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Open Access 20-04-2024 | Thrombectomy | Original Article

Initial experience with a novel stent-based mechanical thrombectomy device for management of acute myocardial infarction cases with large thrombus burden

Authors: Yuan Zhi, Mehdi Madanchi, Giacomo Maria Cioffi, Julian Brunner, Leah Stutz, Eleonora Gnan, Varis Gjergjizi, Adrian Attinger-Toller, Florim Cuculi, Matthias Bossard

Published in: Cardiovascular Intervention and Therapeutics

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Abstract

Background

Patients with acute myocardial infarction (AMI) and large thrombus burden (LTB) still represent a challenge. Afflicted patients have a high morbidity and mortality. Aspiration thrombectomy is often ineffective in those cases. Mechanical thrombectomy devices (MTDs), which are effective for management of ischemic strokes, were recently CE-approved for treatment of thrombotic coronary lesions. Real-world data about their performance in AMI cases with LTB are scarce. This study sought to summarize our early experience with a novel MTD device in this context.

Methods

We analyzed consecutive patients from the prospective OPTIMISER registry (NCT04988672), who have been managed with the NeVa™ MTD (Vesalio, USA) for AMI with LTB at a tertiary cardiology facility. Outcomes of interest included, among others, periprocedural complications, target lesion failure (TLF), target lesion revascularization (TLR) and target vessel myocardial infarction (TV-MI).

Results

Overall, 15 patients underwent thrombectomy with the NeVa™ device. Thrombectomy was successfully performed in 14 (93%) patients. Final TIMI 3 flow was achieved in 13 (87%) patients, while 2 (13%) patients had TIMI 2 flow. We encountered no relevant periprocedural complications, especially no stroke, stent thrombosis or vessel closure. After a mean follow-up time of 26 ± 2.9 months, 1 (7%) patient presented with TLR due to stent thrombosis (10 months after treatment with the MTD and stenting).

Conclusions

In AMI patients with LTB, the deployment of the novel NeVa™ MTD seems efficient and safe. Further randomized trials are warranted to assess whether the use of the NeVa™ device in cases with LTB improves procedural and clinical outcomes.

Graphical abstract

Literature
4.
go back to reference de Waha S, Patel MR, Granger CB, Ohman EM, Maehara A, Eitel I, et al. Relationship between microvascular obstruction and adverse events following primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: an individual patient data pooled analysis from seven randomized trials. Eur Heart J. 2017;38(47):3502–10. https://doi.org/10.1093/eurheartj/ehx414. (PubMed PMID: 29020248).CrossRefPubMed de Waha S, Patel MR, Granger CB, Ohman EM, Maehara A, Eitel I, et al. Relationship between microvascular obstruction and adverse events following primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: an individual patient data pooled analysis from seven randomized trials. Eur Heart J. 2017;38(47):3502–10. https://​doi.​org/​10.​1093/​eurheartj/​ehx414. (PubMed PMID: 29020248).CrossRefPubMed
14.
go back to reference Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, et al. 2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: the task force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European society of cardiology (ESC). Eur Heart J. 2018;39(2):119–77. https://doi.org/10.1093/eurheartj/ehx393. (PubMed PMID: 28886621).CrossRefPubMed Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, et al. 2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: the task force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European society of cardiology (ESC). Eur Heart J. 2018;39(2):119–77. https://​doi.​org/​10.​1093/​eurheartj/​ehx393. (PubMed PMID: 28886621).CrossRefPubMed
17.
go back to reference Antoniucci D, Valenti R, Migliorini A, Parodi G, Memisha G, Santoro GM, et al. Comparison of rheolytic thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention for acute myocardial infarction. Am J Cardiol. 2004;93(8):1033–5. https://doi.org/10.1016/j.amjcard.2004.01.011. (PubMed PMID: 15081450).CrossRefPubMed Antoniucci D, Valenti R, Migliorini A, Parodi G, Memisha G, Santoro GM, et al. Comparison of rheolytic thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention for acute myocardial infarction. Am J Cardiol. 2004;93(8):1033–5. https://​doi.​org/​10.​1016/​j.​amjcard.​2004.​01.​011. (PubMed PMID: 15081450).CrossRefPubMed
19.
go back to reference Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, et al. Cardiac death and reinfarction after 1 year in the thrombus aspiration during percutaneous coronary intervention in acute myocardial infarction study (TAPAS): a 1-year follow-up study. Lancet. 2008;371(9628):1915–20. https://doi.org/10.1016/s0140-6736(08)60833-8. (Epub 2008/06/10 PubMed PMID: 18539223).CrossRefPubMed Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, et al. Cardiac death and reinfarction after 1 year in the thrombus aspiration during percutaneous coronary intervention in acute myocardial infarction study (TAPAS): a 1-year follow-up study. Lancet. 2008;371(9628):1915–20. https://​doi.​org/​10.​1016/​s0140-6736(08)60833-8. (Epub 2008/06/10 PubMed PMID: 18539223).CrossRefPubMed
20.
go back to reference Ikari Y, Sakurada M, Kozuma K, Kawano S, Katsuki T, Kimura K, et al. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction: report of the VAMPIRE (VAcuuM asPIration thrombus REmoval) trial. JACC Cardiovasc Interv. 2008;1(4):424–31. https://doi.org/10.1016/j.jcin.2008.06.004. (Epub 2009/05/26 PubMed PMID: 19463340).CrossRefPubMed Ikari Y, Sakurada M, Kozuma K, Kawano S, Katsuki T, Kimura K, et al. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction: report of the VAMPIRE (VAcuuM asPIration thrombus REmoval) trial. JACC Cardiovasc Interv. 2008;1(4):424–31. https://​doi.​org/​10.​1016/​j.​jcin.​2008.​06.​004. (Epub 2009/05/26 PubMed PMID: 19463340).CrossRefPubMed
21.
go back to reference Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, et al. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol. 2009;53(4):309–15. https://doi.org/10.1016/j.jacc.2008.10.017. (Epub 2009/01/24 PubMed PMID: 19161878).CrossRefPubMed Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, et al. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol. 2009;53(4):309–15. https://​doi.​org/​10.​1016/​j.​jacc.​2008.​10.​017. (Epub 2009/01/24 PubMed PMID: 19161878).CrossRefPubMed
22.
go back to reference Migliorini A, Stabile A, Rodriguez AE, Gandolfo C, Rodriguez Granillo AM, Valenti R, et al. Comparison of AngioJet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction. The JETSTENT trial. J Am Coll Cardiol. 2010;56(16):1298–306. https://doi.org/10.1016/j.jacc.2010.06.011. (Epub 2010/08/10 PubMed PMID: 20691553).CrossRefPubMed Migliorini A, Stabile A, Rodriguez AE, Gandolfo C, Rodriguez Granillo AM, Valenti R, et al. Comparison of AngioJet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction. The JETSTENT trial. J Am Coll Cardiol. 2010;56(16):1298–306. https://​doi.​org/​10.​1016/​j.​jacc.​2010.​06.​011. (Epub 2010/08/10 PubMed PMID: 20691553).CrossRefPubMed
24.
go back to reference Jolly SS, Cairns JA, Yusuf S, Rokoss MJ, Gao P, Meeks B, et al. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016;387(10014):127–35. https://doi.org/10.1016/s0140-6736(15)00448-1. (Epub 2015/10/18. PubMed PMID: 26474811; PubMed Central PMCID: PMC5007127).CrossRefPubMed Jolly SS, Cairns JA, Yusuf S, Rokoss MJ, Gao P, Meeks B, et al. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016;387(10014):127–35. https://​doi.​org/​10.​1016/​s0140-6736(15)00448-1. (Epub 2015/10/18. PubMed PMID: 26474811; PubMed Central PMCID: PMC5007127).CrossRefPubMed
27.
go back to reference Bhoopalan K, Rajendran R, Alagarsamy S, Kesavamoorthy N. Successful extraction of refractory thrombus from an ectatic coronary artery using stent retriever during primary angioplasty for acute myocardial infarction: a case report. Eur Heart J Case Rep. 2019;3(1):yty161. https://doi.org/10.1093/ehjcr/yty161. (Epub 2019/04/26. PubMed PMID: 31020237; PubMed Central PMCID: PMC6439382).CrossRefPubMedPubMedCentral Bhoopalan K, Rajendran R, Alagarsamy S, Kesavamoorthy N. Successful extraction of refractory thrombus from an ectatic coronary artery using stent retriever during primary angioplasty for acute myocardial infarction: a case report. Eur Heart J Case Rep. 2019;3(1):yty161. https://​doi.​org/​10.​1093/​ehjcr/​yty161. (Epub 2019/04/26. PubMed PMID: 31020237; PubMed Central PMCID: PMC6439382).CrossRefPubMedPubMedCentral
28.
go back to reference Crimi G, Moramarco L, Mandurino-Mirizzi A, Quaretti P, Ferrario M. The combined use of stent retriever and neuro-aspiration as successful bail-out reperfusion strategy in a patient with embolic myocardial infarction. Catheter Cardiovasc Interv. 2019;94(2):E78–81. https://doi.org/10.1002/ccd.28167. (Epub 2019/03/10. PubMed PMID: 30851080).CrossRefPubMed Crimi G, Moramarco L, Mandurino-Mirizzi A, Quaretti P, Ferrario M. The combined use of stent retriever and neuro-aspiration as successful bail-out reperfusion strategy in a patient with embolic myocardial infarction. Catheter Cardiovasc Interv. 2019;94(2):E78–81. https://​doi.​org/​10.​1002/​ccd.​28167. (Epub 2019/03/10. PubMed PMID: 30851080).CrossRefPubMed
30.
go back to reference Sharma V, Jolly SS, Hamid T, Sharma D, Chiha J, Chan W, et al. Myocardial blush and microvascular reperfusion following manual thrombectomy during percutaneous coronary intervention for ST elevation myocardial infarction: insights from the TOTAL trial. Eur Heart J. 2016;37(24):1891–8. https://doi.org/10.1093/eurheartj/ehw157. (Epub 20160428. PubMed PMID: 27125948; PubMed Central PMCID: PMC4917747).CrossRefPubMedPubMedCentral Sharma V, Jolly SS, Hamid T, Sharma D, Chiha J, Chan W, et al. Myocardial blush and microvascular reperfusion following manual thrombectomy during percutaneous coronary intervention for ST elevation myocardial infarction: insights from the TOTAL trial. Eur Heart J. 2016;37(24):1891–8. https://​doi.​org/​10.​1093/​eurheartj/​ehw157. (Epub 20160428. PubMed PMID: 27125948; PubMed Central PMCID: PMC4917747).CrossRefPubMedPubMedCentral
33.
go back to reference Prati F, Romagnoli E, Gatto L, La Manna A, Burzotta F, Limbruno U, et al. Clinical impact of suboptimal stenting and residual intrastent plaque/thrombus protrusion in patients with acute coronary syndrome: the CLI-OPCI ACS substudy (Centro per la Lotta Contro L’Infarto-optimization of percutaneous coronary intervention in acute coronary syndrome). Circ Cardiovasc Interv. 2016. https://doi.org/10.1161/circinterventions.115.003726. (PubMed PMID: 27965297).CrossRefPubMed Prati F, Romagnoli E, Gatto L, La Manna A, Burzotta F, Limbruno U, et al. Clinical impact of suboptimal stenting and residual intrastent plaque/thrombus protrusion in patients with acute coronary syndrome: the CLI-OPCI ACS substudy (Centro per la Lotta Contro L’Infarto-optimization of percutaneous coronary intervention in acute coronary syndrome). Circ Cardiovasc Interv. 2016. https://​doi.​org/​10.​1161/​circintervention​s.​115.​003726. (PubMed PMID: 27965297).CrossRefPubMed
35.
go back to reference Kotronias RA, Marin F, Emfietzoglou M, Langrish JP, Lucking AJ, Channon KM, et al. Rationale and Design of a randomized controlled pilot trial to assess stent retriever thrombectomy for thrombus burden reduction in patients with acute myocardial infarction: the RETRIEVE-AMI study. Cardiovasc Revasc Med. 2023;52:75–85. https://doi.org/10.1016/j.carrev.2023.02.012. (Epub 2023/03/10. PubMed PMID: 36894360).CrossRefPubMed Kotronias RA, Marin F, Emfietzoglou M, Langrish JP, Lucking AJ, Channon KM, et al. Rationale and Design of a randomized controlled pilot trial to assess stent retriever thrombectomy for thrombus burden reduction in patients with acute myocardial infarction: the RETRIEVE-AMI study. Cardiovasc Revasc Med. 2023;52:75–85. https://​doi.​org/​10.​1016/​j.​carrev.​2023.​02.​012. (Epub 2023/03/10. PubMed PMID: 36894360).CrossRefPubMed
Metadata
Title
Initial experience with a novel stent-based mechanical thrombectomy device for management of acute myocardial infarction cases with large thrombus burden
Authors
Yuan Zhi
Mehdi Madanchi
Giacomo Maria Cioffi
Julian Brunner
Leah Stutz
Eleonora Gnan
Varis Gjergjizi
Adrian Attinger-Toller
Florim Cuculi
Matthias Bossard
Publication date
20-04-2024
Publisher
Springer Nature Singapore
Published in
Cardiovascular Intervention and Therapeutics
Print ISSN: 1868-4300
Electronic ISSN: 1868-4297
DOI
https://doi.org/10.1007/s12928-024-00998-3