Safety profile of GreenLight XPS laser photoselective vaporisation of the prostate in patients at high risk of bleeding

2021 ◽  
pp. 205141582110418
Author(s):  
Darragh K Waters ◽  
Raihan Khalid ◽  
Fatalla Mustafa ◽  
Frederick Omeire ◽  
Barry J Jones

Objective: This study aimed to assess the utility and safety profile of the GreenLight Xcelerated Performance System (XPS) photoselective vaporisation of the prostate (PVP) to treat benign prostatic hyperplasia (BPH) in high-risk patients. Patients and methods: A retrospective study of a prospectively managed database was carried out. The study reviewed a single surgeon’s experience of treating high-risk patients with GreenLight XPS PVP between two sites over a four-year period. Patients considered to be high risk were those who were at an increased risk of bleeding, those who had a prostate size >80 mL, those with preoperative urinary retention and/or those aged >80 years. Results: In total, 374 patients were identified as being high risk for GreenLight PVP. Patient age ranged from 44 to 96 years ( Mage=71 years). Of the 374 patients, 103 were aged >80 years. All 374 patients were considered to be at an increased risk of bleeding, as they underwent GreenLight PVP while taking antiplatelet agents (not including aspirin), anticoagulant agents or both. Ninety-one patients had preoperative urinary retention and indwelling urinary catheter. Fifty-four patients had a prostate size >80 mL. Length of stay varied from 1 to 14 days. Most patients ( n=270) were discharged on postoperative day 1. There were no perioperative blood transfusions. One patient developed acute coronary syndrome on postoperative day 4, requiring percutaneous coronary intervention. Twenty-two patients required readmission: 12 due to urinary retention with or without haematuria, and 10 due to haematuria without associated acute retention. Two patients required cystoscopy and bladder washout. There were two blood transfusions in the ‘readmission due to haematuria’ group. Outcomes for patients aged >80 years were favourable. The average length of stay was 2.7 days (range 1–14 days). This group was responsible for 12 of the 22 readmissions. There were no perioperative cardiovascular events. Conclusion: We conclude that GreenLight XPS PVP is a safe procedure in patients with one or more high-risk factors. The ability to proceed without the need to stop antiplatelets or anticoagulant agents also allows for high-risk medical patients to be treated without the additional risks of cardiovascular events. Level of evidence: Not applicable for this multicentre audit.

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 2-OR
Author(s):  
MARCUS V.B. MALACHIAS ◽  
PARDEEP JHUND ◽  
BRIAN CLAGGETT ◽  
MAGNUS O. WIJKMAN ◽  
RHONDA BENTLEY-LEWIS ◽  
...  

2021 ◽  
Vol 12 ◽  
pp. 204062072110196
Author(s):  
Albert Oriol ◽  
Laura Abril ◽  
Anna Torrent ◽  
Gladys Ibarra ◽  
Josep-Maria Ribera

The development of several treatment options over the last 2 decades has led to a notable improvement in the survival of patients with multiple myeloma. Despite these advances, the disease remains incurable for most patients. Moreover, standard combinations of alkylating agents, immunomodulatory drugs, proteasome inhibitors, and monoclonal antibodies targeting CD38 and corticoids are exhausted relatively fast in a proportion of high-risk patients. Such high-risk patients account for over 20% of cases and currently represent a major unmet medical need. The challenge of drug resistance requires the development of highly active new agents with a radically different mechanism of action. Several immunotherapeutic modalities, including antibody–drug conjugates and T-cell engagers, appear to be promising choices for patients who develop resistance to standard combinations. Chimeric antigen-receptor-modified T cells (CAR-Ts) targeting B-cell maturation antigen have demonstrated encouraging efficacy and an acceptable safety profile compared with alternative options. Multiple CAR-Ts are in early stages of clinical development, but the first phase III trials with CAR-Ts are ongoing for two of them. After the recent publication of the results of a phase II trial confirming a notable efficacy and acceptable safety profile, idecabtagene vicleucel is the first CAR-T to gain regulatory US Food and Drug Administration approval to treat refractory multiple myeloma patients who have already been exposed to antibodies against CD38, proteasome inhibitors, and immunomodulatory agents and who are refractory to the last therapy. Here, we will discuss the preclinical and clinical development of idecabtagene vicleucel and its future role in the changing treatment landscape of relapsed and refractory multiple myeloma.


2021 ◽  
Vol 12 ◽  
pp. 215145932199274
Author(s):  
Sanjit R. Konda ◽  
Joseph R. Johnson ◽  
Nicket Dedhia ◽  
Erin A. Kelly ◽  
Kenneth A. Egol

Introduction: This study sought to investigate whether a validated trauma triage tool can stratify hospital quality measures and inpatient cost for middle-aged and geriatric trauma patients with isolated proximal and midshaft humerus fractures. Materials and Methods: Patients aged 55 and older who sustained a proximal or midshaft humerus fracture and required inpatient treatment were included. Patient demographic, comorbidity, and injury severity information was used to calculate each patient’s Score for Trauma Triage in the Geriatric and Middle-Aged (STTGMA). Based on scores, patients were stratified to create minimal, low, moderate, and high risk groups. Outcomes included length of stay, complications, operative management, ICU/SDU-level care, discharge disposition, unplanned readmission, and index admission costs. Results: Seventy-four patients with 74 humerus fractures met final inclusion criteria. Fifty-eight (78.4%) patients presented with proximal humerus and 16 (21.6%) with midshaft humerus fractures. Mean length of stay was 5.5 ± 3.4 days with a significant difference among risk groups (P = 0.029). Lower risk patients were more likely to undergo surgical management (P = 0.015) while higher risk patients required more ICU/SDU-level care (P < 0.001). Twenty-six (70.3%) minimal risk patients were discharged home compared to zero high risk patients (P = 0.001). Higher risk patients experienced higher total inpatient costs across operative and nonoperative treatment groups. Conclusion: The STTGMA tool is able to reliably predict hospital quality measures and cost outcomes that may allow hospitals and providers to improve value-based care and clinical decision-making for patients presenting with proximal and midshaft humerus fractures. Level of Evidence: Prognostic Level III.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Macaela N Rudeck ◽  
Catherine P Benziger

Introduction: Atrial fibrillation (AF) and flutter lead to increased risk of thromboembolism (TE). The CHA 2 DS 2 -VASc score is used to determine the risk of TE. Objective: We aim to evaluate the anticoagulation use across CHA 2 DS 2 -VASc scores calculated using a validated automatic calculator. Methods: An AF registry was created for patients with AF or atrial flutter who had seen a primary care or cardiology provider within the past 2 years (5/28/2018-5/28/2020). An automatic CHA 2 DS 2 -VASc calculator was integrated into the electronic medical record system at Essentia Health on 10/1/2019. High-risk of TE was defined as a score of ≥3 for females and a score of ≥2 for males. AF registry included demographics, anticoagulation prescription, CHA 2 DS 2 -VASc and ATRIA bleed score, contraindications, and presence of left atrial appendage (LAA) occlusion device. Results: A total of 10992 patients with AF or atrial flutter were included in the registry (74.8 ±11.8 years, 41.7% female). A total of 6703 (61.0%) had a CHA 2 DS 2 -VASc score calculated (mean score 3.9 ± 1.5). Mean ATRIA bleed score was 3.0 ± 2.0. Within these patients, 90.7% of males and 93.0% of females were at high-risk of TE. Of these high-risk patients, anticoagulation use was 82.7% for females and 83.5% for males and increased with increasing score (p<0.01 for males, p<0.01 for females) (Figure 1). Overall, 36.9% were prescribed NOAC, 47.0% warfarin, and 0.8% heparin. There was no sex difference in the prescription of NOAC (37.7% male vs. 35.9% female, p=0.1). Fewer than 1% had WATCHMAN LAA device (0.3% male vs. 0.4% female, p=0.5). Conclusion: Four out of 5 patients at increased risk of TE are prescribed an anticoagulant. Interventions to improve anticoagulation use in high-risk patients are needed. Figure 1. Anticoagulation prescription use in atrial fibrillation patients by CHA 2 DS 2 -VASc score and sex between 5/28/2018-5/28/2020 at Essentia Health (N=6703).


2021 ◽  
pp. 4-8
Author(s):  
Ananay Vishvakarma ◽  
Subhasish Roychowdhury ◽  
Anil Kumar Saha

Background: Perforation is one of the common complication of peptic ulcer disease which is associated with signicant morbidity and mortality. It is a disease which needs emergent surgical intervention. Accurate and early identication of high-risk patients with Perforated Peptic Ulcer is important for risk stratication. Here, we calculate the three prognostic factor scores, (i) The Boey Score, (ii) The Peptic ulcer perforation (PULP) score, and (iii) The quick sequential organ failure assessment (q-SOFA) score, preoperatively to predict postoperative outcome. Aims & Objective: The aim of the study is to identify patients with an increased risk of adverse outcome, so that we can target the level of perioperative monitoring and treatment in high-risk patients. Also, to determine and compare the ability of three prognostic factor scores to predict morbidity and mortality in patients of Perforated Peptic Ulcer. Methods: Aprospective comparative observational study was conducted comprising of 92 patients with conrmed perforated peptic ulcer (PPU) attending the emergency ward of Department of General Surgery between February 2019 to July 2020. After conrmation of diagnosis, risk stratication according to the three prognostic factor scores (Boey score, PULP score, and q-SOFA score) was done. Acomparison was made between each score through calculation of positive predictive value (PPV) and negative predictive value (NPV). We used receiver operating characteristics (ROC) curve in my study to estimate the predictive ability of each scoring system. Results: The study include 92 patients. Female 41.3% and Male 58.7%. The mean age was 45.38 years. The most common site of PPU was the rst part of duodenum - D1 (64.1%). The most common operative procedure done was the Grahm's patch repair. The morbidity rate was 28.3%. Overall mortality rate was 10.9%. The AUROC for morbidity prediction was 0.791 for Boey score, 0.918 for PULP score, and 0.61 for q-SOFAscore. The AUROC for mortality prediction was 0.829 for Boey score, 0.865 for PULPscore, and 0.602 for q-SOFAscore. Conclusion:Boey score and PULP score helps in accurate and early identication of PPU patients with an increased risk of adverse outcome. q-SOFA score cannot signicantly predict morbidity and mortality in PPU patients. Overall, PULP score performs best but Boey score is crude and simple to calculate and is used to assess the patient rapidly


2021 ◽  
Vol 17 (2) ◽  
pp. 109-113
Author(s):  
Julienne K. Kirk, PharmD, CDE, BCPS ◽  
Matthew Q. Tran, PharmD ◽  
Samantha Pelc, PharmD ◽  
Katherine G. Moore, PharmD, BCPS, BCACP

Objective: To determine whether a pharmacist-led intervention would increase the number of naloxone prescriptions and naloxone administration education in a primary care family medicine setting.Design: Prospective quality improvement intervention in an academic family medicine clinic.Methods: We surveyed providers about naloxone knowledge, prescribing habits, and prescribing barriers. We identified patients on chronic opioid therapy, through electronic health records for the year 2019. Overdose risk categories based upon morphine milligram equivalent doses and concomitant benzodiazepine use were used to determine patients who met criteria for naloxone. Pharmacists phoned qualified patients to discuss overdose risk and naloxone benefits. Patients who accepted naloxone prescriptions used their local pharmacy through a department-approved standing order set.Results: From the survey results, there were 47 of 54 provider responses, and the majority noted that they do not routinely prescribe naloxone in high-risk patients. The predominant barriers were lack of time during visit and naloxone administration education. The population of patients from chart review included 93 high-risk patients with a mean age of 58 years. During the time of intervention, 71 patients remained eligible for naloxone coprescribing. Of the patients contacted, 29 (40 percent) accepted the intervention prescription, and subsequently, 22 picked up their prescription from the pharmacy. Sixteen received counseling with a support person. Twelve patients had naloxone already at home, and two received counseling with a support person.Conclusion: The naloxone prescribing intervention is achievable. The results of this intervention support identifying patients at increased risk of opioid overdose and offer education of a support person for naloxone in a large academic family medicine clinic.


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