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ECHONOMY
Tools for Echocardiographic Calculations

Muhamed Saric, MD, PhD
New York University
 

CoreValve


CoreValve Trial in a Nutshell

Trial details at ClinicalTrials.gov

DATELINE: US CoreValve trial is schedule to be completed around the middle of 2012.

HIGH RISK ARM: The trial contains a “high risk” arm, defined as an estimated surgical mortality risk of 15%, in which patients are randomized 1:1 against standard surgical AV replacement.

EXTREME RISK ARM: There is also an “extreme risk” registry for patients whose estimated surgical mortality is > 50%. All “extreme risk” patients receive the stent valve. This group, however, must be considered likely to live at least one year, but might be wheel chair bound, excessively frail or have porcelain aorta for example.

INCLUSION CRITERIA: All patients must be symptomatic from severe AS defined as an AV area < 0.8 cm2 AND a mean AV gradient >40 mm Hg.

EXCLUSION CRITERIA: Major exclusion criteria are prior heart valve replacement, LVEF < 20%, creatinine clearance < 20 or dialysis, and severe dementia.
 
PRE-ENROLLMENT CATH + ECHO + CT: Prior to enrollment patients must have a cardiac cath to exclude the need for revascularization, an echo to confirm severe AS and abdominal and chest CT scans with contrast to define relevant anatomy related to valve delivery.
 

Inclusion Criteria

 

Valve Area Mean Gradient

Peak Velocity

1. Severe Aortic Stenosis < 0 .8 cm2
(< 0.5 cm2/m2)
> 40 mm Hg

> 4 m/sec

2. Trileaflet Aortic Valve      
3. Annulus Diameter (AD)  

2.0 cm < AD < 2.7 cm

 

Note for annular measurements: Go into the calcification
: 1.0 mm on each side  on TTE
: 0.5 mm  on each side on TEE
 

Exclusion Criteria

 

Exclusion Values  
1. Valvular Regurgitation Severe AI, MR or TR  
2. Valvular Stenosis

Moderate or Severe MS

 
3. Low LVEF

LVEF < 20%

 
4. Narrow LVOT

Basal septal hypertrophy with
LVOT obstruction

 
4. Dilated Asc Aorta

Asc aorta > 4.3 cm

 
     

Timing of Echo Studies

bulletPRE PROCEDURE
bulletScreeining echo
 
bulletPERI PROCEDURE
bulletIntraprocedure and before discharge
 
bulletPOST PROCEDURE
bulletMonths 1, 6 and 12
bulletYears 2, 3, 4, 5
 
bulletPerform all aortic valve measurements in MID SYSTOLE.

Reference

Courtesy of Dr. James Slater, Director, Cath Lab, NYU.

CoreValve literature provided by Medtronic, the maker of CoreValve