Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation.

NCT01237743 | Completed

• 1 other identifier: Dnr304-09
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate. By avoiding the effects of cardiopulmonary bypass on cerebral hemodynamics and microembolic load, TAVI is assumed to be beneficial regarding risk for neurological complications. We anticipated that the extensive endovascular retrograde manipulation in ascending aorta and aortic root would generate a detectable cerebral microembolic load, and thus an increase in serological markers of neuronal injury postoperatively. Our hypothesis is that there is a positive correlation between the total amount of cerebral microembolic events during the TAVI procedure and the Area under curve (AUC24hrs) for the release pattern of two markers of neuronal injury. We also wish to describe the extent and distribution of microembolisms during the TAVI procedure using Transcranial Doppler (TCD).

Conditions

Aortic Stenosis

Keywords

Embolism; Nervous system; Aorta; Valves; Ultrasonics

Outcome Measures

Primary Outcomes (1)

• Transcranial Doppler microembolic signals during transcatheter aortic valve implantation

  During surgery

Secondary Outcomes (1)

• Area under curve for the release pattern of serum S-100β after transcatheter aortic valve implantation

  24 Hour after Surgery

Interventions

Transcatheter aortic valve implantation. DEVICE

Transcatheter aortic valve implantation,femoral access.

Also known as: Core Valve ® (Medtronic, Inc., Minneapolis, Minnesota)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with aortic stenosis rejected for open-heart surgery due to unacceptable risks.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Department of Thoracic Anaesthesia & Intensive Care,Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (5)

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 BACKGROUND

• Dittrich R, Ringelstein EB. Occurrence and clinical impact of microembolic signals during or after cardiosurgical procedures. Stroke. 2008 Feb;39(2):503-11. doi: 10.1161/STROKEAHA.107.491241. Epub 2008 Jan 3.

  PMID: 18174490 BACKGROUND

• Lund C, Nes RB, Ugelstad TP, Due-Tonnessen P, Andersen R, Hol PK, Brucher R, Russell D. Cerebral emboli during left heart catheterization may cause acute brain injury. Eur Heart J. 2005 Jul;26(13):1269-75. doi: 10.1093/eurheartj/ehi148. Epub 2005 Feb 16.

  PMID: 15716287 BACKGROUND

• Webb JG, Pasupati S, Humphries K, Thompson C, Altwegg L, Moss R, Sinhal A, Carere RG, Munt B, Ricci D, Ye J, Cheung A, Lichtenstein SV. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation. 2007 Aug 14;116(7):755-63. doi: 10.1161/CIRCULATIONAHA.107.698258. Epub 2007 Jul 23.

  PMID: 17646579 BACKGROUND

• Reinsfelt B, Westerlind A, Ioanes D, Zetterberg H, Freden-Lindqvist J, Ricksten SE. Transcranial Doppler microembolic signals and serum marker evidence of brain injury during transcatheter aortic valve implantation. Acta Anaesthesiol Scand. 2012 Feb;56(2):240-7. doi: 10.1111/j.1399-6576.2011.02563.x. Epub 2011 Oct 19.

  PMID: 22092012 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum levels of S-100β Determined by an electrochemoluminescence immunoassay using the Modular system and the S100β reagent kit (Roche Diagnostics, Basel, Switzerland).

MeSH Terms

Conditions

Aortic Valve Stenosis; Embolism; Neurologic Manifestations

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Embolism and Thrombosis; Vascular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Sven Erik Ricksten, Professor

  Sahlgrenska University Hospital,Thoracic Anesthesia & Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 15, 2011

Record last verified: 2010-11

Locations

SE (1)