Shockwave IVL for Pre-TAVR

Shockwave Intravascular Lithotripsy (IVL) provides a low-risk, effective way to preserve transfemoral access as a primary option in heavily calcified iliacs in TAVR patients and increases vessel compliance for safer delivery of large devices.

Shockwave IVL for Peripheral Artery Disease Shockwave IVL for Pre-EVAR Shockwave Peripheral IVL Reimbursement
digital rendering of Shockwave L6 device and blue pulses from catheter
digital rendering of Shockwave L6 device and blue pulses from catheter

Change Compliance to Change the Game: Shockwave IVL for Transfemoral TAVR & Impella

Prepping for TAVR can prevent the risk of serious complications due to calcium, thanks to the unique mechanism of action (MOA) of Shockwave IVL. In fact, clinical evidence shows: 1–4

  • Shockwave IVL-assisted transfemoral-TAVR is safe and effective 
  • Shockwave IVL is a primary option to preserve transfemoral access  
  • Shockwave IVL increases vessel compliance for safe delivery of large devices 

 

1: E. Armstrong, LINC Scientific Sessions, 2023
2: Nardi & De Backer et al. EuroIntervention, 202
3: Di Mario C. Curr Cardiol Rep, 2019
4: DeBacker et al. Frontiers in Cardiovascular Medicine, 2021 

Featured Case: Shockwave IVL Opens Calcified Iliacs to Enable Passage of Transcatheter Aortic Valve Replacement (TAVR) Device

Case courtesy of Dr. Samer Garas  

  • Patient background: 78-year-old female with claudication, severely calcified bilateral iliacs   
  • Case goal: Safely modify the calcium in order for vessel compliance to occur and facilitate a TAVR system to be advanced  
  • Why Shockwave IVL: Shockwave’s mechanism of action (MOA) can safely and effectively treat eccentric calcified lesions. Shockwave L6 treats short, focal lesions with a consistent energy profile across the treatment area  
  • Outcome: Shockwave IVL provided effective calcium modification and allowed for desired transfemoral access for TAVR procedure  

Series of four angiogram images showing the use of intravascular lithotripsy (IVL) to modify the right common iliac artery (RCIA) in preparation for transfemoral access in TAVI

How Shockwave IVL Has Helped Keep TAVR Transfemoral

Shockwave IVL-Assisted Transfemoral TAVR Proved to be Safe and Effective

European Registry: IVL to facilitate transfemoral TAVR

Accordion Section

To report on the safety and efficacy of Shockwave IVL-assisted TF TAVR in an all-comers population. 

  • Prospective, real-world, multi-center registry 
  • All patients treated by Shockwave IVL-assisted TF TAVR ’18 – ’20 
  • 6 high-volume European centers 
  • 108 patients 
  • Target lesion-minimum lumen diameter 4.6 ± 0.9 mm with 318° of calcium 

Procedure Success n (%)
Valve delivery success  108 (100%) 
Valve implantation success  106 (98.2%) 

 

IVL-Related Vascular Complications n (%)
Perforations  1 (0.9%) 
Rupture  0 (0.0%) 
Minor dissection types (types A-C)  4 (3.7%) 
Major dissection types (types D-F)  3 (2.8%) 
Covered stent  2 (1.8%) 
Bare metal stent  3 (2.8%) 

Shockwave IVL has helped expand the indications for TF TAVR in patients with severe calcific peripheral artery disease (PAD). 

Nardi & De Backer et al. Peripheral intravascular lithotripsy of iliofemoral arteries to facilitate transfemoral TAVI: a multicentre prospective registry. EuroIntervention 2021;17-online publish-ahead-of-print November 2021. 

Publications

  • A Prospective Registry of Intravascular Lithotripsy-Enabled Vascular Access for Transfemoral Transcatheter Aortic Valve Replacement, Di Mario et al, JACC Interventions, March 2019.

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  • Intravascular Lithotripsy-Assisted Transfemoral TAVI: The Copenhagen Experience and Literature Review, De Backer et al, Frontiers in Cardiovascular Medicine, September 2021.

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  • Peripheral Intravascular Lithotripsy for transcatheter aortic valve implantation: a multicentre observational study, Nardi et al, Eurointervention, April 2022.

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