Spinal cord stimulation in the treatment of refractory angina: systematic review and meta-analysis of randomised controlled trials

Rod S Taylor, Jessica De Vries, Eric Buchser, Mike J L Dejongste, Rod S Taylor, Jessica De Vries, Eric Buchser, Mike J L Dejongste

Abstract

Background: The aim of this paper was undertake a systematic review and meta-analysis of the use of spinal cord stimulation (SCS) in the management of refractory angina.

Methods: We searched a number of electronic databases including Medline, Embase and Cochrane Library up to February 2008 to identify randomised controlled trials (RCTs) reporting exercise capacity, ischemic burden, functional class, quality of life, usage of anti-anginal medication, costs and adverse events including mortality. Results were reported both descriptively for each study and using random effects meta-analysis. Given the variety in outcomes reported, some outcome results were pooled as standardised mean differences (SMD) and reported in standard deviation units.

Results: Seven RCTs were identified in a total of 270 refractory angina patients. The outcomes of SCS were found to be similar when directly compared to coronary artery bypass grafting (CABG) and percutaneous myocardial laser revascularisation (PMR). Compared to a 'no stimulation' control, there was some evidence of improvement in all outcomes following SCS implantation with significant gains observed in pooled exercise capacity (SMD: 0.76, 0.07 to 1.46, p = 0.03) and health-related quality of life (SMD: 0.83, 95% CI: 0.32 to 1.34, p = 0.001). Trials were small and were judged to range considerably in their quality. The healthcare costs of SCS appeared to be lower than CABG at 2-years follow up.

Conclusion: SCS appears to be an effective and safe treatment option in the management of refractory angina patients and of similar efficacy and safety to PMR, a potential alternative treatment. Further high quality RCT and cost effectiveness evidence is needed before SCS can be accepted as a routine treatment for refractory angina.

Figures

Figure 1
Figure 1
Summary of study selection and exclusion process.
Figure 2
Figure 2
Exercise capacity – between-group difference.
Figure 3
Figure 3
Ischemic burden – between-group difference.
Figure 4
Figure 4
Nitrate drug consumption – between-group difference.
Figure 5
Figure 5
Health related quality of life – between-group difference. Based on NHP part 1 score for ESBY 1993; SF-36 physical health scale at 2-years for SPiRiT, 2006; ADL score for DeJongste 1994, EQ-5D VAS score for Eddicks 2008; LASA score for Hauvast 1998.

References

    1. Mannheimer C, Camici P, Chester MR, Collins A, DeJongste M, Eliasson T, Follath F, Hellemans I, Herlitz J, Lüscher T, Pasic M, Thelle D. The problem of chronic refractory angina; report from the ESC Joint Study Group on the Treatment of Refractory Angina. Eur Heart J. 2002;23:355–70. doi: 10.1053/euhj.2001.2706.
    1. Mukherjee D, Bhatt DL, Roe MT, Patel V, Ellis SG. Direct myocardial revascularization and angiogenesis – how many patients might be eligible? Am J Cardiol. 1999;84:598–60. doi: 10.1016/S0002-9149(99)00387-2.
    1. Svorkdal N. Treatment of inoperable coronary disease and refractory angina: spinal stimulators, epidurals, gene therapy, transmyocardial laser, and counterpulsation. Semin Cardiothorac Vasc Anesth. 2004;8:43–58. doi: 10.1177/108925320400800109.
    1. Murphy DF, Giles KE. Dorsal column stimulation for pain relief from intractable angina pectoris. Pain. 1987;28:365–8. doi: 10.1016/0304-3959(87)90070-4.
    1. Ubbink DT, Vermeulen H. Spinal Cord Stimulation for Critical Leg Ischemia: A Review of Effectiveness & Optimal Patient Selection. J Pain Symptom Manage. 2006;31:S30–5. doi: 10.1016/j.jpainsymman.2005.12.013.
    1. Kemler MA, Barendse GA, van Kleef M, de Vet HC, Rijks CP, Furnee CA, Wildenberg FA van den. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000;348:618–624. doi: 10.1056/NEJM200008313430904.
    1. Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Moletf J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson G, North RB. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. ISRCTN 77527324. Pain. 2007;132:179–88. doi: 10.1016/j.pain.2007.07.028.
    1. Satran D, Traverse JH, Barsness GW, Lerman A, Simari RD, Poulose AK, Johnson RK, Henry TD. Emerging therapies for refractory angina. Minn Med. 2008;91:36–9.
    1. De Vries J, Foreman RD, DeJongste MJ. The anti-ischemic effects of electrical neurostimulation in the heart. Cleve Clin J Med. 2007;74:S42–7.
    1. Buchser E, Durrer A, Albrecht E. Spinal cord stimulation for the management of refractory angina pectoris. J Pain Symptom Manage. 2006;31:S36–42. doi: 10.1016/j.jpainsymman.2005.12.008.
    1. Augustinsson LE. Spinal cord stimulation in peripheral vascular disease and angina pectoris. J Neurosurg Sci. 2003;47:37–40.
    1. DeJongste MJ, Tio RA, Foreman RD. Chronic therapeutically refractory angina pectoris. Heart. 2004;90:225–30. doi: 10.1136/hrt.2003.025031.
    1. Fraker TD, Jr, Fihn SD, 2002 Chronic Stable Angina Writing Committee; American College of Cardiology; American Heart Association. Gibbons RJ, Abrams J, Chatterjee K, Daley J, Deedwania PC, Douglas JS, Ferguson TB, Jr, Gardin JM, O'Rourke RA, Williams SV, Smith SC, Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 chronic angina focused update of the ACC/AHA 2002 guidelines for the management of patients with chronic stable angina: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Writing Group to develop the focused update of the 2002 guidelines for the management of patients with chronic stable angina. J Am Coll Cardiol. 2007;50:2264–74. doi: 10.1016/j.jacc.2007.08.002.
    1. Higgins JPT, Green S, editors . Version 500 [updated February 2008] The Cochrane Collaboration; 2008. Cochrane Handbook for Systematic Reviews of Interventions.
    1. Jadad AR, Cook DJ, Jones A, Klassen TP, Tugwell P, Moher M, Moher D. Methodology and reports of systematic reviews and meta-analyses: a comparison of Cochrane reviews with articles published in paper-based journals. JAMA. 1998;280:278–80. doi: 10.1001/jama.280.3.278.
    1. Follmann D, Elliot P, Suh I, Cutler J. Variance imputation for overviews of clinical trials with continuous response. J Clin Epidemiol. 1992;45:769–773. doi: 10.1016/0895-4356(92)90054-Q.
    1. DerSimonsen R, Laird N. Meta analysis in clinical trials. Control Clin Trials. 1986;7:177–188. doi: 10.1016/0197-2456(86)90046-2.
    1. Egger M, Davey-Smith G, Schneider M, Minder C. Bias in meta analysis detected by a simple graphical test. BMJ. 1997;315:629–634.
    1. Mannheimer C, Eliasson T, Augustinsson LE, Blomstrand C, Emanuelsson H, Larsson S, Norrsell H, Hjalmarsson A. Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris: the ESBY study. Circulation. 1998;97:1157–63.
    1. Andrell P, Ekre O, Eliasson T, Blomstrand C, Börjesson M, Nilsson M, Mannheimer C. Cost-effectiveness of spinal cord stimulation versus coronary artery bypass grafting in patients with severe angina pectoris – long-term results from the ESBY study. Cardiology. 2003;99:20–4. doi: 10.1159/000068447.
    1. Ekre O, Eliasson T, Norrsell H, Währborg P, Mannheimer C. Electrical Stimulation versus Coronary Artery Bypass Surgery in Severe Angina Pectoris. Long-term effects of spinal cord stimulation and coronary artery bypass grafting on quality of life and survival in the ESBY study. Eur Heart J. 2002;23:1938–45. doi: 10.1053/euhj.2002.3286.
    1. Norrsell H, Pilhall M, Eliasson T, Mannheimer C. Effects of spinal cord stimulation and coronary artery bypass grafting on myocardial ischemia and heart rate variability: further results from the ESBY study. Cardiology. 2000;94:12–18. doi: 10.1159/000007040.
    1. McNab D, Khan SN, Sharples LD, Ryan JY, Freeman C, Caine N, Tait S, Hardy I, Schofield PM. An open label, single-centre, randomized trial of spinal cord stimulation vs. percutaneous myocardial laser revascularization in patients with refractory angina pectoris: the SPiRiT trial. Eur Heart J. 2006;27:1048–53. doi: 10.1093/eurheartj/ehi827.
    1. De Jongste MJ, Staal MJ. Preliminary results of a randomized study on the clinical efficacy of spinal cord stimulation for refractory severe angina pectoris. Acta Neurochir Suppl (Wien) 1993;58:161–4.
    1. De Jongste MJ, Hautvast RW, Hillege HL, Lie KI. Efficacy of spinal cord stimulation as adjuvant therapy for intractable angina pectoris: a prospective, randomized clinical study. Working Group on Neurocardiology. J Am Coll Cardiol. 1994;23:1592–7.
    1. Di Pede F, Zuin G, Giada F, Pinato G, Turiano G, Bevilacqua M, Cazzin R, Raviele A. Long-term effects of spinal cord stimulation on myocardial ischemia and heart rate variability: results of a 48-hour ambulatory electrocardiographic monitoring. Ital Heart J. 2001;2:690–5.
    1. Hautvast RW, De Jongste MJ, Staal MJ, van Gilst WH, Lie KI. Spinal cord stimulation in chronic intractable angina pectoris: a randomized, controlled efficacy study. Am Heart J. 1998;136:1114–20. doi: 10.1016/S0002-8703(98)70171-1.
    1. Jessurun GA, De Jongste MJ, Hautvast RW, Tio RA, Brouwer J, van Lelieveld S, Crijns HJ. Clinical follow-up after cessation of chronic electrical neuromodulation in patients with severe coronary artery disease: a prospective randomized controlled study on putative involvement of sympathetic activity. Pacing Clin Electrophysiol. 1999;22:1432–9. doi: 10.1111/j.1540-8159.1999.tb00346.x.
    1. Eddicks S, Maier-Hauff K, Schenk M, Müller A, Baumann G, Theres H. Thoracic spinal cord stimulation improves functional status and relieves symptoms in patients with refractory angina pectoris: the first placebo-controlled randomised study. Heart. 2007;93:585–90. doi: 10.1136/hrt.2006.100784.
    1. Lanza GA, Sestito A, Sgueglia GA, Infusino F, Papacci F, Visocchi M, Ierardi C, Meglio M, Bellocci F, Crea F. Effect of spinal cord stimulation on spontaneous and stress-induced angina and 'ischemia-like' ST-segment depression in patients with cardiac syndrome X. Eur Heart J. 2005;26:983–9. doi: 10.1093/eurheartj/ehi089.
    1. Wu M, Linderoth B, Foreman RD. Putative mechanisms behind effects of spinal cord stimulation on vascular diseases: A review of experimental studies. Auton Neurosci. 2008;138:9–23. doi: 10.1016/j.autneu.2007.11.001.
    1. Van Zundert J. Clinical research in interventional pain management techniques: the clinician's point of view. Pain Pract. 2007;7:221–9. doi: 10.1111/j.1533-2500.2007.00139.x.
    1. Dyer MT, Goldsmith KA, Khan SN, Sharples LD, Freeman C, Hardy I, Buxton MJ, Schofield PM. Clinical and cost-effectiveness analysis of an open label, single-centre, randomised trial of spinal cord stimulation (SCS) versus percutaneous myocardial laser revascularisation (PMR) in patients with refractory angina pectoris: The SPiRiT trial. BMC Trials. 2008;9:40. doi: 10.1186/1745-6215-9-40.

Source: PubMed

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