GLASS (Global Limb Anatomic Staging System): a critical appraisal.

BACKGROUND: THE Global Vascular Guidelines (GVGs) propose a new Global Anatomic Staging System (GLASS) resulting in three stages of complexity for intervention. The aim of this study was to retrospectively classify a large cohort of CLTI patients according to the GLASS, evaluating its distribution in a real-world setting. METHODS: Retrospective, single center, observational study enrolling all consecutive CLTI patients submitted to infra-inguinal endovascular revascularization in our institution, between June 2014 and September 2019. Patients were categorized according to the GLASS for femoro-popliteal (FP), infra-popliteal (IP) and infra-malleolar grading. FP and IP grades were merged to get the final GLASS stage for each limb. RESULTS: The study included 1995 CLTI patients who underwent 2850 endovascular procedures in which 6009 arterial lesions were successfully treated. The FP segment was classified as: 1292 (45.3%) grade 0, 475 (16.6%) grade 1, 159 (5.6%) grade 2, 209 (7.4%) grade 3, and 715 (25.1%) grade 4. The IP segment was classified as: 1529 (53.6%) grade 0, 183 (6.4%) grade 1, 80 (2.8%) grade 2, 207 (7.3%) grade 3, and 851 (29.9%) grade 4. The combination of FP and IP grading led to GLASS stages: 922 (32.3%) stage 1, 375 (13.2%) stage 2, 1472 (51.6%) stage 3. CONCLUSIONS: The distribution of the FP, IP and final GLASS grading was mainly grouped at the two extremes, letting the intermediate grades rather scarce. The majority of patients present with an absent or severely diseased pedal arch, stressing the need to incorporate infra-malleolar disease into the GLASS.

Foot Angiosomes: Instructions for Use.

In the last 15 years an abundance of literature has demonstrated that angiosome-targeted revascularization, either endovascular or open, can lead to better clinical results in patients with chronic limb-threatening ischemia. According to this literature, the angiosome concept should guide our treatment strategy in every chronic limb-threatening ischemia patient. However, in our daily practice, its application is often difficult or impossible. Most foot wounds spread over multiple angiosomes and, moreover, the value of an angiosome-guided revascularization approach can vary according to vascular anatomy, collateral vessel network, type of revascularization, and wound. The aim of this article is to explore values and limits of the angiosome concept, and to propose some "instructions for use" regarding its application in our daily practice.

Hybrid Foot Vein Arterialization in No-Option Patients With Critical Limb Ischemia: A Preliminary Report.

PURPOSE: To describe a preliminary experience in treating no-option critical limb ischemia (CLI) patients with a hybrid foot vein arterialization (HFVA) technique combining open plus endovascular approaches. MATERIALS AND METHODS: Between May 2016 and January 2018, 35 consecutive patients (mean age 68±12 years; 28 men) with 36 no-option CLI limbs underwent HFVA in our center. All limbs had grade 3 WIfI (Wound, Ischemia, and foot Infection) ischemia, and the wound classification was grade 1 in 4 (11%) limbs, grade 2 in 4 (11%), and grade 3 in 28 (78%). Surgical bypass was done on the medial marginal vein or a posterior tibial vein, followed by endovascular removal of foot vein valves and embolization of foot vein collaterals. A "tension-free" surgical approach was used to treat foot lesions. RESULTS: At a mean follow-up of 10.8±2 months, limb salvage was achieved in 25 (69%) limbs and wound healing in 16 (44%); 9 patients presented an unhealed wound. Eleven (31%) patients underwent a major amputation (2 below the knee and 9 thigh). One patient with an unhealed wound and open bypass died of myocardial infarction. CONCLUSION: HFVA is a promising technique able to achieve acceptable rates of limb salvage and wound healing in no-option patients generally considered candidates for an impending major amputation. Further studies are needed to standardize the technique and better identify patients who can benefit from this approach.

Comparison of SFA lesion treatment with Zilver PTX in diabetics vs. non-diabetics: 2-year clinical and functional results.

BACKGROUND: Prospective single-arm study, aimed at evaluating safety and effectiveness at 12 and 24 months of the paclitaxel-eluting nitinol stent (Zilver PTX), and focused in particular on the treatment of complex lesions and/or diabetic patients. METHODS: Between May 2010 and March 2012, 67 patients (78% males) were treated by Zilver PTX, because of stenosis or occlusions of the superficial femoral artery in one of two centers. The mean age of patients was 70.1±8 years. Thirty-two of 67 (48%) were diabetics, 14 (21%) active smokers and 11 (14.6%) had chronic renal failure (end stage renal disease). The average length of lesions was 104±60 mm. Occlusion was complete in 46.3% of cases, whereas severely calcified lesions were present in 30% of patients (18.8% in diabetics and 31.4% in non-diabetics). Twenty-six patients (39%) had type C or D lesions according to TASC 2. RESULTS: One hundred-two stents were used (1.7±0.9 per patients); median 1 (range 1-4). All patients had successful stent placement. Primary patency, evaluated by Kaplan-Meier method was 88±0.06% at 12 months, and 68±0.1% at 24 months. In particular, the difference between diabetics (D) and non-diabetics (non-D) was not significant (P=0.07, Log-Rank). Patients turned from 4.2±1.3 to 1.6±1.3 Rutherford class. There were 5 deaths due to systemic comorbidities. There also were 3 major amputations, all of them also in the D group. Among the other patients, differences between D and non-D patients were not significant in terms of wound healing, bipedal stay and spontaneous ambulation. The mean follow-up length was 28±5 months (range 24-36 months). There was only one patient who had fracture and stent migration (1.5%). In 13 diabetic patients, tibial PTA was also associated. Additional treatment was required in 6 D and 1 non-D. CONCLUSIONS: The use of Zilver PTX is safe and effective in the treatment of SFA lesions. In particular, both stent patency and functional results on the basis of both clinical and instrumental tools were similar in D and non-D, suggesting a particularly favorable activity of PTX in a subpopulation of diabetics. Further studies are required to confirm these results, which seem to be particularly promising in diabetic patients.

Prospective study on microangiopathy in type 2 diabetic foot ulcer.

AIMS/HYPOTHESIS: We investigated the significance of microangiopathy in the development of foot ulcer, which is still disputed. METHODS: We assessed microangiopathy by histological analysis of the capillary ultrastructure using transmission electron microscopy and capillary density and arteriolar morphology in paraffin-embedded sections from the skin of type 2 diabetic patients: 30 neuroischaemic patients (Isc) revascularised with peripheral angioplasty and 30 neuropathic patients (Neu) with foot ulcer, compared with ten non-diabetic volunteers. RESULTS: In the diabetic patients, capillaries in the dermal papillary layer were fewer (-22.2%, 159 ± 43 vs 205 ± 52 mm(2) in non-diabetic volunteers, p < 0.01). They also showed detrimental remodelling, with a 2.2-fold increase in capillary basement membrane thickness (3.44 ± 1.19 vs 1.53 ± 0.34 µm in non-diabetic volunteers, p < 0.001) and a 57.7% decrease in lumen area (14.6 ± 11.1 vs 34.7 ± 27.5 µm(2), p < 0.001). No differences were observed between the diabetic Isc or Neu patients. Isc were more prone to develop arteriolar occlusion than Neu (16.8 ± 6.9% vs 6.7 ± 3.7%, respectively, p < 0.001). No patient had been amputated at 30 days and healing time was significantly longer in Isc (180 ± 120 vs 64 ± 50 days in Neu, p < 0.001). CONCLUSIONS/INTERPRETATION: Capillary microangiopathy is present in equal measure in neuroischaemic and neuropathic diabetic foot skin. The predominance of arteriolar occlusions with neuroischaemia indicated the existence of an additional 'small vessel disease' that did not affect an effective revascularisation and did not worsen the prognosis of major amputations but slowed the healing process of the neuroischaemic foot ulcer. TRIAL REGISTRATION: ClinicalTrials.gov NCT02610036.

Outcomes of Chopart Amputation in a Tertiary Referral Diabetic Foot Clinic: Data From a Consecutive Series of 83 Hospitalized Patients.

The purpose of the present retrospective study was to evaluate the outcomes (ie, ulcer recurrence, major amputation, death) in diabetic patients undergoing Chopart amputation because of deep infection or gangrene extending to the midfoot. From 2009 to 2011, 83 patients, aged 71.4 ± 9.3 years, underwent a midtarsal amputation and were followed up until December 31, 2012 (mean follow-up 2.8 ± 0.8 years). Of the 83 patients, 26 were female, 61 required insulin, 47 had renal insufficiency, 19 underwent hemodialysis, 65 had hypertension, 34 had a history of cardiac disease, and 4 had a history of stroke. Chopart amputation was performed in 38 patients (45.8%) with gangrene, 31 (37.4%) with abscess, and 14 (16.9%) with osteomyelitis. Urgent surgery was performed in 56 patients (67.5%). Effective revascularization was performed in 64 patients (77.1%) patients. Of the 83 patients, 47 had healed at a mean period of 164.7 (range 11 to 698) days. Ulcer recurrence developed in 15 patients (31.9%). A major amputation was necessary in 23 patients (27.7%), with an annual incidence of 13.0%. None of the included variables on logistic regression analysis was significantly associated with proximal amputation. Of the 83 patients, 38 (45.8%) died, with an annual incidence of 25.8%. On logistic regression analysis, age (odds ratio [OR] 1.11, 95% confidence interval [CI] 1.01 to 1.16), history of stroke (OR 9.94, 95% CI 3.16 to 31.24), and urgent surgery (OR 2.60, 95% CI 1.14 to 5.93) were associated with mortality. Chopart amputation represents the last chance to avoid major amputation for diabetic patients with serious foot complications. Our success rate was great enough to consider Chopart amputation a viable option for limb salvage in this high-risk population.

Severity of demographic and clinical characteristics, revascularization feasibility, major amputation, and mortality rate in diabetic patients admitted to a tertiary diabetic foot center for critical limb ischemia: comparison of 2 cohorts recruited at a 10-year distance.

BACKGROUND: To compare demographic and clinical characteristics, revascularization, major amputation, and mortality among patients admitted to a diabetic foot center because of critical limb ischemia (CLI) during 1999-2003 (cohort 1) and 2009 (cohort 2). METHODS: During 1999-2003, 564 diabetic patients with CLI (cohort 1) were admitted to our center, and 344 patients (360 affected limbs) were admitted during 2009 (cohort 2). Data on demographic and clinical characteristics, revascularization by peripheral angioplasty (PTA) or bypass graft (BPG), major amputation, and mortality were recorded. RESULTS: Patients belonging to cohort 2 were older than patients of cohort 1 (P = 0.001). In cohort 2, there were more subjects requiring insulin (P = 0.008) and duration of diabetes was longer (P = 0.001); moreover, there were more patients requiring dialysis (P = 0.001), patients with history of stroke (P = 0.004), or foot ulcer (P = 0.001). No significant difference between the 2 groups was found concerning gender, metabolic control, hypertension, lipid values, neuropathy, and retinopathy. Occlusion was more frequent than stenosis in the posterior tibial (P < 0.001) and peroneal (P = 0.016) arteries. However, the revascularization rate did not differ (P = 0.318) between the 2 groups. Restenosis after PTA was not significantly different (P = 0.627), whereas BPG failure was significantly more frequent (P = 0.010) in cohort 2 (2009). Major amputation (P = 0.222) and mortality rate (P = 0.727) did not differ between the 2 groups. CONCLUSIONS: The severity of either foot lesions or patients comorbidities should be concomitantly assessed and taken into proper consideration when evaluating changes in the amputation rate among different studies or in different temporal settings.

Diagnóstico, clasificación y tratamiento de las infecciones en el pie diabético / Diagnosis, classification, and treatment of infections in the diabetic foot

Objetivo: Revisar la literatura para establecer lineamientos y recomendaciones para disminuir la amputación y muerte relacionadas con las infecciones del pie diabético. Sede: Centro de Prevención y Salvamento de Pie Diabético San Elian, Veracruz, Veracruz. Diseño: Revisión de la literatura. Material y Métodos: Se realizó una búsqueda en la literatura para la respuesta adecuada de los siguientes ejes de investigación: clasificación de la infección (cómo se determina la gravedad de la infección); importancia de clasificar (cómo se define una infección grave, qué puntaje tiene la osteomielitis en la gravedad de la infección), y tratamiento (momento óptimo, tratamiento no quirúrgico, uso de antibióticos, cultivos, manejo de osteomielitis y tiempo de tratamiento). Resultados: Las clasificaciones de PEDIS (Perfusión, extensión, profundidad, infección y sensibilidad), IDSA (Infectious Disease Society of America) y San Elian clasifican la gravedad de la infección en leve, moderada y grave. La desbridación quirúrgica de tejido infectado debe realizarse sin diferimiento en forma inicial y subsecuente tantas veces como sea necesario con ''destechamiento'' de trayectos fistulosos. En las infecciones de moderadas a graves se recomienda tratamiento empírico de amplia cobertura (Gram positivos, Gram negativos y anaerobios). El cultivo de la herida antes de iniciar o continuar el tratamiento empírico se hace en infecciones moderadas o graves y se ajusta con el resultado del cultivo si no mejora o empeora la infección. El Staphylococcus aureus se aísla en un 40 y 50 %, con resistencia a la meticilina en un 30 a 40 %. Los antibióticos de elección son la vancomicina, la tigeciclina o el linezolid. La osteomielitis es una infección moderada profunda, caracterizada por descarga purulenta, exposición del hueso, ''dedo en salchicha'', o prueba del estilete positivo. El diagnóstico definitivo se hace con biopsia o resonancia magnética nuclear. La hospitalización está indicada en casos graves en pacientes hemodinámicamente y metabólicamente inestables. Conclusiones: Las infecciones de pie diabético pueden ser de leves a graves y pueden culminar en amputación parcial del pie, de la extremidad o hasta causar la defunción del paciente. Se requiere de una atención sistemática e integral con base en la clasificación y puntaje de San Elian.

Objective: To review the literature to establish guidelines and recommendations to diminish amputation and deaths related to diabetic foot infections. Setting: Centro de Prevención y Salvamento de Pie Diabético San Elian, Veracruz, Veracruz, Mexico. Design: Review of the literature. Material and Methods: We performed a search in the literature to find an adequate answer to the following research questions: classification of the infection (how to determine the severity of the infection), relevance of classifying (how is a severe infection defined, what score can be given to osteomyelitis in the severity of the infection) and treatment (optimal time, non-surgical treatment, antibiotics use, handling of osteomyelitis, and time of treatment). Results: PEDIS (perfusion, extension, depth, infection, and sensitivity), IDSA (Infectious Disease Society of America) and San Elian classify the infection as mild, moderate and severe. Surgical debridement of the infected tissue must be performed without delay initially and subsequently as many times as required with ''unroofing'' of fistulous tracts. In moderate to severe infections an ample coverage (Gram positive and Gram negative and anaerobic bacteria) treatment is recommended. Culturing of the injury before or during empirical treatment is performed for moderate to severe infections and should be adjusted to the result of the culture if the infections does not improve or gets worse. Staphylococcus aureus is isolated 40 to 50%, with resistance to methicillin in 30 to 40%. Choice antibiotics are vancomycin, tigecycline and linezolid. Osteomyelitys is a deep moderate infection, characterized by purulent discharge, bone exposure, ''sausage toe'' or positive probe-to bone test. Definite diagnosis is reached with biopsy or magnetic nuclear resonance. Hospitalization is indicated in severe cases of hemodynamically and metabolically unstable patients. Conclusions: Diabetic foot infections can go from mild to severe and end in partial amputation of the feet, the extremity, or even cause death of the patient. Systematic and integral care based on the San Elian classification and score is required.

Feasibility and effectiveness of internal pedal amputation of phalanx or metatarsal head in diabetic patients with forefoot osteomyelitis.

From January 2007 to December 2009, 207 diabetic patients were consecutively admitted to our foot center because of osteomyelitis of a phalanx or metatarsal head. The removal of infected bone was performed by internal bone resection in 110 patients (group A) and amputation in 97 patients (46.9%; group B). Dehiscence occurred in 15 patients (13.6%) patients in group A and 10 patients (10.3%) in group B (p = 0.464). A total of 206 patients (99.5%) were followed up from January 1, 2007 to December 31, 2011. Ulcer relapse occurred in 12 patients (12.4%) in group A and 18 patients (16.4%) in group B (p = .437). A contralateral ulcer occurred in 10 group A patients (10.3%) and 14 group B patients (12.7%; p = .667). The results of the present study have demonstrated that bone resection with preservation of the soft tissue envelope is feasible in approximately one half of diabetic patients with forefoot osteomyelitis and does not result in any risk of major dehiscence or ulcer recurrence compared with ray or toe amputation.

Limb revascularization feasibility in diabetic patients with critical limb ischemia: results from a cohort of 344 consecutive unselected diabetic patients evaluated in 2009.

AIMS: To evaluate the feasibility of peripheral revascularization by angioplasty (PTA) or bypass grafting (BPG) in diabetic patients with critical limb ischemia (CLI). METHODS: All diabetic patients referred to our Diabetic Foot Centre for foot lesion or rest pain were assessed for the presence of CLI as assessed by the TASC criteria. All patients underwent angiography that was evaluated jointly by an interventional radiologist, a vascular surgeon and a diabetologist of the diabetic foot care team. RESULTS: During 2009, 344 diabetics were admitted because of CLI in a total of 360 limbs. PTA was performed in 308 (85.6%) limbs, and BPG was performed in 40 (11.1%) limbs in which PTA was not feasible. Revascularization could not be carried out in 12 (3.3%) limbs due to the lack of target vessel (9 limbs) or high surgical risk (3 limbs). According to the judgement of the vascular surgeon, BPG was anatomically feasible in 180 (58.4%) of the 308 limbs that underwent PTA. Therefore, considering also the 40 limbs that underwent BPG, surgical revascularization was judged anatomically possible in a total of 220 (61.1%) limbs. At 30 days, 19 (5.3%) above-the-ankle amputations were performed: 8 (66.7%) amputations were performed in the 12 non-revascularized limbs, 8 (2.6%) amputations were performed in the 308 limbs treated with PTA and 3 (7.5%) amputations were performed in the 40 limbs treated with BPG. CONCLUSIONS: Revascularization by PTA is highly feasible in diabetics with CLI. The feasibility of revascularization by BPG is lower but nonetheless consistent. In centres where both revascularization procedures are available, it is possible to revascularize more than 96% of diabetics with CLI.

Prognostic difference between soft tissue abscess and osteomyelitis of the foot in patients with diabetes: data from a consecutive series of 452 hospitalized patients.

From January 2008 to December 2010, 452 patients with diabetes were admitted to our diabetic foot unit because of deep soft tissue abscess (group A: n = 210) or chronic osteomyelitis (group B: n = 242). Patients from group A underwent emergency debridement in the operating room. Patients from group B underwent elective surgery. Twenty-six (5.8%) major amputations were performed: of these, 18 (8.57%) were performed in patients from group A and 8 (3.31%) were performed in patients from group B (p = .024). Multivariate analysis showed the independent role on amputation outcome of the abscess (odds ratio, 2.64; p = .029; confidence interval [CI] 1.11 to 6.28), dialysis treatment (odds ratio, 3.17; p = .039, CI 1.06-9.51), and C-reactive protein > 0.5 mg/dL (odds ratio, 3.75; p = .022, CI 1.21-11.64). In group A, 43 (22.6%) patients healed only with drainage, and 147 (70.0%) minor amputations were performed: 53 (36.1%) at the level of the forefoot and 94 (63.9%) at the level of the midfoot. In group B, 234 (96.7%) minor amputations were performed, 208 (88.9%) at the forefoot and 26 (11.1%) at the midfoot level (p < .001). Fourteen postoperative complications occurred in patients from group A and 2 in patients from group B (p < .001). In group A, 3 patients died during hospitalization, 1 from septic shock and 2 from sudden death. None of the group B patients died. This study demonstrates that the severity of a foot soft tissue abscess is not comparable with that of a chronic osteomyelitis not only because of a higher rate of major amputation, but also because of a much more proximal level of minor amputation.

A novel device for true lumen re-entry after subintimal recanalization of superficial femoral arteries: first-in-man experience and technical description.

Subintimal angioplasty (SAP) is frequently performed for the treatment of critical limb ischemia (CLI) and has been recognized as an effective technique for these patients. Nevertheless, this approach is limited by the lack of controlled re-entry into the true lumen of the target vessel. We describe a novel device for true lumen re-entry after subintimal recanalization of superficial femoral arteries (SFA). We report our experience with six patients treated between April 2009 and January 2010 with a novel system designed to facilitate true lumen re-entry. The device was advanced by ipsilateral antegrade approach through a 6-French sheath. Successful reaccess into the true lumen was obtained in five of six patients without complications. The patient in whom the reaccess to the true lumen was not possible underwent successful bypass surgery. At 30 days follow-up, the SFA was patent in all patients according to echo-Doppler examination. Our preliminary experience indicates that this novel re-entry device increases the success rate of percutaneous revascularization of chronically occluded SFA.

Evaluation of feasibility of ankle pressure and foot oximetry values for the detection of critical limb ischemia in diabetic patients.

A total of 261 diabetic patients were admitted because of rest pain and/or foot ulcer in 1 limb. Ankle pressure (AP) and transcutaneous oxygen tension (TcPO(2)) were measured, and digital subtraction arteriography was performed. Transcutaneous oxygen tension was <30 mm Hg in 213 patients and >or=30<50 mm Hg in 48 patients. Ankle pressure could not be measured in 109 patients. In 50 patients, AP was <70 mm Hg and in 102 patients, it was >or=70 mm Hg. Arteriography showed evidence of stenoses >50% of vessel lumen diameter in all patients. Major amputation was performed in 16 patients; AP was <70 mm Hg in 4 patients and >or=70 mm Hg in 6. It was not practicable in the remaining 6 patients. Transcutaneous oxygen tension was <30 mm Hg in 15 patients and >or=30 mm Hg in 1 patient. For diagnosis of critical limb ischemia (CLI) in diabetic patients presenting with rest pain or foot ulcer, measurement of TcPO( 2) is essential not only when AP is not measurable but also when this value is >or=70 mm Hg.

Mortality after major amputation in diabetic patients with critical limb ischemia who did and did not undergo previous peripheral revascularization Data of a cohort study of 564 consecutive diabetic patients.

BACKGROUND: To evaluate the survival after major lower limb amputation, at a level either below (BKA) or above (AKA) the knee, in diabetic patients admitted to hospital because of critical limb ischemia (CLI). METHODS: From January 1999 to December 2003, 564 diabetic patients were consecutively admitted to our Foot Center because of CLI and followed up until December 2005. A revascularization procedure was performed in 537 patients (95.2%): in 420 with peripheral angioplasty, in 117 with peripheral bypass graft. Neither endoluminal nor surgical revascularization was practicable in 27 (4.8%) patients. RESULTS: Major amputation was performed in a total of 55 (9.8%) patients. Among the clinical and demographic variables evaluated, age was significantly lower (67.3+/-10.1 vs. 76.7+/-10.4, P<.001), duration of diabetes was higher (17.1+/-11.1 vs. 13.4+/-10.0, P=.013), and current smoking was more frequent (38.5% vs. 25.0%, P<.001) in revascularized amputees. The amputation free median time for revascularized patients was 5.11 months, and for nonrevascularized patients, 0.33 months. The log-rank test for equality of survivor function without amputation between amputees with or without revascularization was 31.76 (P<.001). Among the 55 amputees, 11 (28.2%) out of the 39 revascularized patients and 13 (81.2%) out of the 16 nonrevascularized patients died. The log-rank test for equality of survivor function was 6.83 (P=.009). The Cox model performed to evaluate the association between the recorded variables and the mortality showed a significant hazard ratio only with age (hazard ratio for 1 year 1.11, P=.003, confidence interval 1.04-1.19). CONCLUSIONS: Our data suggest that the revascularization allows to postpone the major amputation, and that the survival of revascularized amputees is better than that of nonrevascularized amputated patients. All these data offer further encouragement to revascularize all diabetic patients with CLI.

The efficacy and safety of closure of brachial access using the AngioSeal closure device: experience with 161 interventions in diabetic patients with critical limb ischemia.

PURPOSE: This study retrospectively evaluated the efficacy and safety of the 6F Angio-Seal (St. Jude Medical, St. Paul, Minn) as a closure device for transbrachial artery access for endovascular procedures in diabetic patients with critical limb ischemia. METHODS: From January 2005 and September 2007, 1887 diabetic patients underwent interventional procedures in the lower limbs at a two diabetic foot centers. Patients presented with rest pain (16%), ulcers (80%), or gangrene (4%). Systemic anticoagulation with sodium heparin (70 IU/kg) was obtained for all patients at the beginning of the endovascular treatment. A total of 249 brachial arteries (238 patients) were evaluated for possible Angio-Seal use after endovascular recanalization of the leg. Color Doppler ultrasound imaging of the artery was obtained before revascularization only in patients with previous Angio-Seal placement in the brachial artery. No further imaging studies were done in the remaining brachial arteries where the Angio-Seal was deployed at the operator's discretion. Impairment or disappearance of the radial pulse or onsets of hand ischemia or hand pain, or impairment of hand function during or at the end of the endovascular revascularization were all regarded as contraindications to Angio-Seal usage. Evidence of a highly calcified plaque of the brachial artery access site at the time of vessel puncture was regarded as an absolute contraindication to the Angio-Seal use. Patients were seen before discharge, at 1, 3, and 8 weeks after the procedure, and at 3-month intervals thereafter. Complications included hemorrhage, pseudoaneurysm, infection, and vessel occlusion. RESULTS: A total of 1947 Angio-Seal collagen plugs were deployed in 1709 diabetic patients (90.5%). The Angio-Seal was used for brachial artery closure in 159 patients (8.4%) in 161 procedures (159 in the left, 2 in the right brachial artery). In 79 patients (4.2%) in 88 procedures (87 in the left and 1 in the right brachial artery), the device was deemed contraindicated due to small vessel size in 73 patients (92.4%) or presence of calcium at the access site in five patients (6.3%). One patient (1.3%) refused the collagen plug closure after revascularization. The non-Angio-Seal group was evaluated for comparison. The success rate for achieving hemostasis in the Angio-Seal group was 96.9%. Five major complications (3.1%) at 30 days consisted of two puncture site hematomas >4 cm, two brachial artery occlusions, and one brachial artery pseudoaneurysm, with three patients requiring open surgery. Minor complications (7.50%) were three puncture site hematomas < 4 cm, three oozing of blood from the access site, and six patients had mild pain in the cubital fossa. No further complications were recorded in the 14-month follow-up (range 1-25 months) of a total of 140 patients. CONCLUSIONS: This retrospective study shows that the 6F Angio-Seal is a valuable and safe vascular closure device for transbrachial access in diabetic patients undergoing interventional procedures for critical limb ischemia.

The role of early surgical debridement and revascularization in patients with diabetes and deep foot space abscess: retrospective review of 106 patients with diabetes.

One hundred-six patients underwent emergency debridement of a deep foot space abscess. While 43 patients were admitted after an outpatient visit with immediate surgical debridement (group A), 63 patients were transferred from other hospitals after a mean stay of 6.2+/-7.5 days without debridement (group B). No significant differences were observed in the demographic and clinical features between the 2 groups, except for the following differences in group B: higher blood glucose level on admission (P=.015), lower serum albumin level (P=.005), and a more frequent extension of the infection to the heel (P=.005). Eradication of the infection was obtained in group A without amputation in 9 patients, with an amputation of 1 or more rays in 21, with metatarsal amputations in 12, and with a Chopart amputation in 1. In group B, incision and drainage alone were performed in 4 patients, amputation of 1 or more rays in 21, metatarsal amputations in 10, Chopart amputations in 23, and an above-the-ankle amputation in 5. The amputation level was significantly more proximal in group B (chi2=24.4, P<.001). There was no significant difference in the presence of peripheral arterial occlusive disease between the 2 groups (P=.841). Regression logistic analysis showed a significant relationship between the amputation level and the number of days elapsed before debridement (odds ratio, 1.61; P=.015; confidence interval, 1.10-2.36), but not with the presence of peripheral occlusive disease (odds ratio, 1.73; P=.376; confidence interval, 0.29-15.3). These data show that a delay in the surgical debridement of a deep space abscess increases the amputation level. Accuracy in the diagnosis of peripheral occlusive disease and immediate revascularization yield similar outcomes in patients with or without peripheral occlusive disease.