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Balloon expandable transcatheter aortic valve implantation via the transfemoral route with or without pre-dilation of the aortic valve - rationale and design of a multicentre registry (EASE-IT TF).

ABSTRACT: Transcatheter aortic valve implantation via the transfemoral route (TF-TAVI) is commonly performed as a treatment for severe aortic stenosis (AS) in patients at high surgical risk. Pre-deployment balloon aortic valvuloplasty (BAV) has generally been considered an essential step for preparing the valve landing zone for receipt of the prosthesis. However, there is little evidence supporting the clinical value of BAV, while several associated complications have been documented. This has provoked several groups to evaluate the feasibility and safety of omitting BAV form the TF-TAVI procedure (direct TF-TAVI), with encouraging results. However, studies comparing the clinical outcomes of direct TF-TAVI to standard TF-TAVI are lacking.EASE-IT TF is a prospective, observational, two-armed, multicentre registry designed to gather data on procedural aspects, adverse events and survival rates associated with direct TF-TAVI using the Edwards SAPIEN 3 balloon-expandable prosthesis.EASE-IT-TF data will be analysed firstly to determine the risks and benefits associated with direct TF-TAVI vs. standard TF-TAVI, and secondly to identify associations between patient variables and specific outcomes. This may assist identification of patients who stand to benefit from direct TF-TAVI, therefore contributing to clinical reductions in TF-TAVI-associated morbidity and mortality rates in high-risk AS patients.Clinictrials.gov: NCT02760771.

SUBMITTER: Butter C

PROVIDER: S-EPMC5111278 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Balloon expandable transcatheter aortic valve implantation via the transfemoral route with or without pre-dilation of the aortic valve - rationale and design of a multicentre registry (EASE-IT TF).

Butter Christian C Bramlage Peter P Rudolph Tanja T Jacobshagen Claudius C Rothe Jürgen J Treede Hendrik H Kerber Sebastian S Frank Derk D Seilerova Lenka L Schymik Gerhard G

BMC cardiovascular disorders 20161115 1

<h4>Background</h4>Transcatheter aortic valve implantation via the transfemoral route (TF-TAVI) is commonly performed as a treatment for severe aortic stenosis (AS) in patients at high surgical risk. Pre-deployment balloon aortic valvuloplasty (BAV) has generally been considered an essential step for preparing the valve landing zone for receipt of the prosthesis. However, there is little evidence supporting the clinical value of BAV, while several associated complications have been documented. T ...[more]

PMID: 27846807

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Project description:BackgroundCoronary obstruction during transcatheter aortic valve replacement (TAVR) is a rare, yet life-threatening, complication. The routine use of left main (LM) protection with or without stent placement in high-risk patients remains controversial. The aim of this study was to evaluate the outcomes of LM protection during TAVR and identify anatomic factors associated with need for stent placement.MethodsWe retrospectively reviewed all TAVR cases (native and valve-in-valve) performed in our institution between 2014 and 2019 and identified patients who underwent LM protection with a coronary wire, balloon, and/or stent during the procedure. We compared the pre-TAVR computed tomography aortic root characteristics, procedural data, short-, and long-term outcomes among the patients who eventually received an LM stent and those who did not.ResultsAmong 1925 TAVR patients, 41 (2.1%) underwent LM protection, and 10 of them (25%) had eventually a stent placed in the LM for threatened obstruction after valve deployment. In the native TAVR group (n = 35), 8 patients underwent LM stenting. A larger TAVR prosthesis, larger annular circumference (83.8 vs 76.1 mm; P = .038), lower ratio of sinotubular junction diameter to prosthesis size (1.02 vs 1.11; P = .032), and longer left coronary cusp (15.1 vs 13.9 mm; P = .18) were associated with higher incidence of LM stenting. In the valve-in-valve TAVR group (n = 6), 5 patients had a valve-to-coronary distance of less than 4 mm, and 2 of them received an LM stent. Both stent and nonstent groups had excellent outcomes with no major adverse cardiovascular events or coronary obstruction at 30 days. After a median follow-up of 351 days, 4 patients died (9.7%) (1 in the stent and 3 in the nonstent group), without any cases of late coronary obstruction or percutaneous coronary intervention in either group.ConclusionsLM protection with a coronary guidewire, balloon, or stent is a safe and effective method of coronary protection during TAVR in appropriately selected high-risk patients. Annular circumference, prosthesis size, left coronary cusp length, LM ostial height, and ratio of sinotubular junction to prosthesis size are important predictors of stent deployment.

Dataset Information

Balloon expandable transcatheter aortic valve implantation via the transfemoral route with or without pre-dilation of the aortic valve - rationale and design of a multicentre registry (EASE-IT TF).

Publications

Balloon expandable transcatheter aortic valve implantation via the transfemoral route with or without pre-dilation of the aortic valve - rationale and design of a multicentre registry (EASE-IT TF).

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