bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety and efficacy of the NovaCross microcatheter in facilitating crossing of chronic total occlusion coronary lesions: a multicenter, single-arm clinical trial
Authors: Walsh Simon J. , Dudek Darius , Bryniarski Leszek , Nicholson William , Karmpaliotis Dimtri , Uretsky Barry , McEntegart Margaret , Assali Abid , Knaapen Paul , Kornowski Ran , Spratt James C. , Goodwin Mark , Hanratty Colm G. 
Published: August 2020

Background
The aim of this study was to evaluate the safety and efficacy of the novel NovaCross microcatheter system in patients with ischemic heart disease due to coronary chronic total occlusions (CTO).

Methods
A total of 191 subjects between the ages of 25–80 years were recruited in 10 investigational sites. Each subject underwent a percutaneous coronary intervention (PCI) of a CTO lesion using the NovaCross microcatheter, equipped with expandable nitinol scaffolds to enhance guidewire penetration and crossing of the CTO lesion. The primary safety endpoint was procedural major adverse cardiac events [composite of death, myocardial infarction (MI), or urgent target vessel revascularization]. The primary efficacy endpoint was to assess the ability of the NovaCross microcatheter to successfully facilitate the placement of a guidewire beyond a native coronary CTO in the true vessel lumen. After the PCI, subjects remained in hospital until a 12-lead ECG and blood tests for cardiac biomarkers were taken at 3–6 h and 8–16 h post-procedure.

Results
No deaths, urgent revascularization, or urgent coronary artery bypass surgery were reported. The reported MI rate according to the protocol definition was 12.3%, and technical success was achieved in 75.3% of the subjects regardless of CTO procedure technique. In 89.2% of the subjects, the NovaCross succeeded in penetrating the proximal CTO cap, and in 25.8% of the subjects, the extendable portion of the NovaCross crossed the full length of the CTO lesion.

Conclusions
The NovaCross met both the primary safety endpoint and the primary efficacy endpoint. We, therefore, conclude that the device is well tolerated, effective, and could be easily adopted by interventional cardiologists.
Temporal trends in referral patterns for invasive coronary angiography – a multicenter 10-year analysis
Authors: Gonçalves Mariana , Roque David , de Araújo Gonçalves Pedro , Borges Santos Miguel , Faustino Mariana , Campante Teles Rui , Farto e Abreu Pedro , de Sousa Almeida Manuel , Ferreira António Miguel 
Published: August 2020

Aim
To assess the temporal trends in the usage pattern of non-invasive testing before invasive coronary angiography (ICA) and its diagnostic yield in patients with suspected coronary artery disease (CAD).

Methods
Cross-sectional observational multicenter study of 4805 consecutive patients (60% male, mean age 66 ± 10 years) with suspected CAD undergoing elective ICA due to angina pectoris in two centers, from 2008 to 2017. The use of noninvasive testing and the proportion of patients with obstructive CAD (defined as the presence of at least one ≥50% stenosis on ICA) were assessed.

Results
There were 4038 (84%) patients referred for ICA with positive noninvasive test, mainly SPECT (38%, n = 1828) and exercise ECG (36%, n = 1731). Obstructive CAD was found in 54.5% (n = 2621) of the patients and 37.9% (n = 1822) underwent revascularization. The prevalence of obstructive CAD was higher in patients with vs. without previous noninvasive testing (55.8% vs. 48.1%, respectively, P < 0.001) and tended to decrease during the study period (P for trend <0.001). Both the presence of obstructive CAD and revascularization rate were higher in patients who underwent anatomical evaluation with CCTA compared with noninvasive functional tests (P = 0.001 and P = 0.018, respectively). The number of patients referred after exercise testing and SPECT decreased (p for trend 0.005 and 0.006, respectively) and after CCTA and stress CMR increased (both P for trend <0.001). The proportion of patients referred without previous testing remained stable.

Conclusion
Nearly half of the patients undergoing ICA for suspected CAD did not have obstructive coronary lesions. This proportion tended to increase over the 10-year span of this study. Better clinical assessment tools and diagnostic pathways for stable CAD are warranted.
Benefits of early administration of Sacubitril/Valsartan in patients with ST-elevation myocardial infarction after primary percutaneous coronary intervention
Authors: Zhang Yi , Wu Yongbo , Zhang Kai , Ke Zili , Hu Peng , Jin Daoqun 
Published: August 2020

Objective
To evaluate the effects of early administration of Sacubitril/Valsartan (Sac/Val) in patients with ST-elevation myocardial infarction after primary percutaneous coronary intervention (pPCI).

Methods
This prospective, controlled, single-center study randomized 186 ST-segment elevation myocardial infarction patients to one of the following two groups: Sac/Val group: early administration of Sac/Val within 24 hours after pPCI; control group: conventional angiotensin-converting enzyme inhibitors (ACEI) application. The creatine Kinase (CK) peak after the surgery, the incidence of acute heart failure during hospitalization, level of NT-proBNP and left ventricular ejection fraction (LVEF) measured by ultrasound before discharge and soluble suppression of tumorigenicity2 (sST2), LVEF, infarct size determined by single photon emission computed tomography (SPECT), readmission rate within 6 months were recorded and compared between two groups.

Results
Compared to the control group, Sac/Val could decrease the CK peak and the incidence of acute heart failure after pPCI; the level of NT-proBNP was lower and LVEF was higher before discharge in the Sac/Val group. After 6 months, the patients who had taken Sac/Val had a higher LVEF, a smaller infarct size determined by SPECT, lower sST2 and readmission rate.

Conclusion
Patients with ST-elevation myocardial infarction after primary percutaneous coronary intervention could benefit from early administration of Sacubitril/Valsartan, the effect was superior to conventional ACEI.
Culprit lesion morphology in patients with ST-segment elevation myocardial infarction assessed by optical coherence tomography
Authors: Hansen Kirstine Nørregaard , Antonsen Lisbeth , Maehara Akiko , Maeng Michael , Ellert Julia , Jakobsen Lars , Ahlehoff Ole , Thim Troels , Veien Karsten , Junker Anders , Fallesen Christian , Terkelsen Christian Juhl , Christiansen Evald Høj , Jensen Lisette Okkels 
Published: August 2020

Aims
This study sought to evaluate the incidence of ruptured plaques and nonruptured plaques (NRP) and to compare patient characteristics and detailed plaque morphology features between the two culprit types in ST-segment elevation myocardial infarction (STEMI) patients, using optical coherence tomography (OCT).

Methods and results
Using OCT, the culprit lesions in patients with STEMI were assessed prior to stent implantation. The culprit lesion was categorized as ruptured plaques or NRP, and the plaque components were evaluated. Fifty-two patients (69.3%) presented with ruptured plaques and 23 (30.7%) with NRP. Patients with NRP were younger (58.0 ± 10.4 vs 64.7 ± 9.9 years, P = 0.01) and more often smokers (72.7% vs 37.1%, P = 0.001), compared to ruptured plaques. NRP contained significantly more fibrotic plaque (20.0% [interquartile range (IQR) 13.7–29.8] vs 11.3% [IQR 6.9–18.1], P = 0.005), but less lipidic plaque (44.0% ± 13.7 vs 59.3% ± 13.6, P < 0.001), less superficial [5.0% (IQR 2.8–7.5) vs 8.1% (IQR 5.7–11.0), P = 0.005] and profound macrophages [0.9% (IQR 0.0–1.7) vs 2.2% (IQR 0.9–4.7), P = 0.003]. The prevalence, numbers and lengths of thin-cap fibroatheroma (TCFA) were significantly lower in NRP, compared to ruptured plaques [47.8% vs 88.5%, 0 (IQR 0–1) vs 1 (IQR 1–2) and 0 mm (IQR 0–2.7) vs 4.5 mm (IQR 2.3–7.7), P < 0.001].

Conclusions
One-third of STEMI patients had culprit lesions without an OCT-detectable ruptured plaque. Culprit lesions with NRP contained less vulnerable plaque components, such as lipid plaque, TCFAs and macrophages compared to ruptured plaques.
Dietary protein intake and obesity-associated cardiometabolic function
Authors: Fappi Alan , Mittendorfer Bettina 
Published: August 2020

Purpose of review
High-protein intake is commonly recommended to help people manage body weight. However, high-protein intake could have adverse health consequences. Here we review the latest findings concerning the effect of high-protein intake on cardiometabolic health.

Recent findings
Calorie-reduced, high-protein, low-carbohydrate diets lower plasma glucose in people with type 2 diabetes (T2D). However, when carbohydrate intake is not markedly reduced, high-protein intake often does not alter plasma glucose and increases insulin and glucagon concentrations, which are risk factors for T2D and ischemic heart disease. High-protein intake does not alter plasma triglyceride and cholesterol concentrations but promotes atherogenesis in animal models. The effect of high-protein intake on liver fat remains unclear. In population studies, high-protein intake is associated with increased risk for T2D, nonalcoholic fatty liver disease, and possibly cardiovascular diseases.

Summary
The relationship between protein intake and cardiometabolic health is complex and influenced by concomitant changes in body weight and overall diet composition. Although a high-protein, low-carbohydrate, reduced-energy diet can have beneficial effects on body weight and plasma glucose, habitual high-protein intake, without marked carbohydrate and energy restriction, is associated with increased cardiometabolic disease risk, presumably mediated by the changes in the hormonal milieu after high-protein intake.
Current mechanisms in obesity and tumor progression
Authors: Fosam Andin , Perry Rachel J. 
Published: August 2020

Purpose of review
Hyperadiposity, as present in obesity, is a substantial threat to cancer risk and prognosis. Studies that have investigated the link between obesity and tumor progression have proposed several mechanistic frameworks, yet, these mechanisms are not fully defined. Further, a comprehensive understanding of how these various mechanisms may interact to create a dynamic disease state is lacking in the current literature.

Recent findings
Recent work has begun to explore not only discrete mechanisms by which obesity may promote tumor growth (for instance, metabolic and growth factor functions of insulin; inflammatory cytokines; adipokines; and others), but also how these putative tumor-promoting factors may interact.

Summary
This review will highlight the present understanding of obesity, as it relates to tumor development and progression. First, we will introduce the impact of obesity in cancer within the dynamic tumor microenvironment, which will serve as a theme to frame this review. The core of this review will discuss recently proposed mechanisms that implicate obesity in tumor progression, including chronic inflammation and the role of pro-inflammatory cytokines, adipokines, hormones, and genetic approaches. Furthermore, we intend to offer current insight in targeting adipose tissue during the development of cancer prevention and treatment strategies.
Objectively assessed disease activity and drug persistence during ustekinumab treatment in a nationwide real-world Crohn’s disease cohort
Authors: af Björkesten Clas-Göran , Ilus Tuire , Hallinen Taru , Soini Erkki , Eberl Anja , Hakala Kalle , Heikura Mikko , Jussila Airi , Koskela Ritva , Koskinen Inka , Moilanen Veikko , Nielsen Christian , Nieminen Urpo , Nuutinen Heikki , Heikkinen Markku , Suhonen Ulla-Maija , Tillonen Jyrki , Utriainen Karri , Vihriälä Ilkka , Wennerström Christina , Borsi Andras , Nissinen Riikka , Koivunen Minni R. , Sipponen Taina 
Published: August 2020

Objective
Long-term evidence on ustekinumab treatment response and persistence in patients with Crohn’s disease in a real-world setting is scarce. We performed a retrospective nationwide chart review study of long-term clinical outcomes in Crohn’s disease patients treated with ustekinumab.

Methods
The study was conducted in 17 Finnish hospitals and included adult Crohn’s disease patients who received an initial intravenous dose of ustekinumab during 2017–2018. Disease activity data were collected at baseline, 16 weeks, and 1 year from health records.

Results
The study included 155 patients. The disease was stricturing or penetrating in 69 and 59% had prior Crohn’s disease-related surgeries, and 97% had a treatment history of at least one biologic agent. Of 93 patients with ≥1 year of follow-up, 77 (83%) were still on ustekinumab at 1 year. In patients with data available, from baseline to the 1-year follow-up the simple endoscopic score for Crohn’s disease (SES-CD) decreased from 10 to 3 (P = 0.033), C-reactive protein from 7  to 5 mg/L, (P < 0.001) and faecal calprotectin from 776 to 305 μg/g (P < 0.001).

Conclusions
Ustekinumab treatment in patients with highly refractory Crohn’s disease resulted in high long-term treatment persistence and significantly reduced disease activity, assessed with objective markers for intestinal inflammatory activity.
Predictive markers of nonalcoholic fatty liver disease in lean patients. A multinomial regression model and a 2k factorial analysis
Authors: Purón-González Emma , González-Cantú Arnulfo , Coronado-Alejandro Edgar Ulises , Sánchez-Dávila Oswaldo Enrique , Cobos-Aguilar Héctor , Romero-Ibarguengoitia Maria Elena 
Published: August 2020

Objective
Nonalcoholic fatty liver disease (NAFLD) is associated with obesity and insulin resistance; however, there is a group of non-obese patients with NAFLD that need to be characterized. Our aim was to evaluate the factors associated with NAFLD in non-obese subjects in a third-level hospital.

Methods
A comparative cross-sectional study was performed. Participants were divided into four groups: non-obese without NAFLD (group 1), non-obese with NAFLD (group 2), obese without NAFLD (group 3), and obese with NAFLD (group 4). We evaluated the effect of clinical and biochemical characteristics with the disease by groups using a multinomial regression model and a 2K factorial analysis.

Results
We included 278 participants. Low platelet–lymphocyte ratio (PLR) as a novel parameter associated with NAFLD in non-obese subjects. Age, uric acid, alanine transaminase (ALT), high-density lipoprotein (HDL)-cholesterol, and neutrophil–lymphocyte ratio (NLR) were other related parameters (akaike information criterion = 557). NLR had the larger OR in groups with NAFLD (lean with NAFLD 7.12, obese with NAFLD 13.02). The 2k factorial design found inverse effect on PLR by NAFLD (effect –21.89, P < 0.001), which was higher than BMI (effect –1.33, P < 0.045).

Conclusion
Our study found that PLR is a novel parameter with inverse correlation with NAFLD in non-obese patients. Other related parameters are age, hyperuricemia, elevation of ALT and NLR, and low HDL-cholesterol.
Proton-pump-inhibitor use associated with lower short-term rebleeding and mortality in patients receiving esophageal variceal band ligation: a retrospective cohort study
Authors: Ghoz Hassan , Patel Payal , Stancampiano Fernando , Patel Sheetal , Fox Erin A. , Yousaf Mohammad B. , Omer Mohamed , Heckman Michael G. , Spiegel Matthew R. , Palmer William C. 
Published: August 2020

Background
The impact of proton-pump inhibitor (PPI) therapy on subsequent hemorrhage and mortality after variceal hemorrhage is unclear.

Aim
Evaluate the associations of PPI use with upper gastrointestinal bleeding (UGIB) and death within 30 days of undergoing esophageal variceal band ligation (EBL) separately in inpatient and outpatient settings.

Methods
Retrospective review of cirrhotic patients with variceal hemorrhage who underwent EBL between 2005 and 2018. Endoscopic findings, PPI use at admission (inpatients only), PPI use at discharge (inpatients and outpatients), and adverse outcomes data (liver transplant, UGIB, transjugular intrahepatic portosystemic shunt, and death within 30 days of discharge or death during hospitalization) were reviewed.

Results
A total of 446 patients (164 inpatients, 282 outpatients) were included. The most commonly observed outcomes were death within 30 days of discharge in inpatients (12.8%), UGIB within 30 days of discharge in inpatients (21.3%), and UGIB within 30 days of discharge in outpatients (8.5%). For inpatients, prescription of PPI at discharge was associated with a lower risk of bleeding within 30 days (odds ratio: 0.30, P = 0.025) and death within 30 days (odds ratio = 0.16, P = 0.002). No other significant associations of PPI with death or UGIB were reported.

Conclusion
Post-EBL PPI therapy is associated with reduced risk of bleeding and death within 30 days after variceal hemorrhage in hospitalized patients.
Do Insurance-mandated Precertification Criteria and Insurance Plan Type Determine the Utilization of Bariatric Surgery Among Individuals With Private Insurance?
Authors: Gasoyan Hamlet , Soans Rohit , Ibrahim Jennifer K. , Aaronson William E. , Sarwer David B. 
Published: August 2020

Background:
Access to bariatric surgery is restricted by insurers in numerous ways, including by precertification criteria such as 3–6 months preoperative supervised medical weight management and documented 2-year weight history.

Objectives:
To investigate if there is an association between the aforementioned precertification criteria, insurance plan type, and the likelihood of undergoing bariatric surgery, after controlling for potential sociodemographic confounders.

Research Design:
The study was conducted using the Pennsylvania Health Care Cost Containment Council’s data in 5 counties of Pennsylvania in 2016 and records of preoperative insurance requirements maintained by the Temple University Bariatric Surgery Program.
Privately insured bariatric surgery patients and individuals who met the eligibility criteria but did not undergo surgery were identified and 1:1 matched by sex, race, age group, and zip code (n=1054). Univariate tests and logistic regression analysis were utilized for data analysis.

Results:
The insurance requirement for 3–6 months preoperative supervised medical weight management was associated with smaller odds of undergoing surgery [odds ratio (OR)=0.459; 95% confidence interval (CI), 0.253–0.832; P=0.010], after controlling for insurance plan type and the requirement for documented weight history.
Preferred provider organization (OR=1.422; 95% CI, 1.063–1.902; P=0.018) and fee-for-service (OR=1.447; 95% CI, 1.021–2.050; P=0.038) plans were associated with greater odds of undergoing surgery, compared with health maintenance organization plans, after controlling for the studied precertification requirements. The documented weight history requirement was not a significant predictor of the odds of undergoing surgery (P=0.132).

Conclusions:
There is a need for consideration of insurance benefits design as a determinant of access to bariatric surgery.
Cystatin C is ready for clinical use
Authors: Ebert Natalie , Shlipak Michael G. 
Published: August 2020

Purpose of review
The goal of this update is to raise awareness of clinical scenarios where cystatin C has clear and immediate benefits as an alternative glomerular filtration rate (GFR) biomarker to supplement creatinine. An additional goal is to focus the estimated GFR (eGFR) controversy onto medication prescribing for agents with narrow therapeutic windows where better GFR estimation will lead to improved medical care.

Recent findings
Equations that include cystatin C predict GFR more accurately than serum creatinine in children, adults, and older adults with larger effects among persons who are acutely ill. Numerous studies have evaluated medication dosing based on either GFR estimate; vancomycin was the most frequently studied drug and its target level and elimination were better predicted by cystatin C. Overall, approaches to medication dosing and monitoring that include cystatin C concentrations have been shown to result in a better achievement of drug trough levels. Furthermore, cystatin C offers the opportunity to avoid the race coefficient that is required for any current creatinine-based eGFR equation, which has been appropriately criticized for introducing unnecessary imprecision, assumptions and values on GFR estimation.

Summary
Hospital laboratories must make cystatin C available for clinical care to improve the safety and efficacy of medications that have narrow therapeutic windows.
Host immune interactions in chronic inflammatory gastrointestinal conditions
Authors: Caminero Alberto , Pinto-Sanchez MI 
Published: August 2020

Purpose of review
We performed a literature review of the latest studies on the interactions between the host immune system and microbes in chronic intestinal inflammatory conditions.

Recent findings
The mechanisms leading to celiac disease (CeD) and inflammatory bowel disease (IBD), the most common chronic inflammatory gastrointestinal conditions, are complex. The intestinal homeostasis depends on the interactions between the microbiota, the intestinal mucosa and the host immune system. Failure to achieve or maintain equilibrium between a host and its microbiota has the potential to induce chronic conditions with an underlying inflammatory component. Mechanisms by which intestinal microbes trigger inflammation include the alteration of intestinal permeability, activation of the host immune system and digestion of dietary antigens with a consequent repercussion on tolerance to food. Therefore, therapies modulating gut microbiota, including diet, antibiotics, probiotics and faecal transplantation have a potential in CeD and IBD. Probiotics are effective to treat pouchitis and faecal transplant for ulcerative colitis, but the evidence is less clear in Crohn's disease or CeD.

Summary
Diverse regulatory mechanisms cooperate to maintain intestinal homeostasis, and a breakdown in these pathways may precipitate inflammation. The role of microbiota inducing immune dysfunction and inflammation supports the therapeutic rationale of manipulating microbiota to treat chronic inflammatory conditions.
Proton pump inhibitors: misconceptions and proper prescribing practice
Authors: Schubert Mitchell L. 
Published: August 2020

Purpose of review
The current review summarizes and attempts to place in proper perspective the past year's literature regarding purported adverse effects of proton pump inhibitors (PPIs).

Recent findings
Although generally considered safe, physicians are inundated with retrospective database-driven epidemiologic studies, and meta-analyses on the same studies, claiming a panoply of serious adverse effects associated with long-term use of PPIs. The quality of the evidence underlying most of these associations is very low and cannot ascribe cause and effect. Nonetheless, these reports have stoked fears, in both prescribers and patients. As a result, patients are being harmed. Physicians are not prescribing PPIs when medically indicated and patients are stopping PPIs without consulting their caregivers. It is reassuring that a cross-sectional analysis of data from the National Ambulatory Medical Care Survey as well as a double-blinded, placebo-controlled trial report no safety concerns with PPIs, other than a possible small association with enteric infection.

Summary
Most of the publicized serious putative adverse effects attributed to PPIs have been debunked in more recent and properly designed studies. Nevertheless, PPIs should be prescribed for valid indications and, when prescribed long-term, they should be used at the lowest effective dose and their ongoing need periodically assessed.