{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T21:51:33Z","timestamp":1761947493645},"reference-count":14,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2008,10]]},"abstract":"<jats:p>\n            <jats:bold>\n              <jats:italic>Background\u2014<\/jats:italic>\n            <\/jats:bold>\n            To assess the feasibility and safety of retrograde transarterial implantation of a novel nonmetallic aortic valve prosthesis (Direct Flow Medical Inc, Santa Rosa, Calif), a prospective single-center study was performed in patients with severe aortic stenosis at high risk for open-heart surgery.\n          <\/jats:p>\n          <jats:p>\n            <jats:bold>\n              <jats:italic>Methods and Results\u2014<\/jats:italic>\n            <\/jats:bold>\n            Fifteen patients (intention-to-treat cohort) with an aortic valve area \u22640.8 cm\n            <jats:sup>2<\/jats:sup>\n            , a \u226535-mm Hg mean transvalvular pressure gradient, and a logistic EuroSCORE \u226520% were enrolled. Percutaneous aortic valve replacement was performed with the patient under general anesthesia. Hemodynamic parameters were assessed before and after implantation by transesophageal echocardiography. Clinical follow-up and transthoracic echocardiographic assessment were obtained at 30 days. Procedural success was achieved in 12 patients (80%). Surgical conversion became necessary at day 2 in 1 patient; 11 patients (73%) were discharged with a permanent implant. In these patients, implantation resulted acutely in a significant increase in aortic valve area (median, 1.64 [interquartile range, 1.27 to 1.74] versus 0.60 [0.46 to 0.69] cm\n            <jats:sup>2<\/jats:sup>\n            ;\n            <jats:italic>P<\/jats:italic>\n            =0.0033) and a concomitant reduction in the mean pressure gradient (14.0 [13.2 to 16.5] versus 54.0 [43.2 to 59.8] mm Hg;\n            <jats:italic>P<\/jats:italic>\n            =0.0033). At 30 days, 1 cardiac death (6.7%; 95% CI, 0.2% to 32.0%) and 1 major stroke were observed. The 10 surviving patients with a permanent implant showed marked hemodynamic and clinical improvement at this time point.\n          <\/jats:p>\n          <jats:p>\n            <jats:bold>\n              <jats:italic>Conclusions\u2014<\/jats:italic>\n            <\/jats:bold>\n            In this small series of patients, percutaneous implantation of the Direct Flow Medical aortic valve prosthesis in high\u2013surgical-risk patients was feasible and associated with a reasonably low safety profile.\n          <\/jats:p>","DOI":"10.1161\/circinterventions.108.800607","type":"journal-article","created":{"date-parts":[[2008,9,4]],"date-time":"2008-09-04T00:58:20Z","timestamp":1220489900000},"page":"126-133","update-policy":"http:\/\/dx.doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":46,"title":["Retrograde Transarterial Implantation of a Nonmetallic Aortic Valve Prosthesis in High\u2013Surgical-Risk Patients With Severe Aortic Stenosis"],"prefix":"10.1161","volume":"1","author":[{"given":"Joachim","family":"Schofer","sequence":"first","affiliation":[{"name":"From the Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center (J.S., M.S., T.T., A.P.), and Departments of Cardiovascular Surgery (H.T., H.R.) and Cardiology\/Angiology (O.W.F., T.M.), University Heart Center Hamburg, Hamburg, Germany; Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, Calif (R.I.L.); and University of Michigan Cardiovascular Center, Ann Arbor, Mich (S.F.B.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Schlu\u0308ter","sequence":"additional","affiliation":[{"name":"From the Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center (J.S., M.S., T.T., A.P.), and Departments of Cardiovascular Surgery (H.T., H.R.) and Cardiology\/Angiology (O.W.F., T.M.), University Heart Center Hamburg, Hamburg, Germany; Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, Calif (R.I.L.); and University of Michigan Cardiovascular Center, Ann Arbor, Mich (S.F.B.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hendrik","family":"Treede","sequence":"additional","affiliation":[{"name":"From the Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center (J.S., M.S., T.T., A.P.), and Departments of Cardiovascular Surgery (H.T., H.R.) and Cardiology\/Angiology (O.W.F., T.M.), University Heart Center Hamburg, Hamburg, Germany; Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, Calif (R.I.L.); and University of Michigan Cardiovascular Center, Ann Arbor, Mich (S.F.B.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olaf W.","family":"Franzen","sequence":"additional","affiliation":[{"name":"From the Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center (J.S., M.S., T.T., A.P.), and Departments of Cardiovascular Surgery (H.T., H.R.) and Cardiology\/Angiology (O.W.F., T.M.), University Heart Center Hamburg, Hamburg, Germany; Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, Calif (R.I.L.); and University of Michigan Cardiovascular Center, Ann Arbor, Mich (S.F.B.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thilo","family":"Tu\u0308bler","sequence":"additional","affiliation":[{"name":"From the Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center (J.S., M.S., T.T., A.P.), and Departments of Cardiovascular Surgery (H.T., H.R.) and Cardiology\/Angiology (O.W.F., T.M.), University Heart Center Hamburg, Hamburg, Germany; Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, Calif (R.I.L.); and University of Michigan Cardiovascular Center, Ann Arbor, Mich (S.F.B.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Pascotto","sequence":"additional","affiliation":[{"name":"From the Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center (J.S., M.S., T.T., A.P.), and Departments of Cardiovascular Surgery (H.T., H.R.) and Cardiology\/Angiology (O.W.F., T.M.), University Heart Center Hamburg, Hamburg, Germany; Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, Calif (R.I.L.); and University of Michigan Cardiovascular Center, Ann Arbor, Mich (S.F.B.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reginald I.","family":"Low","sequence":"additional","affiliation":[{"name":"From the Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center (J.S., M.S., T.T., A.P.), and Departments of Cardiovascular Surgery (H.T., H.R.) and Cardiology\/Angiology (O.W.F., T.M.), University Heart Center Hamburg, Hamburg, Germany; Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, Calif (R.I.L.); and University of Michigan Cardiovascular Center, Ann Arbor, Mich (S.F.B.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven F.","family":"Bolling","sequence":"additional","affiliation":[{"name":"From the Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center (J.S., M.S., T.T., A.P.), and Departments of Cardiovascular Surgery (H.T., H.R.) and Cardiology\/Angiology (O.W.F., T.M.), University Heart Center Hamburg, Hamburg, Germany; Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, Calif (R.I.L.); and University of Michigan Cardiovascular Center, Ann Arbor, Mich (S.F.B.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Meinertz","sequence":"additional","affiliation":[{"name":"From the Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center (J.S., M.S., T.T., A.P.), and Departments of Cardiovascular Surgery (H.T., H.R.) and Cardiology\/Angiology (O.W.F., T.M.), University Heart Center Hamburg, Hamburg, Germany; Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, Calif (R.I.L.); and University of Michigan Cardiovascular Center, Ann Arbor, Mich (S.F.B.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hermann","family":"Reichenspurner","sequence":"additional","affiliation":[{"name":"From the Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center (J.S., M.S., T.T., A.P.), and Departments of Cardiovascular Surgery (H.T., H.R.) and Cardiology\/Angiology (O.W.F., T.M.), University Heart Center Hamburg, Hamburg, Germany; Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, Calif (R.I.L.); and University of Michigan Cardiovascular Center, Ann Arbor, Mich (S.F.B.)."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","reference":[{"key":"e_1_3_2_1_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.0000047200.36165.b8"},{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2003.11.026"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2006.01.049"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.105.582882"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1161\/circulationaha.106.639450"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.106.632927"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1161\/circulationaha.107.698258"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2007.04.047"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.106.677237"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehn081"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehn183"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1010-7940(99)00134-7"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV4I1A23"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV4I2A45"}],"container-title":["Circulation: Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCINTERVENTIONS.108.800607","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T02:17:50Z","timestamp":1715566670000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCINTERVENTIONS.108.800607"}},"subtitle":["A First-in-Man Feasibility and Safety Study"],"short-title":[],"issued":{"date-parts":[[2008,10]]},"references-count":14,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2008,10]]}},"alternative-id":["10.1161\/CIRCINTERVENTIONS.108.800607"],"URL":"https:\/\/doi.org\/10.1161\/circinterventions.108.800607","relation":{},"ISSN":["1941-7640","1941-7632"],"issn-type":[{"value":"1941-7640","type":"print"},{"value":"1941-7632","type":"electronic"}],"subject":[],"published":{"date-parts":[[2008,10]]},"assertion":[{"value":"2008-09-03","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}