The purpose of this study was to examine the safety, efficacy and device performance of the MegaVac as a Proximal Embolic Protection Device (EPD) for use in percutaneous coronary interventions (PCI). The evaluated use was for proximal embolic protection in a first in man trial during PCI in vessels ≥2.0mm and ≤5.5mm, with no limit on lesion length.
The study received approval by all local Governmental and Ethics Committees prior to commencement. The study was carried out as a prospective, multicenter trial with 48 patients at 6 different sites and 9 Cardiologist throughout Europe and New Zealand.
Inclusion criteria was that patients were undergoing PCI with planned stenting of one or more lesions and that the patient was considered a high risk for distal embolization. Patients were excluded for aorto-ostial lesions, recent MI or stroke, serum creatinine ≥2.5 mg/dL, saphenous vein graft (SVG) age < 6 months, left ventricular ejection fraction <25% and planned use of a thrombectomy device.
There were 3 primary endpoints of the study: safety, efficacy and device performance. Safety was monitored during the procedure and with a 30-day follow-up for Major Adverse Cardiac Events (MACE), defined as death, Q-wave or non Q-wave MI, emergent coronary artery bypass surgery, the need for repeat target lesion revascularization, or an increase ≥ 3 times normal in cardiac enzyme levels. Efficacy was assessed using pre and post TIMI flow and analysis of debris aspirate. Device performance was analyzed by recording access and deployment success, occlusion time, occlusion success, aspiration success and ease of use.
48 patients were enrolled with a single vein graft (n=25) or native vessel (n=23) lesion that the physician deemed to be at an increased risk for distal embolism. The majority of the native vessel lesions were in the right coronary arteries (n=17). Patients were predominantly male (79%), with a mean age of 65 years (37-80 range).
Vessel TIMI 3 flow was present in 35/48 (73%) at the start and 47/48 (98%) at the end of the procedure. Debris analysis from 35 procedures revealed a large fragment mean particle area of 0.30 +/- 0.02mm2 and mean embolic volume of 8.9 +/- 1.5 µm3. Approximately 80% of particulate was 100 µ or smaller. Histology demonstrated a mixture of platelet-containing thrombi and combined thrombus and plaque.
Physician assessment of vessel occlusion was deemed “successful” or “very successful” in 91% of the procedures. The same rating was given to debris aspiration in 93% of cases. In 2 patients there was a MACE that involved post-PCI creatine kinase-MB rise that was possibly device related.
Diagnostic Cine; Right Coronary Artery with dual stenosis. Note side branch that could potentially be compromised when using a distal protection filter during stenting.
Embolic Protection Device (EPD) inserted through a guide catheter and deployed. Note stagnant contrast due to occlusion.
With EPD funnel tip deployed and flow arrested, the stent is deployed over the stenosis and side branch.
The first generation Proximal Occlusion Embolic Protection Device provided effective vessel occlusion and debris aspiration during PCI procedures with high risk for distal embolism. Further development of the device for use in coronary, graft and other vascular beds is warranted.