Download Preparatory Balloon Aortic Valvuloplasty During Transcatheter Aortic

JACC: CARDIOVASCULAR INTERVENTIONS
VOL. 6, NO. 9, 2013
ª 2013 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
PUBLISHED BY ELSEVIER INC.
ISSN 1936-8798/$36.00
http://dx.doi.org/10.1016/j.jcin.2013.05.006
Preparatory Balloon Aortic Valvuloplasty
During Transcatheter Aortic Valve
Implantation for Improved Valve Sizing
Polykarpos C. Patsalis, MD,* Fadi Al-Rashid, MD,* Till Neumann, MD,* Björn Plicht, MD,*
Heike A. Hildebrandt, MD,* Daniel Wendt, MD,y Matthias Thielmann, MD,y
Heinz G. Jakob, MD,y Gerd Heusch, MD,z Raimund Erbel, MD,* Philipp Kahlert, MD*
Essen, Germany
Objectives This study sought to evaluate whether supra-aortic angiography during preparatory
balloon aortic valvuloplasty (BAV) improves valve sizing.
Background Current recommendations for valve size selection are based on annular measurements
by transesophageal echocardiography and computed tomography, but paravalvular aortic
regurgitation (PAR) is a frequent problem.
Methods Data of 270 consecutive patients with either conventional sizing (group 1, n ¼ 167) or
balloon aortic valvuloplasty–based sizing (group 2, n ¼ 103) were compared. PAR was graded
angiographically and quantitatively using several hemodynamic indices.
Results PAR was observed in 113 patients of group 1 and 41 patients of group 2 (67.7% vs. 39.8%,
p < 0.001). More than mild PAR was found in 24 (14.4%) patients of group 1 and 8 (7.8%) patients of
group 2. According to pre-interventional imaging, 40 (39%) patients had a borderline annulus size,
raising uncertainty regarding valve size selection. Balloon sizing resulted in selection of the bigger
prosthesis in 30 (29%) and the smaller prosthesis in the remaining patients, and only 1 of these 40
patients had more than mild PAR. As predicted by the hemodynamic indices of PAR, mortality at 30
days and 1 year was less in group 2 than in group 1 (5.8% vs. 9%, p ¼ 0.2 and 10.6% vs. 20%, p ¼ 0.01).
Conclusions Preparatory balloon aortic valvuloplasty during transcatheter aortic valve implantation
improves valve size selection, reduces the associated PAR, and increases survival in borderline
cases. (J Am Coll Cardiol Intv 2013;6:965–71) ª 2013 by the American College of Cardiology
Foundation
From the *Department of Cardiology, West German Heart Center Essen, Essen University Hospital, University Duisburg-Essen,
Essen, Germany; yDepartment of Thoracic and Cardiovascular Surgery, West German Heart Center Essen, Essen University
Hospital, University Duisburg-Essen, Essen, Germany; and the zInstitute for Pathophysiology, West German Heart Center Essen,
Essen University Hospital, University Duisburg-Essen, Essen, Germany. Drs. Thielmann and Kahlert have received honoraria for
their work as proctors for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the
contents of this paper to disclose.
Manuscript received February 24, 2013; revised manuscript received April 18, 2013, accepted May 9, 2013.
966
Patsalis et al.
Balloon Sizing for TF-TAVI
Paravalvular aortic regurgitation (PAR) after transcatheter
aortic valve implantation (TAVI) is associated with increased
in-hospital mortality and unfavorable long-term outcome
(1). Reduction of PAR by appropriate valve size selection is
key. Current recommendations for valve size selection are
based on transesophageal echocardiography, but multislice
computed tomography (MSCT) is increasingly used (2). The
choice of correct prosthesis size based on pre-interventional
See page 972
Abbreviations
and Acronyms
AR index = aortic
regurgitation index
BAV = balloon aortic
valvuloplasty
DAP = diastolic aortic
pressure
DPTI = diastolic pressure
time integral
DPTI:SPTI = ratio of diastolic
over systolic pressure time
integral
DPDAP–LVEDP = pressure
gradient between DAP and
LVEDP
LV = left ventricular
LVEDP = left ventricular enddiastolic pressure
imaging of annular size can be
difficult, and relevant PAR with
negative impact on survival still
results in up to 20% of cases
(1–15). TAVI generally requires
preparatory balloon aortic valvuloplasty (BAV) to facilitate the
prosthesis implantation and expansion. Accurate annular sizing
remains challenging and is
a prerequisite for reduction of
PAR and associated mortality.
The purpose of the present
study, therefore, was to evaluate
whether supra-aortic angiography during BAV improves
valve size selection and reduces
PAR especially in cases with
borderline annulus size.
MCV = Medtronic CoreValve
MSCT = multislice computed
tomography
Methods
Patient population. Data from
270 consecutive high-risk patients
SPTI = systolic pressure time
with symptomatic aortic valve
integral
stenosis who underwent transTAVI = transcatheter aortic
femoral or transsubclavian TAVI
valve implantation
using the Medtronic CoreValve
TEE = transesophageal
(MCV) (Medtronic Inc., Minechocardiography
neapolis, Minneapolis; n ¼ 104
[38.5%]) or the Edwards Sapien
(Edwards Lifesciences Inc., Irvine, California; n ¼ 166
[61.5%]) bioprosthesis were analyzed: 167 patients underwent conventional sizing by echocardiography (conventional
sizing) and were compared with 103 subsequent patients, in
whom BAV was additionally used for valve size selection
(balloon sizing). The decision for TAVI was made by an
interdisciplinary heart team (10,12,16–19). TAVI procedures were performed according to standard techniques
(16,18,19).
Valve size selection. There is an overlap between 2
different prosthesis sizes for both the MCV and the
PAR = paravalvular aortic
regurgitation
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 6, NO. 9, 2013
SEPTEMBER 2013:965–71
Edwards Sapien bioprostheses where valve size selection is
left to the physician’s choice. For conventional sizing
(group 1), the choice of the prosthetic size was based
on pre-interventional transesophageal echocardiography
(TEE) by an experienced investigator (2–10). For balloon
sizing (group 2), patients underwent preparatory BAV
(Z-MED balloon, NuMED, Inc., Hopkinton, New York or
Edwards balloon) during TAVI. Supra-aortic angiography
during BAV was used to measure the size of the aortic
annulus. At the time of full balloon inflation, supra-aortic
angiography was performed perpendicular to the native
valve plane in a slight cranial/left anterior oblique projection over a 6-F pigtail catheter (Cordis Corporation,
East Bridgewater, New Jersey) placed in the noncoronary
cusp. Contrast regurgitation into the left ventricle after
injection of 20 ml of contrast at a flow rate of 10 ml/s
served to indicate annulus size underestimation by TEE
and resulted in the selection of a bigger prosthesis (Fig. 1,
Online Video 1). For TAVI using the Edwards Sapien
bioprosthesis, balloon sizing was performed with a 23-mm
Edwards balloon for selection between the 23- and 26-mm
valve and with a 25-mm Z-MED balloon for selection
between the 26- and 29-mm valve. For TAVI using the
MCV, balloon sizing was performed with a 23-mm
Z-MED balloon for selection between the 26- and 29-mm
valve and with a 25-mm Z-MED balloon for selection
between the 29- and 31-mm valve. In order to achieve
a 23-mm diameter using the 23-mm Edwards balloon or
the 23-mm Z-MED balloon, inflation with 21 ml of
saline/contrast mixture was necessary. In order to achieve
a 25-mm diameter using the 25-mm Z-MED balloon inflation with 22 ml was necessary. A diameter of 26 mm was
achieved by inflating the 25-mm Z-MED balloon with 23 ml
of saline/contrast mixture. Of note, a 26-mm balloon was not
available in our catheterization laboratory at that time. The
volume needed to achieve a certain diameter was calibrated in
vitro using a saline/contrast medium mix. To evaluate the
congruence between the aortic annulus and the device, we also
calculated the “cover index” as a ratio of: 100 ([prosthesis
diameter TEE annulus diameter]/prosthesis diameter) (7).
PAR severity. The severity of residual PAR was graded
qualitatively by the amount of regurgitating contrast
medium during supra-aortic angiography after final device
deployment and catheter removal using the Sellers criteria
(12,14,20): absent 0/4; mild 1/4; moderate 2/4; moderateto-severe 3/4; and severe 4/4. Simultaneous left ventricular
(LV) and aortic pressures were recorded at 50 mm/s and
averaged over 3 representative cardiac cycles after the
procedure. The aortic regurgitation index (AR index) as the
ratio of the gradient between diastolic aortic pressure and
left ventricular end-diastolic pressure (LVEDP) to systolic
blood pressure 100 (11), the pressure gradient between
diastolic aortic pressure (DAP) and left ventricular enddiastolic pressure (DPDAP–LVEDP) (14), and the myocardial
Patsalis et al.
Balloon Sizing for TF-TAVI
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 6, NO. 9, 2013
SEPTEMBER 2013:965–71
967
Figure 1. Supra-Aortic Angiography During Preparatory BAV for Valve Size Selection
(A) After balloon inflation, supra-aortic angiography was performed with a 23-mm balloon. Contrast regurgitation into the left ventricle was an indicator of annulus size
underestimation by transesophageal echocardiography and resulted in the selection of a bigger prosthesis. (B) Absence of contrast regurgitation into the left ventricle
during balloon sizing with a 23-mm balloon confirmed annular sizing based on pre-interventional transesophageal echocardiography and resulted in the selection of
the smaller prosthesis. See Online Video 1 for an accompanying video. BAV ¼ balloon aortic valvuloplasty.
supply-demand ratio (DPTI:SPTI) (15) from planimetric
integration of the diastolic pressure time integral (DPTI) and
systolic pressure time integral (SPTI) were calculated. An AR
index <25, a DPDAP–LVEDP 18 mm Hg, and a DPTI:SPTI
0.7 have been previously proposed as cutoff values for
increased mortality associated with PAR after TAVI.
Endpoint. The primary endpoint was mortality over the
duration of the study according to Valve Academic Research
Consortium II definitions (19). All patients were followed
for at least 1 year.
Post-interventional protocol. After TAVI, patients were
transferred for 24 h to an intensive care unit for postinterventional monitoring. Besides the clinical examination,
electrocardiogram, body temperature, and chest x-ray, all
blood parameters, which had already been determined at the
initial examination, were determined again. Follow-up
examinations were performed 3 months and 1 year after
discharge.
Statistical analysis. Categorical data are presented as frequencies and percentages; continuous variables are presented as mean SD. The normal distribution of the
variables was tested by the Shapiro-Wilk test (p-Wert
0.1). Comparisons were made with 2-sided chi-square
tests or 2-sided Fisher exact tests for categorical variables
and 1-way analysis of variance for continuous variables,
using Bonferroni correction for multiple testing. Analysis of
variance and the Student t test were used to compare
normally distributed variables (age, aortic annulus, weight,
height) and the Mann-Whitney U test was used compare
the other non-normally distributed variables between the 2
groups. A p value of <0.05 was considered significant.
Survival analyses for conventional and balloon sizing were
performed by the Kaplan-Meier method, with patients
censored as of the last date known alive. All statistical
analyses were performed using SPSS (version 17.0, SPSS,
Chicago, Illinois).
Results
Baseline and procedural characteristics. Our study cohort
represents a typical TAVI patient population at high risk for
open-heart surgery (logistic EuroSCORE [European System
for Cardiac Operative Risk Evaluation]: 21.0 12.8%, STS
[Society of Thoracic Surgeons] score: 7.7 6.7%) with
symptomatic aortic stenosis (aortic valve area: 0.63 0.2 cm2, transvalvular gradient: 55.7 9.6 mm Hg). There
were no significant differences in baseline and procedural
characteristics between the retrospective conventional-sizing
group and the balloon-sizing group (Tables 1 and 2).
BAV for valve size selection. For 63 (61%) patients of group
2 who had a distinct annulus size, balloon sizing was used to
confirm annular sizing based on the pre-interventional
TEE. In all 63 patients, absence of contrast regurgitation
into the LV after balloon inflation confirmed annulus sizing
by TEE and resulted in the implantation of the expected
valve size (Fig. 2).
In cases of borderline annulus size, balloon sizing was
used for valve size selection. According to pre-interventional
968
Patsalis et al.
Balloon Sizing for TF-TAVI
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 6, NO. 9, 2013
SEPTEMBER 2013:965–71
Table 1. Baseline Characteristics
Overall
(n ¼ 270)
Age, yrs
Male
Weight, kg
Conventional Sizing
(n ¼ 167)
80.9 6.2
80.7 6.6
110 (40.7)
75.5 13.2
Balloon Sizing
(n ¼ 103)
p Value
81.5 5.3
0.2
70 (41.9)
40 (38.8)
0.7
75.2 14.2
76.3 14.1
0.5
0.31
166.4 7.4
166.2 8.3
167.1 6.4
17.9 (16.0, 27.1)
18.3 (16.1, 26.7)
16.8 (15.7, 27.7)
0.2
7.3 (6.7, 9.1)
7.2 (6.8, 8.7)
7.5 (7.1, 9.3)
0.6
Aortic valve area, cm2
0.61 (0.5, 0.7)
0.60 (0.5, 0.7)
0.65 (0.5, 0.8)
0.15
Mean transvalvular PG, mm Hg
54.7 (46.0, 61.0)
55.0 (48.0, 63.0)
54.0 (47.0, 60.0)
52 (42.0, 56.0)
51 (40.0, 55.0)
53 (43.0, 56.0)
Height, cm
Logistic EuroSCORE, %
STS score, %
LVEF, %
Aortic annulus diameter, mm
CAD
22.9 1.9
22.8 1.4
0.2
0.36
23.1 1.4
0.08
174 (64.4)
105 (62.9)
69 (66.9)
0.5
Prior MI
10 (3.7)
4 (2.4)
6 (5.8)
0.2
Prior PCI
107 (39.6)
62 (37.1)
45 (43.7)
0.4
Prior heart surgery
47 (17.4)
28 (16.8)
19 (18.4)
0.75
PVD
38 (14.0)
25 (15.0)
13 (12.6)
0.7
Values are mean SD, n (%), or median (interquartile range).
CAD ¼ coronary artery disease; EuroSCORE ¼ European System for Cardiac Operative Risk Evaluation; LVEF ¼ left ventricular ejection fraction; MI ¼ myocardial
infarction; PCI ¼ percutaneous coronary intervention; PG ¼ pressure gradient; PVD ¼ peripheral vascular disease; STS ¼ Society of Thoracic Surgeons.
imaging by TEE, 40 (39%) patients had a borderline
annulus size. Balloon sizing performed in these cases
revealed an underestimation of annulus size in 30 patients
(29%), so that on-table the bigger prosthesis was selected,
whereas the smaller prosthesis was chosen in the remaining
patients, resulting in only 1 of these 40 patients with at least
moderate PAR (Fig. 2). Of note, there were no complications
associated with angiography during BAV. Specifically, there
were no annulus ruptures associated with balloon sizing.
PAR after TAVI. The angiographic assessment of postprocedural PAR revealed a lower frequency of PAR in the
balloon sizing than in the retrospective conventional sizing
group (Table 3A). At least mild PAR was observed in 113
patients of the retrospective conventional-sizing group and
41 patients of the balloon-sizing group. Severe PAR did not
occur in any of our study patients (67.7% vs. 39.8%, p <
0.001).
An AR index <25, a pressure difference 18 mm Hg,
and a DPTI:SPTI 0.7 were observed less often in patients
who underwent balloon sizing than in those who underwent
conventional sizing (Table 3B).
There was a tendency toward a lower cover index in the
retrospective conventional-sizing group compared with the
balloon-sizing cohort but without significance (6.4 5% vs.
6.8 6%, respectively, p ¼ 0.6). Correcting maneuvers for
PAR treatment in the retrospective conventional-sizing
group have been described before (14). Twenty-three
patients underwent post-dilation with an improvement in
PAR grade to <2/4 in 13 (54%) of them. One patient with
severe PAR due to low implantation of a MCV underwent
post-deployment repositioning by snaring, which resulted in
PAR improvement to 1/4. In the balloon-sizing cohort, 10
patients underwent post-dilation with an improvement in
PAR grade to <2/4 in 2 (20%) of them. The reduced rate of
Table 2. Procedural Characteristics
Overall
(n ¼ 270)
Transfemoral
Transsubclavian
CoreValve
Conventional Sizing
(n ¼ 167)
Balloon Sizing
(n ¼ 103)
260 (96.3)
158 (94.6)
10 (3.7)
9 (5.4)
1 (1.0)
104 (38.5)
88 (52.7)
16 (15.5)
<0.001
87 (84.5)
<0.001
0.095
0.095
Edwards
166 (61.5)
Procedural duration, min
71.1 (53.0–101.0)
72.0 (55.0–105.0)
69.2 (50.0–95.0)
0.16
Fluoroscopy time, min
13.5 (10.6–17.9)
13.1 (10.3–17.5)
14.0 (11.1–18.5)
0.1
Contrast amount, ml
175 (134.0–207.0)
173.5 (130.0–205.0)
179.6 (137.0–210.0)
0.4
9.0 (6.0–13.0)
9.7 (7.3–13.9)
0.2
Post-procedural transvalvular mean PG, mm Hg
Values are n (%) or median (interquartile range).
PG ¼ pressure gradient.
9.3 (7.0–14.0)
79 (47.3)
102 (99)
p Value
Patsalis et al.
Balloon Sizing for TF-TAVI
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 6, NO. 9, 2013
SEPTEMBER 2013:965–71
Figure 2. Balloon Sizing
According to pre-interventional transesophageal echocardiography, 40
patients had a borderline annulus size. When balloon sizing was performed, it
revealed an underestimation of annulus size in 30 patients (29%), so that
on-table, a bigger prosthesis was selected.
post-dilation due to the reduced incidence of PAR in the
balloon-sizing group did not significantly affect stroke rate.
PAR and associated mortality in relation to the sizing
method. Mortality at 30 days and 1 year was less in patients
who underwent additional balloon sizing in comparison to
those who underwent conventional sizing (5.8% vs. 9%, p ¼ 0.2,
and 10.6% vs. 20%, p ¼ 0.01) (Fig. 3).
Discussion
The present study is the first to demonstrate that supraaortic angiography during preparatory BAV improves valve
size selection and reduces PAR and the associated mortality
after TAVI. Qualitatively, the frequency of post-procedural
PAR was lower in patients who underwent additional
balloon sizing than in those who underwent only conventional sizing. Quantitative assessment of PAR severity by use
of the AR index, the pressure gradient DPDAP–LVEDP, and
the myocardial supply/demand ratio showed that the
frequency of exceeding the cutoff values that have previously
been associated with increased mortality was decreased in
the balloon-sizing group (11,14,15). Reduction of PAR and
its associated hemodynamic burden could play an important
969
role in the improvement of outcome after TAVI, although
this remains speculative.
Aortic annulus sizing in TAVI. Accurate annulus measurements and the selection of the appropriate prosthesis size are
critical in order to avoid valve migration, severe PAR, or
annulus rupture (2). The aortic annulus can be measured by
echocardiography, MSCT, or angiography. Recommendations for valve size selection are currently based on annular
measurements by TEE. Recent studies, however, show an
underestimation of the annulus size by echocardiography so
that possibly undersized valves are implanted (2). Given the
structure of the aortic root and semilunar-shaped cusps, 2dimensional imaging possibly “cuts” the oval plane at many
angles, resulting in inaccurate measurements (12,21). MSCT
is increasingly used for annular sizing and provides additional
anatomical information regarding the coronary arteries, the
aortic valve area, and the distribution of aortic valve calcifications (2,22–25). Although recent data show a correlation
between echocardiographic and MSCT sizing, results between
these methods are not identical (2). The calculation of the
annular diameter from maximum/minimum cross-sectional
diameter but also cross-sectional area has been proposed for
more accurate sizing (26); however, radiation exposure and
contrast medium injection are important limitations (2). In
a recent analysis, computed tomography sizing recommendations resulted in mean annular oversizing of 13.9% (27).
Use of preparatory BAV for improved valve size selection. Due
to conflicting measurements obtained with multimodal
imaging, asymmetric calcifications, or eccentric leaflets, there
can be uncertainties regarding the optimal valve size selection
for TAVI (2,21). When measurements of the aortic annulus
are ambiguous between 2 different available prosthesis sizes,
valve size selection based only on indirect annular sizing
(TEE, MSCT) is critical (21). Therefore, in patients with
borderline annulus, currently available prostheses might be
undersized, resulting in annulus-to-device discrepancy. In this
setting, there was a tendency toward a lower cover index in
the retrospective conventional sizing group but without
significance, probably due to the small number of patients
with relevant PAR. In our hands, supra-aortic angiography
during BAV provides a simple, direct, and effective measure
to improve sizing with a reduction of PAR frequency and
Table 3. Assessment of PAR Severity
A
Conventional Sizing
(n ¼ 167)
Balloon Sizing
(n ¼ 103)
p Value
B
Conventional Sizing
(n ¼ 167)
Balloon Sizing
(n ¼ 103)
p Value
0.02
Absent (0/4)
54 pts (32.3%)
62 pts (60.2%)
<0.001
Trace or mild (1/4)
89 pts (53.3%)
33 pts (32%)
<0.001
AR index <25
45 (26.9%)
16 (15.5%)
Moderate (2/4)
21 pts (12.6%)
7 pts (6.8%)
<0.001
DpDAP–LVEDP 18 mm Hg
44 (26.3%)
15 (14.5%)
0.02
Moderate-to-severe (3/4)
3 pts (1.8%)
1 pts (1.0%)
<0.001
DPTI:SPTI 0.7
20 (11.9%)
5 (4.8%)
0.05
Severe (4/4)
0 pts (0%)
0 pts (0%)
<0.001
The distribution of post-procedural PAR was associated with the sizing method (A). An AR index <25, a Dp DAP–LVEDP 18 mm Hg and a DPTI:SPTI 0.7 were observed more frequently in the
conventional- than in the balloon- sizing group (B).
970
Patsalis et al.
Balloon Sizing for TF-TAVI
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 6, NO. 9, 2013
SEPTEMBER 2013:965–71
self-expandable nitinol frame of the MCV permit the selection of the larger valve to avoid PAR in cases of borderline
annulus size, but still complications such as atrioventricular
block may result (30). Taking the significant discrepancies
(31) between measurements using 2- and 3-dimensional
imaging, but also the lack of sizing recommendations
based on 3-dimensional imaging under consideration, we
focused on the current manufacturer’s guidelines and used
2-dimensional TEE for annulus measurements. It remains
hypothetical whether we would have potentially used the
bigger valve in borderline cases without our current procedure
of valve sizing, but it must be noted that in 10 of 40 patients
with borderline annulus size, the smaller valve was ultimately
chosen.
Conclusions
Figure 3. Cumulative Survival According to the Sizing Method
Mortality at 30 days and 1 year was decreased in patients who underwent
additional balloon sizing in comparison to those who underwent only
conventional sizing (log-rank ¼ 0.03).
severity and therefore may serve in decision making on valve
size selection, especially in cases with borderline annulus size.
TAVI generally requires preparatory BAV to facilitate the
prosthesis implantation, and therefore balloon sizing cannot
be considered as an additional risk factor for stroke. On the
other hand, a reduced stroke rate was not observed due to
decreased rate of post-dilation in the balloon-sizing group.
In a recent study for the detection of procedural cerebral
microembolization during TAVI, the majority of highintensity transient signals (HITS) recorded by transcranial
Doppler ultrasonography was seen during direct valve
manipulation while positioning and implanting the prosthesis, revealing that the calcified aortic valve is the main
source of emboli (28). In addition, the number of HITS
during BAV was unexpectedly low, possibly due to the
endothelial coverage preventing calcific debris from release
and embolization at this stage of the procedure (28).
Although this explanation remains speculative, it is supported by the relatively low stroke rates of 1% to 2% reported
in a recent series of BAV (29).
Study limitations. Our data are derived from a retrospective
analysis of consecutive patients and not from a prospective,
randomized trial. We, therefore, cannot exclude that part of
the observed benefit in group 2 versus group 1 is due to
a learning curve and not specifically to the technique of
balloon sizing. In addition, growing awareness of the clinical
impact of relevant PAR and therefore focus on avoidance of
annulus-to-prosthesis mismatch as well as better selection of
TAVI patients could have also played a role in the observed
benefit in group 2 and are consequently potential confounders of our current study. The characteristics of the
At least mild PAR and quantitative parameters of PAR
severity, such as an AR index <25, a DPDAP–LVEDP 18
mm Hg, and a DPTI:SPTI 0.7, all associated with an
increased mortality, were observed less often in patients
who underwent additional balloon sizing than in those
who underwent only conventional sizing. Preparatory
BAV during TAVI improves valve size selection, reduces
PAR, and thus improves survival, especially in borderline
cases.
Acknowledgment
The authors thank André Scherag, Institute for Medical
Informatics, Biometry and Epidemiology, University Duisburg-Essen, for statistical support.
Reprint requests and correspondence: Dr. Polykarpos C. Patsalis,
West-German Heart Center Essen, Department of Cardiology,
Essen University Hospital, Hufelandstrasse 55, 45122 Essen,
Germany. E-mail: [email protected].
REFERENCES
1. Généreux P, Head SJ, Hahn R, et al. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles’ heel? A comprehensive review of the literature. J Am Coll Cardiol 2013;61:1125–36.
2. Messika-Zeitoun D, Serfaty JM, Brochet E, et al. Multimodal assessment of the aortic annulus diameter: implications for transcatheter aortic
valve implantation. J Am Coll Cardiol 2010;55:186–94.
3. Moss RR, Ivens E, Pasupati S, et al. Role of echocardiography in
percutaneous aortic valve implantation. J Am Coll Cardiol Img 2008;1:
15–24.
4. Babaliaros VC, Liff D, Chen EP, et al. Can balloon aortic valvuloplasty
help determine appropriate transcatheter aortic valve size? J Am Coll
Cardiol Intv 2008;1:580–6.
5. Smith CR, Leon MB, Mack MJ, et al., for the PARTNER Trial
Investigators. Transcatheter versus surgical aortic-valve replacement in
high-risk patients. N Engl J Med 2011;364:2187–98.
6. Rajani R, Kakad M, Khawaja MZ, et al. Paravalvular regurgitation one
year after transcatheter aortic valve implantation. Catheter Cardiovasc
Interv 2010;75:868–72.
Patsalis et al.
Balloon Sizing for TF-TAVI
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 6, NO. 9, 2013
SEPTEMBER 2013:965–71
7. Détaint D, Lepage L, Himbert D, et al. Determinants of significant
paravalvular regurgitation after transcatheter aortic valve implantation:
impact of device and annulus discongruence. J Am Coll Cardiol Intv
2009;2:821–7.
8. Takagi K, Latib A, Al-Lamee R, et al. Predictors of moderate-to-severe
paravalvular aortic regurgitation immediately after CoreValve implantation and the impact of postdilatation. Catheter Cardiovasc Interv
2011;78:432–43.
9. Zahn R, Gerckens U, Grube E, et al., for the German Transcatheter
Aortic Valve Interventions Registry Investigators. Transcatheter aortic
valve implantation: first results from a multi-centre real-world registry.
Eur Heart J 2011;32:198–204.
10. Tamburino C, Capodanno D, Ramondo A, et al. Incidence and
predictors of early and late mortality after transcatheter aortic valve
implantation in 663 patients with severe aortic stenosis. Circulation
2011;123:299–308.
11. Sinning JM, Hammerstingl C, Vasa-Nicotera M, et al. Aortic regurgitation index defines severity of peri-prosthetic regurgitation and
predicts out-come in patients after transcatheter aortic valve implantation. J Am Coll Cardiol 2012;59:1134–41.
12. Abdel-Wahab M, Zahn R, Horack M, et al., for the German Transcatheter Aortic Valve Interventions Registry Investigators. Aortic
regurgitation after transcatheter aortic valve implantation: incidence and
early outcome. Results from the German Transcatheter Aortic Valve
Interventions Registry. Heart 2011;97:899–906.
13. Kodali SK, Williams MR, Smith CR, et al., for the PARTNER Trial
Investigators. Two-year outcomes after transcatheter or surgical aorticvalve replacement. N Engl J Med 2012;366:1686–95.
14. Patsalis PC, Konorza TFM, Al-Rashid F, et al. Incidence, outcome and
correlates of residual paravalvular aortic regurgitation after transcatheter
aortic valve implantation and importance of hemodynamic assessment.
EuroIntervention 2013;8:1398–406.
15. Patsalis PC, Konorza TFM, Al-Rashid F, et al. Hemodynamic
assessment of residual paravalvular aortic regurgitation (PAR)
after TAVI: impact of myocardial supply-demand ratio (DPTI:
SPTI) on survival. Am J Physiol Heart Circ Physiol 2013;304:
H1023–8.
16. Vahanian A, Alfieri O, Al-Attar N, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the
European Association of Cardio-Thoracic Surgery (EACTS) and the
European Society of Cardiology (ESC), in collaboration with the
European Association of Per-cutaneous Cardiovascular Interventions
(EAPCI). Eur Heart J 2008;29:1463–70.
17. Webb JG, Pasupati S, Humphries K, et al. Percutaneous transarterial
aortic valve replacement in selected high-risk patients with aortic
stenosis. Circulation 2007;116:755–63.
18. Grube E, Schuler G, Buellesfeld L, et al. Percutaneous aortic valve
replacement for severe aortic stenosis in high-risk patients using the
second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol
2007;50:69–76.
19. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized
endpoint definitions for transcatheter aortic valve implantation: the
971
Valve Academic Research Consortium-2 consensus document. J Am
Coll Cardiol 2012;60:1438–54.
20. Sellers RD, Levy MJ, Amplatz K, Lillehei CW. Left retrograde cardioangiography in acquired cardiac disease: technic, indications and
interpretations in 700 cases. Am J Cardiol 1964;14:437–47.
21. Kasel AM, Cassese S, Bleiziffer S, et al. Standardized imaging for aortic
annular sizing: implications for transcatheter valve selection. J Am Coll
Cardiol Img 2013;6:249–62.
22. Gilard M, Cornily JC, Pennec PY, et al. Accuracy of multislice
computed tomography in the preoperative assessment of coronary
disease in patients with aortic valve stenosis. J Am Coll Cardiol 2006;47:
2020–4.
23. Reant P, Brunot S, Lafitte S, et al. Predictive value of noninvasive
coronary angiography with multidetector computed tomography to
detect significant coronary stenosis before valve surgery. Am J Cardiol
2006;97:1506–10.
24. Bouvier E, Logeart D, Sablayrolles JL, et al. Diagnosis of aortic valvular
stenosis by multislice cardiac computed tomography. Eur Heart J 2006;
27:3033–8.
25. Feuchtner GM, Dichtl W, Friedrich GJ, et al. Multislice computed
tomography for detection of patients with aortic valve stenosis and
quantification of severity. J Am Coll Cardiol 2006;47:1410–7.
26. Jilaihawi H, Kashif M, Fontana G, et al. Cross-sectional computed
tomographic assessment improves accuracy of aortic annular sizing for
transcatheter aortic valve replacement and reduces the incidence of
paravalvular aortic regurgitation. J Am Coll Cardiol 2012;59:1275–86.
27. Willson AB, Webb JG, Freeman M, et al. Computed tomographybased sizing recommendations for transcatheter aortic valve replacement
with balloon-expandable valves: comparison with transesophageal
echocardiography and rationale for implementation in a prospective
trial. J Cardiovasc Comput Tomogr 2012;6:406–14.
28. Kahlert P, Doettger P, Mori K, et al. Cerebral embolization during
transcatheter aortic valve implantation (TAVI): a transcranial Doppler
study. Circulation 2012;126:1245–55.
29. Sack S, Kahlert P, Khandanpour S, et al. Revival of an old method with
new techniques: balloon aortic valvuloplasty of the calcified aortic
stenosis in the elderly. Clin Res Cardiol 2008;97:288–97.
30. Khawaja MZ, Rajani R, Cook A, et al. Permanent pacemaker insertion
after CoreValve transcatheter aortic valve implantation: incidence and
contributing factors (the UK CoreValve Collaborative). Circulation
2011;123:951–60.
31. Jánosi RA, Kahlert P, Plicht B, et al. Measurement of the aortic annulus
size by real-time three-dimensional transesophageal echocardiography.
Minim Invasive Ther Allied Technol 2011;20:85–94.
Key Words: aortic regurgitation - balloon valvuloplasty
transcatheter aortic valve implantation.
-
APPENDIX
For an accompanying video, please see the online version of this article.