First in man evaluation of a novel circulatory support device: Early experience with the Impella 5.5 after CE mark approval in Germany

Bernhardt, A.; Potapov, Evgenij; Schibilsky, David; Ruhparwar, Arjang; Tschöpe, Carsten; Spillmann, Frank; Benk, Christoph; Schmack, Bastian; Schmitto, Jan D.; Napp, L. Christian; Mayer-Wingert, N.; Doll, Nicolas; Reichenspurner, Hermann; Schulte-Eistrup, S.

doi:10.1016/j.healun.2021.04.001

Cited by 38 publications

(44 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…11,12 In our study, we report a median support duration of 7 days (IQR 5.0-11.0), which is only half of the median duration of Impella® therapy reported by Ramzy et al 11 In the first German multicenter Impella® 5.5 registry, Bernhardt et al report to have bridged to recovery of 34.8% of the cohort. 4 Interestingly, we were able to successfully wean 53.1% of patients from Impella® support, with over one-third of the entire cohort being bridged to durable LVAD. Nevertheless, due to the small population size, the power of the study does not allow us to discuss the significance of the survival difference between these two bridge concepts.…”

Section: Discussionmentioning

confidence: 92%

Early experience with the Impella pump: Single‐center registry

et al. 2022

Self Cite

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 92%

Early experience with the Impella pump: Single‐center registry

et al. 2022

Self Cite

View full text Add to dashboard Cite

show abstract

“…As described, Impella 5+ implantation was performed via FA only as a second choice if implantation via SA was deemed unfavorable, which is in line with current practice globally ( 11 ). In this sense, Impella 5+ was implanted via FA only in 6 patients (9.0%) ( Table 3 ).…”

Section: Resultsmentioning

confidence: 66%

“…Bernhardt et al had reported the first experience with Impella 5.5 in Germany. They reported the incidence of dislocation in 21.7% of patients in the first generation of the device with a shorter cannula (11). Since the device length has been modified, the incidence of dislocation would be improved.…”

Section: Discussionmentioning

confidence: 99%

Outcome of Patients Supported by Large Impella Systems After Re-implantation Due to Continued or Recurrent Need of Temporary Mechanical Circulatory Support

Sugimura

Bauer²,

Immohr³

et al. 2022

Front. Cardiovasc. Med.

View full text Add to dashboard Cite

Despite the growing utilization of a large microaxial pump, i. e., Impella 5.0 or 5.5 (Abiomed Inc., Danvers, MA, USA) (Impella 5+) for patients with cardiogenic shock (CS), adverse events including the necessity of re-implantation have not been well discussed. In all 67 patients, in-hospital mortality was 52.2% (n = 35). Explantation of Impella 5+ was performed in 39 patients (58.2%), 22 of whom (32.8%) recovered under Impella 5+, and ten further patients (14.9%) survived after a successful transition to permanent mechanical circulatory support. Embolic events were considerable complications in each access. They occurred in the right arm after the removal of Impella 5+ via a subclavian artery (SA) (n = 3, 9.1%) or in the form of leg ischemia in patients with Impella 5+ via femoral artery (FA) (n = 2, 33.3%). Re-implantation was necessary for 10 patients (14.9%) due to 1) recurrent CS (n = 3), 2) pump thrombosis (n = 5), or 3) pump dislocation (n = 2), all of which were successfully performed via the same access route. In univariate analysis, FA access was a significant risk factor for Impella dysfunction compared to SA access (FA vs. SA, 42.9% vs. 9.8%, p < 0.05, odds ratio 6.88). No statistical difference of overall mortality was observed in patients with Impella 5+ re-implantation (n = 10) compared to patients with primary Impella 5+ support (n = 57) (80.0% (n = 8/10) vs. 47.4% (n = 27/57), p = 0.09). Our results suggested the acceptable clinical outcome of Impella 5+ despite a 15% re-implantation rate. Our observational data may merit further analysis of anticoagulation strategies, including risk stratification for embolic events.

show abstract

“…In 2018, the Impella 5.5 received CE mark in Germany for longer-term support and showed promising early results. 25 , 26 The newly designed device is lacking the pigtail catheter and its design allows more precise placement in the LV, potentially leading to lower rates of hemolysis. 27 In the initial series of 46 patients from 6 German centers who received an Impella 5.5, the 30-day survival was 73.9% with an overall favorable adverse events profile.…”

Section: Ecmella Therapy Using Axillary Impella 50/55 Devices and Bri...mentioning

confidence: 99%

“… 27 In the initial series of 46 patients from 6 German centers who received an Impella 5.5, the 30-day survival was 73.9% with an overall favorable adverse events profile. 26 Later, the Food and Drug Administration approved the device in the United States. 28 The Impella 5.5 is designed for an axillary approach only.…”

Section: Ecmella Therapy Using Axillary Impella 50/55 Devices and Bri...mentioning

confidence: 99%

Extracorporeal membrane oxygenation evolution: Left ventricular unloading strategies

Bernhardt¹,

Schrage²,

Westermann³

et al. 2021

JTCVS Open

Self Cite

View full text Add to dashboard Cite

First in man evaluation of a novel circulatory support device: Early experience with the Impella 5.5 after CE mark approval in Germany

Cited by 38 publications

References 19 publications

Early experience with the Impella pump: Single‐center registry

Early experience with the Impella pump: Single‐center registry

Outcome of Patients Supported by Large Impella Systems After Re-implantation Due to Continued or Recurrent Need of Temporary Mechanical Circulatory Support

Extracorporeal membrane oxygenation evolution: Left ventricular unloading strategies

Contact Info

Product

Resources

About