Intravascular Lithotripsy in Calcified Peripheral Lesions: Single-Center JEN-Experience

Pawel Aftanski; Marcus Thieme; Friederike Klein; P. Christian Schulze; Sven Möbius-Winkler; Daniel Kretzschmar

doi:10.1055/s-0042-1751229

International Journal of Angiology, Inhaltsverzeichnis

Int J Angiol 2023; 32(01): 011-020
DOI: 10.1055/s-0042-1751229

Original Article

Intravascular Lithotripsy in Calcified Peripheral Lesions: Single-Center JEN-Experience

Autor*innen

Pawel Aftanski ‡^*

¹Department of Internal Medicine I, Jena University Hospital, Friedrich-Schiller University Jena, Jena, Germany
Marcus Thieme‡^*

¹Department of Internal Medicine I, Jena University Hospital, Friedrich-Schiller University Jena, Jena, Germany

²Department of Angiology, Cardiology, Diabetology, Regiomed-Vascular Center, Sonneberg, Germany
Friederike Klein

¹Department of Internal Medicine I, Jena University Hospital, Friedrich-Schiller University Jena, Jena, Germany
P. Christian Schulze

¹Department of Internal Medicine I, Jena University Hospital, Friedrich-Schiller University Jena, Jena, Germany
Sven Möbius-Winkler‡^*

¹Department of Internal Medicine I, Jena University Hospital, Friedrich-Schiller University Jena, Jena, Germany
Daniel Kretzschmar‡^*

¹Department of Internal Medicine I, Jena University Hospital, Friedrich-Schiller University Jena, Jena, Germany

Abstract

Peripheral artery disease (PAD) shows increasing need for revascularization therapy. Interventional success in calcified lesions is limited. Here, intravascular lithotripsy (IVL), modifying intimal and medial calcium, is a promising treatment approach. A single-center, prospective all-comers registry for patients undergoing peripheral IVL was established to examine treatment success in PAD with severe vessel calcification. Periprocedural safety events as well as short-term and intermediate follow-up clinical data were evaluated. Between December 2018 and January 2021 all consecutive patients receiving peripheral lithotripsy at our center were analyzed. Clinical and angiographic data were evaluated. Angiographic images were analyzed using a semiautomatic software for quantitative vessel analysis. Eighty-five lesions in 61 limbs were treated with IVL in 51 patients presenting with Rutherford classes 2 to 5. Most lesions (68%) were localized in the superficial femoral artery. Mean calcified lesion length was 102.5 mm (10–390 mm), with a median peripheral arterial calcium score of 3, indicating a highly calcified status. In 58% of the patients, IVL was used as a stand-alone therapy. IVL resulted in a mean acute luminal gain of 2.6 ± 0.9 mm, resulting in stenosis reduction by 42.1 ± 15%. Mean ankle brachial index (ABI) improved significantly from 0.6 to 0.8 (p < 0.0001) on day 1 after the intervention and remained stable at 6 months. This large real-world data of peripheral IVL reports compelling safety in a complex patient cohort. For the first time, clinical follow-up data demonstrated a sustained significant improvement in ABI after 6 months.

Keywords

intravascular lithotripsy - peripheral artery disease - calcification - single-center experience - ankle brachial index

Volltext

Referenzen

References
1 Song P, Rudan D, Zhu Y. et al. Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: an updated systematic review and analysis. Lancet Glob Health 2019; 7 (08) e1020-e1030
2 Kokkinidis DG, Armstrong EJ. Current developments in endovascular therapy of peripheral vascular disease. J Thorac Dis 2020; 12 (04) 1681-1694
3 Lanzer P, Boehm M, Sorribas V. et al. Medial vascular calcification revisited: review and perspectives. Eur Heart J 2014; 35 (23) 1515-1525
4 Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation 1992; 86 (01) 64-70
5 Ichihashi S, Shibata T, Fujimura N. et al. Vessel calcification as a risk factor for in-stent restenosis in complex femoropopliteal lesions after Zilver PTX paclitaxel-coated stent placement. J Endovasc Ther 2019; 26 (05) 613-620
6 Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv 2014; 83 (06) E212-E220
7 Okuno S, Iida O, Shiraki T. et al. Impact of calcification on clinical outcomes after endovascular therapy for superficial femoral artery disease: assessment using the Peripheral Artery Calcification Scoring System. J Endovasc Ther 2016; 23 (05) 731-737
8 Guzman RJ, Brinkley DM, Schumacher PM, Donahue RM, Beavers H, Qin X. Tibial artery calcification as a marker of amputation risk in patients with peripheral arterial disease. J Am Coll Cardiol 2008; 51 (20) 1967-1974
9 Huang CL, Wu IH, Wu YW. et al. Association of lower extremity arterial calcification with amputation and mortality in patients with symptomatic peripheral artery disease. PLoS One 2014; 9 (02) e90201
10 Baumann F, Fust J, Engelberger RP. et al. Early recoil after balloon angioplasty of tibial artery obstructions in patients with critical limb ischemia. J Endovasc Ther 2014; 21 (01) 44-51
11 Fanelli F, Cannavale A, Gazzetti M. et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol 2014; 37 (04) 898-907
12 Lugenbiel I, Grebner M, Zhou Q. et al. Treatment of femoropopliteal lesions with the AngioSculpt scoring balloon - results from the Heidelberg PANTHER registry. Vasa 2018; 47 (01) 49-55
13 Kronlage M, Werner C, Dufner M. et al. Long-term outcome upon treatment of calcified lesions of the lower limb using scoring angioplasty balloon (AngioSculpt™). Clin Res Cardiol 2020; 109 (09) 1177-1185
14 Giannopoulos S, Secemsky EA, Mustapha JA. et al. Three-year outcomes of orbital atherectomy for the endovascular treatment of infrainguinal claudication or chronic limb-threatening ischemia. J Endovasc Ther 2020; 27 (05) 714-725
15 Adams GL, Das T, Lee MS, Beasley R, Mustapha J. Subanalysis of the CONFIRM registries: acute procedural outcomes in claudicant and critical limb ischemia patients with varying levels of calcification treated for peripheral arterial disease with orbital atherectomy. J Invasive Cardiol 2015; 27 (11) 516-520
16 Azar Y, DeRubertis B, Baril D, Woo K. Atherectomy-associated complications in the Southern California vascular outcomes improvement collaborative. Ann Vasc Surg 2018; 49: 241-246
17 Semaan E, Hamburg N, Nasr W. et al. Endovascular management of the popliteal artery: comparison of atherectomy and angioplasty. Vasc Endovascular Surg 2010; 44 (01) 25-31
18 Brodmann M, Werner M, Brinton TJ. et al. Safety and Performance of Lithoplasty for Treatment of Calcified Peripheral Artery Lesions. J Am Coll Cardiol 2017; 70 (07) 908-910
19 Grillo P, Tripolino C, Tassone EJ, Morabito G, Missiroli B. Critical calcified carotid stenosis treated with shockwave lithoplasty. Arch Med Sci Atheroscler Dis 2018; 3: e164-e165
20 Vadalà G, Galassi AR, Nerla R, Micari A. Shockwave intravascular lithoplasty for the treatment of calcified carotid artery stenosis: a very early single-center experience. Catheter Cardiovasc Interv 2020; 96 (06) E608-E613
21 Cubero-Gallego H, Millán R, Fuertes M. et al. Coronary lithoplasty for calcified lesions: real-world multicenter registry. Rev Esp Cardiol (Engl Ed) 2020; 73 (12) 1003-1010
22 Forero MNT, Daemen J. The coronary intravascular lithotripsy system. Interv Cardiol 2019; 14 (03) 174-181
23 Adams G, Shammas N, Mangalmurti S. et al. Intravascular lithotripsy for treatment of calcified lower extremity arterial stenosis: initial analysis of the Disrupt PAD III study. J Endovasc Ther 2020; 27 (03) 473-480
24 Armstrong EJ, Soukas PA, Shammas N. et al. Intravascular lithotripsy for treatment of calcified, stenotic iliac arteries: a cohort analysis from the Disrupt PAD III study. Cardiovasc Revasc Med 2020; 21 (10) 1262-1268
25 Brodmann M, Werner M, Holden A. et al. Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: results of Disrupt PAD II. Catheter Cardiovasc Interv 2019; 93 (02) 335-342
26 Tepe G, Brodmann M, Werner M. et al; Disrupt PAD III Investigators. Intravascular lithotripsy for peripheral artery calcification: 30-day outcomes from the randomized Disrupt PAD III trial. JACC Cardiovasc Interv 2021; 14 (12) 1352-1361
27 Radaideh Q, Shammas N, Shammas G, Shammas W. Safety and efficacy of lithoplasty in treating severely calcified iliac arterial disease: a single center experience. Vascular Dis Manag 2019; 16: E55
28 López Otero D, Sanmartín Pena XC, Trillo Nouche R, Cid Álvarez B, Antúnez Muiños P, Gonzalez Juanatey JR. Shockwave lithoplasty-facilitated transfemoral access for transcatheter aortic valve replacement. an initial single-center experience in Spain. Rev Esp Cardiol (Engl Ed) 2019; 72 (11) 980-982
29 Aboyans V, Ricco JB, Bartelink MEL. et al; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries. Endorsed by: the European Stroke Organization (ESO) The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J 2018; 39 (09) 763-816
30 Cosentino F, Grant PJ, Aboyans V. et al; ESC Scientific Document Group. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J 2020; 41 (02) 255-323
31 Mach F, Baigent C, Catapano AL. et al; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J 2020; 41 (01) 111-188
32 Williams B, Mancia G, Spiering W. et al; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J 2018; 39 (33) 3021-3104
33 Bonaca MP, Bauersachs RM, Anand SS. et al. Rivaroxaban in peripheral artery disease after revascularization. N Engl J Med 2020; 382 (21) 1994-2004
34 Medis Medical Imaging Systems BV Netherlands. Accessed June 15, 2022 at: https://medisimaging.com/
35 Brodmann M, Schwindt A, Argyriou A, Gammon R. Safety and feasibility of intravascular lithotripsy for treatment of common femoral artery stenoses. J Endovasc Ther 2019; 26 (03) 283-287
36 Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc 2018; 7 (24) e011245
37 Patel MR, Conte MS, Cutlip DE. et al. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol 2015; 65 (09) 931-941
38 Yin D, Maehara A, Shimshak TM. et al. Intravascular ultrasound validation of contemporary angiographic scores evaluating the severity of calcification in peripheral arteries. J Endovasc Ther 2017; 24 (04) 478-487
39 Conte MS, Bradbury AW, Kolh P. et al; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global vascular guidelines on the management of chronic limb-threatening ischemia. Eur J Vasc Endovasc Surg 2019; 58 (1S): S1-S109, 109.e33
40 Gouëffic Y, Della Schiava N, Thaveau F. et al. Stenting or surgery for de novo common femoral artery stenosis. JACC Cardiovasc Interv 2017; 10 (13) 1344-1354
41 Cruz-González I, González Ferreiro R, Martín Moreiras J. et al. Facilitated transfemoral access by shockwave lithoplasty for transcatheter aortic valve replacement. JACC Cardiovasc Interv 2019; 12 (05) e35-e38
42 Di Mario C, Chiriatti N, Stolcova M, Meucci F, Squillantini G. Lithoplasty-assisted transfemoral aortic valve implantation. Eur Heart J 2018;
43 Gorla R, Cannone GS, Bedogni F, De Marco F. Transfemoral aortic valve implantation following lithoplasty of iliac artery in a patient with poor vascular access. Catheter Cardiovasc Interv 2019; 93 (03) E140-E142
44 cardWorks by Schwarzer Cardiotek GmbH Germany. Accessed June 15, 2022 at: https://www.schwarzercardiotek.com/