Evidence map›Paper›PMID 36434335›Full record

Trial reportThe international journal of cardiovascular imaging2022

Fractal dimension of the aortic annulus: a novel predictor of paravalvular leak after transcatheter aortic valve implantation.

Georg Stachel, Mohamed Abdel-Wahab, Suzanne de Waha-Thiele, Steffen Desch, Hans-Josef Feistritzer, Mitsunobu Kitamura, Serdar Farhan, Ingo Eitel, Thomas Kurz, Holger Thiele

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The international journal of cardiovascular imaging, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02737150 (CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT02737150 naunknown statusnot on this map

CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)

TypeinterventionalSponsorHelios Health Institute GmbHRan2016 to 2021Enrolled444ConditionsAortic StenosisArmsCoreValve Evolut R, Edwards Sapien 3, Local anesthesia with conscious sedation, General anesthesia
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Georg StachelDepartment of Internal Medicine/Cardiology and Leipzig Heart Institute, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
Mohamed Abdel-WahabDepartment of Internal Medicine/Cardiology and Leipzig Heart Institute, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
Suzanne de Waha-ThieleDepartment of Cardiac Surgery, Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289, Leipzig, Germany.
Steffen DeschDepartment of Internal Medicine/Cardiology and Leipzig Heart Institute, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
Hans-Josef FeistritzerDepartment of Internal Medicine/Cardiology and Leipzig Heart Institute, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
Mitsunobu KitamuraDepartment of Internal Medicine/Cardiology and Leipzig Heart Institute, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
Serdar FarhanThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Ingo EitelUniversity Clinic Schleswig-Holstein, University Heart Center Luebeck, Lübeck, Germany.
Thomas KurzUniversity Clinic Schleswig-Holstein, University Heart Center Luebeck, Lübeck, Germany.
Holger ThieleDepartment of Internal Medicine/Cardiology and Leipzig Heart Institute, Heart Center Leipzig at University of Leipzig, Leipzig, Germany. holger.thiele@medizin.uni-leipzig.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To evaluate the prognostic relevance of aortic annulus (AA) and left ventricular outflow tract (LVOT) Fractal dimension (FD). FD is a mathematical concept that describes geometric complexity of a structure and has been shown to predict adverse outcomes in several contexts. Computed tomography (CT) scans from the SOLVE-TAVI trial, which, in a 2 × 2 factorial design, randomized 447 patients to TAVI with the balloon-expandable Edwards Sapien 3 or the self-expanding Medtronic Evolut R, and conscious sedation or general anesthesia, were analyzed semi-automatically with a custom-built software to determine border of AA and LVOT. FD was measured by box counting using grid calibers between 0.8 and 6.75 mm and was compared between patients with none/trivial and mild/moderate paravalvular regurgitation (PVR). Overall, 122 patients had CT scans sufficient for semi-automatic PVR in 30-day echocardiography. PVR was none in 65(53.3%) patients, trace in 9(7.4%), mild in 46(37.7%), moderate in 2(1.6%) and severe in 0 patients. FD determined in diastolic images was significantly higher in patients with mild/moderate PVR (1.0558 ± 0.0289 vs. 1.0401 ± 0.0284, p = 0.017). Annulus eccentricity was the only conventional measure of AA and LVOT geometry significantly correlated to FD (R = 0.337, p < 0.01). Area under the curve (AUC) of diastolic annular FD for prediction of mild/moderate PVR in ROC analysis was 0.661 (0.542-0.779, p = 0.014). FD shows promise in prediction of PVR after TAVI. Further evaluation using larger patient numbers and refined algorithms to better understand its predictive performance is warranted.Trial Registration: www.clinicaltrials.gov , identifier: NCT02737150, date of registration: 13.04.2016.

Indexed as

Aortic Valve InsufficiencyAortic Valve StenosisTranscatheter Aortic Valve ReplacementAortic ValveFractalsHumansMultidetector Computed TomographyPostoperative ComplicationsPredictive Value of TestsAortic stenosisAutomated image analysisComputerized tomography (CT)Fractal dimensionTranscatheter aortic valve implantation

Identifiers

PMID36434335
PMCPMC9700572

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Registered trials

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.