Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2022 Apr 1;17(17):e1397-e1406.
doi: 10.4244/EIJ-D-21-00581.

Peripheral intravascular lithotripsy for transcatheter aortic valve implantation: a multicentre observational study

Giulia Nardi  1 , Ole De Backer  2 , Francesco Saia  3 , Lars Søndergaard  2 , Francesca Ristalli  1 , Francesco Meucci  1 , Miroslava Stolcova  1 , Alessio Mattesini  1 , Pierluigi Demola  1 , Xi Wang  2   4 , Anees Al Jabri  5 , Tullio Palmerini  3 , Antonio Giulio Bruno  3 , Alfonso Ielasi  6 , Eric Van Belle  7 , Sergio Berti  5 , Carlo di Mario  1
Affiliations
Observational Study

Peripheral intravascular lithotripsy for transcatheter aortic valve implantation: a multicentre observational study

Giulia Nardi et al. EuroIntervention. .

Abstract

Background: The presence of severe calcific atherosclerosis at the iliofemoral axis may preclude transcatheter aortic valve implantation (TAVI) by the transfemoral (TF) approach. Intravascular lithotripsy (IVL) is a novel technology that fractures intimal/medial calcium and increases vessel compliance allowing TF TAVI in selected patients with peripheral artery disease (PAD).

Aims: The aim of this study was to report on the safety and efficacy of IVL-assisted TF TAVI in an all-comers population.

Methods: Clinical, imaging and procedural data on all consecutive patients treated by IVL-assisted TF TAVI in six high-volume European centres (2018-2020) were collected in this prospective, real-world, multicentre registry.

Results: IVL-assisted TF TAVI was performed in 108 patients, increasing from 2.4% to 6.5% of all TAVI from 2018 to 2020, respectively. The target lesion was most often localised at the common and/or external iliac artery (93.5% of cases; average TL-MLD 4.6±0.9 mm with 318 degrees of calcium arc). Transfemoral aortic valve delivery was successful in 100% of cases; final procedural success in 98.2% (two conversions to cardiac open surgery for annular rupture and valve migration). Complications of the IVL-treated segments consisted of 1 perforation and 3 major dissections requiring stent implantation (2 covered stents and 2 BMS). Access-site-related complications included 3 major bleedings. Three in-hospital deaths were recorded (2.8%, 1 failed surgical conversion after annular rupture, 1 cardiac arrest after initial valvuloplasty, 1 late hyperkalaemia in renal dysfunction).

Conclusions: IVL-assisted TF TAVI proved to be a safe and effective approach, which helps to expand the indications for TF TAVI in patients with severe calcific PAD. However, these patients continue to have a higher-than-average incidence of periprocedural complications.

PubMed Disclaimer

Conflict of interest statement

O. De Backer has received institutional research grants and consulting fees from Abbott, Boston Scientific and Shockwave Medical Inc. O. De Backer has received speaker fees from Shockwave Medical. F. Saia is a member of the Advisory Board for Edwards, Medtronic, Abbott, Bayer, Biotronik, Amgen, Boehringer-Ingelheim, and AstraZeneca, and has received lecture fees from Edwards, Medtronic, Abbott, Bayer, Amgen, Boehringer-Ingelheim, AstraZeneca, Boston Scientific, Volcano, and Chiesi, outside the submitted work. F. Meucci reports receiving speaker and consultation fees from Medtronic, Edwards and Boston Scientific. T. Palmerini has received lecture fees from Biotronik and Edwards. C. Di Mario has received research or educational grants from Abbott, Amgen, Asahi Intecc, AstraZeneca, Boston Scientific, Cardinal Health, CSL Behring, Chiesi, Daiichi Sankyo, Edwards, Medtronic, Menarini, Pfizer, Sanofi, Shockwave, Teleflex, and Volcano/Philips. The other authors have no conflicts of interest to declare. The Guest Editor reports lecture fees paid to his institution from Amgen, Bayer Healthcare, Biotronik, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, Ferrer, Pfizer, and Novartis, consultancy fees paid to his institution from Boehringer Ingelheim, and grant support from Bayer Healthcare, Boston Scientific, Biotronik, Edwards Lifesciences, GlaxoSmithKline, Medtronic, and Pfizer.

Figures

Figure 1
Figure 1. Preprocedural computed tomography (CT) scan to assess iliac and femoral calcification in order to evaluate TAVI access.
Case example (part 1). Central panel: CT image of the iliac bifurcation showing severe tortuosity and calcification of both iliac arteries. CT longitudinal image of the severely calcified right common, external iliac and right common femoral artery (CFA) (panel A) and left common external iliac artery (panel B). In each panel, multiple cross-sections with diameters, area of near circumferential calcification and thick protruding nodules are shown. The right common femoral artery was the access artery selected for this patient, who underwent IVL treatment as shown in Figure 2. CSA: cross-sectional area; IVL: intravascular lithotripsy; TAVI; transcatheter aortic valve implantation
Figure 2
Figure 2. IVL predilatation to allow transfemoral TAVI.
Case example (part 2). A) & B) 7 mm IVL balloon on left common iliac artery (4 atm) with evident dog-boning effect. C) & D) Peripheral angiography showing occluded superficial femoral artery, critical calcific stenosis, and tortuosity of the common femoral artery extending to the deep femoral artery (C) that were treated with a 5 mm IVL balloon (4 atm) (D). E) Right common femoral artery puncture. F) & G) Peripheral lithotripsy with 7 mm Shockwave IVL balloon on right common iliac artery (4 atm), main TAVI access. H) Final aortogram with no dissection or extravasation. IVL: intravascular lithotripsy; TAVI; transcatheter aortic valve implantation
Central illustration
Central illustration. Cumulative data from Careggi University Hospital (Italy), Rigshospitalet Copenhagen University Hospital (Denmark), CNR Cardiovascular Centre (Italy) and Policlinico San Orsola, University of Bologna (Italy).
Istituto Clinico Sant'Ambrogio (Italy) and Institut Cœur Poumon, CHU de Lille (France) introduced lithotripsy in their clinical practice in 2020, therefore data from these centres are not included in this figure. Data are reported as percentage (histograms A-C) and as total number of cases (histogram B). Transfemoral TAVI is displayed in blue, non-transfemoral in red and IVL-assisted in green. Between 2016 and 2020, a total of 3,705 TAVI procedures were performed at the four participating centres, with 3,469 (93.6%) performed via a transfemoral route while the remaining 6.4% required alternative approaches mainly represented by trans-subclavian and transapical accesses (B & C). In the period from 2018-2020, a total of 108 cases of IVL-assisted TAVI were performed, increasing from 16 (2.4%) in 2018 to 59 (6.5%) in 2020 (C). The use of alternative approaches progressively decreased from 10% in 2016 to 3% in 2020. IVL: intravascular lithotripsy; TAVI; transcatheter aortic valve implantation; TF: transfemoral
See this image and copyright information in PMC

References

    1. Patel JS, Krishnaswamy A, Svensson LG, Tuzcu EM, Mick S, Kapadia SR. Access Options for Transcatheter Aortic Valve Replacement in Patients with Unfavorable Aortoiliofemoral Anatomy. Curr Cardiol Rep. 2016;18:110. - PubMed
    1. Kurra V, Schoenhagen P, Roselli EE, Kapadia SR, Tuzcu EM, Greenberg R, Akhtar M, Desai MY, Flamm SD, Halliburton SS, Svensson LG, Sola S. Prevalence of significant peripheral artery disease in patients evaluated for percutaneous aortic valve insertion: Preprocedural assessment with multidetector computed tomography. J Thorac Cardiovasc Surg. 2009;137:1258–64. - PubMed
    1. Arai T, Romano M, Lefèvre T, Hovasse T, Farge A, Le Houerou, Hayashida K, Watanabe Y, Garot P, Benamer H, Unterseeh T, Bouvier E, Morice MC, Chevalier B. Direct Comparison of Feasibility and Safety of Transfemoral Versus Transaortic Versus Transapical Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2016;9:2320–5. - PubMed
    1. Guedeney P, Mehran R. Non-femoral TAVR: Time to stratify alternative vascular approaches. Catheter Cardiovasc Interv. 2018;92:1194–5. - PubMed
    1. Brodmann M, Werner M, Holden A, Tepe G, Scheinert D, Schwindt A, Wolf F, Jaff M, Lansky A, Zeller T. Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II. Catheter Cardiovasc Interv. 2019;93:335–42. - PubMed

Publication types

MeSH terms