Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries: Report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT)

Joanna J. Wykrzykowska; Roberto Diletti; Juan Luis Gutierrez-Chico; Robert Jan Van Geuns; Wim J. Van Der Giessen; Steven Ramcharitar; H. Eric Duckers; Carl Schultz; Pim De Feyter; Martin Van Der Ent; Evelyn Regar; Peter De Jaegere; Hector M. Garcia-Garcia; Rawindra Pawar; Nieves Gonzalo; Jurgen Ligthart; Jean De Schepper; Nico Van Den Berg; Krzysztof Milewski; Juan F. Granada; Patrick W. Serruys

doi:10.4244/EIJV8I8A144

Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries: Report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT)

Joanna J. Wykrzykowska, Roberto Diletti, Juan Luis Gutierrez-Chico, Robert Jan Van Geuns, Wim J. Van Der Giessen, Steven Ramcharitar, H. Eric Duckers, Carl Schultz, Pim De Feyter, Martin Van Der Ent, Evelyn Regar, Peter De Jaegere, Hector M. Garcia-Garcia, Rawindra Pawar, Nieves Gonzalo, Jurgen Ligthart, Jean De Schepper, Nico Van Den Berg, Krzysztof Milewski, Juan F. GranadaPatrick W. Serruys

Research output: Contribution to journal › Article › peer-review

50 Citations (Scopus)

Abstract

Aims: The aim of the pilot SECRITT trial was to evaluate the safety and feasibility of sealing the high risk IVUS and optical coherence tomography-derived thin cap fibroatheroma (TCFA), with a dedicated nitinol self-expanding vShield device. Methods and results: After screening with angiography, fractional flow reserve (FFR), intravascular ultrasound virtual histology (IVUS-VH) and optical coherence tomography (OCT), 23 patients met enrolment criteria (presence of non-obstructive VH-derived TCFA lesion with thin cap on OCT) and were randomised to vShield (n=13) versus medical therapy (n=10). In the shielded group, baseline percent diameter stenosis was 33.2±13.5%, FFR was 0.93±0.06. At six-month follow-up in shielded patients percent diameter stenosis further decreased to 18.7±16.9% and FFR remained the same 0.93±0.05. Average late loss was 0.24±0.13 mm. Average baseline fibrous cap thickness was 48±12 μm. After shield placement at six-month follow-up neo-cap formation was observed with average cap thickness of 201±168 μm. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.76±2.16 mm² increased to 9.45±2.30 mm², that is by 9% at six-month follow-up. The number of malapposed struts decreased from 10.7% to 7.6% and the number of uncovered struts at six months was 8.1%. There were no device-related major adverse cardiovascular events (MACE) events at six-month follow-up. Conclusions: High risk plaque passivation and sealing with a vShield self-expanding nitinol device appears feasible and safe. A long-term larger randomised study with streamlined screening criteria is needed to evaluate the efficacy of this approach over medical therapy.

Original language	English
Pages (from-to)	945-954
Number of pages	10
Journal	EuroIntervention
Volume	8
Issue number	8
DOIs	https://doi.org/10.4244/EIJV8I8A144
Publication status	Published - 1 Dec 2012
Externally published	Yes

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Wykrzykowska, J. J., Diletti, R., Gutierrez-Chico, J. L., Van Geuns, R. J., Van Der Giessen, W. J., Ramcharitar, S., Duckers, H. E., Schultz, C., De Feyter, P., Van Der Ent, M., Regar, E., De Jaegere, P., Garcia-Garcia, H. M., Pawar, R., Gonzalo, N., Ligthart, J., De Schepper, J., Van Den Berg, N., Milewski, K., ... Serruys, P. W. (2012). Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries: Report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT). EuroIntervention, 8(8), 945-954. https://doi.org/10.4244/EIJV8I8A144

Wykrzykowska, Joanna J. ; Diletti, Roberto ; Gutierrez-Chico, Juan Luis et al. / Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries : Report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT). In: EuroIntervention. 2012 ; Vol. 8, No. 8. pp. 945-954.

@article{a650086cface46359d60ee8da35e97d2,

title = "Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries: Report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT)",

abstract = "Aims: The aim of the pilot SECRITT trial was to evaluate the safety and feasibility of sealing the high risk IVUS and optical coherence tomography-derived thin cap fibroatheroma (TCFA), with a dedicated nitinol self-expanding vShield device. Methods and results: After screening with angiography, fractional flow reserve (FFR), intravascular ultrasound virtual histology (IVUS-VH) and optical coherence tomography (OCT), 23 patients met enrolment criteria (presence of non-obstructive VH-derived TCFA lesion with thin cap on OCT) and were randomised to vShield (n=13) versus medical therapy (n=10). In the shielded group, baseline percent diameter stenosis was 33.2±13.5%, FFR was 0.93±0.06. At six-month follow-up in shielded patients percent diameter stenosis further decreased to 18.7±16.9% and FFR remained the same 0.93±0.05. Average late loss was 0.24±0.13 mm. Average baseline fibrous cap thickness was 48±12 μm. After shield placement at six-month follow-up neo-cap formation was observed with average cap thickness of 201±168 μm. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.76±2.16 mm2 increased to 9.45±2.30 mm2, that is by 9% at six-month follow-up. The number of malapposed struts decreased from 10.7% to 7.6% and the number of uncovered struts at six months was 8.1%. There were no device-related major adverse cardiovascular events (MACE) events at six-month follow-up. Conclusions: High risk plaque passivation and sealing with a vShield self-expanding nitinol device appears feasible and safe. A long-term larger randomised study with streamlined screening criteria is needed to evaluate the efficacy of this approach over medical therapy.",

keywords = "OFDI-OCT, Self-expanding shield, TCFA, Vulnerable plaque",

author = "Wykrzykowska, {Joanna J.} and Roberto Diletti and Gutierrez-Chico, {Juan Luis} and {Van Geuns}, {Robert Jan} and {Van Der Giessen}, {Wim J.} and Steven Ramcharitar and Duckers, {H. Eric} and Carl Schultz and {De Feyter}, Pim and {Van Der Ent}, Martin and Evelyn Regar and {De Jaegere}, Peter and Garcia-Garcia, {Hector M.} and Rawindra Pawar and Nieves Gonzalo and Jurgen Ligthart and {De Schepper}, Jean and {Van Den Berg}, Nico and Krzysztof Milewski and Granada, {Juan F.} and Serruys, {Patrick W.}",

year = "2012",

month = dec,

day = "1",

doi = "10.4244/EIJV8I8A144",

language = "English",

volume = "8",

pages = "945--954",

journal = "EuroIntervention",

issn = "1774-024X",

publisher = "EuroPCR",

number = "8",

}

Wykrzykowska, JJ, Diletti, R, Gutierrez-Chico, JL, Van Geuns, RJ, Van Der Giessen, WJ, Ramcharitar, S, Duckers, HE, Schultz, C, De Feyter, P, Van Der Ent, M, Regar, E, De Jaegere, P, Garcia-Garcia, HM, Pawar, R, Gonzalo, N, Ligthart, J, De Schepper, J, Van Den Berg, N, Milewski, K, Granada, JF & Serruys, PW 2012, 'Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries: Report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT)', EuroIntervention, vol. 8, no. 8, pp. 945-954. https://doi.org/10.4244/EIJV8I8A144

Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries: Report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT). / Wykrzykowska, Joanna J.; Diletti, Roberto; Gutierrez-Chico, Juan Luis et al.
In: EuroIntervention, Vol. 8, No. 8, 01.12.2012, p. 945-954.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries

T2 - Report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT)

AU - Wykrzykowska, Joanna J.

AU - Diletti, Roberto

AU - Gutierrez-Chico, Juan Luis

AU - Van Geuns, Robert Jan

AU - Van Der Giessen, Wim J.

AU - Ramcharitar, Steven

AU - Duckers, H. Eric

AU - Schultz, Carl

AU - De Feyter, Pim

AU - Van Der Ent, Martin

AU - Regar, Evelyn

AU - De Jaegere, Peter

AU - Garcia-Garcia, Hector M.

AU - Pawar, Rawindra

AU - Gonzalo, Nieves

AU - Ligthart, Jurgen

AU - De Schepper, Jean

AU - Van Den Berg, Nico

AU - Milewski, Krzysztof

AU - Granada, Juan F.

AU - Serruys, Patrick W.

PY - 2012/12/1

Y1 - 2012/12/1

N2 - Aims: The aim of the pilot SECRITT trial was to evaluate the safety and feasibility of sealing the high risk IVUS and optical coherence tomography-derived thin cap fibroatheroma (TCFA), with a dedicated nitinol self-expanding vShield device. Methods and results: After screening with angiography, fractional flow reserve (FFR), intravascular ultrasound virtual histology (IVUS-VH) and optical coherence tomography (OCT), 23 patients met enrolment criteria (presence of non-obstructive VH-derived TCFA lesion with thin cap on OCT) and were randomised to vShield (n=13) versus medical therapy (n=10). In the shielded group, baseline percent diameter stenosis was 33.2±13.5%, FFR was 0.93±0.06. At six-month follow-up in shielded patients percent diameter stenosis further decreased to 18.7±16.9% and FFR remained the same 0.93±0.05. Average late loss was 0.24±0.13 mm. Average baseline fibrous cap thickness was 48±12 μm. After shield placement at six-month follow-up neo-cap formation was observed with average cap thickness of 201±168 μm. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.76±2.16 mm2 increased to 9.45±2.30 mm2, that is by 9% at six-month follow-up. The number of malapposed struts decreased from 10.7% to 7.6% and the number of uncovered struts at six months was 8.1%. There were no device-related major adverse cardiovascular events (MACE) events at six-month follow-up. Conclusions: High risk plaque passivation and sealing with a vShield self-expanding nitinol device appears feasible and safe. A long-term larger randomised study with streamlined screening criteria is needed to evaluate the efficacy of this approach over medical therapy.

AB - Aims: The aim of the pilot SECRITT trial was to evaluate the safety and feasibility of sealing the high risk IVUS and optical coherence tomography-derived thin cap fibroatheroma (TCFA), with a dedicated nitinol self-expanding vShield device. Methods and results: After screening with angiography, fractional flow reserve (FFR), intravascular ultrasound virtual histology (IVUS-VH) and optical coherence tomography (OCT), 23 patients met enrolment criteria (presence of non-obstructive VH-derived TCFA lesion with thin cap on OCT) and were randomised to vShield (n=13) versus medical therapy (n=10). In the shielded group, baseline percent diameter stenosis was 33.2±13.5%, FFR was 0.93±0.06. At six-month follow-up in shielded patients percent diameter stenosis further decreased to 18.7±16.9% and FFR remained the same 0.93±0.05. Average late loss was 0.24±0.13 mm. Average baseline fibrous cap thickness was 48±12 μm. After shield placement at six-month follow-up neo-cap formation was observed with average cap thickness of 201±168 μm. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.76±2.16 mm2 increased to 9.45±2.30 mm2, that is by 9% at six-month follow-up. The number of malapposed struts decreased from 10.7% to 7.6% and the number of uncovered struts at six months was 8.1%. There were no device-related major adverse cardiovascular events (MACE) events at six-month follow-up. Conclusions: High risk plaque passivation and sealing with a vShield self-expanding nitinol device appears feasible and safe. A long-term larger randomised study with streamlined screening criteria is needed to evaluate the efficacy of this approach over medical therapy.

KW - OFDI-OCT

KW - Self-expanding shield

KW - TCFA

KW - Vulnerable plaque

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U2 - 10.4244/EIJV8I8A144

DO - 10.4244/EIJV8I8A144

M3 - Article

C2 - 22669133

AN - SCOPUS:84872132499

SN - 1774-024X

VL - 8

SP - 945

EP - 954

JO - EuroIntervention

JF - EuroIntervention

IS - 8

ER -

Wykrzykowska JJ, Diletti R, Gutierrez-Chico JL, Van Geuns RJ, Van Der Giessen WJ, Ramcharitar S et al. Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries: Report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT). EuroIntervention. 2012 Dec 1;8(8):945-954. doi: 10.4244/EIJV8I8A144

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