Evidence map›Paper›PMID 40895419›Full record

ArticleStructural heart : the journal of the Heart Team2025

The ABC Bicuspid Sizing Protocol for SAPIEN 3 Balloon-Expandable Valves.

Tej Sheth, Umar Ismail, Jorge Chavarria, Warkaa Al Shamkani, Ahmed Makhdoum, Kandace Forsyth, Iqbal Jaffer, James Velianou, Madhu Natarajan

Abstract read
In one paragraph

Article in Structural heart : the journal of the Heart Team, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Tej ShethDivision of Cardiology and Cardiac Surgery, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Umar IsmailDivision of Cardiology and Cardiac Surgery, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Jorge ChavarriaDivision of Cardiology and Cardiac Surgery, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Warkaa Al ShamkaniDivision of Cardiology and Cardiac Surgery, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Ahmed MakhdoumDivision of Cardiology and Cardiac Surgery, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Kandace ForsythDivision of Cardiology and Cardiac Surgery, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Iqbal JafferDivision of Cardiology and Cardiac Surgery, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
James VelianouDivision of Cardiology and Cardiac Surgery, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Madhu NatarajanDivision of Cardiology and Cardiac Surgery, McMaster University and Hamilton Health Sciences, Hamilton, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The computed tomography selection of patients with bicuspid aortic stenosis for treatment with balloon-expandable valve (BEV) transcatheter aortic valve replacement (TAVR) is uncertain. We therefore evaluated a novel sizing algorithm for SAPIEN 3 BEV. Methods: A prospective single-center registry from February 2020 to May 2024 including patients with bicuspid aortic stenosis treated with TAVR (and surgical aortic valve replacement starting in September 2022). TAVR patients were treated according to the ABC bicuspid sizing algorithm with criteria for annular area (<10% oversizing or <5% with calcification), below annular (left ventricular outflow tract [LVOT]) area (<10% oversizing or <5% with calcification), intercommissural distance (>planned valve diameter - 1 mm), maximum sinus diameter (>planned valve diameter + 6 mm), and avoidance of high-risk leaflet calcification. The study endpoints were technical success and device success at 30 days. Results: From February 2020 to May 2024, 106 patients were treated with TAVR, and (from September 2022) 10 patients were treated with surgical aortic valve replacement due to inadequate sinus dimensions for TAVR or the presence of high-risk calcium. Among TAVR-treated patients, final valve sizing was determined by annular area in 77.5%, LVOT in 21.7%, and intercommissural distance in 1.9%. Most changes (84%) involved reducing planned valve diameter, resulting in modest final annular (1.032%) and LVOT (1.042%) oversizing. Technical success was obtained in 105 (99%) patients, and device success at 30 days in 102 (96.2%) patients. Conclusions: A dedicated sizing algorithm for BEVs was able to select patients for BEV with very high device success.

Indexed as

Balloon-expandable valveBicuspid valvecomputed tomographytranscatheter aortic valve replacement

Identifiers

PMID40895419
PMCPMC12395169

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.