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Role of Interventional Catheterization in Post-Operative
TOF Patients
Jennifer Rutledge, MDOctober 25, 2013
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What is our role?
• To keep patients with TOF away from the surgeons as long as possible
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What is our role?
• Treat / palliate the residual lesions patients may be left with and delay the need for future cardiac surgery
• Hopefully to improve outcome and quality of life
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Outline
• When, Why and How?– Timing of intervention
• Immediate post-operative versus later
– Palliative procedures versus complete repair• Shunts• Pulmonary arteries• Conduits and Valves
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Timing of Intervention: Early Post-Op
• Patients who have difficulty recovering after surgery have a higher incidence of residual lesions
• Diagnostic cath can be performed safely in the early post-op period and often results in the discovery of lesions that require further intervention
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Timing of Intervention: Early Post-Op
• Interventional cath has historically been avoided in the immediate post-op period
• Concerns:– Transport of critically ill patients– Worsening clinical status as a result of the
procedure– Fear of disruption (rupture) of fresh suture line
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Timing of Intervention: Early Post-Op
• Commonly thought a minimum of 6 weeks of adequate scar tissue formation is required for safe intervention
• Recent data suggests intervention can be performed safely < 6 weeks
• Performance of successful catheter intervention can improve survival to discharge
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Timing of Intervention: Early Post-Op
• Intervention only considered if the lesion is severe enough to compromise clinical status and repeat surgery is considered to be high risk
• Requires multidisciplinary team• Interventional cath doc• Surgeon• Intensivist• Anesthesiologist• Nurses, RT, anesthesia and radiology technicians• ECMO team• Operating room team including nursing and perfusion
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Timing of Intervention
• Timing of catheterization outside of the immediate post-op period is largely based on non-invasive imaging and standard criteria– Significant right ventricular outflow tract
obstruction– Branch pulmonary artery stenosis – Severe pulmonary valve regurgitation
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Types of Intervention: Neonatal Shunts
• Rarely performed in this population– Anomalous coronary artery– Multiple large VSD’s or TOF/AVSD– Contraindication to bypass
• Central versus modified Blalock-Taussig shunt
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Shunts
• Shunt obstruction can occur 3-20% of cases– Thrombosis, suture line stenosis, intimal
proliferation, vascular distortion, ductal tissue constriction
– Results in cyanosis of the patient – can be life-threatening
– Most often occurs acutely after surgery but can occur late
– Risk factors: small shunt and pulmonary artery size, polycythemia, competitive blood flow
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Shunts
• Interventional cath options:– Mechanical or pharmacological disruption of clot
• Goal is to break up the clot and dislodge it distally, improving flow across the shunt
• Can be achieved manually by using catheters/wires/balloons but only useful for fresh clot
• May be achieved by local thrombolysis or thrombectomy
– Local injection of TPA – often requires prolonged infusions» Not practical for shunts or fresh post-op patients
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Shunts
• Shunt thrombosis most often develops in association with a stenosis of the shunt and/or adjacent blood vessel– Balloon dilation or stenting performed to disrupt
the clot and treat the stenotic lesion– In the immediate post-op period stenting likely
safer • More predictable and durable result, less recoil of
vessel, smaller balloon/stenosis ratio for effective expansion
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Shunts
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Shunts
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Shunts
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Pulmonary Arteries
• Branch pulmonary artery stenosis is a well-known association in TOF population– Post-surgical: at suture line (shunts, proximal
branches), ductal constriction– Native: proximal or distal branches
• Balloon dilation or stenting– What type of intervention is determined by
patient/vessel size and anatomy, timing of surgical intervention (past, present and future)
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Pulmonary Arteries
• Lots of toys– Regular balloons– High pressure balloons– Ultra-high pressure balloons– Cutting balloons
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Pulmonary Arteries
• Intravascular Stents:– Ideally we like to implant stents that can be
further dilated to adult size– Depending on the patient size, this is not always
possible• Place smaller stents that will then need to be cut across
at the time of subsequent surgery
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Pulmonary Arteries
Bergersen L et al. Cardiol Young 2005;15:597-604
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Pulmonary Arteries
Bergersen L et al. Cardiol Young 2005;15:597-604
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Pulmonary Arteries
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Pulmonary Arteries
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Pulmonary Arteries
Angtuaco, M. et al. Cathet Cardiovasc Int. 2011;77:395-399.
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Pulmonary Artery Growth
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Conduits
• Frequently used in patients with TOF at various stages of life
• Conduits fail due to stenosis and/or regurgitation
• Freedom from conduit replacement 68-95% at 5 years and 0-59% at 10 years
• Surgical conduit revision may be delayed in some patients by cath intervention
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Conduits
• Balloon dilation alone rarely achieves good result
• Contraindication to conduit stenting– Anomalous coronary
artery positioned behind the conduit
• Risk of coronary compression
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Conduits
Peng LF et al. Circulation 2006;113:2598-2605.
Freedom from conduit surgery
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Conduits
• Risk factors for need for earlier re-intervention– Younger age, higher pre-stent RV pressure,
diagnosis OTHER than TOF, homograft conduits, conduits ≤ 10 mm
• Stent fracture seen in 43%– 89% immediately behind the sternum– 82% had compromise of the integrity of the stent
Peng LF et al. Circulation 2006;113:2598-2605.
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Conduits
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Chronic Pulmonary Regurgitation
• Any patient with transannular patch repair• Majority of patients following conduit or
bioprosthetic valve implantation• Ultimately all patients with TOF will require
therapy (repeated) for chronic PR
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Transcatheter Valves
• Developed to treat dysfunctional bioprosthetic valves or conduits and reduce number of and prolong time to next surgical intervention
• Two current options– Medtronic Melody valve– Edwards Sapien valve
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Melody Valve
• Bovine jugular vein; platinum/iridium stent
• Available in Canada since late 2005; as of May 2013 there have been over 5000 implants in 180 centers in 35 countries– ~50% have underlying diagnosis of TOF
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Melody Valve
• Can be considered in patients:– > 30 kg, vessels large enough to accommodate the
22F sheath– Implant site 16-22 (24) mm in diameter – Evidence of conduit/valve dysfunction
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Melody Valve
www.medtronic.com
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Patie
nts,
%
0
10
20
30
40
50
60
70
80
90
100
Regurgitation Stenosis Mixed
US IDE
UK
German
Italian
Canadian
Melody Valve
Courtesy Medtronic
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Patie
nts,
%
0
10
20
30
40
50
60
70
80
90
100
Homograft Bioprosthetic Synthetic/other
Baseline Patient CharacteristicsConduit Type
US IDE
UK
German
Italian
Canadian
Melody Valve
Courtesy Medtronic
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Long-term OutcomesPulmonary Valve Competence by Echocardiography
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
US IDE UK Canadian
6 months
None
Trace
Mild
Moderate
SeverePa
tient
s, %
1 year
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
US IDE UK Canadian
None
Trace
Mild
Moderate
Severe
Patie
nts,
%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
US IDE UK Canadian
3 years
None
Trace
Mild
Moderate
Severe
Patie
nts,
%
Long Term Pulmonary Valve Competence
Courtesy Medtronic
Courtesy Medtronic
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Melody Valve
• Freedom from re-operation:– Canada: 91%, 83% and 83% at 12, 24 and 36
months, respectively• Freedom from transcatheter intervention
– Canada: 91% 1 year, 80% 2 year
Courtesy Medtronic
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ComplicationsStent Fractures (%)Pa
tient
s, %
24 28 12 30 7.5Follow up (months)
Melody Valve: Complications
• Stent fracture in 5-25%– Increased use of pre-stenting of conduits reduces
this risk• Conduit rupture - ~4% requiring treatment
(covered stent/surgery)– <1% “uncontained” rupture but can be fatal
• Coronary artery compression– Can be seen in ~5% of patients during test evaluation– Can be catastrophic
Morray BH et al. Circ Cardio Int;2013:6:535-542
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Transcatheter Valve
• Melody valve was expanded the role of interventional cath in post-operative patients
• Limited size range• There are many patients with conduits and
valves that are not candidates for a Melody valve
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Sapien Valve
• Bovine pericardial valve leaflets hand-sewn into a slotted stainless steel stent
• Fabric sealing cuff on lower portion of stent• Designed for aortic position• Can be considered for pulmonary valves/conduits
~21 - 30 mm in diameter, patients > 30-35 kg• Shorter stent requires that conduits are fully
stented prior to Sapien valve insertion
Edwards Lifesciences
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Sapien Valve
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Sapien vs. Melody
Faza et al. Cathet Cardiovasc Int 2013;82(4):E535-41.
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Sapien vs. Melody
Faza et al. Cathet Cardiovasc Int 2013;82(4):E535-41.
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Transannular Patch
• What about the really large RVOT’s?• Medtronic Native Outflow Tract Pulmonary
Valve
Courtesy Medtronic
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Medtronic’s Early Feasibility Study: Non-randomized, Prospective
• Primary Objective:– Obtain in vivo data to confirm assumptions on loading conditions for
future in vitro frame evaluations
• Secondary Objectives: – Characterize procedural feasibility, safety & TPV performance
• Up to 20 subjects - Consented for 5 year follow-up at 3 North American Centers (Implants spring 2014 – F/U to 2019)– The Hospital for Sick Children ,Toronto Canada – Dr. Lee Benson– Nationwide Children’s Hospital, Columbus Ohio – Dr. John Cheatham– Children’s Hospital, Boston MA – Dr. Jim Lock
Courtesy Medtronic
Courtesy Medtronic
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Conclusion
• Patients with TOF are left with residual lesions• Cardiac cath lab procedures can treat or
palliate many of these lesions and delay the need for repeat cardiac surgery
• Future advances will expand the therapeutic options to include a broader range of patient diagnoses and patient sizes