Aortic Valve Insufficiency, Aortic Valve Stenosis, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
Conditions
Keywords
Pulmonary Valve, Right Ventricular Outflow Tract Reconstruction, Ross Procedure
Brief summary
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
Detailed description
The CryoValve SG pulmonary human heart valve is recovered from deceased human donors, treated with the SynerGraft® process,which is designed to reduce the donor cells present on the graft. The valve is then cryopreserved for storage until use. Removing cells from the heart valve has been shown to reduce a component of the immune response after implant compared to a standard allograft valve. However, it is not known how this affects the long-term durability of the valve.
Interventions
PROCEDUREEchocardiogram
Patients will have a yearly echocardiogram after enrollment in the study.
Sponsors
CryoLife, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
• Retrospective Patients o Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross or RVOT reconstruction between February 2000 and March 2004 who were included in the 510(k) data collection will be identified using the following general criteria to aid in selection of patients who are most likely to provide adequate follow-up data: Patient is alive and the implanted valve is still in place (has not been explanted). Patient is still under the care of the implanting institution or the implanting surgeon. Patient was identified as previously providing data for at least one echocardiographic follow-up assessment at a minimum of one year post-implant. * Additionally, prospective enrolling centers will have the option to enroll retrospective patients. At these centers, all consecutive patients identified from valve implant data at CryoLife, implanted with a CryoValve SG Pulmonary Valve as a valved pulmonary valve prior to Clearance in 2008 will be targeted for inclusion in the retrospective patient data collection. • Prospective Patients * Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross or RVOT reconstruction after FDA 510(k) clearance in February 2008 at selected institutions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Performance | Most Recent follow-up (average of 3-6 years post implant) | Peak Pulmonary Gradient Mean Pulmonary Gradient |
| Safety Assessment | Since Implant of the Valve to a Maximum of 13.0 years | Evaluation of the following adverse events * Mortality (all cause and valve-related) * Reoperation/reintervention * Explant * Endocarditis * Structural valve deterioration (defined as \>40 mmHg peak pulmonary gradient or \>30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency) * Thrombosis * Thromboembolism (pulmonary embolism) * Non-structural dysfunction * Perivalvular leak * Bleeding * Hemolysis * Calcification |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Retrospective Patients Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve. | 80 |
| Prospective Patients Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve. | 60 |
| Total | 140 |
Baseline characteristics
| Characteristic | Prospective Patients | Retrospective Patients | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 33 Participants | 66 Participants | 99 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 14 Participants | 40 Participants |
| Age, Continuous | 26.2 years STANDARD_DEVIATION 21.1 | 15.8 years STANDARD_DEVIATION 14.1 | 20.2 years STANDARD_DEVIATION 18.1 |
| Region of Enrollment United States | 60 participants | 80 participants | 140 participants |
| Sex: Female, Male Female | 16 Participants | 27 Participants | 43 Participants |
| Sex: Female, Male Male | 44 Participants | 53 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 5 / 68 | 11 / 72 |
Outcome results
Primary
Hemodynamic Performance
Peak Pulmonary Gradient Mean Pulmonary Gradient
Time frame: Most Recent follow-up (average of 3-6 years post implant)
Population: The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retrospective Ross | Hemodynamic Performance | Peak Pulmonary Gradient | 22.2 mmHg | Standard Deviation 16 |
| Retrospective Ross | Hemodynamic Performance | Mean Pulmonary Gradient | 12.1 mmHg | Standard Deviation 8.3 |
| Prospective Ross | Hemodynamic Performance | Mean Pulmonary Gradient | 7.5 mmHg | Standard Deviation 5.7 |
| Prospective Ross | Hemodynamic Performance | Peak Pulmonary Gradient | 13.5 mmHg | Standard Deviation 10.9 |
| Retrospective Right Ventricular Outflow Tract (RVOT) | Hemodynamic Performance | Mean Pulmonary Gradient | 12.3 mmHg | Standard Deviation 6.5 |
| Retrospective Right Ventricular Outflow Tract (RVOT) | Hemodynamic Performance | Peak Pulmonary Gradient | 21.2 mmHg | Standard Deviation 11.4 |
| Prospective RVOT | Hemodynamic Performance | Peak Pulmonary Gradient | 21.9 mmHg | Standard Deviation 12.1 |
| Prospective RVOT | Hemodynamic Performance | Mean Pulmonary Gradient | 11.7 mmHg | Standard Deviation 6.7 |
Primary
Hemodynamic Performance
Pulmonary Insufficiency Grade
Time frame: Most Recent Follow-up (average of 4 to 6 years post implant)
Population: The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retrospective Ross | Hemodynamic Performance | None | 6 participants |
| Retrospective Ross | Hemodynamic Performance | Trivial | 6 participants |
| Retrospective Ross | Hemodynamic Performance | Mild | 10 participants |
| Retrospective Ross | Hemodynamic Performance | Moderate | 2 participants |
| Retrospective Ross | Hemodynamic Performance | Moderate-Severe | 1 participants |
| Retrospective Ross | Hemodynamic Performance | Severe | 0 participants |
| Prospective Ross | Hemodynamic Performance | Severe | 1 participants |
| Prospective Ross | Hemodynamic Performance | Moderate | 1 participants |
| Prospective Ross | Hemodynamic Performance | None | 12 participants |
| Prospective Ross | Hemodynamic Performance | Mild | 6 participants |
| Prospective Ross | Hemodynamic Performance | Trivial | 18 participants |
| Prospective Ross | Hemodynamic Performance | Moderate-Severe | 1 participants |
| Retrospective Right Ventricular Outflow Tract (RVOT) | Hemodynamic Performance | Trivial | 14 participants |
| Retrospective Right Ventricular Outflow Tract (RVOT) | Hemodynamic Performance | Mild | 12 participants |
| Retrospective Right Ventricular Outflow Tract (RVOT) | Hemodynamic Performance | Moderate | 10 participants |
| Retrospective Right Ventricular Outflow Tract (RVOT) | Hemodynamic Performance | Severe | 3 participants |
| Retrospective Right Ventricular Outflow Tract (RVOT) | Hemodynamic Performance | Moderate-Severe | 1 participants |
| Retrospective Right Ventricular Outflow Tract (RVOT) | Hemodynamic Performance | None | 8 participants |
| Prospective RVOT | Hemodynamic Performance | Moderate-Severe | 0 participants |
| Prospective RVOT | Hemodynamic Performance | Severe | 0 participants |
| Prospective RVOT | Hemodynamic Performance | Trivial | 13 participants |
| Prospective RVOT | Hemodynamic Performance | Moderate | 1 participants |
| Prospective RVOT | Hemodynamic Performance | None | 3 participants |
| Prospective RVOT | Hemodynamic Performance | Mild | 2 participants |
Primary
Safety Assessment
Evaluation of the following adverse events * Mortality (all cause and valve-related) * Reoperation/reintervention * Explant * Endocarditis * Structural valve deterioration (defined as \>40 mmHg peak pulmonary gradient or \>30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency) * Thrombosis * Thromboembolism (pulmonary embolism) * Non-structural dysfunction * Perivalvular leak * Bleeding * Hemolysis * Calcification
Time frame: Since Implant of the Valve to a Maximum of 13.0 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retrospective Ross | Safety Assessment | 10-Year Freedom from SVD | 74 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Reoperation/Reintervention | 100 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Thrombosis | 100 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Hemolysis | 100 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Thromboembolism | 100 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Explant | 100 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Non-structural Dysfunction | 100 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Valve-Related Mortality | 100 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Perivalvular Leak | 100 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Endocarditis | 100 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Bleeding | 96 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Calcification | 80 percentage of patients |
| Retrospective Ross | Safety Assessment | 10-Year Freedom from Mortality | 84 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Calcification | 63 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Hemolysis | 100 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Mortality | 97 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Valve-Related Mortality | 100 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Reoperation/Reintervention | 81 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Explant | 88 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Endocarditis | 96 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from SVD | 52 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Thrombosis | 100 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Thromboembolism | 100 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Non-structural Dysfunction | 100 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Perivalvular Leak | 100 percentage of patients |
| Prospective Ross | Safety Assessment | 10-Year Freedom from Bleeding | 96 percentage of patients |