Standardized Prophylaxis Research Articles

Personalized CZA-ATM dosing against an XDR E. coli in liver transplant patients; the application of the in vitro hollow fiber system.

A patient with an extensively drug-resistant (XDR) New Delhi metallo-β-lactamase (NDM) and oxacillinase (OXA-48) producing Escherichia coli (E. coli) infection was awaiting orthotopic liver transplant. There is no standardized antibiotic prophylaxis regimen; however, in line with the Infectious Diseases Society of America guidance, an antibiotic prophylactic regimen of ceftazidime-avibactam 2.5g TDS with aztreonam 2g three times a day (TDS) IV was proposed. The hollow fiber system (HFS) was applied to inform the individualized pharmacodynamic outcome likelihood prior to prophylaxis. A 4-log reduction in CFU/mL in the first 10 h of the regimen exposure was observed; however, the killing dynamics were slow and six 8-hourly infusions were required to reduce bacterial cells to below the limit of quantification. Thus, the HFS supported the use of the regimen for infection clearance; however, it highlighted the need for several infusions. Standard local practice is to administer prophylaxis antibiotics at induction of orthotopic liver transplantation (OLT); however, the HFS provided data to rationalize earlier dosing. Therefore, the patient was dosed at 24 h prior to their OLT induction and subsequently discharged 8 days after surgery. The HFS provides a dynamic culture solution for informing individualized medicine by testing antibiotic combinations and exposures against the bacterial isolates cultured from the patient's infection. .

Infections and antimicrobial prophylaxis in patients with myelodysplastic syndromes

Infectious complications are an important cause of morbidity and mortality in patients with myelodysplastic syndromes (MDS). Preventing infections could significantly improve both survival and quality of life. Unfortunately, both infections and antimicrobial prophylaxis in patients with MDS are incompletely assessed due to the heterogeneity of disorders included in each publication, changing definitions over time, and lack of standardized prophylaxis practices. Despite these limitations, some basic statements can be made. Infections in MDS are associated with neutropenia. Patients with lower-risk (LR) MDS tend to have fewer infections compared to patients with higher-risk (HR) MDS, which may be related to the different prevalence of neutropenia in the 2 groups. Pneumonia is the most common infection, and bacteria are the most common pathogens. Invasive fungal infections (IFI) are uncommon. Reactivation of latent viruses are rare. With the limited data available, we agree that antibacterial prophylaxis can be considered in patients with HR-MDS during severe neutropenia and early cycles of therapy when infections are most likely to occur. Given the low prevalence of IFI and viral reactivation, antimicrobial prophylaxis for these pathogens is less likely to be advantageous for most patients, although antifungal prophylaxis with activity against mold is commonly used in patients with persistent, profound neutropenia. Ultimately, improved data collection regarding infections and antimicrobial prophylaxis is needed to improve care for patients with MDS.

An Effective Protocol for Perioperative Venous Thromboembolism Prophylaxis in DIEP Flap Breast Reconstruction: A Single Institution Retrospective Review.

Deep inferior epigastric artery perforator (DIEP) free flap breast reconstruction is one of the most highly used procedures for autologous breast reconstruction. Many venous thromboembolism (VTE) risk assessment models have been proposed in breast reconstructive surgery, including the widely used Caprini score. However, a paucity of data suggests an effective standardized VTE protocol. The purpose of this study was to determine the rate of VTE in our DIEP flap patients who were treated with this protocol. A retrospective single-center review of DIEP flap breast reconstruction from 2016 to 2021 was performed. Data were collected on 554 patients and 893 flaps including demographics, intraoperative and perioperative details, and postoperative course. Patients who were not treated with our standard protocol were excluded. Data were analyzed with alpha = 0.05. The average age was 50.4 ± 9.9 years, and the total follow-up time was 16.9 ± 12.6 months. The average body mass index for the cohort was 30.1 ± 5.2. During the 90 postoperative days, the mean length of hospital stay was 4.3 days. There were six cases of postoperative VTE: five patients presented with pulmonary embolism (0.9%) and one patient (0.2%) had deep venous thrombosis with an overall VTE prevalence of 1.1%. No specific single factor could be attributed to VTE occurrence. Using our standardized VTE prophylaxis protocol, our institution was effective at keeping VTE rates low. Additional studies would be beneficial to determine optimal VTE prophylaxis protocols in higher-risk patients, such as those with known clotting disorders.

An observational study of an adjusted patient blood management protocol intended to lower rates of transfusion following total knee arthroplasty in patients with preoperative anemia

BackgroundPatients with preoperative anemia have a higher risk of requiring blood transfusion after major orthopedic surgery due to increased blood loss and closer transfusion thresholds. Various patient blood management (PBM) policies aim to reduce transfusion rates. This observational study aimed to investigate blood loss and evaluate the effectiveness of an adjusted surgical PBM protocol in patients with anemic chronic disease (ACD) undergoing elective total knee arthroplasty (TKA).MethodsA consecutive cohort of patients underwent elective unilateral TKA with an adjusted PBM protocol. The protocol consisted of epoetin (EPO) alfa therapy prescribed by the surgeon, routine administration of tranexamic acid (TXA), and standardized postoperative pharmacologic prophylaxis for thromboembolism. The performance of this PBM protocol was analyzed in patients with a baseline hemoglobin level of less than 12 g/dl. Hemoglobin levels were controlled at admission, on postoperative day (POD) 1, and on POD 7 ± 1. A bleeding index (BI-7) was used as an estimate of blood loss up until POD 7. Multiple linear regression was used to assess whether there were any differences in BI-7 between ACD– and ACD + patients.ResultsA total of 751 patients with complete hemoglobin monitoring were included in the study. Of these patients, 68 (9.1%) had a baseline hemoglobin concentration of less than 12 g/dl (ACD group). In this group, 28 patients (41.2%) received preoperative EPO therapy. The mean adjusted BI-7 for the study population was 3.0 (95% CI, 2.9 to 3.0) g/dl in the ACD– group and 2.3 (95% CI, 2.0–2.6) g/dl in the ACD + group. The difference in BI-7 was statistically significant (difference, 0.6 [95% CI: 0.3 to 0.9] g/dl, p < 0.001). No major complications occurred in the ACD + group, whereas there were three complications in the ACD– group (p = 1.00).ConclusionsACD patients undergoing TKA did not have an increased risk of bleeding or bleeding complications with the use of the adjusted PBM protocol. None of ACD patients required transfusion. ACD patients undergoing TKA experienced significantly less blood loss than patients with no preoperative anemia with the use of the adjusted PBM. We now consider the use of EPO in ACD patients with no nutritional deficiencies undergoing TKA at a baseline hemoglobin level of 11 g/dl. However, this should be validated in larger cohorts with a higher prevalence of ACD patients.

An Open Label Study Comparing Photobiomodulation Therapy to Cryotherapy in Patients at High Risk for Drug-Induced Oral Mucositis

Background and rationale Oral mucositis (OM) is one of the most common side effects of chemotherapy and may lead to weight loss and increased risk for infection ultimately impairing overall survival. Evaluated options for mucositis prophylaxis in patients receiving a high-dose chemotherapy include oral cryotherapy (CT) and photobiomodulation therapy (PBMT) using laser diodes to reduce incidence and severity of OM. However, standards of mucositis prophylaxis in German hospitals differ substantially. While CT has been standard of care in melphalan treated patients, the German guidelines for supportive oncology do not recommend the use of PBMT for patients receiving high-dose chemotherapy. Several clinical trials have demonstrated the beneficial effect of PBMT, however, no randomized clinical trials (RCT) exist to compare the efficacy of oral CT versus PBMT. Study design This is a single-center, open-label, randomized, two-arm interventional trial to evaluate the efficacy of PBMT and CT as prophylaxis of OM in patients with hematological malignancies receiving high-dose chemotherapy as part of a conditioning regimen prior to hematopoietic cell transplantation (HCT) or high-dose methotrexate (MTX, defined as ≥ 500 mg/m 2). Randomization will occur 1:1, stratified according to conditioning regimen/chemotherapy protocol. The primary endpoint of the trial is rate of severe OM as assessed by the world health organization (WHO) OM grading scale grade 3 or higher. Key secondary endpoints include duration of OM, patient reported pain, total parenteral nutrition, opioid usage, weight loss, length of in-patient stay and overall survival. Eligible patients randomized to receive PBMT will undergo daily laser therapy at 4 J/cm² of the oral mucosal areas most frequently affected by OM, starting on the first day of the administration of chemotherapy, until neutrophil engraftment or resolution of OM, whatever occurs first. Eligible patients randomized to oral CT will receive ice chips (IC) made from filtered tap water or flavored ice popsicles on days of chemotherapy infusions only, starting 5 min prior to chemotherapy until 30 min after the end of infusion. Patients ≥ 18 years of age, receiving therapies with high potential to induce OM, including the conditioning regimen high-dose melphalan, carmustine/etoposide/cytarabine/melphalan (BEAM), thiotepa/etoposide/cytarabine/melphalan (TEAM), fludarabine/thiotepa/melphalan (FTM) and fludarabine/melphalan (FM) or chemotherapy protocols with high-dose MTX, are included in this trial. The trial tests the null hypothesis (H 0) that the observed rate of severe OM with PBMT and CT prophylaxis are equal versus the alternative hypothesis (H 1) that the observed rate of severe OM differs between CT and PBMT. We estimate a rate of severe OM of 45 % in our trial population (H 0). With a power of 80 %, a type 1 error rate of 5 %, and an expected difference in severe OM rate of 30 % considered relevant between both arms, with an expected dropout rate of 5 %, n = 86 patients should participate in the study to ensure discrimination of H 0 and H 1. Conclusion This study aims to compare PBMT and CT with regard to their effectiveness in the prevention of severe OM in a randomized trial for the first time. Our objective is to provide data that may guide the development of a standardized OM prophylaxis for patients undergoing high-dose chemotherapy. At the time of abstract submission, 8 patients have been randomized in the study. Acknowledgments This is an independent academic trial conducted under the sponsor role of the University Cancer Center Schleswig-Holstein, Germany. This study is conducted in compliance with the protocol, Good Clinical Practice (GCP), all applicable regulatory requirements and the ethical principles of the Declaration of Helsinki.

Impact of integrating standardized venous thromboembolism (VTE) prophylaxis orders for patients with multiple myeloma into an electronic health record (EHR).

469 Background: VTE is a serious complication in multiple myeloma patients, who have a 9-fold increased risk compared to the general population. Prophylaxis for VTE is recommended by international guidelines in multiple myeloma patients based on VTE risk assessment, but published studies have demonstrated prescribing may be suboptimal. Our aim was to evaluate the impact of integrating standardized VTE prophylaxis orders for multiple myeloma patients on active treatment into our EHR, which services over 2300 providers within 500 community cancer treatment locations across the United States. Methods: National Comprehensive Cancer Network Guideline-recommended VTE prophylaxis agents were integrated as optional orders into multiple myeloma EHR regimen templates from June to July 2022. Optional informational orders were also included: a “VTE Prophylaxis Reminder” order served as a trigger for the care team if prophylaxis was not prescribed and a “VTE Prophylaxis Exception” order served as documentation if the patient did not qualify for anticoagulation. An educational guide about VTE risk stratification and prophylaxis in multiple myeloma was developed and embedded in regimen templates. To evaluate the impact of this intervention, a structured EHR data export was used to identify multiple myeloma patients with regimen templates ordered during the prespecified time frames. A retrospective chart review was conducted to identify documentation of anticoagulation or reason for exception on or prior to cycle 1 day 1 of the multiple myeloma regimen. Data were compared using the Fisher’s exact test. We also evaluated ordering of VTE prophylaxis and use of informational orders from regimens during the post-implementation phase. Results: A total of 297 patients were identified, with 128 during the pre-implementation phase (May 2022) and 169 during the post-implementation phase (September 2022). Documentation of anticoagulation or reason for exception on or prior to cycle 1 day 1 of the multiple myeloma regimen increased from 70% (89/128) during the pre-implementation phase to 81% (137/169) during the post-implementation phase (two-sided p=0.0276). Aspirin was the most common agent prescribed in 73% and 64% of patients, respectively. During the post-implementation phase, VTE prophylaxis was prescribed directly from the regimen in 16% of patients. The “VTE Prophylaxis Reminder” order was utilized for 89% of patients and the “VTE Prophylaxis Exception” order was utilized for 1 patient. Conclusions: Integration of standardized orders into EHR regimen templates may facilitate prescribing and serve as reminders for the care team. We saw an 11% increase in documentation of VTE prophylaxis, which may potentially reduce risk of VTE in this patient population. Efforts are ongoing to highlight the need for anticoagulation and importance of documentation.

Postoperative infections associated with microvascular free flaps in head and neck reconstruction: Analysis of risk factors and results with a standardized prophylaxis protocol

Currently, large defects of the head and neck regions are mainly reconstructed using microvascular free flap. Postoperative infections, including surgical site infections (SSIs) and medical postoperative infections (MPI), are important causes of morbidity and worsening of surgical outcomes. The authors aimed to analyze the results obtained using a standardized prophylaxis protocol in a series of 100 consecutive patients who underwent microvascular reconstruction surgery between 2016 and 2021 at a single institution, to identify the risk factors, which could be overcome, to minimize the incidence of infectious complications. In this study, 24 patients developed infectious complications. Higher American Society of Anesthesiologists(ASA) score was statistically associated with higher risk of infectious complications (p=0.01), need for postoperative transfusions (p=0.01), and higher T and N stage (p=0.03 and p=0.02, respectively) in patients with cancer. We also found a correlation between the increase in surgery duration, hospitalization, and intensive care unit (ICU) stay with higher risk of infection (p=0.03, p=0.01, and p=0.001, respectively). Nine patients reported partial or total flap necrosis and in this group of patients, a higher incidence of infectious complication was recorded (p=0.001). Our experience shows that SSIs and MPIs affect the global and surgical outcomes of patients and both their incidences can be reduced by correcting potential risk factors preoperatively (e.g., anemia), intraoperatively (amount of blood loss and duration of surgery), and postoperatively (duration of hospitalization and ICU stay and early elimination of potential sources of infection).

Achieving durable compliance with venous thromboembolism prophylaxis in bariatric surgery: 3-year data from a major academic medical center

BackgroundMetabolic and bariatric surgery (MBS) venous thromboembolism (VTE) prescribing practices vary widely. Our institutional VTE prophylaxis protocol has historically been unstandardized. ObjectivesTo create a standardized MBS VTE prophylaxis protocol, track protocol compliance, and identify barriers to protocol compliance and address them with Plan-Do-Study-Act (PDSA) cycles. SettingSingle Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program-accredited academic hospital. MethodsWe conducted a retrospective study for all patients undergoing MBS (January 2019 to September 2022). A multidisciplinary group of bariatric clinicians reviewed literature and developed the following standardized VTE prophylaxis protocol: 5000 units preoperative subcutaneous (SC) heparin within 60 minutes of anesthesia induction and postoperative 40 mg SC low molecular weight heparin (LMWH) within 24 hours of surgery. This protocol was distributed to relevant clinical stakeholders. We assessed monthly compliance rates through chart review. Goal compliance was ≥90%. We identified sources of noncompliance and addressed them with PDSA methodology. ResultsA total of 796 patients were included. Preoperative heparin administration increased from a mean of 47% (107/228) preintervention to 96% (545/568) postintervention (P < .0001), and postoperative LMWH administration increased from 71% (47/66) to 96% (573/597, P = .0002). These compliance rates were sustained for 3 years. Barriers to protocol noncompliance included order set timing errors (n = 45), surgeon error (n = 44), surgeon discretion (n = 40), and nursing error (n = 20). No change in bleeding or VTE rates was observed. ConclusionsDeveloping a standardized VTE prophylaxis protocol, monitoring process measures, and engaging relevant stakeholders in PDSA cycles resulted in drastic and durable improvement in VTE prophylaxis compliance rates.

742 Evaluation of Anti-Xa Levels and Venous Thromboembolism Prophylaxis with Enoxaparin in Burn Patients

Abstract Introduction Previous studies have found that standard dose enoxaparin is inadequate in achieving goal prophylactic anti-Xa levels in burn patients. A new venous thromboembolism (VTE) prophylaxis protocol was implemented at our institution (Table 1). The objective of this study was to assess the efficacy and safety of the updated VTE prophylaxis protocol to determine if goal anti-Xa levels can be achieved earlier compared to the previous enoxaparin dosing protocol. Methods This was a retrospective cohort study evaluating a historic protocol group from 3/1/21 to 5/31/21 and a new protocol group from 10/1/21 to 12/31/21. Revisions were made to the new protocol group and evaluated from 7/1/22 to 8/31/22. Adult patients admitted with cutaneous and/or inhalation burn who received enoxaparin for VTE prophylaxis and had anti-Xa monitoring were included. The primary endpoint was protocol efficacy defined as percentage of initial anti-Xa levels within goal range and time to goal anti-Xa level. Secondary endpoints included protocol adherence, rate of VTE occurrence, number of missed or held doses if VTE occurred, correlation to published enoxaparin dosing equations in burn patients, and bleeding events. Results Results can be found in Table 2. The median (IQR) initial anti-Xa level in the historical (n=29) vs. new protocol group (n=22) was 0.09 (0.04-0.14) units/mL vs. 0.15 (0.10-0.19) units/mL (p=0.036). After adjusting the BMI cutoff in the new protocol from 40 kg/m2 to 35 kg/m2, the median initial anti-Xa was 0.16 (0.12-0.22) units/mL vs. 0.24 (0.19-0.28) units/mL (p=0.018). The mean ± SD time for patients to achieve goal anti-Xa level was 5 ± 3 days in the historical protocol and 5 ± 2 days in the new protocol group (p = 0.456). After protocol modification, the median time to goal anti-Xa level was 4 (3-6) days vs. 2 (1-3) days (p=0.002). No differences were noted in secondary outcomes. Conclusions The new protocol resulted in a higher initial anti-Xa level with more patients within goal anti-Xa range which was reached in less time after modification of the BMI cutoff for weight-based dosing. The maximum anti-Xa level in the modified group was still within the prophylactic range with the new protocol, indicating no increase in supratherapeutic levels compared to previously utilized dosing strategies and there were no differences in major or minor bleeding events which supports its safety. Applicability of Research to Practice This protocol can be replicated and utilized by other burn centers with the potential for a multicenter analysis and provides a framework for developing standardized VTE prophylaxis dosing recommendations with enoxaparin in burn patients.

Which Procedures Contribute Most to the System-Wide Burden of Postoperative Venous Thromboembolism?

While clinical risk assessment models examine patient-level characteristics that portend morbidity, there is a paucity of literature exploring which procedures contribute most to the system-wide burden of venous thromboembolism (VTE). We aimed to identify highly contributory procedures as potential targets for quality improvement. All patients in the 2020 National Surgical Quality Improvement Program (NSQIP) Public User File were included. Current Procedural Terminology (CPT) codes were analyzed individually and grouped by National Healthcare Safety Network groupings. We counted prevalence of VTE and calculated VTE rate for each CPT and for each grouping. Of 902,968 included patients, 7501 (.83%) sustained postoperative VTE. Of 2748 unique CPT codes, VTE occurred for 762 (28%). Twenty procedure codes (.7%) contributed 39% of the total VTE. VTE rates of these procedures ranged from high-volume procedures with low VTE rates such as laparoscopic cholecystectomy (.25%) and laparoscopic hysterectomy (.32%) to lower volume procedures with high VTE rate such as Hartmann's procedure (4.32%), Whipple procedure (3.85%), and distal pancreatectomy (3.82%). The CPT grouping with the most VTE was colon surgeries (1275/7501). A small number of procedures contributes to the system-wide burden of VTE. High-risk procedures are important targets for standardized prophylaxis protocols. For low-risk procedures, careful attention should be paid to patient-specific factors that may increase VTE risk such as obesity, cancer, or limited mobility, as many common procedures contribute greatly to the systemic burden of VTE. Overall, surveillance can perhaps be targeted on a smaller number of procedures, allowing for more efficient use of quality improvement resources.

Thromboembolic outcomes are decreased with the use of a standardized venous thromboembolism risk assessment and prophylaxis protocol for patients undergoing superficial venous procedures

ObjectivePatients with venous insufficiency can be treated with ablation or phlebectomy, or both. Patients undergoing superficial venous procedures have an elevated risk of deep vein thrombosis (DVT) and pulmonary embolism (PE). At our institution, we initiated a standardized protocol in which patients with a Caprini score (2005 version) of ≥8 are treated with 1 week of prophylactic anticoagulation after the procedure. Duplex ultrasound was performed at 1 week and then within 90 days after the procedure. This aim of the present study was to determine the thrombotic and clinical outcomes after superficial vein procedures using a standardized protocol for DVT/PE risk assessment and prophylaxis. MethodsWe performed a retrospective analysis of prospectively collected data of superficial vein procedures from 2015 to 2021 at a single center. The patient demographics, CEAP (Clinical-Etiology-Anatomy-Pathophysiology) clinical class, venous clinical severity score, patient-reported outcomes, treatment type, Caprini scores, pre- and postoperative anticoagulation use, and outcomes were collected. Descriptive statistics were used for the patient demographics, procedure details, and unadjusted surgical outcomes. Multivariable logistic regression was used to evaluate the relationship between procedure type and DVT and PE after adjusting for patient characteristics, disease severity, periprocedural anticoagulation, and Caprini score. ResultsA total of 1738 limbs were treated with ablation (n = 820), phlebectomy (n = 181), or ablation and phlebectomy (n = 737). More patients were women (67.1%) and White (90.9%). The overall incidence of DVT/PE was 1.4%. Patients undergoing ablation with phlebectomy had higher rates of DVT/PE (2.7%) than those undergoing ablation (0.2%) or phlebectomy alone (1.7%; P < .01). However, only 30% of DVTs were above the knee. On multivariate analysis, only the procedure type predicted for DVT/PE. However, patients undergoing ablation and phlebectomy achieved better patient-reported outcomes (Caprini score, 5.9) compared with those undergoing ablation (Caprini score, 7.2) or phlebectomy (Caprini score, 7.9) alone (P < .01). The best improvement in the venous clinical severity score was seen with phlebectomy alone. ConclusionsThe expected difference in the DVT/PE rates between high- and low-risk groups did not materialize in our patients, perhaps secondary to the additional chemoprophylaxis prescribed for the high-risk cohort (Caprini score, ≥8). These results call for a randomized trial to assess the efficacy of a standardized protocol in the reduction of DVT/PE after superficial vein procedures.

Endoscopic Excision of Hip Heterotopic Ossification, Plus Indomethacin and Radiation, Is Effective in Treating and Preventing Recurrence

To describe the clinical and patient-reported outcomes of heterotopic ossification (HO) excision as well as the results of a standardized HO prophylaxis protocol among a group of patients who previously underwent open or arthroscopic hip surgery. Patients who developed HO after index hip surgery and were subsequently treated with arthroscopic excision of HO and postoperative HO prophylaxis using 2 weeks of indomethacin and radiation were retrospectively identified. All patients were seen by a single surgeon and were treated with the same arthroscopic technique. Patients were also placed on a regimen of 2 weeks of indomethacin 50 mg and radiation therapy with 700 cGy in one fraction on the first postoperative day. Outcomes assessed included recurrence of HO and conversion to total hip arthroplasty by latest follow-up. Other outcomes included Modified Harris Hip Scores and Non-Arthritic Hip Scores, which were collected preoperatively and at 1-year and 2-year follow-up. There were 5 female and 9 male subjects, with an average age of 39 years (range 22-66) and average body mass index of 27.1 (19.1-37.5). Average follow-up time was 46 months (range 4-136). No patients had experienced HO recurrence by latest follow-up. Only 2 patients converted to total hip arthroplasty, one at 6 months and the other at 11 months postexcision. Average outcome scores improved by 2-year follow-up (average Modified Harris Hip Scores 52.8 improved to 86.5, average Non-Arthritic Hip Scores 49.4 improved to 83.8). Minimally invasive arthroscopic excision of HO and postoperative prophylaxis with combined indomethacin and radiation therapy effectively treats and prevents the recurrence of HO. Level IV, case series, therapeutic.

Improved Outcomes in Acute Myeloid Leukemia Patients Receiving 7+3 Induction By Using Protocolized Antifungal Prophylaxis in a Community Setting

Introduction: Invasive fungal infections (IFI) are a leading cause of mortality in patients with acute myeloid leukemia (AML) undergoing induction chemotherapy including "7+3” regimen of cytarabine and daunorubicin.1 Posaconazole improves survival and reduces IFI rates in comparison with fluconazole.2 The aim of our study was to compare outcomes of patients receiving induction chemotherapy for AML at our institution before and after implementation of a priority matrix (PM) including standardized antifungal prophylaxis. Our primary endpoint was incidence of IFI, and our secondary endpoints were mortality at 30 days and 1 year. Methods: All patients admitted with AML and receiving 7+3 induction chemotherapy at Gundersen Health System between January 2013 and January 2022 were included in our study. Patients were assigned either to Pre-PM or Post-PM group (whether induction was started before or after January 1, 2019, respectively). The priority matrix (Figure) included mandatory treatment with appropriate prophylaxis (posaconazole /voriconazole), patient education, electronic health record (EHR) updates, standardized work up for refractory fevers, and other optimization practices. Antifungal agent was given starting on day 8 after initiation of induction until resolution of neutropenia, defined as an absolute neutrophil count >500/uL. Treatment-related mortality rates (TRMR) and Charlson Comorbidity Index (CCI) were calculated at time of diagnosis. Statistical analyses using chi-square, Fisher exact, Wilcoxon rank sum tests, and Cox proportional hazards were done in SAS version 9.4. Results: The study population consisted of 37 patients: 23 in the Pre-PM group (prior to Jan 1, 2019) and 14 in the Post-PM group. The population was predominantly white, non-Hispanic with a median age 63 years, and was 60% male. Groups were similar with regard to median age, sex, TRMR, and CCI. Of the 23 Pre-PM patients, 6 received fluconazole. All patients in the Post-PM group received prophylaxis-1 with voriconazole, and 13 with posaconazole. Six Pre-PM patients (26%) developed IFI, compared with 1 Post-PM patient (7%; p=0.22). Five of the 6 Pre-PM patients who received fluconazole developed IFI, as did 1 Post-PM patient who received posaconazole (p<0.001). Four (17%) Pre-PM patients, none of whom received fluconazole died within 30 days, and there were no deaths in the Post-PM group (p=NS). Fifteen (65%) Pre-PM patients died within 1 year (5 had received fluconazole prophylaxis), compared with 3 (21%) Post-PM patients. Mortality rates were not significantly different between groups at 30 days (p=0.22)); however, mortality at 1 year was significantly higher in the Pre-PM group (log rank p=0.004), including in those receiving fluconazole (log rank p=0.0005). Conclusions: Our study shows significantly improved outcomes with use of a standardized protocol in AML patients receiving 7+3 induction by using posaconazole over fluconazole per our PM intervention. We reduced IFI rates to our goal of <10% in AML patients and improved 30-day and 1 -year survival at our institution, rates comparable to national averages. Because community health care facilities are increasingly treating patients with AML, we share our protocol to help improve care in this setting. References 1Hsu A. et al. Supportive Care in Cancer, . 2021;29(2):707-712. 2Cornely OA, et al. N Engl J Med. 2007;356:348-359 Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Impact of narrowing perioperative antibiotic prophylaxis for left ventricular assist device implantation.

Although infections are a significant potential complication among patients undergoing left ventricular assist device (LVAD) implantation, standardized surgical infection prophylaxis (SIP) regimens are not well defined. At Montefiore Medical Center, a 4-drug SIP regimen containing fluconazole, ciprofloxacin, rifampin, and vancomycin was previously utilized. In January 2020, the antimicrobial stewardship program implemented a 2-drug SIP regimen of vancomycin and cefazolin to limit exposure to broad-spectrum antibiotics. This study evaluated LVAD-associated infection rates prior to and following the SIP revision. A retrospective review of patients who underwent LVAD implantation from 1/2018 to 4/2021 was performed. Infections were classified using the International Society for Heart and Lung Transplantation definitions. Infection rates at 2weeks, 30 days, and 90 days post-implantation in the 4-drug SIP regimen (1/2018-12/2019) and the 2-drug SIP regimen (1/2020 to 4/2021) were compared. A total of 71 patients were included. The number of patients with LVAD-associated infections (including surgical site infections) was not significantly different in either SIP group at 2weeks (9%vs. 4%, p=.64), 30 days (9%vs. 11%, p=.99), or 90 days (19%vs. 14%, p=.75). There was no statistically significant difference in 30 or 90-day mortality. LVAD-associated gram-negative (7%vs. 7%; p>.99) and fungal (5%vs. 0%; p=.51) infections were uncommon. The most common organism isolated was Staphylococcus aureus, and the most common type of infection was pneumonia in both SIP groups. No significant difference in LVAD-associated infections or infection-related mortality was observed with de-escalation of perioperative antibiotics. Additional studies with larger sample sizes are needed to endorse the findings of this study.

Pulmonary embolism in pediatrics: A 10-year experience from a tertiary center in Brazil

IntroductionAlthough still rare, pulmonary embolism (PE) in children has been increasing over the years. Data regarding this group of patients are still sparse, which contributes to the lack of standardized prophylaxis protocols and the misdiagnosis. This study aimed to determine the incidence of pediatric PE at a Brazilian tertiary hospital, describe clinical characteristics and identify possible risk factors. We also analyzed the diagnosis and management of PE. MethodsThis was a retrospective review of tertiary Brazilian single-center data of all pediatric patients (0 – 18 years) with acute PE, diagnosed radiologically, from September 2009 to May 2019. ResultsThe incidence of PE was 3.3 cases per 10,000 hospitalized children. All the twenty-three cases had some risk factor identified and sixteen of them (69.5%) had more than one risk factor. The most important were central venous catheter (39.1%), malignancy (34.8%) and recent surgery (34.8%). Among the children with identifiable symptoms (69.5%), the most common was dyspnea (56.2%). Only one patient did not receive antithrombotic therapy because of the high bleeding risk and most patients (70.6%) were treated for 3 to 6 months. Among the nineteen patients alive at the end of the six-month follow-up, ten (52.6%) repeated the PE image control. Seven of them (70.0%) had complete or partial resolution of the thrombosis and none had worsening images. ConclusionOur lower incidence than that of the current literature may reflect underdiagnosis due to low suspicion of PE. At least one risk factor was identified in all patients, which emphasizes the importance of increasing awareness of high-risk children.

Evaluation of Safety and Effectiveness of the Paragonix™ SherpaPak Cardiac Transport System in Donation After Circulatory Death Heart Transplantation (clinicaltrials.gov Identifier: Nct05038943)

Purpose To evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System (CTS) in the transportation of cardiac allografts recovered from donors after circulatory death (DCD) with thoracoabdominal normothermic regional perfusion (TA-NRP). Methods Institutional Review Board (IRB#0478-21-FB) approved this single center pilot study for a total number of 5 heart transplants. The study is designed as a single arm feasibility study. The study opened for enrollment on September 15th 2021, the anticipated duration is one year. All patients included in DCD NRP study (NCT04615182) will be consented to participate in DCD NRP Paragonix study (NCT05038943). Inclusion and exclusion criteria are summarized in Table 1. Donor organs will be procured after no more than 30 minutes of warm ischemia (defined as a time period commencing from systolic blood pressure < 50 mmHg to the start of reperfusion) and resuscitated in-situ with TA-NRP in accordance with the approved institutional protocol. Criteria for donor acceptance for transplantation are depicted in Table 2. Allografts will be transported from a donor site to recipient center with the SherpaPak™ CTS. All implantation procedures will be performed at our institution. Recipients will receive standardized immunosuppression and infection prophylaxis and will undergo rejection surveillance with serial endomyocardial biopsies. Endpoints Primary outcome is primary graft dysfunction (PGD) at 24, 48, and 72 hours (using ISHLT definition). Secondary outcomes are: need for cardioversion or pacing to restart transplanted heart; vasoactive-inotropic score at 24, 48, and 72 hours (dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x epinephrine dose (µg/kg/min) + 100 x norepinephrine dose (µg/kg/min); intensive care unit and hospital length of stay; and 30-day, 90-day, 1-year survival. To evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System (CTS) in the transportation of cardiac allografts recovered from donors after circulatory death (DCD) with thoracoabdominal normothermic regional perfusion (TA-NRP). Institutional Review Board (IRB#0478-21-FB) approved this single center pilot study for a total number of 5 heart transplants. The study is designed as a single arm feasibility study. The study opened for enrollment on September 15th 2021, the anticipated duration is one year. All patients included in DCD NRP study (NCT04615182) will be consented to participate in DCD NRP Paragonix study (NCT05038943). Inclusion and exclusion criteria are summarized in Table 1. Donor organs will be procured after no more than 30 minutes of warm ischemia (defined as a time period commencing from systolic blood pressure < 50 mmHg to the start of reperfusion) and resuscitated in-situ with TA-NRP in accordance with the approved institutional protocol. Criteria for donor acceptance for transplantation are depicted in Table 2. Allografts will be transported from a donor site to recipient center with the SherpaPak™ CTS. All implantation procedures will be performed at our institution. Recipients will receive standardized immunosuppression and infection prophylaxis and will undergo rejection surveillance with serial endomyocardial biopsies. Primary outcome is primary graft dysfunction (PGD) at 24, 48, and 72 hours (using ISHLT definition). Secondary outcomes are: need for cardioversion or pacing to restart transplanted heart; vasoactive-inotropic score at 24, 48, and 72 hours (dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x epinephrine dose (µg/kg/min) + 100 x norepinephrine dose (µg/kg/min); intensive care unit and hospital length of stay; and 30-day, 90-day, 1-year survival.

Early Outcomes of Donation After Circulatory Death Heart Transplantation with Thoracoabdominal Normothermic Regional Perfusion

<h3>Purpose</h3> To evaluate the early outcomes of donation after circulatory death (DCD) heart transplantation using thoracoabdominal normothermic regional perfusion (TA-NRP). <h3>Methods</h3> The study is designed as a single center prospective study with single arm. Institutional Review Board approved this pilot for a total number of 60 potential DCD heart recipients using grafts recovered with TA-NRP technique (IRB#460-20-FB). The first patient was enrolled on January 3rd 2021. The anticipated study duration is one year for a total of 10 transplant procedures. Recipient inclusion criteria are age ≥ 19 years, signed informed consent, and eligibility for heart transplantation based on standardized institutional criteria. Patients listed for dual organ transplantation and patients with previous cardiac operation including durable LVAD implantation will also be included. All hearts will be recovered with TA-NRP after no more than 30 minutes of warm ischemia (defined as the time period commencing from SBP < 50 mmHg to in-situ reperfusion). TA-NRP protocol is summarized in Figure 1. Acceptance for transplantation will be based upon the functional assessment with TEE and invasive hemodynamic measurements combined with the visual inspection after separation from mechanical support. Grafts will be recovered using 2,000mL of Celsior® for cardio protection, and transported with colds storage. All implantation procedures will be performed at our institution. Recipients will receive standardized immunosuppression and infection prophylaxis and will undergo rejection surveillance with serial endomyocardial biopsies. <h3>Endpoints</h3> Primary outcome is 30-day patient survival. Secondary outcomes are primary graft dysfunction and inotropic score at 72 hours, ICU and hospital length of stay, ventilation duration, and the need for renal replacement therapy.

Improving Intrapartum Group B Streptococcus Prophylaxis in Patients with a Reported Penicillin or Cephalosporin Allergy: A Quality Improvement Project

ObjectiveTo evaluate the impact of a standardized allergy-guided approach to Group B Streptococcus (GBS) prophylaxis in pregnant women with reported penicillin or cephalosporin allergy. MethodsThis interrupted time-series analysis included obstetric patients requiring GBS prophylaxis who reported penicillin or cephalosporin allergies. Patients were divided into baseline (April 1, 2019 to July 21, 2020) and intervention (July 22, 2020 to July 31, 2021) groups. The primary outcome was prophylaxis appropriateness, based on antibiotic type, nature of reaction, and cross-reactivity risk. Secondary outcomes included type of prophylaxis received and antibiotic-related adverse events. ResultsThe study included 88 patients in the baseline period and 52 patients in the intervention period. Appropriate prophylaxis increased from 47% (41/88) to 85% (44/52), with the segmented regression model confirming a statistically significant increase over time (incidence rate ratio 1.57; 95% CI 1.02–2.43, P = 0.04, slope coefficient 1.06/month; 95% CI 1.01–1.10, P = 0.01). Penicillin and cefazolin use increased from 61% (54/88) to 87% (45/52) in the intervention period (P = 0.002), and no hypersensitivity reactions occurred during this period. ConclusionsImplementation of standardized allergy-guided prophylaxis safely improved appropriate β-lactam antibiotic use in obstetric patients requiring GBS prophylaxis who reported penicillin and cephalosporin allergies.

Postdischarge pain, nausea and patient satisfaction after diagnostic and breast-conserving ambulatory surgery for breast cancer: A cross-sectional study.

The aims of this study were to assess first day postdischarge pain, nausea and patient satisfaction in ambulatory breast cancer surgical patients, after diagnostic and breast conserving procedures. A total of 781 women, aged 18-85years were included in this prospective, cross-sectional study. All patients received standardized multimodal pain prophylaxis with paracetamol, COX-II inhibitor, dexamethasone and wound infiltration with local anaesthetics. Nausea prophylaxis was provided with ondansetron. Most patients received general anaesthesia with propofol and remifentanil. Data were collected using a validated questionnaire during telephone follow-up on the first postoperative day. The response rate was 94.5%. NRS≥4 was reported by 5.3% at rest, by 17% during activity and by 30.7% as the worst pain score. Young age was strongly associated with more pain both at rest, during activity and regarding worst pain since discharge. Postdischarge nausea was present in 17.8%, and vomiting in 1.2%. High pain score during activity and higher level of worst pain, were associated with nausea. There was no association between nausea and age, type of anaesthesia, surgical procedure or pain at rest. Patient satisfaction was high (97.8%-99.7%) regarding information, time for discharge and overall satisfaction. Pain scores and incidence of nausea were generally low on the day after surgery. Young age was a strong predictor for postdischarge pain. A high worst pain score and high pain score during the activity were associated with postdischarge nausea. Patient satisfaction was high.

Blank spaces in the management of venous thromboembolism prophylaxis at surgical departments and the impact of a clinical pharmacist

A venous thromboembolism (VTE) prophylaxis policy should be in place at all hospitals. While professional societies provide general guidance, they do not take into account the full range of procedures in this area. The aim of this study was to fill these &#8220;blank spaces&#8221; and design a VTE prophylaxis system which would reflect the wide range of surgical procedures. We conducted an extensive literature review. Surgeons were subsequently asked to help score procedures according to VTE and bleeding risk while taking into consideration procedure type and duration, surgical techniques, etc. Results: Clinical pharmacists proposed a standardized VTE prophylaxis protocol. For some surgical fields the Caprini risk assessment model (RAM) was adapted. A unique VTE prophylaxis system was created for surgical fields where Caprini RAM has not been validated. We proposed dosage adjustments for obese patients and for patients with renal impairment. A dedicated software application was developed. The implementation of the VTE prophylaxis system resulted in a uniform and more rational prescription of pharmacological and mechanical prophylaxis as well as in financial savings. The development of the app increased compliance with the system and, in combination with real-time auditing, significantly improved safe drug administration practices at Military University Hospital Prague. The system is unique in continental Europe and contains wide range of surgical procedures and matching VTE prophylaxis, which has never before been published in this scope. It demonstrates the contribution of clinical pharmacists to the improvement of hospital care quality.