Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): A randomised controlled trial

The Lancet

Volumn 385, Issue 9978, 2015, Pages 1634-1641

  Lobo, Melvin D ^a   Sobotka, Paul A ^b,c   Stanton, Alice ^d   Cockcroft, John R ^e   Sulke, Neil ^f   Dolan, Eamon ^g   Van Der Giet, Markus ^h   Hoyer, Joachim ⁱ   Furniss, Stephen S ^j   Foran, John P ^k,l   Witkowski, Adam ^m   Januszewicz, Andrzej ^m   Schoors, Danny ⁿ   Tsioufis, Konstantinos ^o   Rensing, Benno J ^p   Scott, Benjamin ^q   Ng, G André ^r   Ott, Christian ^s   Schmieder, Roland E ^s  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b ROX Medical Inc   (United States)

^c OHIO STATE UNIVERSITY   (United States)

^d ROYAL COLLEGE OF SURGEONS IN IRELAND   (Ireland)

^e CARDIFF UNIVERSITY   (United Kingdom)

^f EASTBOURNE DISTRICT GENERAL HOSPITAL   (United Kingdom)

^g Royal College of Surgeons in Ireland   (Ireland)

^h CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

ⁱ UNIVERSITY HOSPITAL MARBURG   (Germany)

^j EAST SUSSEX HEALTHCARE NHS TRUST   (United Kingdom)

^k ROYAL BROMPTON HOSPITAL   (United Kingdom)

^l ST HELIER HOSPITAL   (United Kingdom)

^m INSTITUTE OF CARDIOLOGY   (Poland)

ⁿ UNIVERSITY HOSPITAL BRUSSELS   (Belgium)

^o KAT HOSPITAL   (Greece)

^p ST ANTONIUS HOSPITAL   (Netherlands)

^q ZNA Cardio Middelheim ^*  (Belgium)

^r UNIVERSITY OF LEICESTER   (United Kingdom)

^s UNIVERSITY HOSPITAL ERLANGEN   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIHYPERTENSIVE AGENT;

ADULT; AGED; ANASTOMOSIS; ANASTOMOTIC DEVICE; ANEMIA; ANTIHYPERTENSIVE THERAPY; ARTERY DISSECTION; ARTICLE; BLOOD PRESSURE; BLOOD PRESSURE MONITORING; BRADYCARDIA; CENTRAL ARTERIOVENOUS ANASTOMOSIS; CLINICAL ARTICLE; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DIASTOLIC BLOOD PRESSURE; FEMALE; FOLLOW UP; HUMAN; HYPERTENSION; INTENTION TO TREAT ANALYSIS; LEG PAIN; LETHARGY; MALE; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCREENING; STENT; SURGICAL TECHNIQUE; SYSTOLIC BLOOD PRESSURE; URINE RETENTION; VEIN OCCLUSION; ADOLESCENT; ARTERIOVENOUS SHUNT; CLINICAL TRIAL; ILIAC ARTERY; ILIAC VEIN; MIDDLE AGED; PROCEDURES; SURGERY; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANASTOMOSIS, SURGICAL; ARTERIOVENOUS SHUNT, SURGICAL; FEMALE; HUMANS; HYPERTENSION; ILIAC ARTERY; ILIAC VEIN; INTENTION TO TREAT ANALYSIS; MALE; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84933279414     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(14)62053-5     Document Type: Article

References (33)

1. Kannel WB, Schwartz MJ, McNamara PM. Blood pressure and risk of coronary heart disease: the Framingham study. Dis Chest 1969; 56: 43-52.
2. Kannel WB, Wolf PA, Verter J, McNamara PM. Epidemiologic assessment of the role of blood pressure in stroke. The Framingham study. JAMA 1970; 214: 301-10.
3. Klahr S, Schreiner G, Ichikawa I. The progression of renal disease. N Engl J Med 1988; 318: 1657-66.
4. Dunlay SM, Weston SA, Jacobsen SJ, Roger VL. Risk factors for heart failure: a population-based case-control study. Am J Med 2009; 122: 1023-28.
5. Irvin MR, Shimbo D, Mann DM, et al. Prevalence and correlates of low medication adherence in apparent treatment-resistant hypertension. J Clin Hypertens 2012; 14: 694-700.
6. Van Wijk BL, Klungel OH, Heerdink ER, de Boer A. Rate and determinants of 10-year persistence with antihypertensive drugs. J Hypertens 2005; 23: 2101-07.
7. Yiannakopoulou E, Papadopulos JS, Cokkinos DV, Mountokalakis TD. Adherence to antihypertensive treatment: a critical factor for blood pressure control. Eur J Cardiovasc Prev Rehabil 2005; 12: 243-49.
8. Daugherty SL, Powers JD, Magid DJ, et al. Incidence and prognosis of resistant hypertension in hypertensive patients. Circulation 2012; 125: 1635-42.
9. Pimenta E, Calhoun DA. Resistant hypertension: incidence, prevalence, and prognosis. Circulation 2012; 125: 1594-96.
10. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics-2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-220.
11. Lewington S, Clarke R, Qizilbash N, Peto R, Collins R, for the Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002; 360: 1903-13.
12. Coutinho T, Turner ST, Kullo IJ. Aortic pulse wave velocity is associated with measures of subclinical target organ damage. JACC Cardiovasc Imaging 2011; 4: 754-61.
13. Mitchell GF, Hwang SJ, Vasan RS, et al. Arterial stiffness and cardiovascular events: the Framingham Heart Study. Circulation 2010; 121: 505-11.
14. Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol 2010; 55: 1318-27.
15. Agabiti-Rosei E, Mancia G, O'Rourke MF, et al. Central blood pressure measurements and antihypertensive therapy: a consensus document. Hypertension 2007; 50: 154-60.
16. Ben-Shlomo Y, Spears M, Boustred C, et al. Aortic pulse wave velocity improves cardiovascular event prediction: an individual participant meta-analysis of prospective observational data from 17 635 subjects. J Am Coll Cardiol 2014; 63: 636-46.
17. Foran JP, Jain AK, Casserly I, et al. The ROX Coupler creation of a fixed iliac arteriovenous anastomosis for the treatment of systemic arterial hypetension, exploiting the physical properties of the arterial vasculature. Catheter Cardiovasc Intervent 2014; published online Nov 1. DOI:10.1002/ccd.25707.
18. Korsheed S, Eldehni MT, John SG, Fluck RJ, McIntyre CW. Effects of arteriovenous fistula formation on arterial stiffness and cardiovascular performance and function. Nephrol Dial Transplant 2011; 26: 3296-302.
19. Faul J, Schoors D, Brouwers S, et al. Creation of an iliac arteriovenous shunt lowers blood pressure in chronic obstructive pulmonary disease patients with hypertension. J Vasc Surg 2014; 59: 1078-83
20. Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD 2008; 5: 376-81.
21. Burchell AE, Lobo MD, Sulke N, Sobotka PA, Paton JF. Arteriovenous anastomosis: is this the way to control hypertension? Hypertension 2014; 64: 6-12.
22. Chobanian AV, Bakris GL, Black HR, et al. The seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure: the JNC 7 report. JAMA 2003; 289: 2560-72.
23. Mancia G, De Backer G, Dominiczak A, et al. 2007 Guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 2007; 28: 1462-536.
24. Westerhof N, Lankhaar JW, Westerhof BE. The arterial Windkessel. Med Biol Eng Comput 2009; 47: 131-41.
25. Sobotka PA, Munnery M, Davies L, Ossei-Gerning N, Gale NS, Cockcroft JR. Creation of a fixed central arterial-venous anastomosis affects arterial stiffness and central haemodynamics: a treatment for hypertension targeting the phsyical properties of the arterial vasculature. North American Artery 4th Annual Meeting; Chicago, IL, USA; Sept 5-6, 2014.
26. Gore JM, Peterson E, Amin A, et al. Predictors of 90-day readmission among patients with acute severe hypertension. The cross-sectional observational Studying the Treatment of Acute hyperTension (STAT) study. Am Heart J 2010; 160: 521-27. e1.
27. Bisognano JD, Bakris G, Nadim MK, et al. Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: results from the double-blind, randomized, placebo-controlled rheos pivotal trial. J Am Coll Cardiol 2011; 58: 765-73.
28. Symplicity HTN-2 Investigators. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet 2010;376: 1903-09.
29. Bhatt DL, Kandzari DE, O'Neill WW, et al. A controlled trial of renal denervation for resistant hypertension. N Engl J Med 2014; 370: 1393-401.
30. Saratzis N, Saratzis A, Sarafidis PA, Melas N, Ktenidis K, Kiskinis D. Quantitative evaluation of the systemic effects of transposed basilic vein to brachial artery arteriovenous fistula: a prospective study. J Vasc Access 2008; 9: 285-90.
31. Ori Y, Korzets A, Katz M, Perek Y, Zahavi I, Gafter U. Haemodialysis arteriovenous access - a prospective haemodynamic evaluation. Nephrol Dial Transplant 1996; 11: 94-97.
32. MacRae JM, Pandeya S, Humen DP, Krivitski N, Lindsay RM. Arteriovenous fistula-associated high-output cardiac failure: a review of mechanisms. Am J Kidney Dis 2004; 43: E17-22.
33. Basile C, Lomonte C, Vernaglione L, Casucci F, Antonelli M, Losurdo N. The relationship between the flow of arteriovenous fistula and cardiac output in haemodialysis patients. Nephrol Dial Transplant 2008; 23: 282-87.