Arterial Preparation by Longitudinal Micro-Incisions Before Balloon Angioplasty of the Superficial Femoral and Popliteal Artery: Acute and 12-Month Results

Purpose: Percutaneous transluminal angioplasty (PTA) with conventional plain old balloon (POBA) and/or drug-coated balloon (DCB) is the primary intervention to treat peripheral artery stenoses. However, acute dissections during the procedure and potential for future target lesion revascularization remain procedural complications. The purpose of this study was to assess the acute and 12-month outcomes in patients who underwent novel vessel preparation with longitudinal, controlled-depth micro-incisions prior to PTA. Materials and Methods: Patients with symptomatic lower extremity peripheral arterial disease with a Rutherford class of 2 to 6 and >70% de novo stenosis of the superficial femoral or popliteal arteries were included in this retrospective study. Patients with thrombotic or embolic lesions, restenosis, or in-stent restenosis were excluded. The FLEX Vessel Prep System (FLEX VP) was used to prepare the vessel prior to PTA by creating micro-incisions at the target lesion. The FLEX VP was followed by POBA or paclitaxel DCB. Results: The study included 65 patients. Lesion characteristics were 90% median stenosis (range = 70%–100%), 75.4% mild-to-severe calcifications, and 33.8% occlusion rate, and median lesion length was 196 (range = 10–480) mm. Following vessel preparation, 82.1% of the patients had low severity dissection or no flow-limiting dissection. The provisional stent rate postprocedure was 16.9%, with a median stent length of 60 mm. The freedom from target lesion revascularization (FFTLR) in 63 evaluable patients at 6 and 12 months was 98.4% and 93.7%, respectively. Freedom from amputation was 100%. Conclusion: In this real-world/all-comers patient population with long, stenotic lesions across the calcification spectrum, vessel preparation with longitudinal micro-incisions prior to PTA was associated with low dissection rate, low dissection severity, low stent implantation, and high FFTLR with the absence of amputation at 12 months relative to published reports in long-lesion cohorts. These results support vessel preparation via micro-incisions.

Clinical performance of polymer-coated paclitaxel-eluting stent implanted for diffuse and calcified superficial femoral artery stenotic lesions: Insights from a patient on hemodialysis

In recent years, various devices have been approved for peripheral artery disease with femoropopliteal lesions. However, treatment of long, calcified, and diffused lesions is still challenging because these lesions are associated with restenosis. This report described the case of an 82-year-old man with bilateral severely calcified and diffused long lesions in the superficial femoral artery that was treated using polymer-coated paclitaxel-eluting stent and interwoven nitinol stent. After 6 months, in-stent restenosis was observed at the implantation site of the interwoven nitinol stents. Polymer-coated paclitaxel-eluting stents were deployed at the in-stent restenosis site. After another 6 months, angiography and intravascular ultrasound imaging revealed no restenosis at the polymer-coated paclitaxel-eluting stent site. Optical coherence tomography was also performed, revealing that the stent struts were well covered by neointima, which was very thin at approximately 0.1 mm. This representative case demonstrated substantial differences in the effects of devices; in other words, the superiority of polymer-coated paclitaxel-eluting stent in treating long, diffuse, and calcified lesions indicated that its implantation is a reasonable option when the initial gain was obtained following sufficient vessel preparation.

An update on vessel preparation in lower limb arterial intervention

Background Plain balloon angioplasty has traditionally been used to treat lower limb arterial disease but can be limited by significant residual stenosis, vessel recoil, dissection, and by late restenosis. Appropriate vessel preparation may significantly improve short and long-term outcomes. We aim to give an overview of some of the devices currently available, or under investigation, for vessel preparation in the lower limb. Main text Vessel preparation devices include those that remove plaque (atherectomy devices) and those that modify plaque. The four groups of plaque removing atherectomy devices are defined by their plaque removal method: Directional, rotational orbital and excimer laser are categories of devices investigated for plaque modification. Intravascular lithotripsy devices generate sonic pulsatile pressure waves that pass into the vessel wall cracking calcified plaques whilst sparing soft tissue. This enables dilatation of calcified lesions at low pressure by conventional balloons and enables full stent expansion. Other balloon based vessel preparation devices were designed to modify plaque and produce more controlled, lower pressure luminal expansion without major dissections and potentially with less recoil than conventional angioplasty balloons. Scoring balloons have a helical nitinol element attached to the balloon that scores plaque facilitating uniform luminal enlargement. Further specialty balloons have been developed in recent years, including the Chocolate, Phoenix and Serranator balloons. Finally, the temporary Spur self-expanding retrievable nitinol stent has a series of radially aligned spurs that are driven into the vessel wall by post-dilatation, potentially improving drug delivery. Conclusion Lesion specific vessel preparation aims to improve both short and long term outcomes through improved penetration of anti-proliferative drug, maximising luminal gain, reducing the need for stent placement and minimising intimal injury. Some forms of vessel preparation appear to improve short term outcomes; long-term outcomes remain uncertain. An overview of some of the multiple devices available for vessel preparation is presented.

Infrapopliteal Artery Occlusive Disease: An Overview of Vessel Preparation and Treatment Options

Critical limb ischemia (CLI) is defined as chronic rest pain and/or the presence of tissue loss (ulcers or gangrene) in the lower extremities secondary to ischemia. CLI is a limb and potentially life-threatening disease associated with a poor prognosis with only 50% of patients being able to preserve both limbs within 12 months of diagnosis. CLI related to diabetes is often more extensive with multi-level long segmental arterial disease resulting in a 5–30-fold increased rate of amputation. As the incidence and prevalence of diabetes mellitus increases within our aging society, the rate of infrapopliteal artery occlusive disease (IPOD) and the need for intervention rises with it. The aim of this manuscript is to provide the reader with an overview of the various devices available for vessel preparation (VP) and treatment of IPOD in order to optimize patency rates, symptom resolution, healing of wounds, and minimize complications.

Orbital atherectomy for treating calcified iliac artery disease to enable large bore device delivery: A case series report

The current standard of care for the treatment of flow-limiting calcific iliac artery disease is balloon angioplasty and subsequent stent placement. However, the presence of calcified lesions may prevent adequate stent expansion or impede the delivery of large bore devices, such as those for transcatheter aortic valve replacement or endovascular aneurysm repair implants. Plaque modification through vessel preparation with orbital atherectomy may enable stent expansion and subsequent proper large device delivery with low rates of procedural complications. A retrospective, single center, case series of 13 subjects treated with orbital atherectomy in iliac arteries to enable large bore device delivery was conducted. Patients were selected for treatment based on iliac artery disease or inability to deliver devices. The procedural complication rate was defined as the composite of flow-limiting dissection, perforation, slow flow, vessel closure, spasm, embolism, and thrombosis. Technical success was assessed as angiographic luminal gain and subsequent successful delivery of large bore devices through the treatment area, as well as freedom from procedural complications. Orbital atherectomy vessel preparation of severely calcified iliac artery lesions resulted in adequate stent expansion safely and enabled delivery of rigid/large profile devices. Further studies are warranted to evaluate patient selection criteria, as well as long-term efficacy and safety rates of orbital atherectomy in the iliac artery.

Acute Outcomes With a Novel Plaque Modification System in Real-World Femoropopliteal Lesions

Purpose: To report outcomes of a multicenter feasibility study using the FLEX Vessel Prep (VP) System, a novel technology that facilitates plaque incision and lumen gain in stenosed or occluded femoropopliteal arteries prior to balloon angioplasty. Materials and Methods: Two hundred fifty-five patients (mean age 71.8±9.1 years) were treated with the FLEX VP System at 38 centers between December 2015 and November 2017. Average lesion length was 133±88 mm. Average baseline stenosis was 92%±11%; 112 (44.3%) of 253 patients presented with a chronic total occlusion. Conventional or drug-coated balloon (DCB) angioplasty was performed in all patients after vessel preparation. Vessel measurements were derived from angiograms acquired at baseline, after FLEX passage, and after subsequent ancillary procedures. Logistic regression analyses were performed to identify baseline or procedure variables that predicted the need for provisional stenting. Results: Average percent reduction in vessel stenosis following treatment with the FLEX VP System was 27%±17%. No flow-limiting dissection, vessel perforation, or embolization was observed; 15 (5.9%) patients had minor (type A or B) dissections. Provisional stenting was performed in 49 (19.2%) patients. Average stenosis following angioplasty ± stenting was 9.1%±7.4%; 9 (3.6%) patients had significant residual stenosis ≥30%. Logistic regression analyses found that patients with dissections, longer lesions, and those receiving conventional balloon dilation alone were most likely to undergo stenting. Conclusion: In a real-world patient population with long, complex femoropopliteal lesions, use of the FLEX VP System as vessel preparation for angioplasty improved acute outcomes compared to historical controls. The rate of provisional stenting was low, and no serious vessel complications were observed.