What question did this study set out to answer?

To describe the design of the prospective EASE-IT registry evaluating procedural success, adverse events, and mortality in patients undergoing transapical TAVI with versus without pre-dilation.

November 18, 2014BMC Cardiovascular DisordersOpen Access

Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve – rationale and design of a multicenter registry (EASE-IT)

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Severe calcific aortic stenosis (n=200). Intervention: Transapical transcatheter aortic valve implantation without pre-dilation vs. Transapical transcatheter aortic valve implantation with pre-dilation. Primary outcome: Combined endpoint of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, and pacemaker implantation within 30 days after TAVI.

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Key result

The EASE-IT registry is a planned prospective observational study designed to compare the safety and efficacy of transapical transcatheter aortic valve implantation with versus without pre-dilation, and thus reports no clinical results.

Why the study?

Does transapical transcatheter aortic valve implantation without pre-dilation improve clinical outcomes and safety compared to implantation with pre-dilation in adults with severe calcific aortic stenosis?

Population

200 adults with severe calcific aortic stenosis eligible for transapical transcatheter aortic valve…

Comparison

Transapical transcatheter aortic valve… vs Transapical transcatheter aortic valve…

Design

Cohort

Follow-up

6 months

Authors

PBPeter BramlagePreventive Cardiology JSJustus StrauchBG University Hospital Bergmannsheil Bochum HSHolger SchröfelUniversity of Freiburg

Discussion

Member takes

Implication

The EASE-IT registry protocol outlines a prospective observational study to evaluate the safety and efficacy of omitting balloon pre-dilation during transapical TAVI with the Edwards SAPIEN 3 valve.

Key Points

To describe the design of the prospective EASE-IT registry evaluating procedural success, adverse events, and mortality in patients undergoing transapical TAVI with versus without pre-dilation.
Prospective, two-armed, multicenter trial registry (NCT02127580).
Enrolls patients with severe calcific aortic stenosis undergoing transapical transcatheter aortic valve implantation with Edwards SAPIEN 3 balloon-expandable heart valves.
Compares procedural success, complication profiles, and mortality rates between cohorts receiving valve deployment with versus without pre-ballooning.
Presents the structural framework and clinical rationale of the registry without reporting final outcome event rates in this study design publication.
Identifies key outcome endpoints including procedural success rates, valve landing zone complications, and all-cause mortality across patient subgroups.

Study Design

Type

Observational (n=200)

Multicenter

Yes

Structured PICO

Population

A planned prospective, multicenter registry of 200 adult patients with severe calcific aortic stenosis undergoing transapical transcatheter aortic valve implantation to compare outcomes with and without pre-dilation.

Exposure

Transapical transcatheter aortic valve implantation (TA-TAVI) using the Edwards SAPIEN 3 balloon expandable heart valve without pre-dilation (balloon aortic valvuloplasty).

Comparator

Transapical transcatheter aortic valve implantation (TA-TAVI) using the Edwards SAPIEN 3 balloon expandable heart valve with pre-dilation (balloon aortic valvuloplasty).

Outcome

Combined endpoint of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, and pacemaker implantation within 30 days after TAVI as to VARC2.composite

The EASE-IT registry protocol outlines a prospective observational study to evaluate the safety and efficacy of omitting balloon pre-dilation during transapical TAVI with the Edwards SAPIEN 3 valve.

Limitations

Non-randomized nature of the registry could lead to potential bias
Exclusion of patients only eligible for one of the routes
Registry data tend to be less complete when compared to randomized clinical trials
6-month follow-up may not be sufficient to detect differences in long-term adverse outcomes
Missing patients only eligible for one of the routes
6-month follow-up might not be sufficient to detect differences in long-term adverse outcomes

Cite This Study

Bramlage et al. (2014) conducted an observational in Severe calcific aortic stenosis (n=200). Transapical transcatheter aortic valve implantation without pre-dilation vs. Transapical transcatheter aortic valve implantation with pre-dilation was evaluated on Combined endpoint of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, and pacemaker implantation within 30 days after TAVI. The EASE-IT registry is a planned prospective observational study designed to compare the safety and efficacy of transapical transcatheter aortic valve implantation with versus without pre-dilation, and thus reports no clinical results.

synapsesocial.com/papers/6a7935ca4c448619ca0da0e8 https://doi.org/10.1186/1471-2261-14-160

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Implication

The EASE-IT registry protocol outlines a prospective observational study to evaluate the safety and efficacy of omitting balloon pre-dilation during transapical TAVI with the Edwards SAPIEN 3 valve.

Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve – rationale and design of a multicenter registry (EASE-IT)

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Limitations

Cite This Study

Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve – rationale and design of a multicenter registry (EASE-IT)

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Limitations

Cite This Study

Also Consider

Also Consider