Cleveland Clinic

Cleveland Clinic Picks Top 10 Medical Innovations for 2022

Posted by

0


Cleveland Clinic has announced the Top 10 Medical Innovations for 2022 selected by a committee of Cleveland Clinic subject matter experts, led by D. Geoffrey Vince, PhD, executive director of Innovations and chair of Biomedical Engineering at Cleveland Clinic.

“At Cleveland Clinic, a shared passion for the delivery of superior care and an embedded culture of innovation foster continuous healthcare improvement dialogue among our clinicians and researchers,” said Dr. Vince. “As such, our experts always have their finger on the pulse of new technologies slated to change the face of healthcare. The Top 10 Medical Innovations program was launched to share their insight with the broader healthcare community, and year after year, our professionals continue to successfully predict device, technology, theme and therapy advances.”

In order of importance, the top medical innovations selected by the Cleveland Clinic are the following.

Next Generation of mRNA Vaccinology. Advancements in the generation, purification and cellular delivery of RNA have enabled the development of mRNA vaccines across a broad array of applications, such as cancer and Zika virus infection. The technology is cost-effective, relatively simple to manufacture, and elicits immunity in a novel way. Furthermore, the emergence of the COVID-19 pandemic demonstrated that the world needed rapid development of a vaccine that was deployable around the globe. Because of previous research that laid the groundwork for this technology, an effective COVID-19 vaccine was developed, produced, approved and deployed in less than a year. This landscape-changing technology has the potential to be used to manage some of healthcare’s most challenging diseases quickly and efficiently.

PSMA-Targeted Therapy in Prostate Cancer. Each year, more than 200,000 American men receive a diagnosis of prostate cancer –making it the most commonly diagnosed cancer among men in the United States. Accurate imaging is critical for tumor localization, staging the disease and detecting recurrences. PSMA, an antigen found in high levels on the surface of prostate cancer cells, is a potential biomarker for the disease. PMSA PET scans use a radioactive tracer to attach to PSMA proteins, which are then combined with CT or MRI scans to visualize the location of prostate cancer cells. In 2020, this technology received FDA approval based on phase III clinical trials, which showed substantially increased accuracy for detecting prostate cancer metastasis compared to conventional imaging with bone and CT scans. When detected early by PSMA PET scans, recurrent prostate cancer can be treated through a targeted approach with stereotactic body radiation therapy, surgery and/or systemic therapy in a personalized manner.

New Treatment for the Reduction of LDL. High levels of blood cholesterol, particularly low-density lipoproteins (LDL-C), are known to be a significant contributor to cardiovascular disease. In 2019, the FDA reviewed the application for inclisiran in treating primary hyperlipidemia in adults who have elevated LDL-C while on a maximally tolerated dose of statin therapy. Inclisiran is an injectable small interfering RNA that targets the PCSK9 protein. In contrast to statins, it requires infrequent dosing (twice per year) and provides effective and sustained LDL-C reduction in conjunction along with statins. Its prolonged effect may help alleviate medication non-compliance, one of the leading causes of failure to lower cholesterol levels. Inclisiran was FDA approved in December 2021 and is widely considered a game-changer for heart disease patients.

Novel Drug for Treatment of Type 2 Diabetes. In the United States, 1 in 10 individuals has diabetes, which affects how the body processes food into energy. One potential therapy is a once-weekly injectable dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide receptor agonist (GLP-1) that aims to control blood sugar. Injected under the skin, GLP-1 and GIP receptors cause the pancreas to release insulin and block the hormone glucagon, limiting blood sugar spikes after a meal. Additionally, it slows digestion, resulting in individuals remaining full longer and eating less. Thus far, late phase III clinical trials reveal that the treatment significantly reduces hemoglobin A1C in type 2 diabetes and supports weight loss, making it potentially the most effective therapy for diabetes and obesity yet developed.

Breakthrough Treatment for Postpartum Depression. Experts believe the rate of postpartum depression could be at least twice as high as what current statistics reveal because many cases go undiagnosed. Currently, counseling and anti-depressant medications are the primary treatments but some women do not respond to these therapies. In 2019, the FDA approved an intravenous infusion treatment designed to treat postpartum depression specifically. This novel therapy, administered around the clock for 60 hours, uses a neurosteroid to control the brain’s response to stress. This treatment design is groundbreaking as it targets the signaling thought to be deficient in hormone-sensitive postpartum depression. Additionally, this treatment appears to show benefits very quickly, while traditional anti-depressants typically take two to four weeks to have a significant effect. This rapid treatment option would be a breakthrough for women with this often overlooked condition.

Targeted Medication for Hypertrophic Cardiomyopathy. For decades, clinicians have only been able to treat patients’ hypertrophic cardiomyopathy (HCM) symptoms—using drugs developed to treat other heart conditions—with limited effectiveness. Currently, non-specific medications are prescribed to treat some of the symptoms that HCM shares with other cardiovascular diseases. These therapies include beta-blockers, anti-arrhythmic drugs, calcium channel blockers and anticoagulants. A new treatment, however, works to reduce the root cause of the problem in many patients. A first-in-class medication specifically targets heart muscle to reduce abnormal contractions caused by genetic variants that put the heart into overdrive. By acting specifically on this mechanism in HCM patients, this novel treatment not only improves symptoms and quality of life, but potentially could slow progression of the disease. The FDA has assigned a target action date for this therapy of April 28, 2022. If approved, this would be the first medication explicitly dedicated to treating HCM and providing new hope to patients and physicians.

Non-Hormonal Alternatives for Menopause. More than 50 percent of all menopausal women experience hot flashes, which can persist for an average of seven years. While effective and safe when used appropriately, hormone therapy involves some risk and not all patients are appropriate candidates or ready to try this treatment option. Fortunately, a new group of non-hormonal drugs, called NK3R antagonists, have emerged as a viable alternative to hormone therapy. These drugs disrupt a signaling pathway in the brain that has been linked to the development of hot flashes and have shown promise in clinical trials for relieving moderate to severe menopausal hot flashes as effectively as hormones. While additional studies are needed to fully understand the effectiveness and safety of these new drugs, it is clear that the next generation of non-hormonal treatments for menopausal hot flashes is on the horizon.

Implantable for Severe Paralysis. Approximately one in 50 Americans, or 5.4 million people, have some form of paralysis. Most patients experience a significant decline in their overall health. Recently, a team has offered new hope for these patients by leveraging implanted brain-computer interface technology to recover lost motor control and enable patients to control digital devices. The technology uses implanted electrodes to collect movement signals from the brain and decode them into movement commands. It has been shown to restore voluntary motor impulses in patients with severe paralysis due to brain, spinal cord, peripheral nerve or muscle dysfunction. While the interface technology is in its infancy, the FDA has designated the implantable a “breakthrough device,” reinforcing the need to move this technology to the bedside of patients who need it most.

AI for Early Detection of Sepsis. Sepsis is a severe inflammatory response to infection and a leading cause of hospitalization and death worldwide. Because septic shock has a very high mortality rate, early diagnosis of sepsis is critical. Diagnosis can be complicated because early symptoms are common across other conditions, and the current standard for diagnosis is non-specific. Artificial intelligence (AI) has surfaced as a new tool that can help rapidly detect sepsis. Using AI algorithms, the tool detects several key risk factors in real time by monitoring patients’ electronic medical records as physicians input information. Flagging high-risk patients can help facilitate early intervention, which can improve outcomes, lower healthcare costs and save lives.

Predictive Analytics and Hypertension. Often referred to as the “silent killer,” hypertension, or high blood pressure, usually shows no symptoms while increasing risk for serious health problems, including heart disease, heart failure and stroke. Effective treatment options exist; however, many adults remain unaware that they have hypertension until they experience a significant health crisis. Using machine learning, a type of artificial intelligence, physicians are able to better select more effective medications, medication combinations, and dosages to improve control of hypertension. AI also will allow physicians to predict cardiovascular morbidities and enable physicians to focus on interventions before they occur. Predictive analytics equip providers with the key that could open the door to preventing hypertension and many other diseases.

Can I Really Not Sleep With a Tampon in During My Period?

Posted by

0


Let’s talk toxic shock syndrome.
tampon-at-night

You’ve probably heard a lot of alarming warnings about toxic shock syndrome (TSS), a rare but life-threatening complication of certain bacterial infections.

One of the most prevalent rumors is that sleeping with a tampon in during your period is practically a guarantee that you’ll wind up with TSS, so you should never do it unless you want to take that risk. But sleeping with a tampon in also happens to be way more convenient and significantly less messy than relying on a pad—so how concerned should you really be? Here, experts discuss the truth about tampons and toxic shock syndrome.

No doubt you’ve heard of TSS before, but you may be hazy on the details.

TSS is primarily caused by Staphylococcus aureus (staph) bacteria, but it can also be caused by a kind of Streptococcus (strep) bacteria, according to the Mayo Clinic. Clostridium sordellii can cause this infection as well, according to the Cleveland Clinic.

Your vagina has its own natural bacterial flora, and it can contain these bacteria without making you sick, G. Thomas Ruiz, M.D., an ob/gyn at MemorialCare Orange Coast Medical Center in Fountain Valley, Calif., tells SELF. But sometimes this bacteria can produce the toxins that lead to toxic shock syndrome, according to the Mayo Clinic.

Unfortunately, no one really knows the exact mechanism that links tampons to TSS, Mary Jane Minkin, M.D., a clinical professor of obstetrics and gynecology and reproductive sciences at Yale Medical School, tells SELF. One theory is that if you leave a tampon in for too long, these bacteria can flourish and become trapped, then enter your uterus through your cervix, according to the Cleveland Clinic.

This may be more likely if you use a really absorbent tampon when your period is too light to need one. Not only does this make it less likely that you’ll change it as often as you should, but the more absorbent a tampon is, the more it can dry out your vaginal mucosa, Lauren Streicher, M.D., an associate professor of clinical obstetrics and gynecology at Northwestern University Feinberg School of Medicine, tells SELF. This can increase the risk of tears in the vagina, which can allow bacteria to enter the body. The cuts don’t need to be big—even microscopic disruptions in your vaginal mucosa can be enough, Dr. Streicher says.

But TSS isn’t just associated with tampons. People can also develop TSS after getting a cut or burn on their skin, having recent surgery, using diaphragms or sponges, or having a viral infection like the flu or chickenpox, according to the Mayo Clinic.

While present-day tampons can cause TSS, the condition was most prevalent when women were using ultra-absorbent tampons that are no longer on the market.

Those tampons contained ingredients like polyester foam and carboxymethylcellulose, a thickening agent that enabled more expansion than other tampons did, according to the Centers for Disease Control and Prevention (CDC). This allowed women to keep ultra-absorbent tampons in for longer periods of time, but the longer wear allowed bacteria to colonize, Suzanne Fenske, M.D., assistant professor of obstetrics, gynecology, and reproductive sciences at Mount Sinai Health System, tells SELF.

Tampons with these ingredients were pulled from shelves after the spate of TSS cases, according to the CDC. Now, the Food and Drug Administration requires that manufacturers use a set system for measuring tampon absorbency so as not to get into dangerous territory. That doesn’t mean that the tampons on sale today can’t cause TSS, but that they’re much less likely to do so than higher-absorbency ones from decades ago.

The vast majority of people who leave a tampon in too long will be fine.

TSS isn’t as common as it once was, but there’s still a small risk of developing it. At its peak in 1980, incidence rates of TSS were 6 to 12 per 100,000 women between the ages of 12 and 49, according to the CDC. By 1986, that went down to 1 in 100,000 women between the ages of 15 and 44, and that’s still the approximate incidence today.

“The most common side effect [of using a tampon for too long] is a smelly vaginal odor,” Sherry A. Ross, M.D., an ob/gyn and women’s health expert at Providence Saint John’s Health Center in Santa Monica, Calif., and author of She-ology: The Definitive Guide to Women’s Intimate Health. Period., tells SELF.

It’s unclear why a few unlucky people develop TSS after leaving a tampon in for too long while so many others others don’t, Maura Quinlan, M.D., M.P.H., an assistant professor in the Department of Obstetrics and Gynecology at the Northwestern University Feinberg School of Medicine, tells SELF. “For some women, their immune system may not fight off the bacteria as well,” she says. But again, doctors really don’t know.

Still, it’s important to learn the signs of TSS so that, if it ever does happen to you or someone close to you, you can get help as soon as possible.

Common TSS symptoms include a sudden high fever, low blood pressure, vomiting or diarrhea, a rash that looks like a sunburn, confusion, muscle aches, seizures, and headaches, according to the Mayo Clinic.

If you suspect that you have TSS, get to the emergency room immediately—the condition can progress quickly, Dr. Quinlan says. There’s no one test for TSS, but doctors will likely take blood and urine samples to test for a staph or strep infection, according to the Mayo Clinic.

While doctors try to figure out the source of the infection, you’ll be treated with antibiotics, receive medication to stabilize your blood pressure if it’s low, get fluids to treat dehydration, and have other care based on how your illness is presenting. In very serious cases, surgery can be necessary to remove dead tissue that resulted from the infection.

Bottom line: TSS is scary, but you can sleep with a tampon in as long as you don’t push the eight-hour limit.

It’s also important to use the lowest-absorbency tampon possible to lower the odds that you’ll develop TSS, Dr. Minkin says. The less absorbent your tampon, the less likely you’ll leave it in for too long, and the less likely it’ll sap your vaginal mucosa of too much moisture. The guidelines are there for a reason—if you want to be as safe as possible, follow them.

Dr. Ruiz recommends putting in a new tampon right before you go to sleep and changing it as soon as you get up. Even better if you can manage it when you get up to pee in the middle of the night, he says, but it’s not a requirement—if you’d rather tumble back into bed and deal with it in the morning, feel free. And if you’d prefer to avoid the whole question of sleeping with a tampon in altogether, you may want to try something like a menstrual cup instead. These reusable products are typically made of medical-grade silicone, collect blood rather than absorbing it, and can be used safely for up to 12 hours—more than enough time to hit snooze and still be completely in the clear.

Failed Uterus Transplant Caused By Vaginal Yeast Infection

Posted by

0


Cleveland Clinic
The Cleveland Clinic reveals last month’s failed uterus transplant was caused by a vaginal yeast infection.

The Cleveland Clinic has finally identified the complication that led to the removal of Lindsey McFarland’s uterus transplant: a vaginal yeast infection.

Cleveland Clinic

“Preliminary results suggest that the complication was due to an infection caused by an organism that is commonly found in a woman’s reproductive system,” the Clinic said in a paragraph-long statement. “The infection appears to have compromised the blood supply to the uterus, causing the need for its removal. The health of our patient is and has always been our primary concern.”

The surgery initially seemed to go off without a hitch. McFarland, 26, who was born without a uterus, was doing well for nearly two weeks after undergoing the nine-hour transplant surgery. She said in a news conference that she was at the beginning of a long-desired journey to experience pregnancy. But on March 9, McFarland shared the transplanted uterus was removed due to a sudden, unspecified complication.

At the time, doctors saw an infection had extended into an artery they had connected to provide blood flow to the uterus, which damaged the vessel and caused clots, according to theNew York Times. It was potentially life-threatening, Dr. Andreas G. Tzakis, a leader of the surgical team, told the Times, so the transplant was immediately removed.

Once surgeons learned that the complication was caused by the fungus responsible for yeast infections, Candida albicans, they prescribed McFarland anti-fungal medication. Since she was no longer taking anti-rejection drugs, which suppress the immune system in order to prevent the rejection of transplanted organs, her body was able to control the infection and usher into recovery.

C.albicans is normally found in the body, but when it grows out of control, it can cause irritation, discharge, and intense itchiness of the vagina and vulva. In more severe cases, it can weaken the intestinal wall and find its way to the bloodstream. There, it releases toxic byproducts into the body and not only becomes extremely difficult to treat, but it can also be fatal.

Doctors aren’t sure yet if the infection came from the donor or the recipient. The transplant included some vaginal tissue from the donor, as well as the uterus. Either way, the surgical team will hold off on doing any more uterus transplants until it has better transplant practices in place. These could include adjustments to the technique, as well as using antifungal medicines preventively and washing both the donor’s and recipient’s tissues to reduce risk of infection, Tzakis said.

As for McFarland, she is reportedly doing well.

“[She] is a wonderful young lady, with a very powerful personality, an excellent family and able to handle this extremely well,” Tzakis said. “She is a pioneer and her heart is all in.”

Tool Predicts Sleeve Gastrectomy Risk

Posted by

0


A new risk calculator may help clinicians better select which patients are candidates for sleeve gastrectomy, researchers reported here.

The new tool, available online, takes into account seven of the most important risk factors and resulted in moderate discrimination (c-statistic 0.682), Philip Schauer, MD, of the Cleveland Clinic, and colleagues reported here at Obesity Week.

Laparoscopic sleeve gastrectomy has risen in popularity in recent years, and some estimates say it is the most common bariatric procedure performed in the U.S., the researchers said.

Estimating the risk of postoperative adverse events can improve surgical decision-making and informed patient consent, they explained.

Even though there are some risk prediction models available, Schauer and colleagues said they have limitations. For instance, the Obesity Surgery — Mortality Risk Score (OS-MRS) was developed based on data from 1995 to 2004, when the procedure was much newer, so it includes only old data, they said.

To create an improved risk prediction tool, they looked at data from the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) database, which collects data on more than 150 variables for patients having major surgical procedures in more than 300 centers around the U.S.

Their assessment was based on 5,871 patients who had sleeve gastrectomy in 2012, with a mean age of 43.8, a mean body mass index (BMI) of 45.9, and 80% of them were women.

The 30-day postoperative mortality and composite adverse events were 0.05% and 2.4%, respectively.

For their model, Schauer and colleagues looked at a host of variables and ultimately decided to include seven of the most high-risk ones: history of congestive heart failure, steroid use for chronic conditions, male sex, diabetes, preoperative serum total bilirubin level, BMI, and preoperative hematocrit level.

They found that the model demonstrated a good calibration on the Hosmer-Lemeshow goodness-of-fit test (chi square 16.02, P=0.591) and a moderate discrimination with a c-statistic of 0.682.

They subsequently validated their model on a different validation dataset and found relatively similar performance with a c-statistic of 0.63.

Schauer and colleagues concluded that the data point to the overall safety of sleeve gastrectomy as a treatment for severe obesity and that their new tool could contribute to surgical decision-making, informed patient consent, and prediction of surgical risk — thereby ultimately improving patient care.

They noted that further studies are needed to externally validate the risk model in a different population of sleeve gastrectomy patients.

Mitch Roslin, MD, a bariatric surgeon at Lenox Hill Hospital in New York, who was not involved in the study, noted that the model could be helpful, but cautioned that surgeon interpretation still needs to play a key role in decision-making.

“Yes, if you have heart failure, you are high risk … but that does not mean the surgery shouldn’t be done,” Roslin said. “You may have more to gain.”

Innovations in Heart Rhythm Technology

Posted by

0


The field of electrophysiology is abuzz with technological developments. Five recent advances have the potential to improve patient outcomes and make procedures safer.

Two of these innovations—subcutaneous ICDs and contact force ablation catheters—recently received FDA approval. Cleveland Clinic electrophysiologists remain involved in clinical trials of other techniques and technologies that are expected to improve medical practice: leadless pacemakers, a vagal nerve stimulator and a left atrial appendage occlusion device.

“It’s exciting to be part of these clinical trials. As a physician, you always want to serve your patients in ways that are better and safer,” says Cleveland Clinic electrophysiologist Daniel Cantillon, MD.

Leadless pacing

With the lead and the surgical pocket being the weakest links in any pacing system,leadless pacemakers are expected to lower complication rates.

More than 116 patients in the U.S. and Canada—six at Cleveland Clinic—have received St. Jude Medical’s single-chamber Nanostim device to date through the LEADLESS II trial.

“Our experience at Cleveland Clinic has been quite favorable, but it’s still early,” says Dr. Cantillon, who serves on the steering committee for the North American trial and as principal site investigator. “Our endpoint is six months’ freedom from complications. Since our first Nanostim was implanted on Valentine’s Day, we are just approaching that six-month mark.”

Cleveland Clinic will also participate in clinical trials of a second leadless pacemaker, Medtronic’s single-chamber Micra device, with Bruce Wilkoff, MD, as site investigator. Patient enrollment should begin soon.

Neuromodulation for heart failure

With new treatments for heart failure few and far between, all eyes are focused on CardioFit. This pacemaker-style device is the first to successfully activate the autonomic nervous system in order to improve heart failure.

The device is implanted under the skin, with one electrode leading to the vagus nerve and the other secured in the heart muscle. The device senses heart rate and delivers a stimulus to the vagus nerve to mitigate harmful changes that occur as part of the heart failure disease process. In a European pilot study, the system improved 6-minute walk distance, left ventricular ejection fraction and heart failure symptoms (NYHA class) for the patients who received this device.

A randomized trial called INOVATE HF is now underway in the U.S. and Canada comparing CardioFit plus optimal medical care to medical care alone. Outcomes include heart-failure hospitalization and all-cause mortality.

The trial is unique in two ways: Patients with pre-existing ICDs may be enrolled, and each site must have a neurosurgeon as co-principal investigator.

“The CardioFit system requires the skill set of both specialists. If the device receives FDA approval, a neurosurgeon and electrophysiologist will have to work together on these patients,” says Dr. Cantillon, who is serving as principal site co-investigator with his neurosurgery colleague Andre Machado, MD. Randall Starling, MD, head of the Section of Heart Failure, is on the steering committee for North America.

Left atrial appendage closure (LAAC) device

Data from clinical trials of the WATCHMAN left atrial appendage (LAA) occlusion device are now being reviewed by the FDA. If the device is approved, “it will change practice by making it possible to wall off the LAA in a catheter-based procedure to reduce the risk of stroke,” Dr. Cantillon explains.

Cleveland Clinic was one of 65 centers that participated in the PROTECT AF trial. When compared with warfarin, the WATCHMAN reduced the rate of stroke 40 percent, cardiovascular death 60 percent and all-cause mortality 35 percent.

A better ablation catheter

The Contact Force ablation catheter provides better, more consistent contact with tissue during ablation for atrial fibrillation, thereby producing greater freedom from arrhythmias. Its pressure sensor measures and displays contact force in real time, allowing the operator to avoid excess pressure that would increase the risk of tissue perforation. Cleveland Clinic was one of 22 centers participating in studies of the device that led to its FDA approval.

“I was not an investigator, but I became a fast adopter of this technology and now use it for almost all complex ablations,” says Dr. Cantillon.

Subcutaneous ICDs

Like pacemaker leads, ICD leads cause more than their share of complications. While the public was shocked by lead failures and fractures that led to high-profile recalls, physicians were also concerned about endovascular infections requiring extraction and complications and deaths from lead extraction procedures requiring laser tools to remove damaged or infected leads ingrown in the body.

For these reasons, FDA approval of the S-ICD, a leadless, subcutaneous ICD, was welcome news.  The device has no leads and is not vulnerable to transvenous lead failures. Because it is implanted in soft tissue, it can be removed easily and safely if needed.

The S-ICD does have drawbacks, however, in that it does not have pacing capability or offer anti-tachycardia pacing. It’s also currently a little larger than a traditional ICD.

“These are important limitations,” says Dr. Cantillon. “However, the S-ICD is an excellent option for some patients, such as those with heritable conditions that render them vulnerable to sudden death at a young age, like Brugada syndrome.”

Someday, this device might be combined with a leadless pacemaker to create a safer ICD that could maintain pacing capabilities.

“I can foresee that future ICD platforms may supply some degree of pacing support without using leads,” says Dr. Cantillon.

Mediterranean Diets Beat Low-Fat for CVD Prevention.

Posted by

0


 A Mediterranean diet supplemented with either extra virgin olive oil or mixed nuts may cut the risk of cardiovascular events by as much as 30% in subjects at high risk of developing heart disease, as compared with people advised to eat a reduced-fat diet [1].

Those are the key findings from the randomized controlledPREDIMED primary-prevention trial presented here at theInternational Congress on Vegetarian Nutrition.

The Mediterranean diet already reigns supreme in secondary prevention of CV events. PREDIMED, which looked at diet effects on hard clinical end points, carves out an important role for this dietary eating pattern in primary prevention.

“These results support the benefits of the Mediterranean diet for CV risk reduction [and] are particularly relevant given the challenges of achieving and maintaining weight loss,” investigators write in a paper published in advance of the presentation in the New England Journal of Medicine. PREDIMED was led by Dr Ramón Estruch(Hospital Clinic, Barcelona, Spain) and Dr Miguel Angel Martínez-González (Clinical Universidad de Navaraa, Pamplona, Spain).

Commenting on the study for heartwire , Dr Marc Gillinov (Cleveland Clinic, OH), who was not involved in the study, pointed out that there are very few studies of any diets that are rigorously designed and that address hard clinical outcomes. “This randomized controlled trial is by far the best in class when it comes to dietary studies. We should take its results seriously: if you have risk factors for cardiovascular disease–and the majority of adult Americans do–your best bet is to follow a Mediterranean diet.”

PREDIMED: Oil and Nuts Over Fat Restriction

PREDIMED enrolled 7447 men and women ranging in age from 55 to 80 years, none of whom had established cardiovascular disease but who were at high CV risk. Subjects were randomized to one of two Mediterranean diet groups (one supplemented with olive oil, the other with nuts) or to a control diet wherein subjects were advised to try to reduce dietary fat.

Patients in the Mediterranean-diet groups were invited to regular dietary training sessions; by contrast, those in the control group were, for the first three years, sent leaflets explaining a low-fat diet. After a protocol amendment at the three-year mark, low-fat-diet patients were also invited to regular group sessions and offered personalized advice at the same level of intensity as the Mediterranean groups.

The study was stopped when an interim analysis at 4.8 years revealed a clear signal of benefit among subjects eating the Mediterranean diets. In the olive-oil and mixed-nut Mediterranean diet groups, the primary end point (MI, stroke, or CV death) was reduced by 30% and 28% respectively, as compared with the control group.

Study dropouts, meanwhile, were twice as common in the control diet group as in the Mediterranean diet group (11.3% vs 4.9%). “Favorable trends” were seen for both stroke and MI rates among subjects eating the Mediterranean diet, but numbers were too low to be relevant statistically. A total of 288 subjects experienced an event in the study: 96 events in the olive-oil group, 83 in the nut group, and 109 in the control group.

Of special note, subjects randomized to the Mediterranean diets were not told to reduce calories, a major barrier to success in many dietary interventions, particularly the long-supported “low-fat” approach.

Good Fat and Bad

In an email to heartwire , Estruch highlighted the importance of differentiating between different types of fat “Animal fat should be avoided,” he said, whereas “vegetal fats–extra virgin olive oil and nuts–should be recommended [within] a healthy food pattern such as the Mediterranean diet.”

Asked whether the findings would be applicable to other parts of the world where saturated fats are such a common component of everyday eating, Estruch stressed the importance of education.

“People should know that the Mediterranean diet is a diet healthier than others and should know the key components of this food pattern. The plan should be to increase the intake of the key foods (vegetables, fruit, nuts, fish, legumes, extra virgin olive oil, and red wine in moderation), also increase the intake of white meat, and decrease the intake of red and processed meat, soda drinks, whole dairy products, commercial bakery goods, and sweets and pastries.”

He continued: “To achieve a score of 14 in the 14-item adherence scale to traditional Mediterranean diet [laid out in a supplemental appendix in the paper] is more or less impossible, but to upgrade two to three points in this score is enough to reduce your cardiovascular risk by 30%.”

Gillinov, in turn, pointed out that there are no data of a similar quality supporting a low-fat diet, although these have long been promoted by physicians and professional medical groups. “The Mediterranean diet contains moderate quantities of fat, and it clearly wins in this trial of primary prevention,” he said.

Dr Steven Nissen , also of the Cleveland Clinic, was even more effusive, calling PREDIMED “a spectacular study that was extremely difficult to perform.”

“The findings are compelling and should alter the dietary advice we give patients. The currently popular ultralow-fat diets . . . are clearly not best for patients,” he told heartwire in an email. “The standard AHA-recommended diet should be modified to reflect these findings: fat is not the problem with the American diet, we just eat the wrong types of fats.”

Source: Medscape.com

 

Top 10 Innovations Of 2013 In The Medical Field.

Posted by

0


Since the dawn of the 20th century rapid and remarkable changes have been occurring in the field of science. Few of these simple changes have made deep impression in our lives because of the solutions that these scientific innovations provide for the difficult problems that have not been addressed for a long period of time. It is very much possible that the things which are inevitable to us would be obsolete in the new generations to come. New developments will always be there, we don’t need to wonder and be in awe because the majestic curtains will always be open to unveil innovative ideas which are not current, but would be used for future advantages. Few days ago, the Cleveland Clinic made an announcement about the top 10 medical innovations in 2013. How it would affect and the impact it would leave in some of the unresolved medical human conditions will be found out during the coming months and years.

10. Health Care Programs and Its Incentives:

The Bipartisan Medicare Better Health Rewards Program Act of 2012 will privilege the people to maintain stable health conditions with reduced medical expenditures at the same time. It has been tied up with rewards (such as money) for being watchful about their health by alleviating or avoiding complex illnesses and diseases, which can be potential threat to life. Based on this program, financial incentives have been given to improve health at personal level and  wellness is assessed by six essential parts of human health including body mass index, blood pressure, cholesterol, diabetes indicators, status of vaccination and use of tobacco products. There are progressive measurements, which will allow recipients to keep themselves healthy and be able to receive monetary rewards up to $400 during second and third year of the program.

9. Tomosynthesis Of Breast:

Breast Cancer is one of the leading cause of mortality and morbidity among women. Early detection and treatment can significantly reduce the mortality and morbidity in these patients.  Breast Tomosynthesis is the new technology that will be used in 2013, it is a 3D mammography that will be helpful in early diagnosis and has been approved already by Food and Drug Administration in 2011 in order to have a clearer and refined view of breast. 2D mammography will not become obsolete, it will still be used in combination with this new innovation. Tomosynthesis is also expected to reduce the rate of repetition of mammography due to lack of clarity.
8. Complex Aneurysm Treatment:
This is good news for patients with complex aneurysm, which is the 13th leading cause of mortality in the United States. This problem can lead to internal bleeding, loss of consciousness, shock and even death. At present this condition is being treated with endografts but the gap of waiting time is to be bridged with a fabric graft, thus making it very painful for the patient in a way that he/she has not only to wait but also has to undergo the procedure twice.  FDA has approved a new treatment known as modular stent device  which will be available in 2013 and will pass through the aneurysm to strengthen the weak walls of the blood vessels. This treatment is expected to save many lives and prevent a lot of disability.

7. Ex Vivo Lung Perfusion:

Lung transplantation is the treatment of choice for nonmalignant end-stage lung disease in case of failure of all other medical and surgical treatment options. However, the demand for donor lungs exceeds the number of available organs by far, resulting in substantial waiting list mortality. The lung is especially susceptible to damage in donors not only due to its direct external contact, but also due to the development of neurogenic edema and proinflammatory changes caused by brain death. As a consequence of that, lungs are currently used from only 15% of all reported donors. One approach to overcome the scarcity of donor organs is the use of marginal donor lungs. However, there is evidence suggesting an increased incidence of primary graft dysfunction (PGD) in recipients of such marginal organs. The most recent approach to expand the available pool of donor lungs is ex vivo lung perfusion (EVLP). This procedure is performed by perfusing the donor lung outside the body (ex-vivo organ perfusion) on a closed loop circuit simulating the in-vivo scenario, utilizing a specially developed protective perfusion solution (Steen Solution™). It helps the marginal donor lungs to be ready for transplant and eliminate rejection.

6. Femtosecond Laser Cataract Surgery:

This is the fastest method of cataract surgery and causes less inflammation , which uses laser application rather than relying on traditional surgical blade, which is not accurate enough to give a precise incision in the eye. The Femtosecond Laser separates the tissues by ablation and cleavage. The advantage of this laser is the higher level of accuracy and precision  in giving a smaller incision. This new technology has proven to be very effective and has resulted in clearer visions without undergoing the surgery.

5. Handheld Optical Scan for Melanoma:

More than 76,000 people have been diagnosed with melanoma, a type of skin cancer, which is attributed to exposure to ultraviolet (UV) radiation. Hand-held optical scan is a noninvasive method of diagnosis of melanoma. The US government has allocated $3 billion for the treatment of melanoma. Early and noninvasive diagnosis with this device will not only reduce the costs of treatment but also morbidity and mortality.

4. Novel Medications for Advanced Prostate Cancer:

Prostate cancer is a common type of malignancy among men in their senior years. This cancer has a rapid spread both locally and by metastasis to remote tissues like bones, and other parts of the body. Hence  it is one of the leading causes of death among older men.  Over the past two years various research groups have introduced five new drugs, which have been approved by the DFA, for the treatment of advanced prostate cancers in men. These drugs include abiraterone, cabazitaxel, denosumab,  enzalutamide, and sipuleucel-T, which  increase cancer survival rate among men. Another drug which is not yet included in Novel New medicines for prostate cancer is radium-223 dichloride, which is expected to be approved this year.

3. Mass Spectrometry for Bacterial Identification:

A new technology known as mass spectrometry has been developed for quick identification for recognition of bacteria that infect and cause disease among human beings. Identification of bacteria takes days to be done under presently available technology thus making both doctors and patients to wait until definite results are available for definite treatment to be started. This new technology will revolutionize the diagnosis and treatment of bacterial infections.

2. Neuromodulation To Relieve Cluster and Migraine Headaches:

Headache is a very common complaint among people in all parts of the world. Most of the time there is no definite underlying cause. Headache can be divided into tension headache, cluster headache, migrain etc. Most of the people suffering from headache take any pain killer and get through this. A new therapy technique known as Neuromodulation has been developed which relieves headache within 10 minutes in about 70% of patients suffering from headaches.

1. Bariatric Surgery To Control Diabetes:

Bariatric surgery is done to reduce the volume of stomach so that the treated person eats less at a time. The main principle behind dietary management of diabetes is to have 6 small snacks during the day instead of having 3 large meals. Because large meals result in sudden rise and then fall in blood sugar level while small frequent snacks result in relatively steady blood sugar levels. This surgery not only results in weight reduction but also prevents the sudden spikes of blood sugar level that result from single large meals.

 

FDA Approves New Cholesterol-Cutting Combination Drug .

Posted by

0


The FDA has approved a new ezetimibe-atorvastatin tablet (brand name, Liptruzet) for lowering cholesterol in patients with primary or mixed hyperlipidemia, and in those with homozygous familial hypercholesterolemia.

In a trial of some 620 patients, the once-daily tablet reduced LDL cholesterol by 53% at the lowest dose (10/10 mg) and 61% at the highest dose (10/80 mg). Common side effects include changes in liver function tests, muscle pain, memory loss, and tendon problems.

The combination treatment has not been shown to improve cardiovascular outcomes better than atorvastatin, which has some cardiologists questioning the FDA’s decision. Steven Nissen, chairman of cardiology at the Cleveland Clinic, says in Forbes that the agency seems to be “tone deaf” to concerns “about approving drugs with surrogate endpoints like cholesterol without evidence of a benefit for the disease [cardiologists] are truly trying to treat — cardiovascular disease.”

Source: Forbes 

 

 

 

Echocardiography on the Space Station.

Posted by

0


How do you detect heart disease when you’re in space and the nearest cardiologist is 230 miles below? Cleveland Clinic’s James Thomas, MD, helped find a way.

There is no Cleveland Clinic in space. Yet. But today’s space travelers benefit from innovations led by Cleveland Clinic cardiologist James D. Thomas, MD. Back in 1997, Dr. Thomas received a grant from NASA to develop a digital echocardiology services for the International Space Station (ISS). He and his team developed the means to read echocardiograms from the space station, and today, ultrasound equipment is part of the medical monitoring gear on the ISS.

“Echocardiography stands out as the only thing that is going to work in space,” Dr. Thomas told theHeart.org in 1999, “It doesn’t have radiation, it doesn’t have a magnet. It’s relatively low power and it’s light-weight.”

Today, he is studying the effects of prolonged weightlessness on the astronauts’ hearts. “About once a month we can monitor echocardiograms being performed up in space as they are broadcast live via the secure NASA science network,” says Dr. Thomas. “This is going to teach us a great deal about what happens to the heart in space, and may explain why the astronauts have problems with low blood pressure when they come back to earth or difficulties exerting themselves. This is critical information that we need so that we can develop countermeasures that can keep astronauts healthy as we extend our reach ever farther from earth, perhaps even to Mars in the next few decades.”

In addition to being a staff cardiologist at Cleveland Clinic, Dr. Thomas is also Lead Scientist for Ultrasound at NASA.

Watch Dr Thomas on youtube:   http://www.youtube.com/watch?v=f58Z2EHwEMM&feature=player_embedded

Source: Cleveland Clinic.

 

 

 

Posted by

0


Diabetes: Is It Now a Surgical Disease?

Hi. I’m Dr. Henry Black. I’m Clinical Professor of Internal Medicine at the New York University School of Medicine, a member of the Center for the Prevention of Cardiovascular Disease at that institution, and former President of the American Society of Hypertension. If I had said 10 years ago that diabetes was going to become a surgical disease, I think I would have been laughed off the stage; yet, increasing evidence shows that this may not be a completely far-out idea. Two very small but important studies were recently published in the New England Journal of Medicine, one from the Cleveland Clinic[1] and one from Italy.[2] Both of them looked at people with high body mass index (BMI). BMIs were somewhat lower in the Cleveland Clinic study, with an average of about 34; in the Italian study, the average BMI was 45 and the average weight was about 300 lb. The investigators compared intensive medical therapy given by experts with surgical approaches. The Cleveland study looked at sleeve gastrectomies and bypass, and the Italian study compared intensive medical therapy (including exercise, which wasn’t specifically done in the Cleveland Clinic study) with ileojejunostomy and bypass.

The results were strikingly similar. These were small studies; there were about 20 patients per group in the Italian study and about 50 per group in the Cleveland Clinic study. They both showed dramatic reductions in weight that were generally seen within 3 months. Patients were followed for 1 year in Cleveland and 2 years in the Italian study, and a significant improvement in all the metabolic parameters that we follow in diabetics — including lipids, hemoglobin A1c, and even blood pressure — happened before the weight loss was completely achieved. Patients with jejunostomy and bypass were able to be taken off diabetic medicines and, in some cases, lipid-lowering therapy, something that was never seen in patients who received only medical therapy.

This implies that we have to start thinking about using one of these techniques sooner until we can find a way to deliver behavioral therapy that people will follow. There is no question that some things in this study are not necessarily generalizable. The Cleveland Clinic study had a single surgeon and the Italian study had teams that were well trained. We don’t know whether this is going to translate into every surgeon in every community, but it is an important thing to bear in mind. We also have to do some assessment of outcomes.

These were very small studies. Reoperations were necessary in both studies, but there were no fatalities. BMIs went to under 30 in the Italian study and were similar in the Cleveland Clinic study. It’s time for those of us who see obese patients with diabetes to start talking about this as something that is getting close to being proven. An old Swedish study[3] showed outcome improvement with what was more complicated surgery than we are doing now. Also, how are we going to better deliver behavioral therapy? This is something the public needs to know and needs to know now. Thank you.

References

  1. Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366:1567-1576. Abstract
  2. Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012;366:1577-1585. Abstract
  3. Sjostrom L, Lindroos AK, Peltonen M, et al; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004;351:2683-2693. Abstract

Source: Medscape.com