Elective Mechanical Circulatory Support in the Percutaneous Treatment of Patients With Combined Complex Coronary Artery Disease and Severe Aortic Valve Stenosis.

OBJECTIVES: One of the procedural concerns during percutaneous treatment of patients with concomitant coronary artery disease (CAD) and aortic valve stenosis (AS) is the risk of hemodynamic instability. In the present study, we assessed the safety and effectiveness of elective hemodynamic support with the Impella 2.5 system (Abiomed, Inc) in patients undergoing combined high-risk percutaneous coronary intervention (PCI) and balloon aortic valvuloplasty (BAV), as a bridge to transcatheter aortic valve replacement. METHODS: Ten patients suffering from acute coronary syndrome (ACS) and severe AS were included. In all patients, we first performed PCI with the hemodynamic support of the Impella 2.5 system, and then BAV. RESULTS: The Impella catheter was successfully positioned in the left ventricle in all instances. All cases were successful, without any intraprocedural complications. All patients were discharged without any major clinical events. CONCLUSIONS: These preliminary results suggest that elective use of the Impella 2.5 system is safe and effective when performing PCI and BAV in high-risk ACS patients suffering from concomitant severe CAD and AS.

Left ventricular support during complex transradial percutaneous coronary intervention for complete revascularization.

Although there is not uniform definition of high-risk percutaneous coronary intervention (PCI), patients with severe three-vessel disease, left main disease, single remaining patent vessel and/or depressed left ventricular ejection fraction are considered a high-risk population. In this setting, periprocedural hemodynamic instability represents a serious issue. Percutaneous mechanical circulatory support (MCS) devices may improve both safety and efficacy of high-risk PCI. Indeed, MCS help to maintain coronary perfusion pressure and reduce myocardial workload, providing the operator sufficient time to reach the target of complete revascularization. The most used MCS are intra-aortic balloon pump and Impella. There are a plenty of data in literature about the efficacy and safety of the use of MCS in high-risk PCI performed through the femoral access. However, there is a paucity of data about the use of MCS in transradial high-risk PCI. Radial over femoral access has been showed to reduce bleeding complications and therefore may further improve the outcome of high-risk PCI. Herein we report a case of transradial high-risk PCI supported by the Impella 2.5 L and review the available data on this topic.

RenalGuard System for the prevention of acute kidney injury in patients undergoing transcatheter aortic valve implantation.

AIMS: We aimed to assess whether the RenalGuard™ System is effective in preventing acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Forty-eight consecutive patients with chronic kidney disease (CKD) scheduled for TAVI were assigned to: 1) hydration with sodium bicarbonate solution (Control group), or 2) hydration with RenalGuard Therapy (RenalGuard group). Hypotension was defined as periprocedural mean blood pressure <55 mmHg. The primary endpoint was the occurrence of AKI (i.e., an increase of ≥0.3 mg/dL in the serum creatinine concentration at seven days). AKI occurred in 10/26 (38.5%) patients in the Control group and in 1/22 (4.5%) patients in the RenalGuard group (p=0.005, odds ratio [OR] 0.076, 95% confidence interval [CI]: 0.009-0.66). RenalGuard Therapy protected against AKI (OR 0.71, 95% CI: 0.07-0.775, p=0.026), whereas post-procedural hypotension (OR 3.88, 95% CI: 1.06-14.24, p=0.040), and contrast media volume (OR 3.65, 95% CI: 1.15-5.75, p=0.043) increased the risk of AKI. CONCLUSIONS: This non-randomised pilot study suggests that RenalGuard Therapy may be effective in preventing AKI in CKD patients undergoing TAVI.

Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Internal Carotid Artery Stent Implantation.

OBJECTIVES: This study sought to investigate acute kidney injury (AKI) following carotid artery stenting (CAS). BACKGROUND: Few data exist on AKI following CAS. METHODS: This study evaluated 126 chronic kidney disease (CKD) patients who underwent CAS. The risk for contrast-induced AKI was defined by the Mehran score. Hemodynamic depression (i.e., periprocedural systolic blood pressure <90 mm Hg or heart rate <60 beats/min), AKI (i.e., an increase of ≥0.3 mg/dl in the serum creatinine concentration at 48 h), and 30-day major adverse events (including death, stroke, and acute myocardial infarction) were assessed. RESULTS: AKI occurred in 26 patients (21%). Although baseline kidney function and contrast volume were similar in the AKI group and the non-AKI group, the risk score was higher (10 ± 3 vs. 8 ± 3; p = 0.032), and hemodynamic depression (mostly due to hypotension) (65.5% vs. 35%; p = 0.005) was more common in the AKI group. The threshold of hemodynamic depression duration for AKI development was 2.5 min (sensitivity 54%, specificity 82%). Independent predictors of AKI were hemodynamic depression (odds ratio [OR]: 4.01; 95% confidence interval [CI]: 1.07 to 15.03; p = 0.009), risk score (OR: 1.29; 95% CI: 1.03 to 1.60; p = 0.024), and male sex (OR: 6.07; 95% CI: 1.18 to 31.08; p = 0.021). Independent predictors of 30-day major adverse events that occurred more often in the AKI group (19.5% vs. 7%; p = 0.058) were AKI (HR: 4.83; 95% CI: 1.10 to 21.24; p = 0.037) and hemodynamic depression (HR: 5.58; 95% CI: 1.10 to 28.31; p = 0.038). CONCLUSIONS: AKI in CKD patients undergoing CAS is mostly due to hemodynamic depression and is associated with a higher 30-day major adverse events rate.

Novel approaches for preventing or limiting events (Naples) III trial: randomized comparison of bivalirudin versus unfractionated heparin in patients at increased risk of bleeding undergoing transfemoral elective coronary stenting.

OBJECTIVES: This study sought to assess the safety and the efficacy of bivalirudin compared with unfractionated heparin (UFH) alone in the subset of patients at increased risk of bleeding undergoing transfemoral elective percutaneous coronary intervention (PCI). BACKGROUND: Bivalirudin, a synthetic direct thrombin inhibitor, determines a significant decrease of in-hospital bleeding following PCI. METHODS: This is a single-center, investigator-initiated, randomized, double-blind, controlled trial. Consecutive biomarker-negative patients at increased bleeding risk undergoing PCI through the femoral approach were randomized to UFH (UFH group; n = 419) or bivalirudin (bivalirudin group; n = 418). The primary endpoint was the rate of in-hospital major bleeding. RESULTS: The primary endpoint occurred in 11 patients (2.6%) in the UFH group versus 14 patients (3.3%) in the bivalirudin group (odds ratio: 0.78; 95% confidence interval: 0.35 to 1.72; p = 0.54). Distribution of access-site and non-access-site bleeding was 18% and 82% in the UFH group versus 50% and 50% in the bivalirudin group (p = 0.10). CONCLUSIONS: The results of this randomized study, carried out at a single institution, suggest that there is no difference in major bleeding rate between bivalirudin and UFH in increased-risk patients undergoing transfemoral PCI. (Novel Approaches in Preventing and Limiting Events III Trial: Bivalirudin in High-Risk Bleeding Patients [NAPLES III]; NCT01465503).

Novel Approaches for Preventing or Limiting Events (NAPLES III) Trial: randomised comparison of bivalirudin versus unfractionated heparin in patients at high risk of bleeding undergoing elective coronary stenting throught the femoral approach. rationale and design.

PURPOSE: Bivalirudin (Angiox, The Medicine's Company, Parsippany, NJ), a synthetic direct thrombin inhibitor, when compared with standard antithrombotic therapy (including unfractionated heparin [UFH] alone or plus a glycoprotein IIb/IIIa inhibitor) determines a significant decrease of major and minor bleeding and similar protection against ischemic events both in elective and in urgent percutaneous coronary intervention (PCI). There is a lack of prospective clinical trial assessing the safety and the efficacy of bivalirudin compared with UFH alone in the subset of biomarker negative patients at high risk of bleeding undergoing to elective PCI through the femoral approach. METHODS: This is a single-center, investigator-driven, randomized, double-blind, controlled trial ( www.clinicaltrial.gov registration: NCT01465503). Consecutive patients at high bleeding risk (score ≥10 according to Nikolsky et al.) undergoing elective PCI through the femoral approach will be screened for eligibility. Included patients will be randomized (ratio 1.1) to bivalirudin (Bivalirudin group) and UFH (UFH group). The primary endpoint will be the rate of major bleeding (REPLACE 2 criteria). We expect a major bleeding rate ≥5 % in the UFH group versus a ≤3 % event rate in the Bivalirudin group. Aiming for a 0.05 alpha and 0.80 power, a total of 662 patients will be needed. This number will be increased by about 25 % (leading to a total of ≈830 patients) because of uncertainty about expected endpoint rates. CONCLUSIONS: The present trial will give important information on what is the best anticoagulation regimen when performing PCI through the femoral approach in patients at high risk for bleeding.

Endovascular repair of a carotid pseudoaneurysm with Fluency Plus stent graft implantation.

We describe the case of a 76-year-old male with a pseudoaneurysm of the left common carotid artery that developed 7 months following carotid endarterectomy (CEA) and was treated by stent graft implantation, which may represent a valid alternative to surgical repair for the treatment of post-CEA pseudoaneurysm.