Neuromodulation device therapy for treatment of hypertensive heart disease

Circulation Journal

Volumn 77, Issue 6, 2013, Pages 1351-1363

  Todoran, Thomas M ^a,b   Zile, Michael R ^a,b  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^b RALPH H JOHNSON VA MEDICAL CENTER   (United States)

Author keywords

Baroreflex activation therapy; Hypertension; Spinal cord stimulation; Sympathetic renal denervation; Vagal nerve stimulation

Indexed keywords

AUTONOMIC NERVOUS SYSTEM; BLOOD PRESSURE; CAROTID SINUS PRESSORECEPTOR; CATHETER ABLATION; DEVICE THERAPY; DIASTOLIC BLOOD PRESSURE; DRUG DELIVERY DEVICE; ECHOGRAPHY; GLUCOSE METABOLISM; HEART DISEASE; HEART RATE; HUMAN; HYPERTENSION; KIDNEY INJURY; METABOLIC SYNDROME X; MORBIDITY; MORTALITY; MULTICENTER STUDY (TOPIC); MUSCLE CONTRACTILITY; NERVE STIMULATOR; NEUROLOGIC DISEASE; NEUROMODULATION; PEROPERATIVE COMPLICATION; PREVALENCE; RADIOFREQUENCY ABLATION DEVICE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RENIN ANGIOTENSIN ALDOSTERONE SYSTEM; REVIEW; SPINAL CORD STIMULATION; SYMPATHECTOMY; SYSTOLIC BLOOD PRESSURE; VAGUS NERVE STIMULATION; VASOCONSTRICTION;

HEART DISEASES; HUMANS; HYPERTENSION; PARASYMPATHETIC NERVOUS SYSTEM; SYMPATHETIC NERVOUS SYSTEM; UNITED STATES; VAGUS NERVE STIMULATION;

EID: 84878227739     PISSN: 13469843     EISSN: 13474820     Source Type: Journal    
DOI: 10.1253/circj.CJ-13-0390     Document Type: Review

References (47)

1. Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: Analysis of worldwide data. Lancet 2005; 365: 217-223.
2. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, et al, on behalf of the American Heart Association Statistics C, Stroke Statistics S. Executive summary: Heart disease and stroke statistics-2013 update: A report from the American Heart Association. Circulation 2013; 127: 143-152.
3. Kane GC, Karon BL, Mahoney DW, Redfield MM, Roger VL, Burnett JC, et al. Progression of left ventricular diastolic dysfunction and risk of heart failure. JAMA 2011; 306: 856-863.
4. Halley CM, Houghtaling PL, Khalil MK, Thomas JD, Jaber WA. Mortality rate in patients with diastolic dysfunction and normal systolic function. Arch Intern Med 2011; 171: 1082-1087.
5. Takemoto Y, Barnes ME, Seward JB, Lester SJ, Appleton CA, Gersh BJ, et al. Usefulness of left atrial volume in predicting first congestive heart failure in patients > or = 65 years of age with well-preserved left ventricular systolic function. Am J Cardiol 2005; 96: 832-836.
6. Ristow B, Ali S, Whooley MA, Schiller NB. Usefulness of left atrial volume index to predict heart failure hospitalization and mortality in ambulatory patients with coronary heart disease and comparison to left ventricular ejection fraction (from the Heart and Soul Study). Am J Cardiol 2008; 102: 70-76.
7. Fagard RH, Celis H, Thijs L, Wouters S. Regression of left ventricular mass by antihypertensive treatment: A meta-analysis of randomized comparative studies. Hypertension 2009; 54: 1084-1091.
8. Klingbeil AU, Schneider M, Martus P, Messerli FH, Schmieder RE. A meta-analysis of the effects of treatment on left ventricular mass in essential hypertension. Am J Med 2003; 115: 41-46.
9. Pierdomenico SD, Cuccurullo F. Risk reduction after regression of echocardiographic left ventricular hypertrophy in hypertension: A meta-analysis. Am J Hypertens 2010; 23: 876-881.
10. Schmieder RE, Martus P, Klingbeil A. Reversal of left ventricular hypertrophy in essential hypertension: A meta-analysis of randomized double-blind studies. JAMA 1996; 275: 1507-1513.
11. Grassi G, Seravalle G, Dell'Oro R, Mancia G. Sympathetic mechanisms, organ damage, and antihypertensive treatment. Curr Hyper-tens Rep 2011; 13: 303-308.
12. Krum H, Sobotka P, Mahfoud F, Bohm M, Esler M, Schlaich M. Device-based antihypertensive therapy: Therapeutic modulation of the autonomic nervous system. Circulation 2011; 123: 209-215.
13. Parati G, Esler M. The human sympathetic nervous system: Its relevance in hypertension and heart failure. Eur Heart J 2012; 33: 1058-1066.
14. DiBona GF, Kopp UC. Neural control of renal function. Physiol Rev 1997; 77: 75-197.
15. Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, et al. Resistant hypertension: Diagnosis, evaluation, and treatment: A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation 2008; 117: e510-e526.
16. Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, et al. Catheter-based renal sympathetic denervation for resistant hypertension: A multicentre safety and proof-of-principle cohort study. Lancet 2009; 373: 1275-1281.
17. Symplicity HTNI. Catheter-based renal sympathetic denervation for resistant hypertension: Durability of blood pressure reduction out to 24 months. Hypertension 2011; 57: 911-917.
18. Symplicity HTN-2 Investigators, Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplic-ity HTN-2 trial): A randomised controlled trial. Lancet 2010; 376: 1903-1909.
19. Esler MD, Krum H, Schlaich M, Schmieder RE, Bohm M, Sobotka PA; for the Symplicity HTNI. Renal sympathetic denervation for treatment of drug-resistant hypertension: One-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation 2012; 126: 2976-2982.
20. Kandzari DE, Bhatt DL, Sobotka PA, O'Neill WW, Esler M, Flack JM, et al. Catheter-based renal denervation for resistant hypertension: Rationale and design of the Symplicity HTN-3 Trial. Clin Car-diol 2012; 35: 528-535.
21. Papademetriou V. EnligHTN I: Safety and efficacy of a novel multi-electrode renal denervation catheter in patients with resistant hypertension. A first-in-human multicenter study. Presented at AHA 2012 Congress, November 2012, Los Angeles, CA, USA.
22. Margolis JR. REDUCE-HTN Post-Market Surveillance Clinical Study. Data presented at the 2012 Transcatheter Cardiovascular Therapeutics, October 2012, Miami, FL, USA.
23. Ormiston JA, Watson T, van Pelt N, Stewart R, Haworth P, Stewart JT, et al. First-in-human use of the OneShot™ renal denervation system from Covidien. EuroIntervention 2013; 8: 1090-1094.
24. Ormiston J. First report of the 6-month first in human results of the OneShot™ renal denervation system: The RHAS study: Data presented at the 2012 Transcatheter Cardiovascular Therapeutics, October 2012, Miami, FL, USA.
25. Ormiston J, Watson T, van Pelt N, Stewart R, Haworth P, Stewart J, et al. First report of the 6-month first in human results of the OneShot™ renal denervation system: the RHAS study. J Am Coll Cardiol 2012; 60: B62.
26. Ahmed H, Neuzil P, Skoda J, Petru J, Sediva L, Schejbalova M, et al. Renal sympathetic denervation using an irrigated radiofrequency ablation catheter for the management of drug-resistant hypertension. JACC Cardiovasc Interv 2012; 5: 758-765.
27. Bonan R. ReCor Medical-PARADISE: FIM results of a novel circumferential catheter-based ultrasound technology for renal denervation. Abstract presented at the 2012 Annual Scientific Sessions of the European Association for Percutaneous Cardiovascular Interventions, May 2012, Paris, France.
28. Brinton T. Externally focused ultrasound for sympathetic renal denervation WAVE I first-in-man study Kona Medical, Inc. Abstract presented at the 2012 Transcatheter Cardiovascular Therapeutics Conference, October 2012, Miami, FL, USA.
29. Stefanadis C, Toutouzas K, Synetos A, Tsioufs C, Karanasos A, Agrogiannis G, et al. Chemical denervation of the renal artery by vincristine in swine: A new catheter-based technique. Int J Cardiol 2012 January 20, doi:10.1016/j.ijcard.2012.01.002 [Epub ahead of print].
30. Lohmeier TE, Irwin ED, Rossing MA, Serdar DJ, Kieval RS. Prolonged activation of the barorefex produces sustained hypotension. Hypertension 2004; 43: 306-311.
31. Tordoir JH, Scheffers I, Schmidli J, Savolainen H, Liebeskind U, Hansky B, et al. An implantable carotid sinus barorefex activating system: Surgical technique and short-term outcome from a multi-center feasibility trial for the treatment of resistant hypertension. Eur J Vasc Endovasc Surg 2007; 33: 414-421.
32. Illig KA, Levy M, Sanchez L, Trachiotis GD, Shanley C, Irwin E, et al. An implantable carotid sinus stimulator for drug-resistant hypertension: Surgical technique and short-term outcome from the multi-center phase II Rheos Feasibility Trial. J Vasc Surg 2006; 44: 1213-1218.
33. Scheffers IJ, Kroon AA, Schmidli J, Jordan J, Tordoir JJ, Mohaupt MG, et al. Novel barorefex activation therapy in resistant hypertension: Results of a European multi-center feasibility study. J Am Coll Cardiol 2010; 56: 1254-1258.
34. Wustmann K, Kucera JP, Scheffers I, Mohaupt M, Kroon AA, de Leeuw PW, et al. Effects of chronic baroreceptor stimulation on the autonomic cardiovascular regulation in patients with drug-resistant arterial hypertension. Hypertension 2009; 54: 530-536.
35. Heusser K, Tank J, Engeli S, Diedrich A, Menne J, Eckert S, et al. Carotid baroreceptor stimulation, sympathetic activity, barorefex function, and blood pressure in hypertensive patients. Hypertension 2010; 55: 619-626.
36. Bisognano JD, Bakris G, Nadim MK, Sanchez L, Kroon AA, Schafer J, et al. Barorefex activation therapy lowers blood pressure in patients with resistant hypertension: Results from the double-blind, randomized, placebo-controlled rheos pivotal trial. J Am Coll Car-diol 2011; 58: 765-773.
37. Bakris GL, Nadim MK, Haller H, Lovett EG, Schafer JE, Bisognano JD. Barorefex activation therapy provides durable benefit in patients with resistant hypertension: Results of long-term follow-up in the Rheos Pivotal Trial. J Am Soc Hypertens 2012; 6: 152-158.
38. Hoppe UC, Brandt MC, Wachter R, Beige J, Rump LC, Kroon AA, et al. Minimally invasive system for barorefex activation therapy chronically lowers blood pressure with pacemaker-like safety pro-fle: Results from the Barostim neo trial. J Am Soc Hypertens 2012; 6: 270-276.
39. Schwartz PJ, De Ferrari GM, Sanzo A, Landolina M, Rordorf R, Raineri C, et al. Long term vagal stimulation in patients with advanced heart failure: First experience in man. Eur J Heart Fail 2008; 10: 884-891.
40. De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, et al; CardioFit Multicenter Trial Iinvestigators. Chronic vagus nerve stimulation: A new and promising therapeutic approach for chronic heart failure. Eur Heart J 2011; 32: 847-855.
41. Hauptman PJ, Schwartz PJ, Gold MR, Borggrefe M, Van Veldhuisen DJ, Starling RC, et al. Rationale and study design of the increase of vagal tone in heart failure study: INOVATE-HF. Am Heart J 2012; 163: 954-962 e951.
42. Brandt MC, Mahfoud F, Reda S, Schirmer SH, Erdmann E, Bohm M, et al. Renal sympathetic denervation reduces left ventricular hypertrophy and improves cardiac function in patients with resistant hypertension. J Am Coll Cardiol 2012; 59: 901-909.
43. Bisognano JD, Kaufman CL, Bach DS, Lovett EG, de Leeuw P; DEBuT-HT and Rheos Feasibility Trial Investigators. Improved cardiac structure and function with chronic treatment using an implant-able device in resistant hypertension: Results from European and United States trials of the Rheos system. J Am Coll Cardiol 2011; 57: 1787-1788.
44. Mancia G, Bousquet P, Elghozi JL, Esler M, Grassi G, Julius S, et al. The sympathetic nervous system and the metabolic syndrome. J Hypertens 2007; 25: 909-920.
45. Mahfoud F, Schlaich M, Kindermann I, Ukena C, Cremers B, Brandt MC, et al. Effect of renal sympathetic denervation on glucose metabolism in patients with resistant hypertension: A pilot study. Circulation 2011; 123: 1940-1946.
46. Ruttanaumpawan P, Nopmaneejumruslers C, Logan AG, Lazarescu A, Qian I, Bradley TD. Association between refractory hypertension and obstructive sleep apnea. J Hypertens 2009; 27: 1439-1445.
47. Witkowski A, Prejbisz A, Florczak E, Kadziela J, Sliwinski P, Bielen P, et al. Effects of renal sympathetic denervation on blood pressure, sleep apnea course, and glycemic control in patients with resistant hypertension and sleep apnea. Hypertension 2011; 58: 559-565.