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In COVID’s immediate wake, the 2020 death toll from a different enemy of the public’s health — gun violence — ticked up by 15 percent in the United States from the previous year. Meanwhile, the U.S. Supreme Court issued an opinion in Caniglia v. Strom that will allow people who have recently threatened suicide — with a gun — to keep unsecured guns in their home unless police take time to obtain a search warrant to remove them.

The Carpentier-Edwards PERIMOUNT Magna Ease valve is a third-generation bioprosthesis for aortic valve replacement (AVR). This is a postapproval study reporting on its 8-year outcomes.Adults undergoing AVR with the Magna Ease valve between October 2007 and December 2012 were enrolled for this prospective, nonrandomized, single-arm, and multicenter study. Assessments occurred preoperatively, at hospital discharge, 6 months, 1 year, and annually thereafter for up to 8 years. Outcomes included safety endpoints, hemodynamic performance, and New York Heart Association (NYHA) functional class.Of the 258 study patients, 67.5% were in NYHA Class I or II, and 32.5% were in NYHA Class III or IV at baseline. Concomitant procedures were performed in 44.2%. Total follow-up was 1597.6 patient-years, and median follow-up was 7 years (interquartile range: 5.5-8.0 years). Eight years following AVR, the functional class remained improved from baseline with 93.9% in NYHA Class I/II and 6.1% in NYHA Class III; 38 deaths had occurred, 8 of which were valve related; freedom from all-cause mortality was 80.7% (95% confidence intervals: 74.9, 86.4); freedom from valve-related mortality was 95.8% (92.8, 98.8); freedom from reintervention, explant, major bleeding events, and structural valve deterioration was 89.8% (85.1, 94.6), 94.8% (91.7, 97.9), 85.1% (80.0, 90.1), and 90.1% (84.7, 95.4), respectively; effective orifice area was 1.5 ± 0.5 cmThis study demonstrated satisfactory safety and sustained hemodynamic and functional improvements at 8 years following AVR with the Magna Ease valve.

Enhanced Recovery After Surgery (ERAS) pathways have improved clinical outcomes, cost-effectiveness, and patient satisfaction across multiple non-cardiac surgical specialties. Since the adaptation of ERAS in cardiac surgery is rapidly increasing yet still evolving, herein, we demonstrate early results of our implementation of ERAS cardiac guidelines. We retrospectively reviewed all patients who were managed with our institutional ERAS Cardiac Surgery guidelines between 5/2018 and 6/2019(N = 102). Postoperative primary outcomes (total ventilation times(hours), intensive-care unit(ICU) stay, and postoperative hospital length of stay (LOS)) were compared to 1:1 propensity matched controls from the pre ERAS era between January 2017 and March 2019. A total of 76 propensity-matched pairs were identified. Compared to the matched controls, ERAS patients had significantly shorter median ventilation times(3.5 vs. 5.3 hours, p = .01), ICU stays(median 28 vs 48 hours, p=.005) and postoperative hospital LOS (median 5 vs. 6 days, p = .03). There were no operative mortalities and no significant differences in 30-day readmission rates. There were also no significant differences in post-operative stroke, acute kidney injury, atrial fibrillation, and reoperation rates for bleeding. Two-year survival was also not statistically different between the two cohorts (p = .22). Our initial experience with implementation of ERAS protocols in cardiac surgery appear to demonstrate that these protocols are associated with shorter ventilation times, ICU stay, and hospital LOS without compromising patient outcomes. While these results are promising yet preliminary, further studies are warranted to demonstrate whether ERAS algorithms in cardiac surgery can consistently expedite postoperative recovery and improve outcomes.

Background Central airway occlusion is a feared complication of general anesthesia in patients with mediastinal masses. Maintenance of spontaneous ventilation and avoiding neuromuscular blockade are recommended to reduce this risk. Physiologic arguments supporting these recommendations are controversial and direct evidence is lacking. The authors hypothesized that, in adult patients with moderate to severe mediastinal mass–mediated tracheobronchial compression, anesthetic interventions including positive pressure ventilation and neuromuscular blockade could be instituted without compromising central airway patency. Methods Seventeen adult patients with large mediastinal masses requiring general anesthesia underwent awake intubation followed by continuous video bronchoscopy recordings of the compromised portion of the airway during staged induction. Assessments of changes in anterior–posterior airway diameter relative to baseline (awake, spontaneous ventilation) were performed using the following patency scores: unchanged = 0; 25 to 50% larger = +1; more than 50% larger = +2; 25 to 50% smaller = −1; more than 50% smaller = −2. Assessments were made by seven experienced bronchoscopists in side-by-side blinded and scrambled comparisons between (1) baseline awake, spontaneous breathing; (2) anesthetized with spontaneous ventilation; (3) anesthetized with positive pressure ventilation; and (4) anesthetized with positive pressure ventilation and neuromuscular blockade. Tidal volumes, respiratory rate, and inspiratory/expiratory ratio were similar between phases. Results No significant change from baseline was observed in the mean airway patency scores after the induction of general anesthesia (0 [95% CI, 0 to 0]; P = 0.953). The mean airway patency score increased with the addition of positive pressure ventilation (0 [95% CI, 0 to 1]; P = 0.024) and neuromuscular blockade (1 [95% CI, 0 to 1]; P < 0.001). No patient suffered airway collapse or difficult ventilation during any anesthetic phase. Conclusions These observations suggest a need to reassess prevailing assumptions regarding positive pressure ventilation and/or paralysis and mediastinal mass–mediated airway collapse, but do not prove that conventional (nonstaged) inductions are safe for such patients. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Introduction The Carpentier-Edwards PERIMOUNT Magna Ease valve is a third-generation bioprosthesis for aortic valve replacement (AVR). This is a postapproval study reporting on its 8‑year outcomes. Methods Adults undergoing AVR with the Magna Ease valve between October 2007 and December 2012 were enrolled for this prospective, nonrandomized, single‑arm, multicenter study. Assessments occurred preoperatively, at hospital discharge, 6 months, 1 year, and annually thereafter up to 8 years. Outcomes included safety endpoints, hemodynamic performance, and New York Heart Association (NYHA) Functional Class. Results Of the 258 study patients, 67.5% were in NYHA Class I or II, and 32.5% were in NYHA Class III or IV at baseline. Concomitant procedures were performed in 44.2%. Total follow-up was 1,597.6 patient-years, median follow‑up was 7 years (interquartile range: 5.5–8.0 years). Eight years following AVR, functional class remained improved from baseline with 93.9% in NYHA Class I/II and 6.1% in NYHA Class III; thirty-eight deaths had occurred, eight of which were valve related; freedom from all‑cause mortality was 80.7% (95% confidence intervals 74.9, 86.4); freedom from valve-related mortality was 95.8% (92.8, 98.8); freedom from reintervention, explant, major bleeding events, and structural valve deterioration were 89.8% (85.1, 94.6), 94.8% (91.7, 97.9), 85.1% (80.0, 90.1), and 90.1% (84.7, 95.4), respectively; effective orifice area was 1.5±0.5 cm , mean gradient was 14.8±8.3 mmHg, and 88.6% of patients had no or trivial aortic regurgitation. Conclusions This study demonstrated satisfactory safety and sustained hemodynamic and functional improvements at 8 years following AVR with the Magna Ease valve.

The partisanship of a policy maker is often noted as correlated with a state government's support for social welfare. However, less attention has been paid to how a governor is able to steer the budget in a manner that reflects her political views. This study assesses how changes in the economy and level of budgetary authority of the governor can jointly condition the effect of a governor's partisanship on the change in social welfare spending. Using the panel data for 49 U.S. states from 1987 to 2014, we examine whether budgetary authority allows governors to respond to an economic contraction in the expected partisan manner. Using a three‐way interaction model, we found that Democratic governors are more likely to increase social welfare funding when the economy contracts, particularly when she has high budgetary authority relative to non‐Democratic counterparts. The results highlight how the state of the economy and institutional constraints jointly condition the budget process. 一名决策者的党派性时常被认为与州政府对社会福利的支持相关。然而，较少的关注聚焦于州长如何以一种反映其政治观点的方式来操纵预算。本研究评估了经济变革和州长预算权的大小如何共同影响州长党派性对社会福利开支变化产生的效果。通过使用1987年至2014年间美国49个州的面板数据，我们检验了预算权是否允许州长以预期的党派方式对经济收缩进行响应。通过使用一项三方互动模型，我们发现，民主党籍州长更有可能在经济收缩时增加社会福利资金，特别是当其相对于非民主党籍州长拥有高预算权时。研究结果强调了经济状态与制度限制如何共同影响预算过程。 El partidismo de un formulador de politicas a menudo se observa como correlacionado con el apoyo de un gobierno estatal para el bienestar social. Sin embargo, se ha prestado menos atencion a como un gobernador puede dirigir el presupuesto de una manera que refleje sus puntos de vista politicos. Este estudio evalua como los cambios en la economia y el nivel de autoridad presupuestaria del gobernador pueden condicionar conjuntamente el efecto del partidismo de un gobernador sobre el cambio en el gasto de bienestar social. Utilizando datos de panel para 49 estados de EE. UU. Desde 1987 hasta 2014, examinamos si la autoridad presupuestaria permite a los gobernadores responder a una contraccion economica de la manera partidista esperada. Usando un modelo de interaccion de tres vias, descubrimos que los gobernadores democratas tienen mas probabilidades de aumentar los fondos de bienestar social cuando la economia se contrae, particularmente cuando tiene una alta autoridad presupuestaria en relacion con sus contrapartes no democratas. Los resultados destacan como el estado de la economia y las restricciones institucionales condicionan conjuntamente el proceso presupuestario.

This paper looks at whether fiscal decentralization of welfare programs made state governments effective at alleviating poverty. We make use of the National Association of State Budget Officers’ (N...

Policymakers have been debating the value of social assistance programs, specifically whether they create a dependence resulting in unnecessary waste. We examine the impact of targeted social assistance programs on infant health, while also accounting for variations in sociodemographic and economic factors across the nation. Using information from the Centers for Disease Control (CDC), we combine information on infant health with data on state social assistance programs taken mostly from the University of Kentucky’s Center for Poverty Research between the years 1998 and 2015 for all US states. We find that an increase in TANF and SNAP generosity within a state is associated with an improvement in infant health. Our findings demonstrate the need for a social safety net to help the less fortunate and keep a productive society healthy.

BACKGROUND: Focused cardiac ultrasound (FoCUS) is an increasingly used diagnostic modality for anesthesiologists and intensivists. However, training residents in its use can be resource intensive. We investigated the feasibility of implementing a self-guided FoCUS curriculum for anesthesiology residents rotating in the postanesthesia care unit (PACU). METHODS: We created a FoCUS curriculum with the aim of providing a consistent largely self-guided experience that would improve FoCUS knowledge and skills while minimizing ongoing time commitment from faculty. To achieve this, we used several methods: (1) developed video didactics and quizzes; (2) used an online educational delivery platform to automate delivery of educational content, monitor resident progress, and elicit feedback; (3) used the transthoracic echocardiography simulator for aided hands-on learning; (4) dedicated educational time that integrated into PACU workflow; (5) worked with a cardiac sonographer; and (6) used image storage software to facilitate remote feedback by ultrasound faculty. The response to the curriculum was evaluated using Kirkpatrick levels 1–3. RESULTS: Forty-one anesthesiology residents rotated through the PACU over a 1-year period and completed this weeklong self-guided FoCUS curriculum. Interesting findings include: (1) favorable evaluation from the residents and (2) improvement in image acquisition skills by objective measures. Once the curriculum was established, ongoing faculty time commitment was approximately 1 hour 20 minutes per week. CONCLUSIONS: The implementation of a FoCUS curriculum in the PACU resulted in favorable resident evaluation and improved FoCUS skills. The curriculum was feasible and self-sustainable because of the novel educational approach employed.

What factors are associated with state government preemption of local government policies? This research asks whether state courts limit local authority in areas in which local preferences differ from the state’s, and whether this is conditioned by the level of autonomy the state grants the local government. Using a newly constructed data set of 404 local governments that had local ordinances challenged in state courts between the years 1996 and 2017, we find that local governments with citizen ideological preferences that differ from the state are less likely to have an ordinance preempted by the courts when the level of local autonomy given by the state is high. Thus, institutions like home rule provide local governments with certain legal protections from challenges to local authority.

Introduction Enhanced Recovery after Cardiac Surgery (ERACS) pathways can increase patient satisfaction, reduce the length of hospital stay and stay in the intensive care unit. The reported incidence of acute kidney injury (AKI) after cardiac surgery varies from 2.5% to 40% and is associated with an increased 30-day mortality¹. We examined the effect of ERACS on the total amount of fluid administered and the incidence of AKI. Methods We retrospectively analyzed prospectively collected outcome data of patients undergoing cardiac surgery enrolled in the ERAS pathway (n = 107) compared to a historical standard care group (n = 173). The ERAS pathway included pre-operative patient education, multimodal pain management to minimize opioid usage, carbohydrate loading 2-4hrs before induction of anesthesia, tight glucose control, early postoperative invasive access and chest tube removal, early extubation, and early mobilization. Intraoperatively, 500mL of the cardiopulmonary bypass (CBP) priming fluid was replaced with albumin 5% and the patients received 250mL albumin 5% before initiation and 250mL after separation from CBP. Crystalloid boli were administered in the intensie care unit (ICU) for clinical signs of hypovolemia, increasing pressor requirements or worsening metabolic acidosis. The standard care group was treated per preexisting institutional guidelines. AKI was defined using modified KDIGO (Kidney Disease Improving Global Outcomes) criteria, patients with pre-existing renal injury were excluded. Data were compared using univariate analysis: parametric and non-parametric data were analyzed with Student's t-test and Wilcoxon rank-sum test, respectively. A p-value of less than 0.05 was considered statistically significant. Results The mean (SD) creatinine pre-operatively, at discharge, and the peak creatinine were not different between the ERACS and the standard care group (table). Less fluid was administered in the ERACS group, but the total fluid balance was not different. No significant difference exists between the occurrence of AKI between those groups; no patient developed AKI worse than KDIGO stage 1 (modified). Discussion Although the ERACS patients received less fluid than the standard care group during the hospital stay, the incidence of AKI did not differ, nor did the serum creatinine at discharge between both groups. A restrictive fluid management with intraoperative albumin administration does not increase the incidence of acute kidney injury for patients in the ERACS pathway.

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Case management programs often designate a nurse or social worker to take responsibility for guiding care when patients are expected to be expensive or risk a major decline. We hypothesized that though an intuitively appealing idea, careful program design and faithful implementation are essential if case management programs are to succeed. We employed two theory perspectives, principal–agent framework and street-level bureaucratic theory to describe the relationship between program designers (principals) and case managers (agents/street-level bureaucrats) to review 65 case management studies. Most programs were successful in limited program-specific process and outcome goals. But there was much less success in cost-saving or cost-effectiveness—the original and overarching goal of case management. Cost results might be improved if additional ideas of agency and street-level theory were adopted, specifically, incentives, as well as “green tape,” clear rules, guidelines, and algorithms relating to resource allocation among patients.

Introduction Enhanced Recovery After Surgery (ERAS) pathways have been proven to increase patient satisfaction scores, decrease the complication rate, decrease the length of stay (LOS), and decrease cost for many surgical specialties. Recently, ERAS for cardiac surgery guidelines have been published and are being implemented in many centers. However, few data are reported on clinically important outcomes. We examined the effect of ERAS for cardiac patients on the duration of mechanical ventilation, ICU and hospital LOS.¹ Methods We retrospectively analyzed prospectively collected outcome data of patients undergoing cardiac surgery enrolled in the ERAS pathway (n = 115) compared to a historical standard care group (n = 188). The ERAS pathway included pre-operative patient education, multimodal pain management to minimize opioid usage, carbohydrate loading 2-4hrs before induction of anesthesia, minimizing crystalloid infusions, tight glucose control, early postoperative invasive access and chest tube removal, early extubation, and early mobilization. The standard care group was treated per preexisting institutional guidelines. Data were compared using univariate analysis: parametric and non-parametric data were analyzed with Student's t-test and Wilcoxon rank-sum test, respectively. A p-value of less than 0.05 was considered statistically significant. Results The median (25th, 75th) intensive care unit (ICU) length of stay (LOS) was 1 day (1, 2) in the ERAS group and 2 days (1, 3) in the standard care group (p Discussion The Enhanced Recovery Pathway after Surgery pathway uses a standardized approach to perioperative patient care. Implementation of ERAS for cardiac surgery results in shorter ICU and hospital LOS, comparable ICU and 30-day readmission rates, without a noticeable increase in 30-day mortality. Further studies focusing on other relevant outcome parameters are warranted.

Background: We aimed to compare periprocedural transesophageal echocardiography (TEE) with postprocedural transthoracic echocardiography (TTE) for the diagnosis of aortic regurgitation (AR). Methods and Results: TEE and TTE images of 163 transcatheter aortic valve replacement (TAVR) patients (mean age 81 ± 8 years; 56% men) were reviewed separately and blinded to each other as well as to all clinical data. The median time between TEE during TAVR (TEE/TAVR) and TTE was 4 days (IQR 2-10 days). After TAVR, 48% of the patients had at least trace AR by TEE, 56% by angiography and 67% by TTE. The majority of AR was paravalvular (78%). More patients were classified with mild-to-moderate AR by TTE than by TEE (44 vs. 22%, p < 0.01). When examining the 46 patients with AR by TTE which was not at TEE/TAVR, both systolic and diastolic blood pressure (SBP and DBP) were significantly higher during TTE than during TEE (mean ΔSBP = 9 ± 4 mm Hg and mean ΔDBP = 6 ± 2 mm Hg, p < 0.01 for both). No differences in BP between TEE and TTE were found among patients with no AR or among those who had AR in both studies. At a median follow-up of 185 days (IQR 39-424 days), the overall mortality was 17%, but this was not associated with the presence of AR on TTE or TEE. Conclusions: Patients' hemodynamic conditions may result in underdiagnosis of paravalvular regurgitation in periprocedural TEE. Our findings suggest that a postprocedural evaluation for AR by TTE could serve as a reasonable alternative to TEE for the evaluation of AR.

F-FDG accumulates in glycolytically active tissues and is known to concentrate in tissues that are rich in activated macrophages. In this study, we tested the hypotheses that human granulocyte-macrophage colony-stimulating factor (GM-CSF), a clinically used cytokine, increases macrophage glycolysis and deoxyglucose uptake in vitro and acutely enhances F-FDG uptake within inflamed tissues such as atherosclerotic plaques in vivo. Methods: In vitro experiments were conducted on human macrophages whereby inflammatory activation and uptake of radiolabeled 2-deoxyglucose was assessed before and after GM-CSF exposure. In vivo studies were performed on mice and New Zealand White rabbits to assess the effect of GM-CSF on F-FDG uptake in normal versus inflamed arteries, using PET. Results: Incubation of human macrophages with GM-CSF resulted in increased glycolysis and increased 2-deoxyglucose uptake (P , 0.05). This effect was attenuated by neutralizing antibodies against tumor necrosis factor-α or after silencing or inhibition of 6-phosphofructo- 2-kinase. In vivo, in mice and in rabbits, intravenous GM-CSF administration resulted in a 70% and 73% increase (P , 0.01 for both), respectively, in arterial F-FDG uptake in atherosclerotic animals but not in nonatherosclerotic controls. Histopathologic analysis demonstrated a significant correlation between in vivo F-FDG uptake and macrophage staining (R 5 0.75, P , 0.01). Conclusion: GM-CSF substantially augments glycolytic flux in vitro (via a mechanism dependent on ubiquitous type 6-phosphofructo-2-kinase and tumor necrosis factor-α) and increases F-FDG uptake within inflamed atheroma in vivo. These findings demonstrate that GM-CSF can be used to enhance detection of inflammation. Further studies should explore the role of GM-CSF stimulation to enhance the detection of inflammatory foci in other disease states., James H.F. Rudd is in part supported by the NIHR Cambridge Biomedical Research Centre, the British Heart Foundation, and HEFCE. Zahi A. Fayad is supported by NIH/NHLBI R01 HL071021, R01 HL078667, NIH/NBIB R01 EB009638, and the NIH/NHLBI Program of Excellence in Nanotechnology (PEN) Award, contract HHSN268201000045C. Parmanand Singh was supported by a grant from the NHLBI (5T32 HL076136) and is funded by the Marfan Foundation. Lisardo Boscá was supported by SAF2014-52492R, RTC2015-3741 from MINECO, and RD12/0042/0019. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas is funded by the Instituto de Salud Carlos III and S2010/BMD-2378 from Comunidad de Madrid. Ahmed Tawakol is supported by NIH/NHLBI R01 HL122177.

This study explored the association between Medicare cost-sharing requirements and the probability of use of various mental health outpatient services among Medicare enrollees with schizophrenia.Multivariate logistic regression was used to estimate the probability of use of each of seven types of services over six months. Patients were recruited from public and private mental health treatment provider organizations in six states. The analyses included 1,088 Medicare enrollees, of whom approximately 55 percent were also enrolled in Medicaid.Medicare-only patients (with greater cost-sharing) were 25 to 45 percent less likely to have used rehabilitation services, individual therapy with nonpsychiatrist mental health providers, and case management. No association was found between Medicaid enrollment and probability of service use for medical clinic visits, group therapy, individual contact with a psychiatrist, or receipt of second-generation antipsychotics.Among Medicare enrollees with schizophrenia, gaps in Medicare coverage may be more problematic for rehabilitation, case management, and contact with nonpsychiatrist providers. Local public and private subsidies for mental health treatment may compensate for some of the gaps in coverage. However, such subsidies are not universally or uniformly provided.

The US Army Research Laboratory (ARL) is creating a Meteorological Sensor Array (MSA) to improve Army decisions by strengthening environmentally-dependent decision aids through validated high-resolution atmospheric models in the boundary layer to provide reliable and persistent data resources, which allow modelers and sensor developers to validate model and sensor performance with atmospheric observations. This report outlines the multiphase MSA Development Plan, and documents the MSA-Phase I (Proof of Concept). Phase I included a) 5 equally-spaced meteorological towers located around a large Solar Photovoltaic Farm in southern NM; b) measurements of pressure, temperature (2 m/10 m), relative humidity (2 m), insolation (2 m) and winds (2 m/10 m); c) solar-powered instrumentation; and d) wireless data download, monitoring, and time synchronization. The MSA data processing included data merging, plotting and formatting for applications. Automating data quality assurance was investigated. Model validation and verification (V&V) was one of several MSA-Phase I data applications. The Weather Running Estimate-Nowcast (WRE-N) model was used to confirm the feasibility of Model V&V with MSA data. Based on the success of Phase I, the authors look forward to future, fruitful phases.

Aims The effects of a new potassium channel opener KRN4884 on human arteries have not been studied. This study was designed to investigate the effects of KRN4884 on the human internal mammary artery (IMA) in order to provide information on possible clinical applications of KRN4884 for preventing and relieving vasospasm of arterial grafts in coronary artery bypass grafting. Methods IMA segments (n = 140) taken from patients undergoing coronary surgery were studied in the organ chamber. Concentration-relaxation curves for KRN4884 were established in the IMA precontracted with noradrenaline (NA), 5-hydroxytryptamine (5-HT), angiotensin II (ANG II), and endothelin-1 (ET-1). The effect of glibenclamide (GBC) on the KRN4884-induced relaxation was also examined in NA or 5-HT-precontracted IMA. Concentration-contraction curves for the four vasoconstrictors were constructed without/with pretreatment of KNR4884 (1 or 30 µm) for 15 min. Results KRN4884 induced less relaxation (P 0.05). Conclusion KRN4884 has marked vasorelaxant effects on the human IMA contracted by a variety of vasoconstrictors and the effect is vasoconstrictor-selective.

Military operations and weapon systems are adversely affected to some extent by the environment, even those advertised as all weather capable. In an effort to simplify the manner in which environmental impacts on weapon systems are determined, the My Weather Impacts Decision Aid (MyWIDA) was developed. This report documents the second generation (GEN II) of weather effects decision aids, MyWIDA, a sophisticated, rules-based expert system based on thousands of identified (and validated) weather sensitivities of Army, Air Force, Navy, Marine, and threat weapons systems and tactical operations. GEN II automatically ingests multi-day weather forecasts which are compared with system engineering limitations (rules) and identifies and provides favorable, marginal, and unfavorable weather-effects impacts in the form of a stop light chart overlaid on a map background in a four-dimensional format for the user to examine. GEN II may be tailored to specific tactical operations and missions providing detailed weather impacts information in terms of what operations and equipment are affected. GEN II also includes the Automated Impacts Routing (AIR) application, which calculates least cost paths for a user-selected system type (aircraft or ground vehicle) given a set of two or more waypoints.

Methods: To analyze the long-term outcome of dynamic cardiomyoplasty, we retrospectively studied 127 consecutive patients who underwent this procedure in Paris, France (n = 76), São Paulo, Brazil (n = 37), and Portland, Oregon (n = 14). Preoperative data were collected for patients operated on between January 1985 and June 1994 and examined with respect to effect on long-term survival. Patients had a mean age of 50 ± 13 years and were predominantly male (82%). In 46% the cause of disease was ischemic. Concomitant operations were performed in 22 patients. Results: Operative mortality was 12% (15/127). Kaplan-Meier survival ± standard error at 1 through 5 years was 73% ± 4%, 57% ± 5%, 49% ± 6%, 44% ± 6%, and 40% ± 7%, respectively. There was a distinct improvement at 6 months in New York Heart Association functional class (3.2 ± 0.05 vs 1.7 ± 0.07, p < 0.0001) and a small but significant increase in left ventricular ejection fraction (20% ± 0.8% vs 23% ± 1.5%, p = 0.04). Ninety-day mortality was associated with low right ventricular ejection fraction, a blunted hemodynamic response to exercise testing, and requirement for an intraaortic balloon pump at the time of the operation. Using a stepwise Cox regression method of multivariable survival analysis (n = 101), we determined that atrial fibrillation, New York Heart Association class IV, high pulmonary capillary wedge pressure, and balloon pump use were independent variables simultaneously associated with poor overall survival. When metabolic testing variables were added to this model, peak oxygen consumption eliminated both pulmonary capillary wedge pressure and functional class from the model, albeit with fewer (n = 74) patients. Conclusion: Dynamic cardiomyoplasty is an evolving therapy for symptomatic congestive heart failure, the results of which may be enhanced by intelligent, risk-sensitive patient selection. (J Thorac Cardiovasc Surg 1996;112:1640-50)

Background The Mitroflow valve (Sorin Group, Milan, Italy) has been in use since 1982 and has shown long-term durability in large studies from European centers but has not been studied for long-term hemodynamics in large standardized multicenter trials. This study sought to assess the hemodynamics of the Mitroflow valve by extending the duration of follow-up in an ongoing prospective multicenter trial conducted in North America. Methods Six sites participated in this midterm study requiring annual follow-up and echocardiographic evaluation using a standardized transthoracic echocardiography acquisition protocol. Results There were 276 patients enrolled (age 74 ± 8 years) and 54% were in New York Heart Association (NYHA) functional class III-IV. Follow-up from the time of valve implantation had a mean of 4.0 ± 1.7 years with a cumulative follow-up of 1,102 patient-years. At 5 years of follow-up, 99% of patients were free of moderate or severe aortic regurgitation and 94% were in NYHA functional class I or II. Between baseline and 5 years, mean gradients increased an average of 0.4 to 4.3 mm Hg. The change in effective orifice area was appreciably small (−0.1 to −0.3 cm 2 ) after 5 years. There were 57 deaths (4 early and 53 late) and 9 valve explants. Conclusions The Mitroflow valve implanted in the aortic position has shown to be hemodynamically stable over a 5-year follow-up in an elderly population with a high prevalence of comorbid conditions.

Although empirical research has examined factors associated with increased violence risk among individuals with severe mental illness (SMI) and among veterans without SMI, less attention has been devoted to identifying violence risk factors among veterans with SMI. Using multivariable analysis of a large pooled sample of individuals with SMI, this study examines violence risk factors of N = 278 veterans with SMI. In multivariate modeling, violence by veterans with SMI was associated with head injury, posttraumatic stress disorder (PTSD), substance abuse, and homelessness. Results support the view clinicians assessing violence risk among veterans with SMI should consider a combination of characteristics empirically related to violence by non-veterans with SMI (e.g., homelessness) and veterans without SMI (e.g., PTSD).

Psychiatric advance directives (PADs) are legal instruments that allow competent persons to document their preferences regarding future mental health treatment and to designate a surrogate decisionmaker in the event they lose capacity to make reliable treatment decisions during an acute episode of psychiatric illness. This study reports the findings of a survey of 1,011 psychiatric outpatients in five U.S. cities about their interest in, and completion of, PADs. Across the sites, only 4 to 13 percent of participants had completed a PAD; however, between 66 and 77 percent reported wanting to complete one if given assistance. Significantly higher demand for PADs was found among participants who were female; were nonwhite; had a history of self-harm, arrest, and decreased personal autonomy; and those who felt pressured to take medication. Actual completion of PADs was more likely among participants with higher insight, those reporting leverage by a representative payee, and those who felt external pressure to keep outpatient appointments for mental health treatment.

Background Sustained lymph stagnation engenders a pathological response that is complex and not well characterized. Tissue inflammation in lymphedema may reflect either an active or passive consequence of impaired immune traffic. Methods and Findings We studied an experimental model of acute post-surgical lymphedema in the tails of female hairless, immunocompetent SKH-1 mice. We performed in vivo imaging of impaired immune traffic in experimental, murine acquired lymphatic insufficiency. We demonstrated impaired mobilization of immunocompetent cells from the lymphedematous region. These findings correlated with histopathological alterations and large-scale transcriptional profiling results. We found intense inflammatory changes in the dermis and the subdermis. The molecular pattern in the RNA extracted from the whole tissue was dominated by the upregulation of genes related to acute inflammation, immune response, complement activation, wound healing, fibrosis, and oxidative stress response. Conclusions We have characterized a mouse model of acute, acquired lymphedema using in vivo functional imaging and histopathological correlation. The model closely simulates the volume response, histopathology, and lymphoscintigraphic characteristics of human acquired lymphedema, and the response is accompanied by an increase in the number and size of microlymphatic structures in the lymphedematous cutaneous tissues. Molecular characterization through clustering of genes with known functions provides insights into processes and signaling pathways that compose the acute tissue response to lymph stagnation. Further study of genes identified through this effort will continue to elucidate the molecular mechanisms and lead to potential therapeutic strategies for lymphatic vascular insufficiency., Editors' Summary Background. Lymphedema is the term used to describe the swelling that can occur after surgery, especially after axillary lymph node dissection for breast cancer, when the lymph vessels that carry protein-rich interstitial fluid from the tissues to the heart are damaged. Lymphedema can be extremely unpleasant and is very hard to treat; treatments that are currently used include those aimed to help massage the flow of lymph back to the chest. Lymphedema seems to be more than just accumulation of lymph, however, as changes also occur in the tissue surrounding the damaged lymph vessels. Currently, very little is known at the most basic level about what exactly these changes are, although they appear to be similar to an inflammatory process. One way of studying such a disease process in humans is to make an animal model that mimics the human condition and study the changes that occur there. For lymphedema, such a model can be made in the mouse tail by cutting lymph vessels there. Why Was This Study Done? The authors wanted to look closely at what happens in the tissues surrounding damaged lymph vessels to try to understand better what these changes are. They also wanted to study the movement of the cells that are normally carried in the lymph. What Did the Researchers Do and Find? The mouse model that the authors developed closely simulates the characteristics of human acquired lymphedema. In the mouse tails that had had their lymph vessels damaged, the authors were able to show that the tails were swollen compared with those of normal animals and of animals that hadhad sham (pretend) surgery. In the animals with lymphedema, many small lymph vessels were seen, as the lymph was unable to flow away normally. The area affected by the lymphedema had the appearance often seen in inflamed tissue, and analysis of genes from the same area to see how active, or “expressed,” they were showed changes that are often seen in, for example, acute inflammation and wound healing. The authors also showed that when these animals were injected with immune cells marked with a light marker, they were less able to remove the cells from the circulation. What Do These Findings Mean? These results show that the response to lymph stagnation is complex, but looks similar to that seen in acute inflammation. These results and this model may be useful in suggesting, and at a later date perhaps testing, treatments for lymphedema. One difference, however, between this mouse model and the condition in humans is that whereas lymphedema in humans is a rather chronic condition, here the researchers were only able to look at the changes over a short period of time. In a related Perspective article, Peter Carmeliet and colleagues further discuss the clinical relevance of these findings ( http://dx.doi.org/10.1371/journal.pmed.0030264). Additional Information. Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030254. • The National Cancer Institute has information for patients and health professionals on lymphedema • Cancerbackup is a United Kingdom cancer information service with information on many aspects of cancer, including lymphedema • The Lymphatic Research Foundation Description has information on lymphatic system research, Rockson and colleagues characterized a mouse model of acute, acquired lymphedema using in vivo functional imaging, histopathological examination, and transcriptional profiling.

Background We report our initial experience with the application of robotic-assisted technologies to the treatment of diseases of the anterior mediastinum. Methods Between October 2001 and December 2003, 18 consecutive patients with anterior mediastinal masses were referred for diagnosis and treatment. Fifteen patients underwent robotic-assisted surgery with the da Vinci robotic system. A single surgical team performed all operations. Resection was accomplished by either median sternotomy or robotic-assisted techniques. Results Fourteen patients underwent successful robotic-assisted thymectomy. One patient underwent robotic-assisted biopsy of a mass that was later determined to be a poorly differentiated carcinoma, 3 patients underwent complete thymectomy by median sternotomy for biopsy-proven extracapsular thymoma, 7 patients had thymoma, and 3 had myasthenia gravis. There were 2 patients each with benign thymic cysts and thymic hyperplasia. Primary thymic carcinoid, thymolipoma, papillary thyroid cancer, and poorly differentiated carcinoma were present in 1 patient each. No conversions, intraoperative complications, or deaths occurred in the 15 patients who underwent robotic-assisted resection. The mean operative time was 96 minutes (range 62 to 132 minutes). The mean robotic time was 48 minutes (range 22 to 76). The median hospital stay was 2 days. All patients are doing well, with a median follow-up of 1 year. Conclusions Robotic-assisted surgery of the anterior mediastinum, and particularly thymectomy, can be performed safely and efficiently. The increased visualization and instrument dexterity afforded by this technology provides an optimal minimally invasive approach to the anterior mediastinum. From this experience we have formulated a comprehensive treatment algorithm for the surgical evaluation and treatment of patients with anterior mediastinal diseases.

BACKGROUND This paper unveils some of the clinical lessons we have learned from caring for cardiomyoplasty patients over the past 7 years. We examine both the clinical and scientific rationale for expanding the time frame of "procedural mortality" from 30 days to 90 days. METHODS Utilizing this definition of procedural mortality, preoperative patient variables were applied to postoperative patient outcomes in order to develop a risk sensitive method of patient selection. Preoperative atrial fibrillation, elevated pulmonary capillary wedge pressure, decreased peak oxygen consumption, and the requirement of intra-aortic balloon pump at the time of cardiomyoplasty, were all found to be independent risk factors for early death following cardiomyoplasty. RESULTS This analysis, which has been previously published, is reviewed and enhanced with the mathematical equations for duplicating these relative risk calculations. The mathematical model presented herein allows a method of risk stratification, which obviates the need for randomized congestive heart failure controls in the future. In the absence of a statistically regulated control population, we also examine the 1-year clinical outcomes of the nonrandomizd control group of patients, who were followed during the North American FDA Phase II Cardiomyoplasty Trial. CONCLUSIONS This quality of life comparison with cardiomyoplasty patients at 1 year revealed a significant decrease in intensive care unit patient-days, a significant increase in activity of daily living score, and a significant improvement in New York Heart Association functional class as compared to control.

A newborn was found to have truncus arteriosus and an interrupted aortic arch, and underwent primary repair. The patient did well initially, but, by 8 weeks postoperatively, showed evidence of severe compression of the right pulmonary artery. At reoperation, the pulmonary artery was found to be compressed by a large aortic root (truncal root) and the retroaortic area was narrowed. The pulmonary artery bifurcation was therefore translocated anteriorly to alleviate the compression.

The consequences of postoperative infection at the site of microsurgical repair were studied. The experiment used 60 Wistar rats which were divided into 3 groups of 20 each. The femoral artery, vein, and nerve were transected unilaterally and repaired using microsurgical techniques. Staphylococcus aureus was then inoculated into the wound of group 1. Beta-hemolytic Streptococcus was inoculated into the wound of group 2. Group 3 rats served as controls. Clinical, anatomical, bacteriological and histopathological examinations were performed on postoperative days 8 and 30. Wounds in which S. aureus was inoculated demonstrated a significant tendency toward vascular thrombosis with extensive tissue destruction. In the majority of these cases, the necrosis caused by the primary infection engendered an associated, opportunistic infection. Streptococcal inoculations in group 2 demonstrated less severe changes than in group 1. These changes were characterized by injury of the vascular structures themselves with a significant tendency for thickening of the arterial wall, perivascular inflammation, and hematoma formation at the site of the repair. This model allows demonstration of the enzymatic and toxic consequences of bacterial infection in a postoperative site characterized by cellular destruction and interstitial edema surrounding foreign bodies represented by sutures.

The degree of muscular ischemia and its reversibility can be quantified in the early stages. This histochemical enzymatic study utilized Nitroblue tetrazolium (NBT) which when reduced by tissue dehydrogenase produces a blue pigment: "formazan." Seventy Wistar rats were subjected to transient hindlimb ischemia by means of a tourniquet for 3, 6, 9, 12, 15 and 18 hours, followed by reperfu sion. Microsurgical muscle biopsies were obtained in each rat at 1 and 12 hours, and 3, 7, 14 days after reperfusion. Time increased in muscle staining demon strated a succino-dehydrogenase deficit confirmed by clinical and histopatho logical follow-up. NBT staining time was 2 minutes (± 8 sec.) in the control group, between 2 and 6 minutes in the reversible ischemia group (rats with 3 and 6 hours of tourniquet), and more than 9 minutes (± 14 sec.) in the irrevers ible ischemia group (animals with more than 9 hours of tourniquet). In vascular surgery and in limb reimplantation this protocol is a practical method of evalu ating cytoplasmic enzymatic activity and the status of myofibrillar oxidation in the early phases of ischemic injury, before histologic changes are clearly deline ated.

Fifty-day-old female, albino Sprague-Dawley rats were induced with DMBA, a potent carcinogen that reliably causes multiple breast tumors. Prophylactic subcutaneous mastectomy was performed 2 weeks after injection. Control animals had no breast tissue removed and developed 5.14 tumors per animal, or 1.3 tumors per quadrant. Animals subjected to 50 percent (unilateral) mastectomy developed 5.4 tumors per animal, with 0.72 tumors per surgical quadrant. Animals that underwent 75 percent (three quadrant) mastectomy developed 4.33 tumors per animal, or 0.48 tumors per surgical quadrant. The incidence of tumors was significantly reduced in the surgical areas. However, the risk of any animal developing a breast neoplasm was not reduced in direct proportion to the percentage of breast tissue removed. We believe that this model may prove valuable in evaluating prophylactic subcutaneous mastectomy.

Cetuximab, an antibody directed against the epidermal growth factor receptor, is an effective clinical therapy for patients with colorectal, head and neck, and non-small cell lung cancer, particularly for those with KRAS and BRAF wild-type cancers. Treatment in all patients is limited eventually by the development of acquired resistance, but little is known about the underlying mechanism. Here, we show that activation of ERBB2 signaling in cell lines, either through ERBB2 amplification or through heregulin up-regulation, leads to persistent extracellular signal-regulated kinase 1/2 signaling and consequently to cetuximab resistance. Inhibition of ERBB2 or disruption of ERBB2/ERBB3 heterodimerization restores cetuximab sensitivity in vitro and in vivo. A subset of colorectal cancer patients who exhibit either de novo or acquired resistance to cetuximab-based therapy has ERBB2 amplification or high levels of circulating heregulin. Collectively, these findings identify two distinct resistance mechanisms, both of which promote aberrant ERBB2 signaling, that mediate cetuximab resistance. Moreover, these results suggest that ERBB2 inhibitors, in combination with cetuximab, represent a rational therapeutic strategy that should be assessed in patients with cetuximab-resistant cancers.

Retrograde cardioplegia through the coronary sinus has been shown to overcome the problems of cardioplegia delivery in aortic valve incompetence and coronary stenosis. Since specific complications, such as coronary sinus injury and lack of perfusion of the thebesian veins, may result from its use, we present a technique of cardioplegia delivery through the right atrium after caval and pulmonary artery exclusion that we believe is safer and more reliable than delivery through the coronary sinus.