TY - JOUR
T1 - Prevalence of bleeding events in real-world Japanese registry for Percutaneous Ventricular Assist Device
AU - J-PVAD Investigators
AU - Nishimura, Takashi
AU - Toda, Koichi
AU - Ako, Junya
AU - Hirayama, Atsushi
AU - Kinugawa, Koichiro
AU - Kobayashi, Yoshio
AU - Ono, Minoru
AU - Sato, Naoki
AU - Shindo, Takahiro
AU - Shiose, Akira
AU - Takayama, Morimasa
AU - Yasukochi, Satoshi
AU - Sawa, Yoshiki
N1 - Publisher Copyright:
© The Japanese Society for Artificial Organs 2024.
PY - 2024/12
Y1 - 2024/12
N2 - Purpose: Bleeding complication is a critical risk factor for outcomes of acute heart failure patients requiring mechanical circulatory support (MCS), including percutaneous catheter-type heart pumps (Impella). The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) is an ongoing, large-scale, real-world registry to characterize Japanese patients requiring Impella. Here we analyzed bleeding complication profiles in patients who received Impella. Methods: All consecutive Japanese patients who received Impella from October 2017 to January 2020 were enrolled. The 30-day survival and bleeding complications were analyzed. Results: A total of 1344 patients were included: 653 patients received Impella alone, 685 patients received a combination of veno-arterial extracorporeal membrane oxygenation and Impella (ECPELLA), and 6 patients had failed Impella delivery. Overall 30-day survival was 67.0%, with Impella alone at 81.9% and ECPELLA at 52.7%. Overall bleeding/hematoma adverse events with a relation or not-excluded relation to Impella was 6.92%. Among them, the rates of hematoma and bleeding from medical device access sites were 1.41% and 4.09%, respectively. There was no difference between etiologies for these events. Conclusion: This study represents the first 3-year survival and the safety profile focused on bleeding adverse events from the J-PVAD registry. The results show that the real-world frequency of bleeding adverse events for patients who received Impella was an expected range from previous reports, and future real-world studies should aim to expand this data set to improve outcomes and adverse events.
AB - Purpose: Bleeding complication is a critical risk factor for outcomes of acute heart failure patients requiring mechanical circulatory support (MCS), including percutaneous catheter-type heart pumps (Impella). The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) is an ongoing, large-scale, real-world registry to characterize Japanese patients requiring Impella. Here we analyzed bleeding complication profiles in patients who received Impella. Methods: All consecutive Japanese patients who received Impella from October 2017 to January 2020 were enrolled. The 30-day survival and bleeding complications were analyzed. Results: A total of 1344 patients were included: 653 patients received Impella alone, 685 patients received a combination of veno-arterial extracorporeal membrane oxygenation and Impella (ECPELLA), and 6 patients had failed Impella delivery. Overall 30-day survival was 67.0%, with Impella alone at 81.9% and ECPELLA at 52.7%. Overall bleeding/hematoma adverse events with a relation or not-excluded relation to Impella was 6.92%. Among them, the rates of hematoma and bleeding from medical device access sites were 1.41% and 4.09%, respectively. There was no difference between etiologies for these events. Conclusion: This study represents the first 3-year survival and the safety profile focused on bleeding adverse events from the J-PVAD registry. The results show that the real-world frequency of bleeding adverse events for patients who received Impella was an expected range from previous reports, and future real-world studies should aim to expand this data set to improve outcomes and adverse events.
KW - Bleeding
KW - Cardiogenic shock
KW - Impella
KW - Mechanical circulatory support
KW - Veno-arterial extracorporeal membrane oxygenation
UR - http://www.scopus.com/inward/record.url?scp=85187303191&partnerID=8YFLogxK
U2 - 10.1007/s10047-023-01429-5
DO - 10.1007/s10047-023-01429-5
M3 - 学術論文
C2 - 38396197
AN - SCOPUS:85187303191
SN - 1434-7229
VL - 27
SP - 375
EP - 384
JO - Journal of Artificial Organs
JF - Journal of Artificial Organs
IS - 4
ER -