One-Year Outcome of Percutaneous Rotational Atherectomy with Aspiration in Infrainguinal Peripheral Arterial Occlusive Disease: The Multicenter Pathway PVD Trial

Purpose: To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions. Methods: From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51–93; 47% diabetics) with Rutherfor...

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Veröffentlicht in:Journal of endovascular therapy 2009-12, Vol.16 (6), p.653-662
Hauptverfasser: Zeller, Thomas, Krankenberg, Hans, Steinkamp, Hermann, Rastan, Aljoscha, Sixt, Sebastian, Schmidt, Andrej, Sievert, Horst, Minar, Erich, Bosiers, Marc, Peeters, Patrick, Balzer, Jörn O., Gray, William, Tübler, Thilo, Wissgott, Christian, Schwarzwälder, Uwe, Scheinert, Dierk
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container_end_page 662
container_issue 6
container_start_page 653
container_title Journal of endovascular therapy
container_volume 16
creator Zeller, Thomas
Krankenberg, Hans
Steinkamp, Hermann
Rastan, Aljoscha
Sixt, Sebastian
Schmidt, Andrej
Sievert, Horst
Minar, Erich
Bosiers, Marc
Peeters, Patrick
Balzer, Jörn O.
Gray, William
Tübler, Thilo
Wissgott, Christian
Schwarzwälder, Uwe
Scheinert, Dierk
description Purpose: To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions. Methods: From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51–93; 47% diabetics) with Rutherford class 1–5 lower limb ischemia were enrolled at 9 study sites. Inclusion criteria were atherosclerotic stenoses >70% and up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the infrapopliteal vessels (reference vessel diameter 3.0–5.0 mm). In the study, 210 lesions (mean length 2.7 cm) were treated with the Pathway PV System, including total occlusions (31%), lesions with a moderate to high calcium score (51%), and post-angioplasty (non-stent) restenotic lesions (15%). The primary study endpoint was the 30-day major adverse event (MAE) rate. Results: Device success was 99% (208/210 lesions). MAE at 30 days was 1% (2 preplanned amputations). Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively. The 1-year restenosis rate was 38.2% based on duplex imaging. The ankle-brachial index increased significantly from 0.59±0.21 at baseline to 0.82±0.27 (p
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Methods: From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51–93; 47% diabetics) with Rutherford class 1–5 lower limb ischemia were enrolled at 9 study sites. Inclusion criteria were atherosclerotic stenoses &gt;70% and up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the infrapopliteal vessels (reference vessel diameter 3.0–5.0 mm). In the study, 210 lesions (mean length 2.7 cm) were treated with the Pathway PV System, including total occlusions (31%), lesions with a moderate to high calcium score (51%), and post-angioplasty (non-stent) restenotic lesions (15%). The primary study endpoint was the 30-day major adverse event (MAE) rate. Results: Device success was 99% (208/210 lesions). MAE at 30 days was 1% (2 preplanned amputations). Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively. The 1-year restenosis rate was 38.2% based on duplex imaging. The ankle-brachial index increased significantly from 0.59±0.21 at baseline to 0.82±0.27 (p&lt;0.05) at 12 months. Mean Rutherford class improved from 3.0±0.9 at baseline to 1.5±1.3 at 1 year (p&lt;0.05). Conclusion: The use of the Pathway PV System in atherosclerotic lesions appears to be safe and effective in improving stenosis severity, even in the presence of challenging lesion conditions. Vessel patency following intervention appears to be good up to 12 months, and these results translate into clinical benefit.</description><identifier>ISSN: 1526-6028</identifier><identifier>EISSN: 1545-1550</identifier><identifier>DOI: 10.1583/09-2826.1</identifier><identifier>PMID: 19995118</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Aged ; Aged, 80 and over ; Amputation ; Angioplasty, Balloon ; Ankle - blood supply ; Arterial Occlusive Diseases - diagnosis ; Arterial Occlusive Diseases - physiopathology ; Arterial Occlusive Diseases - therapy ; Atherectomy - adverse effects ; Atherectomy - instrumentation ; Atherectomy - methods ; Blood Pressure ; Brachial Artery - physiopathology ; Clinical outcomes ; Constriction, Pathologic ; Equipment Design ; Europe ; Female ; Humans ; Limb Salvage ; Lower Extremity - blood supply ; Male ; Middle Aged ; Peripheral Vascular Diseases - diagnosis ; Peripheral Vascular Diseases - physiopathology ; Peripheral Vascular Diseases - therapy ; Prospective Studies ; Recurrence ; Severity of Illness Index ; Suction - adverse effects ; Suction - instrumentation ; Time Factors ; Treatment Outcome ; Ultrasonography, Doppler, Duplex ; Vascular surgery ; Vein &amp; artery diseases</subject><ispartof>Journal of endovascular therapy, 2009-12, Vol.16 (6), p.653-662</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-d062260396972d66dbbb43bc54b60fac1cef278bf29e7edb9f3e79dcbd564ff53</citedby><cites>FETCH-LOGICAL-c342t-d062260396972d66dbbb43bc54b60fac1cef278bf29e7edb9f3e79dcbd564ff53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1583/09-2826.1$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1583/09-2826.1$$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/19995118$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zeller, Thomas</creatorcontrib><creatorcontrib>Krankenberg, Hans</creatorcontrib><creatorcontrib>Steinkamp, Hermann</creatorcontrib><creatorcontrib>Rastan, Aljoscha</creatorcontrib><creatorcontrib>Sixt, Sebastian</creatorcontrib><creatorcontrib>Schmidt, Andrej</creatorcontrib><creatorcontrib>Sievert, Horst</creatorcontrib><creatorcontrib>Minar, Erich</creatorcontrib><creatorcontrib>Bosiers, Marc</creatorcontrib><creatorcontrib>Peeters, Patrick</creatorcontrib><creatorcontrib>Balzer, Jörn O.</creatorcontrib><creatorcontrib>Gray, William</creatorcontrib><creatorcontrib>Tübler, Thilo</creatorcontrib><creatorcontrib>Wissgott, Christian</creatorcontrib><creatorcontrib>Schwarzwälder, Uwe</creatorcontrib><creatorcontrib>Scheinert, Dierk</creatorcontrib><title>One-Year Outcome of Percutaneous Rotational Atherectomy with Aspiration in Infrainguinal Peripheral Arterial Occlusive Disease: The Multicenter Pathway PVD Trial</title><title>Journal of endovascular therapy</title><addtitle>J Endovasc Ther</addtitle><description>Purpose: To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions. Methods: From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51–93; 47% diabetics) with Rutherford class 1–5 lower limb ischemia were enrolled at 9 study sites. Inclusion criteria were atherosclerotic stenoses &gt;70% and up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the infrapopliteal vessels (reference vessel diameter 3.0–5.0 mm). In the study, 210 lesions (mean length 2.7 cm) were treated with the Pathway PV System, including total occlusions (31%), lesions with a moderate to high calcium score (51%), and post-angioplasty (non-stent) restenotic lesions (15%). The primary study endpoint was the 30-day major adverse event (MAE) rate. Results: Device success was 99% (208/210 lesions). MAE at 30 days was 1% (2 preplanned amputations). Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively. The 1-year restenosis rate was 38.2% based on duplex imaging. The ankle-brachial index increased significantly from 0.59±0.21 at baseline to 0.82±0.27 (p&lt;0.05) at 12 months. Mean Rutherford class improved from 3.0±0.9 at baseline to 1.5±1.3 at 1 year (p&lt;0.05). Conclusion: The use of the Pathway PV System in atherosclerotic lesions appears to be safe and effective in improving stenosis severity, even in the presence of challenging lesion conditions. Vessel patency following intervention appears to be good up to 12 months, and these results translate into clinical benefit.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Amputation</subject><subject>Angioplasty, Balloon</subject><subject>Ankle - blood supply</subject><subject>Arterial Occlusive Diseases - diagnosis</subject><subject>Arterial Occlusive Diseases - physiopathology</subject><subject>Arterial Occlusive Diseases - therapy</subject><subject>Atherectomy - adverse effects</subject><subject>Atherectomy - instrumentation</subject><subject>Atherectomy - methods</subject><subject>Blood Pressure</subject><subject>Brachial Artery - physiopathology</subject><subject>Clinical outcomes</subject><subject>Constriction, Pathologic</subject><subject>Equipment Design</subject><subject>Europe</subject><subject>Female</subject><subject>Humans</subject><subject>Limb Salvage</subject><subject>Lower Extremity - blood supply</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Peripheral Vascular Diseases - diagnosis</subject><subject>Peripheral Vascular Diseases - physiopathology</subject><subject>Peripheral Vascular Diseases - therapy</subject><subject>Prospective Studies</subject><subject>Recurrence</subject><subject>Severity of Illness Index</subject><subject>Suction - adverse effects</subject><subject>Suction - instrumentation</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Ultrasonography, Doppler, Duplex</subject><subject>Vascular surgery</subject><subject>Vein &amp; 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Krankenberg, Hans ; Steinkamp, Hermann ; Rastan, Aljoscha ; Sixt, Sebastian ; Schmidt, Andrej ; Sievert, Horst ; Minar, Erich ; Bosiers, Marc ; Peeters, Patrick ; Balzer, Jörn O. ; Gray, William ; Tübler, Thilo ; Wissgott, Christian ; Schwarzwälder, Uwe ; Scheinert, Dierk</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c342t-d062260396972d66dbbb43bc54b60fac1cef278bf29e7edb9f3e79dcbd564ff53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Amputation</topic><topic>Angioplasty, Balloon</topic><topic>Ankle - blood supply</topic><topic>Arterial Occlusive Diseases - diagnosis</topic><topic>Arterial Occlusive Diseases - physiopathology</topic><topic>Arterial Occlusive Diseases - therapy</topic><topic>Atherectomy - adverse effects</topic><topic>Atherectomy - instrumentation</topic><topic>Atherectomy - methods</topic><topic>Blood Pressure</topic><topic>Brachial Artery - physiopathology</topic><topic>Clinical outcomes</topic><topic>Constriction, Pathologic</topic><topic>Equipment Design</topic><topic>Europe</topic><topic>Female</topic><topic>Humans</topic><topic>Limb Salvage</topic><topic>Lower Extremity - blood supply</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Peripheral Vascular Diseases - diagnosis</topic><topic>Peripheral Vascular Diseases - physiopathology</topic><topic>Peripheral Vascular Diseases - therapy</topic><topic>Prospective Studies</topic><topic>Recurrence</topic><topic>Severity of Illness Index</topic><topic>Suction - adverse effects</topic><topic>Suction - instrumentation</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Ultrasonography, Doppler, Duplex</topic><topic>Vascular surgery</topic><topic>Vein &amp; artery diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zeller, Thomas</creatorcontrib><creatorcontrib>Krankenberg, Hans</creatorcontrib><creatorcontrib>Steinkamp, Hermann</creatorcontrib><creatorcontrib>Rastan, Aljoscha</creatorcontrib><creatorcontrib>Sixt, Sebastian</creatorcontrib><creatorcontrib>Schmidt, Andrej</creatorcontrib><creatorcontrib>Sievert, Horst</creatorcontrib><creatorcontrib>Minar, Erich</creatorcontrib><creatorcontrib>Bosiers, Marc</creatorcontrib><creatorcontrib>Peeters, Patrick</creatorcontrib><creatorcontrib>Balzer, Jörn O.</creatorcontrib><creatorcontrib>Gray, William</creatorcontrib><creatorcontrib>Tübler, Thilo</creatorcontrib><creatorcontrib>Wissgott, Christian</creatorcontrib><creatorcontrib>Schwarzwälder, Uwe</creatorcontrib><creatorcontrib>Scheinert, Dierk</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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Methods: From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51–93; 47% diabetics) with Rutherford class 1–5 lower limb ischemia were enrolled at 9 study sites. Inclusion criteria were atherosclerotic stenoses &gt;70% and up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the infrapopliteal vessels (reference vessel diameter 3.0–5.0 mm). In the study, 210 lesions (mean length 2.7 cm) were treated with the Pathway PV System, including total occlusions (31%), lesions with a moderate to high calcium score (51%), and post-angioplasty (non-stent) restenotic lesions (15%). The primary study endpoint was the 30-day major adverse event (MAE) rate. Results: Device success was 99% (208/210 lesions). MAE at 30 days was 1% (2 preplanned amputations). Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively. The 1-year restenosis rate was 38.2% based on duplex imaging. The ankle-brachial index increased significantly from 0.59±0.21 at baseline to 0.82±0.27 (p&lt;0.05) at 12 months. Mean Rutherford class improved from 3.0±0.9 at baseline to 1.5±1.3 at 1 year (p&lt;0.05). Conclusion: The use of the Pathway PV System in atherosclerotic lesions appears to be safe and effective in improving stenosis severity, even in the presence of challenging lesion conditions. Vessel patency following intervention appears to be good up to 12 months, and these results translate into clinical benefit.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>19995118</pmid><doi>10.1583/09-2826.1</doi><tpages>10</tpages></addata></record>
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subjects Aged
Aged, 80 and over
Amputation
Angioplasty, Balloon
Ankle - blood supply
Arterial Occlusive Diseases - diagnosis
Arterial Occlusive Diseases - physiopathology
Arterial Occlusive Diseases - therapy
Atherectomy - adverse effects
Atherectomy - instrumentation
Atherectomy - methods
Blood Pressure
Brachial Artery - physiopathology
Clinical outcomes
Constriction, Pathologic
Equipment Design
Europe
Female
Humans
Limb Salvage
Lower Extremity - blood supply
Male
Middle Aged
Peripheral Vascular Diseases - diagnosis
Peripheral Vascular Diseases - physiopathology
Peripheral Vascular Diseases - therapy
Prospective Studies
Recurrence
Severity of Illness Index
Suction - adverse effects
Suction - instrumentation
Time Factors
Treatment Outcome
Ultrasonography, Doppler, Duplex
Vascular surgery
Vein & artery diseases
title One-Year Outcome of Percutaneous Rotational Atherectomy with Aspiration in Infrainguinal Peripheral Arterial Occlusive Disease: The Multicenter Pathway PVD Trial
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