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

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.

Study Overview

• Status: Completed
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Procedure: Bailout edge to edge

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent a mitral valve repair surgery and in whom, at the intraoperative echo control, results where not satisfying, so an edge-to-edge repair was also performed as a bailout procedure

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	Up to 22 years
Reintervention for MR recurrency	Up to 22 years
MR recurrency	Up to 22 years

Collaborators and Investigators

• Sponsor: Michele De Bonis

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: ETEB-SOR-VLT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No