VACC benefits - VACC Vascular Access Updated: 2023
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Exam Code: VACC VACC Vascular Access benefits November 2023 by Killexams.com team|
VACC VACC Vascular Access
DOMAIN CATEGORY I: Clinical Knowledge and Application
A. Device Assessment and Selection
1. Central venous access devices
2. Peripheral intravenous devices
3. Dialysis, apheresis and aquapheresis catheters
4. Intraosseous devices
5. Arterial catheters
6. Pulmonary artery catheters
7. Device characteristics (e.g., single versus multi-lumen devices, optimal insertion and tip location)
B. Patient Assessment
1. Vascular pathology (e.g., impact of disease processes on vascular access)
2. Device selection (e.g., infusion therapy, alternative to IV placement, vesicants and osmolality)
3. Patient specific characteristics (e.g., compromised skin integrity, product reaction) and resources to maintain vascular access devices
4. Imaging technology (e.g., ultrasound, transillumination, fluoroscopy / venogram, chest x-ray)
1. Infection prevention procedures, concepts and principles (e.g., sterile field, aseptic non-touch technique [ANTT], common pathogens)
2. Anatomy and physiology
3. Growth and development implications
DOMAIN CATEGORY I (continued): Clinical Knowledge and Application
1. Vascular access device and insertion components
2. Insertion techniques (e.g., Modified Seldinger)
3. Flushing and locking solutions / procedures
4. Imaging technology (e.g., ultrasound, infra-red, transillumination)
5. Laboratory values relevant to device placement and maintenance
6. Tip location and confirmation systems
7. Engineered securement devices
8. Complications and emergency interventions (e.g., inadvertent arterial puncture, pneumothorax, catheter tip malposition, nerve injury)
E. Care and Maintenance of Vascular Access
1. Insertion / exit site assessment
2. Lumen patency and catheter clearance (e.g., flushing protocol, occlusion therapy)
3. Infusion equipment and add-on supplies (e.g., needleless connector)
4. Dressing change procedure
5. Patient / caregiver education
6. Care plan throughout the healthcare continuum (e.g., catheter insertion information, care and maintenance instructions, patient restrictions)
7. Vascular access device removal (e.g., removal length of PICC, removal complications, patient tolerance of removal procedure)
F. Troubleshooting, Complications, and Interventions
1. Post-insertion risks and complications (e.g., extravasation, thrombosis, infection, catheter tip migration, occlusion, nerve damage, phlebitis)
2. Pharmacologic interventions (e.g., catheter clearance, antibiotic lock, ethanol lock, extravasation treatment)
3. Catheter repair / exchange
4. Other complications (e.g., central vein occlusion, internal fracture, compromised skin integrity)
DOMAIN CATEGORY II: Interpersonal and Communication Skills
A. Interpersonal Communication
1. Communication with patient / caregiver (e.g., risks, benefits and alternatives; device care; infection prevention)
2. Communication with patient / caregiver with additional needs (e.g., developmental/ cognitive deficit, psychosocial concerns)
3. Cultural competency (e.g., cultural and religious differences, family involvement, language barrier)
4. Collaboration with patient's care team
B. Mentoring and education
1. Educational / staff development opportunities (e.g., quality improvement, hospital committees, early assessment for vessel preservation)
2. Infection control measures and techniques
DOMAIN CATEGORY III: Professional Development
A. Evidence-based Practice and Continuing Education
1. Evidence-based practice guidelines (e.g., AVA, INS, MAGIC, KDOQI, ACCP, SHEA)
2. Process improvement initiatives and outcome evaluation (e.g., implementation of new techniques and / or products)
3. Professional practice and development (e.g., seminars, webinars, conferences, certification)
4. Critical analysis of published research (e.g., research methodologies)
DOMAIN CATEGORY IV: Legal and Ethical Considerations
A. Legal Considerations
1. Professional codes of conduct, professional guidelines, scope of practice and standards of care
2. Legal principles in the practice of vascular access (e.g., consent, liability, HIPAA)
3. Documentation requirements
4. Manufacturer's guidelines for product use (e.g., Instructions for Use [IFUs], expiration dates, off-label use)
B. Ethical Considerations
1. Patient advocacy (e.g., patient preferences, end of life care)
2. Reporting requirements (e.g., MAUDE database, Joint Commission [JC], state health department)
3. Fiscal responsibility (e.g., accurate recording of charges, use of supplies and equipment, use of time)
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VACC Vascular Access
The nurse is gathering equipment for an arterial puncture. She has gathered the
following equipment: heparin solution of 1,000 IU per ml, sterile gauze, betadine
wipes, sterile needle, and syringe. What has the nurse forgotten?
A. Container of ice water.
B. Alcohol wipes.
D. Requisition form.
The urse has forgotten to gather a container for ice water. An arterial blood
sample is placed in a container of ice water to keep blood gasses from escaping.
The trial should be transported to the lab in the container of ice water and
analyzed within ten minutes of being collected. A tourniquet is not required for
arterial punctures, because of arterial pressure. Tincture of iodine is used to
cleanse the puncture site.
The nurse is aware that their hospital has a policy that allows nursing aides to
remove intravenous lines while on the surgical unit. The nurse delegates this task
to the aide and the intravenous catheter is removed incorrectly. Who is
responsible for this mistake?
A. The hospital, because the policy allowed the procedure.
B. The nurse, because they supervised the procedure.
C. The aide, because they performed the procedure.
D. Both B and C
In this situation, the nurse is responsible for the aide’s actions, because they
supervised the procedure. Tasks delegated to unlicensed personnel are ultimately
the responsibility of the nurse. Although the hospital may have a policy allowing
unlicensed personnel to perform certain tasks, this cannot override the state’s
nurse practice act.
The nurse is preparing to insert an intravenous catheter to administer fluids for a
patient who will have surgery. What is the most important factor that affects the
nurse’s choice of location for this site?
A. The type of cannula to be used
B. The duration of the infusion
C. The condition of the vein for use
D. Both B and C
When preparing to insert a catheter for intravenous fluids during surgery, factors
that influence the site location choice include the infusion duration and the
condition of the vein for use. An infusion that will run over a long period requires
a vein that will tolerate the instillation of large amounts of fluid over time, rather
than a short injection of fluid or medication. Additionally, veins that are in poor
condition may be difficult to cannulate and may not tolerate a fluid infusion.
What special precaution should be observed when collecting a specimen for blood
A. Maintaining aseptic technique.
B. Maintaining postural position.
C. Maintaining calmness.
A special precaution when collecting a specimen for blood cultures is
establishing and maintaining aseptic technique during the collection process.
Bacteria are found on the skin surface and are considered normal. Without using
special precautions, the normal skin bacteria may contaminate the specimen. The
puncture site and rubber stopper on collection bottles are prepared using tincture
of iodine. After area has been prepared, the nurse should take care not to
contaminate the site by inadvertently touching or allowing the tourniquet to touch
A patient is admitted with severe burns over 50 percent of their body. The nurse
inserts an IV to begin fluid administration and for medications. What is the
typical process of fluid shift for this type of patient within the first 48 hours?
A. Fluid is pulled out of the blood vessels and into the tissues.
B. Fluid is pulled out of the tissues and into the blood vessels.
C. Fluid maintains equilibrium between the blood vessels and the tissues.
D. Fluid movement depends on the type of burn and the patient’s electrolyte
During the first 48 hours following a burn, fluid is pulled out of the blood vessels
and into the tissues. The nurse must administer adequate fluids to prevent
hypovolemia and subsequent hypotension. The tissues will swell with the excess
fluid, but after approximately two to three days, the shift reverses and the fluid
returns to circulation.
Which statement is a requirement when managing exposure to blood borne
A. Nurses should receive training in handling occupational exposure if there is a
risk of coming in contact with blood borne pathogens.
B. Food and drink should be kept on a separate table in the operating suite, away
from the patient.
C. A contaminated needle should be carefully recapped before placing it in a
D. Employers are required to provide measures for hand hygiene practices.
Employers are required to provide measures for hand hygiene practices. If
employees are expected to wash their hands to protect themselves from blood
borne pathogens, employers are mandated to provide materials for them,
according to the Occupational Safety and Health Administration. Food and drink
should be separate from operative procedures and not in the same room, and
contaminated needles should never be recapped to reduce risk of injury. All
healthcare personnel should receive training on exposure to blood borne
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(CNN) - Results from a landmark clinical trial this summer suggested, for the first time, that a medication given for weight loss alone could reduce the risk of heart attack, stroke or heart-related death in people with cardiovascular disease, bolstering physicians' excitement about an already-exploding class of new medicines.
Novo Nordisk's Wegovy, part of the booming group of drugs called GLP-1 receptor agonists, was shown to reduce those people's risk of another cardiovascular event by 20%, results that were confirmed in a presentation of the full dataset Saturday at the American Heart Association conference in Philadelphia.
"Imagine a future where we're treating obesity and, in effect, treating these other obesity-related diseases" like hypertension, high cholesterol and type 2 diabetes, Dr. Ania Jastreboff, director of the Yale Obesity Research Center, who helped conduct the trial, said at a briefing Friday. "Treating obesity clearly improves health outcomes."
A key question about the initial results, though, remained not fully answered: Is the heart benefit from Wegovy attributable to how much weight people lose while using the medicine? Or is it because Wegovy has other effects as well?
"It remains unclear to what degree the trial findings were dependent on weight loss, concomitant reductions in risk factors, or other salutary mechanisms of GLP-1 receptor agonism," Dr. Amit Khera, of the University of Texas Southwestern Medical Center Dallas, and the National Institutes of Health's Dr. Tiffany M. Powell-Wiley wrote in an editorial that was published Saturday in the New England Journal of Medicine along with the full results of the study, called Select.
Nonetheless, they added, "We are in a new era of treating obesity and cardiometabolic risk with a growing armamentarium of options."
The tool chest grew this week with US Food and Drug Administration approval of Zepbound for obesity, a drug from Eli Lilly that will compete directly with Wegovy. Both medicines were preceded by drugs for type 2 diabetes that use the same active compounds: Wegovy's sister drug is Ozempic, and both use semaglutide, while Zepbound's is Mounjaro, and both use tirzepatide. They're all taken once a week as a self-administered shot.
GLP-1 receptor agonists mimic hormones that stimulate the production of insulin, promote feelings of fullness and reduce appetite. Semaglutide targets GLP-1, while tirzepatide targets both GLP-1 and a hormone called GIP.
The trial showed that after two years, people using Wegovy were less likely to develop diabetes or blood sugar levels considered "prediabetes"; lost 9.4% of their body weight, compared with 0.9% on placebo; reduced their waist circumference by an additional 6.6 centimeters over placebo; and had greater reductions in systolic blood pressure, a marker of inflammation called C-reactive protein and triglycerides.
To cardiologist Dr. Steven Nissen of the Cleveland Clinic, who wasn't involved in the trial but is leading a similar one of tirzepatide, those effects are all evidence of the benefits of weight loss.
"When you lose weight, a lot of things change," Nissen said in an interview Saturday from the conference just after the Wegovy study presentation, which was given to a packed house with several rows of audience members standing at the back.
"We now have, for the first time in history, treatments that can actually really [help patients] lose enough weight to make a difference," Nissen said.
Tirzepatide has shown greater levels of weight loss than semaglutide in clinical trials, leading many, including Nissen, to hope it will show even stronger cardiovascular benefits.
The Wegovy study, sponsored by Novo Nordisk, enrolled 17,604 people whose body mass index was 27 or higher, putting them in the overweight category, and who had cardiovascular disease, meaning a previous heart attack or stroke or symptoms of peripheral artery disease - clogged arteries in the arms or legs.
Importantly, participants didn't have a history of diabetes; a previous trial had shown that treating people with diabetes with a GLP-1 drug, Ozempic, reduced their cardiovascular risk.
The Wegovy trial showed that 569 of 8,803 people taking the drug had a heart attack or stroke or died from heart-related causes, or 6.5%. That's compared with 701 of 8,801 people on a placebo, or 8%. The difference in those rates is what amounts to the 20% benefit reported in August.
The benefit was seen on top of medicines like statins to lower cholesterol, which 90% of the trial participants were taking, and other drugs considered the standard of care for heart patients.
"The differences in rates between the two treatment groups began to emerge very early after initiation of treatment, within the first months," the Cleveland Clinic's Dr. A. Michael Lincoff, who led the trial, said Friday.
The 20% reduction was on a combination of three measures; when looked at separately, not all reached statistical significance. The first individual measure the researchers looked at was death from cardiovascular causes, and while it appeared Wegovy lowered the risk by 15%, the results weren't statistically significant, meaning they don't hold as much weight.
The biggest benefit appeared to be in preventing heart attacks, where the risk reduction was 28%. Strokes were reduced by 7%. It's unclear what the statistical significance of those measures was, because researchers didn't calculate those values after the finding on deaths didn't meet the threshold. The overall finding of 20% risk reduction, though, was statistically very strong.
The study didn't uncover any new safety concerns, but it found that more people stopped taking semaglutide than placebo because of adverse events. The most common were gastrointestinal disorders like nausea, vomiting and diarrhea, and there was a small increase in gallbladder-related disorders on Wegovy compared with placebo.
The amount of weight loss seen in the trial, 9.4%, was less than in other studies of Wegovy, which showed average weight loss closer to 15%. Lincoff noted that this trial wasn't focused on weight management, where trials typically involve changes in diet and exercise and "close monitoring," but instead "models the way cardiovascular disease is treated in the real world."
He also noted that not all of the participants got the highest dose of Wegovy in this study; the dose of medicine was adjusted based on whether they had side effects.
On the question of whether the benefit in the trial came primarily from weight loss or from other drug effects, Lincoff pointed out that the heart benefits became apparent in the study earlier than the major differences between Wegovy and placebo on weight loss, and he noted that "lighter-weight patients to start with experienced the same magnitude of benefit."
"I think most of us believe that some of this is weight loss, but I think that that oversimplifies a very complex molecule, a complex receptor on multiple tissues, and I don't think it's as a simple as that," he said. "That's part of the reason why I don't think weight loss itself is the surrogate; we have to look at the mechanism of the weight loss."
"And," Jastreboff added, "it may be a combination of both."
The study left a few additional questions unanswered: It looked at heart risk only in people with existing cardiovascular disease, and researchers said it would be important to know whether the drug could benefit people who hadn't had a cardiac event. The trial also had racial and gender imbalances: Only 3.8% of participants overall were Black, and 28% were women.
The findings are expected to increase demand for the drug, which already is in short supply, and potentially Improve insurance coverage, which is spotty. Wegovy costs $1,349 a month before insurance.
And while "millions of additional patients" could benefit from the drug based on these results, Khera and Powell-Wiley wrote in their editorial, "semaglutide comes with a significant cost both to patients and to society at the current pricing for GLP-1 receptor agonists, which makes this treatment inaccessible for many."
The case has never been clearer: Eat less bacon and more beans.
An analysis published Wednesday in the journal BMC Medicine, drawing on data from 37 studies, adds to the evidence that eating fewer animal-based foods â€” especially processed meats â€” and replacing them with whole grains, legumes and nuts is linked to a reduced risk of cardiovascular disease and Type 2 diabetes.
The study is particularly useful because it details which dietary changes are most strongly linked to better health, said Qi Sun, an associate professor of nutrition and epidemiology at the Harvard T.H. Chan School of Public Health, who was not involved with the study. For example, the study estimated that replacing one serving per day of processed meats, like hot dogs, sausage, deli meats or bacon, with a serving of whole grains, nuts or beans was associated with a 23 to 36 percent lower risk of cardiovascular issues, including stroke, heart attack and coronary heart disease.
The analysis combined the results from studies in the United States, Europe and Asia that asked participants detailed questions about the foods they typically ate. Researchers followed them for an average of 19 years and looked for correlations between their diets and health. They adjusted for other factors that can affect health, including calorie intake, physical activity, smoking and alcohol use.
These types of studies canâ€™t determine if plant-based foods directly prevent cardiovascular disease or Type 2 diabetes â€” only that there is an association between eating more of such foods and a lower risk of developing these conditions, said Sabrina Schlesinger, an epidemiologist and nutrition scientist at the German Diabetes Center in DĂĽsseldorf, Germany, and a lead author of the study. But the findings were consistent between studies, she said, and are supported by other research that points in the same direction.
The study was partially funded by the Alpro Foundation, a nonprofit research arm of a Belgium-based company that makes plant-based milks and yogurts; the organization was not involved with planning, conducting or interpreting the study, Dr. Schlesinger said.
Why more plants and less meat can be beneficial
The benefits of following a diet rich in whole grains, nuts and legumes and lower in red and processed meats are backed by at least 30 years of scientific evidence, said Maya Vadiveloo, an associate professor of nutrition at the University of Rhode Island.
Those plant-based foods are full of heart-healthy fats and fiber, which can help control blood sugar and lower diabetes risk, Dr. Sun said. They also contain beneficial plant-based compounds; legumes, for example, are rich in isoflavones, which are thought to reduce inflammation and act as antioxidants, he said.
Red and processed meats, on the other hand, can be higher in saturated fat, sodium or certain compounds that can promote inflammation, all of which may contribute to chronic disease risk, Dr. Schlesinger said.
The study researchers found that eating nuts instead of processed meats was associated with a 22 percent lower risk of Type 2 diabetes and a 21 percent lower risk of early death. Replacing unprocessed red meat with plant-based foods was also tied to better health outcomes, though the reductions in risk were smaller and the evidence less certain.
The researchers also found that substituting eggs with nuts was linked with a reduced risk of Type 2 diabetes, cardiovascular disease and early death. Thatâ€™s somewhat surprising, Dr. Sun said, since most research suggests that itâ€™s OK to eat one to two eggs per day. But in a head-to-head comparison, nuts may be healthier, he said.
The study did not look at plant-based milks and yogurts or meat substitutes; more research is needed to know how these products affect health, Dr. Schlesinger said.
How to make plant-based shifts
The study showed that even relatively small dietary swaps are linked to better health, Dr. Schlesinger said. â€śAdopting a plant-based diet does not necessarily mean eliminating all animal products.â€ť
Taking steps toward eating less red meat â€ścan be good for cardiovascular health, and can help you have a more balanced, higher overall diet quality thatâ€™s also good for the environment,â€ť Dr. Vadiveloo said. Itâ€™s also linked to a reduced risk of some cancers, and it might save you money at the grocery store, too, she added.
Dr. Vadiveloo recommended identifying small changes that feel doable and focusing on foods that you already enjoy. If you usually have bacon for breakfast or a sandwich with deli meat for lunch, try alternatives a few days per week, she said â€” like beans or chicken instead of bacon, or peanut butter and jelly instead of a club sandwich. You can also make gradual substitutions in some meals, like replacing some of the ground beef in your tacos with beans, she said.
People sometimes worry that they wonâ€™t get enough protein if they eat less meat, but beans, tofu and nuts all provide high-quality protein, Dr. Sun said. By reducing meat consumption and adding these nutritious plant-based foods, â€śyou cannot go wrong,â€ť he said.
Women with high blood pressure during pregnancy had long-term blood pressure and cardiac benefits if their blood pressure was carefully controlled for the first few weeks after having a baby, according to late-breaking science presented today at the American Heart Association's Scientific Sessions 2023. The meeting, Nov. 11-13, in Philadelphia, is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science. The full manuscript is also simultaneously published today in The Journal of the American Medical Association.
In this prospective, randomized trial conducted in the U.K., researchers investigated the effects of improving blood pressure control immediately after pregnancy on long-term blood pressure levels.
This study included 220 new mothers who had high blood pressure during pregnancy and still needed medication for high blood pressure after giving birth.
Half of the participants were randomly assigned to the group that received a wireless blood pressure monitor and asked to send daily blood pressure readings via a phone app to the study doctors. The phone and app were connected to the blood pressure monitor via Bluetooth, and blood pressure measures were automatically uploaded to the app and automatically shared with the study doctors. The app sent automated prompts to the participants based on their blood pressure levels â€” to either repeat a studying or, if the studying was in a range that needed changes to their blood pressure medication, advised them to contact their doctor in the trial. The doctors then advised participants via phone or video call about how to adjust their medication to make sure their blood pressure remained below 140/90 mm Hg.
The remaining half of the participants received usual postpartum care, which, in the U.K., involves an office visit with the family physician or midwife 5-10 days after delivery and another at 6-8 weeks after giving birth.
"The trial suggests the timing of this second appointment may miss a critical window for early blood pressure optimization," Leeson said. "While this visit includes a blood pressure examination and participants are likely to be on blood pressure medication until their blood pressure is back in a normal range, their blood pressure will not be as carefully monitored and medication will not be as tightly adjusted as in the intervention group of the trial."
The trial results found:
"We were surprised by the size and consistency of the blood pressure reduction in the women who received the intervention. The benefits started to emerge within the first week or two after pregnancy, and the effect on blood pressure persisted after the medication was stopped," Leeson said.
"A 5-10 mm Hg reduction in blood pressure is typically associated with a 20% reduction in longer-term cardiovascular risk," he added. "If the reduction in blood pressure we observed at nine months is sustained long-term, this could slow progression to needing treatment for hypertension by an average of up to a decade."
Approximately 90% of participants agreed to have the researchers also perform cardiac magnetic resonance imaging and echocardiography on them at nine months postpartum. Women who had received the tighter blood pressure control after delivery showed clear improvements in the structure and function of the heart compared to women who had usual care.
Study details and background:
Study limitations included that the study was conducted at a single research center, meaning that the intervention may need to be modified before being repeated at multiple centers, and that the research team delivering the study intervention knew who had the self-monitoring devices, which may bias results. To overcome this potential for bias, the researchers ensured that blood pressure measurements were digitally collected by the participants' 24-hour blood pressure machines, which downloaded measurements and added them to the research database. This method was independent of the study team and mothers, and those who conducted the analysis were blinded to how the home blood pressure monitoring devices were allocated, Leeson said.
Future work will involve replicating the study in more racially and ethnically diverse patient populations in the U.K., identifying the optimal way to provide care after pregnancy and exploring the potential mechanisms of cardiac remodeling that may underpin the long-term lowering of blood pressure, Leeson said.
The 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults classifies stage 1 hypertension as having clinic top and bottom numbers greater than or equal to 130/80 mm Hg and stage 2 hypertension as having top and bottom numbers greater than or equal to 140/90 mm Hg.
Health- and fitness-conscious individuals worldwide opt for artificially sweetened beverages (ASBs) over their sugar-sweetened counterparts (SSBs), but the health advantages of ASBs remain debated within the scientific community. In a accurate umbrella review published in the journal Advantages in Nutrition, researchers examined the results of previous systematic reviews and meta-analyses to verify the credibility of medical and ASB-industry-funded research to evaluate whether AIBs truly meet the health gains that their manufacturers market. Their findings from 11 meta-analyses and seven systematic reviews indicate that frequent ASB consumption can lead to a higher risk of obesity, all-cause mortality, hypertension, type 2 diabetes (T2D), and cardiovascular disease (CBD), contrary to current consumer belief.
Review: Artificially Sweetened Beverages and Health Outcomes: An Umbrella Review. Image Credit: VTT StudioÂ / Shutterstock
What are AIBs?
Artificially sweetened beverages (ASBs) are beverages containing sucrose-replacing sweeteners, including saccharin, sucralose, neotame, and advantame. Since they contain little to no conventional sugar (sucrose), they have little calorific value and are marketed as healthier alternatives to traditional sugar-sweetened beverages (SSBs). These drinks are trendy amongst health- and fitness-minded individuals and those overweight or obese based on the assumption that fewer calories, all else being equal, is better than more.
Recent medical research has challenged these assumptions, with a growing body of literature suggesting that ASBs may be linked to rapid unwanted changes in the gut microbiome and associated with increased all-cause mortality risk. Alarmingly, some studies have reported ABSs as contributing to cancers and cardiovascular disease (CVD), while others have found no such association. These conflicting medical reports are further complicated by industry-funded research, most of which gives ASBs their approval as safe for human consumption.
Umbrella reviews are a novel class of reviews that summarize and evaluate the results of previous reviews and meta-analyses while also verifying the technical and scientific soundness of the methodology and analyses that led to those results. They present an ideal means of cutting through the fluff, especially when multiple scientific reports suggest starkly contradictory outcomes (healthy versus not healthy) of the same treatment (ASB consumption).
About the study
The present umbrella review aims to examine the certainty of claimed health outcomes due to ASBs and identify potential biases or inconsistencies in the literature. This review further evaluates the methodologies employed in previous reviews and meta-analyses both as a test for credibility and to inform future authors of the best practices to use when conducting ASB-health studies.
This study adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Data was collated from three publication repositories, PubMed, Embase, and the Web of Science, from their inception until 25 May 2022. Inclusion criteria comprised all systematic reviews, meta-analyses, cohort, and case-control studies testing the associations between ASBs and health. However, cross-sectional studies were excluded due to the inherent weakness of evidence the study design suffers from. Results from systematic reviews comprising mixed study designs (cross-sectional alongside others) were filtered to remove the cross-sectional results, with the remaining results reanalyzed.
Collated data included the first author's name, the year of study publication, PECO (population, exposure, comparison group, outcome), exposure and outcome variables, and effect sizes. Additionally, the funding source of studies, both the meta-analyses and their constituent publications, were recorded.
The A MeaSurement Tool to Assess systematic Reviews (AMSTAR) tool (specifically AMSTAR-2) was used to evaluate the methodological soundness of included studies. The tool comprises 16 items that guide researchers in verifying the quality of systematic reviews.
A random-effects model using the lowest study-specific ASB consumption as a standardization parameter was used to estimate the average effects of each 'high-quality' systematic review to test the effects of inter-study heterogeneity. This was then compared to results from a fixed-effects model assuming a lack of inter-study heterogeneity. Inconsistency between studies was computed using I2, a metric that presents the amount of variability in effect results due to heterogeneity rather than study sampling error. Egger's test was used to compute slight study effect bias.
The initial repository sweep identified 7,218 publications, of which 68 met inclusion criteria following title and abstract screeningâ€”of these 68, full-text screening and the exclusion of cross-sectional studies resulted in seven systematic reviews and 11 meta-analyses reporting PECO that were included in the statistical pipeline.
Collectively, the included studies reported the associations between ASB consumption and 13 health outcomes. Of these, present study analyses revealed that high- and regular ASB consumption depicted a positive association with CVD risk, CVD-associated mortality, chronic kidney disease, obesity, all-cause mortality, hypertension, T2D, and pancreatic cancer. Following AMSTAR assessments of the studies reporting these findings, however, the association between ASBs and CVD-associated mortality, chronic kidney disease, and pancreatic cancer was found to be weak and inconclusive.
Dependable study results revealed that sucralose and saccharin used in most ASBs have a rapid and severely detrimental impact on the human cardiovascular system, impairing glucose tolerance in hitherto healthy adults following only two weeks of daily ASB consumption. Human and animal studies further showed that some artificial sweeteners stimulate immune inflammatory responses in the gut wall.
Outstanding 12-month first-in-human data from Xeltisâ€™ aXess hemodialysis vascular conduit trial presented at VEITHsymposium 2023
EINDHOVEN, The Netherlands â€“ 17 November 2023, Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces outstanding 12-month data from its first-in-human (FIH) aXess vascular conduit trial (NCT04898153). The data was presented yesterday by Prof. Dr. Frans Moll at the 50th Annual VEITHsymposium in New York.
At 12 months, 100% secondary patency, 78% primary assisted patency and 0% infections were observed in data from 20 patients implanted with the aXess conduit. These outstanding results represent a significant improvement over current standard of care. This performance builds on the very encouraging 6-month data presented in April 2023 at the Vascular Access Society Congress in Porto, Portugal. To date, more than 3500 dialysis sessions have been conducted across the six centers in Belgium, Italy, Latvia and Lithuania.
aXess is a restorative conduit which enables the creation of a new, long-term living vessel for hemodialysis vascular access. The aXess FIH trial is a single arm feasibility study in Europe evaluating the preliminary safety and performance of the aXess graft in subjects older than 18 years with end-stage renal disease and deemed unsuitable for fistula creation. Follow-up visits were conducted at regular intervals after the initial procedure, with study follow-up visits to be conducted for five years. A separate pivotal trial of aXess is underway, enrolling up to 110 patients across up to 25 sites in nine EU countries, with over 40 patients already implanted.
The full data were presented today by Prof. Dr. Frans Moll, Department of Vascular Surgery, University Medical Centre Utrecht, The Netherlands, in a presentation entitled: Novel Application Of Polymer Technology To Create Endogenous Tissue with Host Collagen And Endothelium Compatible With Flowing Blood: 1-Year Clinical Results Of The aXess Graft.
Professor Dr. Frans Moll, vascular surgeon and member of Xeltisâ€™ Medical Advisory Board, said: â€śThe 12-month data from the aXess FIH trial are highly encouraging, and continue to demonstrate the potential of the aXess vascular conduit to combine the early benefits of AVG, such as early cannulation and no maturation needed, with the long-term advantages of AVF, including better patency rates, a reduced need for intervention and low infection rates.â€ť
Eliane Schutte, CEO of Xeltis commented: â€śThe outstanding 12-month data from our FIH study highlights aXessâ€™ potential to transform the field of vascular access as a whole by stopping the cycle of interventions and infections. These latest results, alongside the excellent progress in enrollment for our pivotal trial, brings us closer to bringing our breakthrough solution to hemodialysis patients worldwide.â€ť
Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors.
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