The purpose of this RCT is to improve the outcome of surgical treatment of severe and/or symptomatic aortic valve pathology with or without concomitant coronary artery disease by reducing morbidity (stroke) and change of operative strategy in…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Subclinical stroke rate (i.e., presence of new ischemic brain lesions) as
identified with the use of DW-MRI made within one week postoperatively or
before discharge
Secondary outcome
- National Institutes of Health Stroke Scale (NIHSS) score one week
postoperatively or before discharge (assessment will be performed by a
neurologist).
- Clinical ischemic stroke (conform VARC-3) diagnosed by a neurologist one week
postoperatively or before discharge
- TIA diagnosed by a neurologist one week postoperatively or before discharge
(conform VARC-3).
- Mortality at 30 days
- Change in intervention strategy (no unfavourable change, cancellation of
surgery (before or after sternotomy), switch to TAVR preprocedural, conversion
from limited access to conventional full median sternotomy, conversion to TAVR)
- Change in cannulation strategy (no change, use of different cannula, avoiding
cannulation of the ascending aorta/arch (thus femoral or subclavian
cannulation), higher cannulation (arch), lower cannulation, echo-guided
cannulation)
- Change in clamping strategy (no change, change of clamping site, no clamping)
- Procedural times: Implantation time (defined period from start of the valve
assessment until the completion of the prosthesis implantation = fixation of
last suture), surgical time, aortic cross-clamp (ACC) time, cardio-pulmonary
bypass (CPB) time
- Quality of life (assessed by EQ-5D and KCCQ) at baseline and at two-month
follow-up
- Fractional flow reserve derived from MSCT (only in patients who are
randomized to preoperative MSCT)
- Fractional flow reserve measured with standard preprocedural coronary
angiography (only in patients who are randomized to preoperative MSCT)
Background summary
When determining the strategy for aortic valve replacement, echocardiography is
still considered the golden standard. While pre-procedural MSCT is standard of
care in TAVR patients, this is not yet part of routine clinical practice in
SAVR patients. We hypothesise that when atherosclerosis of the ascending aorta
is identified preoperatively on multi-slice computed tomography (MSCT), the
perioperative (subclinical) stroke rate can be reduced by modification of the
operative strategy if necessary.
Study objective
The purpose of this RCT is to improve the outcome of surgical treatment of
severe and/or symptomatic aortic valve pathology with or without concomitant
coronary artery disease by reducing morbidity (stroke) and change of operative
strategy in patients undergoing SAVR with or without CABG. A positive outcome
of this trial will lead to a change in the guidelines for the preoperative
work-up of aortic valve interventions, which in turn could lead to an
improvement in safety and outcome of aortic valve interventions.
Study design
This is a prospective, single center, parallel, open-label randomized
controlled trial (RCT) with a 1:1 randomization including patients aged 18
years and older accepted for SAVR with or without concomitant CABG by the Heart
Team at the St. Antonius Hospital Nieuwegein. All patients enrolled in the
study will be randomized to additional pre-operative MSCT or no pre-operative
MSCT. The duration of enrollment is estimated to be 2 years. The total period
of follow-up will be 1 month.
Intervention
Low-dose contrast-enhanced CT of the total aorta
Study burden and risks
When severe calcification of the ascending aorta is identified preoperatively
on multi-slice computed tomography (MSCT), the operative strategy can be
modified if necessary. This could possibly prevent stroke or even mortality in
the study patients randomized to additional pre-operative MSCT.
The MSCT will take 5-10 minutes. In theory, CT is associated with radiation
exposure with a concomitant small risk of radiation-induced malignancy. In this
study, only low-dose contrast-enhanced CT of the total aorta will be used,
which results in a very low radiation risk. Since contrast will be used,
patients with renal failure will be excluded from participation in this study.
The patients receiving a preoperative CT-scan will have to be informed about
all incidental findings found on the CT-scan.
A possible disadvantage is found in the additional costs of a CT-scan, but the
costs associated with stroke would outweigh the costs of a preoperative
CT-scan.
All patients will receive a DW-MRI before discharge. Contra-indications for MRI
include pacemaker wires or implantable cardioverter defibrillators (ICDs),
metallic implants, cochlear/ear implants, Swan-Ganz catheter, claustrophobia
and contrast allergy.
In addition to the investigations and visits that are already part of the
standard preoperative work-up, all patients will be asked to fill out a
questionnaire at baseline and within 30 days postoperatively. Since this will
soon be implemented as part of standard care, the latter is not seen as extra
burden for the patients.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
- Primary symptomatic severe aortic valve stenosis (defined as an aortic valve
area of <1.0cm2 and either a mean valve gradient of at least 40mmHg or a peak
velocity of at least 4.0 m/s)
- Accepted for SAVR (either planned to be done by a limited access approach
(partial J-shaped sternotomy or right anterior thoracotomy or conventional
median sternotomy approach at the preference of the patient and/or the
discretion of the surgeon) with or without concomitant CABG by the Heart Team
- Informed consent
Exclusion criteria
- Previous aortic valve replacement
- Emergency procedure
- Pregnant women
- Patient unwilling to be informed about unrequested findings on the CT-scan or
MRI-scan
- Contra-indication for MRI
- Patient who did not agree to the informed consent and/or refused to
participate
- Patient unable to understand the informed consent/study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77700.100.21 |