The preDIlatation in tRanscathEter aortiC Valve implanTation Trial (DIRECT)

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring transcatheter aortic valve implantation, Balloon aortic valvuloplasty, Aortic stenosis, TAVI, TAVR (transcatheter aortic valve replacement), CoreValve, BAV, Evolut R Read More

Inclusion Criteria:

1. Diameter of >5mm for Evolut R and >6mm for CoreValve of the vessel.
2. Aortic valve diameter of ≥20mm and ≤29mm as measured by echo.
3. Ascending aorta diameter ≤ 43mm at the sinotubular junction.
4. Severe aortic stenosis, defined as aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2) by the continuity equation, AND mean gradient > 40 mmHg or maximal aortic valve velocity > 4.0 m/sec by resting echocardiogram.

5. STS score of ≥ 8 OR LogEuroSCORE> 20%, OR

   • 80 years old OR

   • 65 years old with 1 or 2 (but not more than two) from the following criteria:

     • Liver cirrhosis (Class A or B).
     • Pulmonary insufficiency: VMS<1 liter.
     • Previous heart surgery (CABG, vascular surgery).
     • Porcelain aorta.
     • Pulmonary artery systolic pressure >60 mmHg and high risk for heart surgery.
     • Relapsing pulmonary embolism.
     • Right ventricular insufficiency.
     • Thoracic wall injuries that contraindicate an open heart surgery.
     • History of radiation therapy of the mediastinum.
     • Connective tissue disease that contraindicates an open heart surgery.
     • Frailty/cachexia.
6. Patients will be informed on the nature of the study and provide written consent.

Exclusion Criteria:

1. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin or heparin and bivalirudin, ticlopidine and clopidogrel, nitinol (titanium or nickel), contrast media
2. Ongoing sepsis, including active endocarditis.
3. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to Heart Team assessment.
4. Echocardiographic evidence of LV or LA thrombus.
5. Mitral or tricuspid valve insufficiency (> grade II).
6. Previous aortic valve replacement (mechanical or bioprosthetic).
7. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).

8. Patients with:

   Femoral, iliac or aortic vascular disease (stenosis etc) that precludes the insertion of a transcatheter sheath.

   OR Symptomatic carotid or vertebral artery disease (> 70% stenosis).

9. The patient has a bleeding diathesis, coagulopathy or denies blood transfusion.
10. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
11. Creatinine clearance < 20 ml/min.
12. Active gastritis or ulcer.
13. Pregnancy.
14. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%.
15. Unicuspid or bicuspid aortic valve.
16. Mixed aortic valve disease (aortic stenosis and aortic regurgitation> 2+).
17. Liver failure (Child-Pugh class C).
18. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
19. Extreme aortic valve calcification and calcific asymmetry (if semiquantitively measured: grade 4, Agatston score: grade 4 AgS>5000 AU).
20. Aortic valve area of < 0.4 cm2.