Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve - rationale and design of a multicenter registry (EASE-IT).
BACKGROUND
In patients with severe calcific aortic stenosis, balloon aortic valvuloplasty (BAV) is routinely performed in order to pre-dilate the stenosed aortic valve prior to transcatheter aortic valve implantation (TAVI). Although pre-dilation is considered to be essential for the preparation of the valve landing zone, there is no clear evidence to support its clinical value. In contrast, BAV has been suggested to be linked to several complications. Notably, while preliminary evidence has supported the feasibility and safety of TAVI without pre-dilation, larger studies directly comparing the benefit/risk profile of TAVI in the presence and absence of pre-dilation are required.


METHODS
Therefore, a prospective, two-armed, multicenter registry (EASE-IT) was designed to obtain essential data concerning procedural success rates, adverse events, and mortality in a large cohort of patients undergoing transapical (TA)-TAVI using the Edwards SAPIEN 3 balloon expandable heart valves with and without pre-ballooning.


CONCLUSIONS
Data provided by EASE-IT will be used to assess the relevance of BAV during the TAVI procedure and to investigate associations between patient characteristics and outcomes. Therefore, results obtained from the EASE-IT registry could contribute to reduced rates of TAVI-associated morbidity and mortality in patients with severe, calcific aortic stenosis.


BACKGROUND
ClinicalTrials.gov Identifier: NCT02127580.
Institute for Pharmacology and Preventive Medicine, Bahnhofstrasse 20, 49661 Cloppenburg, Germany. peter.bramlage@ippmed.de.
Peter
P
Bramlage
Justus
J
Strauch
Holger
H
Schröfel
D001021:Aortic Valve / Q000473:pathology*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D063126:Balloon Valvuloplasty / Q000009:adverse effects / Q000401:mortality; D002114:Calcinosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D005858:Germany; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006801:Humans; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012107:Research Design; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome