A prospective, first-in-human use of the NeVa mechanical thrombectomy device for patients with acute coronary syndromes

Spirito, Alessandro; Quagliana, Angelo; Coiro, Marco; Melaku, Gebremedhin D.; Vandenberghe, Stijn; Leibundgut, Gregor; Häner, Jonas; Moscarelli, Marco; Araco, Marco; Garcia, Hector M.; Valgimigli, Marco

doi:10.4244/eij-d-21-00741

Cited by 10 publications

(12 citation statements)

References 17 publications

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“…More recently, Spirito et al reported the results of the first in-human use of the EnVast stent retrieval catheter (previously known as NeVa device) [59]. The authors included 61 patients presenting with AMI and a large thrombus burden and reported excellent safety data, with a single patient suffering from side-branch embolization.…”

Section: Emerging Thrombectomy Technologiesmentioning

confidence: 99%

“…Another side effect was reversible coronary spasm in 23% of patients, but there were no reports of coronary dissection or perforation. The results of EnVast on its own (prior to stenting) were excellent, with only 10% of patients having TIMI flow < 3 and almost one quarter having MBG < 2 [59]. EnVast received CE marking for use in AMI in 2019 [60].…”

Section: Emerging Thrombectomy Technologiesmentioning

confidence: 99%

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The Use of Thrombectomy during Primary Percutaneous Coronary Intervention: Resurrecting an Old Concept in Contemporary Practice

Satti,

Omari,

Bawamia

et al. 2024

JCM

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Optimal myocardial reperfusion during primary percutaneous coronary intervention (pPCI) is increasingly recognized to be beyond restoring epicardial coronary flow. Both invasive and non-invasive tools have highlighted the limitation of using this metric, and more efforts are focused towards achieving optimal reperfusion at the level of the microcirculation. Recent data highlighted the close relationship between thrombus burden and impaired microcirculation in patients presenting with ST-segment elevation myocardial infarction (STEMI). Moreover, distal embolization was an independent predictor of mortality in patients with STEMI. Likewise, the development of no-reflow phenomenon has been directly linked with worse clinical outcomes. Adjunctive thrombus aspiration during pPCI is intuitively intended to remove atherothrombotic material to mitigate the risk of distal embolization and the no-reflow phenomenon (NRP). However, prior trials on the use of thrombectomy during pPCI did not support its routine use, with comparable clinical endpoints to patients who underwent PCI alone. This article aims to review the existing literature highlighting the limitation on the use of thrombectomy and provide future insights into trials investigating the role of thrombectomy in contemporary pPCI.

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Section: Emerging Thrombectomy Technologiesmentioning

confidence: 99%

Section: Emerging Thrombectomy Technologiesmentioning

confidence: 99%

The Use of Thrombectomy during Primary Percutaneous Coronary Intervention: Resurrecting an Old Concept in Contemporary Practice

Satti,

Omari,

Bawamia

et al. 2024

JCM

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“…Stent retrievers represent self-expanding nitinol devices. By design, they enable capture and removal of the target thrombus upon device deployment, which permits flow restoration [ 13 ]. Stent-based MTDs, in combination with continuous aspiration techniques to omit distal or side branch thrombus embolization, have become the standard of care for ischemic stroke treatment [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

“…By design, they enable capture and removal of the target thrombus upon device deployment, which permits flow restoration [ 13 ]. Stent-based MTDs, in combination with continuous aspiration techniques to omit distal or side branch thrombus embolization, have become the standard of care for ischemic stroke treatment [ 13 ]. In this context, the NeVa™ device (Vesalio, USA) has been successfully used for treatment of ischemic strokes [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

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

Zhi,

Madanchi,

Cioffi

et al. 2024

Cardiovasc Interv and Ther

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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

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“…Ultimately, a large thrombus burden is often a jeopardizing situation in complex anatomies that might be the cause of no-reflow/slow-flow and incomplete recanalization of infarct-related arteries. In this regard, new devices such as the latest mechanical thrombectomy catheter “NeVa” [ 16 ] have demonstrated excellent efficacy and should be tested in larger RCTs.…”

mentioning

confidence: 99%

Complex Coronary Interventions: Are We Reaching a Plateau?

Franchin

Boccuzzi

Moniaci

et al. 2022

JPM

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A prospective, first-in-human use of the NeVa mechanical thrombectomy device for patients with acute coronary syndromes

Cited by 10 publications

References 17 publications

The Use of Thrombectomy during Primary Percutaneous Coronary Intervention: Resurrecting an Old Concept in Contemporary Practice

The Use of Thrombectomy during Primary Percutaneous Coronary Intervention: Resurrecting an Old Concept in Contemporary Practice

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

Complex Coronary Interventions: Are We Reaching a Plateau?

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