AFib is a fast, irregular heartbeat.

Cancer detection and treatment methods have improved significantly over time, leading to a greater number of older people who are surviving and living longer after a cancer diagnosis, and as a result, developing other health conditions. AFib specifically is an important simultaneously occurring condition in many cancer patients. Both have several common predisposing factors, including advanced age and inflammation, and certain chemotherapeutic agents have been linked to the development of AFib.

How to best care for the increasing number of cancer survivors who are reaching older ages is a challenge for clinicians since conditions that exist separately and usually span multiple specialties. This study looked at the relationship between early cardiology involvement after an AFib diagnosis in patients with a history of cancer and how that affected outcomes.

“Overall, our data suggest that suboptimal antithrombotic [medicines that reduce the risk of blood clots] care exists in AFib patients who have a history of cancer,” Wesley T. O’Neal, MD, MPH, lead author of the study and a cardiology fellow at Emory University School of Medicine, said in a news release from the American College of Cardiolog. “The decision to initiate antithrombotic therapy or refer to a cardiology provider should be individualized to the patient, but our data suggest that cardiology providers positively influence outcomes among these patients.”

Researchers looked at over 380,000 AFib patients in the MarketScan database and found 17 percent had a history of cancer. Prostate and breast cancers were the most common types of cancer, and patients with a history of cancer were also older and more likely to have other cardiovascular conditions. The data showed that patients with a history of cancer were less likely to see a cardiologist after AFib diagnosis and less likely to fill prescriptions for oral anticoagulants, which are essential to reducing the future risk of stroke. Differences were similar when looking at active cancers versus remote history of cancer.

The researchers confirmed that a beneficial association existed between early cardiology involvement at the time of AFib diagnosis among patients with a history of cancer. After 1.1 years of follow up, cancer patients who did see a cardiologist were more likely to fill their prescriptions, showed a reduced risk of stroke and did not show an increased risk of bleeding. These patients were more likely to be hospitalized, which may be due to more aggressive treatments.

According to a related editorial, the number of cancer survivors in the United States is expected to increase from over 15 million to over 20 million by 2026, which will lead to an increased focus on addressing their long-term medical and psychosocial need.

“The management of cancer patients must extend beyond their primary malignancy and will require an interdisciplinary approach from oncologists, primary care providers and other subspecialists,” said Sean T. Chen, MD, an author of the editorial from Duke University Medical Center. “The increase in survivorship is a testament to the dramatic improvements in cancer therapy, but continued emphasis on a patient’s diagnosis of cancer can shift significant attention away from other essential aspects of care.”

The analysis was made by physicians from the University of California, Davis.

Medications can help reduce AFib symptoms and risks by controlling heart rate and rhythm and reducing blood clots. Ablation is a more long-term solution that involves using heat or extreme cold to destroy the heart tissue responsible for the faulty electrical signals, reducing the need for rhythm-control medications.

Ablation is currently only recommended when AFib medications don’t work or aren’t well tolerated.

“Less than 2 percent of patients undergo ablation early in the course of AFib when the procedure can be most beneficial,” said lead author Uma Srivatsa, professor of cardiovascular medicine at UC Davis Health. “Our study shows that ablation may be considered as a primary treatment for everyone with the condition.”

Part of the hesitation to use ablation earlier and more often could be because comparative outcomes research so far has produced inconsistent results. Most of those studies focused on single centers or were controversial in terms of patient selection and cross over, according to Srivatsa.

The new study, published in the journal Circulation: Arrhythmia and Electrophysiology, addresses those limitations by evaluating AFib treatment outcomes over a long period of time and for large numbers of multi-ethnic patients with similar health statuses.

“It’s only with more robust, real-world studies like ours that we’ll be able to develop a clear picture of what works best in addressing clinical outcomes for AFib patients,” Srivatsa said.

It’s estimated that at least 2.7 million Americans have AFib, which is diagnosed when the heart beats inconsistently due to uncoordinated signals between its upper chambers. The condition can cause lightheadedness, fatigue, shortness of breath and chest pain, and is associated with increased risks of stroke and death.

In conducting the study, Srivatsa and her colleagues evaluated medical records from the California Office of Statewide Health Planning and Development for AFib patients hospitalized between 2005 and 2013. Two groups of about 4,000 each were compared: one that was treated with ablation and another that was not. The groups were matched in terms of AFib patterns and prior hospitalizations.

Outcomes for both groups were similar in terms of rates of death, ischemic stroke and hemorrhagic stroke within 30 days of hospitalization. Beyond 30 days, however, the benefits of ablation were apparent:

• 84 patients in the ablation group died, versus 189 in the control group
• 55 patients in the ablation group had ischemic strokes, versus 86 in the control group
• 17 patients in the ablation group had hemorrhagic strokes, versus 53 in the control group.

The study confirms the overall short- and long-term safety of ablation as an AFib treatment, according to Srivatsa.

“Our data supports wider utilization of ablation along with improving the awareness of its benefits,” she said in a news release from the UC Davis Health System.

In an editorial published with the study, cardiologists from the University of Toronto wrote that, while retrospective studies have some limits, Srivatsa and her colleagues have highlighted a significant area for additional research. Together with randomized trials, they said, the UC Davis work will help “confirm or refute whether or not [AFib] ablation is truly a life or death situation.”

The composite stroke decision tool studied by researchers from the Intermountain Medical Center Heart Institute in Salt Lake City combines the widely used CHA2DS2-VASc with the Intermountain Risk Scores (IMRS) to derive and validate new stroke prediction scores.

According to a news release from the Intermountain Institute, the study shows the new model, IMRS-VASc, was significantly more effective in predicting stroke risk and will give clinicians a more effective and accurate tool to assess patients with cardiovascular disease.

Researchers found that the new IMRS-VASc risk score model nearly doubles their ability to appropriately predict stroke risk compared to the traditional CHA2DS2-VASc risk tool. The development of the IMRS-VASc risk score model is the first step in a research pathway for other conditions that will ultimately result in time and cost savings for both patient and physician.

Researchers presented results from the study at the Heart Rhythm Society’s 39th annual Scientific Sessions in Boston, on Friday, May 11,m 2018.

This improved effectiveness of the new risk score model results from better assignment of low-risk and high-risk people to the appropriate stroke prognosis category, said Benjamin Horne, PhD, lead author of the study, and director of cardiovascular and genetic epidemiology of the Intermountain Medical Center Heart Institute.

He notes that the CHA2DS2-VASc score places about 80% of women and 50% of men with atrial fibrillation in a group of people at high risk of stroke. In contrast, IMRS-VASc places one third of all people each in a low, moderate, and high-risk category.

Additionally, the news release said, the study found that IMRS-VASc more appropriately assigns people to the risk group that relates to their actual prognosis, with a lower rate of stroke in the low-risk group (about 1% having a stroke over a two-year period for women and men), and a higher rate in the high-risk category (two-year stroke rates of 6% in women, 5% in men).

This improved effectiveness may help to limit the near-term use of treatments for atrial fibrillation among people who do not yet need the therapies and reinforce and encourage the use of treatments among those whose short-term risk actually is high, Horne said.

“We provide information to clinicians so they can make better decisions about who should have oral anticoagulants and who should have other types of medications and diagnostics tests, and which patients need to have more frequent clinic visits,” said Horne. “The result will be care that can be more precisely targeted to each patient’s risks and more likely to prevent a stroke.”

Dr. Horne said the integrated IMRS-VASc model combines tried-and-true attributes of the CHA2DS2-VASc and the IMRS.

“While the CHA2DS2-VASc is easy to use, it does not reliably predict what will happen in the future. The Intermountain Risk Score incorporates data available to clinicians in the electronic health record to calculate a score that predicts what’s going to happen in the future and the two combined result in IMRS-VASc Models,” he notes.

For the observational study, researchers collected existing data from patients who visited an Intermountain Healthcare clinic from 1990 to 2013. There were 56,000 individuals evaluated in the study to create the score.

Another set of 24,000 patients were then tested after the new combined risk score was created to validate that it worked in a separate set of individuals who hadn’t been involved in the creation of the risk score.

The takeaway for patients from the study is more personalized care from clinicians, Horne said. “We’re working to precisely determine what medications are needed and what tests need to be ordered, so care is tailored to the patient’s specific individual needs.”

In atrial fibrillation, the upper chambers of the heart, or atria, quiver instead of beat to move blood effectively. Untreated atrial fibrillation increases the risk of heart-related death and is linked to a five times increased risk of stroke. In the new research, having the condition more than tripled a person’s risk of dying.

“It’s crucial to better understand modifiable risk factors of atrial fibrillation,” said study author Christina Magnussen, M.D., a medical specialist in Internal Medicine and Cardiology at the University Heart Center in Hamburg, Germany. “If prevention strategies succeed in targeting these risk factors, we expect a noticeable decline in new-onset atrial fibrillation.”

This would lead to less illness, fewer deaths and lower health-related costs, she said.

Researchers reviewed records of 79,793 people (aged 24 to 97) in four community-based studies in Europe. The participants did not have atrial fibrillation at the outset. Later assessments of their health — with a median follow-up period of 12.6 to a maximum of 28.2 years — showed that 4.4 percent of the women and 6.4 percent of the men had been diagnosed with the condition.

Researchers noted atrial fibrillation:

• diagnosis rates jumped when men were 50 or older and women were 60 or older;
• developed in about 24 percent of both men and women by age 90;
• onset was tied to higher blood levels of C-reactive protein (inflammation marker) in men; and
• new atrial fibrillation cases increased more in men than women with increases in body mass index (BMI): 31 percent in men and 18 percent in women.

“We advise weight reduction for both men and women,” Magnussen said. “As elevated body mass index seems to be more detrimental for men, weight control seems to be essential, particularly in overweight and obese men.”

Researchers were surprised to find that higher total cholesterol, a risk factor for heart disease, lowered risk for developing atrial fibrillation, especially in women, although exactly why is not clear.

Due to its design, the study could not shed light on factors causing sex differences in atrial fibrillation risk. The authors also note that atrial fibrillation might have been underdiagnosed at the study’s start and later records may not reflect all cases. Strengths of the research include that it studied the condition in the general population and noted how individuals fared over long periods.

Since study participants were from both northern and southern Europe, the findings will probably apply to other Caucasian populations but cannot be generalized to other groups, Magnussen said. However, since BMI in the study was such a strong risk factor for atrial fibrillation, it is likely to also be a factor in other groups, she added.

According to American Heart Association statistics, between 2.7 and 6 million Americans are living with atrial fibrillation, and more than 12 million are expected to have the condition in 2030. Risk factors include body mass index, systolic blood pressure, total cholesterol, diabetes, smoking, alcohol consumption, previous heart attack or stroke and presence of heart disease.

The study, part of the BiomarCaRE (Biomarker for Cardiovascular Risk Assessment in Europe) project, was co-funded by the European Union Seventh Framework Programme and involved researchers from nearly a dozen countries.

Statements and conclusions of study authors published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association’s policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations and health insurance providers are available at www.heart.org/corporatefunding.

About the American Heart Association

The American Heart Association is devoted to saving people from heart disease and stroke – the two leading causes of death in the world. We team with millions of volunteers to fund innovative research, fight for stronger public health policies and provide lifesaving tools and information to prevent and treat these diseases. The Dallas-based association is the nation’s oldest and largest voluntary organization dedicated to fighting heart disease and stroke. To learn more or to get involved, call 1-800-AHA-USA1, visit www.heart.org or call any of our offices.

As a caregiver for someone with AFib, your crucial role comes with extra responsibilities and challenges. Here, AFib specialist Dr. Shephal Doshi, M.D., Director of Cardiac Electrophysiology and Pacing at Providence, Saint John’s Health Center, in Santa Monica, CA shares ways you can provide necessary and tailored support that will improve the patient’s quality of life.

Prescreen your loved ones

Older age is a major risk factor in AFib causing a stroke. But the scary thing is that many people with AFib are unaware they have it because they can’t feel it.

“There’s no preventing a stroke once it happens, and over twenty percent of strokes are caused by atrial fibrillation,” Doshi says. “Prescreen the person you care for by periodically checking his or her pulse. If it’s irregular or unsteady, see a doctor.”

Know and help manage triggers

Especially with paroxysmal (on-and-off) AFib, certain triggers exacerbate the condition and increase the patient’s risk of stroke. These include high blood pressure, sleep apnea, excessive caffeine and alcohol consumption, stress, and poor cardiovascular health.

Keep close tabs on your loved one’s blood pressure, and suggest skipping that nightly glass of wine. “Red wine can help the heart’s plumbing, but not the electrical,” Doshi explains. Additionally, encourage him or her to stay active—go on walks to boost cardio or take a yoga class together, since meditation is proven to help decrease arrhythmia. Ask the patient’s doctor what kind of exercise is appropriate.

Ask questions and discuss options

Many patients aren’t used to asking questions during their medical appointments. However, it’s extremely important to be proactive about an AFib diagnosis. As the caregiver, you can help by acting as an extra voice and set of ears at doctor’s appointments. And extra moral support is always beneficial.

With AFib, understanding all available treatment options is critical to the patient’s well-being. “Blood thinners are extremely important in preventing blood clots in AFib patients, yet one-third of sufferers aren’t taking them,” Doshi says. Some people with the condition can’t tolerate blood thinners because of the subsequent bruising and excessive bleeding; others just stop taking them because of the unfortunate side effects.

If you know your loved one is suffering but tends not to speak up, inform the doctor yourself of his or her issues with blood thinners. This way, you can find another option to lower the chance of stroke—for instance, the Watchman Device is a new atrial appendage closure that was FDA-approved in 2015.

See a specialist

“Caregivers should urge a loved one suffering with AFib to meet with a cardiac electrophysiologist at least once,” Doshi suggests. A professional who specializes in the heart’s electrical problems is best equipped to tailoring treatment to a specific patient’s needs and goals—and thus, bettering your loved one’s quality of living.

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The study, funded by a grant from the Doris Duke Foundation and led by Jared Magnani, M.D., associate professor of medicine, Division of Cardiology, University of Pittsburgh School of Medicine, and cardiologist at the UPMC Heart and Vascular Institute, analyzed data from the Atherosclerosis Risk in Communities (ARIC) Study to examine racial differences in adverse outcomes associated with AFib.

AFib is the most common heart rhythm problem in the U.S. It affects approximately 1 percent of the adult population and more than 5 percent of those 65 years old and older. It also is known to be strongly associated with increased risks of stroke, heart failure and mortality.

“We knew blacks were likely to have an increased risk of stroke, but the findings for heart failure, CHD and mortality are novel and important,” Magnani said. “This should put the focus on improving prevention efforts for adverse outcomes in blacks with atrial fibrillation, and drive further studies into the reasons behind why this is happening.”

The ARIC Study, sponsored by the National Heart, Lung, and Blood Institute, recruited 15,792 men and women, 45 to 64 years old, from four communities in the United States—Forsyth County, North Carolina; Jackson, Mississippi; the northwest suburbs of Minneapolis, Minnesota; and Washington County, Maryland. The community-based cohort was designed to investigate causes of atherosclerosis and cardiovascular disease, and included baseline examinations in 1986 and more than 20 years follow up.

After exclusions, 15,080 participants (8,290 women and 3,831 blacks) were included in the new analysis. Noteworthy racial differences at baseline examination included a body mass index of 27 percent for whites and 29.6 percent for blacks. Black participants also had a higher prevalence of hypertension and diabetes.

During analysis of the 20-year follow-up, 2,348 cases of AFib were identified—1,914 in whites with an incidence rate of 8.1 per 1,000 person-years, and 434 in blacks, with an incidence rate of 5.8 per 1,000 person-years. Researchers found that adverse outcomes in black participants were almost double that for whites.

The incidence rate of strokes in black participants was 21.4 compared to 10.2 in their white counterparts. For heart failure and CHD, the rate difference was almost two-fold higher in blacks than whites. Blacks also had a rate difference of 106 for mortality compared to 55.9 in whites.

Researchers also believe the results are enough to warrant an addition to the current guidelines for the management of patients with AFib developed by the American College of Cardiology, American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society to include the significant difference in adverse outcomes between blacks and whites with AFib.

Limitations of the study noted by researchers included that ARIC participants were from only four geographic regions and that the study investigated only two racial groups. The researchers noted that generalizability to other geographic regions or to other races and ethnicities may be limited.

The study, which measured the chronic consumption of caffeinated products over a 12-month period, rather than acute consumption, appears in the Journal of the American Heart Association. It is the largest to date to have evaluated dietary patterns in relation to extra heartbeats.

“Clinical recommendations advising against the regular consumption of caffeinated products to prevent disturbances of the heart’s cardiac rhythm should be reconsidered, as we may unnecessarily be discouraging consumption of items like chocolate, coffee and tea that might actually have cardiovascular benefits,” said senior author Gregory Marcus, MD, MAS, a UCSF Health cardiologist and director of clinical research in the UCSF Division of Cardiology.

Excessive premature atrial contractions (PACs) have been shown to result in atrial fibrillation, stroke and death, while excessive premature ventricular contractions (PVCs) have been shown to result in increased heart failure, coronary artery disease and death. Both abnormalities have been tied to caffeine consumption through studies and trials, but these studies were performed several decades ago and did not use PACs and PVCs as a primary outcome.

Nonetheless, the American College of Cardiology/American Heart Association guidelines on the management of PVCs state that if a patient’s history is consistent with premature extra beats, potential exacerbating factors such as caffeine, alcohol and nicotine should be eliminated. Other online medical resources for clinicians offer similar recommendations.

Recent growing evidence indicates the potential cardiovascular benefits of several common caffeinated products such as coffee, chocolate and tea. The result is clinician uncertainty in counseling patients on consumption of these products, with patients possibly reducing their intake to avoid presumed cardiac issues.

In their study, Marcus and his colleagues analyzed 1,388 randomly selected participants from the National Heart, Lung and Blood Institute (NHLBI) Cardiovascular Health Study database of nearly 6,000 patients, excluding those with persistent extra heartbeats. They were given a baseline food frequency assessment and 24-hour ambulatory electrocardiography monitoring. Frequencies of habitual coffee, tea and chocolate consumption were determined through a survey.

Of the total participants, 840 (61 percent) consumed more than one caffeinated product daily.

The researchers found no differences in the number of PACs or PVCs per hour across levels of coffee, tea and chocolate consumption. More frequent consumption of these products was not associated with extra heartbeats.

“This was the first community-based sample to look at the impact of caffeine on extra heartbeats, as previous studies looked at people with known arrhythmias,” said lead author Shalini Dixit, BA, a fourth-year medical student at UCSF. “Whether acute consumption of these caffeinated products affects extra heartbeats requires further study.”

A stroke occurs when blood flow to the brain is blocked by a clot, depriving brain cells of oxygen. In people with atrial fibrillation, blood flow is sluggish in the top chambers of the heart, and blood clots can form there. When a piece of a clot breaks off, it can travel to the brain and cause a stroke. That’s where blood thinners come in. Blood thinners, or anticoagulants, decrease the chances of blood clots forming in the heart, reducing the risk of stroke.

But as many as half of the people with atrial fibrillation who could benefit from a blood thinner don’t take them. There are two main reasons for this: Anticoagulants don’t affect how patients feel, and they can cause bleeding.

“Most drugs are used to improve how patients feel or function, but anticoagulants aren’t used this way. They are preventive drugs, used to prevent strokes in people who generally feel well,” says Ellis F. Unger, M.D., the Director of FDA’s Office of Drug Evaluation I in the Office of New Drugs.

“When treatment is successful, patients dramatically reduce their risk of experiencing a stroke, but the drugs don’t improve the symptoms of atrial fibrillation,” Unger adds. “So patients don’t feel any noticeable benefit while taking them. But they are well aware of the downside of the drugs — their inconvenience, bleeding side effects, and cost. But when patients avoid anticoagulants for these reasons, they put themselves at risk of irreversible brain damage and disability. The benefit of a decreased risk of stroke clearly outweighs the risks and inconveniences of these drugs.”

New Blood Thinners Available

FDA has approved four blood thinners in recent years — dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), and edoxaban (Savaysa). Along with warfarin, a drug approved 60 years ago, these drugs are used to prevent stroke in patients with atrial fibrillation.

There are some important differences among these drugs. Warfarin interacts with certain drugs and foods that make it less effective or more likely to cause bleeding, and so its effects must be monitored with periodic blood tests. The new drugs have fewer interactions and don’t require blood monitoring.

Although all anticoagulants reduce the risk of a stroke caused by clots from the heart, they increase the risk of a stroke caused by bleeding into the brain (a hemorrhagic stroke). The newer drugs cause fewer bleeding strokes than warfarin, and the overall rates of strokes (caused by blood clots or bleeding) are lower with some of the newer drugs.

Another difference is how fast the drugs start and stop working. “When starting warfarin, it takes a few days before the drug takes effect,” Unger says. “And when stopping warfarin, it takes a few days for its effects to wear off.”

He adds: “The new drugs start working rapidly, and their effects wear off fairly rapidly. For most patients, this is an advantage.”

He cautions: “Rarely, however, when patients have life-threatening bleeding or need urgent surgery, it can be important to stop the effects of these drugs immediately.”

For the rare patient with life-threatening bleeding, reversal agents can be used to counter the effects of anticoagulants. For example, Vitamin K is the reversal agent for warfarin. FDA recently approved the first reversal agent — Praxbind (idrucizumab) — for Pradaxa. Praxbind can be used in emergency situations when bleeding caused by Pradaxa’s anticoagulant effects can’t be controlled.

Drugs Help Prevent Strokes

Strokes are often devastating to patients and their families.

“A stroke can ruin a life — or end one. Having a stroke can affect your ability to speak, eat, walk, work, care for yourself, and interact with others,” Unger says. Why don’t more people take blood thinners? “Both warfarin and the new drugs can cause bleeding, and we think fear of bleeding is the main reason many patients do not use them,” he says.

But most bleeding is not serious. It can be as minor as what occurs when you brush your teeth or shave. More serious bleeding, such as internal bleeding, can occur, but it’s rarely life-threatening, he says.

“Bleeding is scary, but it is usually treatable and unlikely to cause permanent damage,” he adds. “And it’s much less dangerous overall than a stroke.”

What You Can Do

If you have atrial fibrillation, talk to your health care provider to make sure you’re being treated properly to prevent stroke. Some factors increase the likelihood that you will have a stroke. They include being 65 or older, having a history of previous stroke, diabetes, high blood pressure, and heart failure. The risks are also higher in women, patients with diminished kidney function, and people with a prior heart attack.

Some patients believe that because their atrial fibrillation is “mild” there is no need for them to take a blood thinner. They may have this impression because their atrial fibrillation causes few symptoms, or because it comes and goes. In fact, their risk of stroke has more to do with other factors and might be quite high, Unger says. So even if you have mild atrial fibrillation or atrial fibrillation that comes and goes, you should have a frank talk with your health care provider about treatment options.

What the Future Holds

FDA continues to work with manufacturers that are studying drugs to reverse the effects of some of the new anticoagulants, Unger says. “We hope these drugs will reduce the consequences of bleeding in some patients, and increase acceptance of anticoagulants in the medical community so that fewer patients with atrial fibrillation go untreated,” he adds.

When the new anticoagulants were being studied, the emphasis was on showing that they worked well compared to warfarin, without the need for blood monitoring. Since then, there has been more interest in individualized treatment. For example, this might include using the new drugs with occasional blood monitoring to further reduce the risks of stroke and bleeding.

“Too little use or underuse of anticoagulants in people with atrial fibrillation is a critical, preventable, public health problem. For most patients with atrial fibrillation, taking an anticoagulant as prescribed is the most beneficial thing you can do to reduce your chance of having a life-changing stroke,” he says.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products. Reprited courtesy of the FDA.

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You can read the recommendations for yourself here. When you get there, click on “Draft: Related Information for Consumers” to download the pdf. Also, you have until October 12th 2015 to leave comments if you want to do that here.

Finally, be sure to consult with your own physician regarding aspirin use no matter what your heath status or your age may be. Don’t “self medicate”. But you knew that!

A release from the university quotes study senior author Jay Giri, MD, MPH, assistant professor in the Cardiovascular Medicine Division at Penn, as saying, “Not only do we believe that high-quality, randomized clinical trials are necessary to determine the safety of the Lariat device for off-label procedures, but our analysis raises broader issues with the FDA 510(k) clearance protocol for medical devices/ We believe there needs to be a method for reassessing the safety of a device that has been cleared for one use but is being frequently used for a different purpose in real-world practice.”

The Lariat device received FDA 510(k) class II (intermediate risk) clearance for soft tissue approximation in June 2006 based on stated “substantial equivalence” with other devices used to place sutures during laparoscopic surgeries or vein harvesting. The FDA 510(k) clearance pathway does not require the rigorous testing and evaluation that is needed for full FDA pre-market approval of class I (high-risk) devices. However, the researchers say it appears that the Lariat device has never been used for these purposes. Instead, all reported instances of Lariat use have been for off-label left atrial appendage exclusion, a complex and technically demanding cardiac procedure that theoretically may decrease stroke risk in patients with atrial fibrillation who are unable or unwilling to take blood thinning medications.

“The 510(k) clearance protocol is providing a regulatory loophole that allows manufacturers to avoid full safety and efficacy testing of devices cleared for one purpose, but used in practice for another higher-risk application,” said Giri. “In addition to the Lariat, this issue could be important for other devices used in complex procedures that have been cleared through the 510(k) pathway.”

The new study consisted of two sources: a systemic review of published reports, and an analytic review of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. For the systematic review, the researchers searched PubMed, EMBASE, CINAHL and the Cochrane Library for any reports of outcomes associated with the use of the Lariat device for left atrial appendage exclusion. They found seven cases of urgent need for cardiac surgery following use of the device (2.3 percent of the 309 procedures reviewed) and one death (0.3 percent of the 309 procedures), with an overall procedural success rate of 90.3 percent. The analytic review of the FDA MAUDE database identified five adverse event reports that noted death and another 23 reports of cases necessitating urgent cardiac surgery.

“The Lariat is an ingenious piece of engineering for closing the left atrial appendage, but ingenuity does not guarantee safety and efficacy,” added Giri. “The Lariat must be assessed as a device for left atrial appendage exclusion with randomized, controlled trials before widespread use is adopted by the medical community.”