Calcium Modification During Peripheral Intervention With a Novel Intravascular Lithotripsy System: An Institutional Experience.

BACKGROUND: Calcium modification techniques have improved the outcomes of endovascular treatment for severely calcified stenotic lesions. In contrast to balloon angioplasty and modified balloons, intravascular lithotripsy (IVL) modifies both superficial and deep vascular calcium by delivering pulsatile sonic energy, which creates circumferential and longitudinal fractures with subsequent optimization of therapies such as stent implantation. We describe the clinical and procedural characteristics, as well as outcomes, from our initial experience with the Shockwave Javelin peripheral IVL catheter (Shockwave Medical), a novel forward IVL platform designed for difficult-to-cross calcified lesions.

METHODS: The first 10 patients treated with this catheter at our institution (The Christ Hospital, Cincinnati, Ohio) were included. The primary outcome was device success, defined as the ability to deliver and advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL catheter. Safety outcomes included in-hospital death and procedural complication rates.

RESULTS: A total of 16 lesions in 10 patients were analyzed following IVL therapy using the Javelin device. The mean age at the time of the procedure was 74.1 ± 7.6 years. Of the 10 patients, 4 were classified as Rutherford class III, 1 as Rutherford class IV, and 5 as Rutherford class V. Additionally, 9 of 16 lesions were chronic total occlusions. All 16 lesions exhibited significant arterial calcification, with grade 3 (19%) or grade 4 (81%) calcification based on the Peripheral Arterial Calcium Scoring System (PACSS), which quantifies the severity of arterial calcification to guide treatment planning. Device success was achieved in 15/16 lesions. All patients received the maximum allowable 120 pulses with the Javelin catheter. None of the patients required a second Javelin device, but 3 of 16 lesions were treated with additional balloon-based IVL catheters. Three everolimus-eluting resorbable scaffolds were placed across 3 lesions (all below the knee). Drug-coated balloons were utilized in 5 of 16 lesions (all above the knee). Following forward IVL with the Javelin device, no arterial dissections were observed, and 3 arterial dissections occurred following subsequent balloon dilatation, none of which resulted in residual dissection after resorbable scaffold implantation. No in-hospital mortality or other postprocedural complications were noted.

CONCLUSIONS: The Javelin peripheral IVL catheter appears to demonstrate high device success rates in real-world complex peripheral arterial stenoses and safely facilitates access to additional therapies. Further studies are required to better define the safety and effectiveness of Javelin IVL treatment for heavily calcified peripheral lesions.