| 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
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