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ECHONOMY
Tools for Echocardiographic Calculations
Muhamed Saric, MD, PhD
New York University
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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.
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Inclusion Criteria |
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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 |
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3. Annulus Diameter (AD) |
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2.0 cm < AD < 2.7 cm |
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Note for annular measurements: Go into the calcification
: 1.0 mm on each side on TTE
: 0.5 mm on each side on TEE
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Exclusion Criteria |
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Exclusion Values |
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1. Valvular Regurgitation |
Severe AI, MR or TR |
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2. Valvular Stenosis |
Moderate or Severe MS |
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3. Low LVEF |
LVEF < 20% |
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4. Narrow LVOT |
Basal septal hypertrophy with
LVOT obstruction |
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4. Dilated Asc Aorta |
Asc aorta > 4.3 cm |
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Timing of Echo Studies |
| PRE PROCEDURE
| Screeining echo
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| PERI PROCEDURE
| Intraprocedure and before discharge
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| POST PROCEDURE
| Months 1, 6 and 12 |
| Years 2, 3, 4, 5
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| Perform all aortic valve measurements in MID SYSTOLE. |
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Reference |
Courtesy of Dr. James Slater,
Director, Cath Lab, NYU. CoreValve literature provided by
Medtronic, the maker of CoreValve |
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