First-in-human experience with Aortix intraaortic pump.

BACKGROUND: There are limited options for percutaneous mechanical circulatory support (pMCS) in patients requiring high-risk percutaneous coronary intervention. OBJECTIVES: This first-in-human, single-center study aimed to evaluate the safety and feasibility of a novel pMCS device in high-risk percutaneous coronary intervention patients. METHODS: Aortix (Procyrion, Houston, Texas) is a pMCS device deployed in the descending aorta via the femoral artery that uses axial flow to provide cardiac unloading and augment renal and systemic perfusion. We assessed the use and effect of the Aortix device in six patients undergoing high-risk PCI. All patients had impaired left ventricular function, complex coronary disease, renal dysfunction, and suitable iliofemoral anatomy for Aortix placement via transfemoral approach. We recorded periprocedural events including hemodynamic effects of the device on cardiac output and urine output. We then followed patients up to 30 days following the PCI procedure for adverse events. RESULTS: Aortix delivery (18 Fr sheath) took 4-9 min, mean support time was 70 (range 47-95) min, and mean flow rate through the device was 3.5 L/min. During support, mean rate of urine output increased 10-fold (range 2.5-25.0x). Estimated GFR improved at discharge compared with baseline (mean increase 6.95 ± 8.09 mL/min). There were no device failures and PCI was successful in all patients. Aortix was removed and hemostasis was achieved with a vascular closure device and manual pressure. No patients experienced adverse events or hemodynamic compromise. No clinically significant hemolysis occurred (mean LDH 239.2 ± 73.6 mU/mL at baseline and 206.4 ± 82.2 mU/mL at discharge). No vascular access complications were observed. CONCLUSIONS: Aortix, a novel pMCS device, was successfully deployed and retrieved in all initial patients undergoing high-risk PCI. We noted no significant hemolysis with temporary use of this axial flow device. Improvement in eGFR suggests a potential renal protective effect and is an important area for future investigation in patients with impaired left ventricular function and renal dysfunction.

Association of Electronic Health Record Use With Quality of Care and Outcomes in Heart Failure: An Analysis of Get With The Guidelines-Heart Failure.

BACKGROUND: Adoption of electronic health record (EHR) systems has increased significantly across the nation. Whether EHR use has translated into improved quality of care and outcomes in heart failure (HF) is not well studied. METHODS AND RESULTS: We examined participants from the Get With The Guidelines-HF registry who were admitted with HF in 2008 (N=21 222), using various degrees of EHR implementation (no EHR, partial EHR, and full EHR). We performed multivariable logistic regression to determine the relation between EHR status and several in-hospital quality metrics and outcomes. In a substudy of Medicare participants (N=8421), we assessed the relation between EHR status and rates of 30-day mortality, readmission, and a composite outcome. In the cohort, the mean age was 71±15 years, 49% were women, and 64% were white. The mean ejection fraction was 39±17%. Participants were admitted to hospitals with no EHR (N=1484), partial EHR (N=13 473), and full EHR (N=6265). There was no association between EHR status and several quality metrics (aside from ß blocker at discharge) or in-hospital outcomes on multivariable adjusted logistic regression (P>0.05 for all comparisons). In the Medicare cohort, there was no association between EHR status and 30-day mortality, readmission, or the combined outcome. CONCLUSIONS: In a large registry of hospitalized patients with HF, there was no association between degrees of EHR implementation and several quality metrics and 30-day postdischarge death or readmission. Our results suggest that EHR may not be sufficient to improve HF quality or related outcomes.