Procedure

Transfemoral transcatheter aortic valve

implantation using the balloon expandable
SAPIEN transcatheter heart valve device

Summary

Transcatheter alternatives to standard aortic valve

replacement have been developed to reduce the
anticipated mortality and morbidity of therapy in
patients in whom the risk of conventional surgery for
critical aortic stenosis is considered to be too high.
Patient selection, multidisciplinary approach and
trained physicians are fundamental for the success of
the procedure.

Introduction

Aortic stenosis is the most frequent acquired heart

valve disease requiring hospitalization in Europe.
Although surgery provides excellent and durable
results in most patients, advanced age and
comorbidities may lead to an increased risk for
surgery. Moreover, conservative treatment of aortic
stenosis carries a grave prognosis. Therefore,
alternative, minimally invasive techniques need to be
further developed to treat these very high-risk
patients. We describe here an overview of the
technique of implantation of a percutaneous balloon
expandable aortic valve: the SAPIEN transcatheter
heart valve (THV) (Edwards Lifesciences Inc., CA –
MMCTSLink 173).

Patient selection
Potential candidates to transcatheter aortic valve
implantation (TAVI) are mainly high-risk and elderly
symptomatic patients with severe aortic stenosis. At
present, the use of TAVI in young patients, at low
surgical risk, patients with long life expectancy, and in
asymptomatic patients is strongly discouraged
because of the uncertainty regarding long-term
durability and clinical results compared to surgery.
Patients with life expectancy shorter than one year
should also not be considered for TAVI. Surgical risk
should be assessed by a combination of scores and by
clinical judgment. To be considered for TAVI using the
SAPIEN THV transfemoral approach, annular diameter
of the native valve should be between 18 mm and
24 mm, and the iliac vessel anatomy should be
favorable for introduction of the given delivery
system.

Surgical technique

The SAPIEN THV valves and delivery systems

The SAPIEN THV valve (Edwards Lifesciences Inc.,
CA, USA) consists of three bovine pericardial leaflets
mounted within a tubular stainless-steel, balloon-
expandable stent. It is available in 23 and 26 mm
sizes (Photo 1).
 Photo 1 The SAPIEN THV valve
(courtesy of Edwards Lifesciences Inc.,
CA, USA) alone and mounted on a
balloon (MMCTSLink 173).

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The valve is associated to a retrograde transfemoral

delivery system (steerable guide catheter, called
Retroflex, Photo 2) available in two sizes, according to
the valve size, requiring either a 22F or a 24F
introducer sheath. The valve is preserved in
glutaraldehyde, and is crimped on the balloon at the
time of the implant to preserve the function of the
pericardial leaflets.

Photo 2 The Retroflex catheter (courtesy of

Edwards Lifesciences Inc., CA, USA).

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Screening process
Selection of patients is the most critical step of the
procedure. It includes: confirmation of severity of
aortic stenosis (by means of Doppler
echocardiography, or rarely by catheterization, Photo
3), analysis of aortic valve and root anatomy (by a
combination of angiography, echocardiography and
MDCT scanning, Photo 4) and analysis of iliofemoral
access (by angiography and MDCT, Photo 5). Annular
diameter has to be precisely determined, to avoid
valve embolization and perivalvular leakage. Annular
diameter is measured by transesophageal,
transthoracic echocardiography and by MDCT (Photo
6). Iliofemoral anatomy is analyzed by angiography
and/or MDCT scanning to determine size (Photo 7),
presence of calcifications (Photo 8) and tortuosity
(Photo 9).

Photo 3 Cath lab and echocardiographic

calculation of aortic gradient.

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 Photo 4 Echocardiographic imaging of aortic
stenosis.

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Photo 5 MDCT imaging 3D reconstruction of iliac

artery.

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 Photo 6 MDCT imaging for calculation of the
dimension of the aortic annulus.

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Photo 7 MDCT imaging for calculation of the

diameter of iliac/femoral arteries.

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 Photo 8 MDCT imaging for arterial
calcification.

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Photo 9 Angiographic imaging for calculation

of the diameter of iliac/femoral arteries.

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Performance and logistic set-up

The implant should be performed in a well equipped
suite. Ideally the implant should be done in a hybrid
OR with state-of-the-art radiologic equipment and
sterility standards, with a radiotransparent operating
table, which allows either a complete percutaneous or
a surgical approach. The screening process,
periprocedural management as well as the implant
involves a multidisciplinary team including a surgeon,
an interventional cardiologist and an anesthesiologist.
The implant requires at least three expert operators
acting as a team. In addition, another team takes care
of the preparation of the prosthesis (crimping and
assembling of the delivery system). Scrub nurses,
perfusionist and vascular surgeons are on call. Heart
lung machine is in stand-by. Percutaneous fem-fem
bypass system is ready available, as well as the
surgical armamentarium to proceed to bailout
surgery. The procedure is usually performed under
general anesthesia. Central venous catheterization is
used to monitor central venous pressure and to
administer i.v. therapy under the complete
responsibility of the anesthesiologist. An
echocardiography machine is in the room and TEE or
TTE is used to monitor valve and ventricular function
throughout the procedure.

Prepping and draping: the patient is in supine position

on the radiotransparent table. A warming blanket is
used to maintain the physiologic temperature.
Electrodes and defibrillator pads are positioned in the
chest having taken care not to have them in the
midline.

After anesthesia induction the lower abdominal,

inguinal and upper legs regions are prepped and
draped with surgical standards. A long drape is used
as it is standard for interventional procedures.

Diagnostic arterious access: the femoral artery

controlateral to the access planned for the
introduction of the delivery system is punctured and a
6F sheath is introduced (Video 1).

Video 1 Controlateral arterial puncture and

sheath introduction.

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video

A pigtail is positioned in the abdominal aorta, just

above the bifurcation to obtain an iliofemoral
angiography of the controlateral side (Video 2).

Video 2 Pigtail introduction.

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A mosquito is positioned in the skin at the intended

location of the puncture as reference (Video 3). The
pigtail is then connected to the pressure line for
continuous arterial pressure monitoring.
 Video 3 Angiographic indication for the
arterial puncture.

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video

Femoral vein access: omolateral to the diagnostic

access, the femoral vein is punctured and a 7F sheath
is introduced. The vein access is used either for right
catheterization and for positioning the temporary lead
for rapid pacing (Video 4).

Video 4 Venous puncture.

Click on image to view video

Therapy arterial access: according to preoperative

imaging (CT scan and/or angiograms), the best
iliofemoral access is chosen to position the delivery
system. Percutaneous puncture is usually preferred.
Alternatively, the access could be surgically prepared.
Femoral puncture is performed using the usual
landmarks, and the angiographic guidance. A perfect
stick is mandatory because of the large profile of the
delivery system. A standard diagnostic J 0.035
guidewire is inserted and a 14F long (24 cm) sheath is
inserted in the artery. Heparin is administered (Video
5).

Video 5 Fluoro-assisted puncture.

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Valve crossing: a standard diagnostic J wire is

introduced in the ascending aorta to carry an Amplatz
(AL1) guide-catheter in the ascending aorta. The J
wire is exchanged for a straight tip 0.035 guidewire to
cross the aortic valve. Once the valve is crossed, the
AL1 is advanced in the ventricle and the wire is
exchanged with an Amplatz extrastiff 0.035 inches,
260 cm length guidewire (Video 6).

Video 6 Crossing the aortic valve with

Amplatz extrastiff wire.

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video
Pacing test: the temporary pacing lead is positioned
in the right ventricle and output and sensing
thresholds are tested at low rate (Video 7).

Video 7 Introducing the ventricular lead for

stimulation.

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video

A rapid pacing test is performed. Pacing rate is

usually around 200 bpm, to obtain a mean pressure
below 50 mmHg and a pulse pressure lower than
10 mmHg. During rapid pacing the defibrillator is
charged and ready to shock.

Balloon aortic valvuloplasty: the valve package is

opened. On a separate side table, the valve and the
delivery system are assembled (Video 8).

Video 8 Preparing the balloon on the side

table.
 Click on image to view
video

The valve is rinsed in saline. A 20x30 mm (for the 23

valve implantation) or a 23x30 mm (for the 26 valve
implantation) balloon is advanced over the wire across
the aortic valve. The balloon is deaired and indeflators
are used filled with a 10% contrast media solution.
Balloon valvuloplasty is used to enlarge the valve and
allow easier passage of the delivery system, but also
to rehearse the procedural steps of the valve delivery.
An appropriate angiographic projection is chosen in
line with the plane of the annulus. In most occasions
this is around LAO20°/CRAN20°. Angiography tests
are used to fine adjustments. This step is critical for
reliable delivery of the prosthesis. The midpoint of the
balloon is then positioned at the annular level. The
first operator is the only one allowed to talk. He
delivers the commands in this sequence: ‘PACE’ the
operator responsible for pacing starts pacing; once
pressure is low and ejection is abolished (Video 9),
the first operator commands ‘INFLATE’, the second
operator rapidly inflates the balloon. Calcium shifting
is observed during the inflation. In case of doubts,
before balloon deflation the operator may command
‘CHECK’ and the technician/nurse will inject contrast
from the pigtail. Once the balloon is fully expanded
the operator commands ‘DEFLATE’. Only when the
balloon is fully deflated the operator commands ‘STOP
PACING’. If the balloon inflation has been suboptimal
(balloon escape, residual neck on the balloon), the
procedure is repeated after a period of recovery. The
balloon is removed, leaving the guidewire in place
(Videos 10 and 11).
 Video 9 Lowering of blood pressure during
rapid cardiac pacing.

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video

Video 10 Introduction of a 14 Fr sheath and

the balloon for valvuloplasty.

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video

Video 11 Angiographic image of

valvuloplasty.

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video
Access preparation: the 14F sheath is removed,
leaving the wire in place. The femoral artery is
progressively dilated under fluoroscopic guidance with
a set of dilators (16F, 18F, 20F, 22F...) (Video 12).

Video 12 Introduction of crescent diameter

sheaths.

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video

In the meanwhile the valve is crimped on the balloon,

and the orientation of the valve is checked by the first
operator (Videos 13 and 14).

Video 13 Preparation of the balloon on the

side table.

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video
 Video 14 Valve crimping.

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The introducer sheath (22F for the 23 mm valve and

24F for the 26 mm valve) is then positioned and
secured at the skin with a stay suture to avoid any
displacement. The dilator is left in place until the
valve is ready to be implanted to avoid kinking of the
introducer sheath. ACT is checked (Video 15).

Video 15 Introduction of the sheath for the

valve delivery.

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video

Retroflex delivery system introduction: The retroflex

catheter and the valve crimped over the balloon
system are advanced in the introducer using a
presenter to avoid displacement of the prosthesis
while crossing the sheath sealing valve (Videos 16 and
17).
 Video 16 Introduction of the delivery system
into the sheath.

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video

Video 17 Progression of the retroflex

catheter.

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video

The catheter is advanced under fluoroscopic guidance.

At this time it is still possible to check again the
orientation of the valve, since the distal (upper)
portion of the stent is more radiopaque. The retroflex
catheter is steerable, and this property could be used
to purchase difficult aortic anatomy and reach the
aortic arch.

Retroflex positioning and crossing of the native valve:

at the isthmus, using an LAO projection, the retroflex
is partially steered to safely cross the arch avoiding
scratching the outer curvature (Video 18).
 Video 18 Angiographic progression of the
retroflex catheter.

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video

Once in proximity to the valve, the catheter is fully

steered to get the maximum curvature and gain a
central and coaxial orientation to the native valve. The
native valve is crossed and the retroflex catheter is
retracted to fully expose the balloon.

Delivery of the valve: the angiographic view in line

with the annulus is again obtained. Prosthesis position
relative to the native leaflet is checked with
angiographic checks. A final check is done during
rapid pacing to observe the position in a stable
condition prior to the definitive deployment. The
midportion of the prosthesis is positioned at the level
of the bottom line of the angiographic root. Two-thirds
of the valve should stay in the ventricle at this time.

The pigtail is pulled back to avoid jailing in the

prosthesis. First operator commands ‘PACE’, the
pacing operator starts pacing and pressure drops, first
operator commands ‘CHECK’ and a root shot is given,
the first operator commands ‘INFLATE’, the second
operator inflates forcefully using the indeflator
system; after full deployment of the valve the
operator commands ‘DEFLATE’ and once the balloon is
completely deflated he commands ‘STOP PACING’
(Videos 19 and 20).

Video 19 Valve expansion.

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Video 20 Correct positioning.

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Evaluation of the implant: the balloon is pulled back

in the ascending aorta, maintaining the guidewire
across the valve. The need for additional inflation is
ruled out, otherwise the guidewire is pulled back and
the final result of the valve implant is assessed by a
full root angiogram (Video 21), by a transaortic
gradient measurement (Graph 1) and by TEE or TTE
(Photo 10).
 Video 21 Angiographic control.

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Graph 1 Post procedural mean hemodynamic

transaortic gradient.

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Photo 10 Echocardiographic transthoracic mean

aortic gradient assessment.

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Delivery system retrieval and access closure: the
retroflex catheter is fully released to abolish any curve
and it is removed. A crossover wire from the
controlateral of the therapeutic access site provides a
safety removal of the introducer sheath, especially
when small peripheral or diseased vessels may
suspect some vascular troubles. A peripheral balloon
should be advanced into the therapeutic site, usually
into the origin of the commune iliac artery and then
the introducer sheath is pulled back until the tip is at
the level of the distal external iliac artery. A control
angiogram is performed through the side arm of the
long armed sheath, positioned at the Carrefour. The
introducer sheath is completely removed and the
access is closed either surgically or percutaneously. A
final angiogram of the access is done. The pacing
leads are removed and the sheaths left in place for at
least 12 h. Patient is either weaned from anesthesia
or transferred to the intensive or intermediate care
unit.

Results
Top
Summary
Introduction
Surgical technique
Results
Discussion
References
Initial published data on procedural mortality and
morbidity have demonstrated acceptable preliminary
results in a high-risk environment. Webb et al. [3]
published their TAVI experience on 50 symptomatic
patients with severe aortic stenosis. Valve
implantation was successful in 86% of patients.
Intraprocedural mortality was 2%. Discharge home
occurred at a median of five days (interquartile range,
4–13). Mortality at 30 days was 12% in patients in
whom the logistic European System for Cardiac
Operative Risk Evaluation risk score was 28%. With
experience, procedural success increased from 76% in
the first 25 patients to 96% in the second 25
(P=0.10), and 30-day mortality fell from 16 to 8%
(P=0.67). Mild paravalvular regurgitation was
common but was well tolerated. After valve insertion,
there was a significant improvement in left ventricular
ejection fraction (P<0.0001), mitral regurgitation
(P=0.01), and functional class (P<0.0001).
Improvement was maintained at one year. Structural
valve deterioration was not observed with a median
follow-up of 359 days.

Discussion
Top
Summary
Introduction
Surgical technique
Results
Discussion
References
TAVI is a new technology. Self-expanding and balloon
expanding valves are currently implanted in Europe.
At the moment TAVI are performed only in selected
centers with a multidisciplinary approach. Their role in
the management of aortic stenosis is evolving.
Initially TAVI was only performed in end-stage
patients. Today TAVI is performed also in high-risk
patients. Before TAVI being proposed for current
surgical candidates, safety efficacy and durability of
the implants have to be determined on a large scale.

Footnotes

1
Consultant for Edwards Lifesciences LLC.

References
Top
Summary
Introduction
Surgical technique
Results
Discussion
References
1. Iung B, Baron G, Butchart EG, Delahaye F,
Gohlke-Bärwolf C, Levang OW, Tornos P,
Vanoverschelde JL, Vermeer F, Boersma E,
Ravaud P, Vahanian A. A prospective survey of
patients with valvular heart disease in Europe:
the Euro Heart Survey on Valvular Heart Disease.
Eur Heart J 2003;24:1231–1243.
[Abstract/Free Full Text]

2. Varadarajan P, Kapoor N, Bansal RC, Pai RG.

Clinical profile and natural history of 453
nonsurgically managed patients with severe
aortic stenosis. Ann Thorac Surg 2006;82:2111–
2115.[Abstract/Free Full Text]

3. Webb JG, Pasupati S, Humphries K, Thompson C,

Altwegg L, Moss R, Sinhal A, Carere RG, Munt B,
Ricci D, Ye J, Cheung A, Lichtenstein SV.
Percutaneous transarterial aortic valve
replacement in selected high-risk patients with
aortic stenosis. Circulation 2007;116:755–763.
[Abstract/Free Full Text]

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