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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-Right |
| ||
| Sternotomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Right minithoracotomy | Procedure | Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Death | The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk | 12 years |
| Severe MR | The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk | 12 years |
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Inclusion Criteria:
Patients treated for bileaflet prolapse in Barlow's Disease between 1997 and 2011
Exclusion Criteria:
Age inferior to 18 years
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Patients with severe MR due to the prolapse of both leaflets in the context of Barlow's disease submitted to EE repair via a video-assisted right minithoracotomy (minithoracotomy group) and patients with Barlow's disease treated with surgical mitral repair with the EE technique through a conventional median sternotomy (sternotomy group).
The diagnosis of Barlow's disease was made during a preoperative transoesophageal echocardiographic (TEE) examination and confirmed by the surgeon's direct assessment of the valve. All patients had excessive leaflet tissue, annular dilatation and bileaflet prolapse. Cases with a forme fruste of Barlow's disease were excluded.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22922698 | Background | Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MT-Right | Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space |
| FG001 | Sternotomy | Sternotomy: Longitudinal resection of the sternum |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sternotomy | Procedure | Longitudinal resection of the sternum |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MT-Right | Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space |
| BG001 | Sternotomy | Sternotomy: Longitudinal resection of the sternum |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 2 patients lost to follow-up | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | 2 patients lost to follow-up | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cardiac Death | The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk | Posted | Number | 95% Confidence Interval | percentage of participants with event | 12 years |
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| Primary | Severe MR | The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk | Posted | Number | 95% Confidence Interval | percentage of participants with event | 12 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MT-Right | Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space | 11 | 102 | 0 | 102 | ||
| EG001 | Sternotomy | Sternotomy: Longitudinal resection of the sternum | 10 | 104 | 0 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reoperation | Surgical and medical procedures | Systematic Assessment |
|
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Limitations due to retrospective design.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Michele De Bonis | IRCCSSRaffaele | +390226437102 | debonis.michele@hsr.it |
| ID | Term |
|---|---|
| D008945 | Mitral Valve Prolapse |
| ID | Term |
|---|---|
| D016127 | Heart Valve Prolapse |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D056346 | Sternotomy |
| ID | Term |
|---|---|
| D019616 | Thoracic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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