Advancement in Opioid Abuse-deterrent Formulation Technologies and Regulatory Expectation.

Chronic pain is a byproduct of many diseases and conditions. Along with long-term opioid medication use in chronic pain management, misuse of this vital medication has been a topic of much debate over the last two decades. Abuse-deterrent formulations play a critical role in comprehensive opioid risk management strategies, limiting the attractiveness and drug-liking qualities of an opioid drug by limiting their bioavailability, making abuse of the tampered opioid medication less appealing or rewarding, or impeding the extraction of the opioid drug and thus impeding the administration of the opioid formulation via alternative routes.

Self-regulated Anti-Overdose Crush and Extraction-Resistant Drug Delivery System to Combat Opioid Overdose Crisis.

Pharmaceutical opioid dosage forms are commonly misused via an oral route in non-manipulated form, i.e., overdose in intact form, or manipulated form, i.

Clinical Performance of the Consensus Immunoscore in Colon Cancer in the Asian Population from the Multicenter International SITC Study.

BACKGROUND: In this study, we evaluated the prognostic value of Immunoscore in patients with stage I−III colon cancer (CC) in the Asian population. These patients were originally included in an international study led by the Society for Immunotherapy of Cancer (SITC) on 2681 patients with AJCC/UICC-TNM stages I−III CC. METHODS: CD3+ and cytotoxic CD8+ T-lymphocyte densities were quantified in the tumor and invasive margin by digital pathology.

Transcatheter Closure of Left Ventricular Outflow Tract-to-Left Atrium Fistula.

Surgical and rarely transcatheter aortic valve replacement can be complicated by intracardiac fistula. Transcatheter closure of those shunts has been previously reported with favorable results. We describe a case of percutaneous closure of left ventricular outflow tract-to-left atrium fistula after surgical aortic valve replacement using an Amplatzer Vascular Plug II.

Multicenter International Society for Immunotherapy of Cancer Study of the Consensus Immunoscore for the Prediction of Survival and Response to Chemotherapy in Stage III Colon Cancer.

Purpose: The purpose of this study was to evaluate the prognostic value of Immunoscore in patients with stage III colon cancer (CC) and to analyze its association with the effect of chemotherapy on time to recurrence (TTR).

Methods: An international study led by the Society for Immunotherapy of Cancer evaluated the predefined consensus Immunoscore in 763 patients with American Joint Committee on Cancer/Union for International Cancer Control TNM stage III CC from cohort 1 (Canada/United States) and cohort 2 (Europe/Asia). CD3+ and cytotoxic CD8+ T lymphocyte densities were quantified in the tumor and invasive margin by digital pathology.

Design of a novel rapid immunoassay for simultaneous detection of hepatitis C virus core antigen and antibodies.

HCV is a potential cause of viral hepatitis, which leads to blood-borne chronic hepatitis, liver cirrhosis and hepatocellular carcinoma. Anti-HCV antibody detection assays detect HCV infection after approximately 70 days. HCV core antigen can be detected much earlier than anti-HCV antibodies.

Percutaneous Retrieval of a Watchman Device from the Left Ventricle Using a Transarterial Approach.

Left atrial appendage closure device embolization is a rare yet serious complication. The location of the embolized device is a major determinant of the retrieval approach, percutaneous or surgical. This paper presents the case of Watchman device embolization in the left ventricle, which was retrieved percutaneously by using a transarterial approach.

The Tendyne transcatheter mitral valve replacement system for the treatment of mitral regurgitation.

Mitral valve regurgitation (MR) is the most prevalent valvular disorder among the growing elderly population, occurring in over 6% of those aged >65. Unfortunately, many individuals with severe MR (particularly those with systolic dysfunction or secondary MR) will not be candidates for surgical valve repair or replacement due to high or prohibitive operative risk. For such patients, transcatheter mitral valve replacement represents a viable option.

Coronary Artery Disease and Transcatheter Aortic Valve Replacement: When to Intervene.

"In patients with coronary artery disease undergoing transcatheter aortic valve replacement (TAVR), the decision of whether to revascularize, which lesions to revascularize, and the optimal timing of revascularization remains controversial. The sequence of revascularization should be made on a case-by-case basis. Pre-TAVR revascularization (staged or simultaneous with TAVR) is preferred due to unobstructed access to coronary ostia and is important to consider especially in cases in which long self-expanding valves are used.

Analysis of readmissions after transoral robotic surgery for oropharyngeal squamous cell carcinoma.

Background: As transoral robotic surgery (TORS) is being increasingly used to treat patients with oropharyngeal squamous cell carcinoma (OPSCC), there is an interest in determining contributors to readmission.

Methods: We conducted this retrospective multivariate analysis modeling 30-day readmission using the Nationwide Readmissions Database (2012-2014).

Results: Of 950 patients, 117 (12.

International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study.

Background: The estimation of risk of recurrence for patients with colon carcinoma must be improved. A robust immune score quantification is needed to introduce immune parameters into cancer classification. The aim of the study was to assess the prognostic value of total tumour-infiltrating T-cell counts and cytotoxic tumour-infiltrating T-cells counts with the consensus Immunoscore assay in patients with stage I-III colon cancer.

Optimizing hemodynamics of transcatheter aortic valve-in-valve implantation in 19-mm surgical aortic prostheses.

Objective: To demonstrate the feasibility of achieving good hemodynamic results with valve-in-valve transcatheter aortic valve replacement (ViV TAVR) for degenerated 19 mm surgical bioprosthetic valves.

Background: Considerable controversy exists regarding ViV TAVR within 19mm surgical prostheses due to concerns of elevated valve gradients and mortality.

Methods: Among all patient undergoing ViV TAVR between 7/2016 and 4/2017 for symptomatic severe bioprosthetic aortic stenosis (AS), five had a 19 mm surgical valve in place and were included in this publication.

Access Options for Transcatheter Aortic Valve Replacement in Patients with Unfavorable Aortoiliofemoral Anatomy.

In the current era, 10-15 % of transcatheter aortic valve replacement (TAVR)-eligible high and prohibitive risk patients with severe symptomatic aortic stenosis are not candidates for transfemoral arterial access. Knowledge of the various alternative access options can enable TAVR teams to provide improved quality of life and potentially life-saving treatment for a group of patients who otherwise have no viable options. In this article, we review approach to patients with unfavorable femoral arterial anatomy and provide an in-depth discussion on the various alternative routes for TAVR.

Clinical significance of inflammatory mediators in the pathogenesis of oral cancer.

Oral cancer has become a grave problem in many parts of the globe with two.thirds of the cases occurring in developing countries. Chronic inflammation plays a prominent role in the development of oral cancer.

Transcatheter Advances in the Treatment of Adult and Congenital Valvular Heart Disease.

Transcatheter valve therapies represent the newest frontier in interventional cardiology. At present, transcatheter aortic valve replacement and mitral valve edge-to-edge repair are currently approved by the US FDA in appropriately selected patients. These transcatheter therapies are typically employed in patients of advanced age with comorbid conditions.

Association of Lower Fractional Flow Reserve Values With Higher Risk of Adverse Cardiac Events for Lesions Deferred Revascularization Among Patients With Acute Coronary Syndrome.

Background: The safety of deferring revascularization based on fractional flow reserve (FFR) during acute coronary syndrome (ACS) is unclear. We evaluated the association of FFR and adverse cardiac events among patients with coronary lesions deferred revascularization based on FFR in the setting of ACS versus non-ACS.

Methods And Results: The study population (674 patients; 816 lesions) was divided into ACS (n=334) and non-ACS (n=340) groups based on the diagnosis when revascularization was deferred based on FFR values >0.

Clinical outcomes with use of erythropoiesis stimulating agents in patients with the HeartMate II left ventricular assist device.

Objectives: This study evaluated clinical outcomes associated with erythropoiesis stimulating agent (ESA) use in left ventricular assist devices (LVAD)-supported patients.

Background: Use of ESAs in patients with LVADs may minimize blood transfusions and decrease allosensitization. ESAs increase thrombotic events, which is concerning because LVADs are sensitive to pump thrombosis (PT).

Risk model for estimating the 1-year risk of deferred lesion intervention following deferred revascularization after fractional flow reserve assessment.

Aims: Although lesions deferred revascularization following fractional flow reserve (FFR) assessment have a low risk of adverse cardiac events, variability in risk for deferred lesion intervention (DLI) has not been previously evaluated. The aim of this study was to develop a prediction model to estimate 1-year risk of DLI for coronary lesions where revascularization was not performed following FFR assessment.

Methods And Results: A prediction model for DLI was developed from a cohort of 721 patients with 882 coronary lesions where revascularization was deferred based on FFR between 10/2002 and 7/2010.

Outcomes of coronary stenoses deferred revascularization for borderline versus nonborderline fractional flow reserve values.

Current evidence supports deferral of revascularization for lesions with fractional flow reserve (FFR) values >0.80. The natural history after deferral of revascularization of lesions with borderline FFR values is unknown.

Impact of intravascular ultrasound on the long-term clinical outcomes in the treatment of coronary ostial lesions.

Objectives: To evaluate the long-term outcomes of patients with ostial lesions who underwent percutaneous coronary intervention (PCI) with and without the use of intravascular ultrasound (IVUS).

Background: A higher rate of adverse cardiac events is associated with PCI of ostial lesions as compared with nonostial disease.

Methods: From 7/2002 to 8/2010, 225 patients with 233 coronary ostial lesions underwent PCI with (n = 82) and without (n = 143) IVUS guidance.

Long-term clinical outcomes with the use of a modified provisional jailed-balloon stenting technique for the treatment of nonleft main coronary bifurcation lesions.

Objectives: To assess the long-term clinical outcomes associated with treatment of nonleft main coronary bifurcation lesions using a modified provisional jailed-balloon technique (JBT).

Background: Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with a higher risk of adverse events, including the risk of side branch (SB) loss during main branch (MB) stenting.

Methods: From 4/2003 to 8/2010, 406 patients with 424 nonleft main coronary bifurcation lesions underwent PCI with (n = 95) and without (n = 311) the use of JBT.

Role of nitric oxide and antioxidant enzymes in the pathogenesis of oral cancer.

Background: Oral cancer is the leading malignancy in India. Nitric oxide and antioxidant enzymes play an important role in etiology of oral cancer. Therefore, the present study evaluates nitric oxide and antioxidant enzyme levels in healthy individual without tobacco habits (NHT, N=30) and healthy individuals with tobacco habits (WHT, n=90), patients with oral precancers (OPC, n=15) and oral cancer patients (n=126).