Infection and mortality after implantation of a subcutaneous ICD after transvenous ICD extraction
Background The subcutaneous implantable cardioverter-defibrillator (S-ICD) provides an alternative to the transvenous implantable cardioverter-defibrillator (TV-ICD). Patients undergoing TV-ICD explantation may be eligible for reimplantation with an S-ICD; however, information on safety outcomes in...
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| creator | Boersma, Lucas, MD, PhD Burke, Martin C., DO Neuzil, Petr, MD, PhD Lambiase, Pier, MD, PhD Friehling, Ted, MD Theuns, Dominic A., PhD Garcia, Fermin, MD Carter, Nathan Stivland, Timothy Weiss, Raul, MD |
| description | Background The subcutaneous implantable cardioverter-defibrillator (S-ICD) provides an alternative to the transvenous implantable cardioverter-defibrillator (TV-ICD). Patients undergoing TV-ICD explantation may be eligible for reimplantation with an S-ICD; however, information on safety outcomes in this complex population is limited. Objective This analysis was designed to provide outcome and safety data from S-ICD patients who received their device after TV-ICD explantation. Methods Patients in the S-ICD IDE Study and EFFORTLESS Registry with a prior TV-ICD explantation, as well as those with no prior implantable cardioverter-defibrillator (ICD), were included. Patients were divided into 3 groups: those implanted with the S-ICD after TV-ICD extraction for system-related infection (n = 75); those implanted after TV-ICD extraction for reasons other than system-related infection (n = 44); and patients with no prior ICD (de novo implantations, n = 747). Results Mean follow-up duration was 651 days, and all-cause mortality was low (3.2%). Patients previously explanted for TV-ICD infection were older (55.5 ± 14.6, 47.8 ± 14.3 and 49.9 ± 17.3 years in the infection, noninfection, and de novo cohorts, respectively; P = .01), were more likely to have received the ICD for secondary prevention (42.7%, 37.2% and 25.6%; P < 0.0001) and had higher percentages of comorbidities, including atrial fibrillation, congestive heart failure, diabetes mellitus, and hypertension, in line with the highest mortality rate (6.7%). Major infection after S-ICD implantation was low in all groups, with no evidence that patients implanted with the S-ICD after TV-ICD explantation for infection were more likely to experience a subsequent reinfection. Conclusion The S-ICD is a suitable alternative for TV-ICD patients whose devices are explanted for any reason. Postimplantation risk of infection remains low even in patients whose devices were explanted for prior TV-ICD infection. |
| doi_str_mv | 10.1016/j.hrthm.2015.08.039 |
| format | Article |
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Patients undergoing TV-ICD explantation may be eligible for reimplantation with an S-ICD; however, information on safety outcomes in this complex population is limited. Objective This analysis was designed to provide outcome and safety data from S-ICD patients who received their device after TV-ICD explantation. Methods Patients in the S-ICD IDE Study and EFFORTLESS Registry with a prior TV-ICD explantation, as well as those with no prior implantable cardioverter-defibrillator (ICD), were included. Patients were divided into 3 groups: those implanted with the S-ICD after TV-ICD extraction for system-related infection (n = 75); those implanted after TV-ICD extraction for reasons other than system-related infection (n = 44); and patients with no prior ICD (de novo implantations, n = 747). Results Mean follow-up duration was 651 days, and all-cause mortality was low (3.2%). Patients previously explanted for TV-ICD infection were older (55.5 ± 14.6, 47.8 ± 14.3 and 49.9 ± 17.3 years in the infection, noninfection, and de novo cohorts, respectively; P = .01), were more likely to have received the ICD for secondary prevention (42.7%, 37.2% and 25.6%; P < 0.0001) and had higher percentages of comorbidities, including atrial fibrillation, congestive heart failure, diabetes mellitus, and hypertension, in line with the highest mortality rate (6.7%). Major infection after S-ICD implantation was low in all groups, with no evidence that patients implanted with the S-ICD after TV-ICD explantation for infection were more likely to experience a subsequent reinfection. Conclusion The S-ICD is a suitable alternative for TV-ICD patients whose devices are explanted for any reason. Postimplantation risk of infection remains low even in patients whose devices were explanted for prior TV-ICD infection.</description><identifier>ISSN: 1547-5271</identifier><identifier>EISSN: 1556-3871</identifier><identifier>DOI: 10.1016/j.hrthm.2015.08.039</identifier><identifier>PMID: 26341604</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Cardiovascular ; Death ; Defibrillators, Implantable - adverse effects ; Defibrillators, Implantable - statistics & numerical data ; Electric Countershock - instrumentation ; Electric Countershock - methods ; Equipment Failure - statistics & numerical data ; Female ; Humans ; Infection ; Male ; Middle Aged ; Prosthesis Implantation - adverse effects ; Prosthesis Implantation - methods ; Prosthesis Implantation - mortality ; Reoperation - statistics & numerical data ; Safety ; Subcutaneous ICD ; sudden ; Surgical Wound Infection - diagnosis ; Surgical Wound Infection - epidemiology ; Surgical Wound Infection - therapy ; Survival Analysis ; Tachycardia, Ventricular - therapy ; Treatment Outcome</subject><ispartof>Heart rhythm, 2016, Vol.13 (1), p.157-164</ispartof><rights>Heart Rhythm Society</rights><rights>2016 Heart Rhythm Society</rights><rights>Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c459t-673bea60305ae5eaac007d77843a637f8102e3a842a3b0d6474ad09bea56a1f3</citedby><cites>FETCH-LOGICAL-c459t-673bea60305ae5eaac007d77843a637f8102e3a842a3b0d6474ad09bea56a1f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.hrthm.2015.08.039$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,778,782,3539,4012,27906,27907,27908,45978</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26341604$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Boersma, Lucas, MD, PhD</creatorcontrib><creatorcontrib>Burke, Martin C., DO</creatorcontrib><creatorcontrib>Neuzil, Petr, MD, PhD</creatorcontrib><creatorcontrib>Lambiase, Pier, MD, PhD</creatorcontrib><creatorcontrib>Friehling, Ted, MD</creatorcontrib><creatorcontrib>Theuns, Dominic A., PhD</creatorcontrib><creatorcontrib>Garcia, Fermin, MD</creatorcontrib><creatorcontrib>Carter, Nathan</creatorcontrib><creatorcontrib>Stivland, Timothy</creatorcontrib><creatorcontrib>Weiss, Raul, MD</creatorcontrib><creatorcontrib>on behalf of the EFFORTLESS and IDE Study Investigators</creatorcontrib><creatorcontrib>EFFORTLESS and IDE Study Investigators</creatorcontrib><title>Infection and mortality after implantation of a subcutaneous ICD after transvenous ICD extraction</title><title>Heart rhythm</title><addtitle>Heart Rhythm</addtitle><description>Background The subcutaneous implantable cardioverter-defibrillator (S-ICD) provides an alternative to the transvenous implantable cardioverter-defibrillator (TV-ICD). Patients undergoing TV-ICD explantation may be eligible for reimplantation with an S-ICD; however, information on safety outcomes in this complex population is limited. Objective This analysis was designed to provide outcome and safety data from S-ICD patients who received their device after TV-ICD explantation. Methods Patients in the S-ICD IDE Study and EFFORTLESS Registry with a prior TV-ICD explantation, as well as those with no prior implantable cardioverter-defibrillator (ICD), were included. Patients were divided into 3 groups: those implanted with the S-ICD after TV-ICD extraction for system-related infection (n = 75); those implanted after TV-ICD extraction for reasons other than system-related infection (n = 44); and patients with no prior ICD (de novo implantations, n = 747). Results Mean follow-up duration was 651 days, and all-cause mortality was low (3.2%). Patients previously explanted for TV-ICD infection were older (55.5 ± 14.6, 47.8 ± 14.3 and 49.9 ± 17.3 years in the infection, noninfection, and de novo cohorts, respectively; P = .01), were more likely to have received the ICD for secondary prevention (42.7%, 37.2% and 25.6%; P < 0.0001) and had higher percentages of comorbidities, including atrial fibrillation, congestive heart failure, diabetes mellitus, and hypertension, in line with the highest mortality rate (6.7%). Major infection after S-ICD implantation was low in all groups, with no evidence that patients implanted with the S-ICD after TV-ICD explantation for infection were more likely to experience a subsequent reinfection. Conclusion The S-ICD is a suitable alternative for TV-ICD patients whose devices are explanted for any reason. Postimplantation risk of infection remains low even in patients whose devices were explanted for prior TV-ICD infection.</description><subject>Adult</subject><subject>Aged</subject><subject>Cardiovascular</subject><subject>Death</subject><subject>Defibrillators, Implantable - adverse effects</subject><subject>Defibrillators, Implantable - statistics & numerical data</subject><subject>Electric Countershock - instrumentation</subject><subject>Electric Countershock - methods</subject><subject>Equipment Failure - statistics & numerical data</subject><subject>Female</subject><subject>Humans</subject><subject>Infection</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prosthesis Implantation - adverse effects</subject><subject>Prosthesis Implantation - methods</subject><subject>Prosthesis Implantation - mortality</subject><subject>Reoperation - statistics & numerical data</subject><subject>Safety</subject><subject>Subcutaneous ICD</subject><subject>sudden</subject><subject>Surgical Wound Infection - diagnosis</subject><subject>Surgical Wound Infection - epidemiology</subject><subject>Surgical Wound Infection - therapy</subject><subject>Survival Analysis</subject><subject>Tachycardia, Ventricular - therapy</subject><subject>Treatment Outcome</subject><issn>1547-5271</issn><issn>1556-3871</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU2P0zAQhi0EYpeFX4CEcuSSMI5jOzmAhMpXpZU4sHdr6ky0LolTbGdF_z1O2-XAhdOMRu87H88w9ppDxYGrd_vqPqT7qaqBywraCkT3hF1zKVUpWs2frnmjS1lrfsVexLgHqDsF4jm7qpVouILmmuHWD2STm32Bvi-mOSQcXToWOCQKhZsOI_qEJ8E8FFjEZWeXhJ7mJRbbzaeLMAX08YH8Y5V-58qp70v2bMAx0qtLvGF3Xz7fbb6Vt9-_bjcfb0vbyC6VSosdYV4PJJIkRAuge63bRqASemg51CSwbWoUO-hVoxvsocseqZAP4oa9Pbc9hPnXQjGZyUVL43he1XAtBfC64zpLxVlqwxxjoMEcgpswHA0Hs6I1e3NCa1a0BlqT0WbXm8uAZTdR_9fzyDIL3p8FlK98cBRMtI68pd6FjNj0s_vPgA__-O3ovLM4_qQjxf28BJ8BGm5ibcD8WL-7PpdL4PkwLf4AUyyhCQ</recordid><startdate>2016</startdate><enddate>2016</enddate><creator>Boersma, Lucas, MD, PhD</creator><creator>Burke, Martin C., DO</creator><creator>Neuzil, Petr, MD, PhD</creator><creator>Lambiase, Pier, MD, PhD</creator><creator>Friehling, Ted, MD</creator><creator>Theuns, Dominic A., PhD</creator><creator>Garcia, Fermin, MD</creator><creator>Carter, Nathan</creator><creator>Stivland, Timothy</creator><creator>Weiss, Raul, MD</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><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></search><sort><creationdate>2016</creationdate><title>Infection and mortality after implantation of a subcutaneous ICD after transvenous ICD extraction</title><author>Boersma, Lucas, MD, PhD ; Burke, Martin C., DO ; Neuzil, Petr, MD, PhD ; Lambiase, Pier, MD, PhD ; Friehling, Ted, MD ; Theuns, Dominic A., PhD ; Garcia, Fermin, MD ; Carter, Nathan ; Stivland, Timothy ; Weiss, Raul, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c459t-673bea60305ae5eaac007d77843a637f8102e3a842a3b0d6474ad09bea56a1f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Cardiovascular</topic><topic>Death</topic><topic>Defibrillators, Implantable - adverse effects</topic><topic>Defibrillators, Implantable - statistics & numerical data</topic><topic>Electric Countershock - instrumentation</topic><topic>Electric Countershock - methods</topic><topic>Equipment Failure - statistics & numerical data</topic><topic>Female</topic><topic>Humans</topic><topic>Infection</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prosthesis Implantation - adverse effects</topic><topic>Prosthesis Implantation - methods</topic><topic>Prosthesis Implantation - mortality</topic><topic>Reoperation - statistics & numerical data</topic><topic>Safety</topic><topic>Subcutaneous ICD</topic><topic>sudden</topic><topic>Surgical Wound Infection - diagnosis</topic><topic>Surgical Wound Infection - epidemiology</topic><topic>Surgical Wound Infection - therapy</topic><topic>Survival Analysis</topic><topic>Tachycardia, Ventricular - therapy</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Boersma, Lucas, MD, PhD</creatorcontrib><creatorcontrib>Burke, Martin C., DO</creatorcontrib><creatorcontrib>Neuzil, Petr, MD, PhD</creatorcontrib><creatorcontrib>Lambiase, Pier, MD, PhD</creatorcontrib><creatorcontrib>Friehling, Ted, MD</creatorcontrib><creatorcontrib>Theuns, Dominic A., PhD</creatorcontrib><creatorcontrib>Garcia, Fermin, MD</creatorcontrib><creatorcontrib>Carter, Nathan</creatorcontrib><creatorcontrib>Stivland, Timothy</creatorcontrib><creatorcontrib>Weiss, Raul, MD</creatorcontrib><creatorcontrib>on behalf of the EFFORTLESS and IDE Study Investigators</creatorcontrib><creatorcontrib>EFFORTLESS and IDE Study Investigators</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><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><jtitle>Heart rhythm</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Boersma, Lucas, MD, PhD</au><au>Burke, Martin C., DO</au><au>Neuzil, Petr, MD, PhD</au><au>Lambiase, Pier, MD, PhD</au><au>Friehling, Ted, MD</au><au>Theuns, Dominic A., PhD</au><au>Garcia, Fermin, MD</au><au>Carter, Nathan</au><au>Stivland, Timothy</au><au>Weiss, Raul, MD</au><aucorp>on behalf of the EFFORTLESS and IDE Study Investigators</aucorp><aucorp>EFFORTLESS and IDE Study Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Infection and mortality after implantation of a subcutaneous ICD after transvenous ICD extraction</atitle><jtitle>Heart rhythm</jtitle><addtitle>Heart Rhythm</addtitle><date>2016</date><risdate>2016</risdate><volume>13</volume><issue>1</issue><spage>157</spage><epage>164</epage><pages>157-164</pages><issn>1547-5271</issn><eissn>1556-3871</eissn><abstract>Background The subcutaneous implantable cardioverter-defibrillator (S-ICD) provides an alternative to the transvenous implantable cardioverter-defibrillator (TV-ICD). Patients undergoing TV-ICD explantation may be eligible for reimplantation with an S-ICD; however, information on safety outcomes in this complex population is limited. Objective This analysis was designed to provide outcome and safety data from S-ICD patients who received their device after TV-ICD explantation. Methods Patients in the S-ICD IDE Study and EFFORTLESS Registry with a prior TV-ICD explantation, as well as those with no prior implantable cardioverter-defibrillator (ICD), were included. Patients were divided into 3 groups: those implanted with the S-ICD after TV-ICD extraction for system-related infection (n = 75); those implanted after TV-ICD extraction for reasons other than system-related infection (n = 44); and patients with no prior ICD (de novo implantations, n = 747). Results Mean follow-up duration was 651 days, and all-cause mortality was low (3.2%). Patients previously explanted for TV-ICD infection were older (55.5 ± 14.6, 47.8 ± 14.3 and 49.9 ± 17.3 years in the infection, noninfection, and de novo cohorts, respectively; P = .01), were more likely to have received the ICD for secondary prevention (42.7%, 37.2% and 25.6%; P < 0.0001) and had higher percentages of comorbidities, including atrial fibrillation, congestive heart failure, diabetes mellitus, and hypertension, in line with the highest mortality rate (6.7%). Major infection after S-ICD implantation was low in all groups, with no evidence that patients implanted with the S-ICD after TV-ICD explantation for infection were more likely to experience a subsequent reinfection. Conclusion The S-ICD is a suitable alternative for TV-ICD patients whose devices are explanted for any reason. Postimplantation risk of infection remains low even in patients whose devices were explanted for prior TV-ICD infection.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26341604</pmid><doi>10.1016/j.hrthm.2015.08.039</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Cardiovascular Death Defibrillators, Implantable - adverse effects Defibrillators, Implantable - statistics & numerical data Electric Countershock - instrumentation Electric Countershock - methods Equipment Failure - statistics & numerical data Female Humans Infection Male Middle Aged Prosthesis Implantation - adverse effects Prosthesis Implantation - methods Prosthesis Implantation - mortality Reoperation - statistics & numerical data Safety Subcutaneous ICD sudden Surgical Wound Infection - diagnosis Surgical Wound Infection - epidemiology Surgical Wound Infection - therapy Survival Analysis Tachycardia, Ventricular - therapy Treatment Outcome |
| title | Infection and mortality after implantation of a subcutaneous ICD after transvenous ICD extraction |
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