Arterial Interventions and Peripheral Arterial Disease (PAD)
Samuel A. Salazar, B.S. (he/him/his)
FIU Herbert Wertheim College of Medicine
Disclosure(s): No financial relationships to disclose
Brian J. Schiro, MD
Vascular and Interventional Radiologist
Miami Cardiac & Vascular Institute / Radiology Associates of South Florida
Critical limb ischemia (CLI) represents a severe form of lower extremity peripheral artery disease (PAD) and is associated with significant risk of limb loss and mortality. The purpose of this study is to evaluate the efficacy and safety of intravascular lithotripsy in the treatment of CLI. The primary endpoints are acute reduction in luminal stenosis (i.e., luminal gain) and improvement in ankle-brachial index (ABI) following treatment.
Materials and Methods:
Philips’ IntelliSpace PACS Radiology was used to identify patients from 2018-2022 who underwent intravascular lithotripsy for treatment of lower extremity calcified lesions. Chart review using Cerner EHR was used to identify those patients with CLI, defined as Rutherford classification 4 - 6. Data was collected including pre- and post-IVL luminal stenosis, lesion location, adjunctive therapies used at the target lesion, pre- and post-IVL ABI in the treated limb, and intra-procedural complications. A total of 57 target lesions treated with intravascular lithotripsy were identified in 36 CLI patients. Of these, luminal stenosis data was available in 41 target lesions treated in 28 patients. ABI data was available in 20 treated lower extremities in 19 patients, with one patient receiving bilateral intervention. ABI measurements were analyzed using a paired sample t-test.
In all 41 target lesions, treatment with intravascular lithotripsy yielded a mean luminal gain of 75.49% . Mean luminal gain by vessel location was measured at 87.25%, 57%, 78.5% for target lesions in the aortoiliac (n=8), common femoral (n=9), and femoropopliteal (n=24) regions, respectively. The percentage of target lesions receiving any adjunctive therapy was 76%. Treatment with intravascular lithotripsy as the sole intervention (n=10) yielded a mean luminal gain of 71.40%, while treatment alongside adjunctive therapy (n=31) yielded a 76.81% gain. In 20 treated lower extremities for which ABI data was recorded, intravascular lithotripsy produced a mean improvement in ABI of 0.20 (p=0.002) following treatment. Intra-procedural complications were present in only 1 out of 36 patients (3%), which was one instance of distal embolization.
Intravascular lithotripsy is an effective and safe option for lower extremity revascularization in patients with CLI, given the marked reduction in luminal stenosis, improvement in ABI, and low rate of intra-procedural complications.