In a letter to healthcare providers, the US FDA summarized a recent evaluation of a postapproval study of the Abiomed Impella RP system. In clinical trials, 73% of patients survived 30 days after device explant, hospital discharge, or to definitive intervention. In the postapproval study, just over 17% of patients met this goal.
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VAD
January 30, 2019
Garbade and colleagues compared outcomes reported during the European Conformity (CE) Mark clinical trial of the HeartMate 3 left ventricular assist device (LVAD) to outcomes for patients treated since the device came to market.
November 30, 2018
Netuka provides several important technical nuances to consider when implanting the HeartMate 3 left heart assist device. He focuses on apical cuff attachment, optimal positioning of the pump in the pericardial cavity, and positioning of the outflow graft.
October 23, 2018
A post-market study (ELEVATE registry) of the fully magnetically levitated continuous flow HeartMate III left ventricular assist device (LVAD) found no pump thrombosis in 463 patients in Europe and Kazakhstan.
October 2, 2018
Will await the full paper to test the titular preliminary assertion.
June 22, 2018
Patient Care and General Interest
June 6, 2018
Dobrovie and colleagues performed a retrospective analysis of mitral regurgitation (MR) in 128 patients who had a left ventricular assist device (LVAD) implanted. The authors found that even severe MR improved following LVAD implantation without intraoperative repair of the valve.
May 25, 2018
Patient Care and General Interest
Coal miners in central Appalachia in the US have an increasing incidence of severe black lung disease and an associated increased need for lung transplantation.
May 3, 2018
A somewhat delayed publication of a 2016 paper that discusses important trends in cardiac transplanation in the light of increasing use of ECMO.
April 3, 2018
Gosev and colleagues evaluated the baseline characteristics and outcomes in 156 patients from 12 centers who survived at least four years on left ventricular assist device (LVAD) support. Among this group of patients, mean survival was 7.1 years (95% CI 6.7 to 7.5 years).