Pre TAVI Membranous Septum Measurement Predicts High Grade Iatrioventricular Conduction Disorders in Patients With Specific Pacemaker Implanted After TAVI. The STIM TAVI-MS Study (STIM TAVI MS)

Conduction disturbances are a major complication of TAVI. There is no predictor of post-TAVI conduction disorder. The study of the membranous septum on the pre-TAVI scanner and the valve implantation height are promising and little studied data on the occurrence of post-TAVI conduction disorders.

Study Overview

• Status: Completed
• Conditions: Conduction Disturbance; Trans Aortic Valve Implantation (TAVI)
• Intervention / Treatment: Diagnostic test: Trans aortic valve implantation

Detailed Description

After being developed for the treatment of aortic stenosis in inoperable patients, trans aortic valve implantation (TAVI) techniques and devices have gradually improved, and its use can now be considered in low-risk populations. . However, the need for pacemaker implantation after TAVI remains one of the most common complications, and this issue needs to be addressed before further expanding the TAVI indications.

Implantation of PM after TAVI is associated with increased morbidity and mortality, and there are no formal predictors of these conduction disturbances. Some studies suggest that the existence of preoperative conduction disturbances (eg, right bundle branch block or 1st degree AVB) are associated with greater PM implantation or greater reliance on ventricular pacing.

Other studies have focused on anatomical measurements such as the height of the membranous septum obtained on the pre TAVI scanner, calcifications of the aortic ring and the depth of the valve implantation obtained on the angiography of the TAVI procedure. . The depth of valve implantation in relation to the height of the membranous septum would be a predictor of conduction disorders and PM implantation post TAVI.

Anatomically, the left branch of the bundle of HIS originates approximately 6 mm below the aortic annulus. Implantation of TAVI can affect the conduction tissues and lead to conduction abnormalities where the penetrating portion of the HIS emerges on the surface of the LV flushing chamber. The farther away the emerging part of the HIS is from the ring, the less likely it is that an implant will encroach on it, and impair conduction.

Because the emerging part of the bundle of His is "sandwiched" between the membranous septum and the posterior crest of the muscular septum, the lower end of the membranous septum provides an anatomical landmark for the left ventricular exit point of the bundle of His, with the length of the membranous septum equivalent to the distance aortic ring - bundle of HIS.

The STIM TAVI study showed that 30% of patients implanted with a post-TAVI pacemaker did not have high-grade AVB beyond 7 days post-implantation. Patients with early AVB (D1-D7) were at high risk of developing late AVB. The study did not identify a population at low risk of late-onset AVB, nor any pre-TAVI clinical or paraclinical criteria predictive of post-TAVI AVB.

The study of the anatomy of the membranous septum and the height of implantation of the aortic prosthesis in the STIM TAVI population would make it possible to analyze new predictive criteria for late AVB (after D7).

• Study Type: Observational
• Enrollment (Actual): 197

Contacts and Locations

Study Locations

• France
  • Annecy, France, 74370
    • Ch Annecy Genevois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients included in the STIM TAVI study with full follow-up (not excluded from STIM TAVI for lack of data)

Description

Inclusion Criteria:

• 18 years old
• Patients included in the STIM TAVI study with full follow-up (not excluded from STIM TAVI for lack of data)
• Patients who did not object to the use of CT and angiography data

Exclusion Criteria:

• Oral opposition to participate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One late high-grade AVB	Presence of at least one late high-grade AVB episode	between day 7 to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT and angiographic measurements,	Feasibility of CT and angiographic measurements,	one year
intra and inter observer variability	intra and inter observer variability.	one year

Collaborators and Investigators

• Sponsor: Association de Recherche en Cardiologie des Alpes

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2020
• Primary Completion (Actual): February 26, 2021
• Study Completion (Actual): February 26, 2021

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: predictive factors; membranous septum; valve implantation height
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease
• Other Study ID Numbers: AlpinARC

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