ROx Coupler

PURPOSE OF REVIEW: Novel, interventional treatments have emerged in the last decade for the treatment of resistant hypertension. This review focuses on a unique device that creates a fixed calibre, central iliac arteriovenous anastomosis that is significantly different in haemodynamic and safety profile from traditional haemodialysis fistulae. The background, physiology, and clinical data to date will be presented. RECENT FINDINGS: The single, randomized, controlled clinical trial using the ROX coupler in patients with resistant hypertension demonstrated substantial reductions in both office and ambulatory blood pressure to 12-month postimplantation...

Creation of a central iliac arteriovenous anastomosis using a novel nitinol coupler device results in an immediate, significant reduction of blood pressure (BP). We present efficacy and safety findings at 12 months post-coupler insertion. This open-label, multicenter, prospective, randomized trial enrolled patients with a baseline office systolic BP ≥140 mm Hg and average daytime ambulatory BP ≥135/85 mm Hg. Subjects were randomly allocated to coupler implantation and continuing previous pharmacotherapy or to maintain previous treatment alone...

We report a case of the successful use of a central arteriovenous (cAV) coupler device to treat severe drug-resistant primary hypertension in a 46-year-old female. The device is inserted via a femoral approach to create an ateriovenous fistula between the external iliac artery and vein and has shown promise in the treatment of severe hypertension. The patient's 24-hr ambulatory blood pressure (ABP) pre device insertion on eleven anti-hypertensive medications revealed a mean 24-hr ABP of 165/98 mm Hg. The insertion of the cAV coupler resulted in a sustained anti-hypertensive effect nine months post-procedure, with mean 24-hr ABP of 154/91 mm Hg on only two anti-hypertensives...

BACKGROUND: Options for interventional therapy to lower blood pressure (BP) in patients with treatment-resistant hypertension include renal denervation and the creation of an arteriovenous anastomosis using the ROX coupler. It has been shown that BP response after renal denervation is greater in patients with combined hypertension (CH) than in patients with isolated systolic hypertension (ISH). We analyzed the effect of ROX coupler implantation in patients with CH as compared with ISH...

OBJECTIVE: Creation of a central iliac arteriovenous (AV) anastomosis using a novel nitinol coupler device results in an immediate, significant reduction of blood pressure (BP). We present efficacy and safety findings at 12 months post coupler insertion, extending the initial 6 month primary endpoint report (Lancet 2015). DESIGN AND METHOD: This open-label, multicentre, prospective, randomised trial, enrolled patients with a baseline office systolic blood pressure (SBP) >140 mmHg, average daytime ambulatory SBP > 135 mmHg, and ambulatory diastolic blood pressure (DBP) > 85 mmHg...

The ROX Coupler is a device that allows creation of a central arteriovenous anastomosis at the iliac level. The device has been shown to improve exercise capacity in patients with chronic obstructive pulmonary disease and is CE marked for the treatment of resistant and uncontrolled hypertension. Reflex syncope is a challenging clinical condition with limited proven therapeutic options. We describe the resolution of symptoms and tilt table response of a patient who underwent insertion of a ROX Coupler to treat hypertension, and also incidentally had pre-existing vasodepressor syncope...

New non-pharmacological therapies for the treatment of resistant hypertension, such as baroreflex stimulation, renal denervation and barostenting, have recently been introduced. The latest development is lowering blood pressure by creating an arteriovenous anastomosis between the common iliac vein and artery by means of a metal coupler device. The randomised, non-blinded ROX CONTROL HTN study showed that office systolic blood pressure was reduced by 27 mmHg in patients assigned to arteriovenous coupler therapy, compared with a reduction of 4 mmHg in patients assigned to normal care...

OBJECTIVE: Several interventional therapeutic options for blood pressure (BP) lowering in patients with treatment-resistant hypertension (TRH) were introduced, such as renal denervation (RDN) and creation of an arteriovenous (AV) anastomosis using the ROX coupler. It was shown that BP response after RDN is greater in patients with combined hypertension (CH) compared to patients with isolated systolic hypertension (ISH). We analyzed now the effect of ROX coupler implantation in the subgroups with CH and ISH...

OBJECTIVE: Intolerance of antihypertensive medications is a major cause of non-adherence to pharmacotherapy leading to poor blood pressure control in the hypertensive population. We investigated the role of a central iliac arteriovenous (AV) anastomosis in a woman with uncontrolled hypertension due to multidrug intolerances. DESIGN AND METHOD: A sixty-one year old Caucasian female with long-standing poorly-controlled hypertension was referred with multiple drug intolerances...

The ROX Coupler is a stented arterial-venous anastomosis intended for implantation in the external iliac artery and vein. Prior studies of the ROX Coupler show that it increases cardiac output, oxygen delivery, and decreases systemic vascular resistance, thereby lowering blood pressure. Clinical data for the ROX Coupler demonstrates significant reduction in blood pressure but proximal venous stenoses have been seen post-implantation requiring treatment.

BACKGROUND: Hypertension contributes to cardiovascular morbidity and mortality. We assessed the safety and efficacy of a central iliac arteriovenous anastomosis to alter the mechanical arterial properties and reduce blood pressure in patients with uncontrolled hypertension. METHODS: We enrolled patients in this open-label, multicentre, prospective, randomised, controlled trial between October, 2012, and April, 2014. Eligible patients had baseline office systolic blood pressure of 140 mm Hg or higher and average daytime ambulatory blood pressure of 135 mm Hg or higher systolic and 85 mm Hg or higher diastolic despite antihypertensive treatment...

OBJECTIVES: Uncontrolled hypertension, whether due to drug resistance or poor adherence and persistence, remains a problem in many patients. The ROX coupler is a novel technology designed to reduce arterial blood pressure consequent to the predicted physical effects of reducing vascular resistance and improving arterial compliance. This article describes the technical aspects of the device and implantation procedure, results from a preclinical study, patient selection criteria, and potential complications of this therapy for uncontrolled hypertension...