Sedation or General Anesthesia During TAVR

NCT04347603 | Completed

• 3 other identifiers: RECHMPL19_0350UF78252020-A00497-32
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 2

Brief Summary

Transcatheter aortic valve replacement TAVR is become the reference method for patients with severe aortic stenosis who are contraindicated or at risk for surgical aortic replacement. Initially performed under general anesthesia (GA), recent developpement of minimalist approach of TAVR include the use of local anesthesia (LA) with or without conscious sedation (CS) associated with full percutaneous access and no routine transoesophageal echocardiography (T0E). The aim is to simplify the procedure and to allow fast recovery of patients with early discharge and reduced cost. Evidence guiding the decision of whether to perform TAVR under GA or LA-CS is limited to non-randomized trials and registry data Current evidence is however limited by probable patient selection bias, methodological variability between studies, various methods of anesthesia and a lack of agreement regarding appropriate clinical end-points. The potential benefits of TAVR with LA include reduced procedure time, shorter intensive care unit (ICU) length of stay, reduced need for intraprocedural vasopressor support, and the potential to perform the procedure without the direct presence of an anesthetist for cost-saving reasons. As LA with CS is preferred with good results in main centers, GA may be useful to facilitate intraprocedural TOE which is necessary in case of intraprocedural complications and may facilitate the procedure for the physician particularly when the patient is anxious or disturbed. A resulted better concentration without precipitation may influence the outcomes in term of valve positioning. The patient comfort could also be better during femoral puncture or rapid pacing. The aim of the study is to compare transfemoral TAVR under general anesthesia (experimental group) versus local anaesthesia with sedation (control group) with a safety primary combined end point of adverse events at 72 h follow-up (hemodynamic parameters and VARC 3 criteria). Secondary end points include hospitalization length, satisfaction of the patients and operators and 30 days mortality. The hypothesis is a non inferoirity of the GA staregy regarding the primary end point.

Conditions

Stenoses, Aortic

Outcome Measures

Primary Outcomes (2)

• Hemodynamic instability

  Hemodynamic instability (defined by the need for fluid loading \>1500 ml associated or not with the use of inotrope support) within the first 72 hours

  within 72 hours after intervention

• Major complications (according to VARC 3 criteria)

  Major complications (according to VARC 3 criteria) within the first 72 hours : * death in hospital, * major vascular events, * neurological events, * myocardial infarction, * aortic regurgitation \>2, * conductive disorders requiring pacemaker implantation, * acute renal failure (KDIGO criteria), * pericardial tamponade.

  within 72 hours after intervention

Study Arms (2)

General Anesthesia

EXPERIMENTAL

\- General anesthesia : After pre-anesthetic preparation (25-50 mg Hydroxizine orally), the anesthesia induction will be performed by IV perfusion of Propofol 1 to 2 mg/kg, Sufentanyl for analgesia 0,2 to 0,4 µg/kg, curarisation with Atracurium 0,15 mg/kg. The anaethesia depth will be monitored by the bispectral index (BIS). Orotracheal intubation will be performed, the patient will be ventilated to controlled volume with 6-8 mL/kg of current volume based on expected body weight (PBW). The respiratory rate will be adjusted to have an ETCO2 between 35 and 45 mmHg. The anesthesia will be maintained through the Sevorane at 0.7-1 MAC, the average blood pressure will be controlled through a pressure cuff with a target between 60 and 80 mmHg. The Fio2 will be adapted to obtain saturation \> 94% with 5 cmH2O PEEP.

Procedure: TAVR

Local Anesthesia

ACTIVE COMPARATOR

Local anesthesia at the device introduction site will be obtained by infiltration of Naropein.

Procedure: TAVR

Interventions

TAVR PROCEDURE

Femoral percutaneous aortic prosthesis (TAVR)

General Anesthesia; Local Anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• Consecutive patients referred to the cardiology department of the CHU in Montpellier, France, for TAVI via transfemoral access.
• Patients for whom the procedure is indicated after decision by the heart team and according to the current recommendations of the European Society of Cardiology.
• Patients with severe aortic stenosis defined by mean gradient \> 40 mmHg and/or aortic valve area 1 cm2 or 0.8 cm2/m2 as recommended. May also include patients with low gradient (\< 40mm hg) and low flow (stroke volume index \< 35ml/minute) which are classic indications for aortic valve replacement
• Ability to consent to participate in study
• Patient affiliated with or beneficiary of a social security scheme

You may not qualify if:

• Chronic respiratory insufficiency treated by long term oxygeno therapy
• Pulmonary hypertension above 50mmHg
• BMI\>35
• TAVI by carotidian or apical way
• Pregnant women
• Vulnerable person according to L1121-6 of Public Health reglementation in France

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

University hospital

Montpellier, France

Location

University hospital

Nîmes, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 15, 2020
• Study Start: December 8, 2020
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: September 30, 2025

Record last verified: 2024-05

Locations

FR (2)