Fast Track Concept for Transfemoral TAVI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of a Fast Track Concept for Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation Based on Individualized Low-dose Analgosedation and Preprocedural Fluid Optimization Using Echocardiography.

Conditions
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Heart Valve Diseases, Complication,Postoperative

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for transfemoral TAVI informed written consent Exclusion Criteria: rejection by the patient switching to another procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| analgosedation group<br>analgosedation concept | |
| historical group<br>standard historical concept | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay in hospital | time in hospital | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | acute renal failure, pulmonary edema, pneumonia, wound infection | through study completion, an average of 1 year | 
| one year mortality | survival during one year | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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length of stay in hospital, transfemoral transaortic valve implantation