Experimental: ABRO™ Binder Arm for Intra-Abdominal Hypertension

About 5 million Americans have IAH each year. IAH is associated with increased mortality, especially in those with cirrhosis. At least 5% of US patients requiring liver transplantation have IAH.

Signs include extreme abdominal pain, palpable abdominal distension and tenderness, an abnormal increase of white cell count and an increase in arterial CO2 level in the abdominal aorta.

In many patients presenting with abdominal tenderness with clinical signs of acute illness such as confusion, nausea, vomiting, and abdominal pain, intra-abdominal pressure is increased to a greater degree than a normal reading, because of an abnormally compliant retroperitoneum. Patients who have increased intra-abdominal pressure (>20 cm H2O) should undergo prompt surgical exploration to rule out abdominal pathologic conditions such as a perforated/tender and free fluid. However, for an appropriately selected patient, in the setting of low intra-abdominal pressure (<20 cm H2O), one may delay, and even withhold, explorative laparoscopy until definitive diagnostic tests such as a CT have been obtained.

The inability to exclude a spontaneous cause of intra-abdominal hypertension suggests that IAH of intra-abdominal pressure < 6 mmHg is not necessarily associated with an intra-abdominal disorder. In a few patients intra-abdominal pressure > 6 mmHg may in fact be related to intra-abdominal disorders. Thus further research is required to determine whether IAP > 6 mmHg is related to the pathology of intra-abdominal disorders.

Sepsis remains the major cause of death in the intensive care unit (ICU). In ICDS patients, sepsis is the most common cause of death. Although various studies showed that most often hypotensive shock is caused either by sepsis or by cardiac arrest, current recommendations recommend a diagnostic and therapeutic approach similar regardless between the first or second type of ICDS. However, there is no specific treatment for hypotensive shock.

Intra-abdominal hypertension may be caused by a variety of disorders. The diagnosis can be delayed by insufficient knowledge of the disease or of the physical examination. In these cases of IAH, an urgent abdominal CT is advisable.

The effectiveness of the IAP-BA and its ease of use, in conjunction with other treatments (e.g. fluids, blood), support its use for the management of IAH in severely ill patients who would otherwise be unable to tolerate invasive treatment.

In this series, 1.5 months of Abrobinder treatment produced no difference in IAP, IAP change and IAP variability compared to placebo. IAP decreased following IAP reduction which could be explained by a spontaneous decrease.

Arterial grafts can be used to maintain patency and prevent thrombosis of grafts in the treatment of abdominal aortic aneurysms, in accordance with the most modern studies, that reported excellent survival. In the experimental field, we showed that the binder arterial graft, produced with the Arterial Binder-Abro (ABA) device, can reduce intraluminal distension after arterial grafts from grafts perforated during aortic operation and be an effective and safe experimental approach to treat abdominal aortic aneurysms, through the incorporation of tissue engineering techniques.

The prevalence of clinically important IAH at presentation and in the acute period is increasing and increasing health care expenditure are at risk of being the cause. A group of patients with IAH should be targeted for referral to clinical trials in a multicentre manner. Patients with IAH associated with intra-abdominal hypertension should be targeted for a clinical trial.