Fast Track Concept for Transfemoral TAVI

Completed

• Conditions: Heart Valve Diseases; Complication,Postoperative

• Registration Number: NCT04792827
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

Transcatheter aortic valve implantation (TAVI) in high-risk patients with severe aortic valve stenosis has developed itself until today as an established minimally invasive alternative procedure worldwide, with a focus on the transfemoral access (TF-TAVI). Meanwhile a number of studies have shown that analgosedation for patients undergoing TF-TAVI is a safe and feasible alternative to general anaesthesia (1). The median length of stay in hospital in Europe is currently 8 days independent to the anesthesia management (2). In the University Hospital Schleswig-Holstein, Campus Kiel, a new TF-TAVI fast-track-concept has been implemented in June 2018. The main intraprocedural aspects of the concept are the preprocedural fluid optimization using transthoracic echocardiography, the idea to decrease or omit the central venous line and the urinary catheter, if reasonable, and finally the individualized low-dose, bolus-based AS.

Detailed Description

The investigators are going to monitor 200 patients in 2019 treated with the newly established fast-track concept. During the premedication visit, the investigators informed the patients that the intention is to perform the TF-TAVI, if acceptable, solely in local anaesthesia, in order to minimize potentially adverse pharmacological central effects by analgosedation. After insertion of two peripheral venous lines and an arterial line, monitoring of cerebral oxygenation using near-infrared spectroscopy was established. Transthoracic echocardiography has been performed to evaluate volume status, using the inferior vena cava collapsibility index. Additionally, cardiac output and ejection fraction was calculated.

Based on the data of the investigators and current data from the literature, the investigators assume a postoperative hospital stay of 8 days after TF-TAVI. With a possible reduction of the hospital stay by about 25%, the investigators calculated a case number of 100 patients per group. The study is designed with a control group under standard therapy. Data are recorded and analyzed descriptively. Qualitative comparisons will be made in the discussion of previously published data.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Study First Submitted: 2020-12-17
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-10
• Last Update Submitted: 2021-03-10
• Study First Posted: 2021-03-11
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• scheduled for transfemoral TAVI
• informed written consent

Exclusion Criteria

• rejection by the patient
• switching to another procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
length of stay in hospital	through study completion, an average of 1 year	time in hospital

Secondary Outcome Measures

Name	Time	Method
postoperative complications	through study completion, an average of 1 year	acute renal failure, pulmonary edema, pneumonia, wound infection
one year mortality	through study completion, an average of 1 year	survival during one year

Trial Locations

Locations (1)

Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin; 🇩🇪 Kiel, Deutschland (deu), Germany