a future without re-operations? - mended hearts · 2019. 6. 26. · prof. dr. gerardus bennink...
TRANSCRIPT
Prof. Dr. Gerardus Bennink
Chief and head of pediatric cardio-thoracic congenital surgeryHeart Center of the University of Cologne
A FUTURE WITHOUT RE-OPERATIONS?
New horizons in pulmonary heart valve therapyJanuary 29, 2018
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CHDs: - Most common birth defect (1%)- Around 40,000 U.S. babies each year
CHD of RVOT15-20% of all CHDs:
- Tetralogy of Fallot- Truncus Arteriosus- Pulmonary Atresia- TGA+VSD+LVOTO
Congenital heart defectsRVOT reconstruction
- Pulmonary heart valve replacement
Procedure
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What to expect
Average duration: 2-4 hours
Recovery time and discharge: up to a week
Life at home: a life as normal as possible
Methods
Reconstruction- Valve replacement (valved conduit)- Valve insertion (transcatheter)
Repairs- Monoscusp patch- Transannular patch
RVOT Surgery
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Pulmonary heart valve options
Homograft Valved conduits with biological/mechanical valve
Xenograft Mechanical valve alone
Homograft with pericardial hood
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Less invasive: No open-heart surgery
- Not for babies/smaller children- Not first heart valve replacement option
Transcatheter pulmonary heart valves - TPVs
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Life after surgery is progressing
Artificial heart valves are life savers
# Children with CHD = # Adults with CHD
Surgery is often not a definitive cure
Most patients require additional operation(s)/medications
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Reducedblood flow
Heart valve replacement is currently unavoidable
Calcification Patient growth Stenosis
Reduced oxygen in the blood
Re-intervention
BreathlessnessTiredness
Fatigue
Figure 2: Freedom from the second redo pulmonary valve replacement. Numbers above the x-axis represent patients remaining at risk.
Lee C, Lee C-H, Kwak JC. Outcomes of redo pulmonary valve replacement for bioprosthetic pulmonary valve failure in 61 patients with congenital heart disease. Eur J Cardiothorac Surg. 2016 Sep;50(3):470-5. doi: 10.1093/ejcts/ezw037. Epub 2016 Feb 17.
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Ideal valve?
Readily available
Non-thrombogenic
Life-long guarantee
All sizesExcellent
flow dynamic
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On the horizon
! NB: investigational devices only
Fully synthetic restorative
heart valves
De-celluralizedhomografts
Stem-cells (very early
stages)
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Xeltis’ Restorative Heart Valve technology
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Xeltis’ Restorative Heart Valve technology
Unique absorbable
matrices
Restorative Valves
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In-vitro Pre-clinical Clinical
Pediatric conduit (Fontan)Positive 31-month clinical data
Presented WCPCCS 2017
Pulmonary ValvePositive 2-year preclinical data
Published in Eurointervention 2017First clinical experience ongoing
Aortic Heart ValveExtending pipeline to high pressure circuit
Published in Eurointervention 2017
Vascular ApplicationsFurther pipeline expansion underway
Restorative technology in trials
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• Over 50 sheep implanted • Juvenile and adult sheep• Up to 24 months implantation
• Key findings– Better survival than controls (Hancock)– After 24 months significant degradation, small fragments remaining– Stable healing and tissue restoration– Positive functionality overtime– Limited calcification compared to controls– No aneurysms seen in any case (most important for this indication)
Pulmonary ValvePre-Clinical Animal Data
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Inflammation and ingrowth of new tissue at resorption site.
12m
Resorption of the conduit.
6m
Dr. Renu Virmani
New tissue thickening at the base.
Conduit is covered by new tissue.
Partial breakdown of the leaflet with inflammation
New tissuecoverageof leaflet
New tissuecovered 2/3of the leaflet.
Histopathology detailsBalanced scaffold absorption and tissue restoration
2m
New tissue Conduit Leaflet
2mm2mm 2mm
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Pulmonary valve in patientsFirst trial in EU/Asia
Target indication• RVOT correction or reconstruction • Patients younger than 22 years • Patients with the following CHDs
– Tetralogy of Fallot– Truncus Arteriosus– Pulmonary Atresia– Transposition of Great Arteries with
Ventricular Septum Defect (VSD)– Pulmonary Stenosis in combination with
other defects in CHD syndromes
Additional indication• Replacement of previously implanted, but
dysfunctional, pulmonary heart valves
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Enrollment Started: 07.07.16 Enrollment Completed: 14.12.16
Summary/Trial StatusPulmonary valve in patients
• Patients enrolled: 12 (6 boys)• Age range: 2–12 years• Clinical sites:
– Budapest (4)
– Krakow (3)– Kuala Lumpur (5)
• Follow-up reached:– 12 months – 12– 18 months – ongoing
• All patients are doing well• No deaths, no reintervention or
reoperation• No device-related serious adverse
events• Information on:
– Surgical techniques– Patients’ anatomy
– Product efficiencies
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www.xplore2trial.com
US Restorative pulmonary valve trialTrial Centers
Children’s Healthcare of Atlanta
Investigator: Kirk Kanter, MD
Contact: Janet Fernandez
Boston Children’s Hospital
Investigator: Christopher Baird, MD
Contact: Michele Borisuk
New York Presbyterian Hospital –
Columbia University
Investigator: Emile Bacha, MD
Contact: Kydanis Clase
columbiasurgery.org/clinical-trials/xplore-ii
Children’s Hospital of Philadelphia
Investigator: J William Gaynor, MD
Contact: Brenna Klepczynski
Visit:
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Ideal valve technology?
� Readily available
� All sizes
� Promising results
� Potentially longer lasting
A future not to be missed!18
Prof. Gerardus Bennink
Thank you!
A FUTURE WITHOUT RE-OPERATIONS?
New horizons in pulmonary heart valve therapy
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