Outcomes of open and endovascular interventions in patients with chronic limb threatening ischemia

Abstract

Objectives

Widespread adoption of endovascular therapy for the treatment of chronic limb-threatening ischemia has transformed the field of vascular surgery. In this modern era, we aimed to define where open surgical interventions are of greatest benefit for limb salvage.

Methods

Patients who underwent interventions for chronic limb-threatening ischemia were identified in the vascular-targeted lower extremity National Surgical Quality Improvement Program database for open surgical interventions (OPEN) and endovascular surgical interventions (ENDO) from 2011 to 2017. Patients were further stratified based on the criteria of chronic limb-threatening ischemia (rest pain or tissue loss), and the location of the diseased arteries (femoropopliteal or tibioperoneal). The main outcomes measured included 30-day mortality, amputation, and major adverse cardiovascular events.

Results

A total of 17,193 patients were revascularized for chronic limb-threatening ischemia: 10,532 were OPEN and 6661 were ENDO. OPEN had higher 30-day mortality, major adverse cardiovascular events, pulmonary, renal dysfunction, and wound complications. However, OPEN resulted in significantly lower 30-day major amputation (3.8% vs. 5.0%, odds ratio (OR): 0.83 [0.72–0.97], P = .018). Subgroup analysis revealed a higher mortality rate in OPEN was observed only in tibioperoneal intervention for tissue loss. Major adverse cardiovascular event was higher in OPEN for most subgroups. OPEN for patients with tissue loss had significantly lower amputation rate than ENDO in both femoropopliteal and tibioperoneal subgroups (3.7% vs. 5.1%, OR: 0.76 [0.59–0.98], P = .036, and 4.7% vs. 6.6%, OR: 0.74 [0.57–0.96], P = .024, respectively). The benefit of open surgery in reducing the amputation rate was not seen in patients with rest pain.

Conclusions

Open surgical intervention is associated with significantly better limb salvage than endovascular intervention in patients with tissue loss. Surgical options should be given more emphasis as the first-line option in this cohort of patients unless the cardiopulmonary risk is prohibitive.

Keywords

Chronic limb threatening ischemia endovascular bypass tissue loss rest pain

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References

Fowkes

FGR

Rudan

, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet 2013; 382: 1329–1340.

Norgren

Hiatt

Dormandy

, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg 2007; 45: S5–67.

Teraa

Conte

Moll

, et al. Critical limb ischemia: current trends and future directions. J Am Heart Assoc 2016; 5: e002938.

Abu Dabrh

Steffen

Undavalli

, et al. The natural history of untreated severe or critical limb ischemia. J Vasc Surg 2015; 62: 1642–1651.e3.

Beard

JD.

Which is the best revascularization for critical limb ischemia: endovascular or open surgery?

J Vasc Surg 2008; 48: 11S–16S.

Abu Dabrh

Steffen

Asi

, et al. Bypass surgery versus endovascular interventions in severe or critical limb ischemia. J Vasc Surg 2016; 63: 244–253.e11.

Adam

Beard

Cleveland

, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005; 366: 1925–1934.

Bradbury

Adam

Bell

, et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: analysis of amputation free and overall survival by treatment received. J Vasc Surg 2010; 51: 18S–31S.

Stavroulakis

Borowski

Torsello

, et al. One-year results of first-line treatment strategies in patients with critical limb ischemia (CRITISCH Registry). J Endovasc Ther 2018; 25: 320–329.

10.

Chen

Whealon

Kabutey

N-K

, et al. Outcomes of open and endovascular lower extremity revascularization in active smokers with advanced peripheral arterial disease. J Vasc Surg 2017; 65: 1680–1689.

11.

Lawrence

Chandra

When should open surgery be the initial option for critical limb ischaemia?

Eur J Vasc Endovasc Surg 2010; 39: S32–S37.

12.

American College of Surgeons. About ACS NSQIP, https://www.facs.org/quality-programs/acs-nsqip/about (2019, accessed 27 October 2020).

13.

Maggard-Gibbons

The use of report cards and outcome measurements to improve the safety of surgical care: the American College of Surgeons National Surgical Quality Improvement Program. BMJ Qual Saf 2014; 23: 589–599.

14.

Steinberg

Popa

Michalek

, et al. Comparison of risk adjustment methodologies in surgical quality improvement. Surgery 2008; 144: 662–667.

15.

Conte

Geraghty

Bradbury

, et al. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg 2009; 50: 1462–1473.

16.

Bursac

Gauss

Williams

, et al. Purposeful selection of variables in logistic regression. Source Code Biol Med 2008; 3: 17. https://scfbm.biomedcentral.com/articles/10.1186/1751-0473-3-17

17.

Mehaffey

Hawkins

Fashandi

, et al. Lower extremity bypass for critical limb ischemia decreases major adverse limb events with equivalent cardiac risk compared with endovascular intervention. J Vasc Surg 2017; 66: 1109–1116.e1.

18.

Farber

Eberhardt

RT.

The current state of critical limb ischemia: a systematic review. JAMA Surg 2016; 151: 1070–1077. 01

19.

Conte

MS.

Diabetic revascularization: endovascular versus open bypass–do we have the answer?

Semin Vasc Surg 2012; 25: 108–114.

20.

Iida O, Takahara M, Soga Y, et al. Three-Year Outcomes of Surgical Versus Endovascular Revascularization for Critical Limb Ischemia: The SPINACH Study (Surgical Reconstruction Versus Peripheral Intervention in Patients With Critical Limb Ischemia). Circ Cardiovasc Interv 2017; 10(12): e005531.

21.

Ramanan

Ahmed

, et al. Determinants of midterm functional outcomes, wound healing, and resources used in a hospital-based limb preservation program. J Vasc Surg 2017; 66: 1765–1774.

22.

Vogel

Dombrovskiy

Carson

, et al. In-hospital and 30-day outcomes after tibioperoneal interventions in the US Medicare population with critical limb ischemia. J Vasc Surg 2011; 54: 109–115.

23.

Spreen

Gremmels

Teraa

, et al. Diabetes is associated with decreased limb survival in patients with critical limb ischemia: pooled data from two randomized controlled trials. Diabetes Care 2016; 39: 2058–2064.

24.

Conte

Bradbury

Kolh

, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg 2019; 69: 3S–125S.e40.

25.

Dosluoglu

Lall

Harris

, et al. 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: 361–371.e3.

26.

Hicks

Najafian

Farber

, et al. Below-knee endovascular interventions have better outcomes compared to open bypass for patients with critical limb ischemia. Vasc Med 2017; 22: 28–34.

27.

Goodney

Beck

Nagle

, et al. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations. J Vasc Surg 2009; 50: 54–60.

28.

Dosluoglu

Lall

Blochle

, et al. Clinical presentation and outcome after failed infrainguinal endovascular and open revascularization in patients with chronic limb ischemia. J Vasc Surg 2013; 58: 98–104.e1.

29.

Meecham

Patel

Bate

, et al. Editor’s choice—a comparison of clinical outcomes between primary bypass and secondary bypass after failed plain balloon angioplasty in the bypass versus angioplasty for severe ischaemia of the limb (BASIL) trial. Eur J Vasc Endovasc Surg 2018; 55: 666–671.

30.

Siracuse

Giles

Pomposelli

, et al. Results for primary bypass versus primary angioplasty/stent for intermittent claudication due to superficial femoral artery occlusive disease. J Vasc Surg 2012; 55: 1001–1007.

31.

Neville

Kayssi

Development of a limb-preservation program. Blood Purif 2017; 43: 218–225.

32.

Patel

RS.

Team approach to critical limb ischemia care and research. Tech Vasc Interv Radiol 2016; 19: 101–103.