Catheterization and Cardiovascular Interventions 86:1189–1194 (2015)

PEDIATRIC AND CONGENITAL HEART DISEASE

Original Studies

Creation of a Transcatheter Fenestration in Children

With Failure of Fontan Circulation: Focus on Extracardiac
Conduit Connection
Stefan Rupp,1 MD, Christin Schieke,1 MD, Gunter Kerst,1 MD, Nona Mazhari,1 MD,
Axel Moysich,1 MD, Heiner Latus,1 MD, Ina Michel-Behnke,2 MD,
Hakan Akintuerk,1 MD, and Dietmar Schranz,1* MD

Objectives: We report our experience with a transcatheter technique to bypass the lung
and to thus improve single-ventricle preload and reduce venous congestion in Fontan
patients. Background: In the absence of a dedicated power source to serve the pul-
monary circulation and a significantly elevated transpulmonary pressure gradient, fen-
estration of the Fontan circulation is an option to improve hemodynamics in patients
by relieving excessive systemic venous pressure. Methods and Results: From 2005 to
2011, 22 transcatheter fenestrations were performed without any major complications
in 19 patients (median age 3.2 years, interquartile range (IQR) 2.7–3.7 years)) with failing
Fontan circulation and exceeding systemic venous pressure. In 16 patients, the proce-
dure was performed for acute postoperative failure 1–24 days after surgery. After per-
foration of the conduit and atrial wall by a Brockenbrough needle and gradual balloon
dilation, premounted stents were expanded to create a diabolo configuration with flar-
ing stent edges, leaving a slight but definitive central waist. The procedure resulted in
regression of pleural effusions and a significant decrease in systemic venous pressure.
Clinical improvement was observed in 16 of the 19 treated patients. Follow-up demon-
strated sustained fenestration in 85% of treated patients for at least 24 months. Con-
clusion: Transcatheter creation of a Fontan fenestration is a safe approach despite the
anatomic gap between the extracardiac conduit cavity and the atrial wall. Stent im-
plantation allows defining the diameter of the fenestration, reduces spontaneous
occlusion, and ensures sustained clinical improvement. VC 2015 Wiley Periodicals, Inc.

Key words: Fontan failure; transcatheter fenestration; extracardiac conduit

INTRODUCTION
In what is known as a Fontan circulation, the sys-
temic venous circulation is connected directly to the
pulmonary arteries. The surgical technique has been
modified over time since its introduction in 1971 and
has become the established palliative treatment for
single-ventricle circulation [1,2]. Originally described
for patients with tricuspid atresia, the Fontan procedure
has now been extended to almost all forms of single-
ventricle circulations such as mitral atresia, double-inlet
left ventricle, and hypoplastic left or right ventricle [3].
However, the altered hemodynamic situation in indi-
viduals with a Fontan circuit results in an 65% lower
exercise capacity compared to biventricular healthy
1
Pediatric Heart Center, University of Giessen and Marburg,
Giessen, Germany
2
Division of Pediatric Cardiology, Department of Pediatrics
and Adolescent Medicine, Medical University Vienna, Vienna,
Austria
Conflict of interest: Nothing to report.
*Correspondence to: Dietmar Schranz, Pediatric Heart Center, Uni-
versity of Giessen and Marburg, Feulgenstrasse 12, 35390 Giessen,
Germany, E-mail: dietmar.schranz@paediat.med.unigiessen.de
Additional Supporting Information may be found in the online ver-
sion of this article.
Received 3 February 2015; Revision accepted 8 May 2015
DOI: 10.1002/ccd.26042
Published online 29 June 2015 in Wiley Online Library
(wileyonlinelibrary.com)

C 2015 Wiley Periodicals, Inc.

V
1190 Rupp et al.
controls [4] and higher overall morbidity. Several
abnormalities such as valve insufficiencies or rhythm
abnormalities may lead to further hemodynamic com-
promise and should be treated to optimize hemody-
namic and clinical outcome [5].
However, the absence of a dedicated power source to
serve the pulmonary circulation is inherently associated
with a chronic elevation of systemic venous pressures
due to its direct connection to the pulmonary artery sys-
tem. Low pulmonary vascular resistance (PVR) is essen-
tial to allow passive blood flow through the pulmonary
vascular system. Increased PVR may lead to chronic ve-
nous congestion and progressively deteriorating function
with effusions, protein-losing enteropathy (PLE), or he-
patic dysfunction. Increased pulmonary resistance may
additionally lead to reduced preload of the systemic ven-
tricle and is responsible for low cardiac output [6,7].
Typically, a distinction is made between high PVR with
a precapillary pulmonary vascular component and a
high transpulmonary gradient and PVR with an elevated
systemic venous pressure due to postcapillary pulmonary
hypertension. In addition, there is mixed PVR with fea-
tures of both types. Medical treatment with drugs such
as phosphodiesterase-5 inhibitors and/or endothelin re-
ceptor blockers is the first-line treatment to lower preca-
pillary PVR. However, medication alone might not be
sufficient to stop clinical deterioration with development
of PLE, pleural effusion, and/or ascites and to improve
the patient’s clinical condition. Several studies suggest
that a Fontan baffle or conduit fenestration might repre-
sent an additional treatment option [8–11]. Conduit fen-
estration allows unsaturated blood to bypass the lung,
resulting in reduced systemic venous pressure and aug-
mented systemic cardiac output at the cost of systemic
arterial blood oxygen desaturation. However, spontane-
ous closure of the fenestration is common, in particular
immediately after surgical creation of a Fontan circuit,
when most patients develop a mixed pre- and postcapil-
lary form of PVR. In these emergency situations, an
additional therapeutic measure that effectively maintains
patency of the fenestration could avoid acute low car-
diac output or systemic organ congestion.
Percutaneous creation of a Fontan fenestration in
total cavopulmonary connection with extra-cardiac tun-
nel was described previously in a small series [12] and
in case reports [13,14]. We present a retrospective data
analysis from the largest cohort of patients treated by
transcatheter fenestration in a Fontan circulation with
extracardiac conduit.
METHODS
The ethics committee of the University Clinic Gies-
sen approved the retrospective study. Cases for inclu-
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
sion in our retrospective analysis were identified by
searching the database of the Pediatric Heart Center in
Giessen, Germany. In the 19 cases retrieved from the
database, the anatomic lesions requiring a Fontan cir-
culation were tricuspid atresia (n ¼ 2), single left ven-
tricle (n ¼ 2), double-inlet left ventricle (n ¼ 3), double-
outlet right ventricle (n ¼ 6), and hypoplastic left heart
syndrome (n ¼ 6). The diameter of the polytetrafluoro-
ethylene (PTFE) Fontan conduit was 16 mm (n ¼ 3),
18 mm (n ¼ 2), 19 mm (n ¼ 11), 20 mm (n ¼ 1), and
unknown in two patients in whom the Fontan operation
was not performed in our pediatric heart center. Clini-
cal reports, laboratory data, echocardiographic and car-
diac catheterization findings, and surgeons’ reports
including technical aspects of each procedure were
reviewed. Perioperative hemodynamic variables such
as systemic venous, left pulmonary artery, right pulmo-
nary artery, ventricular end-diastolic, systemic arterial
pressures as well as arterial and venous blood oxygen
saturations were assessed. Because some patients were
critically ill, not all variables were consistently meas-
ured during the cardiac catheterizations for Fontan fen-
estration.
The paired t test was used to compare the variables
of interest. The authors had full access to the data and
take responsibility for its integrity.
Technique of Transcatheter Fenestration
Conscious sedation for catheterization was preferred
and used in 14 interventions, general anesthesia in 8
interventions. General anesthesia was used when
patients were still intubated and ventilated after surgery.
Intubation was not performed for the transcatheter pro-
cedure alone. Femoral venous access was chosen in all
patients except one in whom the subclavian vein was
used because of obstructed femoral veins. After local
anesthesia, the vessel was cannulated and a bolus of 100
international units (IU) heparin per kilogram body
weight was given before the fenestration was created.
After the procedure, heparin was continued at a dose of
300 IU/kg/day. The Fontan conduit and the systemic
atrium were delineated by angiography.
The step-by-step transcatheter approach is depicted
in Fig. 1a–d. After angiography of the inferior vena
cava and Fontan tunnel (Fig. 1a), a Brockenbrough
needle was advanced through a 6 Fr long sheath
(Cook, Copenhagen) to the selected perforation site of
the extracardiac conduit. Only in one procedure was a
Nykanen radiofrequency ensemble (Baylis Medical,
Montreal) used for reopening a closed surgically cre-
ated fenestration.
After perforation of the conduit and atrial wall with
the needle, the needle position within the atrial cavity
 Transcatheter Fenestration in Fontan Patients 1191

Fig. 1. A: Angiography of the inferior vena cava and Fontan tunnel. B: After perforation of
the conduit and atrial wall, the needle position within the atrial cavity is verified angiographi-
cally after contrast medium injection through the needle. C: Exact placement of the stent
within the septum is guided by angiograms obtained with manual contrast medium injection.
D: The desired configuration of the stent is achieved by slowly filling the balloon with diluted
contrast medium. This allows expansion of the stent from both ends and results in a diabolo
shape of the stent.

was checked by contrast injection through the needle
(Fig. 1b). A Hi-Torque Pilot 0.014 cm  300cm coro-
nary guide-wire (Abbott) was advanced through the
needle and looped within the atrium or positioned in a
pulmonary vein. Next, the needle and the dilator of the
long-sheath were carefully exchanged for a 1.5 to 3–
5 mm low-profile balloon catheter (Maverick, Apex,
Abbott) to pass and dilate the conduit and the atrial
wall. Afterwards, the balloon catheter was exchanged
to further gradually dilate the initially established com-
munication. Because of the ridgid conduit, different
balloon catheter sizes up to a final diameter of 6–
8 mm became necessary for advancing the 6 Fr sheath
to the atrial side. In some cases, an 8 mm balloon cath-
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
eter was needed to dilate the rigid conduit before the
sheath could be advanced. The sheath was advanced
through the conduit and the atrial walls by inflating the
low-profile balloon, so that the taper of the balloon
engaged the end of the long sheath. The balloon-sheath
ensemble was then advanced into the atrium by simul-
taneously pushing the long sheath, with the balloon
effectively functioning as a dilator for the sheath. This
way, the balloon catheter, the inflated balloon, or the
long sheath could nearly continuously seal the open-
ings of the conduit and atrial wall. Using this tech-
nique, bleeding or pericardial effusion was not seen in
any patient. With the long sheath in the atrium, the
balloon was deflated, and removed together with the
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
1192 Rupp et al.
guide wire, and replaced by a balloon-expandable 8 
18 mm bare-metal stent (Genesis, Cordis) on a 003500
exchange wire. The stent was positioned to span the
conduit and atrial walls. Exact placement of the stent
within the septum was guided, as necessary, by
repeated angiograms obtained with manual injection of
contrast medium (Fig. 1c). Controlled configuration of
the stent by slowly filling the balloon with diluted con-
trast medium allowed expansion from the distal ends.
Stent expansion was facilitated by the higher resistance
and elastic recoil in the central segment of the created
canal, which was surrounded by tissue, compared to
the lower resistance at the stent edges within the atrial
and conduit cavities, resulting in a diabolo shape of the
stent. A diameter of 4–6 mm of the fenestration was
aimed at (Fig. 1d). Both oxygen saturation and sys-
temic vein pressure decreased after creation of the
right–left shunting fenestration.
A final angiogram was performed to ensure the cor-
rect position of the stent (see Supporting Information
Video).
RESULTS
Over a 6-year period from February 2005 to April
2011, 121 patients received a Fontan circulation in our
pediatric heart center. Transcatheter fenestrations with
stent placement in the created communication were per-
formed in 19 patients in the same period, however two
patients were transferred to our center for therapy after
the Fontan procedure was performed in another hospital.
Three subjects underwent re-fenestration because of a
closed stent. In two cases the stent was reopened, and a
new stent was placed in the existing stent. In the third
case, the stented fenestration was found to be closed
and a new fenestration with following stent implantation
was performed. These stent implantations are also
included in the statistics. Therefore this report describes
22 stent implantations in 19 patients.
There was no procedure-related death or major com-
plication. At the time of the transcatheter fenestration,
the patients had a median age of 3.2 years (interquartile
range (IQR) 2.7–3.7 years). Transcatheter fenestration
was performed within the first 24 hr after completion of
the Fontan circulation in six patients, between 3 and 24
days after surgery in ten patients, and between 237 and
4,448 days postoperatively in six patients. Spontaneous
closure of an intraoperatively created fenestration was
the main reason for transcatheter re-fenestrating in five
of six patients who needed to be treated within the first
24 hr after completion of Fontan circulation. Elevated
pulmonary artery pressure, ascites, and/or pulmonary or
peripheral edema were present in all patients despite
supposedly optimal medical therapy.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Pre- and Post-Interventional Hemodynamic
Parameters
Preprocedural hemodynamic parameters showed
mean SVC (superior vena cava) and IVC (inferior vena
cava) pressures of 18.3  5.3 mm Hg (n ¼ 19) and
17.8  4.5 mm Hg (n ¼ 20), respectively. Mean pres-
sure in the functional pulmonary venous atrium was
11.0  4.2 mm Hg (n ¼ 12), resulting in an average
transpulmonary gradient of about 7 mm Hg. Corre-
sponding systemic venous oxygen saturation was
62.4  10.1% (n ¼ 12) in the SVC and 57.6  20.8%
(n ¼ 9) in the IVC, while mean systemic arterial oxy-
gen saturation was 92.5  5.5% (n ¼ 22). After creation
and stenting of a Fontan fenestration, mean pressure in
the IVC decreased to 12.9  5.3 mm Hg (P < 0.05).
Systemic arterial oxygen saturation decreased from
93.6%  6% to 84.6%  6% (P < 0.01).
Twelve of the 19 patients showed an improvement
in their clinical condition in terms of resolution of PLE
and effusion within days after fenestration. Four
chronically ill patients improved within 4 weeks, show-
ing reduction of PLE/effusions or plastic bronchitis.
One patient showed only a minor regression of PLE
with a limited improvement of his clinical condition.
In one patient, transcatheter fenestration did not have a
significant effect on early postoperative circulatory
failure, and because of the persisting life-threatening
situation, a takedown operation was performed on the
same day, immediately after cardiac catheterization. In
another patient, fenestration was performed as a rescue
maneuver under extracorporal membrane oxygenation.
The rescue procedure was performed without complica-
tion but did not stabilize the hemodynamic situation
sufficiently and the patient died.
Procedure-Related Complications
In our analysis of 22 transcatheter interventions in
19 patients, the overall rate of intervention-related
complications was low. Severe complications such as
accidental false route perforation with effusion or even
tamponade or acute cardiac decompensation did not
occur. One patient started to vomit after initiation of
sedation. In this case, aspiration could not be ruled out;
however, the respiratory situation remained stable. One
patient suffered from recurrent atrial tachycardia,
which was successfully treated by intravenous injection
of adenosine.
Risk of Spontaneous Stent Closure or Insufficient
Communication
Two patients showed secondary clinical deterioration
after stent implantation. A second heart catheterization

was performed (10 days and 14 days after the first
stent implantation). The stented fenestration was pro-
ven to be closed, and restoration of stent patency by
balloon dilatation was uneventful, and the fenestration
remained patent after the second procedure. In one
case, the stented fenestration was found to be closed
and a new fenestration with following stent implanta-
tion was performed.
Two patients experienced only a slight improvement
of their clinical situation after stent implantation and
suffered from persistent effusion. A second catheteriza-
tion was performed, and the stents were uneventfully
re-dilated to a larger diameter. Effusions resolved over
the following days.
Overall, in 85% of the patients who were discharged
home and followed up in our hospital (13 patients), the
fenestration was found to remain patent for at least 24
months. These patients experienced resolution of effu-
sions or PLE and suffered no thromboembolic events
during the follow-up period.
Anticoagulation
Twelve patients were discharged with phenprocou-
mon (International Normalized Ratio (INR) 1.8–2.5),
one patient was transferred to another hospital with in-
travenous heparin medication and the aim to start
phenprocoumon after clinical stabilization, four patients
were treated with aspirin and folic acid after discharge.
Stent Closure After Adaption to Fontan
Hemodynamics
Ideally, the aim is to close the fenestration after
adaption to the Fontan circulation and sustained stable
clinical condition. In our retrospective study popula-
tion, four fenestrations were closed by transcatheter
technique using different occluder devices during a
mean follow-up of 37.5 months (IQR 8.5–72.5). In
another three patients, partial transcatheter closure of
the fenestration by modulated umbrella devices was
performed. The following devices were used: Cardia-
PFO-Occluder 15 mm (n ¼ 3), Amplatz-Duct-Occluder
II 4/4 mm (n ¼ 2), Amplatzer vascular plug II 8 mm
(n ¼ 1), and 4 mm (n ¼ 1). All closure procedures were
performed without complications. The patients’ clinical
functional status remained stable after complete or par-
tial closure of the Fontan fenestration.
DISCUSSION
The transcatheter technique for creating a fenestra-
tion in a failing Fontan circulation we present here
proved feasible and safe especially in patients in whom
an extracardiac conduit had been inserted for total
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Transcatheter Fenestration in Fontan Patients 1193
cavopulmonary connection. Transcatheter fenestration
improves acute postoperative low cardiac output, pleu-
ral effusions, ascites, and PLE.
Pathophysiologically, different hemodynamic condi-
tions can result in failure of a Fontan circulation. A
fenestration is an effective tool in patients with preca-
pillarily induced systemic vein hypertension (mean
pressure > 15 mm Hg) and an “out-of-proportion”
(>5 mm Hg) transpulmonary pressure gradient (TPG).
In addition, fenestration is useful in mixed systemic
venous hypertension. A mixture of pre- and postcapil-
lary pulmonary artery components is often seen in the
immediate postoperative course after establishment of
a total cavopulmonary connection [15]. A cardiopulmo-
nary bypass induces an inflammatory response that
results in transient endothelial and cardiac stunning
[16,17]. Therefore, fenestration with stenting might
also be a treatment option for patients with a mixed
type of out-of-proportion systemic venous hyperten-
sion.
Most patients treated by transcatheter fenestration in
the present series had venous hypertension of the
mixed type. Following fenestration, 16 of the 19
patients showed hemodynamic and clinical improve-
ment in terms of resolution of effusions in mid-term
follow-up. A stented fenestration remained patent for
at least 24 months in 85% of the patients followed up
in our hospital. Complete or partial closure of the
stented fenestration could be performed in some of the
patients with adapted Fontan circulation. Similar proce-
dures of partial or total occlusion of Fontan fenestra-
tions were previously described [18,19].
Three major technical aspects of the new procedure
we propose for creating a transcatheter fenestration in
extracardiac Fontan tunnel anatomy are of note:
First, the perforation technique to cross and tunnel
the conduit-atrial wall layers is mandatory. Only the
needle has to be advanced to the atrial side without a
trial to follow with the long sheath as done in regular
atrioseptostomy. The described wire-gradual balloon
technique for pushing the long sheath to the atrial side
makes the creation of the fenestration safe without
inducing hemorrhage.
Second, bar metal stents can be used to create a dia-
bolo- or butterfly-shaped configuration for a sufficient
communication with a diameter of 4–6 mm and with-
out inducing hemorrhagic complications. Previously,
we considered graft stent’s to avoid bleeding compli-
caions [14]. Our experience suggests that this approach
can replace the relatively complicated sizing of the
fenestration, as reported before [10]. The described bal-
loon inflation technique allows precise dimensioning of
the effective diameter of the fenestration by gradual
expansion and inflation of the premounted stent
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
1194 Rupp et al.
because of the rigid PTFE (Gore-Tex) conduit adjacent
to the atrial wall.
Additionally, taking the chemicophysical properties of
PTFE into consideration, there is no rationale to support
the use of radiofrequency energy (RF) for crossing
PTFE conduits. In our series, we used RF only in one
case to reopen a surgically created fenestration. PTFE is
a polymeric form of tetrafluorethylene and has dielec-
tric, i.e. insulating properties and a melt temperature of
330degC. However, the mode by which RF energy
causes coagulation necrosis of tissue is electrical con-
duction. These considerations argue in favor of a more
controlled technique such as simple mechanical force.
In conclusion, endovascular transcatheter creation of
a stent-enforced de novo communication of a Fontan
conduit is an important tool to treat acutely or even
chronically diseased patients with a failing Fontan cir-
culation including those with extracardiac cavopulmo-
nary conduits. Patients with precapillary or mixed
types of systemic venous hypertension show significant
and prolonged clinical improvement after fenestration
and stent implantation. We advocate a novel
“transseptal” technique including needle puncture with
no more than mechanical force.
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