Outcome of MC3 Ring Annuloplasty for Functional Tricuspid Regurgitation

• ClinicalTrials.gov Identifier: NCT04078867
• Recruitment Status: Completed
• First Posted: September 6, 2019
• Last Update Posted: September 6, 2019
• Sponsor: Minia University
• Information provided by (Responsible Party): Yasser Ali Kamal, Minia University

Study Description

Brief Summary:

This study includes 105 patients who underwent repair for ≥ moderate tricuspid regurgitation (TR) during mitral valve replacement for rheumatic valve disease. Between January 2016 and December 2018, a group of 23 patients underwent ring annuloplasty with Edward MC3 rings were compared to another group of 82 patients underwent standard suture (DeVega) repair. The primary outcome was residual TR (≥ moderate TR).

Condition or disease	Intervention/treatment
Functional Tricuspid Regurgitation	Procedure: tricuspid valve repair

Detailed Description:

This study evaluated early and midterm outcomes after operations for TV repair which were performed at our institution, between January 2016 and December 2018. The mean follow-up duration was 18.84±9.90 months (range: 3-33 months). The study included 105 patients who underwent repair for FTR during mitral valve replacement for rheumatic valve disease. There were 82 patients underwent suture (DeVega) repair and 23 patients underwent ring annuloplasty using Edward MC3 incomplete 3D ring. The indications of surgery for FTR were: (1) severe TR; or (2) moderate TR with annular dilatation greater than 40 mm and/or preoperative systolic pulmonary artery pressure (SPAP) >50 mmHg. We excluded patients with non-rheumatic mitral disease, combined mitral and aortic valve replacement, mitral valve repair, concomitant coronary artery or aortic surgery, mild or organic tricuspid regurgitation, emergency surgery, reoperations or missed data. Based on echocardiographic data, the severity of TR was graded as: 0 (no TR), 1+ (mild TR), 2+ (mild to moderate TR), 3+ (moderately severe TR), or 4+ (severe).

The type of tricuspid valve repair was chosen in according to surgeon's preference and echocardiographic criteria of TV. The DeVega repair was performed when the patient had minimal annular dilation and lower severity of pulmonary hypertension, while ring annuloplasty was performed in patients with severe tricuspid annular dilation and severe pulmonary hypertension. The DeVega repair was performed on a beating heart using pledget-supported two 4-0 polypropylene running parallel sutures. The MC3 ring annuloplasty was performed through right atriotomy using cardiopulmonary bypass and cardioplegic arrest. The ring size was determined after measurement of the length of the attachments of the tricuspid septal leaflet (the distance between the anteroseptal and septoposterior commissures) or the surface area of the anterior leaflet. The chosen ring was undersized by at least one size. The ring was implanted from the anteroseptal commissure to the middle of the septal leaflet. A series of 8 to10 mattress sutures with a 2-0 Ethibond multifilament suture were made on the tricuspid annulus starting from the center of the septal annulus to the anteroseptal commissure in the counter-clockwise direction, to avoid the atrioventricular conduction tissue. Thereafter, the sutures were placed through the sewing ring of the prosthesis , followed by lowering and securing of the ring to the annulus The collected pre-operative data included age, sex, New York Heart Association (NYHA) functional class, , and the type of preoperative mitral valve disease. The primarily assessed post-operative outcome was residual TR (≥ moderate TR; ≥ grade +2). Other assessed pre- and post-operative parameters included NYHA functional class, and echocardiographic data regarding grade of TR, SPAP, tricuspid annulus (TA) diameter, tricuspid annular plane systolic excursion (TAPSE), left atrial diameter (LAD), left ventricular end-diastolic dimension (LVEDD), left ventricular end-systolic dimension (LVESD), and left ventricular ejection fraction (LVEF).

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 105 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Target Follow-Up Duration: 3 Months
• Official Title: Outcome of MC3 Ring Annuloplasty for Moderate and Severe Functional Tricuspid Regurgitation Associated With Rheumatic Mitral Valve Disease
• Actual Study Start Date: January 1, 2016
• Actual Primary Completion Date: December 31, 2018
• Actual Study Completion Date: December 31, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
DeVega; The DeVega repair is performed when the patient had minimal annular dilation and lower severity of pulmonary hypertension	Procedure: tricuspid valve repair; Tricuspid valve repair during mitral valve replacement for rheumatic heart disease using suture (DeVega) repair or ring annuloplasty
MC3 ring; MC3 ring annuloplasty is performed in patients with severe tricuspid annular dilation and severe pulmonary hypertension	Procedure: tricuspid valve repair; Tricuspid valve repair during mitral valve replacement for rheumatic heart disease using suture (DeVega) repair or ring annuloplasty

Outcome Measures

Primary Outcome Measures :

1. Residual tricuspid regirgitation (TR) [ Time Frame: 3-33 months ]
   residual TR is defined when there is moderate or above degree of TR at the last follow-up echocardiography of the patient

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who underwent repair for functional tricuspid regurgitation during mitral valve replacement for rheumatic valve disease

Criteria

Inclusion Criteria:

• Rheumatic mitral valve disease
• Surgery for mitral valve replacement
• Severe functional tricuspid regurgitation
• Moderate functional tricuspid regurgitation with annular dilatation > 40 mm
• Moderate functional tricuspid regurgitation with preoperative systolic pulmonary artery pressure (SPAP) >50 mmHg

Exclusion Criteria:

• Patients with non-rheumatic mitral disease
• Combined mitral and aortic valve replacement
• Mitral valve repair
• Concomitant coronary artery or aortic surgery
• Mild or organic tricuspid regurgitation
• Emergency surgery
• Reoperations
• Invalid or missed data

Contacts and Locations

Sponsors and Collaborators

Minia University

Investigators

• Principal Investigator: Yasser A Kamal, MD; Minia University

More Information

• Responsible Party: Yasser Ali Kamal, Principal Investigator, Minia University
• ClinicalTrials.gov Identifier: NCT04078867
• Other Study ID Numbers: 62-15
• First Posted: September 6, 2019
• Last Update Posted: September 6, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Yasser Ali Kamal, Minia University:

Tricuspid valve; Functional tricuspid regurgitation; Suture annuloplasty; Ring annuloplasty

Additional relevant MeSH terms:

Tricuspid Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases