Catheter-based renal sympathetic denervation: Limitations to and gaps in the evidence

Current Opinion in Cardiology

Volumn 29, Issue 4, 2014, Pages 336-343

  Hiremath, Swapnil ^a,b   Froeschl, Michael ^c   Ruzicka, Marcel ^a,c  

^a UNIVERSITY OF OTTAWA   (Canada)

^b OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^c UNIVERSITY OF OTTAWA   (Canada)

Author keywords

Ambulatory blood pressure monitoring; Hypertension; Renal sympathetic denervation; Resistant hypertension; Sympathetic nervous system

Indexed keywords

BLOOD PRESSURE; BLOOD PRESSURE MEASUREMENT; FOLLOW UP; HUMAN; HYPERTENSION; INTERNAL VALIDITY; KIDNEY DENERVATION; LONG TERM CARE; LONGEVITY; NONHUMAN; PATIENT SAFETY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RENAL SYMPATHETIC DENERVATION; RESISTANT HYPERTENSION; REVIEW; SYMPATHETIC NERVE; SYMPATHETIC TONE; CATHETER ABLATION; INNERVATION; KIDNEY; PHYSIOLOGY; PROCEDURES; RENAL ARTERY; SYMPATHECTOMY;

BLOOD PRESSURE; CATHETER ABLATION; HUMANS; HYPERTENSION; KIDNEY; RENAL ARTERY; SYMPATHECTOMY;

EID: 84904787044     PISSN: 02684705     EISSN: 15317080     Source Type: Journal    
DOI: 10.1097/HCO.0000000000000076     Document Type: Review

References (42)

1. Koepke JP, DiBona GF. Functions of the renal nerves. Physiologist 1985;28:47-52.
2. DiBona GF. Physiology in perspective: the wisdom of the body. Neural control of the kidney. Am J Physiol Regul Integr Comp Physiol 2005;289:R633-R641.
3. DiBona GF, Esler M. Translational medicine: the antihypertensive effect of renal denervation. Am J Physiol Regul Integr Comp Physiol 2010;298:R245-253.
4. Cowley AW Jr. Long-term control of arterial blood pressure. Physiol Rev 1992;72:231-300.
5. Roman RJ, Cowley AW Jr. Characterization of a new model for the study of pressure-natriuresis in the rat. Am J Physiol 1985;248(2 Pt 2):F190-F198.
6. Kopp UC, Smith LA, DiBona GF. Renorenal reflexes: neural components of ipsilateral and contralateral renal responses. Am J Physiol 1985;249(4 Pt 2):F507-517.
7. Ye S, Zhong H, Yanamadala V, Campese VM. Renal injury caused by intrarenal injection of phenol increases afferent and efferent renal sympathetic nerve activity. Am J Hypertens 2002;15:717-724.
8. Stella A, Zanchetti A. Functional role of renal afferents. Physiol Rev 1991;71:659-682.
9. Campese VM, Kogosov E. Renal afferent denervation prevents hypertension in rats with chronic renal failure. Hypertension 1995;25(4 Pt 2):878-882.
10. Newcombe CP, Shucksmith HS, Suffern WS. Sympathectomy for hypertension; follow-up of 212 patients. Br Med J 1959;1:142-144.
11. Converse RL Jr, Jacobsen TN, Toto RD, et al. Sympathetic overactivity in patients with chronic renal failure. N Engl J Med 1992;327:1912-1918.
12. Hausberg M, Kosch M, Harmelink P, et al. Sympathetic nerve activity in endstage renal disease. Circulation 2002;106:1974-1979.
13. Esler M, Straznicky N, Eikelis N, et al. Mechanisms of sympathetic activation in obesity-related hypertension. Hypertension 2006;48:787-796.
14. Grassi G. Assessment of sympathetic cardiovascular drive in human hypertension: achievements and perspectives. Hypertension 2009;54:690-697.
15. Grassi G, Cattaneo BM, Seravalle G, et al. Baroreflex control of sympathetic nerve activity in essential and secondary hypertension. Hypertension 1998;31:68-72.
16. Grassi G, Seravalle G, Quarti-Trevano F, et al. Adrenergic, metabolic, and reflex abnormalities in reverse and extreme dipper hypertensives. Hypertension 2008;52:925-931.
17. Grassi G, Seravalle G, Trevano FQ, et al. Neurogenic abnormalities in masked hypertension. Hypertension 2007;50:537-542.
18. Krum H, Schlaich M, Whitbourn R, et al. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-ofprinciple cohort study. Lancet 2009;373:1275-1281.
19. Schlaich MP, Sobotka PA, Krum H, et al. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med 2009;361:932-934.
20. Krum H, Schlaich MP, Sobotka PA, et al. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet 2014;383:622-629. These are the final long-term data on the efficacy of RDN in the unblinded controlled trial; it does show persistence of blood pressure lowering, albeit with dwindling numbers of patients for whom follow-up data are available.
21. Esler MD, Krum H, Sobotka PA, et al. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet 2010;376:1903-1909.
22. Worthley SG, Tsioufis CP, Worthley MI, et al. Safety and efficacy of a multielectrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial. Eur Heart J 2013;34:2132-2140.
23. Pokushalov E, Romanov A, Corbucci G, et al. A randomized comparison of pulmonary vein isolation with versus without concomitant renal artery denervation in patients with refractory symptomatic atrial fibrillation and resistant hypertension. J Am Coll Cardiol 2012;60:1163-1170.
24. Hering D, Lambert EA, Marusic P, et al. Substantial reduction in single sympathetic nerve firing after renal denervation in patients with resistant hypertension. Hypertension 2013;61:457-464.
25. Brinkmann J, Heusser K, Schmidt BM, et al. Catheter-based renal nerve ablation and centrally generated sympathetic activity in difficult-to-control hypertensive patients: prospective case series. Hypertension 2012;60:1485-1490.
26. Kline RL, Mercer PF. Functional reinnervation and development of supersensitivity to NE after renal denervation in rats. Am J Physiol 1980;238:R353-358.
27. Arrowood JA, Goudreau E, Minisi AJ, et al. Evidence against reinnervation of cardiac vagal afferents after human orthotopic cardiac transplantation. Circulation 1995;92:402-408.
28. Pickering TG, Gerin W, Schwartz AR. What is the white-coat effect and how should it be measured? Blood Press Monit 2002;7:293-300.
29. Howard JP, Nowbar AN, Francis DP. Size of blood pressure reduction from renal denervation: insights from meta-analysis of antihypertensive drug trials of 4, 121 patients with focus on trial design: the CONVERGE report. Heart 2013;99:1579-1587. This is a careful and thoughtful analysis in which a remarkably prescient prediction was made, that the actual decrease in blood pressure, in a trial with shamprocedure controls, would be lower than that reported so far. It also describes the various weaknesses of other study designs.
30. Barnett AG, van der Pols JC, Dobson AJ. Regression to the mean: what it is and how to deal with it. Int J Epidemiol 2005;34:215-220.
31. Mahfoud F, Ukena C, Schmieder RE, et al. Ambulatory blood pressure changes after renal sympathetic denervation in patients with resistant hypertension. Circulation 2013;128:132-140.
32. Preston RA, Materson BJ, Reda DJ, Williams DW. Placebo-associated blood pressure response and adverse effects in the treatment of hypertension: observations from a Department of Veterans Affairs Cooperative Study. Arch Intern Med 2000;160:1449-1454.
33. Ernst E, Resch KL. The importance of placebo effects. JAMA 1995;273:283; author reply 284.
34. Bruce NG, Shaper AG, Walker M, Wannamethee G. Observer bias in blood pressure studies. J Hypertens 1988;6:375-380.
35. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med 2005;353:487-497.
36. Ruzicka M, McCormick B, Leenen FH, et al. Adherence to blood pressurelowering drugs and resistant hypertension: should trial of direct observation therapy be part of preassessment for renal denervation? Can J Cardiol 2013;29:1741.e1-1741.e3. This case report highlights the fact that patients might seek RDN as a potential 'cure' for hypertension and it is important to rule out pseudo-resistant hypertension before considering RDN.
37. Fadl Elmula FE, Hoffmann P, Fossum E, et al. Renal sympathetic denervation in patients with treatment-resistant hypertension after witnessed intake of medication before qualifying ambulatory blood pressure. Hypertension 2013;62:526-532.
38. Kandzari DE, Bhatt DL, Sobotka PA, et al. Catheter-based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN-3 Trial. Clin Cardiol 2012;35:528-535.
39. Rippy MK, Zarins D, Barman NC, et al. Catheter-based renal sympathetic denervation: chronic preclinical evidence for renal artery safety. Clin Res Cardiol 2011;100:1095-1101.
40. Kaltenbach B, Id D, Franke JC, et al. Renal artery stenosis after renal sympathetic denervation. J Am Coll Cardiol 2012;60:2694-2695.
41. Vonend O, Antoch G, Rump LC, Blondin D. Secondary rise in blood pressure after renal denervation. Lancet 2012;380:778.
42. Bhatt DL, Kandzari DE, O'Neill WW, et al. A controlled trial of renal denervation for resistant hypertension. N Engl J Med 2014;370:1393-1401.