Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve Replacement
NCT ID: NCT05069168
Last Updated: 2025-01-30
Study Results
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Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2023-12-01
2024-12-30
Brief Summary
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Detailed Description
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Since Transcatheter Aortic Valve Replacement (TAVR)was performed for the first time in 2002,TAVR has emerged as a growing prevalent treatment on severe symptomatic AS with the procedure initially performed on the inoperable patients with intermediate and high risks.
Recently, the Food and Drug Administration had approved it on low-risk symptomatic subjects.
AS has to be considered a disease of the left ventricle (LV) rather than purely affecting the aortic valve, Approximately one-third of patients with severe symptomatic AS have LV systolic dysfunction .
Recovery of LV ejection fraction (LVEF) is associated with improvements in clinical outcomes after TAVR as shown by a lot of studies.
The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated that recovery of LV function in patients with severe symptomatic AS and LV systolic dysfunction who underwent TAVR, occurs in 40% to 50% of patients .
Higher trans-aortic mean pressure gradient , less LV hypertrophy, Less LV fibrosis and absence of AF are predictors of recovery of LV function after TAVR .
However, there is still a scanty data about the predictors of LV function recovery after TAVR.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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LVEFrecovery
patient who shows improvement of left ventricular systolic function
Echocardiography before and after TAVR
Evaluation of severity of aortic stenosis using :peak velocity ,peak and mean pressure gradient and aortic valve area by continuity equation.-Evaluation of left ventricular dimensions ,volumes and systolic function as assessed by ejection fraction (EF) by m-mode and biplane simpson's method at apical 4 and 2 chambers view Speckle tracking echocardiography(STE) Apical four-, three-, and two-chamber views were used to obtain longitudinal and circumferential strain before and follow-up after TAVR.
cardiac CT :Routine full protocol before TAVR for evaluation and Detection and calculation of left ventricular fibrosis using extracellular volume.
Coronary angiography:evaluate the presence of CAD and calculation of syntax score(SS)
Non LVEF recovery
patient who don't show improvement of left ventricular systolic function
Echocardiography before and after TAVR
Evaluation of severity of aortic stenosis using :peak velocity ,peak and mean pressure gradient and aortic valve area by continuity equation.-Evaluation of left ventricular dimensions ,volumes and systolic function as assessed by ejection fraction (EF) by m-mode and biplane simpson's method at apical 4 and 2 chambers view Speckle tracking echocardiography(STE) Apical four-, three-, and two-chamber views were used to obtain longitudinal and circumferential strain before and follow-up after TAVR.
cardiac CT :Routine full protocol before TAVR for evaluation and Detection and calculation of left ventricular fibrosis using extracellular volume.
Coronary angiography:evaluate the presence of CAD and calculation of syntax score(SS)
Interventions
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Echocardiography before and after TAVR
Evaluation of severity of aortic stenosis using :peak velocity ,peak and mean pressure gradient and aortic valve area by continuity equation.-Evaluation of left ventricular dimensions ,volumes and systolic function as assessed by ejection fraction (EF) by m-mode and biplane simpson's method at apical 4 and 2 chambers view Speckle tracking echocardiography(STE) Apical four-, three-, and two-chamber views were used to obtain longitudinal and circumferential strain before and follow-up after TAVR.
cardiac CT :Routine full protocol before TAVR for evaluation and Detection and calculation of left ventricular fibrosis using extracellular volume.
Coronary angiography:evaluate the presence of CAD and calculation of syntax score(SS)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous Valve Replacement.
* Previous myocardial infarction.
* Previous Coronary Artery By Bass Graft (CABG)Surgery.
* Post TAVR significant paravalvular leakage
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Anwar S Helen
Principle investigator
Principal Investigators
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Hatem A Helmy
Role: STUDY_DIRECTOR
Assiut University
Locations
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Medicine
Asyut, , Egypt
Countries
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References
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Passeri JJ, Elmariah S, Xu K, Inglessis I, Baker JN, Alu M, Kodali S, Leon MB, Svensson LG, Pibarot P, Fearon WF, Kirtane AJ, Vlahakes GJ, Palacios IF, Douglas PS; PARTNER Investigators. Transcatheter aortic valve replacement and standard therapy in inoperable patients with aortic stenosis and low EF. Heart. 2015 Mar;101(6):463-71. doi: 10.1136/heartjnl-2014-306737. Epub 2015 Jan 13.
Sato K, Kumar A, Jones BM, Mick SL, Krishnaswamy A, Grimm RA, Desai MY, Griffin BP, Rodriguez LL, Kapadia SR, Obuchowski NA, Popovic ZB. Reversibility of Cardiac Function Predicts Outcome After Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis. J Am Heart Assoc. 2017 Jul 11;6(7):e005798. doi: 10.1161/JAHA.117.005798.
Han D, Tamarappoo B, Klein E, Tyler J, Chakravarty T, Otaki Y, Miller R, Eisenberg E, Park R, Singh S, Shiota T, Siegel R, Stegic J, Salseth T, Cheng W, Dey D, Thomson L, Berman D, Makkar R, Friedman J. Computed tomography angiography-derived extracellular volume fraction predicts early recovery of left ventricular systolic function after transcatheter aortic valve replacement. Eur Heart J Cardiovasc Imaging. 2021 Jan 22;22(2):179-185. doi: 10.1093/ehjci/jeaa310.
Jeong YJ, Ahn JM, Kang DY, Park H, Ko E, Kim HJ, Kim JB, Choo SJ, Lee SA, Park SJ, Kim DH, Park DW. Incidence, Predictors, and Prognostic Impact of Immediate Improvement in Left Ventricular Systolic Function After Transcatheter Aortic Valve Implantation. Am J Cardiol. 2021 Aug 1;152:99-105. doi: 10.1016/j.amjcard.2021.04.037. Epub 2021 Jun 11.
Other Identifiers
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TAVR
Identifier Type: -
Identifier Source: org_study_id
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