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DISPOSITIVOS DE PROTECCIÓN CEREBRAL

María Del Trigo

Hospital Universitario Puerta de Hierro

Madrid, Noviembre de 2022

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ALERTA SPOILER

Conclusiones

Evidencia disponible

Principales Dispositivos

Magnitud del Problema

Relevancia Clínica

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CONCLUSIONES

EN ESTUDIOS ALEATORIZADOS EL USO DE DISPOSITIVOS DE PROTECCIÓN CEREBRAL NO DISMINUYÓ LA INCIDENCIA DE ACV PERIPROCEDIMIENTO

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Sentinel® CPS (Boston Scientific)

2 Filtros independientes para capturar debris:

Tronco braquicefálico
A. carótida común izquierda.

Radial 6F.
Guía 0.014.

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EVIDENCIA DISPONIBLE:�PROTECTED TAVR

Kapadia et Al. N Engl J Med 2022

Curio, PCRonline.com 2022

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EVIDENCIA DISPONIBLE:PROTECTED TAVR

Kapadia et Al. N Engl J Med 2022

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�TriGUARD 3™ CEP (Keystone Heart Ltd)�

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TriGUARD 3™ CEP : Screening

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TriGUARD 3™ CEP : Randomized Trial

REFLECT II enrolled 220 of the planned 345 patients (63.8%), including 41 roll-in and 179 randomized patients (121 TG3 and 58 control subjects) at 18 US sites. The sponsor closed the study early after the U.S. Food and Drug Administration recommended enrollment suspension for unblinded safety data review. The trial met its primary safety endpoint compared with the PG (15.9% vs. 34.4% (p < 0.0001).

The REFLECT II trial demonstrated that use of the TG3 CEPD during TAVR was safe compared with a pre-specified performance goal based on historical TAVR data, meeting the primary safety endpoint. However, the TG3 did not demonstrate efficacy compared with control patients in the pre-specified superiority primary hierarchical composite of all death or stroke at 30 days, NIHSS score worsening, freedom from cerebral ischemic lesions, and total cerebral lesion volume.

�

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Nuevos Dispositivos:�Emblok Embolic Protection System

FIM. N=20

Latib, A. et al. J Am Coll Cardiol Intv. 2020

The Emblok device (n = 20 patients) was tested in a prospective, multicenter, non-randomized, first-in-man pilot

study intended to evaluate its efficacy and safety during TAVI (32). The device was successfully positioned in all the cases,

and no major adverse cardiovascular and cerebrovascular events occurred at the 30-day follow-up.

The delivery system is an 11-Fr catheter compatible to be deployed through a single access site supported by 0.035 guidewire and integrates a 4-Fr radiopaque pigtail catheter for aortogram performance.

Anatomical criteria for its use include an ascending aorta length 9 cm, an ascending aorta or aortic arch diameter between 30 and 35 mm, and an arterial femoral access suitable

for an 11-Fr delivery system. The filter is made of a polyurethane mesh with a pore size of 125 mm, supported by a nitinol frame positioned just proximal to the brachiocephalic trunk. Once

he transcatheter valve is deployed, the Emblok system mus

be recaptured to be able to retrieve the transcatheter delivery

system from the body

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Nuevos Dispositivos:�ProtEmbo cerebral protection system

Jagielak, D. et al. Eurointervention 2022

N=41

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LA ETERNA PREGUNTA…

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PACIENTES DE ELEVADO RIESGO DE ACV

FIBRILACIÓN AURICULAR
ACV/AIT PREVIO
IRC
ENF. VASCULAR PERIFÉRICA
ATEROMATOSIS AÓRTICA
DIABETES

AORTA BICÚSPIDE
ÁREA VALVULAR PEQUEÑA
CARGA DE CALCIO
VALVE IN VALVE?
INSUFICIENCIA AÓRTICA>3
BASÍLICA?

PREDILATACIÓN
POSTDILATACIÓN
EMBOLIZACIÓN (2nd VALVE)
REPOSICIONAMIENTO

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MAGNITUD DEL PROBLEMA

Wieneke V et Al. Circ Cardiovasc Interventions 2019

Thiele PCR 2019

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RELEVANCIA CLÍNICA

Coylewright M et Al. Health Expect 2016

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MÁS ALLÁ DE LA TAVI…

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MUCHAS GRACIAS