Fast Track Concept for Transfemoral TAVI

Heart Valve Diseases Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792827
• Other study ID #: IN-TF_TAVI_01
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: March 2021
• Source: University Hospital Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• scheduled for transfemoral TAVI

• informed written consent

Exclusion Criteria:

• rejection by the patient

• switching to another procedure

Related Conditions & MeSH terms

• Complication,Postoperative
• Heart Valve Diseases
• Postoperative Complications

Locations

Country	Name	City	State
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin	Kiel	Deutschland (deu)

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28. — View Citation

Renner J, Tesdorpf A, Freitag-Wolf S, Francksen H, Petzina R, Lutter G, Frey N, Frank D. A retrospective study of conscious sedation versus general anaesthesia in patients scheduled for transfemoral aortic valve implantation: A single center experience. Health Sci Rep. 2018 Nov 1;2(1):e95. doi: 10.1002/hsr2.95. eCollection 2019 Jan. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of stay in hospital	time in hospital	through study completion, an average of 1 year
Secondary	postoperative complications	acute renal failure, pulmonary edema, pneumonia, wound infection	through study completion, an average of 1 year
Secondary	one year mortality	survival during one year	through study completion, an average of 1 year