Incidence of Residual Tricuspid Regurgitation in Patients Undergoing Left-heart Surgery

Completed

• Conditions: Left-sided Cardiac Surgery; Residual Tricuspid Regurgitation

• Registration Number: NCT04414358
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2020-05-31
• Study First Submitted QC: 2020-05-31
• Study First Posted: 2020-06-04
• Study Start: 2020-11-20
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• Mitral valve or aortic valve diseases requiring surgical intervention
• No pathologic changes in TV leaflets
• No previous tricuspid valve surgery

Exclusion Criteria

• Patients with incomplete data
• Patient with history of previous cardiac surgery
• Patient with congenital anomalies of mitral or tricuspid valve
• Patient with both tricuspid stenosis and regurgitation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with residual significant tricuspid regurgitation after left-sided cardiac surgery	during surgery	* Residual significant tricuspid regurgitation: more than moderate tricuspid regurgitation after corrective surgery; * Left-sided cardiac surgery: mitral or aortic valve surgery

Secondary Outcome Measures

Name	Time	Method
Number of patients require re-admission	1 year after surgery	Re-admission due to cardiac cause: right-sided cardiac failure, pulmonary oedema
Length of stay	7 days after surgery	Length of hospital and ICU stay
Number of patients require re-operation	1 year after surgery	Re-operation for tricuspid regurgitation correction
Number of patients with different severity of tricuspid regurgitation	during surgery	Compare between preoperative trans- thoracic echocardiography and intraoperative transesophageal echocardiography result (before cardiopulmonary bypass initiation)

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand