A Correlative Study of Fluid Mechanics and Evidence of Thrombus Formation Within the Penn State 50 CC Left Ventricular Assist Device

Author(s):  
Stephen R. Topper ◽  
Michael A. Navitsky ◽  
Christopher A. Siedlecki ◽  
Steven Deutsch ◽  
Gerson Rosenberg ◽  
...  

An estimated 82.6 million American adults live with one or more forms of cardiovascular disease and in past years, it was the cause of over 55% of all deaths in the United States, more than any other type of major disease [1]. With a limited number of available donors, heart transplants are seldom an option. As a result, ventricular assist devices (VADs) have become a viable alternative to immediate transplant. Today, VADs are widely used as bridge-to-recovery, bridge-to-transplant and destination therapy devices. Despite past improvements in VAD design, a major complication that continues to arise is thrombus formation within the pump.

Author(s):  
Michael A. Navitsky ◽  
Jason C. Nanna ◽  
Stephen R. Topper ◽  
Steven Deutsch ◽  
Keefe B. Manning

Approximately 5.7 million Americans are afflicted with heart failure, with a reported 670,000 new diagnoses each year [1]. Left ventricular assist devices (LVADs) function as a bridge to transplant therapy for advanced staged heart failure patients awaiting a donor heart. A pulsatile 50cc LVAD, Figure 1, is currently under development for cardiac support of patients with limited chest cavity size. Although the 50cc LVAD is functional in assisting a failing ventricle, complications such as thrombus formation may limit long term usage.


Author(s):  
Timothy J Fendler ◽  
Michael E Nassif ◽  
Kevin F Kennedy ◽  
John A Spertus ◽  
Shane J LaRue ◽  
...  

Background: Left ventricular assist device (LVAD) therapy can improve survival and quality of life in advanced heart failure (HF), but some patients may still do poorly after LVAD. Understanding the likelihood of experiencing poorer outcomes after LVAD can better inform patients and calibrate their expectations. Methods: We analyzed patients receiving LVAD therapy from January 2012 to October 2013 at a single, high-volume, high-acuity center. We defined a poor global outcome at 1 year after LVAD as the occurrence of death, disabling stroke (precluding transplant), poor patient-reported health status (most recent KCCQ at 3, 6, or 12 months < 45, corresponding to NYHA class IV), or recurrent HF (≥2 HF readmissions post-implant). We compared characteristics of those with and without poor global outcome. Results: Among 164 LVAD recipients who had 1-year outcomes data, mean age was 56, 76.7% were white, 20.9% were female, and 85.9% were INTERMACS Profile 1 or 2 (cardiogenic shock or declining despite inotropes). Poor global outcome occurred in 58 (35.4%) patients at 1 year, of whom 37 (63.8%) died, 17 (29.3%) had a most recent KCCQ score < 45, 3 (5.2%) had ≥2 HF readmissions, and 1 (1.7%) had a disabling stroke (Figure). Eight of the patients who died also experienced one of the three other poor outcomes prior to death. Patients who experienced a poor global outcome were more likely to be designated for destination therapy (46.4% vs. 23.6%, p=0.01) than bridge to transplant, have longer index admissions (median [IQR]: 39 [24, 57] days vs. 25 [18, 35] days, p=0.003), and have major GI bleeding (44.2% vs. 27.7%, p=0.056), and were less likely to undergo LVAD exchange (0% vs. 12.3%, p=0.004). Conclusion: In this large, single-center study assessing global outcome after LVAD implantation, we found that about a third of all patients had experienced a poor global outcome at 1 year. While LVAD therapy remains life-saving and the standard of care for many patients with advanced heart failure, these findings could help guide discussions with eligible patients and families. Future work should compare patients’ pre-LVAD expectations with likely outcomes and create risk models to estimate the probability of poorer outcomes for individual patients using pre-procedural factors.


ASAIO Journal ◽  
2014 ◽  
Vol 60 (4) ◽  
pp. 369-371 ◽  
Author(s):  
Nicholas G. Kounis ◽  
George D. Soufras ◽  
Periklis Davlouros ◽  
Grigorios Tsigkas ◽  
George Hahalis

Author(s):  
Isabella E. Valenti ◽  
Breigh N. Roszelle ◽  
Michael V. Perone ◽  
Steven Deutsch ◽  
Keefe B. Manning

Congenital cardiovascular defects are the leading cause of death among live births [1]. These defects involve the interior walls of the heart, valves, arteries, and veins and change the normal flow of blood through the heart and into the systemic system. Fortunately, several options exist for the more than 35,000 children born with congenital heart disease. Ventricular assist devices (VADs) currently hold the most promise for bridge-to-transplant treatment; however, a major problem for these devices is thrombus formation and deposition.


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