1Universitätsklinikum Augsburg I. Medizinische Klinik Augsburg, Deutschland
Introduction
The management of coronary lesions with a significant thrombotic burden remains a significant challenge and is still associated with adverse outcomes. While early studies suggested potential benefits of thrombus aspiration during PCI, recent large-scale randomized trials have failed to consistently demonstrate clinical benefit, raising concerns about an increased risk of stroke. In addition, the limited efficacy of manual aspiration in the removal of large thrombi firmly adherent to the vessel wall may limit its applicability.
In stroke intervention, the use of stent retriever-based mechanical thrombectomy has become the established standard for improving blood flow and outcomes.
The EnVast stent retriever-based(Figure1A) device is an innovative coronary thrombectomy system designed to enhance the extraction of organized thrombi. It incorporates staggered drop zones that facilitate effective uptake and removal of clots. Early use of the EnVast system in STEMI patients has demonstrated its safety and efficacy in restoring optimal blood flow. In addition, our histologic analysis has shown that the EnVast device extracts mixed thrombi with a significantly higher prevalence of platelets and connective tissue compared to standard thrombus1.
Objective
We hereby present the outcomes of the first two coronary thrombectomies conducted in Germany employing the EnVast device.
Methods and Results
Case 1
An obese male patient, 50 years old, was admitted to our catheterization laboratory due to a late-presenting STEMI with 24-hours of persistent angina. Coronary angiography revealed coronary ectasia with thrombotic occlusion in the mid-right coronary artery. Initial angioplasty failed to restore blood flow, revealing a large and still obstructive thrombotic lesion. In a last-resort approach, we deployed and retrieved the EnVast stent retriever(4.5x46mm) twice, alongs with vacuum-assisted aspiration involving three vacuum syringes and a guiding catheter extension placed proximal to the stent retriever(Figure1A). After the extraction of substantial thrombotic material which improved the distal flow, a 4.0x32mm drug-eluting stent was implanted and optimized with a 5.0 mm NC balloon, achieving TIMI III flow in all distal vessels.
Case 2:
A 57-year-old female was admitted during the night with STEMI and worsening angina persisting for 36 hours. Angiography revealed a proximal occlusion in the right coronary artery with a substantial thrombotic burden(Figure1B). PTCA with 2.5 and 3.0 balloons failed to restore distal flow(Figure1C). As a bailout technique, we deployed and retrieved the EnVast stent retriever(6.0x35mm) three times with vacuum-assisted aspiration, effectively removing significant thrombotic material and improving flow(Figure1D-F). The PCI was completed with IVUS-guided stenting and optimization using a 5.5 mm NC balloon, achieving TIMI III flow.
At the 30-day follow-up, no major adverse cardiac and cerebrovascular events(MACCE) related to PCI were reported for both cases.
Conclusions
The first coronary thrombectomies conducted in Germany exhibited excellent angiographic outcomes and did not raise any safety concerns. While additional research is warranted, the EnVast device emerges as a valuable addition to the interventional cardiologist's armamentarium particularly in cases involving significant thrombotic burdens.
References
1 Bongiovanni D et al. JACC: Cardiovasc Interv 2023; 16: 112–115.
Figure 1