Predictive Parameters for Clinical Outcome in Patients with Critical Limb Ischemia Who Underwent Percutaneous Transluminal Angioplasty (PTA): A Systematic Review

Sanne M Schreuder, Yvette M G A Hendrix, Jim A Reekers, Shandra Bipat, Sanne M Schreuder, Yvette M G A Hendrix, Jim A Reekers, Shandra Bipat

Abstract

Purpose: To identify possible risk factors in predicting clinical outcome in critical limb ischemia (CLI) patients undergoing percutaneous transluminal angioplasty (PTA).

Materials and methods: PubMed and EMBASE were searched for studies analyzing CLI and clinical outcome after PTA from January 2006 to April 2017. Outcome measures were ulcer healing, amputation free survival (AFS)/limb salvage and overall survival. Data on predictive factors for ulcer healing, AFS/limb salvage and survival were extracted.

Results: Ten articles with a total of 2448 patients were included, all cohorts and based on prospective-designed databases. For ulcers, it seems that complete healing can be achieved in most of the patients within 1 year. No significant predictive factors were found. AFS/limb salvage: AFS rates for 1, 2 and 3 years ranged from 49.5 to 75.2%, 37 to 58% and 22 to 59%, respectively. Limb salvage rates for 1, 2 and 3 years ranged from 71 to 95%, 54 to 93.3% and 32 to 92.7%, respectively. All studies had different univariate and multivariate outcomes for predictive factors; however, age and diabetes were significant predictors in at least three studies. Survival: Survival rates for 1, 2 and 3 years ranged from 65.4 to 91.5%, 45.7 to 76% and 37.3 to 83.1%, respectively. Different predictive factors were found; however, age was found in 2 out of 5 studies reporting on predictive factors.

Conclusions: In several studies two factors, age and diabetes, were found as predictive factors for AFS/limb salvage and survival in patients with CLI undergoing PTA. Therefore, we believe that these factors should be taken into account in future research.

Level of evidence: Level 2a.

Keywords: Amputation free survival; CLI; PTA; Survival.

Conflict of interest statement

Conflict of interest

S.M. Schreuder, Y.M.G.A. Hendrix, J.A. Reekers and S. Bipat declare that they have no conflict of interest.

Ethical Approval

This article does not contain any studies with human participants or animals performed by any of the authors.

Informed Consent

Does not apply.

Figures

Fig. 1
Fig. 1
Search, selection and inclusion of relevant articles. aPatients did not undergo primary or standard PTA (e.g., use of primary stenting or drug eluting stent) or it was not clear what number of patients did undergo PTA. bIn several studies patients did undergo PTA; however, no data were separately mentioned from other procedures (e.g., bypass surgery)

References

    1. Michaels J. Second European Consensus Document on chronic critical leg ischemia. Eur J Vasc Surg. 1992;6 Suppl A:1–32.
    1. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, TASC II Working Group Inter-society consensus for the management of peripheral arterial disease (TASC II) J Vasc Surg. 2007;45 Suppl S:S5–67. doi: 10.1016/j.jvs.2006.12.037.
    1. Feiring AJ. Footnotes on critical limb ischemia. J Am Coll Cardiol. 2008;51(20):1975–1976. doi: 10.1016/j.jacc.2008.02.041.
    1. Teraa M, Conte MS, Moll FL, Verhaar MC. Critical limb ischemia: current trends and future directions. J Am Heart Assoc. 2016;5(2):e002938. doi: 10.1161/JAHA.115.002938.
    1. Blevins WA, Jr, Schneider PA. Endovascular management of critical limb ischemia. Eur J Vasc Endovasc Surg. 2010;39(6):756–761. doi: 10.1016/j.ejvs.2010.02.008.
    1. Beard JD. Which is the best revascularization for critical limb ischemia: endovascular or open surgery? J Vasc Surg. 2008;48(6 Suppl):11S–16S. doi: 10.1016/j.jvs.2008.08.036.
    1. Söderström MI, Arvela EM, Korhonen M, Halmesmäki KH, Albäck AN, Biancari F, et al. Infrapopliteal percutaneous transluminal angioplasty versus bypass surgery as first-line strategies in critical leg ischemia: a propensity score analysis. Ann Surg. 2010;252(5):765–773. doi: 10.1097/SLA.0b013e3181fc3c73.
    1. Conrad MF, Kang J, Cambria RP, Brewster DC, Watkins MT, Kwolek CJ, et al. Infrapopliteal balloon angioplasty for the treatment of chronic occlusive disease. J Vasc Surg. 2009;50(4):799.e4–805.e4. doi: 10.1016/j.jvs.2009.05.026.
    1. Haider SN, Kavanagh EG, Forlee M, Colgan MP, Madhavan P, Moore DJ, et al. Two-year outcome with preferential use of infrainguinal angioplasty for critical ischemia. J Vasc Surg. 2006;43(3):504–512. doi: 10.1016/j.jvs.2005.11.016.
    1. Faglia E, Dalla Paola L, Clerici G, Clerissi J, Graziani L, Fusaro M, et al. Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003. Eur J Vasc Endovasc Surg. 2005;29(6):620–627. doi: 10.1016/j.ejvs.2005.02.035.
    1. Dosluoglu HH, Lall P, Harris LM, Dryjski ML. Long-term limb salvage and survival after endovascular and open revascularization for critical limb ischemia after adoption of endovascular-first approach by vascular surgeons. J Vasc Surg. 2012;56(2):361–371. doi: 10.1016/j.jvs.2012.01.054.
    1. Faglia E, Clerici G, Airoldi F, Tavano D, Caminiti M, Curci V, et al. Revascularization by angioplasty of type D femoropopliteal and long infrapopliteal lesion in diabetic patients with critical limb ischemia: are TASC II recommendations suitable? A population-based cohort study. Int J Low Extrem Wounds. 2012;11(4):277–285. doi: 10.1177/1534734612463701.
    1. Gallagher KA, Meltzer AJ, Ravin RA, Graham A, Shrikhande G, Connolly PH, et al. Endovascular management as first therapy for chronic total occlusion of the lower extremity arteries: comparison of balloon angioplasty, stenting, and directional atherectomy. J Endovasc Ther. 2011;18(5):624–37. Erratum in: J Endovasc Ther. 2011;18(6):A-5.
    1. Iida O, Soga Y, Yamauchi Y, Hirano K, Kawasaki D, Yamaoka T, et al. Clinical efficacy of endovascular therapy for patients with critical limb ischemia attributable to pure isolated infrapopliteal lesions. J Vasc Surg. 2013;57(4):974.e1–981.e1. doi: 10.1016/j.jvs.2012.10.096.
    1. Tomoi Y, Soga Y, Iida O, Hirano K, Suzuki K, Kawasaki D, et al. Efficacy of statin treatment after endovascular therapy for isolated below-the-knee disease in patients with critical limb ischemia. Cardiovasc Interv Ther. 2013;28(4):374–382. doi: 10.1007/s12928-013-0188-6.
    1. Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, et al. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011;32(18):2274–2281. doi: 10.1093/eurheartj/ehr144.
    1. Schmidt A, Ulrich M, Winkler B, Klaeffling C, Bausback Y, Bräunlich S, et al. Angiographic patency and clinical outcome after balloon-angioplasty for extensive infrapopliteal arterial disease. Catheter Cardiovasc Interv. 2010;76(7):1047–1054. doi: 10.1002/ccd.22658.
    1. Treiman GS, Treiman R, Whiting J. Results of percutaneous subintimal angioplasty using routine stenting. J Vasc Surg. 2006;43(3):513–519. doi: 10.1016/j.jvs.2005.11.015.
    1. Smith BM, Stechman M, Gibson M, Torrie EP, Magee TR, Galland RB. Subintimal angioplasty for superficial femoral artery occlusion: poor patency in critical ischaemia. Ann R Coll Surg Engl. 2005;87(5):361–365. doi: 10.1308/1478708051801.
    1. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009;21(339):b2700. doi: 10.1136/bmj.b2700.
    1. Arvela E, Venermo M, Söderström M, Korhonen M, Halmesmäki K, Albäck A, et al. Infrainguinal percutaneous transluminal angioplasty or bypass surgery in patients aged 80 years and older with critical leg ischaemia. Br J Surg. 2011;98(4):518–526. doi: 10.1002/bjs.7390.
    1. Bargellini I, Petruzzi P, Scatena A, Cioni R, Cicorelli A, Vignali C, et al. Primary infrainguinal subintimal angioplasty in diabetic patients. Cardiovasc Interv Radiol. 2008;31(4):713–722. doi: 10.1007/s00270-008-9366-9.
    1. Davies MG, El-Sayed HF. Outcomes of isolated tibial endovascular interventions for tissue loss in CLI patients on hemodialysis. J Endovasc Ther. 2015;22(5):681–689. doi: 10.1177/1526602815602074.
    1. Dick F, Diehm N, Galimanis A, Husmann M, Schmidli J, Baumgartner I. Surgical or endovascular revascularization in patients with critical limb ischemia: influence of diabetes mellitus on clinical outcome. J Vasc Surg. 2007;45(4):751–761. doi: 10.1016/j.jvs.2006.12.022.
    1. Lo RC, Darling J, Bensley RP, Giles KA, Dahlberg SE, Hamdan AD, et al. Outcomes following infrapopliteal angioplasty for critical limb ischemia. J Vasc Surg. 2013;57(6):1455–1463. doi: 10.1016/j.jvs.2012.10.109.
    1. Mathur K, Ayyappan MK, Hodson J, Hopkins J, Tiwari A, Duddy M, et al. Factors affecting medium-term outcomes after crural angioplasty in critically ischemic legs. Vasc Endovascular Surg. 2015;49(3–4):63–68. doi: 10.1177/1538574415591001.
    1. Nakano M, Hirano K, Yamauchi Y, Iida O, Soga Y, Kawasaki D, et al. Three-year clinical outcome after infrapopliteal angioplasty for critical limb ischemia in hemodialysis patients with minor or major tissue loss. Catheter Cardiovasc Interv. 2015;86(2):289–298. doi: 10.1002/ccd.25676.
    1. Okamoto S, Iida O, Nakamura M, Yamauchi Y, Fukunaga M, Yokoi Y, et al. Postprocedural skin perfusion pressure correlates with clinical outcomes 1 year after endovascular therapy for patients with critical limb ischemia. Angiology. 2015;66(9):862–866. doi: 10.1177/0003319715569907.
    1. Siablis D, Karnabatidis D, Katsanos K, Diamantopoulos A, Spiliopoulos S, Kagadis GC, Tsolakis J. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J Vasc Interv Radiol. 2009;20(9):1141–1150. doi: 10.1016/j.jvir.2009.05.031.
    1. Strøm M, Konge L, Lönn L, Schroeder TV, Rørdam P. Amputation-free survival after crural percutaneous transluminal angioplasty for critical limb ischemia. Scand J Surg. 2016;105(1):42–48. doi: 10.1177/1457496915571403.
    1. Bakken AM, Palchik E, Hart JP, Rhodes JM, Saad WE, Davies MG. Impact of diabetes mellitus on outcomes of superficial femoral artery endoluminal interventions. J Vasc Surg. 2007;46(5):946–958. doi: 10.1016/j.jvs.2007.06.047.
    1. Brosi P, Dick F, Do DD, Schmidli J, Baumgartner I, Diehm N. Revascularization for chronic critical lower limb ischemia in octogenarians is worthwhile. J Vasc Surg. 2007;46(6):1198–1207. doi: 10.1016/j.jvs.2007.07.047.
    1. Setacci F, Sirignano P, Raucci A, de Donato G, Chisci E, Galzerano G, et al. Below the knee endovascular revascularization strategy for limb salvage in diabetic patients. Ital J Vasc Endovasc Surg. 2010;17(3):189–194.
    1. Chung J, Modrall JG, Valentine RJ. The need for improved risk stratification in chronic critical limb ischemia. J Vasc Surg. 2014;60(6):1677–1685. doi: 10.1016/j.jvs.2014.07.104.
    1. Altman DG, Bland JM. Missing data. BMJ. 2007;334(7590):424. doi: 10.1136/bmj.38977.682025.2C.

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