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Ethical and Logistical Concerns for Establishing NRP-cDCD Heart Transplantation in the United States

Parent, Brendan; Moazami, Nader; Wall, Stephen; Carillo, Julius; Kon, Zachary; Smith, Deane; Walsh, B Corbett; Caplan, Arthur
Controlled heart donation after circulatory determination of death (cDCD) is well-established internationally with good outcomes and could be adopted in the United States to increase heart supply if ethical and logistical challenges are comprehensively addressed. The most effective and resource-efficient method for mitigating warm ischemia after circulatory arrest is normothermic regional perfusion (NRP) in situ. This strategy requires restarting circulation after declaration of death according to circulatory criteria, which appears to challenge the legal circulatory death definition requiring irreversible cessation. Permanent cessation for life-saving efforts must be achieved to assuage this concern and ligating principal vessels maintains no blood flow to the brain, which ensures natural progression to cessation of brain function. This practice - standard in some countries - raises unique concerns about prioritizing life-saving efforts, informed authorization from decision-makers, and the clinician's role in the patient's death. To preserve public trust, medical integrity, and respect for the donor, the donation conversation must not take place until after an un-coerced decision to withdraw life-sustaining treatment made in accordance with the patient's treatment goals. The decision maker(s) must understand cDCD procedure well enough to provide genuine authorization and the preservation/procurement teams must be kept separate from the clinical care team.
PMID: 31913567
ISSN: 1600-6143
CID: 4257412

Extended-release naltrexonewas feasible, acceptable, and reduced drinking in patients with alcohol use disorders who frequent the emergency department [Meeting Abstract]

McCormack, R P; Rotrosen, J; Wall, S P; Moran, Z; Goldfrank, L; Lee, J; Doran, K M; Shin, S; D'Onofrio, G
Purpose: Almost uniformly, patients with frequent Emergency Department (ED) use and severe alcohol use disorders (AUDs) do not receive alcohol pharmacotherapy and are excluded from research as they are difficult to engage and retain and suffer from myriad bio-psychosocial comorbidities. We assessed the feasibility and acceptability of initiating and continuing treatment with extended-release naltrexone (XR-NTX) as well as studying its effects in this challenging population and clinical setting.
Method(s): In this randomized, open-label study, ED patient-participants with > 4 ED visits and moderate- severe AUD were randomized (1:1) to XR-NTX and research assistant-delivered care management or treatment as usual enhanced by a one-time warm referral and motivation enhancement. XR-NTX was first administered during the index ED visit. Thereafter, participants could receive up to 11 additional doses at clinic visits with arrangements to allow unscheduled visits. Non-clinical research visits (both arms) were scheduled at 3, 6, and 12 months with a considerable date variation permitted and expected. Drinking was assessed via 30-day timeline followback with heavy drinking day (HDD) thresholds of 5 for males and 4 for females. Resuts: The 48 participants were aged 55.0 +/- 8.2, 88% male, 51% white, 79% homeless, and reported an average of 23.4 HDDs in the priormonth and 24.4 standard drinks/drinking day. Approximately 70%lacked reliable contact information. Research visit attendance was 70.8%, 77.1%, and 70.8%with a median time to first visit of 126 days [Interquartile Range: 89-242]. In the XR-NTX arm (N = 24), a total of 173 injections were administered with amean of 7.2 per participant; 20 (83%) participants received 2 or more injections, 14 (56%) received 6 or more injections, and 6 (24%) received 12 injections. There was a significantly greater decrease in HDDs per month among those receiving XR-NTX compared to those who did not: 15.3 (95%CI 9.7-21.0) and 9.6 (95%CI 1.5-17.6), respectively. Baseline rates were imputed for two missing participants in each arm.
Conclusion(s): Among this population whose complicated AUDs pose considerable challenges from clinical and research perspectives, initiating and continuing treatment with XR-NTX was feasible, acceptable, and demonstrated promising preliminary drinking outcomes. Additional sensitivity analyses and evaluation of other outcomes of interest are underway. Further study on a larger scale is warranted
EMBASE:632393612
ISSN: 1530-0277
CID: 4548232

Not all protected bike lanes are the same: Infrastructure and risk of cyclist collisions and falls leading to emergency department visits in three U.S. cities

Cicchino, Jessica B; McCarthy, Melissa L; Newgard, Craig D; Wall, Stephen P; DiMaggio, Charles J; Kulie, Paige E; Arnold, Brittany N; Zuby, David S
OBJECTIVE:Protected bike lanes separated from the roadway by physical barriers are relatively new in the United States. This study examined the risk of collisions or falls leading to emergency department visits associated with bicycle facilities (e.g., protected bike lanes, conventional bike lanes demarcated by painted lines, sharrows) and other roadway characteristics in three U.S. cities. METHODS:We prospectively recruited 604 patients from emergency departments in Washington, DC; New York City; and Portland, Oregon during 2015-2017 who fell or crashed while cycling. We used a case-crossover design and conditional logistic regression to compare each fall or crash site with a randomly selected control location along the route leading to the incident. We validated the presence of site characteristics described by participants using Google Street View and city GIS inventories of bicycle facilities and other roadway features. RESULTS:Compared with cycling on lanes of major roads without bicycle facilities, the risk of crashing or falling was lower on conventional bike lanes (adjusted OR = 0.53; 95 % CI = 0.33, 0.86) and local roads with (adjusted OR = 0.31; 95 % CI = 0.13, 0.75) or without bicycle facilities or traffic calming (adjusted OR = 0.39; 95 % CI = 0.23, 0.65). Protected bike lanes with heavy separation (tall, continuous barriers or grade and horizontal separation) were associated with lower risk (adjusted OR = 0.10; 95 % CI = 0.01, 0.95), but those with lighter separation (e.g., parked cars, posts, low curb) had similar risk to major roads when one way (adjusted OR = 1.19; 95 % CI = 0.46, 3.10) and higher risk when they were two way (adjusted OR = 11.38; 95 % CI = 1.40, 92.57); this risk increase was primarily driven by one lane in Washington. Risk increased in the presence of streetcar or train tracks relative to their absence (adjusted OR = 26.65; 95 % CI = 3.23, 220.17), on downhill relative to flat grades (adjusted OR = 1.92; 95 % CI = 1.38, 2.66), and when temporary features like construction or parked cars blocked the cyclist's path relative to when they did not (adjusted OR = 2.23; 95 % CI = 1.46, 3.39). CONCLUSIONS:Certain bicycle facilities are safer for cyclists than riding on major roads. Protected bike lanes vary in how well they shield riders from crashes and falls. Heavier separation, less frequent intersections with roads and driveways, and less complexity appear to contribute to reduced risk in protected bike lanes. Future research should systematically examine the characteristics that reduce risk in protected lanes to guide design. Planners should minimize conflict points when choosing where to place protected bike lanes and should implement countermeasures to increase visibility at these locations when they are unavoidable.
PMID: 32388015
ISSN: 1879-2057
CID: 4437382

Feasibility and impact of implementing buprenorphine initiation programs in three heterogenous rural and urban emergency departments [Meeting Abstract]

McCormack, R P; Rotrosen, J; D'Onofrio, G; Gauthier, P; Marsch, L A; Matthews, A; Mulatya, C; Edelman, E J; Farkas, S; Fiellin, D A; Goodman, W; Huntley, K; Knight, R; Liu, D; Meyers-Ohki, S; Novo, P; Shin, S -M; Wall, S P; Hawk, K
Background and Objectives: To rapidly develop, implement, and evaluate emergency department (ED) clinical protocols for initiation of buprenorphine (E
EMBASE:632418168
ISSN: 1553-2712
CID: 4547932

Community-Based Hemoglobin A1C Testing in Barbershops to Identify Black Men With Undiagnosed Diabetes

Osorio, Marcela; Ravenell, Joseph E; Sevick, Mary A; Ararso, Yonathan; Young, Ta'Loria; Wall, Stephen P; Lee, David C
PMID: 31985740
ISSN: 2168-6114
CID: 4293912

The unique moral permissibility of uncontrolled lung donation after circulatory death

Parent, Brendan; Caplan, Arthur; Angel, Luis; Kon, Zachary; Dubler, Nancy; Goldfrank, Lewis; Lindner, Jacob; Wall, Stephen P
Implementing uncontrolled donation after circulatory determination of death (uDCDD) in the United States could markedly improve supply of donor lungs for patients in need of transplants. Evidence from U.S. pilot programs suggests families support uDCDD, but only if they are asked permission for using invasive organ preservation procedures prior to initiation. However, non-invasive strategies that confine oxygenation to lungs may be applicable to the overwhelming majority of potential uDCDD donors that have airway devices in place as part of standard resuscitation. We propose an ethical framework for lung uDCDD by: (1) initiating post mortem preservation without requiring prior permission to protect the opportunity for donation until an authorized party can be found; (2) using non-invasive strategies that confine oxygenation to lungs; and (3) maintaining strict separation between the healthcare team and the organ preservation team. Attempting uDCDD in this way has great potential to obtain more transplantable lungs while respecting donor autonomy and family wishes, securing public support, and enabling authorized persons to affirm or cease preservation decisions without requiring evidence of prior organ donation intent. It ensures prioritization of life-saving, the opportunity to allow willing donors to donate, and respect for bodily integrity while adhering to current ethical norms.
PMID: 31550420
ISSN: 1600-6143
CID: 4105452

US Organ Donation Policy [Comment]

Wall, Stephen P; Parent, Brendan; Caplan, Arthur
PMID: 31961413
ISSN: 1538-3598
CID: 4273852

EXTENDED-RELEASE NALTREXONE WAS FEASIBLE, ACCEPTABLE, AND REDUCED DRINKING IN PATIENTS WITH ALCOHOL USE DISORDERS WHO FREQUENT THE EMERGENCY DEPARTMENT [Meeting Abstract]

McCormack, R. P.; Rotrosen, J.; Wall, S. P.; Moran, Z.; Goldfrank, L.; Lee, J.; Doran, K. M.; Shin, S.; D\Onofrio, G.
ISI:000540372300600
ISSN: 0145-6008
CID: 4573282

Community-Based Hemoglobin A1C Testing in Barbershops to Identify Black Men with Undiagnosed Diabetes [Letter]

Osorio, M; Ravenell, J E; Sevick, M A; Ararso, Y; Young, T; Wall, S P; Lee, D C
EMBASE:630713293
ISSN: 2168-6106
CID: 4296472

Hyperbaric oxygen therapy for COVID-19 patients with respiratory distress: treated cases versus propensity-matched controls

Gorenstein, Scott A; Castellano, Michael L; Slone, Eric S; Gillette, Brian; Liu, Helen; Alsamarraie, Cindy; Jacobson, Alan M; Wall, Stephen P; Adhikari, Samrachana; Swartz, Jordan L; McMullen, Jenica J S; Osorio, Marcela; Koziatek, Christian A; Lee, David C
Objective/UNASSIGNED:Given the high mortality and prolonged duration of mechanical ventilation of COVID-19 patients, we evaluated the safety and efficacy of hyperbaric oxygen for COVID-19 patients with respiratory distress. Methods/UNASSIGNED:This is a single-center clinical trial of COVID-19 patients at NYU Winthrop Hospital from March 31 to April 28, 2020. Patients in this trial received hyperbaric oxygen therapy at 2.0 atmospheres of pressure in monoplace hyperbaric chambers for 90 minutes daily for a maximum of five total treatments. Controls were identified using propensity score matching among COVID-19 patients admitted during the same time period. Using competing-risks survival regression, we analyzed our primary outcome of inpatient mortality and secondary outcome of mechanical ventilation. Results/UNASSIGNED:We treated 20 COVID-19 patients with hyperbaric oxygen. Ages ranged from 30 to 79 years with an oxygen requirement ranging from 2 to 15 liters on hospital days 0 to 14. Of these 20 patients, two (10%) were intubated and died, and none remain hospitalized. Among 60 propensity-matched controls based on age, sex, body mass index, coronary artery disease, troponin, D-dimer, hospital day, and oxygen requirement, 18 (30%) were intubated, 13 (22%) have died, and three (5%) remain hospitalized (with one still requiring mechanical ventilation). Assuming no further deaths among controls, we estimate that the adjusted subdistribution hazard ratios were 0.37 for inpatient mortality (p=0.14) and 0.26 for mechanical ventilation (p=0.046). Conclusion/UNASSIGNED:Though limited by its study design, our results demonstrate the safety of hyperbaric oxygen among COVID-19 patients and strongly suggests the need for a well-designed, multicenter randomized control trial.
PMID: 32931666
ISSN: 1066-2936
CID: 4591182