Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use

Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks

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Veröffentlicht in:Journal of endovascular therapy 2017-04, Vol.24 (2), p.191-197
Hauptverfasser: de Donato, Gianmarco, Setacci, Francesco, Bresadola, Luciano, Castelli, Patrizio, Chiesa, Roberto, Mangialardi, Nicola, Nano, Giovanni, Setacci, Carlo, Ricci, Carmelo, Gasparini, Daniele, Piccoli, Gianluca, Kahlberg, Andrea, Stegher, Silvia, Carrafiello, Gianpaolo, Rivolta, Nicola, Novali, Claudio, Rivellini, Carlo, Lenti, Massimo, Isernia, Giacomo, Ronkey, Sonia, Giudice, Rocco, Speziale, Francesco, Sirignano, Pasqualino, Marcucci, Giustino, Accrocca, Federico, Volpe, Pietro, Talarico, Francesco, La Barbera, Gaetano
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container_issue 2
container_start_page 191
container_title Journal of endovascular therapy
container_volume 24
creator de Donato, Gianmarco
Setacci, Francesco
Bresadola, Luciano
Castelli, Patrizio
Chiesa, Roberto
Mangialardi, Nicola
Nano, Giovanni
Setacci, Carlo
Setacci, Carlo
de Donato, Gianmarco
Ricci, Carmelo
Gasparini, Daniele
Piccoli, Gianluca
Chiesa, Roberto
Kahlberg, Andrea
Nano, Giovanni
Stegher, Silvia
Castelli, Patrizio
Carrafiello, Gianpaolo
Rivolta, Nicola
Novali, Claudio
Rivellini, Carlo
Lenti, Massimo
Isernia, Giacomo
Mangialardi, Nicola
Ronkey, Sonia
Giudice, Rocco
Speziale, Francesco
Sirignano, Pasqualino
Bresadola, Luciano
Marcucci, Giustino
Accrocca, Federico
Volpe, Pietro
Talarico, Francesco
La Barbera, Gaetano
description Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks
doi_str_mv 10.1177/1526602816685581
format Article
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Methods: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24–50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or &lt;7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (&gt;2 mm). Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was −0.05±0.8 mm in the IFU group and −0.1±0.5 mm in the OL group. Conclusion: Use of the Ovation stent-graft in patients with neck length &lt;7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration–approved changes to the IFU.</description><identifier>ISSN: 1526-6028</identifier><identifier>EISSN: 1545-1550</identifier><identifier>DOI: 10.1177/1526602816685581</identifier><identifier>PMID: 28058986</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><ispartof>Journal of endovascular therapy, 2017-04, Vol.24 (2), p.191-197</ispartof><rights>The Author(s) 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c379t-3dee8abb8c22b14882882a7930b5fce810bd3e52fdd21d98fa39eee249cb4e053</citedby><cites>FETCH-LOGICAL-c379t-3dee8abb8c22b14882882a7930b5fce810bd3e52fdd21d98fa39eee249cb4e053</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/1526602816685581$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/1526602816685581$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,21798,27901,27902,43597,43598</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28058986$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>de Donato, Gianmarco</creatorcontrib><creatorcontrib>Setacci, Francesco</creatorcontrib><creatorcontrib>Bresadola, Luciano</creatorcontrib><creatorcontrib>Castelli, Patrizio</creatorcontrib><creatorcontrib>Chiesa, Roberto</creatorcontrib><creatorcontrib>Mangialardi, Nicola</creatorcontrib><creatorcontrib>Nano, Giovanni</creatorcontrib><creatorcontrib>Setacci, Carlo</creatorcontrib><creatorcontrib>Setacci, Carlo</creatorcontrib><creatorcontrib>de Donato, Gianmarco</creatorcontrib><creatorcontrib>Ricci, Carmelo</creatorcontrib><creatorcontrib>Gasparini, Daniele</creatorcontrib><creatorcontrib>Piccoli, Gianluca</creatorcontrib><creatorcontrib>Chiesa, Roberto</creatorcontrib><creatorcontrib>Kahlberg, Andrea</creatorcontrib><creatorcontrib>Nano, Giovanni</creatorcontrib><creatorcontrib>Stegher, Silvia</creatorcontrib><creatorcontrib>Castelli, Patrizio</creatorcontrib><creatorcontrib>Carrafiello, Gianpaolo</creatorcontrib><creatorcontrib>Rivolta, Nicola</creatorcontrib><creatorcontrib>Novali, Claudio</creatorcontrib><creatorcontrib>Rivellini, Carlo</creatorcontrib><creatorcontrib>Lenti, Massimo</creatorcontrib><creatorcontrib>Isernia, Giacomo</creatorcontrib><creatorcontrib>Mangialardi, Nicola</creatorcontrib><creatorcontrib>Ronkey, Sonia</creatorcontrib><creatorcontrib>Giudice, Rocco</creatorcontrib><creatorcontrib>Speziale, Francesco</creatorcontrib><creatorcontrib>Sirignano, Pasqualino</creatorcontrib><creatorcontrib>Bresadola, Luciano</creatorcontrib><creatorcontrib>Marcucci, Giustino</creatorcontrib><creatorcontrib>Accrocca, Federico</creatorcontrib><creatorcontrib>Volpe, Pietro</creatorcontrib><creatorcontrib>Talarico, Francesco</creatorcontrib><creatorcontrib>La Barbera, Gaetano</creatorcontrib><creatorcontrib>TriVascular Ovation Italian Study (TOIS) Collaborators</creatorcontrib><creatorcontrib>on behalf of the TriVascular Ovation Italian Study (TOIS) Collaborators</creatorcontrib><title>Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use</title><title>Journal of endovascular therapy</title><addtitle>J Endovasc Ther</addtitle><description>Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks &lt;7 mm long. Methods: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24–50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or &lt;7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (&gt;2 mm). Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was −0.05±0.8 mm in the IFU group and −0.1±0.5 mm in the OL group. Conclusion: Use of the Ovation stent-graft in patients with neck length &lt;7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration–approved changes to the IFU.</description><issn>1526-6028</issn><issn>1545-1550</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNp1kMFLwzAUxoMoTqd3T5Kjl2iSLll6HEOnMJk4h8eSti9bZ9vMJB3uv7dl04MgPHgP3u_74PsQumL0lrHh8I4JLiXlikmphFDsCJ0xMRCECUGPu5tL0v176Nz7NaWcccZOUY8rKlSs5Bn6eC7yAK7Cr-CbMnhsDX5x9quodIlHNTRu5ys8B10W9RK_F2GFwwrwbKtDYWs8D1AHMnHaBDzKMuvyDgsWz2qCtx7PjCFTnUKJFx4u0InRpYfLw-6jxcP92_iRTGeTp_FoSrJoGAcS5QBKp6nKOE_ZQCnejh7GEU2FyUAxmuYRCG7ynLM8VkZHMQDwQZylA6Ai6qObve_G2c8GfEiqwmdQlroG2_iEKSFFLGOpWpTu0cxZ7x2YZOPa6G6XMJp0FSd_K24l1wf3Jq0g_xX8dNoCZA94vYRkbRtXt2n_N_wG7J-DcA</recordid><startdate>201704</startdate><enddate>201704</enddate><creator>de Donato, Gianmarco</creator><creator>Setacci, Francesco</creator><creator>Bresadola, Luciano</creator><creator>Castelli, Patrizio</creator><creator>Chiesa, Roberto</creator><creator>Mangialardi, Nicola</creator><creator>Nano, Giovanni</creator><creator>Setacci, Carlo</creator><creator>Setacci, Carlo</creator><creator>de Donato, Gianmarco</creator><creator>Ricci, Carmelo</creator><creator>Gasparini, Daniele</creator><creator>Piccoli, Gianluca</creator><creator>Chiesa, Roberto</creator><creator>Kahlberg, Andrea</creator><creator>Nano, Giovanni</creator><creator>Stegher, Silvia</creator><creator>Castelli, Patrizio</creator><creator>Carrafiello, Gianpaolo</creator><creator>Rivolta, Nicola</creator><creator>Novali, Claudio</creator><creator>Rivellini, Carlo</creator><creator>Lenti, Massimo</creator><creator>Isernia, Giacomo</creator><creator>Mangialardi, Nicola</creator><creator>Ronkey, Sonia</creator><creator>Giudice, Rocco</creator><creator>Speziale, Francesco</creator><creator>Sirignano, Pasqualino</creator><creator>Bresadola, Luciano</creator><creator>Marcucci, Giustino</creator><creator>Accrocca, Federico</creator><creator>Volpe, Pietro</creator><creator>Talarico, Francesco</creator><creator>La Barbera, Gaetano</creator><general>SAGE Publications</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201704</creationdate><title>Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use</title><author>de Donato, Gianmarco ; Setacci, Francesco ; Bresadola, Luciano ; Castelli, Patrizio ; Chiesa, Roberto ; Mangialardi, Nicola ; Nano, Giovanni ; Setacci, Carlo ; Setacci, Carlo ; de Donato, Gianmarco ; Ricci, Carmelo ; Gasparini, Daniele ; Piccoli, Gianluca ; Chiesa, Roberto ; Kahlberg, Andrea ; Nano, Giovanni ; Stegher, Silvia ; Castelli, Patrizio ; Carrafiello, Gianpaolo ; Rivolta, Nicola ; Novali, Claudio ; Rivellini, Carlo ; Lenti, Massimo ; Isernia, Giacomo ; Mangialardi, Nicola ; Ronkey, Sonia ; Giudice, Rocco ; Speziale, Francesco ; Sirignano, Pasqualino ; Bresadola, Luciano ; Marcucci, Giustino ; Accrocca, Federico ; Volpe, Pietro ; Talarico, Francesco ; La Barbera, Gaetano</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c379t-3dee8abb8c22b14882882a7930b5fce810bd3e52fdd21d98fa39eee249cb4e053</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>de Donato, Gianmarco</creatorcontrib><creatorcontrib>Setacci, Francesco</creatorcontrib><creatorcontrib>Bresadola, Luciano</creatorcontrib><creatorcontrib>Castelli, Patrizio</creatorcontrib><creatorcontrib>Chiesa, Roberto</creatorcontrib><creatorcontrib>Mangialardi, Nicola</creatorcontrib><creatorcontrib>Nano, Giovanni</creatorcontrib><creatorcontrib>Setacci, Carlo</creatorcontrib><creatorcontrib>Setacci, Carlo</creatorcontrib><creatorcontrib>de Donato, Gianmarco</creatorcontrib><creatorcontrib>Ricci, Carmelo</creatorcontrib><creatorcontrib>Gasparini, Daniele</creatorcontrib><creatorcontrib>Piccoli, Gianluca</creatorcontrib><creatorcontrib>Chiesa, Roberto</creatorcontrib><creatorcontrib>Kahlberg, Andrea</creatorcontrib><creatorcontrib>Nano, Giovanni</creatorcontrib><creatorcontrib>Stegher, Silvia</creatorcontrib><creatorcontrib>Castelli, Patrizio</creatorcontrib><creatorcontrib>Carrafiello, Gianpaolo</creatorcontrib><creatorcontrib>Rivolta, Nicola</creatorcontrib><creatorcontrib>Novali, Claudio</creatorcontrib><creatorcontrib>Rivellini, Carlo</creatorcontrib><creatorcontrib>Lenti, Massimo</creatorcontrib><creatorcontrib>Isernia, Giacomo</creatorcontrib><creatorcontrib>Mangialardi, Nicola</creatorcontrib><creatorcontrib>Ronkey, Sonia</creatorcontrib><creatorcontrib>Giudice, Rocco</creatorcontrib><creatorcontrib>Speziale, Francesco</creatorcontrib><creatorcontrib>Sirignano, Pasqualino</creatorcontrib><creatorcontrib>Bresadola, Luciano</creatorcontrib><creatorcontrib>Marcucci, Giustino</creatorcontrib><creatorcontrib>Accrocca, Federico</creatorcontrib><creatorcontrib>Volpe, Pietro</creatorcontrib><creatorcontrib>Talarico, Francesco</creatorcontrib><creatorcontrib>La Barbera, Gaetano</creatorcontrib><creatorcontrib>TriVascular Ovation Italian Study (TOIS) Collaborators</creatorcontrib><creatorcontrib>on behalf of the TriVascular Ovation Italian Study (TOIS) Collaborators</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of endovascular therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>de Donato, Gianmarco</au><au>Setacci, Francesco</au><au>Bresadola, Luciano</au><au>Castelli, Patrizio</au><au>Chiesa, Roberto</au><au>Mangialardi, Nicola</au><au>Nano, Giovanni</au><au>Setacci, Carlo</au><au>Setacci, Carlo</au><au>de Donato, Gianmarco</au><au>Ricci, Carmelo</au><au>Gasparini, Daniele</au><au>Piccoli, Gianluca</au><au>Chiesa, Roberto</au><au>Kahlberg, Andrea</au><au>Nano, Giovanni</au><au>Stegher, Silvia</au><au>Castelli, Patrizio</au><au>Carrafiello, Gianpaolo</au><au>Rivolta, Nicola</au><au>Novali, Claudio</au><au>Rivellini, Carlo</au><au>Lenti, Massimo</au><au>Isernia, Giacomo</au><au>Mangialardi, Nicola</au><au>Ronkey, Sonia</au><au>Giudice, Rocco</au><au>Speziale, Francesco</au><au>Sirignano, Pasqualino</au><au>Bresadola, Luciano</au><au>Marcucci, Giustino</au><au>Accrocca, Federico</au><au>Volpe, Pietro</au><au>Talarico, Francesco</au><au>La Barbera, Gaetano</au><aucorp>TriVascular Ovation Italian Study (TOIS) Collaborators</aucorp><aucorp>on behalf of the TriVascular Ovation Italian Study (TOIS) Collaborators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use</atitle><jtitle>Journal of endovascular therapy</jtitle><addtitle>J Endovasc Ther</addtitle><date>2017-04</date><risdate>2017</risdate><volume>24</volume><issue>2</issue><spage>191</spage><epage>197</epage><pages>191-197</pages><issn>1526-6028</issn><eissn>1545-1550</eissn><abstract>Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks &lt;7 mm long. Methods: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24–50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or &lt;7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (&gt;2 mm). Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was −0.05±0.8 mm in the IFU group and −0.1±0.5 mm in the OL group. Conclusion: Use of the Ovation stent-graft in patients with neck length &lt;7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration–approved changes to the IFU.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>28058986</pmid><doi>10.1177/1526602816685581</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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title Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use
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