Prospective clinical study of a novel left atrial appendage occlusion device.

Purpose: This Food and Drug Administration-approved investigational device exempt trial assessed the safety and efficacy of a novel device for external left atrial appendage (LAA) exclusion.

Description: Delivery tool and implant consisting of connectors imbedded in a compliant, soft silicone applied to the base of the LAA flush with the external wall was assessed.

Evaluation: Patients in this prospective, multicenter trial were undergoing elective, nonendoscopic cardiac operations.

Platelet activation in heart failure patients supported by the HeartMate II ventricular assist device.

Objective: Thromboembolic events have been observed in heart failure (HF) patients supported by long-term mechanical circulatory support (MCS) devices. It has been hypothesized that these adverse events may be the result of platelet activation associated with high rotational speeds common to axial flow pumps. In this study, markers of platelet activation were investigated in HF patients supported by a HeartMate II left ventricular assist device (LVAD).

HeartWare miniature axial-flow ventricular assist device: design and initial feasibility test.

Pulsatile ventricular assist devices have successfully provided circulatory support for many patients throughout the past quarter century; however, persistent complications have hindered expanded clinical application of this technology. Although the use of smaller, continuous-flow ventricular assist device pumps has reduced the frequency and severity of some adverse events, design enhancement may further improve outcomes for patients who require long-term left ventricular support. One new product, the HeartWare, Inc.

Reducing the effects of the systemic inflammatory response to cardiopulmonary bypass: can single dose steroids blunt systemic inflammatory response syndrome?

The use of cardiopulmonary bypass (CPB) is associated with the development of a significant systemic inflammatory response syndrome (SIRS) which can affect patient outcomes. Multiple pathways are involved in initiating and maintaining SIRS. We studied whether a single dose of steroids (dexamethasone) after the induction of anesthesia could blunt the SIRS from CPB.

Embol-X intra-aortic filtration system: capturing particulate emboli in the cardiac surgery patient.

We sought to evaluate the effectiveness of using an intra-aortic filtration system for the prevention of particulate emboli transport and the minimization of significant postoperative complications associated with particulate emboli. Between October of 2000 and October 2001, a total of 146 patients were enrolled at Advocate Christ Medical Center as part of the multi-institutional randomized trial (1289 patients at 22 centers). A total of 74 patients (51%) received the Embol-X intra-aortic filter and 72 patients (49%) were enrolled in the control group.

Prospective study on cardiopulmonary bypass prime reduction and its effect on intraoperative blood product and hemoconcentrator use.

Purpose: Evaluate the feasibility and clinical significance of crystalloid prime reduction during the initiation of cardiopulmonary bypass (CPB) using a modified bridge on the cardioplegia delivery system.

Methods: Prospective trial of crystalloid prime reduction using a standard Duraflow-coated CPB circuit and Vanguard 2:1 cardio plegia delivery system. Standard prime volume was 1500 cc of Plasmalyte.

Minimally invasive mitral valve repair using the da Vinci robotic system.

Background: Minimally invasive mitral valve repair with a shortened hospital stay and quick return to an active lifestyle is the ultimate goal for robotically assisted surgery. We evaluated our da Vinci robotically assisted mitral valve repair experience toward achieving this goal.

Methods: All procedures were performed with peripheral cardiopulmonary bypass, transthoracic aortic cross-clamp, and antegrade cardioplegia.

Peripheral cardiopulmonary bypass with modified assisted venous drainage and transthoracic aortic crossclamp: optimal management for robotic mitral valve repair.

The purpose of this study was to evaluate peripheral cardiopulmonary bypass (CPB) with modified assisted venous drainage (MAVD) and transthoracic aortic cross-clamping to maintain a bloodless surgical field, adequate myocardial protection, systemic flow and pressure during robotic surgical repair of the mitral valve. Peripheral CPB was established with a standard Duraflo-coated closed circuit with femoral arterial and venous cannulation. An additional 17 Fr wire-bound cannula was inserted into the right internal jugular vein and drainage rates of 200-400 mL/min were regulated using a separate roller-head pump.