Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

Study Overview
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Brief Summary
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Late tricuspid regurgitation (TR) is a common complication after left-sided valve surgery (LSVS), which usually progresses slowly and results in right heart failure at terminal stage. Over the past 3 decades, with the advances in minimally invasive surgical techniques, operative mortality after reoperation for severe TR has significantly decreased from 30% to 3-8%, leading to a gradual shift from medical therapy alone to surgery in those patients. However, there has been no consensus on the clinical benefit of minimally invasive tricuspid surgery over medical therapy for severe TR after LSVS.

Detailed Description
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In this multi-center randomized controlled trial, patients with severe TR after LSVS will be recruited. The patients will be randomly assigned to surgery plus medical therapy (surgery group) or medical therapy alone (control group). The primary outcome will be a composite of all-cause mortality, re-admission for right heart failure or the composite. Furthermore, echocardiography-based measurement of right heart function, New York Heart Association functional class, liver and kidney function, and quality of life will be compared between the 2 groups. All outcomes will be assessed at baseline and 6, 12 and 24 months after randomization.

Official Title
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Minimally Invasive Tricuspid Surgery Versus Medical Treatment for Severe Tricuspid Regurgitation After Left-sided Valve Surgery

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Procedure: Minimally Invasive Tricuspid Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe tricuspid regurgitation, as assessed by the clinical site echocardiographer using the transthoracic echocardiography. A history of LSVS, including one or multiple procedures of aortic and/or mitral valve repair and/or replacement. Left ventricular ejection fraction (LVEF) >45%, systolic pulmonary artery pressure <60 mmHg with pulmonary vascular resistance <6 woods unit. Age ≥ 18 years. Able to sign Informed Consent forms. Exclusion Criteria: TR due to: infective endocarditis, congenital tricuspid valve malformation, secondary to correction of congenital heart disease. Left-sided valve dysfunction or coronary artery disease requiring concomitant procedures. Prior surgical or percutaneous tricuspid valve intervention. Evidence of an acute myocardial infarction in the prior 90 days Contraindications to cardiopulmonary bypass or the expected operative mortality >30% (calculated by the Society of Thoracic Surgeons score or the EuroSCORE II). Any comorbidity with life expectancy <2 years Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study protocol. Pregnancy at the time of randomization.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery group<br>receiving minimally invasive tricuspid surgery including tricuspid valve replacement or repair plus medical treatment. | Procedure: Minimally Invasive Tricuspid Surgery<br>* minimally invasive tricuspid surgery including endoscopy-assist right minithoracotomy, vacuum-assist single femoral venous drainage without dissecting or snaring vena cava, direct right atriotomy through pericardium and the beating-heart technique.<br>|
| No Intervention: Medical group<br>receiving medical treatment only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of all-cause death, re-hospitalization due to right heart failure or both of them | the rate of all-cause death, re-hospitalization due to right heart failure or both of them | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| right heart function | echocardiography-based measurement of right heart function | 2 years | 
| New York Heart Association functional class | New York Heart Association functional class including I, II, III, IV class | 2 years | 
| liver function | total bilirubin, conjugated bilirubin | 2 years | 
| liver function | prealbumin. | 2 years | 
| kidney function | blood urea nitrogen | 2 years | 
| kidney function | creatinine | 2 years | 
| kidney function | uric acid. | 2 years | 
| life quality scores | quality of life using the SF-12 form | 2 years |