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.

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.

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.

BMI Is a Risk Factor for Colorectal Cancer Mortality.

BACKGROUND: The relationship between dietary and lifestyle risk factors and long-term mortality from colorectal cancer is poorly understood. Several factors, such as obesity, intakes of red meat, and use of aspirin, have been reported to be associated with risk of colorectal cancer mortality, though these findings have not been replicated in all studies to date. METHODS: In the Minnesota Colon Cancer Control Study, 46,551 participants 50-80 years old were randomly assigned to usual care (control) or annual or biennial screening by fecal occult blood testing. Colon cancer mortality was assessed after 30 years of follow-up. Dietary intake and lifestyle risk factors were assessed by questionnaire at baseline. RESULTS: Age [hazard ratio (HR) 1.09; 95% CI 1.07, -1.11], male sex (HR 1.25; 95% CI 1.01, 1.57), and higher body mass index (BMI) (HR 1.03; 95% CI 1.00-1.05) increased the risk of CRC mortality, while undergoing screening for CRC was associated with a reduced risk of colorectal cancer mortality (HR 0.76; 95% CI 0.61-0.94 and 0.67; 95% CI 0.53-0.83 for biennial and annual screening, respectively). Intakes of grains, meats, proteins, coffee, alcohol, aspirin, fiber, fruits, and vegetables were not associated with colorectal cancer mortality. CONCLUSIONS: Our study confirms the relationship between BMI and long-term colorectal cancer mortality. Modulation of BMI may reduce risk of CRC mortality.

Worklife and Wellness in Academic General Internal Medicine: Results from a National Survey.

BACKGROUND: General internal medicine (GIM) careers are increasingly viewed as challenging and unsustainable. OBJECTIVE: We aimed to assess academic GIM worklife and determine remediable predictors of stress and burnout. DESIGN: We conducted an email survey. PARTICIPANTS: Physicians, nurse practitioners, and physician assistants in 15 GIM divisions participated. MAIN MEASURES: A ten-item survey queried stress, burnout, and work conditions such as electronic medical record (EMR) challenges. An open-ended question assessed stressors and solutions. Results were categorized into burnout, high stress, high control, chaos, good teamwork, high values alignment, documentation time pressure, and excessive home EMR use. Frequencies were determined for national data, Veterans Affairs (VA) versus civilian populations, and hospitalist versus ambulatory roles. A General Linear Mixed Model (GLMM) evaluated associations with burnout. A formal content analysis was performed for open-ended question responses. KEY RESULTS: Of 1235 clinicians sampled, 579 responded (47 %). High stress was present in 67 %, with 38 % burned out (burnout range 10-56 % by division). Half of respondents had low work control, 60 % reported high documentation time pressure, half described too much home EMR time, and most reported very busy or chaotic workplaces. Two-thirds felt aligned with departmental leaders' values, and three-quarters were satisfied with teamwork. Burnout was associated with high stress, low work control, and low values alignment with leaders (all p < 0.001). The 45 VA faculty had less burnout than civilian counterparts (17 % vs. 40 %, p < 0.05). Hospitalists described better teamwork than ambulatory clinicians and fewer hospitalists noted documentation time pressure (both p < 0.001). Key themes from the qualitative analysis were short visits, insufficient support staff, a Relative Value Unit mentality, documentation time pressure, and undervaluing education. CONCLUSIONS: While GIM divisions overall demonstrate high stress and burnout, division rates vary widely. Sustainability efforts within GIM could focus on visit length, staff support, schedule control, clinic chaos, and EMR stress.

Factors Affecting Length of Postoperative Hospitalization for Pediatric Cardiac Operations in a Large North American Registry (1982-2007).

Surgical treatment of congenital heart disease represents a major cause of pediatric hospitalization and healthcare resource use. Larger centers may provide more efficient care with resulting shorter length of postoperative hospitalization (LOH). Data from 46 centers over 25 years were used to evaluate whether surgical volume was an important determinant of LOH using a competing risk regression strategy that concurrently accounted for deaths, transfers, and discharges with some time interactions. Earlier discharge was more likely for infants and older children compared to neonates [subhazard ratios at postoperative day 6 of 1.64 (99 % confidence interval (CI) 1.57, 1.72) and 2.67 (99 % CI 2.53, 2.80), respectively], but less likely for patients undergoing operations in Risk Adjustment for Congenital Heart Surgery categories 2, 3, 4, and 5/6 compared to category 1 [subhazard ratios at postoperative day 6 of 0.66 (99 % CI 0.64, 0.68), 0.34 (95 % CI 0.33, 0.35), 0.28 (99 % CI 0.27, 0.30), and 0.10 (99 % CI 0.09, 0.11), respectively]. There was no difference by sex [non-time-dependent subhazard ratio 1.019 (99 % CI 0.995, 1.040)]. For every 100-operation increase in center annual surgical volume, the non-time-dependent subhazard for discharge was 1.035 (99 % CI 1.006, 1.064) times greater, and center-specific exponentiated random effects ranged from 0.70 to 1.42 with a variance of 0.023. The conditional discharge rate increased with increasing age and later era. No sex-specific difference was found. Centers performing more operations discharged patients sooner than lower volume centers, but this difference appears to be too small to be of clinical significance. Interestingly, unmeasured institutional characteristics estimated by the center random effects were variable, suggesting that these played an important role in LOH and merit further investigation.

Safety of primed repetitive transcranial magnetic stimulation and modified constraint-induced movement therapy in a randomized controlled trial in pediatric hemiparesis.

OBJECTIVE: To investigate the safety of combining a 6-Hz primed low-frequency repetitive transcranial magnetic stimulation (rTMS) intervention in the contralesional hemisphere with a modified constraint-induced movement therapy (mCIMT) program in children with congenital hemiparesis. DESIGN: Phase 1 randomized, double-blinded, placebo-controlled pretest/posttest trial. SETTING: University academic facility and pediatric specialty hospital. PARTICIPANTS: Subjects (N = 19; age range, 8-17 y) with congenital hemiparesis caused by ischemic stroke or periventricular leukomalacia. No subject withdrew because of adverse events. All subjects included completed the study. INTERVENTIONS: Subjects were randomized to 1 of 2 groups: either real rTMS plus mCIMT (n = 10) or sham rTMS plus mCIMT (n = 9). MAIN OUTCOME MEASURES: Adverse events, physician assessment, ipsilateral hand function, stereognosis, cognitive function, subject report of symptoms assessment, and subject questionnaire. RESULTS: No major adverse events occurred. Minor adverse events were found in both groups. The most common events were headaches (real: 50%, sham: 89%; P = .14) and cast irritation (real: 30%, sham: 44%; P = .65). No differences between groups in secondary cognitive and unaffected hand motor measures were found. CONCLUSIONS: Primed rTMS can be used safely with mCIMT in congenital hemiparesis. We provide new information on the use of rTMS in combination with mCIMT in children. These findings could be useful in research and future clinical applications in advancing function in congenital hemiparesis.

Synergistic effect of combined transcranial direct current stimulation/constraint-induced movement therapy in children and young adults with hemiparesis: study protocol.

BACKGROUND: Perinatal stroke occurs in more than 1 in 2,500 live births and resultant congenital hemiparesis necessitates investigation into interventions which may improve long-term function and decreased burden of care beyond current therapies ( http://www.cdc.gov/ncbddd/cp/data.html ). Constraint-Induced Movement Therapy (CIMT) is recognized as an effective hemiparesis rehabilitation intervention. Transcranial direct current stimulation as an adjunct treatment to CIMT may potentiate neuroplastic responses and improve motor function. The methodology of a clinical trial in children designed as a placebo-controlled, serial -session, non-invasive brain stimulation trial incorporating CIMT is described here. The primary hypotheses are 1) that no serious adverse events will occur in children receiving non-invasive brain stimulation and 2) that children in the stimulation intervention group will show significant improvements in hand motor function compared to children in the placebo stimulation control group. METHODS/DESIGN: A randomized, controlled, double-blinded clinical trial. Twenty children and/or young adults (ages 8-21) with congenital hemiparesis, will be enrolled. The intervention group will receive ten 2-hour sessions of transcranial direct current stimulation combined with constraint-induced movement therapy and the control group will receive sham stimulation with CIMT. The primary outcome measure is safety assessment of transcranial direct current stimulation by physician evaluation, vital sign monitoring and symptom reports. Additionally, hand function will be evaluated using the Assisting Hand Assessment, grip strength and assessment of goals using the Canadian Occupational Performance Measure. Neuroimaging will confirm diagnoses, corticospinal tract integrity and cortical activation. Motor cortical excitability will also be examined using transcranial magnetic stimulation techniques. DISCUSSION: Combining non-invasive brain stimulation and CIMT interventions has the potential to improve motor function in children with congenital hemiparesis beyond each intervention independently. Such a combined intervention has the potential to benefit an individual throughout their lifetime. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02250092 Registered 18 September 2014.

A comparison of retesting rates using alternative testing algorithms in the pilot implementation of critical congenital heart disease screening in Minnesota.

Prior to state-wide implementation of newborn screening for critical congenital heart disease (CCHD) in Minnesota, a pilot program was completed using the protocol recommended by the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC). This report compares the retesting rates for newborn screening for CCHDs using the SACHDNC protocol and four alternative algorithms used in large published CCHD screening studies. Data from the original Minnesota study were reanalyzed using the passing values from these four alternative protocols. The retesting rate for the first pulse oximeter measurement ranged from 1.1 % in the SACHDNC protocol to 9.6 % in the Ewer protocol. The SACHDNC protocol generated the lowest rate of retesting among all tested algorithms. Our data suggest that even minor modifications of CCHD screening protocol would significantly impact screening retesting rate. In addition, we provide support for including lower extremity oxygen saturations in the screening algorithm.

Endovascular stent provides more effective early relief of SVC obstruction compared to balloon angioplasty.

OBJECTIVE: To determine whether superior vena cava (SVC) stent implantation is superior to balloon angioplasty for relieving SVC stenosis. BACKGROUND: SVC stent and balloon dilation have been used as treatment for SVC stenosis. Although safe and effective, outcome data comparing the two methods are limited. METHODS: A Pediatric Cardiac Care Consortium review identified SVC stenosis. Patients who required SVC intervention were divided into two subgroups-balloon dilation (Group A) and stent implantation (Group B). Logistic regression and the log-rank test were used to test the need for re-intervention within 6 months after the initial procedure. RESULTS: SVC intervention was performed on 210/637 patients with SVC stenosis (33%). There were 108/210 (51%) patients with balloon dilation (Group A) and 102/210 (49%) with stent implantation (Group B). Re-intervention within 6 months of the initial intervention was more common in Group A compared to Group B [Group A = 31/40 (77.5%); Group B = 5/22 (22.7%)]. The odds-ratio for re-intervention within 6 months of the initial procedure for balloon vs. stent, is 7.3 [95% CI: (2.91, 22.3), P < 0.0001]. In addition, during the first 6 months after an intervention for SVC stenosis the proportion of patients with stent implantation that remained free of re-intervention was significantly higher than after balloon angioplasty (log-rank test, P < 0.0001). Neither age nor weight was significantly associated with the need for re-intervention. CONCLUSIONS: SVC stent implantation is more effective than angioplasty in relief of SVC obstruction. Weight and age are not risk factors for early re-intervention.

Primed low-frequency repetitive transcranial magnetic stimulation and constraint-induced movement therapy in pediatric hemiparesis: a randomized controlled trial.

AIM: The aim of this study was to determine the feasibility and efficacy of five treatments of 6 Hz primed, low-frequency, repetitive transcranial magnetic stimulation (rTMS) combined with constraint-induced movement therapy (CIMT) to promote recovery of the paretic hand in children with congenital hemiparesis. METHOD: Nineteen children with congenital hemiparesis aged between 8 and 17 years (10 males, nine females; mean age 10 years 10 months, SD 2 years 10 months; Manual Ability Classification Scale levels I-III) underwent five sessions of either real rTMS (n=10) or sham rTMS (n=9) alternated daily with CIMT. CIMT consisted of 13 days of continuous long-arm casting with five skin-check sessions. Each child received a total of 10 hours of one-to-one therapy. The primary outcome measure was the Assisting Hand Assessment (AHA) and the secondary outcome variables were the Canadian Occupational Performance Measure (COPM) and stereognosis. A Wilcoxon signed-rank sum test was used to analyze differences between pre- and post-test scores within the groups. Analysis of covariance was used to compute mean differences between groups adjusting for baseline. Fisher's exact test was used to compare individual change in AHA raw scores with the smallest detectable difference (SDD) of 4 points. RESULTS: All participants receiving treatment finished the study. Improvement in AHA differed significantly between groups (p=0.007). No significant differences in the secondary outcome measures were found. Eight out of 10 participants in the rTMS/CIMT group showed improvement greater than the SDD, but only two out of nine in the sham rTMS/CIMT group showed such improvement (p=0.023). No serious adverse events occurred. INTERPRETATION: Primed, low-frequency rTMS combined with CIMT appears to be safe, feasible, and efficacious in pediatric hemiparesis. Larger clinical trials are now indicated.

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.

Surgical volume and center effects on early mortality after pediatric cardiac surgery: 25-year North American experience from a multi-institutional registry.

Mortality after pediatric cardiac surgery varies among centers. Previous research suggests that surgical volume is an important predictor of this variation. This report characterizes the relative contribution of patient factors, center surgical volume, and a volume-independent center effect on early postoperative mortality in a retrospective cohort study of North American centers in the Pediatric Cardiac Care Consortium (up to 500 cases/center/year). From 1982 to 2007, 49 centers reported 109,475 operations, 85,023 of which were analyzed using hierarchical multivariate logistic regression analysis. Patient characteristics varied significantly among the centers. The adjusted odds ratio (OR) for mortality decreased more than 10-fold during the study period (1982 vs. 2007: OR, 12.27, 95 % confidence interval [CI], 8.52-17.66; p < 0.0001). Surgical volume was associated inversely with odds of death (additional 100 cases/year: OR, 0.84; 95 % CI, 0.78-0.90; p < 0.0001). In the analysis of interactions, this effect was fairly consistent across age groups, risk categories (except the lowest), and time periods. However, a volume-independent center effect contributed substantially more to the risk model than did the volume. The Risk Adjusted Classification for Congenital Heart Surgery, version 1 (RACHS-1) risk category remains the strongest predictor of postoperative mortality through the 25-year study period. In conclusion, center-specific variation exists but is only partially explained by operative volume. Low-risk operations are safely performed at centers in all volume categories, whereas regionalization or other quality improvement strategies appear to be warranted for moderate- and high-risk operations. Potentially preventable mortality occurs at centers in all volume categories studied, so referral or regionalization strategies must target centers by observed outcomes rather than assume that volume predicts quality.

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.

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.

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.

Does caregiver burden mediate the effects of behavioral disturbances on nursing home admission?

OBJECTIVES: The primary objective of this study was to determine whether caregiving burden mediated the relationship between specific behavior disturbances and time to nursing home admission (NHA) for persons with dementia (i.e., Alzheimer disease or a related disorder). DESIGN: The study used secondary longitudinal data from the Medicare Alzheimer's Disease Demonstration, a Medicare-covered home care benefit and case management program for family caregivers of persons with dementia. Primary caregivers of persons with dementia were assessed via in-person and telephone interviews every 6 months over a 3-year period. SETTING: Dementia caregivers were recruited from eight catchment areas throughout the United States. PARTICIPANTS: The baseline sample included 5,831 dementia caregivers. Just more than 40% (43.9%; N = 2,556) of persons with dementia permanently entered a nursing home during the 3-year study period. MEASUREMENTS: Individual behavior problems were measured with the Memory and Behavior Problem Checklist. Caregiving burden was assessed with a short version of the Zarit Burden Inventory. Key covariates, including sociodemographic background, functional status, and service utilization, were also considered. RESULTS: Event history analyses revealed that time-varying measures of caregiver burden fully mediated the relationship between four behavioral disturbances (episodes of combativeness, property destruction, repetitive questions, and reliving the past) and NHA. CONCLUSIONS: The findings highlight the multifaceted, complex pathway to NHA for persons with dementia and their family caregivers. The results emphasize the need for comprehensive treatment approaches that incorporate the burden of caregivers and the behavioral/psychiatric symptoms of persons with dementia simultaneously.

The effects of incident and persistent behavioral problems on change in caregiver burden and nursing home admission of persons with dementia.

BACKGROUND: The individual contributions of behavior problems to key and related outcomes in dementia, such as nursing home admission (NHA) or caregiver burden, remain unclear. OBJECTIVES: This study sought to determine the ramifications of temporal change in individual behavior problems when accounting for increases in caregiver burden and time to NHA. Although burden is sometimes conceptualized as an antecedent to NHA, it has also emerged as a relevant outcome in dementia caregiving research. METHODS: A sample of 4545 dementia caregivers who participated in the Medicare Alzheimer disease Demonstration Evaluation was selected for this secondary analysis. Various patterns of change in individual behavior problems were considered as predictors of increases in caregiver burden and time to NHA over a 3-year period via mixed effects and Cox proportional hazards models, respectively. RESULTS: Caregivers who did not indicate a care recipient's dangerous behavior initially but did so subsequently (ie, an "incident" behavior problem) were more likely to experience increases in burden (P < 0.0026). Alternatively, the persistent occurrence of behavior disturbances (particularly memory problems) emerged as the strongest predictors of time to NHA. DISCUSSION: The findings of this study suggest the benefit of examining temporal patterns of individual behavioral disturbances, and that incident and persistent problems account for different dementia outcomes over time. Considering the temporal ramifications and potency of specific behavior problems can facilitate the targeted and timely delivery of effective clinical interventions.