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Revascularization of TASC C/D Iliac Occlusion Extended to Common/Superficial Femoral Artery Using a Mixed Endoluminal and Subintimal Technique through the  Radio-Brachial Access 

Gianluca Rigatelli, MD, PhD, EBIR, Dobrin Vassiliev�, MD, PhD, Fabio dell�Avvocata, MD, Alberto Rigatelli, MD, Massimo Giordan, MD, Paolo Cardaioli, MD

Cardiovascular Diagnosis and Endoluminal Interventions Unit, Rovigo general Hospital , Rovigo, Italy
�Interventional Cardiology Department, Alexandrovska Hospital, Sofia University Medical School, Sofia, Bulgaria
Article type: original study
Word count: 




For correspondence:
Gianluca Rigatelli, Md, PhD, EBIR, FACC, FSCAI, FESC
Cardiovascular Diagnosis and Endoluminal Interventions Unit, 
Rovigo General Hospital , Rovigo, Italy
Fax: +3904254513
Email: jackyheart71@yahoo.it


Abstract
Background. Patients with Trans Atlantic Inter Society Consensus (TASC) C and D iliac lesions extended to common and/or superficial femoral artery  are a very challenging subset of patients. 
Objective. The aim of this study is to discuss the technical implication and short-term outcome of endovascular revascularization through the  radio-brachial access using a mixed endoluminal and subintimal recanalization using a Mmxed endoluminal and subintimal technique.
Methods. From January 2010 to Jannuary 2015 We prospectively enrolled 33 consecutive patients (mean age 79�12.5 years) , with long (> 80 mm) TASC C and TASC D symptomatic chronic iliac arteries occlusion extended to the common/superficial femoral artery, judged not candidates for surgery. Procedure was attempted through the left radial or brachial artery by means of  a mixed endoluminal and subintimal recanalization technique using coronary and peripheral dedicated guidewires. 
Results. The procedure was successful in all but one case (96.9%), mean length and diameter of implanted stents were 160.4�30.2 mm and 8.6�1.4 mm (Everflex  EV3 in 20 patients, Pulsar in 3 patients, Smart Flex in 10 patients) , respectively. 
Complications rate was 9.3% including two vessel ruptures and one distal embolization.   The procedure was successful in 32/33 patients (96.9%):  in one patient the re-entry point into the medium third of the superficial femoral artery cannot be accessed due to severe calcification and revascularization was accomplished through the controlateral femoral approach.  Mean length and diameter of implanted stents were 160.4�30.2 mm and 8.6�1.4 mm (Everflex  EV3 in 20 patients, Pulsar in 2 patients, Smart Flex in 10 patients) , respectively. 
Complications and death rate were both  3.1%. At a mean follow up of 18.1� 11.2 months,  the primary and secondary patency rates were 90.1 and 96.9%, respectively with a significant  improvement of ABI (0.29�0.6 versus 0.88�0.3, p<00.1) and Rutherford class (5.3�0.8 versus 0.7�1.9, P <0.01) compared to baseline.
Conclusion. The described technique appeared to be simple and safe allowing for recanalization of long iliac occlusion extended to common/superficial femoral artery. Large studies with long follow up are warranted to assess long-term effectiveness.
Key words: iliac artery angioplasty, stent, chronic occlusion




















Introduction
Trans Atlantic Inter Society Consensus (TASC [1]) C and D iliac lesions extended to common and/or superficial femoral artery define a subset of patients with very severe and anatomically challenging iliac disease who if symptomatic have indication to surgical revascularization. Unfortunately, this subset of patients are often old, affected by more severe systemic atherosclerosis, multiple comorbidities, and in particular severe coronary artery disease [2] , which all increase the operative risk and related mortality. The radio-brachial approach in this subset of patients appears particularly attractive, especially for reducing complications related to the access form the controlateral femoral artery and avoid possible damage of the distal aorta due to the cross over sheath  while a mixed endoluminal and subintimal revascularization technique appears actractive for this very long vessel disease. Aim of this study is to evaluate in a single center study the feasibility and advantages of radio-brachial approach combined with mixed endoluminal and subintimal recanalization in TASC C/D iliac occlusion extended to common/superficial femoral artery.
Method and Materials
From January 2010 to Jannuary 2015 We prospectively evaluate 38 consecutive patients (mean age 79�12.5 years, Table I) , with long (> 80 mm) TASC C and TASC D symptomatic chronic iliac arteries occlusion extended to the coomon/superficial femoral artery, judged not candidates for surgery due to severe coronary artery disease (19 patients), severe heart failure with ejection fraction < 30% (9 patients) and severe chronic bronco pneumopathy (10 patients) contraindicating the vascular surgical procedure. All patients were symptomatic for critical limb ischemia as defined following TASC II guidelines[1] (Table 1) and were judged not candidable for the procedure from the controlateral femoral due to no viable/kinked controlateral femoral access or due to  occlusion  at the ostium of the common iliac artery. An informed consent was signed by all the patients scheduled for intervention.
After a screening angio-computed tomography useful to determine length of occlusion and potential disease of distal aorta, recanalization has been  attempted from radio-brachial choosing the access site depending on the target vessel diameter on angio computed tomography scan: up to 9 mm the radial approach is preferred, whereas above 9 mm the brachial artery should be selected.  After having obtained the arterial approach, a 6F 90 cm long Shuttle sheath (Cook Group, Bloomington, IN, USA) or a 100 cm long  4 F Fortress sheath (Biotronik AG, Bulack, Switzerland) has been inserted into the left radial or brachial artery reaching the distal aorta, where an injection through the catheter has been made to assess the proximal occlusion cap. A 125 long MPA 4 or 5F catheter (Cordis Corp, Miami Lakes, Florida, FL, USA)   has been advanced over a coronary .014� Persuader 6 or 9 (Medtronic Inc., Minneapolis , MN, USA) or a Confianza Pro 9 or 12 (Asahi Intecc, Nagoya, Japan)  drilling the guidewire and pushing the catheter (Figure 1 A-Figure 2A). Usually the coronary guide-wire has been replaced with a soft Terumo guide-wire (Terumo Corp. Tokyo, Japan) leaving the catheter into the first 6-7 cm to the occlusion and a subintimal recanalization of the distal portion of the occlusion has been accomplished (Figure 1B-Figure 2B). From both approach a high support  .035� or 0.018� guide as the Supracor or V18 (Boston Scientific Corporation, San Jose, CA, USA) has been left in the lumen across the occlusion at any step of dilation and stenting procedures in order to have an easy and fast access to the artery in case of perforation of rupture (Figure 1 C, Figure 2C).
Dilation with Mustang  7 to 9 mm x 60-100 mm balloons (Boston Scientific Corporation, San Jose, CA, USA) with careful and slow increase in pressure and stenting with self expandable stents  with Everflex EV3 7-10 x 60-100 mm (Everflex, EV3 Inc.,Plymouth, MN, USA) or Pulsar 18 (Biotronik AG, Bulack, Switzerland) has been performed (Figure 2D, 2 E, 2F). Mandatory intraprocedural step was to check for perforation or rupture after any stage of the procedure.
All patients were treated after the procedure with aspirin 100 mg daily indefinitly and Clopidogrel 75 mg daily or ticagrelor 90 mg twice a day for 1 month. In patients with previous chronic anticoagulation for other reasons, triple therapy for one month and then anticoagulant only indefinitely can be prescribed. Clinical examination and Doppler Ultrasound was scheduled at one and 6 months and yearly.

Results
Five patients were excluded from the study because the operative risk was judged excessive on the basis of: chronic renal failure and haemoglobin < 8 mg/dl (2 patients); cancer with life expectance < 6 months (1 patient); absence of a re-entry point below the proximal third of the superficial femoral artery (2 patients). Revascularization  has been attempted in 33 patients.
 The procedure was successful in 32/33 patients (96.9%):  in one patient the re-entry point into the medium third of the superficial femoral artery cannot be accessed due to severe calcification and revascularization was accomplished through the controlateral femoral approach.  Mean length and diameter of implanted stents were 160.4�10.2 mm and 8.6�1.4 mm (Everflex  EV3 in 20 patients, Pulsar in 2 patients, Smart Flex in 10 patients) , respectively. 
Complications. Complication rate was 9.3%: one patient suffered from embolization to the periphery successfully  treated with thrombolysis, two patients had rupture of the external iliac artery needing a stent-graft (Fluency, Bard Inc., USA).  One of these two patients died for multi organ failure after successful repair of the rupture (death rate 3.1%).  
Patency. Three patients underwent successful re-do PTA of the target vessel due to thrombosis (1 patient) or significant symptomatic in-stent restenosis (2 patients) of  the iliac arteries. At a mean follow up of 18.1� 11.2 months,  the primary and secondary patency rates were 90.1% and 96.9 %, respectively with a significant  improvement of ABI (0.29�0.6 versus 0.88�0.3, p<00.1) and Rutherford class (5.3�0.8 versus 0.7�1.9, P <0.01) compared to baseline.
Discussion
The proposed technique through the radio-brachial  approach appeared to be simple and effective allowing for gain the distal lumen in the common or superficial femoral artery depending on the extension of the occlusive disease. The advantages of this technique might be to minimize access complications and overcome difficult anatomies in very high risk patients with no viable, difficult controlateral femoral access or patients in whom the occlusion is at the ostium of the common iliac artery, virtually enabling a cross over technique.   The short-term clinical outcomes appears encouraging and the complications rate of 9%, considering this very critical  and challenging small population is acceptable.
Nowadays,  iliac artery stenting is accepted therapy for aorto-iliac artery occlusive disease with or without superficial femoral artery involvement [3-4]. Standard routes for iliac artery angioplasty and stenting are the retrotegrade ipsilateral femoral artery access and the antegrade controlateral crossing- over femoral access. Bilateral retrograde access is preferable in the case of bilateral aortoliac stenosis , whereas the antegrade crossing-over access is preferable in cases of controlateral iliac artery occlusion which are poorly approachable retrogradely [5].Recently a radial or brachial  access has been suggested [5-7]. In recent literature, attention has been focused on re-entry device and type of stents to be used in chronic iliac occlusion. CART and Reverse CART techniques have been proposed in some other studies [8] but they imply the use of double access and necessarily increase procedural time and cost using multiple coronary guidewires, snare, ect, requiring a high operator�s skillness.
Covered stents have been suggested to perform better than bare metal stents in TASC C and D iliac lesions [9-10], whereas bifurcated stent-grafts have been suggested to be a good minimally invasive alternative to open surgery [11]. 
Less attention has been posed in the past in access sites and the specific technique and materials to cross the occlusion. Standard femoral monolateral or bilateral approach with hydrophilic .035� guidewire not always allows for gaining the true lumen distal to the occlusion in particular in very long calcified occlusion lesions and often may predispose to entry site complications [3]. Re-entry devices have been suggested to be effective [12-13] but they necessarily increase the cost of the procedure and some technical challenges due to the rigidity of the devices.
 On the contrary, the proposed technique through the radio brachial approach appears simple, requiring usually a single puncture, a coronary occlusion guidewire, a standard 125 cm long  4F Bernstein or MPA diagnostic catheter  and standard balloons and stents. Being the tip of the diagnostic catheter very soft, to peck and drill the stiff coronary guidewire while advancing the diagnostic catheter, offer a quite safe way to advance within the fibrous proximal cap of the occlusion, while the subintimal recanalization of the last portion of the occlusion into the external iliac or the common /superficial femoral artery usually appears relatively easy to perform.
Moreover the radial or brachial approach, depending on the size of the patient, appears to have virtually no complications at the puncture size: the market is ready to have new long 4F sheath and the 4F compatible large balloon and stents which promise to allowing the use of radial approach in every patient, minimizing access complications and increasing patients� comfort.
In our small study, the stent-graft  implantation was feasible through the brachial approach: technical tips include  a meticulous search for any site of contrast dye  leacking  after any step of the procedure, a gentle  and slow inflation  of the predilation  balloon guided by patient�s complains, and  the use of extra-back up .035� guide wire. We didn�t experiences vessel rupture using radial approach probably because the iliac diameter was smaller: radial approach at the moment should be considered a limitation for the emergency use of stent-graft implantation of diameter exceeding 8 mm, because of the small diameter of the radial artery in the majority of the population, which usually can accommodate safely  a 7 F sheath, but less frequently  a 8F or 9F sheath [14-15].
Our  study has a number of limitation including, the small sample size, acceptable considering the complexity of this subset of patients, and the lack of an angiographic follow up, mainly due to ethical issues related to submit these very critical patients to invasive studies not driven by the clinical need. Nevertheless,  although larger studies are required to assess the safety and long term outcomes of this strategy, the proposed technique seems to be feasible, relatively easy and effective with an acceptable rate of complications, implementing the already existing armamentarium of endovascular strategy of the modern endovascular specialist.



















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Table 1. Demographic and clinical data of the patients submitted to intervention.
           No of patients  (%)Age (years)
Female/Male
Body surface area
Hypertension
Smoke habitus
Hypercholesterolemia
Fontaine class III
Fontaine class IV
Coronary artery disease
-previous AMI
-previous PTCA
-previous CABG
Cardiac valve disease
Dilated cardiomyopathy 
Ejection fraction (%)
Chronic renal insufficiency79�12.5 
12/21 
1.82�0.67
30/33 (90.1)
11/33 (33.3)
26/33 (78.8)
29/33 (87.8)
4/33 (12.1)
24/33 (72.7)
12/33 (36.3)
27/33 (81.8)
13/33 (39.4)
6/33 (18.1)
11/33 (3.3)
4.8�21.6
7/33 (21.2)
AMI: acute myocardial infarction; CABG: coronary artery bypass graft; PTCA: percutaneous transluminal coronary angioplasty





Table 2. Peripheral interventions results in the pilot study.
Mean or n� (%)Brachial approach
Radial approach
Monolateral occlusion
-ostial common
-external iliac
Bilateral occlusion
-ostial common
-external iliac
Occlusion extension
-common femoral
-superficial femoral
Mean iliac occlusion length (mm)28/33 (84.8)
5/33 (15.2)
25/33(75.7)
22
3
8/33 (24.2)
     7
     1

  3/33(9.1)
30/33(90.1)
157.4�9.6

























Legend
Figure 1:  (A) Angiography of the abdominal aorta of a 69-year-old man with right limb severe claudication: A with very long TASC D unilateral aortoiliac occlusion was observed. The entire iliac vessel and the right common femoral artery were occluded. Recanalization of the right limb was planned and the patient was approached through the brachial artery with a 100 cm long 4F sheath(B). A Confianza Pro 9(Asahi Intecc, Nagoya, Japan) .014� coronary CTO guidewire was passed through a diagnostic 120  long 4F catheter and navigated through the occlusion till the external iliac artery (B). Then a subintimal angioplasty with re-entry into the superficial femoral artery was accomplished looping a soft .035�Terumo (C-D) guidewire supported by the diagnostic catheter re-entry into the superficial femoral artery (E-F). Final angiography after multiple balloon dilation and implantation of 3 Pulsar 35 8x 100 mm stents confirmed a good result and patency of the superficial femoral artery (G).

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