One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry.

PURPOSE: To report the 1-year outcomes of the prospective Legflow drug-coated balloon (DCB) registry, which evaluated the safety and 12-month efficacy of the Legflow balloon in the treatment of femoropopliteal disease. METHODS: The Legflow is a new generation of DCB that has a homogenous, stable surface coating incorporating 0.1-µm paclitaxel particles. From January 2014 to June 2016, 139 patients (mean age 67.1±10.8 years; 109 men) were enrolled at 4 European institutions. Seventy-nine (56.8%) patients had claudication, while 60 (43.2%) had critical limb ischemia (CLI). Mean lesion length (MLL) was 90.0±41.2 mm. Eighty (57.6%) patients were treated for de novo lesions (MLL 83.2±41.2 mm), 29 (20.9%) for postangioplasty restenosis (MLL 81.2±30.9 mm), and 30 (21.6%) for in-stent restenosis (MLL 117.0±39.5 mm). The primary outcome measure was freedom from binary restenosis as determined by a peak systolic velocity ratio ≥2.4 on duplex or >50% stenosis on digital subtraction angiography at 12 months. The secondary outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. RESULTS: Technical success was achieved in all the 139 treated patients. During the hospital stay, 3 CLI patients died of wound-related complications and 3 CLI patients underwent urgent TLR due to early occlusion in 2 and stent thrombosis in 1. At 12 months, 4 additional patients died of cardiac disease unrelated to the procedure. Of the 132 patients available for 1-year follow-up, the primary outcome (freedom from restenosis) was obtained in 107 (81.1%) patients. Freedom from CD-TLR was obtained in 110 (83.3%). Of the 25 late restenoses >50%, only 3 asymptomatic patients did not require TLR. Freedom from CD-TLR was higher in claudicants (87.0%) than in CLI patients (78.2%, p=0.20). In patients treated for in-stent restenosis, freedom from TLR at 1 year was 89.2%. CONCLUSION: These data suggest that the use of a new generation paclitaxel-coated balloon represents a safe and effective therapeutic strategy for femoropopliteal obstructions in different clinical and anatomical settings. These data will need to be confirmed with longer-term follow-up and in randomized controlled trials.

Endovascular Treatment of No-Stent Zones Quo Vadis?

Endovascular treatment of peripheral artery disease has recently become more important due to its minimally invasive nature. Elderly patients as well as fragile patients, like diabetics and those with end-stage renal disease, can benefit from this low-morbidity/-mortality treatment. Very successful results have been achieved with percutaneous balloon angioplasty and stenting in the superficial femoral and iliac arteries. In some areas, however, such as the common femoral artery and the popliteal artery, vascular physicians remain somewhat reluctant to use endovascular strategies. Common femoral endarterectomy, the most often used technique for treatment of common femoral artery lesions, has shown very good long-term results, but is associated with relatively high complication rates, such as superficial and deep wound problems and lymph leakage. This article describes less-invasive endovascular alternatives, such as atherectomy, drug-coated balloons and stenting, and their results. The popliteal artery is also difficult to treat in an endovascular manner due to biomechanical forces during bending and stretching of the knee or leg. Thus, we also describe currently available minimally invasive treatment options for the popliteal artery.

Three-year outcome of the covered endovascular reconstruction of the aortic bifurcation technique for aortoiliac occlusive disease.

OBJECTIVE: The objective of this study was to demonstrate the 3-year outcome of the covered endovascular reconstruction of the aortic bifurcation (CERAB) technique for the treatment of extensive aortoiliac occlusive disease (AIOD). METHODS: Between February 2009 and July 2016, all patients treated with the CERAB technique for AIOD were identified in the local databases of two centers and analyzed. Demographics and lesion characteristics were scored. Follow-up consisted of clinical assessment, duplex ultrasound, and ankle-brachial indices. Patency rates and clinically driven target lesion revascularization were calculated by Kaplan-Meier analysis. RESULTS: Of 130 patients (69 male and 61 female) treated, 68% were diagnosed with intermittent claudication and 32% suffered from critical limb ischemia. The majority (89%) were TransAtlantic Inter-Society Consensus II D lesions, and the remaining were B and C lesions (both 5%). Median follow-up was 24 months (range, 0-67 months). The technical success rate was 97%, and 67% of cases were performed completely percutaneously. The ankle-brachial index improved significantly from 0.65 ± 0.22 preoperatively to 0.88 ± 0.15 after the procedure. The 30-day minor and major complication rate was 33% and 7%. The median hospital stay was 2 days (range, 1-76 days). At 1 year and 3 years of follow-up, 94% and 96% of the patients clinically improved at least one Rutherford category (2% and 0% unchanged, 4% and 4% worsened). Limb salvage rate was 98% at 1 year and 97% at 3 years of follow-up. Primary, primary assisted, and secondary patency was 86%, 91%, and 97% at 1 year; 84%, 89%, and 97% at 2 years; and 82%, 87%, and 97% at 3 years. Freedom from clinically driven target lesion revascularization was 87% at 1-year follow-up and 86% at both 2-year and 3-year follow-up. CONCLUSIONS: The CERAB technique is a safe and feasible technique for the treatment of extensive AIOD with good 3-year results regarding patency and clinical improvement.

Malrotation deformities of the lower extremity and implications on total knee arthroplasty: a narrative review.

INTRODUCTION: Total knee arthroplasty (TKA) is a successful procedure for the management of osteoarthritis (OA) of the knee. Axial plane deformities are more common than suspected in patients presenting with osteoarthritis of the knee joint. Recent research has indicated that torsional deformities could play an important role in the development of anterior knee pain (AKP). METHODS: In a narrative review of the literature, the aetiology of maltorsion deformity of the lower extremity in both, childhood and adulthood, as well as the development of postoperative femoral axial plane deformities are examined. This includes the numerous surgical interventions that have been described for the treatment of maltorsion syndrome, and the role of patient-specific instrumentation. Finally, correcting for maltorsion deformity during and its potential implications for the current clinical care pathway, in terms of both pre- and perioperative practices is discussed. DISCUSSION AND CONCLUSION: Axial plane alignment is considered the 'third dimension' in TKA. Correct axial alignment the lower extremity and of prosthetic components is deemed an important prerequisite for a postoperatively stable and painless knee. Identification of and, where appropriate, adjustment for any pre-existing maltorsion deformities is thought to significantly reduce the proportion of patients with residual complaints following TKA. Well-designed and well-conducted clinical studies are required to support our hypotheses.

One-year outcome of the everolimus-eluting, balloon-expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in CLI patients.

BACKGROUND: The aim of this study was to investigate the efficacy of the balloon expandable Promus Element and Promus Element Plus stents (both Boston Scientific, Marlborough, MA, USA), coated with everolimus, in the treatment of short, focal infrapopliteal lesions. METHODS: The PREVENT study was a prospective, multicenter, non-randomized, single arm study evaluating the safety and efficacy of the Promus Element and Promus Element Plus stent in the treatment of stenotic or occlusive lesions ≤40 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). A total of 70 study subjects were enrolled in a period of 26 months, between November 2012 and December 2014. The mean age was 77.84±6.62 years (62-90 years) and 47 patients were men (67.1%). Mean lesion length was 22.83±8.78 mm (5-40 mm). Twenty percent of the lesions were occluded, whereas 80.00% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography. Secondary outcomes included hemodynamic primary patency on duplex ultrasound (PSV ratio ≤2.4), limb salvage and freedom from target lesion revascularization (TLR). RESULTS: Technical and procedural success (<30% residual angiographic stenosis without major complications) was achieved in all 70 cases (100%). Primary patency was 93.8% at 6 months and 86.2% at 1 year. Freedom from TLR was 93% at 1 year. Limb salvage rate at 12-month follow-up, defined as absence of major amputation, was 100%. CONCLUSIONS: This study shows the safety and efficacy of the everolimus-eluting, balloon expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in patients with critical limb ischemia.

The CERAB technique: tips, tricks and results.

In this article we wanted to present an overview of the latest study results, in vitro and in vivo, of the Covered Endovascular Reconstruction of the Aortic Bifurcation or CERAB technique and the C-CERAB or Chimney CERAB for the endovascular treatment of either extensive occlusive aortoiliac or iuxtarenal disease with preservation of visceral arteries; in combination with tips and tricks to facilitate recanalization and revascularization. A review was performed of the literature of the last 5 years regarding the endovascular treatment of aortoiliac and iuxtarenal TASC II C& D lesions with covered balloon expandable stents. Furthermore we did a retrospective analysis of our most special techniques to achieve a successful interventional recanalization of these challenging lesions. Both the in vitro and the in vivo studies pointed out that there exists an important benefit of the CERAB configuration with excellent patency rates at one and two years in combination with very low mortality and morbidity, when compared to other techniques. Also the C-CERAB variant seems to be a feasible and safe option; 100% technical success; to deal with iuxtarenal or extensive aortic occlusive disease together with the safeguarding of visceral arteries. The CERAB and C-CERAB techniques may change the treatment algorithm of extensive aortoiliac occlusive disease in the near future and appears to be a safe and feasible alternative with promising results, together with a more anatomical and physiological reconstruction of the aortic bifurcation, being a valid alternative for surgery and/or kissing stents. A few critical issues still need to be solved, such as cost-effectiveness, patient selection, fine-tuning of the technique and defining the optimal medical support.