Barlow's Disease, Prolapse; Mitral
Conditions
Brief summary
The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.
Interventions
PROCEDURERight minithoracotomy
Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space
PROCEDURESternotomy
Longitudinal resection of the sternum
Sponsors
Ospedale San Raffaele
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients treated for bileaflet prolapse in Barlow's Disease between 1997 and 2011
Exclusion criteria
Age inferior to 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Death | 12 years | The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk |
| Severe MR | 12 years | The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) \>\_ 3+, with death as the competing risk |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MT-Right Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space | 104 |
| Sternotomy Sternotomy: Longitudinal resection of the sternum | 104 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | MT-Right | Sternotomy | Total |
|---|---|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 8 | 51 years STANDARD_DEVIATION 13 | 43.5 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment Italy | 102 participants | 104 participants | 206 participants |
| Sex: Female, Male Female | 68 Participants | 38 Participants | 106 Participants |
| Sex: Female, Male Male | 34 Participants | 66 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 102 | 0 / 104 |
| serious Total, serious adverse events | 11 / 102 | 10 / 104 |
Outcome results
Primary
Cardiac Death
The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk
Time frame: 12 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MT-Right | Cardiac Death | 3.9 percentage of participants with event |
| Sternotomy | Cardiac Death | 3.8 percentage of participants with event |
Primary
Severe MR
The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) \>\_ 3+, with death as the competing risk
Time frame: 12 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MT-Right | Severe MR | 5.8 percentage of participants with event |
| Sternotomy | Severe MR | 11.4 percentage of participants with event |