Two-Year Follow Up of the LATERAL Clinical Trial: A Focus on Adverse Events.

Background: The LATERAL trial validated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare HVAD System, leading to Food and Drug Administration approval. We sought to analyze 24-month adverse event (AE) rates, including a temporal analysis of the risk profile, associated with the thoracotomy approach for the HVAD system.

Methods: AEs from the LATERAL trial were evaluated over 2 years postimplant.

Expert Consensus Paper: Lateral Thoracotomy for Centrifugal Ventricular Assist Device Implant.

Background: The increasing prevalence of heart failure has led to the expanded use of left ventricle assist devices (VADs) for end-stage heart failure patients worldwide. Technological improvements witnessed the development of miniaturized VADs and their implantation through less traumatic non-full sternotomy approaches using a lateral thoracotomy (LT). Although adoption of the LT approach is steadily growing, a lack of consensus remains regarding patient selection, details of the surgical technique, and perioperative management.

Cost of Thoracotomy Approach: An Analysis of the LATERAL Trial.

Background: Less invasive techniques for left ventricular assist device implantation have been increasingly prevalent over past years and have been associated with improved clinical outcomes. The procedural economic impact of these techniques remains unknown. We sought to study and report economic outcomes associated with the thoracotomy implantation approach.

Long-Term Survival of Patients With Advanced Heart Failure Receiving an Left Ventricular Assist Device Intended as a Bridge to Transplantation: The Registry to Evaluate the HeartWare Left Ventricular Assist System.

Background: The paucity of available hearts for transplantation means that more patients remain on durable left ventricular support for longer periods of time. The Registry to Evaluate the HeartWare Left Ventricular Assist System was an investigator-initiated multicenter, prospective, single-arm database established to collect post-Conformité Européene mark clinical information on patients receiving the HeartWare ventricular assist device system as a bridge to transplantation. This registry represents the longest multicenter follow-up of primary left ventricular assist device outcomes.

Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial.

Background: The HeartWare centrifugal-flow ventricular assist device system (HVAD) is a viable option for treatment of advanced heart failure. There is a growing trend toward the use of less invasive techniques in cardiac surgery, and the thoracotomy technique for HVAD implantation may provide benefits not available with conventional approaches.

Methods: The LATERAL trial is a multicenter, prospective, non-randomized, single-arm trial that utilized data from 144 patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database at 26 centers in the United States and Canada.

von Willebrand factor disruption and continuous-flow circulatory devices.

Bleeding events remain a significant and frequent complication of continuous-flow left ventricular assist devices (VADs). von Willebrand factor (VWF) is critical to hemostasis by acting as a bridging molecule at sites of vascular injury for normal platelet adhesion as well as promoting platelet aggregation under conditions of high shear. Clinical and experimental data support a role for acquired von Willebrand disease in VAD bleeding episodes caused by shear-induced qualitative defects in VWF.

Lung Transplantation in Germany Since the Introduction of the Lung Allocation Score.

Background: The allocation of donor lungs for transplantation in Germany was changed on 10 December 2011 to a system based on the Lung Allocation Score (LAS). The aim of the present study is to determine whether this change has prolonged the survival of patients on the transplant waiting list and of those who have undergone lung transplantation (LTx).

Methods: We retrospectively compared data from the three-year periods before and after the change to an LAS-based allocation system (2009-2011 vs.

Evaluation of the HeartWare ventricular assist device Lavare cycle in a particle image velocimetry model and in clinical practice.

Objectives: Ventricular blood stasis is a concern for continuous flow mechanical support devices and might contribute to the formation of thromboembolic events. The HeartWare® Ventricular Assist System (HVAD®) is equipped with the Lavare™ cycle that is a periodic speed modulation feature designed to alter flow patterns within the left ventricle and reduce areas of potential blood stasis. Here, we report in vitro and clinical findings on the effects of the Lavare cycle.

Long-term support of patients receiving a left ventricular assist device for advanced heart failure: a follow-up analysis of the Registry to Evaluate the HeartWare Left Ventricular Assist System.

Objectives: The Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is an investigator-initiated multicentre, prospective, single-arm database established to collect post-Conformité Européenne Mark clinical information on patients receiving the HeartWare® Ventricular Assist System (HVAD®). The number of patients requiring longer periods of mechanical circulatory support is ever increasing and so further investigation into long-term outcomes in bridge-to-transplant populations is necessary.

Methods: Data were collected on 254 commercial implants performed between February 2009 and March 2012 from nine centres in Europe (7 centres) and Australia (2 centres).

Repair of an acute Type A aortic dissection with LVAD patient after failed mitral and tricuspid operation.

An acute type A dissection in a patient with a left ventricular assist device was treated by replacement of the ascending aorta and the proximal arch using a prosthesis with a side branch which was connected to the left ventricular assist device outflow branch, greatly simplifying the procedure.

Preoperative Determinants of Quality of Life and Functional Capacity Response to Left Ventricular Assist Device Therapy.

Background: Left ventricular assist devices (LVADs) improve survival, quality of life (QOL), and functional capacity (FC) among patients with end-stage heart failure. Few data are available regarding characteristics associated with QOL and FC response.

Methods And Results: Patients enrolled in the Heartmate II clinical trials that were alive with ongoing LVAD support at 6 months were included.

Circulatory support exceeding five years with a continuous-flow left ventricular assist device for advanced heart failure patients.

Continuous-flow left ventricular assist devices (CF-LVAD) are now providing years of safe circulatory support with enhanced quality of life. We present four cases of patients with advanced heart failure who received support for greater than 5-years with the HeartMate II CF-LVAD. One patient continues with support at 7.

Influence of aortic valve opening in patients with aortic insufficiency after left ventricular assist device implantation.

Objectives: Aortic valve insufficiency (AI) following left ventricular assist device (LVAD) implantation can potentially limit the success of mechanical circulatory support. We examined the prevalence of significant AI in the new generation of LVADs and analysed the role of aortic valve opening in the development of AI in these patients.

Methods: Currently, 102 patients that received a continuous flow LVAD (cf-LVAD) between July 2009 and December 2013 are being treated in our outpatient clinic with an HeartWare ventricular assist device (HVDA) (n = 77) or HeartMate II (HMII, n = 25) and were included and analysed in a retrospective study.

Ventricular assist devices for treatment of acute heart failure and chronic heart failure.

Despite therapeutic advances that improve longevity and quality of life, heart failure (HF) remains a relentless disease. At the end stage of HF, patients may become eligible for mechanical circulatory support (MCS) for the indications of stabilising acute cardiogenic shock or for chronic HF management. MCS use is growing rapidly in the USA and some countries of the European Union, especially in transplant-ineligible patients.

Retrograde in situ versus antegrade pulmonary preservation in clinical lung transplantation: a single-centre experience.

Objective: Experimental and clinical studies have indicated a beneficial effect of retrograde lung preservation on post-transplant results. Accordingly, we conducted a non-randomized trial.

Methods: A total of 209 consecutive recipients transplanted with low-potassium dextrane (LPD)-preserved lungs were eligible for analysis.

Lung Preservation With Perfadex or Celsior in Clinical Transplantation: A Retrospective Single-Center Analysis of Outcomes.

Background: Despite improvement of lung preservation by the introduction of low-potassium dextran (LPD) solution, ischemia-reperfusion injury remains a major contributor to early post-lung transplant graft dysfunction and mortality. After favorable experimental data, Celsior solution was used in our clinical lung transplant program. Data were compared with our historic LPD cohort.

Artificial lungs: are we there yet?

New oxygenator technologies widened the application of extracorporeal life support significantly in the last decade. Currently the use is still limited within intensive care units. Compared to ventricular assist devices for heart failure, lung replacement technology is lagging behind, not allowing discharge on device.