Alexander M Bernhardt1, Evgenij Potapov2, David Schibilsky3, Arjang Ruhparwar4, Carsten Tschöpe5, Frank Spillmann6, Christoph Benk3, Bastian Schmack4, Jan D Schmitto7, L Christian Napp8, Nadja Mayer-Wingert9, Nicolas Doll10, Hermann Reichenspurner11, Sebastian Schulte-Eistrup10. 1. University Heart and Vascular Center Hamburg, Germany/ Department of Cardiovascular Surgery, Germany. Electronic address: al.bernhardt@uke.de. 2. German Heart Center Berlin, Germany/ Department of Thoracic and Cardiovascular Surgery, Germany. 3. University Heart Center, Freiburg, Bad Krozingen, Germany/ Department of Cardiovascular Surgery Faculty of Medicine, University Freiburg, Germany. 4. The West German Heart Center, Essen, Germany/ Department of Cardiovascular Surgery, Germany. 5. Charité - Universitätsmedizin Berlin, Germany/ Campus Virchow/ Department of Cardiology, Germany; Charité - Universitätsmedizin Berlin, Germany/Berlin Institute of Health (BIH) Berlin Brandenburger Center For Regenerative Therapies (BCRT), Germany. 6. Charité - Universitätsmedizin Berlin, Germany/ Campus Virchow/ Department of Cardiology, Germany. 7. Hannover Medical School, Hannover, Germany/ Department of Cardiovascular Surgery, Germany. 8. Hannover Medical School, Hannover, Germany/ Department of Cardiology and Angiology, Germany. 9. Schüchtermann clinic, Bad Rothenfelde, Germany/ Department of Cardiology, Germany. 10. Schüchtermann clinic, Bad Rothenfelde, Germany/ Department of Cardiovascular Surgery, Germany. 11. University Heart and Vascular Center Hamburg, Germany/ Department of Cardiovascular Surgery, Germany.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Yukiharu Sugimura; Sebastian Bauer; Moritz Benjamin Immohr; Arash Mehdiani; Philipp Rellecke; Ralf Westenfeld; Hug Aubin; Udo Boeken; Artur Lichtenberg; Payam Akhyari Journal: Front Cardiovasc Med Date: 2022-07-07