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Identifier 000430391
Title The role of percutaneous angioplasty in the management of chronic lower limb ulcers of arterial aetiology
Alternative Title Ο ρόλος της διαδερμικής αγγειοπλαστικής στην αντιμετώπιση των αρτηριακής αιτιολογίας χρόνιων έλκων των κάτω άκρων
Author Κεχαγιάς-Αθανασόπουλος, Ηλίας
Thesis advisor Τσέτης, Δημήτριος
Reviewer Γκουρτσογιάννης, Νικόλαος
Ιωάννου, Χρήστος
Καραντάνας, Απόστολος
Κοχιαδάκης, Γεώργιος
De Bree, Elcon
Δαμηλάκης, Ιωάννης
Abstract Introduction Lower extremity artery disease (LEAD) is a common disease leading to pronounced morbidity and mortality as well as to consumption of many health-care and social-care resources. Major risk factors include ageing population, increasing prevalence of diabetes and its lower-limb-related complications, along with tobacco consumption. Critical limb ischemia (CLI), the most severe clinical manifestation of LEAD, may present with ischemic foot ulcers, rest pain, and gangrene. Ischemic ulcers often begin as minor traumatic wounds that subsequently fail to heal because the blood supply is insufficient to meet the increased demands of the healing tissue. Furthermore, ischemic ulceration is potentially associated with increased risk for subsequent limb loss, high healthcare costs and mortality. Therefore, the aim of our study was first to evaluate the technical effectiveness of PTA in the management of lower limb atheromatous lesions in patients with ischemic foot ulceration in a real-life setting. The secondary aim was to assess the clinical effectiveness of PTA, including ulcer healing and amputation-free survival in these patients. Materials and methods Study Population We conducted a single-center, prospective cohort, observational study which included patients presenting with ischemic foot ulcers between June 2009 and June 2015. Inclusion criteria were an ulcer in the foot and an ankle-brachial index (ABI) <0.9 or toe-brachial index (TBI) <0.7, in case of incompressible tibial arteries at the level of the ankle. The exclusion criteria were: refusal to participate, refusal of percutaneous transluminal angioplasty (PTA) therapy, absolute contraindication to contrast media injection as determined by the investigator, uncontrollable coagulopathy, unwilling or unable to provide informed consent or return for required follow-up evaluations. Revascularization was performed by endovascular means whenever feasible after an initial evaluation of all patients. Furthermore, cases in which surgical revacularization was considered as first line treatment, were also excluded. All patients provided written informed consent and ethical approval was granted by our Hospital Ethics Committee. If non-invasive parameters suggested LEAD, we performed CT angiography or Digital Subtraction Angiography (DSA). andarranged the endovascular procedure based on angiographic findings In cases where a diagnostic DSA was done, endovascular revascularization was performed during the same session when feasible. Evaluation of short-term and longterm clinical success of the procedure was based on ulcer size and appearance. Technique The main goal of the angioplasty (defining technical success) was to achieve straight-line flow (SLF) from the aorta down to either a patent dorsalis pedis or distal posterior tibial artery supplying the plantar arch. The definition of technical success also included creation of SLF from the aorta to a peroneal artery that supplies either a patent dorsalis pedis or distal posterior tibial via collateral reconstitution. All patients received PTA-first as the primary form of treatment. They also received medical therapy for risk factor modification. Hypertension definition In a subgroup of patients, autologous platelet-rich plasma (PRP) was used with the results published elsewhere. All angioplasties were performed by two interventional radiologists of our department who had 1 and 10 years of expierience, at the beginning of the study. Our typical angioplasty strategy was to attempt intraluminal crossing of the stenoses or occlusions using a combination of a 5F curved catheter and a 0.035 in. straight or curved hydrophilic guidewire (Terumo). In case a subintimal channel was created, we switched our technique and attempted subintimal angioplasty. To facilitate intraluminal crossing of chronic total occlusions, we also used Vibrational angioplasty in a subcohort of our patients (18). Technical success of the endovascular procedure was accomplished when a residual stenosis less than 30% was achieved with antegrade blood flow in at least one distal vessel. Adverse events were classified according to the Society for Vascular Follow-up The study was designed to follow up patients for at least 2 years. However, follow Post-procedure surveillance included quarterly vascular clinic visits, during which clinical improvement (e.g. wound healing, rest pain) was assessed. Follow-up was Results Patients A total of 225 patients with ischemic foot ulceration were initially evaluated during the study period. Among those, 12 patients were excluded due to various contra-indications for endovascular treatment. From the 213 remaining cases, 52 patients had a profoundly unfavourable distribution of lesions for an endovascular approach, according to the vascular team’s consensus, leaving 161 (76%) patients that underwent percutaneous procedures. Moreover, 17 patients were lost to follow-up before reaching any of the study endpoints. Finally, 144 patients were studied, 102 of whom (71%) were followed-up for more than 24 months. PTA was performed in all 144 patients . Lesion type incidence according to TASC II classification was 10 Type A, 19 Type B, 72 Type C, and 43 Type D. In 88 patients PTA was performed in the iliofemoral axis exclusively, in 10 patients in the popliteal/tibial axis exclusively, and in 46 in both levels, with an average of 1.8 procedures per patient. One vessel was treated in 66 cases two vessels in 45 cases,three vessels in 22 casesand four vessels in 11 cases . Stent placements were required in 42 cases. Initial technical success was achieved in 141 cases . Technical success by type of lesion was 100% for Type A and B lesions, 98% for Type C and 95% for Type D lesions. The ABI significantly increased postprocedurally from 0.45 ± 0.2 to 0.76 ± 0.19, p<0.001. Complications Adverse clinical events occurred in 13 patients. One patient Vascular re-interventions Repeat PTA to the initially recanalized artery was performed in 8 patients during the follow-up period. Amputations Despite successful recanalization, minor or major amputation was required in 36 cases. Of these, 17 were major and 19 minor amputations. The need for amputation was correlated with the extent of tissue destruction at inclusion (r=0.3, p=0.039). Ulcer healing In total, 98 (68%) patients healed primarily without major or minor amputation. Median time to healing was 18 weeks (3-52 weeks). Survival At a mean follow-up of 3.1 ± 1.8 years the survival rate was 69% (44 patients died, 28 of whom from cardiac causes, 8 from stroke, 4 from uncontrolled sepsis and 4 from malignancy). Amputation-free survival: During the follow-up period, amputation-free survival was 64%. Amputation-free survival with healed ulcers: During the follow-up period, 62% of patients had achieved ulcer healing and were alive without a major or minor amputation. Our data support the technical and clinical success of PTA in the management of ischemic foot ulcers with high rates of healing and limb salvage. PTA was technically successful and feasible in almost all patients with only a minority of cases unsuitable for percutaneous techniques due to extensive and complex distribution of atherosclerotic lesions. Another important aspect of our study is that most of the patients’ lesions were classified as TASC II Type C and D, with 98% and 95% technical success respectively, indicating that endovascular procedures can be performed in patients to whom surgical intervention was previously recommended. Therefore, our results In conclusion, endovascular intervention as first-line treatment in subjects with arterial insufficiency and ischemic foot ulcers is feasible in the vast majority of patients, and has a very high technical success rate. Percutaneous revascularization results in a high overall incidence of wound healing and limb salvage, accompanied by very low morbidity and mortality rates. Factors that affect clinical success, potentially affecting optimal treatment strategy are the extent of tissue destruction at presentation, along with patient comorbidities
Language English
Subject Ischemia
Peripheral arterial disease
Κάτω άκρο
Περιφερική αρτηριακή νόσος
Issue date 2020-08-05
Collection   Faculty/Department--School of Medicine--Department of Medicine--Doctoral theses
  Type of Work--Doctoral theses
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