Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a new-generation, self-expandable system.

OBJECTIVES: The aim of the study was to evaluate mid- to late clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) with Acurate neo™ (Boston Scientific, Boston, MA). BACKGROUND: TAVR is an established treatment for aortic stenosis (AS). Few data exist on mid- to long-term outcomes and durability after new-generation valves. METHODS: All consecutive patients (n = 104) who underwent Acurate neo™ implantation from 2012 to 2018 were included. Follow-up was systematically performed at 1, 6, 12, and 24 months and yearly thereafter. Outcomes were reported according to VARC-2, and structural valve deterioration (SVD) or bioprosthetic valve failure defined accordingly to new definitions. RESULTS: Mean age was 82 ± 5.4 years, 56.7% were female and the Society of Thoracic Surgeons score for mortality was 5.9 ± 4%. Patients were followed for a median of 3 years (1,092 days; IQR 1.5-4 years), and the maximum follow-up was 7 years. All-cause mortality values at 1 and 5 years were 8.5% and 40.5%, respectively. No relevant changes in mean gradient and orifice area occurred (7.9 ± 3.8 mmHg and 1.9 ± 0.3 cm2 at 1 year; 6.6 ± 2.1 mmHg and 1.8 ± 0.3 cm2 at 5 years), and there was a significant rate of paravalvular leaks resolution at 1, 2, and 3 years (p = .004; p < .001; p < .001, respectively). None of the patients had leaflet thrombosis or endocarditis. One patient developed SVD at 84 months. CONCLUSIONS: Acurate neo™ was associated with sustained echocardiographic results. Reassuring mid- to long-term outcomes was observed in this cohort of elderly patients with severe AS.

Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a newgeneration, self-expandable system / Desfechos clínicos e ecocardiográficos de médio a longo prazo após a substituição da válvula aórtica transcateter com uma nova geração, sistema auto-expansível

Abstract Objectives: The aim of the study was to evaluate mid- to late clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) with A curate neo™ (Boston Scientific, Boston, MA). Background: TAVR is an established treatment for aortic stenosis (AS). Few data exist on mid- to long-term outcomes and durability after new-generation valves. Methods: All consecutive patients (n = 104) who underwent A curate neo™ implantation from 2012 to 2018 were included. Follow-up was systematically performed at 1, 6, 12, and 24 months and yearly thereafter. Outcomes were reported according to VARC-2, and structural valve deterioration (SVD) or bioprosthetic valve failure defined accordingly to new definitions. Results: Mean age was 82 ± 5.4 years, 56.7% were female and the Society of Thoracic Surgeons score for mortality was 5.9 ± 4%. Patients were followed for a median of 3 years (1,092 days; IQR 1.5­4 years), and the maximum follow-up was 7 years. All-cause mortality values at 1 and 5 years were 8.5% and 40.5%, respectively. No relevant changes in mean gradient and orifice area occurred (7.9 ± 3.8 mmHg and 1.9 ± 0.3 cm2 at 1 year; 6.6 ± 2.1 mmHg and 1.8 ± 0.3 cm2 at 5 years), and there was a significant rate of paravalvular leaks resolution at 1, 2, and 3 years (p = .004; p < .001; p < .001, respectively). None of the patients had leaflet thrombosis or endocarditis. One patient developed SVD at 84 months. Conclusions: A curate neo™ was associated with sustained echocardiographic results. Reassuring mid- to long-term outcomes was observed in this cohort of elderly patients with severe AS.

Impacto da Curva de Aprendizado na Seleção de Pacientes e nos Resultados Clínicos do Implante por Cateter de Prótese Aórtica / Impact of Transcatheter Aortic Valve Implantation Learning Curve on Patient Selection and Clinical Outcomes

Introdução: O implante por cateter de prótese aórtica (TAVI, do inglês transcatheter aortic valve implantation) constitui tratamento alternativo para pacientes com estenose aórtica de alto risco cirúrgico ou inoperáveis. Para adquirir competência, o grupo multidisciplinar deve receber treinamento específico e acumular experiência na execução do TAVI. Contudo, sua curva de aprendizado não está bem estabelecida. Nosso objetivo foi analisar o impacto da curva de aprendizado na seleção de pacientes, nos aspectos técnicos e nos resultados clínicos do TAVI. Métodos: Estudo observacional e prospectivo dos primeiros 150 pacientes submetidos a TAVI por via femoral, entre janeiro de 2009 e dezembro de 2013 divididos em tercis (n = 50) de acordo com a data do procedimento. Os desfechos foram definidos conforme os critérios Valve Academic Research Consortium-2 (VARC-2). Resultados: A idade foi de 82,5 ± 6,7 anos, sendo 44% homens e 75% em classe NYHA III/IV. O EuroSCORE (24,2 ± 13% vs. 21,2 ± 10,8% vs. 23,4 ± 14,3%) e o STS Score (5,9 ± 2,9% vs. 6,7 ± 4,3% vs. 5,8 ± 3,1%) foram similares entre os grupos. Observou-se redução gradativa nos tempos do procedimento (107,2 ± 48,1 minutos vs. 90,3 ± 42,2 minutos vs. 76,6 ± 37,7 minutos; p < 0,01) e de fluoroscopia (31,3 ± 9,6 minutos vs. 25,4 ± 8,7 minutos vs. 17,2 ± 6,2 minutos; p = 0,01), e no ...

Background: Transcatheter aortic valve implantation (TAVI) is an alternative treatment for high-risk or inoperable patients with aortic stenosis. The multidisciplinary team must undergo specific training and accumulate experience to achieve optimal results. However, its learning curve is not well established. Our objective was to investigate the impact of learning curve on patient selection, technical aspects and clinical outcomes of TAVI. Methods: Observational, prospective analysis of the first 150 patients undergoing transfemoral TAVI between January 2009 and December 2013. Patients were divided into tertiles (n = 50), according to the procedure date. Outcomes were defined according to Valve Academic Research Consortium-2 (VARC-2) criteria. Results: Mean age was 82.5 ± 6.7 years, 44% were male and 75% were in NYHA class III/IV. EuroS-CORE (24.2 ± 13% vs. 21.2 ± 10.8% vs. 23.4 ± 14.3%) and STS Score (5.9 ± 2.9% vs. 6.7 ± 4.3% vs. 5.8 ± 3.1%) were similar between groups. A gradual decrease was observed in procedure times (107.2 ± 48.1 minutes vs. 90.3 ± 42.2 minutes vs. 76.6 ± 37.7 minutes; p < 0.01), fluoroscopy times (31.3 ± 9,6 minutes vs. 25.4 ± 8.7 minutes vs. 17.2 ± 6.2 minutes; p = 0.01) and contrast volume (145.5 ± 70.9 mL vs. 123.2 ± 87.8 mL vs. 101.1 ± 50 mL; p = 0.01). Mortality decreased gradually (20% vs. 10% vs. 4%; p = 0,047), and lower bleeding and moderate-to-severe aortic regurgitation were ...