Factors associated with wound healing in chronic limb-threatening ischemia patients with hemodynamic failure following endovascular therapy
O Iida, Y H Hata, Y T Tomoi, Y S Soga, M F Fukunaga, T T Tsukizawa, M F Fujihara, D M Matsuda, S I Iwakoshi, S K Kojima, T N Nakama, A T Tanaka, K H Horie, M U Utsunomia, M T TakaharaAbstract
Background
Although revascularization is the primary treatment for chronic limb-threatening ischemia (CLTI), a substantial proportion of patients experience hemodynamic failure despite a technically successful procedure. The clinical consequences and the factors influencing outcomes in this specific patient population have not been systematically studied.
Purpose
The aim of this study was to investigate the 1-year clinical outcomes and their associated factors in CLTI patients who had hemodynamic failure following endovascular therapy (EVT).
Methods
This multicenter, prospective, observational study enrolled consecutive 420 patients (median age: 77 years [70, 84], male: 64.3%, diabetes mellitus: 68.6%, hemodialysis: 55.2%, post-EVT skin perfusion pressure: 26 [20, 32] mmHg, clinical stage of Wound, Ischemia, and foot Infection [WIfI] classification 4: 47.4%) with CLTI who underwent EVT and were subsequently diagnosed with hemodynamic failure, defined as a post-revascularization skin perfusion pressure (SPP) < 40 mmHg. All angiograms were reviewed by an independent core laboratory. Anatomical factors, including small artery disease (SAD), scored based on network of forefoot and calcaneal arteries, and medial arterial calcification (MAC), scored based on below-the-ankle artery calcification severity, were systematically evaluated. The outcome measure was the 1-year wound healing rate, defined as complete epithelialization without any major amputation. A Cox proportional hazards model was used to identify independent predictors of delayed wound healing.
Results
Severe SAD and MAC were present in 43.3% and 33.7% of patients, respectively. The overall Kaplan-Meier estimate for the 1-year wound healing rate was 60.5%. In the multivariate analysis, lower serum albumin (<3.5 g/dL) (Hazard Ratio [HR]: 1.68, 95% Confidence Interval [CI]: 1.01-2.82, p=0.048), severe SAD (HR: 2.35, 95% CI: 1.12-4.96, p=0.024), and severe MAC (HR: 2.85, 95% CI: 1.49-5.48, p=0.002) were significantly associated with delayed wound healing. The 1-year wound healing rate was markedly stratified by the presence of these anatomical risk factors: the rate was 75.7% in patients with neither severe SAD nor severe MAC, but only 33.6% in those with both conditions.
Conclusion
The current study revealed that an acceptable 1-year wound healing rate can still be achieved in CLTI patients with hemodynamic failure after EVT. Risk stratification based on the assessment of severe SAD and MAC would be crucial for guiding further management in this high-risk population.