ANCC-CVNC learner - ANCC (RN-BC) Cardiac-Vascular Nursing Updated: 2024
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Exam Code: ANCC-CVNC ANCC (RN-BC) Cardiac-Vascular Nursing learner January 2024 by Killexams.com team
ANCC-CVNC ANCC (RN-BC) Cardiac-Vascular Nursing
The ANCC Cardiac-Vascular Nursing board certification examination is a competency based examination that provides a valid and reliable assessment of the entry-level clinical knowledge and skills of registered nurses in the cardiac-vascular specialty after initial RN licensure. Once you complete eligibility requirements to take the certification examination and successfully pass the exam, you are awarded the credential: Registered Nurse-Board Certified (RN-BC). This credential is valid for 5 years. You can continue to use this credential by maintaining your license to practice and meeting the renewal requirements in place at the time of your certification renewal. The Accreditation Board for Specialty Nursing Certification accredits this ANCC certification
There are 150 questions on this examination. Of these, 125 are scored questions and 25 are pretest
questions that are not scored. Pretest questions are used to determine how well these questions will
perform before they are used on the scored portion of the examination. The pretest questions cannot
be distinguished from those that will be scored, so it is important for a candidate to answer all
questions. A candidate's score, however, is based solely on the 125 scored questions. Performance on
pretest questions does not affect a candidate's score.
I Assessment and Diagnosis 31 25%
II Planning and Implementation 44 35%
III Evaluation and Modification 28 22%
IV Patient and Community Education 22 18%
TOTAL 125 100%
Assessment and Diagnosis
1. Anatomy and physiology
1. Patient interview (e.g., history, chief complaint, allergies)
2. Cardiac-vascular assessment techniques and tools (e.g., Doppler, stroke scale)
3. Data collection and interpretation (e.g., diagnostic tests, laboratory results)
4. Nursing diagnosis identification and prioritization
II Planning and Implementation
1. Evidence-based practice guidelines (e.g., ACC/AHA guidelines, quality measures)
2. Scope and standards of practice (i.e., cardiovascular nursing, vascular nursing)
3. Legal and ethical considerations (e.g., informed consent, advance directives)
4. Procedures (e.g., angiogram)
5. Surgeries (e.g., coronary artery bypass, carotid endarterectomy)
6. Pharmacologic therapies
7. Non-pharmacologic and complementary therapies
8. Risk-reduction measures (e.g., venous thromboembolism prophylaxis)
1. Care coordination (e.g., interdisciplinary teams, discharge planning)
2. Interventions (e.g., therapeutic hypothermia)
III Evaluation and Modification
1. Expected outcomes
2. Drug interactions (e.g., drug-drug, drug-food)
1. Adverse reactions and events (e.g., heparin-induced thrombocytopenia, hypotension) recognition and treatment
2. Urgent condition (e.g., pseudoaneurysm) recognition and treatment
3. Emergent condition (e.g., STEMI) recognition and treatment
IV Patient and Community Education
1. Cardiac-vascular risk factors (e.g., ethnicity, smoking)
2. Chronic disease management
3. Cardiac-vascular education Topics (e.g., procedures, medications)
4. Self-management strategies (e.g., daily weights, blood pressure logs)
5. Community resources (e.g., cardiac rehabilitation, anticoagulation clinic)
1. Individualized education planning and implementation (e.g., addressing barriers)
2. Home monitoring (e.g., remote telemetry, point-of-care testing)
3. Health promotion (e.g., wellness counseling, health fairs)
|ANCC (RN-BC) Cardiac-Vascular Nursing
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ANCC (RN-BC) Cardiac-Vascular Nursing
Which of the following sets of drugs might slow the conduction through AV node
and cause second degree heart block?
A. Digoxin, statins, nitrates
B. Procainamide, statins, fibrates
C. Digoxin, beta-blockers, calcium channel blockers
D. Calcium channel blockers, potassium channel openers
Digoxin, beta-blockers, and calcium channel blockers might slow the conduction
through AV node and cause second degree heart block. Pharmacologic agents that
slow conduction through the atrioventricular node have been shown to cause
second-degree atrioventricular block type I. These agents include cardioactive
drugs such as digoxin, beta-blockers, calcium channel blockers, and certain
antiarrhythmia drugs such as sodium channel blockers (procainamide).
A patient who has been diagnosed with aneurysm in femoral artery during routine
screening wants to know about the available treatment options. What the nurse
should explain this patient regarding treatment?
A. No treatment is necessary
B. Follow up every month
C. Immediately undergo surgery
D. Undergo angioplasty if aneurysm starts causing symptom
The nurse should tell this patient that as the aneurysm is located in the extremity
and is asymptomatic, no treatment is necessary. Peripheral aneurysms in the
extremities are typically asymptomatic and do not require treatment due to their
low risk of rupture. Treatment of peripheral aneurysms depends on the presence
of symptoms, the location of the aneurysm, and whether the blood flow through
the artery is blocked.
A patient has been diagnosed with aortic aneurysm of abdominal aorta having a
diameter of 3.5 cm. What advice should the nurse deliver this patient about follow-
A. Come for follow up every year
B. Come for follow up after 5 years
C. Come for follow up every 2-3 years
D. No need to come for follow up
The nurse should advise the patient with abdominal or thoracic of size 3 to 4 cm
to come for follow up every year. For patients with an abdominal or thoracic
aortic aneurysm with a diameter less than 3 cm without symptoms, follow-up
screening should be conducted within 5 to 10 years. For patients with an aorta of
3 to 4 cm in diameter, follow-up screening should be performed on a yearly basis.
For patients with a diameter of greater than 4 cm, careful follow-up needs to be
performed on a bi-yearly basis. If a patient presents with an aorta with a diameter
greater than 5 cm, surgery is recommended, which would include abdominal or
open chest repair.
The incorrect statement about Buerger"s disease is:
A. Buerger"s disease is a rare disorder
B. Complications of the disease are ulcerations, infections, and gangrene
C. The disease is more common in men than in women
D. Another name for the disease is Raynaud"s disease
The incorrect statement about Buerger"s disease is Another name for the disease
is Raynaud"s disease. Another name for Buerger"s disease is Thromboangiitis
obliterans. Symptoms of Buerger"s disease include pain and weakness in
extremities, swelling of hands and feet, Raynaud"s phenomenon, open sores on
Which of the following is true about atherosclerotic plaque formation?
A. Plaque formation is caused by an acute inflammatory response and endothelial
dysfunction where lipids, cholesterol, and calcium build up in the arteries
B. Plaque formation is caused by a chronic inflammatory response and epithelial
injury where lipids, cholesterol, and calcium build up in the arteries
C. Plaque formation is caused by a chronic inflammatory response and
endothelial dysfunction where lipids, cholesterol, and calcium build up in the
D. Plaque formation is caused by an acute inflammatory response and epithelial
injury where lipids, cholesterol, and calcium build up in the arteries
The true statement about Plaque formation is caused by a chronic inflammatory
response and epithelial injury where lipids, cholesterol, and calcium build up in
the arteries. Atherosclerotic plaque formation is caused by a chronic
inflammatory response and endothelial dysfunction where lipids, cholesterol,
calcium, and other substances build up in the arteries. There is an imbalance
between deposition of plaque and removal by low-density lipoproteins in smooth
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Margery Quackenbush was attending a board meeting of the nonprofit where she served as executive director when she felt a sharp, stabbing pain in her chest. As the organizationâs president yelled at a board member, Quackenbush â then age 69 â noticed her heart tightening and felt terrified.
After that day more than 15 years ago, her cardiologist began a series of tests. The results showed a blocked artery and she got a stent put in, becoming one of more than 600,000 people in the United States who have a stent placed each year, according to the American Heart Association.
âThe whole thing came as a shock. I like to tell people I didnât know I had a heart,â said Quackenbush, who was then the executive director of the National Association for the Advancement of Psychoanalysis. Years later, at age 85, the therapist lives in New York Cityâs Upper East Side in an apartment she shared with her husband of almost 50 years, childrenâs book author Robert Quackenbush, who died of cancer in 2021.
She became more mindful of her heart, and its needs, by attending regular support groups over the last 15 years. Today, she credits her health in part to the psychological and behavioral support sheâs received while navigating heart disease â an area thatâs all too often neglected in the U.S. health care system.
One in three heart patients live with anxiety, depression, and ongoing stress, according to a 2023 meta-analysis of over 100 studies. But even in the age of 24/7 monitoring via implantable loop recorders and wearables, many patients are without professional support for the mental and emotional social aspects of coping with heart disease.
âThe technology of cardiology is locked down. People get that. Whatâs not locked down is the patient experience,â said Sam Sears, professor of health psychology at East Carolina University, and the author of over 200 research studies on psychological interventions for heart health. âThe human factors in all this just donât get addressed as a standard of care.â
Q uackenbush, however, got lucky. Reeling from surgery and seeking community with others whoâd been through similar experiences, she asked her cardiologist about support groups for heart patients. In 2007, she showed up at the office of cardiac psychologist Robert Allan, whose group she still attends to this day.
On a latest Tuesday evening, Quackenbush put her feet up in her living room and logged onto Zoom from her iPad for her biweekly cardiac support group with Allan. A few members are still there from 2007, while many others have come and gone. The goal has remained the same throughout: to support each other in recovery from heart disease.
âGetting older is scary,â Quackenbush said of the group. âIf something upsets you, you have a place you can go. You know that every other week, you are able to talk about whatever it is.â
The group offers support for healthy habits, too. Since her heart issues were first diagnosed, Quackenbush has embraced exercise, first participating in cardiac rehab, then going to a gym after the rehab center closed, then doing at-home workouts. Her current routine includes sitting down and standing up repeatedly, pelvic floor exercises, clamshells, and weight lifting. The groupâs support has helped her reinforce her exercise regime and healthy cooking habits (she loves making salmon and chicken) and taught her to avoid extra stress on the heart by not eating large meals or having dinner too close to bedtime.
On this night, Quackenbush shares the impact that heated discussions about Israel and Palestine seem to be having on her physical and emotional health.
âIn a [separate] discussion group Iâm in, I noticed some chest pain when the groupâs discussion veered toward the war in the Middle East,â Quackenbush, who lives with anxiety, shared with the group.
That was the cue for Allan to interject and ask how the news was impacting everyone. âAre you taking care of yourself while you monitor the Middle East?â he asked the group.
One member said he canât bring himself to exercise these days. Another member said she hasnât been getting much work done, but was OK with that considering the circumstances.
Allan aims to keep the tone of the group inclusive and encouraging even in the midst of deep discussions, posing open-ended questions and asking people to respond who havenât had a chance to talk yet.
âI try to let the group do its own work. I sort of feel like an orchestra leader. You want to let the musicians play, you want to deliver them some direction,â Allan said.
For the next hour and a half, eight members shared other dispatches from their personal lives: falls, strokes, knee replacements, and even a looming cardiothoracic surgery. The group shared knowing nods and swapped experiences. One person with knee surgery on the horizon said they know they could get through it knowing another member had done it successfully in the past.
Allan has a long history in cardiac psychology. Every Tuesday and Thursday for three decades, Allan ran a psycho-educational group at Weill Cornell Medical Centerâs cardiac care step-down unit for survivors of latest cardiovascular events. He worked with over 15,000 patients and family members until the Covid-19 pandemic shut the program down.
Also a member of the voluntary faculty at Weill Cornell College of Medicine, he ran pro-bono psychoeducational programs in stress and anger management at Weill Cornellâs cardiac rehabs in Manhattan, which closed in 2015, and in Queens, which closed during the pandemic. In addition to having a private practice, Allan also served as a guest instructor with the 92nd Street Yâs former cardiac rehab, where the group Quackenbush belongs to first began.
âI did this because of my own interest,â said Allan, who hasnât had heart trouble himself. But he got into the field because he wanted to help people live differently than his father, who had his first heart attack at age 46, and whom he described as an âangry, primitive, Type A man.â
âI learned about the risk factors, and I started changing my lifestyle dramatically to avoid the same fate as my dad.â
Robert Allan, cardiac psychologist
âI learned about the risk factors, and I started changing my lifestyle dramatically to avoid the same fate as my dad,â Allan said. Then, through therapy, support groups, and psychoeducational programming, he started to teach other people to protect their hearts and minds too.
Earlier in his career, Allan came across cardiologists Meyer Friedman and Ray Rosenmanâs seminal 1959 study linking type A behavior â characterized by anger and joyless striving â with an increased risk of heart attacks in men.
In the 1980s, public health specialists found type A personalities actually survived their heart attacks âbetterâ than those with type B, results that stirred controversy in the field. Over the last 40 years, the landscape shifted from emphasizing the health risks of type A personalities to looking at the impact of other psychosocial factors â such as anxiety, depression, stress, and loneliness â on the heart. This growing body of research led Allan to discover the power of psychosocial support groups.
Support groups, Allan said, âhelp motivate people to change âŚ They support healthy living through communication and validation.â When one group member says they went to the gym three times in the last week, the rest will cheer them on; if a member confesses to one too many bacon cheeseburgers, the others will groan and suggest healthier alternatives.
Research suggests that psychosocial factors play a role in both developing and coping with heart disease.
Depression is both a risk factor for developing cardiac disease and a risk factor after heart surgery. Worsening depression puts people at even greater risk of recurrence of heart disease, with a landmark 1993 study finding that depression can impact cardiac mortality. Research from 2017 also found depression to be a predictor of death in the first decade following a heart disease diagnosis.
Meanwhile, according to a 2022 statement from the American Heart Association, social isolation and loneliness are associated with a 30% percent increase in heart attack and stroke. Stress, too, is a concern: In a 2021 study of over 900 patients, researchers found the presence of mental stress-induced blood flow reduction, compared with no mental stress-induced reduction in blood flow, is significantly associated with an increased risk of cardiovascular death or nonfatal heart attacks.
And in a 2016 analysis of 46 studies spanning more than 2 million participants, researchers found anxiety was linked with higher risk of heart disease, stroke, and cardiovascular mortality.
âIf youâre depressed, if youâre anxious, if youâre isolated, if youâre angry, you can work on those behavior patterns.â
Robert Allan, cardiac psychologist
But depression, anxiety, loneliness, and stress are not inevitable. âIf youâre depressed, if youâre anxious, if youâre isolated, if youâre angry, you can work on those behavior patterns,â said Allan, who emphasizes the power of groups to reduce isolation.
In November of 2023, theÂ American Heart Association hostedÂ aÂ symposium that included findings from two preliminary studies â one on how depression may accelerate cardiovascular risk factors, and one on the link between cumulative stress and plaque build-up in arteries. Cardiologist Glenn Levine emphasized in a statement the importance of screening patients for depression and anxiety: âThese are things we want to aggressively refer people to mental health professionals.â
While the data on psychological risk factors for heart disease is strong, more research on what psychological interventions work in terms of health outcomes and impact on behavioral changes in the long term is needed.
That said, a meta-analysis of 14 randomized controlled trials published in 2023 found cognitive behavioral therapy, delivered individually or within a group, effectively reduced depression in patients with heart disease. And a 2017 review of 35 randomized controlled trials with a total of 10,703 participants with coronary heart disease found that people who received psychological treatment had a reduced rate of death from cardiac events, and their symptoms of depression, anxiety, and stress were alleviated. However, the review did not find evidence that psychological interventions impacted all-cause mortality.
âIâve been struck by how, despite these positive results, how little has really found its way into the routine care of cardiac patients,â said James Blumenthal, professor in psychiatry and behavioral sciences at Duke University, speaking of his and othersâ research on the profound relationship between the mind and heart.
Research by Blumenthal and his team has found that cardiac rehab programs enhanced by group stress management training resulted in lower stress and greater improvements in medical outcomes compared to standard cardiac rehab, which generally includes exercise programs and lifestyle education.
âFor whatever reason, thereâs been a general lack of acceptance when people say, âOh, yeah, we think itâs important,â but it has never actually made its way into the care of patients with heart disease,â Blumenthal said.
Blumenthal developed behavioral interventions delivered in group settings as an approach to psychologically-informed cardiac rehab, working with Dukeâs preventive cardiology program in the 1980s on the cardiac rehab team conducting stress management groups and providing stress management via federally funded research program in the 1990s.
âBecause the intervention was not covered by insurance â and was offered to patients at no cost â it was never incorporated into the routine care of patients,â Blumenthal explained via email. Dukeâs cardiac rehab still evaluates patients for psychosocial risk factors for heart disease and employs a health psychologist, though it hasnât offered formal stress management training and groups in over a decade.
The field of cardiology has often neglected mental health because it tends to place more emphasis on drugs and surgery, experts told STAT. Another issue is that cardiac rehab programs are not a moneymaker for hospitals, since program costs can exceed revenue as hospitals push for more streamlined at-home rehab delivery. Even for hospitals that do offer cardiac rehab, itâs unclear what percentage of the 1,337 cardiac rehab programs registered through American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) offer psychological support.
âThere are pockets of successful integration of psychology and cardiology, and then there are places that are deserts,â said Sears. âUntil we deliver everyone equal access and have equal buy-in from cardiology, itâll be hard for us to see the full success of that type of integration. Instead, we see it center by center instead of state by state.â
Searsâ Cardiac Psychology Lab is part of East Carolina Universityâs Clinical Health Psychology program, one of seven graduate schools focused on the psychology of medicine. There, he trains cardiologists on building resilience and reducing burnout in their work, and shares a clinic and cardiac rehab with cardiologists at East Carolina Heart Institute.
âThe needs of the patient are more than just what a physician and the nurse can deliver.â
Matthew Burg, clinical psychologist and professional of cardiovascular medicine
âWe need a whole new approach to cardiovascular care. And we need the funding initiatives to develop and test those new models of care,â said Matthew Burg, clinical psychologist and professional of cardiovascular medicine at Yale School of Medicine.
Burg is a founding member of the Society of Behavioral Medicineâs Cardiovascular Disease Special Interest Group, where there are over 300 psychologists and cardiologists interested in advancing what they refer to as the field of cardiovascular behavioral medicine.
One big obstacle to greater psychological support for cardiac patients is training: Cardiologists often havenât been trained to work in a team context with psychologists, and vice versa. Thatâs why psychologists such as Burg and Sears teach courses for future cardiologists and encourage psychologists to seek more training in cardiology.
âItâs not just about, we need integrated cardiovascular care so that we start to address mental health issues. Itâs that we need integrated cardiovascular care, because the needs of the patient are more than just what a physician and the nurse can deliver,â said Burg.
Some progress is underway. Last November, over 100 heart patients showed up to a conference room where the launch of a new cardiac support group at Brigham and Womenâs Hospital in Boston, Massachusetts, was hosted by physician assistants Tiffany Andrade and Lauren Rousseau. Brigham and Women also recently launched a department of cardiovascular psychiatry, led by psychiatrist Margo Funk, that offers mental health resources to patients.
Sears was a featured speaker for the Brigham and Women support group launch and delivered a talk called âHow to Make a Cardiac Comeback,â complete with a theme song: âComeback Storyâ by Kings of Leon. His lively talk included references to Mick Jaggerâs transaortic valve replacement and Christian Ericksen, the Denmark soccer star who had a defibrillator implanted after collapsing from cardiac arrest at a Euro 2020 soccer match. He showed photos of what he calls âcardiac swagâ â people with tattoos of defibrillators and T-shirts with inspirational slogans like âI Survived Open Heart Surgery. Whatâs Your Superpower?â
Sears, who compared his style to that of a sergeant and oscillates between offering inspiration and reassurance, tries to impart his audience with motivation for resuming activity after a cardiac event.
âCardiac arrest is a significant medical trauma,â said Sears. The goal of his work, he added, is âto transform the most threatening, scariest day of their life into something that empowers you to be stronger.â
âA core element about heart disease is that it leads people to believe that they can disengage as a self-protective response.â
Sam Sears, professor of health psychology
Searsâ cardiac rehab has been in practice for 16 years. At East Carolina, patients undergo six to 10 sessions of cognitive behavioral therapy, including discussions around how to manage the experience of shock from defibrillator implants while reducing symptoms of PTSD and building âactive problem-oriented coping skillsâ shown to increase quality of life, such as making time for family, setting health goals, and engaging in safe exercise.
âA core element, psychologically and physically, about heart disease is that it leads people to believe that they can disengage as a self-protective response,â Sears said. âAnd the opposite is true. The more engaging they are about the disease, the more engaging they are about whatâs going on in their life to be more deliberate in their behaviors and their emotions, the more likely they are to find peace and quality of life on the other side.â
Learning to be deliberate about, and engaged with, her emotions and health has been a major force for change for Quackenbush. Last year, her heart started to beat faster than normal and she was diagnosed with a condition called atrial flutter. Her doctor told her it wasnât life-threatening.
âWell, when itâs your life, itâs different,â Quackenbush said of the experience when it came up in a latest support group conversation.
A grandmother of two, Quackenbush leads a robust social life, filled with lunches with girlfriends and dating. Every night, she exchanges a photo of her dinner with one of the men she dates. But her cardiac group remains a cornerstone â she even attended a support group on vacation on her iPhone, declining a dinner invitation to do so.
Reflecting on her recovery from heart disease, Quackenbush said, âWhat would I tell myself when I was in my late 60s? Youâre going to survive. You have the support group.â
This story is the latest in a series on the U.S. mental health system, supported by a grant from the NIHCM Foundation. OurÂ financial supportersÂ are not involved in any decisions about our journalism.
As 2023 comes to a close, cardiologists are reflecting on some of the advancements and breakthroughs in their field over the past 12 months.
Heart disease is a pressing issue in the United States. The American Heart Association reports that more than 130 million adults (about 45.1% of the population) will develop some form of cardiovascular disease by 2035, which will lead to $1.1 trillion in projected total costs.
This reality means researchers and clinicians are invested nationwide in developing better interventions and treatments to address the rising prevalence of heart disease among Americans.
To put in perspective how serious this is, heart disease stands as the leading cause of death regardless of gender and spans most racial and ethnic groups in the United States, according to the Centers for Disease Control and Prevention (CDC).
Heart disease kills one person for every 33-second interval nationwide.
Healthline spoke with several experts who weighed in on the major breakthroughs and innovations of the past year as well as promising developments on the horizon in 2024.
Dr. Joseph C. Wu, Ph.D., FAHA, American Heart Association president and director, Stanford Cardiovascular Institute and Simon H. Stertzer Professor of Medicine & Radiology at Stanford School of Medicine, said that glucose-lowering drugs have been a game changer for people with type 2 diabetes, helping them to reduce cardiovascular events and Excellerate their heart health.
Research is now suggesting these same drugs may also improve heart health in people with obesity who arenât also living with diabetes.
âIn one trial of semaglutide, a medication shown to lower the risk of heart problems in people with diabetes and approved for long-term weight management, people with heart failure with preserved ejection fraction and obesity fared better on the drug than on placebo,â Wu said.
What is preserved ejection fraction?
Wu explained that this happens âwhen the heart muscle becomes thick and stiff and canât pump out enough blood to meet the bodyâs needs.â
âThe semaglutide group had greater reductions in heart failure-related symptoms, greater improvements in the ability to exercise and greater weight loss,â he added.
In that trial, researchers looked into whether semaglutide benefitted people who are living with overweight or obesity who did nothave diabetes, but who had cardiovascular disease.
The findings show that the drug was âsuperior to placebo in reducing cardiovascular-related death, nonfatal heart attacks, and nonfatal strokes,â Wu told Healthline.
Dr. Steven Nissen, a cardiologist at Cleveland Clinic, pointed to a different type 2 diabetes medication that he said is also a âblockbusterâ â tirzepatide.
He cited findings released this year that showed thecardiovascular benefits of the dual-acting GIP and GLP-1 agonist, which was originally made available solely for diabetes under brand name Mounjaro, and was recently approved for weight loss and the treatment of obesity under the name Zepbound.
âWeâve had these drugs, but we didnât really know whether theyâd have a favorable effect on cardiovascular outcomes on people who are being treated for obesity,â he said.
The research conducted on this drug had a âvery robust result,â Nissen stressed.
It was shown to have a 20% reduction in body weight for people who were overweight, while showing clear, âpromising hard endpointsâ of lower risk of cardiovascular death, stroke, myocardial infraction, or heart attack.
âThatâs a big reduction, itâs a turning point in the battle against obesity,â he added.
Dr. Karol Watson, PhD, an attending cardiologist and a Professor of Medicine/Cardiology at the David Geffen School of Medicine at UCLA, said all of the big 2023 developments in cardiovascular health center on preventive measures for lipid and hypertension management.
Watson, who is also the director of the UCLA Womenâs Cardiovascular Health Center, the UCLA-Barbra Streisand Womenâs Heart Health Program, the co-director of the UCLA Program in Preventive Cardiology, and director of the UCLA Fellowship Program in Cardiovascular Diseases, told Healthline that the big goal is âtrying to figure out how to get people to take their medications in the least invasive way possible.â
Watson said that, traditionally, you had daily pills people would take or injectables they would have to receive every two weeks. Today, there are more options.
âNow, there is data on the injectables people can do every every six months. Now, there are longer gaps [between injections]. The whole idea is one and done and doing something people will find easier for them. And, it works,â Watson explained. âThe problem is, these things are not going to be cheap.â
The findings of the drug zilebesiran, which showed the potential to lower pressure with an injection every six months, were presented at the American Heart Associationâs Scientific Sessions 2023.
Watson added that this kind of injectable âmakes it easy for people to get the medication they need.â She reiterated a big problem persists.
âThese [medications] are easy, you have one injection every six months,â she said, âbut they are not cheap. That is the problem.â
Wu pointed back to the 2023 Scientific Statement from the American Heart Association, which offers a summary of cardiovascular-kidney-metabolic (CKM) syndrome. He said this is âan interconnection between obesity, chronic kidney disease, diabetes, and cardiovascular disease, which is linked to premature death and disability.â
He said concretely pointing out this relationship is one of the big cardiovascular headlines of the year.
âThe statement summarizes what is known about CKM syndrome and how to prevent and manage it. It highlights a new way to calculate risk of the syndrome, as well as gaps in knowledge and needed research,â Wu added. âAn accompanying Presidential Advisory helps define CKM syndrome and offers guidance on the prevention and treatment of the syndrome across different clinical and community settings.â
Wu pointed to research on endovascular thrombectomy, a minimally invasive surgical procedure used to remove a stroke-causing blood clot from an artery in the brain, as another one of 2023âs big stories.
This procedure restores blood flow and prevents further brain damage and disability. Itâs the standard form of treatment for either small or medium-sized strokes.
âUntil now, it wasnât clear if endovascular thrombectomy would also benefit people with larger, more severe strokes, which account for up to one-fourth of all strokes.
In a study of people with severe strokes from China and in another trial of people in North America, Europe, Australia, and New Zealand, researchers found endovascular thrombectomy within 24 hours of a stroke was superior to standard medical care,â Wu said.
This research showed that these individuals who received this treatment showed signs of experiencing fewer disabilities and âwere more functionally independent during the three months after treatment.â
He pointed to a third study of those treated for severe stroke in Europe and Canada who showed similar outcomes.
âThose who underwent endovascular thrombectomy were more functionally independent than those who had standard medical treatment, alone. This study also showed that thrombectomy patients were less likely to die,â Wu added.
What do these experts see in the year to come? All three cited innovations in gene editing.
Watson said âwe are starting to see the era of gene editing.â
âWhat weâve seen in this small proof of principle study, what weâve seen in these first 10 patients, is that [we saw] durable LDL reduction, but of the 10 patients, two of them had very serious adverse events â one died and one had a heart attack, so the questions of safety will always persist,â she added.
Watson and Wu said that, even more promising, is the FDA approval of a cure for sickle cell disease that harnessed the same CRISPR gene-editing technology. The approval of Casgevy is a major breakthrough â the first medicine that utilizes CRISPR to receive U.S. approval, according to NBC News.
Nissen pointed to the number of drugs in development for treating lipoprotein (a), or Lp(a), as a development to keep front and center for the coming year. He said âthis is a condition, which is a heart disease risk factor in 20 percent of the population that has never been treatable.â
Now, what is known as RNAi, or RNA interference, is being utilized to reduce Lp(a). Nissen said he and his team have published several articles on these new therapies, and one of them involves a clinical trial for a drug called pelacarsen, which he is chairing.
This study has enrolled 8,300 patients and âis now well along toward completion,â he said.
âIf successful, it will be the first time ever that we can treat this disorder, everyone is waiting for the results of the trial,â he said.
Additionally, beyond these innovations, Wu said heâs excited about the FDA Modernization Act 2.0, which opens the door for moving beyond mandatory animal testing and toward a new era of using stem cells, organoids, artificial intelligence and machine learning, and in computer models for drug discovery.
Cardiac arrest is a significant health concern worldwide, particularly in India. Globally, as per the latest World Heart Report 2023 published by the World Heart Federation, cardiovascular diseases (CVDs), which include cardiac arrests, are the leading cause of mortality and a significant contributor to disability. The number of deaths due to CVDs increased from around 12.1 million in 1990 to 18.6 million in 2019, which is an over 53 percent increase in incidences of heart diseases with almost equal distribution between males and females. Over 80 percent of these deaths occur in low- and middle-income countries such as India.
In India, the situation is particularly concerning. It's estimated that about 5-6 lakh people die every year due to sudden cardiac death (SCD), and a significant proportion of these individuals are under the age of 50. More recently, updated findings from the Global Burden of Diseases Collaboration, published in theÂ Journal of the American College of Cardiology, showed age-standardized mortality rates from cardiovascular diseases in South Asia, including India, on the rise and ranging from 225.4 to 326.5 per 100,000 persons in 2022. Moreover, there has been an increasing trend of cardiac arrests in young adults in 2023, highlighting the need for awareness and preventive measures in all age groups, not just older adults.
Heart health isn't a one-size-fits-all approach; it's a dynamic, lifelong journey. Cardiac arrest, a sudden and often fatal event, can strike at any age, but the strategies to mitigate its risks evolve as we journey through life's different stages.
Midlife: The critical checkpoint
Regular monitoring and early detection are crucial in managing heart health, especially from the 40s onwards. A proactive, comprehensive approach is vital to maintaining a healthy heart during these years.
Research has also suggested that family and community activities are critical for heart health in adulthood as they are fun and relaxing times. Being active in a social environment is more than a workout when we team up with our loved ones or neighbours for physical activities. These shared experiences offer a mix of benefits that are great for the heart.
First off, there's the obvious: physical activity. Doing things together, like sports or gardening, makes exercise enjoyable and varied, which is fantastic for cardiovascular health. But the perks go beyond just moving around.
Being part of a group brings emotional support, a powerful stress-buster. Less stress means a lower risk of heart disease. Plus, having fun and relaxing with others is lovely, taking a break from daily worries.
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Then, there's the healthy lifestyle angle. Communities often run health activities and workshops. Being around people who care about their health can inspire us to eat better and stay active. And let's not forget mental health â feeling connected and mentally engaged is just as crucial for a healthy heart.
Routine and accountability also come into play. Regular group activities help us stick to a healthy routine. Knowing others count on us can motivate us to keep up with our fitness and health goals.
And, of course, there's learning. Sharing health tips and learning in a group setting is effective and enjoyable. Community programs also increase heart health awareness, emphasising regular check-ups.
Thus, embracing family and community activities into our lives offers a comprehensive approach to heart health. These activities are not just about physical exercise; they encompass emotional support, stress relief, and learning opportunities, making a heart-healthy lifestyle more enjoyable and sustainable in the long term.
Heart health becomes increasingly important as we age into our 40s and 50s, necessitating regular check-ups and assessments. During this stage of life, specific tests are vital for monitoring heart health:
Blood pressure screening: Essential for identifying high blood pressure, a key risk factor for heart disease. Do this periodically even if you feel completely fine - high blood pressure is known as a silent killer for a reason.
Cholesterol profile: Involves checking levels of total, LDL (bad), and HDL (good) cholesterol, along with triglycerides.
Blood sugar tests: These are important for detecting diabetes or pre-diabetes, as these conditions are linked to a higher risk of heart disease.
C-reactive protein (CRP) test: Measures body inflammation levels to assess cardiovascular disease risk.
Electrocardiogram (EKG/ECG): Helps in examining the heart's electrical activity.
Echocardiogram: An ultrasound to evaluate the heart's structure and function.
Coronary calcium scan: A CT scan detecting calcification in the coronary arteries, an early sign of coronary artery disease.
Carotid Intima-Media Thickness Test (CIMT): An ultrasound test that measures the thickness of the carotid artery walls to indicate potential atherosclerosis.
HbA1c Test: Provides an average blood sugar level over the past three months.
Fasting insulin test: Assesses insulin sensitivity and diabetes risk.
Homocysteine levels: High levels of this amino acid can indicate a risk for heart disease.
Fibrinogen level test: Checks a clotting protein fibrinogen to gauge cardiovascular risk.
Advanced lipid testing: Includes tests like Lipoprotein(a) [Lp(a)] and Apolipoprotein B (Apo B) for a detailed analysis of cholesterol particles.
Stress test: Checks for coronary artery disease or arrhythmias, particularly in those with symptoms or a family history of heart disease.
If you haven't been as diligent about your heart health until your 40s, it's not too late to start. Focus on a balanced diet, regular exercise, and stress management. Be vigilant about symptoms that might indicate heart problems, like chest pain, shortness of breath, or palpitations, and consult a healthcare provider immediately if these occur.
Senior years: Adaptation and awareness
As we age, our bodies change, and so do our heart health strategies. In our 60s and beyond, it's essential to continue with regular physical activity, but the intensity may need to be adjusted. Low-impact exercises like walking, swimming, and yoga are excellent choices. Nutrition remains vital, with a focus on heart-healthy foods. Regular medical check-ups are essential to monitor heart health and manage chronic conditions like hypertension or diabetes.
Keeping your heart healthy is closely tied to how well you stay hydrated, regardless of age. Here's why drinking enough water is so essential for heart health:
Blood volume and pressure: Hydration keeps the blood volume at the right level, ensuring your heart doesn't overwork. Dehydration can lower blood volume, making the heart strain more.
Cardiovascular function: Water helps blood flow smoothly through your vessels, reducing the heart's effort. Dehydration thickens the blood, making circulation more challenging.
Body temperature regulation: When you're hydrated, your body can manage its temperature better, especially during physical activities. This efficiency aids the heart in delivering oxygen effectively.
Muscle function, including the heart: Electrolytes, balanced by fluids, are vital for the heart's rhythm and muscle contractions.
Reduced heart attack and stroke risk: Staying hydrated prevents blood clots, reducing the risk of heart attacks and strokes.
Detoxification: Water facilitates the removal of waste and toxins, cutting down heart disease risks due to harmful buildup.
Avoiding low blood pressure: Proper hydration keeps blood pressure from dropping too low, which is crucial for heart health.
Enhanced physical performance: For active people, hydration boosts endurance and minimises cardiovascular stress during exercise.
The amount of water needed daily varies by age:
Children and adolescents
Ages 4-8 years need about 5 cups (1.2 litres).
For 9-13 years, girls need 7 cups (1.7 litres), and boys need 8 cups (1.9 litres).
For 14-18 years, girls need 8 cups (1.9 litres), and boys need about 11 cups (2.6 litres).
Women need roughly 11.5 cups (2.7 litres), men about 15.5 cups (3.7 litres) from all fluids and foods.
Hydration tips: Carry a water bottle, watch for dehydration signs (like dark urine and dry mouth), hydrate before, during, and after physical activities, and eat fruits and veggies high in water.
Drinking enough water is a simple yet crucial step in heart health, supporting everything from blood circulation to muscle function. It's a vital part of a heart-friendly lifestyle for all ages.
Now, you can't turn back time, but it's good to know what sets people up for habits that are heart-healthy for them throughout life. Perhaps you have children or grandchildren whose nutrition and activity levels you can influence, to set them on the healthiest possible path for them. Read on also, for tips that can still be useful for you in your 40s, 50s, 60s. For example, the absolute upper limit of how much saturated fat and added sugar even a healthy 20-year-old can have.
Childhood and adolescence: Building the foundation
Don't skip this section if you have children or nephews/nieces at this stage of life. Establishing heart-healthy habits early in life is critical. Nutrition, mainly, plays a vital role. For children, it's recommended to focus on fruits, vegetables, whole grains, lentils, and lean protein and reduce processed foods and sugary drinks. Here's a quick rundown of the dietary guidelines for a healthy heart:
Dietary Fibre: Optimal fibre intake is essential for a healthy heart; the recommended intake varies by age. Children aged 1-8 should consume about 14-25 grams daily, while adolescents aged 9-18 should consume 26-38 grams. Adults should aim for 15 grams of fibre for every 1,000 calories consumed.
Fruits and Vegetables: The American Heart Association (AHA) and the United States Department of Agriculture (USDA) recommend specific daily intakes for children and adolescents. Younger children between the ages of 2 and 8 should consume 1 to 2.5 cups of fruits and vegetables daily. For girls aged 9-18, it is 1.5 to 3 cups; for boys aged 9-18, the intake is higher at 1.5 to 4 cups.
Protein: Adequate protein is crucial for growth and heart health. Children should consume about 13-19 grams daily, while adolescents require a little more, around 34-52 grams. Protein can be consumed from animal sources like eggs, lean meats, low-fat dairy, and plant sources such as beans, lentils, and tofu.
These dietary recommendations for protein are minimal as per the Dietary Reference Intakes (DRIs) and would typically vary based on growth rate, body size, and physical activity. Active children and adolescents, particularly those in competitive sports, might need more protein to support muscle repair and growth, ranging from 1.2 grams to 1.6 grams per kilogram of body weight per day.
Alongside diet, regular physical activity is crucial for a strong and healthy heart. Children and adolescents should aim for at least 60 minutes of moderate to vigorous daily activity. This could include sports, cycling, swimming, or running, combining aerobic, muscle-strengthening, and bone-strengthening exercises. Also, maintaining a stress-free environment and good sleep hygiene are essential for heart health. These habits, developed early, are integral to reducing the risk of heart disease later in life.
Young adulthood: Maintaining vigilance
As we enter our 20s and 30s, studies, careers,Â friendsÂ often corner our attention to the exclusion of everything else, including eating healthy and exercising. The distractions of life can often derail our heart health. This is the time to double down on those healthy habits formed in youth.
Also, reducing screen time can be a game-changer for adult heart health. We're often sedentary when we spend hours glued to screens for work or leisure. This inactivity is a known culprit in heart disease. Let's explore how cutting down on screen time can turn things around for our hearts:
Get moving: Less screen time means more chances to be active. Physical activities, from a brisk walk to a full-fledged workout, strengthen the heart, boost circulation, and keep blood pressure and cholesterol in check.
Fight obesity: The more we lounge in front of screens, the higher our risk of obesity, a significant heart disease risk factor. Swapping screen time for active hobbies helps maintain a healthy weight.
Sleep better: Ever noticed how screens before bed mess with your sleep? The artificial blue light from these screens and engaging or disturbing content affect our natural sleep rhythms. Quality sleep is a pillar of heart health, reducing risks of heart issues and stroke.
Eat smarter: Watching content while eating often encourages mindless munching on unhealthy snacks. Cutting back on screen time leads to more mindful eating, meaning better awareness of hunger cues and food choices.
Stress less: Our mobile screens, primarily through social media and work, can be constant sources of stress. Stress is bad news for the heart. Engaging in screen-free activities can help keep stress at bay.
Boost mental health: Good mental health is indirectly linked to a healthy heart. Reducing screen time can decrease anxiety and depression, thus supporting heart health.
Connect more: Less time with screens opens doors to more real-life social interactions, which are great for the heart and overall well-being.
Better posture, less pain: Hours in front of screens often mean poor posture, excessive cervical flexion, weakening the upper back and causing back and shoulder pain. This can hinder our ability to stay active, indirectly affecting heart health.
Here is a pro tip to break free from the screen's grip: Set specific time limits for screen use, take breaks to move around, dive into non-screen hobbies, be mindful about evening screen use, and replace some screen time with physical activities.
Reducing screen time isn't just about lowering inactivity; it's about embracing a heart-friendly lifestyle in multiple ways, from physical activity to mental well-being. A heart-healthy life is just a screen switch-off away!
When it comes to a healthy diet for young adults, there are several vital dietary guidelines to consider:
Saturated and trans fats: Keeping saturated fat intake below 10 percent of your total daily calories is recommended. A 2,000-calorie diet means at most 20 grams per day. Lowering this to 5-6 percent is advised for those with high cholesterol or heart disease risk. Moderating the intake of added fats from sources like butter, ghee, coconut, and palm oil is essential.
Another fat that should be avoided for a healthy heart is trans fats. Aim to keep them close to zero, ideally under 1 percent of your daily calories.
Healthier fat choices: Opt for unsaturated fats in flaxseed, chia seeds, olive oil, avocados, nuts, and fatty fish. These are beneficial for heart health.
Balanced diet and cooking methods: Focus on a diet rich in fruits, vegetables, millet, lean proteins, and healthy fats. Prefer grilling, baking, or steaming over frying, and be mindful of portion sizes.
Sugar intake: The American Heart Association (AHA) suggests limits for added sugar intakeâno more than 100 calories or 25g or six teaspoons per day for women and 150 calories or 37.5g or nine teaspoons per day for men.
It's, however, essential to distinguish between added and natural sugars in fruits and vegetables. Excessive consumption of added sugars is linked to various health risks, including obesity, diabetes, and heart disease.
So, from a dietary perspective, young adults should limit their intake of saturated and trans fats, choose healthier fat sources, and be cautious about added sugars. Monitoring food labels and opting for whole, unprocessed foods can significantly contribute to maintaining heart health and overall well-being.
For younger adults, regular physical activity is critical for maintaining heart health. The American Heart Association (AHA), among others, suggest a well-rounded exercise routine, which includes:
Aerobic activity: Aim for at least 150 minutes of moderate or 75 minutes of vigorous aerobic exercise weekly, spread out over several days. A general indication of moderate activities is those where you can talk but not sing, like brisk walking. In contrast, vigorous ones are more intense, like running or intense cycling, where speaking more than a few words without pausing for breath is challenging.
Muscle strengthening: Engage in moderate to high-intensity muscle-strengthening exercises, such as weight training, at least twice a week.
Flexibility and balance: Incorporate exercises like yogic asanas practice or stretching to Excellerate flexibility and balance.
Consistency in exercise is crucial for heart health. Mixing different exercise modalities keeps the routine exciting and covers various components of fitness. Listening to your body and avoiding pushing it too hard is essential, especially for beginners. Gradually increase the intensity and duration of workouts. Look for opportunities to be active daily, like using stairs, walking, or biking instead of taking lifts, escalators or motorised vehicles for short distances.
However, these are general guidelines, and it's essential to customise your exercise plan to fit your personal fitness level, health conditions, and preferences.
Quit smoking and vaping
Another important step we can take in our 20s and 30s to keep our hearts healthy is choosing to avoid smoking and vaping. This is a decisive step towards better heart health. When we smoke or vape, we're not just inhaling nicotine; we're also exposing our hearts to serious harm. Here's how saying no to these habits makes a big difference:
Heart attack risk drops: Smoking is a big reason behind coronary heart disease, leading to heart attacks. Quit, and you cut down this risk significantly.
Blood pressure and heart rate get better: Nicotine increases your heart rate and blood pressure. Ceasing the habit will lead to these levels starting to normalise.
Blood flows smoother: Smoking and vaping make your blood thick and clot-prone, which is a straight path to strokes and heart attacks. Quitting reverses this.
Less inflammation: Inflammation is the most potent heart disease culprit, and both smoking and vaping fuel it. Stop them, and inflammation goes down.
More oxygen in your blood: Cigarette smoke's carbon monoxide affects your blood's oxygen-carrying ability. Stop smoking, and your oxygen levels bounce back.
Reduced heart failure risk: Smoking's a fast track to heart failure. Quitting eases off this risk.
Cholesterol improves: Smoking wrecks your cholesterol balance, leading to unhealthy increases in LDL cholesterol and decreases in HDL cholesterol. Quitting can Excellerate cholesterol levels.
Better recovery post-heart procedures: If you've had heart surgery or similar procedures, quitting smoking is crucial for your recovery.
Protects loved ones from secondhand smoke: Quitting also shields those around you from the risks of secondhand smoke.
Vaping'sÂ isn't an entirely safe bet: While still under study, it has its risks for your heart.
In a nutshell, dumping the smoke and vaping is a game-changer for your heart. The benefits aren't just immediate; they grow over time, drastically cutting down the risk of heart disease, heart attacks, strokes, and other heart issues. Plus, it's not just about your heart. Quitting smoking and vaping is a win for your overall health, boosting your quality of life and adding years to it.
It's also essential to manage stress through mindfulness, yoga, or meditation, as chronic stress can significantly impact heart health.
Lifelong commitment to heart health
So, protecting against cardiac arrest is a lifelong commitment that requires adaptation at each life stage. Embrace these changes, stay informed, and always prioritise your heart health. Remember, there is always time to start proactively caring for your heart.
On December 12, 2023, Cardiothoracic and Vascular Surgeons, P.A. (âCTVSâ) filed a notice of data breach with the U.S. Department of Health and Human Services Office for Civil Rights after discovering that information on the companyâs computer network was subject to unauthorized access. In this notice, CTVS explains that the incident resulted in an unauthorized party being able to access consumersâ sensitive information, which includes their names, Social Security Numbers, financial account information, driverâs license numbers, dates of birth, medical record numbers, and health information. Upon completing its investigation, CTVS began sending out data breach notification letters to all individuals whose information was affected by the latest data security incident.
If you receive a data breach notification from Cardiothoracic and Vascular Surgeons, P.A., it is essential you understand what is at risk and what you can do about it. A data breach lawyer can help you learn more about how to protect yourself from becoming a victim of fraud or identity theft, as well as discuss your legal options following the Cardiothoracic and Vascular Surgeons data breach. For more information, please see our latest piece on the topic here.
What Caused the Cardiothoracic and Vascular Surgeons Data Breach?
The Cardiothoracic and Vascular Surgeons data breach was only recently announced, and more information is expected in the near future. However, CTVSâs filing with the U.S. Department of Health and Human Services Office for Civil Rights provides some important information on what led up to the breach. According to this source, on October 13, 2023, CTVS detected unusual activity within its computer system. In response, CTVS secured its systems and then began working with outside cybersecurity specialists to investigate the incident.
The CTVS investigation confirmed that an unauthorized party was able to access and potentially acquire confidential patient information stored on the companyâs computer network. The period of unauthorized access was between October 12, 2023 and October 13, 2023.
After learning that sensitive consumer data was accessible to an unauthorized party, Cardiothoracic and Vascular Surgeons reviewed the compromised files to determine what information was leaked and which consumers were impacted. While the breached information varies depending on the individual, it may include your name, Social Security number, credit card information, account number and password, financial account information, driverâs license number, date of birth, medical record number, health insurance numbers and other health insurance information, patient account number, doctor or medical professional name, treatment information, procedure code, diagnosis code, Medicaid/Medicare number, dates of treatment, prescription information, diagnosis and symptoms information.
On December 12, 2023, Cardiothoracic and Vascular Surgeons sent out data breach letters to anyone who was affected by the latest data security incident. These letters should provide victims with a list of what information belonging to them was compromised.
More Information About Cardiothoracic and Vascular Surgeons, P.A.
Cardiothoracic and Vascular Surgeons, P.A. is a healthcare provider that specializes in surgery of the heart, lungs, chest, esophagus, and major blood vessels of the body. CTVS operates three locations in central Texas, including in Austin, Kyle, and Georgetown. Cardiothoracic and Vascular Surgeons employs more than 87 people and generates approximately $12 million in annual revenue.
With Carmen Paun
E&Câs 2024 WISHLIST â The House Energy and Commerce Committee has several health care priorities it wants to get over the finish line this year, according to a GOP committee aide granted anonymity to discuss the panelâs legislative agenda.
The list, which the aide cautioned is ânonexhaustive,â includes getting the Lower Costs, More Transparency Act and the Support for Patients and Communities Reauthorization Act â both of which the House passed last month â signed into law.
Republicans also want to figure out a way to reauthorize the Pandemic and All-Hazards Preparedness Act, extend the governmentâs ability to regulate fentanyl-related substances and prohibit federal agencies from using quality-adjusted life years, a metric used to evaluate the cost-effectiveness of drugs and treatments.
They also want to develop legislation to address drug shortages and to change how Medicare pays doctors and for medical products.
Additionally, the committee wants to address some programs slated to sunset this year if Congress does not take action, including powers from the Building Our Largest Dementia Infrastructure for Alzheimerâs Act, the Traumatic Brain Injury Program Reauthorization Act and the Congenital Heart Futures Reauthorization Act.
ITâS FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We look forward to not driving in or around Washington this weekend.
EUA PURSUIT FOR COVID PREVENTION DRUG â Pharma company Invivyd has asked the FDA to grant emergency use authorization for a prophylactic Covid-19 monoclonal antibody geared toward people with compromised immune systems.
If green lit, the drug, VYD222, would be the first preventive treatment for Covid since the agency restricted the use of AstraZenecaâs Evusheld nearly a year ago after the agency determined the drug would not help patients infected with variants circulating at the time. The only antibody authorized for use, Gohibic, is intended to treat certain people with Covid who are hospitalized.
How does VYD222 work? The monoclonal antibodies that secured EUAs in 2021 and 2022 couldnât keep up with the ever-mutating virus. Invivydâs drug attempts to target areas of the coronavirus that are less likely to change over time in the hope of increasing its effectiveness, CEO Dave Hering told Prescription Pulse.
But Invivydâs goal is to license a platform â as opposed to a single drug â that it could update as the virus evolves, Hering said. The company believes it can predict and model how the coronavirus might change, he said, and has a pipeline of antibodies based on millions of existing viral sequences.
Whatâs next: Itâs unclear when the FDA might decide whether to approve VYD222. An agency spokesperson declined to comment, citing federal disclosure laws.
PARTNERING TO FIGHT FAKE DRUGS IN AFRICA â A top health official in Djibouti hopes that a partnership with French pharma company Sanofi can help the country increase access to drugs for chronic diseases and root out counterfeit medicines, Carmen reports.
People turn to counterfeit drugs when they are easily available and cheaper than legitimate ones, said Deka Ahmed Robleh, managing director of Djiboutiâs national social security fund.
Late last year, Sanofi delivered to the small East African country enoxaparin sodium, an injectable drug used to prevent and treat blood clots, which can reduce the risk of a stroke or heart attack.
The delivery was the first under a 2022 Sanofi initiative to provide 30 drug types to 40 countries with the highest unmet medical needs under a not-for-profit brand named Impact. The drugs are for diabetes, cardiovascular diseases, tuberculosis, malaria and cancer, according to Sanofi.
The Sanofi initiative also includes training local health care professionals to treat patients with these diseases, which are becoming more widespread in Africa but often go undiagnosed due to the lack of capacity in local health systems.
Sanofi makes a small margin from selling the drugs, which is used to fund worker training and other improvements to the health systems in the beneficiary countries, said Jon Fairest, head of Sanofiâs global health unit.
U.S. SPEND ON IRA DRUGS OUTPACES OTHER NATIONS â The U.S. pays more than other rich countries for the vast majority of the drugs CMS selected in August for Medicare price negotiations, according to a new Commonwealth Fund analysis released Thursday.
CMS is slated to send initial price offers to the makers of the drugs by Feb. 1.
Congress directed CMS in the Inflation Reduction Act to negotiate the prices Medicare pays for a small number of drugs slated to grow over time.
The analysis, based on data from research firm IQVIA, shows that listed retail prices in the U.S. for the 10 drugs are âon average, three times higherâ than they are in other high-income countries such as Germany, Japan and Switzerland.
CALIFF HITS CES â FDA Commissioner Robert Califf is slated to appear at the Consumer Electronics Show in Las Vegas this month to discuss the agencyâs priorities for regulating artificial intelligence in health care.
King & Spalding attorney Lisa Dwyer, who was an FDA policy adviser and deputy chief of staff during the Obama administration, will interview Califf.
Her âmoney question,â she told Prescription Pulse, is how the FDA will approach regulating tools that use AI and machine learning. Those that have already received agency approval tend to use locked AI algorithms that arenât constantly learning based on new data, she said.
As AI becomes more integrated with health care, she said, the firms that make the tech and the health systems that use it are growing more interested in the FDAâs thinking.
Dwyer will also ask Califf about the agencyâs new advisory committee on digital health, which seeks members.
BETTER SCREENING, TESTING FOR TB IN TISSUES â A move to halt the use of tuberculosis-contaminated bone grafts last year prevented up to 53 surgeries using the products, which were linked to one donor, according to the CDCâs latest Morbidity and Mortality Weekly Report.
Before public health agency officials could intervene, 36 people underwent surgeries with the contaminated material; five of the patients contracted tuberculosis and two died, the report said.
The reportâs authors, which included CDC and state public health officials, said more measures to shield patients from tissue-derived TB transmission âare urgently neededâ following the outbreak, the second one linked to such surgeries since 2021.
They should include more comprehensive lab testing of tissue cultures and more stringent screening of prospective donors, the authors said.
Taking time: Culture-based testing can take up to eight weeks for final confirmation of infection, they said, but itâs more sensitive than the nucleic acid amplification testing the graft manufacturer used, which didnât detect TB.
Donor information should be more carefully scrutinized to root out those with evidence of sepsis, they said, noting that both donors in the 2021 and 2023 outbreaks showed signs of the complication.
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