The use of inferior vena cava (IVC) filters has decreased significantly over the past 8-year period, and while retrieval rates have increased over this time, only one in seven permanent filters was retrieved in a timely manner after placement; The large, observational SAFE-IVC study shows.

The number of IVC filter insertions among more than 270,000 Medicare fee-for-service beneficiaries decreased from 44,680 insertions per year in 2013 (a rate of 157.8 insertions per 100,000 individuals) to 19,501 insertions in 2021, or 64.1 insertions per 100,000 individuals.

The rate of IVC filters removed also increased from 2013 to 2021, but the number of filters removed remained stable at approximately 4,000 intakes per year, or 13.0 intakes per 100,000 Medicare beneficiaries.

“The percentage of retrieval has increased – from 10% to 20% – and that sounds great, but really it’s because the denominator has decreased,” said lead investigator Enrico Ferro, MD (Beth Israel Deaconess Medical Center, Boston, MA). , he told TCTMD. “The absolute number (of rollbacks) is the same, which makes me think there is some sort of ceiling effect in the end, which means that’s what we’re getting across the board with the current policy.”

IVC filters are used to prevent venous thromboembolism (VTE) and pulmonary embolism (PE) in patients with anticoagulation contraindications and in whom anticoagulation has failed. It is estimated that approximately 40,000 IVC filters are implanted annually in the United States, and almost one-sixth of Medicare beneficiaries with PE receive filters.

US Food and Drug Administration in 2010 and 2014 security communication recommended that doctors remove IVC filters as soon as clinically possible. Devices need to be removed once the patient’s risk of PE decreases because complications such as filter rupture or device embolization can occur if left in place for too long.

Dr. Riyaz Bashir (Temple University Lewis Katz School of Medicine, Philadelphia, PA) Temporary trends in IVC filter use While filter use has decreased in the U.S. following a 2010 FDA recommendation, these latest numbers are still too high, he said.

“We still place far more IVC filters in the United States (compared to anywhere else), leading to significant complication rates in patients who live long enough to retain the filters in their bodies,” he told TCTMD. “Given the healthcare system in this country, you need to be aware of not only the medical consequences of putting in these filters and not taking them out in a timely manner, but also the costs associated with putting in filters, these filters are going in and they are going out.”

SAFE-IVC results were published online earlier this month. JAMA.

Behnood Bikdeli, MD (Brigham and Women’s Hospital/Harvard Medical School, Boston, MA) and Joseph Ross, MD (Yale School of Medicine, New Haven, CT), write in an editorial that the study provides “robust and reliable” estimates of IVC filter use and retrieval attempts that have been largely successful. But they say this is related to why retrieval rates remained so low throughout the study period, given that removal risks increased over time.

Study with FDA

Controversy surrounded Use of IVC filtersbecause the devices are classified as medium-risk products and are approved through the FDA’s 510(k) process; for this process devices need only show “substantial equivalence” with a predicate.

Over the last decade, researchers have found that: IVC filters are overused and that there are few randomized controlled trials testing their effectiveness. Trials show that filters may reduce the risk of PE but increase the risk of deep vein thrombosis (DVT). Some studies suggest there may be a condition survival benefit When used in those at high risk of PE, others suggest that use may be harmful.

Ferro said current data, along with clinical guidelines, suggest that temporary use of filters is safe in cases where there is an active contraindication to anticoagulation and an active risk for venous thromboembolism. “That’s the theory, but no one knew what actually happened,” he said. “There were a lot of questions about something that is incredibly widely used.”

The SAFE-IVC study was conducted in collaboration with the FDA to investigate temporal trends and patterns of app insertion and removal among older US adults. The researchers also wanted to evaluate periprocedural and long-term safety events over the life of the device.

Of the 270,866 patients (mean age 75 years; 53% women) who participated in the study, 14.9% had their devices returned. More than 16,000 operators installed devices in 3,800 hospitals and 8,500 operators in 1,800 centers removed filters. Approximately 30% of the patients had the device inserted and removed in different hospitals. Fully 65% ​​of patients received an IVC filter to treat first-time VTE, 26.3% for recurrent VTE, and 8.8% for VTE prophylaxis. Of those who underwent filtering, 63.3% had a major contraindication to anticoagulation; these included patients who had recently experienced major bleeding (50.8%) and major trauma (25.3%).

IVC filter removal was less likely in older patients, those with significant contraindications to anticoagulation, and those with comorbidities such as heart failure or malignancy. Black patients, those dually enrolled in Medicare and Medicaid, and those living in distressed communities were also less likely to have the filter removed. Those treated at a teaching hospital or larger hospital were more likely to get the filter back.

At 30 days, 27.3% of filtered patients had the composite safety outcome defined as all-cause mortality, IVC filter-related complications, operating room (OR) visits following filter-related procedures, and new diagnosis of DVT. 14.6% die and 9.6% require an operating room visit during the procedure. Complications during implantation were low (0.3%).

93.5% of surviving devices were successfully removed before retrieval, and the 30-day safety incident rate was as low as 3.9%. The majority of filters were removed within the first year (average time 0.3 years).

“There’s a small minority of doctors who are doing it right because they’re getting it out in a timely manner,” Ferro said. “Within 3 months it seemed to me clinically that there was something wrong with the patient and he couldn’t take anticoagulants, so the filter was put in. Then the doctors were reminded to remove it, and they did. That’s how it should be. When you do it right, the risk of withdrawal is low.”

The average follow-up time for those with permanent IVC filters was 1.2 years. Filter-related complications occurred in 1.4% of patients, caval thrombosis in 2.2%, a new diagnosis of DVT in 21.2%, and DVT requiring a hospital visit in 9.2%. After a maximum follow-up of 9 years, 81.0% of patients died.

Multidisciplinary Care

The decline in the use of IVC filters over time indicates that clinical practice is now more aligned with clinical guidelines, Ferro said. The introduction of direct oral anticoagulants, which have a lower risk of bleeding compared to warfarin, has helped improve medical care and made doctors more comfortable using anticoagulants.

Regarding the low reversal rate, Ferro said the fragmentation of patient care (doctors who insert IVC filters are not the same doctors who follow the patient for long periods of time) may be one reason why little improvement is noted over time.

Bashir agreed.

“The physician who sees the patient as part of the (medical) group may not even remember that this patient had an IVC filter inserted during his or her hospitalization,” he said. He added that the breakdown in communication is further exacerbated when patients receive treatment outside of their own hospitals and/or clinics.

Bashir said IVC filters are easy to place and make logical sense: Once the device is placed in the IVC, the patient will not suffer a devastating pulmonary embolism. “The challenge is that this perception leads to overuse of the device,” Bashir said. “The main treatment for blood clots is blood thinners.”

Therefore, Bashir recommends a multidisciplinary team approach when it comes to decisions about filter placement and emphasizes that use should be reserved for patients with active bleeding. This may help eliminate some of the reflexive choice to place a filter, especially in a patient with no obvious contraindications to anticoagulation, he said. Additionally, hospitals should publicly report implantation and removal rates as part of quality improvement efforts.

“At its peak we were placing 25 or 35 times more IVC filters in the U.S. than in Europe,” he said. “The great news is that, as this article shows, the numbers have decreased significantly, but implantation rates are still very high.”

Researchers note that single-center studies have shown that retrieval rates can be increased with follow-up systems, planned outpatient communications, and planned post-discharge vascular clinic visits. Computerized reminders Initiatives such as Medicare’s merit-based payment system to properly evaluate IVC receipt may also be helpful.

Regulatory Framework

Bikdeli and Ross note in their editorial that 90% of devices subject to regulatory review are considered medium risk and approved through the 510(k) pathway. Given the large number of complex devices, short product life cycles, and the learning curve associated with the technology, post-marketing surveillance is critical.

SAFE-IVC addresses important gaps in post-market surveillance, but these data also have limitations. First, there are no data on patients for whom IVC filters may be indicated but remain untreated; this limits insights into the comparative effectiveness and safety of devices for patients at risk of PE. Additionally, researchers were unable to examine results with specific IVC filters due to a lack of unique device identifier (UDI) data. They say UDIs will allow researchers to conduct routine, long-term surveillance throughout a device’s lifecycle.

More efforts are needed to improve postmarket surveillance so that doctors have the best available evidence to guide decisions about filters and other devices, Bikdeli and Ross write.