Critical Limb-Threatening Ischemia (CLTI)

12 Month Outcomes of the SUCCESS PTA Study show consistent safety and effectiveness in claudicant and CLTI patients when using the SELUTION SLR™ drug eluting balloon.

Drug-coated balloons and stents don’t reduce the risk of amputation or improve quality of life for people with peripheral artery disease in the legs. That’s the takeaway from two major clinical trials led by researchers at the University of Gothenburg.

For patients with compromised limb viability, such as acute and chronic limb-threatening ischaemia, or severe functional impairment that does not improve with exercise training, lower extremity revascularization is recommended. Given the complexity of PAD management, a multidisciplinary vascular team is required to achieve the best individualized treatment. Further research efforts should focus on reducing ischaemic events and health disparities and on optimizing the implementation of GDMT and exercise therapy, as well as improving the quality of life in patients with PAD.

According to Reflow Medical, the Spur stent system is the first and only retrievable stent system that features a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system. It is designed for controlled lesion penetration and treatment through a series of radially expandable spikes. Known as retrievable scaffold therapy (RST), the spikes on the Spur stent penetrate the lesion to increase the acute luminal diameter and modify the lesion morphology to change vessel compliance and reduce vessel recoil effect.

Critical Limb Ischemia (CLI) is a condition manifested by pain at rest, a non-healing wound, or gangrene. It occurs due to severe blockages in the arteries of a person’s lower extremities/limbs (legs), which markedly reduces blood flow. This condition is a serious form of Peripheral Arterial Disease or PAD that is caused by the buildup of fats, cholesterol or some other substances in and around your artery walls.

Using the most conservative delta between the two groups in terms of the primary efficacy endpoint at 365 days, not inclusive of the treatment window, the Esprit BTK scaffold costs an additional US$7,086 per primary efficacy endpoint avoided. This led Parikh to report that the Esprit BTK scaffold achieves a 64% probability of cost-effectiveness at a US$10,000 willingness-to-pay threshold compared to angioplasty. As a result of this, he averred: “The use of Esprit BTK at one year alone is likely to be cost effective.”

Humacyte recently announced it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational acellular tissue engineered vessel (ATEV), designed to treat patients with advanced peripheral arterial disease (PAD). This RMAT designation was granted at the same time as the FDA cleared a new Investigational New Drug (IND) application for the PAD indication for ATEV, formerly referred to as the human acellular vessel (HAV).

CD31-coated surfaces promoted the acquisition of a physiologic endothelial cell phenotype and rapid coverage at a significantly higher extent as compared to bare metallic surfaces in vitro. Nitinol and cobalt-chromium stents coated with CD31-mimetic peptides were rapidly integrated within the arterial wall in vivo without thrombo-inflammatory signs up to 30 days after implantation.

Although evidence suggests that the performance of DCBs is independent of lesion complexity, there continues to be a bailout stent ratio > 40% in long lesions (> 20 cm), severely calcified lesions, and a high number of chronic total occlusions. In arteries that are obstructed by overwhelming atherosclerotic plaque deposition, balloon angioplasty increases the vessel lumen through uncontrolled dissection, resulting in longitudinal tears and creating tissue flaps with varying degrees of severity. Additional data also suggest that untreated dissections following plain old balloon angioplasty (POBA), including non–flow-limiting dissections, are associated with reduced patency.

Cardiovascular diseases have been primarily characterized by the dysfunction of the myocardium as the primary and major cause of morbidity and mortality and have shown an increased rate across the globe. Both experimental and clinical studies show that the activation of inflammatory responses, myocardial necrotic, apoptotic, and autophagic processes substantially aggravate cardiac dysfunction, leading to the development of heart failure, ventricular arrhythmias, and sudden cardiac death.

Sahil Parikh (Columbia University Irving Medical Center, New York, USA) reported that, at three years, Esprit BTK demonstrated a 33% relative improvement in the composite primary efficacy endpoint of primary patency and limb salvage compared to percutaneous transluminal angioplasty (PTA; 59.5% vs. 44.8%; p=0.0025 log rank test). Parikh added that the Esprit BTK was also associated with significantly lower rates of binary restenosis (38% vs. 49%; p=0.018 log rank test), and lower clinically driven target lesion revascularisation (CD-TLR) rates, though the latter did not reach statistical significance (10.2% vs. 18.4%; p=0.052 log rank test). Furthermore, the presenter shared that safety outcomes, the composite of freedom from major adverse limb events at three years, and perioperative death at 30 days were similar between the two arms (90.8% vs. 94.2%; p=0.23 log rank test).  

“Endovascular thrombectomy has transformed acute ischaemic stroke care, with onset-to-puncture [OTP] time widely recognised as a critical determinant of outcome,” the authors write, outlining the backdrop to their study. “However, emerging evidence suggests that in-hospital procedure time—from arterial puncture to final recanalisation—may have an equally or more significant impact.”

A new statement from leading heart and blood vessel experts in Europe is providing clinical guidance for treatments to prevent blood clots in patients with a serious condition called chronic limb-threatening ischemia (CLTI), after they have had procedures to restore blood flow in their lower limbs. The statement, and the systematic review it is based on, comes from the European Society of Cardiology (ESC) Working Group on Aorta and Peripheral Vascular Diseases and Working Group on Cardiovascular Pharmacotherapy.

In Wednesday’s peripheral arterial programme, which hosted several podium-first presentations, lower limb drug-eluting technologies took centre stage—signalling a potential shift in the treatment paradigm for chronic limb-threatening ischaemia (CLTI). Investigators shared compelling new data from studies ranging from first-in-human trials to large-scale registries, which vie to redefine durability and safety, as well as cost-effectiveness, in the peripheral arterial treatment landscape.

Presented today, late-breaking data from the second year of the LIFE-BTK clinical trial demonstrate the long-term effectiveness of the US Food and Drug Administration (FDA)-approved Esprit BTK everolimus-eluting resorbable scaffold system (Abbott Vascular) in patients with the most severe form of below-the-knee (BTK) peripheral arterial disease (PAD). The data show that the Esprit BTK offers sustained benefits over balloon angioplasty with fewer repeat procedures at two years.

Using peptides replicating the membrane-distal portion of CD31, which is prominently exposed on the inner side of healthy vessels, can simulate the surface of a healthy endothelium. This approach effectively prevents the deposition and activation of blood platelets and leukocytes, which are abnormally prolonged by the presence of a foreign body at sites of endovascular stent implantation, and promotes the acquisition of physiological phenotype by the ECs covering the surface.

Despite medical and technical progress, therapy of lower extremity arterial disease (LEAD) remains limited by subsequent disease progression and ultimate limb ischaemia. Even today, interventional and surgical revascularisation does not enable long-term success in all patients, and/or may not be technically feasible in end-stage LEAD anymore. Subsequent intractable claudication, impaired quality-of-life and work capacity, limb loss, and associated morbidity and mortality have thus generated impetus for alternative therapies.

Despite decades of effort aimed at developing clinically effective cell therapies, including mixed population mononuclear cells, to revascularize the ischemic limb, there remains a paucity of patient-based studies that inform the function and fate of candidate cell types. In this study, we showed that circulating proangiogenic/arteriogenic monocytes (PAMs) expressing the FcγIIIA receptor CD16 were elevated in patients with chronic limb-threatening ischemia (CLTI), and these amounts decreased after revascularization. Unlike CD16-negative monocytes, PAMs showed large vessel remodeling properties in vitro when cultured with endothelial cells and smooth muscle cells and promoted salvage of the ischemic limb in vivo in a mouse model of hindlimb ischemia. PAMs showed a propensity to migrate toward and bind to ischemic muscle and to secrete angiogenic/arteriogenic factors, vascular endothelial growth factor A (VEGF-A) and heparin-binding epidermal growth factor.

DES was the best regarding 3-year primary patency, TLR, mortality, and 5-year TLR. DCB was the best regarding 3- and 5-year major amputation, and 5-year primary patency. DES and DCB should be given priority in treating de novo femoropopliteal lesions.

VenoStent has developed an absorbable extravascular stent, SelfWrap, which not only retains the function of a non-absorbable extravascular stent like the VasQ, but can also be absorbed by the human body, and more importantly, it can be personalized for the patient to better meet his or her needs. Due to its technological innovation, SelfWrap received FDA Breakthrough Device designation in 2022 and was approved by the FDA for an IDE study last year.