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First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions. / Onsea, Kevin; Agostoni, Pierfrancesco; Samim, Mariam; Voskuil, Michiel; Kluin, Jolanda; Budde, Ricardo; Hendrikse, Jeroen; Ramjankhan, Faiz; van Klarenbosch, Jan; Doesburg, Pieter; Sieswerda, Gertjan; Stella, Pieter.

In: EuroIntervention, Vol. 8, No. 1, 2012, p. 51-56.

Research output: Contribution to journalArticleAcademicpeer-review

Harvard

Onsea, K, Agostoni, P, Samim, M, Voskuil, M, Kluin, J, Budde, R, Hendrikse, J, Ramjankhan, F, van Klarenbosch, J, Doesburg, P, Sieswerda, G & Stella, P 2012, 'First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions', EuroIntervention, vol. 8, no. 1, pp. 51-56. https://doi.org/10.4244/EIJV8I1A9

APA

Onsea, K., Agostoni, P., Samim, M., Voskuil, M., Kluin, J., Budde, R., Hendrikse, J., Ramjankhan, F., van Klarenbosch, J., Doesburg, P., Sieswerda, G., & Stella, P. (2012). First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions. EuroIntervention, 8(1), 51-56. https://doi.org/10.4244/EIJV8I1A9

Vancouver

Author

Onsea, Kevin ; Agostoni, Pierfrancesco ; Samim, Mariam ; Voskuil, Michiel ; Kluin, Jolanda ; Budde, Ricardo ; Hendrikse, Jeroen ; Ramjankhan, Faiz ; van Klarenbosch, Jan ; Doesburg, Pieter ; Sieswerda, Gertjan ; Stella, Pieter. / First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions. In: EuroIntervention. 2012 ; Vol. 8, No. 1. pp. 51-56.

BibTeX

@article{576558bb779044829732e302612e3c48,
title = "First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions",
abstract = "Aims: To report our first-in-man experience with a new cerebral embolic deflection device (SMT Embolic Deflection Device) during transcatheter aortic valve implantation (TAVI). A significant number of strokes and brain infarcts are caused by embolisation of atherosclerotic material, clots and other debris during various phases of invasive cardiac procedures, especially TAVI. The application of a temporary filter in the aortic arch averting dislodged emboli from entering the cerebral circulation might prevent this. Methods and results: In 15 patients (mean age 79 years) with severe aortic stenosis undergoing percutaneous transfemoral or transapical aortic valve implantation, the SMT Embolic Deflection Device was advanced utilising the contralateral femoral artery access using a 9 Fr delivery sheath. Once deployed in the aortic arch, a porous membrane shields the supraaortic-cerebral trunks by deflecting emboli away from the cerebral circulation. Embolic material is not contained or removed by the device. A 6 Fr pigtail catheter can be used through the same sheath throughout the whole procedure. Brain diffusion weighted (DW)-MRI was obtained in 10 patients before and at 4 days after (+/- 2 days) the procedure and retrospectively compared to 20 patients previously undergoing TAVI without a protection device. Successful placement of the embolic protection device was achieved in all patients. Additional procedural time due to the use of the device was 7 min (+/- 2 min). There were no procedural complications. No patient developed new neurological symptoms or clinical findings of stroke except one patient who suffered from a transient ischaemic attack (TIA) two days after the procedure. DW-MRI showed 3.2 new cerebral lesions per patient, compared to 7.2 new lesions per patient in the group without SMT filter. Conclusions: In this first-in-man experience, the feasibility of a new embolic deflection device is demonstrated. Larger randomised, prospective studies are required to confirm these findings and prove safety and efficacy by reducing the incidence of cerebral embolism and stroke after TAVI",
author = "Kevin Onsea and Pierfrancesco Agostoni and Mariam Samim and Michiel Voskuil and Jolanda Kluin and Ricardo Budde and Jeroen Hendrikse and Faiz Ramjankhan and {van Klarenbosch}, Jan and Pieter Doesburg and Gertjan Sieswerda and Pieter Stella",
year = "2012",
doi = "10.4244/EIJV8I1A9",
language = "English",
volume = "8",
pages = "51--56",
journal = "EuroIntervention",
issn = "1774-024X",
publisher = "EuroPCR",
number = "1",

}

RIS

TY - JOUR

T1 - First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions

AU - Onsea, Kevin

AU - Agostoni, Pierfrancesco

AU - Samim, Mariam

AU - Voskuil, Michiel

AU - Kluin, Jolanda

AU - Budde, Ricardo

AU - Hendrikse, Jeroen

AU - Ramjankhan, Faiz

AU - van Klarenbosch, Jan

AU - Doesburg, Pieter

AU - Sieswerda, Gertjan

AU - Stella, Pieter

PY - 2012

Y1 - 2012

N2 - Aims: To report our first-in-man experience with a new cerebral embolic deflection device (SMT Embolic Deflection Device) during transcatheter aortic valve implantation (TAVI). A significant number of strokes and brain infarcts are caused by embolisation of atherosclerotic material, clots and other debris during various phases of invasive cardiac procedures, especially TAVI. The application of a temporary filter in the aortic arch averting dislodged emboli from entering the cerebral circulation might prevent this. Methods and results: In 15 patients (mean age 79 years) with severe aortic stenosis undergoing percutaneous transfemoral or transapical aortic valve implantation, the SMT Embolic Deflection Device was advanced utilising the contralateral femoral artery access using a 9 Fr delivery sheath. Once deployed in the aortic arch, a porous membrane shields the supraaortic-cerebral trunks by deflecting emboli away from the cerebral circulation. Embolic material is not contained or removed by the device. A 6 Fr pigtail catheter can be used through the same sheath throughout the whole procedure. Brain diffusion weighted (DW)-MRI was obtained in 10 patients before and at 4 days after (+/- 2 days) the procedure and retrospectively compared to 20 patients previously undergoing TAVI without a protection device. Successful placement of the embolic protection device was achieved in all patients. Additional procedural time due to the use of the device was 7 min (+/- 2 min). There were no procedural complications. No patient developed new neurological symptoms or clinical findings of stroke except one patient who suffered from a transient ischaemic attack (TIA) two days after the procedure. DW-MRI showed 3.2 new cerebral lesions per patient, compared to 7.2 new lesions per patient in the group without SMT filter. Conclusions: In this first-in-man experience, the feasibility of a new embolic deflection device is demonstrated. Larger randomised, prospective studies are required to confirm these findings and prove safety and efficacy by reducing the incidence of cerebral embolism and stroke after TAVI

AB - Aims: To report our first-in-man experience with a new cerebral embolic deflection device (SMT Embolic Deflection Device) during transcatheter aortic valve implantation (TAVI). A significant number of strokes and brain infarcts are caused by embolisation of atherosclerotic material, clots and other debris during various phases of invasive cardiac procedures, especially TAVI. The application of a temporary filter in the aortic arch averting dislodged emboli from entering the cerebral circulation might prevent this. Methods and results: In 15 patients (mean age 79 years) with severe aortic stenosis undergoing percutaneous transfemoral or transapical aortic valve implantation, the SMT Embolic Deflection Device was advanced utilising the contralateral femoral artery access using a 9 Fr delivery sheath. Once deployed in the aortic arch, a porous membrane shields the supraaortic-cerebral trunks by deflecting emboli away from the cerebral circulation. Embolic material is not contained or removed by the device. A 6 Fr pigtail catheter can be used through the same sheath throughout the whole procedure. Brain diffusion weighted (DW)-MRI was obtained in 10 patients before and at 4 days after (+/- 2 days) the procedure and retrospectively compared to 20 patients previously undergoing TAVI without a protection device. Successful placement of the embolic protection device was achieved in all patients. Additional procedural time due to the use of the device was 7 min (+/- 2 min). There were no procedural complications. No patient developed new neurological symptoms or clinical findings of stroke except one patient who suffered from a transient ischaemic attack (TIA) two days after the procedure. DW-MRI showed 3.2 new cerebral lesions per patient, compared to 7.2 new lesions per patient in the group without SMT filter. Conclusions: In this first-in-man experience, the feasibility of a new embolic deflection device is demonstrated. Larger randomised, prospective studies are required to confirm these findings and prove safety and efficacy by reducing the incidence of cerebral embolism and stroke after TAVI

U2 - 10.4244/EIJV8I1A9

DO - 10.4244/EIJV8I1A9

M3 - Article

C2 - 22580248

VL - 8

SP - 51

EP - 56

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 1

ER -

ID: 2579382