Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-02 @ 2:23 AM
Study NCT ID:
NCT04414358
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2020-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Residual Tricuspid Regurgitation in Patients Undergoing Left-heart Surgery
Sponsor:
Mahidol University
Organization:
Study Overview
Official Title:
Incidence of Residual Significant Tricuspid Regurgitation in Patients Undergoing Left-sided Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Functional tricuspid valve regurgitation is commonly co-existed with left-sided cardiac lesion, especially mitral valve stenosis. Both lesion were recommended to surgically fixed at the same setting. Residual tricuspid regurgitation may effects patients' outcome. The investigators would like to determine the incidence of significant residual tricuspid regurgitation after left-sided cardiac surgery and related clinical outcome.
Detailed Description:
Functional tricuspid regurgitation (TR) was defined as TR occurring secondary to left heart, especially mitral valve stenosis or pulmonary disease. Previous study reported that about 30% - 50% of patients with significant mitral stenosis developed moderate to severe TR. In the past, corrective TR repair was not always indicated because the concept about TR severity will improve after mitral valve lesion was treated.
Later on, several studies demonstrated that the patients with untreated significant (\< moderate) TR had worse clinical outcome including mortality. While simultaneous functional TR repair with left-sided valve surgery did not cause adverse events, but improve clinical outcome and quality of life. The current European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) and American Heart Association(AHA)/American College of Cardiology (ACC) guidelines recommend concomitant tricuspid valve (TV) surgery in patients with severe TR undergoing left-sided valve surgery (class I recommendation). In patients with mild to moderate TR, there is a class IIa indication for concomitant TV surgery in the setting of tricuspid annular dilatation.
However, after TV repair, commonly with annuloplasty ring or De Vega annuloplasty, residual TR may still persist and the residual moderate or severe TR have negative impact to right ventricle (RV). It can cause RV dilatation and RV failure(7, 12). Calafiore et al reported 12.4% of significant TR after surgery and the associated factors for the repair failure. If this group of patients developed symptom of RV failure or progressive RV dilatation or dysfunction is detected, they possessed very high-risk for re-operation.
Preoperative transthoracic echocardiography (TTE) is an important tool to classified severity of TR, measured TV annulus, indicate the surgical correction requirement and demonstrate the result of the TR repair. Due to limitation of TTE operator and machine, time-interval between the latest preoperative TTE result and surgery are varied, so the TR severity may already changed. The postoperative TTE result sometimes comes out late after surgery. Therefore, transesophageal echocardiography (TEE), operated by trained cardiac anesthesiologist, may play role to confirm the severity and provide the instant result of the TV repair to help guide the cardiac surgeon to make a decision whether to re-operate in the same setting to improve the surgical outcome.
Therefore, the investigators would like to determine the incidence of residual significant TR by intraoperative TEE in the patients underwent left-side cardiac surgery and the related clinical outcome, including rate of re-admission from cardiac cause and 1- year mortality.
Later on, several studies demonstrated that the patients with untreated significant (\< moderate) TR had worse clinical outcome including mortality. While simultaneous functional TR repair with left-sided valve surgery did not cause adverse events, but improve clinical outcome and quality of life. The current European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) and American Heart Association(AHA)/American College of Cardiology (ACC) guidelines recommend concomitant tricuspid valve (TV) surgery in patients with severe TR undergoing left-sided valve surgery (class I recommendation). In patients with mild to moderate TR, there is a class IIa indication for concomitant TV surgery in the setting of tricuspid annular dilatation.
However, after TV repair, commonly with annuloplasty ring or De Vega annuloplasty, residual TR may still persist and the residual moderate or severe TR have negative impact to right ventricle (RV). It can cause RV dilatation and RV failure(7, 12). Calafiore et al reported 12.4% of significant TR after surgery and the associated factors for the repair failure. If this group of patients developed symptom of RV failure or progressive RV dilatation or dysfunction is detected, they possessed very high-risk for re-operation.
Preoperative transthoracic echocardiography (TTE) is an important tool to classified severity of TR, measured TV annulus, indicate the surgical correction requirement and demonstrate the result of the TR repair. Due to limitation of TTE operator and machine, time-interval between the latest preoperative TTE result and surgery are varied, so the TR severity may already changed. The postoperative TTE result sometimes comes out late after surgery. Therefore, transesophageal echocardiography (TEE), operated by trained cardiac anesthesiologist, may play role to confirm the severity and provide the instant result of the TV repair to help guide the cardiac surgeon to make a decision whether to re-operate in the same setting to improve the surgical outcome.
Therefore, the investigators would like to determine the incidence of residual significant TR by intraoperative TEE in the patients underwent left-side cardiac surgery and the related clinical outcome, including rate of re-admission from cardiac cause and 1- year mortality.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: