Six-Month Freedom From Amputation Rates and Quality of Life Following Tibial and Pedal Endovascular Revascularization for Critical Limb Ischemia

Abstract

Objective: Patients with critical limb ischemia (CLI) and gangrene have a 10% to 38% rate of major amputation at 6 months. The purpose of this study is to report short-and mid-term major and minor amputation rates for patients who underwent tibial and pedal revascularization in addition to quality-of-life (QoL) scores. Methods: All patients who presented to a single institution with CLI (defined as rest pain or nonhealing wounds) and underwent antegrade or retrograde tibial access, atherectomy and angioplasty of the tibial circulation, and angioplasty of pedal circulation (antegrade or retrograde) from June 2016 to September 2017 were included. The Stark QoL questionnaire was used at each visit. Patients were scored at 1, 3, and 6 months postprocedure. Amputation rates were recorded. Results: Forty-two patients with CLI and gangrene underwent 57 peripheral interventions for limb salvage between June 2016 and September 2017. Thirty-two limbs had dry gangrene along the dorsalis pedis angiosome, 14 limbs had dry gangrene along the posterior tibial angiogram, and 11 limbs had a combined disease pattern. Twelve limbs underwent angioplasty of the superficial femoral artery (SFA), 18 limbs underwent angioplasty and stenting of the SFA, and 14 limbs underwent atherectomy, angioplasty, and stenting of the SFA. All patients had 1 or 2 tibial vessel runoff and high-grade stenosis of the pedal circulation. Immediate technical success defined as 3-vessel outflow to the foot occurred in 49 limbs (86%) with zero 30-day complications (30-day readmission, major amputation, or sepsis). Major amputation rate at 1, 3, and 6 months was 0%, 2%, and 4%, respectively. Patient satisfaction in terms of QoL increased over the 6-month follow-up period. Conclusion: Aggressive tibial and pedal revascularization may improve freedom from minor and major amputation at 6 months and may be associated with a short-and mid-term higher QoL.

A Targeted Literature Review of the Disease Burden in Patients With Symptomatic Peripheral Artery Disease

“…85 Finally, a single-center study on patients with CLI who were not candidates for bypass surgery showed that aggressive revascularization could reduce the need for amputation and improve patient quality of life in the first 6 months after the procedure; larger, randomized studies will be needed to verify these findings. 86…”

Systematic review of inframalleolar endovascular interventions and rates of limb salvage, wound healing, restenosis, rest pain, reintervention and complications

“…A single article reported Stark questionnaire Quality of Life (QoL) scores at one, three and six months postprocedure. 23 They saw an overall increase in QoL scores (À1.3 pre-study to 0.7 at six months follow-up) and significant increases in activity ('fairly' to 'well', p ¼ 0.014) and mood parameters (0 to þ1, p ¼ 0.033). 23 Restenosis (see Tables 3 and 4)…”

“…[14][15][16] The remaining seven articles reported the performance of BTA alongside additional ATA angioplasty with no comparator arm. [17][18][19][20][21][22][23] Articles were all published in the last 10 years, with a range from 2009 to 2019. Studies were undertaken in China, 17 Greece, 19 Italy, 18,22 Japan, 16 Korea, 14 Turkey, 15 UK, 21 and USA.…”

“…Narrative synthesis was performed on 10 articles. [14][15][16][17][18][19][20][21][22][23] Study characteristics (see Tables 1 and 2) Prospective, non-randomised, non-controlled study design was undertaken in four articles. 17,18,22,23 Retrospective cohort analysis was performed in six articles.…”

“…[14][15][16][17][18][19][20][21][22][23] Study characteristics (see Tables 1 and 2) Prospective, non-randomised, non-controlled study design was undertaken in four articles. 17,18,22,23 Retrospective cohort analysis was performed in six articles. [14][15][16][19][20][21] Direct comparison of the performance of BTA angioplasty with ATA angioplasty alone was reported in three articles; all had retrospective study designs.…”