Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis.

BACKGROUND: The treatment of complex infra-inguinal disease with drug-coated balloons (DCBs) is associated with a significant number of patients undergoing provisional stenting to treat a suboptimal result. To determine the potential long-term impact of DCB treatment with provisional bare metal stenting in complex lesions in real-world patients, a post hoc analysis was performed on data from the IN.PACT Global Study (The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral Drug-Eluting Balloon). Five-year outcomes were compared between participants who were stented after DCB treatment versus those treated with DCB alone. METHODS: The IN.PACT Global Study enrolled 1535 participants with intermittent claudication and/or ischemic rest pain caused by femoropopliteal lesions; 1397 patients were included in this subgroup analysis (353 stented and 1044 nonstented). Effectiveness was assessed as freedom from clinically driven target lesion revascularization through 60 months. The primary safety composite end point was defined as freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and clinically driven target vessel revascularization through 60 months. RESULTS: Lesions in the stented group were longer (15.37 versus 10.98 cm; P<0.001) and had more total occlusions (54.7% versus 28.6%; P<0.001) compared with the nonstented group. The 5-year Kaplan-Meier estimated freedom from clinically driven target lesion revascularization was similar between groups (66.8% stented versus 70.0% nonstented group, log-rank P=0.22). The safety composite end point was achieved in 64.5% stented versus 68.2% nonstented participants (log-rank P=0.19) as estimated by the Kaplan-Meier method. No significant difference was observed in the cumulative incidence of major adverse events (49.1% stented versus 45.0% nonstented; log-rank P=0.17), including all-cause death (19.6% stented versus 19.3% nonstented, log-rank P=0.99). CONCLUSIONS: In this real-world study, revascularization of complex femoropopliteal artery lesions with DCB angioplasty alone or DCB followed by provisional bare metal stenting in certain lesions achieved comparable long-term safety and clinical effectiveness. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609296.

Five-Year Outcomes after Paclitaxel Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Diabetic and Chronic Limb-Threatening Ischemia Cohorts: IN.PACT Global Study Post Hoc Analysis.

PURPOSE: To summarize the 5-year outcomes of drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with diabetes mellitus (DM) or chronic limb-threatening ischemia (CLTI) compared to non-DM and intermittent claudication (IC). METHODS: The IN.PACT Global study was a real-world prospective, multicenter, international, single-arm study that enrolled 1535 participants. Post hoc analyses were conducted for participants with DM (n = 560) versus non-DM (n = 842) and CLTI (n = 156) versus IC (n = 1246). Assessments included freedom from clinically driven target lesion revascularization (CD-TLR) through 60 months, a composite safety outcome (freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and freedom from CD-target vessel revascularization within 60 months), and major adverse events (MAEs). RESULTS: Kaplan-Meier estimates of 60-month freedom from CD-TLR were 67.7% and 70.5% (p = 0.25) in the DM and non-DM cohorts; and 60.7% and 70.5% (p = 0.006) in the CLTI and IC cohorts. The Kaplan-Meier 60-month composite safety outcomes were 65.1% DM versus 68.9% non-DM (p = 0.12); 53.2% CLTI versus 69.1% IC (p < 0.001). Between DM and non-DM, MAE rates were not significantly different through 60 months except for all-cause mortality which was higher in DM (23.8% versus 16.6%; p < 0.001). Participants with CLTI had a higher cumulative incidence of major target limb amputation (6.8% versus 1.1%; p < 0.001) and all-cause mortality (37.4% versus 17.4%; p < 0.001) through 60 months compared to IC. CONCLUSIONS: In this real-world study, 5-year reintervention rates following DCB angioplasty were similar between DM and non-DM, but mortality rates were expectedly higher in patients with DM. Reintervention, mortality, and amputation rates were all higher in CLTI patients compared to IC, which is consistent with the known frailty of this patient population. LEVEL OF EVIDENCE: Level 3, Non-randomized controlled cohort/follow-up study.

5-Year Outcomes of Drug-Coated Balloons for Peripheral Artery In-Stent Restenosis, Long Lesions, and CTOs.

BACKGROUND: Long-term data on drug-coated balloon (DCB) outcomes in complex femoropopliteal atherosclerotic lesions are limited. OBJECTIVES: The authors sought to report 5-year safety and effectiveness outcomes of a paclitaxel DCB for the treatment of de novo in-stent restenosis (ISR), long lesions (LL), or chronic total occlusions (CTOs) in the prespecified imaging cohorts of the IN.PACT Global Study. METHODS: The IN.PACT Global study was a prospective, international single-arm study. Assessments through 5 years included freedom from clinically driven target lesion revascularization (CD-TLR), a safety composite (freedom from device- and procedure-related death to 30 days, and freedom from major target limb amputation and freedom from clinically driven target vessel revascularization within 60 months), and major adverse events. RESULTS: The prespecified imaging cohorts enrolled 132 de novo ISR, 158 LL, and 127 CTO participants. Kaplan-Meier estimates of freedom from CD-TLR through 5 years were 58.0% (ISR), 67.3% (LL), and 69.8% (CTO). The cumulative incidences of the composite safety endpoint were 56.0% (ISR), 65.7% (LL), and 69.8% (CTO). The 5-year freedom from all-cause mortality with vital status update were 81.4% (ISR), 75.2% (LL), and 78.2% (CTO). Within the ISR cohort, 15.9% of participants experienced 2 or more TLRs, compared with 9.5% and 5.5% in the LL and CTO groups, respectively. CONCLUSIONS: Results demonstrate long-term safety and effectiveness of this DCB in all 3 cohorts, with low reintervention rates in the LL and CTO cohorts and no safety issues. These results support the inclusion of this DCB into the treatment algorithm for complex femoropopliteal disease.

IN.PACT AV access randomized trial: Japan cohort outcomes through 12 months.

PURPOSE: There is a lack of adjudicated and prospectively randomized published outcomes on the use of drug-coated balloons (DCB) to treat dysfunctional arteriovenous fistula in Asian patients. This post hoc subgroup analysis of 112 Japanese participants from the global IN.PACT AV Access trial reports outcomes through 12 months. MATERIALS AND METHODS: Participants were treated with DCB (n = 58) or standard non-coated percutaneous transluminal angioplasty (PTA) balloons (n = 54). Outcomes included target lesion primary patency (TLPP), access circuit primary patency, and safety. RESULTS: Through 6 months, TLPP was 86.0% (49/57) in the DCB group and 49.1% (26/53) in the PTA group (p < 0.001). Through 12 months, TLPP was 67.3% (37/55) in the DCB group and 43.4% (23/53) in the PTA group (p = 0.013). CONCLUSION: In this post hoc analysis of Japanese participants from the IN.PACT AV Access trial, participants treated with DCB had higher TLPP through 6 and 12 months compared with PTA.

Long-term outcomes after paclitaxel-coated balloon angioplasty of femoropopliteal arteries in Asian patients of the IN.PACT Global Study.

OBJECTIVES: The long-term data on the use of drug-coated balloons (DCBs) for femoropopliteal atherosclerotic lesions in the real-world setting are limited, even more so for racially and geographically distinct populations. The present analysis reports the 5-year safety and effectiveness outcomes of a DCB in the Asian subset of the prospective, real-world IN.PACT Global Study. METHODS: The IN.PACT Global Study was a prospective, multicenter, international, single-arm study designed to assess the long-term safety and effectiveness of the IN.PACT Admiral DCB in real-world participants with femoropopliteal artery disease. The present analysis included 114 Asian participants (138 lesions) treated in South Korea and Singapore. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the safety endpoint (a composite of freedom from device- and procedure-related mortality through 30 days; and freedom from major target limb amputation and clinically driven target vessel revascularization within 60 months after the index procedure) and major adverse events. RESULTS: In this prespecified Asian subset, there was a high incidence of diabetes mellitus (54.4%), hypertension (78.1%), coronary artery disease (43.9%), and concomitant below-the-knee vascular disease of target leg (39.5%). Mean lesion length was 17.4 ± 12.4 cm; 26.8% were in-stent restenosis, and more than half of the lesions were totally occluded (51.4%) and calcified (54.3%). The 5-year Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 77.1% (95% confidence interval: 67.0%-84.5%). The safety composite endpoint was 76.0%; the cumulative incidence of all-cause mortality was 19.9%, and no major target limb amputations were reported through 5 years. CONCLUSIONS: This subset analysis of Asian participants from the IN.PACT Global Study demonstrated consistent results with the previously reported data of the IN.PACT Admiral DCB. The data confirm the durable clinical effectiveness and safety profile of the DCB through 5 years for femoropopliteal atherosclerotic disease in this real-world population.

Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study.

PURPOSE: Data on the long-term safety and effectiveness of drug-coated balloons (DCBs) for the treatment of long femoropopliteal atherosclerotic lesions in the real-world setting are rare. This study reports 3 year and 5 year outcomes of the pre-specified 150 mm balloon sub-cohort of the IN.PACT Global Study. METHODS: The IN.PACT Global Study was a prospective, multicentre, international, single-arm study evaluating the performance of the IN.PACT Admiral DCB in real-world patients with femoropopliteal atherosclerotic disease. This pre-specified 150 mm DCB cohort analysis comprised 107 participants (111 lesions) with all target lesions treated with at least one 150 mm DCB. RESULTS: Mean lesion length was 20.3 ± 9.2 cm; 18.0% had in-stent restenosis, 58.6% were totally occluded, and 17.1% were severely calcified. Through 60 months, the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) was 72.7% [95% confidence interval (CI):62.4%-80.5%]. The safety composite endpoint (freedom from device/procedure-related death through 30 days; freedom from target limb major amputation and clinically driven target vessel revascularization through 5 years) was 70.5%. The cumulative incidence of major amputation was 1.0% and all-cause mortality was 18.4% through 60 months. Freedom from CD-TLR rates in the provisional stented and non-stented subgroups through 36 months were 64.0% [95% CI: 46.1%-77.3%] and 81.9% [95% CI: 69.7%-89.6%] (log-rank p = 0.074), respectively. CONCLUSIONS: The results demonstrate sustained long-term safety of the 150 mm IN.PACT Admiral DCB for long femoropopliteal atherosclerotic lesions in real-world patients. In particular, the results show that DCB angioplasty is an effective revascularization modality in long complex lesions. CLINICALTRIALS: gov identifier: NCT01609296. LEVEL OF EVIDENCE: Level 3, Cohort Study.

Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study.

BACKGROUND: Numerous randomised controlled trials (RCTs) have demonstrated the superiority of paclitaxel drug-coated balloons (DCBs) over non-coated angioplasty balloons for treatment of femoropopliteal peripheral arterial disease (PAD). There is a paucity of clinical evidence in more complex patients who are often excluded from RCTs and long-term data up to 5 years are very limited in PAD revascularisation studies. AIMS: This is a report of the 5-year outcomes from the prospective, single-arm, international IN.PACT Global Study. The IN.PACT Admiral DCB was evaluated for femoropopliteal atherosclerotic disease treatment in a real-world patient population. METHODS: In total, 1,535 patients were enrolled at 64 international sites. The prespecified clinical cohort included 1,406 patients with claudication or rest pain. Patients were evaluated up to 5 years for the occurrence of adverse events and clinically driven target lesion revascularisations (CD-TLR). RESULTS: The mean lesion length was 12.1±9.5 cm in 1,774 lesions, 18.0% had in-stent restenosis, 35.5% were total occlusions and 68.7% were calcified. Per independent clinical events committee adjudication, the Kaplan-Meier estimate of freedom from CD-TLR up to 5 years was 69.4%, and the restricted mean survival time to first CD-TLR was 1,470.1 days. Outcomes were similar for males and females; freedom from CD-TLR was 69.1% in females and 69.6% in males (p=0.602). The cumulative incidence of major adverse events for the clinical cohort was 45.9% and freedom from all-cause mortality with the vital status update was 78.9% up to 5 years. CONCLUSIONS: The IN.PACT Admiral DCB demonstrated safe and durable outcomes in real-world participants with complex femoropopliteal disease. CLINICALTRIALS: gov: NCT01609296.

Integrated, Accountable Care For Medicaid Expansion Enrollees: A Comparative Evaluation of Hennepin Health.

Hennepin Health, a Medicaid accountable care organization, began serving early expansion enrollees (very low-income childless adults) in 2012. It uses an integrated care model to address social and behavioral needs. We compared health care utilization in Hennepin Health with other Medicaid managed care in the same area from 2012 to 2014, controlling for demographics, chronic conditions, and enrollment patterns. Homelessness and substance use were higher in Hennepin Health. Overall adjusted results showed Hennepin Health had 52% more emergency department visits and 11% more primary care visits than comparators. Over time, modeling a 6-month exposure to Hennepin Health, emergency department and primary care visits decreased and dental visits increased; hospitalizations decreased nonsignificantly but increased among comparators. Subgroup analysis of high utilizers showed lower hospitalizations in Hennepin Health. Integrated, accountable care under Medicaid expansion showed some desirable trends and subgroup benefits, but overall did not reduce acute health care utilization versus other managed care.

Pre- and Peri-Operative Factors Associated with Chronic Critical Illness in Liver Transplant Recipients.

Background: Chronic critical illness (CCI) is a new and increasing entity that accounts for substantial cost despite its low incidence. We hypothesized that patients with end-stage liver failure undergoing liver transplant would be at high risk for developing CCI. With limited liver donors it is essential to understand pre- and peritransplant predictors of CCI. Methods: To accomplish this we performed a retrospective cohort study at a large academic transplant center of all adult liver transplant patients from 2011 to 2017. We defined CCI as the need for mechanical ventilation for seven days or more post-transplant. Recipients who had re-transplantation during their index admission, acute rejection, or who died during transplant surgery were excluded. Logistic regression was performed using the Akaike information criterion (AIC) and the likelihood ratio test. Results: We identified 382 transplant recipients. Forty-five (11.8%) developed CCI. Univariable analysis identified 16 pre-transplant factors associated with post-transplant CCI. Subsequent multivariable logistic regression identified eight independent factors associated with CCI in liver transplant recipients including previous liver transplant, acute renal failure, frailty, lower albumin level, higher international normalized ratio, need for mechanical ventilation, and higher systolic pulmonary artery pressure. Pre-transplant factors associated with protection against CCI included higher Model for End-Stage Liver Disease (MELD) score. Conclusion: The incidence of CCI post-liver transplant is similar to the general population admitted to the intensive care unit. Pre-transplant factors associated with CCI can help identify at-risk patients, and furthermore, promote further research and interventions with the goal to decrease the incidence of CCI in the liver transplant recipients.

Influence of Combined Transcranial Direct Current Stimulation and Motor Training on Corticospinal Excitability in Children With Unilateral Cerebral Palsy.

Combined non-invasive brain stimulation (NIBS) and rehabilitation interventions have the potential to improve function in children with unilateral cerebral palsy (UCP), however their effects on developing brain function are not well understood. In a proof-of-principle study, we used single-pulse transcranial magnetic stimulation (TMS) to measure changes in corticospinal excitability and relationships to motor performance following a randomized controlled trial consisting of 10 days of combined constraint-induced movement therapy (CIMT) and cathodal transcranial direct current stimulation (tDCS) applied to the contralesional motor cortex. Twenty children and young adults (mean age = 12 years, 9 months, range = 7 years, 7 months, 21 years, 7 months) with UCP participated. TMS testing was performed before, after, and 6 months after the intervention to measure motor evoked potential (MEP) amplitude and cortical silent period (CSP) duration. The association between neurophysiologic and motor outcomes and differences in excitability between hemispheres were examined. Contralesional MEP amplitude decreased as hypothesized in five of five participants receiving active tDCS immediately after and 6 months after the intervention, however no statistically significant differences between intervention groups were noted for MEP amplitude [mean difference = -323.9 µV, 95% CI = (-989, 341), p = 0.34] or CSP duration [mean difference = 3.9 ms, 95% CI = (-7.7, 15.5), p = 0.51]. Changes in corticospinal excitability were not statistically associated with improvements in hand function after the intervention. Across all participants, MEP amplitudes measured in the more-affected hand from both contralesional (mean difference = -474.5 µV) and ipsilesional hemispheres (-624.5 µV) were smaller compared to the less-affected hand. Assessing neurophysiologic changes after tDCS in children with UCP provides an understanding of long-term effects on brain excitability to help determine its potential as a therapeutic intervention. Additional investigation into the neurophysiologic effects of tDCS in larger samples of children with UCP are needed to confirm these findings.

Safety and Feasibility of Transcranial Magnetic Stimulation as an Exploratory Assessment of Corticospinal Connectivity in Infants After Perinatal Brain Injury: An Observational Study.

BACKGROUND: Perinatal brain injuries often impact the corticospinal system, leading to motor impairment and cerebral palsy. Although transcranial magnetic stimulation (TMS) has been widely used to study corticospinal connectivity in adults and older children, similar studies of young infants are limited. OBJECTIVES: The objective was to establish the safety and feasibility of advanced TMS assessments of the corticospinal connectivity of young infants with perinatal brain injury. DESIGN: This was a pilot, cross-sectional study of 3- to 12-month-old (corrected age) infants with perinatal stroke or intracranial hemorrhage. METHODS: Six participants (2 term, 4 preterm) were assessed with stereotactic neuronavigation-guided TMS. Single-pulse TMS was applied to each hemisphere and responses were recorded simultaneously from both upper limbs. During data collection, vital signs and stress responses were measured to assess safety. Developmental motor outcomes were evaluated using the General Movements Assessment and Bayley Scales of Infant and Toddler Development (3rd edition). A clinical diagnosis of cerebral palsy was recorded, if available. RESULTS: No adverse events occurred during TMS testing. All sessions were well tolerated. Contralateral motor evoked responses were detected in 4 of 6 participants. Both contralateral and ipsilateral responses were observed in 2 of 6 participants. LIMITATIONS: TMS responses were not obtained in all participants. This could be related to the location of brain injury or developmental stage of the corticospinal system controlling the wrist flexor muscle group from which responses were recorded. CONCLUSIONS: This study provides a summary of the framework for performing novel TMS assessments in infants with perinatal brain injury. Implementing this approach to measure corticospinal connectivity in hypothesis-driven studies in young infants appears to be justified. Such studies could inform the characterization of corticospinal development and the neural mechanisms driving recovery following early interventions.

Polyp Sizing Poster Improves Polyp Measurement but not Adenoma Detection Rates by Endoscopists in a Large Community Practice.

BACKGROUND & AIMS: Accurate sizing of polyps and improving adenoma detection rates (ADR) are important goals for high-quality colonoscopy. Surveillance intervals are based on accurate sizing of polyps. There are no clinical tools or interventions that have demonstrated improvement in both these metrics. We investigated the efficacy of a simple, low-cost intervention, based on use of polyp sizing posters to improve measurements of polyps and increase ADRs during colonoscopy at a large gastroenterology community practice. METHODS: We collected data on polyp measurements and ADRs by 62 gastrointestinal endoscopists at a large multi-site community practice, from January to November 2015 (baseline). In a prospective study, endoscopy units were given a polyp sizing poster to be hung above the endoscopy video monitor (intervention group, for 33 endoscopists) or for usual care (control group, for 29 endoscopists) in December 2015, and we collected data on polyp measurements and ADRs over the following 6 months (January-June 2016). We compared the endoscopists' assessment of polyp size and their ADRs before and after the intervention using a mixed effects proportional odds model, controlling for provider age and sex and patient and indication for colonoscopy. Our primary aim was to assess the effect of the snare and forcep-based polyp sizing poster on change in polyp size. The secondary aim was to study the effect of the polyp sizing poster on ADR. RESULTS: Our final analysis included 85,657 polyps from 38,307 colonoscopies. The characteristics of patients who underwent colonoscopy were similar between the control and intervention group (median age, 61 years; 48.1% female; 53.9% undergoing screening; 31.4% undergoing surveillance; 14.7% receiving a diagnostic colonoscopy). The endoscopists' median age was 51 years (range, 33-76) years, and 15 were women (24.2%). During the baseline period, male endoscopists were more likely to size polyps larger than measurements made by female endoscopists (odds ratio [OR], 1.78; 95% CI, 1.24-2.55; P = .002). For the intervention group, 78.6% of polyps were assigned to the 1-5 mm category during the baseline period compared to 76.0% after the intervention, whereas the proportions of polyps assigned to the 6-10 mm category increased from 16.9% during the baseline period to 18.3% after the intervention. In the control group, 78.9% of polyps were assigned to the 1-5 mm category during the baseline period and 78.3% were assigned to this group in the prospective study; 16.5% of polyps were assigned to the 6-10 mm during the baseline period and 17.5% were assigned to this group in the prospective study. The interaction between intervention group and timing (baseline vs after the intervention) was statistically significant, with an increase in the odds of larger polyp sizing after the intervention (OR, 1.15; 95% CI, 1.08-1.23; P < .001). The odds of larger polyp measurement during the intervention period, compared to the baseline period, increased for male endoscopists (OR, 1.17; 95% CI, 1.09-1.27; P < .001) and female endoscopists (OR, 1.18; 95% CI, 1.01-1.36; P = .04), as well as for younger physicians (<50 years; OR, 1.32; 95% CI, 1.20-1.46; P < .001) but not for older physicians (>50 years; OR, 0.96; 95% CI, 0.88-1.06; P = .44). The average ADR for male and female endoscopists combined during the baseline period was 42%. The change in ADR from the baseline vs the post-intervention was an increase of 2.6% in the control group compared to 5.7% in the intervention group (P = .39) CONCLUSIONS: Placement of a polyp sizing poster above the endoscopy video monitor increases the odds of polyps being assigned a larger size but does not affect ADRs.

Mortality Following Pediatric Congenital Heart Surgery: An Analysis of the Causes of Death Derived From the National Death Index.

Background Prior research has focused on early outcomes after congenital heart surgery, but less is known about later risks. We aimed to determine the late causes of death among children (<21 years of age) surviving their initial congenital heart surgery. Methods and Results This is a retrospective cohort study from the Pediatric Cardiac Care Consortium, a US-based registry of interventions for congenital heart defects (CHD). Excluding patients with chromosomal anomalies or inadequate identifiers, we matched those surviving their first congenital heart surgery (1982-2003) against the National Death Index through 2014. Causes of death were obtained from the National Death Index to calculate cause-specific standardized mortality ratios (SMRs). Among 31 132 patients, 2527 deaths (8.1%) occurred over a median follow-up period of 18 years. Causes of death varied by time after surgery and severity of CHD but, overall, 69.9% of deaths were attributed to the CHD or another cardiovascular disorder, with a SMR for CHD/cardiovascular disorder of 67.7 (95% confidence interval: 64.5-70.8). Adjusted odds ratios revealed increased risk of death from CHD/cardiovascular disorder in females [odds ratio=1.28; 95% confidence interval (1.04-1.58); P=0.018] with leading cardiovascular disorder contributing to death being cardiac arrest (16.8%), heart failure (14.8%), and arrhythmias (9.1%). Other major causes of death included coexisting congenital malformations (4.7%, SMR: 7.0), respiratory diseases (3.6%, SMR: 8.2), infections (3.4%, SMR: 8.2), and neoplasms (2.1%, SMR: 1.9). Conclusions Survivors of congenital heart surgery face long-term risks of premature mortality mostly related to residual CHD pathology, heart failure, and arrhythmias, but also to other noncardiac conditions. Ongoing monitoring is warranted to identify target factors to address residual morbidities and improve long-term outcomes.

Decreased Pseudomonas aeruginosa detection in children after separation of pediatric from adult cystic fibrosis clinics: A single center experience.

BACKGROUND: The impact of separating the adult from pediatric patients on Pseudomonas aeruginosa (P. aeriginosa) detection in the respiratory cultures of patients was examined at the University of Minnesota CF Center. METHODS: This study was a retrospective review using data recorded in the University of Minnesota CF Database between 1995 and 2010. Respiratory culture results obtained during routine University of Minnesota Cystic Fibrosis (CF) Center. CF clinic encounters of two cohorts of pediatric and adult CF patients (pre- and post-separation) were analyzed for presence of P. aeruginosa. RESULTS: The odds of a pediatric patient having P. aeruginosa were significantly less if the first culture was obtained after separation of pediatric and adult clinics. Being diagnosed by newborn screening or introduction of inhaled tobramycin did not affect this outcome. This reduction in P. aeruginosa was not detected in the adult cohort. CONCLUSIONS: Separation of pediatric and adult CF clinics has contributed to decrease in P. aeruginosa detection in pediatric patients.

Barriers in Hepatitis C Treatment in Somali Patients in the Direct Acting Antiviral Therapy Era.

BACKGROUND AND AIMS: Hepatitis C virus (HCV) treatment has changed dramatically in the last few years. Our observations suggest that a minority of HCV infected Somalis are treated. In this study, we aimed to evaluate for treatment and health outcome disparities between Somali and non-Somali patients during the direct acting antiviral (DAA) era. METHODS: Patients with HCV seen in the gastroenterology clinic in 2015 were included in the study. Patients were identified using ICD9 and 10 codes. Electronic medical records were analyzed to evaluate for treatment candidacy, acceptance and reasons for refusal of treatment. RESULTS: Genotype 4 followed by 3 were the most common genotypes in the Somalis while genotype 1 was the most common in the non-Somalis. Majority of patients were offered treatment, active alcohol and substance abuse was a common reason for not offering treatment in non-Somalis while the presence of hepatocellular carcinoma was the most common reason in Somalis. Somalis had higher rates of declining treatment given the asymptomatic nature of their disease and the feeling that treatment is not needed. Sustained virologic response rates were comparable in both groups. CONCLUSIONS: Disparities in acceptance of HCV treatment persist in the DAA era. The asymptomatic nature of the infection and potential cultural mistrust makes patients hesitant to undergo treatment. Healthcare providers must find interventions aimed at reducing barriers to treatment and increasing acceptance of HCV treatment.

Randomized controlled trial of a self-administered five-day antiseptic bundle versus usual disinfectant soap showers for preoperative eradication of Staphylococcus aureus colonization.

OBJECTIVE: To determine the efficacy in eradicating Staphylococcus aureus (SA) carriage of a 5-day preoperative decolonization bundle compared to 2 disinfectant soap showers, with both regimens self-administered at home. DESIGN: Open label, single-center, randomized clinical trial. SETTING: Ambulatory orthopedic, urologic, neurologic, colorectal, cardiovascular, and general surgery clinics at a tertiary-care referral center in the United States.ParticipantsPatients at the University of Minnesota Medical Center planning to have elective surgery and not on antibiotics. METHODS: Consenting participants were screened for SA colonization using nasal, throat, axillary, and perianal swab cultures. Carriers of SA were randomized, stratified by methicillin resistance status, to a decolonization bundle group (5 days of nasal mupirocin, chlorhexidine gluconate [CHG] bathing, and CHG mouthwash) or control group (2 preoperative showers with antiseptic soap). Colonization status was reassessed preoperatively. The primary endpoint was absence of SA at all 4 screened body sites. RESULTS: Of 427 participants screened between August 31, 2011, and August 9, 2016, 127 participants (29.7%) were SA carriers. Of these, 121 were randomized and 110 were eligible for efficacy analysis (57 decolonization bundle group, 53 control group). Overall, 90% of evaluable participants had methicillin-susceptible SA strains. Eradication of SA at all body sites was achieved for 41 of 57 participants (71.9%) in the decolonization bundle group and for 13 of 53 participants (24.5%) in the control group, a difference of 47.4% (95% confidence interval [CI], 29.1%-65.7%; P<.0001). CONCLUSION: An outpatient preoperative antiseptic decolonization bundle aimed at 4 body sites was significantly more effective in eradicating SA than the usual disinfectant showers (ie, the control).Trial RegistrationClinicalTrials.gov identifier: NCT02182115.

Trends in Long-Term Mortality After Congenital Heart Surgery.

BACKGROUND: Congenital heart surgery has improved the survival of patients with even the most complex defects, but the long-term survival after these procedures has not been fully described. OBJECTIVES: The purpose of this study was to evaluate the long-term survival of patients (age <21 years) who were operated on for congenital heart defects (CHDs). METHODS: This study used the Pediatric Cardiac Care Consortium data, a U.S.-based, multicenter registry of pediatric cardiac surgery. Survival analysis included 35,998 patients who survived their first congenital heart surgery at <21 years of age and had adequate identifiers for linkage with the National Death Index through 2014. Survival was compared to that in the general population using standardized mortality ratios (SMRs). RESULTS: After a median follow-up of 18 years (645,806 person-years), 3,191 deaths occurred with an overall SMR of 8.3 (95% confidence interval [CI]: 8.0 to 8.7). The 15-year SMR decreased from 12.7 (95% CI: 11.9 to 13.6) in the early era (1982 to 1992) to 10.0 (95% CI: 9.3 to 10.8) in the late era (1998 to 2003). The SMR remained elevated even for mild forms of CHD such as patent ductus arteriosus (SMR 4.5) and atrial septal defects (SMR 4.9). The largest decreases in SMR occurred for patients with transposition of great arteries (early: 11.0 vs. late: 3.8; p < 0.05), complete atrioventricular canal (31.3 vs. 15.3; p < 0.05), and single ventricle (53.7 vs. 31.3; p < 0.05). CONCLUSIONS: In this large U.S. cohort, long-term mortality after congenital heart surgery was elevated across all forms of CHD. Survival has improved over time, particularly for severe defects with significant changes in their management strategy, but still lags behind the general population.

Transcranial direct current stimulation and constraint-induced therapy in cerebral palsy: A randomized, blinded, sham-controlled clinical trial.

We investigated the safety, feasibility, and efficacy of transcranial direct current stimulation (tDCS) combined with constraint-induced movement therapy (CIMT) in children and young adults with unilateral cerebral palsy. Twenty participants were randomized to receive active or sham tDCS. The intervention consisted of 10 consecutive weekday sessions of tDCS applied to the non-lesioned hemisphere (20 min) concurrently with CIMT (120 min). Participants, caregivers, and interventionists were blinded to group assignment. The primary safety outcome investigated adverse events. The primary behavioral outcome was the Assisting Hand Assessment. All 20 participants (mean age = 12.7 yrs, range = 7.4-21.6 years) were evaluated for the primary outcomes. No serious adverse events occurred, and the most commonly reported minor adverse events were headache and itchiness. Both groups demonstrated a significant improvement in hand function after the intervention, although no significant effect of tDCS was observed (between-group difference = -2.18, 95% CI = [-6.48, 2.12], p = 0.30). Although hand function improved overall, no significant differences between intervention groups were found. Children with preserved corticospinal tract circuitry from the lesioned hemisphere, compared to those without, showed greater improvement in hand function (mean difference = 3.04, 95% CI = [-0.64, 6.72], p = 0.099). Our study demonstrates the safety and feasibility of serial sessions of tDCS, and presents preliminary evidence for the effect of CST circuitry on outcomes following tDCS/CIMT. Future work in children with unilateral cerebral palsy should focus on the optimal dosing and consider individual brain circuitry when describing response to combined interventions. CLINICAL TRIALS REGISTRATION: Clinicaltrials.govNCT 02250092.

Outcomes after surgical coronary artery revascularisation in children with congenital heart disease.

OBJECTIVE: Surgical coronary revascularisation in children with congenital heart disease (CHD) is a rare event for which limited information is available. In this study, we review the indications and outcomes of surgical coronary revascularisation from the Pediatric Cardiac Care Consortium, a large US-based multicentre registry of interventions for CHD. METHODS: This is a retrospective cohort study of children (<18 years old) with CHD who underwent surgical coronary revascularisation between 1982 and 2011. In-hospital mortality and graft patency data were obtained from the registry. Long-term transplant-free survival through 2014 was achieved for patients with adequate identifiers via linkage with the US National Death Index and the Organ Procurement and Transplantation Network. RESULTS: Coronary revascularisation was accomplished by bypass grafting (n=72, median age 6.8 years, range 3 days-17.4 years) or other operations (n=65, median age 2.6 years, range 5 days-16.7 years) in 137 patients. Most revascularisations were related to the aortic root (61.3%) or coronary anomalies (27.7%), but 10.9% of them were unrelated to either of them. Twenty in-hospital deaths occurred, 70% of them after urgent 'rescue' revascularisation in association with another operation. Long-term outcomes were available by external linkage for 54 patients surviving to hospital discharge (median follow-up time 15.0 years, max follow-up 29.8 years) with a 15-year transplant-free survival of 91% (95% CI 83% to 99%). CONCLUSIONS: Surgical coronary revascularisation can be performed in children with CHD with acceptable immediate and long-term survival. Outcomes are dependent on indication, with the highest mortality in rescue procedures.

Long-Term Transplant-Free Survival After Repair of Total Anomalous Pulmonary Venous Connection.

BACKGROUND: Long-term survival, risk of transplantation, and causes of death after repair of total anomalous pulmonary venous connection (TAPVC) remain unknown. By linking the Pediatric Cardiac Care Consortium with the National Death Index and the United Network for Organ Sharing, we evaluated long-term transplant-free survival in children undergoing repair of TAPVC. METHODS: We identified 777 infants within the Pediatric Cardiac Care Consortium who underwent TAPVC repair (median 21 days; interquartile range, 5 to 80) and had sufficient personal identifiers for linkage with the National Death Index and United Network for Organ Sharing. Sixty-six deaths, ten cardiac transplantations, and one bilateral lung transplantation had occurred by the end of 2014. Data collected included age and weight at time of procedure, TAPVC type, associated cardiac lesions, and postoperative length of stay. The study cohort was divided into simple and complex TAPVC based on the presence of an associated cardiac lesion. Parametric survival plots were constructed, and risk factor analyses were performed to identify demographic and clinical characteristics associated with long-term outcomes. RESULTS: Mortality or need for transplantation was 9.7% with a median follow-up of 18.4 years and a median age of death or transplant of 0.74 years. The risk of mortality and transplant after TAPVC repair was highest during the first 18 months after hospital discharge. Cardiac causes accounted for the majority of deaths. Multivariate regression models for transplant-free survival demonstrated that complex TAPVC, mixed TAPVC, and postoperative length of stay were associated with increased risk of death/transplant. CONCLUSIONS: Transplant-free survival after TAPVC repair is excellent, with most deaths or transplant events occurring early. Factors associated with the worst long-term outcomes included complex TAPVC, mixed TAPVC, and prolonged postoperative length of stay.