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

NCT05733988 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2023-02-17

No results posted yet for this study

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.

Conditions

  • Mitral Regurgitation

Interventions

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.

Sponsors & Collaborators

  • Michele De Bonis

    lead OTHER

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-10
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05733988 on ClinicalTrials.gov