Transcatheter Aortic Valve Implantation: Moving Forward to Minimize Vascular and Bleeding Complications = Implante Transcatéter de Válvula Aórtica: Avanzando hacia la Reducción de Complicaciones Vasculares y Hemorrágicas

Abstract

[eng] INTRODUCTION: TAVI has settled as the standard of care of AS for inoperable, high-risk, and selected intermediate-risk patients undergoing aortic valve replacement. Vascular and bleeding complications are related to worst outcomes.

HYPOTHESES: a. The reduction and early recognition of vascular and bleeding complications might improve clinical outcomes in patients treated with TAVI. b. A full percutaneous transfemoral approach for TAVI is related to a lower rate of major bleedings in comparison to the surgical cut-down approach. c. The development of post-TAVI thrombocytopenia has a prognosis value in short-term clinical outcomes. d. The kinetics of drop platelet count (DPC) after TAVI are different according to the type of valve implanted.

MATERIALS AND METHODS: Sub-project 1: “Comparison of complications between percutaneous puncture or surgical cut-down for transfemoral access in TAVI” Data from the Spanish TAVI Registry were analyzed. Patients undergoing transfemoral TAVI in 41 Spanish centers from January 2010 to July 2015 were included. Subjects were divided into percutaneous puncture (PG) and cut-down group (CG). A propensity-matched comparison was performed to avoid selection bias. Vascular and bleeding complications were evaluated at 30-days and mid-term follow-up. Sub-project 2: “Study of Thrombocytopenia after TAVI” a. Patients from 2 Spanish centers between 2012 to 2016 were included. Subjects with severe baseline thrombocytopenia (<100x109/L) and peri-procedural death were excluded. Laboratory analyses were performed. Two groups were created according the DPC: ≤30% or >30%. Clinical, procedural characteristics and outcomes were collected retrospectively. b. Patients treated with transfemoral TAVI in a French high-volume center from 2008 to 2016 were included. Exclusion criteria were non-transfemoral approach, severe baseline thrombocytopenia and peri-procedural death. The study protocol was like the previous study. RESULTS: Sub-project 1 A total of 2,465 transfemoral TAVI patients were included. The PG had 1,833 patients (74,3%) and the CG had 632 patients (25,6%). Propensity matching score resulted in 615 pairs. Vascular complications at 30-days were significantly higher in the PG (RR 2,66; IC95% [1,85-3,64], p = <0,001) mainly driven to minor vascular complications. In contrast, the bleeding complications were higher in the CG (RR 0,45; IC95% [0,26-0,78], p = 0,003). At a mean follow-up of 323 days, the rates remained similar. Higher rates of vascular complications in the PG: 15% vs. 5,1% (HR 2,23; IC95% [1,6-3,11]; p = <0,001) and higher rates of major bleedings in the CG: 3,4% vs. 1,6% (HR 0,57; IC95% [0,35-0,95], p = 0,03). Sub-project 2 a) The analyzed population included 195 patients: 100 (52,2%) treated with self-expanding valves (SEV) and 95 (48,8%) with balloon-expandable valves (BEV). The mean percentage of DPC was 31,9±15,3%. The DPC was significantly higher in the BEV population in comparison to SEV (36,3±15,1% vs 27,7±14,4, p<0,001). After multivariate analysis, the use of BEV was independently associated to a DPC>30% (67,4% vs. 36,0%; OR 3,4; 95% CI, 1,42-8,16). AT 30-days, the DPC>30% was associated to a higher rate of major and life-threatening bleedings, vascular complications, sepsis, and death. At 1-year there were no differences in mortality. (6,35% vs. 10,0%; HR 1,54; 95% CI, 0,56-4,25). b) A total of 609 were included. The mean DPC was 32,5±13,9%. The DPC was higher in the BEV group (33.9±14.2 vs 30.7±13.4%, p=0.006), and the nadir was reached significantly later in comparison with the SEV group. (3,0±1,3 vs 2,5±1,1 days, p<0,001). After the multivariate analysis, the factors related to a DPC>30% were the use of BEV, known coronary disease and preserved left ventricle ejection fraction. At 30-days the DPC>30% was associated to a higher rate of major and life-threatening bleedings (6,8 vs 2,1%, p=0.009) and death (3,5 vs 0,8%, p=0.036). At 1-year there were no differences in mortality

CONCLUSIONS: 1. The reduction and early recognition of vascular and bleeding complications is associated to an improvement in clinical outcomes in patients treated with TAVI. 2. The completely percutaneous approach of transfemoral TAVI yielded lower rate of major bleedings and higher rate of minor vascular complications in comparison to the surgical cut-down and closure. 3. A post-procedural DPC>30% is related with worse clinical outcomes at 30-days after TAVI. 4. The use of balloon-expandable valves seems to be associated with a higher risk of drop on platelet counts after TAVI.

[spa] El Implante Transcatéter de Válvula Aórtica (TAVI) se ha consolidado como el tratamiento de elección en pacientes inoperables, de alto y seleccionados con intermedio riesgo quirúrgico. Las complicaciones vasculares y hemorrágicas están asociadas a peores resultados clínicos y a mayor estancia intrahospitalaria. Subproyecto 1: “Comparación entre las complicaciones de la punción percutánea y disección quirúrgica en el Implante Transfemoral de Válvula Aórtica” Análisis retrospectivo del Registro Nacional TAVI. Se incluyeron pacientes tratados con TAVI transfemoral en 41 centros españoles desde enero 2010 hasta julio 2015. Se evaluaron la complicaciones vasculares y hemorrágicas a los 30 días y a medio término. Asimismo, se evaluó la frecuencia de ictus, daño renal agudo, infarto del miocardio y muerte. Para reducir el sesgo de selección se realizó un “score de propensión”. Subproyecto 2: “Estudio de la Trombocitopenia después del Implante Transcatéter de Válvula Aórtica” a) Se incluyeron pacientes tratados con TAVI en 2 centros españoles entre enero 2012 y diciembre 2016. Se excluyeron pacientes con plaquetopenia severa basal (<100x109/L) y con muerte peri-procedimiento. Se realizaron analíticas seriadas durante el ingreso. El seguimiento clínico se realizó a los 30 días, 3 meses y 1 año posterior al procedimiento. Se recogieron las características basales, del procedimiento y los eventos clínicos en una base de datos. Se crearon 2 grupos de acuerdo con el porcentaje de caída de plaquetas: ≤30% y >30%. b) Se incluyeron pacientes tratados con TAVI transfemoral en un centro francés de alto volumen de TAVI, entre enero 2008 y diciembre 2016. Se excluyeron los pacientes con acceso no transfemoral, con plaquetopenia severa pre-procedimiento y con muerte peri-procedimiento. El protocolo del estudio fue similar al del estudio previo.

La disminución y el reconocimiento temprano de complicaciones vasculares y hemorrágicas permite mejores resultados clínicos en pacientes tratados con TAVI. El abordaje completamente percutáneo de la TAVI se asoció a una tasa menor de sangrados mayores y a una mayor tasa de complicaciones vasculares menores en comparación con el abordaje quirúrgico. La caída en el porcentaje de plaquetas >30% se relaciona con peores resultados clínicos a los 30 días post-TAVI. El uso de las prótesis balón-expandibles parece asociarse a un mayor riesgo de disminución de plaquetas.