Mini-invasive Balloon Aortic Valvuloplasty

Study Overview
=================
Brief Summary
-----------------
The spreading of transcatheter aortic valve implantation has paradoxically increased the spectrum of indications for balloon aortic valvuloplasty. Balloon aortic valvuloplasty is currently used as destination therapy for patients excluded from transcatheter aortic valve implantation, as bridge to transcatheter aortic valve implantation or to surgical aortic valve replacement, or as a stratification tool for selected high-risk patients who cannot be immediate candidates for transcatheter aortic valve implantation. Moreover, it has been recently showed that transcatheter aortic valve implantation without balloon aortic valvuloplasty is encumbered by an increased risk of cerebral embolization. However, balloon aortic valvuloplasty has a complication rate comparable to transcatheter aortic valve implantation, mainly related to access site or temporary pacemaker implantation. Thus, a transradial mini-invasive approach with rapid pacing through the 0,035 inch left ventricular support wire could be extremely appealing.

Detailed Description
-----------------
Consecutive patients with severe aortic stenosis with indication to aortic balloon valvuloplasty will be enrolled. An ad hoc informed consent for the procedure will be obtained from all patients. This is a prospective observational study. The Investigators will include patients where aortic ballloon valvuloplasty is attempted by radial access and without temporary pacemaker implantation. The aim is to register and monitor the effectiveness and safety of this approach. Details regarding management of radial access and pacing with 0.035 wire can be found in the references reported below. The primary endpoint will be the 30-day occurence of minor and major vascular complications according VARC 2 classification. The safety endpoint will be the absence of intra- or periprocedural major complications in transradial balloon aortic valvuloplasty, namely balloon entrapment or compartment syndrome requiring surgical intervention. The feasibility endpoint will be a procedural success rate ≥90%. The efficacy endpoint will be a reduction of the mean invasive gradient >30%. At baseline, Handgrip strength test will be performed and angiography of the instrumented arm will be performed at the beginning and at the end of the procedure. All patients will be prospectively followed-up for at least 30 days and all adverse events will be recorded. All patients will be assessed also for frailty according the clinical frailty scale (CFS). During the 30-day follow-up visit two independent blinded operators will evaluate radial artery patency by ultrasonography and perform handgrip strength test in in both arms in all patients.

Official Title
-----------------
Safety and Feasibility of Transradial Mini-invasive Balloon Aortic Valvuloplasty

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Procedure: Transradial balloon aortic valvuloplasty
* Procedure: Transradial balloon aortic valvuloplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty Exclusion Criteria: cardiogenic shock bilateral absence of radial pulse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transradial balloon aortic valvuloplasty<br>Consecutive patients with severe aortic stenosis and receiving as first attempt balloon aortic valvuloplasty by transradial access. | Procedure: Transradial balloon aortic valvuloplasty<br>* Mini-invasive balloon aortic valvuloplasty consisting in transradial access<br>Procedure: Transradial balloon aortic valvuloplasty<br>* Rapid pacing using the 0.035-in. retrograde left ventricular support wire<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular complications | Cumulative occurrence of major and minor bleeding complications according the VARC-2 classification | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transradial balloon aortic valvuloplasty major complications | Balloon entrapment, compartment syndrome requiring surgical intervention | 1 month | 
| Adverse events | Cumulative occurrence of death, stroke, coronary occlusion, coronary dissection, moderate-severe aortic regurgitation, severe hypotension requiring intervention, pericardiocentesis, definitive pace-maker implantation | 1 month | 
| Major vascular complications | Cumulative occurrence of major bleeding complications according the VARC-2 | 1 month | 
| Minor vascular complications | Cumulative occurrence of minor bleeding complications according the VARC-2 | 1 month | 
| Radial artery occlusion | Cumulative occurrence of radial artery occlusion | 1 month | 
| Radial artery occlusion | Cumulative occurrence of radial artery occlusion | 24 hours |