Are the Results of Minimally Invasive Mitral Valve Repair Still Satisfactory When Looked at Very Long-term?

Are the Results of Minimally Invasive Mitral Valve Repair Still Satisfactory When Looked at Very Long-term

Mitral regurgitation (MR) is a disease affecting the mitral valve that it causes a volumetric and pressure overload in the left chambers due to the leak of the unidirectionality normally guaranteed by the heart valve system.

The gold standard for severe mitral regurgitation is currently surgical mitral valve repair (PLM) using longitudinal median sternotomy to expose the heart Since the mid-1990s, the right mini-thoracotomy, ie a surgical access with cut in the 3rd or 4th intercostal space that would allow to reduce the size of the surgical site making it less traumatic and more aesthetic, addressing mainly a young target population.

Since the 2000s this method has spread more and more, expanding all over the world and spreading especially in the United States and Germany. This method has been progressively used in the treatment of the whole mitral valve surgery starting from valve repair up to prosthetic replacements.

Mitral valve repair through minimally invasive access in degenerative pathology has made it possible to obtain excellent long-term results, with low recurrence rates of regurgitation. In our center the results on the first 48 patients have been published in 2005 by Lapenna et al. Over the years this method has been adopted in thousands of patients worldwide, however the data present in the literature they stop at a follow-up of about 10 years. In 2017 De Bonis et al. of the San Raffaele Hospital have published the outcome of a particular subgroup of patients (bileaflet prolapse) treated with minimally invasive access, comparing them with as many subjects subjected to the same method of mitral repair ("edge-to-edge technique or Alfieri stitch"), obtaining superimposable long-term results (about 14 years old).

The goal of the present study is to analyze very long-lasting results in patients treated with mitral valve surgery with access in right mini-thoractotomy.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Disease
• Intervention / Treatment: Procedure: mitral valve repair in right minithoracotomy

• Study Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients operated with mitral valve repair in right minithoracotomy to treat degenerative mitral valve disease

Description

Inclusion Criteria:

• patients with degenerative mitral regurgitation
• patients treated with mitral valve repair in right minithoracotomy

Exclusion Criteria:

• median sternotomy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	through study completion, a minimum of 16 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Reintervention	through study completion, a minimum of 16 years

Collaborators and Investigators

• Sponsor: Michele De Bonis

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2019
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: VLTFUP-MINIMVR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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