“We consider that this miniaturized pump is a further splendid step forward in heart replacement therapy and could potentially change the therapy of advanced heart therapy”, says Günther Laufer, Head of the Department of Clinical Heart Surgery in the University Clinic for Surgery in the Medical University of Vienna.
Start of an international study
HeartWare International is a leading innovator of less invasive miniaturised technologies for supporting circulation which could revolutionize the treatment of advanced heart failure and has this week announced the start of its international clinical study for the CE marking of its MVAD(®) system. The newly developed MVAD pump of the next generation has now been implanted into the first patients in the Freeman Hospital in Newcastle upon Tyne (England) und at the Medical University of Vienna / Vienna General Hospital.
The MVAD pump is a heart pump that can be programmed for several blood flow profiles, in order to support the circulation in patients with advanced heart failure. The MVAD has an impeller with low shear stress and optimal blood flow paths, which together lead to improved haemodynamic performance. In addition, the MVAD has a pulsatility algorithm that allows doctors to adjust the implant for each individual patient. There are four pulse settings, with which the function of the aortic valve can be optimized and chronic bleeding events reduced.
The new MVAD pump is less than half the size of the smallest full support implant (HVAD) that is currently available, and is also inserted with a less invasive thoracotomy technique. The pump weighs only 78 g and has a volume displacement of 22 cc (ml). It has a displaceable sewing cuff, which the surgeon can use to position the inlet needle for optimal blood flow. The integrated Pal control unit and the battery system include a touch screen display and small light batteries in two sizes for locking into place.
“This is why the MVAD pump takes up so little space in the chest. It is then ideally suited for minimally invasive implantation procedures, which is the approach we favour for HVAD pumps of the current generation”, says Daniel Zimpfer, Head of the Program on “Mechanical Circulation Support” at the Medical University of Vienna / Vienna General Hospital. The method to implant heart support systems through small skin incisions was developed in recent years under the leadership of the Department of Clinical Heart Surgery at the Medical University of Vienna / Vienna General Hospital.
The study for CE marking is a multicentre, prospective, non-randomized single arm study to evaluate the clinical safety and performance of the HeartWare MVAD system for the treatment of advanced heart failure. 60 patients in 11 study sites in Great Britain, Austria, Australia, France and Germany have been recruited for the study. The MVAD pump is implanted into the patients by sternotomy or thoracotomy and the short and long term use of the implant is evaluated. The primary endpoint is the survival rate after 6 months.