Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients With Critical Limb Ischemia: Initial Experience Using a Helical Nitinol Stent With Increased Radial Force

Purpose To evaluate efficacy, safety, and midterm patency of a helical, self-expanding nitinol stent after failed percutaneous transluminal angioplasty (PTA) of popliteal artery segments P1 and P2 in patients with chronic critical limb ischemia (CLI) or lifestyle-limiting claudication. Methods Betwe...

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Veröffentlicht in:Journal of endovascular therapy 2012-06, Vol.19 (3), p.450-456
Hauptverfasser: Goltz, Jan P., Ritter, Christian O., Kellersmann, Richard, Klein, Detlef, Hahn, Dietbert, Kickuth, Ralph
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container_end_page 456
container_issue 3
container_start_page 450
container_title Journal of endovascular therapy
container_volume 19
creator Goltz, Jan P.
Ritter, Christian O.
Kellersmann, Richard
Klein, Detlef
Hahn, Dietbert
Kickuth, Ralph
description Purpose To evaluate efficacy, safety, and midterm patency of a helical, self-expanding nitinol stent after failed percutaneous transluminal angioplasty (PTA) of popliteal artery segments P1 and P2 in patients with chronic critical limb ischemia (CLI) or lifestyle-limiting claudication. Methods Between February 2009 and March 2011, 40 patients (23 men; mean age 77±10 years) classified as Rutherford category 3 (n = 10) or 4/5 (n = 30) underwent PTA of the proximal and mid popliteal artery followed by implantation of a SUPERA stent for elastic recoil, residual stenosis, or flow-limiting dissection. All patients had an elevated operative risk. Before and after the procedure and during the 12-month follow-up, a clinical investigation, ankle-brachial-index (ABI) measurement, and color-coded duplex sonography and/or digital subtraction angiography were performed. Primary endpoints were limb salvage and anatomical patency at 12 months. Results Stent implantation was successful in all patients. The major complication rate was 7.5% (an access-site pseudoaneurysm, 2 retroperitoneal hematomas, and 1 death from retroperitoneal bleeding). Mean follow-up was 15.9 months (range 0.5–27.9). The mean baseline ABI of 0.37 significantly increased to 0.91 at 12 months (p
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Methods Between February 2009 and March 2011, 40 patients (23 men; mean age 77±10 years) classified as Rutherford category 3 (n = 10) or 4/5 (n = 30) underwent PTA of the proximal and mid popliteal artery followed by implantation of a SUPERA stent for elastic recoil, residual stenosis, or flow-limiting dissection. All patients had an elevated operative risk. Before and after the procedure and during the 12-month follow-up, a clinical investigation, ankle-brachial-index (ABI) measurement, and color-coded duplex sonography and/or digital subtraction angiography were performed. Primary endpoints were limb salvage and anatomical patency at 12 months. Results Stent implantation was successful in all patients. The major complication rate was 7.5% (an access-site pseudoaneurysm, 2 retroperitoneal hematomas, and 1 death from retroperitoneal bleeding). Mean follow-up was 15.9 months (range 0.5–27.9). The mean baseline ABI of 0.37 significantly increased to 0.91 at 12 months (p&lt;0.01). Three (7.5%) patients underwent bypass surgery owing to lack of clinical improvement (&lt;0.10 improvement in ABI). Primary and secondary patency rates at 12 months in the 34 patients eligible for follow-up were 68.4% and 79.8%, respectively. The major amputation rate was 5% at 1 year. Five (12.5%) in-stent stenoses and 1 of 2 (5.0%) in-stent occlusions were successfully recanalized (the second occlusion was asymptomatic). Conclusion Implantation of this helical stent into segments of the popliteal artery at the knee joint in CLI patients is a safe and clinically effective bailout method with acceptable intermediate patency.</description><identifier>ISSN: 1526-6028</identifier><identifier>EISSN: 1545-1550</identifier><identifier>DOI: 10.1583/11-3591MR.1</identifier><identifier>PMID: 22788900</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Aged ; Aged, 80 and over ; Alloys ; Amputation ; Angiography, Digital Subtraction ; Angioplasty, Balloon - adverse effects ; Angioplasty, Balloon - instrumentation ; Ankle Brachial Index ; Arterial Occlusive Diseases - complications ; Arterial Occlusive Diseases - diagnosis ; Arterial Occlusive Diseases - physiopathology ; Arterial Occlusive Diseases - therapy ; Blood clots ; Chronic illnesses ; Constriction, Pathologic ; Critical Illness ; Female ; Germany ; Humans ; Intermittent Claudication - diagnosis ; Intermittent Claudication - etiology ; Intermittent Claudication - physiopathology ; Intermittent Claudication - therapy ; Ischemia ; Ischemia - diagnosis ; Ischemia - etiology ; Ischemia - physiopathology ; Ischemia - therapy ; Kaplan-Meier Estimate ; Limb Salvage ; Lower Extremity - blood supply ; Magnetic Resonance Angiography ; Male ; Medical imaging ; Middle Aged ; Popliteal Artery - diagnostic imaging ; Popliteal Artery - physiopathology ; Prosthesis Design ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Stents ; Surgery ; Time Factors ; Treatment Outcome ; Ultrasonography, Doppler, Color ; Vascular Patency</subject><ispartof>Journal of endovascular therapy, 2012-06, Vol.19 (3), p.450-456</ispartof><rights>2012 International Society of Endovascular Specialists</rights><rights>Copyright Allen Press Publishing Services Jun 2012</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c350t-beb0531865aa5254a826e895b010a5d953771003ced61d9ac71ae5e99ed6eb853</citedby><cites>FETCH-LOGICAL-c350t-beb0531865aa5254a826e895b010a5d953771003ced61d9ac71ae5e99ed6eb853</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1583/11-3591MR.1$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1583/11-3591MR.1$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,21800,27903,27904,43599,43600</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22788900$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Goltz, Jan P.</creatorcontrib><creatorcontrib>Ritter, Christian O.</creatorcontrib><creatorcontrib>Kellersmann, Richard</creatorcontrib><creatorcontrib>Klein, Detlef</creatorcontrib><creatorcontrib>Hahn, Dietbert</creatorcontrib><creatorcontrib>Kickuth, Ralph</creatorcontrib><title>Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients With Critical Limb Ischemia: Initial Experience Using a Helical Nitinol Stent With Increased Radial Force</title><title>Journal of endovascular therapy</title><addtitle>J Endovasc Ther</addtitle><description>Purpose To evaluate efficacy, safety, and midterm patency of a helical, self-expanding nitinol stent after failed percutaneous transluminal angioplasty (PTA) of popliteal artery segments P1 and P2 in patients with chronic critical limb ischemia (CLI) or lifestyle-limiting claudication. Methods Between February 2009 and March 2011, 40 patients (23 men; mean age 77±10 years) classified as Rutherford category 3 (n = 10) or 4/5 (n = 30) underwent PTA of the proximal and mid popliteal artery followed by implantation of a SUPERA stent for elastic recoil, residual stenosis, or flow-limiting dissection. All patients had an elevated operative risk. Before and after the procedure and during the 12-month follow-up, a clinical investigation, ankle-brachial-index (ABI) measurement, and color-coded duplex sonography and/or digital subtraction angiography were performed. Primary endpoints were limb salvage and anatomical patency at 12 months. Results Stent implantation was successful in all patients. The major complication rate was 7.5% (an access-site pseudoaneurysm, 2 retroperitoneal hematomas, and 1 death from retroperitoneal bleeding). Mean follow-up was 15.9 months (range 0.5–27.9). The mean baseline ABI of 0.37 significantly increased to 0.91 at 12 months (p&lt;0.01). Three (7.5%) patients underwent bypass surgery owing to lack of clinical improvement (&lt;0.10 improvement in ABI). Primary and secondary patency rates at 12 months in the 34 patients eligible for follow-up were 68.4% and 79.8%, respectively. The major amputation rate was 5% at 1 year. Five (12.5%) in-stent stenoses and 1 of 2 (5.0%) in-stent occlusions were successfully recanalized (the second occlusion was asymptomatic). Conclusion Implantation of this helical stent into segments of the popliteal artery at the knee joint in CLI patients is a safe and clinically effective bailout method with acceptable intermediate patency.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Alloys</subject><subject>Amputation</subject><subject>Angiography, Digital Subtraction</subject><subject>Angioplasty, Balloon - adverse effects</subject><subject>Angioplasty, Balloon - instrumentation</subject><subject>Ankle Brachial Index</subject><subject>Arterial Occlusive Diseases - complications</subject><subject>Arterial Occlusive Diseases - diagnosis</subject><subject>Arterial Occlusive Diseases - physiopathology</subject><subject>Arterial Occlusive Diseases - therapy</subject><subject>Blood clots</subject><subject>Chronic illnesses</subject><subject>Constriction, Pathologic</subject><subject>Critical Illness</subject><subject>Female</subject><subject>Germany</subject><subject>Humans</subject><subject>Intermittent Claudication - diagnosis</subject><subject>Intermittent Claudication - etiology</subject><subject>Intermittent Claudication - physiopathology</subject><subject>Intermittent Claudication - therapy</subject><subject>Ischemia</subject><subject>Ischemia - diagnosis</subject><subject>Ischemia - etiology</subject><subject>Ischemia - physiopathology</subject><subject>Ischemia - therapy</subject><subject>Kaplan-Meier Estimate</subject><subject>Limb Salvage</subject><subject>Lower Extremity - blood supply</subject><subject>Magnetic Resonance Angiography</subject><subject>Male</subject><subject>Medical imaging</subject><subject>Middle Aged</subject><subject>Popliteal Artery - diagnostic imaging</subject><subject>Popliteal Artery - physiopathology</subject><subject>Prosthesis Design</subject><subject>Retrospective Studies</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Stents</subject><subject>Surgery</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Ultrasonography, Doppler, Color</subject><subject>Vascular Patency</subject><issn>1526-6028</issn><issn>1545-1550</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNplkUtv1DAUhSMEoqWwYo8ssUFCKb7OOLHZVaMpHWmAUR9iGd04d6auEmewHUR_F38QZ6Y8BCvbx98590g3y14CPwWpincAeSE1fLw8hUfZMciZzEFK_ni6izIvuVBH2bMQ7jgXIACeZkdCVEppzo-zHwvXDt8wmLFDz649YezJRTZs2HrYdTYSduzMR_L37Iq2019ga2DoWrYWzDq2xmj36hcbb9nc22hN8qxs37BlMLfUW3zPli7pSV5835FPvCF2E6zbMmQX1O0dnxLhho5dxanAPm3pTGoUqGWX2E7288Ebep492WAX6MXDeZLdnC-u5xf56vOH5fxslZtC8pg31HBZgColohRyhkqUpLRsOHCUrZZFVQHnhaG2hFajqQBJktbpTY2SxUn25pC788PXkUKsexsMdR06GsZQAxczXSgtZgl9_Q96N4zepXaJKoSuSl6pRL09UMYPIXja1Dtve_T3CaqnXdYA9WGXNST61UPm2PTU_mZ_Le9Pv4Bb-nvg_1k_ASeFphk</recordid><startdate>20120601</startdate><enddate>20120601</enddate><creator>Goltz, Jan P.</creator><creator>Ritter, Christian O.</creator><creator>Kellersmann, Richard</creator><creator>Klein, Detlef</creator><creator>Hahn, Dietbert</creator><creator>Kickuth, Ralph</creator><general>SAGE Publications</general><general>Allen Press Inc</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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20120601</creationdate><title>Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients With Critical Limb Ischemia: Initial Experience Using a Helical Nitinol Stent With Increased Radial Force</title><author>Goltz, Jan P. ; Ritter, Christian O. ; Kellersmann, Richard ; Klein, Detlef ; Hahn, Dietbert ; Kickuth, Ralph</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c350t-beb0531865aa5254a826e895b010a5d953771003ced61d9ac71ae5e99ed6eb853</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Alloys</topic><topic>Amputation</topic><topic>Angiography, Digital Subtraction</topic><topic>Angioplasty, Balloon - adverse effects</topic><topic>Angioplasty, Balloon - instrumentation</topic><topic>Ankle Brachial Index</topic><topic>Arterial Occlusive Diseases - complications</topic><topic>Arterial Occlusive Diseases - diagnosis</topic><topic>Arterial Occlusive Diseases - physiopathology</topic><topic>Arterial Occlusive Diseases - therapy</topic><topic>Blood clots</topic><topic>Chronic illnesses</topic><topic>Constriction, Pathologic</topic><topic>Critical Illness</topic><topic>Female</topic><topic>Germany</topic><topic>Humans</topic><topic>Intermittent Claudication - diagnosis</topic><topic>Intermittent Claudication - etiology</topic><topic>Intermittent Claudication - physiopathology</topic><topic>Intermittent Claudication - therapy</topic><topic>Ischemia</topic><topic>Ischemia - diagnosis</topic><topic>Ischemia - etiology</topic><topic>Ischemia - physiopathology</topic><topic>Ischemia - therapy</topic><topic>Kaplan-Meier Estimate</topic><topic>Limb Salvage</topic><topic>Lower Extremity - blood supply</topic><topic>Magnetic Resonance Angiography</topic><topic>Male</topic><topic>Medical imaging</topic><topic>Middle Aged</topic><topic>Popliteal Artery - diagnostic imaging</topic><topic>Popliteal Artery - physiopathology</topic><topic>Prosthesis Design</topic><topic>Retrospective Studies</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Stents</topic><topic>Surgery</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Ultrasonography, Doppler, Color</topic><topic>Vascular Patency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Goltz, Jan P.</creatorcontrib><creatorcontrib>Ritter, Christian O.</creatorcontrib><creatorcontrib>Kellersmann, Richard</creatorcontrib><creatorcontrib>Klein, Detlef</creatorcontrib><creatorcontrib>Hahn, Dietbert</creatorcontrib><creatorcontrib>Kickuth, Ralph</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; 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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>Goltz, Jan P.</au><au>Ritter, Christian O.</au><au>Kellersmann, Richard</au><au>Klein, Detlef</au><au>Hahn, Dietbert</au><au>Kickuth, Ralph</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients With Critical Limb Ischemia: Initial Experience Using a Helical Nitinol Stent With Increased Radial Force</atitle><jtitle>Journal of endovascular therapy</jtitle><addtitle>J Endovasc Ther</addtitle><date>2012-06-01</date><risdate>2012</risdate><volume>19</volume><issue>3</issue><spage>450</spage><epage>456</epage><pages>450-456</pages><issn>1526-6028</issn><eissn>1545-1550</eissn><abstract>Purpose To evaluate efficacy, safety, and midterm patency of a helical, self-expanding nitinol stent after failed percutaneous transluminal angioplasty (PTA) of popliteal artery segments P1 and P2 in patients with chronic critical limb ischemia (CLI) or lifestyle-limiting claudication. Methods Between February 2009 and March 2011, 40 patients (23 men; mean age 77±10 years) classified as Rutherford category 3 (n = 10) or 4/5 (n = 30) underwent PTA of the proximal and mid popliteal artery followed by implantation of a SUPERA stent for elastic recoil, residual stenosis, or flow-limiting dissection. All patients had an elevated operative risk. Before and after the procedure and during the 12-month follow-up, a clinical investigation, ankle-brachial-index (ABI) measurement, and color-coded duplex sonography and/or digital subtraction angiography were performed. Primary endpoints were limb salvage and anatomical patency at 12 months. Results Stent implantation was successful in all patients. The major complication rate was 7.5% (an access-site pseudoaneurysm, 2 retroperitoneal hematomas, and 1 death from retroperitoneal bleeding). Mean follow-up was 15.9 months (range 0.5–27.9). The mean baseline ABI of 0.37 significantly increased to 0.91 at 12 months (p&lt;0.01). Three (7.5%) patients underwent bypass surgery owing to lack of clinical improvement (&lt;0.10 improvement in ABI). Primary and secondary patency rates at 12 months in the 34 patients eligible for follow-up were 68.4% and 79.8%, respectively. The major amputation rate was 5% at 1 year. Five (12.5%) in-stent stenoses and 1 of 2 (5.0%) in-stent occlusions were successfully recanalized (the second occlusion was asymptomatic). Conclusion Implantation of this helical stent into segments of the popliteal artery at the knee joint in CLI patients is a safe and clinically effective bailout method with acceptable intermediate patency.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>22788900</pmid><doi>10.1583/11-3591MR.1</doi><tpages>7</tpages></addata></record>
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subjects Aged
Aged, 80 and over
Alloys
Amputation
Angiography, Digital Subtraction
Angioplasty, Balloon - adverse effects
Angioplasty, Balloon - instrumentation
Ankle Brachial Index
Arterial Occlusive Diseases - complications
Arterial Occlusive Diseases - diagnosis
Arterial Occlusive Diseases - physiopathology
Arterial Occlusive Diseases - therapy
Blood clots
Chronic illnesses
Constriction, Pathologic
Critical Illness
Female
Germany
Humans
Intermittent Claudication - diagnosis
Intermittent Claudication - etiology
Intermittent Claudication - physiopathology
Intermittent Claudication - therapy
Ischemia
Ischemia - diagnosis
Ischemia - etiology
Ischemia - physiopathology
Ischemia - therapy
Kaplan-Meier Estimate
Limb Salvage
Lower Extremity - blood supply
Magnetic Resonance Angiography
Male
Medical imaging
Middle Aged
Popliteal Artery - diagnostic imaging
Popliteal Artery - physiopathology
Prosthesis Design
Retrospective Studies
Risk Assessment
Risk Factors
Stents
Surgery
Time Factors
Treatment Outcome
Ultrasonography, Doppler, Color
Vascular Patency
title Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients With Critical Limb Ischemia: Initial Experience Using a Helical Nitinol Stent With Increased Radial Force
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