Meta-Analysis of Pulmonary Valve Replacement After Operative

Repair of Tetralogy of Fallot

Eddie Wai-Yin Cheung, MBBS, Wilfred Hang-Sang Wong, MMedSc, and Yiu-Fai Cheung, MD*

The present meta-analysis aimed to determine the outcomes and effect on right ventricular
(RV) function of surgical pulmonary valve replacement (PVR) in patients after repair of
tetralogy of Fallot. The reported outcomes of surgical PVR in children and adults after
tetralogy of Fallot repair were from relatively small observational studies. The PubMed
database was searched from its inception to April 2009. Observational studies reporting on
the following outcomes measures after surgical PVR were reviewed: early and late all-cause
mortalities, the redo-PVR rate, and changes in the indexed RV volumes, ejection fraction,
and QRS duration after PVR. Of the 305 citations screened, 15 met the criteria and were
analyzed. The pooled early mortality rate (n ⴝ 595) was 2.1% (95% confidence interval [CI]
1.1% to 4.0%). The late mortality rate was 0.5%/patient-year (95% CI 0.2% to 0.8%/patient-
year), and the redo-PVR rate was 1.9%/patient-year (95% CI 1.3% to 2.5%/patient-year).
Data on RV volumes and ejection fractions were available from 5 studies (n ⴝ 141). The
pooled mean difference in the indexed RV end-diastolic and end-systolic volume was ⴚ63
ml/m2 (95% CI ⴚ55 to ⴚ72) and ⴚ37 ml/m2 (95% CI ⴚ30 to ⴚ45), respectively. No
significant changes in the pooled mean difference of the RV ejection fraction (95% CI ⴚ1% to
3%) or QRS duration (95% CI ⴚ10 to 1 ms) were observed. In conclusion, surgical PVR in
patients after tetralogy of Fallot repair has been associated with low early and late mortality
and significant decreases in RV volumes but no changes in the RV ejection fraction or QRS
duration. © 2010 Elsevier Inc. All rights reserved. (Am J Cardiol 2010;106:552–557)

The present meta-analysis was conducted to determine resolved between the 2 reviewers. The full texts of all
the outcomes after surgical pulmonary valve replacement eligible articles were retrieved for detailed review. Addi-
(PVR) and its effect on right ventricular (RV) volumes and tionally, potential relevant studies were identified by a man-
ejection fraction and QRS duration in pediatric and adult ual search of the reference lists of all the eligible studies. If
patient populations after operative “repair” of tetralogy of required, the corresponding authors of the publications were
Fallot (TOF). queried for additional information. In the case of multiple
publications arising from the same patient cohort, the most
Methods recent report was selected.
We performed the present systematic review and meta- The extracted data included the study design, study pe-
analysis using the framework proposed by the Meta-analy- riod, patient demographics, surgical technique, follow-up
sis Of Observational Studies in Epidemiology (MOOSE) duration, and outcomes. The outcome measures assessed
group.1 Relevant publications in English were identified by were early and late all-cause mortality, valve complications
searching PubMed (National Library of Medicine) from its and deterioration requiring redo-PVR, changes in QRS du-
inception to April 2009. The terms used for the search were ration, and changes in RV volumes and ejection fractions, as
“tetralogy of Fallot” and “pulmonary valve replacement” or determined by cardiovascular magnetic resonance imaging
“homograft” or “autograft” or “Hancock” or “Contegra” or (CMRI). If an outcome parameter was not reported in an
“valved conduit.” Observational studies reporting the out- eligible study, the study was excluded from the analysis of
comes after PVR were included, and case reports and re- that particular parameter. The studies were divided into
view articles were excluded. Studies on percutaneous PVR pediatric (aged ⱕ18 years) and adult (aged ⬎18 years)
were also excluded from the present review because the data according to the mean age at PVR.
on intermediate- and long-term outcomes remain limited. Fixed-effects meta-analyses were performed using the
One of us (EWYC) screened all the abstracts for eligibility, Mantel-Haenszel method. Odds ratios and weighted mean
and a second reviewer (YFC) independently assessed the differences with 95% confidence intervals (CIs) were cal-
eligibility for inclusion and exclusion. Disagreements were culated for the binary and continuous variables, respec-
tively. The heterogeneity of the studies was assessed using
Cochran’s Q test and I2 statistic. Funnel plots were con-
Department of Paediatrics and Adolescent Medicine, Queen Mary
structed to evaluate study publication bias. All tests were
Hospital, University of Hong Kong, Hong Kong, People’s Republic of
China. Manuscript received February 12, 2010; manuscript received and
2-sided, and p ⬍0.05 was considered statistically signifi-
accepted March 22, 2010. cant. The data were analyzed using Review Manager, ver-
*Corresponding author: Tel: (852) 2255-4090; fax: (852) 2553-9491. sion 5.0.18 (Nordic Cochrane Centre, Cochrane Collabora-
E-mail address: [email protected] (Y.-F. Cheung). tion, Copenhagen, Denmark, 2008).

0002-9149/10/$ – see front matter © 2010 Elsevier Inc. All rights reserved. www.ajconline.org
doi:10.1016/j.amjcard.2010.03.065
 Congenital Heart Disease/Meta-Analysis of PVR in Repaired TOF 553

redo-PVR rate was 1.9%/patient-year (95% CI 1.3% to

2.5%). When the pooled data from the adult and pediatric
series were compared, the pooled early mortality rate was
greater in the pediatric series, the late mortality rate was
similar between the adult and pediatric series, and the redo-
PVR rate was greater in the adult series.
The effects of PVR on the CMRI-derived RV volumes,
RV ejection fraction, pulmonary regurgitant fraction, and
QRS duration are shown in Figure 2. PVR was associated
with a significant reduction in the indexed RV end-diastolic
volume (mean difference ⫺63 ml/m2, 95% CI ⫺55 to ⫺72),
end-systolic volume (mean difference ⫺37 ml/m2, 95% CI
⫺30 to ⫺45), and pulmonary regurgitant fraction (mean
difference ⫺38%, 95% CI ⫺35% to ⫺41%). In contrast,
PVR did not result in significant changes in the RV ejection
fraction (mean difference 1%, 95% CI ⫺1% to 3%) and
QRS duration (mean difference ⫺4 ms, 95% CI ⫺10 to 1).
Of these parameters, significant heterogeneity was only
found in the analysis of the RV end-diastolic volume when
using the fixed-effect model. However, repeating the anal-
ysis using the random-effect model and exclusion of outlier
studies also showed a reduction in the RV end-diastolic
volume after PVR.
Although all 4 studies reported on the reduction of the
mean RV end-systolic volume after PVR,9,10,12,13 none re-
ported on complete normalization of this parameter to ⬍47
ml/m2.9 In contrast, 29,13 of the 5 included studies reported
on the normalization of the RV end-diastolic volume after
PVR to ⬍108 ml/m2.9 A suggestion of an association was
found between an end-diastolic volume ⬎170 ml/m2 before
PVR and failure of normalization of this parameter after
surgery.

Discussion
To our knowledge, this is the first review and meta-
analysis of the outcomes of surgical PVR in children and
Figure 1. Identification and screening of studies for inclusion in meta- adults after repair of TOF. The pooled data have confirmed
analysis. the low early and late mortality of PVR in both the pediatric
and the adult populations. Although earlier graft deteriora-
tion in younger patients has been an issue of concern,17 the
Results
pooled redo-PVR rate has been apparently lower in the pedi-
A total of 305 studies were identified and screened, of atric than in the adult patients (1.2% vs 2.2%). The interpre-
which 290 were excluded (Figure 1). The characteristics of tation has nonetheless been complicated by multiple types of
the 15 studies2–16 that met the criteria and were included in valved conduits used and the variable duration of follow-up
this review are summarized in Table 1. periods in the different studies.
Of these 15 studies, 13 reported early mortality data (n ⫽ Previous studies have implicated the presence of a
595), 11 reported late mortality data (n ⫽ 559, 2,415 pa- threshold for the RV size above which RV remodeling does
tient-years), 9 reported on patients undergoing redo-PVR not occur after PVR.9,12 Although the reduction of RV size
(n ⫽ 524, 2,283 patient-years), 5 reported on changes in was documented in all the adult2,3,8,9,11–14,16 and pedia-
CMRI-derived RV parameters (n ⫽ 142), and 4 reported on tric5–7,10,15 series, none reported on complete normalization
changes in QRS duration (n ⫽ 213). Because Oosterhof et of the RV end-systolic volume. In contrast, 2 of the 5
al11,12 reported the mortality data and CMRI parameters studies reported on the normalization of the RV end-dia-
separately in 2 publications, both of these studies were stolic volume; both were adult series and had patients with
included. Knirsch et al15 provided data only for RV end- a lower preoperative RV end-diastolic volume (⬍170 ml/
diastolic volume but not RV systolic volume or pulmonary m2).9,13 In a pediatric population, Buechel et al10 reported
regurgitant fraction. that RV remodeling occurred promptly when PVR is per-
Table 2 lists the pooled data on the early mortality, late formed when the RV end-diastolic volume is ⬍150 ml/m2.
mortality, and redo-PVR rates. The pooled early mortality However, the evidence from the present review is insuffi-
rate was 2.1% (95% CI 1.1% to 4.0%). The late mortality cient to suggest that PVR when performed at a younger age
rate was 0.5%/patient-year (95% CI 0.2% to 0.8%), and the guarantees complete RV remodeling.
554 The American Journal of Cardiology (www.ajconline.org)

Table 1
Overview of included retrospective publications
Publication Patients PVR Mean Mean Outcome Parameters Available for Analysis
(n) Types Follow-Up (y) Age (y)
Early Late Redo-PVR CMRI QRS
Mortality Mortality Data Duration

Yemets et al,2 1997 85 H,B,M 5.8 20 ⫹ ⫹ ⫹

Discigil et al,3 2001 42 H,B 7.8 22 ⫹ ⫹ ⫹
Therrien et al,4 2001 70 B 4.7 28 ⫹
De Ruijter et al,5 2002 16 H,B 4.6 NA ⫹ ⫹ ⫹
Warner et al,6 2003 36 H,B 6.7 15 ⫹ ⫹ ⫹
Lim et al,7 2004 58 H,B,M 2.5 14 ⫹ ⫹ ⫹ ⫹
Borowski et al,8 2004 18 H 1.3 24 ⫹ ⫹
Therrien et al,9 2005 17 B 1.75 34 ⫹ ⫹ ⫹ ⫹
Buechel et al,10 2005 20 H,B NA 14 ⫹ ⫹ ⫹
Oosterhof et al,11 2006 158 H Median 4.2 NA ⫹ ⫹ ⫹
Oosterhof et al,12 2007 71 H Median 1.6 Median 29 ⫹ ⫹
Ghez et al,13 2007 19 H 1.6 24 ⫹ ⫹ ⫹ ⫹
Graham et al,14 2008 93 H,B,M Median 3 26 ⫹ ⫹ ⫹
Knirsch et al,15 2008 16 H,B NA 12 ⫹ ⫹
Meijboom et al,16 2008 17 NA 6.4 28 ⫹ ⫹

B ⫽ bioprosthetic valve conduit; H ⫽ homograft; M ⫽ mechanical valve; NA ⫽ not available.

Table 2
Pooled outcomes estimates in adult and pediatric series
Publication Early Mortality (%) Late Mortality (%/patient-year) Redo-PVR (%/patient-year)

Adult series
Yemets et al,2 1997 1.2 (0.2–7.9) 0.6 (0.0–1.3) 1.6 (0.5–2.7)
Discigil et al,3 2001 2.4 (0.3–15.1) 1.8 (0.4–3.3) 2.4 (0.7–4.1)
Borowski et al,8 2004 5.6 (0.8–30.7) 2.1 (0.0–7.9) —
Therrien et al,9 2005 2.8 (0.2–32.2) 1.7 (0.0–6.2) 1.7 (0.0–6.2)
Oosterhof et al,11 2006 0.3 (0.0–4.8) 0.3 (0.0–0.7) 2.4 (1.2–3.6)
Ghez et al,13 2007 2.5 (0.2–29.8) 1.6 (0.0–6.1) 3.3 (0.0–9.7)
Graham et al,14 2008 0.5 (0.0–7.9) 0.7 (0.0–1.7) 3.6 (1.4–5.8)
Meijboom et al,16 2008 2.8 (0.2–32.2) 0.5 (0.0–1.7) —
Pooled adult series 1.8 (0.8–4.1) 0.5 (0.2–0.8) 2.2 (1.5–2.9)
Pediatric series
De Ruijter et al,5 2002 6.3 (0.8–33.5) 1.4 (0.0–4.0) 1.4 (0.0–4.0)
Warner et al,6 2003 1.4 (0.1–18.3) 0.4 (0.0–1.2) 0.8 (0.0–2.0)
Lim et al,7 2004 1.7 (0.0–11.2) 0.3 (0.0–1.3) 4.1 (0.8–7.4)
Buechel et al,10 2005 2.4 (0.2–28.7) — —
Knirsch et al,15 2008 2.9 (0.2–33.6) — —
Pooled pediatric series 2.7 (0.9–7.5) 0.4 (0.0–1.0) 1.2 (0.2–2.2)
Pooled total 2.1 (1.1–4.0) 0.5 (0.2–0.8) 1.9 (1.3–2.5)
Heterogeneity test
Chi-square 5.62 5.64 9.0
p Value NS NS NS
I2 0% 0% 0%

Data in parentheses are 95% CIs.

Despite a significant reduction in the RV systolic and Normalization of the ventricular volumes after PVR has
diastolic volumes, the RV ejection fraction remained similar commonly been used as a surrogate end point for improvement
after PVR. In the presence of significant pulmonary regur- in RV function.12 However, excision of the aneurysmal out-
gitation with or without concomitant tricuspid regurgitation, flow during PVR might significantly affect the measured RV
the CMRI-derived RV ejection fraction might overestimate volumes after surgery.19 Furthermore, the implication of fail-
the effective ejection fraction.10,18 By correcting for valvar ure of the normalization of RV volumes after PVR in patients
regurgitation, Vliegen et al18 showed that the RV ejection with TOF remains unclear. Despite the introduction of newer
fraction increased from 25.2% to 43.3% after PVR in 26 echocardiographic techniques such as tissue-Doppler imaging
adults with repaired TOF. Notwithstanding the correction and speckle tracking, which are relatively less load dependent
for valvar regurgitation, the usefulness of the ejection frac- and allow direct evaluation of RV myocardial velocities and
tion as an index of RV systolic function remains debatable deformation,20 –22 the data on the effect of surgical PVR on
given its sensitivity to preload and afterload. these parameters are virtually nonexistent.
 Congenital Heart Disease/Meta-Analysis of PVR in Repaired TOF 555

Figure 2. Forest plots showing effect of PVR on (A) indexed RV end-diastolic volume (EDV), (B) indexed RV end-systolic volume (ESV), (C) RV ejection
fraction, (D) pulmonary regurgitant fraction, and (E) QRS duration. (A) ⫽ adult series; (P) ⫽ pediatric series.
556 The American Journal of Cardiology (www.ajconline.org)

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