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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 admitted to our Institution 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 not modifying our current clinical practice. We will include patients where aortic ballloon valvuloplasty is attempted by radial access and without temporary pacemaker implantation (as per our institutional protocol). The aim is to register and monitor the effectiveness and safety of this protocol. 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 serious adverse events rate (intraprocedural death, stroke, coronary dissection/occlusion, moderate-severe aortic regurgitation, hypotension requiring resuscitation and intubation or cardioversion, tamponade, permanent pacemaker, serious vascular complications requiring intervention).
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. 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. The ulnar frame count will be calculated as previously described.
According previous studies, the cumulative occurrence of 30-day serious adverse events after transfemoral aortic balloon valvuloplasty with temporary pacing is around 20%. The half of these complications can be attributed to femoral access-site or temporary pacemaker implantation. We speculate that transradial mini-invasive balloon aortic valvuloplasty can reduce them. Accordingly, to validate this hypothesis, we will enroll 204 patients (alpha 0.05, power 80%).
Aortic Valve Stenosis
Transradial balloon aortic valvuloplasty, Transradial balloon aortic valvuloplasty
University Hospital of Ferrara
University Hospital of Ferrara
Published on BioPortfolio: 2017-03-22T21:53:21-0400
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