Critical Limb-Threatening Ischemia (CLTI)

The Chocolate Touch showed statistically superiority in its primary efficacy endpoint of 12-month true DCB success—a measure of the target vessel remaining patent without the need for bail-out stenting. Primary patency by Kaplan-Meier (KM) estimate was 83.3% for the Chocolate Touch and 73.0% for Lutonix DCB at 12 months.

Drug-coated scaffolds outperform angioplasty in treating chronic limb-threatening ischemia, leading to higher limb salvage rates and reduced need for repeat procedures, according to a retrospective study.

Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point.

Chronic limb-threatening ischemia (CLTI) is an advanced form of peripheral vascular disease with high rates of morbidity and mortality. Patients often present with claudication, impaired walking, and ischemic pain. Screening for CLTI and peripheral arterial disease is recommended with ankle-brachial indexing. To prevent progression to CLTI, family medicine physicians can intervene with lifestyle modification of hyperlipidemia, obesity, smoking, and encouraging well-rounded high-fiber diets. OMT can be useful in increasing lower-extremity circulation and collateral-vessel development. If refractive to optimized medical management and lifestyle modification, surgical intervention is required. Regardless of intervention, CLTI maintains a high rate of morbidity and mortality, with halting progression being the primary objective.

Chronic limb-threatening ischemia (CLTI) increases the risk of mortality, amputation, and impaired quality of life. The Bare Temporary Spur Stent System, followed by drug-coated balloon treatment, reduces clinically driven target lesion revascularization (CD-TLR), improves wound healing, reduces recoil, and improves vessel patency through one year, compared to historical treatment outcomes with plain balloon angioplasty or a DCB alone.

The DynamX bioadaptor platform is a metallic device designed to support vessels during the healing phase, after which it unlocks and “uncages” them while providing dynamic support to restore function and maintain an open lumen, according to a company press release. The DynamX BTK System for the treatment of BTK vessels impacted by CLTI broadens the use of the technology beyond the treatment of coronary artery disease, the press release stated.

Among patients with CLTI, those eligible for surgical treatment often have two options: surgical bypass (Bypass), where surgeons restore blood and oxygen to the lower limb by reconstructing the blocked vessel, or endovascular therapy (Endo), which involves placing a stent or catheter inside an artery and opening it up to bring blood flow through a blockage.

Cardiovascular diseases remain the leading cause of death worldwide, with ischemic heart disease (IHD) as the most common. Ischemia-induced angiogenesis is a process in which vascular endothelial growth factor (VEGF) plays a crucial role. To conduct research in the field of VEGF’s association in cardiovascular diseases, it is vital to understand its role in the physiological and pathological processes in the heart. VEGF-based therapies have demonstrated a promising role in preclinical studies. However, their potential in human therapies is currently under discussion. Furthermore, VEGF is considered a potential biomarker for collateral circulation assessment and heart failure (HF) mortality. Additionally, as VEGF is involved in angiogenesis, there is a need to elucidate the impact of VEGF-targeted therapies in terms of cardiovascular side effects.

The Esprit BTK System aims to treat the most severe form of peripheral artery disease, a condition known as chronic limb-threatening ischemia, or CLTI, where hampered blood flow can lead to foot or lower leg amputations. Until now, the standard of care has been a single-shot balloon angioplasty procedure to clear a path through the small and twisting arteries that are found from the knee on down—previously there had been no stents or drug-coated balloons approved by the FDA to help the vessels stay open over time.

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STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee) enrolled its final patient earlier this month marking the completion of the study. MicroStent is a vascular stent specifically designed to achieve and maintain tibioperoneal arterial patency improving blood flow and wound healing for below-the-knee amputation reduction in patients with CLTI resulting from progressive peripheral artery disease (PAD).

For patients living with PAD or chronic limb-threatening ischemia (CLTI) who are from racial/ethnic minority groups, economically disadvantaged, or living in areas without access to good vascular care, the future is often dimmed by unnecessary amputations and early death. That reality has been met by a profound lack of accountability and desire for change among the medical professionals they rely on for help, experts said in a special session at VIVA 2022.

The Bare Temporary Spur stent system is a unique clinical solution intended to provide stent-like results while leaving no metal behind, Reflow Medical shares. Known as retrievable stent therapy, or RST, the self-expanding stent is designed with radial spikes for creating channels in the vessel wall to enhance drug absorption and reduce recoil. The stent is then recaptured, removed, and treated with a commercially available DCB.

Rotational atherectomy is a validated technique for the treatment of CLTI with BTK-lesions, demonstrating both safety and effectiveness. Importantly, its application does not demand additional procedural time or specialized experience and training. The use of atherectomy-assisted angioplasty in the BTK segment showed clinical advantages over POBA. In order to establish this promising technology in the arsenal of the modern vascular specialist, multicenter studies with control groups others than POBA and mid- and long-term outcome evaluation are required.

Although simple balloon angioplasty remains the standard due to its safety, cost-effectiveness, and repeatability, it is limited by high rates of restenosis and flow-limiting dissection. The Tack endovascular system is a valuable rescue device post-PTA dissection but still results in a permanent metallic implant in small-calibre arteries. The use of coronary sirolimus-eluting DESs has shown encouraging results, with excellent primary patency compared with PTA and BMSs, but they are limited by their short length, which complicates applicability to long disease segments that represent the majority of infrapopliteal CLTI, as well as affecting cost. Novel DRSs pose a solution to some of these issues by providing an antiproliferative agent before completely resorbing, eliminating the risk of chronic inflammation and late failure associated with permanent implants.

The Freesolve BTK RMS is designed for individuals suffering from chronic limb-threatening ischemia (CLTI). CLTI is the most severe form of peripheral arterial disease (PAD), estimated to affect 11% of the 200 million people suffering from PAD globally. CLTI is associated with high rates of amputation and mortality as well as high care costs

In our experience, for CLTI patients undergoing infrainguinal bypass, satisfactory results in terms of patency and limb salvage rates were achieved using the autologous venous material, even if ectasic or varicose, with the new vascular external support FRAME TM. The use of extra-anatomical venous bypass, combined with a kink-resistant external vascular support, seems to be a feasible solution for the treatment of patients showing upper or lower limb ischemia and without a viable anatomical pathway.

Although the original paclitaxel mortality controversy did not make sense in terms of causation theories, it was appropriate to take this report very seriously. However, in many geographies this resulted in stopping a therapy that had been shown to be more effective and durable than our non-drug-coated strategies. An important question that hasn’t been addressed to date is when depriving patients of a more effective treatment modality, were we causing patients harm? With the benefit of hindsight, can we learn important lessons regarding this?

Informal caregivers play a significant role in providing care for older, often vulnerable, patients, and supporting them as they live with chronic diseases. Due to the rising prevalence of older vascular patients and their use of healthcare, the role of their informal caregivers will become more important. However, little is known about the experiences of informal caregivers of patients with critical limb-threatening ischemia and the impact of informal care on different aspects of these caregivers’ lives.

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While most pharmacy owners hate PBMs, they are a part of our everyday business and the key to success. You can’t ignore them when about 90% of a pharmacy’s revenue is from a PBM.