Derk Frank1,2, Mohamed Abdel-Wahab3, Martine Gilard4, Franck Digne5, Geraud Souteyrand6, Christophe Caussin7, Frédéric Collart8, Vincent Letocart9, Jochen Wöhrle10, Christian Kuhn11,12, Tomas Hovorka13, Helmut Baumgartner14. 1. Department of Internal Medicine III (Cardiology, Angiology, and Critical Care), University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str. 3, Building 6, 24105, Kiel, Germany. derk.frank@uksh.de. 2. DZHK (German Centre for Cardiovascular Research), Partner Site Kiel/Hamburg/Lübeck, Kiel, Germany. derk.frank@uksh.de. 3. Cardiology Department, Heart Center, Leipzig, Germany. 4. Public Hospital La Cavale Blanche, Brest, France. 5. Centre Cardiologique du Nord, Saint-Denis, France. 6. Public Hospital Clermont-Ferrand, Clermont-Ferrand, France. 7. Institut Mutualiste Montsouris, Paris, France. 8. Public Hospital La Timone, Marseille, France. 9. Institut du thorax, Public Hospital Nantes, Nantes, France. 10. Department of Internal Medicine II, University Hospital of Ulm, Ulm, Germany. 11. Department of Internal Medicine III (Cardiology, Angiology, and Critical Care), University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str. 3, Building 6, 24105, Kiel, Germany. 12. DZHK (German Centre for Cardiovascular Research), Partner Site Kiel/Hamburg/Lübeck, Kiel, Germany. 13. Statistics, Edwards Lifesciences, Prague, Czech Republic. 14. Division of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital Muenster, Muenster, Germany.
Abstract
BACKGROUND: Current trials and registries of transcatheter valve implantation (TAVI) mostly include patients older than 75 years. Little is known about younger patients who undergo this treatment. We investigated comorbidities among patients < 75 years old who underwent TAVI in the SAPIEN 3™ European post-approval SOURCE 3 Registry, and analysed outcomes at 30 days and 1 year. METHODS AND RESULTS: Three age groups of patients were analysed for outcomes and characteristics: < 75 (n = 235), 75-80 (n = 391) and ≥ 80 years (n = 1320). Overall, the mean age was 81.6 ± 6.7 years; transfemoral access was used in 87.1% of patients treated with SAPIEN 3 transcatheter heart valves. The mean logistic EuroSCORE increased according to age group (12.6%, 17.3% and 19.7%, respectively, p < 0.001). Younger patients had a higher incidence of comorbidities, particularly those not included in surgical risk score assessment tools, e.g., severe liver disease, previous radiation therapy, and porcelain aorta. Mortality rates were similar between age groups at 30 days (1.7%, 2.0% and 2.3%, respectively, p = 0.79) and 1 year (14.2%, 9.3% and 13.3%, respectively, p = 0.08). However, sudden cardiac death rates were higher in the < 75 years age group compared with the ≥ 85 years age group (20.7% vs. 4.8%, p = 0.010). CONCLUSIONS: In current TAVI practice, patients younger than 75 years are a minority (12%). Despite younger age and lower surgical risk scores, this cohort was characterized by comorbidities not accounted for by traditional surgical risk scores. More data are needed for this age group to guide the appropriate decision between surgery and TAVI. CLINICALTRIAL. GOV NUMBER: NCT02698956.
BACKGROUND: Current trials and registries of transcatheter valve implantation (TAVI) mostly include patients older than 75 years. Little is known about younger patients who undergo this treatment. We investigated comorbidities among patients < 75 years old who underwent TAVI in the SAPIEN 3™ European post-approval SOURCE 3 Registry, and analysed outcomes at 30 days and 1 year. METHODS AND RESULTS: Three age groups of patients were analysed for outcomes and characteristics: < 75 (n = 235), 75-80 (n = 391) and ≥ 80 years (n = 1320). Overall, the mean age was 81.6 ± 6.7 years; transfemoral access was used in 87.1% of patients treated with SAPIEN 3 transcatheter heart valves. The mean logistic EuroSCORE increased according to age group (12.6%, 17.3% and 19.7%, respectively, p < 0.001). Younger patients had a higher incidence of comorbidities, particularly those not included in surgical risk score assessment tools, e.g., severe liver disease, previous radiation therapy, and porcelain aorta. Mortality rates were similar between age groups at 30 days (1.7%, 2.0% and 2.3%, respectively, p = 0.79) and 1 year (14.2%, 9.3% and 13.3%, respectively, p = 0.08). However, sudden cardiac death rates were higher in the < 75 years age group compared with the ≥ 85 years age group (20.7% vs. 4.8%, p = 0.010). CONCLUSIONS: In current TAVI practice, patients younger than 75 years are a minority (12%). Despite younger age and lower surgical risk scores, this cohort was characterized by comorbidities not accounted for by traditional surgical risk scores. More data are needed for this age group to guide the appropriate decision between surgery and TAVI. CLINICALTRIAL. GOV NUMBER: NCT02698956.
Entities:
Keywords:
Aortic stenosis; Balloon-expandable valve; Causes of death; Predictors of mortality; SAPIEN 3; Transcatheter aortic valve implantation
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