Vikas Kapil1,2, Paul A Sobotka3,4, Mel D Lobo1,2, Roland E Schmieder5. 1. Barts Blood Pressure Centre of Excellence, Barts Heart Centre, St Bartholomew's Hospital. 2. Barts NIHR Cardiovascular Biomedical Research Unit, Centre for Clinical Pharmacology, William Harvey Research Institute, Queen Mary University of London, London, UK. 3. Division of Cardiovascular Diseases, Department of Internal Medicine, Ohio State University, Columbus, Ohio. 4. ROX Medical Inc., San Clemente, California, USA. 5. Department of Nephrology and Hypertension, University Hospital, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Bavaria, Germany.
Abstract
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. There was a common, but manageable, adverse effect of upstream iliac venous stenosis causing ipsilateral lower limb oedema. There were no renal safety concerns. The mechanism of action is proposed to be mechanical by provision of a low-pressure parallel circuit attached to the high-pressure arterial system though detailed physiological evaluation is currently lacking. SUMMARY: Preliminary data using the ROX coupler to form a central arteriovenous anastomosis are very encouraging. Concerns regarding the lack of sham control are to some extent mitigated by immediate on table blood pressure reduction with opening of the coupler and will be further addressed in the ongoing pivotal, sham-controlled ROX CONTROL Hypertension2 study which should provide further robust information regarding efficacy and safety.
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. There was a common, but manageable, adverse effect of upstream iliac venous stenosis causing ipsilateral lower limb oedema. There were no renal safety concerns. The mechanism of action is proposed to be mechanical by provision of a low-pressure parallel circuit attached to the high-pressure arterial system though detailed physiological evaluation is currently lacking. SUMMARY: Preliminary data using the ROX coupler to form a central arteriovenous anastomosis are very encouraging. Concerns regarding the lack of sham control are to some extent mitigated by immediate on table blood pressure reduction with opening of the coupler and will be further addressed in the ongoing pivotal, sham-controlled ROX CONTROL Hypertension2 study which should provide further robust information regarding efficacy and safety.
Authors: John S Clemmer; W Andrew Pruett; Robert L Hester; Thomas E Lohmeier Journal: Am J Physiol Heart Circ Physiol Date: 2019-08-30 Impact factor: 4.733
Authors: William Eysenck; Jet van Zalen; Nick Freemantle; Guy Lloyd; Stephen Furniss; Neil Sulke Journal: J Clin Hypertens (Greenwich) Date: 2019-07-26 Impact factor: 3.738