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.

Double protection in patients with a massive thrombus in the infarct-related artery - a single-center retrospective study.

Introduction: ST-segment elevation myocardial infarction (STEMI) is associated with thrombus formation on a ruptured or ulcerated atherosclerotic plaque. The consequences of a massive thrombus (MT) may include lack of reperfusion, extensive myocardial infarction (MI) and its complications. Although there are various treatment options for patients with coronary thrombi, double protection (DP) - manual thrombectomy (MTH) with a distal protection device (DPD) - has not been tested yet. Aim: To present DP outcomes in the treatment of patients with STEMI and MT patients. Material and methods: Fourteen patients with STEMI and MT were included in the study. Those patients underwent primary percutaneous coronary intervention (PPCI) with DP. Results: Inferior MI was found in 12 (85.8%) patients. Stents were implanted in 13 (92.8%) patients. Thrombolysis In Myocardial Infarction (TIMI) Thrombus Grade 5 was present in 11 (78.6%) patients and Grade 4 in 3 (21.4%) patients. The median thrombus length was 39.1 mm. Complete reperfusion (TIMI flow 3) was observed in 11 (78.6%) patients and TIMI flow 2 in 3 (21.4%) patients. Myocardial Blush Grade (MBG) was used in patients with TIMI flow 3 and Grade 3 was found in 5 (35.7%) patients. Resolution in ST-segment elevation > 50% was obtained in 13 (92.8%) patients. No myocardial rupture, stroke, or death occurred during hospitalization. Conclusions: DP in MT patients is a safe and feasible procedure. However, further observations and studies are needed to assess the efficacy of this method.

Pseudo-no-reflow phenomenon in carotid artery stenting using FilterWire EX: successful recovery by aspiration thrombectomy.

Distal protection devices such as FilterWire EX have been widely used in carotid artery stenting, however, the large amount of atherothrombotic debris entrapped in the filter could reduce or stop antegrade flow. We present a case of pseudo-no-reflow phenomenon after postdilatation of the stent in a patient with asymptomatic carotid artery stenosis. After several passes using an Export Aspiration catheter, normal flow in the internal carotid artery was restored. Aspiration thrombectomy can successfully recover pseudo-no-reflow phenomenon.

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).

Association between plaque characteristics and the amount of debris captured by a filter-type distal protection device in patients with acute coronary syndrome.

BACKGROUND AND AIMS: Disruption of atherosclerotic plaque and distal embolism often cause peri-procedural myocardial injury during percutaneous coronary intervention (PCI). In the present study, we evaluate the association between the characteristics of the target lesion and the amount of debris captured by the filter-type distal protection device. METHODS: We enrolled 120 consecutive patients with acute coronary syndrome, who underwent coronary stent implantation with a filter-type distal protection device after integrated backscatter intravascular ultrasound (IB-IVUS) analysis. The amount of debris captured by the protection filter was measured through microscopic evaluation. RESULTS: The lipid and fibrous volume evaluated with IB-IVUS was significantly correlated with the amount of the captured debris (r = 0.657, p < 0.01), (r = 0.322, p < 0.01). The lipid plaque fraction showed a positive correlation (r = 0.335, p < 0.01), while the fibrous plaque fraction was found to be inversely correlated (r = -0.375, p < 0.01) with the amount of captured debris. Multivariate regression analysis showed that lipid volume correlated independently with the amount of captured debris. CONCLUSION: The volume of the lipid-rich plaque was associated with the amount of procedure-related debris released and captured by the filter-type distal protection device.

In vitro assessment of six aspiration catheters using a distal protection filter.

BACKGROUND: We assessed performance of 6 aspiration catheters for distal embolization using a distal protection filter in an in vitro experiment. In acute myocardial infarction, a distal protection filter is used for lesions likely to induce a distal embolism. Which aspiration cathether is most effective when used with a distal protection filter remains still unclear. METHODS: A 0.5-cm3 bolus of gelatin as a model of stagnant pools of coronary plaque debris was captured in the distal protection filter and aspirated by 6 aspiration catheters. We measured and compared the length of the suspended embolus matter. RESULTS: Among the 6 catheters evaluated, the use of the Export Advance catheter (Medtronic) resulted in significantly shorter lengths of the suspended embolus matter compared to the use of the TVAC II (Nipro), Thrombuster III SL (Kaneka), and Rebirth Pro (Goodman) catheters (p < 0.01). The residual embolus matter in all cases had drained distally to the distal protection filter when the filter was retrieved. CONCLUSIONS: The use of the Export Advance catheter showed better performance using a distal protection filter in this in vitro experiment, and its use might be more effective in preventing distal embolisms in combination with a distal protection filter.

Prediction of the filter no-reflow phenomenon in patients with angina pectoris by using multimodality: Magnetic resonance imaging, optical coherence tomography, and serum biomarkers.

BACKGROUND: Although the occurrence of no-reflow during percutaneous coronary intervention (PCI) has been shown to be associated with worse short- and long-term clinical outcomes, the clinical relevance of preventing flow deterioration by using the filter-based distal protection devices (DPDs) is controversial. We investigated predictors of the filter no-reflow (FNR) phenomenon during PCI by using multimodality, such as hyperintense plaques (HIPs) in the coronary artery on T1-weighted imaging (T1WI) non-contrast magnetic resonance, plaque composition by using optical coherence tomography (OCT), and serum biomarkers, in patients with angina pectoris. METHODS AND RESULTS: Fifty lesions from 50 patients with angina were examined. All patients underwent T1WI within 24 h before invasive coronary angiography was performed, and preinterventional OCT was performed on a native atherosclerotic culprit lesion. The signal intensity of coronary plaque to cardiac muscle ratio (PMR) was calculated on a standard console of the magnetic resonance system. Of the 50 lesions, 20 lesions showed FNR during PCI, while non-FNR was observed in 30 lesions. A cut-off value >1.85 of PMR had a sensitivity of 65%, a specificity of 93%, a positive predictive value of 87%, and a negative predictive value of 80% for identifying lesions with FNR. Multivariate analysis revealed that the presence of HIPs with PMR >1.85 (p=0.008) was the only independent predictor of the FNR phenomenon during PCI. CONCLUSIONS: This study shows that the presence of HIPs with PMR >1.85 on T1WI was a novel independent predictor of the FNR phenomenon during PCI in angina patients. This result may help in identifying high-risk lesions for no-reflow to deploy filter-based DPDs.

Comparison of different strategies for acute ST-segment elevation myocardial infarction with high thrombus burden in clinical practice: Symptom-free outcome at one year.

OBJECTIVE: The aim of this study was to evaluate the clinical effects of different strategies for preventing coronary microvascular obstruction in ST elevation myocardial infarction (STEMI) patients with a high thrombus-burden plaque. METHODS: Between January, 2007 and December, 2012, 354 patients suffering from STEMI with high thrombus-burden were enrolled and divided into three groups as the first group received a GP IIb/IIIa inhibitor, and the second group received a distal protective device, and the third group was treated with primary PCI alone. RESULTS: A high percentage of patients in the GP IIb/IIIa inhibitor (96.8% and 90.5%), distal protective device (99.3% and 87.6%) had better thirty-day and one-year symptom-free outcomes when compared with PCI only group (91.6% and 65.6%) (P = 0.008 and P < 0.001; respectively). CONCLUSIONS: Treatment with intracoronary GP IIb/IIIa inhibitor injection or distal protection device to prevent coronary microvascular obstruction was demonstrated to increase the occurrences of thirty-day and one-year symptom-free outcomes; thus, these treatments can help decrease post-MI medical care costs.

Results of the retrospective analysis of renal artery stenting for the salvage of renal function study.

Renal artery stenting is expected to improve or stabilize renal function. However, the efficacy of renal artery stenting in severely reduced renal function is unclear. We evaluated 23 patients with class IV or V renal dysfunction who were treated for renal artery stenosis between 2004 and 2009. Improvement in renal function was found in 7 (30%) patients, all of whom were treated with distal protection device. Deterioration of renal function was found in 4 (17%) cases. In these 4 cases, distal protection device could not be used for anatomical reasons. The use of distal protection device was associated with significantly less renal deterioration after the procedure (P < .05, odds ratio 0.21 [confidence interval 0.09-0.50]). Renal artery stenting can stabilize or improve renal function in patients with severe renal dysfunction. Distal protection devices may be beneficial in patients who require renal artery stenting due to severely reduced renal function.

Distal protection device aggravated microvascular obstruction evaluated by cardiac MR after primary percutaneous intervention for ST-elevation myocardial infarction.

BACKGROUND: Protection of distal embolization by balloon occlusion and thrombus aspiration has not improved microvascular circulation nor decreased myocardial injury during primary percutaneous intervention (PCI) for ST-elevation myocardial infarction (STEMI) in randomized trials. In a prospective randomized trial, we investigated the mechanism of the poor effect of distal protection and thrombus aspiration (DP-TA) in 126 patients with STEMI. METHODS: Patients with first-diagnosed STEMI were randomly assigned to DP-TA pretreatment or conventional PCI (c-PCI). Primary endpoint was reduced left ventricular end-diastolic volume (LVEDV) measured by MRI at post-PCI and 6 months after PCI. Secondary end points were infarct ratio (infarct size to entire LV size) by delayed enhancement (DE), area at risk (AAR) ratio (AAR to entire LV size) by T2 high signal, microvascular occlusion index (MVO) ratio (MVO to entire LV size) by DE, and myocardial salvage index (MSI: (AAR--infarct size)*100/AAR) using cardiac magnetic resonance imaging (MRI) within 3 days after PCI. RESULTS: Baseline characteristics of the patients including cardiovascular risk factors and lesion characteristics were similar between the two groups. DT-PA failed to improve LV remodeling at 6 months (LVEDV 140 ± 39 vs 133 ± 37 in c-PCI group, p=0.418). Infarct ratio, AAR ratio and MSI were not statistically different between DP-TA group and c-PCI group. However, MVO ratio was significantly larger in DP-TA group than in c-PCI group (2.4 ± 2.7 vs 1.1 ± 1.9, p=0.045). CONCLUSION: DP-TA was potentially hazardous in primary PCI for STEMI by increasing MVO. DP-TA should not be used in STEMI.

Long-term outcomes of saphenous vein graft stenting compared with native coronary artery stenting in patients with previous coronary artery bypass graft surgery / Stents en vasos coronarios nativos comparados con endoprótesis en injertos de vena safena en pacientes con cirugía de revascularización coronaria previa. Evolución a largo plazo

Propósito del estudio: el objetivo primario del estudio fue valorar la tasa de eventos cardiacos mayores después de cirugía de revascularización coronaria por angioplastia con stent en el injerto de vena safena, comparados con los de angioplastia con stent en la arteria coronaria nativa, tanto en el periodo de hospitalización como a largo plazo. Métodos: estudiamos a 127 pacientes, 49 con stent en injerto de vena safena (grupo 1) y a 78 con stent en arterias coronarias innatas (grupo 2). Resultados: no hubo diferencias significativas en la edad, ni en frecuencia de diabetes, tabaquismo, hipertensión arterial, dyslipidemia, fracción de expulsión del ventrículo izquierdo o clase funcional entre los grupos. La incidencia del fenómeno de no reflujo persistente fue mayor en el grupo 1 (10.2% contra 1.2%, p = 0.0001) y la suma de eventos cardiacos sólo fue distinta durante el primer mes (10.2% contra 2.5%, p = 0.041). La supervivencia sin eventos cardiacos a 36 meses fue menor en los pacientes del grupo 1 (65.0% contra 89.1%, p = 0.024). Conclusiones: La suma de eventos cardiacos mayores fue mayor en el grupo 1 y la supervivencia sin dichos eventos a 3 años fue superior en los pacientes con endoprótesis en arteria coronaria natural.

Objective: Our main objective was to compare the in-hospital and long-term outcomes of saphenous vein graft stenting and native coronary artery stenting in patients with previous coronary artery bypass grafting. Methods: We studied 127 patients who had prior coronary artery bypass; they were divided in two groups, according to the kind of percutaneous coronary intervention performed. The first group included 49 patients with saphenous vein graft stenting and the second group included 78 patients who underwent native coronary artery stenting. Results: There was no significant difference in age, incidence of diabetes, smoking, arterial hypertension, dyslipidemia, left ventricular ejection fraction or in the New York Heart Association functional class between both groups. The incidence of no reflow phenomenon was higher in group 1 (10.2% vs. 1.2%, p = 0.0001). The cumulative incidence of major adverse cardiac events was different between groups at 1 month (10.2% vs. 2.5%, p = 0.041). There was a lower MACE (major adverse cardiovascular events) free survival at 36 months in the saphenous vein graft stenting group (65.0% vs. 89.1%, p = 0.024). Conclusions: Major in-hospital complications occurred more frequently in the saphenous vein graft stented group. MACE-free survival at 3 years was higher in the native coronary artery stent patients.