Assessing of the microcirculation of the foot, using Laser Speckle Contrast Imaging in patients with end stage PAOD undergoing revascularisation in the Hybrid Operating Theatre

Introduction: In peripheral arterial occlusive disease (PAOD) one or more
arterial stenosis, cause a change in haemodynamics. The change in haemodynamics
results in an insufficient blood supply in the legs. In end stadium PAOD this
can result in severe claudication or tissue loss. Worldwide, 200 million
patients are suffering from PAOD. To prevent tissue loss or to resolve severe
claudication, PAOD patients are treated endovascularly by means of Percutaneous
Transluminal Angioplasty (PTA), possibly supplemented with the placement of a
stent. In Medisch Spectrum Twente (MST) Enschede these endovascular procedures,
are carried out, since January 2016, in the Hybrid Operating Theatre (HOT).
Visualization of blood and oxygen delivery to the affected tissue, the
microcirculation in the patients foot, is not yet possible with the current
imaging techniques used in the HOT. Therefore, besides the conventional
fluoroscopy and angiography, a second imaging module should be present in the
PAOD endovascular operation program, that can visualise the microcirculation of
the foot, throughout the entire PTA procedure. This second imaging module will
show a peroperative outcome/effect of the endovascular treatment to the
affected tissue, which is not yet possible. Laser Speckle Contrast Imaging
(LSCI) could be the solution to provide this method of imaging to have a
visualisation of the procedure outcome peroperative.
The clinical impact of the addition of LSCI, is a better peroperative feedback
about blood flow in the target area, the foot microcirculation.

Rationale: The rationale of this research is to determine whether LSCI could be
integrated in a PAOD endovascular operation program in a HOT, for the
visualisation of the microcirculation of the foot. Therefore, stability and
reproducibility of the system, environmental factors and the influence of
general anaesthesia on the measurement outcome needs to be investigated.

Objective: The primary objective is to analyse whether LSCI could be integrated
in a PAOD endovascular operation program in a HOT, for the visualisation of the
microcirculation of the foot. Therefore, stability and reproducibility of the
system, environmental factors and the influence of general anaesthesia on the
measurement outcome needs to be investigated.

Single centre (MST Enschede) blinded observational pilot study, followed by a
prospective observational single centre (MST Enschede) cohort study.

There are no direct benefits for the subject on short term. The subjects do
contribute to more knowledge about the treatment of PAOD, so that in the
future, patients with PAOD can be better treated. The used technique, LSCI, is
safe for the patient when applied. For the patient there are no risks
associated with LSCI.