Intravascular Lithotripsy and Drug-Coated Balloon Angioplasty for Severely Calcified Femoropopliteal Arterial Disease

Konstantinos Stavroulakis, Theodosios Bisdas, Giovanni Torsello, Nikolaos Tsilimparis, Sarah Damerau, Angeliki Argyriou, Konstantinos Stavroulakis, Theodosios Bisdas, Giovanni Torsello, Nikolaos Tsilimparis, Sarah Damerau, Angeliki Argyriou

Abstract

Introduction: The combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, data regarding the 12 months performance of this treatment option is missing. This study reports on the outcomes of IVL and DCB angioplasty for calcified femoropopliteal disease.

Methods: Patients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included into this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization (TLR) and overall mortality were additionally analyzed.

Results: Fifty-five (n = 55) patients and 71 lesions were analyzed. Most patients presented with long-term limb-threatening ischemia (n = 31, 56%), 47% (n = 26) were diabetics, and 66% (n = 36) had long-term kidney disease. The median lesion length was 77 mm (interquartile range: 45-136), and 20% (n = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels (n = 16), and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% (n = 55) of the treated lesions.The technical success after IVL amounted to 87% (n = 62) and the procedural success to 97% (n = 69). A flow-limiting dissection was observed in 2 cases (3%). Both the rates of target lesion perforation and distal embolization were 1% (n = 1). A bail-out scaffold was deployed in 5 lesions (7%). At 12 months the Kaplan-Meier estimate of primary patency was 81%, the freedom from TLR was 92% and the secondary patency 98%. The overall survival amounted to 89%, while the freedom from major amputation to 98%. The presence of eccentric disease, CTOs, or PACSS Class 4 did not increase the risk for loss of patency or TLR.

Conclusions: In this challenging cohort of patients, the use of IVL and DCB for calcified femoropopliteal lesions was associated with promising 12 months outcomes and an excellent safety profile.

Keywords: DCB; IVL; PAD; femoropopliteal; lithotripsy; paclitaxel.

Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Konstantinos Stavroulakis: Consulting for Phillips, Shockwave, Terumo and received Honoraria from Medtronic, Boston Scientific and Biotronic

Theodosios Bisdas: Consulting for Boston Scientific, Medtronic, BARD and COOK Medical.

Figures

Figure 1.
Figure 1.
Primary patency of intravascular lithotripsy and drug-coated balloon angioplasty at 12 months 81% (SE > 10% at 24 months).
Figure 2.
Figure 2.
Intravascular ultrasound guided intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty: (A) A: calcified femoropopliteal occlusion, B: IVL angioplasty, C: angiogram after IVL, D: DCB angioplasty, E, F: angiogram post-IVL and DCB in two planes with no evidence of a significant dissection and (B) A: intravascular ultrasound revealing a dissection (arrows) of the treated segment, B, C: Eluvia drug eluting stent deployment (Boston Sci.) to treat the dissection.

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