合併症はHeartMate 2に比べHeartMate 3において少ない(LBCT.04)

MOMENTUM 3：新たな心臓ポンプは安全かつ有効であり、血栓形成に関連する合併症が少ないようである
MOMENTUM 3: Novel heart pump appears safe and effective, reduces clotting-related complications
新しいHeartMate 3左室補助循環装置（LVAS）は、有害事象を予防するようにデザインされたが、その有害事象すなわちポンプ内血栓を軽減した、とAmerican Heart Association学術集会late-breaking臨床試験で発表され、同時にNew England Journal of Medicine に掲載された。患者は、HeartMate 3 または HeartMate 2の群にランダムに割り付けられた。この294人の患者を6か月間追跡した事前設定解析において、研究者らは、HeartMate 3がその他の有害事象において明らかな差はなく、ポンプ機能不全による再手術率を軽減したことにより、臨床転帰がますます改善したことを示した。
Full Text

The newer HeartMate 3left ventricular assist system (LVAS) eliminated the adverse event it was designed to prevent— pump thrombosis—the "principal driver" of reoperations with this device according to results reported at a late-breaking clinical-trials session at the American Heart Association (AHA) Scientific Sessions and published online in the New England Journal of Medicine.

Left Ventricular Assist Devices (LVADs) improve survival and quality of life in patients with advanced stages of heart failure, but can lead to serious complications from blood clots, embolism and bleeding complications.

The MOMENTUM 3 trial is evaluating the safety and comparative effectiveness of an implantable novel fully magnetically levitated circulatory pump (HeartMate 3 left ventricular assist system) to the HeartMate II system in a prospective randomized, controlled trial of advance heart failure patients. The HeartMate 3 is engineered to prevent clotting-related complications and destruction of circulating blood cells as they pass through the device.

Patients were randomized to receive HeartMate 3 or the HeartMate II irrespective of the intended use as either bridge to transplantation or destination therapy – those ineligible for a transplant. The primary endpoint of the analysis evaluates if the HeartMate 3 is non-inferior to HeartMateII in terms of survival free of debilitating stroke or reoperation to replace or remove the pump.

In this pre-specified primary analysis of 294 patients followed for six months, Mandeep R. Mehra, M.D., FRCP, Medical Director, Brigham and Women's Hospital Heart and Vascular Center, Boston, MA reported that the HeartMate 3 provides incremental improvement in clinical outcomes due to reduction in the rate of reoperation for pump malfunction without an apparent difference in other adverse events.

The study was supported by St Jude Medical.