Neurological complications and outcomes in the Berlin Heart EXCOR® pediatric investigational device exemption trial
The Berlin Heart EXCOR(®) ventricular assist device has been approved for use in the United States as a bridge to heart transplantation in children. We sought to characterize neurological events in children supported with the Berlin Heart EXCOR(®) device. The multicenter prospective cohort consisted...
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| Veröffentlicht in: | Journal of the American Heart Association 2015-01, Vol.4 (1), p.e001429-e001429 |
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| container_title | Journal of the American Heart Association |
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| creator | Jordan, Lori C Ichord, Rebecca N Reinhartz, Olaf Humpl, Tilman Pruthi, Sumit Tjossem, Christine Rosenthal, David N |
| description | The Berlin Heart EXCOR(®) ventricular assist device has been approved for use in the United States as a bridge to heart transplantation in children. We sought to characterize neurological events in children supported with the Berlin Heart EXCOR(®) device.
The multicenter prospective cohort consisted of all 204 children implanted with the Berlin Heart EXCOR(®) device at 47 centers in North America between May 2007 and December 2010. There were 73 neurological events in 59 patients, with 29% of the cohort experiencing ≥1 neurological event. Events included 52 strokes in 43 patients (21% of the cohort). The neurological event rate was 0.51 events per 100 patient-days. Many of the neurological events occurred early in the course of support, with 30 events recorded during the first 14 days of support. The mortality rate in participants with at least 1 neurological event was 42% (25 of 59), significantly higher than the 18% mortality rate (26 of 145) for those who did not have a neurological event (P=0.0006). Risk-factor analysis did not identify significant preimplantation predictors of neurological injury.
Of children treated with the Berlin Heart EXCOR(®) device as a bridge to transplant, 29% experienced at least 1 neurological event. The majority of neurological events were ischemic strokes, and many of those occurred early in the course of support. Neurological injury was the leading cause of death after implantation of the Berlin Heart EXCOR(®) device. Risk stratification for stroke or neurological injury is not possible based on baseline preimplantation characteristics.
www.clinicaltrials.gov. Unique Identifier: NCT00583661. |
| doi_str_mv | 10.1161/JAHA.114.001429 |
| format | Article |
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The multicenter prospective cohort consisted of all 204 children implanted with the Berlin Heart EXCOR(®) device at 47 centers in North America between May 2007 and December 2010. There were 73 neurological events in 59 patients, with 29% of the cohort experiencing ≥1 neurological event. Events included 52 strokes in 43 patients (21% of the cohort). The neurological event rate was 0.51 events per 100 patient-days. Many of the neurological events occurred early in the course of support, with 30 events recorded during the first 14 days of support. The mortality rate in participants with at least 1 neurological event was 42% (25 of 59), significantly higher than the 18% mortality rate (26 of 145) for those who did not have a neurological event (P=0.0006). Risk-factor analysis did not identify significant preimplantation predictors of neurological injury.
Of children treated with the Berlin Heart EXCOR(®) device as a bridge to transplant, 29% experienced at least 1 neurological event. The majority of neurological events were ischemic strokes, and many of those occurred early in the course of support. Neurological injury was the leading cause of death after implantation of the Berlin Heart EXCOR(®) device. Risk stratification for stroke or neurological injury is not possible based on baseline preimplantation characteristics.
www.clinicaltrials.gov. Unique Identifier: NCT00583661.</description><identifier>ISSN: 2047-9980</identifier><identifier>EISSN: 2047-9980</identifier><identifier>DOI: 10.1161/JAHA.114.001429</identifier><identifier>PMID: 25613996</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Child ; Child, Preschool ; Extracorporeal Membrane Oxygenation - methods ; Female ; Follow-Up Studies ; Heart Failure - diagnosis ; Heart Failure - mortality ; Heart Failure - surgery ; Heart Transplantation ; Heart-Assist Devices - adverse effects ; Humans ; Infant ; Ischemic Attack, Transient - etiology ; Ischemic Attack, Transient - mortality ; Kaplan-Meier Estimate ; Logistic Models ; Male ; Multivariate Analysis ; Original Research ; Pediatrics ; Prospective Studies ; Prosthesis Design ; Risk Assessment ; Stroke - etiology ; Stroke - mortality ; Survival Rate ; Treatment Outcome ; Waiting Lists</subject><ispartof>Journal of the American Heart Association, 2015-01, Vol.4 (1), p.e001429-e001429</ispartof><rights>2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.</rights><rights>2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell. 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-a881d023ed09f8227116b63777b111e8099375c8638e76c29bfbfb09196fb0e23</citedby><cites>FETCH-LOGICAL-c393t-a881d023ed09f8227116b63777b111e8099375c8638e76c29bfbfb09196fb0e23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4330068/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4330068/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25613996$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jordan, Lori C</creatorcontrib><creatorcontrib>Ichord, Rebecca N</creatorcontrib><creatorcontrib>Reinhartz, Olaf</creatorcontrib><creatorcontrib>Humpl, Tilman</creatorcontrib><creatorcontrib>Pruthi, Sumit</creatorcontrib><creatorcontrib>Tjossem, Christine</creatorcontrib><creatorcontrib>Rosenthal, David N</creatorcontrib><title>Neurological complications and outcomes in the Berlin Heart EXCOR® pediatric investigational device exemption trial</title><title>Journal of the American Heart Association</title><addtitle>J Am Heart Assoc</addtitle><description>The Berlin Heart EXCOR(®) ventricular assist device has been approved for use in the United States as a bridge to heart transplantation in children. We sought to characterize neurological events in children supported with the Berlin Heart EXCOR(®) device.
The multicenter prospective cohort consisted of all 204 children implanted with the Berlin Heart EXCOR(®) device at 47 centers in North America between May 2007 and December 2010. There were 73 neurological events in 59 patients, with 29% of the cohort experiencing ≥1 neurological event. Events included 52 strokes in 43 patients (21% of the cohort). The neurological event rate was 0.51 events per 100 patient-days. Many of the neurological events occurred early in the course of support, with 30 events recorded during the first 14 days of support. The mortality rate in participants with at least 1 neurological event was 42% (25 of 59), significantly higher than the 18% mortality rate (26 of 145) for those who did not have a neurological event (P=0.0006). Risk-factor analysis did not identify significant preimplantation predictors of neurological injury.
Of children treated with the Berlin Heart EXCOR(®) device as a bridge to transplant, 29% experienced at least 1 neurological event. The majority of neurological events were ischemic strokes, and many of those occurred early in the course of support. Neurological injury was the leading cause of death after implantation of the Berlin Heart EXCOR(®) device. Risk stratification for stroke or neurological injury is not possible based on baseline preimplantation characteristics.
www.clinicaltrials.gov. Unique Identifier: NCT00583661.</description><subject>Child</subject><subject>Child, Preschool</subject><subject>Extracorporeal Membrane Oxygenation - methods</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Heart Failure - diagnosis</subject><subject>Heart Failure - mortality</subject><subject>Heart Failure - surgery</subject><subject>Heart Transplantation</subject><subject>Heart-Assist Devices - adverse effects</subject><subject>Humans</subject><subject>Infant</subject><subject>Ischemic Attack, Transient - etiology</subject><subject>Ischemic Attack, Transient - mortality</subject><subject>Kaplan-Meier Estimate</subject><subject>Logistic Models</subject><subject>Male</subject><subject>Multivariate Analysis</subject><subject>Original Research</subject><subject>Pediatrics</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>Risk Assessment</subject><subject>Stroke - etiology</subject><subject>Stroke - mortality</subject><subject>Survival Rate</subject><subject>Treatment Outcome</subject><subject>Waiting Lists</subject><issn>2047-9980</issn><issn>2047-9980</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUU1vEzEQtRCIVm3P3JCPXNL6Y-O1L0ghKgRUtVJVJG6W452kRt71Ynuj8qf4EfwyJqRUZXyYp5k3zx4_Qt5wds654hdfFqsFouacMd4I84IcC9a0M2M0e_kMH5GzUr4zDCVaOTevyZGYKy6NUcekXsOUU0zb4F2kPvVjRFRDGgp1Q0fTVLEIhYaB1nugHyBHhCtwudLLb8ub29-_6AhdcDUHj6wdlBq2fxVQsINd8EDhAfpxX6LIcvGUvNq4WODsMZ-Qrx8v75ar2dXNp8_LxdXMSyPrzGnNOyYkdMxstBAtbr1Wsm3bNeccNDNGtnOvldTQKi_MeoOHGW4UJhDyhLw_6I7TuofOw1Czi3bMoXf5p00u2P87Q7i327SzjZT4WxoF3j0K5PRjws1sH4qHGN0AaSqWq7lomG54g9SLA9XnVEqGzdM1nNm9XXZvF6LGHuzCibfPX_fE_2eO_APPtZLp</recordid><startdate>20150122</startdate><enddate>20150122</enddate><creator>Jordan, Lori C</creator><creator>Ichord, Rebecca N</creator><creator>Reinhartz, Olaf</creator><creator>Humpl, Tilman</creator><creator>Pruthi, Sumit</creator><creator>Tjossem, Christine</creator><creator>Rosenthal, David N</creator><general>Blackwell Publishing Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20150122</creationdate><title>Neurological complications and outcomes in the Berlin Heart EXCOR® pediatric investigational device exemption trial</title><author>Jordan, Lori C ; Ichord, Rebecca N ; Reinhartz, Olaf ; Humpl, Tilman ; Pruthi, Sumit ; Tjossem, Christine ; Rosenthal, David N</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-a881d023ed09f8227116b63777b111e8099375c8638e76c29bfbfb09196fb0e23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Child</topic><topic>Child, Preschool</topic><topic>Extracorporeal Membrane Oxygenation - methods</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Heart Failure - diagnosis</topic><topic>Heart Failure - mortality</topic><topic>Heart Failure - surgery</topic><topic>Heart Transplantation</topic><topic>Heart-Assist Devices - adverse effects</topic><topic>Humans</topic><topic>Infant</topic><topic>Ischemic Attack, Transient - etiology</topic><topic>Ischemic Attack, Transient - mortality</topic><topic>Kaplan-Meier Estimate</topic><topic>Logistic Models</topic><topic>Male</topic><topic>Multivariate Analysis</topic><topic>Original Research</topic><topic>Pediatrics</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>Risk Assessment</topic><topic>Stroke - etiology</topic><topic>Stroke - mortality</topic><topic>Survival Rate</topic><topic>Treatment Outcome</topic><topic>Waiting Lists</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jordan, Lori C</creatorcontrib><creatorcontrib>Ichord, Rebecca N</creatorcontrib><creatorcontrib>Reinhartz, Olaf</creatorcontrib><creatorcontrib>Humpl, Tilman</creatorcontrib><creatorcontrib>Pruthi, Sumit</creatorcontrib><creatorcontrib>Tjossem, Christine</creatorcontrib><creatorcontrib>Rosenthal, David N</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of the American Heart Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jordan, Lori C</au><au>Ichord, Rebecca N</au><au>Reinhartz, Olaf</au><au>Humpl, Tilman</au><au>Pruthi, Sumit</au><au>Tjossem, Christine</au><au>Rosenthal, David N</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Neurological complications and outcomes in the Berlin Heart EXCOR® pediatric investigational device exemption trial</atitle><jtitle>Journal of the American Heart Association</jtitle><addtitle>J Am Heart Assoc</addtitle><date>2015-01-22</date><risdate>2015</risdate><volume>4</volume><issue>1</issue><spage>e001429</spage><epage>e001429</epage><pages>e001429-e001429</pages><issn>2047-9980</issn><eissn>2047-9980</eissn><abstract>The Berlin Heart EXCOR(®) ventricular assist device has been approved for use in the United States as a bridge to heart transplantation in children. We sought to characterize neurological events in children supported with the Berlin Heart EXCOR(®) device.
The multicenter prospective cohort consisted of all 204 children implanted with the Berlin Heart EXCOR(®) device at 47 centers in North America between May 2007 and December 2010. There were 73 neurological events in 59 patients, with 29% of the cohort experiencing ≥1 neurological event. Events included 52 strokes in 43 patients (21% of the cohort). The neurological event rate was 0.51 events per 100 patient-days. Many of the neurological events occurred early in the course of support, with 30 events recorded during the first 14 days of support. The mortality rate in participants with at least 1 neurological event was 42% (25 of 59), significantly higher than the 18% mortality rate (26 of 145) for those who did not have a neurological event (P=0.0006). Risk-factor analysis did not identify significant preimplantation predictors of neurological injury.
Of children treated with the Berlin Heart EXCOR(®) device as a bridge to transplant, 29% experienced at least 1 neurological event. The majority of neurological events were ischemic strokes, and many of those occurred early in the course of support. Neurological injury was the leading cause of death after implantation of the Berlin Heart EXCOR(®) device. Risk stratification for stroke or neurological injury is not possible based on baseline preimplantation characteristics.
www.clinicaltrials.gov. Unique Identifier: NCT00583661.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>25613996</pmid><doi>10.1161/JAHA.114.001429</doi><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Wiley Online Library Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Child Child, Preschool Extracorporeal Membrane Oxygenation - methods Female Follow-Up Studies Heart Failure - diagnosis Heart Failure - mortality Heart Failure - surgery Heart Transplantation Heart-Assist Devices - adverse effects Humans Infant Ischemic Attack, Transient - etiology Ischemic Attack, Transient - mortality Kaplan-Meier Estimate Logistic Models Male Multivariate Analysis Original Research Pediatrics Prospective Studies Prosthesis Design Risk Assessment Stroke - etiology Stroke - mortality Survival Rate Treatment Outcome Waiting Lists |
| title | Neurological complications and outcomes in the Berlin Heart EXCOR® pediatric investigational device exemption trial |
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