ABSTRACT
INTRODUCTION AND OBJECTIVE: BPH affects tens of millions of men across the world. Most procedures require either general or regional anesthesia or a transurethral approach. Herein, we present the 3 & 6 months results of NCT04760483 is a phase I prospective, single center, interventional pilot study evaluating transperineal laser ablation (TPLA) of BPH tissues, carried in Office setting under local anesthesia. A detailed step by step video depiction of this procedure is available at the AUA video library. The objectives call for safety, feasibility, and impact in pertinent outcomes measures, such as Uroflowmetry, IPSS, Hematuria, Erectile function, and ejaculation METHODS: The study contemplated accrual of 20 men between 50 and 80 years with prostate volumes between 30 and 120 cc, IPSS scores >9, peak flows between 5 and 15 cc/s and void residuals under <250 ml. Any patient neurological conditions, history of any surgical intervention or urinary retention were excluded. IPSS assessments, Flow studies and prostate volume measures were conducted at 3 months. Herein we present the results. Bayesian analysis for continuous measurements were performed and non-parametric differences were evaluated using chi2 tests. RESULTS: Patients enrolled between December 2020 and February of 2021. The median (IQR) for age and BMI was 68 (58,73) and 29 (27,31), respectively. These parameters for room time, ablation time, watts and total joules were 29 (23,32), 9 minutes (7,12), 6 (5,7) watts and 3,400 (2,600, 3600) joules, respectively. 8(40%) were discharged with a Foley due to elevated residuals. 16 patients had erections and ejaculations before and 3 months after TPLA. 17/20 (85%) had significant improvement in their urinary profile after TPLA (See TABLE for details). One of the initial responders suffered from COVID- 19 infection and developed a CVA that hindered his urinary function. CONCLUSIONS: TPLA in the office setting is feasible and safe. Three month outcomes showed subjective and objective sustained improvement in over 80% of patients for at least 6 months. Furthermore, erections or ejaculations were not affected. This novel and promising approach demands further evaluation in phase II-III trials. (Figure Presented).
ABSTRACT
Introduction: Acquired thrombotic thrombocytopenic purpura (aTTP) due to an acquired deficiency in the enzyme ADAMTS13 leads to ultra-large von Willebrand multimers, thrombocytopenia and microangiopathic hemolytic anemia. Complications include microvascular and macrovascular thrombosis. We present an unusual case of a patient with a history of refractory aTTP who experienced relapsed aTTP following COVID-19 vaccine. Case Description: A 57-year-old African-American male with a history of refractory aTTP experienced a relapse following 3 years of remission after receiving COVID-19 vaccination. The patient was initially diagnosed with aTTP in 2016, after presenting with symptoms of dark urine, mild headaches and transient episodes of aphasia and paresthesia. Due to symptoms and persistently low ADAMTS13 levels, he required prolonged and extensive treatment including over 5 weeks of daily therapeutic plasma exchange (TPE), followed by gradual reduction in frequency of TPE sessions, as well as trials of rituximab, eculizumab, steroids, mycophenolate mofetil and bortezomib. Ultimately, he achieved remission after 9 months of intermittent TPE, 3 months of weekly bortezomib 1 mg/m 2, mycophenolate mofetil up-titrated to 1,750 mg twice daily, and then slowly tapered off over a 2-year period. The patient was doing well for 3 years without manifestations of aTTP (2 years off all therapeutics), until he developed a petechial rash 7 weeks after receiving the second dose of the Moderna COVID-19 vaccine. He was found to have acute thrombocytopenia with platelets of 38 x 10 9/L (normal range 135-317 x 109/L), from a baseline of 200-300 x 10 9/L. He was referred to the emergency department, where additional labs were notable for mildly elevated LDH of 508 U/L (normal range 122-222 U/L), hemoglobin of 12.4 g/dL (normal range 13.2-16.6 g/dL), creatinine at baseline, and peripheral blood smear showing 1-3 schistocytes per high-powered field. ADAMTS13 activity level was t <5% (normal >/= 70%), with positive ADAMTS13 inhibitor screen and titer of 1.5 (normal <0.4), consistent with relapsed aTTP. The patient was admitted to the hospital, and initiated on daily TPE, with steroids and diphenhydramine prior to each TPE session. He quickly improved with TPE alone, but given his history of refractory aTTP, he was discharged on weekly rituximab for 4 weeks and caplacizumab 11 mg daily for 30 days. His platelets remained stable within the upper limit of normal during his 30 day course of caplacizumab. However, 3 weeks after completion of caplacizumab, he had an acute drop in his platelets to 23 x 10 9/L. His ADAMTS13 level was again found to be <5%, and inhibitor level was the highest that it had ever been at 11.4. He was again hospitalized and underwent 8 sessions of daily TPE, as well as re-initiation of caplacizumab, mycophenolate mofetil 500 mg bid (with increasing taper), and a prednisone taper. Intravenous Cyclophosphamide 750 mg/m 2 was also added every 3 weeks. With this regimen, patient's platelet count normalized and remain stable, and his ADAMTS13 activity level has reached 52-59%. Discussion: Cases of vaccine-induced immune thrombotic thrombocytopenia (VITT) have been described as a complication following vaccination with formulations containing replication-defective adenoviral vectors (AstraZeneca-Oxford and Johnson&Johnson COVID-19 vaccines)(Arepally and Ortel 2021, Simpson, Shi et al. 2021). VITT and aTTP are both immune-mediated, however, VITT is distinct and pathogenically linked to autoimmune heparin-induced thrombocytopenia (HIT), given the presence of anti-platelet factor 4 antibodies in these patients, whereas aTTP is due to reduction in ADAMTS13 level, secondary to an antibody inhibitor of ADAMTS13 (Arepally and Ortel 2021). Recently, cases have been reported of de novo aTTP developing shortly after COVID-19 vaccination with all available vaccines, except the Moderna (mRNA-1273) vaccine (Al-Ahmad, Al-Rasheed et al. 2021, de Bruijn, Maes et al. 2021, Maayan, Kirgner et al. 2021, Ruhe, Schnetzke et al. 2021, Waqar, Khan et a . 2021, Yocum and Simon 2021). Additionally, cases of relapsed aTTP have been described following only the BNT162B2 (Pfizer-BioNTech) vaccine (Maayan, Kirgner et al. 2021, Sissa, Al-Khaffaf et al. 2021). This is the first case, to our knowledge, reported in the literature of aTTP following vaccination with Moderna's mRNA-1273 vaccine. Disclosures: No relevant conflicts of interest to declare.
ABSTRACT
Introduction: Patients with coronavirus disease 2019 (COVID-19) have an increased risk for venous thromboembolic events. Thrombotic events contribute to the morbidity and mortality associated with COVID-19 infection, and have prompted investigation into strategies for mitigating thrombosis risk in patients hospitalized with COVID-19 infection. Our team reviewed the charts of patients hospitalized with COVID-19 pneumonia at a tertiary hospital in metropolitan Phoenix Arizona between 2020-2021, to assess frequency and efficacy of utilizing a VTE prophylaxis algorithm designed to prevent thrombosis in patients infected with COVID-19. Methods: A total of 846 patients were retrospectively evaluated to determine if they were treated with guideline-appropriate anticoagulation while hospitalized with COVID-19, as well as if they developed venous or arterial thrombotic events, or major or minor bleeds. 317 patients were excluded for taking therapeutic anticoagulation prior to admission, or for having a COVID-19 diagnosis >7 days after admission. Appropriate anticoagulation was determined by an institutionally designed COVID-19 thromboprophylaxis algorithm, based on platelet count, d-dimer, bleeding risk, and level of medical care required. Regimen options included: no anticoagulation, prophylactic enoxaparin (40 mg SQ daily) or heparin in the setting of kidney dysfunction, weight-based dosing of enoxaparin (40 mg SQ BID if BMI>40), intermediate intensity enoxaparin without thrombus (30 mg BID if BMI<40, or 40 mg BID if BMI>40), and therapeutic anticoagulation (for example enoxaparin 1 mg/kg BID) with thrombus. Demographics: Demographic data and clinical characteristics were collected for 529 patients. Average age was 59 years old, and the majority were men (58.4%). Most patients were White (58.3%), followed by Hispanic (17.8%), or Native American (15.7%). Fewer patients had a normal BMI (21.3%;BMI 18.5 - 24.9) compared to those who were overweight (31.2%;BMI 25-29.9) or obese (43.1% BMI > 30). Other comorbidities included Type 1 or Type 2 diabetes mellitus (N= 172, 32.5%), hypertension (N = 271, 51.2%), and hyperlipidemia (N = 176, 33.3%). Results: A total of 42 patients (8%), were diagnosed with a venous thrombosis during hospitalization. Patients admitted to the ICU were significantly more likely to have a thrombotic event of any type compared to non-ICU patients (21.6% to 5.7%;p < 0.001). Specifically, critically ill patients had higher incidences of deep vein thrombosis (9.5% to 0.7%), pulmonary emboli (8.1% to 4.8%), and superficial thrombi (2.7% to 0.2%). Only 1.1% of patients (6/529) experienced any bleeding, of which 3 were classified as a major bleed. Discussion: Among patients hospitalized at our institution with COVID-19, the majority were anticoagulated appropriately according to the COVID-19 thromboprophylaxis algorithm. Overall incidence of thrombosis in the study population was 8%. A significantly higher percent of critically ill patients had thrombi, supporting reports of correlation between severity of illness and thrombosis risk. The two regimens of anticoagulation least adhered to were weight-based and intermediate-based dosing, likely reflecting a departure from the hospital's thromboprophylaxis regimens prior to COVID-19 pandemic. Further studies are needed to characterize whether identifiable risk factors correlate with the incidence of thrombosis, and whether treatment with lower than recommended doses of anticoagulation, based on the COVID-19 thromboprophylaxis algorithm, were associated with thrombosis. Disclosures: No relevant conflicts of interest to declare.
ABSTRACT
Background: Dialysis patients admitted to a skilled nursing facility (SNF) are characterized by advanced age, frailty, and multiple comorbidities. Based on prior studies which demonstrated shortened dialysis recovery time (DRT) with more frequent dialysis (MFD) in populations aged ∼50s living at home (FREEDOM Study 2010, FHN trial 2006), it was postulated that dialysis patients in a SNF would benefit from MFD. Methods: Patients studied were admitted to SNFs in OH, TX, FL, NY, and PA from November-December 2019 (pre-COVID) and could reliably answer questions about DRT. 80% were undergoing subacute rehabilitation and 20% were permanent residents of the SNF. Patients received NxStage on-site staff assisted MFD 5x (80%) or 4x (20%) per week. StdKt/V was ≥2.1. At every dialysis, patients were asked by their RN caregiver How long did it take you to recover from your last? HD session Responses were deemed unreliable if a patient had cognitive impairment. Reliable responses were used for outcome analysis. In the present study, DRT data was collected by a caregiver nurse, differing from the methodology of the FREEDOM/FHN studies which collected DRT data via KDQOL form or phone interview. The implications of these differences in data collection methods are currently unknown. Results: 485 unique patients were included in the study. Demographics included 53% males, mean age 67.5 +/-13 years, African American 19%, Caucasian 25%, Hispanic 5%, Asian 0.4%, unknown or other 51%. Mean DRT was 1.5 +/-2.6 hours. Mean DRT was calculated using the midpoint recovery time for intervals, or 18 hours when DRT was the next morning or beyond. In 69%, DRT was < 2 hours. Conclusions: In the FREEDOM and FHN conventional HD 3x per week study arms, DRT averaged 6-8 hours. MFD reduced DRT to ∼1.0 hour in those relatively young patients living at home. In our study, HD patients residing in a SNF and receiving MFD experienced DRT of 1.5 hours. Age, frailty and comorbid conditions therefore do not prevent DRT benefits of MFD. DRT benefits could stem from more effective, gentler fluid management by MFD. Further studies are needed to fully explore the impact of shortened DRT on rehabilitation scores, hospitalizations and deaths in elderly patients residing in SNFs.
ABSTRACT
Background: At least one-third of USA COVID-19 deaths are skilled nursing facility (SNF) residents. Since 2016, Dialyze Direct has brought staff-assisted home hemodialysis (HD) on-site to more than 7,000 patients in SNFs. HD is performed 5x per week in a den setting. Since 3/9/20, Dialyze Direct has screened patients for COVID signs or symptoms before every HD. Infection controls include, but are not limited to, patient masks, staff PPE, physical distancing, and cohorting by COVID symptoms or status. The penetrance of likely COVID in SNF HD patients in NY vs FL is presented. Methods: A symptom diagnostic hierarchy tracked presumptive COVID infection and augmented the limited available COVID testing. At every HD, patient symptoms were recorded in an Electronic Health Record. Prevalent infection is defined as the proportion of patients with any of the symptoms during the pandemic living in the SNF during the week of interest. We report on weekly proportion from 3/9/20-5/16/20. Results: Once COVID symptoms appeared among the HD population, penetrance increased over time. In NY, penetrance in week 1,5 (4/5/20), and 10 was 8, 52, and 64%. In FL, comparable data was 13, 15, and 25%. Prevalence differences (5/10/20) for NY (29/45) vs FL (23/92) (RR 2.6, CI 1.7-3.9;p=.000). Conclusions: COVID symptom penetrance in SNF HD patients differed between NY and FL, likely attributable to differences in community disease prevalence, SNF's infection controls, their relationships to referring hospitals, and state health regulatory environment. On 3/25/20, NY mandated SNFs to accept COVID hospital returns and forbade SNFs to demand proof of negative test before accepting the return of suspected patients. COVID symptoms in SNF HD residents can serve as sentinel for COVID for the general SNF population as they are the most intensively monitored patients there. The more frequent 5x per week HD model in the SNF provides intense and relevant local surveillance compared to less frequent conventional off-site HD. This sentinel strategy can inform an urgent pivot of infection containment efforts by the SNF and larger regulatory agents so that lessons learned from successful containment strategies can be implemented early.