Professional Documents
Culture Documents
Introduction
REVIEWS
Key points
Transcatheter aortic valve implantation (TAVI) represents a less-invasive strategy
than surgical aortic valve replacement (SAVR) for the treatment of severe
symptomatic aortic stenosis
The transfemoral approach is usually the first option for TAVI; transapical,
subclavian, axillary, and transaortic routes are alternative approaches
TAVI is currently the treatment of choice for patients not considered to be
candidates for SAVR, and a proven alternative for those considered to be at high
surgical risk
Transcatheter valves are associated with excellent hemodynamic results, usually
with concomitant improvements in the patients functional status and quality of
life; however, minor residual aortic regurgitation occurs in many patients
Periprocedural stroke, vascular and conduction disturbance complications,
occurrence of moderate or severe paravalvular aortic regurgitation, relatively high
midterm mortality, and valve durability beyond 3year follow-up are unresolved
issues in TAVI
The valve-in-valve treatment of surgical prosthesis dysfunction and the
treatment of intermediate-risk patients are two of the most-important fields for
the development of TAVI in the near future
Pre-TAVI work-up
REVIEWS
Although surgical cut-down was the technique used for
the transfemoral approach at the beginning of the TAVI
experience, most centers are now using a fully percutaneous technique for this approach. This strategy makes it
possible to avoid the use of general anesthesia, especially
if the procedure is performed without transesophageal
echocardiographic guidance.
Transapical approach
The transapical approach (Figure3b) was first reported
as an alternative to the transfemoral approach in 2006by
Litchenstein and colleagues, 7 who used the CribierEdwards valve system. The approach requires a small
left lateral thoracotomy and a direct puncture of the left
ventricular apex. A 24French (for the 23mm and 26mm
valves) or 26French (for the 29mm valve) sheath is used
to advance the Edwards SAPIEN XT valve, and implanta
tion is performed in a similar way to that used with the
transfemoral approach (see the next section on valve
placement). In the era when larger catheters (22French)
were used for the transfemoral approach, about half of the
TAVI procedures with the Cribier-Edwards and Edwards
SAPIEN valves were performed using the transapical
approach;19,20 this percentage is expected to decrease with
the use of smaller (18French) catheters. First-in-human
CoreValve implantation by the transapical approach has
been reported,34 but this approach has not been further
developed for this valve system.
Potential advantages of the transapical approach
include the avoidance of using large catheters though
the iliofemoral system, aortic arch, ascending aorta,
and aortic valve; improved coaxility of the valve prosthesis within the aortic annulus, which can be especially
helpful in cases of horizontal aorta;35 and the possibility
of obtaining very accurate transesophageal echocardiographic images for valve positioning, which might lead
to a reduction in the amount of contrast used during the
procedures.35 The main disadvantages are the need for
a thoracotomy; a greater degree of myocardial injury,
owing to the apical perforation of the left ventricle;36 and
the potentially life-threatening bleeding complications
associated with the surgical repair of the apex.
Transaortic approach
In 2009 and 2010, the use of the transaortic approach
through a small right or mid sternotomy (Figure3c) was
proposed as an alternative approach with the Corevalve
and Edwards systems.3739 Although requiring sternotomy,
this approach avoids the use of large catheters through the
iliofemoral system and aortic arch, and avoids puncture
of the ventricular apex.
Subclavian approach
The left subclavian approach (Figure3d) has emerged
as an alternative to the transfemoral approach with the
CoreValve system.40,41 A surgical cut-down is needed
to isolate the subclavian artery (usually the left vessel).
The very short distance between the vascular access and
the native aortic valve might be associated with better
control of the CoreValve prosthesis during positioning
Medical treatment
Surgical aortic
valve replacement
Coronary angiography
Transthoracic/transesophageal echocardiogram
CT
CT angiography and/or iliofemoral angiography
Iliofemoral axis >6 mm (Edwards SAPIEN XT20 mm, 23 mm or CoreValve26 mm, 29 mm, 31 mm)
Iliofemoral axis >6.5 mm (Edwards SAPIEN XT 26 mm)
Iliofemoral axis >7 mm (Edwards SAPIEN XT 29 mm)
Absence of significant peripheral vascular disease
Absense of severe iliofemoral calcification
Yes
Transfemoral approach using the
Edwards SAPIEN XT or CoreValve systems
No
Transapical approach using the
Edwards SAPIEN XT system
or
Subclavian-axillary approach using the
CoreValve system with
axilo-subclavian axis >6 mm
and/or >7 mm with patent LIMA graft
or
Transaortic approach using the
Edwards SAPIEN XT or CoreValve systems
Figure 2 | Pre-procedural work-up in patients with severe aortic stenosis who are
candidates for a TAVI procedure with the Edwards SAPIEN XT(Edwards Lifesciences
Corporation, Irvine, CA, USA) valve or CoreValve(Medtronic CV Luxembourg S.a.r.l.,
Luxembourg) systems. Abbreviations: CT, computed tomography; LIMA, left internal
mammary artery; TAVI, transcatheter aortic valve implantation.
Transaxillary approach
First-in-human CoreValve implantation by the trans
axillary approach (Figure3e) has been reported.42 Like
the subclavian approach, a surgical cut-down is performed to isolate the left axillary artery, and the sheath
and delivery catheters are advanced through the axillary
artery. The potential advantage of this approach versus
the subclavian approach is that any injury to the axillary
artery could be easily repaired with no major clinical
consequences, as compared with the potentially lifethreatening consequences of a subclavian-artery injury.
Indeed, and unlike in iliofemoral vessels, occlusion of
the axillary artery would be compensated by the col
lateral circulation between the thyrocervical trunk of the
subclavian artery and the subscapular artery.
Valve placement
REVIEWS
a
Figure 3 | Approaches used for transcatheter aortic valve implantation. a | The transfemoral approach. The delivery
catheter for implantation of the valve prosthesis is advanced through the right or left femoral arteries. b | The transapical
approach. After left lateral minithoracotomy (usually between the fifth and sixth intercostal spaces), the delivery catheter
for implantation of the valve prosthesis is advanced through the left ventricular apex. c | The transaortic approach. After
right or mid ministernotomy, the delivery catheter for implantation of the valve prosthesis is advanced directly through the
ascending aorta. d | The subclavian approach. The delivery catheter for implantation of the valve prosthesis is advanced
through the subclavian artery (usually the left vessel). e | The transaxillary approach. The delivery catheter for implantation
of the valve prosthesis is advanced through the axillary artery (usually the left vessel).
Mortality
In the aforementioned multicenter registries and series,
mortality was systematically <10% in patients treated
using the transfemoral approach and ranged from
11.3% to 16.9% in patients treated using the transapical approach, probably owing to the higher risk profile
of the patients treated via the latter route.1926 At 1year
follow-up, the survival rates were ~80% (7585%) for
the transfemoral approach and ~70% (6378%) for the
transapical approach.
www.nature.com/nrcardio
REVIEWS
In the nonoperable cohort of the PARTNER trial,27
the 30-day mortality was 5.0% in the TAVI group (trans
femoral approach in all patients) and 2.8% in the medical
treatment group (P=0.41). Importantly, up to 84% of
the patients in the medical treatment group had at least
one procedure of balloon aortic valvuloplasty during the
study period. At 1year follow-up, mortality was 30.7%
in the TAVI group, compared with 50.7% in the medical
treatment group (P<0.0001).
In the high-risk PARTNER trial cohort,28 30-day mortal
ity was 3.4% in the TAVI group, compared with 6.5% in
the SAVR group (P=0.07). Mortality at the 1year followup was 24.2% and 26.8% in the TAVI and SAVR groups,
respectively (P=0.44). In patients eligible for the trans
femoral approach, mortality at the 30-day and 1year
follow-ups in the TAVI group were 3.3% and 22.2%, respectively, and 6.2% and 26.4% in the SAVR group (P=0.13 for
30-day mortality, P=0.29 for 1year mortality). In patients
ineligible for the transfemoral approach, mortality at the
30-day and 1year follow-ups was 3.8% and 29%, respectively, in the TAVI group (using the transapical approach)
and 7.0% and 27.9% in the SAVR group (P=0.32 for 30-day
mortality, P=0.85 for 1year mortality).
Very few data on the long-term results associated
with TAVI procedures exist. Gurvitch etal. reported a
survival rate of 51% at 3year follow-up in 88 patients
who had undergone TAVI with the balloon-expandable
Cribier-Edwards or Edwards SAPIEN valves.44 Among
the patients who survived the TAVI procedure, the survival rates were 74% and 61% at the 2year and 3year
follow-ups, respectively. Buellesfeld etal. reported a
survival rate of 72% at 2year follow-up after TAVI with
the CoreValve system.45 The patients included in these
studies represent the initial TAVI experience and the use of
very early versions of the transcatheter valve and delivery
catheter systems, which, together with the learning-curve
phenomenon, has probably had a negative influence on the
results. Indeed, in the past few years, 1year survival rates
from some registries have been reported to be 80%,1926
and we can expect better survival rates at the 2year and
3year follow-ups in the coming years. Importantly, no
structural failures of the transcatheter valves have been
seen in studies with a follow-up of more than 1year.44,45
The baseline and procedural factors associated with
poorer outcomes after TAVI are shown in Table2.
In summary, baseline cardiovascular factors (low
left ventricular ejection fraction [LVEF], pulmonary
hypertension, and severe mitral regurgitation) and periprocedural complications (low cardiac output, major
vascular complications, cardiac tamponade, conversion
to open heart surgery, acute kidney injury, stroke, and
moderate-to-severe residual aortic regurgitation) seem
to have a major role in acute mortality and in mortality
occurring during the 1year follow-up period.19,22,26,4651
Generally, noncardiac comorbidities, such as chronic
obstructive pulmonary disease, chronic kidney disease,
and liver disease, are important predictors of mortality
during the follow-up period, rather than of acute mortality.19,22,26,4651 Indeed, studies have shown that most deaths
occurring late after TAVI are of noncardiac origin,19,48,52
REVIEWS
Table 1 | Findings from the large multicenter TAVI registries, series, and randomized controlled trial
Study, n
Approach
Valve type
Canadian,19
n=339
TF in 162;
TA in 177
SOURCE,20
n=1,038
MeanSD, or
median (IQR),
Logistic Euro
SCORE (%)
Procedural
success
(%)
30-day
mortality
(%)
Major
vascular
complica
tions (%)
Stroke (%)
Hemodialysis
(%)
Permanent
pacemaker
(%)
1-year
survival
(%)
CribierAll: 27.716.3;
Edwards
TF: 25.814.9;
in 57;
TA: 29.417.2
SAPIEN
in 275;
SAPIENXT
in 7
All: 93.3;
TF: 90.5;
TA: 96.1
All: 10.4;
TF: 9.5;
TA: 11.3
All: 13;
TF: 13.1;
TA: 13.0
All: 2.3;
TF: 3.0;
TA: 1.7
All: 2.6;
TF: 1.8;
TA: 3.4
All: 4.9;
TF: 3.6;
TA: 6.2
All: 76;
TF: 75;
TA: 78
TF in 463;
TA in 575
SAPIEN
TF: 25.714.5;
TA: 29.116.3
All: 93.8;
TF: 95.2;
TA: 92.7
All: 8.5;
TF: 6.3;
TA: 10.3
All: 7.0;
TF: 10.6;
TA: 2.4
All: 2.5;
TF: 2.4;
TA: 2.6
All: 4.3;
TF: 1.3;
TA: 7.1
All: 7.0;
TF: 6.7;
TA: 7.3
All: 76.1;
TF: 81.1;
TA: 72.1
European,21
n=646
TF in 646
CoreValve
TF: 23.113.8
TF: 97.2
TF: 8.0
TF: 1.9
TF: 1.9
N/A
TF: 9.3
N/A
Italian,22
n=663
TF in 599;
SC in 64
CoreValve
All: 23.013.7
All: 98.0
All: 5.4
All: 2.0
All: 1.2
N/A
All: 16.6
All: 85
France,23
n=244
TF with
SAPIEN
in 95;
TA with
SAPIEN
in 71;
TF with
CoreValve
in 66;
SC with
CoreValve
in 12
SAPIEN
in 166;
CoreValve
in 78
All: 25.611.4;
TF with
SAPIEN:
25.611.3;
TA with
SAPIEN:
26.811.6;
TF with
CoreValve:
24.711.2;
SC with
CoreValve:
24.614.5
All: 98.3
All: 12.7;
TF with
SAPIEN:
8.4;
TA with
SAPIEN:
16.9;
TF with
CoreValve:
15.1;
SC with
CoreValve:
8.3
All: 7.3;
TF with
SAPIEN:
6.3;
TA with
SAPIEN:
5.6;
TF with
CoreValve:
7.5;
SC with
CoreValve:
8.3
All: 3.6;
TF with
SAPIEN:
4.2;
TA with
SAPIEN:
2.8;
TF with
CoreValve:
4.5;
SC with
CoreValve:
0
All: 1.6;
TF with
SAPIEN:
1.0;
TA with
SAPIEN:
2.8;
TF with
CoreValve:
1.5;
SC with
CoreValve:
0
All: 11.8;
TF with
SAPIEN:
5.3;
TA with
SAPIEN:
5.6;
TF with
CoreValve:
25.7;
SC with
CoreValve:
25.0
N/A
German,24
n=697
TF in 644;
SC in 22;
TA in 26;
TAo in 5
SAPIEN
in 109;
CoreValve
in 588
All: 20.513.2
All: 98.4
All: 12.4
All: 19.5
All: 2.8
N/A
All: 39.3;
SAPIEN:
22.0;
CoreValve:
42.5
N/A
Belgian,25
n=328
TF or TA
with
SAPIENin
187;
TF with
CoreValve
in 141
SAPIEN
in 187;
CoreValve
in 141
All: 2816;
SAPIEN:
3016;
CoreValve:
2515
All: 97.0;
SAPIEN:
97.0;
CoreValve:
98.0
All: 11.0;
SAPIEN:
12.0;
CoreValve:
11.0
N/A
All: 5.0;
SAPIEN:
5.0;
CoreValve:
4.0
All: 6;
SAPIEN:
6;
CoreValve:
7
All: 13;
SAPIEN: 5;
CoreValve:
22
TF with
SAPIEN:
82;
TA with
SAPIEN:
63;
TF with
CoreValve:
79
UK,26 n=870
TF in 599;
Other
approaches
in 271
SAPIEN
in 410;
CoreValve
in 452
All: 18.5
(11.7, 27.9);
TF: 17.1
(11, 25.5);
Other routes:
21.4
(14.4, 33.6);
CoreValve:
18.1
(11.1, 27.9);
SAPIEN: 18.5
(12.4, 27.7)
All: 97.2;
TF: 97.3;
Other
routes:
97.1;
CoreValve:
98.2;
SAPIEN:
98.1
All: 7.1;
TF: 5.5;
Other
routes:
10.7;
CoreValve:
5.8;
SAPIEN:
8.5
All: 6.3;
TF: 8.4;
Other
routes:
1.9;
CoreValve:
6.2;
SAPIEN:
6.3
All: 4.1;
TF: 4.0;
Other
routes:
4.1;
CoreValve:
4.0;
SAPIEN:
4.2
N/A
All: 16.3;
CoreValve:
24.4;
SAPIEN:
7.4
All: 78.6;
TF: 81.5;
Other
routes:
72.3;
CoreValve:
78.3;
SAPIEN:
79.4
PARTNER
non-operable
cohort,27
n=179
TF in 179
SAPIEN
TF: 26.417.2
TF: 98.8
TF: 5.0
TF: 16.2
TF: 6.7
TF: 1.1
TF: 3.4
TF: 69.3
PARTNER
high-risk
cohort,28
n=348
TF in 244;
TA in 104
SAPIEN
All: 29.316.5
N/A
All: 3.4;
TF: 3.3;
TA: 3.8
All: 11.0
All: 4.6
All: 2.9
All: 3.8
All: 75.8;
TF: 77.8;
TA: 71
Edwards Lifesciences Corporation (Irvine, CA, USA) is the manufacturer and registered trademark owner of the Cribier-Edwards, SAPIEN, and SAPIEN XTvalves. Medtronic Inc. (Minnesota, MN, USA)
manufactures the CoreValve, which is a registered trademark of Medtronic CV Luxembourg S.a.r.l., Luxembourg. Abbreviations: IQR, interquartile range; N/A, data not available; SC, subclavian; TA,
transapical; TAo, transaortic; TAVI, transcatheter aortic valve implantation; TF, transfemoral.
www.nature.com/nrcardio
2011 Macmillan Publishers Limited. All rights reserved
REVIEWS
Table 2 | Factors predictive of 30-day and 1year mortality after trancatheter aortic valve implantation
Predictive factor
Study, n
Mortality period
OR or HR
for mortality
95% CI
1year
1year
1year
1.75
2.9
1.41
1.092.83
1.27.1
1.001.98
1year
1year
1year
30days
1year
30days to 1year
2.30
2.09
1.44
5.9
3.9
2.53
1.383.84
1.343.26
1.051.98
1.424.8
1.69.5
1.016.35
30days
1year
2.66
2.45
1.265.65
1.195.07
BMI <20kg/m2
30days
6.60
1.4829.5
Prior stroke
30days
30days to 1year
4.41
5.47
1.1616.8
1.4720.39
1year
1year
0.07
0.48
0.010.43
0.300.76
Liver disease
1year
1year
2.47
2.89
1.045.85
1.515.53
Dyslipidemia
1year
0.61
0.390.95
Systemic hypertension
1year
0.53
0.350.82
Smoking
Thomas etal.,
n=463 for TF
1year
2.42
1.513.90
Coagulopathy
1year
5.09
1.4917.39
30days
3.51
1.627.62
1year
1.49
1.032.16
Pulmonary hypertension
30day
1year
1year
1year
2.09
1.88
3.1
3.21
1.024.43
1.173.0
1.37.6
1.198.71
1year
30days
4.6
10.1
1.119.9
2.1174.8
30days
2.87
1.246.65
30days
1year
3.01
4.62
1.098.24
1.6612.87
1year
30days to 1year
2.75
2.70
1.325.72
1.096.68
30days
30days
1year
30days
1year
4.14
4.9
5.9
5.47
2.79
1.4212.13
1.220.4
2.414.5
1.2324.21
1.365.71
49
48
19
Periprocedural complications
Acute kidney injury
30days
1year
6.84
2.58
2.0422.93
1.116.0
30days
38.68
2.86522.59
Cardiac tamponade
Tamburino etal.,
n=663
30days
10.97
1.5975.61
30days
8.47
1.6742.82
Procedural stroke
1year
15.76
3.2775.90
30days to 1year
30days
1year
3.79
2.43
1.66
1.579.10
1.224.85
1.102.51
22
22
REVIEWS
document represents an important step forward in
providing consistency across studies and in contributing
to a more-appropriate evaluation of TAVI technology.
Another important consideration when reviewing the
findings of TAVI studies is that, in all published multi
center TAVI registries and series, except SOURCE, 20
data was captured without source verification, and
nodata-monitoring or event-adjudication committee
was established for the validation of clinical events.
Major vascular complications
The use of large sheaths (1824French) in a very old
(usually octogenarian) population has led to a high rate
(>5% to 10% in most series) of major vascular complica
tions during TAVI procedures.428 Accurate evaluation
of the iliofemoral arteries before the procedure (see
Figure2), and the use of alternatives to the transfemoral
approach in borderline cases, seem to have a major role
in avoiding such complications.61,62 The use of smaller
catheters might also have a substantial impact on therate
of vascular complications (complication rate for the
CoreValve system: <5% with 18French sheaths versus
>20% with 24French sheaths).1618,21,22 Finally, appropriate
vascular access with true anterior entry in a disease-free
segment of the common femoral artery is also important.
This access can be achieved using echocardiographically
guided Seldinger puncture, although this puncture technique is used in only a few centers. Alternatively, puncture
can be guided by advancing a catheter into the femoral
artery via the contralateral sitea widespread practice,
but one that does not appropriately depict a disease-free
area of the femoral artery or guarantee a true anterior
entry during the puncture of the artery.
Importantly, the occurrence of major vascular complica
tions has been shown to be an independent predictor of
30-day mortality.22,61 The TAVI team should be able to treat
these complications rapidly and appropriately or have some
back-up with experienced peripheral interventionalists
or vascular surgeons.
In the past, surgical cut-down and vascular repair were
used in most transfemoral TAVI cases performed with
22French catheters, but most centers are now using
percutaneous closure devices such as Prostar or Perclose
(both Abbott Vascular Inc, Red City, CA, USA) in transfemoral cases performed with 18French catheters.6366
Despite the promising preliminary results obtained with
the use of these percutaneous closure devices, more data
are needed to determine the safety and efficacy of these
devices in patients undergoing TAVIprocedures.
Stroke
The occurrence of cerebrovascular events is one of the
most-worrisome complications of TAVI. The 30-day
stroke rate was ~3.5% (ranging from 1.2% to 6.7%) in
the multicenter registries and series and the PARTNER
trial.1928 In the high-risk cohort of the PARTNER trial,
the stroke rate tended to be higher in the TAVI group than
in the SAVR group at 30days (4.6% versus 2.4%, P=0.12)
and at the 1year follow-up (6.0% versus 3.2%, P=0.08).28
The nonoperable cohort of the PARTNER trial also
22 | JANUARY 2012 | VOLUME 9
REVIEWS
2.4
60
50
2.0
47 17
1.61 0.40*
1.6
1.50 0.36*
40
1.2
30
20
0.8
0.60 0.14
10
10 4*
0.4
10 4*
0.0
Baseline
Discharge
1-year follow-up
P = 0.007
(TAVI vs SAVR-ST and SAVR-SL)
P = NS
60
50
50
Patients with severe PPM (%)
Myocardial infarction
TAVI has been associated with a variable rate of myo
cardial infarction, ranging from 0% to 16.3%.428 This variability is probably related to the lack of uniformity in the
definition of periprocedural myocardial infarction among
the various TAVI studies. The VARC definition for periprocedural myocardial infarction is the occurrence of new
symptoms or signs of ischemia associated with an elevation of cardiac biomarkers (preferably creatine kinaseMB)
at least 10 times the upper normal limit or at least 5 times
the upper normal limit with new pathological Q waves.60
However, one study has shown that some degree of myocardial injury occurs in most TAVI procedures, and a
higher degree of myocardial injury was associated with
a reduced LVEF recovery and increased cardiac mortality
at midterm follow-up.36
a 70
40
TAVI
33
32
30
SAVR-ST
31
SAVR-SL
27
20
13
9
10
0
1618
(n = 18)
1920
(n = 66)
2122
(n = 48)
2325
(n = 18)
c 100
Moderate
Patients with aortic regurgitation (%)
Mild
80
46
42
Trivial
None
60
40
26
38
20
22
12
0
At discharge
At 1-year follow-up
REVIEWS
50
TAVI (n = 41)
SAVR (n = 120)
LVEF (%)
45
= 14 15%
= 7 11%
40
35
30
0
Baseline
Discharge
At 1-year follow-up
REVIEWS
Table 3 | Main characteristics of emerging transcatheter valves
Valve type
Valve
material
Stent
material
Valve
size
(mm)
Delivery catheter
size (French)
Approach
Mechanism
of expansion
Repositionable?
Year of
first-inhuman
study
Bovine
pericardium
No stent
(polyester
fabric cuff)
23, 25
18
Transfemoral
or subclavian
Inflation of
ring balloons
by a polymer
Yes
2006
Porcine
pericardium
Nitinol
21, 23
18
Transfemoral
Selfexpandable
Yes
2009
Bovine
pericardium
Stainless
steel
20, 22,
24, 26,
28
Transapical
Balloon
expandable
No
2008
JenaValve(JenaValve Technology,
Munich, Germany)130
Porcine
native aortic
valve leaflets
Nitinol
23, 25,
27
32
Transapical
Selfexpandable
Yes
2009
Porcine
pericardium
Nitinol
23,25
18
Transfemoral
Selfexpandable
Yes
2011
Bovine
pericardium
Nitinol
23, 27
18
Transfemoral
Selfexpandable
Yes
2007
Porcine
native aortic
valve leaflets
Nitinol
23, 25,
27
28
Transapical
Selfexpandable
Yes
2009
Bovine
pericardium
Nitinol
23, 26
28
Transapical
Selfexpandable
Yes
2008
REVIEWS
a
Figure 7 | Images of emerging transcatheter valve technology (valves with first-in-man data). a | Direct Flow Medical
(Direct Flow Medical, Santa Rosa, CA, USA) valve. Permission obtained from Direct Flow Medical. b | HLT (Heart Leaflet
Technologies, Maple Grove, MN, USA) valve. 2011 HLT, Inc. a Bracco Group Co. c | Innovare (Braile Biomedical, So Jos
do Rio Preto, Brazil) valve. Courtesy of Diego Gaia, Federal University of So Paulo, Brazil. d | JenaValve(JenaValve
Technology, Munich, Germany). Permission obtained from JenaValve Technology. e | Portico(St-Jude Medical, St Paul, MN,
USA) valve. f| SadraLotus Medical (Boston Scientific SciMed Inc, Maple Grove, MN, USA) valve. 2011 Boston Scientific
Corporation or its affiliates. All rights reserved. Used with permission of Boston Scientific Corporation. g | Symetis
Accurate (Symetis SA, Lausanne, Switzerland) valve. Permission obtained from Symetis. h | Engager(Medtronic Inc.,
Minneapolis, MN, USA) valve. 2010 Medtronic, Inc. Image provided by Medtronic, Inc.
Conclusions
REVIEWS
Transcatheter valve hemodynamics are excellent, and
even superior to those achieved with surgically implanted
valves, but residual paravalvular aortic regurgitation
(moderate in 517% of cases) remains an issue that
should be addressed in the near future. Preliminary
data on long-term outcomes, valve-in-valve procedures
for the treatment of surgical valve dysfunction, and the
treatment of lower-risk patients have been promising, but
further studies are needed to confirm these results. These
studies might result in the expansion of TAVI to the treatment of a much broader spectrum of patients with severe
aorticstenosis.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
Review criteria
The MEDLINE and PubMed databases were searched for
primary research articles focusing on transcatheter aortic
valve implantation published between 1990 and 2011.
The search terms used were transcatheter aortic valve
implantation/replacement, percutaneous aortic valve
implantation/replacement, transfemoral aortic valve
implantation/replacement, transapical aortic valve
implantation/replacement, alone and in combination. All
papers identified were English-language full-text papers.
We also searched the reference lists of identified articles
for further relevant papers.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
REVIEWS
39. Bapat, V., Thomas, M., Hancock, J. & Wilson, K.
First successful trans-catheter aortic valve
implantation through ascending aorta using
Edwards SAPIEN THV system. Eur. J. Cardiothorac.
Surg. 38, 811813 (2010).
40. Ruge, H. etal. First successful aortic valve
implantation with the CoreValve ReValving
system via right subclavian artery access: a case
report. Heart Surg. Forum 11, 323324 (2008).
41. Petronio, A.S. etal. Safety and efficacy of the
subclavian approach for transcatheter aortic
valve implantation with the CoreValve revalving
system. Circ. Cardiovasc. Interv. 3, 359366
(2010).
42. De Robertis, F. etal. The left axillary artery
a new approach for transcatheter aortic valve
implantation. Eur. J. Cardiothorac. Surg. 36,
807812 (2009).
43. Grube, E. etal. Feasibility of transcatheter aortic
valve implantation without pre-dilation: a pilot
study. JACC Cardiovasc. Intervent. 4, 751757
(2011).
44. Gurvitch, R. etal. Transcatheter aortic valve
implantation. Durability of clinical and
hemodynamic outcomes beyond 3years
in a large patient cohort. Circulation 122,
13191327 (2010).
45. Buellesfeld, L. etal. 2year follow-up of patients
undergoing transcatheter aortic valve
implantation using a self-expandable valve
prosthesis. J. Am. Coll. Cardiol. 57, 16501657
(2011).
46. Nuis, R.J. etal. Frequency, determinants, and
prognostic effects of acute kidney injury and red
blood cell transfusion in patients undergoing
transcatheter aortic valve implantation. Catheter.
Cardiovasc. Interv. 77, 8819 (2011).
47. Sinning, J.M. etal. Renal function as predictor
of mortality in patients after percutaneous
transcatheter aortic valve implantation. JACC
Cardiovasc. Interv. 3, 11411149 (2010).
48. Thomas, M. etal. One-year outcomes of cohort 1
in the Edwards SAPIEN Aortic Bioprosthesis
European Outcome (SOURCE) registry: the
European registry of transcatheter aortic valve
implantation using the Edwards SAPIEN valve.
Circulation 124, 425433 (2011).
49. Wenaweser, P. etal. Clinical outcome and
predictors for adverse events after transcatheter
aortic valve implantation with the use of different
devices and routes. Am. Heart J. 161,
11141124 (2011).
50. Dewey, T.M. etal. Effect of concomitant coronary
artery disease on procedural and late outcomes
of transcatheter aortic valve implantation. Ann.
Thorac. Surg. 89, 758767 (2010).
51. Abdel-Wahab, M. etal. Aortic regurgitation after
transcatheter aortic valve implantation:
incidence and early outcome. Results from the
German transcatheter aortic valve interventions
registry. Heart 97, 899906 (2011).
52. Webb, J.G. etal. Transcatheter aortic valve
implantation. Impact on clinical and valve-related
outcomes. Circulation 119, 30093016 (2009).
53. Bagur, R. etal. Acute kidney injury following
transcatheter aortic valve implantation:
predictive factors, prognostic value, and
comparison with surgical aortic valve
replacement. Eur. Heart J. 31, 865874 (2010).
54. Ranucci, M. etal. Surgical and transcatheter
aortic valve procedures. The limits of risk scores.
Interact. Cardiovasc. Thorac. Surg. 11, 138141
(2010).
55. Dewey, T.M. etal. Reliability of risk algorithms
in predicting early and late operative outcomes
in high-risk patients undergoing aortic valve
replacement. J.Thorac. Cardiovasc. Surg. 135,
180187 (2008).
www.nature.com/nrcardio
2011 Macmillan Publishers Limited. All rights reserved
REVIEWS
implantation with the CoreValve prosthesis.
Am.Heart J. 159, 497503 (2010).
91. Fraccaro, C. etal. Incidence, predictors, and
outcome of conduction disorders after
transcatheter self-expandable aortic valve
implantation. Am. J. Cardiol. 107, 747754 (2011).
92. Khawaja, M.Z. etal. Permanent pacemaker
insertion after CoreValve transcatheter aortic
valve implantation: incidence and contributing
factors (the UK CoreValve collaborative).
Circulation 123, 951960 (2011).
93. Haworth, P. etal. Predictors for permanent pacing
after transcatheter aortic valve implantation.
Catheter. Cardiovasc. Interv. 76, 751756 (2010).
94. Roten, L. etal. Incidence and predictors of
atrioventricular conduction impairment after
transcatheter aortic valve implantation.
Am. J. Cardiol. 106, 14731480 (2010).
95. Clavel, M.A. etal. Comparison of the
hemodynamic performance of percutaneous
and surgical bioprostheses for the treatment
of severe aortic stenosis. J. Am. Coll. Cardiol.
53, 18831891 (2009).
96. Zegdi, R. etal. Is it reasonable to treat all
calcified stenotic aortic valves with a valved
stent? Results from a human anatomic study in
adults. J. Am. Coll. Cardiol. 51, 579584 (2009).
97. Schultz, C.J. etal. Geometry and degree of
apposition of the CoreValve Revalving system
with multislice computed tomography after
implantation in patients with aortic stenosis.
J.Am. Coll. Cardiol. 54, 911918 (2009).
98. Clavel, M.A. etal. Validation and characterization
of transcatheter aortic valve effective orifice area
measured by Doppler-echocardiography. JACC
Cardiovasc. Imaging 4, 10531062 (2011).
99. Kalavrouziotis, D. etal. Transcatheter aortic valve
implantation in patients with severe aortic
stenosis and small aortic annulus. J. Am. Coll.
Cardiol. 58, 10161024 (2011).
100. Bauer, F. etal. Acute improvement in global and
regional left ventricular systolic function after
percutaneous heart valve implantation in
patients with symptomatic aortic stenosis.
Circulation 110, 14731476 (2004).
101. Clavel, M.A. etal. Comparison between
transcatheter and surgical prosthetic valve
implantation in patients with severe aortic
stenosis and reduced left ventricular ejection
fraction. Circulation 122, 19281936 (2010).
102. Rods-Cabau, J., Dumont, E. & Doyle, D.
Valveinvalve for the treatment of paravalvular
leaks following transcatheter aortic valve
implantation. Catheter. Cardiovasc. Interv.
74, 11161119 (2009).
103. Ussia, G.P. etal. The valveinvalve technique
for treatment of aortic bioprosthesis malposition:
an analysis of incidence and 1year clinical
outcomes from the Italian CoreValve registry.
J.Am. Coll. Cardiol 57, 10621068 (2011).
104. Latib, A. etal. Post-implantation repositioning
of the CoreValve percutaneous valve. JACC
Cardiovasc. Interv. 3, 119121 (2010).
105. John, D. etal. Correlation of device landing zone
calcification and acute procedural success in
patients undergoing transcatheter aortic valve