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Original article
DOI: 10.1016/j.rec.2020.09.014
Available online 4 November 2020
Self-expandable transcatheter heart valves for aortic stenosis. Short-term outcome and matched hemodynamic performance
Prótesis percutáneas autoexpandibles para la estenosis aórtica: resultados a corto plazo y comparación hemodinámica tras emparejamiento
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Silvio Vera Veraa,b, Luis Nombela-Francoc, Sandra Santos-Martíneza,b, Raúl Morenod, Victor A. Jiménez-Díazb,e, Tania Rodríguez-Gabellaa,b, Pablo Cataláa,b, Alex F. Castro-Mejíac, Guillermo Galeoted, José Antonio Bazb,e, Hipólito Gutiérreza,b, Ana Serradora,b, Mario García-Gómeza,b, Alfredo Redondoa,b, Carlos Baladróna,b, Roman Arnolda,b, Pilar Jiménez-Quevedoc, Manuel Carrasco-Moralejaa,b, Itziar Gómez Salvadora,b, J. Alberto San Romána,b, Ignacio J. Amat-Santosa,b,
Corresponding author
ijamat@gmail.com

Corresponding author: Servicio de Cardiología, Hospital Clínico Universitario de Valladolid, Avda. Ramón y Cajal 3, 47003 Valladolid, Spain.
a Servicio de Cardiología, Hospital Clínico Universitario, Valladolid, Spain
b Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain
c Servicio de Cardiología, Hospital Clínico San Carlos, Madrid, Spain
d Servicio de Cardiología, Hospital Universitario La Paz, Madrid, Spain
e Servicio de Cardiología, Hospital Álvaro Cunqueiro, Vigo, Spain
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Tables (5)
Table 1. Main baseline characteristics of the global study population and according to valve type
Table 2. Main baseline echocardiographic and computed tomography findings of the global study population and according to valve type
Table 3. Main procedural and in-hospital outcomes of the global study population and according to valve type
Table 4. Main clinical and hemodynamic outcomes between different self-expandable TAVI devices in the unmatched population
Table 5. Hemodynamic outcomes and need for permanent pacemaker implantation among different pairs of self-expandable TAVI devices after matchinga
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Abstract
Introduction and objectives

Aortic self-expandable (SE) transcatheter aortic valve implantation (TAVI) devices are particularly useful for patients with aortic stenosis and small/tortuous vessels, small aortic annuli, or low coronary ostia. However, it is unclear whether the growing range of SE devices shows comparable hemodynamic and clinical outcomes. We aimed to determine the differential hemodynamic (residual valve area and regurgitation) and clinical outcomes of these devices in comparable scenarios.

Methods

All patients were enrolled from 4 institutions and were managed with 4 different SE TAVI devices. Baseline and follow-up clinical data were collected and echocardiographic tests blindly and centrally analyzed. Patients were compared according to valve type and a 1:1 matched comparison was performed according to degree of calcification, aortic annulus dimensions, left ventricular ejection fraction, and body surface area.

Results

In total, 514 patients were included (Evolut R/PRO, 217; ACURATE neo, 107; ALLEGRA, 102; Portico, 88). Surgical risk scores were comparable in the unmatched population. No differences were observed in the post-TAVI regurgitation rate and in in-hospital mortality (2.7%). The rate of pacemaker implantation at discharge was significantly different among devices (P=.049), with Portico showing the highest rate (23%) and ACURATE neo the lowest (9.5%); Evolut R/PRO and ALLEGRA had rates of 15.9% and 21.2%, respectively. The adjusted comparison showed worse residual TAVI gradients and aortic valve area with ACURATE neo vs ALLEGRA (P=.001) but the latter had higher risk of valve embolization and a tendency for more cerebrovascular events.

Conclusions

A matched comparison of 4 SE TAVI devices showed no differences regarding residual aortic regurgitation and in-hospital mortality.

Keywords:
TAVI
Self-expandable valves
Pacemaker
Aortic stenosis
Abbreviations:
AR
PVL
SE
TAVI
Resumen
Introducción y objetivos

El implante percutáneo de válvula aórtica (TAVI) autoexpandible (AE) es particularmente útil para pacientes con estenosis aórtica y accesos vasculares pequeños, anillo pequeño y ostium coronario bajo. Sin embargo, aún no está claro si el resultado clínico y hemodinámico es comparable entre los distintos dispositivos AE. Nuestro objetivo es determinar diferencias clínicas y hemodinámicas entre dispositivos, ajustando por características basales.

Métodos

Se analizaron los casos tratados con TAVI-AE en 4 instituciones. Se incluyeron características basales y al seguimiento, y el análisis de los ecocardiogramas fue centralizado y ciego. Se compararon los 4 dispositivos tras emparejar 1:1 por grado de calcificación, dimensiones del anillo, superficie corporal y función ventricular.

Resultados

Se incluyó a 514 pacientes (Evolut R/PRO, 217; ACURATE neo, 107; ALLEGRA, 102; Portico: 88). No hubo diferencias en las escalas de riesgo. No se detectaron diferencias en insuficiencia aórtica tras el TAVI ni en las tasas de mortalidad hospitalaria (2,7%). La tasa de implante de marcapasos mostró diferencias significativas (p=0,049), con la mayor tasa tras Portico (23%) y la menor tras ACURATE neo (9.5%). La Evolut R/PRO y la ALLEGRA presentaron tasas del 15,9 y el 21,2%. Tras el ajuste, la comparación mostró mayor gradiente residual y menor área valvular aórtica indexada con ACURATE neo que con ALLEGRA (p=0,001), pero con esta se produjo la mayor tasa de embolización del dispositivo y una tendencia estadística a mayor tasa de eventos cerebrovasculares.

Conclusiones

La comparación de 4 TAVI-AE tras ajustar por diferencias basales no demostró diferencias en las tasas de insuficiencia aórtica periprotésica ni en la mortalidad hospitalaria.

Palabras clave:
TAVI
Válvulas autoexpandibles
Marcapasos
Estenosis aórtica

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