Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry.

OBJECTIVES: This retrospective multicenter registry evaluated the safety and feasibility of left ventricular (LV) support with the Impella 2.5 (Abiomed Europe GmbH, Aachen, Germany) during high-risk percutaneous coronary intervention (PCI). BACKGROUND: Patients with complex or high-risk coronary lesions, such as last remaining vessel or left main lesions, are increasingly being treated with PCI. Because periprocedural hemodynamic compromise and complications might occur rapidly, many of these high-risk procedures are being performed with mechanical cardiac assistance, particularly in patients with poor LV function. The Impella 2.5, a percutaneous implantable LV assist device, might be a superior alternative to the traditionally used intra-aortic balloon pump. METHODS: The Europella registry included 144 consecutive patients who underwent a high-risk PCI. Safety and feasibility end points included incidence of 30-day adverse events and successful device function. RESULTS: Patients were older (62% >70 years of age), 54% had an LV ejection fraction < or = 30%, and the prevalence of comorbid conditions was high. Mean European System for Cardiac Operative Risk Evaluation score was 8.2 (SD 3.4), and 43% of the patients were refused for coronary artery bypass grafting. A PCI was considered high-risk due to left main disease, last remaining vessel disease, multivessel coronary artery disease, and low LV function in 53%, 17%, 81%, and 35% of the cases, respectively. Mortality at 30 days was 5.5%. Rates of myocardial infarction, stroke, bleeding requiring transfusion/surgery, and vascular complications at 30 days were 0%, 0.7%, 6.2%, and 4.0%, respectively. CONCLUSIONS: This large multicenter registry supports the safety, feasibility, and potential usefulness of hemodynamic support with Impella 2.5 in high-risk PCI.

Magnetic-guided percutaneous coronary intervention enabled by two-dimensional guidewire steering and three-dimensional virtual angioscopy: initial experiences in daily clinical practice.

AIMS: Percutaneous coronary intervention (PCI) has been broadly established and often includes highly complex stenoses that require difficult navigation. The purpose of this study is to assess the feasibility of a new magnetic navigation system (MNS) to enable intracoronary guidewire deployment and PCI in daily clinical practice and to compare the 2D guidance to the virtual 3D angioscopy feature. METHODS AND RESULTS: We included 30 consecutive patients (pt) in whom 36 coronary arteries were PCI targets. Patients were randomized to guidewire steering by either 2D guidance or virtual 3D angioscopy (33%). In 31/36 (86%) interventions the MNS guidewire successfully passed the culprit stenosis and the procedure was accomplished by PCI. In 5/30 pt an MNS multivessel intervention was performed. Three of 5 unsuccessful procedures failed due to an unsuccessful recanalization of a subtotal chronic occlusion including 1 pt who required surgical intervention. In 2/36 procedures the magnetic guided intervention was performed effectively after prior conventional failure related to complex anatomy. The contrast medium amount needed to position the magnetic guidewire was 60 +/- 101 mL in 2D accomplished interventions vs. 14 +/- 15 mL in 3D procedures (p < 0.05). In 3 pt the MNS did not harm the implanted pacemaker or defibrillator system. CONCLUSION: Magnetic guided PCI is useful in selected patients. In our experience, success is less likely in evidence of a subtotal occlusion.