Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Implantation

Summary

Transcatheter aortic valve implantation (TAVI) has been shown to generate the best clinical outcomes when performed by the percutaneous transfemoral approach. Intravascular lithotripsy (IVL) can facilitate a transfemoral process in patients with calcified iliofemoral vascular disease and borderline intraluminal diameters. The present protocol describes IVL-assisted transfemoral TAVI.

Abstract

During the last decade, transcatheter aortic valve implantation (TAVI) has evolved as a well-established therapy for aging patients suffering from symptomatic severe aortic valve stenosis. This is also reflected in the recently updated international guidelines on managing patients with valvular heart disease. A transfemoral (TF) TAVI approach has proven superior to alternative access strategies. With the introduction of intravascular lithotripsy (IVL), patients with calcified iliofemoral vascular disease and borderline intraluminal diameters have also become candidates for percutaneous TF-TAVI. Moreover, IVL reduces the risk of major vascular complications by modifying the superficial and deep vascular calcium, thereby changing the vessel compliance and controlling luminal expansion. In this way, IVL has shown to safely facilitate TF delivery of TAVI devices in patients with calcified peripheral artery disease. The present article aims to provide a detailed step-by-step description on how to perform IVL-assisted TF-TAVI safely and efficiently. Furthermore, a literature review on the outcomes obtained with this technology is included, along with a concise discussion on this unique TAVI approach.

Introduction

Transcatheter aortic valve implantation (TAVI) has proven to be a valuable therapy for elderly patients suffering from symptomatic severe aortic valve stenosis (AS) across all surgical risk categories^1,2. The data and outcomes are most convincing for those patients in whom the TAVI procedure can be performed by transfemoral (TF) approach. TAVI by alternative access, such as transsubclavian, transaxillary, transcarotid, transcaval, and transapical access, can also be considered. However, the complication rates reported for TAVI by alternative access are higher than TF-TAVI^3,

Protocol

The protocol is approved by the human research ethics committee of Copenhagen University Hospital, and the studies are conducted following the guidelines of the said ethics committee. Following local policies, all patients gave informed consent for the TAVI procedure, cardiac CT scanning, and anonymous data for research.

1. Preprocedural planning

1. Inspect the aorta-iliofemoral vessels ranging from the aortic valve, over the aortic arch, down to the common femoral artery (CFA) and the femoral bifurcation. For an accurate evaluation, perform a dedicated computed tomography (CT) angiography¹⁴....

Results

IVL treatment (Figure 1) of calcified PAD was first investigated in the DISRUPT-PAD European pre-market study¹⁸. The study showed an acute increase in vessel diameter in 35 patients following peripheral IVL treatment at the cost of only minimal vessel injury. The multi-center DISRUPT-PAD II trial¹⁹ confirmed these findings in 60 patients. DISRUPT PAD III²⁰ was designed as a real-world, prospective, multi-center study in .......

Discussion

Since the introduction of TAVI as a treatment option for patients with severe symptomatic AS, studies and registries have demonstrated that TAVI by TF approach generates better procedural success and lower complication rates^3,4,23. As a result, most centers nowadays seek to perform most of their TAVI procedures by percutaneous TF approach²³.

The introduction of IVL as a new too.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
0.014” guidewire	Floppy II Extra Support Guide Wire, Abbott, USA	22299M
0.035’’ stiff guidewire	Amplatz superstiff j-tip 7 cm floppy, Boston Scientific, USA	M001465020
20 mL syringe
6 F or 8 F femoral sheat	Radifocus Introducer II, Terumo	RS*B70N10MRD and RS*B80N10MRD
6-8 F Arrow sheat 35 cm- if contralateral access	Teleflex	CL07635 and CL07835
Arterial puncture needle	Percutaneous entry thinwall needle, Cook Medical	SDN18-18-7.0
Contrast solution	Visipaque 350, GE Healthcare
CT angiography-based 3D reconstruction dedicated software	3mensio, Pie Medical, The Netherlands
Diagnostic catheter	6F IMA diagnostic catheter, Cordis	534-6605
Echo probe sterile cover	CIV-flex transducer cover, CIVCO	610-1212
Indeflator device (20 mL)	Everest 30, Medtronic	AC3200
IVL Connector Cable	Shockwave medical	IVLCC
IVL generator	Shockwave medical	IVLGCC
Local anesthetic	Xylocain 10 mg/mL, Aspen
Non-compliant balloon	Z-MED II balloon 6 to 8 mm, Numed Canada inc.	PDZ622
Safety wire	0.018’’ Platinum Plus guidewire, Boston Scientific, USA	M0014666050
Shockwave M5/M5+ catheter (7 mm-8 mm diameter)	Shockwave medical	M5IVL7060 - M5PIVL7060 - M5PIVL8060
Standard J-wire	angiodyn guide wire j-tip, B. Braun	5050200
Sterile cover for shockwave connector cable	camera drape, Mönlycke health care
Three-way stopcock
Unfractionated heparin	10 mL vials of 1000 IE/mL, Amgros I/S
Vascular closure device	Perclose Prostyle device, Abbott, USA	12773-02
Vascular echo probe
	Manta VCD, Essential Medical, USA	2156NE, 2115NE