Featured articleInitial clinical experience with a novel left ventricular assist device with a magnetically levitated rotor in a multi-institutional trial
Section snippets
HVAD pump
The HVAD pump is a miniaturized centrifugal blood pump with a displaced volume of only 50 ml, a maximum external diameter of 53 mm, and a weight of 140 grams (Figure 1). A short inflow cannula integrated into the pump housing is placed in the apex of the left ventricle, and a 10-mm pre-clotted vascular graft connects as an outflow conduit from the pump to the ascending aorta. This configuration allows intrapericardial placement, thereby avoiding abdominal surgery and pump pockets. A thin and
Device implantation and anticoagulation
Device implantation was performed through a standard sternotomy using normothermic cardiopulmonary bypass (CPB) with beating heart.5 The sewing ring was attached epicardially to the left ventricular (LV) apex, and the inflow cannula was inserted through the sewing ring into the LV. The outflow graft was cut to length and sewn to the ascending aorta using an end-to-side anastomosis. The percutaneous lead was tunneled to exit in the right upper quadrant. After de-airing was completed, the clamp
Results
Between March 2006 and December 2007, 20 men and 3 women with a mean age of 48 ± 12.6 years (range, 25–68 years) who met the study entry criteria were enrolled into the clinical evaluation trial of the HVAD pump. Baseline hemodynamic data are provided in Table 1, and pre-operative risk factors are listed in Table 2. Body surface areas varied widely, with a mean of 1.98 m2 (range, 1.5–2.6 m2), and the mean body mass index was 27.6 kg/m2 (range, 20.2–40.8 kg/m2). Idiopathic cardiomyopathy was the
Adverse events
The most common AE within a 1-year follow-up period was infection, which occurred on 16 occasions in 11 patients (Table 4). Sepsis developed in 3 patients (1 fungal, 2 bacterial). None of the septic episodes were related to the device. Eight local driveline exit site infections developed in 6 patients. The exit site infections appeared rather late, between 102 and 364 days (mean, 238 days) post-operatively. With the exception of 1 surgical débridement, all of the exit sites were successfully
Discussion
In November 1998, when the first miniaturized axial-flow pumps were implanted in humans,7 no one could have anticipated that the evolving technology of rotary blood pumps would replace the displacement pumps used for the previous 20 years. Rotary pumps seemed to provide striking advantages in terms of potential for miniaturization of pumps and controller units, elimination of noise, reduction of driveline diameters, and the need for compliance chambers. However, there was uncertainty regarding
Disclosure statement
G. M. Wieselthaler is member of the Medical Advisory Board of HeartWare Inc, and his institution participates in technical research that is funded by a grant from HeartWare Inc. None of the other authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.
References (14)
- et al.
A prospective, multicenter trial of the VentrAssist left ventricular assist device for bridge to transplant: safety and efficacy
J Heart Lung Transplant
(2008) - et al.
INTERMACS database for durable devices for circulatory support: first annual report
J Heart Lung Transplant
(2008) - et al.
Successful treatment of rotary pump thrombus with the glycoprotein IIb/IIIa inhibitor tirofiban
J Heart Lung Transplant
(2008) - et al.
Lessons learned from the first clinical implants of the DeBakey ventricular assist device axial pump: a single center report
Ann Thorac Surg
(2001) - et al.
Second INTERMACS annual report: more than 1,000 primary left ventricular assist device implants
J Heart Lung Transplant
(2010) - et al.
Clinical experience with an implantable, intracardiac, continuous flow circulatory support device: physiologic implications and their relationship to patient selection
Ann Thorac Surg
(2004) - et al.
Physiology of continuous blood flow in recipients of rotary cardiac assist devices
J Heart Lung Transplant
(2005)