This report comes from 2008. A 53-year old man was taken to the emergency room suffering from acute cardiopulmonary distress. An EKG revealed a cardiac tamponade. The patient was taken into emergency surgery where a 28 gauge wire, 1.5 centimeters long was removed from his right ventricle. A section of the medical device resting in his chest in the inferior vena cava had migrated to the right ventricle, perforated his heart and causing a tamponade.
This article concludes that risks of IVC filters need to be further studied. That is an understatement if there ever was one.
What is Cardiac Tamponade?
What is cardiac tamponade? Simply put, a cardiac tamponade is pressure on the heart which can be caused by an accumulation of fluid between the heart muscle and its outer sac. Also known as pericardial tamponade, the excess pressure slows the heart from working properly and reduces the oxygen-rich blood supply to the body.
A cardiac tamponade can also result from a wound to the heart, such as blunt trauma from a car accident, or from penetrating trauma, such as a metal fragment piercing the heart. The situation requires emergency medical care because the body needs a constant supply of oxygen. Shock, heart attack or death can occur without immediate intervention.
What is an IVC Filter?
IVC filters are placed in the large vein that carries blood from the lower half of the body to the lungs. The inferior vena cava (IVC) is the location where an interventional radiologist will thread the IVC filter device into place in patients who are contraindicated for anticoagulation therapy. The IVC filter is designed with a top like a basket to catch blood clots so they do not travel to the lungs and cause a pulmonary embolism or deep vein thrombosis (DVT), a blood clot from the lower half of the body which travels upward with potentially fatal consequences.
There over 200,000 cases of DVT a year and the standard treatment is anticoagulation medication also known as blood thinners. But some patients cannot take blood thinners and doctors tend to like to use the latest and neatest medical devices. That may partially explain why there has been an increase in the use of IVC filters in recent years.
The filter can be the retrievable or non retrievable models. However reports are up to 70 percent of the retrievable filters are never removed due to failing patient follow-up. IVC filters were thought to be safe by doctors and hospitals until the adverse event reports started to mount.
Injuries Related to IVC Filter Use
There are now more than 900 reports of injuries to patients with an IVC filter. You would think that might be enough for the FDA to initiate a recall, but the agency has not done so.
Among those adverse events, the literature points to cardiac tamponade. If a filter breaks, or its struts (legs) fracture, the heart is the nearest major organ for a free-floating piece of metal to land.
There are other complications. Patients can develop deep vein thrombosis where the filter is implanted, filter migration and erosion, perforation of the ventricle, IVC filter fragment embolization and fracture and thrombosis or obstruction. While the occurrence in the presence of an IVC filter is thought to be rare, the incident above indicates that resting a metal filter in the inferior vena cava vein can have devastating effects. A rare occurrence means nothing if it is happening to you.
Doctors wanted to evaluate the IVC filters made by C.R. Bard of Murray Hill, New Jersey. Anecdotal reports indicated the Bard IVC filters were having the bulk of problems. The first generation was the Bard Recovery. The second generation was the Bard G2 vena cava filters. A total of 80 patients were involved in a clinical trial in York Hospital in Pennsylvania in 2010.
A published study said at least 16 percent of the 80 had at least one leg (strut) fracture. Twenty-five percent of the Bard Recovery IVC filters fractured and embolized or lodged and caused a blockage. In 71 percent of the cases, at least one of the metal fragments from the legs of the device, a thin metal shard, had embolized to the heart, causing life threatening symptoms in three patients. One patient died at home, while the other three experienced cardiac tamponade and ventricular tachycardia. In 12 percent of the cases, the Bard G2 filters fractured and two patients had a fragment movement. The published study in the November 2010 Archives of Internal Medicine concludes the Bard Recovery and G2 filters had “high prevalences of fracture and embolization, with potentially life-threatening sequelae.”
Are All IVC Filters Risky?
Some IVC filters are thought to be less risky than others. When reviewers looked at the safety record of 741 IVC filters, the Celect vena cava filter made by Cook Medical of Bloomington, Indiana, had a better record in resisting fracture. Bard Recovery showed a fracture rate of 25 percent and the Bard G2 fractured in 12 percent of filters.
These were filters left in beyond the recommended 29 to 54 weeks when the danger of DVT and pulmonary embolism has passed. But even during the retrieval of an IVC filter, patients can experience a retrieval failure rate as high as 43 percent.
Patients and their doctors need to understand there is emerging reevaluation about the potentially life-threatening complications of an IVC filter. The FDA in 2010 recommended the retrievable filters actually be removed from a patient’s body and there be careful follow-up and screening following an implantation.
Patients need to be told before they are implanted that there are risks with removing the filters. When all of the information is gathered, patients and their treating physicians may be less likely to want to jump on the newer, shinier medical device bandwagon.
Contact a Dedicated IVC Filter Cardiac Tamponade Attorney Today
Farah & Farah is currently investigating IVC filter related injuries nationwide. If you or a loved one have an IVC filter medically implanted, or have had one implanted in the past, you need to contact a tenacious IVC filter injury attorney today. Farah & Farah can be reached at (800) 533-3555.