Spinal cord stimulation for the treatment of refractory angina pectoris: A multicenter randomized single-blind study (the SCS-ITA trial)

Pain

Volumn 152, Issue 1, 2011, Pages 45-52

  Lanza, Gaetano A ^a   Grimaldi, Roberto ^b   Greco, Salvatore ^c   Ghio, Stefano ^d   Sarullo, Filippo ^e   Zuin, Guerrino ^f   De Luca, Anna ^b   Allegri, Massimo ^d   Di Pede, Francesco ^f   Castagno, Davide ^b   Turco, Annalisa ^d   Sapio, Monica ^e   Pinato, Giampaolo ^f   Cioni, Beatrice ^a   Trevi, Giampaolo ^b   Crea, Filippo ^a  

^a CATHOLIC UNIVERSITY   (Italy)

^b MOLINETTE HOSPITAL   (Italy)

^c SAN FILIPPO NERI HOSPITAL   (Italy)

^d FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

^e Buccheri La Ferla Hospital   (Italy)

^f Ospedale Umberto I   (Italy)

Author keywords

Quality of life; Refractory angina pectoris; Spinal cord stimulation

Indexed keywords

GLYCERYL TRINITRATE; PLACEBO;

AGED; ANGINA PECTORIS; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; FOLLOW UP; HUMAN; IMPLANTATION; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SHAM FEEDING; SHAM PROCEDURE; SINGLE BLIND PROCEDURE; SPINAL CORD STIMULATION; THERAPY EFFECT; TREATMENT DURATION;

AGED; AGED, 80 AND OVER; ANALYSIS OF VARIANCE; ANGINA PECTORIS; ELECTRIC STIMULATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; ITALY; MALE; MIDDLE AGED; PAIN MEASUREMENT; QUALITY OF LIFE; SINGLE-BLIND METHOD; SPINAL CORD; TIME FACTORS;

EID: 78650414512     PISSN: 03043959     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.pain.2010.08.044     Document Type: Article

References (44)

1. ACC/AHA, 2002. Guideline update for the management of patients with chronic stable angina. Circulation 2003;107:149-58.
2. C. Andersen, P. Hole, and H. Oxhøj Spinal cord stimulation as a pain treatment for angina pectoris Pain Clin 8 1995 333 339
3. J.L. Ardell, R. Cardinal, M. Vermeulen, and J.A. Armour Dorsal spinal cord stimulation obtunds the capacity of intrathoracic extracardiac neurons to transduce myocardial ischemia Am J Physiol Regul Integr Comp Physiol 297 2009 R470 R477
4. J.P. Bagger, B.S. Jensen, and G. Johannsen Long-term outcome of spinal cord electrical stimulation in patients with refractory chest pain Clin Cardiol 21 1998 286 288
5. M. Börjesson, P. Andrell, D. Lundberg, and C. Mannheimer Spinal cord stimulation in severe angina pectoris - a systematic review based on the Swedish Council on Technology assessment in health care report on long-standing pain Pain 140 2008 501 508
6. M.J. De Jongste, J. Haaksma, R.W. Hautvast, H.L. Hillege, P.W. Meyler, M.J. Staal, J.E. Sanderson, and K.I. Lie Effects of spinal cord stimulation on myocardial ischaemia during daily life in patients with severe coronary artery disease. A prospective ambulatory electrocardiographic study Br Heart J 71 1994 413 418
7. M.J. de Jongste, R.W. Hautvast, H.L. Hillege, and K.I. Lie 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 23 1994 1592 1597
8. C. De Landsheere, C. Mannheimer, A. Habets, M. Guillaume, I. Bourgeois, L.E. Augustinsson, T. Eliasson, D. Lamotte, H. Kulbertus, and P. Rigo Effect of spinal cord stimulation on regional myocardial perfusion assessed by positron emission tomography Am J Cardiol 69 1992 1143 1149
9. F. Di Pede, G.A. Lanza, G. Zuin, O. Alfieri, M. Rapati, M. Roman, A. Circo, P. Cardano, F. Bellocci, M. Santini, and A. Maseri Immediate and long-term clinical outcome after spinal cord stimulation for refractory stable angina pectoris Am J Cardiol 91 2003 951 955
10. F. Di Pede, G. Zuin, F. Giada, G. Pinato, G. Turiano, M. Bevilacqua, R. Cazzin, and A. Raviele 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 2 2001 690 695
11. H. Diedrichs, C. Zobel, P. Theissen, M. Weber, A. Koulousakis, H. Schicha, and R.H. Schwinger Symptomatic relief precedes improvement of myocardial blood flow in patients under spinal cord stimulation Curr Control Trials Cardiovasc Med 19 2005 6 7
12. S. Eddicks, K. Maier-Hauff, M. Schenk, A. Müller, G. Baumann, and H. Theres Thoracic spinal cord stimulation improves functional status and relieves symptoms in patients with refractory angina pectoris: the first placebo-controlled randomised study Heart 93 2007 585 590
13. O. Ekre, T. Eliasson, H. Norsell, P. Währborg, and C. Mannheimer Long-term effect of spinal cord stimulation and coronary artery bypass grafting on quality of life and survival in the ESBY study Eur Heart J 23 2002 1938 1945
14. T. Eliasson, L.E. Augustinsson, and C. Mannheimer Spinal cord stimulation in severe angina pectoris. Presentation of current studies, indications and clinical experience Pain 65 1996 169 179
15. T. Eliasson, S. Jern, L.E. Augustinsson, and C. Mannheimer Safety aspects of spinal cord stimulation in severe angina pectoris Coron Artery Dis 5 1994 845 850
16. EuroQol Group. EuroQol - a new facility for the measurement of health related quality of life. Health Policy 1990;16:199-208.
17. E. Fricke, S. Eckert, A. Dongas, H. Fricke, R. Preuss, O. Lindner, D. Horstkotte, and W. Burchert Myocardial perfusion after one year of spinal cord stimulation in patients with refractory angina Nuklearmedizin 48 2009 104 109
18. S. Greco, A. Auriti, D. Fiume, G. Gazzeri, G. Gentilucci, L. Antonini, and M. Santini Spinal cord stimulation for the treatment of refractory angina pectoris: a two year followup Pacing Clin Electrophysiol 22 1999 26 32
19. R.W. Hautvast, P.K. Blanksma, M.J. DeJongste, J. Pruim, E.E. van der Wall, W. Vaalburg, and K.I. Lie Effect of spinal cord stimulation on myocardial blood flow assessed by positron emission tomography in patients with refractory angina pectoris Am J Cardiol 77 1996 462 467
20. R.W. Hautvast, M.J. DeJongste, M.J. Staal, W.H. van Gilst, and K.I. Lie Spinal cord stimulation in chronic intractable angina pectoris: a randomized, controlled efficacy study Am Heart J 136 1998 1114 1120
21. R.W. Hautvast, G.J. Ter Horst, B.M. DeJong, M.J. DeJongste, P.K. Blanksma, A.M. Paans, and J. Korf Relative changes in regional cerebral blood flow during spinal cord stimulation in patients with refractory angina pectoris Eur J Neurosci 9 1997 1178 1183
22. G.A. Jessurun, I.A. Ten Vaarwerk, M.J. DeJongste, R.A. Tio, and M.J. Staal Sequelae of spinal cord stimulation for refractory angina pectoris. Reliability and safety profile of long-term clinical application Coron Artery Dis 8 1997 33 38
23. J.G. Kingma, B. Linderoth, J.L. Ardell, J.A. Armour, M.J. DeJongste, and D. Foreman Neuromodulation therapy does not influence blood flow distribution or left ventricular dynamics during acute myocardial ischemia Auton Neurosci 13 2001 47 54
24. G.A. Lanza Alternative treatments for angina Heart 93 2007 544 546
25. L. Lasagna, F. Mosteller, J.M. von Felsinger, and H.K. Beecher A study of the placebo response Am J Med 16 1954 770 779
26. C. Mannheimer, L.E. Augustinsson, C.A. Carlsson, K. Manhem, and C. Wlhelmsson Epidural spinal electrical stimulation in severe angina pectoris Br Heart J 59 1988 56 61
27. C. Mannheimer, P. Camici, M.R. Chester, A. Collins, M. DeJongste, T. Eliasson, F. Follath, I. Hellemans, J. Herlitz, T. Luscher, M. Pasic, and D. Thelle The problem of chronic refractory angina. Report from the ESC Joint Study Group on the Treatment of Refractory Angina Eur Heart J 23 2002 355 370
28. C. Mannheimer, T. Eliasson, L.E. Augustinsson, C. Blomstrand, H. Emanuelsson, S. Larsson, H. Norrsell, and A. Hjalmarsson Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris The ESBY Study Circulation 97 1998 1157 1163
29. D. McNab, S.N. Khan, L.D. Sharples, J.Y. Ryan, C. Freeman, N. Caine, S. Tait, I. Hardy, and P.M. Schofield 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 27 2006 1048 1053
30. D. Mukherjee, D.L. Bhatt, M.T. Roe, V. Patel, and S.G. Ellis Direct myocardial revascularization and angiogenesis - how many patients might be eligible? Am J Cardiol 84 1999 598 600
31. D.F. Murphy, and K.E. Giles Dorsal column stimulation for pain relief from intractable angina pectoris Pain 28 1987 365 368
32. S. Murray, K.G. Carson, P.D. Ewings, P.D. Collins, and M.A. James Spinal cord stimulation significantly decreases the need for acute hospital admission for chest pain in patients with refractory angina pectoris Heart 82 1999 89 92
33. C. Qin, J.P. Farber, B. Linderoth, A. Shahid, and R.D. Foreman Neuromodulation of thoracic intraspinal visceroreceptive transmission by electrical stimulation of spinal dorsal column and somatic afferents in rats J Pain 9 2008 71 78
34. J.E. Sanderson, P. Brooksby, D. Waterhouse, R.B.G. Palmer, and K. Neubauer Epidural spinal electrical stimulation for severe angina: a study of its effects on symptoms, exercise tolerance and degree of ischemia Eur Heart J 1993 628 633
35. J.E. Sanderson, B. Ibrahim, D. Waterhouse, and R.B. Palmer Spinal electrical stimulation for intractable angina long-term clinical outcome and safety Eur Heart J 15 1994 810 814
36. S. Sandric, M. Meglio, and F. Bellocci Clinical and electrocardiographic improvement of ischemic heart disease after spinal cord stimulation Acta Neurochir 33 1984 543 546
37. A. Sestito, G.A. Lanza, D. Le Pera, L. De Armas, G.A. Sgueglia, F. Infusino, R. Miliucci, P.A. Tonali, F. Crea, and M. Valeriani Spinal cord stimulation normalizes abnormal cortical pain processing in patients with cardiac syndrome X Pain 139 2008 82 89
38. C.N. Shealy, J.T. Mortimer, and J.B. Reswick Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report Anesth Analg 46 1967 489 491
39. E.L. Simpson, A. Duenas, M.W. Holmes, D. Papaioannou, and J. Chilcott Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin: systematic review and economic evaluation Health Technol Assess 13 2009 1 176
40. E.M. Southerland, D.M. Milhorn, R.D. Foreman, B. Linderoth, M.J. DeJongste, J.A. Armour, V. Subramanian, M. Singh, K. Singh, and J.L. Ardell Preemptive, but not reactive, spinal cord stimulation mitigates transient ischemia-induced myocardial infarction via cardiac adrenergic neurons Am J Physiol Heart Circ Physiol 292 2007 H311 H317
41. J.A. Spertus, J.A. Winder, T.A. Dewhurst, R.A. Deyo, J. Prodzinski, M. McDonell, and S.D. Fihn Development and evaluation of the Seattle angina questionnaire: a new functional status measure for coronary artery disease J Am Coll Cardiol 25 1995 333 341
42. R.S. Taylor, J. De Vries, E. Buchser, and M.J. Dejongste Spinal cord stimulation in the treatment of refractory angina: systematic review and meta-analysis of randomized controlled trials BMC Cardiovasc Disord 25 2009 9 13
43. I.A. TenVaarwerk, G.A. Jessurun, M.J. DeJongste, C. Andersen, C. Mannheimer, T. Eliasson, W. Tadema, M.J. Staal for the Working Group on Neurocardiology Clinical outcome of patients treated with spinal cord stimulation for therapeutically refractory angina pectoris Heart 82 1999 82 88
44. The Task Force on the Management of Stable Angina Pectoris of the European Society of Cardiology. Guidelines on the management of stable angina pectoris: executive summary: Eur Heart J 2006;27:1341-81.