Drug-coated balloon angioplasty for the management of recurring infrapopliteal disease in diabetic patients with critical limb ischemia.

OBJECTIVE: To describe the 1-year outcomes of recurring infrapopliteal disease after endovascular revascularization with the Lutonix drug-coated balloons (LDCB) in diabetic patients with critical limb ischemia (CLI), and to benchmark our findings with previously published objective performance goals (OPG) addressing safety and efficacy of new catheter-based therapies for CLI. METHODS: The present study was a retrospective, single-center, and single-arm trial of symptomatic diabetic patients with CLI, who underwent LDCB-angioplasty for recurring infrapopliteal disease. Acute procedural and technical success were recorded. TcPO2 metrics variations at baseline and follow up were analyzed. Freedom from clinically driven target lesion revascularization (CD-TLR) was calculated using Kaplan-Meier analysis, and outcomes compared with previously published OPG for infrapopliteal interventions. RESULTS: 21 patients (15 men; mean age 66,6±11,2 years) were followed-up for 356.5±159.2 days and 90.47% had 12-months follow up data available for analysis. TcPO2 increased (14.3±11.6mmHg to 53.8±11.7mmHg; p<0.05). Limb salvage rate was 100%, and 90.4% of patients achieved the combined endpoint of reduction in ulcer size/depth or complete healing. LDCB had superior efficacy (MALE+post-operative death, amputation free survival, freedom from re-intervention, limb salvage and survival rates), while attaining superior or equivalent safety (Major Adverse Limb Events, major adverse cardiovascular events and Amputation) endpoints for the overall, modified clinical and anatomical high-risk groups. CONCLUSIONS: Lutonix DCB is safe and effective for recurring infrapopliteal disease. It outperforms the OPG for CLI patients with clinical and anatomical high-risk features.

Feasibility and 1-Year outcomes of subintimal revascularization with supera® stenting of long femoropopliteal occlusions in critical limb ischemia: The "Supersub" Study.

BACKGROUND: Stent-based revascularization of long femoro-popliteal (FP) lesions has been mainly studied in claudicants and compromised by restenosis and stent fractures. The Supera® stent's biomimetic design allows enhanced fracture resistance. Data for Supera® stenting to treat long chronic total occlusions (CTOs) in patients with critical limb ischemia (CLI), are scarce. OBJECTIVE: To assess long-term outcomes of subintimal revascularization with Supera® stenting, for long FP CTOs in patients with CLI. METHODS: Prospective, single-center, single-arm study of 34 consecutive CLI patients with FP TASC C and D CTOs, who underwent Supera® stenting after subintimal crossing. Primary efficacy endpoint was 1-year patency and freedom from target lesion revascularization (TLR). Primary safety endpoint was the composite rate of freedom from death from any cause, major amputations, and TLR at a year. Secondary endpoints were stent integrity, clinical improvement, amputation free-survival, quality of life, and cost-efficiency. RESULTS: Mean lesion length was 27.9 ± 10.2 cm. Acute technical success was 100%. Primary patency was 94.1%. Freedom from TLR was 97.1%. Limb salvage was 100%. Clinical improvement was observed in 100% of patients: TC PO2 increased from 12.7 ± 6.2 to 54.8 ± 8.4 mm Hg (p < 0,0001); and 100% of patients experienced a shift in Rutherford to class 0 (p < 0.0001). There were no stents fractures. Amputation free-survival was 82.4%. CONCLUSIONS: Subintimal revascularization with Supera® stenting in CLI patients with long FP occlusions, is feasible and superior to validated efficacy performance goals. Larger multicenter studies are needed to validate the safety and efficacy of this novel alternative approach. © 2016 Wiley Periodicals, Inc.

Automated Carbon Dioxide Angiography for the Evaluation and Endovascular Treatment of Diabetic Patients With Critical Limb Ischemia.

PURPOSE: To test the safety, efficacy, and diagnostic accuracy of automated carbon dioxide (CO2) angiography (ACDA) for the evaluation of diabetic patients with critical limb ischemia (CLI) and baseline renal insufficiency and compare ACDA with iodinated contrast medium (ICM) during endovascular treatment. METHODS: From November 2014 to January 2015, 36 consecutive diabetic patients (mean age 74.8±5.8 years; 27 men) with stage ≥3 chronic kidney disease (CKD ≥3) and CLI underwent lower limb angiography with both CO2 and ICM followed by balloon angioplasty in a prospective single-center study. The primary outcome measure was the safety and efficacy of ACDA as the exclusive agent to guide angioplasty in this cohort. The secondary outcomes were the safety and diagnostic accuracy of ACDA injection as compared with ICM digital subtraction angiography (DSA) for invasive evaluation of these patients. RESULTS: ACDA safely and effectively guided angioplasty in all patients without complications. Transcutaneous oxygen pressure improved from 11.8±6.3 to 58.4±7.6 mm Hg (p<0.001). There were no complications related to ACDA during diagnostic imaging and no significant changes in the estimated glomerular filtration rate from baseline to 24 hours (44.7±13.3 vs 47.0±0.8 mL/min/1.73 m(2); nonsignificant). The diagnostic accuracy of CO2 was 89.8% (sensitivity 92.3%; specificity 75%; positive predictive value 95.5%; negative predictive value 63.1%). There was no statistically significant difference in the qualitative diagnostic accuracy between the media (p=0.197). CONCLUSION: ACDA is an accurate, safe, and effective technique that can be utilized to guide endovascular interventions in diabetics with CLI and baseline CKD ≥3. Larger multicenter randomized studies are needed to validate these results.

Angiosomes: how do they affect my treatment?

The number of diabetic patients is actually increasing all around the world, consequently, critical limb ischemia and ischemic diabetic foot disorders related to the presence of diabetic occlusive arterial disease will represent in the next few years a challenging issue for vascular specialists. Revascularization represents one step in the treatment for the multidisciplinary team, reestablishing an adequate blood flow to the wound area, essential for healing and avoiding major amputations. The targets of revascularization can be established to obtain a "complete" revascularization, treating all tibial and foot vessels or following the angiosome and wound-related artery model, obtaining direct blood flow for the wound. In this article, we summarize our experience in endovascular treatment of diabetic critical limb ischemia, focusing on the angiosome and wound-related artery model of revascularization and the technical challenges in treating below-the-knee and below-the-ankle vessels.

Discomfort assessment in peripheral angiography: randomized clinical trial of Iodixanol 270 versus Ioversol 320 in diabetics with critical limb ischemia.

OBJECTIVES: To assess and compare the intra-arterial injection-associated discomfort of iodinated contrast media (CM) and the impact on diagnostic efficacy in diabetics with critical limb ischemia (CLI). BACKGROUND: Arterial revascularization is a mainstay in patients with CLI. Previous diagnostic angiography is a crucial step that can be affected by CM injection discomfort compromising the revascularization results, and it could vary related to the CM agents. METHODS: One hundred forty-eight patients received Iodixanol 270 mg iodine pro ml or Ioversol 320 mg iodine pro ml in a prospective, double-blind, randomized, parallel-group clinical trial. Injection-associated discomfort was assessed by Visual Analogic Scale (VAS). Diagnostic efficacy and safety up to 1 week were evaluated. RESULTS: The incidence of pain has been around 50% of the all population in study, with lesser incidence of pain (25.7% vs 74.3%; P < 0.0001) and of heat sensation (55.4% vs 85.1%; P < 0.0001), after Iodixanol than after Ioversol injection. Discomfort mean score, according to VAS assessment, was less in the Iodixanol group (8.1 ± 15.3) than in the Ioversol group (36.0 ± 29.7), after first injection (P < 0.001) and for all injections (P < 0.001). A significant difference was also observed in favor of Iodixanol (P < 0.001), respect to mean score of discomfort and heat sensation, assessed by the operators after all the CM injections. CONCLUSIONS: Iodixanol caused less frequent and severe discomfort, characterized as pain and heat during intra-arterial administration compared with Ioversol. The pain severity is tightly related to image and diagnosis quality with an impact on the patients for additional injections and larger CM volumes.