Clinical trial NCT05733988: Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results
Official title: Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 81
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: Up to 22 years
measure: Reintervention for MR recurrency
timeFrame: Up to 22 years
measure: MR recurrency
timeFrame: Up to 22 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References: