Aortic Valve Stenosis
Conditions
Keywords
Aortic valve prosthesis, Aortic valve hemodynamics, Prosthesis-patient mismatch, Left ventricular diastolic function, Left ventricular remodeling
Brief summary
The purpose of this study is to: 1. Assess for hemodynamic differences at rest and with exercise between three clinically available tissue aortic valves. 2. Assess for differences in left ventricular (LV) reverse remodeling (recovery of LV hypertrophy, and changes in LV systolic and diastolic function) after aortic valve replacement for severe aortic stenosis (AS) between three clinically available aortic valve bioprosthesis.
Detailed description
Various aortic valve prostheses have unique hemodynamic characteristics, and there is on-going interest in defining those hemodynamic characteristics in the interest of avoiding residual LV outflow obstruction and prosthesis-patient mismatch (residual LV outflow obstruction despite a normally functioning prosthesis ) after aortic valve replacement. Attempts to compare hemodynamics between prostheses have been limited by different sizing systems used by various manufacturers (precluding meaningful comparison of valves by valve size) and biological variability of in vivo gradients and effective orifice area for any valve (making potentially small differences in hemodynamics difficult to detect). Assessment of hemodynamics during increased cardiac output associated with exercise testing has been used to better define potentially subtle differences in hemodynamics between valve prostheses. In addition, assessment for change in LV geometry (notably including LV hypertrophy) after aortic valve replacement has been used as a surrogate marker of aortic prosthesis hemodynamics.
Interventions
DEVICEAortic valve replacement
Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Severe aortic stenosis (AS) based on overall clinical impression, with or without aortic valve mean gradient ≥ 40 mm Hg, EOA \< 1.0 cm2, or EOA index \< 0.6 cm2/m2. * Scheduled for clinically indicated elective aortic valve replacement for a primary diagnosis of severe AS. * Less than moderate aortic regurgitation on preoperative testing. * Isolated aortic valve replacement; or aortic valve replacement with concomitant coronary artery bypass grafting, ascending aorta repair, or mitral and/or tricuspid annuloplasty for functional mitral regurgitation / tricuspid regurgitation. * Left ventricular ejection fraction ≥ 40% on preoperative testing. * Physically able and willing to pedal a recumbent bicycle. * Patient and surgeon agree that the patient will undergo valve replacement with a bioprosthesis. * Patient and surgeon agree that the use of one specific bioprosthesis manufacturer / model is not indicated based on clinical criteria. * Willing to undergo randomization to have implanted one of three bioprosthesis at the time of aortic valve replacement. * Willing and able to undergo preoperative echocardiography/Doppler for purposes of the research study. * Willing and able to undergo post-operative exercise stress echocardiography/Doppler 5 to 7 months after valve replacement for purposes of the research protocol.
Exclusion criteria
* Age \< 18 years. * AS felt by overall clinical impression to be less than severe. * Aortic valve replacement is urgent or emergent. * Moderate of more aortic regurgitation on preoperative testing. * Concomitant mitral or tricuspid valve replacement. * Left ventricular ejection fraction \< 40% on preoperative testing. * Physically unable or unwilling to pedal a recumbent bicycle. * Planned aortic valve replacement with a mechanical prosthesis. * Operating surgeon believes that any one of the three protocol bioprosthetic devices is contraindicated based on clinical criteria. * Not willing to undergo randomization to have implanted one of three bioprosthesis. * Unwilling or unable to undergo preoperative echocardiography/Doppler for purposes of the research protocol. * Unwilling or unable to undergo post-operative exercise stress echocardiography/Doppler 5 to 7 months after valve replacement for purposes of the research protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aortic Valve Mean Gradient (mm Hg) at Peak Exercise | 6 months after aortic valve replacement | This is a measure of the resistance to flow across the aortic bioprosthesis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Freestyle Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta). | 17 |
| Magna Ease Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta). | 21 |
| Trifecta Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta). | 18 |
| Total | 56 |
Baseline characteristics
| Characteristic | Freestyle | Magna Ease | Trifecta | Total |
|---|---|---|---|---|
| Age, Continuous | 74 years | 67 years | 71 years | 70 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 21 Participants | 17 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Gender Female | 6 Participants | 9 Participants | 4 Participants | 19 Participants |
| Gender Male | 11 Participants | 12 Participants | 14 Participants | 37 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 16 Participants | 21 Participants | 17 Participants | 54 Participants |
| Region of Enrollment United States | 17 participants | 21 participants | 18 participants | 56 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 22 | 0 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 22 | 0 / 20 |
Outcome results
Primary
Aortic Valve Mean Gradient (mm Hg) at Peak Exercise
This is a measure of the resistance to flow across the aortic bioprosthesis.
Time frame: 6 months after aortic valve replacement
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Freestyle | Aortic Valve Mean Gradient (mm Hg) at Peak Exercise | 11 mm Hg |
| Magna Ease | Aortic Valve Mean Gradient (mm Hg) at Peak Exercise | 14 mm Hg |
| Trifecta | Aortic Valve Mean Gradient (mm Hg) at Peak Exercise | 11 mm Hg |