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Mini-invasive Balloon Aortic Valvuloplasty

2017-03-22 21:53:21 | BioPortfolio

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.

Description

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%).

Study Design

Conditions

Aortic Valve Stenosis

Intervention

Transradial balloon aortic valvuloplasty, Transradial balloon aortic valvuloplasty

Location

University Hospital of Ferrara
Cona
Ferrara
Italy
44124

Status

Recruiting

Source

University Hospital of Ferrara

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-03-22T21:53:21-0400

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Prospective, two academic center, non-randomized pilot, acute in-patient study correlating pre-operative imaging studies, intra-operative measurements and intra-operative balloon aortic va...

PubMed Articles [1515 Associated PubMed Articles listed on BioPortfolio]

Outcomes Following Balloon Aortic Valvuloplasty Versus Surgical Valvotomy in Congenital Aortic Valve Stenosis: A Meta-Analysis.

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Balloon aortic valvuloplasty: Treatment of rapid deployment aortic valve replacement complicated by a paravalvular leak.

The Edwards Intuity Elite valve system was designed to facilitate minimally invasive surgery and streamline complex aortic valve replacements and has since gained more popularity. Despite the superior...

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We aimed to assess whether the level of aortic root calcification is associated with BAV performance/omission during transcatheter aortic valve implantation (TAVI), and to explore related outcomes.

Pre-Dilatation Versus No Pre-Dilatation for Implantation of a Self-Expanding Valve in All Comers Undergoing TAVR: The DIRECT Trial.

The aim of this study was to compare the implantation of a self-expanding valve with or without balloon aortic valvuloplasty (BAV) in an open-label, noninferiority, randomized trial.

Medical and Biotech [MESH] Definitions

Counterpulsation in which a pumping unit synchronized with the patient's electrocardiogram rapidly fills a balloon in the aorta with helium or carbon dioxide in early diastole and evacuates the balloon at the onset of systole. As the balloon inflates, it raises aortic diastolic pressure, and as it deflates, it lowers aortic systolic pressure. The result is a decrease in left ventricular work and increased myocardial and peripheral perfusion.

Widening of a stenosed HEART VALVE by the insertion of a balloon CATHETER into the valve and inflation of the balloon.

An abnormal balloon- or sac-like dilatation in the wall of the ABDOMINAL AORTA which gives rise to the visceral, the parietal, and the terminal (iliac) branches below the aortic hiatus at the diaphragm.

An abnormal balloon- or sac-like dilatation in the wall of the THORACIC AORTA. This proximal descending portion of aorta gives rise to the visceral and the parietal branches above the aortic hiatus at the diaphragm.

An abnormal balloon- or sac-like dilatation in the wall of AORTA.

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