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Fast Track Concept for Transfemoral TAVI

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04792827
Enrollment
200
Registered
2021-03-11
Start date
2018-06-01
Completion date
2019-10-31
Last updated
2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication,Postoperative, Heart Valve Diseases

Keywords

length of stay in hospital, transfemoral transaortic valve implantation

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.

Interventions

None listed

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* scheduled for transfemoral TAVI * informed written consent

Exclusion criteria

* rejection by the patient * switching to another procedure

Design outcomes

Primary

MeasureTime frameDescription
length of stay in hospitalthrough study completion, an average of 1 yeartime in hospital

Secondary

MeasureTime frameDescription
postoperative complicationsthrough study completion, an average of 1 yearacute renal failure, pulmonary edema, pneumonia, wound infection
one year mortalitythrough study completion, an average of 1 yearsurvival during one year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026