Top Endovascular News of 2023

It was a busy year for endovascular procedures and devices, with big announcements from the US Food and Drug Administration, new data supporting an endovascular-first strategy in chronic limb-threatening ischemia (CLTI), and clearance of a technology that offers hope for no-option patients headed for amputation.

After nearly 5 years of turmoil following the publication of a meta-analysis suggesting heightened mortality with paclitaxel-coated balloons and stents (PACLITAXEL; 17 Down*) in PAD patients, the FDA announced in July that it was lifting all restrictions. Among the many datasets that helped refute the meta-analysis and sway the FDA was an updated patient-level meta-analysis presented at TCT 2023 in October that previously had only been seen by the FDA’s reviewers. It showed no significant increase in death in patients treated with paclitaxel-coated devices in intention-to-treat (ITT), as-treated, and two crossover analyses.

Just a day after the FDA’s momentous news, the US Centers for Medicare & Medicaid Services issued its draft of a proposed national coverage determination (NCD) on carotid (50 Across) stenting. A decision memo followed in October affirming coverage of carotid angioplasty concurrent with stenting with the placement of an FDA-approved carotid stent and an FDA-cleared embolic protection device in Medicare beneficiaries with symptomatic carotid artery stenosis ≥ 50% or asymptomatic carotid artery stenosis ≥ 70%.

While 2022 ended on a slightly sour note with the BEST-CLI study taking a hard stand in favor of surgery over endovascular therapy for many with CLTI (40 Across), 2023 saw data from the multicenter BASIL-2 trial offer a different take, with fewer deaths in patients undergoing endovascular procedures compared with surgery. “What data from both of these studies tell us is that we [have to] look at this on a center to center, case by case basis coupled with active discussion with our patients,” Eric A. Secemsky, MD (Beth Israel Deaconess Medical Center, Boston, MA), told TCTMD at the time.

For many of those with the most-severe CLTI, options are scarce, and amputations often prove inevitable. The PROMISE II study, however, provided evidence that the LimFlow (20 Down) device, which diverts blood flow through arterialization of the deep veins in the foot, may be an answer for some of these “no-option” patients. At 1 year, the limb salvage rate was 69%, with more than 90% of those patients having ongoing wound healing and many reporting significant declines in pain scores. The FDA approved the LimFlow device in September 2023.

Also noteworthy by the FDA was its decision to approve not one, but two of the first renal denervation (RDN; 54 Down) devices in the United States. Following an advisory committee meeting in August, the FDA announced the approval of the ultrasound-based Paradise system (Recor Medical and Otsuka Medical Devices) in early November. Weeks later, it also cleared the Symplicity Spyral system (Medtronic).

What Else Is on the Horizon?

To TCTMD, Sahil Parikh, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), pointed to the LIFE-BTK trial as a bright spot in what has been a dearth of successful trials in below-the-knee (BTK) infrapopliteal interventions. At 1 year, an investigational everolimus-eluting resorbable scaffold (Esprit BTK; Abbott Vascular) was superior to angioplasty for freedom from amputation above the ankle, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion.

“It is novel, and it provides both a new technology that successfully improves patency and clinical outcomes in below-the-knee intervention and . . . a pathway for future trials to be designed and conducted that may also lead to the demonstration of both biological efficacy as well as a clinical efficacy signal,” said Parikh, the trial’s principal investigator.

As for the introduction of the RDN devices, those too are novel and their impact on clinical practice is yet to be determined, he said.

“We don't know how they're going to play out in the real world, and we don't have reimbursement for them yet,” Parikh said. “So, there's going to be a slow launch until reimbursement is clarified. Then there'll be a postmarket phase where we're going to really figure out how to apply this technique [which] has taken more than a decade to reach US operators.”

Operators will also need to gain proficiency with renal denervation, given that it isn’t currently part of traditional interventional training. “As the field evolves, these are going to be skills that people need to acquire and that industry and the professional societies will have to support,” he added.

Also making strides are a myriad of advanced technologies for treating pulmonary embolism (PE), with the initiation of the PEERLESS II trial, which will compare outcomes in intermediate-risk patients treated with anticoagulation plus thrombectomy (FlowTriever; Inari Medical) versus anticoagulation alone, as well as HI-PEITHO, which is testing catheter-directed thrombolysis and standard anticoagulation versus anticoagulation alone in patients with intermediate-high risk PE. Also still to come is STORM-PE, which will enroll patients with intermediate-high risk acute PE treated with anticoagulation plus mechanical aspiration thrombectomy (Lightning Flash; Penumbra) or anticoagulation alone.

“Even though this isn’t headline news yet, because we haven’t seen a data drop or papers, it’s still exciting,” Parikh noted. “There has been a lack of level 1 evidence in this space, and I don’t think people will be able to say that anymore after these trials.”

*All of our end of year stories for 2023 contain clues to our Cardiology Crossword Challenge.