Safety and Efficacy of a Totally Subcutaneous Implantable-Cardioverter Defibrillator
BACKGROUND—The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the...
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| Veröffentlicht in: | Circulation (New York, N.Y.) N.Y.), 2013-08, Vol.128 (9), p.944-953 |
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| container_title | Circulation (New York, N.Y.) |
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| creator | Weiss, Raul Knight, Bradley P. Gold, Michael R. Leon, Angel R. Herre, John M. Hood, Margaret Rashtian, Mayer Kremers, Mark Crozier, Ian Lee, Kerry L. Smith, Warren Burke, Martin C. |
| description | BACKGROUND—The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation).
METHODS AND RESULTS—This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fibrillation conversions of 4 attempts. Detection and conversion of spontaneous episodes were also evaluated. Device implantation was attempted in 321 of 330 enrolled patients, and 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. Both primary end points were metThe 180-day system complication-free rate was 99%, and sensitivity analysis of the acute ventricular fibrillation conversion rate was >90% in the entire cohort. There were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded in 21 patients (6.7%), all of which successfully converted. Forty-one patients (13.1%) received an inappropriate shock.
CONCLUSIONS—The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01064076. |
| doi_str_mv | 10.1161/CIRCULATIONAHA.113.003042 |
| format | Article |
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METHODS AND RESULTS—This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fibrillation conversions of 4 attempts. Detection and conversion of spontaneous episodes were also evaluated. Device implantation was attempted in 321 of 330 enrolled patients, and 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. Both primary end points were metThe 180-day system complication-free rate was 99%, and sensitivity analysis of the acute ventricular fibrillation conversion rate was >90% in the entire cohort. There were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded in 21 patients (6.7%), all of which successfully converted. Forty-one patients (13.1%) received an inappropriate shock.
CONCLUSIONS—The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01064076.</description><identifier>ISSN: 0009-7322</identifier><identifier>EISSN: 1524-4539</identifier><identifier>DOI: 10.1161/CIRCULATIONAHA.113.003042</identifier><identifier>PMID: 23979626</identifier><identifier>CODEN: CIRCAZ</identifier><language>eng</language><publisher>Hagerstown, MD: by the American College of Cardiology Foundation and the American Heart Association, Inc</publisher><subject>Adult ; Aged ; Biological and medical sciences ; Blood and lymphatic vessels ; Cardiology. Vascular system ; Cohort Studies ; Defibrillators, Implantable ; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous ; Equipment Safety ; Female ; Follow-Up Studies ; Humans ; Male ; Medical sciences ; Middle Aged ; Prospective Studies ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Tachycardia, Ventricular - therapy ; Treatment Outcome</subject><ispartof>Circulation (New York, N.Y.), 2013-08, Vol.128 (9), p.944-953</ispartof><rights>2013 by the American College of Cardiology Foundation and the American Heart Association, Inc.</rights><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5654-3f910049e4940836775f715833a1515c98956b638468c8f7521f7ee4a364254f3</citedby><cites>FETCH-LOGICAL-c5654-3f910049e4940836775f715833a1515c98956b638468c8f7521f7ee4a364254f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3674,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27670516$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23979626$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Weiss, Raul</creatorcontrib><creatorcontrib>Knight, Bradley P.</creatorcontrib><creatorcontrib>Gold, Michael R.</creatorcontrib><creatorcontrib>Leon, Angel R.</creatorcontrib><creatorcontrib>Herre, John M.</creatorcontrib><creatorcontrib>Hood, Margaret</creatorcontrib><creatorcontrib>Rashtian, Mayer</creatorcontrib><creatorcontrib>Kremers, Mark</creatorcontrib><creatorcontrib>Crozier, Ian</creatorcontrib><creatorcontrib>Lee, Kerry L.</creatorcontrib><creatorcontrib>Smith, Warren</creatorcontrib><creatorcontrib>Burke, Martin C.</creatorcontrib><title>Safety and Efficacy of a Totally Subcutaneous Implantable-Cardioverter Defibrillator</title><title>Circulation (New York, N.Y.)</title><addtitle>Circulation</addtitle><description>BACKGROUND—The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation).
METHODS AND RESULTS—This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fibrillation conversions of 4 attempts. Detection and conversion of spontaneous episodes were also evaluated. Device implantation was attempted in 321 of 330 enrolled patients, and 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. Both primary end points were metThe 180-day system complication-free rate was 99%, and sensitivity analysis of the acute ventricular fibrillation conversion rate was >90% in the entire cohort. There were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded in 21 patients (6.7%), all of which successfully converted. Forty-one patients (13.1%) received an inappropriate shock.
CONCLUSIONS—The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01064076.</description><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Blood and lymphatic vessels</subject><subject>Cardiology. Vascular system</subject><subject>Cohort Studies</subject><subject>Defibrillators, Implantable</subject><subject>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</subject><subject>Equipment Safety</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Tachycardia, Ventricular - therapy</subject><subject>Treatment Outcome</subject><issn>0009-7322</issn><issn>1524-4539</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkE1PGzEQhq2qqKS0f6FaDpV6WbA9_lgfo4WWSBFIEM6rWccWW5xssHeL8u_rkADiZM2rZ_yOHkJOGT1jTLHzenZb38-ni9nN9fRqmjM4oxSo4J_IhEkuSiHBfCYTSqkpNXB-TL6m9DePCrT8Qo45GG0UVxOyuEPvhm2B62Vx6X1n0W6L3hdYLPoBQ9gWd2NrxwHXrh9TMVttAq4HbIMra4zLrv_n4uBiceF818YuBBz6-I0ceQzJfT-8J-T-9-WivirnN39m9XReWqmkKMEbRqkwThhBK1BaS6-ZrACQSSatqYxUrYJKqMpWXkvOvHZOICjBpfBwQn7t_93E_ml0aWhWXbIuH_FybcOEADDCGJ5Rs0dt7FOKzjeb2K0wbhtGm53U5qPUnEGzl5p3fxxqxnbllm-brxYz8PMAYLIYfMS17dI7p5Wmku04seee-5ClpccwPrvYPDgMw0Nu2_UxXXLKgFZc03IXCfgPoE2O_g</recordid><startdate>20130827</startdate><enddate>20130827</enddate><creator>Weiss, Raul</creator><creator>Knight, Bradley P.</creator><creator>Gold, Michael R.</creator><creator>Leon, Angel R.</creator><creator>Herre, John M.</creator><creator>Hood, Margaret</creator><creator>Rashtian, Mayer</creator><creator>Kremers, Mark</creator><creator>Crozier, Ian</creator><creator>Lee, Kerry L.</creator><creator>Smith, Warren</creator><creator>Burke, Martin C.</creator><general>by the American College of Cardiology Foundation and the American Heart Association, Inc</general><general>Lippincott Williams & Wilkins</general><scope>IQODW</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>20130827</creationdate><title>Safety and Efficacy of a Totally Subcutaneous Implantable-Cardioverter Defibrillator</title><author>Weiss, Raul ; Knight, Bradley P. ; Gold, Michael R. ; Leon, Angel R. ; Herre, John M. ; Hood, Margaret ; Rashtian, Mayer ; Kremers, Mark ; Crozier, Ian ; Lee, Kerry L. ; Smith, Warren ; Burke, Martin C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5654-3f910049e4940836775f715833a1515c98956b638468c8f7521f7ee4a364254f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Blood and lymphatic vessels</topic><topic>Cardiology. Vascular system</topic><topic>Cohort Studies</topic><topic>Defibrillators, Implantable</topic><topic>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</topic><topic>Equipment Safety</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Tachycardia, Ventricular - therapy</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Weiss, Raul</creatorcontrib><creatorcontrib>Knight, Bradley P.</creatorcontrib><creatorcontrib>Gold, Michael R.</creatorcontrib><creatorcontrib>Leon, Angel R.</creatorcontrib><creatorcontrib>Herre, John M.</creatorcontrib><creatorcontrib>Hood, Margaret</creatorcontrib><creatorcontrib>Rashtian, Mayer</creatorcontrib><creatorcontrib>Kremers, Mark</creatorcontrib><creatorcontrib>Crozier, Ian</creatorcontrib><creatorcontrib>Lee, Kerry L.</creatorcontrib><creatorcontrib>Smith, Warren</creatorcontrib><creatorcontrib>Burke, Martin C.</creatorcontrib><collection>Pascal-Francis</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>Circulation (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Weiss, Raul</au><au>Knight, Bradley P.</au><au>Gold, Michael R.</au><au>Leon, Angel R.</au><au>Herre, John M.</au><au>Hood, Margaret</au><au>Rashtian, Mayer</au><au>Kremers, Mark</au><au>Crozier, Ian</au><au>Lee, Kerry L.</au><au>Smith, Warren</au><au>Burke, Martin C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and Efficacy of a Totally Subcutaneous Implantable-Cardioverter Defibrillator</atitle><jtitle>Circulation (New York, N.Y.)</jtitle><addtitle>Circulation</addtitle><date>2013-08-27</date><risdate>2013</risdate><volume>128</volume><issue>9</issue><spage>944</spage><epage>953</epage><pages>944-953</pages><issn>0009-7322</issn><eissn>1524-4539</eissn><coden>CIRCAZ</coden><abstract>BACKGROUND—The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation).
METHODS AND RESULTS—This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fibrillation conversions of 4 attempts. Detection and conversion of spontaneous episodes were also evaluated. Device implantation was attempted in 321 of 330 enrolled patients, and 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. Both primary end points were metThe 180-day system complication-free rate was 99%, and sensitivity analysis of the acute ventricular fibrillation conversion rate was >90% in the entire cohort. There were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded in 21 patients (6.7%), all of which successfully converted. Forty-one patients (13.1%) received an inappropriate shock.
CONCLUSIONS—The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01064076.</abstract><cop>Hagerstown, MD</cop><pub>by the American College of Cardiology Foundation and the American Heart Association, Inc</pub><pmid>23979626</pmid><doi>10.1161/CIRCULATIONAHA.113.003042</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Biological and medical sciences Blood and lymphatic vessels Cardiology. Vascular system Cohort Studies Defibrillators, Implantable Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous Equipment Safety Female Follow-Up Studies Humans Male Medical sciences Middle Aged Prospective Studies Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Tachycardia, Ventricular - therapy Treatment Outcome |
| title | Safety and Efficacy of a Totally Subcutaneous Implantable-Cardioverter Defibrillator |
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