history covariables indicative of potential for abnormal hemostasis. We compared outcomes across predictor values; used Person's chi-square tests to compare differences, and logistic regression to model outcomes. Approximately 36% of patients had all three tests pre-operatively while 16% had none of them; 11.2% had a history predictive of potential abnormal bleeding. Outcomes of interest across the cohort included death in 0.7%, unplanned return to the operating room or re-admission within 30 days in 3.8% and 6.2% of patients; 5.3% received a transfusion during or after surgery. Sub-analyses in each of the nine surgical specialties' most common procedures yielded similar results. The limited predictive value of each hemostatic screening test, as well as excess costs associated with them, across a broad spectrum of elective surgeries, suggests that limiting pre-operative testing to a more select group of patients may be reasonable, equally efficacious, efficient, and cost-effective.

Background This study aimed to prospectively quantify the frequency of serious bleeding during pelvic surgery for locally advanced or recurrent rectal cancer and review the surgical methods used to control this. Methods Consecutive cases of pelvic surgery for curative resection of locally advanced or recurrent rectal cancer were prospectively evaluated over a nine-month period. The procedures undertaken included multivisceral resections, sacrectomies or ultra-low anterior resections. Multivisceral resections were defined as pelvic exenterations, extra-levator abdominoperineal resections (ELAPER) and recurrent anterior resections. The primary endpoint was the proportion of patients sustaining major blood loss, defined as ≥1,000 ml. The secondary endpoint was the blood transfusion rate. Haemostatic adjunct use was recorded. Results Twenty-six patients underwent surgery, comprising 11 pelvic exenterations, 3 ELAPERs, 1 recurrent anterior resection, 5 abdominosacral resections and 6 ultra-low anterior resections. The median intraoperative blood loss was 1,250 ml with 53.8 % of the patients sustaining a loss ≥1,000 ml. Fifty per cent of patients required a blood transfusion within 24 h, and one or more haemostatic adjuncts were necessary in 50 % of the cases. Adjuncts used included a fibrinogen/thrombin haemostatic agent in 38.5 % of patients, temporary intraoperative pelvic packing in 11.5 % of patients and preoperative internal iliac artery embolization in 7.7 % of patients. Conclusions This patient group is at a high risk of intraoperative haemorrhage, and such patients are high consumers of blood products. Haemostatic adjunct use is often necessary to minimize blood loss. We describe our local algorithm to assist in the assessment and intraoperative management of these challenging cases.

Background Although radiofrequency-assisted (RF) precoagulation has been described for open resections, there is little data evaluating precoagulation options in laparoscopic liver resection. The purpose of this study is to provide an algorithm for the use of monopolar and bipolar RF devices in laparoscopic liver resection. Methods Patients undergoing laparoscopic liver resection utilizing precoagulation during the period 2007–2009 were identified from a prospectively maintained, institutional review board-approved database. RF-assisted precoagulation was performed using a second-generation monopolar RF ablation catheter (Starburst XL, AngioDynamics) or bipolar RF device (Habib 4X, AngioDynamics). Results Precoagulation was utilized in 31cases (monopolar, n = 19, and bipolar, n = 12). Procedures performed included segmentectomy/wedge resection in 19 patients and bisegmentectomy in 12 patients. The bipolar RF device was used for left lateral sectionectomies (90%) in which there was linear transaction, whereas the monopolar RF catheter was used for nonlinear segmental and wedge resections involving the right lobe (95%). Time required for precoagulation was 22.5 ± 7.2 min for the bipolar and 33.6 ± 15.9 min for the monopolar device. No patient developed postoperative bleeding, bile duct injury, or liver abscess. At follow-up, one patient in the monopolar group developed a suspected local recurrence. Conclusions We have suggested an algorithm to select a given device based on tumor location and type of resection. With approximately 30 min of time spent for precoagulation, the blood loss and rate of local recurrence were favorable. There also could be an oncologic benefit due to additional functional margin obtained with the RF effect.

Background Transluminal retroperitoneal endoscopic necrosectomy (TREN) is an attractive NOTES technique alternative to surgery for treatment of walled-off pancreatic necrosis (WOPN). The main limitations to this technique are the need for repeated sessions, prolonged external irrigation, and EUS availability. In our study, we introduced new modifications, including the use of hydrogen peroxide, and abandoning the use of EUS and external irrigation. Methods This is a retrospective study of outcome of consecutive patients who underwent TREN for WOPN between April 2011 and August 2012. The technique included (1) non-EUS–guided transluminal drainage, and (2) direct endoscopic debridement using hydrogen peroxide and different accessories. No external irrigation was used. Results Ten patients were included. Initial clinical and technical success was achieved in all patients. Complete radiological success and long-term clinical efficacy was achieved in nine patients (1 patient had an inaccessible left paracolic gutter collection and died 62 days after endotherapy). Mean number of sessions was 1.4 (range 1–2). Complications included bleeding, which was self-limited in three patients and endoscopically controlled in one. All patients avoided surgery, and no recurrence was reported during median follow-up of 289 (range 133–429) days. Conclusions TREN is a safe and effective treatment for WOPN and could be performed safely without EUS guidance in selected cases. Hydrogen peroxide played a major role in reduction of number of sessions and timing. External irrigation of WOPN is not necessary, if adequate debridement could be achieved.

Background: Recombinant factor VIIa (rFVIIa) (Novoseven®) is utilized for the reversal of anticoagulation-associated bleeding and refractory bleeding in cardiac surgery. In August 2015, rFVIIa was transferred from the blood bank to the pharmacy at New York University (NYU) Langone Health. Concordantly, an off-label dosing guideline was developed. The objective of this study was to describe utilization and cost of rFVIIa and assess compliance to our dosing guideline. Methods: We performed a retrospective, observational review of rFVIIa administrations post-implementation of an off-label dosing guideline. All patients who received rFVIIa between September 2015 and June 2017 were evaluated. For each rFVIIa administration, anticoagulation and laboratory values, indications for use, dosing, ordering and administration times, concomitant blood products, and adverse events were collected. Adverse events included venous thromboembolism, stroke, myocardial infarction, and death due to systemic embolism and mortality. The primary endpoint was the utilization of rFVIIa in accordance with the off-label dosing guideline. Secondary endpoints included hemostatic efficacy of rFVIIa, adverse events, blood products administered, and cost-effectiveness of rFVIIa transition to pharmacy. Results: A total of 63 patients [pediatric (n = 6), adult (n = 57)] received rFVIIa, with the majority of use for refractory bleeding after cardiac surgery. The utilization of rVIIa decreased after development of the off-label dosing guideline and transition from blood bank to pharmacy. The total incidence of thromboembolic events within 30 days was 19.6%; 17.6% arterial and 2% venous; 70% of patients with an adverse event were over 70 years of age. Use of rFVIIa reduced the median number of units of blood products administered. Conclusion: Administration of rFVIIa for cardiac surgery appears to be effective for hemostasis. Transitioning rFVIIa from the blood bank to pharmacy and implementation of a dosing guideline appears to have reduced utilization. Patients receiving rFVIIa should be monitored for thromboembolic events. Elderly patients may be at higher risk for thromboembolic events.