Trial Outcomes & Findings for Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery (NCT NCT02675244)

Results Overview

The primary outcome of this trial is treatment failure defined as the composite of (1) death from any cause, (2) reoperation for TR, (3) presence of severe TR at two years post randomization or, for patients enrolled with less than moderate TR and annular dilatation, progression by two grades (i.e., from none/trace TR to moderate TR) at two years post randomization.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

401 participants

Primary outcome timeframe

24 Months

Results posted on

2024-06-18

Participant Flow

From 2016 through 2018, a total of 5208 patients were screened; 885 were eligible to participate in the trial, and 401 underwent randomization

Participant milestones

Participant milestones
Measure	MVS Alone Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques
Overall Study STARTED	203	198
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	203	198

Reasons for withdrawal

Reasons for withdrawal
Measure	MVS Alone Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques
Overall Study Death	9	6
Overall Study Withdrawal by Subject	3	6
Overall Study Lost to Follow-up	1	1
Overall Study Ongoing at 2 Years	190	185

Baseline Characteristics

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MVS Alone n=203 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=198 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	Total n=401 Participants Total of all reporting groups
Age, Continuous	68.2 years STANDARD_DEVIATION 9.7 • n=5 Participants	66.6 years STANDARD_DEVIATION 10.7 • n=7 Participants	67.4 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	51 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	153 Participants n=5 Participants	147 Participants n=7 Participants	300 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	192 Participants n=5 Participants	187 Participants n=7 Participants	379 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	184 Participants n=5 Participants	182 Participants n=7 Participants	366 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Canada	43 participants n=5 Participants	44 participants n=7 Participants	87 participants n=5 Participants
Region of Enrollment United States	116 participants n=5 Participants	120 participants n=7 Participants	236 participants n=5 Participants
Region of Enrollment Germany	44 participants n=5 Participants	34 participants n=7 Participants	78 participants n=5 Participants
Tricuspid-valve annulus dimension (mm)	42.2 mm STANDARD_DEVIATION 4.7 • n=5 Participants	42.0 mm STANDARD_DEVIATION 4.6 • n=7 Participants	42.1 mm STANDARD_DEVIATION 4.6 • n=5 Participants
Tricuspid Regurgitation Moderate	76 Participants n=5 Participants	73 Participants n=7 Participants	149 Participants n=5 Participants
Tricuspid Regurgitation < Moderate	126 Participants n=5 Participants	124 Participants n=7 Participants	250 Participants n=5 Participants
Tricuspid Regurgitation Unable to assess	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Months

The primary outcome of this trial is treatment failure defined as the composite of (1) death from any cause, (2) reoperation for TR, (3) presence of severe TR at two years post randomization or, for patients enrolled with less than moderate TR and annular dilatation, progression by two grades (i.e., from none/trace TR to moderate TR) at two years post randomization.

Outcome measures

Outcome measures
Measure	MVS Alone n=203 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=198 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
Percentage of Participants With Treatment Failure	10.2 percentage of participants Interval 6.0 to 14.5	3.9 percentage of participants Interval 1.1 to 6.7	—	—	—	—

SECONDARY outcome

Timeframe: up to 24 Months

Major Adverse Cardiac and Cerebrovascular Events (MACCE) is defined as a non-weighted composite score comprised of the following components: Death, Stroke, and Serious heart failure events

Outcome measures

Outcome measures
Measure	MVS Alone n=203 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=198 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)	23 Participants	20 Participants	—	—	—	—

SECONDARY outcome

Timeframe: at 24 Months

Functional status will be assessed by the New York Heart Association (NYHA) Classification scale which ranges from 1 (no physical limitations) to 4 (severe limitation of physical activity). 1. Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. 2. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. 4. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. 5. No NYHA class listed or unable to determine

Outcome measures

Outcome measures
Measure	MVS Alone n=203 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=198 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
Number of Participants With NYHA Classification I-IV Class I	150 Participants	155 Participants	—	—	—	—
Number of Participants With NYHA Classification I-IV Class II	24 Participants	22 Participants	—	—	—	—
Number of Participants With NYHA Classification I-IV Class III	5 Participants	2 Participants	—	—	—	—
Number of Participants With NYHA Classification I-IV Class IV	0 Participants	0 Participants	—	—	—	—
Number of Participants With NYHA Classification I-IV Died	9 Participants	6 Participants	—	—	—	—
Number of Participants With NYHA Classification I-IV Withdrew/LTF	4 Participants	7 Participants	—	—	—	—
Number of Participants With NYHA Classification I-IV Missed Assessment	11 Participants	6 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 24 Months

Population: Patients with known diuretic status at 24 months

The diuretic requirements of patients will be assessed.

Outcome measures

Outcome measures
Measure	MVS Alone n=185 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=182 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
Diuretic Use	55 Participants	41 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 24 Months

Population: Patients with observed 6MWT at 24 months

The total distance, in feet, walked in six minutes

Outcome measures

Outcome measures
Measure	MVS Alone n=163 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=169 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
Six Minute Walk Test	1440 feet Interval 1184.0 to 1665.0	1515 feet Interval 1240.0 to 1706.0	—	—	—	—

SECONDARY outcome

Timeframe: up to 24 Months

Degree of TR assessed by echocardiography, categorized according to American Society of Echocardiography guidelines as none/mild/moderate/severe.

Outcome measures

Outcome measures
Measure	MVS Alone n=203 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=198 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
Number of Participants With Degree of TR None/Trace	75 Participants	150 Participants	—	—	—	—
Number of Participants With Degree of TR Mild	59 Participants	23 Participants	—	—	—	—
Number of Participants With Degree of TR Moderate	35 Participants	5 Participants	—	—	—	—
Number of Participants With Degree of TR Severe	10 Participants	1 Participants	—	—	—	—
Number of Participants With Degree of TR Died	9 Participants	6 Participants	—	—	—	—
Number of Participants With Degree of TR Withdrew/LTF	4 Participants	7 Participants	—	—	—	—
Number of Participants With Degree of TR Missed Assessment	11 Participants	6 Participants	—	—	—	—

Timeframe: 24 Months

Population: Patients with observed SF-12 at 24 months

Quality of Life assessed by SF-12. A measure of perceived health (health-related quality of life \[QoL\]) that describes the degree of general physical health status and mental health distress. Higher scores indicate higher levels of health. The physical and mental health scores on the 12-Item Short Form Survey (SF-12) are reported as T scores (mean, 50±10, 50 indicates the population mean with a standard deviation of 10), with higher scores indicating better health status.

Outcome measures

Outcome measures
Measure	MVS Alone n=181 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=183 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
SF-12 Physical Health	47.5 T-Score Standard Deviation 10.0	49.1 T-Score Standard Deviation 9.1	—	—	—	—
SF-12 Mental Health	54.1 T-Score Standard Deviation 9.0	54.3 T-Score Standard Deviation 8.3	—	—	—	—

SECONDARY outcome

Timeframe: 24 Months

Population: Patients with observed KCCQ at 24 months

Quality of Life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life, in which higher scores reflect better health status. Scores on the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary range from 0 to 100, with higher scores indicating a better quality of life and fewer symptoms and physical limitations associated with heart failure.

Outcome measures

Outcome measures
Measure	MVS Alone n=184 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=185 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
Kansas City Cardiomyopathy Questionnaire (KCCQ)	88.0 score on a scale Standard Deviation 16.5	90.3 score on a scale Standard Deviation 14.8	—	—	—	—

SECONDARY outcome

Timeframe: 24 Months

Population: Patients with observed Euro-QOL

Quality of Life assessed by EuroQoL (EQ-5D) - a standardised instrument for use as a measure of health outcome. Scores on the EuroQol (EQ-5D) visual analogue scale range from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate higher levels of health.

Outcome measures

Outcome measures
Measure	MVS Alone n=184 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=185 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
EuroQoL (EQ-5D)	81.6 score on a scale Standard Deviation 15.6	84.0 score on a scale Standard Deviation 13.0	—	—	—	—

SECONDARY outcome

Timeframe: up to 60 Months

Incidence of participants alive

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: average 30 days

Population: Post-surgery hospital LOS between treatment groups compared, separately by region. 1 Canadian patient in the MVS+TA group withdrew prior to discharge from the index hospitalization so do not have their LOS

Outcome measures

Outcome measures
Measure	MVS Alone n=116 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=120 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada n=43 Participants MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada n=43 Participants MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany n=44 Participants MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany n=34 Participants MVS +TA (as described previously) patients randomized in Germany
Length of Index Hospitalization	6 days Interval 5.0 to 8.0	8 days Interval 6.0 to 9.0	7 days Interval 6.0 to 11.0	9 days Interval 7.0 to 14.0	11.5 days Interval 9.0 to 15.0	12 days Interval 9.0 to 16.0

SECONDARY outcome

Timeframe: up to 24 months

Population: \*2 patients in the MVS alone and 3 patients in the MVS+TA group died during the index hospitalization, 1 patient in the MVS+TA group withdrew prior to discharge from the index hospitalization - these patients are excluded from analyses of readmission by 2 years post-randomization

Incidence of readmissions

Outcome measures

Outcome measures
Measure	MVS Alone n=201 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=194 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
Number of Participants With Readmission	66 Participants	69 Participants	—	—	—	—

SECONDARY outcome

Timeframe: up to 24 months

Number of participants with TV reoperations

Outcome measures

Outcome measures
Measure	MVS Alone n=203 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=198 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
Number of Participants With TV Reoperations	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: up to 60 months

Inpatient costs will be measured through the collection of hospital billing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Safety as measured by frequency of serious adverse events.

Outcome measures

Outcome measures
Measure	MVS Alone n=203 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=198 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
Number of Participants With Serious Adverse Events	109 Participants	109 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 24 months

Population: Patients with observed gait speed test at 24 months

Frailty will be assessed using the Gait Speed Test, which measures the average speed of three 5 meter walks

Outcome measures

Outcome measures
Measure	MVS Alone n=164 Participants Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=167 Participants Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	MVS Alone - Canada MVS Alone (as described previously) patients randomized in the Canada	MVS + TA - Canada MVS +TA (as described previously) patients randomized in the Canada	MVS Alone - Germany MVS Alone (as described previously) patients randomized in Germany	MVS + TA - Germany MVS +TA (as described previously) patients randomized in Germany
Gait Speed Test	1.3 m/s Interval 1.0 to 1.7	1.3 m/s Interval 1.1 to 1.7	—	—	—	—

Adverse Events

MVS Alone

Serious events: 109 serious events

Other events: 74 other events

Deaths: 9 deaths

MVS + TV Annuloplasty

Serious events: 109 serious events

Other events: 61 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	MVS Alone n=203 participants at risk Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=198 participants at risk Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques
Vascular disorders Bleeding	5.9% 12/203 • Number of events 13 • 2 years	3.5% 7/198 • Number of events 8 • 2 years
Cardiac disorders Cardiac Arrhythmias - Cardiac arrest	0.49% 1/203 • Number of events 1 • 2 years	0.00% 0/198 • 2 years
Cardiac disorders Cardiac Arrhythmias - Sustained ventricular arrhythmia requiring defibrillation or cardioversion	0.99% 2/203 • Number of events 2 • 2 years	1.0% 2/198 • Number of events 2 • 2 years
Blood and lymphatic system disorders Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio	22.2% 45/203 • Number of events 56 • 2 years	15.2% 30/198 • Number of events 38 • 2 years
Cardiac disorders Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring PPM	2.5% 5/203 • Number of events 5 • 2 years	14.1% 28/198 • Number of events 28 • 2 years
Cardiac disorders Pericardial Fluid Collection	1.5% 3/203 • Number of events 3 • 2 years	1.5% 3/198 • Number of events 3 • 2 years
Respiratory, thoracic and mediastinal disorders Pleural Effusion	7.9% 16/203 • Number of events 20 • 2 years	4.0% 8/198 • Number of events 10 • 2 years
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.5% 3/203 • Number of events 3 • 2 years	2.5% 5/198 • Number of events 5 • 2 years
Hepatobiliary disorders Hepatic Dysfunction	0.99% 2/203 • Number of events 2 • 2 years	0.00% 0/198 • 2 years
Infections and infestations Major Infection - Localized	7.4% 15/203 • Number of events 18 • 2 years	7.6% 15/198 • Number of events 16 • 2 years
Infections and infestations Major Infection - Endocarditis	0.49% 1/203 • Number of events 1 • 2 years	1.0% 2/198 • Number of events 2 • 2 years
Infections and infestations Major Infection - Sepsis	5.4% 11/203 • Number of events 12 • 2 years	2.5% 5/198 • Number of events 5 • 2 years
Cardiac disorders Myocardial Infarction (Non- Procedure Related)	0.99% 2/203 • Number of events 2 • 2 years	1.0% 2/198 • Number of events 2 • 2 years
Cardiac disorders Myocardial Infarction - Peri-CABG	0.49% 1/203 • Number of events 1 • 2 years	0.00% 0/198 • 2 years
Vascular disorders TIA	0.49% 1/203 • Number of events 1 • 2 years	1.0% 2/198 • Number of events 2 • 2 years
Vascular disorders Ischemic Stroke	1.5% 3/203 • Number of events 3 • 2 years	4.5% 9/198 • Number of events 9 • 2 years
Nervous system disorders Hemorrhagic Stroke	0.49% 1/203 • Number of events 1 • 2 years	0.51% 1/198 • Number of events 1 • 2 years
Nervous system disorders Toxic Metabolic Encephalopathy	1.5% 3/203 • Number of events 3 • 2 years	2.0% 4/198 • Number of events 4 • 2 years
Nervous system disorders Seizure	0.99% 2/203 • Number of events 3 • 2 years	1.5% 3/198 • Number of events 3 • 2 years
Renal and urinary disorders Renal Failure	2.5% 5/203 • Number of events 5 • 2 years	1.5% 3/198 • Number of events 3 • 2 years
Respiratory, thoracic and mediastinal disorders Respiratory Failure	2.5% 5/203 • Number of events 7 • 2 years	2.5% 5/198 • Number of events 7 • 2 years
Cardiac disorders Heart Failure	6.4% 13/203 • Number of events 21 • 2 years	4.5% 9/198 • Number of events 14 • 2 years
Vascular disorders Arterial Non-CNS Thromboembolism	0.99% 2/203 • Number of events 2 • 2 years	0.00% 0/198 • 2 years
Vascular disorders Venous Thromboembolic Event	0.99% 2/203 • Number of events 2 • 2 years	0.00% 0/198 • 2 years
Injury, poisoning and procedural complications Wound Dehiscence	0.00% 0/203 • 2 years	1.0% 2/198 • Number of events 2 • 2 years
General disorders Other SAE	23.2% 47/203 • Number of events 71 • 2 years	18.7% 37/198 • Number of events 52 • 2 years
Nervous system disorders Neurological Dysfunction - Other	0.49% 1/203 • Number of events 1 • 2 years	0.00% 0/198 • 2 years

Other adverse events

Other adverse events
Measure	MVS Alone n=203 participants at risk Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	MVS + TV Annuloplasty n=198 participants at risk Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques
Cardiac disorders Cardiac Arrhythmias -Sustained supraventricular arrhythmia requiring drug treatment or cardioversion	28.1% 57/203 • Number of events 62 • 2 years	22.2% 44/198 • Number of events 47 • 2 years
Respiratory, thoracic and mediastinal disorders Pleural Effusion	6.4% 13/203 • Number of events 13 • 2 years	4.5% 9/198 • Number of events 9 • 2 years
Infections and infestations Major Infection - Localized	9.4% 19/203 • Number of events 21 • 2 years	7.6% 15/198 • Number of events 18 • 2 years

Additional Information

Annetine Gelijns

Icahn School of Medicine at Mount Sinai

Phone: 212-659-9567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place