Maurizio Caminiti

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.

When is a technically successful peripheral angioplasty effective in preventing above-the-ankle amputation in diabetic patients with critical limb ischaemia?

Aim  To determine parameters predictive of avoidance of major (above‐the‐ankle) amputation after a technically successful peripheral angioplasty (PTA) in patients with diabetes with critical limb ischaemia.

Association of Obesity and Type II Diabetes Mellitus as a Risk Factor for Gallstones

Age, female sex, and obesity are well-known risk factors for gallstones; in contrast the possible role of type 2 diabetes mellitus (type-2 DM) is controversial. One reason for this discrepancy might be that type 2 DM is often accompanied by obesity. Therefore, the aim of this study was to evaluate the importance of obesity and of type 2 DM, separately and together, as risk factors for gallstones. In all, 203 obese patients with normal glucose tolerance (obese NGT), 446 obese patients with type 2 DM (obese type 2 DM), 269 lean patients with type 2 DM (lean type 2 DM) and 250 lean subjects with a normal glucose tolerance (lean NGT) were evaluated by ultrasonography for the presence of gallstones. At univariate analysis patients with gallstones (177) were older and were more frequently affected by both obesity and type 2 DM, and had higher triglycerides and fasting blood glucose levels. At multiple logistic regression analysis, only age and obesity, both in the presence or in absence of type 2 DM, were strongly associated with gallstones (P < 0.001); diabetes alone had a lower level of statistical significance (P = 0.07). These data suggest that obesity is a stronger risk factor for gallstones than type 2 DM.

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.

Effectiveness of combined therapy with angiotensin-converting enzyme inhibitors and statins in reducing mortality in diabetic patients with critical limb ischemia: An observational study

AIMS To investigate the effect of combined treatment with angiotensin-converting enzyme inhibitors (ACE) and statins on mortality in diabetic patients with critical limb ischemia (CLI). METHODS Prospective observational study of 553 consecutive diabetic patients admitted because of CLI followed for a mean of 2.2 years. All patients underwent peripheral revascularization and antithrombotic therapy was prescribed or continued and therapy with statin and ACE was recorded. Mortality from any cause was assessed and Kaplan-Meier analyses were performed to compare the relationship between survival and recorded variables. RESULTS One hundred thirty-nine patients did not have therapy with statin or an ACE, 78 had therapy with statin without ACE, 164 had therapy with ACE without statin and 172 patients had therapy with both statin and ACE. One hundred thirty-six patients died, 45/139 with neither statin nor ACE, 40/164 with ACE only, 26/78 with statin only, and 25/172 with both statin and ACE. Multivariate analysis confirmed the independent role of age, history of stroke, renal insufficiency and dialysis. Combined treatment with ACE and statin appeared to have a protective role. CONCLUSIONS In patients with diabetes and CLI mortality after two years is high. Life expectancy was better in patients receiving combined therapy with ACE and statin but not with therapy with only a statin or an ACE.