The Edwards SAPIEN Transcatheter Heart Valve (THV) is approved for transfemoral and transapical delivery in an adult patient with severe symptomatic native aortic valve stenosis who has been determined by a cardiac surgeon to be inoperable for open surgical aortic valve replacement, and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis.
Patient Inclusion Criteria
- The patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40mmHg or peak systolic aortic valve velocity greater than 4.0 m/s or an initial aortic valve area of <1.0 cm2.
- The patient is symptomatic from his or her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
Patient Exclusion Criteria
- Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified.
- Active bacterial endocarditis or other severe infection.
Patient Evaluation at the High Risk Valve Clinic
Upon referral of a patient to the John Muir Health High Risk Valve Clinic, the Clinic Coordinator will request from the referring physician’s office pertinent available documents and digital images (CD/DVD) including:
- History & physical examination and cardiology consultation (most recent)
- Chest x-ray
- Echocardiogram (most recent transthoracic study and TEE if available)
- CTA with emphasis on aortic root and aorto-iliac runoff, chest, and abdomen with and without contrast (if already done)
- Cardiac catheterization (if already done) including right and left heart hemodynamics (mean aortic valve gradient, cardiac output, calculated aortic valve area), coronary angiography, aortic root angiography (with DynaCT if available) and aorto-iliac angiography
- Carotid duplex
- PFTs with room air ABGs
- Blood work (most recent) including CBC, comprehensive metabolic panel, PT/INR, PTT, type and screen
If any of these tests are not available or do not provide sufficient data for evaluation, they will be performed at JMH in collaboration with the referring physician. The Clinic Coordinator and one of the Transcatheter Aortic Valve Replacement (TAVR) team physicians assigned on a rotational basis will review the initial patient data. A specialized TAVR trans-thoracic echo will be scheduled and performed by a dedicated technician following a standardized protocol to confirm the diagnosis of critical aortic valve stenosis and to obtain all necessary pre-TAVR measurements. The echo is read by one of the two TAVR imaging cardiologists.
If deemed suitable for further evaluation, the patient will be contacted and scheduled for a formal evaluation at the High Risk Valve Clinic. At the clinic appointment, the patient will be seen by the Clinic Coordinator and two of the four implanting TAVR physicians (one interventional cardiologist and one cardiac surgeon) on a rotational basis. A comprehensive consultation will be performed and all available data will be reviewed by both physicians at this visit, which generally lasts two hours. Following this visit, any further testing will be scheduled as needed and in consultation with the referring physician.
TAVR Team Conference
Following completion of the evaluation and any required additional testing, each patient will be presented by the Clinic Coordinator and the evaluating physicians to the entire multi-disciplinary TAVR Physician Panel. Additional consultants will be utilized as appropriate (e.g., radiology review of CTA, nephrology in case of chronic renal insufficiency).
The TAVR Physician Panel, in consultation with the referring physician, will recommend one of the following options: medical treatment, balloon aortic valvuloplasty, high-risk open surgical aortic valve replacement, or TAVR. If the patient is deemed a suitable TAVR candidate, optimization of the patient’s overall clinical status (e.g., resolving any treatable co-morbidities) and any additional necessary diagnostic studies will be completed. If the TAVR Physician Panel recommends one of the other (non-TAVR) treatment options, the patient will be referred back to his or her referring physician with a formal written summary of the findings and treatment recommendations.