Evaluation of long-term treatment results of patients with critical limb ischemia and diabetes mellitus with different management approaches
- Authors: Kalinin R.E1, Suchkov I.A1, Krylov A.A1,2, Mzhavanadze N.D1, Pshennikov A..1,2, Vinogradov S.A2, Solyanik N.A.1, Karpov V.V2
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Affiliations:
- Ryazan State Medical University
- Ryazan State Clinical Hospital
- Issue: Vol 103, No 1 (2022)
- Pages: 23-34
- Section: Theoretical and clinical medicine
- URL: https://kazanmedjournal.ru/kazanmedj/article/view/80090
- DOI: https://doi.org/10.17816/KMJ2022-23
- ID: 80090
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Abstract
Background. In all cases of critical lower limb ischemia revascularization should be performed. However, the overlay of diabetic angiopathy significantly worsens the prognosis of the surgery, and the conservative therapy also frequently turns out to be ineffective even in the nearest future. Therapeutic stimulation of angiogenesis in this group of patients is an additional application point for the possible improvement of treatment results.
Aim. Evaluating treatment results of patients with critical ischemia and underlying diabetes after 5 years from the beginning of supervising, as well as assessing the benefits of additional angiogenesis as a part of treatment.
Material and methods. The study included data from 140 patients with critical ischemia and diabetes mellitus, divided into 4 groups, who received surgical [groups IA (n=45) and IB (n=30)] or therapeutic [groups IIA (n=40) and IIB (n=25)] treatment. Additional angiogenic therapy was also carried out in two groups (groups IB and IIB). Treatment outcomes were assessed over a 5-year period. Efficacy criteria were evaluated in the form of limb preservation and patient survival. The results were studied using descriptive statistics methods. Qualitative data were analyzed by constructing 2×2 contingency tables and using the xi-square method.
Results. The best indices of limb preservation and the lowest mortality of patients were obtained in the group after revascularization with additional angiogenic therapy. Gene therapy induction significantly improved the course of disease in limb preservation for periods from 6 months to 2 years (30% amputations by 2 years of follow-up, p=0.045). Angiogenic induction of angiogenesis also made it possible to improve the treatment results in the groups of conservative therapy but reliably better indicators of limb preservation were obtained in two groups with surgical interventions.
Conclusion. The optimal management tactic for patients with critical lower limb ischemia and underlying diabetes mellitus is direct revascularizing intervention on the lower limb arteries with additional angiogenic therapy in the postoperative period. Additional gene therapy induction of angiogenesis makes it possible to reduce the number of amputations both as part of combined surgical or therapeutic treatment , but it cannot be an alternative to surgery.
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About the authors
Roman E Kalinin
Ryazan State Medical University
Email: kalinin-re@yandex.ru
ORCID iD: 0000-0002-0817-9573
MD, D.Sc. (Med.), Prof., Rector, Head, Depart. of Cardiovascular, X-ray Endovascular Surgery and Radiology
Russian Federation, Ryazan, RussiaIgor A Suchkov
Ryazan State Medical University
Email: suchkov_med@mail.ru
ORCID iD: 0000-0002-1292-5452
MD, D.Sc. (Med.), Prof., Vice-Rector for Research and Innovative Development, Depart. of Cardiovascular, X-ray Endovascular Surgery and Radiology
Russian Federation, Ryazan, RussiaAndrey A Krylov
Ryazan State Medical University; Ryazan State Clinical Hospital
Author for correspondence.
Email: andrewkrylov1992@gmail.com
ORCID iD: 0000-0002-2393-0716
MD, Cand.Sc. (Med.), Assistant, Depart. of Cardiovascular, X-ray Endovascular Surgery and Radiological Diagnostics; Cardiovascular Surgeon, Depart. of Vascular Surgery
Russian Federation, Ryazan, Russia; Ryazan, RussiaNina D Mzhavanadze
Ryazan State Medical University
Email: nina_mzhavanadze@mail.ru
ORCID iD: 0000-0001-5437-1112
MD, Cand.Sc. (Med.), Assoc. Prof., Depart. of Cardiovascular, X-ray Endovascular Surgery and Radiological Diagnostics
Russian Federation, Ryazan, RussiaAlexander S Pshennikov
Ryazan State Medical University; Ryazan State Clinical Hospital
Email: pshennikov1610@rambler.ru
ORCID iD: 0000-0002-1687-332X
MD, D.Sc. (Med.), Assoc. Prof., Depart. of Cardiovascular, X-ray Endovascular Surgery and Radiological Diagnostics; Cardiovascular Surgeon, Depart. of Vascular Surgery
Russian Federation, Ryazan, Russia; Ryazan, RussiaSergey A Vinogradov
Ryazan State Clinical Hospital
Email: vsergey1993@icloud.com
ORCID iD: 0000-0001-8547-4798
Cardiovascular Surgeon, Depart. of Vascular Surgery
Russian Federation, Ryazan, RussiaNikita A. Solyanik
Ryazan State Medical University
Email: solianik.nikita@gmail.com
ORCID iD: 0000-0002-4667-3513
Clinical Resident, Depart. of Cardiovascular, X-ray Endovascular Surgery and Radiological Diagnostics
Russian Federation, Ryazan, RussiaVyacheslav V Karpov
Ryazan State Clinical Hospital
Email: sdrr@mail.ru
ORCID iD: 0000-0001-5523-112X
MD, Cand.Sc. (Med.), Cardiovascular Surgeon, Depart. of Vascular Surgery
Russian Federation, Ryazan, RussiaReferences
- Prevalence, epidemiology, statistics of peripheral arterial disease. Surgeryzone Medical Site. http://surgeryzone.net/info/info-hirurgia/rasprostranennost-epidemiologiya-statistika-zabolevanijperifericheskix-arterij.html (access date: 13.09.2021). (In Russ.)
- Yang SL, Zhu LY, Han R, Sun L, Li J, Dou J. Pathophysiology of peripheral arterial disease in diabetes mellitus. J Diabetes. 2017;9(2):133–140. doi: 10.1111/1753-0407.12474.
- Strelnikova EA, Trushkina PYu, Surov IYu, Korotkova NV, Mzhavanadze ND, Deev RV. Endothelium in vivo and in vitro. Part 1: histogenesis, structure, cytophysiology and key markers. Nauka Molodykh (Eruditio Juvenium). 2019;7(3):450–465. (In Russ.) doi: 10.23888/HMJ201973450-465.
- Kalinin RE, Suchkov IA, Klimentova EA, Egorov AA, Povarov VO. Apoptosis in vascular pathology: present and future. Rossiyskiy mediko-biologicheskiy vestnik imeni akademika IP Pavlova. 2020;28(1):79–87. (In Russ.) doi: 10.23888/PAVLOVJ202028179-87.
- Kalinin RE, Pshennikov AS, Suchkov IA. Reperfusion injury of tissues in lower limb arterial reconstructive surgery. Novosti Khirurgii. 2015;23(3):348–352. (In Russ.) doi: 10.18484/2305-0047.2015.3.348.
- Veerman KJ, Venegas-Pino DE, Shi Y, Khan MI, Gerstein H, Werstuck GH. Hyperglycaemia is associated with impaired vasa vasorum neovascularization and accelerated atherosclerosis in apolipoprotein-E deficient mice. Atherosclerosis. 2013;227(2):250–258. doi: 10.1016/j.atherosclerosis.2013.01.018.
- Hamasaki H, Moriyama S, Yanai H. A crosstalk between macroangiopathy and microangiopathy in type 2 diabetes. Int J Cardiol. 2013;168(1):550–551. doi: 10.1016/j.ijcard.2013.01.199.
- National guidelines on the diagnosis and treatment of diseases of the arteries of the lower extremities, 2019. Russian conciliation document. http://www.angiolsurgery.org/library/recommendations/2019/recommendations_LLA_2019.pdf (access date: 13.09.2021) (In Russ.)
- Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2019;58(1):1–109. doi: 10.1016/j.ejvs.2019.05.006.
- Forsythe RO, Hinchliffe RJ. Management of critical limb ischemia in the patient with diabetes. Journal of Cardiovascular Surgery. 2016;57(2):273–281.
- Troitsky AB, Lysenko ER, Khabazov RI, Orekhov PYu, Parshin PYu, Korolev VI, Ustyantseva NV, Malyutina ED, Nishchenko AV. Results of reconstructive operations in patients with lesions of the leg arteries. Angiologiya i sosudistaya khirurgiya. 2003;(1):102–108. (In Russ.)
- Dibirov MD, Dibirov AA, Gadzhimuradov RU, Tereshchenko SA, Soboleva SR, Ramazanova YuI, Bazhenov MS. Distal reconstructions under critical lower limb ischemia in elderly patients. Khirurgiya. Zhurnal imeni NI Pirogova. 2009;(1):49–52. (In Russ.)
- Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FGR, Gillepsie I, Ruckley CV, Raab G, Storkey H. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multi-centre, randomized controlled trial. Lancet. 2005;366:1925–1934. doi: 10.1016/S0140-6736(05)67704-5.
- Dorros G, Jaff MR, Dorros AM, Mathiak LM, He T. Tibioperoneal (outflow lesion) angioplasty can be as primary treatment in 235 patients with critical limb ischemia: five-year follow-up. Circulation. 2001;104:2057–2062. doi: 10.1161/hc4201.097943.
- Kalinin RE, Suchkov IA, Deev RV, Mzhavanadze ND, Krylov AA. Gene-mediated induction of angiogenesis in inoperable patients with atherosclerosis and diabetes mellitus. Angiologiya i sosudistaya khirurgiya. 2018;24(2):33–40. (In Russ.)
- Berlanga-Acosta J. Diabetic lower extremity wounds: the rationale for growth factors-based infiltration treatment. Int Wound J. 2011;8(6):612–620. doi: 10.1111/j.1742-481X.2011.00840.x.
- Deev RV, Kalinin RE, Chervyakov YV, Gryaznov SG, Mzhavanadze ND, Kiselev SL, Isaev AA, Schwalb PG, Staroverov IN, Nersessian EG. Results of gen-therapeutic drug “Neovasculgen” in patients with chronic lower limb ischemia: 1 year of observation. Bulletin of Pirogov National Medical & Surgical Center. 2011;6(4):20–25. (In Russ.)
- Deev RV, Bozo IYa, Mzhavanadze ND, Nersesyan EG, Chukhralia OV, Shvalb PG, Chervyakov YuV, Staroverov IN, Kalinin RE, Voronov DA, Gavrilenko AV, Isaev AA. Efficacy of using VEGF165 gene in comprehensive treatment of patients with stage 2A–3 lower limb chronic ischaemia. Angiologiya i sosudistaya khirurgiya. 2014;20(2):38–48. (In Russ.)
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