Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1108 participants
OBSERVATIONAL
2015-06-08
2022-07-01
Brief Summary
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Detailed Description
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Recognizing that the RV adapts to stress signals has led to the idea that leaving mixed residual stenosis and regurgitation may yield to an adaptive change that limits RV dilation while still allowing for adequate cardiac output. Early attempts to limit pulmonary insufficiency and RV damage involve minimal trans-annular patching or complete annulus preservation (AP). Emerging data suggest that patients with a mixed lesion have improved survival, so that 96.6% are alive at 25-years in comparison to 85-90% survival for the conventional technique.
Preliminary Data: A review of data comparing AP to TAP repair at our institution (n=185, AP repair=124, TAP=61) demonstrated that at 10-15 year follow-up those who received an AP repair had smaller RV volumes and pulmonary regurgitant jet width. They were also seen to have improved exercise capacity as measure by VO2 max tests. The AP technique also has been seen to significantly decrease the risk of reoperation in comparison to TAP, 11% and 29% respectively.
Current Problem: Although trans-ventricular VSD closure along with a TAP is known to result in increased risk of long-term morbidity and mortality, it continues to be the predominant repair strategy implemented globally according to STS/EACTS databases. Reasons for this are:
* Trans-ventricular/TAP approach is technically easier than annulus preservation, which often requires multiple pump runs
* There is a fear of leaving too much obstruction
* High quality evidence supporting one approach over the other is lacking.
Gaps in Literature
1. Most data on the impact of surgical strategy emerge from single centre experiences that are retrospective and based on small patient population. This makes the results difficult to standardize to the general TOF population.
2. Retrospective registry data published by STS and EACTS omit many crucial surgical and clinical variables that can potentially impact outcomes.
3. None of the current evidence are based on anatomically matched/adjusted patients
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TOF participants
Tetralogy of fallot patients at any age
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* TOF with pulmonary atresia and confluent pulmonary arteries.
* Admitted with intent to treat (i.e. patient planned to undergo a primary or staged repair).
* Patients with coronary artery anomalies, right aortic arch, and 22q11 deletion may be included
Exclusion Criteria
* Other major cardiac anomalies such as AVSD, multiple VSDs, right atrial isomerism, and MAPCAs. In this instance, the definition of MAPCAs does not include dilated bronchial collateral arteries.
* Unbalanced ventricles precluding biventricular repair
* Major genetic abnormalities/syndromes e.g. trisomy 13,18, and 21
* Major extra cardiac anomalies e.g. diaphragmatic hernia, omphalocele, absent sternum, cerebral palsy
* Infective endocarditis as an indication for intra-cardiac repair
* Stroke in the last 30 days prior to palliation or intra-cardiac repair
* Known diagnosis of HIV or hepatitis B
* Any previous cardiac procedures
* Patient's circumstance that precludes completion of follow-up telephone call and/or obtaining information from the 2-year cardiology follow-up
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Glen Van Arsdell, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Richard Whitlock, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Locations
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Nemours Children's Hospital
Orlando, Florida, United States
Morgan Stanley Children's Hospital
New York, New York, United States
Royal Children's Hospital
Parkville, Victoria, Australia
Hospital for Sick Children
Toronto, Ontario, Canada
West China Hospital
Chengdu, Sichuan, China
Beijing Fuwai Hospital
Beijing, , China
Guangzhou Women and Children's Medical Center
Guangdong, , China
Guangdong Cardiovascular Institute
Guangdong, , China
Shanghai Children's Medical Centre
Shanghai, , China
Shanghai Xinhua Hospital
Shanghai, , China
Fortis Escorts Heart Institute
New Delhi, National Capital Territory of Delhi, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institutev
Mumbai, , India
National Cardiovascular Center Harapan Kita
Jakarta, , Indonesia
Okayama University Hospital
Okayama, , Japan
Manmohan Cardiothoracic Vascular and Transplant Center
Kathmandu, , Nepal
Academician E.N. Meshalkin Research
Novosibirsk, , Russia
King Abdulaziz University Hospital
Jeddah, Mecca Region, Saudi Arabia
King Faisal Specialist Hospital and Research Centre - Jeddah
Jeddah, , Saudi Arabia
Asan Medical Center
Seoul, , South Korea
Children's Cardiac Center - Ukraine
Kyiv, , Ukraine
Countries
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References
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Sarris GE, Comas JV, Tobota Z, Maruszewski B. Results of reparative surgery for tetralogy of Fallot: data from the European Association for Cardio-Thoracic Surgery Congenital Database. Eur J Cardiothorac Surg. 2012 Nov;42(5):766-74; discussion 774. doi: 10.1093/ejcts/ezs478.
Al Habib HF, Jacobs JP, Mavroudis C, Tchervenkov CI, O'Brien SM, Mohammadi S, Jacobs ML. Contemporary patterns of management of tetralogy of Fallot: data from the Society of Thoracic Surgeons Database. Ann Thorac Surg. 2010 Sep;90(3):813-9; discussion 819-20. doi: 10.1016/j.athoracsur.2010.03.110.
Gatzoulis MA, Balaji S, Webber SA, Siu SC, Hokanson JS, Poile C, Rosenthal M, Nakazawa M, Moller JH, Gillette PC, Webb GD, Redington AN. Risk factors for arrhythmia and sudden cardiac death late after repair of tetralogy of Fallot: a multicentre study. Lancet. 2000 Sep 16;356(9234):975-81. doi: 10.1016/S0140-6736(00)02714-8.
d'Udekem Y, Galati JC, Rolley GJ, Konstantinov IE, Weintraub RG, Grigg L, Ramsay JM, Wheaton GR, Hope S, Cheung MH, Brizard CP. Low risk of pulmonary valve implantation after a policy of transatrial repair of tetralogy of Fallot delayed beyond the neonatal period: the Melbourne experience over 25 years. J Am Coll Cardiol. 2014 Feb 18;63(6):563-8. doi: 10.1016/j.jacc.2013.10.011. Epub 2013 Oct 30.
Pondorfer P YT, Cheung M, Ashburn D, Manlhiot C, McCrindle B, Mertens L, Grosse-Wortmann L, Redington A, Van Arsdell G. Abstract 18833: Annulus Preservation Strategy Improves Late Outcomes in Tetralogy of Fallot: An Anatomical Equivalency Study. Circulation. 2014;130:A18833.
Other Identifiers
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TOF-LIFE 2.0 2015-06-11
Identifier Type: -
Identifier Source: org_study_id