Assessment of 2-Year Mortality With Use of Drug-Coated Devices in Femoropopliteal Disease: A Real-World Experience From the Bronx, New York.

The use of drug-coated devices (DCD) in peripheral arterial disease (PAD) intervention continues to remain controversial after a recent meta-analysis raised concerns of higher late mortality outcome with the use of these devices. Given this, there is need for more data with regards to the late mortality outcome with DCD use. We sought to assess the 2-year mortality outcome in patients with PAD treated with DCD in an inner-city public hospital that mainly serves patients of lower socio-economic status. METHODS: This was an observational study of consecutive patients with femoropopliteal arterial disease who had revascularization procedures from 2014 to 2018 at Jacobi Medical Center and were followed for 2 years. Patients were classified into DCD and non-drug-coated (nDCD) groups based on the device used at the index procedure. The primary endpoint was 2-year mortality. Propensity cohort matching was applied. A multivariate Cox regression model was used to identify baseline variables associated with 2-year mortality. RESULTS: 152 patients were included in this analysis (DCD group = 83, nDCD group =69). No significant difference in mortality between the two groups was identified at 2 years after propensity score matching with replacement (DCD: HR 0.72; 95% CI 0.30-1.71; p = 0.457). Patients that had revascularization because of intermittent claudication had lower mortality at 2 years compared to patients with critical limb ischemia as procedure indication (HR 0.18; 95% CI 0.04-0.82; p = 0.026). CONCLUSIONS: This propensity score matched study revealed no difference in 2-year mortality between patients treated with DCD compared to patients treated with nDCD.

Bronchospasmolytic activity and adenosine receptor binding of some newer 1,3-dipropyl-8-phenyl substituted xanthine derivatives.

The aldehyde derivatives of 1,3-dipropyl xanthines as described in this paper, constitutes a new series of selective adenosine ligands displaying bronchospasmolytic activity. The effect of substitution at third- and fourth-position of 8-phenyl xanthine has also been taken into consideration. The synthesized compounds showed varying binding affinities at different adenosine receptor subtypes (A1 , A2A , A2B , and A3 ) and also good in vivo bronchospasmolytic activity against histamine aerosol-induced asthma in guinea pigs. Most of the compounds showed maximum affinity toward the A2A receptor subtype. The monosubstituted 3-aminoalkoxyl 8-phenyl xanthine with a aminodiethyl moiety (compound 12e) was found to be most potent A2A adenosine receptor ligand (Ki  = 0.036 µM) followed by disubstituted 4-aminoalkoxyl-3-methoxy-8-phenyl xanthine (Ki  = 0.050 µM) (compound 10a).

Heart Failure and a Plant-Based Diet. A Case-Report and Literature Review.

A 54-year-old female with grade 3 obesity body mass index (BMI 45.2 kg/m2) and type II diabetes (hemoglobin A1c 8.1%) presented to her primary care physician in May 2017 with a chief complaint of left lower extremity edema. Work-up revealed heart failure with depressed left ventricular systolic function. Upon diagnosis, she substantially altered her lifestyle, changing her diet from a "healthy western" one to a whole food plant-based one. Guideline directed medical therapy for heart failure was also utilized. Over five and a half months, she lost 22.7 kg and reversed her diabetes without the use of diabetes medications. Her left ventricular systolic function normalized. Although causality cannot be determined, this case highlights the potential role of a plant-based diet in helping to reverse heart failure with reduced ejection fraction. This article will review how a minimally processed whole food plant-based dietary pattern and similar dietary patterns, such as the Dietary Approach to Stop Hypertension diet, may contribute to the reversal of left ventricular dysfunction.

Incidence and predictors of right ventricular pacing-induced cardiomyopathy in patients with complete atrioventricular block and preserved left ventricular systolic function.

BACKGROUND: Right ventricular (RV) pacing may worsen left ventricular cardiomyopathy in patients with reduced left ventricular ejection fraction (LVEF) and advanced atrioventricular block. OBJECTIVE: The objectives of this study were to calculate incidence and identify predictors of RV pacing-induced cardiomyopathy (PICM) in complete heart block (CHB) with preserved LVEF and to describe outcomes of subsequent cardiac resynchronization therapy (CRT) upgrade. METHODS: An analysis of consecutive patients receiving permanent pacemaker (PPM) from 2000 to 2014 for CHB with LVEF >50% was performed. PICM was defined as CRT upgrade or post-PPM LVEF ≤40%. PICM association was determined via multivariable regression analysis. CRT response was defined by LVEF increase ≥10% or left ventricular end-systolic volume decrease ≥15%. RESULTS: Of the 823 study patients, 101 (12.3%) developed PICM over the mean follow-up of 4.3 ± 3.9 years, with post-PPM LVEF being 33.7% ± 7.4% in patients with PICM vs 57.6% ± 6.1% in patients without PICM (P < .001). In multivariable analysis, lower pre-PPM LVEF (hazard ratio [HR] 1.047 per 1% LVEF decrease; 95% confidence interval [CI] 1.002-1.087; P = .042) and RV pacing % both as a continuous (HR 1.011 per 1% RV pacing; 95% CI 1.002-1.02; P = .021) and as a categorical (<20% or ≥20% RV pacing) (HR 6.76; 95% CI 2.08-22.0; P = .002) variable were independently associated with PICM. Only 29 patients with PICM (28.7%) received CRT upgrade despite an 84% responder rate (LVEF increase 18.5% ± 8.1% and left ventricular end-systolic volume decrease 45.1% ± 15.0% in responders). CRT upgrade was associated with greater post-PPM LVEF decrease, lower post-PPM LVEF, and post-PPM LVEF ≤35% (P = .006, P = .004, and P = .004, respectively). CONCLUSION: PICM is not uncommon in patients receiving PPM for CHB with preserved LVEF and is strongly associated with RV pacing burden >20%. CRT response rate is high in PICM, but is perhaps underutilized.

Endoscopic surgery of the orbital apex: Outcomes and emerging techniques.

OBJECTIVES/HYPOTHESIS: To review our experience with endoscopic orbital apex surgery. STUDY DESIGN: Retrospective review. METHODS: All cases with Current Procedural Terminology codes for endoscopic orbital decompression between 2002 and 2011 at two institutions were reviewed. Patients with a diagnosis of Graves orbitopathy or an orbital complication of sinusitis were excluded. Presenting symptoms, lesion location, pathology, surgical outcomes, and complications were examined. RESULTS: A total of 27 patients were identified. Seventeen (63%) of the patients were men, and the average age was 56 (range = 14-82) years. Eighteen patients had primary orbital apex lesions, and nine patients had sinonasal lesions that predominantly involved the medial orbital apex. The lesions were found to be on the right in 59% of cases. The etiologies include benign (40.7%), malignant (44%), infectious (7.4%), and metastatic (7.4%) lesions. Obtaining a pathologic diagnosis was successful endoscopically in all but two (7.4%) patients, both with lateral lesions. The two-surgeon, four-handed technique and intraoperative image guidance employing fused computed tomography/magnetic resonance imaging were used in the majority of intraconal cases. Complications occurred in three patients (11%) and included myocardial infarction, deep venous thrombosis, and vision loss. There were no cerebrospinal fluid leaks or postoperative hemorrhages. Notably, vision remained stable or improved in all but one patient (3.7% risk of vision decline). Average follow-up was 4 years (range = 1 month-8 years). CONCLUSIONS: The endoscopic approach to the orbit apex offers significant advantages over traditional external approaches, and should be the preferred approach for all medial and inferior lesions. A two-surgeon multihanded technique can help facilitate difficult cases.

Recognition of incident diabetes mellitus during an acute myocardial infarction.

BACKGROUND: Diabetes mellitus (DM) is common in patients hospitalized with an acute myocardial infarction (AMI), representing in some cases the first opportunity to recognize and treat DM. We report the incidence of new DM and its recognition among patients with AMI. METHODS AND RESULTS: Patients in a 24-site US AMI registry (2005-08) had glycosylated hemoglobin assessed at a core laboratory, with results blinded to clinicians and local clinical measurements left to the discretion of the treating providers. Among 2854 AMI patients without known DM on admission, 287 patients (10%) met criteria for previously unknown DM, defined by a core laboratory glycosylated hemoglobin of ≥6.5%. Among these, 186 (65%) were unrecognized by treating clinicians, receiving neither DM education, glucose-lowering medications at discharge, nor documentation of DM in the chart (median glycosylated hemoglobin of unrecognized patients, 6.7%; range, 6.5-12.3%). Six months after discharge, only 5% of those not recognized as having DM during hospitalization had been initiated on glucose-lowering medications versus 66% of those recognized (P<0.001). CONCLUSIONS: Underlying DM that has not been previously diagnosed is common among AMI patients, affecting 1 in 10 patients, yet is recognized by the care team only one third of the time. Given its frequency and therapeutic implications, including but extending beyond the initiation of glucose-lowering treatment, consideration should be given to screening all AMI patients for DM during hospitalization. Inexpensive, ubiquitous, and endorsed as an acceptable screen for DM, glycosylated hemoglobin testing should be considered for this purpose.

Gene expression profiles in granuloma tissue reveal novel diagnostic markers in sarcoidosis.

Sarcoidosis is an immune-mediated multisystem disease characterized by the formation of non-caseating granulomas. The pathogenesis of sarcoidosis is unclear, with proposed infectious or environmental antigens triggering an aberrant immune response in susceptible hosts. Multiple pro-inflammatory signaling pathways have been implicated in mediating macrophage activation and granuloma formation in sarcoidosis, including IFN-γ/STAT-1, IL-6/STAT-3, and NF-κB. It is difficult to distinguish sarcoidosis from other granulomatous diseases or assess disease severity and treatment response with histopathology alone. Therefore, development of improved diagnostic tools is imperative. Herein, we describe an efficient and reliable technique to classify granulomatous disease through selected gene expression and identify novel genes and cytokine pathways contributing to the pathogenesis of sarcoidosis. We quantified the expression of twenty selected mRNAs extracted from formalin-fixed paraffin embedded (FFPE) tissue (n = 38) of normal lung, suture granulomas, sarcoid granulomas, and fungal granulomas. Utilizing quantitative real-time RT-PCR we analyzed the expression of several genes, including IL-6, COX-2, MCP-1, IFN-γ, T-bet, IRF-1, Nox2, IL-33, and eotaxin-1 and revealed differential regulation between suture, sarcoidosis, and fungal granulomas. This is the first study demonstrating that quantification of target gene expression in FFPE tissue biopsies is a potentially effective diagnostic and research tool in sarcoidosis.

Clinical trials in systemic lupus erythematosus: a status report on ongoing trials.

To describe the characteristics of trials in systemic lupus erythematous (SLE) listed in ClinicalTrials.gov such as study design, funding sources and aspects of the disease and drugs under investigation. We conducted a survey of ongoing clinical trials that were registered in the ClinicalTrials.gov website. We used the advanced search option and applied the following inclusion criteria, "SLE," "open studies," "interventional," and "adults 18 years or older." Of 97 eligible studies, 34.0 % were phase 3 or 4, 49.5 % were phase 1, 2 or 2/3 and in 16.5 %, we could not determine the study phase. Most trials were randomized (69.0 %) and 48.4 % were double blinded; 34 % of the trials were placebo controlled, 19.6 % had an active agent comparator and 46.4 % had no comparator. Universities and pharmaceutical industries were the primary sponsors for 45.3 and 39.1 % of the trials, respectively, and government agencies for 10.3 %. Multi-center trials based in the USA (US) accounted for 40.2 % of the trials, 46.4 % were outside of the US and 13.4 % were in the US as well as other countries. The most frequently used endpoint was drug efficacy (30.9 %) followed by disease severity indices (25.7 %), drug safety (14.4 %), remission rates and times to remission (7.2 %), and inflammatory markers and antibody titers (7.2 %). The majority of ongoing clinical trials in SLE are university or industry-funded, randomized phase 1, 2, or 2/3 trials, focused on drug efficacy. Federal funding for trials in SLE within and outside the US remains low.

Management of sinonasal complications after endoscopic orbital decompression for Graves' orbitopathy.

OBJECTIVES/HYPOTHESIS: Endoscopic orbital decompression (EnOD) has proven to be safe and effective for the treatment of Graves' orbitopathy; however, complications do occur. Although the literature focuses on orbital complications, sinonasal complications including postobstructive sinusitis, hemorrhage, and cerebrospinal fluid (CSF) leak can also be challenging to manage. This study examines the incidence and management of sinonasal complications in these patients. STUDY DESIGN: Retrospective review. METHODS: Clinical data, surgical findings, and postoperative outcomes were reviewed of patients who underwent EnOD for Graves' disease between March 2004 and November 2010. The incidence and management of postoperative sinonasal complications requiring an intervention were examined. RESULTS: The study group consisted of 50 consecutive patients (86 decompression procedures): 11 males and 39 females with an average age of 48.6 years (SD = 12.9). Incidence of significant sinonasal complications was 3.5% (5/86): with one patient experiencing postoperative hemorrhage requiring operative management, three patients with postoperative obstructive sinusitis, and one patient with nasal obstruction secondary to nasal adhesions that required lysis. The maxillary sinus was the most commonly involved and was managed using the mega-antrostomy technique. In the case of frontal sinusitis, an endoscopic transaxillary approach was utilized to avoid injury to decompressed orbital contents. All complications were successfully managed without sequelae. CONCLUSION: Sinonasal complications following EnOD are uncommon. In the setting of a decompressed orbit, even routine types of postoperative issues can be challenging and require additional considerations. Successful management of postoperative sinusitis related to outflow obstruction may require more extensive approaches and novel techniques.

Postradiation osteosarcoma in an older prostate cancer survivor: case study and literature review with emphasis on geriatric principles.

The aging population and the increasing number of cancer survivors will likely be associated with more second primary malignancies due to prior cancer treatment. Since the incidence of most cancers increases with age, these treatment-associated second malignancies will likely disproportionately impact older adults. Here, we present the case of a 78-year-old man with a history of localized prostate cancer treated with external beam radiation therapy 11 years prior, who developed osteosarcoma of the ilium. Geriatric screening showed a fit older male with few comorbidities, functional independence and no other geriatric syndromes. Given the patient's preference for a limb-sparing operation, neoadjuvant chemotherapy was undertaken. With the paucity of clinical trial data on osteosarcoma in older adults, the patient was given a regimen of carboplatin (substituted for cisplatin), doxorubicin and methotrexate. Unfortunately, he developed methotrexate-induced acute kidney injury. Chemotherapy was discontinued, and he proceeded to hemipelvectomy. His postoperative course was marked by numerous complications, including delirium, depression and recurrent hospitalizations. He ultimately developed a local recurrence and elected for hospice care. This case highlights the challenges of managing older adults with treatment-associated malignancies. Clinicians face a lack of clinical trial data from which to extrapolate limitations of therapeutic options because of prior therapy and a limited ability to precisely predict which elders will experience adverse outcomes. Better approaches are needed to help older patients make decisions which fulfill their goals of care and to improve the care of older adults with treatment-associated malignancies.