To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.
Trans-femoral (TF) access has been identified as the best vascular approach for trans-catheter aortic valve implantation (TAVI) in the most recent European Guidelines for the treatment of valvular heart disease. Nevertheless, the TF approach is not possible in a substantial number of TAVI candidates, mainly due to the presence of important peripheral arterial disease (PAD) that is perceived as a contraindication. The presence of PAD limiting TF-TAVI feasibility has always remained a challenging scenario. The concept of preparing TF access through balloon dilatation in case of PAD had been developed and, in this context, percutaneous transluminal angioplasty (PTA) with plain-balloon has been investigated, although available literature is scarce. Intra-vascular lithotripsy (IVL) was proved effective and safe to treat calcified peripheral arteries and such new technology bares the potential for being applied in TF TAVI in patients with concomitant PAD. The rationale is that the Shockwave IVL balloon inflated at low pressure modifies the vessel rigidity with creation of multiple longitudinal and transversal cracks in the calcium present within the vessel wall. Thus, the improved vessel compliance facilitates the successful passage of the valve delivery system resulting in higher rates of procedural success and lower risk for crossover to surgery, vessel injury and major complications.
Study Type
OBSERVATIONAL
Enrollment
50
Trans-femoral TAVI (Trans-catheter Aortic Valve Implantation) with calcified ilio-femoral arteries via PTA (Percutaneous transluminal angioplasty ) or IVL (Intra-vascular Lithotripsy)
AOU Cardiology Ancona
Ancona, Italy
RECRUITINGAULLS3 Cardiology Mestre
Mestre, Italy
RECRUITINGAULSS2 Cardiology Treviso
Treviso, Italy
ACTIVE_NOT_RECRUITINGFeasibility and safety on the trans-femoral (TF) approach
Comparison of feasibility and safety on the TF approach as the composite of: * Valve implant unsuccess due to difficulties in advancing through the ilio-femoral vascular axe * Absence of cross over from PTA to IVL or vice-versa * Absence of severe vascular and bleeding complications at discharge and at 1 month follow up visit, as defined by VARC-3
Time frame: Index procedure - 1 Month
MAEs
30-day composite occurrence of major clinical events: all-cause death, myocardial infarction and stroke
Time frame: Within 30 days after index procedure
Vascular and bleeding complications
30-day occurrence of vascular and bleeding complications according to the VARC-3 definition
Time frame: Within 30 days after index procedure
Device-related vascular complication
Any device-related vascular complication
Time frame: Discharge, 1-months, 6-months
Residual stenosis, Degree of dissection, Final Flow
Angiographic analysis from DSA
Time frame: Index procedure
Procedural time duration, amount of contrast media and radiation dose.
Procedural analysis
Time frame: Index procedure
Centralized analysis of the angiographic parameters
Centralized analysis of the angiographic parameters
Time frame: Index procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AOUI Cardiology Verona
Verona, Italy
RECRUITINGAULLS8 Cardiology Vicenza
Vicenza, Italy
RECRUITINGStent Implantation
Need for stent implantation on the procedural vascular access axe.
Time frame: Index procedure
Functional capacity of the inferior limbs
Functional capacity of the inferior limbs at 6 months.
Time frame: 6-months
Patency at the distal level of the vascular access site
Ultrasound defined patency at the distal level of the vascular access site after 6 months.
Time frame: 6-months