Interventions for valvular disease and heart failure

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

EuroIntervention 2022;17:e1397-e1406. DOI: 10.4244/EIJ-D-21-00581

Giulia Nardi
Giulia Nardi1, MD; Ole De Backer2, MD, PhD, MBA, FESC; Francesco Saia3, MD, PhD; Lars Søndergaard2, MD, DMSc; Francesca Ristalli1, MD; Francesco Meucci1, MD; Miroslava Stolcova1, MD; Alessio Mattesini1, MD; Pierluigi Demola1, MD; Xi Wang2,4, MD; Anees Al Jabri5, MD; Tullio Palmerini3, MD; Antonio Giulio Bruno3, MD, FISC; Alfonso Ielasi6, MD, FESC; Eric Van Belle7, MD, PhD, FESC, FACC; Sergio Berti5, MD; Carlo di Mario1, MD, PhD, FESC, FRCP, FSCAI, FACC
1. Structural Interventional Cardiology, Department of Clinical & Experimental Medicine, University Hospital Careggi, Florence, Italy; 2. The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 3. Interventional Cardiology Unit, Cardio-Thoracic Vascular Department, University Hospital of Bologna, Policlinico Sant’Orsola-Malpighi, Bologna, Italy; 4. Department of Cardiology, West China Hospital, Sichuan University, Chengdu, Sichuan, China; 5. CNR Cardiovascular Centre, Massa, Italy; 6. Istituto Clinico Sant'Ambrogio, Gruppo Ospedaliero San Donato, Milan, Italy; 7. Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, Cardiology, Institut Cœur Poumon, CHU de Lille, Université Lille, Lille, France

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.

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