I Am Not Legally Allowed To Say I Am the Best Florida Lawyer

Patients in the United States who receive permanent pacemakers and defibrillators are now at greater risk of contracting an infection over the life span of the device, new research shows.

Researchers analyzed data from the Nationwide Inpatient Sample — a national database of hospital discharge records — from 1993-2008 and found a significant increase in infections related to cardiac electrophysiological devices or CIED.

Their analysis found that the annual incidence of CIED-related infection increased by 210 percent over the 16-year period studied. 

Further analysis showed a jump in infections after 2004, directly correlating with an increase in four major comorbidities or other medical conditions: renal failure, respiratory failure, heart failure and diabetes.

“We believe the growing number of clinical comorbidities in this patient population plays a large role in the increase in infections associated with CIEDs,” said Dr. Arnold J. Greenspon, professor of medicine at Jefferson Medical College of Thomas Jefferson University, director of Cardiac Electrophysiology at Thomas Jefferson University Hospital, and lead author of the study. “The patients are sicker, which may place them at higher risk for infection.”

Pacemakers and implantable cardioverter-defibrillators or ICDs are important in regulating the electrical signaling to the heart. Pacemakers help to speed up a slow heart rhythm (bradycardia) whereas ICDs help to slow down rapid heart rhythm (tachycardia), a potentially life-threatening condition.

The study showed a 96 percent increase in CIED implantation, mostly due to a marked increase in the use of ICDs.

“The expanding indications for ICD implantation may have contributed to the rise in infections since many of these patients have multiple medical co-morbidities,” said Dr. Greenspon. The highest infection rates occurred in white males over 65.

“The number of Americans receiving pacemakers and defibrillators has dramatically increased. This analysis shows that the infection risk associated with these devices has, unfortunately, increased as well,” said Greenspon. “A better understanding of the risk factors for infection will improve patient care and, hopefully, reduce the prolonged hospital stays that often result.”

Rising CIED infection rates also have economic implications for hospitals, as these patients require prolonged hospital stays which are associated with increased costs.

Researchers say further investigation into the risk factors that predict CIED infection or therapies to mitigate this issue is warranted.

For more on medical safety issues, see the library of articles by Daytona Beach medical malpractice attorney.

The U.S. Food and Drug Administration has cleared the first test for Staphylococcus aureus (S.aureus) infections that is able to quickly identify whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA).

There are many different types of Staphylococci bacteria, which cause skin infections, pneumonia, food and blood infections (blood poisoning). Staphylococcus aureus or “Staph” is a very common germ that about 1 out of every 3 people have on their skin or in their nose. This germ does not cause any problems for most people who have it on their skin. But sometimes it can cause serious infections such as skin or wound infections, pneumonia, or infections of the blood.

While some S.aureus infections are treated easily with antibiotics, others are resistant (MRSA) to commonly prescribed antibiotics such as penicillin and amoxicillin.

The KeyPath MRSA/MSSA Blood Culture Test determines whether bacteria growing in a patient’s positive blood culture sample are MRSA or MSSA within about five hours after any bacterial growth is first detected in the sample. Aside from blood culture equipment, the test does not require any specific instruments to get results, which makes it useful in any laboratory.

“Clearing this test gives health care professionals a test that can confirm S.aureus and then identify whether the bacteria is MRSA or MSSA,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, in a news release.

MRSA infections can occur anywhere; however, infections appearing in health care settings are usually more severe and potentially life-threatening given patients being treated in those facilities may have weakened immune systems and frequently undergo procedures such as surgery, which allows an easier spread of bacteria directly into the body.

It is estimated that in 2005, the staph bug caused severe infections in nearly 95,000 Americans and killed more than 18,500 of them. However, in 2010 results from a CDC study showed that invasive (life-threatening) MRSA infections that began in hospitals declined 28% from 2005 through 2008. The study also showed a 17 percent drop in invasive MRSA infections that were diagnosed before hospital admissions (community onset) in people with recent exposures to healthcare settings.

Most staph skin infections, including MRSA, appear as a bump or infected area on the skin that may be:

• Red
• Swollen
• Painful
• Warm to the touch
• Full of pus or other drainage
• Accompanied by a fever

The FDA based its clearance on a clinical study of 1,116 blood samples evaluated at four major U.S. hospital centers. Within the organisms determined to be S.aureus, the MRSA determination was 98.9 percent accurate (178/180) and the MSSA determination was 99.4 percent accurate (153/154).

“This not only saves time in diagnosing potentially life-threatening infections but also allows health care professionals to optimize treatment and start appropriate contact precautions to prevent the spread of the organism,” Gutierrez said.

For more on medical issues, see the library of articles by Daytona Beach nursing home injury attorney.

During surgery to remove the thyroid gland, the technique surgeons use to identify an important nerve appears to make a difference in terms of complications.

According to researchers, thyroidectomy is a common operation, but it can be associated with serious complications: paralysis of the recurrent laryngeal nerve (RLN, a nerve that transmits motor function and sensation to the larynx, or voice box) and hypoparathyroidism (caused by injury to the parathyroid glands, which make a hormone that controls calcium levels).

Unintentional damage to the RLN by this surgery is reported to cause nerve paralysis in one percent to two percent of cases. Extensive searching for the RLN during thyroid surgery may cause temporary or permanent hypoparathyroidism.

The authors note two methods of identifying the RLN: one approach locates the nerve where it enters the larynx (superior-inferior direction), and the other approach locates the nerve in the trachea-esophageal groove, and traces it in the superior direction (inferior-superior direction).

Dr. Bayram Veyseller, from Bezmialem Vakif University, Istanbul, Turkey, and colleagues conducted a study to compare both techniques. They studied patients undergoing partial or total thyroidectomy between January 2006 and August 2009.

In 67 patients, the superior-inferior RLN identification technique was used, and in 128 patients, the inferior-superior method was used, according to the attending surgeon’s preference.

Researchers evaluated patients’ vocal cord function and blood calcium levels on the first day after the surgery. Follow-up was conducted every three months until patients’ calcium levels improved, for an average of 26 months.

If at the one-year mark blood calcium levels were still low (a sign of hypoparathyroidism) or RLN paralysis did not improve, the conditions were considered permanent.

Permanent paralysis of the RLN occurred in two patients in the inferior-superior group, and none in the other group. Hypoparathyroidism among the superior-inferior group patients was temporary in four and permanent in none; among the inferior-superior group patients, 14 experienced temporary hyperthyroidism and four experienced permanent hypoparathyroidism.

Overall, significantly fewer complications were found in terms of RLN paralysis and hypoparathyroidism in the superior-inferior group, which is when surgeons locate the nerve where it enters the larynx.

“Significantly lower rates of RLN paralysis and hypoparathyroidism were observed in thyroidectomies using a superior-inferior approach,” the authors concluded. They added that more studies should be conducted to corroborate these results.

For more on medical safety issues, see the library of articles by Daytona Beach medical malpractice attorney.

Those who live in the stroke belt, an area in the Southeast known to have significantly higher rates of stroke deaths than the rest of the country, are also at greater risk for sepsis, a severe illness in which the bloodstream is overwhelmed by bacteria, a new study shows.

The term Sepsis Belt might be a new one, though. Sepsis, a severe illness in which the bloodstream is overwhelmed by bacteria, also appears to have a belt of its own.

According to University of Alabama at Birmingham emergency physician Henry Wang, M.D., the death rate for sepsis is much higher in one geographic region of the United States — the same region in which stroke is most prevalent. The Stroke Belt spans 11 states from Louisiana to Virginia, but does not include Florida.

“In 2010, we examined death rates from sepsis across the United States,” said Wang, associate professor and vice chair for research in the UAB Department of Emergency Medicine, in a news release. “Laying it out on a map, we saw that the states with highest sepsis mortality formed a cluster in the Southeast United States, closely mirroring the appearance of the Stroke Belt.”

Wang says sepsis is responsible for 750,000 hospitalizations and some 200,000 deaths in the United States each year, about the same as for heart attack and breast cancer. Sepsis is triggered by infections such as meningitis or bacterial pneumonia, and can lead to shock, organ failure and death.

“There are a host of possible causes for this geographic cluster,” said Wang. “Possibilities include pre-existing medical conditions, health behaviors, diet, genetics and even the environment and air pollution.”

Wang will use data from REGARDS (Reasons for Geographic and Racial Differences in Stroke) study, a large, long-term study of the Stroke Belt, funded by the federal government and based at UAB.

“We’ll be able to make extensive use of the REGARDS infrastructure, with access to information from the more than 30,000 people enrolled in that project,” said Wang. “With that wealth of information, we will be able to identify the characteristics of persons most likely to be hospitalized for sepsis. This information will may lead to strategies to prevent its onset.”

“Sepsis treatment is complex, dealing with disruption of blood flow, organs shutting down and shock,” he said. “Our current best course of action is to prevent sepsis from occurring in the first place. We hope our new research endeavor will lead to novel ways to prevent this disease and its effects.”

For more on medical issues, see the library  of articles by Daytona Beach medical malpractice attorney.

The U.S. Food and Drug Administration has approved Xarelto to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery.

Xarelto (rivaroxaban) is a pill taken once daily. Those undergoing a knee replacement should take the medication for 12 days and patients undergoing a hip replacement procedure should take Xarelto for 35 days.

The safety and effectiveness of Xarelto was evaluated in patients undergoing hip replacement surgery and patients undergoing knee replacement surgery. Clinical studies were designed to identify occurrence of venous thromboembolic events (VTE), deep vein thrombosis (DVT), pulmonary embolism (PE) or death in patients treated. Treatment with Xarelto was compared to treatment with enoxaparin, a drug that prevents DVTs or blood clotting.

“Xarelto represents a new oral treatment option to help prevent blood clotting in patients receiving a hip or knee replacement,” said Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, in a news release. Xarelto was reviewed by the Division of Hematology Products within the Office of Oncology Drug Products.

More than 6,000 patients undergoing hip or knee replacement surgery received Xarelto in clinical studies. Among patients undergoing knee replacement surgery, 9.7 percent of those treated with Xarelto had VTE compared with 18.8 percent of patients who received enoxaparin.

In a study involving hip replacement surgery, 1.1 percent of patients who received Xarelto had VTE compared with 3.9 percent of those who received enoxaparin. In another study of hip replacement patients, 2.0 percent of those treated with Xarelto had VTE compared with 8.4 percent of those who received enoxaparin.

The most common side effect observed in patients treated with Xarelto was bleeding.
Other FDA approved drugs to prevent blood clotting include Lovenox (enoxaparin), generic versions of enoxaparin, Arixtra (fondaparinux), Fragmin (dalteparin) for hip replacement surgery only, Coumadin (warfarin) and heparin.

For more on senior medical issues, see the library of articles by Daytona Beach nursing home injury attorney.

The number of surgical errors at VA medical centers is on the decline, according to the results of a new three-year study.

Researchers reviewed the VA National Center for Patient Safety database, looking for surgical adverse events and close calls that occurred between July 2006 and December 2009. The authors suggest possible reasons for the decline in adverse events, such as a greater emphasis on safety, team training and communication.

Julia Neily, R.N., from the VHA in White River Junction, Vt., and colleagues coded cases into categories (type of event, body segment, etc.) and root causes, and then reached consensus.

The data were analyzed in the context of the VHA’s Medical Team Training program, implemented across the country between 2006 and 2009, which aims to decrease the number of incorrect surgeries that occur in VHA medical center operating rooms.

Of the 237 reports that the researchers identified, 101 were adverse events and 136 were close calls. Roughly half of the adverse events took place in the operating room, but their severity, on average, decreased. A significant decrease in the number of adverse events per month was reported (2.4 in this study, vs. 3.21 in the previous study), whereas close calls increased from 1.97 reports per month to 3.24.

Researchers also found that reports of surgeons operating on the wrong body part ranged between 0.09 per 10,000 patients in some locations to 4.5 per 10,000 patients — a 50-fold difference.

“This 50-fold range in the estimated incidence reflects the variety of results reported in various settings and different methods for defining adverse events in this area,” explain the authors. Their article represents a follow-up report to research on surgical adverse events in the VHA system from 2001 to mid-2006, and also includes information about recent systemwide interventions.

The authors determined that 204 root causes contributed to the adverse events, the most common one being lack of standardization of clinical processes. The rate of “highest harm” adverse events decreased by 14 percent annually.

“Despite the overall decrease in patient harm, opportunities exist to further decrease the number of incorrect surgical and invasive procedures,” they write. “We must continue to improve.”

For more on medical safety issues, see the library of articles by Daytona Beach medical malpractice attorney.

Obese patients are nearly 12 times more likely to suffer a complication following elective surgery than their normal-weight counterparts, according to new research.

“Our data demonstrate that obesity is a major risk factor for complications following certain kinds of elective surgery,” said Dr. Marty Makary, an associate professor of surgery at the Johns Hopkins University School of Medicine and leader of the study.

Not only are these findings relevant to physicians due to potential surgical site infections in heavier patients but also to policymakers whose metrics for surgical quality and reimbursement do not account for the higher risk of worse outcomes in the obese.

“With the government and other insurers penalizing doctors whose patients get infections or are readmitted to the hospital — and with obese patients more likely to have those problems — policymakers need to make sure they aren’t giving physicians financial incentives to discriminate on the basis of weight,” Makary said in a news release.

In the study, Makary and his colleagues examined insurance claims data from seven Blue Cross and Blue Shield plans and identified patients who underwent elective breast procedures covered by insurance between 2002 and 2006. There were 2,403 patients in the obese group and 5,597 patients in the normal weight control group. The most common procedure, by far, was breast reduction, followed by breast reconstruction, augmentation and breast lift.

Within 30 days of surgery, 18.3 percent of the obese group experienced at least once complication, compared to 2.2 percent of patients in the control group. The differences between the two groups were most pronounced in complications, such as inflammation (with obese patients 22 times more likely to suffer a complication), infection (13 times) and pain (11 times).

Thirty-four percent of adults in the United States are now estimated to be obese, up from just 15 percent a decade ago. Meanwhile, the number of people nationwide having elective plastic surgery has also increased in recent years — with annual plastic surgery volume up 725 percent between 1992 and 2005.

Surgical outcomes are increasingly judged using standardized measures to evaluate quality and to inform the public and insurance companies. These metrics also are used more and more to penalize hospitals with higher complication rates. But, Makary says, they do not take into account that obese patients may suffer more complications, as this new research finds.

Operations on obese patients are more taxing, says Makary, a surgeon himself. These surgeries usually take longer, the operating fields are deeper, the spaces in which an infection can set in are often greater and blood flow in fat tissue is less than in other types of tissue, which results in slower healing, he says.

“But payments are based on the complexity of the procedure and are not adjusted for the complexity of the patient,” he said.

“There are definitely incentives there for surgeons and institutions to select healthier patients,” he said. “They’re getting reimbursed less per unit of work for obese patients.”

According to Makary, more research needs to be done on the role of obesity in surgical complications covering a wider variety of surgeries so that new metrics can be developed to account for any differences due to obesity.

For more on medical safety issues, see the library of articles by Daytona Beach medical malpractice attorney.

The number of U.S. workers  with elevated blood lead levels has dropped by more than 50 percent over the past two decades — from 14 per 100,000 in 1994 to 6.3 per 100,000 in 2009, a new study shows.

“Although the prevalence of high blood lead levels has decreased, the health effects from lead exposure are well characterized,’ according to an agency release from  the Center for Disease Control and Prevention.  “Workers in the manufacturing, construction, and mining industries account for the highest proportions of workers with elevated levels.”

Lead exposure can result in acute or chronic adverse effects in multiple organ systems, ranging from subclinical changes in function to symptomatic, life-threatening toxicity.

Despite improvements in public health policies and substantial reductions in blood lead levels in adults, lead exposure remains an important health problem worldwide, the agency says.

To update rate trends and identify industry subsectors and nonoccupational activities with high lead exposures, CDC collected and analyzed 2008–2009 data from 40 states. Industry subsectors with the highest numbers of lead-exposed workers were battery manufacturing, secondary smelting and refining of nonferrous metals, and painting and paper hanging.

The most common nonoccupational exposures to lead were shooting firearms; remodeling, renovating, or painting; retained bullets (gunshot wounds); and lead casting.

The number of states with high prevalence of elevated levels decreased from six of 17 states in 1994 to three of 40 states in 2009.  State resident prevalence of elevated levels  for 2008 ranged from 0.5 per 100,000 employed adults in Hawaii to 37.6 in Pennsylvania;  and for 2009, from 0.3 in Hawaii to  32.0 in Pennsylvania.

To calculate annual state prevalences, the numbers of adults with elevated blood lead levels  from each of the 40 states reporting were divided by the state’s annual employed population and expressed as a rate per 100,000 employed adults. The combined state numerators and denominators for each year were then used to calculate national (40-state) prevalence rates for 2008-2009.

“The findings underscore the need for government agencies, employers, public health professionals, health-care providers, and worker-affiliated organizations to increase interventions to prevent workplace lead exposure, and the importance of conducting lead exposure surveillance to assess the effectiveness of these interventions,” the agency said.

Measures to improve and expand preventive interventions focused in the manufacturing, construction, and mining industries should be implemented by government agencies, employers, and worker-affiliated organizations, says the CDC. It is also important to conduct and improve lead exposure surveillance to assess the effectiveness of these interventions.

For more on medical safety issues, see the library of articles by Daytona Beach personal injury attorney.

A new study shows that office workers who frequently wash their hands not only keep germs at bay but also have lower levels of hormone-disrupting flame-retardant chemicals on their hands and in their blood.

The authors of the study found that the amount of polybrominated diphenyl ethers (PBDEs) on workers’ hands was a good predictor of how much was measured in their blood. Further, frequent hand-washing was found to reduce exposure to certain PBDEs, flame retardants that have been widely used over the past few decades.

While PBDEs have been the subject of a number of studies, this is the first peer-reviewed research to correlate levels of the chemicals on people’s hands to concentrations in their blood, said lead author Deborah Watkins, a Ph.D. candidate in Boston University School of Public Health’s Department of Environmental Health.

In the study, PBDEs were detected in all 31 Boston offices that the research team tested. Certain PBDEs have been banned by the Stockholm Convention on Persistent Organic Pollutants, but because of slow turnover of products and the long half-life of PBDEs in the environment, human exposure to the compounds will continue for many years, the authors noted.

PBDEs were once widely used in computers and other electronics, as well as the polyurethane foam padding in office chairs, furniture and carpeting, so the chemicals are likely to be found in offices throughout the U.S. In recent years, epidemiologic studies have linked exposure to constituents of the PBDE formulation penta-BDE, which was used in polyurethane foam, with changes in people’s thyroid hormones, impaired fertility in women, lowered levels of testosterone in men, neuro-developmental deficits in children, and undescended testicles in babies.

U.S. manufacturers voluntarily discontinued production of penta-BDE and another PBDE formulation, known as octa-BDE, at the end of 2004. These formulations also are banned in the European Union. Manufacturers of a third formulation, deca-BDE, have agreed to discontinue production by the end of 2013.

Although scientists don’t know exactly how people accumulate PBDEs in their bodies, hand-to-mouth exposure is thought to play a significant role. In this study, workers who reported washing their hands with soap and water four or more times per day tended to have lower levels of penta-PBDEs on their hands than those who washed their hands less often. They also had, on average, three times lower concentrations of penta-PBDEs in their blood.

“This suggests that people’s hands play a key role in how they are exposed to PBDEs,” Watkins said. “This could be through hand-to-mouth behaviors such as eating oily food without washing your hands, or because the PBDEs are absorbed into the blood from the skin.”

Whatever the source, Watkins stressed that “good old-fashioned soap and water may be needed to remove the PBDEs.” The authors did not study whether use of alcohol-based hand sanitizers also was linked to lower hand levels of the compounds.

The concentrations of the PBDEs in the tested office dust varied dramatically, which Watkins said is consistent with other studies.

The authors did not investigate the sources of the PBDEs they detected, but Watkins noted that even offices in a new building with brand-new furniture had compounds associated with PBDEs in their dust. The 31 offices tested in the study, each housing one worker, were located in eight different buildings.

For more on medical safety issues, see the library of articles by Daytona Beach personal injury attorney.

Emergency department physicians are frustrated and burned out from treating patients who frequent the ED for their care, according to a survey of physicians from across the country.

The survey found that 59 percent of physicians acknowledged having less empathy for so-called frequent users than other patients, and 77 percent held bias for frequent users. Physicians defined frequent users in the survey as patients who visit the ED at least 10 times a year.

Other highlights of the survey include:

• 91 percent of physicians say frequent users pose challenges for the ED.
• 71 percent of physicians believe a program to manage frequent users is necessary.
• 82 percent of physicians say they feel some level of burnout.
• Experience did not shield physicians from burnout.

Physicians who responded to the survey comprised seasoned professionals, up-and-coming residents and alumni whose experience ranged from one year to 30 years. They represented every state, except Alaska.

While frequent users long have been linked with provoking negative attitudes in the ED, the survey’s findings are believed to be the first time physicians’ opinions have been measured. The findings were presented at the annual meeting of the Society for Academic Emergency Medicine June 1-5 in Boston.

“Our findings should be a wake-up call for hospital administrators to look at ways to manage these types of patients,” said Dr. Jennifer Peltzer-Jones, a clinical psychologist at Henry Ford’s Department of Emergency Medicine who led the survey, in a press release.  In 2004, the hospital created the Community Resources for Emergency Department Overuse (CREDO) in response to increased frequent users in its ED.

“Only 31 percent of the physicians surveyed said they had a program to help manage patients who are frequent users. Hospital administrators have to realize that these patients are invoking burnout and staff want and need additional resources,” Dr. Peltzer-Jones says.

Findings were compiled from an 18-question, anonymous survey randomly sent to 1,500 physicians nationally between July-October 2010. Of the 1,500 surveys sent, 418 physicians responded.

“People go to the Emergency Department because it’s accessible 24/7,” Dr. Peltzer-Jones says. “However, the ED is meant for emergent care, not primary care. ED physicians are not equipped to be primary care providers and case managers.”

Dr. Peltzer-Jones says many social factors contribute to patients frequently using the ED: lack of access to primary and specialty care, homelessness, lack of transportation for appointments, substance abuse, psychiatric disorders and chronic medical conditions.

Contrary to popular belief, many frequent users do have some type of medical insurance, she says.

“Physicians are feeling frustrated because they want to assist their patients who have emergent care issues. But they find they are managing chronic medical and social problems with very little resources ,” Dr. Peltzer-Jones said in the release. “The Emergency Department is supposed to be the last, not first, resource for patient care. That’s not the case with the frequent user population.”

For more on medical issues, see the library of articles by Daytona Beach personal injury attorney.