{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T16:01:40Z","timestamp":1790092900343,"version":"4.0.1"},"reference-count":6,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,5,11]],"date-time":"2025-05-11T00:00:00Z","timestamp":1746921600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,5,11]],"date-time":"2025-05-11T00:00:00Z","timestamp":1746921600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The Impella 5.5 is increasingly being used in patients with cardiogenic shock, but experience with the device remains limited, and severe complications, including death, have been reported. This study aims to investigate causes of Impella 5.5\u2010related deaths.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data were extracted from the FDA Manufacturer and User Facility Device Experience (MAUDE) database using the search term \u201cImpella 5.5\u201d with the outcome \u201cdeath.\u201d Case details were reviewed and summarized.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 47 cases were reviewed. Of these, four cases were excluded as unrelated to the device. Among the 43 cases included, 40 involved either procedural\u2010related or device\u2010related complications. The remaining three cases had an indeterminant cause. Procedural complications were observed in 26 cases (61%). Of these, 16 cases (37%) involved cardiac perforation, which was frequently caused by improper placement or re\u2010positioning of the device. Five cases (12%) involved graft\/vessel\u2010related complications, including bleeding, detachment from the aorta, or dissection, which were linked to technical difficulties during insertion or suturing. The remaining five cases (12%) involved valve damage or device malposition. Device\u2010related complications were reported in 14 cases (33%). Of these, eight cases (19%) were device malfunctions including pump stoppage due to issues such as electrical failure, biomaterial ingestion, or lumen damage. Six patients (14%) experienced device\u2010related clot formation and\/or stroke.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Cardiac perforation emerged as the most frequent complication associated with Impella 5.5\u2010related deaths, followed by device malfunction. These findings highlight the need for improved operational techniques, better device reliability, and refined safety protocols for Impella 5.5 usage.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ccd.31580","type":"journal-article","created":{"date-parts":[[2025,5,12]],"date-time":"2025-05-12T02:22:44Z","timestamp":1747016564000},"page":"550-552","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Complications Leading to Death in Patients Supported by the Impella 5.5: Analysis From the FDA MAUDE Database"],"prefix":"10.1002","volume":"106","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-9726-3785","authenticated-orcid":false,"given":"Omar","family":"Khalil","sequence":"first","affiliation":[{"name":"Department of Internal Medicine Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-6460-4708","authenticated-orcid":false,"given":"Hussein","family":"Krayem","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aditya","family":"Kesari","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Division of Cardiology Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arun U.","family":"Mahtani","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Division of Cardiology Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew G.","family":"Kaye","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Division of Cardiology Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Roberts","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Division of Cardiology Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inna","family":"Tchoukina","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Division of Cardiology Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa C.","family":"Smallfield","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Division of Cardiology Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josue","family":"Chery","sequence":"additional","affiliation":[{"name":"Department of Surgery, Pauley Heart Center Division of Cardiothoracic Surgery Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zubair A.","family":"Hashmi","sequence":"additional","affiliation":[{"name":"Department of Surgery, Pauley Heart Center Division of Cardiothoracic Surgery Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael C.","family":"Kontos","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Division of Cardiology Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keyur B.","family":"Shah","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Division of Cardiology Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pengyang","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Division of Cardiology Virginia Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,11]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xjon.2024.04.014"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.healun.2023.01.011"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.123.030819"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.mat.0000840872.47810.49"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ihjccr.2023.06.002"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(22)01478-4"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.31580","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ccd.31580","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.31580","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T06:08:45Z","timestamp":1771222125000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.31580"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,11]]},"references-count":6,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,7]]}},"alternative-id":["10.1002\/ccd.31580"],"URL":"https:\/\/doi.org\/10.1002\/ccd.31580","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,11]]},"assertion":[{"value":"2025-03-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication 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