To evaluate the immediate impact of TAVI or TMVr on a battery of coronary (non-) hyperemic physiology tests in patient with severe aortic valve stenosis or functional/degenerative mitral regurgitation and at least intermediate coronary artery…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in the FFR value before and after transcatheter left-sided valvular
intervention (i.e. TAVI or TMVR).
Secondary outcome
The change in
• RFR;
• Pd/Pa;
• CFR;
• IMR;
• dPR;
• transvalvular gradient;
• LVEDP;
• Systemic aortic pressure;
• Heart rate;
before and after transcatheter valvular intervention (either TAVI or TMVR).
Differences in changes in the physiology indices mentioned above between the
TAVI cohort and the TMVR cohort.
The number of patients in who the post FFR, RFR, Pd/Pa or dPR value crosses the
border of hemodynamic significance as compared to the value pre-valvular
intervention.
The number of patients in whom the decision for coronary revascularization is
changed when based on the post-procedural FFR value instead of angiographic
stenosis severity.
The diagnostic performance of a new physiological index that is corrected for
the hemodynamic changes induced by either aortic stenosis or mitral
regurgitation.
(i.e. sensitivity, specificity, agreement, positive predictive value, negative
predictive value, area under the curve of the receiver operating curve).
The diagnostic performance of vFFR in the setting of valvular heart disease.
The vFFR pre-intervention will be validated against the FFR-value both pre- and
post-intervention (i.e. sensitivity, specificity, agreement, positive
predictive value, negative predictive value, area under the curve of the
receiver operating curve).
Background summary
Patients who undergo transcatheter aortic valve implantation (TAVI) or
transcatheter mitral edge-to-edge valve repair (TMVr) often have concomitant
coronary artery disease. Fractional Flow Reserve (FFR) guided percutaneous
coronary intervention (PCI) has proven its superiority over angiography-guided
PCI in patients with stable angina, but has not been validated in patients with
valvular heart disease. Valvular heart disease induces a number of changes in
myocardial mass and intracardiac pressures that may affect coronary flow
patterns. Coronary physiology in general and epicardial and microvascular flow
in the context of left sided valve disease is only partially understood and its
clinical applicability is so far unsettled. Previous studies have found
contradictory results comparing hyperemic and non-hyperemic pressure ratios
pre- and post-TAVI, whereas no studies have been performed to evaluate the
effect of TMVr on physiological indices. The purpose of the present study is to
provide a comprehensive overview of physiological and hemodynamic changes after
transcatheter left-sided valvular treatment and unravel coronary physiology
patterns that may help promote the adoption of physiology-guided PCI in
patients with valvular heart disease.
Study objective
To evaluate the immediate impact of TAVI or TMVr on a battery of coronary
(non-) hyperemic physiology tests in patient with severe aortic valve stenosis
or functional/degenerative mitral regurgitation and at least intermediate
coronary artery disease.
Study design
Prospective, single-arm, observational study with invasive measurements in two
cohorts (TAVI cohort and TMVr cohort). Coronary physiological measurements in
the coronary artery of interest directly before and after the valvular
intervention. A pressure wire will be advanced distal to the lesion of interest
and Pd/Pa, RFR and CFR will be measured under resting circumstances, and FFR,
CFR and IMR will be measured during maximal hyperaemia.
Study burden and risks
Coronary physiological measurements are part of the standard practice in our
coronary catheterization laboratory. The burden of participation in this study
is limited to selective catheterization of the right and/or left coronary
artery and the navigation of a pressure wire down to assess coronary physiology
under hyperemic and non-hyperemic conditions before and after the valve
intervention. This implies a prolonged procedural time of approximately 15
minutes per procedure. The invasive physiological measurements carry a small
additional risk of 0.09% (this includes conduction disturbances, bronchospasm,
ventricular arrhythmia, thrombus formation) on top of the standard risks of
transcatheter valve treatment. The majority of these cases are relatively easy
to solve and almost never have lasting harmful consequences. The induction of
maximum hyperaemia might lead to mild complaints (chest discomfort and dyspnea)
in up to 30% of patients. These complaints are brief and self-limiting after
discontinuation of intravenous adenosine. Of note, patients receiving TMVr will
not experience these side-effects because the procedure takes place under
general anaesthesia. Benefits for patients participating in this study might
include adequate hemodynamic assessment of intermediate coronary lesions which
might result in 1) deferral of angiographically severe coronary lesions with
post-valvular intervention FFR > 0.80 and 2) revascularization of coronary
lesions with diameter stenosis < 70% but post-valvular intervention FFR <=
0.80.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 18.
2. a. TAVI Cohort: severe aortic valve stenosis for which TAVI is scheduled
after discussion in the Heart Team.
b. TVMR Cohort: severe functional mitral regurgitation for which TVMR
is scheduled after discussion in the Heart Team.
3. At least intermediate coronary artery disease, defined as 50 - 99% DS in a
vessel >=2.5 mm.
4. Elective procedure.
5. Written informed consent.
Exclusion criteria
1. TAVI cohort: height coronary ostia < 10 mm.
2. Severe chronic kindey disease, defined as estimated glomerular filtration
rate < 30 ml/min.
3. Contra-indication for intravenous adenosine (severe asthma or chronic
obstructive pulmonary disease, known allergy to adenosine or precious reported
bronchospasm in response to adenosine).
4. Degenerated surgical or transcatheter aortic valve bioprosthesis.
5. Vessels that have collaterals to a chronic total occlusion or that are
supplied by an arterial or venous bypass graft will not be interrogated in this
study.
Design
Recruitment
Medical products/devices used
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 | NL75310.078.20 |