STIMTAVI : Evolution of Atrioventricular Conduction Disorders After TAVI (STIMTAVI)

STIMulation Cardiaque et TAVI : évolution Des Troubles Conductifs Atrio-ventriculaires après TAVI

The investigators propose to carry out an observational study of patients implanted with a pacemaker using AAI SafeR® mode after a TAVI procedure. This study aims to define the persistence or not of high-grade AVB beyond seven days after the procedure, based on the analysis of PM memories, and define definitive cardiac pacing indications after TAVI procedure.

Study Overview

• Status: Unknown
• Conditions: Pacemaker Implantation; TAVI

Detailed Description

Atrioventricular (A-V) conduction disorders are common after Transcatheter Aortic Valve Implantation (TAVI) and the average of a pacemaker implantation after TAVI is 15% to 17%.

The European Society of Cardiology recommends to implant a permanent pacemaker (PM) in case of persistant high-grade A-V block (AVB) within 7 days of a TAVI procedure (class I recommendation, level of evidence C).

Some conduction disturbances are transient and might not need a definitive indication for pacemaker implantation. A recent study, based on dependency of patients to pacing, estimate that in half the patients, conduction disturbances that led to the implantation of a pacemaker after TAVI procedure would have disappear 30 days after the procedure.

Many studies tried to better define the indications of these devices. However, their evaluation criteria do not allow to prove these pacemakers were useful, because these studies are mainly based on the rate of implantation of pacemakers, or on the percentage of ventricular pacing. These studies may overestimate the usefulness of the pacemaker because of unnecessary ventricular pacing, or underestimate it in patients with high grade paroxysmal AVB, that could have been responsible for syncope or death.

Today some pacemakers allow a better occurrence of spontaneous A-V conduction and monitor precisely the atrioventricular conduction.

The AAI SafeR® mode from Sorin® allows the pacemaker to switch from a single to a dual chamber mode in case of AVB; these switches are stored in the memories of PM as endocardial electrogram (EGM) which can be validated afterwards. The use of this algorithm could allow an accurate assessment of the persistence of high level conduction disturbances in patients implanted with a pacemaker after a TAVI procedure. A study published in late 2014 using this tool in monitoring post TAVI conduction disorders on a small number of patients, other studies used the same tool in other cardiac pathologies.

• Study Type: Observational
• Enrollment (Actual): 275

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

275 patients over 18 years who underwent implantation of a TAVI and that were implanted during the hospitalization with a dual chamber pacemaker Sorin®, set in AAI SafeR ® or AAI SafeR-R® mode.

Description

Inclusion Criteria:

• All patients over 18 years who underwent implantation of a TAVI and that were implanted during the hospitalization with a dual chamber pacemaker Sorin®, set in AAI SafeR ® or AAI SafeR-R® mode.

Exclusion Criteria:

• Patients with life expectancy at hospital discharge estimated as less than 1 year
• TAVI procedure failure
• Patients refusing to be involved in the study
• Patients implanted with a PM of a brand different than Sorin® during the hospital phase or implanted Sorin® PM but not set in a AAI or AAI SafeR SafeR-R mode
• Patients with PM implant before TAVI
• Permanent AF at the implantation time
• Patients with Single or Triple chamber PM

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To look for one or several high level A-V block episodes beyond seven days after a TAVI procedure, by the analysis of the EKG and of the pacemaker memories during the follow-up visits	High level A-V Block in patients after TAVI procedure is defined: Either by the analysis of the pacemaker memories during the follow-up visits showing the switches from AAI Safe-R to DDD mode after one or more of these three reasons:a succession of at least 2 consecutive blocked P wavesmore than 3 blocked P waves among 12 consecutive cyclesventricular pause for over 2 seconds with at least one blocked P wave; Either by the presence of a high level AVB on the EKG during the follow-up visit (pacemaker temporally set to DDI 30 bpm mode) We classify as transitional AVB (D7 persistent, non-persistent beyond 1 month), and permanent AVB (persistent beyond 1 month).	Until the completion of the study (first follow-up visit 1 to 3 months after TAVI, last follow-up visit 1 year after TAVI)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the influence of certain predefined factors on the risk of high-level A-V block after a TAVI procedure.	In accordance with the secondary objective, we will study the influence of certain predefined factors on the risk of high-level A-V block after a TAVI procedure : preexisting conduction disturbances (complete right bundle branch block, left anterior hemiblock, first degree A-V block), high grade AVB during the TAVI procedure, worsening of conduction disturbances during the procedure or within the next hour (appearance of a left bundle branch block, QRS widening beyond 120ms, prolongation of PR beyond 200ms ), lengthening of the HV interval immediately after the procedure TAVI or later (if an electrophysiological study is performed), implantation of a Medtronic® CoreValve prosthesis (compared to an Edwards® Sapien prosthesis), height of the implantation of the valve, oversizing.	An average of 8 days (from the day before the TAVI procedure to 7 days after TAVI)

Collaborators and Investigators

• Sponsor: Association de Recherche en Cardiologie des Alpes
• Collaborators: LivaNova
• Investigators: Study Director: Didier IRLES, Dr, Association de Recherche en Cardiologie des Alpes

Publications and helpful links

General Publications

• Irles D, Salerno F, Cassagneau R, Eschalier R, Maupain C, Dupuis JM, Mansourati J, Guedon L, Marijon E, Frey P; Other members of the STIMulation cardiaque post-TAVI (STIM-TAVI) study. Evolution of high-grade atrioventricular conduction disorders after transcatheter aortic valve implantation in patients who underwent implantation of a pacemaker with specific mode-that minimizes ventricular pacing-activated. J Cardiovasc Electrophysiol. 2021 May;32(5):1376-1384. doi: 10.1111/jce.14970. Epub 2021 Mar 4.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Anticipated): January 19, 2018
• Study Completion (Anticipated): April 19, 2018

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: TAVI; Pacemaker; Conduction disturbance
• Other Study ID Numbers: ARCAlpes

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