Showing papers by "Jewish Hospital published in 2014"

The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty

Abstract: Objectives This study sought to evaluate the safety and efficacy of the Lutonix drug-coated balloon (DCB) coated with 2 μg/mm2 paclitaxel and a polysorbate/sorbitol carrier for treatment of femoropopliteal lesions. Background Percutaneous treatment of peripheral vascular disease is associated with a high recurrence. Paclitaxel-coated balloons at 3 μg/mm2 formulated differently have shown promising results with reduced restenosis. Methods Subjects at 9 centers with Rutherford class 2 to 5 femoropopliteal lesions were randomized between June 2009 and December 2009 to treatment with Lutonix DCB (n = 49) versus uncoated balloons (control group [n = 52]), stratified by whether balloon-only treatment (n = 75) or stenting (n = 26) was intended. The primary endpoint was angiographic late lumen loss at 6 months. Secondary outcomes included adjudicated major adverse events (death, amputation, target lesion thrombosis, reintervention), functional outcomes, and pharmacokinetics. Results Demographic, peripheral vascular disease, and lesion characteristics were matched, with mean lesion length of 8.1 ± 3.8 cm and 42% total occlusions. At 6 months, late lumen loss was 58% lower for the Lutonix DCB group (0.46 ± 1.13 mm) than for the control group (1.09 ± 1.07 mm; p = 0.016). Composite 24-month major adverse events were 39% for the DCB group, including 15 target lesion revascularizations, 1 amputation, and 4 deaths versus 46% for uncoated balloon group, with 20 target lesion revascularizations, 1 thrombosis, and 5 deaths. Pharmacokinetics showed biexponential decay with peak concentration (Cmax) of 59 ng/ml and total observed exposure (AUCall) of 73 ng h/ml. For successful DCB deployment excluding 8 malfunctions, 6-month late lumen loss was 0.39 mm and the 24-month target lesion revascularization rate was 24%. Conclusions Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty. (LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis; NCT00930813 )

Comparative definitions for moderate-severe ischemia in stress nuclear, echocardiography, and magnetic resonance imaging

Abstract: The lack of standardized reporting of the magnitude of ischemia on noninvasive imaging contributes to variability in translating the severity of ischemia across stress imaging modalities We identified the risk of coronary artery disease (CAD) death or myocardial infarction (MI) associated with ≥10% ischemic myocardium on stress nuclear imaging as the risk threshold for stress echocardiography and cardiac magnetic resonance A narrative review revealed that ≥10% ischemic myocardium on stress nuclear imaging was associated with a median rate of CAD death or MI of 49%/year (interquartile range: 375% to 53%) For stress echocardiography, ≥3 newly dysfunctional segments portend a median rate of CAD death or MI of 45%/year (interquartile range: 38% to 59%) Although imprecisely delineated, moderate-severe ischemia on cardiac magnetic resonance may be indicated by ≥4 of 32 stress perfusion defects or ≥3 dobutamine-induced dysfunctional segments Risk-based thresholds can define equivalent amounts of ischemia across the stress imaging modalities, which will help to translate a common understanding of patient risk on which to guide subsequent management decisions

Clinical healing rates of meniscus repairs of tears in the central-third (red-white) zone.

Abstract: Purpose To determine the clinical healing rate of repairs of meniscus tears that extend into the central one-third region and the factors that affect the outcome. Methods A systematic search of PubMed was conducted to determine the outcome of meniscus repairs in the red-white (R/W) zone. Inclusion criteria were as follows: English language, clinical trials published from 1996 to 2013, R/W tears analyzed separately from tears in other zones, arthroscopic suture-based repairs, and all evidence levels. Results Of 344 articles identified, 23 met the inclusion criteria. There were 1,232 patients who had 1,326 meniscus repairs, of which 767 were in the R/W zone. Concurrent anterior cruciate ligament reconstruction was performed in 955 patients (78%). The mean age was 25 years, and the mean follow-up was 4 years. Evaluation criteria included clinical examination in 22 studies, follow-up arthroscopy in 15, magnetic resonance imaging in 6, weight-bearing radiographs in 3, and the International Knee Documentation Committee subjective score in 1. Overall, 637 (83%) of the repairs were considered clinically healed because no additional surgery was required and no obvious clinical meniscus symptoms were detected. This included 382 of 470 inside-out suture repairs (81%) and 255 of 297 all-inside suture repairs (86%). Twenty-two factors were assessed in 13 studies to determine their influence on the outcome, with varying results. Authors generally found that patient age, chronicity of injury, involved tibiofemoral compartment, gender, and concurrent anterior cruciate ligament reconstruction did not adversely affect the results. Insufficient data existed to assess the healing rates according to the type of meniscus tear except for single longitudinal tears. Complications were reported in 3% of the patients in this review. Long-term assessment of a chondroprotective effect of the repairs was conducted in only 2 studies. Conclusions An acceptable midterm clinical healing rate was found for R/W meniscus repairs, supporting this procedure when appropriately indicated. Long-term studies assessing the chondroprotective effect in the involved tibiofemoral compartment using magnetic resonance imaging and radiographs are needed. Level of Evidence Level IV, systematic review of Level I-IV studies.

Neuromuscular Retraining Intervention Programs: Do They Reduce Noncontact Anterior Cruciate Ligament Injury Rates in Adolescent Female Athletes?

Abstract: Purpose: The purpose of this study was to identify neuromuscular training intervention programs that significantly reduced the incidence of noncontact anterior cruciate ligament (ACL) injury rates in female adolescent athletes. Methods: A systematic search of PubMed was conducted to determine the outcome of ACL neuromuscular retraining programs in a specific population. The inclusion criteria were English language, published from 1994-2013, original clinical trials, all evidence levels, female athletes aged 19 years or younger, and noncontact ACL injury incidence rates determined by athlete-exposures. Results: Of 694 articles identified, 8 met the inclusion criteria. Three training programs significantly reduced noncontact ACL injury incidence rates in female adolescent athletes. These were the Sportsmetrics, Prevent Injury and Enhance Performance, and Knee Injury Prevention programs. The estimated number of athletes who needed to train to prevent 1 ACL injury in these 3 studies ranged from 70 to 98, and the relative risk reduction ranged from 75% to 100%. Five programs did not significantly reduce noncontact ACL injury incidence rates. The ACL injury incidence rates for control subjects were lower in these studies (0.03 to 0.08 per 1,000 athlete-exposures) than in those investigations that had a significant effect (0.21 to 0.49 per 1,000 athlete-exposures). There was wide variability among all programs in the frequency, duration, and timing of training; how training was conducted, supervised, or controlled; the components of the program; how exposure data were calculated; noncontact ACL injury incidence rates in the control groups; and compliance with training. Conclusions: Three ACL intervention programs successfully reduced noncontact ACL injury incidence rates in female adolescent athletes. Pooling of data of all ACL intervention programs is not recommended because of numerous methodologic differences among studies. Level of Evidence: Level II, systematic review of Level I and II studies.

Testosterone therapy, thrombosis, thrombophilia, cardiovascular events.

Abstract: There are similar time intervals between starting testosterone therapy (TT) and development of thrombotic (~4.5 months) or cardiovascular (CVD) events (~3 months) which may, speculatively, reflect a shared pathophysiology. We have described thrombotic events 5 months (median) after starting TT in 38 men and 4 women, including 27 with deep venous thrombosis-pulmonary embolism, 12 with osteonecrosis, 1 with central retinal vein thrombosis, 1 with amaurosis fugax, and 1 with spinal cord infarction. In 8 men whose TT was continued, second thrombotic events occurred despite adequate anticoagulation with Coumadin in 8 men, 3 of whom had a third thrombotic event. Of these 42 cases, 40 had measures of thrombophilia-hypofibrinolysis, and 39 were found to have previously undiagnosed thrombophilia-hypofibrinolysis. Before beginning TT, especially in men with previous history of thrombotic events, we suggest that, at a minimum, measurements be made for the Factor V Leiden and Prothrombin mutations, Factors VIII and XI, and homocysteine, to identify men who should not receive TT. We need prospective data focused on whether there should be pre-TT screening based on history of previous venous thromboembolism or for all subjects for major gene thrombophilias. To better resolve questions about TT and all cause and cardiovascular morbidity and mortality and thrombosis, a long term, prospective, randomized, blinded study following the example of the Women's Health Initiative is needed. While we wait for prospective placebo-controlled TT outcome data, TT should be restricted to men with well-defined androgen deficiency syndromes.

Testosterone therapy, thrombophilia-hypofibrinolysis, and hospitalization for deep venous thrombosis-pulmonary embolus: an exploratory, hypothesis-generating study.

Abstract: In our study of 596 men hospitalized in the last 3 years for deep venous thrombosis-pulmonary emboli (DVT-PE), we determined the prevalence of exogenous testosterone (T) use with subsequent develop...

Mechanically assisted taper corrosion in modular TKA.

Abstract: The purpose of this study was to characterize the prevalence of taper damage in modular TKA components. One hundred ninety-eight modular components were revised after 3.9±4.2 years of implantation. Modular components were evaluated for fretting corrosion using a semi-quantitative 4-point scoring system. Design features and patient information were assessed as predictors of fretting corrosion damage. Mild-to-severe fretting corrosion (score ≥2) was observed in 94/101 tapers on the modular femoral components and 90/97 tapers on the modular tibial components. Mixed alloy pairs (p=0.03), taper design (p<0.001), and component type (p=0.02) were associated with taper corrosion. The results from this study supported the hypothesis that there is taper corrosion in TKA. However the clinical implications remain unclear.

Testosterone, thrombophilia, thrombosis.

Abstract: We assessed previously undiagnosed thrombophilia-hypofibrinolysis in 11 testosterone (T)-taking men, five of whom developed deep venous thrombosis (DVT), four pulmonary embolism, one spinal cord infarction, and one osteonecrosis 35 months (median) after starting T gel (50-160 mg/day) or T intramuscular (50-250 mg/week) In the order of referral because of thrombosis after starting T, thrombophilia-hypofibrinolysis was studied in 11 men, and, separately, in two control groups without thrombosis - 44 healthy normal male controls and 39 healthy men taking T Nine men had DVT or DVT-pulmonary embolism after 35 months (median) on T, one spinal cord infarction after 5 days on T, and one had osteonecrosis (knee and then hip osteonecrosis after 6 and 18 months on T) Four of the 11 men (36%) had high factor VIII (≥150%) vs one of 42 (2%) controls (P = 0005), and vs one of 25 (4%) T-controls, (P = 0023) Of the 11 men, two (18%) had factor V Leiden heterozygosity vs none of 44 controls, (P = 004) and vs none of 39 T-controls(P = 0045) Of the 11 men, three had 4G4G plasminogen activator inhibitor-1 homozygosity, one prothrombin G20210A heterozygosity, one low protein S, and one high factor XI When T was continued, second DVT-pulmonary embolism recurred in three of 11 men despite adequate anticoagulation T interacts with thrombophilia-hypofibrinolysis leading to thrombosis Men sustaining DVT-pulmonary embolism-osteonecrosis on T should be studied for thrombophilia Continuation of T in thrombophilic men appears to be contraindicated because of recurrent thrombosis despite adequate anticoagulation Before starting T, to prevent T-associated thrombosis, we recommend measures of factor V Leiden, factor VIII, and the prothrombin gene

Testosterone, thrombophilia, and thrombosis.

Abstract: We describe thrombosis, deep venous thrombosis (DVT) pulmonary embolism (PE; n = 9) and hip-knee osteonecrosis (n = 5) that developed after testosterone therapy (median 11 months) in 14 previously healthy patients (13 men and 1 woman; 13 Caucasian and 1 African American), with no antecedent thrombosis and previously undiagnosed thrombophilia-hypofibrinolysis. Of the 14 patients, 3 were found to be factor V Leiden heterozygotes, 3 had high factor VIII, 3 had plasminogen activator inhibitor 1 4G4G homozygosity, 2 had high factor XI, 2 had high homocysteine, 1 had low antithrombin III, 1 had the lupus anticoagulant, 1 had high anticardiolipin antibody Immunoglobulin G, and 1 had no clotting abnormalities. In 4 men with thrombophilia, DVT-PE recurred when testosterone was continued despite therapeutic international normalized ratio on warfarin. In 60 men on testosterone, 20 (33%) had high estradiol (E2 >42.6 pg/mL). When exogenous testosterone is aromatized to E2, and E2-induced thrombophilia is superimposed on thrombophilia-hypofibrinolysis, thrombosis occurs. The DVT-PE and osteonecrosis after starting testosterone are associated with previously undiagnosed thrombophilia-hypofibrinolysis. Thrombophilia should be ruled out before administration of exogenous testosterone.

Vascularization of the facial bones by the facial artery: implications for full face allotransplantation.

Abstract: Background-The maxillary artery is recognized as the main vascular supply of the facial bones; nonetheless clinical evidence supports a co-dominant role for the facial artery. This study explores the extent of the facial skeleton within a facial allograft that can be harvested based on the facial artery. Methods-Twenty-three cadaver heads were used in this study. In 12 heads, the right facial, superficial temporal and maxillary arteries were injected. In 1 head, facial artery angiography was performed. Ten facial allografts containing the mandible, naso-orbito-maxillo-zygomatic complex and tongue were raised. The soft tissues were dissected to show the arterial anastomotic connections and thereafter removed. Radiograms and CT scans were performed. Results-Constant anastomosis between the facial, inferior alveolar and infraorbital arteries at the mental and infraorbital foramina were found. Facial artery vascularized the homolateral mandibular symphysis, body and ramus. The condylar and coronoid processes were vascularized in 67% of the allografts. The homolateral maxilla was contrasted in all allografts with the exception of the alveolar and palatine processes which contained the contrast in 83% of specimen. The maxillary process of the zygomatic bone was perfused in all allografts, followed by the body, frontal (83%) and temporal processes (67%). The nasal lateral wall and septum were vascularized in 83% of the allografts. The medial and lateral orbital walls and the orbital floor, were stained in all specimens. The zygomatic process of the temporal bone was the least perfused bone. Conclusions- A composite allograft containing 90-95% of the facial bones can be based on bilateral facial arteries.

External validation of the Heidenreich criteria for patient selection for unilateral or bilateral retroperitoneal lymph node dissection for post-chemotherapy residual masses of testicular cancer.

Abstract: Objective To validate the Heidenreich criteria for patient selection for unilateral retroperitoneal lymph node dissection (RPLND) for residual masses after chemotherapy for nonseminomatous germ cell tumor (NSGCT).

Therapeutic play in preparing for surgery: behavior of preschool children during the perioperative period

Abstract: Objective:to describe the behavior of children during the instructional session of therapeutic play (ITP) in the preoperative period and to verify the behavior presented by them during the perioperative period. Methods: Exploratory descriptive study with a quantitative approach, developed in a large private hospital in Sao Paulo, in which the behaviors presented by 30 children between three and five years old, undergoing minor surgery were seen at the hospital during the session of TP and in the surgical center, from admission to awaken from anesthesia. Results: Most children participated in the ITP session (21; 70%), entered the surgical room spontaneously (22; 73.3%) without resisting mother separation (24; 80%), collaborating with the anesthetic procedure (16; 53.3%) and quietly awakening from anesthesia (26; 87%). Conclusion: The use of ITP led the child to understand the surgical procedure, making it less traumatic.

Testosterone, anastrozole, factor V Leiden heterozygosity and osteonecrosis of the jaws.

Abstract: Our specific aim is to describe the development of thrombotic osteonecrosis of the jaws after testosterone-anastrozole therapy in a 55-year-old white man subsequently found to have previously undiagnosed factor V Leiden heterozygosity. Before the diagnosis of V Leiden heterozygosity, he was given testosterone gel, 50 mg/day, and on testosterone, serum testosterone (963 ng/dl) and estradiol were high (50 pg/ml). Anastrozole was started, and testosterone was continued. Six months later, osteonecrosis of the jaws was diagnosed. Exogenous testosterone is aromatized to estradiol and estradiol-induced thrombophilia, when superimposed on underlying familial thrombophilia, as in this case, may lead to thrombosis and osteonecrosis. We recommend that before giving testosterone, at a minimum, screening for the factor V Leiden and G20210A mutations, and factor VIII and XI activity be carried out, to avoid unanticipated thrombosis.

Elevated Levels of Hemoglobin A1c Are Associated With Cerebral White Matter Disease in Patients With Stroke

Abstract: Background and Purpose—This study was conducted to investigate the association of cerebral white matter disease (WMD) on MRI with vascular risk factors and laboratory findings in consecutive first acute ischemic stroke patients. Methods—Acute ischemic stroke patients underwent MRI ≤24 hours after stroke onset and follow-up on day 2. WMD was scored on fluid attenuated inversion recovery MRI according to the Wahlund score. Vascular risk factors and laboratory parameters were assessed during hospital stay. Univariate and multiple logistic regression analyses were performed. Results—We included 512 patients with first acute ischemic stroke (mean age, 68.5 [SD, 13.2] years; 192 women (37.5%); median National Institutes of Health Stroke Scale on admission, 3 [interquartile range, 1–6]; and median Wahlund score, 4 [interquartile range, 2–9]). WMD was present in 460 (89.8%) patients. In univariate analysis, age, arterial hypertension, reduced estimated glomerular filtration rate, hemoglobin A1c (HbA1c) levels, di...

A hyperoxic lung injury model in premature rabbits: the influence of different gestational ages and oxygen concentrations.

Abstract: Background Many animal models have been developed to study bronchopulmonary dysplasia (BPD). The preterm rabbit is a low-cost, easy-to-handle model, but it has a high mortality rate in response to the high oxygen concentrations used to induce lung injury. The aim of this study was to compare the mortality rates of two models of hyperoxia-induced lung injury in preterm rabbits. Methods Pregnant New Zealand white rabbits were subjected to caesarean section on gestational day 28 or 29 (full term = 31 days). The premature rabbits in the 28-day gestation group were exposed to room air or FiO2 ≥95%, and the rabbits in the 29-day gestation group were exposed to room air or FiO2 = 80% for 11 days. The mean linear intercept (Lm), internal surface area (ISA), number of alveoli, septal thickness and proportion of elastic and collagen fibers were quantified. Results The survival rates in the 29-day groups were improved compared with the 28-day groups. Hyperoxia impaired the normal development of the lung, as demonstrated by an increase in the Lm, the septal thickness and the proportion of elastic fibers. Hyperoxia also decreased the ISA, the number of alveoli and the proportion of collagen fibers in the 28-day oxygen-exposed group compared with the control 28-day group. A reduced number of alveoli was found in the 29-day oxygen exposed animals compared with the control 29-day group. Conclusions The 29-day preterm rabbits had a reduced mortality rate compared with the 28-day preterm rabbits and maintained a reduction in the alveoli number, which is comparable to BPD in humans.

Magnetic resonance imaging, computed tomography, and radiographic correlation of nonunion of the posteromedial tubercle of the talus: a case report.

Abstract: Fracture of the posteromedial tubercle of the talus is an uncommon injury that is often missed on plain radiographs. In the present report, we describe the case of an adult male with a chronic nonunited fracture of the medial tubercle of the posterior process of the talus after having undergone clinical and radiographic evaluation in a community hospital emergency department. A review of the computed tomographic, magnetic resonance imaging, and plain film radiographic findings associated with nonunion of the posteromedial tubercle of the talus is also presented.

Brinquedo terapêutico no preparo para a cirurgia: comportamentos de pré-escolares no período transoperatório

Abstract: Objetivo: Descrever o comportamento de criancas durante a sessao de brinquedo terapeutico instrucional (BTI) no periodo pre-operatorio e verificar o comportamento apresentado por elas no periodo transoperatorio. Metodo: Pesquisa descritiva exploratoria de abordagem quantitativa, desenvolvida em um hospital particular de grande porte da cidade de Sao Paulo, na qual os comportamentos apresentados por 30 criancas entre tres e cinco anos submetidas a cirurgia de pequeno porte foram observados na unidade de internacao durante a sessao de BT e na sala de cirurgia, desde a admissao ate despertarem da anestesia. Resultados: A maioria participou efetivamente da sessao de BTI (21; 70%), entrou espontaneamente na sala operatoria (22; 73,3%) e sem resistir a separacao da mae (24; 80%), colaborando com o procedimento anestesico (16; 53,3%) e despertando da anestesia tranquilamente (26; 87%). Conclusao: O uso do BTI propiciou a crianca compreender o procedimento cirurgico, tornando-o menos traumatico.

Treatment of Osteonecrosis of the Hip and Knee with Enoxaparin

Abstract: In a prospective study, we hypothesized that a 3-month course of enoxaparin would prevent progression of Ficat stages I–II primary osteonecrosis (ON) of the hip(s) associated with thrombophilia-hypofibrinolysis, having previously shown that despite enoxaparin, hips staged as Ficat III or IV routinely progressed to total hip replacement (THR) as did hips in patients with ON secondary to corticosteroids, alcohol, etc. After 3 months on enoxaparin, 20 patients (30 hips) with ≥ 1 thrombophilia-hypofibrinolysis and Ficat stages I–II primary ON of ≥ 1 hip were followed for 4–7 years. Maintenance of Ficat stages I–II versus progression to stages III–IV or THR over a follow-up period of 4–7 years was the current study’s endpoint. The first 16 patients (25 hips) received enoxaparin (60 mg/day) for 3 months. The next 4 patients (5 hips) received enoxaparin 1.5 mg/kg/day for 3 months. Two of these 4 patients were subsequently maintained on enoxaparin and then Xarelto 10 mg/day for 6 years, and Warfarin (INR 3–3.5) for 13 years, respectively. Based on intent to treat, at 4-year follow-up, 22 of the original 30 hips (73 %) remained unchanged (Ficat stages I or II), as did 16 of 30 hips (53 %) at 7 years. The two patients with chronic anticoagulation had no change from pretreatment Ficat I–II ON of ≥ 1 hip at 6 and 13 years follow-up. Compared with untreated historical controls (approximately 20 % 2-year hip survival), 4-year survival of 73 % of hips, based on intent to treat, suggests that the original 12 week enoxaparin treatment produces lasting benefit in primary ON in patients with heritable thrombophilia-hypofibrinolysis.

Culturally sensitive approaches to recruitment and retention of Hispanics in the national lung screening trial.

Abstract: Hispanics are underrepresented in medical research. At the National Lung Screening Trial’s University of Colorado Denver screening center, traditional recruitment methods resulted in enrollment of few Hispanics. In response, the center adopted culturally sensitive recruitment techniques, including use of carefully-crafted bilingual materials. Bilingual interviewers were hired, and persons familiar with culture and language of groups of different Hispanic origin were consulted. Representation of Hispanics among participants enrolled at the Colorado center increased nearly threefold, from 3.3 to 9.4 %, after adoption of these methods. In this manuscript, we report on the specialized recruitment methods that were developed and how they were used to address known barriers to Hispanic recruitment.

Understanding the experiences of caregivers of children with tuberculosis in directly observed therapy

Abstract: Objective To understand the situations and communications experienced by caregivers of children with tuberculosis (TB) with regard to directly observed therapy (DOT). Method A descriptive exploratory study with a qualitative approach was applied and developed in the ambulatory of Programa Einstein na Comunidade de Paraisopolis (PECP). The data were collected using semi-structured interviews of 13 caregivers of children with TB in DOT. The Collective Subject Discourse (CSD) method was used to analyze the data. Results Seven CSDs were identified and grouped into four categories: "Living in a difficult situation", "Changing the family routine", "Responsibility almost always fall son the mother", and "Adapting to the DOT". Conclusions The difficulties faced by the caregiver of the child at the beginning of DOT significantly changed the familiar routine. The responsibility for its continuity was assigned to the mother, who must adapt to the demands of the treatment and face the situation.