A Regional Health System Journey from Volume to Value: Roadmap to the Recognition as a 15 Top Health System in the USA for Quality Excellence.

The 15 Top Health System program, an IBM Watson study, objectively measures health systems' performance overall on an annual basis using publicly reported data available from the Center for Medicare and Medicaid Services (CMS) and state data banks. Genesis Health System was recognized as an IBM Watson Health 15 Top Health System for two consecutive years in 2020 and 2021. A system-based approach with a "physician-lead, professionally-managed" framework, led to accomplishing the 15 Top Health System. The steps needed included adoption of the IBM Watson database to determine current status of certain key performance indicators, establishing a clinical effectiveness program and governance structure, and adopting Lean methodologies to analyze and determine appropriate interventions with long-term solution. The desire and willingness to accomplish this ambitious goal start with adoption by the Board and the administration of the health system while supplying appropriate financial and human resources that are dedicated to the success of the journey. In this manuscript, we describe the journey and steps implemented to accomplish the outcomes that led to the recognition as a 15 Top Health System for quality excellence.

Education of Self-Radial Pulse Palpation and Atrial Fibrillation Signs and Symptoms.

The purpose of this evidence-based education initiative was to increase A Fib detection in a cardiovascular diseased population in which participants were taught radial pulse palpation and signs/symptoms of A Fib. Participants were evaluated after initial education on performance of radial pulse palpation and teach back of signs/symptoms of the arrhythmia and again at three weeks on adherence to daily self-screening and recall of signs/symptoms of A Fib. Post initial education, 88% of eligible participants learned pulse-palpation and 93% could verbalize at minimum one sign/symptom. After three weeks, 94.7% reported daily self-screening, but only 44.7% could verbalize at minimum one sign/symptom. This indicated that participants were continuing to self-screen, but in need of booster education sessions. Educating individuals on self-screening and signs/symptoms of A Fib is clinically feasible.

Dynavision Normative Data for Healthy Adults: Reaction Test Program.

IMPORTANCE: Previous research has calculated normative data for the Dynavision D2 Visuomotor Training (D2) System among healthy athletes to understand concussion management, but to date no studies have identified the norms for healthy adults over a large age range (18-80 yr) for physical response speed. OBJECTIVE: To provide normative data for the D2 for physical response speed in adults ages 18-80 yr. DESIGN: Cross-sectional, descriptive study to obtain normative data on physical response speed using the D2 for adults in age categories 18-40, 41-60, and 61-80 yr. SETTING: Genesis Physical Therapy and Wellness Center, a Midwestern outpatient hospital-based therapy center. PARTICIPANTS: Three hundred adults, stratified into three different age categories. Normal standards with quartiles were identified for each age and sex category. OUTCOMES AND MEASURES: Multiple regression model of the inverse response times. RESULTS: The results showed a significant difference in physical response speed between men and women and between the different age groups. Women in all age categories were slower than men. Physical response speed increased with age in both sexes, but each had significantly different age and sex main effects (p < .0005). CONCLUSIONS AND RELEVANCE: Occupational therapy practitioners can use the normative standards identified in this study in their assessment of clients with visual and cognitive deficits after a brain injury, stroke, or other neurologic pathology. WHAT THIS ARTICLE ADDS: This study's results can be added to the battery of other common evaluation measures that occupational therapists use to evaluate visual and cognitive deficits after neurological impairments.

Assessment of Time to Hospital Encounter after an Initial Hospitalization for Heart Failure: Results from a Tertiary Medical Center.

BACKGROUND: Hospital inpatient readmissions for patients admitted initially with the primary diagnosis of heart failure (HF) can be as high as 20-25% within 30 days of discharge. This, however, does not include admissions for observations or emergency department (ED) visits within the same time frame and does not show a time-dependent hospital encounter following discharge after an index admission. We present data on time-dependent hospital encounter of HF patients discharged after an index admission for a primary diagnosis of HF. METHODS: The study recruited patients from 2 hospitals within the same health system. 500 consecutive admissions with the ICD diagnosis of HF were reviewed by inclusion and exclusion screening criteria. The 166 eligible remaining patients were tracked for post hospital discharge encounters consisting of hospital admissions, observation stays, and ED visits. Only those with a primary diagnosis of heart failure were included. Demographics were recorded on all patients. Days until hospital inpatient readmissions or hospital encounters were displayed in Kaplan-Meier plots. RESULTS: A total of 166 patients met inclusion criteria (mean age 79.3 years, males 54%). For the first 90 days following the index admission, there were a total of 287 follow-up visits (1.7 per patient), 1158 total hospitalization days (2.6 per visit, 7.0 per patient, and 8.6 per 100 days at risk), and 21 deaths (12.7%). At 30 days, 25% and 52% of patients had an inpatient readmission or a hospital encounter, respectively. The median time to inpatient readmission was 117 days and to hospital encounter was 27 days. CONCLUSION: Time-dependent excess days in acute care (unplanned inpatient admission, outpatient observation, and ED visit) rather than 30-day hospital inpatient readmission rate is a more realistic measure of the intensity of care required for HF patients after index admission.

Implementation of a patient safety program at a tertiary health system: A longitudinal analysis of interventions and serious safety events.

BACKGROUND: We hypothesize that implementation of a safety program based on high reliability organization principles will reduce serious safety events (SSE). METHODS: The safety program focused on 7 essential elements: (a) safety rounding, (b) safety oversight teams, (c) safety huddles, (d) safety coaches, (e) good catches/safety heroes, (f) safety education, and (g) red rule. An educational curriculum was implemented focusing on changing high-risk behaviors and implementing critical safety policies. All unusual occurrences were captured in the Midas system and investigated by risk specialists, the safety officer, and the chief medical officer. A multidepartmental committee evaluated these events, and a root cause analysis (RCA) was performed. Events were tabulated and serious safety event (SSE) recorded and plotted over time. Safety success stories (SSSs) were also evaluated over time. RESULTS: A steady drop in SSEs was seen over 9 years. Also a rise in SSSs was evident, reflecting on staff engagement in the program. The parallel change in SSEs, SSSs, and the implementation of various safety interventions highly suggest that the program was successful in achieving its goals. CONCLUSION: A safety program based on high-reliability organization principles and made a core value of the institution can have a significant positive impact on reducing SSEs.

Meta-Analysis-Derived Benchmarks of Patency and Target Lesion Revascularization of Percutaneous Balloon Angioplasty from Prospective Clinical Trials of Symptomatic Femoropopliteal In-Stent Restenosis.

PURPOSE: To establish historic benchmarks of patency and target lesion revascularization (TLR) in a study-level meta-analysis of prospective studies of balloon angioplasty in treating femoropopliteal in-stent restenosis (ISR). MATERIALS AND METHODS: Data from the balloon angioplasty control arms of 4 randomized multicenter trials (1 Food and Drug Administration-approved study in the United States and 3 conducted in Europe) and 1 European prospective registry were included. Trials included patients with Rutherford stage 1-5 disease or Fontaine ischemia classification states IIb, III, IV and femoropopliteal ISR lesion lengths of 4-27 cm. A two-stage meta-analysis was conducted with study-specific estimates obtained from the randomized trials at the first stage and an analysis that pooled all study-specific estimates at the second stage. The Breslow-Day test of homogeneity was performed on patency and TLR at 6 months and 1 year. RESULTS: Analysis of the balloon-angioplasty control arms of the 5 prospective trials identified 303 patients (mean lesion length, 144.5 mm ± 88.0; vessel diameter, 4.9 mm ± 0.7). Six- and 12-month duplex ultrasound patency rates were 60.7% and 33%, respectively. Six- and 12-month TLR rates with and without "bailout" stent placement considered as TLR were 37.9% and 55.4% and 27.0% and 42.6%, respectively. CONCLUSIONS: It is feasible to derive 6-month and 1-year patency and TLR benchmark data from existing prospective trials of balloon angioplasty in femoropopliteal ISR. However, the study is limited by the lack of data from larger prospective trials with longer-term follow-up.

The Gap between Compliance with the Quality Performance Measure "Perioperative Temperature Management" and Normothermia.

The National Quality Forum (NQF) has endorsed the process performance measure Perioperative Temperature Management, which is used by the Joint Commission and the Centers for Medicare and Medicaid Services. Compliance requires either using active warming intraoperatively or achieving normothermia near the end of anesthesia. Compliance may actually be achieved by using forced-air warming incorrectly and without maintaining normothermia. The aim of this study was to determine to what extent compliance with the NQF-endorsed quality performance measure, is congruent with normothermia at the end of the surgical procedure. This study describes the relationship between compliance with this measure and the outcome of normothermia upon admission to the postanesthesia care unit. A retrospective review was undertaken of patients undergoing surgery with general or neuraxial anesthesia during a 48-month period of time in a community hospital. A total of 5.8% of patients for whom the quality performance measure was met were hypothermic upon admission to the postanesthesia care unit. The greatest gaps between compliance with the measure and normothermia were found in urology (8.5%) and orthopedics (7.7%). Patients who receive care compliant with the quality performance measure by receiving active warming are still at risk for hypothermia.

Setting expectations following endoscopic cubital tunnel release.

BACKGROUND: The objective was to evaluate recovery characteristics of patients undergoing endoscopic cubital tunnel release (ECuTR) by determining the following: (1) return to work (RTW) times following ECuTR compared with RTW times of patients that underwent anterior transposition of the ulnar nerve (ATUN), (2) satisfaction rates and factors affecting satisfaction, (3) resolution rates of common preoperative complaints and findings, and (4) effect of preoperative ulnar nerve subluxation on postoperative outcomes. METHODS: A total of 172 cases in 148 patients undergoing ECuTR were prospectively enrolled including 56 women and 92 men. Kaplan-Meier analyses were performed to determine RTW time for ECuTR patients and for a cohort of 15 patients that underwent ATUN. Patients were evaluated for subjective and objective complaints preoperatively and postoperatively. Cases were grouped by Dellon's classification preoperatively and modified by Bishop's postoperatively. RESULTS: Half of ECuTR patients returned to normal work within 8 days postoperatively versus 71 days following ATUN. Variables significantly negatively affecting RTW were male sex, manual labor, and worker's compensation status. Dellon's was the best predictor of postoperative satisfaction. Complete resolution of symptoms occurred in 86 % of patients for weakness, 81 % for pain, 79 % for numbness and tingling (N/T), 78 % for atrophy, 76 % for abnormal two-point discrimination, and 65 % for Wartenberg's. Preoperative ulnar nerve subluxation had no effect on outcome. CONCLUSIONS: Improved RTW time following ECuTR versus ATUN indicates potential and substantial cost-saving implications with respect to reduced worker productivity loss. Patients with more severe preoperative Dellon's classification can expect less optimal results regarding postoperative satisfaction and resolution rates of N/T and pain.

Topical administration of tranexamic acid in primary total hip and total knee arthroplasty.

Major blood loss is a known potential complication in total hip and total knee arthroplasty. We conducted a prospective, stratified, randomized, double-blind, placebo-controlled trial that evaluated 100 patients undergoing total knee or total hip arthroplasty to evaluate the effect on blood loss using the topical application of tranexamic acid. Participants received either 2 g of topical tranexamic acid or the equivalent volume of placebo into the joint prior to surgical closure. Tranexamic acid resulted in a lower mean maximum decline in postoperative hemoglobin levels when compared to placebo (P = 0.013). Patients in the tranexamic acid group demonstrated an improved but non-significant reduction in the units of blood transfused compared to placebo (P = 0.423). There was no clinically significant increase in complications in the tranexamic acid group, including no incidence of venous thromboembolism.

Gender differences in patients treated with the zotarolimus-eluting stent at a tertiary medical center.

BACKGROUND: Gender-related differences in long-term outcomes of patients receiving the Endeavor zotarolimus-eluting stent (ZES) (Medtronic) have not been well defined. In this study, we evaluate the differences between men (M) and women (W) for 2-year target vessel failure (TVF) in an unselected consecutive series of patients treated with the ZES at our institution. METHODS: Data on 197 consecutive patients (133 M, 64 W) stented with the ZES were retrospectively analyzed. The primary endpoint of the study was to compare gender-related outcomes in TVF, defined as the combined endpoint of cardiac death, non-fatal myocardial infarction, and target vessel revascularization (TVR). Secondary endpoints included TLR, TVR, acute stent thrombosis (ST) as defined by the academic research consortium (ARC), and cardiac death. The cine angiograms of the first consecutive 122 patients (79 M, 43 W) were independently reviewed by a cardiologist blinded to clinical outcome and SYNTAX scoring was performed. Follow-up was achieved using medical records and/or phone calls and was censored at 730 days. Descriptive analysis was performed on all variables. Univariate analysis compared the M and W cohorts. Logistic regression analysis modeling for predictors of TVF was performed and survival analysis between the 2 groups was plotted. RESULTS: The 2 groups were well matched for demographic, clinical, angiographic, and procedural variables. Angiographic complexity was also statistically similar between the 2 groups as judged by SYNTAX scoring (15.8 ± 10.9 M vs 13.5 ± 8.3 W; P=.197). At 2-year follow-up, TVF was 22.6% and 32.8% (P=.684) with no statistical difference between TLR (18.1% M vs 12.8% W), TVR (21.8% M vs 32.8% W), cardiac death (2.3% M vs 6.3% W), and definite and probable stent thrombosis (2.26% M vs 3.13% W). Logistic regression analyses modeling for age, gender, New York Heart Association (NYHA) class, non-left main (LM) bifurcation lesions, ostial lesions, trifurcating LM, and pre-percutaneous coronary intervention (PCI) lesion severity showed that a higher NYHA class (odds ratio [OR], 2.68; P=.005), ostial lesions (OR, 5.68; P<.001), bifurcating non-LM lesions (OR, 2.74; P=.015), and trifurcating LM lesions (OR, 28.24; P<.001) predicted a higher TVF. Female gender (P=.086) and age (P=.09) were not independent predictors of TVF. CONCLUSION: In this cohort of patients receiving ZES, men and women had similar outcomes at 2-year follow-up consistent with recent reports in the current era of PCI. Complex coronary anatomy (ostial, non-LM bifurcations, and LM trifurcations) and advanced heart failure were stronger predictors of higher TVF than gender and age.

Arthroscopic resection arthroplasty for treatment of combined carpometacarpal and scaphotrapeziotrapezoid (pantrapezial) arthritis.

PURPOSE: Arthroscopy of the carpometacarpal (CMC) and scaphotrapeziotrapezoid (STT) joints has been described for the purpose of diagnosing, staging, and treating CMC and STT pathology. This study evaluates the short-term outcome of arthroscopic resection arthroplasty (ARA) for pantrapezial arthritis. METHODS: Thirty-five cases of ARA of the CMC and STT joints were performed in 34 patients with one year minimum follow-up. There were 27 women and 7 men. Average age was 63 (range, 46 to 79). All patients had simultaneous ARA of both the CMC and STT joints. A 2- to 3-mm section of bone was resected from the proximal and distal aspect of both the CMC and STT joints. Preoperative data collected included 10-point self-reported pain scale, Disabilities of the Arm, Shoulder, and Hand (DASH) outcome measure, range of motion, grip strength, key and chuck pinch, length of symptoms, and treatment. Postoperative data included the same data plus patient satisfaction, graded on a 0 to 5 scale. Data were collected at postoperative months 1, 3, 6, and 12. RESULTS: Average time of postoperative immobilization was less than 3 weeks (range, 2-6). The DASH scores averaged 46 before surgery, and 51, 30, 20, and 19 respectively, for the aforementioned postoperative intervals. The mean improvement in key pinch was 1.3 kg. The mean improvement in grip was 4.3 kg. Pain improved from 7 before surgery to 1 at one-year follow-up. CONCLUSIONS: Short-term analysis suggests that ARA for pantrapezial arthritis provides satisfactory pain relief and return of strength and function.

Endoscopic cubital tunnel recurrence rates.

Cubital tunnel syndrome is the second most common nerve entrapment in the upper extremity. There are no current publications concerning the recurrence rates after endoscopic cubital tunnel release. The purpose of this study is to evaluate the recurrence rate of endoscopic cubital tunnel release compared to published reports of recurrence following open cubital tunnel procedures. We reviewed 134 consecutive cases of endoscopic cubital tunnel release in 117 patients. There were 104 cases in 94 patients with greater than 3 months follow-up. The mean follow-up time was 736 days. They were grouped using Dellon's classification. Two literature control groups were used from published reports of recurrence rate following open cubital tunnel release. A recurrence was identified if the patient was symptom-free following surgery but had symptoms reappear 3 months or more after surgery as defined in the literature. Of the 104 cases, 92.31% had more than a 4-month follow-up. One case (0.96%) met the criteria for recurrence at 4 months postprocedure. Data were then compared to the literature control groups used from published reports of recurrence rates following open cubital tunnel release. Pooled, the combined controls had 22 of 180 cases (12.22%) with recurrences. The percentage of procedure recurrence varied significantly with p value equal to 0.0004. It is recognized that there is a lack of common classification and comparative analysis of these studies, but they do classify preoperative grading and recurrence similarly. We are 95% confident that our true recurrence rate is between 0.02% and 5.24% and that endoscopic cubital tunnel release has a recurrence rate, which is not higher than open cubital tunnel release literature controls.

Gender differences in adhering to national guidelines in a community lipid clinic.

The aggressive treatment of hypercholesterolemia improves morbidity and mortality in patients with a history of cardiovascular disease irrespective of gender. Electronically tracked data on 4324 patients enrolled in a community lipid clinic were analyzed for gender differences in lipid values and adherence to national guidelines in lipid management. Women were older, more likely to be diabetic and/or hypertensive, and have a family history of coronary heart disease. Women also had higher initial total cholesterol, low-density lipoprotein, and triglyceride levels and were more likely to be at goal at entry for high-density lipoprotein. Men were more likely to have coronary heart disease and lower high-density lipoprotein and were more likely to be at goal at entry for triglyceride level. There were no gender differences in low-density lipoprotein at goal at entry or rate of current smoking. All lipid parameters appeared better with age, irrespective of gender. More men than women reached goal for their low-density lipoprotein (61.5% vs 51.7%) and triglyceride (36.9% vs 25.1%) levels, whereas more women than men reached goal for their high-density lipoprotein (33.1% vs 22.2%). The authors conclude that there are significant gender differences in lipid values at entry to a community lipid clinic and in achieving National Cholesterol Education Program targets following the initiation of therapy. A possible gender-independent survivorship effect exists for low-density lipoprotein and high-density lipoprotein.

Twelve-month results of percutaneous endovascular reconstruction for chronically occluded superficial femoral arteries: a quality-of-life assessment.

BACKGROUND: We report our experience on the technical feasibility and impact on quality of life (QOL) for angioplasty and primary stenting of chronic total occlusion (CTO) of the superficial femoral artery (SFA). METHODS: Forty-four patients (51 legs) underwent attempted percutaneous revascularization for SFA CTO utilizing the self-expanding nitinol SMART stent (Cordis Corp., Miami, Florida). The Walking Impairment Questionnaire (WIQ score range: 0 to 14,080) was used to assess quality of life and ankle-brachial indices (ABI) were obtained pre- and post-procedure. RESULTS: Successful revascularization was achieved in 90.2% of the cases; Mean follow up was 374 +/- 321 days. The mean occlusion length was 15.5 +/- 9.9 cm; the mean stented segment length was 23.2 +/- 12.2 cm. The minimum stent diameter averaged 7.0 +/- 0.6 mm, and the maximum final balloon diameter averaged 5.9 +/- 0.6 mm. The mean pre- and post-intervention WIQ scores were 722 +/- 1503, and 8,421 +/- 5,741 (p < 0.0005), respectively. The mean delta-WIQ was 7,405 (95% CI: 6,555 to 9,245). The mean pre- and post-intervention ABI were 0.61 +/- 0.18, and 0.91 +/- 0.19 (p < 0.0005), respectively. The mean delta-ABI was 0.27 (95% CI: 0.21 to 0.33). The clinically-driven target lesion revascularization rate at 12 months was 11.8%. CONCLUSIONS: Chronically occluded SFAs can be treated by percutaneous nitinol stenting techniques with a high degree of success that is durable at 12-month follow up. Patients have a significant improvement in QOL and ABI. Repeat revascularization rates are reasonably low, and parallel the historical surgical data.

Eptifibatide in peripheral vascular interventions: results of the Integrilin Reduces Inflammation in Peripheral Vascular Interventions (INFLAME) trial.

An acute inflammatory response occurs following percutaneous coronary and peripheral vascular interventions (PVI), partly mediated by platelet activation. Glycoprotein (GP) IIb-IIIa inhibitors might partially attenuate this inflammation rise in the coronary patient, but data in patients undergoing PVI are lacking. In the Integrilin Reduces Inflammation in Peripheral Vascular Interventions trial (INFLAME), we hypothesized that eptifibatide reduces the acute inflammatory responses following PVI. This is a single-center, randomized, open-label study of intravenous eptifibatide (180 micro/kg bolus x 2, 10 minutes apart, then 2 micro/kg/min infusion over 18 hours) and low-dose unfractionated heparin (60 Units per kg, target activated clotting time (ACT) 200-250 sec) [LDH+I group; n = 21] versus high-dose unfractionated heparin alone (100 Units per kg, target ACT 300-400 sec) [HDH group; n = 21] in patients undergoing iliac and infrainguinal interventions. The primary endpoints of the study were markers of inflammation (soluble CD-40L [sCD-40L], high-sensitivity C-reactive protein [hs-CRP] and interleukin-6 [IL-6]), thrombin generation (Fragment 1.2 [F1.2]), and fibrinogen measured at baseline and postrandomization. Markers were assayed at baseline, postdilatation at 30 minutes, 2 hours, 18 hours, 48 hours and 7 days. Mean platelet inhibition with eptifibatide was 98% (range 92-100%) using the Accumetrics Rapid Platelet Function Assay at 10 minutes after final bolus. After adjusting for baseline values, the mean +/- SE difference in sCD-40L (loge scale), hs-CRP and F1.2 between the LDH+I group and the HDH was not significant. Fibrinogen had significantly higher mean levels at 7 days for the LDH+I group (541.19 mg/dL versus 472.26 mg/dL; p-value = 0.024). IL-6 was more detectable in the LDH+I group compared to the HDH following intervention. We conclude that LDH+I combination did not reduce acute inflammatory responses as compared to HDH in patients undergoing peripheral vascular interventions.

Routine visualization of the left internal mammary artery before bypass surgery: is it necessary?

The left internal mammary (LIMA) is an ideal conduit for bypassing the left anterior descending artery (LAD) during coronary artery bypass surgery (CABG). In this study, we evaluate the frequency of significant disease in the LIMA prior to CABG and describe associated significant lateral costal branches (> 1.5 mm), subclavian disease and vertebral disease. In 115 consecutive patients referred to CABG, 101 patients met the inclusion criteria. All patients who underwent routine visualization of the LIMA vessels were reviewed and quantitatively analyzed by an independent reader. Disease in the LIMA, left subclavian and vertebral arteries were graded and considered significant if lesions were > 50%. Lateral costal branches of the LIMA were also noted for their presence and size. Of the 101 patients, 87.1% of the LIMAs prior to surgery were without any disease. One LIMA had a 25-50% narrowing and the remaining LIMAs showed 0-25% disease. Of the LIMAs, 48.5% had lateral costal branches with diameters > 1.5 mm. The incidence of significant left vertebral disease and proximal subclavian disease was 37.6% and 5%, respectively. Cardiolite stress imaging post-CABG (n = 75) showed that when ischemia persisted in the anterior wall in patients with a LIMA to the LAD, this was not associated with the presence of significant LIMA disease, lateral costal branches, or subclavian disease identified pre-operatively. We conclude that the LIMA rarely shows significant disease on routine visualization prior to CABG. Asymptomatic subclavian artery disease and the presence of lateral costal branches pre-operatively did not correlate with post-CABG ischemia in the LAD territory.

Clinical and angiographic predictors of restenosis following renal artery stenting.

UNLABELLED: Percutaneous stenting has become the procedure of choice for treatment of obstructive atherosclerotic renal artery (RA) disease. Restenosis, however, continues to be in the range of 15-25% of treated vessels. In this study, clinical and angiographic predictors of restenosis were assessed. Of 132 vessels included, fifty-eight were followed for restenosis using duplex Doppler (n=15), conventional angiogram (n=33) or multislice computed tomography (CT) angiogram (n=10). Fifteen vessels (26%) met the criteria for restenosis (lesion > or =50% by conventional or CT angiography or >60% by Doppler) at a follow-up range of 2-20 months (5% <2 months; 68% 3-12 months; 27% 13-20 months). Cox Regression analyses were performed for selected variables. A p-value <0.05 was considered statistically significant. History of smoking [odds ratio (OR), 6.6:1; p=0.005] and time to evaluate for restenosis were independent predictors of the occurrence of restenosis. Also, a high restenosis rate (40%) was seen in vessels < or =4 mm in diameter (n=20) in contrast to larger vessels (n=38) >4 mm (18.4%). Although statistical significance was not reached (possibly because of the small sample size), clinically this is a significant finding. A significant drop in systolic (-15.6 mmHg) and diastolic (-6.2 mmHg) blood pressures was seen following RA stenting with no significant change in the total number of antihypertensives used (2.4 versus 2.5 for pre- and post-renal stenting, respectively). CONCLUSION: Restenosis occurred in 26% of successfully stented RAs. History of smoking, time to evaluate for restenosis and small vessels (< or =4 mm) were predictors of its occurrence. Clinically, a significant drop in blood pressure was seen with RA stenting without a change in the total number of antihypertensives on follow-up.

Bivalirudin in peripheral vascular interventions: a single center experience.

Unfractionated heparin is a widely utilized anticoagulant during peripheral angioplasty procedures (PTA). In contrast to heparin, bivalirudin is a direct thrombin inhibitor with predictable anticoagulation, does not activate platelets, and inhibits both soluble and bound thrombin. The experience with bivalirudin during PTA remains limited. In this single-center prospective study, 48 consecutive patients (60.4% males, mean age 70.0 12.1) received bivalirudin as the primary anticoagulant during PTA (0.75 mg/kg bolus, 1.75 mg/kg/h during the procedure). Thirty-four (70.8%) had claudication and 6 (12.5%) had ulceration. Thrombus was angiographically seen in 3 (6.3%) patients. In-hospital serious procedural complications were limited to 2 (4.2%) (exact 95% confidence interval: (0.5%,14.3%]) patients with major bleeding; none (0.0%) of the other following endpoints occurred: death, limb loss, emergent need for revascularization of the same vessel, embolic strokes, and vascular complications (exact 95% confidence intervals: [0.0%,6.1%]). This compared favorably to previously reported data using unfractionated heparin and the same serious procedural complications endpoints from our group at the same institution (9.2%). We conclude that the use of bivalirudin during PTA appears feasible and safe. Large prospective registries are needed to confirm these findings.

In-hospital complications of peripheral vascular interventions using unfractionated heparin as the primary anticoagulant.

Unfractionated heparin is the current antithrombotic of choice in peripheral vascular interventions. The rate of in-hospital major complications during peripheral angioplasty procedures (PTA) using heparin as the primary anticoagulant has not been well defined. In this single-center study, the charts of 213 consecutive PTA procedures in a 1-year period were reviewed. Of unstaged procedures, a total of 131 patients (57.3% males; mean age, 66.4 12.1 years) met inclusion criteria. Forty-five patients (34.4%) had recent onset of claudication and 15 (11.5%) had ulceration. Thrombus was angiographically visualized in 16.7% of patients. Unfractionated heparin was administered at a mean of 4,672 1,238 U (59.1 20.0 U/kg) during the procedure. The highest activated clotting time (ACT) during the procedure was recorded in 114 patients. ACTs were < 300, 300 400 and > 400 seconds in 29.0%, 29.0% and 42.1%, respectively. In-hospital clinical events occurred in 12 patients (9.2%) who met any one of the following endpoints: death (0.8%), limb loss (1.5%), major bleeding (4.6%), emergent need for repeat revascularization of the same vessel (7.6%), embolic stroke (0.0%) and vascular complications (1.5%). The best model associated with salvage revascularization included cigarette smoking within the past year, recent onset of claudication and PTA treatment below the knee. Increased dosages of heparin (U/kg) were associated with a trend toward higher rates of complications. A significant number of patients have in-hospital major complications following PTA procedures using unfractionated heparin as the primary anticoagulant. Current ongoing registries are evaluating the feasibility of direct thrombin inhibitors bivalirudin instead of heparin as a primary anticoagulant during PTA.

Simultaneous estimation of intrarater and interrater agreement for multiple raters under order restrictions for a binary trait.

It is valuable in many studies to assess both intrarater and interrater agreement. Most measures of intrarater agreement do not adjust for unequal estimates of prevalence between the separate rating occasions for a given rater and measures of interrater agreement typically ignore data from the second set of assessments when raters make duplicate assessments. In the event when both measures are assessed there are instances where interrater agreement is larger than at least one of the corresponding intrarater agreements. This implies that a rater agrees less with him/herself and more with another rater. In the situation of multiple raters making duplicate assessments on all subjects, the authors propose properties for an agreement measure based on the odds ratio for a dichotomous trait: (i) estimate a single prevalence across two reading occasions for each rater; (ii) estimate pairwise interrater agreement from all available data; (iii) bound the pairwise interrater agreement above by the corresponding intrarater agreements. Estimation of odds ratios under these properties is done by maximizing the multinomial likelihood with constraints using generalized log-linear models in combination with a generalization of the Lemke-Dykstra iterative-incremental algorithm. An example from a mammography examination reliability study is used to demonstrate the new method.