Translesional pressure measurements to assess clinical relevance of a mesenteric artery stenosis

Chronic mesenteric ischemia (CMI) is an incapacitating disease with a vast
impact on quality of life due to severe abdominal pain after a meal, resulting
in fear of eating and subsequent severe weight loss(1-3). CMI has an incidence
of 9.2 per 100,000, which increases with age to up to 44.3 per 100,000 in
persons of >=80 years. These incidence rates are higher than the incidence rates
of other more well-known disease, such as esophageal cancer (4.3 per 100,000)
or ruptured abdominal aortic aneurysms (7.0 per 100,000) and even approximates
the incidence of Crohn*s disease (10.9 per 100,000). The prevalence of
atherosclerotic mesenteric artery stenosis, the leading cause of CMI, is even
higher (6-29%). An extensive collateral circulation protects the gut against
ischemia in the majority of patients. Hence, not all mesenteric artery stenoses
result in CMI and only those stenoses that are hemodynamically significant
should be treated. In recent years the DMIS (The Dutch Mesenteric Ischemia
Study group) has been searching for a reliable tool to assess hemodynamic
significance of a mesenteric artery stenosis, while accounting for the
collateral circulation, in order to guide treatment decisions and avoid
clinically unbeneficial revascularization procedures.

Intra-arterial pressure measurements are currently the most promising tool to
guide clinical decision making in patients with suspected CMI. Implementation
of pressure measurements could result in major improvements in quality of life
by tailoring treatment to the patient*s needs, thereby, improving the clinical
success of mesenteric artery revascularization and decreasing complication
risks. This will ultimately result in a reduction of population based
healthcare costs by facilitating allocation of health care resources to those
patients actually benefitting from treatment. The DMIS has designed a
multicenter study to determine the ability of intra-arterial pressure
measurements using a microcatheter to predict clinical success of mesenteric
artery revascularization, to set an optimal cut-off for the guidance of
treatment decisions, and to determine cost-effectiveness of future clinical
implementation of intra-arterial pressure measurements.

This study is a prospective multicentre cohort study. All patients undergoing
an interventional endovascular procedure of the mesenteric arteries are asked
to participate. At the intake at the outpatient clinic before the endovascular
procedure patients will receive a Patient Information Folder, explaining the
details of the study. Patients will have the opportunity to ask questions about
the study before informed consent is signed.

The potential risks of this study are deemed low. The difference with patients
not participating in this study is performance of translesional pressure
measurements. Measurements are performed using the same sheath and guiding
catheter as used during the mesenteric artery intervention. A microcatheter is
advanced over a guidewire distal to the stenotic lesion to perform these
pressure measurements. Using of microcatheters to pass stenotic lesions is
common practice in mesenteric artery angioplasty and stenting procedures,
therefore no additional complications are expected due to the pressure
measurements. After performing the pressure measurements, the angioplasty and
stent placement is performed. In the rare occasion of a dissection, consecutive
stenting can be performed to treat the dissection (if not performed already for
treatment purposes).