Giacomo Clerici

Long-Term Prognosis of Diabetic Patients With Critical Limb Ischemia: A population-based cohort study

OBJECTIVE To evaluate the long-term prognosis of critical limb ischemia (CLI) in diabetic patients. RESEARCH DESIGN AND METHODS A total of 564 consecutive diabetic patients were hospitalized for CLI from January 1999 to December 2003; 554 were followed until December 2007. RESULTS The mean follow-up was 5.93 ± 1.28 years. Peripheral angioplasty (PTA) was performed in 420 (74.5%) and bypass graft (BPG) in 117 (20.6%) patients. Neither PTA nor BPG were possible in 27 (4.9%) patients. Major amputations were performed in 74 (13.4%) patients: 34 (8.2%) in PTA, 24 (21.1%) in BPG, and 16 (59.2%) in a group that received no revascularization. Restenosis occurred in 94 patients, bypass failures in 36 patients, and recurrent ulcers in 71 patients. CLI was observed in the contralateral limb of 225 (39.9%) patients; of these, 15 (6.7%) required major amputations (rate in contralateral compared with initial limb, P = 0.007). At total of 276 (49.82%) patients died. The Cox model showed significant hazard ratios (HRs) for mortality with age (1.05 for 1 year [95% CI 1.03–1.07]), unfeasible revascularization (3.06 [1.40–6.70]), dialysis (3.00 [1.63–5.53]), cardiac disease history (1.37 [1.05–1.79]), and impaired ejection fraction (1.08 for 1% point [1.05–1.09]). CONCLUSIONS Diabetic patients with CLI have high risks of amputation and death. In a dedicated diabetic foot center, the major amputation, ulcer recurrence, and major contralateral limb amputation rates were low. Coronary artery disease (CAD) is the leading cause of death, and in patients with CAD history the impaired ejection fraction is the major independent prognostic factor.

Effectiveness of Removable Walker Cast Versus Nonremovable Fiberglass Off-Bearing Cast in the Healing of Diabetic Plantar Foot Ulcer A randomized controlled trial

OBJECTIVE To evaluate the efficacy of a removable cast walker compared with that of a nonremovable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer. RESEARCH DESIGN AND METHODS Forty-five adult diabetic patients with nonischemic, noninfected neuropathic plantar ulcer were randomly assigned for treatment with a nonremovable fiberglass off-bearing cast (total contact cast [TCC] group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment. RESULTS A total of 48 patients were screened; however, 2 patients in the TCC group and 1 patient in the Stabil-D group did not complete the study and were considered dropouts. There were no significant differences in demographic and clinic characteristics of the 45 patients completing the study. Ulcer surface decreased from 1.41 to 0.21 cm2 (P < 0.001) in the TCC group and from 2.18 to 0.45 cm2 (P < 0.001) in the Stabil-D group, with no significant differences between groups (P = 0.722). Seventeen patients (73.9%) in the TCC group and 16 patients (72.7%) in the Stabil-D group achieved healing (P = 0.794). Average healing time was 35.3 ± 3.1 and 39.7 ± 4.2 days in the TCC and Stabil-D group, respectively (P = 0.708). CONCLUSIONS The Stabil-D cast walker, although removable, was equivalent in efficacy to the TCC in terms of ulcer size reduction and total healing rate. The easier use of Stabil-D may help increase the use of off-loading devices in the management of plantar neuropathic diabetic foot ulcers.

Regarding “A comparison of percutaneous transluminal angioplasty versus amputation for critical limb ischemia in patients unsuitable for open surgery”

Background Percutaneous transluminal angioplasty (PTA), although not the traditional therapy, seems to be a safe alternative for patients with critical limb ischemia who are believed to be unsuitable candidates for open surgery. However, the efficacy of PTA in this setting has not been analyzed. The purpose of this study was to compare the outcomes of PTA for limb salvage with outcomes of major limb amputation in physiologically impaired patients believed to be unsuitable for open surgery. Methods From a prospective vascular registry, 314 patients (183 underwent amputation, and 131 underwent complex PTA for limb salvage) were identified as physiologically impaired or unsuitable for open surgery. This was defined as having at least one of the following: functional impairment (homebound ambulatory or transfer only), mental impairment (dementia), or medical impairment (two of the following: end-stage renal disease, coronary artery disease, and chronic obstructive pulmonary disease). Patients undergoing PTA were compared with patients undergoing amputation by examining the outcome parameters of survival, maintenance of ambulation, and maintenance of independent living status. Parameters were assessed by using Kaplan-Meier life-table curves (log-rank test and 95% confidence intervals [CIs]) and hazard ratios (HRs) from the Cox model. Results PTA resulted in a 12-month limb salvage rate of 63%. Thirty-day mortality was 4.4% for the amputation group and 3.8% for the PTA group. After adjustment for age, race, diabetes, prior vascular procedure, dementia, and baseline functional status, PTA patients had significantly lower rates of ambulation failure (HR, 0.44; P = .0002) and loss of independence (HR, 0.53; P = .025) but had significantly higher mortality (HR, 1.62; P = .006) than amputees. However, when life tables were examined, the maintenance of ambulation advantage lasted only 12 months (PTA, 68.6%; 95% CI, 59.6%-77.7%; amputation, 48%; 95% CI, 40.4%-55.5%) and was not statistically significant at 2 years (62.2% [95% CI, 48.8%-71.5%] and 44% [95% CI, 35.8%-52.2%], respectively). Maintenance of independent living status advantage lasted only 3 months, with no statistically significant difference at 2 years (PTA, 60.5%; 95% CI, 45.4%-75.6%; amputation, 52.6%; 95% CI, 40.4%-64.9%). Although mortality was high in both cohorts, patients who underwent amputation had a survival advantage for all time intervals examined (at 2 years: PTA, 29%; 95% CI, 19.9%-38.1%; amputation, 48.1%; 95% CI, 39.2%-56.9%). Conclusions Patients who present with critical limb ischemia and physiologic impairments that preclude open surgery seem to have comorbidities that blunt any functional advantage achieved after PTA for limb salvage. PTA in this setting affords very little benefit compared with amputation alone.

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 operators 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.

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 use of a dermal substitute to preserve maximal foot length in diabetic foot wounds with tendon and bone exposure following urgent surgical debridement for acute infection

In this study, we evaluated the utility of a dermal substitute for preserving maximal foot length after urgent surgical debridement. Patients referred to our Diabetic Foot Center with foot lesions were assessed for sensory–motor neuropathy, infection and critical limb ischaemia. The presence of acute foot infection indicated the need for immediate surgical debridement. The degree of amputation, if necessary, was based on the amount of apparently non infected vital tissue. When vital tendon/bone tissue remained exposed, the lesion was covered with a dermal substitute. From January to December 2008, 393 patients underwent surgical treatment for diabetic foot syndrome; 30 patients underwent immediate surgical debridement resulting in exposed tendon and/or bone tissues. An average of 4·4 ± 2·1 days following surgical debridement, all 30 patients underwent dermal regeneration template grafting to cover‐exposed healthy tendon and bone tissues, instead of achieving primary wound closure with a proximal amputation. After 21 days, a skin graft was performed. Complete wound healing occurred in 26 patients (86·7%). In these patients, the amputation level was significantly more distal (P < 0·003) with respect to that potentially required for immediate wound closure. The average healing time was 74·1 ± 28·9 days. Four patients underwent a more proximal amputation. No patients underwent major amputation. The use of the dermal substitute for treating exposed tendon and bone tissues allowed timely wound healing and preserved maximal foot length. Continued follow‐up will allow assessment of long‐term relapse and complication rates. Such treatment could constitute part of the comprehensive management of diabetic wounds.

Influence of Osteomyelitis Location in the Foot of Diabetic Patients With Transtibial Amputation

Background: To evaluate the prevalence of osteomyelitis in different areas of the foot and the possible correlation between localization and outcome of major amputation. Methods: From January 2008 to December 2010, a total of 350 diabetic patients were admitted to our diabetic foot unit for the surgical treatment of osteomyelitis. Osteomyelitis was diagnosed when both the probe-to-bone maneuver and plain radiography were positive. In all of these patients, osteomyelitis was confirmed by histological examination. Results: Osteomyelitis was localized to the forefoot in 300 (85.7%) patients, to the midfoot in 27 (7.7%) patients, and to the hindfoot in the remaining 23 (6.75) patients. On average, foot lesions had developed 6.6 ± 5.6 months before admission to our unit. Transtibial amputation was performed in 1 (0.33%) patient with forefoot osteomyelitis, in 5 (18.5%) patients with midfoot osteomyelitis, and in 12 (52.2%) patients with osteomyelitis of the heel (χ2 = 128.4, P < .001). Multivariate analysis showed the independent role that osteomyelitis in the heel region had in major amputation outcome (odds ratio 15.3; P < .001; confidence interval, 17.4-5336.0), dialysis treatment (odds ratio 6.3; P = .012; confidence interval, 2.5-1667.2), and leukocyte count greater than 103 mm3 (odds ratio 2.25; P = .036; confidence interval, 1.1-76.6). Conclusions: We found a higher rate of transtibial amputation when osteomyelitis involved the heel instead of the midfoot or forefoot in diabetic patients. Level of Evidence: Level III, retrospective comparative series.

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.

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.

Revascularization by Angioplasty of Type D Femoropopliteal and Long Infrapopliteal Lesion in Diabetic Patients With Critical Limb Ischemia Are TASC II Recommendations Suitable? A Population-Based Cohort Study

Feasibility of revascularization of type D femoropopliteal and long infrapopliteal lesions by angioplasty (peripheral translumenal angioplasty [PTA]) in diabetic patients with critical limb ischemia (CLI) according to the TransAtlantic Inter-Society Consensus (TASC) II recommendations was studied. A total of 292 diabetic patients were admitted for CLI; 308 limbs underwent a PTA. Out of 211 femoropopliteal lesions treated with PTA, 44 were TASC II type A, 45 type B, 48 type C, and 76 type D lesions. In 44 of the 76 patients with type D lesions revascularized by PTA, no artery was patent down to the foot before the PTA. In 172 limbs with all infrapopliteal arteries occluded, revascularization was carried out down to the foot in 167 limbs. Follow-up was 3.1 ± 0.3 years. A first episode of restenosis occurred in 66/308 limbs with an incidence/year of 7.9. PTA procedures were successfully repeated in 57/66 restenosis episodes: secondary patency was 97.1%. The incidence/year of type D femoropopliteal lesions was 5.4, the incidence/year in others was 5.0, without statistically significant differences: P = .417. The only variable found significantly associated with restenosis occurrence on logistic analysis was the presence of lesions in both femoropopliteal and infrapopliteal axes. A total of 26/308 above-the-ankle amputations were performed, with an incidence/year of 2.5. Multivariate analysis showed the independent role of only crural artery occlusion after PTA. These data show that the choice to refer to angioplasty diabetic patients with type D and/or long infrapopliteal lesions without good run-off at the foot and/or high surgical risk allowed high revascularization feasibility, with an optimal amputation outcome.