Durability and efficacy of tibial arterial stent placement for critical limb ischemia.

PURPOSE: To analyze the efficacy and durability of long-term tibioperoneal arterial stent placement for selected cases of symptomatic chronic limb ischemia (CLI). MATERIALS AND METHODS: From January 2005 to June 2012, 168 limbs (155 patients) were treated with percutaneous transluminal angioplasty (PTA)/stent placement for de novo tibial stenosis or occlusion in at least one tibial artery. Most patients (92.9%) were classified with severe disease (Rutherford category 5/6). Concomitant interventions were performed in 58%. Bare metal (84%) and drug-eluting (16%) stents were used. Indications for stent placement were residual stenosis after PTA (> 30%), elastic recoiling, and dissection. Primary endpoints were freedom from symptomatic intrastent restenosis, target lesion revascularization (TLR), major amputation, and overall survival (OS). RESULTS: Technical success rate was 99%. Within 30 days, five deaths (3.2%) occurred, and a 1.8% (95% confidence interval [CI], 0.1%-27.2%) major adverse cardiac event rate, 3.6% (95% CI, 0.1%-22.1%) major adverse limb event rate, and 1.8% (95% CI, 0%-27.5%) amputation rate were recorded. Mean follow-up was 33 months (range, 1-96 mo). Symptomatic intrastent restenosis occurred in 20 limbs (12%) at a mean of 10.3 months ± 11.27; this was identified as a prognostic factor for limb loss (P = .045). TLR was necessary in 10.8% of limbs, for a limb salvage rate of 89.2%. OS was influenced by age (> 75 y; P < .001), diabetes (P = .048), and renal insufficiency and/or dialysis (P < .001). Estimated survival rate was 63% at 36 months (hazard ratio, 1.63; 95% CI, 54%-70%). CONCLUSIONS: Stent placement offers promising short- to long-term restenosis and patency rates, even in cases of multilevel symptomatic disease. Rigorous follow-up is vital.

Use of combined thoracic and abdominal endografts for proximal severe neck angulation in abdominal aortic aneurysms.

PURPOSE: To evaluate endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA) with severe neck angulation (SNA) utilizing a thoracic endograft placed proximal to a bifurcated endograft. METHODS: A retrospective review was conducted of 28 consecutive EVAR patients (25 men; mean age 71 years, range 62-86) with proximal SNA ≥60° treated electively between December 2006 and May 2011. The average AAA neck diameter was 23 mm (range 22-28), with a mean length of 25 mm (range 10-51) and a mean maximum sac diameter of 63 mm (range 55-98). The mean neck angulation was 73° (range 60-92). All patients received an endograft designed for the thoracic aorta (Relay) placed as a proximal extension above a bifurcated abdominal aortic endograft (IntuiTrak Powerlink). RESULTS: Technical success was achieved in 100% of cases. An intraoperative type I proximal endoleak was successfully treated with stent deployment, and 2 type II endoleaks spontaneously resolved within 30 days. In all 28 patients, endograft integrity and correct positioning were confirmed at the latest imaging follow-up (mean 23.7 months, range 6-43). Fifteen (56%) aneurysm sacs were stable and 13 (46%) were reduced in size. Two patients died of unrelated causes during follow-up. CONCLUSION: The unique morphology of SNA requires the development of a precise proximal fixation technology for successful endovascular repair. This hybrid solution exploits the technological advances of the thoracic aortic endograft and the stability of an anatomically fixed bifurcated endograft. This device combination may be an alternative solution for patients with SNA who are unsuitable for traditional surgery.

Urgent carotid artery stenting with technical modifications for patients with transient ischemic attacks and minor stroke.

PURPOSE: To evaluate the safety and efficacy of urgent carotid artery stenting (CAS) with technical modifications in patients with recent (<24 hours) initial or recurrent (≥2 episodes in 24 hours) transient ischemic attacks (TIA) or with minor stroke. METHODS: A single-center, prospective, observational study was begun in March 2005 to assess an urgent CAS protocol for the treatment of selected high-risk patients with carotid artery disease who presented within 24 hours of an initial or recurrent TIA or minor stroke. Up to June 2011, 78 patients (59 men; mean age 76 years) with TIA (n=57) or minor stroke (n=21) underwent urgent CAS (within 48 hours) for severe internal carotid artery stenosis. Outcome measures were major adverse cardiac and cerebrovascular events (MACCE), modifications in the National Institutes of Health Stroke Scale (NIHSS) values for minor stroke patients, and postoperative stroke and death rates. RESULTS: Technical and procedural success rates were 100% and 97.4%, respectively; 1 intraoperative minor stroke occurred due to stent thrombosis. At 30 days, 2 patients had recurrent minor stroke; one subsequently died after a hemorrhagic brain infarction. The MACCE rate was 3.8%. There were no cases of myocardial infarction or access-related complications. Of the 20 surviving minor stroke patients, 14 showed improvement in neurological deficit on the NIHSS scale at 30 days, while 5 remained stable and one was neurologically impaired. CONCLUSION: Urgent CAS in selected patients with symptomatic carotid stenosis was satisfactory in preventing the recurrence of TIA and stroke in this study. Urgent CAS with careful patient selection, contemporary tools (medical and technical), and expert technique may represent a possible solution for some patients with recent or recurrent TIA or minor stroke.

Autologous micro-fragmented adipose tissue for the treatment of diabetic foot minor amputations: a randomized controlled single-center clinical trial (MiFrAADiF).

BACKGROUND: The diabetic foot ulcer (DFU) is one of the most prevalent complications of diabetes mellitus and often develops severe effects that can lead to amputation. A non-healing "minor" amputation often precedes a major amputation resulting in a negative impact on the function and quality of life of the patients. Stem cell-based therapies have emerged as a promising option to improve healing, and the adipose tissue is an abundant and easy to access source. The injection of autologous micro-fragmented adipose tissue at the amputation stump of a diabetic population undergoing a lower limb minor amputation was evaluated and compared with the standard care. METHODS: In this randomized controlled trial with two arms (parallel assignment) and no masking, 114 patients undergoing a lower limb minor amputation were randomized to standard of care or to micro-fragmented adipose tissue injection prepared using a minimal manipulation technique (Lipogems®) in a closed system. Clinical outcomes were determined monthly up to 6 months. Primary endpoint of the study was the evaluation of the healing rate and time after the minor amputation. Secondary endpoints included the assessment of safety, feasibility, technical success, relapse rate, skin tropism, and intensity of pain. RESULTS: At 6 months, 80% of the micro-fragmented adipose tissue-treated feet healed and 20% failed as compared with the control group where 46% healed and 54% failed (p = 0.0064). No treatment-related adverse events nor relapses were documented, and technical success was achieved in all cases. The skin tropism was improved in the treatment group, and the pain scale did not differ between the two groups. CONCLUSION: The results of this randomized controlled trial suggest that the local injection of autologous micro-fragmented adipose tissue is a safe and valid therapeutic option able to improve healing rate following minor amputations of irreversible DFU. The technique overcomes several stem cell therapy-related criticisms and its potential in wound care should be better evaluated and the therapeutic indications could be expanded. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT03276312. Date of registration: September 8, 2017 (retrospectively registered).