Transcatheter aortic valve implantation in very elderly patients: immediate results and medium term follow-up.

OBJECTIVE: To evaluate immediate transcatheter aortic valve implantation (TAVI) results and medium-term follow-up in very elderly patients with severe and symptomatic aortic stenosis (AS). METHODS: This multicenter, observational and prospective study was carried out in three hospitals. We included consecutive very elderly (> 85 years) patients with severe AS treated by TAVI. The primary endpoint was to evaluate death rates from any cause at two years. RESULTS: The study included 160 consecutive patients with a mean age of 87 ± 2.1 years (range from 85 to 94 years) and a mean logistic EuroSCORE of 18.8% ± 11.2% with 57 (35.6%) patients scoring ≥ 20%. Procedural success rate was 97.5%, with 25 (15.6%) patients experiencing acute complications with major bleeding (the most frequent). Global mortality rate during hospitalization was 8.8% (n = 14) and 30-day mortality rate was 10% (n = 16). Median follow up period was 252.24 ± 232.17 days. During the follow-up period, 28 (17.5%) patients died (17 of them due to cardiac causes). The estimated two year overall and cardiac survival rates using the Kaplan-Meier method were 71% and 86.4%, respectively. Cox proportional hazard regression showed that the variable EuroSCORE ≥ 20 was the unique variable associated with overall mortality. CONCLUSIONS: TAVI is safe and effective in a selected population of very elderly patients. Our findings support the adoption of this new procedure in this complex group of patients.

Implante percutáneo de la válvula autoexpandible CoreValve ® en pacientes con estenosis aórtica grave y aorta de porcelana: seguimiento a medio plazo / Percutaneous implantation of the CoreValve ® self-expanding valve prosthesis in patients with severe aortic stenosis and porcelain aorta: medium-term follow-up

Introducción y objetivos. Hay escasa información sobre la utilización del implante valvular aórtico transcatéter en pacientes con estenosis aórtica grave y aorta de porcelana. El objetivo primario del estudio es analizar la mortalidad total tras el implante de una válvula percutánea CoreValve® en pacientes con estenosis aórtica grave, con y sin aorta de porcelana. Métodos. Estudio multicéntrico, observacional y prospectivo. Se implantó una válvula aortica percutánea a 449 pacientes con estenosis aórtica grave calcificada en tres hospitales. De ellos, 36 (8%) reunían criterios de aorta de porcelana. El objetivo primario fue la mortalidad total a 2 años. Resultados. El grupo con aorta de porcelana presentó con mayor frecuencia arteriopatía extracardiaca (11 [30,6%] frente a 49 [11,9%]; p = 0,002), revascularización coronaria previa (15 [41,7%] frente a 98 [23,7%]; p = 0,017) y dislipemia (26 [72,2%] frente a 186 [45%]; p = 0,02). En este grupo se utilizó con mayor frecuencia anestesia general (15 [41,7%] frente a 111 [16,9%]; p = 0,058) y acceso axilar (9 [25%] frente a 34 [8,2%]; p = 0,004). El porcentaje de éxito del procedimiento (el 94,4 frente al 97,3%; p = 0,28) y la incidencia de complicaciones (7 [19,4%] frente a 48 [11,6%]; p = 0,20) fueron similares en ambos grupos. No hubo diferencias estadísticamente significativas en el objetivo primario a los 24 meses de seguimiento (8 [22,2%] frente a 66 [16%]; p = 0,33). La presencia de complicaciones durante el implante (hazard ratio = 2,6; intervalo de confianza del 95%, 1,5-4,5; p = 0,001) fue la única variable predictora del objetivo primario. Conclusiones. El implante percutáneo con la prótesis autoexpandible CoreValve® en pacientes con estenosis aórtica y aorta de porcelana rechazados para cirugía de recambio valvular, es factible y seguro (AU)

Introduction and objectives. There is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve® implantation in patients with severe aortic stenosis, with and without porcelain aorta. Methods. In this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years. Results. Patients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001). Conclusions. In patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve® self-expanding valve prosthesis is safe and feasible (AU)

Pro B-type natriuretic peptide plasma value: a new criterion for the prediction of short- and long-term outcomes after transcatheter aortic valve implantation.

BACKGROUND: To determine the prognostic value of pro B-type natriuretic peptide (pro-BNP) to predict mortality after transcatheter aortic valve implantation (TAVI). Logistic EuroSCORE (LES) overestimates observed mortality after TAVI. A new risk score specific to TAVI is needed to accurately assess mortality and outcome. METHODS: Eighty-five patients were included. Indications for TAVI were nonoperable or surgically high-risk patients (LES>20%). Pro-BNP was measured 24h before the procedure. Cox proportional hazards model was used to evaluate clinical factors. The predictive accuracy of these Cox models was determined by using time-dependent receiver operating characteristic (ROC) curves. RESULTS: Pro-BNP levels (log-transformed) were significantly higher in non-survivors than in survivors at 30 days (3.36 ± 0.43 vs. 3.81 ± 0.43, p<0.004) and at the end of follow-up (3.34 ± 0.42 vs. 3.63 ± 0.48, p<0.011). Multivariate analysis revealed that only increased log pro-BNP levels were associated with higher mortality rate at short [hazard ratio (HR) (95% confidence intervals (CI)]=5.35 (1.74-16.5), p=0.003] and long-term follow-ups [HR=11 (CI: 1.51-81.3), p=0.018]. LES was not associated with increased mortality at either time point [HR=1.03 (CI: 0.95-1.10), p=0.483 and HR=1.03 (CI: 0.98-1.07), p=0.230, respectively]. At 30, 90, 180, and 365 days, the c-index was 0.72 for log pro-BNP and 0.63 for LES (p=0.044). CONCLUSION: Pre-procedure log transform of plasma pro-BNP levels are an independent and strong predictor of short- and long-term outcomes after TAVI and are more discriminatory than LES.

Percutaneous implantation of the CoreValve® self-expanding valve prosthesis in patients with severe aortic stenosis and porcelain aorta: medium-term follow-up.

INTRODUCTION AND OBJECTIVES: There is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve(®) implantation in patients with severe aortic stenosis, with and without porcelain aorta. METHODS: In this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years. RESULTS: Patients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001). CONCLUSIONS: In patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve(®) self-expanding valve prosthesis is safe and feasible.