Mini-invasive Balloon Aortic Valvuloplasty
Mini-invasive Balloon Aortic Valvuloplasty
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.
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.
Inclusion Criteria:

 -  severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty

 Exclusion Criteria:

 -  cardiogenic shock

 -  bilateral absence of radial pulse