Dietmar Boethig1,2, Murat Avsar1, Ulrike M M Bauer3,4, Samir Sarikouch1, Philipp Beerbaum2, Felix Berger5,6, Robert Cesnjevar7, Ingo Dähnert8, Sven Dittrich9,10, Peter Ewert11, Axel Haverich1, Jürgen Hörer11, Martin Kostelka8, Joachim Photiadis12,13,14, Eugen Sandica15, Stephan Schubert15, Aleksandra Urban3, Dmitry Bobylev1, Alexander Horke1. 1. Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hanover Medical School, Hanover, Germany. 2. Department of Pediatric Cardiology and Intensive Care Medicine, Hanover Medical School, Hanover, Germany. 3. National Register for Congenital Heart Defects, German Centre for Cardiovascular Research (DZHK), Berlin, Germany. 4. German Competence Network for Congenital Heart Defects, Berlin, Germany. 5. Department of Congenital HeartDisease/Pediatric Cardiology, German Heart Institute Berlin, Berlin, Germany. 6. Department of Pediatric Cardiology, Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin, Germany. 7. Department of Pediatric Cardiac Surgery, University of Erlangen, Erlangen, Germany. 8. Department of Cardiac Surgery, Heart Centre, University of Leipzig, Clinic for Pediatric Cardiology, Leipzig, Germany. 9. Divisions of Pediatric Cardiology, University of Erlangen, Erlangen, Germany. 10. Division of Pediatric Cardiac Surgery, University of Erlangen, Erlangen, Germany. 11. Department of Paediatric Cardiology and Congenital Heart Defects and Congenital Heart Surgery, German Heart Centre of the Technical University of Munich, Munich, Germany. 12. Department of Congenital Heart Disease, German Heart Institute, German Centre for Cardiovascular Research (DZHK) partner site Berlin, Berlin, Germany. 13. Department of Pediatric Cardiology and Congenital Heart Surgery, German Heart Institute, German Centre for Cardiovascular Research (DZHK) partner site Berlin, Berlin, Germany. 14. Department of Pediatric Heart Surgery, German Heart Institute, German Centre for Cardiovascular Research (DZHK) partner site Berlin, Berlin, Germany. 15. Department of Congenital Heart Disease, Heart and Diabetes Centre, Bad Oeynhausen, Germany.
Abstract
OBJECTIVES: We evaluated 4384 procedures performed between 1957 and 2018, collected in the National Register for Congenital Heart Defects, conducted on 997 patients with 1823 pulmonary valve replacements (PVRs), including 226 implanted via catheter [transcatheter valve (TCV)]. Main study targets are as follows: TCV benefit, valve type durability, decade-wise treatment changes and procedure frequencies over the lifetime of a PVR patient. METHODS: We studied TCV impact on surgical valve replacement (via Kaplan-Meier); pulmonary valve type-specific performance (Kaplan-Meier and Cox regressions with age group as stratification or ordinary variable); procedure interval changes over the decades (Kaplan-Meier); procedure load, i.e. frequency of any procedure/surgical PVR/interventional or surgical PVR by patient age (multistate analyses). RESULTS: TCV performance was equivalent to surgical PVRs and extended durability significantly. Homografts were most durable; Contegras lasted comparably less in older; and Hancock devices lasted less in younger patients. Matrix P-valves showed poorer performance. Age group stratification improves the precision of valve-specific explantation hazard estimations. The current median interval between procedures is 2.6 years; it became significantly shorter in most age groups below 40 years. At 30 years, 80% of patients had undergone ≥3 procedures, 20% ≥3 surgical PVRs and 42% ≥3 surgical or interventional PVRs. CONCLUSIONS: TCVs doubled freedom from explantation of conventional valves. Homografts' age group-specific explantation hazard ratio was lowest; Matrix P's hazard ratio was highest. Age-stratified Cox regressions improve the precision of prosthesis durability evaluations. The median time between procedures for PVR patients shortened significantly to 2.6 years. At 30 years, 42% had ≥3 PVRs.
OBJECTIVES: We evaluated 4384 procedures performed between 1957 and 2018, collected in the National Register for Congenital Heart Defects, conducted on 997 patients with 1823 pulmonary valve replacements (PVRs), including 226 implanted via catheter [transcatheter valve (TCV)]. Main study targets are as follows: TCV benefit, valve type durability, decade-wise treatment changes and procedure frequencies over the lifetime of a PVR patient. METHODS: We studied TCV impact on surgical valve replacement (via Kaplan-Meier); pulmonary valve type-specific performance (Kaplan-Meier and Cox regressions with age group as stratification or ordinary variable); procedure interval changes over the decades (Kaplan-Meier); procedure load, i.e. frequency of any procedure/surgical PVR/interventional or surgical PVR by patient age (multistate analyses). RESULTS: TCV performance was equivalent to surgical PVRs and extended durability significantly. Homografts were most durable; Contegras lasted comparably less in older; and Hancock devices lasted less in younger patients. Matrix P-valves showed poorer performance. Age group stratification improves the precision of valve-specific explantation hazard estimations. The current median interval between procedures is 2.6 years; it became significantly shorter in most age groups below 40 years. At 30 years, 80% of patients had undergone ≥3 procedures, 20% ≥3 surgical PVRs and 42% ≥3 surgical or interventional PVRs. CONCLUSIONS: TCVs doubled freedom from explantation of conventional valves. Homografts' age group-specific explantation hazard ratio was lowest; Matrix P's hazard ratio was highest. Age-stratified Cox regressions improve the precision of prosthesis durability evaluations. The median time between procedures for PVR patients shortened significantly to 2.6 years. At 30 years, 42% had ≥3 PVRs.
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