Transcript Percutaneous interventions in CHD [1]Shunt lesions

Percutaneous interventions in CHD
Shunt lesions
ASD device closure
Natural history:
40 yrs : Majority are symptomatic (exertional SOB, palptn,
reduced FC,frequent lung infns,RHF)
Life expectancy reduced
PAP increases with age .. Severe PAH dvpt is rare(<5%) &
its dvpt requires addl factors like genetic predisposition.
• 1st device …. Plastic button (thoracotomy) … 1959 …
Hufnagel & Gillespie
• 1st successful transcatheter closure (ASD) … King & Mills
…. 1974
• ESC guidelines 2010 .. Device closure  first choice for OS
ASD whenever feasible(stretched diameter <38 mm and
sufficient rim of 5 mm except towards the aorta)[as in
∼80% of patients].
• At present there are no lower age limitations which preclude
device implantation. In many cases, because of the size of
the device and its introduction system device, applicability
may be limited to patients who weigh >8 to 10 kg.
INDICATIONS :[ OS ASDs ]
• ASDs with e/o RV overload or Qp Qs ratio >1.5. Lack of
symptoms is not a contraindication for repair.
• Small ASDs(<5 mm) without e/o Rt heart enlarg  No impact
on natural history ; can be left alone unless a/w paradoxical
embolism
Contraindications:
• Small hemodyn insignif ASD
• Large ASD(>38mm)
• Deficient rims
• Severe PAH [PVRI>5 WU]
• Severe LV dysfunction
• Ostium primum/sinus venosus ASDs/pulm venous anomalies
Outcome is best with repair at age <25 years.
ASD closure after 40 years no longer appears to affect the
frequency of arrhythmia development during follow-up.
Closure at any agepatients benefit with regard to
morbidity (exercise capacity, shortness of breath, right heart
failure).
Poor LV function (systolic and diastolic) may cause
pulmonary congestion after ASD closure and may require
pre-interventional testing (balloon occlusion with
reassessment of haemodynamics) and treatment.
• Closure in elderly : r/o LV Diast Dysfn : may benefit from
diuretics …
ECHO evaluation :
location, no: , size, rims of the defect , pulm venous anatomy
Very difficult to put device via IJV/SCV ..
In cases of IVC/iliac vein interruption,hepatic vein access may
be needed.
ASD CLOSURE DEVICES :
ASO :
• 2 flat disks .. LA disk > RA disk by about 4 mm in diameter
… RA disk is 8-10 mm > than the waist…waist diameter
decides the size of the device … available from 4-40 mm …
thru 6-12 F delivery sheath
• Advantage : complete retrievability …. Useful in
unsatisfactory deployment …[‘metal memory’ property of
nitinol]
GORE® HELEX®SEPTAL OCCLUDER
circular wire frame (nitinol nickel-titanium metal alloy) covered with
a thin ePTFE membrane.
Once inside the heart, the membrane-covered wire frame of the GORE
HELEX Septal Occluder forms two opposing discs connected in the
middle.
The HELEX occluder is suitable for closure of small to
moderate-sized defects (18 mm in diameter) and is easily
repositionable or removable even after release from the catheter
delivery system.
CARDIOSEAL : two joined square shaped umbrellas
made of a cobalt wire alloy skeleton to which a
knitted dacron fabric is attached … addition of a
unique self centered mechanism via a microcoil spring
STARFLEX device
Bodys response to the device
• Within a few days, the body’s own tissue will begin to grow
over the device. By 3 to 6 months, the device is completely
covered by heart tissue and at that point becomes a part of
the wall of the patient’s heart.
Post procedure
After transcatheter occlusion, patients are generally discharged
the next day. Six months of treatment with aspirin with or
without clopidogrel is recommended to prevent thrombus
formation.
Successful closure occurs in 80 to 95% of patients.
PROCEDURE
Vascular access … 7 F sheath in the RFV
ASD crossed with a multipurpose catheter & kept in
RUPV..0.035” wire with 1 cm floppy tip is placed in the
LUPV … delivery sheath is introduced over the wire with a
dilator & tip of the sheath is positioned in the LUPV .. Then
remove the dilator & wire slowly … allow the sheath to
backbleed freely ..
then device is screwed onto the delivery cable & the device
cable assembly is advanced upto the tip of the sheath …. Then
the delivery sheath is withdrawn (to mid LA level) until it
exits the PV… then the cable is fixed firmly & retract the
sheath over the cable …. Deploys the LA disk
• Echo guidance to assess the parallel alignment of the LA
disk to the IAS.
• Then the entire sheath/cable is pulled back as one unit ….
Deploys the connecting waist
• Further retraction of the sheath over the cable &
continuous pulling of the entire unit towards the IVC
deploys the RA disk… then the device position is assessed
with echo [relation to rims ,SVC ,CS ,?residual shunt]
• Assess the stability of the deployed device (“Minnesotta
wiggle”-gently push the cable [sheath fixed] to LA & then
pull backward towards the IVC … stable device wont move
in both directions)
• Stable? … release the device [by rotating the pinvise in a
counterclockwise direction]
Follow-up
• With in 24 hrs … echo is done to confirm the position of
the device & to look for any residual shunts.
• Assessment of residual shunt, RV size and function, TR
and PAP by echo and also assessment of arrhythmias
• Patients repaired under the age of 25 years without relevant
sequelae or residuae (no residual shunt, normal PAP, normal
RV, no arrhythmias) do not require regular follow-up.
• Patients with residual shunt, elevated PAP or arrhythmias
(before or after repair) and those repaired at adult age (esp
>40 years) should be followed on a regular basis .….regular
follow-up during the first 2 years and then, depending on
results, every 2–4 years is recommended.
• Late arrhythmias after surgical repair at age <40 years are
most frequently IART or Afl which can be successfully
treated with RFA.
• Without repair or with repair after 40 years, AF becomes
more common and may require antiarrhythmic therapy
• Sick sinus syndrome or heart block are less common.
• RV size improves rapidly with in 1 month & by 1 yr,only
29% have RV enlargement
• Multiple ASDs separated by >7 mm may need multiple
devices
• Complete closure @ 6 months ? …. Discontinue IE
prophylaxis/aspirin
Complications
• Device embolisation/malposition
• Air emb
• Device erosion
• Device thrombus
• EKG changes … rarely high grade AVB esp with large
defects
• AR : cause may be overgrowth of the device by tissue,
leading to changes in interatrial septal geometry and
traction on the root of the non-coronary aortic cusp.
Device embolisation
• Incidence 0.5%
• Mainly due to …..deficient septal margins … use of
undersized devices
• Usually occur during the first 24 hrs post deployment…
usually well tolerated unless the device aligns parallel with
the plane of any heart valve
• Most commonly embolise to RA
• Retrieved percutaneously ; sometimes surgery may be needed
Malformation of the Amplatzer occluder during deployment
’cobra head’ configuration. The device could be retrieved
into the long sheath and redeploy correctly.
Arrhythmias
• 0.9-2.9%
• Mostly transient …. SVT …. CHB less common (<1%)
• AF or SVT after ASO device implantation  possible
explanation could be the stretching of the IAS by the central
waist of the device.
• Arrythmias during follow up : difficult to differentiate
whether it is device related or part of the disease process
Device erosion [aortic root/ cardiac wallsperforation,tamponade] :
• Incidence 0.1%
• Vulnerable sites : anterosup atrial wall & adjacent aorta
• Increased risk in pts with deficient aortic &/or superior rims;
oversized devices
• Pts with peric effusion @ 24 hrs should have closer follow up
Residual Shunts :
• Usually insignificant
• 11.7% immediately after  9% at day 1 5.9% at 6
months 2 % at 24 months
• None required Sx/ addl interventions
Thrombus formation over the device :
• Incidence 0.2%
• Post-procedure AF and persistent atrial septal aneurysm
were significant predictors of thrombus formation
• ASO less thrombogenic
J Ayub Med Coll Abbottabad 2009;21(3)
Several studies have shown outcomes from transcatheter
device closure of secundum ASD to be comparable to surgical
outcome in carefully selected adult and pediatric patients.
Surgery versus percutaneous intervention.
• The largest study …by Du et al … total of 614 pts with OS
ASDs [442 in the device group and 154 in the surgical group]
• The procedural success rate (no significant residual shunt) was
95.7% for the former and 100% for the latter.
• Efficacy rates (defined as successful closure without major
complications and without a need for surgical intervention)
were not significantly different between the two groups on
discharge (94.8% vs. 96.1%), at 12 months (98.5% vs. 100%)
and after the 2-year study period (91.6% vs. 89.0%).
• Complication rate was statistically higher (24%) for the surgical
group compared to the device group (7.2%), which was largely
influenced by more pericardial effusion with or without
tamponade in the surgical group (p < 0.001).
• There were no mortalities in either group.
Surgery vs Device for ASD closure
Role of ASD closure in elderly pts
• Transcatheter device closure of ASD in patients aged 40
years and older showed regression of RV enlargement and
an improvement in FC.(Neth Heart J 2010;18:537-42.)
• Effects of closure even in elderly patients results in
favourable cardiac remodelling & imprvt of FC… [JACC
Intv 2010; 3:276-281]
Recent advances :
• leaving a foreign implant behind might not be the ideal way
to close these defects.
• The BioSTAR septal repair implant (NMT Medical)… a
bioabsorbable device … made of acellular porcine intestinal
collagen cellular matrix. …absorbed and replaced with
native tissue within 2 years.
• The phase 1 clinical trial of the BioSTAR Evaluation Study
showed excellent closure rates for PFOs & ASDs
• advantages are less potential for thrombus formation,
erosion, arrhythmias and better accessibility to the left
atrium if needed in the future.
VSD CLOSURE
Recommendation for Device Closure of M-VSDs
In infants >5 kg, children and adolescents with
hemodynamically significant MVSD [LV or LA volume
overload or Qp Qs ratio >2:1) ….reasonable to undergo
percutaneous VSD device closure [IIa]
Device closure should not be done in case of inadequate space
between the defect and the AV or semilunar valves
1st VSD closure : in 1988 by James Lock et al using Rashkind
PDA occluding device [Problems…large delivery sheaths, risk
of embolization, inability to reposition, AR and a high rate of
residual shunting]
Amplatzer VSD occluder device [in 1990s]
• Requires the presence of a good septal rim (> 5 mm) for
closure of muscular defects.
• Not well suited for closure of pm VSDs due to close
proximity to the aortic valve, leading to the risk of aortic
valve obstruction.
A new Amplatzer occluder device with asymmetric discs :
introduced later for pm VSDs [not FDA-approved].
(1) Retrograde transaortic access to the left ventricle. (2) A guidewire crosses retrograde from the left to right
ventricle across the VSD. (3) A transfemoral venous snare retrieves the transaortic guidewire from the
pulmonary artery. (4) An arteriovenous loop is exteriorized to provide a rail to deliver the rigid VSD delivery
sheath. (5) The delivery sheath is positioned antegrade across the VSD. (6) The VSD occlusion device is
positioned and released
Patients are discharged the next day on aspirin and
endocarditis prophylaxis for 6 months.
Early complications …. complete heart block especially
with pm VSD closure (1–6%), aortic or tricuspid
regurgitation, device dislodgement, residual shunt,
ventricular rupture, air embolism, hemolysis or death.
Late complications are usually uncommon…a few reports
of late-onset heart block have been reported and may require
close surveillance.
• PMVSD-O …. now the indications for percutaneous
closure were expanded also to cases with only 1 to 2 mm
between the defect and the aortic valve …. Studies in the
literature reported that the rate of successful closure was
between 90% and 100%
PDA CLOSURE
1st described in 1967 with an Ivalon plug by Porstmann et al.
Then by Rashkind et al, who used a hooked single-disk device
in 1979 and a double-disk device in 1987.These systems used
rather large delivery systems.
In 1992, Cambier et al reported a small series using Gianturco
coils to occlude small PDAs. The major advantage of this
technique was the use of small (5F) delivery systems.
Indications for Transcatheter PDA occlusion ….
• moderate-sized or large PDA with LR shunt that results
in any of : CHF, FTT, pulmonary overcirculation (+ PAH)
or an enlarged LA or LV [class1]
• h/o prior endarteritis [class1]
• reasonable in small LR shunt with normal-sized heart
chambers when the PDA is audible by auscultation[IIa]
• may be considered [IIb]
bidirectional PDA shunt due to PAH and obstructive
pulmonary vascular disease but reversible to pure LR
shunting with pulmonary vasodilators
PDA with a small LR shunt with normal heart size
and an inaudible murmur
Options for percutaneous closure ….
• Cook detachable coils
• Occluder devices (Rashkind-type occluders, Amplatzer duct
occluders). Both types of devices have been used with good
procedural success and low morbidity rates.
• Amplatzer duct occluder (ADO) … self-expanding nitinol
stent…..made of a flat retention flange [on the aortic wall]
and a tube (placed in the PDA itself) that contains
thrombogenic material (a polyester patch sewn to the nitinol
stent).
• The diameter of the retention flange is 4 mm larger than the
tube sheath, which is in the form of a cone; the pulmonary
end of the cone is 2 mm smaller than the end that is
attached to the retention flange. The different Amplatzer
duct occluder models refer to the size
in millimeters of the two ends of
the tube: 6/4, 8/6, 10/8.
• PDA <3 mm in diameter …occluding coils >97%
successful with zero mortality and no significant morbidity
• PDAs upto 12 mm …Amplatzer duct occluder  >98%
complete closure rate at 6 months with minimal
complications and no mortality.
• PDAs >12 mm …. septal closure devices (AGA septal
occluder, VSD device, NMT CardioSEAL device) or covered
stents in select cases
Residual shunt :
Although it is common to see initial residual shunting through
an AMPLATZER PDA occluder, a multicenter trial
indicated 99.7% complete occlusion at 1-year
References
• ESC Guidelines for the management of grown-up congenital
heart disease (new version 2010)
• ACC/AHA 2008 Guidelines for the Management of Adults
With CHD…circulation
• Congenital heart disease: the catheterization manual…..By
Lisa Bergersen
• Indications for Cardiac Catheterization and Intervention in
Pediatric Cardiac Disease … AHA scientific statement ..
Circulation 2011
• Transcatheter Closure of Perimembranous Ventricular
Septal Defects Butera et al JACC 2007
• Moss & Adams CHD
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