Inflammatory Response to Aortic Valve Replacement

Reduced Inflammatory Response Using Transcatheter Aortic Valve Replacement as Compared to Conventional Surgery

A controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. As a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal TAVI.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: Transarterial aortic valve implantation - TAVI; Procedure: Surgical aortic valve replacement - SAVR

Detailed Description

18 patients admitted successively for conventional surgical aortic valve replacement and 18 patients admitted for transcatheter aortic valve implantation (TAVI) (9 transfemoral and 9 transaortic) are included.

A plasma sample is obtained at defined timepoints before, during and after surgery. At each time points the following biomarkers are analyzed:Concentrations of the complement activation products C3bc and the terminal C5b-9 complement complex (TCC), the neutrophil release product myeloperoxidase (MPO), the cytokines IL-6, eotaxin, MCP-1 and MIP-1β (12). As marker of a myocardial cellular injury troponin T levels will be analyzed. The following clinical outcomes will also be monitored: Death (in hospital, 30 day and one year), blood transfusion, stroke, myocardial infarction.

A dedicated registry will be established at the hospital according to the hospital's standard for storage of patient data. The registry will be deleted after completion of the study.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients eligible for aortic valve replacement without need for concurrent surgery

Exclusion Criteria:

• known inflammatory disease and anti-inflammatory treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transarterial aortic valve implantation; Patients that are treated by trans arterial valve implantation (TAVI)	Procedure: Transarterial aortic valve implantation - TAVI; After insertion of a guidewire, either through the femoral artery or through the ascending aorta, the aortic ostium is dilated by a balloon and the valve is introduced through a catheter and expanded in the ostium.
Active Comparator: Surgical aortic valve replacement; Patients that are treated by surgical aortic valve replacement (SAVR)	Procedure: Surgical aortic valve replacement - SAVR; The patient is operated through a sternotomy and coupled to a heart lung machine. The aorta is opened and the native valve excised. Then a biological artificial heart valve is sutured in place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generation of several inflammatory markers measured through repeated blood samples	The total generation of several inflammatory markers is compared between the groups	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	ml blood loss compared between the groups	24 hrs
Blood transfusion	Number of blood Products tranfused after the procedure	24 hrs

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo
• Investigators: Principal Investigator: Erik Fosse, MD PhD, Oslo University Hospital/University of Oslo; Study Chair: Karoline KH Fiane, Med Student, University of Oslo

Publications and helpful links

General Publications

• Fiane KKH, Dahle G, Bendz B, Halvorsen PS, Abdelnoor M, Mollnes TE, Fosse E. Reduced inflammatory response by transcatheter, as compared to surgical aortic valve replacement. Scand Cardiovasc J. 2018 Feb;52(1):43-50. doi: 10.1080/14017431.2017.1416157. Epub 2017 Dec 12.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): December 31, 2013
• Study Completion (Actual): December 31, 2013

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 3, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Cardiac surgery; TAVI
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2012/7919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No