{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T13:36:07Z","timestamp":1790861767059,"version":"4.1.0"},"reference-count":22,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2022,6,16]],"date-time":"2022-06-16T00:00:00Z","timestamp":1655337600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Cardiovasc. Med."],"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Nearly 2\/3 of patients with dilated right ventricular outflow tract (RVOT) were excluded from pulmonary valves transplantation due to the lack of size-matched valves. Here, we explored the safety and efficacy of the Med-Zenith PT-Valve for the treatment of patients with severe pulmonary regurgitation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>22 Patients with severe PR (grade 3+,4+) were enrolled based on the anatomical features of native RVOT and the valve design. The immediate, 3-months and 1-year post-procedural follow-up data were analyzed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The baseline mean systolic diameters in the distal main pulmonary artery (MPA), MPA sinus junction, MPA sinus, pulmonary annulus, RVOT aneurysm and muscular outlet measured with computed tomography were 33.6 \u00b1 6.1, 34.0 \u00b1 5.8, 37.9 \u00b1 6.0, 32.4 \u00b1 7.3, 41.9 \u00b1 9.3, and 34.4 \u00b1 8.0 mm, respectively. The PT-Valve landing zone was set within these levels. Successful valve implantations were achieved in all patients without noticeable device malposition, coronary artery compression, pulmonary branch obstruction or paravalvular leak during follow-ups. Post-procedural pulmonary artery diastolic pressure increased from 5.8 \u00b1 3.1 to 11.3 \u00b1 2.5 mmHg. In the 3-month and 1-year follow-up, the right ventricular end diastolic volume index reduced from the baseline 181.6 \u00b1 29.0 to 143.7 \u00b1 29.7 ml\/m\n                      <jats:sup>2<\/jats:sup>\n                      and 123.4 \u00b1 31.2 ml\/m\n                      <jats:sup>2<\/jats:sup>\n                      , and the trans-pulmonary valve gradient decreased from 25.6 \u00b1 22.2 to 10.64 \u00b1 3.54 mmHg and 11.16 \u00b1 3.0 mmHg, respectively. The 6-min walk distance increased from 416.6 \u00b1 97.9 to 455.9 \u00b1 64.6 m and 467.8 \u00b1 61.2 m, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This clinical trial revealed favorable outcomes for the safety, efficacy and feasibility of the Med-Zenith PT-Valve in the treatment of severe PR with significantly enlarged RVOT.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fcvm.2022.887886","type":"journal-article","created":{"date-parts":[[2022,6,16]],"date-time":"2022-06-16T02:48:32Z","timestamp":1655347712000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":20,"title":["The Clinical Trial Outcomes of Med-Zenith PT-Valve in the Treatment of Patients With Severe Pulmonary Regurgitation"],"prefix":"10.3389","volume":"9","author":[{"given":"Xiaoke","family":"Shang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nianguo","family":"Dong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Changdong","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanggan","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2022,6,16]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"507","DOI":"10.1161\/CIRCULATIONAHA.109.921692","article-title":"Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial","volume":"122","author":"McElhinney","year":"2010","journal-title":"Circulation."},{"key":"B2","doi-asserted-by":"publisher","first-page":"1960","DOI":"10.1161\/CIRCULATIONAHA.114.013588","article-title":"Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial","volume":"131","author":"Cheatham","year":"2015","journal-title":"Circulation."},{"key":"B3","doi-asserted-by":"publisher","first-page":"117","DOI":"10.1002\/ccd.26263","article-title":"Transcatheter pulmonary valve replacement: state of the art","volume":"87","author":"Holzer","year":"2016","journal-title":"Catheter Cardiovasc Interv."},{"key":"B4","doi-asserted-by":"publisher","first-page":"118","DOI":"10.1016\/j.amjcard.2014.09.054","article-title":"Trends in pulmonary valve replacement in children and adults with tetralogy of fallot","volume":"115","author":"O'Byrne","year":"2015","journal-title":"Am J Cardiol."},{"key":"B5","doi-asserted-by":"publisher","first-page":"498","DOI":"10.1016\/j.amjcard.2018.04.028","article-title":"Transcatheter versus surgical pulmonary valve replacement in repaired tetralogy of fallot","volume":"122","author":"Daily","year":"2018","journal-title":"Am J Cardiol."},{"key":"B6","doi-asserted-by":"publisher","first-page":"II153","DOI":"10.1161\/01.CIR.0000138397.60956.c2","article-title":"Pulmonary regurgitation is an important determinant of right ventricular contractile dysfunction in patients with surgically repaired tetralogy of Fallot","volume":"110","author":"Frigiola","year":"2004","journal-title":"Circulation."},{"key":"B7","doi-asserted-by":"publisher","first-page":"2248","DOI":"10.1016\/j.jacc.2011.07.040","article-title":"Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an international multicenter clinical trial","volume":"58","author":"Kenny","year":"2011","journal-title":"J Am Coll Cardiol."},{"key":"B8","doi-asserted-by":"publisher","first-page":"1371","DOI":"10.4244\/EIJ-D-18-00715","article-title":"A self-expanding percutaneous valve for patients with pulmonary regurgitation and an enlarged native right ventricular outflow tract: one-year results","volume":"14","author":"Zhou","year":"2019","journal-title":"EuroIntervention."},{"key":"B9","doi-asserted-by":"publisher","first-page":"e006432","DOI":"10.1161\/JAHA.117.006432","article-title":"Transcatheter pulmonary valve implantation: a comprehensive systematic review and meta-analyses of observational studies","volume":"6","author":"Chatterjee","year":"2017","journal-title":"J Am Heart Assoc"},{"key":"B10","doi-asserted-by":"publisher","first-page":"1347","DOI":"10.4244\/EIJV14I13A243","article-title":"Why we need another percutaneous pulmonary valve: if size matters","volume":"14","author":"Lurz","year":"2019","journal-title":"EuroIntervention."},{"key":"B11","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1016\/j.ijcard.2017.11.091","article-title":"Percutaneous pulmonary valve implantation in patients with dysfunction of a \u201cnative\u201d right ventricular outflow tract - 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