Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Transcranial Doppler Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation|
- Transcranial Doppler microembolic signals during transcatheter aortic valve implantation [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]
- Area under curve for the release pattern of serum S-100β after transcatheter aortic valve implantation [ Time Frame: 24 Hour after Surgery ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||July 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Device: Transcatheter aortic valve implantation.
Patients scheduled for TAVI at our institution are screened for inclusion into this prospective, observational study. A multidisciplinary expert committee evaluate all high-risk patients diagnosed with aortic stenosis. If rejected for open-heart surgery, and without contraindications for transcatheter approach, the patient is offered treatment with TAVI using the CoreValve ® (Medtronic, Inc., Minneapolis, Minnesota) system. The Human Ethics Committee of the University of Gothenburg, approved the study protocol, and all patients sign an informed, written consent. CoreValve ® is a TAVI system delivering a tri-leaflet bioprosthetic porcine pericardial tissue valve mounted and sutured in a self-expanding nitinol frame, using a trans-femoral or trans-subclavian artery access approach. Details regarding the TAVI procedure have been described previously . On the evening before surgery, the patients receive a loading dose of clopidogrel 300 mg. The morning of surgery an additional dose of clopidogrel 75 mg, together with acetylsalicylic acid 75 mg is given.
No sedative premedication is given before the procedure. On arrival at OR, standard perioperative monitoring is established, including an Auditory Evoked Potential (AEP) monitor for anaesthetic depth measurements (AEP Monitor/2, Danmeter, Odense, Denmark) and radial arterial and central venous lines. General anaesthesia is induced with propofol 0.5-1 mg/kg and fentanyl 100-150 μg. Tracheal intubation facilitated using atracurium 0,5 mg/kg. A propofol infusion is used to maintain an anaesthetic depth adjusted to an AAI index of 15-30 as recorded by the AEP monitor. Hemodynamic stability is obtained by the use of colloidal solution administration, guided by the use of intra-operative transesophageal echocardiography, and norephineprine to maintain a mean arterial pressure above 75 mmHg. During the procedure, intravenous heparin is administered to achieve an activated clotting time > 250 sec. Catheters and guide-wires are flushed and cleaned according to standard procedures at our laboratory. The preparation of the valve is performed according to the instructions of the manufacturer. The balloon valvuloplasty of the native aortic valve is performed under rapid right ventricular pacing (180 bpm) and the self-expandable prosthesis deployed stepwise without pacing. The same team of two interventional cardiologists and one cardiothoracic anaesthesiologist perform all procedures. A certified cardiologist or anaesthesiologist assess focal neurological impairment before and within 24 hours after the procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237743
|Department of Thoracic Anaesthesia & Intensive Care,Sahlgrenska University Hospital|
|Gothenburg, Sweden, 41345|
|Study Director:||Sven Erik Ricksten, Professor||Sahlgrenska University Hospital,Thoracic Anesthesia & Intensive Care|