Abstract
Purpose
To evaluate the efficacy and safety of “Direct Stent Puncture” technique for intraluminal stent recanalization in the femoro-popliteal segments.
Methods and Materials
A cohort of diabetics who had symptomatic in-stent occlusion of the superficial femoral or popliteal arteries underwent endovascular recanalization. After antegrade failure, direct stent puncture technique was performed.
The primary end-point was to efficacy assessment, intended as technical success and clinical improvement. The secondary end-point was safety assessment, intended as free of complication rate.
Results
Fifty-four patients (37 men; 73.6 ± 8.5 years) underwent direct stent puncture technique, after several unsuccessful antegrade attempts to cross the occluded stent. Technical success for intraluminal stent recanalization was achieved in 53/54 (98.2%) of cases and failed in 1/54 (1.8%).
Clinical improvement was obtained in 51/54 (94.4%) of cases, with regression of the clinical symptoms and improvement of the TcPO 2 , from 3 ± 18 mmHg to 43 ± 11 mmHg after 15 days ( p < 0.001).
Free of complications rate was 92.5%. In 2/54 (3.7%) of cases distal embolization occurred, in 1/54 (1.9%) case a sudden vessel thrombosis was diagnosed after 12 hours and in 1/54 (1.9%) case hematoma at the stent puncture site was observed.
Conclusions
Direct Stent Puncture technique is an efficacy and safety option for intraluminal stent recanalization in the femoro-popliteal segment in-stent occlusion.
1
Introduction
Endovascular treatment and stent deployment in the femoropopliteal tract was introduced almost two decades ago and, according to many studies , the use of stents has been found to have a high rate of initial technical success and low risk of complications. Important advances in technology have led to the development of self-expanding nitinol stents, which have significantly improved intermediate outcomes of superficial femoral artery (SFA) stenting in several prospective clinical trials .
However, in a long-term follow up the most important complication of endovascular stenting is the in-stent occlusion .
The options to treat in-stent occlusion are endovascular or open surgery intervention.
Endovascular treatment is a less invasive option to treat femoropopliteal occlusive disease, but in cases of in-stent occlusion, sometimes crossing the occluded stent is very difficult or impossible. In fact, a subintimal progression of the wire at the edge of the occluded stent or in correspondence to stent struts fractures is a frequent problem .
The purpose of the study was to evaluate the efficacy and safety of “Direct Stent Puncture” technique for the intraluminal in-stent recanalization in the femoropopliteal occlusive disease, after failure of antegrade recanalization.
2
Material and methods
2.1
Study design and patient population
This is a prospective study of procedural and early clinical outcome in a consecutive cohort of diabetics undergoing endovascular treatment for CLI. Eligibility was based on the presence of rest pain, no healing ulcerations or gangrene. All patients had femoro-popliteal in-stent long occlusion, classified as C-D class according to TASC II, diagnosed by doppler ultrasound or CT-angiography and confirmed by peripheral digital angiography.
Patients considered poor candidates for a surgical by-pass on the basis of absence of an adequate greater saphenous vein for distal bypass, absence of the good distal by-pass target vessel (tibial vessels ≤ 1 mm in diameter or diffusely diseased tibial vessels), presence of severe comorbid conditions that contraindicate surgical intervention or patients with bypass graft failure, underwent endovascular intervention. The endovascular treatment was performed in the same session than the angiography study.
Preprocedural and postprocedural transcutaneous oxygen tension (TcPO 2 ) was used to assess hemodynamic and tissue perfusion improvement.
Written informed consent was obtained from all patients.
Patient’s demographics and risk factors are summarized in Table 1 .
| Number | 54 |
| Age | 73.6 ± 8.5 |
| Male | 37 (68.5%) |
| Risk factors | |
| Diabetes | 54 (100%) |
| Hypertension | 39 (72.2%) |
| Dyslipidemia | 45 (83.3%) |
| Smoking | 20 (37%) |
| Renal failure | 33 (61.1%) |
| Coronary disease | 28 (51.8%) |
| Risk factors for surgery | |
| By-pass failure | 37 (68.5%) |
| Absence of conduits | 24 (44.4%) |
| Absence of good distal target vessel | 46 (85.1%) |
| Surgical contraindication (by vascular surgeon) | 49 (90.8%) |
| PAD clinical stage | |
| Rutherford 4 | 5 (9.2%) |
| Rutherford 5-6 | 49 (90.8%) |
2.2
Endovascular treatment
All patients were started on ticlopidine, 250 mg daily and acetylsalicylic acid, 100 mg daily 3 days before the procedure. The double antiaggregation was continued for 12 weeks after the procedure and acetylsalicylic acid was prescribed for life. All patients were administered of 5.000 IU of heparin at the beginning of the procedure.
The endovascular procedure was started after local anaesthesia, performing an ipsilateral antegrade access in a Common Femoral Artery under US guidance (Esaote, 7.5 MHz, linear probe), and a 5F sheath was deployed. The angiographic study was performed to quantify the extent of the disease and to confirm the in-stent occlusion.
When the occluded stent was successfully crossed via antegrade access, with 0.018″-in. guide-wire (V18®, Boston Scientific), the lesion was successfully treated with 5 or 6 mm long balloon (Dorado®, BARD).
In cases of antegrade recanalization failure, after several unsuccessful attempts to engage and cross the occluded stent, Direct Stent Puncture technique was performed ( Fig. 1 ). This novel approach has preliminary been described , and consists of a retrograde direct puncture of the occluded stent and intraluminal retrograde recanalization of the stent, followed by antegrade angioplasty (PTA and haemostasis). Direct stent puncture technique was always performed in the same session.
Balloon inflation times varied from 60 to 300 seconds at a nominal pressure. New stent in the femoropopliteal tract was only deployed in cases with flow-limiting dissections, sever elastic recoil or misaligned stent struts fractures.
2.3
Endpoints
The primary endpoint was to evaluate the efficacy of direct stent puncture technique, intended as acute technical success and post procedure clinical improvement of CLI symptoms. The secondary endpoint was to assess the safety of this technique, intended as free of complications procedure.
2.4
Statistical analysis
Continuous variables are reported as mean ± standard deviation. Categorical variables are reported as N (%). Groups were compared with di chi-square or Student t test as appropriate; p < 0.05 was considered the threshold of significance. SPSS 16.0 (SPSS Inc, Chicago, IL, USA) statistical software was used for all computations.
2
Material and methods
2.1
Study design and patient population
This is a prospective study of procedural and early clinical outcome in a consecutive cohort of diabetics undergoing endovascular treatment for CLI. Eligibility was based on the presence of rest pain, no healing ulcerations or gangrene. All patients had femoro-popliteal in-stent long occlusion, classified as C-D class according to TASC II, diagnosed by doppler ultrasound or CT-angiography and confirmed by peripheral digital angiography.
Patients considered poor candidates for a surgical by-pass on the basis of absence of an adequate greater saphenous vein for distal bypass, absence of the good distal by-pass target vessel (tibial vessels ≤ 1 mm in diameter or diffusely diseased tibial vessels), presence of severe comorbid conditions that contraindicate surgical intervention or patients with bypass graft failure, underwent endovascular intervention. The endovascular treatment was performed in the same session than the angiography study.
Preprocedural and postprocedural transcutaneous oxygen tension (TcPO 2 ) was used to assess hemodynamic and tissue perfusion improvement.
Written informed consent was obtained from all patients.
Patient’s demographics and risk factors are summarized in Table 1 .
| Number | 54 |
| Age | 73.6 ± 8.5 |
| Male | 37 (68.5%) |
| Risk factors | |
| Diabetes | 54 (100%) |
| Hypertension | 39 (72.2%) |
| Dyslipidemia | 45 (83.3%) |
| Smoking | 20 (37%) |
| Renal failure | 33 (61.1%) |
| Coronary disease | 28 (51.8%) |
| Risk factors for surgery | |
| By-pass failure | 37 (68.5%) |
| Absence of conduits | 24 (44.4%) |
| Absence of good distal target vessel | 46 (85.1%) |
| Surgical contraindication (by vascular surgeon) | 49 (90.8%) |
| PAD clinical stage | |
| Rutherford 4 | 5 (9.2%) |
| Rutherford 5-6 | 49 (90.8%) |
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