1. Patients with chronic limb ischemia (CLI) treated with low-intensity pulsed ultrasound (LIPUS) had lower rates of amputation compared to those treated under standard care without LIPUS, after 5-year follow-up.
2. No difference in 5-year rates of survival or major adverse cardiovascular events were found between CLI patients treated with or without LIPUS.
Evidence Rating Level: 2 (Good)
Critical limb ischemia (CLI) is defined as insufficient tissue perfusion for greater than 14 days, and is considered the end-stage of peripheral artery disease (PAD). CLI patients are at greater risk of amputation, cardiovascular issues, and death. In fact, one third or more of CLI patients are not offered a choice when it comes to amputation. When considering the costs, rehabilitation needs, and psychological burden for CLI patients with amputations, less invasive interventions for CLI could vastly improve quality of life. Low-intensity pulsed ultrasound (LIPUS) has been shown to induce microvascular regeneration by stimulating various angiogenic factors, such as IL-8 and vascular endothelial growth factor (VEGF). The current cohort study based in Hiroshima, Japan examined 5-year outcomes for atherosclerotic CLI patients that were and were not treated with LIPUS. The study population consisted of 14 patients in the LIPUS group, enrolled between 2011 and 2015, with 14 historical control patients that were treated under standard guidelines (no LIPUS) between those same years. No significant differences in sample parameters were found between the groups. The average (SD) LIPUS exposure duration was 381 (283) days. The results showed that there were fewer amputations in the LIPUS group, with only 3 major amputations compared to 14 in the control: The amputation-free survival rate was significantly greater in the LIPUS group. However, there were no differences in deaths or mortality-free survival rates, with both groups having 7 deaths. Finally, there were no differences in major adverse cardiovascular events (MACE): the LIPUS group had 2 cardiovascular deaths, 1 patient with stroke, and 1 hospitalized for heart failure, whereas the control group had 3 cardiovascular deaths, 1 patient with stroke, and 2 myocardial infarctions. Overall, LIPUS is associated with a lower risk of amputation in CLI patients, but not with any differences in survival or MACE rates.
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