Predictors Of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR

Detailed Description
-----------------
Calcific aortic stenosis (AS) is the most common valve disease in the western world requiring intervention,Although Surgical Aortic Valve Replacement (SAVR) was considered as the first therapeutic method, approximately one-third of AS patients cannot undergo SAVR due to its' high risk or contraindication. 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.

Official Title
-----------------
Predictors Of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve

Conditions
-----------------
Left Ventricular Systolic Function

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiography before and after TAVR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with symptomatic severe aortic stenosis eligible for TAVR with LV systolic function less than 50%. Exclusion Criteria: Severe Rheumatic or degenerative mitral regurgitation. Previous Valve Replacement. Previous myocardial infarction. Previous Coronary Artery By Bass Graft (CABG)Surgery. Post TAVR significant paravalvular leakage
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LVEFrecovery<br>patient who shows improvement of left ventricular systolic function | Diagnostic Test: Echocardiography before and after TAVR<br>* 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)<br>* Other names: cardiac computed tomography and coronary angiography;|
| Non LVEF recovery<br>patient who don't show improvement of left ventricular systolic function | Diagnostic Test: Echocardiography before and after TAVR<br>* 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)<br>* Other names: cardiac computed tomography and coronary angiography;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular systolic function recovery by ejection fraction | absolute increase of ≥10% in EF compared with baseline | 30 days post TAVR | 
| left ventricular systolic function recovery by STE | Myocardial recovery by STE is defined as a ≥20% relative increase in the magnitude of global longitudinal strain compared with baseline | 30 days post TAVR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment | NIHA class . | 30days post TAVR |