Vol. 23 No. 1 (2019)
NEUROSURGERY

Quality of life of patients with critical lower limb ischemia after prolonged spinal cord stimulation

PDF (Русский)
  • A. Ashurkov,
  • E. Levin,
  • V. Murtazin,
  • R. Kiselev,
  • M. Kilychukov,
  • A. Klinkova,
  • O. Kamenskaya,
  • K. Orlov,
  • V. Shabalov,
  • A. Karaskov
A. Ashurkov
Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
Bio
E. Levin
Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
V. Murtazin
Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
R. Kiselev
Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
M. Kilychukov
Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
A. Klinkova
Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
O. Kamenskaya
Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
K. Orlov
Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
V. Shabalov
Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
A. Karaskov
Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
DOI: https://doi.org/10.21688/1681-3472-2019-1-42-53

Published 2019-03-09

Keywords

  • critical lower limb ischemia,
  • limb survival spinal cord stimulation,
  • quality of life

How to Cite

Ashurkov, A., Levin, E., Murtazin, V., Kiselev, R., Kilychukov, M., Klinkova, A., Kamenskaya, O., Orlov, K., Shabalov, V., & Karaskov, A. (2019). Quality of life of patients with critical lower limb ischemia after prolonged spinal cord stimulation. Patologiya Krovoobrashcheniya I Kardiokhirurgiya, 23(1), 42–53. https://doi.org/10.21688/1681-3472-2019-1-42-53

Copyright (c) 2019 Ashurkov A. V., Levin E. A., Murtazin V. I., Kiselev R. S., Kilychukov M. G., Klinkova A. S., Kamenskaya O. V., Orlov K. Yu., Shabalov V. A., Karaskov A. M.

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

Background. Several previous studies have demonstrated that spinal cord stimulation (SCS) can reduce the amputation rate in patients with critical lower limb ischemia (CLLI) and improve blood circulation parameters of the lower limbs. However, there is a lack of studies on the long-term effects of SCS on the quality of life (QoL) of patients with CLLI.
Aim. The present study aimed to assess QoL changes in patients with CLLI after SCS system implantation in the long run (i.e., 30–60 months).
Methods. This study included 38 patients with CLLI (10 females, 28 males; age range: 39–83 years) who underwent surgery in 2012–2016. QoL was analyzed using the SF-36 questionnaire before and 30–60 months after SCS. The mortality and amputation rates and amputation levels of the patients were also analyzed. The SF-36 questionnaire scores were normalized according to the data of the respective sex and age groups in the general Russian population. The obtained scores were analyzed in their dynamics and compared with the scores of the general population.
Results. The preoperative scores of three of four physical well-being QoL parameters of the patients significantly reduced compared with the scores of the general population (p < 0.001). However, the scores of mental well-being QoL parameters were close to those of the general population. The total physical well-being score reduced (37.9 ± 9.2 points), whereas the total mental well-being score was within the medium range (48.1 ± 8.3 points). At 30–60 months after SCS system implantation, 5 patients or their representatives were unavailable, 12 died, 3 underwent amputation at the tibial level, and 16 showed preserved support function of the legs (2 of these patients underwent toe amputation). SCS system failure was noted in 3 patients. Patients with preserved support function of the legs completed the SF-36 questionnaire at 30–60 months after SCS system implantation. All QoL parameter scores showed increases, and the total postoperative physical well-being score of these patients was close to that of the general population (46.3 ± 10.6 points, p = 0.050 compared with the preoperative score). However, the total mental well-being score of the patients was higher than that of the general population (57.9 ± 3.8 points, p = 0.041).
Conclusion. SCS does not reduce the mortality rate in patients with CLLI compared with conservative therapy. However, it reduces the amputation rate in patients who survive. Significant positive changes in QoL persist for a long time after SCS system implantation in most patients.

Funding: The study did not have sponsorship.

Conflict of interest: Authors declare no conflict of interest.

PDF (Русский)

References

  1. Национальные рекомендации по ведению пациентов с заболеваниями артерий нижних конечностей. Российский согласительный документ. Ангиология и сосудистая хирургия. 2013;19(приложение):1-67. [National guidelines on the management of patients with arterial diseases of the lower extremities. Russian consensus document. Angiologiya i sosudistaya khirurgiya = Angiology and Vascular Surgery. 2013;19(Suppl.):1-67. (In Russ.)]
  2. Ambler G.K., Dapaah A., Al Zuhir N., Hayes P.D., Gohel M.S., Boyle J.R., Varty K., Coughlin P.A. Independence and mobility after infrainguinal lower limb bypass surgery for critical limb ischemia. J Vasc Surg. 2014;59(4):983-987.e2. PMID: 24368039. http://dx.doi.org/10.1016/j.jvs.2013.10.077
  3. Beard J.D. Which is the best revascularization for critical limb ischemia: endovascular or open surgery? J Vasc Surg. 2008;48(6 Suppl):11S-16S. PMID: 19084730. http://dx.doi.org/10.1016/j.jvs.2008.08.036
  4. Uccioli L., Meloni M., Izzo V., Giurato L., Merolla S., Gandini R. Critical limb ischemia: current challenges and future prospects. Vasc Health Risk Manag. 2018;14:63-74. PMID: 29731636, PMCID: PMC5927064. http://dx.doi.org/10.2147/vhrm.s125065
  5. Dabrh A.M.A., Steffen M.W., Undavalli C., Asi N., Wang Z., Elamin M.B., Conte M.S., Murad M.H. The natural history of untreated severe or critical limb ischemia. J Vasc Surg. 2015;62(6):1642-1651.e3. http://dx.doi.org/10.1016/j.jvs.2015.07.065
  6. Freeman N.E., Leeds F.H., Gardner R.E. Sympathectomy for obliterative arterial disease; indications and contraindications. Annals of Surgery. 1947;126(6):873-886.
  7. Sanni A., Hamid A., Dunning J. Is sympathectomy of benefit in critical leg ischaemia not amenable to revascularisation? Interact Cardiovasc Thorac Surg. 2005;4(5):478-483. PMID: 26391460. http://dx.doi.org/10.1510/icvts.2005.115410
  8. Hassanshahi M., Khabbazi S., Peymanfar Y., Hassanshahi A., Hosseini‐Khah Z., Su Y.-W., Xian C.J. Critical limb ischemia: Current and novel therapeutic strategies. J Cell Physiol. 2019;1-15. [Epub ahead of print] PMID: 30637723. http://dx.doi.org/10.1002/jcp.28141
  9. Aboyans V., Ricco J.B., Bartelink M.E.L., Björck M., Brodmann M., Cohnert T., Collet J.P., Czerny M., De Carlo M., Debus S., Espinola-Klein C., Kahan T., Kownator S., Mazzolai L., Naylor A.R., Roffi M., Röther J., Sprynger M., Tendera M., Tepe G., Venermo M., Vlachopoulos C., Desormais I.; ESC Scientific Document Group. 2017 ESC Guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS) Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries Endorsed by: the European Stroke Organization (ESO) The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018;39(9):763-816. PMID: 28886620. http://dx.doi.org/ /10.1016/j.ejvs.2017.07.018
  10. Шевцов В.И., Попков А.В., Бунов В.С. Нереконструктивные реваскуляризирующие операции при ишемии конечности. Ангиология и сосудистая хирургия. 2009;15(2):108-112. PMID: 19806949. [Shevtsov V.I., Popkov A.V., Bunov V.S. Nonreconstructive revascularizing operations in limb ischaemia. Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery. 2009;15(2):108-112. (In Russ.) PMID: 19806949.]
  11. Корабельников Ю.А., Щурова Е.Н., Речкин М.Ю. Исследование динамики чрескожного напряжения кислорода и углекислого газа при применении повторных туннелизаций у больных с облитерирующим атеросклерозом нижних конечностей. Гений ортопедии. 2011;(3):112-6. [Korabelnikov Yu.A., Shchurova E.N., Rechkin M.Yu. The study of the dynamics of oxygen and carbon dioxide transcutaneous tension for re-tunnelization procedures in patients with obliterating atherosclerosis of the lower limbs. Genij Ortopedii. 2011;(3):112-6. (In Russ.)]
  12. Patwa J.J., Krishnan A. Buerger’s disease (thromboangiitis obliterans) – Management by Ilizarov’s technique of horizontal distraction. A retrospective study of 60 cases. Indian J Surg. 2011;73(1):40-7. PMID: 22211037, PMCID: PMC3077184. http://dx.doi.org/10.1007/s12262-010-0186-1
  13. Shealy C.N., Mortimer J.T., Reswick J.B. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg. 1967;46(4):489-91. PMID: 4952225. http://dx.doi.org/10.1213/00000539-196707000-00025
  14. Cook A.W., Oygar A., Baggenstos P., Pacheco S., Kleriga E. Vascular disease of extremities. Electric stimulation of spinal cord and posterior roots. N Y State J Med. 1976;76(3):366-8. PMID: 1062688.
  15. Tshomba Y., Psacharopulo D., Frezza S., Marone E.M., Astore D., Chiesa R. Predictors of improved quality of life and claudication in patients undergoing spinal cord stimulation for critical lower limb ischemia. Ann Vasc Surg. 2014;28(3):628-32. PMID: 24342447. http://dx.doi.org/10.1016/j.avsg.2013.06.020
  16. Lee S., Abd-Elsayed A. Some Non-FDA Approved Uses for Neuromodulation: A Review of the Evidence. Pain Prac. 2016;16(7):935-47. PMID: 26603822. http://dx.doi.org/10.1111/papr.12405
  17. Клинкова А.С., Ашурков А.В., Каменская О.В., Карпенко А.А., Ломиворотов В.В., Муртазин В.И., Стародубцев В.Б. Спинальная нейростимуляция и периферическая перфузия у пациентов с критической ишемией нижних конечностей. Регионарное кровообращение и микроциркуляция. 2018;17(3):107-114. http://dx.doi.org/10.24884/1682-6655-2018-17-3-107-114 [Klinkova A.S., Ashurkov A.V., Kamenskaya O. V., Karpenko A.A., Lomivorotov V.V., Murtazin V.I., Starodubtsev V.B. Spinal cord stimulation and peripheral perfusion in patients with critical lower limb ischemia. Regional blood circulation and microcirculation. 2018;17(3):107-114. (In Russ.) http://dx.doi.org/10.24884/1682-6655-2018-17-3-107-114]
  18. Ашурков А.В., Левин Е.А., Муртазин В.И., Киселев Р.С., Орлов К.Ю., Кривошапкин А.Л., Шабалов В.А. Использование спинальной нейростимуляции в лечении пациентов с критической ишемией нижних конечностей. Патология кровообращения и кардиохирургия. 2017;21(2):29-42. http://dx.doi.org/10.21688/1681-3472-2017-2-29-42 [Ashurkov A.V., Levin E.A., Murtazin V.I., Kiselev R.S., Orlov K.Yu., Krivoshapkin A.L., Shabalov V.A. Spinal cord stimulation in treatment of patients with critical lower limb ischemia. Patologiya krovoobrashcheniya i kardiokhirurgiya = Circulation Pathology and Cardiac Surgery. 2017;21(2):29-42. (In Russ.) http://dx.doi.org/10.21688/1681-3472-2017-2-29-42]
  19. Ubbink D.T., Vermuelen H. Spinal cord stimulation for non-reconstructable chronic critical leg ischemia. Cochrane Database Syst Rev. 2013;(2):CD004001. PMID: 23450547. http://dx.doi.org/10.1002/14651858.CD004001.pub3
  20. Claeys L.G.Y. Pain relief and improvement of nutritional skin blood flow under spinal cord stimulation in patients with limb-threatening ischemia. The Pain Clinic. 2000;12(1):39-46. http://dx.doi.org/10.1163/156856900750228088
  21. Klomp H.M., Spincemaille G.H., Steyerberg E.W., Habbema J.D., van Urk H. Spinal-cord stimulation in critical limb ischaemia: A randomised trial. ESES Study Group. Lancet. 1999;353(9158):1040-4. http://dx.doi.org/10.1016/S0140-6736(98)05069-7
  22. Новик А.А., Ионова Т.И. Руководство по исследованию качества жизни в медицине. 2-е издание / Под ред. Ю. Л. Шевченко. М.: ЗАО «ОЛМА Медиа Групп», 2007. 320 с. [Novik A.A., Ionova T.I. Guide to the quality of life study in medicine. 2nd ed. Shevchenko Yu.L., editor. Moscow: OLMA Media Group; 2007. 320 p. (in Russ.)]
  23. Ware J.E. Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000;25(24):3130-9. PMID: 11124729.
  24. Амирджанова В.Н., Горячев Д.В., Коршунов Н.И., Ребров А.П., Сороцкая В.Н. Популяционные показатели качества жизни по опроснику SF-36 (результаты многоцентрового исследования качества жизни «Мираж»). Научно-практическая ревматология. 2008;(1):36-48. http://dx.doi.org/10.14412/1995-4484-2008-852 [Amirdjanova V.N., Goryachev D.V., Korshunov N.I., Rebrov A.P., Sorotskaya V.N SF-36 questionnaire population quality of life indices. Rheumatology Science and Practice. 2008;46(1):36-48. (In Russ.) https://doi.org/10.14412/1995-4484-2008-852]
  25. Spincemaille G.H., Klomp H.M., Steyerbergc E.W., Habbemac J.D. Pain and quality of life in patients with critical limb ischaemia: reslts of a randomized controlled multicentre study on the effect of spinal cord stimulation. ESES study group. Eur J Pain. 2000;4(2):173-184. PMID: 10957698. http://dx.doi.org/10.1053/eujp.2000.0170
  26. Second European consensus document on chronic critical leg ischemia. Circulation. 1991;84(4 Suppl):IV1-26. PMID: 1834364.
  27. Кэш Р., Уиклер Д., Саксена А., Капрон А. Этические аспекты проведения международных исследований в области здравоохранения. Сборник ситуационных задач. Всемирная организация здравоохранения, 2012 г. 214 с. https://apps.who.int/iris/bitstream/handle/10665/87659/9789244547724_rus.pdf
  28. Human Mortality Database. University of California, Berkeley (USA), and Max Planck Institute for Demographic Research (Germany). https://www.mortality.org (data downloaded on 27.12.2018).
  29. Макаров Д.Н. Биохимические параметры крови как предикторы госпитальной летальности при ампутации конечности у пациентов с заболеваниями периферических артерий. Медицина в Кузбассе. 2016;15(2):23-27. [Makarov D.N. Biochemical blood parameters as predictors of hospital mortality related to limb amputation in patients with peripheral arterial disease. Meditsina v Kuzbasse = Medicine in Kuzbass. 2016;15(2):23-27. (In Russ.)]
  30. Horsch S., Schulte S., Hess S. Spinal cord stimulation in the treatment of peripheral vascular disease: results of a single-center study of 258 patients. Angiology. 2004;55(2):111-8. PMID: 15026864. http://dx.doi.org/10.1177/000331970405500201
  31. Brummer U., Condini V., Cappelli P., Di Liberato L., Scesi M., Bonomini M., Costantini A. Spinal cord stimulation in hemodialysis patients with critical lower-limb ischemia. Am J Kidney Dis. 2006;47(5):842-7. http://dx.doi.org/10.1053/j.ajkd.2006.02.172
  32. Klomp H.M., Steyerberg E.W., Habbema J.D., van Urk H.; ESES study group. What is the evidence on efficacy of spinal cord stimulation in (subgroups of) patients with critical limb ischemia? Ann Vasc Surg. 2009;23(3):355-63. PMID: 19128928. http://dx.doi.org/10.1016/j.avsg.2008.08.016
  33. Reig E., Abejon D. Spinal cord stimulation: A 20-year retrospective analysis in 260 patients. Neuromodulation. 2009;12(3):232-9. PMID: 22151366. http://dx.doi.org/10.1111/j.1525-1403.2009.00220.x
  34. Colini Baldeschi G., Carlizza A. Spinal cord stimulation: parameters predictive of outcome in patients suffering from lower limb ischemia critical. A preliminary study. Neuromodulation. 2011;14(6):530-2. PMID: 21854490. http://dx.doi.org/10.1111/j.1525-1403.2011.00378.x
  35. Schade C.M., Sasaki J., Schultz D.M., Tamayo N., King G., Johanek L.M. Assessment of patient preference for constant voltage and constant current spinal cord stimulation. Neuromodulation. 2010;13(3):210-7. PMID: 21992834. http://dx.doi.org/10.1111/j.1525-1403.2010.00284.x
  36. Qin C., Martinez M., Tang R., Huynh J., Goodman Keiser M., Farber J.P., Carman J.C., Wienecke G.M., Niederauer G., Foreman R.D. Is constant current or constant voltage spinal cord stimulation superior for the suppression of nociceptive visceral and somatic stimuli? A rat model. Neuromodulation. 2012;15(2):132-42. PMID: 22364336. http://dx.doi.org/10.1111/j.1525-1403.2012.00431.x
  37. Washburn S., Catlin R., Bethel K. Canlas B. Patient-perceived differences between constant current and constant voltage spinal cord stimulation systems. Neuromodulation. 2014;17(1):28-36. PMID: 23837549. http://dx.doi.org/10.1111/ner.12119
  38. Dones I., Levi V. Spinal cord stimulation for neuropathic pain: current trends and future applications. Brain Sciences. 2018;8(8). PMID: 30042314, PMCID: PMC6119923. http://dx.doi.org/10.3390/brainsci8080138

Similar Articles

You may also start an advanced similarity search for this article.