Trans-pedal Access for Endovascular Revascularization in Complex Infra-popliteal Lesions in Critically Ischemic Limb
Condition: Critical Lower Limb Ischemia
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      Background: critical limb ischemia is one of the most challenging cases we face nowadays with
      high risk for amputation, retrograde trans-pedal angioplasty offers an alternative technique
      after failure of traditional ante-grade angioplasty.

      Patients and Methods: 96 patients underwent trans-pedal or trans-tibial retrograde
      angioplasty after failure of the traditional ante-grade angioplasty with the aid of US,
      21-gauge needle and 0.018 wire through sheath-less approach as a last chance for
      revascularization
    

Detailed description: 
      Study Design: This prospective non randomized study that had been performed at vascular
      surgery department at Mansoura University Hospital between March 2018 and April 2020, who was
      selected for 96patients undergoing endovascular BTK revascularization for CLI owing to tibial
      vascular diseases and gave written informed consent. Such cases who not give good response
      following traditional ante-grade ipsilateral trans-femoral approach and consequently
      underwent retrograde Trans-pedal or transtibial access to provide endovascular management for
      the lesions.

      Inclusion criteria:

        -  all patients aged from (18-80) years, males and female

        -  patients with 1ry lesion (without previous trial of angioplasty or bypass)

        -  2ry lesion (after previous trial of angioplasty or bypass),

        -  the patients with fountain classification (stage IIB, stage III, stage IV)

        -  patients with Rutherford classification (grade I "category 3", grade II, Category 4",
           grade III, Category 4&category 5.

      Exclusion criteria:

        -  patients with untreated osteomyelitis,

        -  patients with mixed lesions with other comorbidities (CVI & Lymphoedema),

        -  patients with vasculitis or Buerger's dis.

        -  Also, who can't give consent (mentally retarded patients) or those with behavioral
           disorders .

      Study tools History Data: included patient's demographics, underlying medical conditions, any
      previous surgery, transplanted kidney and other associated morbidity.

      Examination: Full arterial assessments included pulse examination, and the ABPI (ankle
      brachial pressure index).

      Laboratory: Blood picture, Blood sugar level, Kidney functions, Liver functions and
      Coagulation profile.

      Imaging: Duplex ultra-sonographic (US) examination and CTA. Technique: Entire cases underwent
      full therapeutic medication prior to interference. Entire cases were tried ante-grade
      re-vascularization with a subsequent failure. A lower limb angiogram was be ready in entire
      cases prior to the retrograde procedure performance. Briefly, conventional femoral access
      will be conducted in the traditional manner and involve the sheath while the catheter was
      introduced close to the proximal degree of lesion.

      Access to a pedal vessel: Using a 21-guage needle with insertion of 0.018-inch wire by
      sheathless technique (Figure 1) or by utilizing a micro puncture access set. A duplex-guided
      access has a great importance in terms of evaluation of the pedal as well as tibial blood
      vessels. Such vessel is recognized using the US probe. Color flow is utilized for
      identification of the objective artery flow, after that color disappeared while the needle is
      utilized for accessing the anterior vascular surface by utilizing duplex US , such approach
      performed in 54 patients. There are technical points worth mentioning utilizing such
      procedure: usage the smallest ready US as the major ones are bulky and may have a role in
      interference with the access process. In addition, marked vascular calcification may induce
      marked shadow making the identification very hard to be detected. In such conditions, a
      fluoroscopy might enable a good possibility for efficient access. In addition, it was
      suggested to utilize micro-puncture needle supposed to have echogenic pattern as the tip of
      regular needle is very hard to visualize utilizing the duplex US probe. Also, use of straight
      fluoroscopy or road mapping may offer a better chance for successful access, as we mentioned
      before, this method is done in 31 cases . Appropriate section of the actual place of vascular
      access is essential for the successfulness of such procedure. Generally, a patent vascular is
      selected to be the access situation. A micro-puncture needle is utilized for access.
      Occasionally, bending the needle tip has the ability to make the possibility of vascular
      evaluation easy which has great importance if the access point in the ATA beyond the ankle.
      Another method is open method (cut down) on tibial vessels, this method is done in 11 cases.
      Following evaluating the artery, established by back hemorrhage, the micro puncture access
      wire is introduced via the needle into the vessels underneath fluoroscopic guide in a
      retrograde fashion. The needle is removed and micro puncture set (4F) or the balloon itself
      is passed over the wire to secure the access. According to micro puncture introducer set it
      includes a 21- gauge, 7- cm echogenic needle, 10 - cm long micro puncture 4-french introducer
      and 2.9F inner caliber permitting passage of the equipment. When the retrograde introducers
      are in position, the case is completely heparinized to prevent any thrombus development
      throughout the interference process. An exchange dimension 0.018-inch wire was utilized to
      try passing across the disorder in a retrograde manner, it has very accurate outcomes
      crossing the obstruction for combination of a small sufficient diameter with adequate body
      support to permit crossing of the obstruction calcified in several patients. The V18 TM
      Control Wire Guide Wire is specifically beneficial at such condition. It has a hydrophilic
      tip which may assist in sliding via the blockade with mild frictions, and simultaneously the
      wire has sufficient stiffness to pass across the overall occlusion. In sometimes, the usage
      of the 0.018 system only aiming for crossing isn't sufficient. Such condition specifically
      develops when there are prolonged occlusions and when there is marked calcification. In such
      patients, additional reinforcement is required for the platform to permit the crossing. Thus,
      up-sizing to a 0.035 system might help in disorder crossing. When we pass through the
      disorder, an angiogram from below is conducted to prove the situation in the actual lumen
      beyond the disorder. The 0.018-inch system and wire were removed and hemostasis secured via
      digital compression for 8 minutes or by ante-grade balloon dilatation at the site of puncture
      for about 2-3 minutes.

      Patient follow-up: Patients had been evaluated through the ABPI and duplex US examination:
      immediately, three mo., 6 mo., and 1 year following the surgery.
    

Intervention name(s): Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limb
Intervention type(s): Procedure
Intervention description(s): Briefly, conventional femoral access will be conducted in the traditional manner and involve the sheath while the catheter was introduced close to the proximal degree of lesion.
Access to a pedal vessel: Using a 21-guage needle or by utilizing a micro puncture access set. Such vessel is recognized using the US probe. such approach performed in 54 patients.a fluoroscopy might enable a good possibility for efficient access. In addition, it was suggested to utilize micro-puncture needle supposed to have echogenic pattern as the tip of regular needle is very hard to visualize utilizing the duplex US probe. Also, use of straight fluoroscopy or road mapping may offer a better chance for successful access, this method is done in 31 cases . Another method is open method (cut down) on tibial vessels, this method is done in 11 cases.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transpedal access; retrogradeangioplasty; critical limb ischemia