Trial Outcomes & Findings for Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve (NCT NCT01700439)

Last Updated: 2023-05-19

Results Overview

Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]

Recruitment status

COMPLETED

Study phase

Target enrollment

934 participants

Primary outcome timeframe

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

Results posted on

2023-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Edwards TRANSFORM Trial Cohort Subjects who were enrolled in the TRANSFORM trial and were eligible to receive an INTUITY study surgical aortic heart valve.
Overall Study STARTED	934
Overall Study Study Valve Group	885
Overall Study Discharge	925
Overall Study 3 Month	862
Overall Study 1 Year	842
Overall Study 2 Year	795
Overall Study 3 Year	720
Overall Study 4 Year	667
Overall Study 5 Year	577
Overall Study 6 Year	357
Overall Study 7 Year	164
Overall Study 8 Year	40
Overall Study COMPLETED	518
Overall Study NOT COMPLETED	416

Reasons for withdrawal

Reasons for withdrawal
Measure	Edwards TRANSFORM Trial Cohort Subjects who were enrolled in the TRANSFORM trial and were eligible to receive an INTUITY study surgical aortic heart valve.
Overall Study Lost to Follow-up	47
Overall Study Withdrawal by Subject	183
Overall Study Death	186

Baseline Characteristics

Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Edwards TRANSFORM Trial Cohort n=934 Participants Subjects who were enrolled in the TRANSFORM trial and were eligible to receive an Edwards INTUITY surgical aortic heart valve.
Age, Continuous	73.4 Years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	336 Participants n=5 Participants
Sex: Female, Male Male	598 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	865 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	65 Participants n=5 Participants
Region of Enrollment United States	934 participants n=5 Participants

PRIMARY outcome

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

Population: The group of subjects that received the Edwards INTUITY surgical aortic heart valve.

Outcome measures

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=885 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort All cause mortality	3.9 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Valve related mortality	0.9 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Study valve reoperation	0.6 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Study valve explant	0.3 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Thromboembolism	1.8 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Valve thrombosis	0.0 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Endocarditis	0.1 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort All bleeding	4.7 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Major bleeding	2.4 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort All paravalvular leak	0.5 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Major paravalvular leak (PVL)	0.3 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Hemolysis	0.2 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Non-structural valve dysfunction other than PVL	0.1 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Valve migration/embolization	0.0 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Valve malposition	0.0 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Valve instability	0.0 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Valve dislodgement	0.0 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Valve stenosis	0.1 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Structural valve deterioration	0.4 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Conduction defects	0.4 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Conduction defects with permanent pacemaker	0.1 Percentage of events/late patient years	—	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort Conduction defects without permanent pacemaker	0.3 Percentage of events/late patient years	—	—	—	—

SECONDARY outcome

Timeframe: Day of procedure

Population: Patients who were eligible to receive an Edwards INTUITY surgical aortic heart valve.

Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.

Outcome measures

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=934 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success	94.8 Percentage of subjects	—	—	—	—

SECONDARY outcome

Timeframe: Day of procedure through discharge or 10 days post index procedure, whichever comes first.

Population: Patients who were eligible to receive an Edwards INTUITY surgical aortic heart valve.

Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.

Outcome measures

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=934 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success	94.4 Percentage of subjects	—	—	—	—

SECONDARY outcome

Timeframe: Day of procedure

Population: The group of subjects that received the Edwards INTUITY surgical aortic heart valve.

Surgical and hospitalization factors - Cardiopulmonary bypass time

Outcome measures

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=885 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Average Amount of Time Subject Spent on Cardiopulmonary Bypass	86.6 Minutes Standard Deviation 37.4	—	—	—	—

SECONDARY outcome

Timeframe: Day of procedure

Population: The group of subjects that received the Edwards INTUITY surgical aortic heart valve. Data is not available for one subject.

Surgical and hospitalization factors - Cardiopulmonary cross clamp time

Outcome measures

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=884 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Average Subject Time on Cardiopulmonary Cross Clamp	65.4 Minutes Standard Deviation 29.7	—	—	—	—

SECONDARY outcome

Timeframe: Day of procedure through discharge from the hospital

Population: The group of subjects that received the Edwards INTUITY surgical aortic heart valve. Data is not available for 4 subjects.

Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.

Outcome measures

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=881 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Average Number of Days Subjects Were in the Intensive Care Unit (ICU)	3.1 Days Standard Deviation 3.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years

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

The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.

Outcome measures

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=885 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II n=885 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III n=885 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV n=885 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Subject's New York Heart Association (NYHA) Classification Over Time 7 Years	109 Participants	31 Participants	4 Participants	0 Participants	—
Subject's New York Heart Association (NYHA) Classification Over Time 8 Years	28 Participants	5 Participants	1 Participants	0 Participants	—
Subject's New York Heart Association (NYHA) Classification Over Time 6 Years	251 Participants	63 Participants	14 Participants	0 Participants	—
Subject's New York Heart Association (NYHA) Classification Over Time 5 Years	420 Participants	109 Participants	14 Participants	0 Participants	—
Subject's New York Heart Association (NYHA) Classification Over Time Baseline	135 Participants	468 Participants	264 Participants	15 Participants	—
Subject's New York Heart Association (NYHA) Classification Over Time 3 months	671 Participants	148 Participants	20 Participants	0 Participants	—
Subject's New York Heart Association (NYHA) Classification Over Time 1 Year	648 Participants	145 Participants	18 Participants	3 Participants	—
Subject's New York Heart Association (NYHA) Classification Over Time 2 Years	606 Participants	133 Participants	22 Participants	3 Participants	—
Subject's New York Heart Association (NYHA) Classification Over Time 3 Years	551 Participants	122 Participants	19 Participants	1 Participants	—
Subject's New York Heart Association (NYHA) Classification Over Time 4 Years	487 Participants	123 Participants	21 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up

Mean gradient is the average flow of blood through the aortic 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

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II n=179 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III n=291 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV n=261 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm n=105 Participants Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Average Mean Gradient Measurements Over Time Discharge	17.7 mmHg Standard Deviation 6.2	13.0 mmHg Standard Deviation 4.1	12.3 mmHg Standard Deviation 4.0	11.2 mmHg Standard Deviation 3.7	9.7 mmHg Standard Deviation 3.2
Subject's Average Mean Gradient Measurements Over Time 3 months	14.4 mmHg Standard Deviation 4.4	11.1 mmHg Standard Deviation 3.3	10.3 mmHg Standard Deviation 3.5	9.7 mmHg Standard Deviation 3.2	8.3 mmHg Standard Deviation 2.5
Subject's Average Mean Gradient Measurements Over Time 8 Years	11.2 mmHg Standard Deviation 0.0	13.2 mmHg Standard Deviation 5.0	12.3 mmHg Standard Deviation 8.3	12.9 mmHg Standard Deviation 8.2	9.4 mmHg Standard Deviation 2.2
Subject's Average Mean Gradient Measurements Over Time 1 Year	13.9 mmHg Standard Deviation 4.0	11.3 mmHg Standard Deviation 3.6	10.0 mmHg Standard Deviation 3.2	9.3 mmHg Standard Deviation 3.0	8.1 mmHg Standard Deviation 3.3
Subject's Average Mean Gradient Measurements Over Time 2 Years	13.1 mmHg Standard Deviation 4.5	11.1 mmHg Standard Deviation 3.6	10.0 mmHg Standard Deviation 3.7	9.3 mmHg Standard Deviation 2.9	8.1 mmHg Standard Deviation 3.6
Subject's Average Mean Gradient Measurements Over Time 3 Years	13.7 mmHg Standard Deviation 4.6	11.0 mmHg Standard Deviation 4.3	10.0 mmHg Standard Deviation 3.4	9.5 mmHg Standard Deviation 3.5	7.9 mmHg Standard Deviation 2.9
Subject's Average Mean Gradient Measurements Over Time 4 Years	12.8 mmHg Standard Deviation 3.8	10.8 mmHg Standard Deviation 3.7	10.3 mmHg Standard Deviation 6.7	9.5 mmHg Standard Deviation 4.0	8.0 mmHg Standard Deviation 3.7
Subject's Average Mean Gradient Measurements Over Time 5 Years	12.4 mmHg Standard Deviation 3.5	10.7 mmHg Standard Deviation 3.9	10.0 mmHg Standard Deviation 5.6	9.8 mmHg Standard Deviation 6.5	7.9 mmHg Standard Deviation 4.4
Subject's Average Mean Gradient Measurements Over Time 6 Years	13.1 mmHg Standard Deviation 3.9	10.5 mmHg Standard Deviation 3.6	11.1 mmHg Standard Deviation 6.4	9.3 mmHg Standard Deviation 4.0	9.2 mmHg Standard Deviation 6.5
Subject's Average Mean Gradient Measurements Over Time 7 Years	12.1 mmHg Standard Deviation 4.0	10.8 mmHg Standard Deviation 3.1	12.8 mmHg Standard Deviation 7.4	9.8 mmHg Standard Deviation 4.0	7.7 mmHg Standard Deviation 1.8

SECONDARY outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up

Peak gradient is the maximum value measured of flow of blood through the aortic 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

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II n=179 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III n=291 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV n=261 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm n=105 Participants Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Average Peak Gradient Measurements Over Time 5 Years	22.7 mmHg Standard Deviation 6.3	19.5 mmHg Standard Deviation 7.0	18.4 mmHg Standard Deviation 10.0	17.9 mmHg Standard Deviation 10.7	14.5 mmHg Standard Deviation 7.6
Subject's Average Peak Gradient Measurements Over Time 6 Years	23.6 mmHg Standard Deviation 6.1	19.1 mmHg Standard Deviation 6.7	19.8 mmHg Standard Deviation 9.4	17.1 mmHg Standard Deviation 7.3	16.9 mmHg Standard Deviation 10.9
Subject's Average Peak Gradient Measurements Over Time Discharge	32.8 mmHg Standard Deviation 11.9	24.1 mmHg Standard Deviation 7.9	22.9 mmHg Standard Deviation 7.8	20.8 mmHg Standard Deviation 6.8	17.9 mmHg Standard Deviation 5.8
Subject's Average Peak Gradient Measurements Over Time 3 months	26.0 mmHg Standard Deviation 8.0	19.9 mmHg Standard Deviation 6.4	19.0 mmHg Standard Deviation 6.5	17.6 mmHg Standard Deviation 5.8	15.0 mmHg Standard Deviation 4.4
Subject's Average Peak Gradient Measurements Over Time 1 Year	25.0 mmHg Standard Deviation 7.7	20.5 mmHg Standard Deviation 6.5	18.2 mmHg Standard Deviation 6.0	17.0 mmHg Standard Deviation 5.7	14.6 mmHg Standard Deviation 5.8
Subject's Average Peak Gradient Measurements Over Time 2 Years	23.4 mmHg Standard Deviation 7.9	20.2 mmHg Standard Deviation 6.6	18.4 mmHg Standard Deviation 6.8	17.0 mmHg Standard Deviation 5.3	14.6 mmHg Standard Deviation 6.2
Subject's Average Peak Gradient Measurements Over Time 3 Years	24.7 mmHg Standard Deviation 8.2	20.0 mmHg Standard Deviation 7.8	18.5 mmHg Standard Deviation 6.3	17.4 mmHg Standard Deviation 6.3	14.5 mmHg Standard Deviation 5.6
Subject's Average Peak Gradient Measurements Over Time 7 Years	22.1 mmHg Standard Deviation 7.1	19.6 mmHg Standard Deviation 5.9	23.5 mmHg Standard Deviation 13.3	18.5 mmHg Standard Deviation 7.7	14.6 mmHg Standard Deviation 3.7
Subject's Average Peak Gradient Measurements Over Time 4 Years	23.0 mmHg Standard Deviation 6.6	19.8 mmHg Standard Deviation 6.8	18.9 mmHg Standard Deviation 10.4	17.6 mmHg Standard Deviation 7.2	14.6 mmHg Standard Deviation 6.6
Subject's Average Peak Gradient Measurements Over Time 8 Years	21.3 mmHg Standard Deviation 0.0	24.4 mmHg Standard Deviation 8.1	21.0 mmHg Standard Deviation 12.6	22.7 mmHg Standard Deviation 14.7	17.2 mmHg Standard Deviation 3.6

SECONDARY outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic 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

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II n=179 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III n=291 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV n=261 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm n=105 Participants Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Effective Orifice Area (EOA) Measurement Over Time 4 Years	1.2 Centimeters squared Standard Deviation 0.1	1.4 Centimeters squared Standard Deviation 0.1	1.7 Centimeters squared Standard Deviation 0.2	1.9 Centimeters squared Standard Deviation 0.2	2.1 Centimeters squared Standard Deviation 0.3
Subject's Effective Orifice Area (EOA) Measurement Over Time 5 Years	1.2 Centimeters squared Standard Deviation 0.1	1.4 Centimeters squared Standard Deviation 0.2	1.7 Centimeters squared Standard Deviation 0.2	1.8 Centimeters squared Standard Deviation 0.2	2.1 Centimeters squared Standard Deviation 0.3
Subject's Effective Orifice Area (EOA) Measurement Over Time 6 Years	1.2 Centimeters squared Standard Deviation 0.1	1.4 Centimeters squared Standard Deviation 0.1	1.6 Centimeters squared Standard Deviation 0.2	1.9 Centimeters squared Standard Deviation 0.2	2.0 Centimeters squared Standard Deviation 0.3
Subject's Effective Orifice Area (EOA) Measurement Over Time 2 Years	1.1 Centimeters squared Standard Deviation 0.1	1.4 Centimeters squared Standard Deviation 0.1	1.7 Centimeters squared Standard Deviation 0.2	1.9 Centimeters squared Standard Deviation 0.2	2.2 Centimeters squared Standard Deviation 0.2
Subject's Effective Orifice Area (EOA) Measurement Over Time 3 Years	1.1 Centimeters squared Standard Deviation 0.1	1.4 Centimeters squared Standard Deviation 0.1	1.7 Centimeters squared Standard Deviation 0.2	1.9 Centimeters squared Standard Deviation 0.2	2.1 Centimeters squared Standard Deviation 0.2
Subject's Effective Orifice Area (EOA) Measurement Over Time Discharge	1.1 Centimeters squared Standard Deviation 0.1	1.3 Centimeters squared Standard Deviation 0.2	1.7 Centimeters squared Standard Deviation 0.2	1.9 Centimeters squared Standard Deviation 0.2	2.2 Centimeters squared Standard Deviation 0.2
Subject's Effective Orifice Area (EOA) Measurement Over Time 3 months	1.1 Centimeters squared Standard Deviation 0.1	1.3 Centimeters squared Standard Deviation 0.1	1.7 Centimeters squared Standard Deviation 0.2	1.9 Centimeters squared Standard Deviation 0.2	2.2 Centimeters squared Standard Deviation 0.2
Subject's Effective Orifice Area (EOA) Measurement Over Time 1 Year	1.1 Centimeters squared Standard Deviation 0.1	1.4 Centimeters squared Standard Deviation 0.1	1.7 Centimeters squared Standard Deviation 0.2	1.9 Centimeters squared Standard Deviation 0.2	2.2 Centimeters squared Standard Deviation 0.2
Subject's Effective Orifice Area (EOA) Measurement Over Time 7 Years	1.2 Centimeters squared Standard Deviation 0.1	1.4 Centimeters squared Standard Deviation 0.1	1.6 Centimeters squared Standard Deviation 0.3	1.8 Centimeters squared Standard Deviation 0.3	2.1 Centimeters squared Standard Deviation 0.1
Subject's Effective Orifice Area (EOA) Measurement Over Time 8 Years	1.1 Centimeters squared Standard Deviation 0.0	1.4 Centimeters squared Standard Deviation 0.1	1.6 Centimeters squared Standard Deviation 0.3	1.7 Centimeters squared Standard Deviation 0.3	2.1 Centimeters squared Standard Deviation 0.1

SECONDARY outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

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

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II n=179 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III n=291 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV n=261 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm n=105 Participants Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time Discharge	0.6 centimeters squared/meters squared Standard Deviation 0.1	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.1	0.9 centimeters squared/meters squared Standard Deviation 0.1	1.0 centimeters squared/meters squared Standard Deviation 0.1
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time 3 months	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.1	0.9 centimeters squared/meters squared Standard Deviation 0.1	1.0 centimeters squared/meters squared Standard Deviation 0.1
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time 1 Year	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.1	0.9 centimeters squared/meters squared Standard Deviation 0.1	1.0 centimeters squared/meters squared Standard Deviation 0.1
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time 2 Years	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.1	0.9 centimeters squared/meters squared Standard Deviation 0.1	1.0 centimeters squared/meters squared Standard Deviation 0.1
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time 3 Years	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.1	0.9 centimeters squared/meters squared Standard Deviation 0.1	1.0 centimeters squared/meters squared Standard Deviation 0.1
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time 5 Years	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.1	0.9 centimeters squared/meters squared Standard Deviation 0.1	1.0 centimeters squared/meters squared Standard Deviation 0.1
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time 6 Years	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.1	0.9 centimeters squared/meters squared Standard Deviation 0.1	0.9 centimeters squared/meters squared Standard Deviation 0.2
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time 4 Years	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.1	0.9 centimeters squared/meters squared Standard Deviation 0.1	1.0 centimeters squared/meters squared Standard Deviation 0.1
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time 7 Years	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.2	0.9 centimeters squared/meters squared Standard Deviation 0.2	1.0 centimeters squared/meters squared Standard Deviation 0.1
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time 8 Years	0.6 centimeters squared/meters squared Standard Deviation 0.0	0.7 centimeters squared/meters squared Standard Deviation 0.1	0.8 centimeters squared/meters squared Standard Deviation 0.2	0.8 centimeters squared/meters squared Standard Deviation 0.2	1.0 centimeters squared/meters squared Standard Deviation 0.1

SECONDARY outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. 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

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II n=179 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III n=291 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV n=261 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm n=105 Participants Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Performance Index Measurement Over Time Discharge	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.1
Subject's Performance Index Measurement Over Time 3 months	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.1
Subject's Performance Index Measurement Over Time 3 Years	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.1
Subject's Performance Index Measurement Over Time 1 Year	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.1
Subject's Performance Index Measurement Over Time 2 Years	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.1
Subject's Performance Index Measurement Over Time 4 Years	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.1
Subject's Performance Index Measurement Over Time 5 Years	1.0 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.1
Subject's Performance Index Measurement Over Time 7 Years	1.0 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.0
Subject's Performance Index Measurement Over Time 8 Years	0.9 Centimeters squared/meters squared Standard Deviation 0.0	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.2	0.8 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.0
Subject's Performance Index Measurement Over Time 6 Years	1.0 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.1	0.9 Centimeters squared/meters squared Standard Deviation 0.1	0.8 Centimeters squared/meters squared Standard Deviation 0.1

SECONDARY outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

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

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II n=179 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III n=291 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV n=261 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm n=105 Participants Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Cardiac Output Measurement at Over Time 8 Years	2.9 Liters/minutes Standard Deviation 0.0	4.9 Liters/minutes Standard Deviation 1.6	5.4 Liters/minutes Standard Deviation 1.3	4.9 Liters/minutes Standard Deviation 1.3	5.5 Liters/minutes Standard Deviation 1.3
Subject's Cardiac Output Measurement at Over Time Discharge	4.3 Liters/minutes Standard Deviation 0.9	4.6 Liters/minutes Standard Deviation 0.9	5.4 Liters/minutes Standard Deviation 1.1	5.6 Liters/minutes Standard Deviation 1.1	5.9 Liters/minutes Standard Deviation 1.3
Subject's Cardiac Output Measurement at Over Time 3 months	4.3 Liters/minutes Standard Deviation 0.7	4.4 Liters/minutes Standard Deviation 0.8	5.0 Liters/minutes Standard Deviation 0.9	5.2 Liters/minutes Standard Deviation 1.0	5.4 Liters/minutes Standard Deviation 1.1
Subject's Cardiac Output Measurement at Over Time 1 Year	4.3 Liters/minutes Standard Deviation 0.9	4.4 Liters/minutes Standard Deviation 1.0	4.9 Liters/minutes Standard Deviation 0.9	5.1 Liters/minutes Standard Deviation 1.0	5.5 Liters/minutes Standard Deviation 1.2
Subject's Cardiac Output Measurement at Over Time 2 Years	4.1 Liters/minutes Standard Deviation 0.8	4.3 Liters/minutes Standard Deviation 0.8	4.9 Liters/minutes Standard Deviation 0.9	5.0 Liters/minutes Standard Deviation 1.0	5.3 Liters/minutes Standard Deviation 1.0
Subject's Cardiac Output Measurement at Over Time 3 Years	4.0 Liters/minutes Standard Deviation 0.7	4.3 Liters/minutes Standard Deviation 0.9	4.9 Liters/minutes Standard Deviation 0.9	5.1 Liters/minutes Standard Deviation 1.0	5.2 Liters/minutes Standard Deviation 1.1
Subject's Cardiac Output Measurement at Over Time 4 Years	4.1 Liters/minutes Standard Deviation 0.8	4.1 Liters/minutes Standard Deviation 0.8	4.9 Liters/minutes Standard Deviation 1.0	5.1 Liters/minutes Standard Deviation 1.0	5.2 Liters/minutes Standard Deviation 1.1
Subject's Cardiac Output Measurement at Over Time 5 Years	4.2 Liters/minutes Standard Deviation 0.7	4.3 Liters/minutes Standard Deviation 0.9	4.8 Liters/minutes Standard Deviation 1.0	5.0 Liters/minutes Standard Deviation 1.1	5.2 Liters/minutes Standard Deviation 0.9
Subject's Cardiac Output Measurement at Over Time 6 Years	4.3 Liters/minutes Standard Deviation 0.7	4.2 Liters/minutes Standard Deviation 0.9	4.9 Liters/minutes Standard Deviation 1.1	5.0 Liters/minutes Standard Deviation 1.1	5.3 Liters/minutes Standard Deviation 1.2
Subject's Cardiac Output Measurement at Over Time 7 Years	3.9 Liters/minutes Standard Deviation 0.6	4.2 Liters/minutes Standard Deviation 0.8	5.0 Liters/minutes Standard Deviation 1.0	5.1 Liters/minutes Standard Deviation 1.1	5.0 Liters/minutes Standard Deviation 0.9

SECONDARY outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

Hemodynamic performance - 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

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II n=179 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III n=291 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV n=261 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm n=105 Participants Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Cardiac Index Measurement Over Time Discharge	2.5 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.7 Liters/minutes/meters squared Standard Deviation 0.5	2.6 Liters/minutes/meters squared Standard Deviation 0.6	2.7 Liters/minutes/meters squared Standard Deviation 0.6
Subject's Cardiac Index Measurement Over Time 3 months	2.6 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.4	2.5 Liters/minutes/meters squared Standard Deviation 0.5	2.5 Liters/minutes/meters squared Standard Deviation 0.5	2.5 Liters/minutes/meters squared Standard Deviation 0.5
Subject's Cardiac Index Measurement Over Time 1 Year	2.5 Liters/minutes/meters squared Standard Deviation 0.6	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.4	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.5 Liters/minutes/meters squared Standard Deviation 0.6
Subject's Cardiac Index Measurement Over Time 2 Years	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.3 Liters/minutes/meters squared Standard Deviation 0.4	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.4
Subject's Cardiac Index Measurement Over Time 3 Years	2.3 Liters/minutes/meters squared Standard Deviation 0.4	2.3 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.4	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.5
Subject's Cardiac Index Measurement Over Time 4 Years	2.3 Liters/minutes/meters squared Standard Deviation 0.5	2.3 Liters/minutes/meters squared Standard Deviation 0.4	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.5
Subject's Cardiac Index Measurement Over Time 5 Years	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.3 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.3 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.4
Subject's Cardiac Index Measurement Over Time 6 Years	2.5 Liters/minutes/meters squared Standard Deviation 0.5	2.3 Liters/minutes/meters squared Standard Deviation 0.4	2.4 Liters/minutes/meters squared Standard Deviation 0.6	2.4 Liters/minutes/meters squared Standard Deviation 0.6	2.4 Liters/minutes/meters squared Standard Deviation 0.6
Subject's Cardiac Index Measurement Over Time 7 Years	2.3 Liters/minutes/meters squared Standard Deviation 0.4	2.2 Liters/minutes/meters squared Standard Deviation 0.4	2.5 Liters/minutes/meters squared Standard Deviation 0.5	2.4 Liters/minutes/meters squared Standard Deviation 0.5	2.3 Liters/minutes/meters squared Standard Deviation 0.3
Subject's Cardiac Index Measurement Over Time 8 Years	1.5 Liters/minutes/meters squared Standard Deviation 0.0	2.6 Liters/minutes/meters squared Standard Deviation 0.9	2.6 Liters/minutes/meters squared Standard Deviation 0.6	2.4 Liters/minutes/meters squared Standard Deviation 0.6	2.8 Liters/minutes/meters squared Standard Deviation 0.2

SECONDARY outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. Higher numbers on the scale show a worsening outcome.

Outcome measures

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=49 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II n=179 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III n=291 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV n=261 Participants Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm n=105 Participants Subjects who received an INTUITY study surgical aortic heart valve.
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 3 months · Mild (+2)	2 Participants	12 Participants	16 Participants	18 Participants	4 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 3 months · Moderate (+3)	0 Participants	0 Participants	4 Participants	6 Participants	4 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 3 months · Severe (+4)	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 1 Year · None (0)/Trival (+1)	40 Participants	156 Participants	245 Participants	200 Participants	89 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 1 Year · Mild (+2)	5 Participants	9 Participants	18 Participants	21 Participants	5 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 1 Year · Moderate (+3)	0 Participants	1 Participants	5 Participants	2 Participants	1 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 1 Year · Severe (+4)	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size Discharge · Moderate (+3)	0 Participants	2 Participants	4 Participants	0 Participants	2 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 2 Years · None (0)/Trival (+1)	38 Participants	138 Participants	229 Participants	193 Participants	86 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 6 Years · Moderate (+3)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 2 Years · Mild (+2)	5 Participants	8 Participants	19 Participants	23 Participants	4 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 2 Years · Moderate (+3)	0 Participants	0 Participants	4 Participants	0 Participants	2 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 2 Years · Severe (+4)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 3 Years · None (0)/Trival (+1)	33 Participants	120 Participants	211 Participants	179 Participants	79 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 3 Years · Mild (+2)	5 Participants	7 Participants	18 Participants	18 Participants	5 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 3 Years · Moderate (+3)	0 Participants	0 Participants	3 Participants	0 Participants	2 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 3 Years · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 4 Years · None (0)/Trival (+1)	31 Participants	104 Participants	191 Participants	160 Participants	77 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 4 Years · Mild (+2)	4 Participants	9 Participants	17 Participants	19 Participants	5 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 4 Years · Moderate (+3)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 4 Years · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 5 Years · None (0)/Trival (+1)	26 Participants	87 Participants	146 Participants	129 Participants	61 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 5 Years · Moderate (+3)	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 5 Years · Mild (+2)	2 Participants	7 Participants	15 Participants	18 Participants	4 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 5 Years · Severe (+4)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size Discharge · Severe (+4)	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 3 months · None (0)/Trival (+1)	43 Participants	156 Participants	245 Participants	219 Participants	97 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 6 Years · Mild (+2)	2 Participants	2 Participants	9 Participants	10 Participants	2 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 6 Years · None (0)/Trival (+1)	20 Participants	53 Participants	87 Participants	78 Participants	31 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size Discharge · None (0)/Trival (+1)	46 Participants	171 Participants	266 Participants	235 Participants	97 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size Discharge · Mild (+2)	2 Participants	3 Participants	12 Participants	13 Participants	3 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 6 Years · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 7 Years · None (0)/Trival (+1)	7 Participants	25 Participants	30 Participants	22 Participants	6 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 7 Years · Mild (+2)	2 Participants	1 Participants	5 Participants	6 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 7 Years · Moderate (+3)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 7 Years · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 8 Years · None (0)/Trival (+1)	1 Participants	6 Participants	10 Participants	4 Participants	2 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 8 Years · Mild (+2)	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 8 Years · Moderate (+3)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size 8 Years · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and one year follow-up

Population: This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available at both the baseline and 1 year follow-up visits. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status.

Outcome measures

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=524 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey Physical Health - Baseline	41.8 Units on a scale Standard Deviation 10.2	—	—	—	—
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey Mental Health - Baseline	51.3 Units on a scale Standard Deviation 9.9	—	—	—	—
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey Mental Health - 1 year follow-up	54.3 Units on a scale Standard Deviation 8.5	—	—	—	—
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey Physical Health - 1 year follow-up	47.6 Units on a scale Standard Deviation 9.7	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

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 10\^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=885 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Average White Blood Cell Count Over Time Discharge	9.54 10^3 cells/microliters Standard Deviation 3.0	—	—	—	—
Subject's Average White Blood Cell Count Over Time 3 months	7.27 10^3 cells/microliters Standard Deviation 2.5	—	—	—	—
Subject's Average White Blood Cell Count Over Time 1 Year	7.31 10^3 cells/microliters Standard Deviation 2.8	—	—	—	—
Subject's Average White Blood Cell Count Over Time 2 Years	7.47 10^3 cells/microliters Standard Deviation 4.5	—	—	—	—
Subject's Average White Blood Cell Count Over Time 3 Years	7.47 10^3 cells/microliters Standard Deviation 5.7	—	—	—	—
Subject's Average White Blood Cell Count Over Time 4 Years	7.41 10^3 cells/microliters Standard Deviation 3.0	—	—	—	—
Subject's Average White Blood Cell Count Over Time 5 Years	7.37 10^3 cells/microliters Standard Deviation 3.6	—	—	—	—
Subject's Average White Blood Cell Count Over Time 6 Years	7.47 10^3 cells/microliters Standard Deviation 6.1	—	—	—	—
Subject's Average White Blood Cell Count Over Time 7 Years	8.05 10^3 cells/microliters Standard Deviation 9.8	—	—	—	—
Subject's Average White Blood Cell Count Over Time 8 Years	14.0 10^3 cells/microliters Standard Deviation 36.8	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

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 can indicate something is wrong.

Outcome measures

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=885 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Average Red Blood Cell Count Over Time Discharge	3.31 10^6 cells/microliters Standard Deviation 0.5	—	—	—	—
Subject's Average Red Blood Cell Count Over Time 3 months	4.51 10^6 cells/microliters Standard Deviation 0.5	—	—	—	—
Subject's Average Red Blood Cell Count Over Time 1 Year	4.46 10^6 cells/microliters Standard Deviation 0.5	—	—	—	—
Subject's Average Red Blood Cell Count Over Time 2 Years	4.45 10^6 cells/microliters Standard Deviation 0.5	—	—	—	—
Subject's Average Red Blood Cell Count Over Time 3 Years	4.46 10^6 cells/microliters Standard Deviation 0.5	—	—	—	—
Subject's Average Red Blood Cell Count Over Time 4 Years	4.44 10^6 cells/microliters Standard Deviation 0.5	—	—	—	—
Subject's Average Red Blood Cell Count Over Time 5 Years	4.43 10^6 cells/microliters Standard Deviation 0.6	—	—	—	—
Subject's Average Red Blood Cell Count Over Time 6 Years	4.38 10^6 cells/microliters Standard Deviation 0.5	—	—	—	—
Subject's Average Red Blood Cell Count Over Time 7 Years	4.33 10^6 cells/microliters Standard Deviation 0.6	—	—	—	—
Subject's Average Red Blood Cell Count Over Time 8 Years	4.28 10^6 cells/microliters Standard Deviation 0.7	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

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

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=885 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Average Hematocrit Percentage Over Time Discharge	29.94 Percentage of RBC Standard Deviation 4.0	—	—	—	—
Subject's Average Hematocrit Percentage Over Time 3 months	39.28 Percentage of RBC Standard Deviation 4.2	—	—	—	—
Subject's Average Hematocrit Percentage Over Time 1 Year	40.25 Percentage of RBC Standard Deviation 4.4	—	—	—	—
Subject's Average Hematocrit Percentage Over Time 2 Years	40.30 Percentage of RBC Standard Deviation 4.4	—	—	—	—
Subject's Average Hematocrit Percentage Over Time 3 Years	40.42 Percentage of RBC Standard Deviation 4.1	—	—	—	—
Subject's Average Hematocrit Percentage Over Time 4 Years	40.40 Percentage of RBC Standard Deviation 4.2	—	—	—	—
Subject's Average Hematocrit Percentage Over Time 5 Years	40.66 Percentage of RBC Standard Deviation 4.5	—	—	—	—
Subject's Average Hematocrit Percentage Over Time 6 Years	40.41 Percentage of RBC Standard Deviation 4.4	—	—	—	—
Subject's Average Hematocrit Percentage Over Time 7 Years	40.00 Percentage of RBC Standard Deviation 4.8	—	—	—	—
Subject's Average Hematocrit Percentage Over Time 8 Years	39.31 Percentage of RBC Standard Deviation 5.4	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

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

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=885 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Average Hemoglobin Percentage Over Time Discharge	9.95 g/dL Standard Deviation 1.4	—	—	—	—
Subject's Average Hemoglobin Percentage Over Time 3 months	12.82 g/dL Standard Deviation 1.6	—	—	—	—
Subject's Average Hemoglobin Percentage Over Time 1 Year	13.33 g/dL Standard Deviation 1.6	—	—	—	—
Subject's Average Hemoglobin Percentage Over Time 2 Years	13.37 g/dL Standard Deviation 1.6	—	—	—	—
Subject's Average Hemoglobin Percentage Over Time 3 Years	13.42 g/dL Standard Deviation 1.6	—	—	—	—
Subject's Average Hemoglobin Percentage Over Time 4 Years	13.39 g/dL Standard Deviation 1.6	—	—	—	—
Subject's Average Hemoglobin Percentage Over Time 5 Years	13.22 g/dL Standard Deviation 2.2	—	—	—	—
Subject's Average Hemoglobin Percentage Over Time 6 Years	13.20 g/dL Standard Deviation 1.8	—	—	—	—
Subject's Average Hemoglobin Percentage Over Time 7 Years	13.10 g/dL Standard Deviation 1.8	—	—	—	—
Subject's Average Hemoglobin Percentage Over Time 8 Years	12.87 g/dL Standard Deviation 1.9	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up

Laboratory Analysis of Plasma Free Hemoglobin (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

Outcome measures
Measure	Edwards INTUITY Surgical Aortic Heart Valve n=885 Participants Subjects who received an Edwards INTUITY surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class II Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class III Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - Class IV Subjects who received an INTUITY study surgical aortic heart valve.	Edwards INTUITY Surgical Aortic Heart Valve - 27mm Subjects who received an INTUITY study surgical aortic heart valve.
Subject's Average Plasma Free Hemoglobin Over Time Discharge	11.89 mg/dL Standard Deviation 14.6	—	—	—	—
Subject's Average Plasma Free Hemoglobin Over Time 3 months	13.12 mg/dL Standard Deviation 13.5	—	—	—	—
Subject's Average Plasma Free Hemoglobin Over Time 1 Year	12.08 mg/dL Standard Deviation 12.9	—	—	—	—
Subject's Average Plasma Free Hemoglobin Over Time 2 Years	12.06 mg/dL Standard Deviation 13.5	—	—	—	—
Subject's Average Plasma Free Hemoglobin Over Time 3 Years	11.90 mg/dL Standard Deviation 15.7	—	—	—	—
Subject's Average Plasma Free Hemoglobin Over Time 4 Years	11.88 mg/dL Standard Deviation 14.5	—	—	—	—
Subject's Average Plasma Free Hemoglobin Over Time 5 Years	12.73 mg/dL Standard Deviation 16.9	—	—	—	—
Subject's Average Plasma Free Hemoglobin Over Time 6 Years	16.32 mg/dL Standard Deviation 14.4	—	—	—	—
Subject's Average Plasma Free Hemoglobin Over Time 7 Years	18.43 mg/dL Standard Deviation 14.9	—	—	—	—
Subject's Average Plasma Free Hemoglobin Over Time 8 Years	22.61 mg/dL Standard Deviation 11.4	—	—	—	—

Adverse Events

Edwards TRANSFORM INTUITY Aortic Valve Study Cohort

Serious events: 756 serious events

Other events: 868 other events

Deaths: 178 deaths

Commercially Available Aortic Valve Study Cohort

Serious events: 37 serious events

Other events: 47 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Additional Information

Jennifer Currin, Senior VP of Medical and Clinical Affairs, Surgical Structural Heart

Edwards Lifesciences, LLC

Phone: 949-250-2500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI can't publish/present on overall study results not yet published but may publish his own data subject to EW review prior to submission/presentation, but data analyses of site-specific results can occur only in intervals as specified in the CTA. Publication/presentation of the PI's site-specific results of devices which haven't been market released and which still may be undergoing development, shall not include claims of device safety/effectiveness and will require the review/approval of EW.
Publication restrictions are in place

Restriction type: OTHER

Measure	Edwards TRANSFORM INTUITY Aortic Valve Study Cohort n=885 participants at risk The data from the 885 subjects who received the investigational Edwards INTUITY surgical aortic heart valve.	Commercially Available Aortic Valve Study Cohort n=49 participants at risk The data from the 49 subjects who received an alternate FDA approved surgical aortic heart valve.
Blood and lymphatic system disorders THROMBOCYTOPENIA - NON-HEPARIN INDUCED	49.9% 442/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	57.1% 28/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Blood and lymphatic system disorders BLOOD/LYMPHATIC - OTHER	29.3% 259/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	6.1% 3/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Blood and lymphatic system disorders ANEMIA - BLEEDING RELATED - MINOR	22.1% 196/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	20.4% 10/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Blood and lymphatic system disorders ANEMIA - NON-BLEEDING RELATED	9.4% 83/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	18.4% 9/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)	29.6% 262/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	30.6% 15/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT	31.5% 279/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	18.4% 9/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders ARRHYTHMIA - AV BLOCK - 1ST DEGREE	26.2% 232/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	22.4% 11/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders ARRHYTHMIA - OTHER	28.0% 248/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	24.5% 12/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders ARRHYTHMIA - BRADYCARDIA	15.5% 137/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	10.2% 5/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT	10.4% 92/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	12.2% 6/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders HYPOTENSION	18.2% 161/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	12.2% 6/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders CARDIOVASCULAR - OTHER	17.4% 154/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	6.1% 3/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders HYPERTENSION - SYSTEMIC	9.0% 80/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	2.0% 1/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Gastrointestinal disorders GASTROINTESTINAL - OTHER	15.5% 137/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	10.2% 5/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Renal and urinary disorders URINARY TRACT INFECTION (UTI)	11.9% 105/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	14.3% 7/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Musculoskeletal and connective tissue disorders MUSCULAR SKELETAL/DERMATOLOGIC - OTHER	26.4% 234/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	16.3% 8/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
General disorders NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION	28.6% 253/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	16.3% 8/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Psychiatric disorders PSYCHIATRIC - OTHER	8.7% 77/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	6.1% 3/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	39.3% 348/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	28.6% 14/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION - BILATERAL	7.1% 63/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	2.0% 1/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Endocrine disorders ENDOCRINE COMPLICATIONS	6.9% 61/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	2.0% 1/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Renal and urinary disorders RENAL DYSFUNCTION	6.9% 61/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	6.1% 3/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Renal and urinary disorders RENAL - OTHER	6.7% 59/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	4.1% 2/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Renal and urinary disorders RENAL FAILURE - ACUTE	6.4% 57/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	2.0% 1/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Infections and infestations INFECTION/INFLAMMATION - OTHER	9.9% 88/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	8.2% 4/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Musculoskeletal and connective tissue disorders BONE FRACTURE/BREAK	6.1% 54/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	2.0% 1/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Vascular disorders VASCULAR - OTHER	6.4% 57/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	4.1% 2/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Respiratory, thoracic and mediastinal disorders PULMONARY/RESPIRATORY - OTHER	12.2% 108/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	6.1% 3/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Respiratory, thoracic and mediastinal disorders RESPIRATORY INFECTION - UPPER (URI)	6.8% 60/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	6.1% 3/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Blood and lymphatic system disorders THROMBOCYTOPENIA - HEPARIN INDUCED (HIT)	1.4% 12/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	6.1% 3/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders ARRHYTHMIA - ATRIAL FLUTTER	5.0% 44/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	6.1% 3/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders ARRHYTHMIA - PERSISTENT ATRIAL FIBRILLATION	4.3% 38/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	6.1% 3/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR	4.1% 36/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	8.2% 4/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders HEART FAILURE - ACUTE	3.3% 29/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	8.2% 4/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Cardiac disorders PERICARDITIS	1.5% 13/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	6.1% 3/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Renal and urinary disorders GENITOURINARY - OTHER	4.0% 35/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	8.2% 4/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Eye disorders VISION DISORDER	5.3% 47/885 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.	0.00% 0/49 • Events occurring from the day of aortic heart valve surgery up through 8 years post implant.