Characteristics and outcomes of patients ≤ 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry.

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.

Prevalence, clinical characteristics and outcomes of high-risk patients treated for severe aortic stenosis prior to and after transcatheter aortic valve implantation availability.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has emerged as an effective treatment for high-risk patients with severe aortic stenosis (AS). The aim of our study was to compare the prevalence, characteristics and outcomes of high-risk patients treated prior to and after the availability of TAVI in our high-volume surgical institution. METHODS: Among 879 consecutive patients treated 2 years before ('pre-TAVI era') and after ('modern era') the availability of TAVI in our institution, 83 patients were at high risk [defined by logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) >20%]. RESULTS: Among all patients treated for severe AS, the prevalence of high-risk patients was higher in the modern era (12.7 vs 4.9%, P < 0.0001). In the modern era, high-risk patients were treated by TAVI in 89% of cases. Despite similar logistic EuroSCORE (34.9 vs 34%, P = 0.96), the clinical characteristics of these patients have evolved: high-risk patients in the modern era were older (85.3 ± 5.9 vs 78.5 ± 6.5 years, P = 0.0005) and presented more frequently with New York Heart Association class III-IV (92.3 vs 61.1%, P = 0.003), while high-risk patients treated by surgical aortic valve replacement in the pre-TAVI era presented more frequently with a critical preoperative status (33.3 vs 7.7%, P = 0.01), lower left ventricular ejection fraction (41 ± 14 vs 49 ± 15%, P = 0.05) and a history of recent myocardial infarction (27.8 vs 6.1%, P = 0.02). The overall 1-year survival was not different for high-risk patients treated in the pre-TAVI era or in the modern era (61 ± 11 vs 68 ± 6%, P = 0.52). CONCLUSIONS: The availability of TAVI has increased the prevalence of high-risk patients treated for severe AS and changed the clinical features of this kind of patients who were rarely surgically treated before. The 1-year survival was similar between pre-TAVI and modern eras.

Seguimento angiográfico e clínico tardio do novo stent farmacológico não-polimérico liberador de paclitaxel para o tratamento de lesões coronárias De Novo: resultados do Estudo PAX-B / Late clinical and angiographic follow-up of the new non-polymeric paclitaxel-eluting stent for the treatment of De Novo coronary lesions: outcomes of the PAX-B Study

Introdução: O stent farmacológico eluidor de paclitaxel, não-polimérico, Amazonia® PAX não mostrou diferença na reestenose coronária ou eventos clínicos aos 4 meses de evolução quando comparado com o stent Taxus®. Entretanto, o desempenho do stent Amazonia® PAX em cenários de maior complexidade e com seguimento angiográfico mais longo ainda não foi demonstrado. Métodos: O Estudo PAX-Bfoi um estudo prospectivo, não-randomizado, multicêntrico, que avaliou os resultados tardios de pacientes tratados com o stent Amazonia® PAX. O desfecho primário foi a perda tardiado lúmen intrastent. Resultados: Foram incluídos 103 pacientes com média de idade de 61,3 ± 11,4 anos, 26,2% eramdiabéticos, 24,3% apresentaram-se com síndrome coronária aguda e 71,6% tinham lesões tipo B2/C. Implante de múltiplos stents ocorreu em 4,7% dos casos e o sucesso angiográfico foi de 100%. Na fase hospitalar, a taxa de infarto agudo do miocárdio periprocedimento foi de 3,9%, e um desses eventos levou à revascularização da lesão-alvo (RLA). No seguimento angiográfico de 9 meses, a mediana da perda tardia do lúmen intrastent foi de 0,91 [0,50; 1,21] mm. As taxas cumulativas de eventos cardíacos adversos maiores nos seguimentos de 6meses, 9 meses e 12 meses foram, respectivamente, de 7,8%, 18,5% e 21,3%, principalmente em decorrência de RLA. Não se observou morte ou trombose de stent em 12 meses.Conclusões: O stent Amazonia® PAX demonstrou excelentes resultados imediatos e alto perfil de segurança. Entretanto, as taxas de recorrência angiográfica foram relativamente altas,em razão da pouca eficácia na inibição da formação de hiperplasia neointimal.