Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR
Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR
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.
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.
Inclusion Criteria:

 1. Severe tricuspid regurgitation, as assessed by the clinical site echocardiographer
 using the transthoracic echocardiography.

 2. A history of LSVS, including one or multiple procedures of aortic and/or mitral valve
 repair and/or replacement.

 3. Left ventricular ejection fraction (LVEF) >45%, systolic pulmonary artery pressure <60
 mmHg with pulmonary vascular resistance <6 woods unit.

 4. Age ≥ 18 years.

 5. Able to sign Informed Consent forms.

 Exclusion Criteria:

 1. TR due to: infective endocarditis, congenital tricuspid valve malformation, secondary
 to correction of congenital heart disease.

 2. Left-sided valve dysfunction or coronary artery disease requiring concomitant
 procedures.

 3. Prior surgical or percutaneous tricuspid valve intervention.

 4. Evidence of an acute myocardial infarction in the prior 90 days

 5. Contraindications to cardiopulmonary bypass or the expected operative mortality >30%
 (calculated by the Society of Thoracic Surgeons score or the EuroSCORE II).

 6. Any comorbidity with life expectancy <2 years

 7. Recent history of psychiatric disease (including drug or alcohol abuse) that is likely
 to impair compliance with the study protocol.

 8. Pregnancy at the time of randomization.