Cardiac contractility modulation improves long-term survival and hospitalizations in heart failure with reduced ejection fraction.

Aims: Cardiac contractility modulation (CCM) improves symptoms and exercise tolerance and reduces heart failure (HF) hospitalizations over 6-month follow-up in patients with New York Heart Association (NYHA) class III or IV symptoms, QRS < 130 ms and 25% ≤ left ventricular ejection fraction (LVEF) ≤ 45% (FIX-HF-5C study). The current prospective registry study (CCM-REG) aimed to assess the longer-term impact of CCM on hospitalizations and mortality in real-world experience in this same population.

Methods And Results: A total of 140 patients with 25% ≤ LVEF ≤ 45% receiving CCM therapy (CCM-REG ) for clinical indications were included.

Patients Awaiting Heart Transplantation on HVAD Support for Greater Than 2 Years.

Advanced heart failure patients who are classified as bridge to transplant (BTT) often remain on mechanical circulatory support (MCS) for long durations because of the limited supply of donor organs. Here, we present the outcomes of patients who have been supported by the HeartWare ventricular assist device system for more than 2 years. In the HeartWare BTT and continued access protocol trial, 74 of the 382 total patients (19.

The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies.

Objectives: The purpose of this study was to determine the risk factors for ischemic in hemorrhage cerebrovascular events in patients supported by the HeartWare ventricular assist device (HVAD).

Background: Patients supported with left ventricular assist devices are at risk for both ischemic and hemorrhagic cerebrovascular events.

Methods: Patients undergoing implantation with a HVAD as part of the bridge-to-transplant trial and subsequent continued access protocol were included.

Gastrointestinal bleeding in recipients of the HeartWare Ventricular Assist System.

Objectives: This study evaluated gastrointestinal bleeding (GIB) in patients receiving the HeartWare HVAD System (HeartWare Inc., Framingham, Massachusetts) in the pivotal BTT (Bridge to Transplant) trial and under the continued access protocol (CAP).

Background: GIB has become a significant problem for recipients of continuous flow device left ventricular assist devices (CF-LVAD).

Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures.

Background: Cardiac valve procedures are commonly performed concurrently during implantation of left ventricular assist devices, but the added procedural risk has not been studied in detail.

Methods And Results: Data from patients receiving the HeartWare Ventricular Assist Device in the ADVANCE bridge to transplant (BTT) trial and continued access protocol were reviewed. Of 382 consecutive patients who completed follow-up between August 2008 and June 2013 (mean time on support 389 days, median 271 days), 262 (68.

Drive-line infections and sepsis in patients receiving the HVAD system as a left ventricular assist device.

Background: Drive-line infections and sepsis lead to significant morbidity and even mortality in patients with ventricular assist devices (VADs). The HeartWare HVAD system is unique compared with other VAD systems in that it has a thin, flexible drive-line and is implanted directly into the pericardial space without the need for a pump pocket. We reviewed 332 patients receiving the HVAD in the pivotal ADVANCE Bridge to Transplant (BTT) trial and Continued Access Protocol (CAP) to determine the incidence of drive-line infections and sepsis.

An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial.

Background: The HeartWare left ventricular assist device (HVAD, HeartWare Inc, Framingham, MA) is the first implantable centrifugal continuous-flow pump approved for use as a bridge to transplantation. An infrequent but serious adverse event of LVAD support is thrombus ingestion or formation in the pump. In this study, we analyze the incidence of pump thrombus, evaluate the comparative effectiveness of various treatment strategies, and examine factors pre-disposing to the development of pump thrombus.