Efficacy and safety of intravascular lithotripsy for the treatment of peripheral arterial disease: An individual patient‐level pooled data analysis

Abstract

Background: Peripheral arterial disease (PAD) is one of the most common manifestations of atherosclerotic disease worldwide. Peripheral arterial calcification reduces acute success and long-term patency of endovascular therapy for PAD. Several calcium modification devices are available for use in peripheral interventions. Outcomes after peripheral intravascular lithotripsy (IVL), a novel approach using pulsatile sonic waves to treat luminal and medial calcium in patients with PAD, have not been extensively characterized. Therefore, we sought to perform an individual patient-level data (IPD) pooled analysis of available studies to evaluate the efficacy and safety of IVL in the treatment of PAD. Methods and results: We pooled IPD, including baseline and procedural variables, from five prospective studies which assessed IVL in the treatment of patients with extensive peripheral artery calcification. Final postprocedural percent diameter stenosis (%DS) and procedural angiographic complications were assessed by independent core laboratory. Efficacy endpoints were analyzed using linear mixed effects models and safety endpoints were tabulated overall and by vascular bed. Among 336 patients who underwent endovascular revascularization with use of IVL, there was a significant reduction between pre-procedural and final %DS of 55.1% (95% confidence interval 53.3-57.0%, p < .0001). Core-laboratory assessed lesion-level complications, including flow-limiting dissections (Types D-F), vessel perforation, distal embolization, thrombus, abrupt closure, and no reflow, occurred in 4/328 (1.22%) of treated lesions.Conclusions: The present IPD of five prospective studies, marking the largest analysis to date evaluating the use of IVL in significantly calcified PAD lesions, demonstrates this treatment strategy to be both effective and safe.Abbreviations: ABI, ankle brachial index; DS, diameter stenosis; IPD, individual patient-level data; IVL, intravascular lithotripsy; MLD, minimal lumen diameter; PAD, peripheral arterial disease; RVD, reference vessel diameter.

Intravascular lithotripsy to treat an ostial left main coronary artery stenosis due to porcelain aorta in a patient with congenital HDL deficiency

“…The management of calcified coronary artery lesions remains one of the major limitations of PCI ( 1 ). IVL has recently emerged as a new technology that may efficaciously address calcified coronary or lower extremity atherosclerotic calcified lesions ( 2 , 3 ). Via a balloon inflated in the vessel, IVL delivers pulsatile sonic pressure waves converted to mechanical energy that may modify vascular calcium by the induction of calcium fractures, allowing for proper stent expansion ( 4 ).…”

Common Calcified Femoral Artery Rupture After Intravascular Lithotripsy for TAVR Implantation

“…Furthermore, some complications related to IVL have been recently reported, including femoral artery dissection during peripheral interventions. In particular, this last complication has been documented in about 14.6% of the cases, of which 0.9% were flow-limiting ( 10 ). In our case, we observed a long dissection of the iliac-femoral axis and the rupture of the femoral artery near the puncture site.…”

Plaquemodifikation durch intravaskuläre Lithotripsie

“…Sicherheit und Wirksamkeit wurden in mehreren klinischen Studien nachgewiesen. Eine Datenanalyse von 5 prospektiven Studien mit insgesamt 336 Patienten mit mäßig bis stark kalzifizierten peripheren Läsionen konnte die Effektivität und Sicherheit mit einer konsistenten Reduktion der Flächenstenose mittels der IVL-Thera-pie bestätigen [11]. Zudem besteht eine zunehmende klinische Erfahrung beim Einsatz der IVL bei der Verwendung von großlumigen Kathetern im Bereich schwer kalzifizierter Beckenarterien.…”