Aortic Stenosis, Calcific Clinical Trial
Official title:
Accuracy of Using 2D Transesophageal Echocardiography Compared to Balloon Sizing in Determining Valve Size During Transcatheter Aortic Valve Implantation
The method of transcatheter aortic valve implantation (TAVI) introduced in 2002 by Alain
Cribier et al. has offered new prospects for patients with severe aortic stenosis and
multiple comorbidities, who are at high operative risk(1).
The PARTNER series of randomized controlled trials has firmly established the role of TAVI
with the balloon-expandable Edwards Sapien valve in patients with severe symptomatic aortic
stenosis (AS) at prohibitive risk of surgery (PARTNER IA), high risk for surgery (PARTNER
IB), and intermediate risk for surgery (PARTNER 2).(2)
Also PARTNER 3 and Evolut Low Risk trial strongly suggest that TAVI is not only a suitable
alternative and may be superior to surgical aortic valve replacement ( SAVR) in low-risk
patients.(2)
The accurate determination of the size of the implant is dependent on pre-procedural imaging.
Annular measurements are important in the TAVI as inaccurate estimation can lead to
complications e.g paravalvular leakage .(3) Transthoracic echocardiography (TTE),
transoesophageal echocardiography (TOE), multidetector computed tomography (MDCT) and
magnetic resonance imaging (MRI) have been extensively studied with respect to pre-procedural
aortic annular sizing.(3).
However, even with some of the evidence returning a discrepancy in annular measurements
between techniques, the literature to date does not clarify whether TOE undersizes
inappropriately or appropriately with respect to MDCT.(3) In a recent study, 29.5% of
patients would have been deemed ineligible for TAVI because of overestimation of annular
measurements by MDCT, a figure reduced to 1.3% with the use of TOE (4)
In a recent small retrospective study, TOE, MDCT and MRI all performed comparatively well
with device sizing. (5)
Balloon aortic valvuloplasty (BAV) dilatation before TAVI is considered a mandatory
procedural step in the early years of TAVR. BAV is used to confirm annular sizing and to
enhance trans-catheter heart valve (THV) deliverability.(6) However till now there is no
comparison of annular measurement by 2D transesophgeal echocardiography with balloon sizing.
Aim of work To compare accuracy of 2D transesophageal echocardiography versus balloon sizing
in determining size of device during transcatheter aortic valve implantation and inhospital
outcomes of this approach using 2D TEE and balloon sizing only during TAVI .
Patients and methods. The study will include (100) patients, prospective observational study
All patient will undergo :
1-Written consent. 2-Detailed history including symptoms (NYHA class) ,co morbidities
3-Clinical examination 4-Electrocardiogram (detection of conduction disturbance , ischemic
changes). 5-Laboratory investigation (hemoglobin level, creatinine, glomerular filteration
rate(GFR)) 6-Risk stratification: using STS score 6- Transthoracic Echocardiography: (7)
1-Assesment of aortic valve by
1. Mean and maximum pressure gradiant (severe AS if mean pressure >40mmhg and maximum
pressure >64mmhg) in presence of normal ejection fraction (EF).
2. Aortic valve area by continuity equation (severe AS if < 1cm2).
3. Measurement of aortic valve annulus (in parasternal long axis view) .
4. Assesment of associated aortic regurge (8) :
-Regurge jet width/LVOT width (mild <25%,moderate 25-65%, severe >65%)
- Vena contracta (VC) (mild <0.3cm, moderate 0.3-0.6cm, severe >0.6cm)
- Regurge volume (RV) (mild <30ml, moderate 30-60ml, severe >60ml).
- Regurge fraction (RF) (mild <30%, moderate 30-50% and severe > 50%).
- Effective regurgitant orifice area (EROA) (mild <0.1 cm, moderate 0.1-0.29cm and
severe ≥0.3cm) 2- Assesment of EF (by M-mode and simpsons method). 3-Assesment of
other valves .
7-Transesophegeal Echocardiography.(9):
1. Morphology of valve (tricuspid, bicuspid , unicuspid).
2. Measurement of aortic valve area (AVA) by planimetry.
3. Extent, distribution and location of Calcification. (annular calcification
symmetrical or asymmetrical, sinuotubular junction , subvalvular
calcification)
4. Measurement of aortic annulus dimension, LVOT, sinus of valsalva, sinotubular
junction and ascending aorta dimensions.
Determinations of 2D TEE aortic annular and LVOT diameters were performed in the
3-chamber long-axis view at approximately the 120◦ angle during early systole . The
aortic annular diameter was measured from the junction of the aortic leaflet with the
septal endocardium to the junction of the leaflet with the mitral valve posteriorly,
using the inner edge to inner edge. The LVOT diameter was obtained 5 mm into the LVOT
from the level of the annulus.(10) Calculation of a cover index: defined as a 100 x
(prosthesis diameter - transoesophageal echocardiography annulus diameter)/prosthesis
diameter. (11).
6- Aortic atheroma: The Katz classification for grading aortic atheromas is as follows:
Grade 1, normal-appearing intima of the aorta; Grade 2, extensive intimal thickening;
Grade 3, sessile atheroma protruding <5 mm into the aorta; Grade 4, sessile atheroma
protruding >5 mm; and Grade 5, mobile atheroma.(12) 7-Associated basal septal
hypertrophy . 8-Assesment of associated aortic regurge. 8-Pre-TAVI workup in cardiac
catheterization laboratory:
1. Access route evaluation: assess peripheral vasculature for size, tortuosity,
calcification -Iliofemoral angiography: A 5F metric (graded) pigtail is used for
calibration and accurate determination of vessel calibre and minimal lumen
diameter. The pigtail is placed at the lumber 4/5 level, which approximates a
position just proximal to the common iliac bifurcation with injection of 15-20mls
contrast at 20mls/sec.
-Iliofemoral diameter: determined by Sheath-to-iliofemoral artery ratio (SIFAR) was
defined as sheath outer diameter divided by access-side vasculature diameter.
-Iliofemoral calcification: Calcification can be evaluated on fluoroscopy and
graded as: none, mild (spotty), moderate (coalescing), severe (bulky, protruding,
horse-shoe, circumferential ). Iliofemoral tortuosity : determined by tortuosity
score which is defined as follows: 0 = no tortuosity; 1 = mild tortuosity (30° to
60°); 2 = moderate tortuosity (60° to 90°); and 3 = marked tortuosity (>90°).(13)
-Subclavian or axillary angiography if femoral axis is unsuitable.
2. Diagnostic coronary angiography: for assessment of presence and severity of
coronary artery disease.
3. Aortogram: is done to asses for angle between LVOT and ascending aorta , distance
of coronary vessels from annulus and presence of aortic regurge.
- 5F graded pigtail is placed into the non-coronary cusp (NCC) and an aortogram
performed (20mls contrast at 20mls/sec). Fluoroscopic projection of RAO 30◦
and LAO 30◦.
4. Aortic valve cross over: to demonstrate feasibility of crossing valve.
5. Hemodynamic assessment: assess invasive transaortic gradiant with simultaneous
pressure transduction.
- Pigtail will be crossed into the LV cavity, simultaneous measurement of
pressures from the LV and femoral artery can be obtained. Use of a 5F pigtail
enables simultaneous pressures to be transduced from the 6F femoral artery
sheath without the need for a second arterial sheath.
6. Left ventriculogram: assess EF by eyeballing (mild 40-50%,moderate 30-40% and
severe <30%) and presence of MR according to seller criteria described later on.
Left ventriculography is done using 25ml contrast at rate 10ml/second in both RAO
30◦ and LAO 60◦
7. Right heart catheterization: assess pulmonary artery (PA) pressure, Pulmonary
capillary wedge pressure (PCWP).
TAVI procedure:
The detailed steps of procedure are reported by Nijhoff F,etal. TAVI is performed
through transfemoral or transapical approach, based on the feasibility of the
iliofemoral anatomy and suitable access sites. All procedures are performed in a fully
equipped hybrid cardiac catheterization laboratory. Surgical cutdown is used to close
the vascular access site at the femoral arteries.
Fluoroscopy is used to guide the deployment of the valves and prosthesis positioning.
Both predilatation of the native valve and prosthetic valve implantation are performed
during rapid right ventricular pacing (160 to 200 beats/min). Prosthesis position,
function, and coronary ostia patency are assessed with fluoroscopy and aortography .
-Balloon sizing: An appropriately sized valvuloplasty balloon is choiced .The initial
volume of inflation is set to obtain a balloon size of 1 mm less than the TEE
measurement. The balloon is positioned across the aortic valve through femoral sheath
and inflated with the same volume during rapid ventricular pacing, using a 30 cc
inflation syringe.
At full inflation, an aortography is performed. The following parameters are recorded:
(I) presence of a waist on the balloon at the level of the annulus, (II) intra-balloon
pressure, (III) patency of the coronary artery ostia and their relations with the
displaced aortic valve cusps, (IV) presence and entity of aortic regurgitation on
aortography at full balloon inflation ("para-balloon leak"). In the absence of a waist
on the balloon and/or in case of major para-balloon leak, the procedure is repeated with
a larger diameter balloon (larger balloon or same balloon inflated with a larger volume
of contrast media).
Assesment of inhospital outcomes after TAVI procedure:
1- paravalvular leakage : Assessment of paravalvular leakage
1-Angiographic evaluation of paravalvular leakage :
Ten minutes after the deployment of the prosthetic valve, angiography of the aortic root
is performed to assess the severity of aortic regurgitation according to Sellers
criteria (14):
(0) no regurgitation.
1. only trace of contrast could be seen in the left ventricle, and it is cleared in
each systole.
2. contrast filling the entire LV in diastole with less density compared with
opacification of the ascending aorta.
3. contrast filling the entire LV in diastole equal in density to the contrast
opacification of the ascending aorta.
4. contrast filling of the entire LV in diastole on the first beat with greater
density compared with the contrast opacification of the ascending aorta.
Two observers independently score the images. In case of discrepancy the images will be
re-evaluated and consensus will be reached by a third observer. .
2-Transthoracic Echocardiographic study:
All patients will be evaluated after TAVI by pre-discharge transthoracic
echocardiography. The extent of PVL is assessed according to the main VARC criteria
(15):
1. Semiquantitative parameters
1. Diastolic flow reversal in the descending aorta-pulsed wave : mild (Absent or
brief) ,moderate ( early diastolic Intermediate), severe (Prominent holodiastolic)
2. Circumferential extent of prosthetic valve paravalvular regurgitation:
(0) no regurgitation; (1) mild PVL is defined as<10 % circumferential extent; (2)
moderate PVL was defined as [>10 % but<30 % of PVL and (3) severe PVL is defined as >30
% according to the updated VARC guideline , that is the circumferential extent of PVL in
a parasternal short-axis view (19).
2. Quantitative parameters:
1. Regurgitant volume (ml/beat) mild (<30) , moderate (30-59) ,severe (>60).
2. Regurgitant fraction (%) mild (< 30), moderate (30-49 ) ,severe (>50).
3. Effective regurgitant orifice area (cm2) mild (<0.10) ,moderate (0.10-0.29) ,
severe (>0.30).
2-Other complication results from inaccurate annular sizing : prosthesis embolization,
annular rupture, aortic dissection, coronary artery occlusion , conduction defects.
3-Assesment of other complication ,vascular site complication, bleeding, stroke and
mortality.
Statistical analysis:
The collected data will be tabulated and statistically analyzed and will be shown in
tables and figures.
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