Massive IVC Filter Study Underway

The Surgeon General estimates about one half million Americans are affected by blood clots annually and between 100,000 and 180,000 people die of pulmonary embolism (PE), a blood clot that travels to the lungs. To combat this problem, doctors implant hundreds of thousands of Inferior Vena Cava (IVC) filters inside patients each year to stop blood clots before they reach the lungs. Retrievable IVC filters have been reported to cause serious injuries if left in the body too long, however some physicians fail to remove the filters once the threat of pulmonary embolism has passed.

PRESERVE Study Investigating IVC Filter Safety

IVC filters have been linked to catastrophic injury and death.In August of 2010, the FDA issued a medical alert, warning that retrievable IVC filters can move or break, causing serious injuries, prompting researchers to begin investigating the devices. In 2014, the FDA issued an updated safety communication and in 2016, a study entitled, Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) began enrollment. The IVC Filter Study Group Foundation, sponsored jointly by the Society for Vascular Surgery (SVS) and the Society of Interventional Radiology (SIR), oversees the project. Over the course of the five-year study, 2,100 patients are expected to participate through 60 different medical sites around the U.S. 

“Our foremost commitment is to patient safety, and this study will help determine how well filters prevent pulmonary embolism and how they function over the course of their implantation,” said Matthew S. Johnson, Fellow of the Society of Interventional Radiology and professor of radiology and surgery at Indiana University School of Medicine.

According to the PRESERVE website, the study is unusual because, “More typically, studies follow one or two devices. Studying filters produced by seven different manufacturers at once is an enormous undertaking. The trial will follow 300 patients per device.”

Participating Manufacturers:

  • ALN Vena Cava Filter – ALN Implants Chirurgicaux
  • Option™ Elite Retrievable Vena Cava Filter – Argon Medical Devices, Inc. (designed and manufactured by Rex Medical)
  • VenaTech® LP Vena Cava Filter – B. Braun Interventional Systems Inc.
  • Cook Günther Tulip Vena Cava Filter – Cook Incorporated
  • DENALI® Vena Cava Filter System – CR Bard Peripheral Vascular, Inc.
  • Cordis OptEase® Retrievable Vena Cava Filter – Cordis Corporation
  • Cordis TrapEase® Vena Cava Filter – Cordis Corporation
  • Crux® Vena Cava Filter System – Volcano Corporation

“The treatment of deep vein thrombosis in trauma patients has challenged physicians to know the best way to take care of those patients,” said co-principal investigator Dr. David Gillespie, chief of vascular and endovascular surgery at Southcoast Health System, Fall River, Mass. “There are a lot of devices from different manufacturers to choose from. Physicians have been using the retrievable filters with the idea they will retrieve them, but for many reasons they often don’t.

IVC filter lawsuits  

Patients from across the country who were harmed by IVC filters have begun to file lawsuits against device manufacturers, seeking compensation for their injuries. Sadly, some family members of IVC filter patients filed a wrongful death claim as a result of the dangerous device.

Avoid having surgery during the summer: What Ohio hospitals aren’t telling you

by R. Craig McLaughlin

It’s the championship football game and your favorite team is driving down the field to score a touchdown. Your star quarterback and seasoned offensive linemen are working together like a well-oiled machine. Everyone is in perfect sync and the entire team is seemingly moving as one. Your team can’t be stopped.

But wait! What’s this? A time out is called and in come a slew of substitutions. Your veteran quarterback and linemen are replaced by a rookie and four other practice squad players, who are being asked to play positions they have never played before.

For the rest of the game, lack of experience, unfamiliarity with each other and poor communication between the players lead to sacks, turnovers and a loss for your team.

Would the fans ever tolerate a change in personnel like this during the middle of an important game? No way!

But this is exactly the type of substitution that happens at Ohio’s teaching hospitals every summer and it puts patients at risk.

The most dangerous month for surgery

Every July, at teaching hospitals like The Cleveland Clinic, Ohio State University Hospital and Cincinnati Children’s Hospital Medical Center, there is a change of health care providers that threatens the safety of the patients at these facilities.

This is when the most experienced residents graduate and leave the hospital. These graduating residents have spent the past three to six years training under the guidance of more experienced doctors and the patients at these teaching hospitals served as their case studies.

However, these experienced residents are replaced by brand new doctors who just graduated from medical school. To compound the problem, the remaining residents who have been at the hospital for a year or two are now being asked to assume new and unfamiliar roles. Consequently, this can be a very dangerous time for patients at these teaching hospitals.

A medical team performing an operation
Do you know which month is most dangerous for surgery?

This is such a dangerous time of year for patients that studies show the rate of patient deaths and complications from medical procedures increases between 8% and 34% during the month of July.

Dr. John Young of the University of California, San Francisco, reported these findings in a study he published in the Annals of Internal Medicine. Every year this “July effect” – as the hospitals sometimes refer to it – affects about 100,000 doctors in teaching hospitals around the country. According to Dr. Young, no other industry undergoes such a dramatic change in personnel on such a regular basis.

Steps for a safer medical operation

So what can you do to protect yourself and your family members? Here are three tips from an experienced Ohio medical malpractice attorney:

1. Ask your doctor if he or she will be performing your surgery at a teaching hospital where doctors in training may be involved in your care. Some hospitals are not teaching hospitals or your procedure might be performed at a surgery center that does not use residents. If that is the case, then you likely won’t be affected by this problem.

2. If your surgery is elective and it is safe for you to put it off, request that your surgery be scheduled during the first six months of the year. At that time, the doctors being trained at a teaching hospital will be more experienced and familiar with the hospital’s policies, procedures and nursing staff, and there will be less of a chance for a mistake to be made.

3. If you have to have your surgery during the summer months because it can’t wait, let it be known that you want the most experienced doctor to perform your surgery and to be very involved in your care. Ohio’s teaching hospitals are important to train the doctors of the future, but your health and well-being should not suffer because you are being used as the guinea pig for a brand new doctor.

 

Craig McLaughlin represents people who have been seriously injured or killed as a result of nursing home neglect, motor vehicle crashes, defective products, workplace accidents and medical negligence. He has been recognized by Super Lawyers, Martindale-Hubbell, AVVO and is a life member of the Multi-Million Dollar Advocates Forum and Million Dollar Advocates Forum.

Is your hospital safe?

Not all hospitals are the same. In fact, one recent study showed patients who undergo common surgeries are safer at busy hospitals that perform the procedures regularly.

Hospital surgical volume matters

A medical team performing an operationAn article published in U.S. News and World report has shed the light on a little-known surgical risk: inexperience. Extrapolating data from Medicare statistics, the study revealed that hospitals performing only a small number of common surgical procedures place patients at a far greater risk than high-volume hospitals.

How big of a problem is it? “You can save your life by picking the right place,” says Leah Binder, director of the Leapfrog Group, a nonprofit organization that measures hospital safety and performance.

Dr. John Birkmeyer, Professor of Surgery at Dartmouth–Hitchcock Medical Center has estimated that as many as 11,000 deaths could have been prevented nationally if patients who went low-volume hospitals opted to for the highest volume hospitals instead. For example, at one low-volume Colorado hospital, patients were three times more likely to die during hip replacement surgery and 24 times more likely to die during a knee replacement.

Increased risks with low-volume hospitals

According to the study, hip replacement patients who had their surgery in in the lowest-volume hospitals were about 50 percent more likely to die than patients treated at surgical centers in the top 20 percent. Knee replacement patients took a larger gamble using low-volume hospitals, with a nearly 70 percent higher risk of death. Patients with congestive heart failure and chronic obstructive pulmonary disease fared somewhat better; however, they still had a 20 percent increased risk of dying.

While these numbers are dramatic, it’s important to remember that volume is only one indicator patients should consider when selecting a healthcare facility. In fact, some low-volume hospitals provide excellent care. Conversely, some high-volume centers may perform unnecessary surgeries.

Choosing a hospital

One of the best ways to make a decision is to ask questions. Here are a few examples:

  1. What procedures do you recommend for my case, and why?
  2. Do I need this surgery? What other options are there?
  3. How many times have you performed this procedure in the past year?
  4. What is your complication rate?
  5. How do you follow a patient post-surgery?
  6. What will my follow-up care look like?
  7. Tell me about your medical team – nurses, physical therapists, and others who can help guide me pre and post-surgery.

There are also rating systems available online, including U.S. News Best Hospitals and Hospital Safety Score. So how do you know which hospital or surgeon is right for you? There is no magic formula, but most experts agree patients should take the time to educate themselves about the doctors and medical facilities they choose.

 

Sources:

“Risks Are High at Low-Volume Hospitals” by Steve Sternberg and Geoff Dougherty, U.S. News & World Report, May 18, 2015.

“Hospitals Move to Limit Low-Volume Surgeries” by Steve Sternberg, U.S. News & World Report, May 19, 2015.

Benzodiazepines Linked to Alzheimer’s Disease

Most of us take medications knowing there is a risk of side effects, but that risk is small, right? Surely the FDA ensures the health benefits outweigh these minor inconveniences, right? But what if I told you that if your grandmother took a sleeping pill, she’d be 50% more likely to develop Alzheimer’s disease? Do I have your attention now?

Benzodiazepines linked to Alzheimer's Disease.A study published in the British Journal of Medicine has yielded some startling results. Researchers found that for older adults who took benzodiazepines for at least 90 days, the risk of developing Alzheimer’s disease was increased by 43% to 51% during a five year period.

The study also revealed that people who were on a long-acting benzodiazepine like diazepam (Valium) and flurazepam (Dalmane) were at greater risk than those on a short-acting one like triazolam (Halcion), lorazepam (Ativan), alprazolam (Xanax), and temazepam (Restoril).

What are Benzodiazepines?

Benzodiazepines are a class drugs used to treat anxiety, insomnia, and a range of other conditions. Commonly known as tranquilizers, these medications act directly on the brain and central nervous system, affecting a person’s mood. They are one of the most widely prescribed medications in the U.S., particularly among elderly patients. Benzos are commonly divided in groups:

Short-acting anti-anxiety benzodiazepines

  • alprazolam (Xanax)
  • lorazepam (Ativan)
  • oxazepam (Seresta)
  • diazepam (Valium)

Longer-acting anti-seizure and “hypnotic” drugs frequently used to treat insomnia:

  • clonazepam (Klonopin)
  • flurazepam (Dalmane)midazolam (Versed)
  • nitrazepam (Mogadon)
  • temazepam (Restoril)
  • triazolam (Halcion)

The authors of the study warn that doctors should “carefully balance the benefits and risks when initiating or renewing a treatment with benzodiazepines and related products in older patients.” Although the study only included elderly patients, it is important for people of all ages to discuss the use of benzodiazepines with their health care provider.

Other Risks

It is important to note that benzodiazepines may pose other serious risks for seniors. In 2012, the American Geriatrics Society added benzodiazepines to their list of Potentially Inappropriate Medication Use in Older Adults. The group warned that an increased sensitivity to benzodiazepines and decreased metabolism of long-acting agents could pose serious dangers, stating, “In general, all benzodiazepines increase risk of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents in older adults.”

Source:

de Gage, S.B., Moride, Y., Ducruet, T., et al. Benzodiazepine use and risk of Alzheimer’s disease: case-control study. BMJ 2014; 349:g5205. Published September 9, 2014. Accessed October 29, 2014.

Using Technology to Prevent Bedsores

For millions of Americans, staying in a long-term healthcare facility means an increased risk of developing bedsores. Also known as pressure ulcers, these skin lesions can cause serious and painful infections of the skin, bones and joints. Complications can include tissue and nerve damage, organ failure and even cancer.

Bedsores can be prevented.The best way to prevent pressure sores from occurring is to reposition patients frequently – doctors recommend changing positions every two hours. Unfortunately, with many nursing homes and other long-term healthcare facilities woefully understaffed, many patients are neglected. As a result, more than 2.5 million people in the United States develop pressure ulcers every ear.

Preventing Bedsores with Patient Monitors

An exciting new medical device may hold the answer to this pervasive medical mistake. A company called Leaf Healthcare, Inc. has developed a wearable patient sensor, which can help medical professionals reduce bedsores. Created for healthcare facilities, the Leaf System is comprised of patient sensors and a wireless central monitoring system. The system electronically monitors patients’ position and movements, recording each time a patient is moved and alerting caregivers when patients need to be repositioned.

Leaf Healthcare recently conducted a multiphase clinical trial, which yielded encouraging results. According to a news release, “The study showed that use of the device increased compliance with hospital turn protocols – a standard of care method to prevent pressure ulcers – from a baseline of 64 percent at the start of the trial to 98 percent after the monitoring system was deployed.”

Nursing Home Residents’ Rights

Section 3721.13 of the Ohio Revised Code provides residents of nursing homes with certain rights. Among these is the right to an “adequate and appropriate” level of care, which includes taking steps to prevent bedsores. If you have questions about nursing home neglect or abuse, including whether standards of care are being met, contact our experienced attorneys for a free, confidential case review.

 

*Links to other sites are for informational purposes only. The inclusion of links to other web sites does not imply any endorsement of the material on the web sites or any association with their operators. 

 

Sources:

Tarver, Chris; Schutt, Suann; Pezzani, Michelle. “We’re Sensing You! A Multiphase Clinical Trial Examining Innovative Technology to Improve Patient-Turning Compliance.” [Presentation]. ANCC National Magnet Conference® Dallas, TX. 08 October 2014 to 10 October 2014.

 Leaf Healthcare, Inc., (16 Oct. 2014). “Study Shows Leaf Healthcare Wearable Sensor Dramatically Improves Compliance with Pressure-Ulcer Prevention Efforts.” [Press Release]. [Accessed 28 Oct. 2014].