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The Abiomed Impella 5.5 (Danvers, MA) is a newly developed axial flow transaortic cardiac support device mounted on a 9 Fr steering catheter with a 21 Fr pump cannula. Impella 5.5 is intended for longer use and was approved for 30 days in 2018. This study evaluated the first-in-man series at six high-volume mechanical circulatory support centers in Germany after CE approval. The first 46 consecutive patients worldwide underwent implantation in six German centers between March 2018 and September 2019 for post-CE approval evaluation. The primary end-point was 30 days and 90 days all-cause mortality. The mean age of patients was 59.0 ± 11.5 years , and 43 (93.4%) were men. Half of the patients had acute on chronic heart failure. The main indication for Impella 5.5 implantation was ischemic cardiomyopathy and acute myocardial infarction (47.8%). The mean support time was 15.5 ± 24.2 days (range 0-164, median 10 days (IQR = 7-19)) with a total of 712 patient-days on support. The 30 days and 90 days survival rates were 73.9% (95% CI: 63.3–88.9%) and 71.7% (95% CI: 60.7-87.1%), respectively. Additionally, 16 patients (34.8%) were weaned from the device for native heart recovery, and 19 (41.3%) were bridged to a durable device. Fifteen patients (32.6%) were mobilized to a chair, and 15 (32.6%) were ambulatory. We only noted one stroke and found no other thromboembolic complications. No aortic valve damage was observed in the study cohort. Finally, seven patients (15.2 %) had pump thrombosis, and nine (19.6 %) underwent device exchange. Sixteen patients (34.8 %) suffered from bleeding requiring transfusions during the whole treatment course. In ten patients (21.7%), the inflow cannula dislocated into the aortic root. The first version of the Impella 5.5 presents promising early outcomes for patients with acute heart failure and expands the spectrum of available devices. The adverse event profile is favorable for short-term devices. Dislocations have been addressed by design changes. With increasing experience with this device, our study suggests that the indications for use will expand to other cardiac shock etiologies and may improve myocardial recovery and survival in patients with cardiogenic shock. [ABSTRACT FROM AUTHOR]

Syncope is a common phenomenon in the general population. Although most of the causes are of benign origin, some comorbidities are accompanied by high mortality. We aimed to compare the in-hospital mortality of patients with syncope related to different comorbities and investigate the impact of syncope in patients with atrial fibrillation/flutter (AF). The nationwide inpatient sample of Germany of the years 2011–2014 was used for this analysis. Patients with syncope (ICD-code R55) were stratified by presence of selected comorbidities. Additionally, AF patients with and without syncope were compared. Incidence of syncope and in-hospital mortality were calculated. Syncope as a predictor of adverse outcome in AF patients was investigated. In total, 1,628,859 hospitalizations of patients with syncope were identified; incidence was 504.6/100,000 citizens/year with case-fatality rate of 1.6%. Patients with syncope revealed frequently comorbidities as AF, heart failure and pneumonia. In-hospital mortality was high in syncope patients with pulmonary embolism (PE, 13.0%), pneumonia (12.8%), myocardial infarction (MI, 9.7%) and stroke (8.5%). We analysed 1,106,019 hospitalizations (52.9% females, 54.9% aged > 70 years) of patients with AF (2011–2014). Among these, 23,694 (2.1%) were coded with syncope and 0.7% died. Syncope had no significant impact on in-hospital mortality (OR 1.04, 95%CI 0.92–1.17, P =.503) independently of age, sex and comorbidities, but was associated with PE (OR 1.83, 95%CI 1.42–2.36, P <.001), MI (OR 1.68, 95%CI 1.48–1.90, P <.001), stroke (OR 1.66, 95%CI 1.42–1.94, P <.001) and pneumonia (OR 1.26, 95%CI 1.16–1.37, P <.001). Syncope is a frequent cause for referrals in hospitals. While the overall in-hospital mortality rate is low (<2%), syncope in coprevalence with PE, pneumonia, MI and stroke showed a mortality rate > 8%. Syncope in AF patients had no independent impact on in-hospital mortality. • Syncope is a frequent cause for referrals in hospitals. • The overall in-hospital mortality was 1.6%. • Syncope in PE, pneumonia, MI and stroke showed an in-hospital mortality rate > 8%. • Syncope in AF patients was accompanied by higher in-hospital mortality. • Syncope did not influence the risk to die in-hospital independently in AF patients. [ABSTRACT FROM AUTHOR]