Shockwave Lithotripsy Facilitates Large-Bore Vascular Access Through Calcified Arteries

Abstract Introduction Our objective is to explore The Peripheral Intravascular Lithotripsy (IVL) System in the treatment of calcific access vessels during Thoracic Endovascular Aortic Repair (TEVAR), Endovascular Aortic Repair (EVAR), and Transcatheter Aortic Valve Intervention (TAVI). Methods Retrospective, single-center study evaluated the outcomes of patients undergoing TEVAR, EVAR or TAVI with severe calcific arterial disease between July 2018 to August 2019. Maximum circumferential calcification, length of calcification, and inner/outer diameter measurements were collected with curved planar reformation by medical imaging software, Aquarius APS, TeraRecon. Effective luminal gain was calculated using the minimal inner diameter and the largest bore passed within the vessel lumen. Endpoints included technical success, mortality, adverse events, and requirement for bail out maneuvers. Technical success was defined as successful delivery and deployment of device or endograft. Results Nine patients were included (mean age of 79.3 [SD, ±9.79 yrs; range, 59-97 yrs])- four TAVR, one TEVAR, one EVAR, and three fenestrated EVAR. Six patients (66.7%) had more than one artery treated; the segments treated included common iliac artery (7 patients, 77.8%), the external iliac artery (7 patients, 77.8%), and the common femoral artery (1 patient, 11.1%). Average inner iliac vessel diameter was 3.38 mm (SD, ±0.99 mm; range, 1.87-4.72 mm). Average outside diameter of device introduced was 7.2 mm (SD, ±0.94; range, 6.3-8.8mm) with 229% effective luminal gain. Technical success was achieved in 100% of cases with a 0% mortality. Adjunctive measures were needed in 5 cases (55.6%). One vessel perforation was controlled with covered stent (Viabahn) deployment. Dissection was identified in two cases requiring stent placement. Two cases required the use of the Terumo International Systems SOLOPATH® Balloon Expandable TransFemoral System. One case deployed a Viabahn stent applying the "crack and pave" technique. Conclusions As the population of the United States ages, calcified arterial disease will become an everyday clinical conundrum. Furthermore, the procedures for which the IVL system is geared towards facilitating will likely also increase in use. The IVL system is an additional tool in the vascular surgeon's armamentarium to obtain large bore access in these calcified vessels. Further studies are needed to better assess the clinical effectiveness of the IVL System.