Follow-up After TAVR Without Systematic Intensive Care Unit Admission

NCT ID: NCT04335149

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2022-12-01

Brief Summary

Since the first case described in 2002, TAVI (transcatheter Aortic Valve Implantation) revolutionized the management of severe symptomatic aortic stenosis. Initially reserved for patients with prohibitive surgical risk, transfemoral TAVI in now indicated according to European Guidelines for patients at intermediate surgical risk and those > 75 ans. Post-procedure intensive care admission (ICU), initially considered as the rule regarding the risk of complications, (particularly conductive disorders), may be avoided in 1/3 of patients regarding drastic reduction in serious complications and growing experience of operators as the investigator shown in a previous prospective study. Predictive criteria for low-risk of complications were therefore established by our team and may be used in routine to select patients that might avoid ICU. However, long-term impact of this triage strategy remains unknown.

Objective:

The objective of this study is to assess 1-year outcomes according to unit admission selection (ICU or conventional care unit (CCU)) in patients undergoing TAVI.

Since the first case described in 2002, TAVI (transcatheter Aortic Valve Implantation) revolutionized the management of severe symptomatic aortic stenosis. Initially reserved for patients with prohibitive surgical risk, transfemoral TAVI in now indicated according to European Guidelines for patients at intermediate surgical risk and those > 75 ans. Post-procedure intensive care admission (ICU), initially considered as the rule regarding the risk of complications, (particularly conductive disorders), may be avoided in 1/3 of patients regarding drastic reduction in serious complications and growing experience of operators as the investigator shown in a previous prospective study. Predictive criteria for low-risk of complications were therefore established by our team and may be used in routine to select patients that might avoid ICU. However, long-term impact of this triage strategy remains unknown.

Objective:

The objective of this study is to assess 1-year outcomes according to unit admission selection (ICU or conventional care unit (CCU)) in patients undergoing TAVI.

Detailed Description

Since the first case described in 2002, indications of TAVI (transcatheter Aortic Valve Implantation) procedures increased in the treatment of symptomatic severe aortic stenosis. Initially reserved for inoperable patients or at high surgical risk, the indication for TAVI was recently extended to patients at intermediate surgical risk. Post-procedure intensive care admission (ICU) was initially considered the rule for all patients regarding the risk of high-grade conductive disorders, vascular or neurological complications. However, given the drastic reduction in serious complications and the increasing number of procedures, systematic ICU admission may be safely avoided. Selection criteria for ICU admission were established by our team in a previous study. The use of these low risk criteria, the growing experience of operators as well as technological improvements allow to safely avoid ICU admission in 1/3 of patients. However, long-term impact of this triage strategy remains unknown.

Objective:

The objective of this study is to assess 1-year outcomes of patients undergoing TAVI according to unit admission (ICU or conventional care unit (CCU)).

Methods This monocentric observational study retrospectively includes all patients undergoing TAVI at the Montpellier University Hospital from 2017. TAVI is indicated in patients with symptomatic severe aortic stenosis with a life expectancy > 1year and contra-indicated for conventional surgery, at high risk or intermediate surgical risk> 75 years after "heart team" decision. Exclusion criteria are patients who died before unit admission or referred a non-cardiological unit after the procedure. Two groups of patients are defined: (1) patients referred to the ICU and (2) patients referred to the CCU after the procedure according to risk-stratification criteria. Low-risk of complications criteria were defined as the absence of major comorbidities, hemodynamic stability, absence of pre-procedure right bundle branch block, LVEF> 40% and absence of procedural complications, particularly the absence of any new conductive disorder after 2 hours monitoring. The primary endpoint is 1-year major events (all-cause mortality, major cardiovascular event and rehospitalization for cardiac causes) according to the VARC-2 criteria. The secondary endpoints include hospitalization duration, 1-month major events and all-cause mortality during follow-up > 1 year depending on the group.

Data assessment Data on patients' baseline characteristics, procedural details and in-hospital outcomes is collected from a prospective TAVI database. No additional testing or biological samples were specifically required for this study

Conditions

Aortic Valve Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

COREVALVE

Patients undergoing a TAVI at Montpellier University Hospital since 2017 with implantation of a COREVALVE

No interventions assigned to this group

EDWARDS

Patients undergoing a TAVI at Montpellier University Hospital since 2017 with implantation of a EDWARDS

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• age > 18 yo
• Patients undergoing a TAVI at Montpellier University Hospital since 2017
• With implantation of a COREVALVE or EDWARDS

Exclusion Criteria

• Minor patient
• Patient unable to give consent for reasons of understanding or language barrier
• Death before unit admission
• Patients referred to a non cardiological unit after the procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence Leclercq, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL20_0169

Identifier Type: -

Identifier Source: org_study_id