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ROx Coupler

M Lobo, M Saxena, P A Sobotka, C Ott, E Dolan, J Foran, S S Furniss, J Cockcroft, M Van Der Giet, J Hoyer, A Januszewicz, G A Ng, B Rensing, B Scott, D Schoors, A Stanton, N Sulke, C Tsioufis, A Witkowski, R E Schmieder
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...
September 2016: Journal of Hypertension
Neil Sulke, William Eysenck, Sveeta Badiani, Stephen Furniss
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...
2016: BMJ Case Reports
Wilko Spiering, Peter W de Leeuw
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...
2015: Nederlands Tijdschrift Voor Geneeskunde
R E Schmieder, C Ott, M D Lobo, P A Sobotka, F Mahfoud
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...
June 2015: Journal of Hypertension
M Saxena, D Collier, A Jain, C Knight, A Mathur, P Sobotka, M Lobo
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...
June 2015: Journal of Hypertension
Marvin H Eng, Andrew J P Klein
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.
April 2015: Catheterization and Cardiovascular Interventions
Melvin D Lobo, Paul A Sobotka, Alice Stanton, John R Cockcroft, Neil Sulke, Eamon Dolan, Markus van der Giet, Joachim Hoyer, Stephen S Furniss, John P Foran, Adam Witkowski, Andrzej Januszewicz, Danny Schoors, Konstantinos Tsioufis, Benno J Rensing, Benjamin Scott, G André Ng, Christian Ott, Roland E Schmieder
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...
April 25, 2015: Lancet
John P Foran, Ajay K Jain, Ivan P Casserly, David E Kandzari, Krishna J Rocha-Singh, Adam Witkowski, Barry T Katzen, David Deaton, Peter Balmforth, Paul A Sobotka
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...
April 2015: Catheterization and Cardiovascular Interventions
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