Sergio Losa

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.

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

PURPOSEnThis 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.nnnMETHODSnFrom 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.nnnRESULTSnA 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.nnnCONCLUSIONSnThis 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

BACKGROUNDnTo 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).nnnMETHODSnFrom 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.nnnRESULTSnMajor 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).nnnCONCLUSIONSnOur 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.

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

AIMSnTo evaluate the feasibility of peripheral revascularization by angioplasty (PTA) or bypass grafting (BPG) in diabetic patients with critical limb ischemia (CLI).nnnMETHODSnAll 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.nnnRESULTSnDuring 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.nnnCONCLUSIONSnRevascularization 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.

Regarding the ''SAFARI'' Technique: A Word of Caution

Recently a few authors have reported experience regarding the safety and efficacy of planned combined subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) in patients with critical limb ischemia (CLI) presenting long occlusions involving the popliteal trifurcation. Spinosa et al. described the use of this technique in 20 limbs (21 cases), with a limb salvage rate of 90% at 6 months. The authors concluded that the SAFARI technique can be useful for completing subintimal recanalization when there is failure to reenter the distal true lumen from an antegrade approach or when there is limited distal target artery available for reentry. Also, according to these authors the SAFARI technique improves technical success in the performance of subintimal recanalization, and limb salvage rates are comparable to those with antegrade subintimal recanalization [1]. Gandini et al reported the use of this novel technique in four out of 104 patients with CLI. In their paper those authors concluded that the SAFARI technique should be adopted as a ‘‘standard procedure’’ in CLI cases showing long occlusions involving the trifurcation and presenting risk of amputation [2]. While we agree with Spinosa et al. that the SAFARI technique should be adopted in the presence of failure to reenter the distal true lumen from an antegrade approach, we do not think that this technique should always be used as first choice in the presence of long occlusion involving the trifurcation. Indeed, the SAFARI technique is indubitably an attractive option but, in view of the limited number of cases reported in the literature, should not yet be regarded as a standard procedure. According to the literature [3–5], intraluminal or subintimal recanalization of long occlusions involving the popliteal trifurcation is normally achieved by the transfemoral approach. In the last 2 years more than 1000 diabetic patients with CLI have been successfully treated endovascularly at our two centers (Multimedica IRCCS, Milan, and Multimedica Santa Maria Hospital, Castellanza, Va.). In this large cohort of subjects the use of the SAFARI technique was deemed necessary in four cases only (one posterior tibial and three anterior tibial artery approaches) and, importantly, after unsuccessful repeated attempts at distal revascularization. To the present authors, direct puncture of the distal third of a calf artery is not free of serious complications, leading in certain instances to flowlimiting dissection (due to introducer sheath advancement or due to the puncture itself) as well as thrombosis of the accessed artery (mainly at the end of the intervention during manual compression of the puncture site). Also, as reported by Gandini et al., the ‘‘presence of ulcers at the entry zone is an important limitation to the performance of this type of approach.’’ Finally, this type of procedure is time-consuming, which is a main limitation in such critically ill patients (heart and renal comorbidities are often associated). In conclusion, at this moment in time the use of the SAFARI technique should not be regarded as the first option for the treatment of diabetic patients with CLI. In expert hands, however, it may be considered in selected cases, after unsuccessful attempts at revascularization from the femoral artery. Most importantly, when this novel approach is deemed necessary, surgical exposure rather T. Lupattelli (&) Department of Radiology and Interventional Radiology, Via milanese 300, Sesto San Giovanni, Milan 20099, Italy e-mail: tommasolupattelli@hotmail.com

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 30xa0days 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.

Bilateral ureteroarterial fistula: a case report and review of literature.

Ureteral arterial fistula (UAF) is an uncommon condition characterized by a direct fistulous communication between a ureter and an iliac artery resulting in bleeding into the ureter, which can be massive and life-threatening because of hemodynamic instability, as confirmed by the high mortality rate (7-23% overall). This condition is actually increasing in frequency because of its relation to predisposing factors such as vascular pathology, previous radiation therapy, previous surgery, and necessity of ureteral stenting. Diagnosis is often challenging, as in most patients, the only symptom is hematuria and the treatment may require a multidisciplinary approach, including the expertise of the urologist, vascular surgeon, and interventional radiologist. Endovascular approach offers advantages over open surgery decreasing morbidity (reduced risk of injury to adjacent structure) and shortening hospital staying. There is no consensus regarding the safety of intentional occlusion of the hypogastric artery: proximal occlusion of a hypogastric artery typically produces little or no clinical symptoms due to well-collateralized pelvic arterial networks. On the contrary, significant complications, such as colonic ischemia, spinal cord paralysis, buttock claudication, or erectile dysfunction, are well-recognized adverse events after hypogastric artery embolization, especially in bilateral cases. We describe our experience of a bilateral UAF treated with bilateral endvascular approach.

Antegrade approach for percutaneous interventions of ostial superficial femoral artery: outcomes from a prospective series of diabetic patients presenting with critical limb ischemia

OBJECTIVESnThis is a prospective evaluation of percutaneous interventions (PTAs) performed by the antegrade femoral approach in diabetic patients with critical limb ischemia (CLI) and ostial superficial femoral artery (SFA) lesions.nnnMETHODSnThe puncture site was selected according to duplex scan analysis and physical examination (brachial, crossover, or antegrade). In cases of antegrade approach, a bare needle angiogram of the femoral bifurcation was performed in order to have an adequate distance (>2 cm) from the target lesion.nnnRESULTSnBetween January 2010 and August 2011, 64 diabetic patients underwent PTA for ostial SFA lesions. Crossover or brachial approach was electively adopted in 19/64 (30%) patients. The antegrade bare needle angiogram was performed in the remaining 45/64 (70%) patients. In two patients, the vascular anatomy was considered not suitable for antegrade approach, and they were treated in crossover. Technical success was achieved in 38/45 (84%) of patients. During hospital stay, one patient had SFA stent thrombosis treated with urgent bypass grafting.nnnCONCLUSIONSnThe antegrade approach can be safely performed in most patients presenting with CLI and ostial SFA lesions. The use of clinical and radiographic criteria correctly identifies patients with ostial SFA lesions suitable for an antegrade approach in 42/44 (95%) of cases.

Commentary: Critical Limb Ischemia and Hemodialysis: Revascularization Against All Odds.

This was part of the dialogue I had with a 75-year-old lady last month. The patient was diabetic with end-stage renal disease (ESRD) on hemodialysis for 2 years. Duplex scan showed multilevel lower limb arterial disease with a transcutaneous PO 2 of 12 mm Hg. The lesion on the fifth toe was infected, with deep soft tissue and bone involvement. With no revascularization, these clinical characteristics imply a 100% risk of major limb amputation and a 2-year mortality risk exceeding 40%. The multicenter study conducted by Shiraki et al in Japan highlights, once again, how a combination of hemodialysis and critical limb ischemia (CLI) represents a dramatic scenario with very poor life expectancy. When CLI ensues in patients >75 years of age with left ventricular ejection fraction <50%, 2-year mortality may exceed 60%, worse than most cancers. Nevertheless, patients and relatives are often not fully conscious of the risk of short-term major (cardiovascular) adverse events, and awareness of the disease is limited to foot lesions. On one hand, patients and their families, and (often) physicians on the other, do not show apparent apprehension, in striking contrast to a diagnosis of cancer. In the latter situation, patients ask for near-emergent scheduling of any potential diagnostic or therapeutic measures, including staging, chemoor radiotherapy, and radical surgery, irrespective of side effects. Conversely, and paradoxically, the underlying poor prognosis for CLI patients may lead to overtreatment or conservative treatment in patients on hemodialysis. Three key elements have to be considered to better understand the reasons for this attitude. First, chronic renal failure and hemodialysis are associated with diffuse and severe arterial calcifications. The association with multiple risk factors for atherosclerosis, diabetes in particular, may create an extensive plaque burden leading to multilevel peripheral vascular disease from the iliac arteries to the foot vessels. Besides, 90% of lower limb arteries are totally occluded in diabetic patients with CLI and ESRD, whereas a high operative risk profile and the extent of calcification tend to dissuade surgeons from complex revascularization. Consequently, the majority of patients are treated with endovascular approaches, despite technically demanding procedures requiring specific skills and expertise, and a dedicated armamentarium of guidewires, microcatheters, low-profile balloons, and debulking systems, all of which are more likely to be present in highvolume centers. In their Methods section, the authors indicate that consecutive patients who underwent lower limb revascularizations were enrolled in the study. However, no information is provided regarding the number of hemodialysis patients with CLI who were not candidates for any revascularization during the same time frame. In all, 246 patients at 10 institutions were included over a period of 3 years, which returns a mean of only 8.2 patients/year treated by each center. This is likely a result of patient selection and, possibly, a conservative attitude related in turn to low volume itself. Second, the presence of comorbidities mandates a multidisciplinary approach pivoting on strict collaboration among nephrologists, interventional radiologists, interventional 601367 JETXXX10.1177/1526602815601367Journal of Endovascular TherapyAiroldi et al research-article2015

Commentary: Critical Limb Ischemia and Hemodialysis

This was part of the dialogue I had with a 75-year-old lady last month. The patient was diabetic with end-stage renal disease (ESRD) on hemodialysis for 2 years. Duplex scan showed multilevel lower limb arterial disease with a transcutaneous PO 2 of 12 mm Hg. The lesion on the fifth toe was infected, with deep soft tissue and bone involvement. With no revascularization, these clinical characteristics imply a 100% risk of major limb amputation and a 2-year mortality risk exceeding 40%. The multicenter study conducted by Shiraki et al in Japan highlights, once again, how a combination of hemodialysis and critical limb ischemia (CLI) represents a dramatic scenario with very poor life expectancy. When CLI ensues in patients >75 years of age with left ventricular ejection fraction <50%, 2-year mortality may exceed 60%, worse than most cancers. Nevertheless, patients and relatives are often not fully conscious of the risk of short-term major (cardiovascular) adverse events, and awareness of the disease is limited to foot lesions. On one hand, patients and their families, and (often) physicians on the other, do not show apparent apprehension, in striking contrast to a diagnosis of cancer. In the latter situation, patients ask for near-emergent scheduling of any potential diagnostic or therapeutic measures, including staging, chemoor radiotherapy, and radical surgery, irrespective of side effects. Conversely, and paradoxically, the underlying poor prognosis for CLI patients may lead to overtreatment or conservative treatment in patients on hemodialysis. Three key elements have to be considered to better understand the reasons for this attitude. First, chronic renal failure and hemodialysis are associated with diffuse and severe arterial calcifications. The association with multiple risk factors for atherosclerosis, diabetes in particular, may create an extensive plaque burden leading to multilevel peripheral vascular disease from the iliac arteries to the foot vessels. Besides, 90% of lower limb arteries are totally occluded in diabetic patients with CLI and ESRD, whereas a high operative risk profile and the extent of calcification tend to dissuade surgeons from complex revascularization. Consequently, the majority of patients are treated with endovascular approaches, despite technically demanding procedures requiring specific skills and expertise, and a dedicated armamentarium of guidewires, microcatheters, low-profile balloons, and debulking systems, all of which are more likely to be present in highvolume centers. In their Methods section, the authors indicate that consecutive patients who underwent lower limb revascularizations were enrolled in the study. However, no information is provided regarding the number of hemodialysis patients with CLI who were not candidates for any revascularization during the same time frame. In all, 246 patients at 10 institutions were included over a period of 3 years, which returns a mean of only 8.2 patients/year treated by each center. This is likely a result of patient selection and, possibly, a conservative attitude related in turn to low volume itself. Second, the presence of comorbidities mandates a multidisciplinary approach pivoting on strict collaboration among nephrologists, interventional radiologists, interventional 601367 JETXXX10.1177/1526602815601367Journal of Endovascular TherapyAiroldi et al research-article2015