Design considerations for clinical trials of autonomic modulation therapies targeting hypertension and heart failure

Hypertension

Volumn 65, Issue 1, 2015, Pages 5-15

  Zannad, Faiez ^a   Stough, Wendy Gattis ^b   Mahfoud, Felix ^c   Bakris, George L ^c,d   Kjeldsen, Sverre E ^e,l   Kieval, Robert S ^f   Haller, Hermann ^g,m   Yared, Nadim ^f   De Ferrari, Gaetano M ^h   Piña, Ileana L ⁱ   Stein, Kenneth ^j,k   Azizi, Michel ^k,n  

^a UNIVERSITY HOSPITAL OF NANCY   (France)

^b CAMPBELL UNIVERSITY   (United States)

^c Klinik Für Innere Medizin III Kardiologie Angiologie und Internistische Intensivmedizin   (Germany)

^d USA   (United States)

^e UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^f ULLEVÅL UNIVERSITY HOSPITAL   (Norway)

^g CVRX INC   (United States)

^h HANNOVER MEDICAL SCHOOL   (Germany)

ⁱ FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

^j MONTEFIORE MEDICAL CENTER   (United States)

^k BOSTON SCIENTIFIC CORPORATION   (United States)

^l UNIVERSITÉ PARIS DESCARTES   (France)

^m HÔPITAL EUROPÉEN GEORGES POMPIDOU   (France)

ⁿ INSERM   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIHYPERTENSIVE THERAPY; AUTONOMIC NERVOUS SYSTEM; CLINICAL TRIAL (TOPIC); CONTROL GROUP; FOLLOW UP; HEART FAILURE; HUMAN; HYPERTENSION; KIDNEY DENERVATION; RESISTANT HYPERTENSION; REVIEW; RISK ASSESSMENT; STUDY DESIGN; PATHOPHYSIOLOGY; PRESSORECEPTOR; PROCEDURES;

AUTONOMIC NERVOUS SYSTEM; CLINICAL TRIALS AS TOPIC; HEART FAILURE; HUMANS; HYPERTENSION; PRESSORECEPTORS;

EID: 84919457720     PISSN: 0194911X     EISSN: 15244563     Source Type: Journal    
DOI: 10.1161/HYPERTENSIONAHA.114.04057     Document Type: Review

References (97)

1. Zile MR, Little WC. Effects of autonomic modulation: more than just blood pressure. J Am Coll Cardiol. 2012;59:910-912.
2. Mearns BM. Hypertension: Further EnligHTNment on renal sympathetic denervation. Nat Rev Cardiol. 2013;10:490.
3. Scheffers IJ, Kroon AA, Schmidli J, et al. Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. J Am Coll Cardiol. 2010;56:1254-1258.
4. Kroon A. Sustained blood pressure reduction by baroreflex activation therapy with a chronically iimplanted system: 4-year data from the Rheos DEBuT-HT study in patients with resistant hypertension [abstract]. J Hypertens. 2010;28:e441.
5. Illig KA, Levy M, Sanchez L, Trachiotis GD, Shanley C, Irwin E, Pertile T, Kieval R, Cody R. An implantable carotid sinus stimulator for drug-resistant hypertension: surgical technique and short-term outcome from the multicenter phase II Rheos feasibility trial. J Vasc Surg. 2006;44:1213-1218.
6. Hoppe UC, Brandt MC, Wachter R, Beige J, Rump LC, Kroon AA, Cates AW, Lovett EG, Haller H. Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial. J Am Soc Hypertens. 2012;6:270-276.
7. Alnima T, de Leeuw PW, Kroon AA. Baroreflex activation therapy for the treatment of drug-resistant hypertension: new developments. Cardiol Res Pract. 2012;2012:587194.
8. Georgakopoulos D, Little WC, Abraham WT, Weaver FA, Zile MR. Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. J Card Fail. 2011;17:167-178.
9. La Rovere MT, Bigger JT Jr, Marcus FI, Mortara A, Schwartz PJ. Baroreflex sensitivity and heart-rate variability in prediction of total cardiac mortality after myocardial infarction. ATRAMI (Autonomic Tone and Reflexes After Myocardial Infarction) Investigators. Lancet. 1998;351:478-484.
10. Schwartz PJ, Vanoli E, Stramba-Badiale M, De Ferrari GM, Billman GE, Foreman RD. Autonomic mechanisms and sudden death. New insights from analysis of baroreceptor reflexes in conscious dogs with and without a myocardial infarction. Circulation. 1988;78:969-979.
11. Billman GE, Schwartz PJ, Stone HL. Baroreceptor reflex control of heart rate: a predictor of sudden cardiac death. Circulation. 1982;66:874-880.
12. Olshansky B, Sabbah HN, Hauptman PJ, Colucci WS. Parasympathetic nervous system and heart failure: pathophysiology and potential implications for therapy. Circulation. 2008;118:863-871.
13. Smith PA, Graham LN, Mackintosh AF, Stoker JB, Mary DA. Relationship between central sympathetic activity and stages of human hypertension. Am J Hypertens. 2004;17:217-222.
14. Mahfoud F, Lüscher TF, Andersson B, et al; European Society of Cardiology. Expert consensus document from the European Society of Cardiology on catheter-based renal denervation. Eur Heart J. 2013;34:2149-2157.
15. Mahfoud F, Kjeldsen SE. Catheter-based renal denervation: a word of caution. EuroIntervention. 2013;8:997-998.
16. Azizi M, Steichen O, Frank M, Bobrie G, Plouin PF, Sapoval M. Catheterbased radiofrequency renal-nerve ablation in patients with resistant hypertension. Eur J Vasc Endovasc Surg. 2012;43:293-299.
17. Persu A, Azizi M, Burnier M, Staessen JA. Residual effect of renal denervation in patients with truly resistant hypertension. Hypertension. 2013;62:450-452.
18. Hering D, Lambert EA, Marusic P, Walton AS, Krum H, Lambert GW, Esler MD, Schlaich MP. Substantial reduction in single sympathetic nerve firing after renal denervation in patients with resistant hypertension. Hypertension. 2013;61:457-464.
19. Fadel PJ, Stromstad M, Wray DW, Smith SA, Raven PB, Secher NH. New insights into differential baroreflex control of heart rate in humans. Am J Physiol Heart Circ Physiol. 2003;284:H735-H743.
20. Krum H, Sobotka P, Mahfoud F, Böhm M, Esler M, Schlaich M. Devicebased antihypertensive therapy: therapeutic modulation of the autonomic nervous system. Circulation. 2011;123:209-215.
21. Bhatt DL, Kandzari DE, ONeill WW, DAgostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014;370:1393-1401.
22. Bohm M, Schlaich M, Narkiewicz K, Ruilope L, Williams B, Schmieder R, Mahfoud F, Mancia G. The Global SYMPLICITY Registry: safety and effectiveness of renal artery denervation in real world patients with uncontrolled hypertension [abstract] [Late Breaking Sessions, March 30, 2014]. Am Coll Cardiol. 2014.
23. Hróbjartsson A, Thomsen AS, Emanuelsson F, Tendal B, Hilden J, Boutron I, Ravaud P, Brorson S. Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and nonblinded outcome assessors. BMJ. 2012;344:e1119.
24. Scheffers IJ, Kroon AA, de Leeuw PW. Carotid baroreflex activation: past, present, and future. Curr Hypertens Rep. 2010;12:61-66.
25. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408-412.
26. Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet. 2002;359:696-700.
27. Esler MD, Krum H, Schlaich M, Schmieder RE, Böhm M, Sobotka PA; Symplicity HTN-2 Investigators. 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.
28. Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009;373:1275-1281.
29. Bakris GL, Nadim MK, Haller H, Lovett EG, Schafer JE, Bisognano JD. Baroreflex 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.
30. Bisognano JD, Bakris G, Nadim MK, Sanchez L, Kroon AA, Schafer J, de Leeuw PW, Sica DA. 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;58:765-773.
31. Psaty BM, Prentice RL. Minimizing bias in randomized trials: the importance of blinding. JAMA. 2010;304:793-794.
32. Zannad F, Garcia AA, Anker SD, et al. Clinical outcome end points in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail. 2013;15:1082-1094.
33. Food and Drug Administration Center for Drug Evaluation and Research. Guidance for Industry. Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm075072.pdf. 2011. Accessed May 9, 2014.
34. Schwartz PJ, De Ferrari GM, Sanzo A, Landolina M, Rordorf R, Raineri C, Campana C, Revera M, Ajmone-Marsan N, Tavazzi L, Odero A. Long term vagal stimulation in patients with advanced heart failure: first experience in man. Eur J Heart Fail. 2008;10:884-891.
35. Kirklin JK, Naftel DC, Pagani FD, Kormos RL, Stevenson LW, Blume ED, Miller MA, Timothy Baldwin J, Young JB. Sixth INTERMACS annual report: a 10, 000-patient database. J Heart Lung Transplant. 2014;33:555-564.
36. US Department of Health and Human Services Food and Drug Administration. Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff: Design Considerations for Pivotal Clinical Investigations for Medical Devices. www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM373766.pdf. 2013. Accessed May 9, 2014.
37. European Medicines Agency. Reflection Paper on Methodological Issues in Confirmatory Clinical Trials Planned With an Adaptive Design. www. ema.europa.eu. 2007. Accessed May 9, 2014.
38. Food and Drug Administration. Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 2010. Accessed May 9, 2014.
39. Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, Levine JH, Saksena S, Waldo AL, Wilber D, Brown MW, Heo M. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med. 1996;335:1933-1940.
40. Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877-883.
41. Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiacresynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361:1329-1338.
42. Coffey CS, Levin B, Clark C, Timmerman C, Wittes J, Gilbert P, Harris S. Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop. Clin Trials. 2012;9:671-680.
43. Emerson SS, Fleming TR. Adaptive methods: telling the rest of the story. J Biopharm Stat. 2010;20:1150-1165.
44. Wittes J. Comments on the FDA draft guidance on adaptive designs. J Biopharm Stat. 2010;20:1166-1170.
45. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med. 1996;125:605-613.
46. Mancia G, Fagard R, Narkiewicz K, et al; Task Force Members. 2013 ESH/ESC 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). J Hypertens. 2013;31:1281-1357.
47. SHEP Cooperative Research Group. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA. 1991;265:3255-3264.
48. Staessen JA, Fagard R, Thijs L, et al. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. The Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Lancet. 1997;350:757-764.
49. Staessen JA, Wang JG, Thijs L. Cardiovascular protection and blood pressure reduction: a meta-analysis. Lancet. 2001;358:1305-1315.
50. Dorenkamp M, Bonaventura K, Leber AW, Boldt J, Sohns C, Boldt LH, Haverkamp W, Frei U, Roser M. Potential lifetime cost-effectiveness of catheter-based renal sympathetic denervation in patients with resistant hypertension. Eur Heart J. 2013;34:451-461.
51. Young KC, Teeters JC, Benesch CG, Bisognano JD, Illig KA. Costeffectiveness of treating resistant hypertension with an implantable carotid body stimulator. J Clin Hypertens (Greenwich). 2009;11:555-563.
52. Drummond M, Barbieri M, Cook J, Glick HA, Lis J, Malik F, Reed SD, Rutten F, Sculpher M, Severens J. Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force report. Value Health. 2009;12:409-418.
53. Reed SD, Anstrom KJ, Bakhai A, et al. Conducting economic evaluations alongside multinational clinical trials: toward a research consensus. Am Heart J. 2005;149:434-443.
54. Reed SD. How country-specific should a country-specific cost-effectiveness analysis be? Eur Heart J. 2013;34:166-167.
55. Torti FM Jr, Reed SD, Schulman KA. Analytic considerations in economic evaluations of multinational cardiovascular clinical trials. Value Health. 2006;9:281-291.
56. Vink EE, Verloop WL, Bost RB, Voskuil M, Spiering W, Vonken EJ, Bots ML, Blankestijn PJ. The blood pressure-lowering effect of renal denervation is inversely related to kidney function. J Hypertens. 2014;32:2045-2053.
57. Hering D, Mahfoud F, Walton AS, Krum H, Lambert GW, Lambert EA, Sobotka PA, Böhm M, Cremers B, Esler MD, Schlaich MP. Renal denervation in moderate to severe CKD. J Am Soc Nephrol. 2012;23:1250-1257.
58. Verloop WL, Vink EE, Voskuil M, Vonken EJ, Rookmaaker MB, Bots ML, Doevendans PA, Blankestijn PJ, Spiering W. Eligibility for percutaneous renal denervation: the importance of a systematic screening. J Hypertens. 2013;31:1662-1668.
59. Persu A, Jin Y, Baelen M, et al; European Network Coordinating research on REnal Denervation Consortium. Eligibility for renal denervation: experience at 11 European expert centers. Hypertension. 2014;63:1319-1325.
60. National Institute for Health and Care Excellence. Hypertension: Clinical management of primary hypertension in adults. http://www.nice.org.uk/guidance/cg127/chapter/guidance. 2011. Accessed May 9, 2014.
61. Schmieder RE, Redon J, Grassi G, Kjeldsen SE, Mancia G, Narkiewicz K, Parati G, Ruilope L, van de Borne P, Tsioufis C. ESH position paper: renal denervation -an interventional therapy of resistant hypertension. J Hypertens. 2012;30:837-841.
62. Jin Y, Jacobs L, Baelen M, Thijs L, Renkin J, Hammer F, Kefer J, Petit T, Verhamme P, Janssens S, Sinnaeve P, Lengelé JP, Persu A, Staessen JA; Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) Iinvestigators. Rationale and design of the Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial. Blood Press. 2014;23:138-146.
63. 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.
64. Doumas M, Anyfanti P, Bakris G. Should ambulatory blood pressure monitoring be mandatory for future studies in resistant hypertension: a perspective. J Hypertens. 2012;30:874-876.
65. Kandzari DE, Bhatt DL, Sobotka PA, ONeill WW, Esler M, Flack JM, Katzen BT, Leon MB, Massaro JM, Negoita M, Oparil S, Rocha-Singh K, Straley C, Townsend RR, Bakris G. Catheter-based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN-3 Trial. Clin Cardiol. 2012;35:528-535.
66. Tousek P, Jr, Rosa J, Curila K, Branny M, Nykl I, Taborsky M, Vaclavik J, Widimsky P. Catheter-based renal denervation versus intensified medical treatment in patients with resistant hypertension: Rationale and design of a multicenter randomized study-PRAGUE-15. Cor et Vasa. 2014;56:e235-e239.
67. Ceral J, Habrdova V, Vorisek V, Bima M, Pelouch R, Solar M. Difficult-tocontrol arterial hypertension or uncooperative patients? The assessment of serum antihypertensive drug levels to differentiate non-responsiveness from non-dherence to recommended therapy. Hypertens Res. 2011;34:87-90.
68. Tomaszewski M, White C, Patel P, Masca N, Damani R, Hepworth J, Samani NJ, Gupta P, Madira W, Stanley A, Williams B. High rates of nonadherence to antihypertensive treatment revealed by high-performance liquid chromatography-tandem mass spectrometry (HP LC-MS/MS) urine analysis. Heart. 2014;100:855-861.
69. Fadl Elmula FE, Hoffmann P, Larstorp AC, Fossum E, Brekke M, Kjeldsen SE, Gjønnss E, Hjørnholm U, Kjaer VN, Rostrup M, Os I, Stenehjem A, Høieggen A. Adjusted drug treatment is superior to renal sympathetic denervation in patients with true treatment-resistant hypertension. Hypertension. 2014;63:991-999.
70. Fadl Elmula FE, Hoffmann P, Fossum E, Brekke M, Gjønnss E, Hjørnholm U, Kjr VN, Rostrup M, Kjeldsen SE, Os I, Stenehjem AE, Høieggen A. Renal sympathetic denervation in patients with treatmentresistant hypertension after witnessed intake of medication before qualifying ambulatory blood pressure. Hypertension. 2013;62:526-532.
71. Jung O, Gechter JL, Wunder C, Paulke A, Bartel C, Geiger H, Toennes SW. Resistant hypertension? Assessment of adherence by toxicological urine analysis. J Hypertens. 2013;31:766-774.
72. Persu A, Jin Y, Azizi M, et al; European Network COordinating research on Renal Denervation (ENCOReD). Blood pressure changes after renal denervation at 10 European expert centers. J Hum Hypertens. 2014;28:150-156.
73. Esler M. Illusions of truths in the Symplicity HTN-3 trial: generic design strengths but neuroscience failings. J Am Soc Hypertens. 2014;8:593-598.
74. Ukena C, Cremers B, Ewen S, Böhm M, Mahfoud F. Response and nonresponse to renal denervation: who is the ideal candidate? EuroIntervention. 2013;9(suppl R):R54-R57.
75. De Ferrari GM, Schwartz PJ. Vagus nerve stimulation: from preclinical to clinical application: challenges and future directions. Heart Fail Rev. 2011;16:195-203.
76. Heusser K, Tank J, Engeli S, Diedrich A, Menne J, Eckert S, Peters T, Sweep FC, Haller H, Pichlmaier AM, Luft FC, Jordan J. Carotid baroreceptor stimulation, sympathetic activity, baroreflex function, and blood pressure in hypertensive patients. Hypertension. 2010;55:619-626.
77. Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med. 2009;361:932-934.
78. Vogel B, Kirchberger M, Zeier M, Stoll F, Meder B, Saure D, Andrassy M, Mueller OJ, Hardt S, Schwenger V, Strothmeyer A, Katus HA, Blessing E. Renal sympathetic denervation therapy in the real world: results from the Heidelberg registry. Clin Res Cardiol. 2014;103:117-124.
79. Myat A, Redwood SR, Qureshi AC, Thackray S, Cleland JG, Bhatt DL, Williams B, Gersh BJ. Renal sympathetic denervation therapy for resistant hypertension: a contemporary synopsis and future implications. Circ Cardiovasc Interv. 2013;6:184-197.
80. Mahfoud F, Bhatt DL. Catheter-based renal denervation: the black box procedure. JACC Cardiovasc Interv. 2013;6:1092-1094.
81. Davis MI, Filion KB, Zhang D, Eisenberg MJ, Afilalo J, Schiffrin EL, Joyal D. Effectiveness of renal denervation therapy for resistant hypertension: a systematic review and meta-analysis. J Am Coll Cardiol. 2013;62:231-241.
82. Perloff D, Sokolow M, Cowan R. The prognostic value of ambulatory blood pressure monitoring in treated hypertensive patients. J Hypertens Suppl. 1991;9:S33-9; discussion S39.
83. Clement DL, De Buyzere ML, De Bacquer DA, de Leeuw PW, Duprez DA, Fagard RH, Gheeraert PJ, Missault LH, Braun JJ, Six RO, Van Der Niepen P, OBrien E; Office versus Ambulatory Pressure Study Investigators. Prognostic value of ambulatory blood-pressure recordings in patients with treated hypertension. N Engl J Med. 2003;348:2407-2415.
84. Smith DH, Neutel JM, Lacourcière Y, Kempthorne-Rawson J. Prospective, randomized, open-label, blinded-end point (PROBE) designed trials yield the same results as double-blind, placebo-controlled trials with respect to ABPM measurements. J Hypertens. 2003;21:1291-1298.
85. White WB, Giles T, Bakris GL, Neutel JM, Davidai G, Weber MA. Measuring the efficacy of antihypertensive therapy by ambulatory blood pressure monitoring in the primary care setting. Am Heart J. 2006;151:176-184.
86. Gassler JP, Lynch PS, Bisognano JD. The role of baroreflex activation therapy in sympathetic modulation for the treatment of resistant hypertension. Heart. 2012;98:1689-1692.
87. Krum H, Schlaich MP, Sobotka PA, Böhm M, Mahfoud F, Rocha-Singh K, Katholi R, Esler MD. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014;383:622-629.
88. Hauser RG. Here we go again-failure of postmarketing device surveillance. N Engl J Med. 2012;366:873-875.
89. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011;171:1006-1011.
90. Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010;376:1903-1909.
91. Kaltenbach B, Id D, Franke JC, Sievert H, Hennersdorf M, Maier J, Bertog SC. Renal artery stenosis after renal sympathetic denervation. J Am Coll Cardiol. 2012;60:2694-2695.
92. Vonend O, Antoch G, Rump LC, Blondin D. Secondary rise in blood pressure after renal denervation. Lancet. 2012;380:778.
93. Jaen AF, Mediavilla Garcia JD, Molina NE, Vargas Hitos JA, Fernandez-Torres C. Bilateral renal artery stenosis after renal denervation. Hypertension. 2014;63:e126-e127.
94. De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J, Raspopovic S, Klein H, Swedberg K, Schwartz PJ; CardioFit Multicenter Trial Investigators. Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure. Eur Heart J. 2011;32:847-855.
95. Li M, Zheng C, Sato T, Kawada T, Sugimachi M, Sunagawa K. Vagal nerve stimulation markedly improves long-term survival after chronic heart failure in rats. Circulation. 2004;109:120-124.
96. Zhang Y, Popovic ZB, Bibevski S, Fakhry I, Sica DA, Van Wagoner DR, Mazgalev TN. Chronic vagus nerve stimulation improves autonomic control and attenuates systemic inflammation and heart failure progression in a canine high-rate pacing model. Circ Heart Fail. 2009;2:692-699.
97. Hauptman PJ, Schwartz PJ, Gold MR, Borggrefe M, Van Veldhuisen DJ, Starling RC, Mann DL. Rationale and study design of the increase of vagal tone in heart failure study: INOVATE-HF. Am Heart J. 2012;163:954-962.e1.