Long-Term Clinical Outcomes After Filter Protection During Percutaneous Coronary Intervention in Patients With Attenuated Plaque　- 1-Year Follow up of the VAMPIRE 3 (Vacuum Aspiration Thrombus Reemoval 3) Trial.

BACKGROUND: Selective use of distal filter protection during percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) decreased the incidence of no-reflow phenomena and in-hospital serious adverse cardiac events compared with conventional PCI in patients with attenuated plaque ≥5 mm; however, its long-term clinical outcome remains unknown.Methods and Results:Patients who had ACS with attenuated plaque ≥5 mm were assigned to receive distal protection (DP) (n=98) or conventional treatment (CT) (n=96). The rate of major adverse cardiovascular events (MACE), a composite of death from any cause, non-fatal myocardial infarction, or target vessel revascularization (TVR) at 1 year, was the pre-specified secondary endpoint of the trial. MACE at 1 year occurred in 12 patients (12.2%) in the DP group and 3 patients (3.1%) in the CT group (P=0.029), which was driven by a higher risk of TVR (11 [11.2%] vs. 2 [2.1%], P=0.018). In patients treated with bare-metal stents (n=42), MACE occurred in 25.0% of the patients in the DP group and in none of the patients in the CT group (P=0.029), whereas in patients treated with drug-eluting stents (n=151), rates of MACE were similar in the groups (8.1% vs. 3.9%, P=0.32). CONCLUSIONS: In ACS patients with attenuated plaque ≥5 mm, the 1-year rates of MACE were higher in the DP group than in the CT group. This effect might be mitigated by the use of drug-eluting stents.

Pre-navigation balloon technique: Distal emboli protection during stent retriever thrombectomy.

OBJECTIVE: During stent retriever thrombectomy, a balloon guide catheter reduces distal emboli and consequently improves clinical outcomes. Because balloons are usually used before stent retrieval, these can affect the thrombus including the distal emboli while performing microcatheter navigation. This study aimed to evaluate the usefulness and safety of the pre-navigation balloon technique during microcatheter and microwire navigation. METHODS: Patients who underwent stent retriever thrombectomy secondary to an anterior circulation large-artery occlusion were retrospectively evaluated. The pre-navigation balloon technique was used, and the number of retrievals, procedure time, final recanalization, presence of distal emboli, first-pass effect (FPE), symptomatic intracranial hemorrhage including procedure-related complications, and clinical outcomes at 3 months were evaluated. RESULTS: In total 123 patients were analyzed, and occurrence of distal emboli was lesser in the pre-navigation balloon than in the non-preballoon group (4.4% vs. 11.5%, p = 0.02). No statistical difference was found in successful recanalization, mortality, and procedure-related complications. Moreover, the pre-navigation balloon group had a higher FPE than the non-balloon group (37.8% vs. 20.5%, p = 0.004). Although no statistical difference was found in the pre-navigation balloon group, a trend toward a higher rate of good clinical outcomes was observed (mRS 0-2 at 3 months, 55.6% vs. 48.7%, p = 0.09). For ICA occlusion(n = 35), significant effects were seen in decreasing distal embolism (0(0%) vs 3(16%), p = 0.01), increasing FPE (8(50%) vs 6(32%), p = 0.003), and improving clinical outcomes (mRS 0-2 at 3 months, 9(56%) vs 7(37%), p = 0.03) in the pre-navigation balloon group. In the multivariate analysis, lesser distal embolism (0.91 [0.80-1.00], p = 0.02), higher successful recanalization (3.52 [1.11-7.03], p = 0.016), and higher FPE (3.17 [1.83-7.37], p = 0.001) secondary to the procedure was a predictor of favorable clinical outcomes. CONCLUSIONS: The pre-navigation balloon technique significantly reduced occurrence of distal embolism and increased the FPE.

Novel use of a closed-tip stent retriever to prevent distal embolism in the posterior circulation: illustrative case.

BACKGROUND: In mechanical thrombectomy for tandem occlusions in vertebrobasilar stroke, distal emboli from the vertebral artery lesion should be prevented. However, no suitable embolic protection devices are currently available in the posterior circulation. Here, the authors describe the case of a vertebral artery lesion effectively treated with a closed-tip stent retriever as an embolic protection device in the posterior circulation. OBSERVATIONS: A 65-year-old male underwent mechanical thrombectomy for basilar artery occlusion, with tandem occlusion of the proximal vertebral artery. After basilar artery recanalization via the nonoccluded vertebral artery, a subsequent mechanical thrombectomy was performed for the occluded proximal vertebral artery. To prevent distal embolization of the basilar artery, an EmboTrap III stent retriever was deployed as an embolic protection device within the basilar artery to successfully capture the thrombus. LESSONS: A stent retriever with a closed-tip structure can effectively capture thrombi, making it a suitable distal embolic protection device in the posterior circulation.

Use of a Cutting Balloon Reduces the Incidence of Distal Embolism in Acute Coronary Syndrome Requiring Predilatation Before Stenting.

Background: Acute coronary syndrome (ACS) patients with solid lesions often require predilatation before stenting. Predilatation with high pressure may increase the risk of distal embolism, whereas direct stenting increases the risk of stent underexpansion. We recently reported that, in severely calcified lesions, using a cutting balloon (CB) can provide greater acute gain compared with other scoring balloons. Therefore, we hypothesized that predilatation with CB may reduce the incidence of distal embolism in ACS patients with solid lesions. Methods and Results: This study retrospectively analyzed data for 175 ACS patients who required predilatation, either with a conventional balloon (n=136) or CB (n=39). The occurrence of distal embolism was significantly lower in the CB than conventional balloon group (10.3% vs 32.4%, respectively; P=0.007). Multivariate analysis showed that the occurrence of distal embolism was positively associated with Thrombolysis in Myocardial Infarction (TIMI) grade and the presence of attenuated plaque, but negatively associated with the use of a CB. To support this clinical observation, we compared thrombus dispersal using a CB and non-compliant balloon in an ex vivo experimental model using a pseudo-thrombus. In this model, pseudo-thrombus dispersal was significantly smaller when a CB rather than non-compliant balloon was used (1.8±1.0% vs 2.6±1.2%, respectively; n=20, for each; P=0.002). Conclusions: In ACS patients with solid lesions that require predilatation, predilatation with a CB may reduce the incidence of distal embolism.

Transradial dual-balloon protection system for subclavian artery stenting: "Balloon Switching" technique and literature review.

PURPOSE: Endovascular treatment for subclavian artery (SA) occlusive disease is well established; however, a potential risk remains for posterior circulation embolism, which can be life threatening. To reduce the risk of vertebral artery (VA) embolism, we have devised a transradial dual-balloon protection system referred to as the balloon switching technique. Herein, we describe a patient with left SA stenosis who successfully underwent SA stenting using the balloon switching technique. Case presentation A 79-year-old woman with left arm claudication was diagnosed with left subclavian steal syndrome due to severe stenosis of the proximal left SA. Endovascular revascularization using the balloon switching technique was employed. To obtain VA embolic protection during device advancement through the SA lesion, an 8F balloon-guiding catheter was inflated in the left SA at the level of the VA takeoff using the left transradial sheathless approach. A balloon-expandable stent was inflated in the SA lesion, followed by deflation of the balloon-guiding catheter. The stagnant left VA flow was flushed away toward the distal left SA. Following reinflation of the balloon-guiding catheter, the stent delivery system was deflated and removed. Floating debris in the SA proximal to the balloon-guiding catheter was adequately aspirated, followed by deflation of the balloon-guiding catheter. Left SA angiography showed successful revascularization, and postprocedural neuroimaging showed no evidence of ischemic stroke. CONCLUSIONS: The balloon switching technique reduces the risk of VA embolism during left SA stenting via the transradial access. This method is a useful therapeutic option for patients with left SA occlusive disease.

A Randomized Study of Distal Filter Protection Versus Conventional Treatment During Percutaneous Coronary Intervention in Patients With Attenuated Plaque Identified by Intravascular Ultrasound.

OBJECTIVES: The aim of this study was to evaluate the utility of distal protection during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes at high risk for distal embolization. BACKGROUND: The results of previous clinical trials indicated that the routine use of distal protection in patients with ST-segment elevation myocardial infarction did not improve clinical outcomes. However, selective use of distal protection by means of a filter-based distal protection system has not been evaluated. METHODS: Two hundred patients with acute coronary syndromes who had native coronary artery lesions and attenuated plaque with longitudinal length ≥5 mm on pre-PCI intravascular ultrasound were randomly assigned to undergo PCI with distal protection or conventional treatment. RESULTS: The primary endpoint (no-reflow phenomenon) occurred in 26 patients (26.5%) in the distal protection group and 39 patients (41.7%) in the conventional treatment group (p = 0.026), and the corrected TIMI (Thrombolysis In Myocardial Infarction) frame count after revascularization was significantly lower in the distal protection group (23 vs. 30.5; p = 0.0003). The incidence of cardiac death, cardiac arrest, cardiogenic shock after revascularization requiring defibrillation, cardiopulmonary resuscitation, or extracorporeal membrane oxygenation was significantly lower in the distal protection group than in the conventional treatment group (0% vs. 5.2%; p = 0.028). CONCLUSIONS: The use of distal embolic protection applied with a filter device decreased the incidence of the no-reflow phenomenon and was associated with fewer serious adverse cardiac events after revascularization than conventional PCI in patients with acute coronary syndromes with attenuated plaque ≥5 mm in length. (Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome [ACS] [VAMPIRE3]; NCT01460966).