None listed
Conditions
Brief summary
Aortic stenosis(AS) is the most common valvular condition with an increasing prevalence in an ever-ageing population. Historically, the only treatment was surgical valve replacement, but transcatheter aortic valve replacement(TAVR) has emerged as the treatment of choice for those patients at high or intermediate surgical risk. Coronary artery disease(CAD) is common in patients with AS. But the assessment of CAD severity is challenging as our usual physiological tools are not reliable in this group. One of their problems is that they do not assess coronary microcirculation, which is altered in severe AS. A potential solution would be to measure absolute coronary flow to better understand the microcirculation and lead to more reliable estimates. This project seeks to validate absolute flow in patients with severe AS using a novel catheter, Rayflow(Hexacath, France), that measures coronary flow using thermodilution. Once validated, we would then ascertain if this can translate into routine practice with serial measurements pre and post TAVR.
Interventions
Study setting: This project will take place at MonashHeart, Monash Health. MonashHeart is a high volume transcatheter aortic valve replacement (TAVR) centre in Victoria and is an established academic cardiothoracic centre. MonashHeart is acknowledged as a leading site for research into coronary physiology and cardiac CT. Annually, over 200 aortic valve implantations (both TAVR and SAVR) and >3000 cardiac CTs are carried out at MonashHeart making recruitment targets achievable. Patient recruitment: Patients who are due to undergo aortic valve replacement, either TAVR or SAVR are referred for an invasive diagnostic coronary angiography as part of their routine clinical care and pre-procedural assessment. Potential participants will be identified from referrals to the Structural Heart Disease Service or from referring Cardiology Clinics based at the MonashHeart and Monash Health. For detailed inclusion and exclusion criteria, please refer to step 5: Key Inclusion criteria and Step 5: Key Exclusion criteria. Consent: Potential participants will be identified at the point of referral to the Structural Heart disease service, or other cardiac clinics. They will be provided with the Participant Information and Consent form (PICF) ahead of the coronary angiogram with ample opportunity to discuss the study with members of the research team. They will be informed of the voluntary nature of participation. Consenting will take place before the invasive coronary angiogram, which occurs as part of their routine clinical care. Cardiac catheterisation protocol: When the patients will present for their diagnostic angiogram, which is part of the standard clinical work-up prior to aortic valve intervention, we will assess the coronary physiology and the absolute coronary flow using a pressure and temperature sensing guide wire (Pressure Wire X, Abbott, USA) and RayFlow monorail catheter (Hexacath, France). The left main coronary artery will be engaged using a guiding catheter and a guidewire equipped with a pressure a temperature sensor (Pressure Wire X, Abbott, IL) is advanced into the left anterior descending artery (LAD). Resting and hyperaemic indices of coronary physiology are measured using intravenous adenosine infusion to achieve maximal hyperemia. A dedicated monorail catheter (Rayflow, Hexacath, Paris, France) is then advanced over the guidewire into the proximal segment of the LAD. A continuous infusion of normal saline is then infused through this catheter at rates of 15, 20, 25 and 30ml/min to produce a hyperaemic state. The absolute coronary flow measurements are recorded at the different flow rates. The measurements will be repeated in upto three arteries. Obtaining these measurements will add an additional 15minutes to the overall diagnostic angiogram. A member of the study team will oversee that the protocol is adhered to for all measurements. This will help understand the significance of concomitant coronary artery disease, which in turn will help guide future management strategies of the coronary artery disease.
Sponsors
Study design
Eligibility
Inclusion criteria
1) Age greater than or equal to 18yrs and less than or equal to 95yr old. 2) Able to provide informed, written consent. 3) Patients with no more that 30% visual stenosis in at least one coronary artery at time of coronary angiography. 4) Patients presenting for a diagnostic angiogram for severe symptomatic aortic stenosis (mean gradient >=40mmHg or Vmax >=4m/s or DI <=0.25 on screening transthoracic echocardiogram
Exclusion criteria
1) Left ventricular ejection fraction <=30% 2) Chronic renal impairment, as defined by estimated glomerular filtration rate <=30ml.min/1,73m2. 3) Resting bradycardia, heart rate <=40 beats/min. 4) Myocardial infarction within last three months. 5) Previous coronary artery bypass surgery 6) Unfavourable coronary anatomy that would prohibit safe guidewire passage. 7) Women of childbearing age. 8) Low flow low gradient aortic stenosis. 9) History of asthma precluding use of adenosine. 10) Persistent atrial fibrillation. 11) Prior PCI to target vessel.