{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T13:32:17Z","timestamp":1762867937217,"version":"3.40.5"},"reference-count":11,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,9,30]],"date-time":"2019-09-30T00:00:00Z","timestamp":1569801600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP).<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A 20, 22, 24, 26, and 28\u2009mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z\u2010MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The mean diameter at the middle of the 20, 22, 24, 26, and 28\u2009mm TD balloon at nominal pressure (3 atm) was 20.02\u2009\u00b1\u20090.09, 21.77\u2009\u00b1\u20090.07, 23.9\u2009\u00b1\u20090.06, 25.82\u2009\u00b1\u20090.08, and 27.62\u2009\u00b1\u20090.08\u2009mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28\u2009mm TD balloon was 20.39\u2009\u00b1\u20090.03\u2009mm (15\u2009atm), 22.35\u2009\u00b1\u20090.03\u2009mm (15\u2009atm), 24.55\u2009\u00b1\u20090.02\u2009mm (15\u2009atm), 26.48\u2009\u00b1\u20090.02\u2009mm (12\u2009atm), and 28.39\u2009\u00b1\u20090.03\u2009mm (12\u2009atm), respectively. The 20\/22\/24 and 26\/28\u2009mm balloon failed when inflated beyond 15\u2009atm and 12\u2009atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z\u2010MED balloons.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12\u2009atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.28503","type":"journal-article","created":{"date-parts":[[2019,10,1]],"date-time":"2019-10-01T04:12:14Z","timestamp":1569903134000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study"],"prefix":"10.1002","volume":"96","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9513-9440","authenticated-orcid":false,"given":"Janarthanan","family":"Sathananthan","sequence":"first","affiliation":[{"name":"Centre for Heart Valve Innovation St. Paul's Hospital, University of British Columbia  Vancouver Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9270-6446","authenticated-orcid":false,"given":"Mark","family":"Hensey","sequence":"additional","affiliation":[{"name":"Centre for Heart Valve Innovation St. Paul's Hospital, University of British Columbia  Vancouver Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie","family":"Sellers","sequence":"additional","affiliation":[{"name":"Centre for Heart Lung Innovation St. Paul's Hospital, University of British Columbia  Vancouver Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aaron M.","family":"Barlow","sequence":"additional","affiliation":[{"name":"Centre for Heart Lung Innovation St. Paul's Hospital, University of British Columbia  Vancouver Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adnan K.","family":"Chhatriwalla","sequence":"additional","affiliation":[{"name":"Saint Luke's Hospital, St. Luke's Mid America Heart Institute  Kansas City Missouri"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keith B.","family":"Allen","sequence":"additional","affiliation":[{"name":"Saint Luke's Hospital, St. Luke's Mid America Heart Institute  Kansas City Missouri"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anson","family":"Cheung","sequence":"additional","affiliation":[{"name":"Centre for Heart Valve Innovation St. Paul's Hospital, University of British Columbia  Vancouver Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars","family":"S\u00f8ndergaard","sequence":"additional","affiliation":[{"name":"Rigshospitalet, Cardiology  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philipp","family":"Blanke","sequence":"additional","affiliation":[{"name":"Centre for Heart Valve Innovation St. Paul's Hospital, University of British Columbia  Vancouver Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1939-7573","authenticated-orcid":false,"given":"Jian","family":"Ye","sequence":"additional","affiliation":[{"name":"Centre for Heart Valve Innovation St. Paul's Hospital, University of British Columbia  Vancouver Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan","family":"Leipsic","sequence":"additional","affiliation":[{"name":"Centre for Heart Valve Innovation St. Paul's Hospital, University of British Columbia  Vancouver Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Wood","sequence":"additional","affiliation":[{"name":"Centre for Heart Valve Innovation St. Paul's Hospital, University of British Columbia  Vancouver Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Webb","sequence":"additional","affiliation":[{"name":"Centre for Heart Valve Innovation St. Paul's Hospital, University of British Columbia  Vancouver Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,9,30]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1514616"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1700456"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198807213190301"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2013.10.019"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2017.04.007"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.117.005216"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.4244\/EIJ-D-17-00563"},{"key":"e_1_2_8_9_1","unstructured":"Administration USFaD. Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. September2010."},{"key":"e_1_2_8_10_1","unstructured":"10555\u20104 I. Intravascular catheters\u2014Sterile and single\u2010use catheters\u2014Part 4: Balloon dilatation catheters.2013."},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2017.05.011"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hlc.2015.04.177"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.28503","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ccd.28503","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.28503","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,4]],"date-time":"2023-09-04T19:20:15Z","timestamp":1693855215000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.28503"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,9,30]]},"references-count":11,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,8]]}},"alternative-id":["10.1002\/ccd.28503"],"URL":"https:\/\/doi.org\/10.1002\/ccd.28503","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"type":"print","value":"1522-1946"},{"type":"electronic","value":"1522-726X"}],"subject":[],"published":{"date-parts":[[2019,9,30]]},"assertion":[{"value":"2019-07-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-09-05","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-09-30","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}