Trial Outcomes & Findings for Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol (NCT NCT00853632)

NCT ID: NCT00853632

Last Updated: 2025-05-14

Results Overview

A linearized rate percentage is calculated by the following equation: \[(Total number of late adverse events in each category/total number of late patient years) x 100\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 329 participants
• Primary outcome timeframe: Events occurring ≥ 31 days and up through 8 years post-implant
• Results posted on: 2025-05-14

Participant Flow

Participant milestones

Measure	Device - CEP Mitral Valve Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Overall Study STARTED	329
Overall Study COMPLETED	127
Overall Study NOT COMPLETED	202

Reasons for withdrawal

Measure	Device - CEP Mitral Valve Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Overall Study Death	88
Overall Study Withdrawal by Subject	45
Overall Study Lost to Follow-up	30
Overall Study Reoperation/Explant	17
Overall Study Exit with other reason	22

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Device - CEP Mitral Valve n=329 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Age, Continuous	69.7 Years STANDARD_DEVIATION 10.7 • n=329 Participants
Sex: Female, Male Female	201 Participants n=329 Participants
Sex: Female, Male Male	128 Participants n=329 Participants
Region of Enrollment Canada	55 participants n=329 Participants
Region of Enrollment Europe	105 participants n=329 Participants
Region of Enrollment United States	169 participants n=329 Participants

PRIMARY outcome

Timeframe: Events occurring ≥ 31 days and up through 8 years post-implant

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.

A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.

Outcome measures

Measure	Device - CEP Mitral Valve n=329 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Thromboembolism	2.0 Linearized rate percentage	—	—	—	—
Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort All paravalvular leak	0.3 Linearized rate percentage	—	—	—	—
Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Endocarditis	0.3 Linearized rate percentage	—	—	—	—
Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort All bleeding events	5.8 Linearized rate percentage	—	—	—	—

PRIMARY outcome

Timeframe: 8 years post-implant

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

The primary effectiveness endpoint will be the percentage of subjects in NYHA functional classification I or II at 8 years post-implant.

Outcome measures

Measure	Device - CEP Mitral Valve n=106 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Primary Effectiveness Endpoints	93 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Events occurring within 30 days of procedure

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.

Total number of early adverse events, in each category, occurring within 30 days of procedure divided by the number of enrolled subjects times 100.

Outcome measures

Measure	Device - CEP Mitral Valve n=329 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Percent of Early Adverse Events Valve Thrombosis	0.0 percentage	—	—	—	—
Percent of Early Adverse Events All Bleeding Events	12.2 percentage	—	—	—	—
Percent of Early Adverse Events Major bleeding	9.4 percentage	—	—	—	—
Percent of Early Adverse Events Endocarditis	0.0 percentage	—	—	—	—
Percent of Early Adverse Events Hemolysis	0.0 percentage	—	—	—	—
Percent of Early Adverse Events Thromboembolism	2.1 percentage	—	—	—	—
Percent of Early Adverse Events Structural Valve Deterioration	0.0 percentage	—	—	—	—
Percent of Early Adverse Events Non-Structural Valve Dysfunction	1.5 percentage	—	—	—	—
Percent of Early Adverse Events Reoperation	0.9 percentage	—	—	—	—
Percent of Early Adverse Events Explant	0.9 percentage	—	—	—	—
Percent of Early Adverse Events Death	2.7 percentage	—	—	—	—

SECONDARY outcome

Timeframe: 6 months post-implant

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from a minimum of 0 and a maximum of 100. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.

Outcome measures

Measure	Device - CEP Mitral Valve n=214 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time Baseline	63.1 units on a scale Standard Deviation 20.7	—	—	—	—
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time 6 months	75.4 units on a scale Standard Deviation 17.8	—	—	—	—

SECONDARY outcome

Timeframe: Events occurring ≥ 31 days and up through 8 years post-implant

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.

A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.

Outcome measures

Measure	Device - CEP Mitral Valve n=329 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Thromboembolism	2.0 Linearized rate percentage	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Valve Thrombosis	0.1 Linearized rate percentage	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Major bleeding	3.2 Linearized rate percentage	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Endocarditis	0.3 Linearized rate percentage	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Hemolysis	0.0 Linearized rate percentage	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort All Bleeding Events	5.8 Linearized rate percentage	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Structural Valve Deterioration	1.8 Linearized rate percentage	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Non-Structural Valve Dysfunction	0.4 Linearized rate percentage	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Reoperation	0.2 Linearized rate percentage	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Explant	1.1 Linearized rate percentage	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort Death	5.3 Linearized rate percentage	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 years post-implant

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.

Outcome measures

Measure	Device - CEP Mitral Valve n=175 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Mean Gradient Measurement Baseline	8.03 mmHg Standard Deviation 5.42	—	—	—	—
Subject's Average Mean Gradient Measurement 8 years	5.70 mmHg Standard Deviation 2.85	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 years post-implant

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.

Outcome measures

Measure	Device - CEP Mitral Valve n=176 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Peak Gradient Measurement 8 years	14.57 mmHg Standard Deviation 6.62	—	—	—	—
Subject's Average Peak Gradient Measurement Baseline	18.56 mmHg Standard Deviation 9.63	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 years post-implant

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.

Outcome measures

Measure	Device - CEP Mitral Valve n=110 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Effective Orifice Area (EOA) Measurement Baseline	1.39 cm^2 Standard Deviation 0.93	—	—	—	—
Subject's Average Effective Orifice Area (EOA) Measurement 8 years	1.90 cm^2 Standard Deviation 0.67	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 years post-implant

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.

Outcome measures

Measure	Device - CEP Mitral Valve n=110 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Effective Orifice Area Index (EOAI) Measurement Baseline	0.73 cm^2/m^2 Standard Deviation 0.48	—	—	—	—
Subject's Average Effective Orifice Area Index (EOAI) Measurement 8 years	1.03 cm^2/m^2 Standard Deviation 0.38	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 years post-implant

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.

Outcome measures

Measure	Device - CEP Mitral Valve n=138 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Cardiac Output Measurement Baseline	4.70 L/min Standard Deviation 1.67	—	—	—	—
Subject's Average Cardiac Output Measurement 8 years	6.02 L/min Standard Deviation 1.52	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 years post-implant

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient.

Outcome measures

Measure	Device - CEP Mitral Valve n=98 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Cardiac Index Measurement Baseline	2.50 L/min/m^2 Standard Deviation 0.86	—	—	—	—
Subject's Average Cardiac Index Measurement 8 years	3.32 L/min/m^2 Standard Deviation 0.91	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 years post-implant

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Patients can experience an enlargement of the left ventricle (chamber) of their heart because it works harder with a defective heart valve. Left ventricular mass regression evaluates if the patient experiences a decrease in the size of the left ventricle (chamber) after the repair or replacement of their heart valve.

Outcome measures

Measure	Device - CEP Mitral Valve n=193 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Left Ventricular Mass Regression Baseline	213.21 grams Standard Deviation 90.50	—	—	—	—
Subject's Average Left Ventricular Mass Regression 8 years	163.71 grams Standard Deviation 54.50	—	—	—	—

SECONDARY outcome

Timeframe: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10^6 cells/microliters and for men is 4.7 to 6.1 10^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range may indicate something is wrong.

Outcome measures

Measure	Device - CEP Mitral Valve n=76 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm n=117 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm n=81 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm n=39 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm n=16 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Red Blood Cell Count 6 years	4.3 10^6 cells/uL Standard Deviation 0.6	4.4 10^6 cells/uL Standard Deviation 0.5	4.3 10^6 cells/uL Standard Deviation 0.6	4.3 10^6 cells/uL Standard Deviation 0.8	4.6 10^6 cells/uL Standard Deviation 0.4
Subject's Average Red Blood Cell Count 7 years	4.5 10^6 cells/uL Standard Deviation 0.5	4.3 10^6 cells/uL Standard Deviation 0.6	4.2 10^6 cells/uL Standard Deviation 0.7	4.1 10^6 cells/uL Standard Deviation 0.8	4.6 10^6 cells/uL Standard Deviation 0.3
Subject's Average Red Blood Cell Count 3 years	4.3 10^6 cells/uL Standard Deviation 0.5	4.4 10^6 cells/uL Standard Deviation 0.5	4.4 10^6 cells/uL Standard Deviation 0.7	4.3 10^6 cells/uL Standard Deviation 0.7	4.6 10^6 cells/uL Standard Deviation 0.3
Subject's Average Red Blood Cell Count 4 years	4.3 10^6 cells/uL Standard Deviation 0.5	4.4 10^6 cells/uL Standard Deviation 0.4	4.3 10^6 cells/uL Standard Deviation 0.5	4.4 10^6 cells/uL Standard Deviation 0.6	4.6 10^6 cells/uL Standard Deviation 0.3
Subject's Average Red Blood Cell Count 6 months	4.4 10^6 cells/uL Standard Deviation 0.6	4.4 10^6 cells/uL Standard Deviation 0.6	4.3 10^6 cells/uL Standard Deviation 0.6	4.3 10^6 cells/uL Standard Deviation 0.6	4.6 10^6 cells/uL Standard Deviation 0.5
Subject's Average Red Blood Cell Count 1 year	4.4 10^6 cells/uL Standard Deviation 0.5	4.3 10^6 cells/uL Standard Deviation 0.5	4.4 10^6 cells/uL Standard Deviation 0.5	4.2 10^6 cells/uL Standard Deviation 0.6	4.6 10^6 cells/uL Standard Deviation 0.4
Subject's Average Red Blood Cell Count 2 years	4.3 10^6 cells/uL Standard Deviation 0.5	4.4 10^6 cells/uL Standard Deviation 0.5	4.4 10^6 cells/uL Standard Deviation 0.6	4.3 10^6 cells/uL Standard Deviation 0.6	4.6 10^6 cells/uL Standard Deviation 0.3
Subject's Average Red Blood Cell Count 5 years	4.4 10^6 cells/uL Standard Deviation 0.5	4.4 10^6 cells/uL Standard Deviation 0.5	4.3 10^6 cells/uL Standard Deviation 0.6	4.2 10^6 cells/uL Standard Deviation 0.8	4.5 10^6 cells/uL Standard Deviation 0.4
Subject's Average Red Blood Cell Count 8 years	4.3 10^6 cells/uL Standard Deviation 0.6	4.4 10^6 cells/uL Standard Deviation 0.6	4.3 10^6 cells/uL Standard Deviation 0.6	4.1 10^6 cells/uL Standard Deviation 1.0	4.4 10^6 cells/uL Standard Deviation 0.4

SECONDARY outcome

Timeframe: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10.0 10^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Device - CEP Mitral Valve n=76 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm n=117 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm n=81 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm n=39 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm n=16 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average White Blood Cell Count 6 months	6.9 10^3 cells/uL Standard Deviation 1.6	6.9 10^3 cells/uL Standard Deviation 1.7	7.2 10^3 cells/uL Standard Deviation 2.1	7.1 10^3 cells/uL Standard Deviation 2.2	6.7 10^3 cells/uL Standard Deviation 1.2
Subject's Average White Blood Cell Count 2 years	6.9 10^3 cells/uL Standard Deviation 2.4	6.8 10^3 cells/uL Standard Deviation 1.9	7.2 10^3 cells/uL Standard Deviation 2.0	6.5 10^3 cells/uL Standard Deviation 1.8	5.8 10^3 cells/uL Standard Deviation 1.2
Subject's Average White Blood Cell Count 3 years	6.5 10^3 cells/uL Standard Deviation 2.4	6.8 10^3 cells/uL Standard Deviation 1.8	7.0 10^3 cells/uL Standard Deviation 2.2	7.1 10^3 cells/uL Standard Deviation 2.2	6.1 10^3 cells/uL Standard Deviation 1.3
Subject's Average White Blood Cell Count 4 years	6.9 10^3 cells/uL Standard Deviation 2.7	6.9 10^3 cells/uL Standard Deviation 1.9	7.6 10^3 cells/uL Standard Deviation 2.6	6.5 10^3 cells/uL Standard Deviation 1.6	6.0 10^3 cells/uL Standard Deviation 1.3
Subject's Average White Blood Cell Count 5 years	6.2 10^3 cells/uL Standard Deviation 1.7	6.8 10^3 cells/uL Standard Deviation 1.7	7.3 10^3 cells/uL Standard Deviation 2.2	6.8 10^3 cells/uL Standard Deviation 1.7	6.9 10^3 cells/uL Standard Deviation 3.8
Subject's Average White Blood Cell Count 7 years	6.8 10^3 cells/uL Standard Deviation 2.3	7.2 10^3 cells/uL Standard Deviation 2.2	7.0 10^3 cells/uL Standard Deviation 2.2	6.7 10^3 cells/uL Standard Deviation 2.1	6.1 10^3 cells/uL Standard Deviation 1.7
Subject's Average White Blood Cell Count 8 years	6.0 10^3 cells/uL Standard Deviation 1.7	7.0 10^3 cells/uL Standard Deviation 2.1	7.9 10^3 cells/uL Standard Deviation 2.1	5.8 10^3 cells/uL Standard Deviation 1.5	6.6 10^3 cells/uL Standard Deviation 1.1
Subject's Average White Blood Cell Count 1 year	7.1 10^3 cells/uL Standard Deviation 2.0	6.9 10^3 cells/uL Standard Deviation 2.0	7.1 10^3 cells/uL Standard Deviation 1.8	7.5 10^3 cells/uL Standard Deviation 2.0	7.2 10^3 cells/uL Standard Deviation 1.3
Subject's Average White Blood Cell Count 6 years	6.4 10^3 cells/uL Standard Deviation 2.0	7.0 10^3 cells/uL Standard Deviation 1.6	6.9 10^3 cells/uL Standard Deviation 2.1	7.4 10^3 cells/uL Standard Deviation 1.8	5.9 10^3 cells/uL Standard Deviation 1.0

SECONDARY outcome

Timeframe: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

This is the laboratory analysis of Hemoglobin count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Device - CEP Mitral Valve n=76 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm n=117 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm n=81 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm n=39 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm n=16 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Hemoglobin Count 3 years	12.9 g/dL Standard Deviation 1.5	13.0 g/dL Standard Deviation 1.5	13.1 g/dL Standard Deviation 1.4	13.1 g/dL Standard Deviation 2.0	14.0 g/dL Standard Deviation 1.8
Subject's Average Hemoglobin Count 1 year	12.9 g/dL Standard Deviation 1.5	12.8 g/dL Standard Deviation 1.7	13.3 g/dL Standard Deviation 1.4	12.9 g/dL Standard Deviation 1.7	13.9 g/dL Standard Deviation 1.4
Subject's Average Hemoglobin Count 2 years	12.5 g/dL Standard Deviation 2.3	13.2 g/dL Standard Deviation 1.4	13.3 g/dL Standard Deviation 1.7	13.2 g/dL Standard Deviation 1.9	14.0 g/dL Standard Deviation 1.1
Subject's Average Hemoglobin Count 7 years	12.8 g/dL Standard Deviation 1.6	12.7 g/dL Standard Deviation 1.7	12.3 g/dL Standard Deviation 1.8	12.7 g/dL Standard Deviation 2.3	14.0 g/dL Standard Deviation 1.5
Subject's Average Hemoglobin Count 6 months	12.4 g/dL Standard Deviation 1.6	12.5 g/dL Standard Deviation 1.5	12.8 g/dL Standard Deviation 1.3	12.8 g/dL Standard Deviation 1.6	13.7 g/dL Standard Deviation 2.2
Subject's Average Hemoglobin Count 4 years	12.6 g/dL Standard Deviation 1.5	13.0 g/dL Standard Deviation 1.5	12.9 g/dL Standard Deviation 1.6	13.6 g/dL Standard Deviation 1.7	14.2 g/dL Standard Deviation 0.7
Subject's Average Hemoglobin Count 5 years	13.1 g/dL Standard Deviation 1.4	13.0 g/dL Standard Deviation 1.7	13.0 g/dL Standard Deviation 1.6	13.0 g/dL Standard Deviation 2.3	13.8 g/dL Standard Deviation 1.4
Subject's Average Hemoglobin Count 6 years	12.5 g/dL Standard Deviation 1.7	12.7 g/dL Standard Deviation 1.7	12.7 g/dL Standard Deviation 1.3	13.4 g/dL Standard Deviation 2.0	14.4 g/dL Standard Deviation 1.1
Subject's Average Hemoglobin Count 8 years	12.5 g/dL Standard Deviation 1.7	12.8 g/dL Standard Deviation 2.0	13.1 g/dL Standard Deviation 1.4	12.8 g/dL Standard Deviation 2.7	13.6 g/dL Standard Deviation 1.8

SECONDARY outcome

Timeframe: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

This is laboratory analysis of Hematocrit percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Device - CEP Mitral Valve n=76 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm n=117 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm n=81 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm n=39 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm n=16 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Hematocrit Count 5 years	40.0 Percentage of red blood cells Standard Deviation 4.5	39.7 Percentage of red blood cells Standard Deviation 4.6	39.8 Percentage of red blood cells Standard Deviation 4.7	39.4 Percentage of red blood cells Standard Deviation 6.5	41.0 Percentage of red blood cells Standard Deviation 3.7
Subject's Average Hematocrit Count 6 years	38.7 Percentage of red blood cells Standard Deviation 4.8	39.3 Percentage of red blood cells Standard Deviation 4.6	38.8 Percentage of red blood cells Standard Deviation 4.0	40.3 Percentage of red blood cells Standard Deviation 5.9	42.3 Percentage of red blood cells Standard Deviation 3.1
Subject's Average Hematocrit Count 1 year	39.4 Percentage of red blood cells Standard Deviation 4.0	38.6 Percentage of red blood cells Standard Deviation 4.3	39.7 Percentage of red blood cells Standard Deviation 4.1	38.6 Percentage of red blood cells Standard Deviation 4.8	41.6 Percentage of red blood cells Standard Deviation 3.6
Subject's Average Hematocrit Count 2 years	39.0 Percentage of red blood cells Standard Deviation 4.5	39.6 Percentage of red blood cells Standard Deviation 3.7	40.0 Percentage of red blood cells Standard Deviation 4.7	39.9 Percentage of red blood cells Standard Deviation 5.1	41.6 Percentage of red blood cells Standard Deviation 3.1
Subject's Average Hematocrit Count 3 years	39.4 Percentage of red blood cells Standard Deviation 4.4	39.1 Percentage of red blood cells Standard Deviation 4.3	39.5 Percentage of red blood cells Standard Deviation 3.8	39.4 Percentage of red blood cells Standard Deviation 5.2	41.7 Percentage of red blood cells Standard Deviation 5.0
Subject's Average Hematocrit Count 7 years	39.8 Percentage of red blood cells Standard Deviation 4.8	37.3 Percentage of red blood cells Standard Deviation 8.2	38.1 Percentage of red blood cells Standard Deviation 5.1	38.1 Percentage of red blood cells Standard Deviation 6.1	42.4 Percentage of red blood cells Standard Deviation 4.4
Subject's Average Hematocrit Count 4 years	39.0 Percentage of red blood cells Standard Deviation 4.7	39.4 Percentage of red blood cells Standard Deviation 3.9	39.2 Percentage of red blood cells Standard Deviation 4.3	40.9 Percentage of red blood cells Standard Deviation 4.3	42.4 Percentage of red blood cells Standard Deviation 1.2
Subject's Average Hematocrit Count 6 months	38.0 Percentage of red blood cells Standard Deviation 4.3	37.9 Percentage of red blood cells Standard Deviation 4.3	38.7 Percentage of red blood cells Standard Deviation 3.8	38.6 Percentage of red blood cells Standard Deviation 4.8	40.7 Percentage of red blood cells Standard Deviation 5.9
Subject's Average Hematocrit Count 8 years	38.6 Percentage of red blood cells Standard Deviation 5.5	39.6 Percentage of red blood cells Standard Deviation 5.1	39.8 Percentage of red blood cells Standard Deviation 4.2	38.5 Percentage of red blood cells Standard Deviation 7.4	40.9 Percentage of red blood cells Standard Deviation 5.3

SECONDARY outcome

Timeframe: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Laboratory Analysis of reticulocytes on blood drawn from subjects. Reticulocytes are newly produced immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood. The reference range for reticulocytes is 0.5 - 2.6 % of red blood cells. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Device - CEP Mitral Valve n=76 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm n=117 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm n=81 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm n=39 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm n=16 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Reticulocytes Percentage Over Time 1 year	1.4 Percentage of reticulocytes Standard Deviation 0.6	1.4 Percentage of reticulocytes Standard Deviation 0.6	1.3 Percentage of reticulocytes Standard Deviation 0.5	1.3 Percentage of reticulocytes Standard Deviation 0.5	1.2 Percentage of reticulocytes Standard Deviation 0.6
Subject's Average Reticulocytes Percentage Over Time 3 years	1.5 Percentage of reticulocytes Standard Deviation 0.5	1.5 Percentage of reticulocytes Standard Deviation 0.7	1.4 Percentage of reticulocytes Standard Deviation 0.5	1.3 Percentage of reticulocytes Standard Deviation 0.5	1.2 Percentage of reticulocytes Standard Deviation 0.6
Subject's Average Reticulocytes Percentage Over Time 4 years	1.4 Percentage of reticulocytes Standard Deviation 0.5	2.8 Percentage of reticulocytes Standard Deviation 10.3	1.6 Percentage of reticulocytes Standard Deviation 0.5	1.2 Percentage of reticulocytes Standard Deviation 0.4	1.1 Percentage of reticulocytes Standard Deviation 0.4
Subject's Average Reticulocytes Percentage Over Time 6 months	1.2 Percentage of reticulocytes Standard Deviation 0.6	1.4 Percentage of reticulocytes Standard Deviation 0.7	1.4 Percentage of reticulocytes Standard Deviation 0.6	1.2 Percentage of reticulocytes Standard Deviation 0.6	1.1 Percentage of reticulocytes Standard Deviation 0.4
Subject's Average Reticulocytes Percentage Over Time 2 years	1.5 Percentage of reticulocytes Standard Deviation 0.6	1.4 Percentage of reticulocytes Standard Deviation 0.5	1.4 Percentage of reticulocytes Standard Deviation 0.6	1.2 Percentage of reticulocytes Standard Deviation 0.4	2.9 Percentage of reticulocytes Standard Deviation 4.9
Subject's Average Reticulocytes Percentage Over Time 5 years	1.4 Percentage of reticulocytes Standard Deviation 0.5	2.6 Percentage of reticulocytes Standard Deviation 6.6	1.5 Percentage of reticulocytes Standard Deviation 0.6	1.4 Percentage of reticulocytes Standard Deviation 0.4	1.3 Percentage of reticulocytes Standard Deviation 0.5
Subject's Average Reticulocytes Percentage Over Time 6 years	1.5 Percentage of reticulocytes Standard Deviation 0.5	1.5 Percentage of reticulocytes Standard Deviation 0.6	1.4 Percentage of reticulocytes Standard Deviation 0.6	1.4 Percentage of reticulocytes Standard Deviation 0.4	1.1 Percentage of reticulocytes Standard Deviation 0.3
Subject's Average Reticulocytes Percentage Over Time 7 years	1.6 Percentage of reticulocytes Standard Deviation 0.4	2.0 Percentage of reticulocytes Standard Deviation 2.8	1.7 Percentage of reticulocytes Standard Deviation 1.0	1.3 Percentage of reticulocytes Standard Deviation 0.5	1.2 Percentage of reticulocytes Standard Deviation 0.2
Subject's Average Reticulocytes Percentage Over Time 8 years	1.6 Percentage of reticulocytes Standard Deviation 0.5	1.5 Percentage of reticulocytes Standard Deviation 0.6	2.2 Percentage of reticulocytes Standard Deviation 2.8	1.6 Percentage of reticulocytes Standard Deviation 0.8	1.5 Percentage of reticulocytes Standard Deviation 0.3

SECONDARY outcome

Timeframe: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

This is laboratory analysis of Platelet count on blood drawn from subjects. The purpose of platelets is to create hemostasis, which is the prevention of hemorrhaging (bleeding) and the process of keeping blood inside the vessel walls. A normal platelet range is 150 to 450 10^3 cells/microliter. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Device - CEP Mitral Valve n=76 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm n=117 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm n=81 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm n=39 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm n=16 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Platelet Count Over Time 3 years	208.0 10^3 cells/microliter Standard Deviation 87.2	210.8 10^3 cells/microliter Standard Deviation 80.2	200.3 10^3 cells/microliter Standard Deviation 86.6	197.4 10^3 cells/microliter Standard Deviation 45.8	191.0 10^3 cells/microliter Standard Deviation 48.9
Subject's Average Platelet Count Over Time 6 months	242.2 10^3 cells/microliter Standard Deviation 85.7	218.5 10^3 cells/microliter Standard Deviation 83.7	211.6 10^3 cells/microliter Standard Deviation 68.9	202.0 10^3 cells/microliter Standard Deviation 49.2	202.0 10^3 cells/microliter Standard Deviation 58.4
Subject's Average Platelet Count Over Time 1 year	224.3 10^3 cells/microliter Standard Deviation 64.9	214.7 10^3 cells/microliter Standard Deviation 76.9	201.6 10^3 cells/microliter Standard Deviation 69.1	196.0 10^3 cells/microliter Standard Deviation 42.1	201.5 10^3 cells/microliter Standard Deviation 54.2
Subject's Average Platelet Count Over Time 2 years	217.1 10^3 cells/microliter Standard Deviation 66.8	208.9 10^3 cells/microliter Standard Deviation 70.2	208.4 10^3 cells/microliter Standard Deviation 80.5	190.6 10^3 cells/microliter Standard Deviation 35.9	175.9 10^3 cells/microliter Standard Deviation 31.0
Subject's Average Platelet Count Over Time 4 years	207.2 10^3 cells/microliter Standard Deviation 79.7	212.0 10^3 cells/microliter Standard Deviation 78.6	213.8 10^3 cells/microliter Standard Deviation 108.2	188.1 10^3 cells/microliter Standard Deviation 45.6	190.9 10^3 cells/microliter Standard Deviation 40.3
Subject's Average Platelet Count Over Time 5 years	203.5 10^3 cells/microliter Standard Deviation 64.5	208.1 10^3 cells/microliter Standard Deviation 74.6	207.4 10^3 cells/microliter Standard Deviation 123.8	177.7 10^3 cells/microliter Standard Deviation 37.6	212.2 10^3 cells/microliter Standard Deviation 65.7
Subject's Average Platelet Count Over Time 6 years	197.0 10^3 cells/microliter Standard Deviation 61.3	214.3 10^3 cells/microliter Standard Deviation 90.9	224.0 10^3 cells/microliter Standard Deviation 197.2	190.4 10^3 cells/microliter Standard Deviation 35.0	185.3 10^3 cells/microliter Standard Deviation 27.3
Subject's Average Platelet Count Over Time 7 years	203.4 10^3 cells/microliter Standard Deviation 60.2	219.6 10^3 cells/microliter Standard Deviation 77.3	237.2 10^3 cells/microliter Standard Deviation 197.9	202.4 10^3 cells/microliter Standard Deviation 46.7	181.5 10^3 cells/microliter Standard Deviation 37.1
Subject's Average Platelet Count Over Time 8 years	175.1 10^3 cells/microliter Standard Deviation 48.4	225.1 10^3 cells/microliter Standard Deviation 92.3	198.8 10^3 cells/microliter Standard Deviation 53.6	189.3 10^3 cells/microliter Standard Deviation 40.5	177.8 10^3 cells/microliter Standard Deviation 27.9

SECONDARY outcome

Timeframe: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. The protocol allowed subjects to have the option of having (haptoglobin and SLDH tests) or alternatively a plasma free hemoglobin test at each timeframe. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

The serum lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. Normal levels of LDH in the blood can vary depending on the lab but usually range between 140 units per liter (U/L) to 280 U/L for adults and tend to be higher for children and teens. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Device - CEP Mitral Valve n=76 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm n=117 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm n=81 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm n=39 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm n=16 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time 6 months	241.4 U/L Standard Deviation 48.4	247.3 U/L Standard Deviation 100.1	322.5 U/L Standard Deviation 189.8	274.2 U/L Standard Deviation 141.0	300.5 U/L Standard Deviation 182.0
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time 1 year	232.7 U/L Standard Deviation 44.0	250.2 U/L Standard Deviation 100.4	294.5 U/L Standard Deviation 145.0	229.5 U/L Standard Deviation 103.1	472.3 U/L Standard Deviation 223.8
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time 2 years	228.7 U/L Standard Deviation 54.0	231.9 U/L Standard Deviation 82.0	263.8 U/L Standard Deviation 103.1	209.1 U/L Standard Deviation 51.6	405.3 U/L Standard Deviation 219.8
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time 3 years	243.1 U/L Standard Deviation 41.4	227.0 U/L Standard Deviation 66.0	274.7 U/L Standard Deviation 102.0	240.2 U/L Standard Deviation 56.4	332.5 U/L Standard Deviation 149.2
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time 4 years	243.0 U/L Standard Deviation 53.1	220.1 U/L Standard Deviation 45.0	247.8 U/L Standard Deviation 33.7	251.0 U/L Standard Deviation 43.7	286.0 U/L Standard Deviation 127.3
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time 5 years	227.3 U/L Standard Deviation 23.7	227.3 U/L Standard Deviation 42.5	221.4 U/L Standard Deviation 31.3	238.5 U/L Standard Deviation 19.1	287.0 U/L Standard Deviation 118.8
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time 6 years	256.7 U/L Standard Deviation 71.3	248.5 U/L Standard Deviation 94.4	245.3 U/L Standard Deviation 33.8	269.3 U/L Standard Deviation 43.0	393 U/L
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time 7 years	—	202.5 U/L Standard Deviation 109.7	255.8 U/L Standard Deviation 24.2	254.0 U/L Standard Deviation 22.0	200.0 U/L
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time 8 years	253.0 U/L	254.5 U/L Standard Deviation 56.1	257.4 U/L Standard Deviation 28.4	369.7 U/L Standard Deviation 189.7	423.0 U/L

SECONDARY outcome

Timeframe: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. The protocol allowed subjects to have the option of having a plasma free hemoglobin test or alternatively a (haptoglobin and SLDH tests) at each timeframe. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Laboratory analysis of Plasma Free Hemoglobin (Pf Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.

Outcome measures

Measure	Device - CEP Mitral Valve n=76 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm n=117 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm n=81 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm n=39 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm n=16 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Plasma Free Hemoglobin Over Time 6 months	10.7 mg/dL Standard Deviation 8.6	8.3 mg/dL Standard Deviation 7.2	14.4 mg/dL Standard Deviation 23.4	17.8 mg/dL Standard Deviation 35.3	20.1 mg/dL Standard Deviation 19.0
Subject's Average Plasma Free Hemoglobin Over Time 1 year	16.3 mg/dL Standard Deviation 17.5	11.7 mg/dL Standard Deviation 11.6	11.5 mg/dL Standard Deviation 13.5	18.3 mg/dL Standard Deviation 25.7	12.6 mg/dL Standard Deviation 8.0
Subject's Average Plasma Free Hemoglobin Over Time 2 years	15.2 mg/dL Standard Deviation 19.3	14.0 mg/dL Standard Deviation 18.4	7.9 mg/dL Standard Deviation 6.5	17.0 mg/dL Standard Deviation 14.0	12.3 mg/dL Standard Deviation 7.6
Subject's Average Plasma Free Hemoglobin Over Time 3 years	15.8 mg/dL Standard Deviation 20.1	11.6 mg/dL Standard Deviation 14.2	9.0 mg/dL Standard Deviation 8.7	7.4 mg/dL Standard Deviation 5.3	15.4 mg/dL Standard Deviation 8.9
Subject's Average Plasma Free Hemoglobin Over Time 4 years	26.3 mg/dL Standard Deviation 35.2	8.4 mg/dL Standard Deviation 7.5	13.6 mg/dL Standard Deviation 29.9	16.2 mg/dL Standard Deviation 21.8	10.0 mg/dL Standard Deviation 3.2
Subject's Average Plasma Free Hemoglobin Over Time 5 years	13.8 mg/dL Standard Deviation 17.6	7.5 mg/dL Standard Deviation 5.8	9.7 mg/dL Standard Deviation 9.5	9.6 mg/dL Standard Deviation 10.9	17.0 mg/dL Standard Deviation 7.8
Subject's Average Plasma Free Hemoglobin Over Time 6 years	14.0 mg/dL Standard Deviation 15.0	6.6 mg/dL Standard Deviation 4.1	12.2 mg/dL Standard Deviation 13.7	12.1 mg/dL Standard Deviation 11.9	29.8 mg/dL Standard Deviation 40.2
Subject's Average Plasma Free Hemoglobin Over Time 7 years	20.6 mg/dL Standard Deviation 32.1	12.3 mg/dL Standard Deviation 24.5	20.7 mg/dL Standard Deviation 31.5	8.5 mg/dL Standard Deviation 5.6	9.0 mg/dL Standard Deviation 4.8
Subject's Average Plasma Free Hemoglobin Over Time 8 years	14.2 mg/dL Standard Deviation 12.2	11.5 mg/dL Standard Deviation 9.7	12.5 mg/dL Standard Deviation 11.2	13.7 mg/dL Standard Deviation 11.8	8.0 mg/dL Standard Deviation 2.9

SECONDARY outcome

Timeframe: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits

Population: This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. The protocol allowed subjects to have the option of having (haptoglobin and SLDH tests) or alternatively a plasma free hemoglobin test at each timeframe. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Haptoglobin is a protein produced by your liver. It binds with hemoglobin, which is a protein found in red blood cells. When red blood cells are destroyed, they release hemoglobin. The released hemoglobin is called "free hemoglobin." Haptoglobin attaches to the free hemoglobin to create a haptoglobin-hemoglobin complex. This complex travels to the liver, where it's removed from the body. A normal haptoglobin level falls between 45 and 200 milligrams of haptoglobin per deciliter of blood. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Device - CEP Mitral Valve n=76 Participants Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 27mm n=117 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 29mm n=81 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 31mm n=39 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve	Device - CEP Mitral Valve - 33mm n=16 Participants Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve
Subject's Average Haptoglobin Over Time 6 months	118.7 mg/dL Standard Deviation 59.0	143.9 mg/dL Standard Deviation 90.8	118.0 mg/dL Standard Deviation 63.6	119.2 mg/dL Standard Deviation 65.5	70.9 mg/dL Standard Deviation 68.4
Subject's Average Haptoglobin Over Time 1 year	110.0 mg/dL Standard Deviation 52.0	120.8 mg/dL Standard Deviation 68.9	107.9 mg/dL Standard Deviation 67.0	128.3 mg/dL Standard Deviation 60.5	123.7 mg/dL Standard Deviation 62.1
Subject's Average Haptoglobin Over Time 2 years	110.1 mg/dL Standard Deviation 38.9	127.1 mg/dL Standard Deviation 76.2	124.2 mg/dL Standard Deviation 57.6	101.8 mg/dL Standard Deviation 48.3	109.8 mg/dL Standard Deviation 89.4
Subject's Average Haptoglobin Over Time 3 years	103.6 mg/dL Standard Deviation 46.6	139.2 mg/dL Standard Deviation 80.3	96.2 mg/dL Standard Deviation 52.5	117.0 mg/dL Standard Deviation 36.1	109.0 mg/dL Standard Deviation 19.8
Subject's Average Haptoglobin Over Time 4 years	111.4 mg/dL Standard Deviation 54.9	139.9 mg/dL Standard Deviation 77.9	97.6 mg/dL Standard Deviation 49.6	96.9 mg/dL Standard Deviation 53.5	81.1 mg/dL Standard Deviation 113.0
Subject's Average Haptoglobin Over Time 5 years	79.0 mg/dL Standard Deviation 49.1	152.4 mg/dL Standard Deviation 81.5	111.6 mg/dL Standard Deviation 56.3	80.2 mg/dL Standard Deviation 91.6	120.1 mg/dL Standard Deviation 168.1
Subject's Average Haptoglobin Over Time 6 years	118.7 mg/dL Standard Deviation 95.5	109.8 mg/dL Standard Deviation 71.4	103.6 mg/dL Standard Deviation 58.6	126.8 mg/dL Standard Deviation 37.9	151.0 mg/dL Standard Deviation 70.7
Subject's Average Haptoglobin Over Time 7 years	—	85.2 mg/dL Standard Deviation 78.0	107.2 mg/dL Standard Deviation 72.6	51.7 mg/dL Standard Deviation 40.2	239.0 mg/dL
Subject's Average Haptoglobin Over Time 8 years	115.0 mg/dL	129.0 mg/dL Standard Deviation 23.3	106.4 mg/dL Standard Deviation 40.0	96.0 mg/dL Standard Deviation 22.6	117.0 mg/dL

Adverse Events

Device - CEP Mitral Valve

Serious events: 281 serious events

Other events: 206 other events

Deaths: 88 deaths

Serious adverse events

Measure	Device - CEP Mitral Valve n=329 participants at risk Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Blood and lymphatic system disorders BLEEDING - MAJOR	18.2% 60/329 • Number of events 78 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Blood and lymphatic system disorders BLEEDING - MINOR	7.0% 23/329 • Number of events 26 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders ANGINA	4.0% 13/329 • Number of events 19 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders AORTIC REGURGITATION (NATIVE)	0.61% 2/329 • Number of events 2 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders ARRHYTHMIA	30.1% 99/329 • Number of events 149 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders CARDIAC CONDUCTION DISTURBANCE	15.8% 52/329 • Number of events 52 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders CARDIAC FAILURE	22.2% 73/329 • Number of events 108 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders CARDIOVASCULAR - OTHER	9.7% 32/329 • Number of events 37 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders CARDIOVASCULAR DISSECTION / TEAR / INJURY	1.2% 4/329 • Number of events 4 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders ENDOCARDITIS	1.5% 5/329 • Number of events 5 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders MYOCARDIAL INFARCTION	1.8% 6/329 • Number of events 6 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders NSVD - INAPPROPRIATE SIZING	0.30% 1/329 • Number of events 1 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders NSVD - PARAVALVULAR LEAK - MAJOR	2.1% 7/329 • Number of events 7 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders PLEURAL EFFUSION	14.9% 49/329 • Number of events 57 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders PNEUMOTHORAX / HEMOTHORAX	0.91% 3/329 • Number of events 3 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders PULMONARY EMBOLISM	1.8% 6/329 • Number of events 6 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders SVD - OTHER STRUCTURAL VALVE DETERIORATION	3.0% 10/329 • Number of events 10 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders SVD - STUDY VALVE CALCIFICATION	1.8% 6/329 • Number of events 6 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders SVD - STUDY VALVE WEAR	0.30% 1/329 • Number of events 1 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders THROMBOEMBOLISM - NON-CEREBRAL	0.91% 3/329 • Number of events 4 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders THROMBOEMBOLISM - STROKE	5.5% 18/329 • Number of events 20 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders THROMBOEMBOLISM - TIA	1.8% 6/329 • Number of events 7 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders TRICUSPID REGURGITATION (NATIVE)	0.61% 2/329 • Number of events 2 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders VALVE THROMBOSIS	0.30% 1/329 • Number of events 1 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders VASCULAR COMPLICATION	3.3% 11/329 • Number of events 11 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders VENTRICULAR RUPTURE	0.61% 2/329 • Number of events 2 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Blood and lymphatic system disorders ABNORMAL LAB VALUES	2.7% 9/329 • Number of events 11 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Blood and lymphatic system disorders ANEMIA	9.4% 31/329 • Number of events 32 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Musculoskeletal and connective tissue disorders BONE FRACTURE	8.8% 29/329 • Number of events 32 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER	8.5% 28/329 • Number of events 33 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders CARDIAC ARREST	2.4% 8/329 • Number of events 9 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Blood and lymphatic system disorders COAGULOPATHY	1.5% 5/329 • Number of events 5 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders DRUG REACTION	0.61% 2/329 • Number of events 2 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders EDEMA	0.91% 3/329 • Number of events 3 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Infections and infestations FEVER - UNKNOWN ORIGIN	0.30% 1/329 • Number of events 1 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Gastrointestinal disorders GASTRO-INTESTINAL COMPLICATION	16.1% 53/329 • Number of events 69 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Blood and lymphatic system disorders HEMATOLOGICAL DISORDER	5.8% 19/329 • Number of events 21 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Hepatobiliary disorders HEPATIC COMPLICATION	1.8% 6/329 • Number of events 6 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders HYPERTENSION	1.5% 5/329 • Number of events 6 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders HYPOTENSION	1.5% 5/329 • Number of events 5 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Infections and infestations INFECTION / INFLAMMATION	17.9% 59/329 • Number of events 98 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Metabolism and nutrition disorders METABOLIC COMPLICATION	3.3% 11/329 • Number of events 11 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders MULTIPLE ORGAN FAILURE	3.6% 12/329 • Number of events 12 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders NEUROLOGICAL COMPLICATION	5.5% 18/329 • Number of events 20 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders OTHER	24.0% 79/329 • Number of events 112 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Psychiatric disorders PSYCHIATRIC COMPLICATION	3.0% 10/329 • Number of events 10 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Renal and urinary disorders RENAL COMPLICATION	10.9% 36/329 • Number of events 42 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Respiratory, thoracic and mediastinal disorders RESPIRATORY COMPLICATION	26.1% 86/329 • Number of events 133 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders SEPTICEMIA	3.0% 10/329 • Number of events 11 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders STERNAL / THORACIC WOUND COMPLICATION	3.3% 11/329 • Number of events 11 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders SUDDEN DEATH	1.5% 5/329 • Number of events 5 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders SUICIDE	0.30% 1/329 • Number of events 1 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders SYNCOPE	3.6% 12/329 • Number of events 13 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Renal and urinary disorders URINARY TRACT INFECTION	3.6% 12/329 • Number of events 15 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Eye disorders VISION DISORDER	3.3% 11/329 • Number of events 12 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.

Other adverse events

Measure	Device - CEP Mitral Valve n=329 participants at risk Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Blood and lymphatic system disorders BLEEDING - MINOR	5.2% 17/329 • Number of events 22 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders ARRHYTHMIA	21.3% 70/329 • Number of events 108 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders CARDIAC CONDUCTION DISTURBANCE	10.3% 34/329 • Number of events 42 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders CARDIOVASCULAR - OTHER	7.9% 26/329 • Number of events 32 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Cardiac disorders PLEURAL EFFUSION	13.4% 44/329 • Number of events 45 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Blood and lymphatic system disorders ABNORMAL LAB VALUES	7.9% 26/329 • Number of events 41 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Blood and lymphatic system disorders ANEMIA	10.9% 36/329 • Number of events 40 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Gastrointestinal disorders GASTRO-INTESTINAL COMPLICATION	7.3% 24/329 • Number of events 30 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Blood and lymphatic system disorders HEMATOLOGICAL DISORDER	8.2% 27/329 • Number of events 30 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders HYPOTENSION	5.5% 18/329 • Number of events 22 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Infections and infestations INFECTION / INFLAMMATION	10.6% 35/329 • Number of events 54 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders NEUROLOGICAL COMPLICATION	5.8% 19/329 • Number of events 24 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
General disorders OTHER	23.7% 78/329 • Number of events 173 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Renal and urinary disorders RENAL COMPLICATION	9.4% 31/329 • Number of events 34 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Respiratory, thoracic and mediastinal disorders RESPIRATORY COMPLICATION	18.8% 62/329 • Number of events 96 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Renal and urinary disorders URINARY TRACT INFECTION	9.1% 30/329 • Number of events 37 • Events occurring from baseline through eight years of follow-up post implant. Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.

Additional Information

Director of Clinical Affairs

Edwards Lifesciences

Phone: 949-250-2500

Email: Aya_Westbrook@edwards.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 30 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 60-day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.
• Publication restrictions are in place

Restriction type: OTHER