Cost-effectiveness of Barostim therapy for the treatment of resistant hypertension in European settings

Journal of Hypertension

Volumn 32, Issue 3, 2014, Pages 681-692

  Borisenko, Oleg ^a   Beige, Joachim ^b   Lovett, Eric G ^c   Hoppe, Uta C ^d   Bjessmo, Staffan ^e  

^a Synergus AB   (Sweden)

^b Klinikum St Georg   (Germany)

^c CVRX INC   (United States)

^d PARACELSUS MEDICAL UNIVERSITY   (Austria)

^e KAROLINSKA INSTITUTE   (Sweden)

Author keywords

Baroreflex activation therapy; Barostim; Costeffectiveness analysis; Resistant hypertension

Indexed keywords

ARTICLE; CEREBROVASCULAR ACCIDENT; CLINICAL EFFECTIVENESS; COST EFFECTIVENESS ANALYSIS; DECISION TREE; DEVICE THERAPY; ECONOMIC EVALUATION; END STAGE RENAL DISEASE; EUROPE; HEART FAILURE; HEART INFARCTION; PLACEBO EFFECT; PRIORITY JOURNAL; RESISTANT HYPERTENSION; SIMULATION;

CAROTID ARTERIES; COMPUTER SIMULATION; COST-BENEFIT ANALYSIS; DECISION SUPPORT TECHNIQUES; ELECTRIC STIMULATION THERAPY; EUROPE; HUMANS; HYPERTENSION; MALE; MIDDLE AGED; PRESSORECEPTORS; QUALITY-ADJUSTED LIFE YEARS;

EID: 84894043717     PISSN: 02636352     EISSN: 14735598     Source Type: Journal    
DOI: 10.1097/HJH.0000000000000071     Document Type: Article

References (59)

1. Kannel WB. Blood pressure as a cardiovascular risk factor: prevention and treatment. JAMA 1996; 275:1571-1576.
2. Wolf-Maier K, Cooper R, Kramer H, Banegas J, Giampaoli S, Joffres M, et al. Hypertension treatment and control in Five European countries, Canada, and the United States. Hypertension 2004; 43:10-17.
3. Sander GE, Giles TD. Resistant hypertension: concepts and approach to management. Curr Hypertens Rep 2011; 13:347-355.
4. Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, et al. The Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). ESH/ESC Guidelines for the management of arterial hypertension. J Hypertens 2013; 31:1281-1357.
5. Drummond MF, Sculpher MJ, Torrance GW, O'Brian BJ, Stoddart GL. Methods for the economic evaluation of healthcare programmes. New York: Oxford University Press; 2005.
6. Conroy RM, Pyorala K, Fitzgerald AP, Sans S, Menotti A, De Backer G, et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J 2003; 24:987-1003.
7. Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J 1991; 121:293-298.
8. D'Agostino RB, Wolf PA, Belanger AJ, Kannel WB. Stroke risk profile: adjustment for antihypertensive medication. The Framingham Study. Stroke 1994; 25:40-43.
9. Kannel WB, D'Agostino RB, Silbershatz H, Belanger AJ, Wilson PW, Levy D. Profile for estimating risk of heart failure. Arch Intern Med 1999; 159:1197-1204.
10. Wolf PA, D'Agostino RB, Belanger AJ, KannelWB. Probability of stroke: a risk profile from the Framingham study. Stroke 1991; 22:312-318.
11. Hsu CY, McCulloch CE, Darbinian J, Go AS, Iribarren C. Elevated blood pressure and risk of end-stage renal disease in subjects without baseline kidney disease. Arch Intern Med 2005; 165:923-928.
12. Mortality rates. German Federal Statistics Office 2010. https://wwwgenesis.destatis.de/genesis/online;jsessionid=69D8F957255CAC3244- D997EE9EC933B4.tomcat-GO-1-1?operation=previous&levelindex=0&levelid= 1348918258785&step=0 [Accessed 18 June 2013].
13. Life tables. German Federal Statistics Office 2008-2010. https://www.destatis.de/EN/FactsFigures/SocietyState/Population/Deaths/Deaths. html [Accessed 18 June 2013].
14. Bisognano JD, Bakris G,NadimMK, Sanchez L, Kroon AA, Schafer J, 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; 58:765-773.
15. 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.
16. Kroon ASJ, Scheffers I, Tordoir J, Mohaupt M, Allemann Y, Jordan J, et al. Sustained blood pressure reduction by Baroreflex activation therapy with a chronically implanted system: 4-year data of Rheos Debut-HT study in patients with resistant hypertension. J Hypertens 2010; 28:e441.
17. Scheffers I, Kroon SJ, Tordoir AA, Mohaupt J, Allemann M, Jordan Y, et al. Sustained blood pressure reduction by baroreflex hypertension therapy with a chronically implanted system: 3-year data from the Rheos DEBuT study in patients with resistant hypertension. J Hypertens 2009; 27 (suppl 4):S421.
18. Scheffers IJ, Kroon AA, Schmidli J, Jordan J, Tordoir JJ, Mohaupt MG, et al. Novel baroreflex activation therapy in resistant hypertension: results of a European multicenter feasibility study. J Am Coll Cardiol 2010; 56:1254-1258.
19. Hoppe UC, Brandt MC, Wachter R, Beige J, Rump LC, Kroon AA, et al. 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.
20. Rosengren A, Wilhelmsen L, Hagman M, Wedel H. Natural history of myocardial infarction and angina pectoris in a general population sample of middle-aged men: a 16-year follow-up of the Primary Prevention Study, Goteborg, Sweden. J Intern Med 1998; 244:495-505.
21. Zanchetti A,Hansson L,Dahlof B, Elmfeldt D, Kjeldsen S,Kolloch R, et al. Effects of individual risk factors on the incidence of cardiovascular events in the treated hypertensive patients of the Hypertension Optimal Treatment Study. HOT Study Group. J Hypertens 2001; 19:1149-1159.
22. Krumholz HM, Wang Y, Chen J, Drye EE, Spertus JA, Ross JS, et al. Reduction in acute myocardial infarction mortality in the United States: risk-standardized mortality rates from 1995-2006. JAMA 2009; 302:767-773.
23. Dennis MS, Burn JP, Sandercock PA, Bamford JM, Wade DT, Warlow CP. Long-term survival after first-ever stroke: the Oxfordshire Community Stroke Project. Stroke 1993; 24:796-800.
24. Ovbiagele B, Diener HC, Yusuf S, Martin RH, Cotton D, Vinisko R, et al. Level of systolic blood pressure within the normal range and risk of recurrent stroke. JAMA 2011; 306:2137-2144.
25. Seliger SL, Gillen DL, Longstreth WT, Kestenbaum B, Stehman-Breen CO. Elevated risk of stroke among patients with end-stage renal disease. Kidney Int 2003; 64:603-609.
26. Witt BJ, Ballman KV, Brown RD, Meverden RA, Jacobsen SJ, Roger VL. The incidence of stroke after myocardial infarction: a meta-analysis. Am J Med 2006; 119:354 e1-354 e19.
27. Witt BJ, Gami AS, Ballman KV, Brown RD, Meverden RA, Jacobsen SJ, et al. The incidence of ischemic stroke in chronic heart failure: a metaanalysis. J Cardiac Fail 2007; 13:489-496.
28. Arnold JM, Yusuf S, Young J, Mathew J, Johnstone D, Avezum A, et al. Prevention of Heart Failure in Patients in the Heart Outcomes Prevention Evaluation (HOPE) Study. Circulation 2003; 107:1284-1290.
29. Velagaleti RS, Pencina MJ, Murabito JM, Wang TJ, Parikh NI, D'Agostino RB, et al. Long-term trends in the incidence of heart failure after myocardial infarction. Circulation 2008; 118:2057-2062.
30. Villar E, Remontet L, Labeeuw M, Ecochard R. Effect of age, gender, and diabetes on excess death in end-stage renal failure. J Am Soc Nephrol 2007; 18:2125-2134.
31. de Silva R, Nikitin NP, Witte KK, Rigby AS, Goode K, Bhandari S, et al. Incidence of renal dysfunction over 6 months in patients with chronic heart failure due to left ventricular systolic dysfunction: contributing factors and relationship to prognosis. Eur Heart J 2006; 27:569-581.
32. Rabbat CG, Thorpe KE, Russell JD, Churchill DN. Comparison of mortality risk for dialysis patients and cadaveric first renal transplant recipients in Ontario, Canada. J Am Soc Nephrol 2000; 11:917-922.
33. Briggs A, Claxton K, Sculpher M. Decision modelling for health economic evaluation. New York: Oxford University Press; 2006.
34. Brüggenjürgen B, Rupprecht HJ, Willich SN, Spannagl M, Ehlken B, Smala A, et al. Cost of atherothrombotic diseases-myocardial infarction, ischaemic stroke and peripheral arterial occlusive disease-in Germany. J Public Health 2005; 13:216-224.
35. Dodel RC, Haacke C, Zamzow K, Paweilik S, Spottke A, Rethfeldt M, et al. Resource utilization and costs of stroke unit care in Germany. Value Health 2004; 7:144-152.
36. Kolominsky-Rabas PL, Heuschmann PU, Marschall D, Emmert M, Baltzer N, Neundorfer B, et al. Lifetime cost of ischemic stroke in Germany: results and national projections from a population-based stroke registry - the Erlangen Stroke Project. Stroke 2006; 37:1179-1183.
37. McMurray JJ, Andersson FL, Stewart S, Svensson K, Solal AC, Dietz R, et al. Dialysis: a regional population-based analysis. Nephrology Assessment of Reduction in Mortality and Morbidity (CHARM) programme. Eur Heart J 2006; 27:1447-1458.
38. Icks A, Haastert B, Gandjour A, Chernyak N, Rathmann W, Giani G, et al. Costs of dialysis: a regional population-based analysis. Nephrol Dial Transplant 2010; 25:1647-1652.
39. Hagenmeyer EG, Haussler B, Hempel E, Grannas G, Kalo Z, Kilburg A, et al. Resource use and treatment costs after kidney transplantation: impact of demographic factors, comorbidities, and complications. Transplantation 2004; 77:1545-1550.
40. PharmNet.Bund-Drug Information System. German Institute of Medical Documentation and Information 2012. http://www.dimdi.de/static/de/index.html. [Accessed 18 June 2013].
41. Einheitlicher Bewertungsmaßstab. 2012. http://www.kbv.de/ebm 2012/EBMGesamt.htm. [Accessed 18 June 2013].
42. Consumer Price Index. 2012. https://www.destatis.de/EN/Facts Figures/NationalEconomyEnvironment/Prices/ConsumerPriceIndices/Tables-/ ConsumerPricesCategories.html?cms-gtp=151228-list%253D1 %2526151226- slot%253D2&https=1. [Accessed 18 June 2013].
43. Calvert MJ, Freemantle N, Cleland JF. The impact of chronic heart failure on health-related quality of life data acquired in the baseline phase of the CARE-HF study. Eur J Heart Fail 2005; 7:243-251.
44. Dorman P, Dennis M, Sandercock P. Are the modified 'simple questions' a valid and reliable measure of health related quality of life after stroke? J Neurol Neurosurg Psychiatry 2000; 69:487-493.
45. Haacke C, Althaus A, Spottke A, Siebert U, Back T, Dodel R. Long-term outcome after stroke. Stroke 2006; 37:193-198.
46. Lee AJ, Morgan CL, Conway P, Currie CJ. Characterisation and comparison of health-related quality of life for patients with renal failure. Curr Med Res Opin 2005; 21:1777-1783.
47. Mahoney EM, Jurkovitz CT, Chu H, Becker ER, Culler S, Kosinski A, et al. Cost and cost-effectiveness of an early invasive vs conservative strategy for the treatment of unstable angina and non-ST-segment elevation myocardial infarction. JAMA 2002; 288:1851-1858.
48. Stein JD, Brown GC, Brown MM, Sharma S, Hollands H, Stein HD. The quality of life of patients with hypertension. J Clin Hypertens 2002; 4:181-188.
49. Sullivan PW, Slejko JF, Sculpher MJ, Ghushchyan V. Catalogue of EQ-5D scores for the United Kingdom. Med Decis Making 2011; 31:800-804.
50. Erbel R, Eisele L, Moebus S, Dragano N, Mohlenkamp S, Bauer M, et al. The Heinz Nixdorf Recall study. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2012; 55:809-815.
51. Eichler HG, Kong SX, Gerth WC, Mavros P, Jönsson B. Use of costeffectiveness analysis in health-care resource allocation decisionmaking: how are cost-effectiveness thresholds expected to emerge? Value Health 2004; 7:518-528.
52. Belgian Healthcare Knowledge Centre. Threshold values for costeffectiveness in healthcare; 2008.
53. General Methods for the Assessment of the Relation of Benefits to Costs Version 1.0. German National Institute for Quality and Efficiency in Healthcare; 2009.
54. Dahlöf B, Sever PS, Poulter NR, Wedel H, Beevers DG, Caulfield M, et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet 2005; 366:895-906.
55. Sever PS, Dahlöf B, Poulter NR, Wedel H, Beevers G, Caulfield M, et al. Rationale, design, methods and baseline demography of participants of the Anglo-Scandinavian Cardiac Outcomes Trial ASCOT investigators. J Hypertens 2001; 19:1139-1147.
56. Young KC, Teeters JC, Benesch CG, Bisognano JD, Illig KA. Costeffectiveness of treating resistant hypertension with an implantable carotid body stimulator. J Clin Hypertens 2009; 11:555-563.
57. Geisler BP, Egan BM, Cohen JT, Garner AM, Akehurst RL, Esler MD, et al. Cost-effectiveness and clinical effectiveness of catheter-based renal denervation for resistant hypertension. J Am Coll Cardiol 2012; 60:1271-1277.
58. Siebert U, Alagoz O, Bayoumi AM, Jahn B, Owens DK, Cohen DJ, et al. State-Transition Modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-3. Value Health 2012; 15:812-820.
59. 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.