Donor Electrocardiogram Associations With Cardiac Dysfunction, Heart Transplant Use, and Survival: The Donor Heart Study.

BACKGROUND: Potential organ donors often exhibit abnormalities on electrocardiograms (ECGs) after brain death, but the physiological and prognostic significance of such abnormalities is unknown. OBJECTIVES: This study sought to characterize the prevalence of ECG abnormalities in a nationwide cohort of potential cardiac donors and their associations with cardiac dysfunction, use for heart transplantation (HT), and recipient outcomes. METHODS: The Donor Heart Study enrolled 4,333 potential cardiac organ donors at 8 organ procurement organizations across the United States from 2015 to 2020. A blinded expert reviewer interpreted all ECGs, which were obtained once hemodynamic stability was achieved after brain death and were repeated 24 ± 6 hours later. ECG findings were summarized, and their associations with other cardiac diagnostic findings, use for HT, and graft survival were assessed using univariable and multivariable regression. RESULTS: Initial ECGs were interpretable for 4,136 potential donors. Overall, 64% of ECGs were deemed clinically abnormal, most commonly as a result of a nonspecific St-T-wave abnormality (39%), T-wave inversion (19%), and/or QTc interval >500 ms (17%). Conduction abnormalities, ectopy, pathologic Q waves, and ST-segment elevations were less common (each present in ≤5% of donors) and resolved on repeat ECGs in most cases. Only pathological Q waves were significant predictors of donor heart nonuse (adjusted OR: 0.39; 95% CI: 0.29-0.53), and none were associated with graft survival at 1 year post-HT. CONCLUSIONS: ECG abnormalities are common in potential heart donors but often resolve on serial testing. Pathologic Q waves are associated with a lower likelihood of use for HT, but they do not portend worse graft survival.

Deficiency in Re-Orienting of Attention in Adults with Attention-Deficit Hyperactivity Disorder.

Objective: To characterize potential brain indexes of attention deficit hyperactivity disorder (ADHD) in adults. Methods: In an effort to develop objective, laboratory-based tests that can help to establish ADHD diagnosis, the brain indexes of distractibility was investigated in a group of adults. We used event-related brain potentials (ERPs) and performance measures in a forced-choice visual task. Results: Behaviorally aberrant distractibility in the ADHD group was significantly higher. Across three ERP components of distraction: N1 enhancement, P300 (P3a), and Reorienting Negativity (RON) the significant difference between ADHD and matched controls was found in the amplitude of the RON. We used non-parametric randomization tests, enabling us to statistically validated this difference between-group. Conclusions: Our main results of this feasibility study suggest that among other ERP components associated with auditory distraction, the RON response is promising index for a potential biomarker of deficient re-orienting of attention in adults s with ADHD.

Contemporary Management of Cardiogenic Shock During Pregnancy.

Cardiogenic shock is the most extreme cardiovascular disease state during pregnancy. Peripartum cardiomyopathy is the most common cause of cardiogenic shock toward the end of pregnancy and in the early postpartum period. Therapy for cardiogenic shock relies on appropriate phenotyping of shock etiology, severity and ventricular predominance, which are critical in the appropriate selection of medical and mechanical therapy. Mechanical circulatory support may be used as a bridge to recovery or as definitive therapy. Intra-aortic balloon pumps, percutaneous left ventricular assist devices and venoarterial extracorporeal circulatory devices have been successfully used in pregnancy and the postpartum period. The most commonly used mechanical therapy in the pregnant patient is extracorporeal membranous oxygenation circulatory support. The use of mechanical circulatory devices in peripartum cardiomyopathy has contributed to improved survival rates in recent years. Further efforts to identify the optimal mechanical circulatory support strategy for peripartum cardiomyopathy and cardiogenic shock in the peripartum period are needed.

COVID-19 infection characteristics and outcomes in a predominantly Latino community hospital.

Introduction: The coronavirus disease 2019 (COVID-19) pandemic has rapidly spread worldwide and claimed millions of lives. Several studies have attempted to understand the relationship between COVID-19 infection and health disparities. The aim of the current work was to evaluate the pre-admission health characteristics, symptomatology, diagnostic abnormalities, treatment measures and clinical outcomes of the community served by our institution, with a sub-analysis of our Hispanic community. Methods: This is a single-center, cross-sectional cohort study of patients with COVID-19 admitted from 15 March 2020 to 30 April 2020 to MacNeal Hospital. A retrospective chart review was performed including patients >18 years and a positive nasopharyngeal SARS-CoV-2 PCR. Demographical data, comorbidities, clinical data, treatment regimen, and patient outcomes were collected. Results: A total of 257 patients were included in the study of which 60.4% were identified as Hispanic. The median age at admission of Hispanic patients was significantly lower compared to non-Hispanic patients (56.6 vs. 65.7 years, p<0.01). Non-Hispanic patients had lower prevalence of hypertension, coronary artery disease, and chronic lung disease. Most common at presentation were shortness of breath (69.6%), cough (69.2%), and fever (64%). Hypertension was the most common comorbidity (53.6%). Approximately 89% of the patients received antibiotics, 40.4% hydroxy-chloroquine, 13.2% steroids, and 6% tocilizumab. Twenty six percent required mechanical ventilation (MV), and over half of them (56.7%) were Hispanic. The strongest factors associated with MV were smoking (OR 2.97, 95%CI 1.01-8.69), CRP >10 mg/dL (OR 4.53, 95%CI 1.49-13.38) and D-dimer >1.5 mcg/mL (OR 3.63, 95%CI 1.31-10.05). An oxygen saturation of >90% on room air on presentation was a protective factor when predicting intubation (OR 0.11, 95%CI 0.03-0.33). The overall 30-day mortality rate was 17.1% (n=44); 11.9% in the Hispanic group vs 26.3% in the non-Hispanic group (p<0.003). Conclusions: Our review of consecutive patients admitted with COVID-19 demonstrated that over half of patients were of Hispanic descent. Interestingly enough, despite being significantly younger and healthier, the need for mechanical ventilation in the Hispanic group was not significantly different compared to the non-Hispanic group. However, the Hispanic group had a lower mortality rate.

Superior outcomes with double-balloon enteroscopy for small bowel lesion marking followed by intracorporeal as opposed to extracorporeal resection and reconstruction.

BACKGROUND: Double-balloon enteroscopy (DBE) is used for the diagnosis and therapy of small bowel disease. Endoscopic sampling and marking small bowel lesions destined for surgery permit intracorporeal resection and reconstruction (IRR), thereby facilitating a complete minimally invasive technique. There are limited data that compare outcomes of IRR to conventional extracorporeal resection and reconstruction (ERR). The purpose of this study was to evaluate the surgical outcomes of patients undergoing pre-operative DBE for lesion marking followed by laparoscopic IRR compared to those undergoing ERR. METHODS: A retrospective chart review was performed on patients who underwent DBE followed by small bowel resection from 2006 to 2017 at a single tertiary care medical center. IRR was defined as laparoscopic inspection to identify the lesion (previously marked by DBE or by laparoscopic-assisted DBE) followed by intra-abdominal bowel resection and anastomosis with specimen extraction via minimal extension of a laparoscopic port site. ERR was defined as extracorporeal resection and/or reconstruction performed via a conventional or mini-laparotomy abdominal incision. RESULTS: A total of 82 patients met inclusion criteria and were reviewed. Thirty-two patients (39%) had ERR and 50 patients (61%) had IRR. The most common indications for DBE were small bowel bleeding (76%) and small bowel mass or thickening on prior imaging studies (16%). Successful DBE was higher in the IRR group when compared to the ERR group, but not significantly different (90% vs 75%, p-value 0.07). Patients who underwent IRR had faster bowel function recovery (2 vs 4 days, p < 0.01), shorter time to discharge (3 vs 7 days, p < 0.01), and fewer post-operative complications (10 vs 18; p < 0.01), when compared to the ERR group. CONCLUSION: DBE successfully facilitated laparoscopic small bowel IRR and this approach was associated with faster return of bowel function, shorter recovery time, and decreased morbidity when compared to ERR.

Restarting Warfarin vs Direct Oral Anticoagulants After Major Gastrointestinal Bleeding and Associated Outcomes in Atrial Fibrillation: A Cohort Study.

BACKGROUND & AIMS: Limited data exist on the management of anticoagulation after hospitalization for gastrointestinal bleeding (GIB) and the risks of recurrent GIB and thromboembolism in patients who are prescribed warfarin vs direct oral anticoagulants (DOACs). The purpose of this study was to assess the risk of recurrent GIB and thromboembolism with resumption of anticoagulation after GIB. METHODS: This was a retrospective analysis of adults with atrial fibrillation prescribed warfarin or DOACs and subsequently hospitalized for GIB. We used claims data from IBM MarketScan Databases from January 2008 through December 2017. Multivariable time-varying regression was used to determine the risks of recurrent GIB and thromboembolism within 6 months of the index hospitalization. RESULTS: There were 2991 patients hospitalized for GIB on anticoagulants (warfarin, n = 1872; rivaroxaban, n = 676; dabigatran, n = 293; and apixaban, n = 250). Of warfarin users, 46% (n = 869) resumed warfarin after discharge compared with 43% (n = 483) of DOAC users who resumed DOACs. In the regression analysis modeling time-varying coefficients for anticoagulant use, warfarin resumption was associated with an increased risk of recurrent GIB (hazard ratio [HR], 2.12; 95% CI, 1.43-3.14; P = .0002) compared with no anticoagulant resumption, whereas there was no association with DOAC resumption and recurrent bleeding (HR, 1.43; 95% CI, 0.81-2.52; P = .22). Rivaroxaban was the only individual DOAC that was associated with recurrent GIB (HR, 2.73; 95% CI, 1.43-5.20; P = .002). Both warfarin (HR, 0.61; 95% CI, 0.39-0.96; P = .033) and DOAC (HR, 0.52; 95% CI, 0.28-0.98; P = .044) resumption as a class was associated with a decreased risk of thromboembolism. CONCLUSIONS: Either warfarin or DOAC resumption after hospitalization for GIB was associated with a decreased risk of thromboembolism, whereas warfarin and rivaroxaban resumption were associated with an increased risk of recurrent GIB.

Sedation Usage in COVID-19 Acute Respiratory Distress Syndrome: A Multicenter Study.

BACKGROUND: Patients with COVID-19 acute respiratory distress syndrome (ARDS) have been shown to have high sedation requirements. OBJECTIVE: The purpose of this study was to compare sedative use between patients with COVID-19 ARDS and non-COVID-19 ARDS. METHODS: This was a retrospective study of patients with COVID-19 ARDS compared with historical controls of non-COVID-19 ARDS who were admitted to 2 hospitals from March 1, 2020, to April 30, 2020, and April 1, 2018, to December 31, 2019, respectively. The primary outcome was median cumulative dose of propofol (µg/kg) at 24 hours after intubation. RESULTS: There were 92 patients with COVID-19 ARDS and 37 patients with non-COVID-19 ARDS included. Within the first 24 hours of intubation, patients with COVID-19 ARDS required higher total median doses of propofol: 51 045 µg/kg (interquartile range, 26 150-62 365 µg/kg) versus 33 350 µg/kg (9632-51 455 µg/kg; P = 0.004). COVID-19 patients were more likely receive intravenous lorazepam (37% vs 14%; P = 0.02) and higher cumulative median doses of midazolam by days 5 (14 vs 4 mg; P = 0.04) and 7 of intubation (89 vs 4 mg; P = 0.03) to achieve the same median Richmond Analgesia-Sedation Scale scores. COVID-19 ARDS patients required more ventilator days (10 vs 6 days; P = 0.02). There was no difference in 30-day mortality. CONCLUSION AND RELEVANCE: Patients with COVID-19 ARDS required higher doses of propofol and benzodiazepines than patients with non-COVID-19 ARDS to achieve the same median levels of sedation.

Lower socioeconomic factors are associated with higher mortality in patients with septic shock.

BACKGROUND: Previous studies have explored the relationship between socioeconomic status and sepsis outcomes OBJECTIVES: The purpose of this investigation is to determine if race, ethnicity, economic stability, neighborhood environment, and access to health care are predictive of mortality in patients with septic shock. METHODS: Retrospective study of septic shock patients admitted to two medical centers. RESULTS: Caucasian patients had higher proportion of outpatient physician visits in the year prior to admission and were less likely to be Medicare or Medicaid beneficiaries. Thirty-day mortality was lower for the Caucasian cohort (39.3% vs. 48.7%, p < 0.01). Multivariate logistic regression found several predictors of 30-day mortality including Minority race/ethnicity (OR 1.44, 95% CI 1.12-1.86), unemployment (OR 1.40, 95% CI 1.09-1.81), and neighborhood poverty rate ≥10% (OR 1.43, 95% CI 1.01-2.01). CONCLUSIONS: Minority patients, unemployed patients, and those living in neighborhoods with poverty rates greater than 10% suffered from higher 30-day mortality when admitted for septic shock.

Resuming Anticoagulation Following Hospitalization for Gastrointestinal Bleeding Is Associated with Reduced Thromboembolic Events and Improved Mortality: Results from a Systematic Review and Meta-Analysis.

BACKGROUND: Systemic anticoagulants are widely prescribed for prevention and treatment of thromboembolism, but are commonly complicated by gastrointestinal bleeding (GIB). Limited data exist on the management of anticoagulation after hospitalization for GIB and the subsequent risks of recurrent GIB, thromboembolism, and mortality. METHODS: We performed a systematic review and meta-analysis of studies to determine risk of recurrent GIB, thromboembolism, and mortality after resuming anticoagulation following GIB. PubMed, EMBASE, and Scopus were searched for randomized controlled trials and cohort studies in patients with atrial fibrillation, venous thromboembolism, or valvular heart disease who received long-term warfarin or direct oral anticoagulants before experiencing GIB. Studies were included if data were available on anticoagulation management and outcomes of recurrent GIB, thromboembolism, and mortality following GIB. RESULTS: A total of 5354 studies were reviewed of which 10 were included in the meta-analysis. There were 2080 patients who resumed anticoagulation and 2296 patients who discontinued anticoagulation post-index GIB. Resumption of anticoagulation was associated with a significant increase in recurrent GIB (OR 1.646, 95% CI 1.035-2.617, p = 0.035). There was a significant decrease in thromboembolic events in patients who resumed anticoagulation compared to those who did not (OR 0.340, 95% CI 0.178-0.652, p = 0.001, I2 = 62.7%). Resumption of anticoagulation was associated with a significant reduction in all-cause mortality (OR 0.499, 95% CI 0.419-0.595, p < 0.0001). CONCLUSION: While resumption of anticoagulation following index GIB was associated with a significant increase in recurrent GIB, it was also associated with a significant decrease in thromboembolic events and all-cause mortality.

A multicomponent oxygen delivery strategy for COVID-19 patients in a step-down intensive care unit: A case series.

Coronavirus disease 2019 (COVID-19) is the cause of the pandemic that has affected millions of people worldwide with pulmonary manifestations ranging from mild pneumonia to ARDS and characterized by hypoxia. This has led to questions regarding the most efficacious and least harmful oxygen delivery strategies that minimize exposure to health care workers. In this case series, we present the hospital course of 4 patients that were managed with a multi-component oxygen delivery method in a COVID-19 step down unit.

Evaluation of the Order SMARTT: An Initiative to Reduce Phlebotomy and Improve Sleep-Friendly Labs on General Medicine Services.

We assessed the effectiveness of a quality improvement project to reduce routine labs in clinically stable patients, while also promoting sleep-friendly lab timing. The electronic health record was modified with an "Order Sleep" shortcut to facilitate sleep-friendly lab draws. A "4 AM Labs" column was added to electronic patient lists to signal which patients had early morning labs ordered. Among 7,045 patients over 50,951 total patient-days, on average we observed 26.3% fewer routine lab draws per patient-day per week postintervention (4.68 before vs 3.45 after; difference, 1.23; 95% CI, 0.82-1.63; P < .05). In interrupted time series analysis, the "Order Sleep" tool was associated with a significant increase in sleep-friendly lab orders per encounter per week on resident medicine services (intercept, 1.03; standard error (SE), 0.29; P < .001). The "4 AM Labs" column was associated with a significant increase in sleep-friendly lab orders per patient encounter per week on the hospitalist medical service (intercept, 1.17; SE, 0.50; P = .02). We demonstrate the success of an initiative to simultaneously reduce daily labs and improve sleep-friendly ordering.

Myocardial strain analysis of the right ventricle: comparison of different cardiovascular magnetic resonance and echocardiographic techniques.

BACKGROUND: Right ventricular (RV) strain is a useful predictor of prognosis in various cardiovascular diseases, including those traditionally believed to impact only the left ventricle. We aimed to determine inter-modality and inter-technique agreement in RV longitudinal strain (LS) measurements between currently available cardiovascular magnetic resonance (CMR) and echocardiographic techniques, as well as their reproducibility and the impact of layer-specific strain measurements. METHODS: RV-LS was determined in 62 patients using 2D speckle tracking echocardiography (STE, Epsilon) and two CMR techniques: feature tracking (FT) and strain-encoding (SENC), and in 17 healthy subjects using FT and SENC only. Measurements included global and free-wall LS (GLS, FWLS). Inter-technique agreement was assessed using linear regression and Bland-Altman analysis. Reproducibility was quantified using intraclass correlation (ICC) and coefficients of variation (CoV). RESULTS: We found similar moderate agreement between both CMR techniques and STE in patients: r = 0.57-0.63 for SENC; r = 0.50-0.62 for FT. The correlation between SENC and STE was better for GLS (r = 0.63) than for FWLS (r = 0.57). Conversely, the correlation between FT and STE was higher for FWLS (r = 0.60-0.62) than GLS (r = 0.50-0.54). FT-midmyocardial strain correlated better with SENC and STE than FT-subendocardial strain. The agreement between SENC and FT was fair (r = 0.36-0.41, bias: - 6.4 to - 10.4%) in the entire study group. All techniques except FT showed excellent reproducibility (ICC: 0.62-0.96, CoV: 0.04-0.30). CONCLUSIONS: We found only moderate inter-modality agreement with STE in RV-LS for both FT and SENC and poor agreement when comparing between the CMR techniques. Different modalities and techniques should not be used interchangeably to determine and monitor RV strain.

Echocardiography and cardiovascular magnetic resonance based evaluation of myocardial strain and relationship with late gadolinium enhancement.

OBJECTIVES: We sought to: (1) determine the agreement in cardiovascular magnetic resonance (CMR) and speckle tracking echocardiography (STE) derived strain measurements, (2) compare their reproducibility, (3) determine which approach is best related to CMR late gadolinium enhancement (LGE). BACKGROUND: While STE-derived strain is routinely used to assess left ventricular (LV) function, CMR strain measurements are not yet standardized. Strain can be measured using dedicated pulse sequences (strain-encoding, SENC), or post-processing of cine images (feature tracking, FT). It is unclear whether these measurements are interchangeable, and whether strain can be used as an alternative to LGE. METHODS: Fifty patients underwent 2D echocardiography and 1.5 T CMR. Global longitudinal strain (GLS) was measured by STE (Epsilon), FT (NeoSoft) and SENC (Myocardial Solutions) and circumferential strain (GCS) by FT and SENC. RESULTS: GLS showed good inter-modality agreement (r-values: 0.71-0.75), small biases (< 1%) but considerable limits of agreement (- 7 to 8%). The agreement between the CMR techniques was better for GLS than GCS (r = 0.81 vs 0.67; smaller bias). Repeated measurements showed low intra- and inter-observer variability for both GLS and GCS (intraclass correlations 0.86-0.99; coefficients of variation 3-13%). LGE was present in 22 (44%) of patients. Both SENC- and FT-derived GLS and GCS were associated with LGE, while STE-GLS was not. Irrespective of CMR technique, this association was stronger for GCS (AUC 0.77-0.78) than GLS (AUC 0.67-0.72) and STE-GLS (AUC = 0.58). CONCLUSION: There is good inter-technique agreement in strain measurements, which were highly reproducible, irrespective of modality or analysis technique. GCS may better reflect the presence of underlying LGE than GLS.

Comparison of clinical prediction tools and identification of risk factors for adverse outcomes in acute lower GI bleeding.

BACKGROUND AND AIMS: Limited data exist on prediction of adverse outcomes in patients with acute lower GI bleeding (LGIB). The purpose of our study was to compare the ability of existing validated clinical risk scores to predict relevant outcomes in LGIB. METHODS: We performed a prospective observational study of patients admitted with LGIB who underwent colonoscopy at a single center between April 2016 and September 2017. Seven risk scores were calculated at admission (Strate, NOBLADS, Sengupta, Oakland, Blatchford, AIMS65, and Charlson Comorbidity Index). The risk of severe LGIB was determined via univariable and multivariable logistic regression. Area under the receiver operating characteristic curve (AUC) analysis was used to compare the scores. RESULTS: We included 170 patients admitted with LGIB requiring colonoscopy. Fifty-two percent (n = 89) fit criteria for severe bleeding. Patients with severe bleeding had lower admission hemoglobin levels (8.6 g/dL vs 11.1 g/dL; P = .0001), were more likely to have blood transfusions (85% vs 36%; P < .0001), intensive care unit stays (49% vs 19%; P < .0001), and had a longer length of stay (6 days vs 4 days; P = .0009). The Oakland score was best for prediction of severe bleeding (AUC, .74), Blatchford score for blood transfusion (AUC, .87), and Strate score for in-hospital recurrent bleeding (AUC, .66) and endoscopic intervention (AUC, .62). The strongest individual predictors of severe bleeding were low admission hemoglobin (odds ratio, 1.28 per 1-g/dL decrease; P = .0015; 95% confidence interval, 1.10-1.49) and low albumin (odds ratio, 2.56 per 1-g/dL decrease; P = .02; 95% confidence interval, 1.16-5.56). CONCLUSION: Admission albumin and hemoglobin levels were the strongest predictors of severe bleeding. No singular clinical risk tool had the best predictive ability across all outcomes.

Event related potentials study of aberrations in voice control mechanisms in adults with attention deficit hyperactivity disorder.

OBJECTIVE: The present study was designed to test for neural signs of impulsivity related to voice motor control in young adults with ADHD using EEG recordings in a voice pitch perturbation paradigm. METHODS: Two age-matched groups of young adults were presented with brief pitch shifts of auditory feedback during vocalization. Compensatory behavioral and corresponding bioelectrical brain responses were elicited by the pitch-shifted voice feedback. RESULTS: The analysis of bioelectrical responses showed that the ADHD group had shorter peak latency and onset time of motor-related bioelectrical brain responses as compared to the controls. CONCLUSIONS: These results were interpreted to suggest differences in executive functions between ADHD and control participants. SIGNIFICANCE: We hypothesize that more rapid motor-related bioelectrical responses found in the present study may be a manifestation of impulsiveness in adults with ADHD at the involuntary level of voice control.

Growth factor release from a chemically modified elastomeric poly(1,8-octanediol-co-citrate) thin film promotes angiogenesis in vivo.

The ultimate success of in vivo organ formation utilizing ex vivo expanded "starter" tissues relies heavily upon the level of vascularization provided by either endogenous or artificial induction of angiogenic or vasculogenic events. To facilitate proangiogenic outcomes and promote tissue growth, an elastomeric scaffold previously shown to be instrumental in the urinary bladder regenerative process was modified to release proangiogenic growth factors. Carboxylic acid groups on poly(1,8-octanediol-co-citrate) films (POCfs) were modified with heparan sulfate creating a heparan binding POCf (HBPOCf). Release of proangiogenic growth factors vascular endothelial growth factor (VEGF), fibroblast growth factor 2 (FGF2), and insulin-like growth factor 1 (IGF-1) from HBPOCfs demonstrated an approximate threefold increase over controls during a 30-day time course in vitro. Atomic force microscopy demonstrated significant topological differences between films. Subcutaneous implantation of POCf alone, HBPOCf, POCf-VEGF, and HBPOCf-VEGF within the dorsa of nude rats yielded increased vascular growth in HBPOCf-VEGF constructs. Vessel quantification studies revealed that POCfs alone contained 41.1 ± 4.1 vessels/mm², while HBPOCf, POCf-VEGF, and HBPOCF-VEGF contained 41.7 ± 2.6, 76.3 ± 9.4, and 167.72 ± 15.3 vessels/mm², respectively. Presence of increased vessel growth was demonstrated by CD31 and vWF immunostaining in HBPOCf-VEGF implanted areas. Data demonstrate that elastomeric POCfs can be chemically modified and possess the ability to promote angiogenesis in vivo.

A nonhuman primate model for urinary bladder regeneration using autologous sources of bone marrow-derived mesenchymal stem cells.

Animal models that have been used to examine the regenerative capacity of cell-seeded scaffolds in a urinary bladder augmentation model have ultimately translated poorly in the clinical setting. This may be due to a number of factors including cell types used for regeneration and anatomical/physiological differences between lower primate species and their human counterparts. We postulated that mesenchymal stem cells (MSCs) could provide a cell source for partial bladder regeneration in a newly described nonhuman primate bladder (baboon) augmentation model. Cell-sorted CD105(+) /CD73(+) /CD34(-) /CD45(-) baboon MSCs transduced with green fluorescent protein (GFP) were seeded onto small intestinal submucosa (SIS) scaffolds. Baboons underwent an approximate 40%-50% cystectomy followed by augmentation cystoplasty with the aforementioned scaffolds or controls and finally enveloped with omentum. Bladders from sham, unseeded SIS, and MSC/SIS scaffolds were subjected to trichrome, H&E, and immunofluorescent staining 10 weeks postaugmentation. Immunofluorescence staining for muscle markers combined with an anti-GFP antibody revealed that >90% of the cells were GFP(+) /muscle marker(+) and >70% were GFP(+) /Ki-67(+) demonstrating grafted cells were present and actively proliferating within the grafted region. Trichrome staining of MSC/SIS-augmented bladders exhibited typical bladder architecture and quantitative morphometry analyses revealed an approximate 32% and 52% muscle to collagen ratio in unseeded versus seeded animals, respectively. H&E staining revealed a lack of infiltration of inflammatory cells in grafted animals and in corresponding kidneys and ureters. Simple cystometry indicated recovery between 28% and 40% of native bladder capacity. Data demonstrate MSC/SIS composites support regeneration of bladder tissue and validate this new bladder augmentation model.