{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T23:31:38Z","timestamp":1787959898382,"version":"build-2784847793"},"reference-count":22,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"8","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Heart Failure"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Ambulatory hemodynamic monitoring with an implantable pulmonary artery (PA) sensor is approved for patients with New York Heart Association Class III heart failure (HF) and a prior HF hospitalization (HFH) within 12 months. The objective of this study was to assess the efficacy and safety of PA pressure-guided therapy in routine clinical practice with special focus on subgroups defined by sex, race, and ejection fraction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This multi-center, prospective, open-label, observational, single-arm trial of 1200 patients across 104 centers within the United States with New York Heart Association class III HF and a prior HFH within 12 months evaluated patients undergoing PA pressure sensor implantation between September 1, 2014, and October 11, 2017. The primary efficacy outcome was the difference between rates of adjudicated HFH 1 year after compared with the 1 year before sensor implantation. Safety end points were freedom from device- or system-related complications at 2 years and freedom from pressure sensor failure at 2 years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Mean age for the population was 69 years, 37.7% were women, 17.2% were non-White, and 46.8% had preserved ejection fraction. During the year after sensor implantation, the mean rate of daily pressure transmission was 76\u00b124% and PA pressures declined significantly. The rate of HFH was significantly lower at 1 year compared with the year before implantation (0.54 versus 1.25 events\/patient-years, hazard ratio 0.43 [95% CI, 0.39\u20130.47],\n                      <jats:italic>P<\/jats:italic>\n                      &lt;0.0001). The rate of all-cause hospitalization was also lower following sensor implantation (1.67 versus 2.28 events\/patient-years, hazard ratio 0.73 [95% CI, 0.68\u20130.78],\n                      <jats:italic>P<\/jats:italic>\n                      &lt;0.0001). Results were consistent across subgroups defined by ejection fraction, sex, race, cause of cardiomyopathy, presence\/absence of implantable cardiac defibrillator or cardiac resynchronization therapy and ejection fraction. Freedom from device- or system-related complications was 99.6%, and freedom from pressure sensor failure was 99.9% at 1 year.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>In routine clinical practice as in clinical trials, PA pressure-guided therapy for HF was associated with lower PA pressures, lower rates of HFH and all-cause hospitalization, and low rates of adverse events across a broad range of patients with symptomatic HF and prior HFH.<\/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: NCT02279888.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circheartfailure.119.006863","type":"journal-article","created":{"date-parts":[[2020,8,6]],"date-time":"2020-08-06T05:01:06Z","timestamp":1596690066000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":189,"title":["Lower Rates of Heart Failure and All-Cause Hospitalizations During Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure"],"prefix":"10.1161","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct02279888","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9209-9807","authenticated-orcid":true,"given":"David M.","family":"Shavelle","sequence":"first","affiliation":[{"name":"Division of Cardiovascular Medicine, University of Southern California, Los Angeles (D.M.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akshay S.","family":"Desai","sequence":"additional","affiliation":[{"name":"Cardiovascular Division, Brigham and Women\u2019s Hospital, Boston, MA (A.S.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William T.","family":"Abraham","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, The Ohio State University Medical Center, Columbus (W.T.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert C.","family":"Bourge","sequence":"additional","affiliation":[{"name":"University of Alabama at Birmingham (R.C.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nirav","family":"Raval","sequence":"additional","affiliation":[{"name":"Florida Hospital Transplant Institute, Orlando (N.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa D.","family":"Rathman","sequence":"additional","affiliation":[{"name":"Cardiovascular Medicine Division, Lancaster General Hospital, PA (L.D.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. Thomas","family":"Heywood","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Scripps Green Hospital, La Jolla, CA (J.T.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita A.","family":"Jermyn","sequence":"additional","affiliation":[{"name":"Division of Cardiology, St Francis Hospital, Roslyn, NY (R.A.J.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jamie","family":"Pelzel","sequence":"additional","affiliation":[{"name":"Centracare Heart and Vascular Center, St Cloud, MN (J.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orvar T.","family":"Jonsson","sequence":"additional","affiliation":[{"name":"Sanford Cardiovascular Institute, Sanford University of South Dakota Medical Center, Sioux Falls (O.T.J.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Rosa","family":"Costanzo","sequence":"additional","affiliation":[{"name":"Advocate Heart Institute, Naperville, IL (M.R.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John D.","family":"Henderson","sequence":"additional","affiliation":[{"name":"Abbott, Sylmar, CA (J.D.H., M.-E.B., P.B.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie-Elena","family":"Brett","sequence":"additional","affiliation":[{"name":"Abbott, Sylmar, CA (J.D.H., M.-E.B., P.B.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip B.","family":"Adamson","sequence":"additional","affiliation":[{"name":"Abbott, Sylmar, CA (J.D.H., M.-E.B., P.B.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynne W.","family":"Stevenson","sequence":"additional","affiliation":[{"name":"Division of Advanced Heart Failure and Transplant Cardiology, Vanderbilt University Medical Center, Nashville, TN (L.W.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the CardioMEMS Post-Approval Study Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0b013e31823ac046"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.1161\/HHF.0b013e318291329a"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2007.10.061"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1010029"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2015.7712"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cardfail.2011.01.010"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)60101-3"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)00723-0"},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.019902"},{"key":"e_1_3_5_11_2","first-page":"104","article-title":"[World Medical Association (AMM). Helsinki Declaration. Ethical principles for medical research involving human subjects].","volume":"20","author":"World Medical Association","year":"2001","unstructured":"World Medical Association. [World Medical Association (AMM). Helsinki Declaration. Ethical principles for medical research involving human subjects]. Assist Inferm Ric. 2001; 20:104\u2013107.","journal-title":"Assist Inferm Ric"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2017.03.009"},{"key":"e_1_3_5_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2006.08.046"},{"key":"e_1_3_5_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cardfail.2014.12.008"},{"key":"e_1_3_5_15_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1806640"},{"key":"e_1_3_5_16_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCHEARTFAILURE.109.912683"},{"key":"e_1_3_5_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.04.070"},{"key":"e_1_3_5_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31808-7"},{"key":"e_1_3_5_19_2","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-med-041316-090654"},{"key":"e_1_3_5_20_2","doi-asserted-by":"publisher","DOI":"10.1002\/ehf2.12353"},{"key":"e_1_3_5_21_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCHEARTFAILURE.113.001229"},{"key":"e_1_3_5_22_2","doi-asserted-by":"publisher","DOI":"10.3238\/arztebl.2009.0664"},{"key":"e_1_3_5_23_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.111.018473"}],"container-title":["Circulation: Heart Failure"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCHEARTFAILURE.119.006863","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,12]],"date-time":"2024-05-12T21:44:34Z","timestamp":1715550274000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCHEARTFAILURE.119.006863"}},"subtitle":["One-Year Outcomes From the CardioMEMS Post-Approval Study"],"short-title":[],"issued":{"date-parts":[[2020,8]]},"references-count":22,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2020,8]]}},"alternative-id":["10.1161\/CIRCHEARTFAILURE.119.006863"],"URL":"https:\/\/doi.org\/10.1161\/circheartfailure.119.006863","relation":{},"ISSN":["1941-3289","1941-3297"],"issn-type":[{"value":"1941-3289","type":"print"},{"value":"1941-3297","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,8]]},"assertion":[{"value":"2019-12-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-06-08","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-08-06","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e006863"}}