Clinical Implications of Diabetic Peripheral Neuropathy in Primary Infrapopliteal Angioplasty Approach for Neuro-Ischemic Foot Wounds.

BACKGROUND: To assess the clinical effects of diabetic peripheral neuropathy (DPN) in patients with chronic limb-threatening ischemia (CLTI) treated by primary infrapopliteal angioplasty for neuro-ischemic Rutherford 5, foot wounds. MATERIALS AND METHODS: Over a 10-year period (2009-2019), a series of 304 diabetic ischemic limbs adding or not evincible neuropathic affectation were treated by primary infrapopliteal angioplasty and their files were retrospectively reviewed. Mean length of treated arterial lesions was 6.1 cm (range 1-22 cm). Inferior limb vibration perception threshold diagnostic was performed for comparing and scoring detectable DPN in all studied diabetic patients (classed from 0 to 10 points). There were 19% limbs with normal (0-1 points) perception (group 1), 55% others with "mild" and "moderate" (2-6 points) neuropathic impairment (group 2), and 26% limbs showing "severe" (7-10 points) DPN (group 3). RESULTS: Primary infrapopliteal angioplasty succeeded in 89% cases in group 1, in 82% in group 2, and in 68% of limbs in group 3. This latest group assembled the heaviest neuropathic affectation and arterial calcifications and proved the lowest clinical benefit at 36 months: 35% (95% confidence interval [CI]=22% to 48%) of primary patency, 36% (95% CI=22% to 50%) wound healing, and 54% (95% CI=39% to 69%) limb preservation rates. A comparison between groups 1 vs 3 and 2 vs 3 of primary patency (p=0.014 and p=0.043), tissue healing (p=0.049 and p=0.01), and limb salvage (p=0.006 and p=0.023) proved significant, yet without statistical weight for group 1 vs 2 (p>0.05). Overall survival was not significantly affected between groups (p=0.34). CONCLUSION: The presence of severe DPN may jeopardize the results of infrapopliteal angioplasty in terms of patency, tissue cicatrization, and limb preservation, yet without significance on survival of these patients. When present, DPN requires appropriate stratification as specific indicator in CLTI treatment.

Grades of Below-the-Ankle Arterial Occlusive Disease following the Angiosome Perfusion: A New Morphological Assessment and Correlations with the Inframalleolar GVG Stratification in CLTI Patients.

PURPOSE: To assess a specific classification of the foot atherosclerotic disease concerning the angiosomal source arteries, the connected foot arches and attached collaterals for Rutherford 5, CLTI patients. To compare eventual analogies of this novel grading system with previously reported GLASS/GVG inframalleolar patterns of occlusive disease (P0-P2). MATERIALS AND METHODS: A series of 336 ischemic feet (221 diabetics) were selected and retrospectively analyzed. For each angiographic pattern of inframalleolar atherosclerotic disease, 4 severity classes of targeted angiosomal artery path (TAAP), associating 4 other classes concerning linked foot arches (LFA) and collaterals occlusive disease were described. By associating the 4 TAAP with the 4 others parallel LFA and collaterals classes, 4 novel anatomical "Grades" (A-D) of occlusive disease were described. Limb salvage was studied between groups of diabetic and non-diabetic patients. RESULTS: Using a primary endovascular approach, limb preservation comparison of grade A/B proved without significance for diabetics (P = 0.032) and non-diabetics (P = 0.226). Comparison in diabetics and/or non-diabetics between A/C (P = 0.045 and 0.046), A/D (P = 0.027 and 0.030,B/C (P = 0.009 and 0.038), and B/D (P = 0.006 and P = 0.042), as well as C/D groups (P = 0.048 and P = 0.034) proved ponderous. Parallel analysis of similar grades (A/A, B/B, etc.) with, or without diabetes appeared without significance (P > 0.05). Further comparison between grades A+B (assigned as P0/GVG), versus C (P1), and D (P2), proved significant (P < 0.0001). CONCLUSION: The present grading system proposes a useful correlation between the severity of foot angiosomal arteries, arches, and collaterals disease and limb salvage, confirming the clinical significance of P0-P2 GVG severity score. This analysis also points the limits of EVT to be probably avoided in grade D patients.

Healing of Diabetic Neuroischemic Foot Wounds With vs Without Wound-Targeted Revascularization: Preliminary Observations From an 8-Year Prospective Dual-Center Registry.

Purpose: To assess the clinical efficacy of endovascular angiosome-oriented wound-targeted revascularization (WTR) vs indirect (wound-indifferent) revascularization (IR) in diabetic patients with neuroischemic foot ulcers. Materials and Methods: Between April 2009 and July 2017, 167 diabetic patients (mean age 72.8 years; 137 men) with chronic limb-threatening ischemia (Rutherford category 5) and foot wounds (Wagner 2-4) in 194 limbs were prospectively registered and scheduled for primary infragenicular endovascular treatment. Specific angiosome source artery reperfusion sustained by patent foot arches or arterial-arterial connections was attempted initially. If this approach failed, topographic revascularization via available collaterals (WTRc) and IR were sequentially attempted. Results: Reperfusion was successful in 176 (91%) of 194 limbs (113 with WTR, 28 with WTRc, and 35 with IR); the global angiosome-oriented technical success (WTR and WTRc) was 73% (141/194). The mean follow-up was 10.9±0.7 months (range 3-12.5). Over 1 year, 102 (58%) of the 176 successfully treated limbs experienced wound healing [79/113 (70%) in the WTR group, 15/28 (54%) in the WTRc group, and 7/35 (20%) in the IR group; p=0.011]. The mean time to healing was 6.8±0.4 months in the WTR group, 7.9±0.6 months in the WTRc group, and 9.8±0.7 months in the IR group (p=0.001). Relapses were noted in 18 (16%) WTR limbs, 5 (18%) WTRc limbs, and 6 (17%) IR limbs. Comparison between WTR and IR and WTRc vs IR showed improved cicatrization in the angiosome-oriented groups (p<0.05). Major adverse limb events (MALE) and limb salvage were different between WTR and WTRc and between WTR and IR groups (p<0.05), while WTRc vs IR was not. Amputation-free survival was not influenced by the revascularization strategy (p=0.093). Conclusion: Wound healing in diabetic patients with chronic limb-threatening ischemia appeared to be improved by intentional wound-targeted revascularization, but no uniform benefit concerning MALE or limb preservation was observed. IR still represents an alternative for limb salvage in cases in which angiosome-guided revascularization fails.

A reliable approach to diabetic neuroischemic foot wounds: below-the-knee angiosome-oriented angioplasty.

PURPOSE: To evaluate the clinical benefit in wound healing and limb preservation after primary below-the-knee angioplasty guided by an angiosome model of perfusion in diabetic patients with neuroischemic foot ulcers. METHODS: From September 2001 to April 2010, 232 limb-threatening neuroischemic wounds in 208 diabetic patients (147 men; mean age 74.3 years, range 42-97) were treated by below-the-knee endoluminal and/or subintimal angioplasty. There were 19 (8%) TASC II type B, 80 (34%) type C, and 133 (57%) type D infrapopliteal lesions. Patients treated prior to 2005 when the angiosome-targeted revascularization protocol was introduced (89 limbs, group 1) were compared to 134 limbs treated subsequently according to the angiosome model (group 2). The angiosome-oriented group 2 included 25% procedures focusing on the anterior tibial and dorsalis pedis arteries, 68% on the posterior tibial and plantar vessels, and 7% on the peroneal arteries. RESULTS: The global technical success was 80% (187/232): 82% in group 1 and 79% in group 2. The cumulative patient survival rates were 90%, 78%, and 65% in group 1 and 93%, 82%, and 71% in group 2 at 12, 24, and 36 months, respectively (p = 0.545). At the same time points, the freedom from amputation rates were 84%, 79%, and 79% in group 1 versus 90%, 89%, and 89% in group 2 (p = 0.035). Clinical success rates were 76%, 68%, 68% in the group 1 and 85%, 79%, and 79% in group 2 (p = 0.025). Primary and secondary patency rates did not differ between groups (p = 0.813 and p = 0.511). Patients in group 2 treated with angiosome-targeted revascularization had significantly better wound healing (p<0.018) and limb preservation (p<0.030). CONCLUSION: Below-the-knee first-line angioplasty guided by an angiosome model may prove beneficial in terms of better wound healing of diabetic foot ulcers and subsequent limb salvage. Further technical improvements and large comparative studies are necessary to support these observations.

Selective primary angioplasty following an angiosome model of reperfusion in the treatment of Wagner 1-4 diabetic foot lesions: practice in a multidisciplinary diabetic limb service.

PURPOSE: To evaluate the technical and clinical outcomes of primary subintimal (SA) and endoluminal angioplasty (EA) guided by an angiosome model of revascularization in diabetic patients with critical limb ischemia (CLI) and Wagner grade 1-4 foot ulcers. METHODS: A retrospective review was undertaken of 98 diabetic CLI patients (68 men; mean age 72.8 years, range 46-94) who presented to our institution from January 2005 to January 2008 for treatment of Wagner grade 1-4 foot ulcers involving 124 limbs. Following the angiosome model of perfusion in the foot and ankle, the target arterial lesions in the 124 limbs were treated with 80 (64%) associated SA and EA procedures, 21 (17%) multilevel EAs, and 23 (18%) single SA techniques. RESULTS: Initial technical success was achieved in 102 (82%) interventions: 82/103 SAs and 20/21 of the EAs. The 30-day survival rate was 98% (1 fatal myocardial infarction). The cumulative rates of primary and secondary patency, limb salvage, and clinical success were: 57%+/-4%, 71%+/-4%, 91%+/-3%, and 85%+/-3% at 12 months and 48%+/-5%, 61%+/-4%, 84%+/-6%, and 73%+/-6% at 32 months, respectively. Limb salvage appeared to be negatively affected at 3 years by the presence of Wagner grade 3-4 lesions (p<0.0002), the bedridden condition of patients (p<0.0001), end-stage renal disease (p<0.0001), left ventricular dysfunction (p<0.0001), and peripheral neuropathy (p = 0.023). Using the angiosome approach, complete healing of ulcers with or without minor amputation was seen in 79% (98/124 limbs), while 62 of 70 Wagner grade 1-2 and 36 of 54 Wagner 3-4 foot lesions healed in the first 1 to 3 months after revascularization. CONCLUSION: Targeted primary angioplasty following the angiosome model could be an effective therapeutic method in the ulcer healing process. However, beyond appropriate revascularization, aggressive control of concurrent risk factors in diabetic wound healing probably plays an equally relevant role.