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Prehospital Thrombolysis: A Manual from Berlin
Published on: November 26, 2013
Initial experience with a novel stent-based mechanical thrombectomy device for management of acute myocardial
Yuan Zhi1,2, Mehdi Madanchi1,3, Giacomo Maria Cioffi1,3
1Cardiology Division, Heart Center, Luzerner Kantonsspital, 6000, Lucerne 16, Switzerland.
Insights
Mechanical thrombectomy devices (MTDs) show promise for acute myocardial infarction (AMI) with large thrombus burden (LTB). Early results suggest the NeVa™ MTD is safe and effective in this challenging patient group.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Acute myocardial infarction (AMI) with large thrombus burden (LTB) presents significant clinical challenges.
- Aspiration thrombectomy is often insufficient for LTB cases.
- Mechanical thrombectomy devices (MTDs) offer a new therapeutic option for coronary thrombotic lesions.
Purpose of the Study:
- To evaluate the early real-world experience with a novel mechanical thrombectomy device (NeVa™ MTD).
- To assess the safety and efficacy of the NeVa™ MTD in patients with AMI and LTB.
Main Methods:
- Analysis of consecutive patients from the prospective OPTIMISER registry (NCT04988672).
- Patients were treated with the NeVa™ MTD for AMI with LTB at a tertiary cardiology facility.
- Outcomes included periprocedural complications, target lesion failure (TLF), target lesion revascularization (TLR), and target vessel myocardial infarction (TV-MI).
Main Results:
- Successful thrombectomy was achieved in 14 out of 15 patients (93%).
- Final TIMI 3 flow was obtained in 87% of patients; no major periprocedural complications occurred.
- One patient (7%) experienced TLR due to stent thrombosis at 10 months post-procedure.
Conclusions:
- The novel NeVa™ MTD appears to be an efficient and safe option for AMI patients with LTB.
- Further randomized trials are necessary to confirm the benefits of the NeVa™ device on procedural and clinical outcomes.
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.
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