FDA: Interim data from post-market Abiomed Impella RP study shows 17% survival rate

The FDA yesterday said that interim data from a post-approval study of Abiomed‘s (NSDQ:ABMD) Impella RP heart pump system showed only a 17.4% survival rate, approximately 55% lower than the rate noted in the premarket study of the device. The federal watchdog said that it is currently evaluating data from the study and that it will continue to monitor survival rates, but added that it still believes the system’s benefits outweigh the risks when used correctly. In premarket clinical trials, results indicated a 73.3% survival rate to 30 days post device explant or hospital discharge, or to the start of the next longer term therapy, satisfying the study’s primary survival endpoint. The post-market approval study of the device, which is slated to follow 60 patients through to one year, will have a similar primary endpoint of survival to 30 days post-explant, hospital discharge or the start of longer term therapy, the FDA said. Interim results from the post-approval study, which currently has 23 patients, indicate a survival rate of only 17.4% of patients, or four of 23, have met the primary survival endpoint. Upon analyzing the interim data, Abiomed said that the higher mortality rate may be primarily due to differences in pre-implant characteristics of patients, as 16 of the 23 patients in the post-approval study would “not have met the enrollment criteria for the premarket clinical studies,” according to the FDA release. Patients in the post-a...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Featured Food & Drug Administration (FDA) Abiomed Source Type: news

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Balloon aortic valvuloplasty (BAV) is indicated in patients with acute decompensated heart failure or cardiogenic shock secondary to severe aortic stenosis,1 either as palliative therapy for patients who are not candidates for valve replacement,2 or as a bridge to transcatheter (TAVR) or surgical aortic valve replacement (SAVR).1,3 Given the high morbidity and mortality associated with BAV, especially because it is performed not infrequently in critically ill patients, it is important to understand the effect of hospital procedural volume on outcomes following BAV.
Source: The American Journal of Cardiology - Category: Cardiology Authors: Source Type: research
We present our initial experience managing children with coronavirus disease 2019–related acute myocardial injury. The 3 patients presented here represent a spectrum of the cardiac involvement noted in children with coronavirus disease 2019–related multisystem inflammatory syndrome, including myocarditis presenting as cardiogenic shock or heart failure with biventricular dysfunction, valvulitis, coronary artery changes, and pericardial effusion.
Source: Cardiology in Review - Category: Cardiology Tags: Invited Review Articles Source Type: research
CONCLUSION: Wide variation exists in the care delivered and/or resources available for patients with CS. Our survey suggests opportunities for standardization of care. PMID: 32999090 [PubMed - in process]
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
AbstractCardiogenic shock (CS) is a life-threatening condition of poor end-organ perfusion, caused by any cardiovascular disease resulting in a severe depression of cardiac output. Despite recent advances in replacement therapies, the outcome of CS is still poor, and its management depends more on empirical decisions rather than on evidence-based strategies. By its side, acute kidney injury (AKI) is a frequent complication of CS, resulting in the onset of a cardiorenal syndrome. The combination of CS with AKI depicts a worse clinical scenario and holds a worse prognosis. Many factors can lead to acute renal impairment in t...
Source: Heart Failure Reviews - Category: Cardiology Source Type: research
This study is meant to evaluate the safety of ultrasound guided Swan-Ganz catheter (USSGC) insertion when compared to RHC done in the catheterization laboratory, with respect to major adverse events.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: 177 Source Type: research
In patients with refractory heart failure, there is increasing interest in the use of temporary mechanical circulatory support devices as a bridge to recovery or advanced cardiac therapies. One such family of devices, Impella (ABIOMED), is approved for use in acute myocardial infarction complicated by cardiogenic shock (AMI-CS), but has seen increased use in non-AMI-CS. The goal of this study was to better characterize patient selection for device implantation and outcomes among a contemporary cohort of patients supported with Impella for cardiogenic shock.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: 451 Source Type: research
We sought to determine the disease trajectory of patients with chronic heart failure complicated with cardiogenic shock and the impact of surrogates related to clinical severity and impaired hemometabolic status.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: 156 Source Type: research
Temporary mechanical circulatory support (tMCS) can be used in cardiogenic shock (CS) as a bridge to advanced heart failure therapies (AHFT) (durable LVAD, cardiac transplantation). tMCS escalation in worsening CS has never been studied and prognostication in this cohort is needed, particularly in candidates for AHFT. We evaluated potential predictors of survival and outcomes of those that received AHFT.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: 152 Source Type: research
Right ventricular failure (RVF) is associated with increased mortality among patients receiving left ventricular mechanical circulatory support (LV-MCS) for cardiogenic shock and requires prompt recognition and management. Increased central venous pressure (CVP) is an indicator of potential RVF. We analyzed the association between hemodynamic parameters and clinical outcomes among 132 patients with cardiogenic shock due to acute myocardial infarction in the cVAD registry who had a CVP measured during left-sided Impella support.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: 151 Source Type: research
Currently, the most frequently used mechanical assist device for cardiogenic shock is the intra-aortic balloon pump (IABP). IABPSHOCK II trial in 2012 failed to show any benefits, therefore, the use of an IABP was downgraded to a Class IIA recommendation in the 2013 AHA/ACC guidelines. With recent innovations, the use of percutaneous ventricular assist devices (pVADs) is becoming common. We have looked at the recent trends in the use of pVADS and IABP in patients of heart failure with cardiogenic shock.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: 406 Source Type: research
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