Rex Hospital

Introduction: Available literature suggests albumin resuscitation in septic shock (SS) may reduce vasopressor requirements and cumulative fluid balance, but albumin timing varies. The purpose of this study was to assess optimal timing of albumin within 72 hours of initial SS crystalloid resuscitation. Methods: This retrospective study included SS patients that received guideline-recommended 30 mL/kg of crystalloid resuscitation. The primary objective was to assess the impact of albumin timing on vasopressor alive-and-free days. Secondary endpoints included vasopressor-free days, time to shock resolution, shock recurrence, need for new renal replacement therapy, ICU length of stay, hospital length of stay, and 28-day mortality. Results: Of patients included, 59 received albumin within 72 hours after initial crystalloid resuscitation, while 27 patients did not. Patients received a median of 31.9 mL/kg of initial crystalloid resuscitation that consisted mostly of lactated ringers (54.7%). For patients that received albumin, the median initial dose was 25 g at a concentration of 5% (79.7%). When albumin and no albumin groups were compared, results found no difference in vasopressor alive-and-free days, time to shock resolution, ICU and hospital length of stay (LOS), and 28-day mortality. However, there were significant differences in shock recurrence (13.6% vs 44.4%) and new renal replacement therapy (10.2% vs 0.0%). When albumin is given for SS, optimal timing was found to be 8.75 to 72 hours after initial crystalloid resuscitation for a perceived 6.92 day improvement in vasopressor alive-and-free days compared to those outside the perceived optimal timing. Conclusions: Patients that received albumin within 72 hours of initial SS crystalloid resuscitation had similar vasopressor alive-and-free days with reduced shock recurrence when compared to patients that did not receive albumin. Findings suggest optimal timing for albumin may be 8.75 to 72 hours after crystalloid resuscitation warranting further investigation.

Background: The A3 methodology is a key component of Lean performance improvement and is designed to uncover the gaps that exist between current state and future state. The structure of A3 thinking aligns with the scientific method and nursing process by focusing on addressing root causes to resolve problems. At this Comprehensive Stroke Center, the stroke program applied A3 methodology to enhance program efficiency in the setting of growing priorities while creating focus, engagement, and driving process improvement. Purpose: The purpose of this study was to utilize Lean A3 methodology to improve stroke program efficiency by focusing on reducing waste and enhancing interdisciplinary collaboration. Methods: The stroke team identified that 50% of their time was spent on manual data abstraction, which reduced meeting collaboration as the coordinator lacked time to organize and facilitate meaningful dialogue. The team defined the program’s current state by time spent on manual abstraction, number of automated reports utilized, percent of one-way dialogue in meetings, and number of programmatic evaluations done annually. Next, attainable target state metrics were set. Artificial intelligence (AI) was used to assist in brainstorming ideas into actionable gaps. The team then used the 5-whys method to identify the root causes of each gap. Finally, solution approaches were implemented using plan-do-study-act (PDSA) cycles. Results: Solution approaches included leveraging AI to optimize workflows, maximizing electronic health record (EHR) data reporting, and implementing organizational planning tools. The stroke coordinator also developed a template for leaders to report their unit data and quality initiatives at meetings. A detailed completion plan that listed ownership, due dates, and status of each action item tracked the team’s progress. Conclusions: Applying the A3 methodology helped organize stroke program operations, establish concrete deadlines, and initiate a shift towards automation. On-going monitoring is scheduled to evaluate effectiveness and adjust as additional priorities present themselves. In conclusion, the stroke team reported improved efficiency and collaboration across departments, highlighting how the A3 methodology enhanced internal reporting and reduced waste, ultimately supporting accurate Get With The Guidelines abstraction and quality stroke care.

128 Background: Oncology treatment trial conduct is often limited to academic medical centers (AMCs) distantly located from the patients they serve. Legal and contractual barriers often preclude AMCs from opening clinical trials at community sites and those sites may lack robust onsite clinical research infrastructure. Limiting clinical trials to the main AMC creates barriers to patient participation including logistical challenges such as travel, missed work, financial stress, and loss of access to local resources designed to support patient needs (e.g., transportation, on-site meals, trusted provider relationships, local cultural, linguistic, and educational resources). AMCs need to partner with local healthcare providers (HCPs) to design innovative solutions to bring clinical trials closer to patients without adding undue burden on community sites. Methods: UNC Lineberger, in collaboration with local HCPs working across North Carolina, developed and implemented hybrid decentralized clinical trial (DCT) infrastructure and methodologies. The emphasis was on facilitating protocol-mandated assessments and visits to be conducted by local HCPs, who are not considered "engaged in research" per the regulatory definition and do not need to be formally associated with UNC Lineberger via legal research agreements. HARMONY (NCT03769415), an interventional treatment study designed to determine the impact of molecular information on clinical decision-making in metastatic breast cancer, was chosen for pilot testing as a hybrid DCT due to straightforward design, relevant research questions, and expressed interest from community providers. Results: HARMONY was amended for hybrid DCT methodologies with specific adaptations to account for local biospecimen collection, remote screening of local HCP schedules, collaboration with local HCPs on introducing the study, remote consent, and returning of molecular results to local HCPs. This pilot was successfully operationalized with limited administrative burden to local providers and the enrollment of 20 local HCP patients over a 1-year period in comparison to 23 at the AMC. Compliance analysis showed high protocol adherence with only 2 deviations associated with the patients enrolled from a remote site. Conclusions: Pilot trial success indicates that AMCs can successfully partner with local HCPs to operationalize hybrid decentralized oncology treatment trials moving most, if not all, assessments closer to patient homes without overburdening community sites or incurring non-compliance. This work addresses questions raised by an American Society of Clinical Oncology (ASCO) taskforce regarding application of such a design to oncology clinical research, and stressing the need to amend and formalize procedures to compliantly conduct such studies. Clinical trial information: NCT03769415 .

Prion diseases are fatal neurological disorders characterized by the accumulation of abnormal proteins in the central nervous system, leading to rapid neurodegeneration. We present a male his 70s who developed rapidly progressive dementia three weeks after a routine platelet-rich plasma (PRP) injection for chronic hip pain. MRI revealed multifocal cortical diffusion restriction involving the basal ganglia. CSF analysis via real-time quaking-induced conversion (RT-QuIC) confirmed prion disease, with elevated T-tau and 14-3-3 gamma proteins. He also tested seropositive for Ehrlichia, though other infectious causes were ruled out. Despite treatment with IV immunoglobulins (IGs) and antibiotics, his condition declined with worsening myoclonus and hyperreflexia. He died one week after discharge to hospice, six weeks after symptom onset. This case demonstrates several classic clinical features of sporadic Creutzfeldt-Jacob disease (sCJD) and raises the possibility that an acute inflammatory response from PRP injection may have triggered sCJD in the setting of a pre-existing chronic inflammatory state from tick-borne infection.

Endovascular revascularization of below-the-knee lesions is a crucial treatment for patients with chronic limb-threatening ischemia (CLTI). However, the optimal approach to revascularizing infrapopliteal arteries remains uncertain. This study aims to compare the safety and efficacy outcomes of various endovascular treatment modalities for infrapopliteal artery disease and provide an evidence-based update through a network meta-analysis. We performed a systematic literature search in MEDLINE, EMBASE, and the Cochrane Database for randomized controlled trials published between January 01, 2005, and January 12, 2025. The study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was prospectively registered in PROSPERO database (CRD42022323480). The primary safety outcome was major adverse events defined as a composite of all-cause death, major amputation, and any re-intervention of the target limb at 30 days. The primary efficacy outcomes included freedom from composite of major amputation, target lesion occlusion, and clinically driven target lesion revascularization (CD-TLR) and primary patency defined as freedom from binary restenosis and CD-TLR at 6 months. The network meta-analysis was conducted in the frequentist framework using random effects model and conventional percutaneous transluminal angioplasty (PTA) as the reference intervention. Treatment effects were reported as odds ratio (OR) with 95% confidence interval (CI) compared with conventional PTA and interventions were ranked using P-scores. Twenty-three studies including 3091 patients treated with PTA, paclitaxel drug-coated balloons (DCB), drug-eluting stents (DES), bare metal stents (BMS), bioresorbable vascular scaffold (BVS), and atherectomy were included. There were no significant differences in the primary safety outcome between different treatment modalities. At 6 months, DCB, atherectomy with DCB, and DES produced the largest benefit for primary efficacy outcomes. DCB (OR, 3.68; 95% CI, 1.37-9.92) had a higher freedom from the primary composite, and atherectomy with DCB (OR, 7.65; 95% CI, 1.03-56.98) and DES (OR, 5.48; 95% CI, 1.54-19.49) had higher primary patency compared with PTA. At 12 months, the benefit of atherectomy with DCB was sustained for primary patency, and BVS was ranked first for freedom from the primary composite. There was no benefit of BMS compared with PTA at any timepoint. This network meta-analysis evaluating 7 endovascular treatment modalities provides evidence of improved efficacy outcomes with DCB, atherectomy with DCB, DES, and BVS compared with PTA for treating infrapopliteal lesions in patients with CLTI.Clinical ImpactLocal antiproliferative drug delivery, whether by balloon-expandable sirolimus/everolimus DES or paclitaxel DCB or everolimus BVS, is necessary to improve patency and efficacy outcomes for the treatment of infrapopliteal artery disease. Furthermore, combining atherectomy with drug delivery shows promising potential. Emerging endovascular targeted drug delivery therapies with limus-based DCB or scaffolds promise to provide greater drug transfer efficiency and a more effective therapeutic alternative that overcomes the limitations of metallic stents in one of the most challenging vascular beds.

Acute ischemic stroke (AIS) due to intracranial atherosclerotic disease (ICAD) carries a high risk of recurrence despite aggressive medical management. The aim of our study is to present our initial experience with the Onyx Frontier™ balloon-mounted drug-eluting stent (Medtronic, Santa Rosa, CA) for AIS due to ICAD. We conducted a multicenter retrospective cohort study describing the technical feasibility, safety, and performance of using the Onyx Frontier™ balloon-mounted drug-eluting stent in patients with acute intracranial vessel occlusion due to ICAD across three comprehensive stroke centers in the United States. We included 23 patients in our study (mean age 67.3 [10.7]; females: n = 13/23, 56.5%). Most patients were Black (n = 14/23, 60.9%). The most common site of vessel occlusion was the M1 branch of the middle cerebral artery (MCA) (n = 14/23, 60.9%), followed by the vertebrobasilar system (n = 5/23, 21.7%), and the internal carotid artery (n = 3/23, 13.0%). Treatment with the Onyx Frontier™ stent was associated with a final mTICI score ≥2b for 100% of patients, with no vessel perforations or distal embolization. None of the patients had any restenosis or re-treatment over a median follow-up of 3.5 months (interquartile range [IQR] 7.8). All cases required a single stent except for one, where two were deployed. Transfemoral access was used in most cases (n = 18/23, 78.3%), with one in-hospital death due to access site complication (n = 1/23, 4.3%). This is the largest multicenter cohort study demonstrating the feasibility and safety of using the Onyx Frontier™ balloon-mounted zotarolimus-eluting stent to treat symptomatic AIS due to ICAD.

Contact aspiration mechanical thrombectomy (CAMT) with 0.088-inch catheters may improve first-pass success rates, but delivery of such catheters can be challenging and limit effectiveness. This study examines the initial multicenter experience using the FreeClimb 88 catheter paired with the Tenzing 8 delivery catheter. Retrospective analysis was performed of consecutive patients with large vessel occlusion (LVO) of the internal carotid artery (ICA) or M1 segment of the middle cerebral artery treated with off-label CAMT using the FreeClimb 88 and Tenzing 8 at eight sites participating in the early limited release for these devices. Demographic and procedural variables were collected and analyzed with descriptive statistics and multivariable analysis. Fifty-three consecutive patients were treated. Large vessel occlusion was located in the ICA in 19/53 (35.8%) patients; 34/53 (64.2%) were in the M1 segment. FreeClimb 88 was successfully delivered to the site of occlusion in 50/53 (94.3%) of patients. First-pass TICI 2c or 3 was achieved with FreeClimb 88 delivered by Tenzing 8 in 36 (67.9%) cases. Among cases with successful FreeClimb 88 delivery 9/50 (18.0%) required additional smaller devices to perform thrombectomy of distal occlusions after recanalization of the initial LVO. No complications or symptomatic hemorrhages occurred following thrombectomy. Contact aspiration mechanical thrombectomy performed for ICA or M1 LVOs using FreeClimb 88 delivered with Tenzing 8 was safe, effective, and efficient in this early experience, with first-pass TICI 2c or 3 was achieved in 68% of patients without procedural complications occurring in any cases.