FDA confirms Class I recall for thousands of stroke prevention devices

 YOU better be prepared to quiz your doctor on this.

I'm missing the reasoning behind even using these. The obvious solution is check if the Circle of Willis is complete, then close up the offending artery! You would still have 3 arteries supplying blood to the brain.

FDA confirms Class I recall for thousands of stroke prevention devices

Image courtesy of Boston Scientific.

The U.S. Food and Drug Administration (FDA) has confirmed a new recall for Boston Scientific’s Enroute Transcarotid Neuroprotection System and Enroute Transcarotid Neuroprotection System Plus. The recall was put in place due to a risk of arterial sheath tip separation or partial tip separation during use. One serious injury has been linked to this issue.

The FDA first warned the public about these risks in July as part of its Early Alert pilot program. The issue was still under investigation at that time. Now, the agency has reached its conclusion that this is a Class I recall, which means these devices are associated with a risk of “serious adverse health consequences or death.”  

This recall includes more than 115,000 units of the Enroute Transcarotid Neuroprotection System and nearly 50,000 units of the Enroute Transcarotid Neuroprotection System Plus. Customers with any of these devices on hand should stop using them right away and start the process of returning them to Boston Scientific. If customers know of any Enroute systems forwarded from one facility to the next, they should communicate with that facility about this concern.

Click here for more information from the FDA, including specific lot numbers.

Additional details about these devices

The Enroute Transcarotid Neuroprotection System and Enroute Transcarotid Neuroprotection System Plus are used by vascular surgeons and interventional cardiologists to perform transcarotid artery revascularization procedures. The Enroute system delivers transcarotid vascular access to clinicians and reduces the risk of stroke for patients presenting with carotid artery disease. It reverses blood flow in a way that keeps embolic debris away from the brain, providing clinicians with a minimally invasive alternative to carotid endarterectomy.

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Effectiveness of Transcarotid vs Transfemoral Carotid Stenting for Stroke Prevention

 Why do this? Verify the Circle of Willis is complete and close the offending artery. No complications from stenting or TCAR. I'm not medically trained, so ask your doctor EXACTLY WHY THEY WANT TO DO THESE PROCEDURES! Revenue generation I bet. And I bet you don't get a guarantee of no complications; that tells you about their confidence in these procedures!

Like other types of carotid revascularization, TCAR carries a risk of:

• Injury of your carotid artery.

• Bleeding around your neck wound.

• Swelling around the cut in your neck.

• Nerve damage.

• Stroke.

• Heart attack.

• Death.

Here is why your doctor needs to GUARANTEE NO complications from stenting!

• stenting (22 posts to May 2011)

• carotid stenting (21 posts to May 2016)

• carotid artery stenting (7 posts to November 2021)

Effectiveness of Transcarotid vs Transfemoral Carotid Stenting for Stroke Prevention

Jesse A. Columbo, MD, MS^1,2; Pablo Martinez-Camblor, PhD^3,4; David H. Stone, MD^1,2; et al Philip P. Goodney, MD, MS^1,2; Mark A. Creager, MD^1,5; Todd A. MacKenzie, PhD^3,6; Jialin Mao, MD, PhD⁷; Aruna Pradhan, MD⁸; Sanuja Bose, MD, MPH⁹; Haobin Chen, BS³; A. James O’Malley, PhD^3,4; Caitlin W. Hicks, MD, MS⁹

Author Affiliations Article Information

JAMA Netw Open. 2025;8(4):e259143. doi:10.1001/jamanetworkopen.2025.9143

Key Points

Question  What is the comparative risk of stroke after transcarotid artery revascularization (TCAR) vs transfemoral carotid artery stenting (TF-CAS) for patients with carotid artery stenosis?

Findings  In this comparative effectiveness study of 5798 asymptomatic and 4721 symptomatic patients who underwent carotid stenting, TCAR was associated with a lower risk of stroke than was TF-CAS. This finding was consistent in both asymptomatic and symptomatic patients and was durable over a 3-year interval.

Meaning  With no completed or enrolling randomized clinical trial to evaluate TCAR, these comparative stroke risk results can inform future procedure choice for patients who are considering carotid artery stenting.

Abstract

Importance  The effectiveness of surgical transcarotid artery revascularization (TCAR) compared with percutaneous transfemoral carotid artery stenting (TF-CAS) for stroke prevention beyond the periprocedural period is poorly quantified.

Objective  To compare the risk of stroke after TCAR vs TF-CAS.

Design, Setting, and Participants  This retrospective cohort study used data from the Vascular Implant Surveillance and Outcomes Network (VISION), a procedural registry linked to Medicare claims data that captures clinical, procedural, and outcome data on patients who underwent carotid stenting. Patients who underwent TCAR or TF-CAS between October 1, 2016, and December 31, 2019, and were captured in the VISION database were included. Data were analyzed between January and June 2024.

Exposure  Type of carotid stenting (TCAR vs TF-CAS).

Main Outcomes and Measures  The primary outcomes were any stroke, including both periprocedural and during follow-up, defined using a validated claims code list, and death. Asymptomatic and symptomatic patients were analyzed separately. Kaplan-Meier analysis was used to calculate the cumulative incidence of the outcomes, and a multivariable Cox proportional hazards model was used to determine hazard ratios (HRs).

Results  There were 5798 asymptomatic patients (mean [SD] age, 74.6 [7.7] years; 3631 male [62.6%]; 3482 underwent TCAR; 2316 underwent TF-CAS) and 4721 symptomatic patients (mean [SD] age, 74.2 [8.3] years; 2969 male [62.9%]; 2377 underwent TCAR; 2344 underwent TF-CAS) who underwent carotid stenting. Patients who underwent TCAR were older, more likely to be female, and less likely to have had a prior ipsilateral carotid revascularization procedure. Among asymptomatic patients, the Kaplan-Meier 3-year risk of stroke was lower after TCAR (5.1%; 95% CI, 3.0%-7.1%) than TF-CAS (9.2%; 95% CI, 7.7%-10.7%) (log-rank P < .001). The composite 3-year stroke or death risk after TCAR was 22.6% (95% CI, 18.8%-26.3%), compared with 31.4% (95% CI, 28.3%-34.3%) after TF-CAS (log-rank P < .001). Compared with TCAR, the adjusted HR of stroke after TF-CAS among asymptomatic patients was 1.69 (95% CI, 1.25-2.28; P < .001). Among patients with symptomatic carotid stenosis, the 3-year stroke risk was also lower for TCAR (16.6%; 95% CI, 12.1%-20.9%) than for TF-CAS (20.9%; 95% CI, 17.5%-24.1%) (log-rank P < .001). The composite 3-year stroke or death risk after TCAR was 35.9% (95% CI, 30.1%-41.2%), compared with 41.5% (95% CI, 37.6%-45.1%) after TF-CAS (log-rank P < .001). Compared with TCAR, the adjusted HR for stroke after TF-CAS among symptomatic patients was 1.42 (95% CI, 1.17-1.73; P < .001). Sensitivity analyses yielded similar results.

Conclusions and Relevance  In this comparative effectiveness study, TCAR was associated with a lower risk of stroke than TF-CAS. This finding was consistent in both asymptomatic and symptomatic patients and durable over a 3-year interval. These findings can inform procedure choices for patients considering carotid artery stenting.

More at link.

How 20-minute stroke surgery technique could save thousands of lives

Fascinating, is your hospital aware of this?

Do you prefer your  hospital incompetence NOT KNOWING? OR NOT DOING? Because your hospital is incompetent if nothing is being done to apply this to stroke patients, in my opinion.

How 20-minute stroke surgery technique could save thousands of lives

Professor of vascular and endovascular surgery at NUI Galway, Sherif Sultan

Laura Lynott

August 15 2022 09:34 AM

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An innovative 20-minute Irish stroke surgery technique could save thousands of later stage stroke patients’ lives and prevent serious disability, a leading surgeon has stated.

The technique, which takes place under general anesthetic, works by reducing the patient’s body temperature, administering intravenous medication(What medication?) and inserting a tube through the neck.

The tube, along with a stent is placed into the carotid artery - the main artery to the brain. The clot is removed and a hole in the artery is closed with a dissolvable disc.

Professor of vascular and endovascular surgery at NUI Galway, Sherif Sultan, said: “A stroke patient normally has to be treated within 24 hours - the golden hours - but with this treatment, we can save those who’ve gone beyond this timeframe.”

Professor Sultan stated the first patient to receive the treatment was an Irish-based boss of a famous multinational company.

The businessman had been in a public hospital, where treatment had not worked.

“It was 96 hours before he came to me,” Prof Sultan said. “The other team had been trying but so much time had gone by, the patient wasn’t able to move his right hand or right leg.

“But he was still talking and he said ‘Just do anything to help me.’

The patient was referred to Professor Sultan, as word had spread about the treatment. His body temperature was reduced and the procedure was carried out.

“The treatment saved his life,” Prof Sultan said. “He woke up moving his limbs, as if nothing had happened. It changed everything.

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“He sends me Christmas cards, thanking me for saving his life.

“After 24 hours it’s often a case of throwing the towel in, a case of nothing more can be done - but this treatment changes that and offers a higher chance of recovery.

“Within two weeks, this man was driving his car and living his life normally. His daughter now wants to be a vascular surgeon. She sees what this surgery did for her dad. We need more surgeons, we need more young people to read about cases like this, to realise we can really help change lives for the better.”

Prof Sultan and a team at NUI Galway developed the technique and around 100 patients globally have been treated with the method - Transcervical Percutaneous Carotid Angioplasty and Stenting Therapy or (TCAR).

88pc recovered fully and were discharged home within three days. However, 12pc of patients did need rehabilitation.

Stroke surgery is normally carried out by inserting a stent through the groin and this is routed up to the brain, to remove a clot.

TCAR offers a “quicker route to the brain” and provides an opportunity to “save those who might have gone beyond the 24 hour period,” Prof Sultan said.

“We started publishing this work because we just want to save patients’ lives, to prevent them having serious disabilities, if treatment has gone beyond 24 hours.

“We don’t want anyone to throw the towel in because nothing has worked and the golden time period has passed.

“Stroke rehabilitation in Ireland costs approximately €100,000 million. In the UK, it’s close to €2.4bn. This treatment is a paradigm shift in how to treat strokes and the treatment cost around €300.”

The procedure, which is awaiting European, UK and FDA approval, could potentially help thousands of stroke patients, if rolled out.

Prof Sultan stated any surgeon trained in vascular surgery could be easily trained on how to use the device.

The procedure, he stated, cut the risk of nerve damage to the brain and also helped the patient avoid a lengthy stay in hospital.

The professor also stated the procedure resulted in less pain, fewer side effects and a more rapid recovery.

According to the Irish Heart Foundation, one in six people will have a stroke during their life. Most of these are aged over 65. However, a stroke can occur at any age and even young people and children can be affected.

“This procedure was created and developed in Ireland by an Irish-based team,” Prof Sultan said.

“I want to see it introduced to help patients live normal lives, to reduce disability, to help families and to reduce the cost to the exchequer.

“As well as that, it could potentially create lots of Irish jobs.”

Registry: More Options for Blocked Carotids Mean Better Outcomes

In my opinion being not medically trained they missed the most important option.

1. Determine if the Circle of Willis is complete.

2. If yes, then completely close up the offending artery.

3. Your other three arteries supplying the Circle of Willis provide enough blood for you to function just fine. 

4. This is why I would never consider a carotid endarterectomy as long as the Circle of Willis is complete.
   

5. Cognitive Dysfunction and Mortality After Carotid Endarterectomy

6. Risks of TCAR are here: Transcarotid Artery Revascularization,  you don't want them to happen and they put a stent in besides.

7. And this problem tied to stents:Plaque Protrusion Tied to Stroke in Carotid Stenting 3% rate

 

 The latest here:

Registry: More Options for Blocked Carotids Mean Better Outcomes

 

Adoption of TCAR may be good for carotid revascularization in general

by Nicole Lou, Staff Writer, MedPage Today February 22, 2021

Centers adding transcarotid artery revascularization (TCAR) to their treatment options had improved perioperative outcomes for patients with carotid artery stenosis, according to the Vascular Quality Initiative (VQI) registry.

Major adverse cardiovascular event (MACE) rates -- counting in-hospital stroke, MI, and death at 30 days -- were similar between patients undergoing TCAR and those getting surgical carotid endarterectomy (CEA; 2.3% vs 2.4%, P=0.91), reported a group led by Jesse Columbo, MD, MS, of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.

Despite such similar results, VQI centers had 10% less MACE in their overall carotid revascularization programs in the year after adopting TCAR than if they had stuck with the surgical option alone (OR 0.90, 95% CI 0.81-0.99), according to a difference-in-difference analysis by Columbo's group, published online in JAMA Open Network.

"This finding suggests that this new technology may have allowed proceduralists to select patients for whom TCAR may be superior to CEA, while still performing CEA on patients for whom that procedure was appropriate," study authors said.

"Overall, while observational in nature, these data imply that both TCAR and CEA may be reasonable treatment choices for patients undergoing carotid revascularization and providers may be able to choose the modality they feel best aligns with the patient's clinical presentation and anatomy," they concluded.

Moreover, the observed 10% MACE reduction, already "impressive," may in fact be an underestimation of the benefits of TCAR adoption, because the study included only VQI hospitals, which record only 10% of the CEAs performed in the U.S., commented Peter Groeneveld, MD, of the University of Pennsylvania in Philadelphia, in an invited commentary.

In contrast, device sales records indicate that the registry captures more than 95% of TCAR procedures.

TCAR was introduced to the U.S. market with the 2015 FDA approval of the Enroute stent system from Silk Road Medical.

The carotid procedure is designed to be a lower-risk alternative to surgery for patients at high risk due to anatomic or medical challenges. It is also designed with no need to traverse the aortic arch and carotid lesion prior to embolic protection, unlike transfemoral carotid stenting.

Whether TCAR is truly noninferior to CEA has not been proven in a randomized controlled trial. Transfemoral carotid stenting has been linked to more periprocedural events but no difference in outcomes at 10 years compared with surgery.

"An ongoing challenge for cardiovascular surgeons and interventionalists is to ascertain whether new therapeutic options for patients with a severe cardiovascular disease improve clinical outcomes across the full spectrum of patients with the disease. There are no guarantees that new therapies will produce net benefits across broad populations," Groeneveld cautioned.

He cited the examples of percutaneous coronary intervention, which may have "inappropriately shifted numerous patients away from the better treatment option" of coronary artery bypass grafting, and transcatheter aortic valve replacement, which conversely increased the accessibility of treatment while "potentially improving outcomes across the full spectrum of patients with aortic valve disease."

In general, better clinical outcomes for heart procedure recipients will require a "collective learning process" that harnesses data collection and judicious interpretation of statistical analyses, according to Groeneveld.

The study was a retrospective analysis of a national quality improvement registry maintained by the Society for Vascular Surgery. Included were people who underwent carotid procedures in 2015-2019. Those who got transfemoral carotid stenting were excluded.

A total of 86,027 patients at 469 participating VQI centers constituted the study cohort. Although only 8.9% got TCAR, TCAR procedures had jumped from 0.7% of all carotid procedures in 2015 to 17.0% in 2019. Accordingly, adoption of TCAR rose from 15 VQI centers in 2015 to 247 in 2019.

The TCAR group was significantly older on average (73.1 vs 70.6 years) and included fewer women (36.4% vs 39.5%) than the CEA group.

Unobserved confounding was a major potential limitation to the study.

"The primary threat to this study's validity is whether TCAR adoption by a hospital was associated with other concurrent quality-of-care initiatives that were the actual effectors of lower MACE rates. For example, it would not be surprising if TCAR-adopting hospitals were on a different trajectory for surgical quality than hospitals that did not adopt TCAR or did so slowly," according to Groeneveld.

A randomized trial "is likely the only way to dispel any lingering doubts regarding TCAR's comparative effectiveness" against surgery, but the "preponderance of existing observational data and evidence from single-group trials certainly supports TCAR's noninferiority to CEA," the editorialist acknowledged.

• 

  Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow

Disclosures

Columbo and Groeneveld had no disclosures.

Study coauthors reported ties to the NIH, the Patient-Centered Outcomes Research Institute, and Silk Road Medical.

Primary Source

JAMA Open Network

Source Reference: Columbo JA, et al "Association of adoption of transcarotid artery revascularization with center-level perioperative outcomes" JAMA Network Open 2021; DOI: 10.1001/jamanetworkopen.2020.37885.

Secondary Source

JAMA Open Network

Source Reference: Groeneveld PW "Assessing the outcomes of procedural innovation" JAMA Network Open 2021; DOI: 10.1001/jamanetworkopen.2021.0328.

TCAR procedure offers potentially safer method for high-risk stroke patients - carotid artery cleanout

Just in case you need to go down this route.

TCAR procedure offers potentially safer method for high-risk stroke patients - carotid artery cleanout

The carotid arteries supply oxygenated blood to the brain. Every year, more than 300,000 people in the United States are diagnosed with blockages, or plaques, in their carotid artery. When these arteries become blocked due to plaque build-up, an individual is at high risk for a stroke if the plaque ruptures and flows to the brain. Many individuals can manage carotid artery disease with medications and lifestyle changes. However, many may require carotid artery revascularization surgery to repair the blockage in the artery. Carotid endarterectomy has been the gold standard of treatment with carotid stenting reserved for those who are high risk for open surgery. While largely effective in some patients, carotid stenting from the transfemoral route has been found to carry a higher risk of stroke, with a significant amount of this risk felt to be related to the approach.
The FDA recently approved a new Transcarotid Artery Revascularization (TCAR) procedure that utilizes the ENROUTE® Transcarotid Neuroprotection and Stent System from Silk Road Medical. The TCAR procedure offers patients a potentially safer method of carotid stenting through a small cut down at the base of the neck and direct carotid artery access along with neuro-protective flow reversal during delivery of the stent. The Minneapolis Heart Institute Foundation® (MHIF) was selected as the only center in the four state area to participate in the ROADSTER 2 Study. Jessica Titus, MD, and Timothy Sullivan, MD, vascular surgeons at the Minneapolis Heart Institute® at Abbott Northwestern Hospital, will serve as Principal Investigator and Co-Investigator, respectively, for the trial. "We are excited to be able to bring this carotid artery revascularization option to our patients. It combines the advantages of a minimally invasive approach for high risk patients with a lower stroke risk than the standard method for carotid stent placement." said Dr. Titus.

The ENROUTE Transcarotid Neuroprotection System utilizes robust flow reversal during transcarotid stent placement to remove micro and macro emboli throughout the intervention. Erica Rogers, CEO of Silk Road Medical notes, "We selected the staff and researchers at MHIF as a key trial partner because they have the vascular surgery and research expertise we need to participate in this important study and provide this less invasive and more efficient TCAR procedure for their patients presenting with carotid artery disease." The first registry trial participant at MHIF is scheduled for first quarter 2016. In total, the ROADSTER2 study will assess the real world treatment of individuals at risk for stroke due to carotid artery disease with the ENROUTE® Transcarotid Neuroprotection (NPS) and Stent System with a minimum of 600 participants around the country.

Source:

Minneapolis Heart Institute Foundation