Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results

Mitral Regurgitation Clinical Trial

Official title:

Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05733988
• Other study ID #: ETEB-SOR-VLT
• Status: Completed
• Start date: July 10, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: February 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The absence of residual mitral regurgitation (MR) after mitral valve repair is of paramount importance for the long term durability of the valve repair. Thus, ideally, after weaning from cardio-pulmonary by-pass (CPB) the trans-esophageal echocardiogram (TEE) should show no (or only trivial) residual MR, good coaptation length and no iatrogenic mitral valve stenosis. However, mild or more residual MR can be present in up to 4% of the patients after the initial mitral valve repair and a second CPB run may be necessary to improve the repair results. Mechanism of residual MR can be dynamic, related to systolic anterior motion (SAM) or to severe left ventricular dysfunction, and anatomical, related to residual prolapse, cleft, and suture or ring dehiscence. In several cases medical therapy can be effective in the management of the intra-operatively detected SAM, and residual cleft or suture dehiscence can be easily corrected during a second CPB run. However, in other cases SAM is not responsive to medical therapy or the residual MR jet would require complex and time-consuming techniques to be addressed, or even worse scenario, a mitral valve replacement could be necessary. In such cases the edge-to-edge (EE) technique can be used as a bail-out procedure. The anatomical characteristics of the mitral valve after an initial sub-optimal repair are certainly not ideal for the edge-to-edge technique, due to a possible significant reduction in the valve area, especially in case of posterior leaflet resection or small ring implanted. Nevertheless, in the short term the edge-to-edge technique used to rescue patients with sub-optimal initial repair resulted effective. However, the very long-term results of the edge-to-edge technique used as bail-out are not known. Thus, the aim of this study is to evaluate the clinical and echocardiographic results of the edge-to-edge technique used to rescue patients with initial sub-optimal mitral repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Adult patients;
• Patients underwent mitral valve repair, with more than mild residual MR at the intraoperative TEE after leaving the CPB;
• Patients in whom EtE alone has been added to the repair already performed, as a technique to reduce residual MR after first attempt of mitral valve repair;
• Patients operated both in median sternotomy or in minithoracotomy;
• Patients operated on at the Cardiac Surgery departmet of San Raffaele Hospital since January 1999 to December 2015.

Exclusion Criteria:

• Patients in whom other techniques have been used as a bailout procedure, concurrently or instead of EtE;
• Patients where the initial repair has been modified or undone;
• Patients whose mitral valve has been replaced.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Procedure:
• Bailout edge to edge
Edge to edge repair is the suture of the mitral valve leaflets in the regurgitant spot. It can be used as a bailout procedure when the first attempt of mitral valve repair with other surgical techniques is not satisfactory at intraoperative echo control. In this case, a second run of cardiopulmonary bypass is carried out, the heart is reopened and an edge-to-edge is performed.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		Up to 22 years
Primary	Reintervention for MR recurrency		Up to 22 years
Primary	MR recurrency		Up to 22 years