Early Experience with a New Concept of Angioplasty Nitinol-Constrained Balloon Catheter (Chocolate®) in Severely Claudicant Patients
Background To report our experience in treating severely claudicant patients, employing a “nitinol-constrained” balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA—USA) before drug-coated balloon (DCB) in a standardized protocol. Methods Eighty-one (84 limbs) consecutive Rutherford category (RC...
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| Veröffentlicht in: | Cardiovascular and interventional radiology 2018-03, Vol.41 (3), p.377-384 |
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| creator | Sirignano, Pasqualino Mansour, Wassim d’Adamo, Alessandro Cuozzo, Simone Capoccia, Laura Speziale, Francesco |
| description | Background
To report our experience in treating severely claudicant patients, employing a “nitinol-constrained” balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA—USA) before drug-coated balloon (DCB) in a standardized protocol.
Methods
Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up.
Results
Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150 mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC = 0). Mean follow-up was 12.3 ± 5.6 months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (
p
= 0.725). CTO length impacted early results: in cases of CTOs 150 mm, it was 83.3% (
p
= 0031). ABI at 12-month was significantly higher with respect to preoperative values (
p
|
| doi_str_mv | 10.1007/s00270-017-1840-9 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1966993287</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1966993287</sourcerecordid><originalsourceid>FETCH-LOGICAL-c372t-4ece7e1eef6f984325c5ca29ccbef1814d7c3bd8774fb1fa57810af82507c82c3</originalsourceid><addsrcrecordid>eNp1kc2KFDEUhYMoTjv6AG4k4GZclCapSiVZzhTtDwyjoIK7kE7dms6QTsok5dgP4Ov4ED6ZGXsUEVwFcr57zr0chB5T8pwSIl5kQpggDaGiobIjjbqDVrRrWUNk_-kuWlWhayjn9Ag9yPmKEMol4_fREVOUq152K_RtbZLf4_XXGZKDYAFfu7LFBl_ANR5i_ZgLjhM-DZcuzt7ksscXrrgQfVPlXJJxAUZ8ZryPMeDBlC0USPhk2EYbvSnw4_sz7AJ-D18gQc0avFlGZ00o-J0pNbTkh-jeZHyGR7fvMfr4cv1heN2cv331Zjg9b2wrWGk6sCCAAkz9pGQ9lFtuDVPWbmCiknajsO1mlEJ004ZOhgtJiZnqzURYyWx7jE4OvnOKnxfIRe9ctuC9CRCXrKnqe6VaJkVFn_6DXsUlhbrdL4qpVnFWKXqgbIo5J5j0nNzOpL2mRN90pA8d6VqFvulIqzrz5NZ52exg_DPxu5QKsAOQqxQuIf0V_V_Xn72ZnmU</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1966293952</pqid></control><display><type>article</type><title>Early Experience with a New Concept of Angioplasty Nitinol-Constrained Balloon Catheter (Chocolate®) in Severely Claudicant Patients</title><source>SpringerNature Journals</source><creator>Sirignano, Pasqualino ; Mansour, Wassim ; d’Adamo, Alessandro ; Cuozzo, Simone ; Capoccia, Laura ; Speziale, Francesco</creator><creatorcontrib>Sirignano, Pasqualino ; Mansour, Wassim ; d’Adamo, Alessandro ; Cuozzo, Simone ; Capoccia, Laura ; Speziale, Francesco</creatorcontrib><description>Background
To report our experience in treating severely claudicant patients, employing a “nitinol-constrained” balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA—USA) before drug-coated balloon (DCB) in a standardized protocol.
Methods
Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up.
Results
Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150 mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC = 0). Mean follow-up was 12.3 ± 5.6 months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (
p
= 0.725). CTO length impacted early results: in cases of CTOs < 150 mm, PP was 100%, while in CTOs > 150 mm, it was 83.3% (
p
= 0031). ABI at 12-month was significantly higher with respect to preoperative values (
p
< 0.001).
Conclusions
In this preliminary experience, our protocol seems to be safe and effective in treating SFA and PA lesions in claudicant patients with satisfactory early and 12-month results.</description><identifier>ISSN: 0174-1551</identifier><identifier>EISSN: 1432-086X</identifier><identifier>DOI: 10.1007/s00270-017-1840-9</identifier><identifier>PMID: 29159684</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Angioplasty ; Ankle ; Balloon catheters ; Balloon treatment ; Cardiology ; Catheters ; Chocolate ; Clinical Investigation ; Early experience ; Femoral artery ; Femur ; Imaging ; Implantation ; Lesions ; Limbs ; Medical instruments ; Medicine ; Medicine & Public Health ; Nickel titanides ; Nuclear Medicine ; Occlusion ; Patients ; Radiology ; Shape memory alloys ; Stenosis ; Ultrasound</subject><ispartof>Cardiovascular and interventional radiology, 2018-03, Vol.41 (3), p.377-384</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2017</rights><rights>CardioVascular and Interventional Radiology is a copyright of Springer, (2017). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-4ece7e1eef6f984325c5ca29ccbef1814d7c3bd8774fb1fa57810af82507c82c3</citedby><cites>FETCH-LOGICAL-c372t-4ece7e1eef6f984325c5ca29ccbef1814d7c3bd8774fb1fa57810af82507c82c3</cites><orcidid>0000-0002-1312-1915</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00270-017-1840-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00270-017-1840-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,782,786,27931,27932,41495,42564,51326</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29159684$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sirignano, Pasqualino</creatorcontrib><creatorcontrib>Mansour, Wassim</creatorcontrib><creatorcontrib>d’Adamo, Alessandro</creatorcontrib><creatorcontrib>Cuozzo, Simone</creatorcontrib><creatorcontrib>Capoccia, Laura</creatorcontrib><creatorcontrib>Speziale, Francesco</creatorcontrib><title>Early Experience with a New Concept of Angioplasty Nitinol-Constrained Balloon Catheter (Chocolate®) in Severely Claudicant Patients</title><title>Cardiovascular and interventional radiology</title><addtitle>Cardiovasc Intervent Radiol</addtitle><addtitle>Cardiovasc Intervent Radiol</addtitle><description>Background
To report our experience in treating severely claudicant patients, employing a “nitinol-constrained” balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA—USA) before drug-coated balloon (DCB) in a standardized protocol.
Methods
Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up.
Results
Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150 mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC = 0). Mean follow-up was 12.3 ± 5.6 months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (
p
= 0.725). CTO length impacted early results: in cases of CTOs < 150 mm, PP was 100%, while in CTOs > 150 mm, it was 83.3% (
p
= 0031). ABI at 12-month was significantly higher with respect to preoperative values (
p
< 0.001).
Conclusions
In this preliminary experience, our protocol seems to be safe and effective in treating SFA and PA lesions in claudicant patients with satisfactory early and 12-month results.</description><subject>Angioplasty</subject><subject>Ankle</subject><subject>Balloon catheters</subject><subject>Balloon treatment</subject><subject>Cardiology</subject><subject>Catheters</subject><subject>Chocolate</subject><subject>Clinical Investigation</subject><subject>Early experience</subject><subject>Femoral artery</subject><subject>Femur</subject><subject>Imaging</subject><subject>Implantation</subject><subject>Lesions</subject><subject>Limbs</subject><subject>Medical instruments</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Nickel titanides</subject><subject>Nuclear Medicine</subject><subject>Occlusion</subject><subject>Patients</subject><subject>Radiology</subject><subject>Shape memory alloys</subject><subject>Stenosis</subject><subject>Ultrasound</subject><issn>0174-1551</issn><issn>1432-086X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kc2KFDEUhYMoTjv6AG4k4GZclCapSiVZzhTtDwyjoIK7kE7dms6QTsok5dgP4Ov4ED6ZGXsUEVwFcr57zr0chB5T8pwSIl5kQpggDaGiobIjjbqDVrRrWUNk_-kuWlWhayjn9Ag9yPmKEMol4_fREVOUq152K_RtbZLf4_XXGZKDYAFfu7LFBl_ANR5i_ZgLjhM-DZcuzt7ksscXrrgQfVPlXJJxAUZ8ZryPMeDBlC0USPhk2EYbvSnw4_sz7AJ-D18gQc0avFlGZ00o-J0pNbTkh-jeZHyGR7fvMfr4cv1heN2cv331Zjg9b2wrWGk6sCCAAkz9pGQ9lFtuDVPWbmCiknajsO1mlEJ004ZOhgtJiZnqzURYyWx7jE4OvnOKnxfIRe9ctuC9CRCXrKnqe6VaJkVFn_6DXsUlhbrdL4qpVnFWKXqgbIo5J5j0nNzOpL2mRN90pA8d6VqFvulIqzrz5NZ52exg_DPxu5QKsAOQqxQuIf0V_V_Xn72ZnmU</recordid><startdate>20180301</startdate><enddate>20180301</enddate><creator>Sirignano, Pasqualino</creator><creator>Mansour, Wassim</creator><creator>d’Adamo, Alessandro</creator><creator>Cuozzo, Simone</creator><creator>Capoccia, Laura</creator><creator>Speziale, Francesco</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</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>H94</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><orcidid>https://orcid.org/0000-0002-1312-1915</orcidid></search><sort><creationdate>20180301</creationdate><title>Early Experience with a New Concept of Angioplasty Nitinol-Constrained Balloon Catheter (Chocolate®) in Severely Claudicant Patients</title><author>Sirignano, Pasqualino ; Mansour, Wassim ; d’Adamo, Alessandro ; Cuozzo, Simone ; Capoccia, Laura ; Speziale, Francesco</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-4ece7e1eef6f984325c5ca29ccbef1814d7c3bd8774fb1fa57810af82507c82c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Angioplasty</topic><topic>Ankle</topic><topic>Balloon catheters</topic><topic>Balloon treatment</topic><topic>Cardiology</topic><topic>Catheters</topic><topic>Chocolate</topic><topic>Clinical Investigation</topic><topic>Early experience</topic><topic>Femoral artery</topic><topic>Femur</topic><topic>Imaging</topic><topic>Implantation</topic><topic>Lesions</topic><topic>Limbs</topic><topic>Medical instruments</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Nickel titanides</topic><topic>Nuclear Medicine</topic><topic>Occlusion</topic><topic>Patients</topic><topic>Radiology</topic><topic>Shape memory alloys</topic><topic>Stenosis</topic><topic>Ultrasound</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sirignano, Pasqualino</creatorcontrib><creatorcontrib>Mansour, Wassim</creatorcontrib><creatorcontrib>d’Adamo, Alessandro</creatorcontrib><creatorcontrib>Cuozzo, Simone</creatorcontrib><creatorcontrib>Capoccia, Laura</creatorcontrib><creatorcontrib>Speziale, Francesco</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & 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>Cardiovascular and interventional radiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sirignano, Pasqualino</au><au>Mansour, Wassim</au><au>d’Adamo, Alessandro</au><au>Cuozzo, Simone</au><au>Capoccia, Laura</au><au>Speziale, Francesco</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Early Experience with a New Concept of Angioplasty Nitinol-Constrained Balloon Catheter (Chocolate®) in Severely Claudicant Patients</atitle><jtitle>Cardiovascular and interventional radiology</jtitle><stitle>Cardiovasc Intervent Radiol</stitle><addtitle>Cardiovasc Intervent Radiol</addtitle><date>2018-03-01</date><risdate>2018</risdate><volume>41</volume><issue>3</issue><spage>377</spage><epage>384</epage><pages>377-384</pages><issn>0174-1551</issn><eissn>1432-086X</eissn><abstract>Background
To report our experience in treating severely claudicant patients, employing a “nitinol-constrained” balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA—USA) before drug-coated balloon (DCB) in a standardized protocol.
Methods
Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up.
Results
Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150 mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC = 0). Mean follow-up was 12.3 ± 5.6 months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (
p
= 0.725). CTO length impacted early results: in cases of CTOs < 150 mm, PP was 100%, while in CTOs > 150 mm, it was 83.3% (
p
= 0031). ABI at 12-month was significantly higher with respect to preoperative values (
p
< 0.001).
Conclusions
In this preliminary experience, our protocol seems to be safe and effective in treating SFA and PA lesions in claudicant patients with satisfactory early and 12-month results.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>29159684</pmid><doi>10.1007/s00270-017-1840-9</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-1312-1915</orcidid></addata></record> |
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| ispartof | Cardiovascular and interventional radiology, 2018-03, Vol.41 (3), p.377-384 |
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| language | eng |
| recordid | cdi_proquest_miscellaneous_1966993287 |
| source | SpringerNature Journals |
| subjects | Angioplasty Ankle Balloon catheters Balloon treatment Cardiology Catheters Chocolate Clinical Investigation Early experience Femoral artery Femur Imaging Implantation Lesions Limbs Medical instruments Medicine Medicine & Public Health Nickel titanides Nuclear Medicine Occlusion Patients Radiology Shape memory alloys Stenosis Ultrasound |
| title | Early Experience with a New Concept of Angioplasty Nitinol-Constrained Balloon Catheter (Chocolate®) in Severely Claudicant Patients |
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