- Email: [email protected]
Effect of balloon annulus ratio on the outcome post balloon pulmonary valvuloplasty in children
Accepted Manuscript Effect of balloon annulus ratio on the outcome post balloon pulmonary valvuloplasty in children
Alaa Mahmoud Roushdy, Rana Salah Eldin, Dina Adel Ezz Eldin PII: DOI: Reference:
S1058-9813(16)30152-7 doi: 10.1016/j.ppedcard.2017.05.004 PPC 991
To appear in:
Progress in Pediatric Cardiology
Received date: Revised date: Accepted date:
15 December 2016 ###REVISEDDATE### 5 May 2017
Please cite this article as: Alaa Mahmoud Roushdy, Rana Salah Eldin, Dina Adel Ezz Eldin , Effect of balloon annulus ratio on the outcome post balloon pulmonary valvuloplasty in children, Progress in Pediatric Cardiology (2017), doi: 10.1016/j.ppedcard.2017.05.004
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Title page
Effect of balloon annulus ratio on the outcome post balloon pulmonary valvuloplasty in children
IP
T
Alaa Mahmoud Roushdy, MD, Rana Salah eldin, MSC, Dina Adel Ezz Eldin, MD
CR
Authors' affiliation:
US
Cardiology Department – Ain Shams University Hospital – Cairo - Egypt
AN
No relationship with industry exist for any of the above mentioned authors
M
Correspondence:
AC
CE
PT
ED
Dr. Dina Adel, MD. Cardiology Department – Ain Shams University Hospital Abbassya – Cairo – Egypt Fax 202 24820416 Email: [email protected]
ACCEPTED MANUSCRIPT Manuscript Title page
Effect of balloon annulus ratio on the outcome post balloon pulmonary valvuloplasty in children
CR
IP
T
Alaa Mahmoud Roushdy, MD, Rana Salah eldin, MSC, Dina Adel Ezz Eldin, MD
Authors' affiliation:
US
Cardiology Department – Ain Shams University Hospital – Cairo - Egypt
M
AN
No relationship with industry exist for any of the above mentioned authors
Correspondence:
AC
CE
PT
ED
Dr. Dina Adel, MD. Cardiology Department – Ain Shams University Hospital Abbassya – Cairo – Egypt Fax 202 24820416 Email: [email protected]
ACCEPTED MANUSCRIPT Abstract BACKGROUND AND OBJECTIVES Balloon pulmonary valvuloplasty (BPV) has been the treatment of choice for valvular pulmonary stenosis, the success of the procedure largely depends on the proper balloon size choice, which is based on pulmonary valve annulus measurement. We sought to establish a balloon annulus ratio
T
that could achieve the least side effects and the best results post BPV.
CR
IP
METHODS The study included 70 patients with valvular pulmonary stenosis who underwent BPV 2-8 years before and were coming for routine follow up echocardiography post BPV at Ain shams
US
university hospital from August 2015 to February 2016. All patients had a detailed revision of their records including the BPV procedure report and the immediate follow up echocardiogram
AN
together with a full echocardiographic study at time of presentation. RESULTS
M
The median age of the study group at time of procedure was 2.39 years. The patients were divided based on their balloon annulus ratio into two groups: group 1 with balloon annulus ration
ED
≤1.3 (n = 43) and group 2 with balloon annulus ratio >1.3 (n = 27). At follow up, BPV was successful in 95.7% of the cases. Pulmonary valve systolic pressure gradient decreased from
PT
81.06±20.75 to 18.46±8.25 mmHg immediately after BPV and to 20.81±5.79 mmHg at late follow up (P=0.000).The difference in pulmonary gradient reduction was not significant between
CE
the two groups (P = 0.79). Although both groups had an increase in pulmonary valve insufficiency from baseline, group 1 had significantly less pulmonary insufficiency (P =0 .011).
AC
Conclusion
Using a more conservative balloon annulus ratio of ≤1.3 for BPV would achieve better results in terms of effective gradient reduction, less re-intervention for the pulmonary valve later in life and less pulmonary insufficiency.
Key words: Pulmonary valve, Balloon pulmonary valvuloplasty, pulmonary insufficiency
ACCEPTED MANUSCRIPT Introduction Pulmonary stenosis is the second most common congenital cardiac malformation which comprises of 7.5–9% of all congenital heart defects. Surgical valvotomy used to be the treatment of choice; however, since its introduction by Kan et al in 1982, balloon valvuloplasty has gained
IP
T
acceptance as the first option in the management of congenital pulmonary valve stenosis. (1) The procedure provides long-term relief of pulmonary valvular obstruction in the majority of
(2, 3)
However the procedure is not without
US
1.4 makes the procedure effective and safe.
CR
patients. The use of oversized balloons is recommended and a balloon-to-annulus ratio of 1.2 to
complications one of which is pulmonary insufficiency with an incidence 44- 88 %
(4)
.
M
necessitate pulmonary valve replacement. (5)
AN
Pulmonary insufficiency can cause RV dilatation, limited functional capacity and may
ED
So although the safety and efficacy of the procedure is well studied, optimizing the outcome of the procedure is still an area of active research, in this study we intend to evaluate the effect of
Methods
CE
PT
balloon annulus ratio choice on procedural outcome.
This study was approved by our institutional review board and informed consent was obtained
AC
from the parents of all the children enrolled in the study. The study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki.
This was a retrospective cross sectional study which included all patients who came for follow up echocardiography at Ain Shams university hospital post BPV over a period of 6 months ending February 2016. The study included 70 patients with the following inclusion criteria
ACCEPTED MANUSCRIPT patients younger than 16 years of age who had isolated valvular pulmonary stenosis and who underwent BPV at least 2 years before.
Data collection: All patients’ records were revised and a custom made sheet was done to include the following:
IP
T
1-Patient demographic data including age at time of procedure, gender, body weight, body
CR
surface area. 2- Pre BPV echocardiographic data including; pulmonary valve annulus, peak pressure gradient across the pulmonary valve, valve morphology, degree of tricuspid
US
regurgitation, right ventricular size and functions and 3- procedural data including the pre and post procedure pressure gradient, pulmonary valve annulus, balloon type and balloon size used,
M
Follow up echocardiogram:
AN
balloon annulus ratio and any intra or immediate post procedure complications
ED
All patients underwent full echocardiographic study at time of presentation using a Philips Ie33 machine. The pulmonary valve was evaluated from the parasternal short-axis and long-axis
PT
views as well as the sub costal sagittal views. The valve leaflets were evaluated regarding
CE
thickness and systolic motion. The degree of stenosis was classified according to the AHA guidelines into mild: peak pressure gradient less than 36 mmHg, moderate: peak pressure (3)
. The
AC
gradient between 36 and 64 mmHg and severe: peak pressure gradient above 64 mmHg
pulmonary valve annulus was measured in the parasternal short axis view. The main pulmonary artery and branches were measured in the high parasternal short axis and crab views and the largest diameter was recorded (6) (Figure 1) Pulmonary regurgitation was assessed in parasternal short axis view by color flow mapping and graded as none, mild, or greater than mild using visual inspection of the width of the regurgitant jet in relation to the outflow tract diameter, vena contracta width and extent of regurgitation into
ACCEPTED MANUSCRIPT the pulmonary tree in collaboration according to the recommendation of the European Association of cardiovascular imaging (7) (Figure 2) The RV dimensions were then assessed from apical 4 chamber, modified RV focused view and sub costal views. Three measurements were taken, the RV longitudinal dimension, transverse (8)
. PV annulus and
T
mid cavity dimension and TV annulus diameter, all obtained at end diastole
IP
its Z-value and tricuspid valve annulus and its Z-value (Z-value was used to standardize
CR
pulmonary and tricuspid valves dimensions with body size). Z-scores <2 were taken to represent a small valve annulus while Z scores <3 marked a hypoplastic valve annulus (9).
US
RV function was assessed by tricuspid annular peak systolic excursion (TAPSE) by M mode and
AN
fractional area change (FAC) which was estimated by tracing the RV in the apical four chamber view to obtain the end diastolic and the end systolic area then the percentage change between
M
them was calculated according to the following equation: Fractional area change
= (end-
ED
diastolic area – end-systolic area)/end-diastolic area x 100. A fractional area change of >32.2%
Statistical analysis
PT
was used to define normal RV function (10, 11)
CE
All data were collected, tabulated, and statistically analyzed. Patient and procedural
AC
characteristics were tabulated and reported as frequencies or medians. Continuous variables were expressed as mean plus or minus standard deviation, and categorical variables were expressed as a percentage. Statistical significance was assessed by paired as well as independent sample t-test for numerical values and Chi-square test for categorical values. ROC curve analysis was done to generate a cutoff point for balloon annuls ratio with the highest balanced sensitivity and specificity to predict no or mild PR post BPV. Values were considered significantly different when p was less than 0.05.
ACCEPTED MANUSCRIPT
Results The study included 28 females (40 %) and 42 males (60 %) with a mean age of 2.39 years (range
IP
Demographic characteristics of both groups are listed in Table 1.
T
from 1 month to 8.5 years) at time of BPV. The mean follow up period was 2.88 +/- 1.43 years.
CR
There was a highly significant drop in pressure gradient from a mean of 81.06 ± 20.75 mmHg to
US
a mean of 20.81 ± 5.79 mm Hg immediately after BPV, this drop in the PG was maintained during the follow-up with a mean of 18.46 ± 8.25 mm Hg. At follow up, there was a significant
AN
increase in patients with PR compared to baseline before BPV, 49% had mild PR, 15.7% had
M
moderate PR, and 4.3% had severe PR compared to only 2 patients who had mild PR before BPV. There was a significant increase in patients with moderate TR from 4.3% before BPV to
ED
11.4% at follow up and a significant decrease in patients with severe TR from 5.7% before BPV
PT
to 0% at follow up after BPV. (Table 2)
CE
ROC curve analysis was done to generate a cutoff point for balloon annulus ratio with the highest balanced sensitivity and specificity that would result in mild or no PR at follow up. A
AC
cutoff point for balloon annulus ratio of ≤ 1.36 had 75% sensitivity and 71.4% specificity to predict no or mild PR post BPV with area under the curve of 0.707 and P value of 0.009 (Figure 3).
We subdivided the study group into 2 subgroups based on the balloon annulus ratio used during BPV; group 1 in which the balloon annulus ratio was 1.3 or less and group 2 in which the balloon annulus ratio was more than 1.3. The balloon annulus ratio in group 1 had a median of
ACCEPTED MANUSCRIPT 1.25 compared to a median of 1.5 in group 2. There was no significant difference between the 2 groups as regard age at time of BPV (P = 0.75) as well as the follow up duration (P = 0.58). There was no significant difference between the two groups as regard the baseline pressure gradient (P = 0.099). Both groups showed significant decrease in pressure gradient across the
IP
T
pulmonary valve at follow up which was not significantly different between the 2 groups (P = 0.43) (Figure 4). Group 1 had 76.07+/- 11% drop in pressure gradient across the pulmonary
US
reduction in pressure gradient at follow up (P = 0.79).
CR
valve at follow up compared to baseline gradient before BPV while group 2 had 76.8+/-14.2%
There was no significant difference between the 2 groups as regard RV FAC at follow up. The
AN
RV FAC was 44.9 +/- 9.8% in group 1 compared to 46.2+/-10.7% in group 2 (P = 0.63),
M
however the TAPSE was 1.95+/-0.15 in group 1 compared to 2.07 +/- 0.26 in group 2 (P = 0.04).
ED
Although both groups showed significant difference as regard the pulmonary valve annulus and its Z score at baseline (P = 0.04 & 0.02 respectively), this difference was abolished at follow up
PT
due to adequate growth of the pulmonary annulus and improvement of its Z score (P = 0.17 &
CE
0.11 respectively) irrespective of the balloon annulus ratio.
AC
At follow up, there was significant difference between the two groups as regard pulmonary regurgitation. Group (1) had lower degree of PR as 16.3% had no PR, 74.4% had mild PR, 7% had moderate PR and 2.3 % had severe PR, while Group (2) had higher degree of PR as 63% had mild PR, 29.6% had moderate PR and 7.4% had severe PR (P = 0.01) (Figure 5). There was also significant difference between the 2 groups as regard tricuspid regurgitation at follow up, 97.7% of patients in group 1 had mild TR (n=42) and 2.3% had moderate TR (n=1) compared to 74.1%
ACCEPTED MANUSCRIPT of patients in group 2 who had mild TR (n=20) and 25.9% who had moderate TR (n=7) (P = 0.008) (Figure 6).
Discussion
IP
T
BPV popularity has increased over time as more studies have confirmed its efficacy and relative (12)
. Current practice is the
CR
safety with respect to immediate, short-term, and long-term effects
use of a balloon annulus ratio from 1.2 to 1.4 so as to ensure significant decrease in gradient
US
pressure and lessen the probability of re intervention. In a study by Yu ZX in 2009, 65 patients ranged from 1 to 48 years with isolated PS were diagnosed by echocardiography and received
AN
balloon valvuloplasty. The ratio of balloon/valve ranged from 1.00 to 1.19 in 19 patients, from
M
1.20 to 1.39 in 42 patients, and greater than 1.40 in 4 patients. Superior outcome was linked with
ED
balloon/valve ratio between1.20 to 1.39 (13).
In the current study there was a gradual and continuous reduction of pressure gradient after
PT
initial valvuloplasty throughout a mean follow up period of 2.88 +/- 1.4 years. There was also a
CE
significant increase in the mean PV annulus diameter after balloon dilatation. This was consistent with the data obtained by Saad et al
(14)
despite that our study group were older and were
AC
followed up for a longer period of time than their patients. PR was thought to be well tolerated in the past but recent studies proved the detrimental effects of significant pulmonary insufficiency on the RV size, functions and functional capacity (3, 4). PR remains the main post procedural complication post BPV with a great impact on the patient’s symptoms and future need for pulmonary valve replacement. In the current study, there was a significant increase in patients with PR during follow up; however, most of these patients (70%) had mild PR. These results were consistent with those of
ACCEPTED MANUSCRIPT Al Balushi AY et al. (15), where 50 consecutive patients who underwent BPV were analyzed. The authors found that 32 patients (64%) had mild pulmonary valve regurgitation. Harrild et al. (16)
studied 41 patients with a mean follow-up of 13.1 years and found a significant percentage of
moderate pulmonary regurgitation and mild ventricular dilatation, although severe regurgitation
IP
(14)
in which the authors found that the severity of PR
CR
Based on the results of Saad et al
T
or dilatation was very rare.
correlated with the increase in balloon/annulus ratio and that patients who developed mild PR
US
had a balloon annulus ratio of 1.29 +/- 0.05 we sought to divide the study group into 2 subgroups with a cutoff point for balloon annulus ratio of 1.3. Rao S (1) stated that a balloon annulus ratio of
AN
1.2 to 1.25 may produce optimal results. In the current study there was no significant difference
M
regarding pressure gradient at follow up (P=0.43) or regarding percentage of change in pressure gradient over the follow up period (P=0.79) between the 2 sub groups. However, there was a
ED
significant difference between the two groups regarding the degree of pulmonary regurgitation
PT
favoring group 1 with balloon annulus ratio ≤ 1.3. These results were in agreement with those of Pathak SJ et al.(17) who confirmed that procedural
CE
success defined as gradient reduction at follow up in BPV could be achieved regardless of the
AC
balloon annulus ratio, however better outcome regarding PR occurred in patients with balloon annulus ratio < 1.2. Our data differed from those of Pathak SJ et al concerning the cutoff point of the balloon annulus ratio used as well as the patient’s age and duration of follow up; our patients were older and were followed up for a longer period of time. Unlike the arbitrary cutoff point of 1.2 our cutoff point for balloon annulus ratio ≤ 1.3 was based on data from previous study
(14)
as
well as the cutoff point generated with the highest balanced sensitivity and specificity generated by ROC curve analysis of the whole study group in our study. It is worth mentioning that in the
ACCEPTED MANUSCRIPT study by Pathak SJ et al the group with balloon annulus ratio < 1.2 had a range of 0.89 to 1.2 with median of 1.1 and had an immediate pressure gradient post BPV of 27.7 mmHg, whereas Rao S (1) stated that predictors of re stenosis include balloon annulus ratio < 1.2 and immediate pressure gradient post BPV of 30 mmHg or more.
T
Study limitations.
IP
Although the use of smaller balloon annulus ratio is in favor of achieving successful reduction in
CR
pressure gradient post BPV and at the same time decrease the possibility of significant PR, further longer term follow up is needed to determine whether smaller balloon annulus ratio than
US
the postulated cutoff point in this study will increase late re stenosis rate. Perhaps a comparative
AN
study between a balloon annulus ratio < 1.2 and that of 1.2-1.3 can address the issue of re
M
stenosis rate to complete the data achieved in the current study. Further longer-term follow up studies (10-20 years) and lifelong clinical follow up is needed to
ED
evaluate the significance of residual PR post BPV.
PT
Conclusions:
CE
While the recommendation to use balloons 1.2–1.4 times the annulus are generally followed, recent reports of pulmonary insufficiency at late follow-up raised concerns regarding the balloon
AC
size. Using a balloon: annulus ratio of 1.2 to 1.3 in BPV provides the best procedural success rates regarding effective reduction in the Peak pressure gradient across the PV with reduced need for re-intervention at follow up and less post-balloon pulmonary regurgitation, the use of a larger balloon: annulus ratio >1.3 offers no advantage to the patient as both groups have similar gradient reduction, similar re intervention rates in a 2 to 8 years follow up period but the group with smaller balloon annulus ratio had less incidence of pulmonary insufficiency at follow up.
ACCEPTED MANUSCRIPT
Compliance with ethical standards:
IP
T
No funding was available for this study
CR
Conflict of interest: All authors declare that there is no conflict of interest
US
This study was approved by our institutional review board and informed consent
AN
was obtained from the parents of all the children enrolled in the study. The study
AC
CE
PT
ED
M
protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki.
ACCEPTED MANUSCRIPT
Figure legends Figure 1: Two dimensional echocardiogram in patient number 16 showing (A) parasternal short
T
axis view to measure pulmonary valve annulus and MPA (B) supra sternal crab view to measure
IP
RPA.
CR
Figure 2: Two dimensional and color flow echocardiogram in parasternal short axis view in
US
patient number 4 showing severe pulmonary regurgitation with jet diameter occupying more than 60% of the pulmonary annulus diameter and color flow reversal extending to the pulmonary
AN
branches.
M
Figure 3: ROC curve analysis to generate a balloon annulus ratio cutoff point with highest
ED
balanced sensitivity and specificity to predict mild or no PR at follow up Figure 4: A trend graph showing the progressive drop in the pressure gradient across the
PT
pulmonary valve throughout the follow-up period in both groups
AC
both groups
CE
Figure 5: Column graph comparing degree of pulmonary regurgitation at follow-up between
Figure 6: Column graph comparing degree of tricuspid regurgitation at follow-up between both groups
ACCEPTED MANUSCRIPT Tables Table 1: Demographic characteristics of the study groups Table 2: Comparison between different parameters measured before and after BPV
IP
T
Table 3: Comparison between group 1 and group 2 as regard different
AC
CE
PT
ED
M
AN
US
CR
parameters measured
ACCEPTED MANUSCRIPT
References 1- Rao PS. Percutaneous balloon pulmonary valvuloplasty: state of the art. Catheterization
T
and Cardiovascular Interventions. 2007; 69(5):747-63.
IP
2- Janus B, Krol-Jawien W, Demkow M, et al. Pulmonary Artery Dissection: A Rare
Procedure. J Am Soc Echocardiogr 2006; 19:1191.
CR
Complication of Pulmonary Balloon Valvuloplasty Diagnosed 11 Years After the
US
3- Radtke W, Keane JF, Fellows KE, Lang P, Lock JE. Percutaneous balloon valvotomy of congenital pulmonary stenosis using oversized balloons. J Am Coll Cardiol 1986; 8:909–
AN
915.
4- Ammash NM, Dearani JA, Burkhart HM, Connolly HM. Pulmonary regurgitation after
M
tetralogy of Fallot repair: clinical features, sequelae, and timing of pulmonary valve
ED
replacement. Congenit Heart Dis. 2007; 2:386–403. 5- Aldoss O, Gruenstein D. Percutaneous balloon pulmonary valvuloplasty. Pediatr
PT
Therapeut. 2012; S5:003.
6- Baumgartner H, Hung J,
Bermejo J, et al. Echocardiographic assessment of valve
CE
stenosis: EAE/ASE recommendations for clinical practice European Journal of
AC
Echocardiography, 2009, 10, 1–25 7- Lancellotti P, Tribouilloy C, Hagendorff A, Popescu B, Edvardsen T, et al. Recommendations for the echocardiographic assessment of native valvular regurgitation: an executive summary from the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging 2013; 14 (7): 611-644 8- Mercer-Rosa L, Yang W, Kutty S, et al. Quantifying Pulmonary Regurgitation and Right Ventricular Function in Surgically Repaired Tetralogy of Fallot: A Comparative Analysis
ACCEPTED MANUSCRIPT of Echocardiography and Magnetic Resonance Imaging. Circulation Cardiovascular imaging. 2012; 5(5):637-643. 9- Gildein, H.P., Kleinert, S., Goh, T.H., Wilkinson, J.L. Treatment of critical pulmonary valve stenosis by balloon dilatation in the neonate. Am. Heart J. 1996; 131 (5): 1007–
IP
T
1011.
CR
10- Ling LF, Marwick TH. Echocardiographic Assessment of Right Ventricular Function JACC cardiovascular imaging 2012; 5(7): 747-753.
US
11- Kossaify A. Echocardiographic assessment of the right ventricle from the conventional
AN
approach to speckle tracking, three dimensional imaging and insights into the “right way” to explore the forgotten chamber. Clinical Medicine Insights cardiology, 2015; 9:65-75.
ED
Intervent. 2007; 69(5):747–763.
M
12- Rao PS. Percutaneous balloon pulmonary valvuloplasty: state of the art. Cathet Cardiovas
PT
13- Yu ZX, Ma YT, Yang YN, et al. [Outcome of percutaneous balloon pulmonary valvuloplasty for patients with pulmonary valve stenosis]. Zhonghua xin xue guan bing
CE
za zhi. 2009; 37(11):1006-9.
AC
14- Saad M, Roushdy A, El sayed M. Immediate and medium term effects of balloon pulmonary valvuloplasty in infants with critical pulmonary stenoses during the first year of life. A prospective single center study. Journal of the Saudi Heart Association, 2010; 22: 195–201 15- Al Balushi AY, Al Shuaili H, Al Khabori M, et al. Pulmonary valve regurgitation following balloon valvuloplasty for pulmonary valve stenosis: Single center experience. Annals of Pediatric Cardiology. 2013; 6(2):141-144.
ACCEPTED MANUSCRIPT 16- Harrild DM, Powell AJ, Trang TX, et al. Long-term pulmonary regurgitation following balloon valvuloplasty for pulmonary stenosis: risk factors and relationship to exercise capacity and ventricular volume and function. Journal of the American College of Cardiology. 2010; 55(10):1041-7.
T
17- Pathak SJ, Pockett CR, Moore JW, et al. Effect of Balloon: Annulus Ratio on Incidence
11:415–419.
AN
US
Abbreviation list
CR
IP
of Pulmonary Insufficiency Following Valvuloplasty. Congenital heart disease. 2016;
M
Abbreviations
= balloon pulmonary valvuloplasty
RV
= right ventricle
AHA
= American heart association
TV
= tricuspid valve
PT
ED
BPV
= pulmonary valve
TAPSE
=tricuspid annular peak systolic excursion
FAC
= Fractional area change
PR TR
AC
PG
CE
PV
= pressure gradient
= pulmonary regurgitation
= Tricuspid regurgitation
PT
ED
M
AN
US
CR
IP
T
ACCEPTED MANUSCRIPT
AC
CE
Figure 1
M
AN
US
CR
IP
T
ACCEPTED MANUSCRIPT
AC
CE
PT
ED
Figure 2
Figure 3
US
CR
IP
T
ACCEPTED MANUSCRIPT
AC
CE
PT
ED
M
AN
Figure 4
Figure 5
US
CR
IP
T
ACCEPTED MANUSCRIPT
AC
CE
PT
ED
M
AN
Figure 6
ACCEPTED MANUSCRIPT
Tables Table 1: Demographic characteristics of the study groups
Group 2
N=43
N=27
T
Group 1
Age at BPV (mean+/- SD) in years
2.35+-2.2
Weight (mean+/- SD) in kilograms
12.17+-7.8 2
0.51+-0.21
M
Body surface area (mean+/- SD) in m
16/11
US
26/17
AN
Gender (M/F)
CR
IP
Characteristics
Age at follow up
AC
CE
PT
ED
Follow up duration
2.17+-2.42 12.04+-7.4 0.50+/-0.22
5.16+-2.75
5.63+-3.39
2.81+-1.48
3.0+-1.37
ACCEPTED MANUSCRIPT Table (2): Comparison between different parameters measured before and after BPV: At follow up
p-value
PV annulus
10.93±2.75
14.75 ± 3.32
0.000
PG
81.06±20.75
18.46 ± 8.25
0.000
63 (90.0%)
62 (88.6%)
Moderate
3 (4.3%)
8 (11.4%)
Severe
4 (5.7%)
0 (0.0%)
No PR
68 (97.1%)
7 (10.0%)
Mild
2 (2.9%)
49 (70.0%)
Moderate
0 (0.0%)
11 (15.7%)
Severe
0 (0.0%)
3 (4.3%)
106.07±25.48
26.90 ± 5.96
PR
AC
CE
PT
ED
M
AN
RV pressure
IP
0.009
CR
TR
US
Mild
T
Pre cath.
0.000
0.000
ACCEPTED MANUSCRIPT Table 3: Comparison between group 1 and group 2 as regard different parameters measured Independent sample T test
Study group variables
(Balloon annulus ratio ≤ 1.3)
(Balloon annulus ratio > 1.3)
t
P
100.116
+-
20.5429
115.556
+-
29.8178
2.362
0.0229
Baseline PG across pulmonary valve
77.465
+-
16.3523
86.778
+-
25.5920
1.687
0.0996
Baseline Pulmonary valve annulus
11.663
+-
2.8509
9.759
+-
-2.975
0.0040
Baseline Pulmonary valve annulus z score
-1.005
+-
0.9486
-1.677
Size of balloon used
14.605
+-
3.4236
14.320
RVSP at follow up
26.209
+-
4.7537
28.000
PG across pulmonary valve at follow up
19.233
+-
9.6383
%of change in PG
76.07
+-
11.41
Pulmonary valve annulus
14.279
+-
2.7400
Pulmonary valve annulus z score
0.196
+-
RV FAC
44.933
RV TAPSE MPA
LP Z SCORE
CR
0.0024
+-
3.2624
-0.336
0.7377
+-
7.4730
1.112
0.2730
17.778
+-
5.8660
-0.785
0.4352
76.88
+-
14.24
0.263
0.794
15.496
+-
4.0331
1.381
0.1748
1.2683
0.881
+-
1.9904
1.597
0.1184
+-
9.8304
46.122
+-
10.7188
0.476
0.6356
1.958
+-
0.1500
2.074
+-
0.2625
2.091
0.0435
15.400
+-
2.6300
17.996
+-
3.2130
3.688
0.0005
1.7750
3.459
3.645
0.0005
1.7664
11.778
0.983
0.3292
2.0813
3.506
1.023
0.3100
1.4859
11.722
1.045
0.2999
1.7907
3.500
1.080
0.2839
ED
PT
1.671
11.356 2.987
11.333 3.017
M
-3.153
US
RPA Z SCORE LPA
0.7219
CE
RPA
2.1507
+-
AC
MPA Z SCORE
T
Baseline RVSP
IP
Group 2
AN
Group 1
+++++-
+++++-
2.3099 1.7192 2.0503 1.5710 1.8654
Alaa Mahmoud Roushdy, Rana Salah Eldin, Dina Adel Ezz Eldin PII: DOI: Reference:
S1058-9813(16)30152-7 doi: 10.1016/j.ppedcard.2017.05.004 PPC 991
To appear in:
Progress in Pediatric Cardiology
Received date: Revised date: Accepted date:
15 December 2016 ###REVISEDDATE### 5 May 2017
Please cite this article as: Alaa Mahmoud Roushdy, Rana Salah Eldin, Dina Adel Ezz Eldin , Effect of balloon annulus ratio on the outcome post balloon pulmonary valvuloplasty in children, Progress in Pediatric Cardiology (2017), doi: 10.1016/j.ppedcard.2017.05.004
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Title page
Effect of balloon annulus ratio on the outcome post balloon pulmonary valvuloplasty in children
IP
T
Alaa Mahmoud Roushdy, MD, Rana Salah eldin, MSC, Dina Adel Ezz Eldin, MD
CR
Authors' affiliation:
US
Cardiology Department – Ain Shams University Hospital – Cairo - Egypt
AN
No relationship with industry exist for any of the above mentioned authors
M
Correspondence:
AC
CE
PT
ED
Dr. Dina Adel, MD. Cardiology Department – Ain Shams University Hospital Abbassya – Cairo – Egypt Fax 202 24820416 Email: [email protected]
ACCEPTED MANUSCRIPT Manuscript Title page
Effect of balloon annulus ratio on the outcome post balloon pulmonary valvuloplasty in children
CR
IP
T
Alaa Mahmoud Roushdy, MD, Rana Salah eldin, MSC, Dina Adel Ezz Eldin, MD
Authors' affiliation:
US
Cardiology Department – Ain Shams University Hospital – Cairo - Egypt
M
AN
No relationship with industry exist for any of the above mentioned authors
Correspondence:
AC
CE
PT
ED
Dr. Dina Adel, MD. Cardiology Department – Ain Shams University Hospital Abbassya – Cairo – Egypt Fax 202 24820416 Email: [email protected]
ACCEPTED MANUSCRIPT Abstract BACKGROUND AND OBJECTIVES Balloon pulmonary valvuloplasty (BPV) has been the treatment of choice for valvular pulmonary stenosis, the success of the procedure largely depends on the proper balloon size choice, which is based on pulmonary valve annulus measurement. We sought to establish a balloon annulus ratio
T
that could achieve the least side effects and the best results post BPV.
CR
IP
METHODS The study included 70 patients with valvular pulmonary stenosis who underwent BPV 2-8 years before and were coming for routine follow up echocardiography post BPV at Ain shams
US
university hospital from August 2015 to February 2016. All patients had a detailed revision of their records including the BPV procedure report and the immediate follow up echocardiogram
AN
together with a full echocardiographic study at time of presentation. RESULTS
M
The median age of the study group at time of procedure was 2.39 years. The patients were divided based on their balloon annulus ratio into two groups: group 1 with balloon annulus ration
ED
≤1.3 (n = 43) and group 2 with balloon annulus ratio >1.3 (n = 27). At follow up, BPV was successful in 95.7% of the cases. Pulmonary valve systolic pressure gradient decreased from
PT
81.06±20.75 to 18.46±8.25 mmHg immediately after BPV and to 20.81±5.79 mmHg at late follow up (P=0.000).The difference in pulmonary gradient reduction was not significant between
CE
the two groups (P = 0.79). Although both groups had an increase in pulmonary valve insufficiency from baseline, group 1 had significantly less pulmonary insufficiency (P =0 .011).
AC
Conclusion
Using a more conservative balloon annulus ratio of ≤1.3 for BPV would achieve better results in terms of effective gradient reduction, less re-intervention for the pulmonary valve later in life and less pulmonary insufficiency.
Key words: Pulmonary valve, Balloon pulmonary valvuloplasty, pulmonary insufficiency
ACCEPTED MANUSCRIPT Introduction Pulmonary stenosis is the second most common congenital cardiac malformation which comprises of 7.5–9% of all congenital heart defects. Surgical valvotomy used to be the treatment of choice; however, since its introduction by Kan et al in 1982, balloon valvuloplasty has gained
IP
T
acceptance as the first option in the management of congenital pulmonary valve stenosis. (1) The procedure provides long-term relief of pulmonary valvular obstruction in the majority of
(2, 3)
However the procedure is not without
US
1.4 makes the procedure effective and safe.
CR
patients. The use of oversized balloons is recommended and a balloon-to-annulus ratio of 1.2 to
complications one of which is pulmonary insufficiency with an incidence 44- 88 %
(4)
.
M
necessitate pulmonary valve replacement. (5)
AN
Pulmonary insufficiency can cause RV dilatation, limited functional capacity and may
ED
So although the safety and efficacy of the procedure is well studied, optimizing the outcome of the procedure is still an area of active research, in this study we intend to evaluate the effect of
Methods
CE
PT
balloon annulus ratio choice on procedural outcome.
This study was approved by our institutional review board and informed consent was obtained
AC
from the parents of all the children enrolled in the study. The study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki.
This was a retrospective cross sectional study which included all patients who came for follow up echocardiography at Ain Shams university hospital post BPV over a period of 6 months ending February 2016. The study included 70 patients with the following inclusion criteria
ACCEPTED MANUSCRIPT patients younger than 16 years of age who had isolated valvular pulmonary stenosis and who underwent BPV at least 2 years before.
Data collection: All patients’ records were revised and a custom made sheet was done to include the following:
IP
T
1-Patient demographic data including age at time of procedure, gender, body weight, body
CR
surface area. 2- Pre BPV echocardiographic data including; pulmonary valve annulus, peak pressure gradient across the pulmonary valve, valve morphology, degree of tricuspid
US
regurgitation, right ventricular size and functions and 3- procedural data including the pre and post procedure pressure gradient, pulmonary valve annulus, balloon type and balloon size used,
M
Follow up echocardiogram:
AN
balloon annulus ratio and any intra or immediate post procedure complications
ED
All patients underwent full echocardiographic study at time of presentation using a Philips Ie33 machine. The pulmonary valve was evaluated from the parasternal short-axis and long-axis
PT
views as well as the sub costal sagittal views. The valve leaflets were evaluated regarding
CE
thickness and systolic motion. The degree of stenosis was classified according to the AHA guidelines into mild: peak pressure gradient less than 36 mmHg, moderate: peak pressure (3)
. The
AC
gradient between 36 and 64 mmHg and severe: peak pressure gradient above 64 mmHg
pulmonary valve annulus was measured in the parasternal short axis view. The main pulmonary artery and branches were measured in the high parasternal short axis and crab views and the largest diameter was recorded (6) (Figure 1) Pulmonary regurgitation was assessed in parasternal short axis view by color flow mapping and graded as none, mild, or greater than mild using visual inspection of the width of the regurgitant jet in relation to the outflow tract diameter, vena contracta width and extent of regurgitation into
ACCEPTED MANUSCRIPT the pulmonary tree in collaboration according to the recommendation of the European Association of cardiovascular imaging (7) (Figure 2) The RV dimensions were then assessed from apical 4 chamber, modified RV focused view and sub costal views. Three measurements were taken, the RV longitudinal dimension, transverse (8)
. PV annulus and
T
mid cavity dimension and TV annulus diameter, all obtained at end diastole
IP
its Z-value and tricuspid valve annulus and its Z-value (Z-value was used to standardize
CR
pulmonary and tricuspid valves dimensions with body size). Z-scores <2 were taken to represent a small valve annulus while Z scores <3 marked a hypoplastic valve annulus (9).
US
RV function was assessed by tricuspid annular peak systolic excursion (TAPSE) by M mode and
AN
fractional area change (FAC) which was estimated by tracing the RV in the apical four chamber view to obtain the end diastolic and the end systolic area then the percentage change between
M
them was calculated according to the following equation: Fractional area change
= (end-
ED
diastolic area – end-systolic area)/end-diastolic area x 100. A fractional area change of >32.2%
Statistical analysis
PT
was used to define normal RV function (10, 11)
CE
All data were collected, tabulated, and statistically analyzed. Patient and procedural
AC
characteristics were tabulated and reported as frequencies or medians. Continuous variables were expressed as mean plus or minus standard deviation, and categorical variables were expressed as a percentage. Statistical significance was assessed by paired as well as independent sample t-test for numerical values and Chi-square test for categorical values. ROC curve analysis was done to generate a cutoff point for balloon annuls ratio with the highest balanced sensitivity and specificity to predict no or mild PR post BPV. Values were considered significantly different when p was less than 0.05.
ACCEPTED MANUSCRIPT
Results The study included 28 females (40 %) and 42 males (60 %) with a mean age of 2.39 years (range
IP
Demographic characteristics of both groups are listed in Table 1.
T
from 1 month to 8.5 years) at time of BPV. The mean follow up period was 2.88 +/- 1.43 years.
CR
There was a highly significant drop in pressure gradient from a mean of 81.06 ± 20.75 mmHg to
US
a mean of 20.81 ± 5.79 mm Hg immediately after BPV, this drop in the PG was maintained during the follow-up with a mean of 18.46 ± 8.25 mm Hg. At follow up, there was a significant
AN
increase in patients with PR compared to baseline before BPV, 49% had mild PR, 15.7% had
M
moderate PR, and 4.3% had severe PR compared to only 2 patients who had mild PR before BPV. There was a significant increase in patients with moderate TR from 4.3% before BPV to
ED
11.4% at follow up and a significant decrease in patients with severe TR from 5.7% before BPV
PT
to 0% at follow up after BPV. (Table 2)
CE
ROC curve analysis was done to generate a cutoff point for balloon annulus ratio with the highest balanced sensitivity and specificity that would result in mild or no PR at follow up. A
AC
cutoff point for balloon annulus ratio of ≤ 1.36 had 75% sensitivity and 71.4% specificity to predict no or mild PR post BPV with area under the curve of 0.707 and P value of 0.009 (Figure 3).
We subdivided the study group into 2 subgroups based on the balloon annulus ratio used during BPV; group 1 in which the balloon annulus ratio was 1.3 or less and group 2 in which the balloon annulus ratio was more than 1.3. The balloon annulus ratio in group 1 had a median of
ACCEPTED MANUSCRIPT 1.25 compared to a median of 1.5 in group 2. There was no significant difference between the 2 groups as regard age at time of BPV (P = 0.75) as well as the follow up duration (P = 0.58). There was no significant difference between the two groups as regard the baseline pressure gradient (P = 0.099). Both groups showed significant decrease in pressure gradient across the
IP
T
pulmonary valve at follow up which was not significantly different between the 2 groups (P = 0.43) (Figure 4). Group 1 had 76.07+/- 11% drop in pressure gradient across the pulmonary
US
reduction in pressure gradient at follow up (P = 0.79).
CR
valve at follow up compared to baseline gradient before BPV while group 2 had 76.8+/-14.2%
There was no significant difference between the 2 groups as regard RV FAC at follow up. The
AN
RV FAC was 44.9 +/- 9.8% in group 1 compared to 46.2+/-10.7% in group 2 (P = 0.63),
M
however the TAPSE was 1.95+/-0.15 in group 1 compared to 2.07 +/- 0.26 in group 2 (P = 0.04).
ED
Although both groups showed significant difference as regard the pulmonary valve annulus and its Z score at baseline (P = 0.04 & 0.02 respectively), this difference was abolished at follow up
PT
due to adequate growth of the pulmonary annulus and improvement of its Z score (P = 0.17 &
CE
0.11 respectively) irrespective of the balloon annulus ratio.
AC
At follow up, there was significant difference between the two groups as regard pulmonary regurgitation. Group (1) had lower degree of PR as 16.3% had no PR, 74.4% had mild PR, 7% had moderate PR and 2.3 % had severe PR, while Group (2) had higher degree of PR as 63% had mild PR, 29.6% had moderate PR and 7.4% had severe PR (P = 0.01) (Figure 5). There was also significant difference between the 2 groups as regard tricuspid regurgitation at follow up, 97.7% of patients in group 1 had mild TR (n=42) and 2.3% had moderate TR (n=1) compared to 74.1%
ACCEPTED MANUSCRIPT of patients in group 2 who had mild TR (n=20) and 25.9% who had moderate TR (n=7) (P = 0.008) (Figure 6).
Discussion
IP
T
BPV popularity has increased over time as more studies have confirmed its efficacy and relative (12)
. Current practice is the
CR
safety with respect to immediate, short-term, and long-term effects
use of a balloon annulus ratio from 1.2 to 1.4 so as to ensure significant decrease in gradient
US
pressure and lessen the probability of re intervention. In a study by Yu ZX in 2009, 65 patients ranged from 1 to 48 years with isolated PS were diagnosed by echocardiography and received
AN
balloon valvuloplasty. The ratio of balloon/valve ranged from 1.00 to 1.19 in 19 patients, from
M
1.20 to 1.39 in 42 patients, and greater than 1.40 in 4 patients. Superior outcome was linked with
ED
balloon/valve ratio between1.20 to 1.39 (13).
In the current study there was a gradual and continuous reduction of pressure gradient after
PT
initial valvuloplasty throughout a mean follow up period of 2.88 +/- 1.4 years. There was also a
CE
significant increase in the mean PV annulus diameter after balloon dilatation. This was consistent with the data obtained by Saad et al
(14)
despite that our study group were older and were
AC
followed up for a longer period of time than their patients. PR was thought to be well tolerated in the past but recent studies proved the detrimental effects of significant pulmonary insufficiency on the RV size, functions and functional capacity (3, 4). PR remains the main post procedural complication post BPV with a great impact on the patient’s symptoms and future need for pulmonary valve replacement. In the current study, there was a significant increase in patients with PR during follow up; however, most of these patients (70%) had mild PR. These results were consistent with those of
ACCEPTED MANUSCRIPT Al Balushi AY et al. (15), where 50 consecutive patients who underwent BPV were analyzed. The authors found that 32 patients (64%) had mild pulmonary valve regurgitation. Harrild et al. (16)
studied 41 patients with a mean follow-up of 13.1 years and found a significant percentage of
moderate pulmonary regurgitation and mild ventricular dilatation, although severe regurgitation
IP
(14)
in which the authors found that the severity of PR
CR
Based on the results of Saad et al
T
or dilatation was very rare.
correlated with the increase in balloon/annulus ratio and that patients who developed mild PR
US
had a balloon annulus ratio of 1.29 +/- 0.05 we sought to divide the study group into 2 subgroups with a cutoff point for balloon annulus ratio of 1.3. Rao S (1) stated that a balloon annulus ratio of
AN
1.2 to 1.25 may produce optimal results. In the current study there was no significant difference
M
regarding pressure gradient at follow up (P=0.43) or regarding percentage of change in pressure gradient over the follow up period (P=0.79) between the 2 sub groups. However, there was a
ED
significant difference between the two groups regarding the degree of pulmonary regurgitation
PT
favoring group 1 with balloon annulus ratio ≤ 1.3. These results were in agreement with those of Pathak SJ et al.(17) who confirmed that procedural
CE
success defined as gradient reduction at follow up in BPV could be achieved regardless of the
AC
balloon annulus ratio, however better outcome regarding PR occurred in patients with balloon annulus ratio < 1.2. Our data differed from those of Pathak SJ et al concerning the cutoff point of the balloon annulus ratio used as well as the patient’s age and duration of follow up; our patients were older and were followed up for a longer period of time. Unlike the arbitrary cutoff point of 1.2 our cutoff point for balloon annulus ratio ≤ 1.3 was based on data from previous study
(14)
as
well as the cutoff point generated with the highest balanced sensitivity and specificity generated by ROC curve analysis of the whole study group in our study. It is worth mentioning that in the
ACCEPTED MANUSCRIPT study by Pathak SJ et al the group with balloon annulus ratio < 1.2 had a range of 0.89 to 1.2 with median of 1.1 and had an immediate pressure gradient post BPV of 27.7 mmHg, whereas Rao S (1) stated that predictors of re stenosis include balloon annulus ratio < 1.2 and immediate pressure gradient post BPV of 30 mmHg or more.
T
Study limitations.
IP
Although the use of smaller balloon annulus ratio is in favor of achieving successful reduction in
CR
pressure gradient post BPV and at the same time decrease the possibility of significant PR, further longer term follow up is needed to determine whether smaller balloon annulus ratio than
US
the postulated cutoff point in this study will increase late re stenosis rate. Perhaps a comparative
AN
study between a balloon annulus ratio < 1.2 and that of 1.2-1.3 can address the issue of re
M
stenosis rate to complete the data achieved in the current study. Further longer-term follow up studies (10-20 years) and lifelong clinical follow up is needed to
ED
evaluate the significance of residual PR post BPV.
PT
Conclusions:
CE
While the recommendation to use balloons 1.2–1.4 times the annulus are generally followed, recent reports of pulmonary insufficiency at late follow-up raised concerns regarding the balloon
AC
size. Using a balloon: annulus ratio of 1.2 to 1.3 in BPV provides the best procedural success rates regarding effective reduction in the Peak pressure gradient across the PV with reduced need for re-intervention at follow up and less post-balloon pulmonary regurgitation, the use of a larger balloon: annulus ratio >1.3 offers no advantage to the patient as both groups have similar gradient reduction, similar re intervention rates in a 2 to 8 years follow up period but the group with smaller balloon annulus ratio had less incidence of pulmonary insufficiency at follow up.
ACCEPTED MANUSCRIPT
Compliance with ethical standards:
IP
T
No funding was available for this study
CR
Conflict of interest: All authors declare that there is no conflict of interest
US
This study was approved by our institutional review board and informed consent
AN
was obtained from the parents of all the children enrolled in the study. The study
AC
CE
PT
ED
M
protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki.
ACCEPTED MANUSCRIPT
Figure legends Figure 1: Two dimensional echocardiogram in patient number 16 showing (A) parasternal short
T
axis view to measure pulmonary valve annulus and MPA (B) supra sternal crab view to measure
IP
RPA.
CR
Figure 2: Two dimensional and color flow echocardiogram in parasternal short axis view in
US
patient number 4 showing severe pulmonary regurgitation with jet diameter occupying more than 60% of the pulmonary annulus diameter and color flow reversal extending to the pulmonary
AN
branches.
M
Figure 3: ROC curve analysis to generate a balloon annulus ratio cutoff point with highest
ED
balanced sensitivity and specificity to predict mild or no PR at follow up Figure 4: A trend graph showing the progressive drop in the pressure gradient across the
PT
pulmonary valve throughout the follow-up period in both groups
AC
both groups
CE
Figure 5: Column graph comparing degree of pulmonary regurgitation at follow-up between
Figure 6: Column graph comparing degree of tricuspid regurgitation at follow-up between both groups
ACCEPTED MANUSCRIPT Tables Table 1: Demographic characteristics of the study groups Table 2: Comparison between different parameters measured before and after BPV
IP
T
Table 3: Comparison between group 1 and group 2 as regard different
AC
CE
PT
ED
M
AN
US
CR
parameters measured
ACCEPTED MANUSCRIPT
References 1- Rao PS. Percutaneous balloon pulmonary valvuloplasty: state of the art. Catheterization
T
and Cardiovascular Interventions. 2007; 69(5):747-63.
IP
2- Janus B, Krol-Jawien W, Demkow M, et al. Pulmonary Artery Dissection: A Rare
Procedure. J Am Soc Echocardiogr 2006; 19:1191.
CR
Complication of Pulmonary Balloon Valvuloplasty Diagnosed 11 Years After the
US
3- Radtke W, Keane JF, Fellows KE, Lang P, Lock JE. Percutaneous balloon valvotomy of congenital pulmonary stenosis using oversized balloons. J Am Coll Cardiol 1986; 8:909–
AN
915.
4- Ammash NM, Dearani JA, Burkhart HM, Connolly HM. Pulmonary regurgitation after
M
tetralogy of Fallot repair: clinical features, sequelae, and timing of pulmonary valve
ED
replacement. Congenit Heart Dis. 2007; 2:386–403. 5- Aldoss O, Gruenstein D. Percutaneous balloon pulmonary valvuloplasty. Pediatr
PT
Therapeut. 2012; S5:003.
6- Baumgartner H, Hung J,
Bermejo J, et al. Echocardiographic assessment of valve
CE
stenosis: EAE/ASE recommendations for clinical practice European Journal of
AC
Echocardiography, 2009, 10, 1–25 7- Lancellotti P, Tribouilloy C, Hagendorff A, Popescu B, Edvardsen T, et al. Recommendations for the echocardiographic assessment of native valvular regurgitation: an executive summary from the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging 2013; 14 (7): 611-644 8- Mercer-Rosa L, Yang W, Kutty S, et al. Quantifying Pulmonary Regurgitation and Right Ventricular Function in Surgically Repaired Tetralogy of Fallot: A Comparative Analysis
ACCEPTED MANUSCRIPT of Echocardiography and Magnetic Resonance Imaging. Circulation Cardiovascular imaging. 2012; 5(5):637-643. 9- Gildein, H.P., Kleinert, S., Goh, T.H., Wilkinson, J.L. Treatment of critical pulmonary valve stenosis by balloon dilatation in the neonate. Am. Heart J. 1996; 131 (5): 1007–
IP
T
1011.
CR
10- Ling LF, Marwick TH. Echocardiographic Assessment of Right Ventricular Function JACC cardiovascular imaging 2012; 5(7): 747-753.
US
11- Kossaify A. Echocardiographic assessment of the right ventricle from the conventional
AN
approach to speckle tracking, three dimensional imaging and insights into the “right way” to explore the forgotten chamber. Clinical Medicine Insights cardiology, 2015; 9:65-75.
ED
Intervent. 2007; 69(5):747–763.
M
12- Rao PS. Percutaneous balloon pulmonary valvuloplasty: state of the art. Cathet Cardiovas
PT
13- Yu ZX, Ma YT, Yang YN, et al. [Outcome of percutaneous balloon pulmonary valvuloplasty for patients with pulmonary valve stenosis]. Zhonghua xin xue guan bing
CE
za zhi. 2009; 37(11):1006-9.
AC
14- Saad M, Roushdy A, El sayed M. Immediate and medium term effects of balloon pulmonary valvuloplasty in infants with critical pulmonary stenoses during the first year of life. A prospective single center study. Journal of the Saudi Heart Association, 2010; 22: 195–201 15- Al Balushi AY, Al Shuaili H, Al Khabori M, et al. Pulmonary valve regurgitation following balloon valvuloplasty for pulmonary valve stenosis: Single center experience. Annals of Pediatric Cardiology. 2013; 6(2):141-144.
ACCEPTED MANUSCRIPT 16- Harrild DM, Powell AJ, Trang TX, et al. Long-term pulmonary regurgitation following balloon valvuloplasty for pulmonary stenosis: risk factors and relationship to exercise capacity and ventricular volume and function. Journal of the American College of Cardiology. 2010; 55(10):1041-7.
T
17- Pathak SJ, Pockett CR, Moore JW, et al. Effect of Balloon: Annulus Ratio on Incidence
11:415–419.
AN
US
Abbreviation list
CR
IP
of Pulmonary Insufficiency Following Valvuloplasty. Congenital heart disease. 2016;
M
Abbreviations
= balloon pulmonary valvuloplasty
RV
= right ventricle
AHA
= American heart association
TV
= tricuspid valve
PT
ED
BPV
= pulmonary valve
TAPSE
=tricuspid annular peak systolic excursion
FAC
= Fractional area change
PR TR
AC
PG
CE
PV
= pressure gradient
= pulmonary regurgitation
= Tricuspid regurgitation
PT
ED
M
AN
US
CR
IP
T
ACCEPTED MANUSCRIPT
AC
CE
Figure 1
M
AN
US
CR
IP
T
ACCEPTED MANUSCRIPT
AC
CE
PT
ED
Figure 2
Figure 3
US
CR
IP
T
ACCEPTED MANUSCRIPT
AC
CE
PT
ED
M
AN
Figure 4
Figure 5
US
CR
IP
T
ACCEPTED MANUSCRIPT
AC
CE
PT
ED
M
AN
Figure 6
ACCEPTED MANUSCRIPT
Tables Table 1: Demographic characteristics of the study groups
Group 2
N=43
N=27
T
Group 1
Age at BPV (mean+/- SD) in years
2.35+-2.2
Weight (mean+/- SD) in kilograms
12.17+-7.8 2
0.51+-0.21
M
Body surface area (mean+/- SD) in m
16/11
US
26/17
AN
Gender (M/F)
CR
IP
Characteristics
Age at follow up
AC
CE
PT
ED
Follow up duration
2.17+-2.42 12.04+-7.4 0.50+/-0.22
5.16+-2.75
5.63+-3.39
2.81+-1.48
3.0+-1.37
ACCEPTED MANUSCRIPT Table (2): Comparison between different parameters measured before and after BPV: At follow up
p-value
PV annulus
10.93±2.75
14.75 ± 3.32
0.000
PG
81.06±20.75
18.46 ± 8.25
0.000
63 (90.0%)
62 (88.6%)
Moderate
3 (4.3%)
8 (11.4%)
Severe
4 (5.7%)
0 (0.0%)
No PR
68 (97.1%)
7 (10.0%)
Mild
2 (2.9%)
49 (70.0%)
Moderate
0 (0.0%)
11 (15.7%)
Severe
0 (0.0%)
3 (4.3%)
106.07±25.48
26.90 ± 5.96
PR
AC
CE
PT
ED
M
AN
RV pressure
IP
0.009
CR
TR
US
Mild
T
Pre cath.
0.000
0.000
ACCEPTED MANUSCRIPT Table 3: Comparison between group 1 and group 2 as regard different parameters measured Independent sample T test
Study group variables
(Balloon annulus ratio ≤ 1.3)
(Balloon annulus ratio > 1.3)
t
P
100.116
+-
20.5429
115.556
+-
29.8178
2.362
0.0229
Baseline PG across pulmonary valve
77.465
+-
16.3523
86.778
+-
25.5920
1.687
0.0996
Baseline Pulmonary valve annulus
11.663
+-
2.8509
9.759
+-
-2.975
0.0040
Baseline Pulmonary valve annulus z score
-1.005
+-
0.9486
-1.677
Size of balloon used
14.605
+-
3.4236
14.320
RVSP at follow up
26.209
+-
4.7537
28.000
PG across pulmonary valve at follow up
19.233
+-
9.6383
%of change in PG
76.07
+-
11.41
Pulmonary valve annulus
14.279
+-
2.7400
Pulmonary valve annulus z score
0.196
+-
RV FAC
44.933
RV TAPSE MPA
LP Z SCORE
CR
0.0024
+-
3.2624
-0.336
0.7377
+-
7.4730
1.112
0.2730
17.778
+-
5.8660
-0.785
0.4352
76.88
+-
14.24
0.263
0.794
15.496
+-
4.0331
1.381
0.1748
1.2683
0.881
+-
1.9904
1.597
0.1184
+-
9.8304
46.122
+-
10.7188
0.476
0.6356
1.958
+-
0.1500
2.074
+-
0.2625
2.091
0.0435
15.400
+-
2.6300
17.996
+-
3.2130
3.688
0.0005
1.7750
3.459
3.645
0.0005
1.7664
11.778
0.983
0.3292
2.0813
3.506
1.023
0.3100
1.4859
11.722
1.045
0.2999
1.7907
3.500
1.080
0.2839
ED
PT
1.671
11.356 2.987
11.333 3.017
M
-3.153
US
RPA Z SCORE LPA
0.7219
CE
RPA
2.1507
+-
AC
MPA Z SCORE
T
Baseline RVSP
IP
Group 2
AN
Group 1
+++++-
+++++-
2.3099 1.7192 2.0503 1.5710 1.8654