Comparación de la hemodinámica valvular de la prótesis transcatéter con balón expandible SAPIEN 3 frente a la autoexpandible Evolut R: estudio de casos emparejados / Comparison of the hemodynamic performance of the balloon-expandable SAPIEN 3 versus self-expandable evolut R transcatheter valve: a case-matched study

Introducción y objetivos: Las válvulas SAPIEN 3 (S3) y Medtronic Evolut R (EVR) son prótesis transcatéter de segunda generación, diseñadas para reducir el grado de insuficiencia aórtica (IAo) paravalvular. El objetivo es comparar la hemodinámica valvular en un estudio de casos emparejados con análisis ecocardiográfico independiente. Métodos: De una población de 201 pacientes tratados con implante percutáneo de válvula aórtica, se emparejó a un total de 144 (S3, n = 80; EVR, n = 64) en función del diámetro del anillo y de la puntuación de calcio aórtico medidos por tomografía computarizada. Los ecocardiogramas de seguimiento basal, al mes y a los 6 meses se analizaron de manera independiente y centralizada. Resultados: No se observaron diferencias respecto a las características basales clínicas y ecocardiográficas. La prótesis EVR mostró un mejor perfil hemodinámico evaluado mediante gradiente aórtico máximo (EVR frente a S3, 13 ± 7 frente a 20 ± 10; p < 0,001), gradiente aórtico medio (7 ± 3 frente a 11 ± 6; p < 0,001) e índice de velocidad Doppler (0,65 ± 0,15 frente a 0,51 ± 0,16; p < 0,001). Por otro lado, la tasa de IAo paravalvular moderada-grave o de cualquier grado de IAo paravalvular (≥ leve) fue mayor en el grupo de EVR (el 11 y el 50%) que en el de S3 (el 2,5 y el 21%; p < 0,05), con mayor número de chorros regurgitantes (p < 0,001). Conclusiones: En una cohorte de casos emparejados tratados con implante percutáneo de válvula aórtica de segunda generación, la S3 se asoció con una menor tasa de IAo paravalvular y mayor gradiente transprotésico residual que con la EVR

Introduction and objectives: The SAPIEN 3 (S3) valve and the Medtronic Evolut R (EVR) are second-generation transcatheter valves, designed to further reduce the rate of paravalvular aortic regurgitation (AoR). The aim of this study was to compare the 2 devices in terms of valve performance in a case-matched study with independent echocardiographic analysis. Methods: Of a population of 201 patients who underwent transcatheter aortic valve implantation, 144 patients (S3, n = 80; EVR, n = 64) were matched according to aortic annulus diameter and aortic valve calcium score, as assessed by computed tomography. All echocardiographic examinations collected at baseline and at 1- and 6-month follow-up were centrally analyzed. Results: The 2 groups were well balanced in baseline clinical and echocardiographic characteristics. The EVR valve showed a better hemodynamic profile as assessed by peak aortic gradient (EVR 13 ± 7 vs S3 20 ± 10 mmHg; P < .001), mean aortic gradient (EVR 7 ± 3 vs S3 11 ± 6 mmHg; P < .001), and Doppler velocity index (EVR 0.65 ± 0.15 vs S3 0.51 ± 0.16; P < .001). The rate of moderate-severe or any paravalvular (≥ mild) AoR was higher in the EVR group (11% and 50%) than in the S3 group (2.5% and 21%; P < .05, respectively), with a larger number of paravalvular jets (P < .001). Conclusions: In a case-matched cohort of transcatheter aortic valve implantation patients, the S3 valve was associated with a lower rate of paravalvular AoR but also with a higher residual gradient than the EVR system

Comparison of the Hemodynamic Performance of the Balloon-expandable SAPIEN 3 Versus Self-expandable Evolut R Transcatheter Valve: A Case-matched Study.

INTRODUCTION AND OBJECTIVES: The SAPIEN 3 (S3) valve and the Medtronic Evolut R (EVR) are second-generation transcatheter valves, designed to further reduce the rate of paravalvular aortic regurgitation (AoR). The aim of this study was to compare the 2 devices in terms of valve performance in a case-matched study with independent echocardiographic analysis. METHODS: Of a population of 201 patients who underwent transcatheter aortic valve implantation, 144 patients (S3, n = 80; EVR, n = 64) were matched according to aortic annulus diameter and aortic valve calcium score, as assessed by computed tomography. All echocardiographic examinations collected at baseline and at 1- and 6-month follow-up were centrally analyzed. RESULTS: The 2 groups were well balanced in baseline clinical and echocardiographic characteristics. The EVR valve showed a better hemodynamic profile as assessed by peak aortic gradient (EVR 13 ± 7 vs S3 20 ± 10mmHg; P<.001), mean aortic gradient (EVR 7 ± 3 vs S3 11 ± 6mmHg; P<.001), and Doppler velocity index (EVR 0.65±0.15 vs S3 0.51±0.16; P<.001). The rate of moderate-severe or any paravalvular (≥ mild) AoR was higher in the EVR group (11% and 50%) than in the S3 group (2.5% and 21%; P <.05, respectively), with a larger number of paravalvular jets (P <.001). CONCLUSIONS: In a case-matched cohort of transcatheter aortic valve implantation patients, the S3 valve was associated with a lower rate of paravalvular AoR but also with a higher residual gradient than the EVR system.

Propensity score matched comparison of transcatheter aortic valve implantation versus conventional surgery in intermediate and low risk aortic stenosis patients: A hint of real-world.

BACKGROUND: Recently, the use of transcatheter aortic valve implantation (TAVI) in inter-mediate-low risk patients has been evaluated in the PARTNER II randomized trial. However, in the last years, this therapy has been employed in this scenario with underreported results, as compared to surgical aortic valve replacement (SAVR). METHODS: We enrolled 362 consecutive patients with severe symptomatic aortic stenosis and intermediate-low surgical risk (logEuroSCORE < 20%), treated in our center with TAVI (103 patients) or single SAVR (259 patients) between 2009 and 2014. Patients were matched according to age, gender, logEuroSCORE, and use of bioprosthesis. RESULTS: Mean age of the patients was 73 ± 10.4 years, and 40.3% were women. LogEuroSCORE and Society Thoracic Surgeons score were 7.0 ± 4.4% and 4.2 ± 2.5%, respectively, with mean left ventricular ejection fraction of 52 ± 9%. There were no differences regarding other comorbidities. The length-of-hospitalization was 11 ± 5 days after TAVI vs. 17 ± 9 days after SAVR (p = 0.003). After matched comparison, no differences in terms of in-hospital mortality (5.7% after TAVI vs. 2.9% after SAVR, p = 0.687) and 1-year mortality (11.4% vs. 7.1%, p = 0.381) were found. The combined endpoint of stroke and mortality at 1-year was also similar between both groups (15.7% in TAVI patients vs. 14.4% after SAVR, p = 0.136). Multivariate analysis determined that aortic regurgitation (AR) was an independent predictor of mortality (OR = 3.623, 95% CI: 1.267-10.358, p = 0.016). Although the rate of AR was higher after TAVI, none of the patients treated with the newest generation devices (10.7%) presented more than a mild degree of AR. CONCLUSIONS: TAVI is feasible and shows comparable results to surgery in terms of early, 1-year mortality, as well as cerebrovascular events in patients with severe aortic stenosis and intermediate-low operative risk. Better transvalvular gradients, yet higher rates of AR were found, however, newer devices presented comparable rate of AR.