Autologous Peripheral Blood Mononuclear Cells for Limb Salvage in Diabetic Foot Patients with No-Option Critical Limb Ischemia.

Peripheral blood mononuclear cells (PBMNCs) are reported to prevent major amputation and healing in no-option critical limb ischemia (NO-CLI). The aim of this study is to evaluate PBMNC treatment in comparison to standard treatment in NO-CLI patients with diabetic foot ulcers (DFUs). The study included 76 NO-CLI patients admitted to our centers because of CLI with DFUs. All patients were treated with the same standard care (control group), but 38 patients were also treated with autologous PBMNC implants. Major amputations, overall mortality, and number of healed patients were evaluated as the primary endpoint. Only 4 out 38 amputations (10.5%) were observed in the PBMNC group, while 15 out of 38 amputations (39.5%) were recorded in the control group (p = 0.0037). The Kaplan-Meier curves and the log-rank test results showed a significantly lower amputation rate in the PBMNCs group vs. the control group (p = 0.000). At two years follow-up, nearly 80% of the PBMNCs group was still alive vs. only 20% of the control group (p = 0.000). In the PBMNC group, 33 patients healed (86.6%) while only one patient healed in the control group (p = 0.000). PBMNCs showed a positive clinical outcome at two years follow-up in patients with DFUs and NO-CLI, significantly reducing the amputation rate and improving survival and wound healing. According to our study results, intramuscular and peri-lesional injection of autologous PBMNCs could prevent amputations in NO-CLI diabetic patients.

Medial-to-lateral plantar loop technique for retrograde transcollateral recanalization of the lateral plantar artery in patients with type 3 plantar arch.

A 89-year-old male presented with severe untreatable pain and ischemic non-healing ulcer in the left forefoot. The pre-procedural angiograms showed multiple stenosis of the superficial femoral and popliteal arteries, occlusion of anterior tibial artery, tibio-peroneal trunk (TTP) and distal posterior tibial artery (PTA), stenosis of the peroneal artery, and the patency of the medial plantar artery (MPA) as a single pedal artery, with very poor perfusion of the lateral aspect of the forefoot. The TTP and PTA were recanalized, and balloon angioplasty of superficial femoral artery and popliteal artery and peroneal artery was carried out. After unsuccessful antegrade attempts, the lateral plantar artery (LPA) was retrogradely recanalized performing the medial-to-lateral plantar loop, navigating from the deep branch of MPA to the plantar arch and reentering back in the common plantar artery through the LPA. Balloon angioplasty of LPA was performed though the retrograde and antegrade route. When the MPA is the single pedal artery, and the antegrade recanalization of the dorsalis pedis artery (DPA) and the LPA is not possible, the medial-to-lateral plantar loop is a feasible technique to recanalize the LPA retrogradely through the plantar arch.

A tailored approach to overcoming challenges of a bovine aortic arch during left internal carotid artery stenting.

PURPOSE: To investigate the efficacy and safety of a tailored approach to fit access and engagement techniques to the individual arch anatomy in patients with bovine-type aortic arch (BTAA) to overcome the perceived increased risk of technical failure and cerebral embolization during left internal carotid artery (LICA) stenting. METHODS: Thirty-five high surgical risk patients (23 men; mean age 68.6 years, range 62-90) with BTAA and LICA stenosis underwent carotid artery stenting (CAS). Left common carotid artery (LCCA) engagement was achieved by means of different techniques according to the configuration of the BTAA, arch type (I, II, or III), and angle between the innominate artery and the LCCA. The clinical, anatomical, and procedural data were retrieved from a prospectively maintained database and analyzed retrospectively to identify technical modifications required during the procedure compared with planning. RESULTS: The technical success rate was 100%. Transfemoral access was used in 21 (60%) cases. In this group, the soft engagement technique with hockey stick (HS) guiding catheter and buddy wire in the external carotid artery (ECA) was used in 13 (62%) cases, a simple telescopic technique with 6-F armed introducer or 7-F 40° guiding catheter in 5 (24%) cases, and a sequential technique with a MOMA proximal protection system in the remaining 3 (14%) cases. Among the 14 (40%) right brachial access cases, the telescopic technique with 6-F armed introducer was used in 13 cases. The remaining case was the only one in which the planned technique was changed (from the telescopic to sequential technique with ECA wire exchange). There were no intraprocedural or 30-day neurological events. CONCLUSION: An appropriate tailored interventional strategy, planned by means of preprocedural recognition of bovine arch anatomy, is associated with satisfactory safety and good success.

Should we modify our indications after the EVAR-2 trial conclusions?

BACKGROUND: To compare the results of the endovascular aneurysm repair (EVAR) in patients considered as unfit for surgery in a "high volume" center with the EVAR-2 trial results. METHODS: In our center, between January 2006 and December 2008, 469 endovascular aorta treatments were performed in high-risk patients. All the data were prospectively collected in a database. Among 469 patients, we selected 191 patients considered as unfit for open surgery (group 1) corresponding to the EVAR trial criteria. Variables such as postoperative mortality at 30 days and 1 year, complications rates, as well as early and late redo surgery were evaluated. Long-term pharmacological treatment before surgery was listed. These results were compared with the EVAR trial (group 2). Survival during the follow-up was calculated according to the Kaplan-Meier method. RESULTS: Mortality at 30 days was 1.6% and 9% in groups 1 and 2, respectively (p = 0.002). Global complication rate was 44% and 43% in groups 1 and 2, respectively (p = 0.52). Over the follow-up period, the redo surgery rate was 13% and 26% in groups 1 and 2, respectively (p = 0.0102). In our cohort, the survival rate at 2 years was 84% with a residual number of 102 patients. Before surgery, a long-term antiplatelet treatment was prescribed in 89% and 58% of the patients and statins in 74% and 39% of the patients in groups 1 and 2, respectively (p < 0.0001). CONCLUSION: The EVAR-2 trial conclusions are in opposition to the practice of French vascular surgeons. Endovascular treatment of abdominal aortic aneurysms in high-risk patients is justified. This study confirms the importance of a multidisciplinary treatment for high-risk patients in high-volume centers.

Inverted limbs in fenestrated and branched endografts.

PURPOSE: To describe our experience with the use of custom-designed branched or fenestrated endoprostheses incorporating an inverted contralateral limb in the bifurcated component. METHODS: Retrospective analysis was performed of a prospectively maintained database of all patients undergoing endovascular aneurysm repair using modular branched or fenestrated devices at a university teaching hospital between January 2004 and February 2010. Of 102 cases, 7 male patients (mean age 69 years) were treated with modular devices that incorporated an inverted contralateral limb in the bifurcated component. Five patients had thoracoabdominal aortic aneurysm (4 type IV and 1 type II), 1 patient had a pararenal abdominal aortic aneurysm, and another had type I endoleak from a migrated AneuRx stent-graft. The technique was used primarily because of an existing bifurcated prosthesis (n=5), but in 2 patients without prior open surgery, this technique was needed because of anatomical constraints. RESULTS: All devices were implanted as planned. There was no mortality. One patient required temporary hemodialysis prior to discharge; another patient developed permanent paraplegia, likely related to extensive aortic coverage. No device migration, component separation, or type I or III endoleaks were detected during a mean follow-up of 25 months, and no reinterventions have been necessary. CONCLUSION: The use of an inverted limb in the bifurcated component of modular endografts may allow endovascular treatment in scenarios where there is insufficient space to deploy a standard bifurcated component. This design modification allows an adequate sealing zone between the iliac extension limbs and the bifurcated component.

Challenging treatment of a secondary endoleak in a fenestrated endograft.

PURPOSE: To describe the novel use of an Amplatzer occluder device to seal a secondary endoleak arising at a scallop in a fenestrated stent-graft. CASE REPORT: A 67-year-old man with comorbidities precluding standard endovascular repair of a pararenal aortic aneurysm was treated with a fenestrated endoprosthesis containing one fenestration for the left renal artery and one scallop for the celiac trunk; the right renal and superior mesenteric arteries were occluded at presentation. Interval imaging at 2 years showed a proximal type I endoleak at the celiac trunk scallop associated with expansion of the aneurysm sac. Attempted repair with an aortic extension cuff and a "chimney" stent was unsuccessful. An Amplatzer Patent Foramen Ovale occluder device was deployed across the endoleak to provide aneurysm sac exclusion, which has been maintained at 6-month follow-up. CONCLUSION: Treatment of a secondary type I endoleak after implantation of a fenestrated endoprosthesis is challenging. The novel use of an Amplatzer occluder in this setting may be applicable to other situations in which an endovascular solution is desirable for complications of complex endovascular aneurysm repair.

Lipoprotein(a) and other serum lipid subfractions influencing primary patency after infrainguinal percutaneous transluminal angioplasty.

PURPOSE: To evaluate the influence of serum lipid subfraction concentrations on arterial patency after percutaneous transluminal angioplasty (PTA) in patients with infrainguinal peripheral artery occlusive disease (PAOD). METHODS: From January 2007 to June 2008, a prospective study was conducted involving 39 patients (29 men; mean age 68.6+/-10.0 years) with infrainguinal PAOD in 41 limbs who had preprocedural lipid assessment and underwent successful PTA (<30% residual stenosis). Patient demographics, Fontaine clinical stage classification, Texas University Classification of ulcers, coexisting medical conditions, endovascular procedures, and lipid profiles were collected in a database. Follow-up included clinical and duplex ultrasound evaluation at discharge and at 1, 3, 6, and 12 months. To analyze any correlation between various lipid subfractions and the loss of primary patency (Cox proportional hazards modeling), the patients were dichotomized into high and low groups according to these thresholds: LDL-C >100 mg/dL, HDL-C <40 mg/dL, Lp(a) >30 mg/dL, and an Apo(B)/Apo(A) ratio >0.8 mg/dL. RESULTS: Mean follow-up was 7.5 months (range 3-12). After 1, 3, and 6 months, the primary patency rates by Kaplan-Meier analysis were 94.9%, 73.7%, and 64.1%, respectively. Restenosis at 6 months was significantly related to female gender (HR 95.9, 95% CI 6.8 to 1352.5, p = 0.001), HDL-C <40 mg/dL (HR 86.9, 95% CI 6.4 to 1183.1, p = 0.001), LDL-C >100 mg/dL (HR 9.6, 95% CI 1.6 to 57.4, p = 0.013), and Lp(a) >30 mg/dL (HR 6.1, 95% CI 1.4 to 26.3, p = 0.016). CONCLUSION: Our results suggest that Lp(a), LDL-C, and HDL-C are independent risk factors for restenosis after infrainguinal PTA.

What's next after optimal infrapopliteal angioplasty? Clinical and ultrasonographic results of a prospective single-center study.

PURPOSE: To evaluate arterial patency and factors influencing outcomes after successful tibial artery angioplasty in patients with critical limb ischemia (CLI). METHODS: From January 2005 to August 2007, a prospective single-center study was conducted involving 80 CLI patients (56 men; mean age 71.7+/-8.8 years) who underwent successful tibial artery angioplasty (<30% residual stenosis) in 87 limbs. Eighty (92%) limbs showed ischemic ulcers or gangrene at baseline. In two thirds, a more proximal lesion was treated, and a secondary stent was implanted in 14 (16%). Follow-up included clinical examination for wound healing (WH), limb salvage (LS), and duplex-documented target vessel patency or restenosis at discharge and at 1, 3, 6, 9, 12, 18, and then every 6 months. Patency rates, WH, and LS were assessed with the Kaplan-Meier method, and factors influencing these outcomes were analyzed using Cox proportional hazards models. RESULTS: Mean follow-up was 10.9 months (range 2 days - 29 months). At 12 months, the primary and assisted primary patency rates were 37.9% and 71.2%, respectively. Restenosis was significantly correlated with smoking (HR 3.58, 95% CI 1.15 to 11.18; p = 0.02), infected ulcers (HR 2.04, 95% CI 1.02 to 4.09; p = 0.04), and posterior tibial artery angioplasty (HR 3.76, 95% CI 1.59 to 8.87; p = 0.003). Rates of LS and WH at 12 months were 92.7% and 74.9%, respectively. Peroneal angioplasty was significantly correlated with WH (HR 1.83, 95% CI 1.04 to 3.25; p = 0.03), and wound healing increased with classes of age (HR 1.60, 95% CI 1.07 to 2.39; p = 0.02). CONCLUSION: One-year restenosis after optimal tibial artery angioplasty is significant and positively correlated with smoking, infection of trophic lesions, and posterior tibial artery angioplasty. Close ultrasound surveillance provides good limb salvage after optimal infrapopliteal angioplasty in patients with CLI.