{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T09:49:29Z","timestamp":1793785769707,"version":"4.6.1"},"reference-count":30,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"11","license":[{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>Mechanical thrombectomy offers a promising alternative to thrombolytic-based approaches for reducing thrombus burden and right heart strain in acute pulmonary embolism. This pivotal Food and Drug Administration\u2013approval trial evaluated the safety and efficacy of the Symphony Thrombectomy System (Imperative Care, Inc, Campbell, CA) in acute intermediate-risk pulmonary embolism.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>Patients with intermediate-risk pulmonary embolism (systolic blood pressure \u226590 mm\u2009Hg; right ventricle-to-left ventricle ratio &gt;0.9) were enrolled without roll-ins. The primary safety end point was the rate of major adverse events within 48 hours, defined as a composite of all-cause major bleeding, device-related mortality, and serious device-related events, adjudicated by an academic independent safety board. The primary efficacy end point was the core laboratory\u2013assessed mean change in right ventricle-to-left ventricle ratio from baseline to 48 hours. Prespecified performance goals were set for both. Exploratory end points included immediate postprocedure change in mean pulmonary artery pressure and change in modified Miller index at 48 hours. Safety was assessed in the intention-to-treat cohort and efficacy in the modified intention-to-treat cohort, excluding patients receiving nonstudy device treatments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      Between December 2023 and May 2025, 109 patients were treated at 17 US centers (intention-to-treat), with 106 in the modified intention-to-treat cohort. The major adverse events rate was 0.9% (1\/109), with an upper 97.5% CI of 5.7%, meeting the &lt;15% safety goal (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001). No device-related clinical deterioration, pulmonary vascular injury, or cardiac injury occurred at 48 hours; no mortality occurred through 30 days. The mean right ventricle-to-left ventricle ratio decrease was 0.44, with a lower 97.5% CI of 0.36, exceeding the &gt;0.20 performance goal (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001). Mean pulmonary artery pressure decreased from 29.1\u00b17.2 to 22.2\u00b16.6 mm\u2009Hg (24%) and the modified Miller index from 24.2\u00b14.1 to 14.9\u00b15.4 (38%), both\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>These data support the safety and effectiveness of the Symphony Thrombectomy System in patients with acute intermediate-risk pulmonary embolism.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>REGISTRATION:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifier: NCT06062329.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circinterventions.125.015815","type":"journal-article","created":{"date-parts":[[2025,9,17]],"date-time":"2025-09-17T22:45:08Z","timestamp":1758149108000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":10,"title":["Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial"],"prefix":"10.1161","volume":"18","clinical-trial-number":[{"clinical-trial-number":"nct06062329","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9485-0652","authenticated-orcid":true,"given":"Sripal","family":"Bangalore","sequence":"first","affiliation":[{"name":"Division of Cardiology, NYU Langone Health, New York (S. Bangalore)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. Dana","family":"Tomalty","sequence":"additional","affiliation":[{"name":"Radiology of Huntsville, Huntsville Hospital, AL (R.D.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9419-981X","authenticated-orcid":true,"given":"Herman","family":"Kado","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Corewell Health William Beaumont Hospital, Royal Oak, MI (H.K., J.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-4979-6107","authenticated-orcid":true,"given":"Sameh","family":"Sayfo","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Baylor Scott and White, The Heart Hospital, Plano, TX (S.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam","family":"Raskin","sequence":"additional","affiliation":[{"name":"Division of Endovascular Cardiovascular Medicine, Mercy Health, Inc, Cincinnati, OH (A.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0607-1240","authenticated-orcid":true,"given":"Arman","family":"Qamar","sequence":"additional","affiliation":[{"name":"Division of Interventional Cardiology and Vascular Medicine, Endeavor Health (NorthShore University HealthSystem), Glenbrook Hospital, Glenview, IL (A.Q.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andres","family":"Vargas Estrada","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Tallahassee Memorial Hospital, Tallahassee Research Institute, Inc, FL (A.V.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9877-1334","authenticated-orcid":true,"given":"Kirema","family":"Garcia-Reyes","sequence":"additional","affiliation":[{"name":"Department of Diagnostic, Molecular, and Interventional Radiology, Mount Sinai Health System, New York (K.G.-R., V.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H. Gabriel","family":"Lipshutz","sequence":"additional","affiliation":[{"name":"Division of Interventional Radiology, Cedars-Sinai Medical Center, Los Angeles, CA (H.G.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Srinivas","family":"Yallapragada","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Medical City Dallas, TX (S.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabah","family":"Butty","sequence":"additional","affiliation":[{"name":"Department of Radiology, Indiana University, Indianapolis (S. Butty)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sagar","family":"Gandhi","sequence":"additional","affiliation":[{"name":"Division of Vascular Surgery, Department of Surgery, Prisma Health, Greenville, SC (S.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1366-3906","authenticated-orcid":true,"given":"David","family":"Dexter","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Sentara, Norfolk, VA (D.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Trivax","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Corewell Health William Beaumont Hospital, Royal Oak, MI (H.K., J.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Farhan","family":"Ali","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Medical City Fort Worth, TX 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