Percutaneous Endovascular Aortic Aneurysm Repair: A Prospective Evaluation of Safety, Efficiency, and Risk Factors

Purpose: To evaluate the efficiency of totally percutaneous endovascular aortic aneurysm repair in a large cohort of patients and to define risk factors for failure with a 10-F vascular closure system. Methods: A prospective study examined the feasibility and safety of percutaneous femoral artery cl...

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Veröffentlicht in:Journal of endovascular therapy 2009-12, Vol.16 (6), p.708-713
Hauptverfasser: Eisenack, Markus, Umscheid, Thomas, Tessarek, Joerg, Torsello, Giovanni F., Torsello, Giovanni B.
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container_end_page 713
container_issue 6
container_start_page 708
container_title Journal of endovascular therapy
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creator Eisenack, Markus
Umscheid, Thomas
Tessarek, Joerg
Torsello, Giovanni F.
Torsello, Giovanni B.
description Purpose: To evaluate the efficiency of totally percutaneous endovascular aortic aneurysm repair in a large cohort of patients and to define risk factors for failure with a 10-F vascular closure system. Methods: A prospective study examined the feasibility and safety of percutaneous femoral artery closure with a single Prostar XL 10-F vascular closure device applied in conjunction with the preclose technique. Between January 2004 and December 2005, 535 consecutive patients were treated for aortic aneurysmal disease. Thirty-five patients were excluded, leaving 500 patients (417 men; mean age 72±6.6 years) treated for aortic aneurysms using the Talent or Zenith stent-graft delivered through sheaths measuring 14-F (191, 21.2%), 16-F (33, 3.7%), 18-F (179, 19.8%), 20-F (2, 0.2%), 22-F (228, 25.2%), and 24-F (271, 29.9%). Primary clinical success was defined as the freedom from additional early or late procedures to treat any complication at the access site. Data were analyzed to reveal any correlation of access site complications or early/late repairs to operator experience or risk factors (obesity, extensive femoral artery calcification, and previous interventions/scars in the groin). Results: Primary success was achieved in 96.1% of all percutaneous approaches. Twenty-three patients developed early (n=16) or late (n=7) complications at the access vessel; in 12 cases, hemostasis was achieved using pledgets with the Prostar sutures. No wound complications were recorded. The need for early conversion to an open access correlated with CFA calcification (OR 74.5, 95% CI 17.8 to 310.7; p
doi_str_mv 10.1583/08-2622.1
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Methods: A prospective study examined the feasibility and safety of percutaneous femoral artery closure with a single Prostar XL 10-F vascular closure device applied in conjunction with the preclose technique. Between January 2004 and December 2005, 535 consecutive patients were treated for aortic aneurysmal disease. Thirty-five patients were excluded, leaving 500 patients (417 men; mean age 72±6.6 years) treated for aortic aneurysms using the Talent or Zenith stent-graft delivered through sheaths measuring 14-F (191, 21.2%), 16-F (33, 3.7%), 18-F (179, 19.8%), 20-F (2, 0.2%), 22-F (228, 25.2%), and 24-F (271, 29.9%). Primary clinical success was defined as the freedom from additional early or late procedures to treat any complication at the access site. Data were analyzed to reveal any correlation of access site complications or early/late repairs to operator experience or risk factors (obesity, extensive femoral artery calcification, and previous interventions/scars in the groin). Results: Primary success was achieved in 96.1% of all percutaneous approaches. Twenty-three patients developed early (n=16) or late (n=7) complications at the access vessel; in 12 cases, hemostasis was achieved using pledgets with the Prostar sutures. No wound complications were recorded. The need for early conversion to an open access correlated with CFA calcification (OR 74.5, 95% CI 17.8 to 310.7; p&lt;0.001) and operator experience (OR 43.2, 95% CI 9.8 to 189.0; p&lt;0.001). The risk of late access site repairs was significantly higher in the presence of a groin scar (OR 48.8, 95% CI 9.2 to 259.0; p&lt;0.001). Correlation of sheath size with early conversion to open access was weaker compared to all the other factors (OR 1.2, CI 95% 1.0 to 1.4; p&lt;0.05). Obesity was not a risk factor for any complication. Conclusion: Percutaneous EVAR using the Prostar XL is safe, with minimal early and late complications. Operator experience is one of the most significant predictors of success. Anterior wall calcification and severe fibrosis of the access vessel are also predictors of primary failure, whereas obesity and sheath size are not.</description><identifier>ISSN: 1526-6028</identifier><identifier>EISSN: 1545-1550</identifier><identifier>DOI: 10.1583/08-2622.1</identifier><identifier>PMID: 19995109</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Aged ; Aneurysms ; Aortic Aneurysm, Abdominal - surgery ; Aortic Aneurysm, Thoracic - surgery ; Blood Vessel Prosthesis ; Blood Vessel Prosthesis Implantation - adverse effects ; Blood Vessel Prosthesis Implantation - instrumentation ; Blood Vessel Prosthesis Implantation - methods ; Catheterization, Peripheral - adverse effects ; Clinical Competence ; Feasibility Studies ; Female ; Femoral Artery ; Hemorrhage - etiology ; Hemorrhage - prevention &amp; control ; Hemostatic Techniques - adverse effects ; Hemostatic Techniques - instrumentation ; Humans ; Male ; Odds Ratio ; Proportional Hazards Models ; Prospective Studies ; Prosthesis Design ; Punctures ; Risk Assessment ; Risk Factors ; Stents ; Treatment Failure ; Vascular surgery</subject><ispartof>Journal of endovascular therapy, 2009-12, Vol.16 (6), p.708-713</ispartof><rights>2009 International Society of Endovascular Specialists</rights><rights>Copyright Allen Press Publishing Services Dec 2009</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c342t-70edcc28d379015d2b5029562f14a6f17f421398b287877d77bc68074846e8e03</citedby><cites>FETCH-LOGICAL-c342t-70edcc28d379015d2b5029562f14a6f17f421398b287877d77bc68074846e8e03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1583/08-2622.1$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1583/08-2622.1$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,780,784,21819,27924,27925,43621,43622</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19995109$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Eisenack, Markus</creatorcontrib><creatorcontrib>Umscheid, Thomas</creatorcontrib><creatorcontrib>Tessarek, Joerg</creatorcontrib><creatorcontrib>Torsello, Giovanni F.</creatorcontrib><creatorcontrib>Torsello, Giovanni B.</creatorcontrib><title>Percutaneous Endovascular Aortic Aneurysm Repair: A Prospective Evaluation of Safety, Efficiency, and Risk Factors</title><title>Journal of endovascular therapy</title><addtitle>J Endovasc Ther</addtitle><description>Purpose: To evaluate the efficiency of totally percutaneous endovascular aortic aneurysm repair in a large cohort of patients and to define risk factors for failure with a 10-F vascular closure system. Methods: A prospective study examined the feasibility and safety of percutaneous femoral artery closure with a single Prostar XL 10-F vascular closure device applied in conjunction with the preclose technique. Between January 2004 and December 2005, 535 consecutive patients were treated for aortic aneurysmal disease. Thirty-five patients were excluded, leaving 500 patients (417 men; mean age 72±6.6 years) treated for aortic aneurysms using the Talent or Zenith stent-graft delivered through sheaths measuring 14-F (191, 21.2%), 16-F (33, 3.7%), 18-F (179, 19.8%), 20-F (2, 0.2%), 22-F (228, 25.2%), and 24-F (271, 29.9%). Primary clinical success was defined as the freedom from additional early or late procedures to treat any complication at the access site. Data were analyzed to reveal any correlation of access site complications or early/late repairs to operator experience or risk factors (obesity, extensive femoral artery calcification, and previous interventions/scars in the groin). Results: Primary success was achieved in 96.1% of all percutaneous approaches. Twenty-three patients developed early (n=16) or late (n=7) complications at the access vessel; in 12 cases, hemostasis was achieved using pledgets with the Prostar sutures. No wound complications were recorded. The need for early conversion to an open access correlated with CFA calcification (OR 74.5, 95% CI 17.8 to 310.7; p&lt;0.001) and operator experience (OR 43.2, 95% CI 9.8 to 189.0; p&lt;0.001). The risk of late access site repairs was significantly higher in the presence of a groin scar (OR 48.8, 95% CI 9.2 to 259.0; p&lt;0.001). Correlation of sheath size with early conversion to open access was weaker compared to all the other factors (OR 1.2, CI 95% 1.0 to 1.4; p&lt;0.05). Obesity was not a risk factor for any complication. Conclusion: Percutaneous EVAR using the Prostar XL is safe, with minimal early and late complications. Operator experience is one of the most significant predictors of success. 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Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of endovascular therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Eisenack, Markus</au><au>Umscheid, Thomas</au><au>Tessarek, Joerg</au><au>Torsello, Giovanni F.</au><au>Torsello, Giovanni B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Percutaneous Endovascular Aortic Aneurysm Repair: A Prospective Evaluation of Safety, Efficiency, and Risk Factors</atitle><jtitle>Journal of endovascular therapy</jtitle><addtitle>J Endovasc Ther</addtitle><date>2009-12</date><risdate>2009</risdate><volume>16</volume><issue>6</issue><spage>708</spage><epage>713</epage><pages>708-713</pages><issn>1526-6028</issn><eissn>1545-1550</eissn><abstract>Purpose: To evaluate the efficiency of totally percutaneous endovascular aortic aneurysm repair in a large cohort of patients and to define risk factors for failure with a 10-F vascular closure system. Methods: A prospective study examined the feasibility and safety of percutaneous femoral artery closure with a single Prostar XL 10-F vascular closure device applied in conjunction with the preclose technique. Between January 2004 and December 2005, 535 consecutive patients were treated for aortic aneurysmal disease. Thirty-five patients were excluded, leaving 500 patients (417 men; mean age 72±6.6 years) treated for aortic aneurysms using the Talent or Zenith stent-graft delivered through sheaths measuring 14-F (191, 21.2%), 16-F (33, 3.7%), 18-F (179, 19.8%), 20-F (2, 0.2%), 22-F (228, 25.2%), and 24-F (271, 29.9%). Primary clinical success was defined as the freedom from additional early or late procedures to treat any complication at the access site. Data were analyzed to reveal any correlation of access site complications or early/late repairs to operator experience or risk factors (obesity, extensive femoral artery calcification, and previous interventions/scars in the groin). Results: Primary success was achieved in 96.1% of all percutaneous approaches. Twenty-three patients developed early (n=16) or late (n=7) complications at the access vessel; in 12 cases, hemostasis was achieved using pledgets with the Prostar sutures. No wound complications were recorded. The need for early conversion to an open access correlated with CFA calcification (OR 74.5, 95% CI 17.8 to 310.7; p&lt;0.001) and operator experience (OR 43.2, 95% CI 9.8 to 189.0; p&lt;0.001). The risk of late access site repairs was significantly higher in the presence of a groin scar (OR 48.8, 95% CI 9.2 to 259.0; p&lt;0.001). Correlation of sheath size with early conversion to open access was weaker compared to all the other factors (OR 1.2, CI 95% 1.0 to 1.4; p&lt;0.05). Obesity was not a risk factor for any complication. Conclusion: Percutaneous EVAR using the Prostar XL is safe, with minimal early and late complications. Operator experience is one of the most significant predictors of success. Anterior wall calcification and severe fibrosis of the access vessel are also predictors of primary failure, whereas obesity and sheath size are not.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>19995109</pmid><doi>10.1583/08-2622.1</doi><tpages>6</tpages></addata></record>
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subjects Aged
Aneurysms
Aortic Aneurysm, Abdominal - surgery
Aortic Aneurysm, Thoracic - surgery
Blood Vessel Prosthesis
Blood Vessel Prosthesis Implantation - adverse effects
Blood Vessel Prosthesis Implantation - instrumentation
Blood Vessel Prosthesis Implantation - methods
Catheterization, Peripheral - adverse effects
Clinical Competence
Feasibility Studies
Female
Femoral Artery
Hemorrhage - etiology
Hemorrhage - prevention & control
Hemostatic Techniques - adverse effects
Hemostatic Techniques - instrumentation
Humans
Male
Odds Ratio
Proportional Hazards Models
Prospective Studies
Prosthesis Design
Punctures
Risk Assessment
Risk Factors
Stents
Treatment Failure
Vascular surgery
title Percutaneous Endovascular Aortic Aneurysm Repair: A Prospective Evaluation of Safety, Efficiency, and Risk Factors
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