External validation of the Vascular Study Group of New England carotid endarterectomy risk predictive model using an independent U.S. national surgical database.

OBJECTIVE: Previously, we described a Vascular Study Group of New England (VSGNE) risk predictive model to predict composite adverse outcomes (postoperative death, stroke, myocardial infarction, or discharge to extended care facilities) after carotid endarterectomy (CEA). The goal of this study was to externally validate this model using an independent database. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) CEA-targeted database (2010-2014) was used to externally validate the risk predictor model of adverse outcomes after CEA previously created using the VSGNE carotid database. Emergent cases and those in which CEA was combined with another operation were excluded. Cases in which a discharge destination cannot be determined were also excluded. To assess the predictive power of our VSGNE prediction score within this sample, a receiver operating characteristic curve was constructed. Risk scores for each NSQIP patient were also computed using beta weights from the VSGNE CEA model. To further assess the construct validity of our VSGNE prediction score, the observed proportion of adverse outcomes was examined at each level of our prediction scale and within five roughly equally sized risk groups formed on the basis of our VSGNE prediction scores. RESULTS: In this database, 10,889 cases met our inclusion criteria and were used in this analysis. The overall rate of adverse outcomes in this cohort was 8.5%. External validation of the VSGNE model on this sample showed moderately good predictive ability (area under the curve = 0.745). Patients in progressively higher risk groups, based on their VSGNE model scores, exhibited progressively higher rates of observed adverse outcomes, as predicted. CONCLUSIONS: The VSGNE CEA risk predictive model was externally validated on an NSQIP CEA-targeted sample and showed a fairly accurate global predictive ability for adverse outcomes after CEA. Although this model has a good population concordance, the lack of cut point indicates that individual risk prediction requires more evaluation. Further studies should be geared toward identification of variables that make this risk predictive model more robust.

Editor's Choice - Comparison of Outcomes After Open Surgical and Endovascular Lower Extremity Revascularisation Among End Stage Renal Disease Patients on Dialysis.

OBJECTIVES: End stage renal disease (ESRD) patients with peripheral arterial disease (PAD) are at high risk of complications following open surgical revascularisation (OSR). Endovascular revascularisation (ER) is an option, but its role is unclear. This study sought to characterise the outcomes of ER and OSR in ESRD patients treated for claudication or critical limb ischaemia (CLI). METHODS: The United States Renal Data System was used to investigate outcomes after lower extremity ER and OSR from 2005 to 2011. Primary outcomes were mortality, amputation, and peri-procedural myocardial infarction (MI). Kaplan-Meier (K-M) estimates were generated for mortality and amputation, logistic regression models for 30 day predictors, and proportional hazards models for long-term predictors. RESULTS: A total of 20,347 patients underwent OSR and ER (20.3% OSR, 79.7% ER). CLI was the indication in 80.8% of ER and 88.4% of OSR. The unadjusted major amputation rate at 30 days was higher after ER compared with OSR (8.8% vs. 6.4%, p < .001). Conversely, the unadjusted mortality rate at 30 days was lower after ER compared with OSR (8.0% vs. 10.5%, p < .001). Multivariable logistic regression models adjusting for medical covariables and CLI versus claudication status demonstrated increased 30 day mortality risk with OSR compared with ER (OR 2.00, 95% CI 1.43-1.79, p < .001), MI (OR 1.38, 1.23-1.54, p < .001), and the combined endpoint of mortality and major amputation (OR 1.57, 1.16-2.12, p = .004), but lower odds of 30 day major amputation alone (OR 0.67, 0.58-0.77, p < .001). Proportional hazards models demonstrated increased long-term mortality risk with OSR compared with ER (HR 1.05, 1.00-1.09, p = .037), without a difference in major amputation (HR 0.99, 0.93-1.05, p = NS). CONCLUSIONS: In this retrospective analysis of an administrative database, ESRD patients suffer from high mortality and amputation rates following lower extremity revascularisation. Compared with ER, OSR is associated with higher mortality. OSR has better 30 day limb salvage, although long-term outcomes are similar.

The associations of hemodialysis access type and access satisfaction with health-related quality of life.

OBJECTIVE: In addition to age and comorbidities, health-related quality of life (HRQOL) is known to predict mortality in hemodialysis (HD) patients. Understanding the association of vascular access type with HRQOL can help surgeons to provide patient-centered dialysis access recommendations. We sought to understand the impact of HD access type on HRQOL. METHODS: We conducted a cross-sectional prospective study of community-dwelling prevalent HD patients in Pittsburgh, Pennsylvania. We assessed patient satisfaction with their access using the Vascular Access Questionnaire (VAQ) and HRQOL with the Short Form Health Survey. We compared access satisfaction and HRQOL across access types. We used logistic regression modeling to evaluate the association of access type with satisfaction and multivariate analysis of variance to evaluate the association of both of these variables on HRQOL. RESULTS: We surveyed 77 patients. The mean age was 61.8 ± 15.9 years. Arteriovenous fistula (AVF) was used by 62.3%, tunneled dialysis catheter (TDC) by 23.4%, and arteriovenous graft (AVG) by 14.3%. There was a significant difference in satisfaction by access type with lowest median VAQ score (indicating highest satisfaction) in patients with AVF followed by TDC and AVG (4.5 vs 6.5 vs 7.0; P = .013). Defining a VAQ score of <7 to denote satisfaction, AVF patients were more likely to be satisfied with their access, compared with TDC or AVG (77% vs 56% vs 55%; P = NS). Multivariate regression analysis yielded a model that predicted 46% of the variance of VAQ score; important predictors of dissatisfaction included <1 year on dialysis (ß = 3.36; P < .001), increasing number of access-related hospital admissions in the last year (ß = 1.69; P < .001), and AVG (ß = 1.72; P = .04) or TDC (ß = 1.67; P = .02) access. Mean physical and mental QOL scores (the composite scores of Short Form Health Survey) were not different by access type (P = .49; P = .41). In an additive multivariate analysis of variance with the two composite QOL scores as dependent variables, 25.8% of the generalized variance in HRQOL (effect size) was accounted for by access satisfaction with only an additional 3% accounted for by access type. CONCLUSIONS: HD patients experience greatest satisfaction with fistula, and access satisfaction is significantly associated with better HRQOL. Controlling for access satisfaction, there is no significant independent association of access type on HRQOL. Future research should investigate the relationship between access satisfaction, adherence to dialysis regimens, mortality, and the consequent implications for patient-centered care.

Risk stratification for the development of respiratory adverse events following vascular surgery using the Society of Vascular Surgery's Vascular Quality Initiative.

OBJECTIVE: Postoperative respiratory adverse events (RAEs) are associated with high rates of morbidity and mortality in general surgery, however, little is known about these complications in the vascular surgery population, a frail subset with multiple comorbidities. The objective of this study was to describe the contemporary incidence of RAEs in vascular surgery patients, the risk factors for this complication, and the overall impact of RAEs on patient outcomes. METHODS: The Vascular Quality Initiative was queried (2003-2014) for patients who underwent endovascular abdominal aortic repair, open abdominal aortic aneurysm repair, thoracic endovascular aortic repair, suprainguinal bypass, or infrainguinal bypass. A mixed-effects logistic regression model determined the independent risk factors for RAEs. Using a random 85% of the cohort, a risk prediction score for RAEs was created, and the score was validated using the remaining 15% of the cohort, comparing the predicted to the actual incidence of RAE and determining the area under the receiver operating characteristic curve. The independent risk of in-hospital mortality and discharge to a nursing facility associated with RAEs was determined using a mixed-effects logistic regression to control for baseline patient characteristics, operative variables, and other postoperative adverse events. RESULTS: The cohort consisted of 52,562 patients, with a 5.4% incidence of RAEs. The highest rates of RAEs were seen in current smokers (6.1%), recent acute myocardial infarction (10.1%), symptomatic congestive heart failure (9.9%), chronic obstructive pulmonary disease requiring oxygen therapy (11.0%), urgent and emergent procedures (6.4% and 25.9%, respectively), open abdominal aortic aneurysm repairs (17.6%), in situ suprainguinal bypasses (9.68%), and thoracic endovascular aortic repairs (9.6%). The variables included in the risk prediction score were age, body mass index, smoking status, congestive heart failure severity, chronic obstructive pulmonary disease severity, degree of renal insufficiency, ambulatory status, transfer status, urgency, and operative type. The predicted compared with the actual RAE incidence were highly correlated, with a correlation coefficient of 0.943 (P < .0001) and a c-statistic = 0.818. RAEs had a significantly higher rates of in-hospital mortality (25.4% vs 1.2%; P < .0001; adjusted odds ratio, 5.85; P < .0001), and discharge to a nursing facility (57.8% vs 19.0%; P < .0001; adjusted odds ratio, 3.14; P < .0001). CONCLUSIONS: RAEs are frequent and one of the strongest risk factors for in-hospital mortality and inability to be discharged home. Our risk prediction score accurately stratifies patients based on key demographics, comorbidities, presentation, and operative type that can be used to guide patient counseling, preoperative optimization, and postoperative management. Furthermore, it may be useful in developing quality benchmarks for RAE following major vascular surgery.

Contemporary outcomes of intact and ruptured visceral artery aneurysms.

OBJECTIVE: The treatment outcomes of ruptured visceral artery aneurysms (rVAAs) have been sparsely characterized, with no clear comparison between different treatment modalities. The purpose of this paper was to review the perioperative and long-term outcomes of open and endovascular interventions for intact visceral artery aneurysms (iVAAs) and rVAAs. METHODS: This was a retrospective review of all treated VAAs at one institution from 2003 to 2013. Patient demographics, aneurysm characteristics, management, and subsequent outcomes (technical success, mortality, reintervention) and complications were recorded. RESULTS: The study identified 261 patients; 181 patients were repaired (77 ruptured, 104 intact). Pseudoaneurysms were more common in rVAAs (81.8% vs 35.3% for iVAAs; P < .001). The rVAAs were smaller than the iVAAs (20.7 mm vs 27.5 mm; P = .018), and their most common presentation was abdominal pain; 29.7% were hemodynamically unstable. Endovascular intervention was the initial treatment modality for 67.4% (75.3% for rVAAs, 61.5% for iVAAs). The perioperative complication rate was higher for rVAAs (13.7% vs 1% for iVAAs; P = .003), as was mortality at 30 days (13% vs 0% for iVAAs; P = .001), 1 year (32.5% for rVAAs vs 4.1% for iVAAs; P < .001), and 3 years (36.4% for rVAAs vs 8.3% for iVAAs; P < .001). Lower 30-day mortality was noted with endovascular repair for rVAAs (7.4% vs 28.6% open; P = .025). Predictors of mortality for rVAAs included age (odds ratio, 1.04; P = .002), whereas endovascular repair was protective (odds ratio, 0.43; P = .037). Mean follow-up was 26.2 months, and Kaplan-Meier estimates of survival were higher for iVAAs at 3 years (88% vs 62% for rVAAs; P = .045). The 30-day reintervention rate was higher for rVAAs (7.7% vs 19.5% for iVAAs; P = .019) but was similar between open and endovascular repair (8.2% vs 15%; P = NS). CONCLUSIONS: rVAAs have significant mortality. Open and endovascular interventions are equally durable for elective repair of VAAs, but endovascular interventions for rVAAs result in lower morbidity and mortality. Aggressive treatment of pseudoaneurysms is electively recommended at diagnosis regardless of size.

Arteriovenous grafts are associated with earlier catheter removal and fewer catheter days in the United States Renal Data System population.

OBJECTIVE: Arteriovenous fistulas (AVFs) are associated with improved long-term outcomes but longer maturation times and higher primary failure rates compared with arteriovenous grafts (AVGs). The Fistula First Breakthrough Initiative has recently emphasized tunneled dialysis catheter (TDC) avoidance. We sought to characterize the relationship of AVFs and AVGs to the use of TDCs as well as secondary procedures. METHODS: Using the United States Renal Data System (USRDS) database, we identified incident hemodialysis (HD) patients in 2005 that started HD with a TDC and survived at least 1 year. We then monitored them through 2008. Access creation, TDC removal, TDC placement, and secondary procedures were identified by Current Procedural Terminology codes (American Medical Association, Chicago, Ill). Multivariate logistic regression was used to identify risk factors for the primary end points. RESULTS: In 2005, HD was initiated in 56,495 patients, 74% with a TDC. Of these, 6286 had an access procedure ≤3 months and 1 year of follow-up (AVF, 4634; AVG, 1652). Mean age was 67.7 years (AVF, 67.3; AVG, 68.7 years; P < .001), 53.3% were men (AVF, 58.1%; AVG, 40.5%; P < .001), and 33.8% were obese (AVF, 33.6%; AVG, 34.4%; P = not significant). AVG placement was associated with a higher TDC removal at 1 (7.9% vs 3.1%; P < .001), 3 (47.8% vs 17.8%; P < .001), and 6 (60.6% vs 47.2%; P < .001) months. There was no difference at 9 months (AVG, 64.9% vs AVF, 62.3%; P = .06). The median time to TDC removal was lower in the AVG group (70 days vs 155 days; P < .001). Multivariable model found AVFs were associated with decreased odds of TDC removal at 3 (odds ratio, 0.22; P < .001) and 6 months (odds ratio, 0.54; P < .001). AVGs required more secondary procedures than AVFs at all time points up to 1 year and specifically had increased thrombectomy procedures (39.8% vs 11.5%; P < .001). CONCLUSIONS: In patients starting dialysis with a TDC, AVGs are associated with increased TDC removal and fewer catheter days compared with AVFs at up to 6 months. However, AVGs require more secondary procedures at all time points up to 1 year.

Long-term clinical outcomes and cardiovascular events after carotid endarterectomy.

BACKGROUND: Long-term atherosclerotic adverse events are anticipated in patients undergoing carotid endarterectomy (CEA); however, their incidence and risk predictors remain unknown. METHODS: A consecutive cohort of CEAs between 1/1/2000-12/31/2007 was analyzed. End points were any stroke, coronary event (myocardial infarction, coronary bypass, or stenting), vascular interventions for critical limb ischemia, aortic aneurysm or carotid disease, and death. Survival analysis and Cox regression models were used to identify clinical predictors. RESULTS: A total of 1,136 CEAs (bilateral, 89; mean age, 71.2 ± 9.2 years; 56.5% male; 36.3% symptomatic, and 3.9% combined with coronary bypass) were performed during the study period with a mean clinical follow-up of 60 months (0-155 months). The postoperative combined stroke and/or death rate was 2.7% and 1.9% for asymptomatic and 4.1% for symptomatic patients. Five and 10-year risks of the end points were 7.2% and 16.1% for stroke, 18.4% and 31.5% for coronary interventions, 20.6% and 28.5% for major vascular interventions, and 25.8% and 50.1% for death. Statins conferred a significant protective effect for stroke (hazard ratio [HR], 0.53; P = 0.016) and death (HR, 0.66; P < 0.0001). Baseline vascular disease predicted future vascular interventions: aortic aneurysm (HR, 1.90; P = 0.003), peripheral arterial disease (HR, 2.03; P < 0.0001), and contralateral internal carotid artery (ICA) stenosis ≥50% (HR, 4.61; P < 0.0001). Renal insufficiency predicted worse outcomes for all other end points (HR, 2.21; P = 0.023 for stroke; HR, 1.62; P = 0.008 for coronary events; HR, 2.38; P < 0.0001 for death). CONCLUSIONS: Patients undergoing CEA continue to derive long-term low stroke rate benefit but still sustain major coronary events and require vascular interventions, indicating a need for more intensive medical treatment and rigorous follow-up.

Maintaining a social-emotional intervention and its benefits for institutionalized children.

This article reports the maintenance of one of the largest interventions conducted in St. Petersburg (Russian Federation) orphanages for children birth to 4 years using regular caregiving staff. One orphanage received training plus structural changes, another training only, and a third business as usual. The intervention produced substantial differences between these institutions on the Home Observation for Measurement of the Environment (HOME) Inventory and on the Battelle Developmental Inventory scores for children. These institutional differences in HOME scores (N = 298) and Battelle scores for children (N = 357) departing the institutions for families in St. Petersburg and the United States were maintained for at least 6 years after the intervention project. This result may be associated with certain features of the intervention and activities conducted during the follow-up interval.

The role of transitions to new age groups in the development of institutionalized children.

Children in two institutions in St. Petersburg (Russian Federation) experienced ward transitions, one in which caregivers were trained to provide sensitive, responsive caregiving and one that conducted business as usual. A third institution eliminated transitions, received the same training, and implemented a variety of structural and employment changes designed to promote improved caregiver-child interactions and relationships. While the no-transition comprehensive intervention group of children steadily improved in Battelle Developmental Inventory (LINC Associates, 1988) scores across all age intervals, the children in the institution who encouraged some positive caregiver-child interactions improved before and after, but not during, an age period that involved a transition. In contrast, the no-treatment group displayed no developmental changes across any age period with or without a transition. These results suggest that the common institutional practice of ward transitions to new peers and caregivers is potentially disruptive to infants' and toddlers' general development, but primarily in a context in which some degree of caregiver-child sensitive and responsive interactions are encouraged.

The anchor point algorithm: A morphometric analysis of anatomic landmarks to guide placement of temporary aortic Rescue stent grafts for noncompressible torso hemorrhage.

BACKGROUND: Noncompressible hemorrhage remains a high-mortality injury, which requires rapid damage control within minutes to avoid exsanguination. Retrievable stent grafts offer perfusion preserving hemorrhage damage control, and yet algorithms for device selection and positioning are lacking for an anatomically diverse human population. We hypothesized that easily acquired external measurements could be used to rapidly triage patients to receive one of several presized stents and that these metrics may further predict a single target on the aorta by which to optimize both mesenteric perfusion and aortic hemorrhage control. METHODS: Metrics were acquired from computed tomography imaging of 203 male and female patients aged 18 to 50 years. Algorithms for metric based triage and stent sizing were examined against the cohort for effectiveness. Linear regression was used to predict a single target on the aorta for alignment of a multitiered stent. Next, the relationship of the anchor point to the palpable xiphoid was determined. RESULTS: Clavicle to pubis measurements correlated with aortic length and was used to triage patients to one of three stent grafts. Stents for each triage group were sized to achieve >75% coverage of aortic Zones 1 and 3 in most patients while preserving carotid and visceral perfusion. A metric/sex-based equation that predicts the location of the superior mesenteric artery relative to the palpable xiphoid was derived. By alignment of a single point on the stent with this target, known as the anchor point, the remainder of the stent can be rapidly deployed while minimizing coverage of critical branches. When applied back to the cohort, only 10.4% had potential serious branch coverage events predicted. CONCLUSION: Simple anatomic metrics offer rapid triage in this study population to one of three presized stent grafts and predict the location of key vascular branches. Confirmatory human trials will be essential to demonstrate safety and effectiveness of this approach. LEVEL OF EVIDENCE: Prognostic/Epidemiological; Level IV.

Characteristics of environments, caregivers, and children in three Central American orphanages.

This study provides descriptive empirical information on the environments, organizational structure, caregivers, caregiver-child interactions, and children's general behavioral development and problem behaviors from three institutions for young children in Central America. While the institutions were clean, they were physically sparse and had Infant-Toddler Environmental Rating Scale (ITERS; T. Harms, D. Cryer, & R. Clifford, 2006) and Early Childhood Environmental Rating Scale (ECERS; T. Harms, R. Clifford, & D. Cryer, 2005) scores that averaged 1.62 (7 = highest). Caregivers provided routine caregiving with limited emotion, responsiveness, support, empathy, or guidance. Caregivers tended to work long hours and then were off 2 to 3 days, and children periodically graduated to new wards, so there was little stability of caregivers in children's lives. Children's average Battelle Developmental Inventory Total Developmental Quotient = 58 to 63, which would be considered mildly-moderately retarded in noninstitutional U.S. populations; no child scored >90, 80% scored <70, and nearly half scored <60. Children displayed high frequencies of indiscriminate friendliness, noncompliance, and provocative and aggressive/violent behaviors. These data and that of a few other studies represent the only comprehensive, empirical description of institutions for young children, which constitutes the independent variable (institutionalization) for a burgeoning literature on postinstitutional adopted children. Results are consistent with the hypothesis that a lack of warm, sensitive, contingently responsive interactions with relatively few consistently available caregivers may be a major contributor to delayed contemporary development and persistent deficits and problems observed in some postinstitutional adopted children and adolescents.

A Caregiver-Child Social/Emotional and Relationship Rating Scale (CCSERRS).

This paper reports the construction and pilot reliability, validity, and psychometric properties of a new caregiver-child rating scale that emphasizes caregiver-child social-emotional interactions and relationships. While the scale was developed and studied in the context of orphanages for young children, it potentially could be used in non-residential early care and education settings as well as for parent-child interactions in the home. The intent was to assess a few dimensions that comprehensively cover the range of caregiver-child social-emotional interactions and relationships but could be administered in a relatively short period of time in a variety of situations and would not require extensive coder training, manuals, or materials. Results showed that the scale can be reliably administered even using observation periods as short as five minutes, reliability was replicated over seven different coders working in three different orphanages, and ratings of caregivers were similar across different types of caregiving activities (i.e., feeding, dressing/bathing, free play) and for caregivers attending to children birth to 4 and 4 to 8 yrs. of age. In the orphanage context, factor analyses showed the scale primarily reflects caregiver-child mutual engagement and relationship with subordinate components of caregiver punitiveness and caregiver- vs. child-directed behaviors and intrusiveness.

A socioemotional intervention in a Latin American orphanage.

A pilot intervention that emphasized training and technical assistance to promote warm, sensitive, and responsive one-on-one caregiver-child interactions primarily during feeding and bathing/changing was implemented using regular staff in a depressed orphanage for children birth to approximately 8 years of age in Latin America. Despite a variety of unanticipated irregularities in the implementation of the intervention, many beyond the researchers' control, ward environments improved; caregivers displayed more warm, sensitive, and responsive interactions with children; and children improved an average of 13.5 developmental quotient (DQ) points after 4+ months' exposure to the completed intervention. Furthermore, 82% of the children had DQs greater than 70 before the intervention, but only 27.8% did so afterward. Although the training for all caregivers was aimed at children birth to 3 years, the number of different caregivers was reduced, and technical assistance was provided only to caregivers serving children less than 3 years, younger and older children (3-8 years) improved approximately the same amount. However, children who were transitioned from a younger to an older ward during the intervention improved less than did children who remained in either a younger or an older ward, the first evidence suggesting that the common orphanage practice of periodically graduating children from one homogeneous age group to another may impede their development. The study is consistent with others that have shown that orphanages can be changed, and increases primarily in warm, sensitive, responsive caregiver-child interactions can produce improvements in children's development.

Hemodialysis access cost comparisons among incident tunneled catheter patients.

BACKGROUND: Arteriovenous fistula is the ideal hemodialysis access, but most patients start with tunneled dialysis catheter. Arteriovenous fistula and arteriovenous graft surgery may reduce tunneled dialysis catheter use and also increase procedural expenses. We compared Medicare costs associated with arteriovenous fistula, arteriovenous graft, and tunneled dialysis catheter. METHODS: Using the US Renal Data System, we identified incident hemodialysis patients in 2008 who started with tunneled dialysis catheter, survived at least 90 days, and had adequate Medicare records for analysis. We followed them until death or end of 2011; access modality was based on billing evidence of arteriovenous fistula or arteriovenous graft creation. We assumed patients without such records remained with tunneled dialysis catheter. We generated multivariate linear regression models predicting Medicare expenditures, censoring costs when patients died; we included all payments to physicians and institutions. We also created algorithms to identify access-related costs. RESULTS: There were 113,505 patients in the US Renal Data System who started hemodialysis in 2008, of whom 51,002 Medicare patients met inclusion criteria. Of that group, 41,532 (81%) began with tunneled dialysis catheter; 27,064 patients were in the final analysis file. In the first 90 days after hemodialysis initiation, 6100 (22.5%) received arteriovenous fistula, 1813 (6.7%) arteriovenous graft, and 19,151 (70.8%) stayed with tunneled dialysis catheter. Annualized access costs by modality were tunneled dialysis catheter US$13,625 (95% confidence interval: US$13,426-US$13,285); arteriovenous fistula US$16,864 (95% confidence interval: US$16,533-US$17,194); and arteriovenous graft US$20,961 (95% confidence interval: US$20,967-US$21,654; p < .001). Multivariate linear regression demonstrated that staying with tunneled dialysis catheter had lowest access-related costs, arteriovenous fistula was intermediate, and those who underwent arteriovenous graft surgery were highest (p < .021). Access type was not significantly associated with total costs. Additional arteriovenous fistula and arteriovenous graft creation (US$3525 and US$3804 per access per year, respectively) and open and endovascular access-related interventions (US$3102 and US$3569 per procedure per year, respectively; all p < .001) were important predictors of increased cost. CONCLUSIONS: Among patients starting hemodialysis with tunneled dialysis catheter, continued tunneled dialysis catheter use is associated with lowest access-related cost. Both endovascular and open interventions are associated with significant additional costs. Further investigation is warranted to develop efficient patient-centered strategies for hemodialysis access.

Design and rationale of a randomized trial comparing standard versus ultrasound-assisted thrombolysis for submassive pulmonary embolism.

BACKGROUND: Catheter-directed interventions for the treatment of patients with submassive pulmonary embolism (sPE) have shown promise in rapidly improving right-sided heart strain and preventing decompensation to massive pulmonary embolism. Among various catheter interventions, ultrasound-assisted thrombolysis (USAT) has attracted interest as potentially having more efficient lytic effect that could achieve thrombolysis faster and with a reduced lytic dose. However, based on clinical evidence, it is unclear whether USAT is superior to standard catheter-directed thrombolysis (SCDT). We herein describe the study design of the Standard vs UltrasouNd-assiSted CathEter Thrombolysis for Submassive Pulmonary Embolism (SUNSET sPE) trial, an ongoing randomized clinical trial designed to address this question. METHODS: Adults with sPE presenting or referred to our institution are considered for enrollment in the trial. At the discretion of the treatment team, all patients undergo a catheter-directed intervention plus concomitant therapeutic anticoagulation. Participants are randomized 1:1 to a USAT catheter or an SCDT catheter. Study assessors are blinded to treatment group. The primary outcome is clearance of pulmonary thrombus burden, assessed by postprocedure computed tomography angiography. Secondary outcomes include resolution of right ventricular strain by echocardiography; improvement in pulmonary artery pressures; and 3- and 12-month improvement in echocardiographic, functional capacity, and quality of life measures. The study is powered to detect a 50% improvement in pulmonary artery thrombus clearance. Our enrollment target is 40 patients per treatment arm. CONCLUSIONS: SUNSET sPE is an ongoing randomized, head-to-head, single-blinded clinical trial with the goal of assessing whether USAT results in superior thrombus clearance compared with SCDT in patients with sPE. We expect the results of our study to inform future guidelines on choice of thrombolysis modality in this population of challenging patients.

A meta-analysis of outcomes of catheter-directed thrombolysis for high- and intermediate-risk pulmonary embolism.

OBJECTIVE: During the past few years, there has been a surge in the use of catheter-directed thrombolysis (CDT) for acute pulmonary embolism (PE), in the form of either standard CDT or ultrasound-assisted CDT (usCDT). This is a systematic review and meta-analysis of all published series on contemporary CDT for acute PE seeking to determine their clinical efficacy, stratifying by PE severity and CDT modality. METHODS: A comprehensive MEDLINE and Embase search was performed to identify studies that reported outcomes of CDT for acute PE published from 2009 to July 2017. Outcomes included clinical success (in-hospital survival with stabilization of hemodynamics, without decompensation or any major complication), in-hospital mortality, major bleeding, right ventricular/left ventricular ratio, and Miller score changes after CDT. Meta-analyses assumed random effects. RESULTS: Twenty studies with 1168 patients were included in the meta-analysis. Available for subgroup analysis were 210 patients with high-risk PE and 945 patients with intermediate-risk PE; 181 patients received CDT using a standard multiside hole catheter, and 850 received usCDT. The pooled average right ventricular/left ventricular improvement and Miller score drop after CDT were 0.30 (95% confidence interval [CI], 0.22-0.39) and 8.8 (95% CI, 7.1-10.5). For high-risk PE, the pooled estimate for clinical success was 81.3% (95% CI, 72.5%-89.1%), the 30-day mortality estimate was 8.0% (95% CI, 3.2%-14.0%), and major bleeding was 6.7% (95% CI, 1.0%-15.3%). For intermediate-risk PE, the pooled estimate for clinical success was 97.5% (95% CI, 95.3%-99.1%), the 30-day mortality was 0% (95% CI, 0%-0.5%), and major bleeding was 1.4% (95% CI, 0.3%-2.8%). In high-risk PE, clinical success for CDT and usCDT was 70.8% (95% CI, 53.4%-85.8%) and 83.1% (95% CI, 68.5%-94.5%), respectively. In intermediate-risk PE, clinical success for CDT and usCDT was 95.0% (95% CI, 88.5%-99.2%) and 97.5% (95% CI, 95.0%-99.4%), respectively. CONCLUSIONS: Catheter thrombolysis has high clinical success rates in both high- and intermediate-risk PE, but higher mortality and bleeding rates should be anticipated in high-risk PE. Ultrasound-assisted thrombolysis may be more effective than standard CDT in the higher risk population.

Evaluation of an intervention for hospitalized African American smokers.

OBJECTIVE: To evaluate the effectiveness of a smoking cessation intervention based on the transtheoretical model of change with a sample of low-income African American smokers admitted to an indigent-care hospital. METHODS: The intervention incorporated components shown to be effective in increasing cessation in other populations, tailored to a bedside counseling format with follow-up contact postdischarge. RESULTS: Intervention patients were significantly more likely to advance in stage than were control patients. CONCLUSION: A hospital-offered bedside intervention offers promise in reaching underserved smokers with effective, though limited, cessation assistance.

The relationship of perceived self-efficacy to quality of life in chronic obstructive pulmonary disease.

From a biomedical perspective, variations in the quality of life of chronic obstructive pulmonary disease (COPD) patients may be attributed to changes in pulmonary function; thus, an increase in lung function should be correlated with an increased score on a health-related quality-of-life measure. However, inconsistent results regarding correlations between various measures of pulmonary function and quality of life have been reported in the literature. The authors evaluated a social cognitive model of quality of life among persons with COPD by analyzing relationships among biomedical measures, self-efficacy measures, and quality-of-life measures in a recursive path model. Path analysis results indicated that the association of pulmonary function and symptoms with quality of life was mediated by perceived self-efficacy for functional activities.

Breast-feeding and contraception in Peru.

This retrospective study examined duration of breast-feeding and concurrent contraceptive use among 5,648 Peruvian women. Data were gathered during 1986-1992 as part of the Demographic and Health Survey (DHS). The women gave birth to 7,951 infants, 95% of whom were breastfed; 44% of the mothers used contraception while breastfeeding. Consistent with the literature, mothers using oral contraception breastfed for significantly less time than those using other methods. Unexpectedly, mothers using periodic abstinence or withdrawal breastfed longer (15.5 and 15.3 months) than those using other methods or non-contraceptors. Among mothers changing contraceptive methods while breastfeeding the same child, those changing to abstinence and withdrawal breastfed longest (18 months). The relationship of duration of breast-feeding with contraceptive use remained after controlling for other predictors of duration of breast-feeding. Additional data are needed to explain this phenomenon in Peru and perhaps elsewhere.

Transtheoretical model of change among hospitalized African American smokers.

OBJECTIVE: To examine predicted relationships among transtheoretical model of change measures in a sample of 211 low-income, African American hospitalized smokers. METHODS: We used discriminant analysis to examine differences in decisional balance and self-efficacy across stages of change for quitting. RESULTS: Differences in decisional balance and self-efficacy were concurrent with stage differences. The function discriminated among all 3 stages with the clearest differences between precontemplation and preparation. CONCLUSION: Although results with this specialized sample are not generalizable, they add to the evidence that transtheoretical model of change variables are robust across populations.