Allied health and nursing practices in pediatric solid organ transplantation: An international survey.

INTRODUCTION: With improved survival in pediatric solid organ transplantation (SOT) care has focused on optimizing functional, developmental, and psychosocial outcomes, roles often supported by Allied Health and Nursing professionals (AHNP). However, there is a scarcity of research examining frameworks of clinical practice. METHODS: The International Pediatric Transplant Association AHNP Committee developed and disseminated an online survey to transplant centers as a quality improvement project to explore AHNP practice issues. Participant responses were characterized using descriptive statistics, and free-text comments were thematically analyzed. Responses were compared across professional groups; Group 1: Advanced Practice Providers, Group 2: Nursing, Group 3: Allied Health. RESULTS: The survey was completed by 119 AHNP from across the globe, with responses predominantly (78%) from North America. Half of respondents had been working in pediatric transplant for 11+ years. Two-thirds of respondents were formally funded to provide transplant care; however, of these not funded, over half (57%) were allied health, compared to just 6% of advance practice providers. Advanced practice/nursing groups typically provided care to one organ program, with allied health providing care for multiple organ programs. Resource constraints were barriers to practice across all groups and countries. CONCLUSION: In this preliminary survey exploring AHNP roles, professionals provided a range of specialized clinical care. Challenges to practice were funding and breadth of care, highlighting the need for additional resources, alongside the development of clinical practice guidelines for defining, and supporting the role of AHNP within pediatric SOT. Professional organizations, such as IPTA, can offer professional advocacy.

An international survey of allied health & nursing professionals during the COVID-19 pandemic: Perspectives on facilitators of & barriers to care.

BACKGROUND: Allied health and nursing professionals (AHNP) are integral members of transplant teams. During the COVID-19 pandemic, they were required to adapt to changes in their clinical practices. The goal of the present study was to describe AHNP perceptions concerning the impact of the pandemic on their roles, practice, and resource allocation. METHODS: An online survey was distributed globally via email by the International Pediatric Transplant Association to AHNP at transplant centers from September to December 2020. Responses to open-ended questions were collected using an electronic database. Using a thematic analysis approach, coding was conducted by three independent coders who identified patterns in responses, and discrepancies were resolved through discussion. RESULTS: The majority of respondents (n = 119) were from North America (78%), with many other countries represented (e.g., the United Kingdom, Europe, Australia, New Zealand, South Africa, and Central and South America). Four main categories of impacts were identified: (1) workflow changes, (2) the quality of the work environment, (3) patient care, and (4) resources. CONCLUSIONS: Participants indicated that the pandemic heightened existing barriers and resource challenges frequently experienced by AHNP; however, the value of team connections and opportunities afforded by technology were also highlighted. Virtual care was seen as increasing healthcare access but concerns about the quality and consistency of care were also expressed. A notable gap in participant responses was identified; the vast majority did not identify any personal challenges connected with the pandemic (e.g., caring for children while working remotely, personal stress) which likely further impacted their experiences.

Residual cancer burden after neoadjuvant chemotherapy and long-term survival outcomes in breast cancer: a multicentre pooled analysis of 5161 patients.

BACKGROUND: Previous studies have independently validated the prognostic relevance of residual cancer burden (RCB) after neoadjuvant chemotherapy. We used results from several independent cohorts in a pooled patient-level analysis to evaluate the relationship of RCB with long-term prognosis across different phenotypic subtypes of breast cancer, to assess generalisability in a broad range of practice settings. METHODS: In this pooled analysis, 12 institutes and trials in Europe and the USA were identified by personal communications with site investigators. We obtained participant-level RCB results, and data on clinical and pathological stage, tumour subtype and grade, and treatment and follow-up in November, 2019, from patients (aged ≥18 years) with primary stage I-III breast cancer treated with neoadjuvant chemotherapy followed by surgery. We assessed the association between the continuous RCB score and the primary study outcome, event-free survival, using mixed-effects Cox models with the incorporation of random RCB and cohort effects to account for between-study heterogeneity, and stratification to account for differences in baseline hazard across cancer subtypes defined by hormone receptor status and HER2 status. The association was further evaluated within each breast cancer subtype in multivariable analyses incorporating random RCB and cohort effects and adjustments for age and pretreatment clinical T category, nodal status, and tumour grade. Kaplan-Meier estimates of event-free survival at 3, 5, and 10 years were computed for each RCB class within each subtype. FINDINGS: We analysed participant-level data from 5161 patients treated with neoadjuvant chemotherapy between Sept 12, 1994, and Feb 11, 2019. Median age was 49 years (IQR 20-80). 1164 event-free survival events occurred during follow-up (median follow-up 56 months [IQR 0-186]). RCB score was prognostic within each breast cancer subtype, with higher RCB score significantly associated with worse event-free survival. The univariable hazard ratio (HR) associated with one unit increase in RCB ranged from 1·55 (95% CI 1·41-1·71) for hormone receptor-positive, HER2-negative patients to 2·16 (1·79-2·61) for the hormone receptor-negative, HER2-positive group (with or without HER2-targeted therapy; p<0·0001 for all subtypes). RCB score remained prognostic for event-free survival in multivariable models adjusted for age, grade, T category, and nodal status at baseline: the adjusted HR ranged from 1·52 (1·36-1·69) in the hormone receptor-positive, HER2-negative group to 2·09 (1·73-2·53) in the hormone receptor-negative, HER2-positive group (p<0·0001 for all subtypes). INTERPRETATION: RCB score and class were independently prognostic in all subtypes of breast cancer, and generalisable to multiple practice settings. Although variability in hormone receptor subtype definitions and treatment across patients are likely to affect prognostic performance, the association we observed between RCB and a patient's residual risk suggests that prospective evaluation of RCB could be considered to become part of standard pathology reporting after neoadjuvant therapy. FUNDING: National Cancer Institute at the US National Institutes of Health.

Factors affecting the number of sentinel lymph nodes removed in patients having surgery for breast cancer.

PURPOSE: The goal of sentinel lymph node biopsy is to establish the presence or absence of cancer cells in regional axillary nodes. The number of sentinel nodes harvested from each patient varies. The aim of this study was to determine what factors influence the number of sentinel nodes excised at sentinel node biopsy. METHODS: Data from 426 patients with breast cancer who underwent sentinel lymph node biopsy at the Edinburgh Breast Unit by 10 different experienced breast surgeons were included in this analysis. Univariate and multivariable statistical analysis was performed. RESULTS: In the multivariate analysis the number of sentinel nodes biopsied varied significantly between operating surgeon (p < 0.0001) and was also statistically associated with the use of neoadjuvant chemotherapy (p < 0.0001) and with the number of involved lymph nodes (p < 0.0001). More nodes were removed in patients who received neoadjuvant chemotherapy and had metastases in sentinel lymph nodes. CONCLUSIONS: This study shows that the surgeon plays a pivotal and significant role in determining the numbers of sentinel nodes removed by sentinel lymph node biopsy. Surgeons should monitor their own data on the average numbers of sentinel nodes they remove. Some surgeons may not be removing sufficient numbers of sentinel nodes to maintain a low false negative rate for this procedure.

Occult disease in reduction mammoplasties and prophylactic mastectomies.

The aim of this study was to determine the incidence of occult breast carcinoma and significant breast disease in clinically and radiologically unremarkable breast reduction specimens and prophylactic mastectomies. A retrospective search using specimen type codes was performed in the computerized histopathology archive from April 2007 to April 2016. The pathology results of 505 patients were analyzed (782 specimens). A total of 267 patients underwent simple reduction mammoplasties (10 unilateral), 20 had bilateral prophylactic mastectomies and 218 undertook contralateral symmetrizing or prophylactic mastectomy surgery following a history of breast cancer. Overall, normal (unremarkable) breast tissue was found in 42.6% of patients (n = 215), benign tissue (nonproliferative/proliferative disease without atypia) in 51.1% (n = 258), significant disease (LCIS/proliferative disease with atypia) in 5.5% (n = 28), and malignant disease (invasive/ductal carcinoma in situ) in 0.8% (n = 4). The incidence of significant breast pathology was statistically higher (P value < .0001) in prophylactic mastectomies (12.4%) compared to reduction mammoplasties (2.3%). There was however no significant increase in the incidence of malignancy between prophylactic mastectomies (1.2%) and reduction mammoplasties (0.6%). Even though the clear majority of resected tissue in reduction mammoplasties and prophylactic mastectomies is benign, our findings support the continued need for histological examination of these specimens for occult carcinoma and precursor lesions.

Analysis of the Learning Curve and Patient Outcomes of Endovascular Repair of Thoracoabdominal Aortic Aneurysms Using Fenestrated and Branched Stent Grafts: Prospective, Nonrandomized, Single-center Physician-sponsored Investigational Device Exemption Clinical Study.

OBJECTIVE: To evaluate the outcomes and learning curve of fenestrated and branched endovascular repair (F/BEVAR) of thoracoabdominal aneurysms. SUMMARY OF BACKGROUND DATA: Endovascular aneurysm repair has reduced morbidity and mortality compared with open surgical repair. However, application to thoracoabdominal aneurysm repair remains limited by procedural complexity and device availability. METHODS: Fifty patients treated in a prospective, nonrandomized, single-center Investigational Device Exemption (IDE) study between January 2014 and July 2017 were analyzed. Patients (mean age 75.6 ±â€Š7.5 years; mean aneurysm diameter 67.3 ±â€Š9.8 mm) underwent F/BEVAR of thoracoabdominal aneurysms (58% type IV; 42% type I-III) using custom-manufactured endografts. The experience was divided into 3 cohorts (Early: 1 to 17; Mid: 18 to 34; Late: 35 to 50) to evaluate learning curve effects on key process measures. RESULTS: F/BEVAR included 194 visceral arteries (average 3.9 per patient). Technical success was 99.5% (193/194 targeted arteries). Thirty-day major adverse events (MAEs) included 3 (6%) deaths, 1 (2%) new-onset dialysis, 3 (6%) paraparesis/paraplegia, and 2 (4%) strokes. One-year survival was 79 ±â€Š7%. Comparing the Early and Late groups revealed reductions in procedure time (452 ±â€Š74 vs 362 ±â€Š53 minutes; P = 0.0001), fluoroscopy time (130 ±â€Š40 vs 99 ±â€Š27 minutes; P = 0.016), contrast administration (157 ±â€Š73 vs 108 ±â€Š38 mL; P = 0.028), and estimated blood loss (EBL; 1003 ±â€Š933 vs 481 ±â€Š317 mL; P = 0.042). Intensive care unit (ICU) and total length of stay (LOS) decreased from 4 ±â€Š3 to 2 ±â€Š1 days and from 7 ±â€Š6 to 5 ±â€Š2 days, respectively, but was not statistically significant. CONCLUSIONS: Use of F/BEVAR for treatment of thoracoabdominal aneurysms is safe and effective. During this early experience, there was a significant improvement in key process measures reflecting improvements in technique and physician learning over time.

Recurrent epimutations activate gene body promoters in primary glioblastoma.

Aberrant DNA hypomethylation may play an important role in the growth rate of glioblastoma (GBM), but the functional impact on transcription remains poorly understood. We assayed the GBM methylome with MeDIP-seq and MRE-seq, adjusting for copy number differences, in a small set of non-glioma CpG island methylator phenotype (non-G-CIMP) primary tumors. Recurrent hypomethylated loci were enriched within a region of chromosome 5p15 that is specified as a cancer amplicon and also encompasses TERT, encoding telomerase reverse transcriptase, which plays a critical role in tumorigenesis. Overall, 76 gene body promoters were recurrently hypomethylated, including TERT and the oncogenes GLI3 and TP73. Recurring hypomethylation also affected previously unannotated alternative promoters, and luciferase reporter assays for three of four of these promoters confirmed strong promoter activity in GBM cells. Histone H3 lysine 4 trimethylation (H3K4me3) ChIP-seq on tissue from the GBMs uncovered peaks that coincide precisely with tumor-specific decrease of DNA methylation at 200 loci, 133 of which are in gene bodies. Detailed investigation of TP73 and TERT gene body hypomethylation demonstrated increased expression of corresponding alternate transcripts, which in TP73 encodes a truncated p73 protein with oncogenic function and in TERT encodes a putative reverse transcriptase-null protein. Our findings suggest that recurring gene body promoter hypomethylation events, along with histone H3K4 trimethylation, alter the transcriptional landscape of GBM through the activation of a limited number of normally silenced promoters within gene bodies, in at least one case leading to expression of an oncogenic protein.

Assessing the Utility of Low-Cost Particulate Matter Sensors over a 12-Week Period in the Cuyama Valley of California.

The use of low-cost air quality sensors has proliferated among non-profits and citizen scientists, due to their portability, affordability, and ease of use. Researchers are examining the sensors for their potential use in a wide range of applications, including the examination of the spatial and temporal variability of particulate matter (PM). However, few studies have quantified the performance (e.g., accuracy, precision, and reliability) of the sensors under real-world conditions. This study examined the performance of two models of PM sensors, the AirBeam and the Alphasense Optical Particle Counter (OPC-N2), over a 12-week period in the Cuyama Valley of California, where PM concentrations are impacted by wind-blown dust events and regional transport. The sensor measurements were compared with observations from two well-characterized instruments: the GRIMM 11-R optical particle counter, and the Met One beta attenuation monitor (BAM). Both sensor models demonstrated a high degree of collocated precision (R² = 0.8-0.99), and a moderate degree of correlation against the reference instruments (R² = 0.6-0.76). Sensor measurements were influenced by the meteorological environment and the aerosol size distribution. Quantifying the performance of sensors in real-world conditions is a requisite step to ensuring that sensors will be used in ways commensurate with their data quality.

Safety and Effectiveness of Adjunctive Intra-Arterial Abciximab in the Management of Acute Limb Ischemia.

BACKGROUND: Contemporary endovascular management of acute limb ischemia (ALI) generally consists of tissue plasminogen activator (tPA) based catheter-directed thrombolysis (CDT) with or without pharmacomechanical thrombectomy (PMT). Although abciximab (Reopro), a GPIIb/IIIa receptor antagonist, is widely used in coronary revascularization, its safety and effectiveness in the treatment of ALI are unknown. Here, we review our contemporary experience with the endovascular management of ALI and assess the safety and effectiveness of abciximab. METHODS: A total of 49 consecutive patients with Rutherford class II (RII) ALI undergoing CDT for ALI from 2011 to 2014 was identified. Demographics, procedural details, and outcomes were assessed and are reported. RESULTS: A total of 44 patients with RII ALI underwent tPA-based CDT in 49 discrete interventions. In 11 patients adjunctive abciximab infusion was also used. The majority (82%) of patients treated with tPA ± PMT required overnight infusion and at least one subsequent procedure. Single-stage (on-table) thrombolysis was achieved in 91% of cases with adjunctive abciximab use versus 18% with tPA alone (P < 0.001). There was significantly less need for intensive care unit (ICU) monitoring, and there were no bleeding complications associated with adjunctive abciximab use. Overall length of stay and total operating room (OR) time favored the abciximab group but did not reach statistical significance. Overall primary patency, secondary patency, and amputation-free survival were 46 ± 9.9%, 79 ± 6.6%, and 78 ± 9.2% at 1 year. CONCLUSIONS: Early results suggest adjunctive abciximab may safely facilitate on-table thrombolysis for RII ALI. This approach appears to be associated with reduced resource utilization including fewer procedures, shorter OR time, and less ICU admissions. One-year outcomes compare favorably to a similar cohort of ALI patients treated with tPA-based therapy alone.

Outcomes and risk factors of cardiac arrest after vascular surgery procedures.

BACKGROUND: Despite increased awareness of the value of discussing patients' goals of care, advance directives, and code status as part of the surgical informed consent process, the actual outcomes and risks of cardiopulmonary resuscitation (CPR) remain poorly defined among some subsets of surgical patients. Thus, in an effort to generate an evidence base for communication about shared decision making and informed consent for vascular surgery patients and their surrogates, we defined the incidence, risks, and outcomes of postoperative cardiac arrest after primary vascular surgery procedures. METHODS: The 2007 to 2010 National Surgical Quality Improvement Program data were queried to develop a multi-institutional database of patients undergoing vascular surgery (N = 123,581). Univariate analyses and multivariate logistic regression were used to identify crude and adjusted risk factors for postoperative cardiac arrest requiring CPR and to assess outcomes. RESULTS: Postoperative cardiac arrest requiring CPR was seen in 1234 of 123,581 patients (1.0%) after vascular surgery at a mean of 7.2 ± 2 days. The 30-day mortality was 73.4% compared with 2.7% among patients who did not arrest (P < .001). Of CPR survivors, 102 (12.1%) were still hospitalized at 30 days. Patient variables that were most predictive of postoperative cardiac arrest included dependent functional status (odds ratio [OR], 2.9; 95% confidence interval [CI], 2.3-3.6; P < .001), dialysis dependence (OR, 2.7; 95% CI, 2.3-3.2; P < .001), emergent case (OR, 2.2; 95% CI, 1.9-2.5; P < .001), and preoperative ventilator dependence (OR, 2.0; 95% CI, 1.5-2.7; P < .001). Procedures associated with the highest risk included thoracic aortic surgery (OR, 6.9; 95% CI, 4.8-9.9; P < .001), open abdominal procedures (OR, 3.7; 95% CI, 3.1-4.4; P < .001), axillary-femoral bypass (OR, 2.1; 95% CI, 1.3-3.2; P = .001), and peripheral embolectomy (OR, 1.5; 95% CI, 1.2-1.9; P = .002). At least one major complication preceded cardiac arrest in 47.7% of patients including sepsis (23.5%), renal failure (14.5%), and myocardial infarction (12.1%). Patients with do not resuscitate orders were significantly less likely to undergo CPR (OR, 0.59; 95% CI, 0.39-0.93; P = .021). CONCLUSIONS: Patients undergoing vascular surgery who suffer a postoperative cardiac arrest frequently die in spite of receiving CPR; for those who survive, there is likely to be prolonged hospitalization and significant morbidity. These data provide an evidence base for discussing goals of care, advance directives, and code status with vascular surgery patients and their surrogates. Further research into how to best communicate risk, to elicit patient preferences, and to engage in shared decision making is needed.

An Atmospheric Constraint on the NO2 Dependence of Daytime Near-Surface Nitrous Acid (HONO).

Recent observations suggest a large and unknown daytime source of nitrous acid (HONO) to the atmosphere. Multiple mechanisms have been proposed, many of which involve chemistry that reduces nitrogen dioxide (NO2) on some time scale. To examine the NO2 dependence of the daytime HONO source, we compare weekday and weekend measurements of NO2 and HONO in two U.S. cities. We find that daytime HONO does not increase proportionally to increases in same-day NO2, i.e., the local NO2 concentration at that time and several hours earlier. We discuss various published HONO formation pathways in the context of this constraint.

Impact of "Do Not Resuscitate" Status on the Outcome of Major Vascular Surgical Procedures.

BACKGROUND: Patients with Do Not Resuscitate (DNR) orders may still be offered surgery that aims to prolong or improve quality of life. The widely accepted approach of "required reconsideration" mandates that patients and surgeons discuss perioperative risks and expected outcomes in the context of the patient's values and preferences. However, surgical outcomes in this patient population have not been well-defined. The objectives of this study are to assess outcomes in DNR patients undergoing major vascular procedures, and develop an evidence basis for informed, shared decision-making. METHODS: Patients undergoing common major vascular procedures were identified in the 2007-2010 National Surgical Quality Improvement Project databases. DNR patients were defined as those with an active DNR order within 30 days before surgery. Demographics, comorbidities, procedural details, and complications were compared with those without DNR orders. To isolate the impact of DNR status, multivariate regression and 1:1 propensity score matching were used to compare outcomes between DNR patients and a non-DNR cohort of comparably high-risk patients. RESULTS: Of 110,279 patients undergoing major vascular surgery, 1,565 (1.4%) had active DNR orders 30 days preceding surgery. DNR patients were more likely to be functionally dependent (69% vs. 15%; P < 0.0001), over 80 years of age (53% vs. 20%; P < 0.001), and suffer from a variety of cardiac, pulmonary, and systemic comorbidities. The most common procedures in DNR patients were major amputation (38.4%), lower extremity bypass (20%), and peripheral thromboembolectomy (11.7%). Unadjusted 30-day mortality was significantly higher among DNR patients (21% vs. 3.4%; P < 0.001). After 1:1 propensity score matching, with the 2 cohorts differing only with respect to DNR status, perioperative mortality remained significantly higher among DNR patients (21% vs. 13%; P < 0.01). There was a trend toward reduced cardiopulmonary resuscitation in patients with recent DNR (1.7% vs. 2.6%; P = 0.07). CONCLUSIONS: DNR patients are at high risk for major complications and mortality after vascular surgery procedures. Compared with a matched cohort of "high-risk" non-DNR patients, those with DNR orders suffered equivalent rates of postoperative morbidity, but markedly increased mortality. This suggests that DNR status, independent of comorbidities and perioperative complications, may increase the risk of "failure to rescue." These findings have implications not only for risk adjustment, but also provide an evidence basis for shared decision-making in challenging circumstances.

Safety and effectiveness of endovascular therapy for claudication in octogenarians.

BACKGROUND: Advanced age (≥ 80 years) has been associated with adverse outcomes after lower extremity bypass for critical limb ischemia (CLI), but endovascular therapy (ET) is reported to have comparable safety across age groups. Here, we assess the safety and effectiveness of advanced age on outcomes after ET for lifestyle-limiting intermittent claudication (IC). METHODS: A retrospective review of a prospectively maintained institutional database (2007-2012) identified all patients undergoing ET for IC. Demographics, procedural details, and outcomes were assessed via univariate analysis and multivariate Cox regression. Effectiveness was assessed across a panel of outcome metrics including the following: overall survival, freedom from major adverse limb event (MALE), and freedom from reintervention, amputation, or restenosis (RAS). Freedom from MALE + perioperative death (MALE + POD) was the primary safety end point. RESULTS: Two hundred thirty-six patients underwent primary ET for 284 affected limbs. Of these, 46 interventions (16%) were performed in patients ≥ 80 years old. The average age of octogenarians treated was 84.4 years compared with 67.4 years among those aged <80 (P < 0.001). Compared with younger claudicants, octogenarians were less likely to have hypercholesterolemia (43.5% vs. 63.9%, P = 0.01) and more likely to deny a history of smoking (41.3% vs. 14.7%, P < 0.001). Octogenarians were also more likely to undergo interventions involving the popliteal artery (50% vs. 31.9%, P = 0.03). There were no other significant differences in demographics, comorbidities, TransAtlantic Inter-Society Consensus II classification, or treated arterial segment. Thirty-day freedom from MALE + POD was 100% in octogenarians and 99.6% in patients <80 years, with no difference between age groups. There were no differences in freedom from MALE, freedom from RAS, or overall survival at 1- and 3-year follow-up. CONCLUSIONS: Although age >80 years has been identified as an independent risk factor for poor outcomes in the surgical treatment of CLI, our results suggest that ET for selected octogenarians with lifestyle-limiting claudication is as safe and effective as ET in younger patients. Advanced age alone should not prohibit consideration of ET for patients with IC.

Comparative safety of endovascular and open surgical repair of abdominal aortic aneurysms in low-risk male patients.

OBJECTIVE: The prevalence of significant comorbidities among patients with abdominal aortic aneurysms (AAAs) has contributed to widespread enthusiasm for endovascular AAA repair (EVAR). However, the advantages of EVAR in patients at low risk for open surgical repair (OSR) remain unclear. The objective of this study was to assess perioperative outcomes of EVAR and OSR in low-risk patients. METHODS: Patients undergoing EVAR and OSR for infrarenal AAAs were identified in the 2007 to 2010 National Surgical Quality Improvement Program data sets. AAA-specific risk stratification, by the Medicare aneurysm scoring system, was used to create matched low-risk (score <3) cohorts. Perioperative morbidity and mortality were assessed by crude comparisons of matched groups and regression models. RESULTS: Of 11,753 elective patients undergoing EVAR, 4339 (37%) were deemed low risk (score <3). A matched cohort of 1576 low-risk patients was developed from a total of 3804 (41%) undergoing OSR. The low-risk cohorts included only male patients and those <75 years of age, without significant cardiac, pulmonary, or vascular comorbidities. Mean age in both low-risk groups was 67 ± 6 years (P = NS). EVAR patients had higher rates of obesity (40% vs 33%; P < .001), diabetes (16% vs 13%; P = .005), history of cardiac intervention (24% vs 19%; P < .001), cardiac surgery (23% vs 20%; P = .02), steroid use (4% vs 2%; P = .002), and bleeding disorders/anticoagulation (9% vs 6%; P = .001) compared with OSR patients. There were no other differences between the matched cohorts. EVAR was associated with reduced 30-day mortality (0.5% vs 1.5%; P < .01) and reduced rates of major complications, including the following: sepsis (0.7% vs 3.2%; P < .01), unplanned intubation (1.0 vs 5.4%; P < .001), pneumonia (0.8% vs 6.1%; P < .001), acute renal failure (0.4% vs 2.7%; P < .001), and early reoperation (3.7% vs 6.0%; P < .001). Furthermore, EVAR was associated with reduced perioperative morbidity across organ systems, including venous thromboembolism (0.1% vs 0.3%; P = .001), transfusion requirement of more than 4 units (2.0% vs 13.0%; P < .001), cardiac arrest (0.2 vs 0.8; P = .001), neurologic deficits (0.2% vs 0.5%; P = .032), and urinary tract infections (1.2% vs 2%; P = .02). CONCLUSIONS: Our results demonstrate that even among those male patients at low risk for OSR on the basis of comorbidities, EVAR is associated with reduced perioperative mortality and major complications. Whereas clinical decisions must account for safety and long-term effectiveness, the short-term benefit of EVAR is evident even among male patients at the lowest risk for OSR.

Determinants of outcome after endovascular therapy for critical limb ischemia with tissue loss.

BACKGROUND: In this study we examine outcomes of endovascular therapy for critical limb ischemia with tissue loss and identify risk factors for failure of endovascular therapy across a panel of outcome metrics. METHODS: A retrospective review (2006-2010) of patients undergoing endovascular therapy for critical limb ischemia with tissue loss provided data for multivariate models of overall survival, amputation-free survival, limb salvage (LS), and wound healing. RESULTS: One hundred six patients underwent endovascular therapy for Rutherford class 5 (88%) or class 6 (12%) ischemia with ulceration and/or gangrene of the heel (15%), forefoot (16%), toe(s) (43%), calf/ankle (11%), or multiple locations (15%). Sustained limb salvage at 1 year was 87%. One-year overall survival and amputation-free survival were 65% and 49%, respectively. Multivariate regression models identified independent risk factors for reduced primary patency: Rutherford 6 ischemia (P = 0.008; HR 4.7 [95% confidence interval 1.5-14.8]) and infrapopliteal intervention (P = 0.03; HR 2.58 [95% CI 1.08-6.14]). Rutherford class 6 ischemia was independently associated with reduced assisted patency (P = 0.004; HR 5.39 [95% CI 1.74-16.73]). Wound healing was adversely affected by diabetes (P = 0.02; HR 7.0 [95% CI 1.4-36.2]), continued smoking (P = 0.04; HR 5.3 [95% CI 1.1-26.3]), and patency loss (P = 0.04; HR 4.8 [95% CI 1.1-22.30]). Rutherford class 6 ischemia was independently associated with reduced limb salvage (P < 0.0001; HR 35.1 [95% CI 5.4-231.2]) and amputation-free survival (P = 0.007; HR 3.61 [95% CI 1.4-9.18]), in addition to COPD (P = 0.01; 3.58 [95% 1.28-9.55]). Independent predictors of poor overall survival included end-stage renal disease (P = 0.03; HR 2.99 [95% CI 1.1-8.05]), history of angina (P = 0.02; HR 5.08 [95% CI 1.28-20.29]), and COPD (P = 0.001; HR 3.77 [95% CI 1.76-8.34]). CONCLUSIONS: Both increasing severity of tissue loss as well as the presence of severe medical comorbidities are associated with poorer outcomes of endovascular therapy in these patients. Although sustained limb salvage in patients with tissue loss may be achieved with endovascular therapy, this is due to poor overall survival and a competing mortality hazard.

Endovascular repair of infrarenal focal aortic pathology with limited aortic coverage.

BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) for degenerative abdominal aortic aneurysm (AAA) requires complete aortic exclusion to prevent ongoing aneurysmal degeneration in a diseased aorta. Focal infrarenal aortic pathology, such as penetrating atherosclerotic ulcer (PAU), saccular aneurysm, and/or intramural hematoma (IMH) may not necessitate complete aortic coverage. Here, we review our experience with endovascular management of focal aortic pathology with limited aortic coverage. METHODS: A prospectively maintained institutional database of patients undergoing EVAR was retrospectively reviewed to identify all patients treated with a nonbifurcated device (Current Procedural Terminology code: 34,800). Patients without a diagnosis of PAU, saccular aneurysm, IMH, or iatrogenic pseudoaneurysm were excluded. Medical records and imaging studies were reviewed for confirmation of focal aortic pathology. Preoperative imaging and intraoperative details were reviewed. Outcome measures included technical success, symptom-free survival, and freedom from reintervention. RESULTS: Eight patients were identified who underwent repair of a focal aortic defect with an endovascular tube graft from 2004-2011. Six patients underwent surgery for 7 saccular pseudoaneurysms and 2 patients had iatrogenic infrarenal pseudoaneurysms. Six saccular aneurysms were associated with PAU. Seven patients (88%) were men; the median age was 76 years (range: 50-85 years). Four patients (50%) had symptoms attributable to their aneurysm (2 abdominal pain, 1 gastrointestinal symptoms, 1 lower extremity emboli). Aneurysm repair was classified as urgent in 2 patients (25%). Six patients (75%) required placement of a single aortic component, the other 2 patients (25%) required 2 components. All devices used were Zenith (Cook, Inc., Bloomington, IN) ancillary components. The median device diameter was 22 mm (range: 18-28 mm), while the median device length was 56.5 mm (range: 39-80 mm). The technical success rate was 100%. There were no early graft-related complications. All symptomatic patients experienced improvement or resolution of symptoms. In all cases, radiologic follow-up at 1 month showed stable or decreasing aneurysm size. No endoleaks were detected and no patients have required reintervention to date. CONCLUSIONS: The optimal management of many focal infrarenal aortic defects, particularly those that are incidentally discovered, remains unclear. Our experience with endovascular repair of focal aortic pathology with limited aortic coverage suggests this approach is technically feasible and associated with excellent early results.

The reliability and minimal detectable change of common tests and measures for temporomandibular disorders.

BACKGROUND: Temporomandibular disorders are a source of orofacial pain. Understanding clinimetric properties of evaluation procedures is necessary for assessing impairments and determining response to interventions. PURPOSE: Reliability, minimal detectable change (MDC95), and 95% limits of agreement of TMJ examination procedures were investigated. METHODS: Occlusion (central incisor alignment, overjet, overbite), mandibular dynamics (maximal incisor opening, laterotrusion, protrusion active range of motion (AROM)), auscultation, tenderness, and joint play were measured on 50 asymptomatic adults (30 females), mean age 24.8. The inter-rater reliability assessment used an intra-session design. Participants returned 24-48 h later for intra-rater assessments. Intraclass correlation coefficients (ICC) and Kappa values were used to determine reproducibility. RESULTS: Intra-rater reliability for occlusion and AROM was ICC 3,1 ≥ 0.75, whereas interrater reliability was ICC 2,1 ≥ 0.68. Kappa values for inter-rater agreement of joint mobility was K = .18, whereas auscultation and palpation were K ≥ 0.48. Intra-rater Kappa values were ≥ 0.24, with lateral pterygoid region palpation having poor agreement. The MDC95 for occlusion was 1 mm, whereas AROM ranged from 3 to 6 mm. Mean AROM differences between raters were -1.16, -0.42, -0.18, and -0.8 mm for maximal incisor opening, left and right laterotrusion, and protrusion, respectively. CONCLUSION: AROM and occlusion measurements may be used with confidence; however, poor agreement for joint mobility measurements and lateral pterygoid region palpation must be recognized. When re-assessing measurements, a 3-6 and 1-mm change in AROM and occlusion, respectively, is required to be 95% certain change is not due to error. Future symptomatic population research is needed (250/250).

The Comprehensive Risk Assessment for Bypass (CRAB) facilitates efficient perioperative risk assessment for patients with critical limb ischemia.

OBJECTIVE: Specific perioperative risk assessment models have been developed for bariatric, pancreatic, and colorectal surgery. A similar instrument, specific for patients with critical limb ischemia (CLI), could improve patient-centered clinical decision making. We describe a novel tool to predict 30-day major morbidity and mortality (M&M) after bypass surgery for CLI. METHODS: Data for 4985 individuals from the 2007 to 2009 National Surgical Quality Improvement Program were used to develop and internally validate the model. Outcome measures included mortality, major morbidity, and a composite end point (M&M). M&M included mortality and the most severe postoperative morbidities that were highly associated with death (eg, sepsis and major cardiopulmonary complications). More than 30 preoperative factors were tested for association with 30-day mortality, major morbidity, and M&M. Significant predictors in multivariate models were assigned integer values (points), which were added to calculate a patient's Comprehensive Risk Assessment For Bypass (CRAB) score. Performance was assessed (C-index) across all outcome measures and compared with other general tools (American Society of Anesthesiologists class, Surgical Risk Scale) and existing CLI-specific survival prediction models (Finnvasc score, Edifoligide for the Prevention of Infrainguinal Vein Graft Failure [PREVENT III] score) on a distinct validation sample (n = 1620). RESULTS: In the derivation data set (n = 3275), the 30-day mortality rate was 2.9%. The rate of any major morbidity was 19.1%. The composite end point M&M occurred in 10.1%. Significant predictors of M&M by multivariate analysis included age >75 years, prior amputation or revascularization, tissue loss, dialysis dependence, severe cardiac disease, emergency operation, and functional dependence. Applied to a distinct validation sample of 1620 patients, higher CRAB scores were significantly associated with higher rates of mortality, all major morbidities, and M&M (P < .0001). Comparison with other models by assessment of area under the receiver-operating characteristic curve revealed the CRAB was a more accurate predictor of mortality, all major morbidity, and M&M. CONCLUSIONS: The CRAB is a CLI-specific, risk assessment instrument derived from multi-institutional American College of Surgeons-National Surgical Quality Improvement Program surgical outcomes data that out-performs existing prognostic risk indices in the prediction of clinically significant adverse events after bypass surgery. Use of the CRAB as a risk assessment tool provides an evidence basis for patient-centered clinical decision making and may have a role in identifying patients at higher risk for surgical revascularization in whom an endovascular approach is preferable.

Risk factors for early failure after peripheral endovascular intervention: application of a reliability engineering approach.

BACKGROUND: We apply an innovative and novel analytic approach, based on reliability engineering (RE) principles frequently used to characterize the behavior of manufactured products, to examine outcomes after peripheral endovascular intervention. We hypothesized that this would allow for improved prediction of outcome after peripheral endovascular intervention, specifically with regard to identification of risk factors for early failure. METHODS: Patients undergoing infrainguinal endovascular intervention for chronic lower-extremity ischemia from 2005 to 2010 were identified in a prospectively maintained database. The primary outcome of failure was defined as patency loss detected by duplex ultrasonography, with or without clinical failure. Analysis included univariate and multivariate Cox regression models, as well as RE-based analysis including product life-cycle models and Weibull failure plots. Early failures were distinguished using the RE principle of "basic rating life," and multivariate models identified independent risk factors for early failure. RESULTS: From 2005 to 2010, 434 primary endovascular peripheral interventions were performed for claudication (51.8%), rest pain (16.8%), or tissue loss (31.3%). Fifty-five percent of patients were aged ≥75 years; 57% were men. Failure was noted after 159 (36.6%) interventions during a mean follow-up of 18 months (range, 0-71 months). Using multivariate (Cox) regression analysis, rest pain and tissue loss were independent predictors of patency loss, with hazard ratios of 2.5 (95% confidence interval, 1.6-4.1; P < 0.001) and 3.2 (95% confidence interval, 2.0-5.2, P < 0.001), respectively. The distribution of failure times for both claudication and critical limb ischemia fit distinct Weibull plots, with different characteristics: interventions for claudication demonstrated an increasing failure rate (ß = 1.22, θ = 13.46, mean time to failure = 12.603 months, index of fit = 0.99037, R(2) = 0.98084), whereas interventions for critical limb ischemia demonstrated a decreasing failure rate, suggesting the predominance of early failures (ß = 0.7395, θ = 6.8, mean time to failure = 8.2, index of fit = 0.99391, R(2) = 0.98786). By 3.1 months, 10% of interventions failed. This point (90% reliability) was identified as the basic rating life. Using multivariate analysis of failure data, independent predictors of early failure (before 3.1 months) included tissue loss, long lesion length, chronic total occlusions, heart failure, and end-stage renal disease. CONCLUSIONS: Application of a RE framework to the assessment of clinical outcomes after peripheral interventions is feasible, and potentially more informative than traditional techniques. Conceptualization of interventions as "products" permits application of product life-cycle models that allow for empiric definition of "early failure" may facilitate comparative effectiveness analysis and enable the development of individualized surveillance programs after endovascular interventions.

Midterm outcomes after treatment of type II endoleaks associated with aneurysm sac expansion.

PURPOSE: To examine the outcomes following interventions for type II endoleaks in patients with aneurysm sac expansion after endovascular aneurysm repair (EVAR). METHODS: A retrospective review was conducted of all patients who underwent treatment for type II endoleak from July 2001 to September 2010 in a single center. In this time period, 29 (4.7%) patients (22 men; mean age 78.6 years, range 54-87) were identified as having a type II endoleak and enlargement of the aneurysm sac, meeting the criterion for treatment. All patients had at least one attempted percutaneous intervention. Patients were followed both clinically and radiographically, with computed tomographic angiography every 3 to 12 months, over a follow-up period that ranged from 1 to 10 years (mean 3.5). RESULTS: Forty-eight interventions were performed on the 29 patients. Of these, 15 (56%) patients underwent multiple (2-4) procedures. Of the 11 endoleaks with an isolated inferior mesenteric artery identified as the source, initial success for transarterial embolization at 2 years was 72%, with 2 of the failures having successful secondary interventions. For the 18 endoleaks with a lumbar source, the success of the initial intervention was 17% at 2 years; repeated embolization attempts produced a 40% secondary success rate. Seven (24%) patients had continued endoleak despite multiple treatment attempts; 3 ultimately required elective aortic graft explantation. There were no ruptures or deaths during the study period. In a comparison of type II endoleak patients who had stable aneurysm sacs and those who had persistent sac expansion, the only significant differences in preoperative anatomical characteristics were a lower prevalence of mural thrombus (p = 0.036) and longer right iliac arteries (p = 0.012) in the group with sac expansion. Independent predictors of type II endoleak were mural thrombus (p<0.001), patent lumbar arteries (p = 0.004), aneurysm length (p = 0.011), and iliac artery length (p = 0.004). CONCLUSION: This study demonstrates that most patients require multiple reinterventions to treat type II endoleaks; specifically, lumbar artery embolization carries a low midterm success rate.