1. One-year limb salvage and quality of life following mechanical aspiration thrombectomy in patients with acute lower extremity ischemia.
- Author
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Maldonado TS, Powell A, Wendorff H, Rowse J, Nagarsheth KH, Dexter DJ, Dietzek AM, Muck PE, Arko FR, and Chung J
- Subjects
- Humans, Female, Male, Aged, Prospective Studies, Time Factors, Middle Aged, Treatment Outcome, Peripheral Arterial Disease physiopathology, Peripheral Arterial Disease surgery, Peripheral Arterial Disease mortality, Peripheral Arterial Disease therapy, Peripheral Arterial Disease diagnosis, Peripheral Arterial Disease complications, United States, Acute Disease, Aged, 80 and over, Europe, Risk Factors, Quality of Life, Limb Salvage, Thrombectomy adverse effects, Thrombectomy mortality, Ischemia surgery, Ischemia mortality, Ischemia physiopathology, Ischemia diagnosis, Ischemia therapy, Lower Extremity blood supply
- Abstract
Objective: Lower extremity acute limb ischemia (LE-ALI) is associated with high morbidity and mortality rates, and a burden on patient quality of life (QoL). There is limited medium- to long-term evidence on mechanical aspiration thrombectomy (MT) in patients with LE-ALI. The STRIDE study was designed to assess safety and efficacy of MT using the Indigo Aspiration System in patients with LE-ALI. Thirty-day primary and secondary endpoints and additional outcomes were previously published. Here, we report 365-day secondary endpoints and QoL data from STRIDE., Methods: STRIDE was a multicenter, prospective, single-arm, observational cohort study that enrolled 119 patients across 16 sites in the United States and Europe. Patients were treated first-line with MT using the Indigo Aspiration System (Penumbra, Inc). The study completed follow-up in October 2023. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire, developed for evaluating patient-centered QoL outcomes for peripheral arterial disease, was assessed at baseline and follow-up through 365 days., Results: Seventy-three percent of patients (87/119) were available for 365-day follow-up. Mean age of these patients was 65.0 ± 13.3 years, and 44.8% were female. Baseline ischemic severity was classified as Rutherford I in 12.6%, Rutherford IIa in 51.7%, and Rutherford IIb in 35.6%. In general, baseline and disease characteristics (demographics, medical history, comorbidities, target thrombus) of these patients are similar to the enrolled cohort of 119 patients. The secondary endpoints at 365 days for target limb salvage was 88.5% (77/87) and mortality rate was 12.0% (12/100). VascuQoL-6 improved across all domains, with a median total score improvement from 12.0 (interquartile range, 9.0-15.0) at baseline to 19.0 (interquartile range, 16.0-22.0) at 365 days., Conclusions: These 365-day results from STRIDE demonstrate that first-line MT with the Indigo Aspiration System for LE-ALI portray continued high target limb salvage rates and improved patient-reported QoL. These findings indicate Indigo as a safe and effective therapeutic option for LE-ALI., Competing Interests: Disclosures T.M. is the principal investigator for STRIDE and a consultant for Penumbra. P.M. is a speaker/consultant for Penumbra. F.A. is a speaker/consultant for Penumbra., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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