Novel Compliant Scaffold With Specific Design for the Treatment of Non-thrombotic Stenosis of Internal Jugular Veins in Patients With Chronic Headache Poor Responder to Best Medical Therapy

Chronic headache is a disabling neurologic condition that affects 2-3 % of the general population. According to Headache Classification Committee of the International Headache Society, the chronic headache is defined as of at least one headache episode for 15 days a month, with at least eight days a month on which their headaches and associated symptoms meet diagnostic criteria. It is a neurologic condition characterized by attacks of headache, hypersensitivity to visual, auditory, olfactory, and cutaneous stimuli, nausea and vomiting.

Chronic migraine is common, often affects people during their most productive years of life, exerts substantial individual and societal costs, and is associated with numerous comorbid disorders. Idiopathic intracranial hypertension (IIH) has been involved in the development of chronic headache. In most of cases, IIH and chronic headache have been associated with a stenosis of the internal jugular vein (IJV). Some studies have shown that IJV compression aggravates the severity of migraine and has a possible role in the pathophysiology of migraine. Moreover, patients with migraine have less compliant IJV, which makes them susceptible to cerebral venous hypertension; these veins are more likely to develop and transmit venous hypertension caused by the increased venous blood volume during IJV compression. So, it cannot be excluded that an obstruction of the venous blood flow can lead to an increase in intracranial venous pressure and, consequently, a state of latent intracranial hypertension which justifies the chronicity of the headache. Moreover, the absence of alteration of the intracranial venous blood flow and the elevated intracranial pressure are found in about half of patients with chronic primary headache.

Based on this, among the risk factors of migraine chronicity, IIH has been evaluated like a risk factor for headache chronicity to overlap of clinical manifestations, such as persistent or high frequency headache, allodynia and to share of some factors (female sex, obesity and sleep disorders) and to the common therapeutic response to topiramate. In patients with chronic headache and IIH, a stenosis at the junction of the transverse and sigmoid sinuses has been recognized through venography but, recently, the role of isolated non-thrombotic IJV stenosis in IIH has gained a vested interest. Recent studies suggest that non-thrombotic stenosis of IJV may worsen the headache clinical severity, suggesting a possible causative role in the pathogenesis of chronic headache. It is demonstrated that the intervention of percutaneous transluminal angioplasty (PTA) was associated with a sustained improvement in clinical symptoms of patients with persistent headaches and concomitant obstructive disease of the IJV.

Balloon angioplasty and endovascular stenting of dural venous sinus stenosis in patients with IIH is a newer and actively debated treatment and has recently gained popularity. Initial studies indicate that it reduces headache in 60-88% of patients but carries 2% risk for significant morbidity and mortality.

For these reasons, given the promising risk- benefit ratio, these two therapeutics options have become an accepted treatment modality characterized by a low patency and clinical improvement rates.