title: Impact of Practice-Based Management of Pulmonary Artery Pressures in 2000 Patients Implanted With the CardioMEMS Sensor.
abstract: BACKGROUND
  Elevated pulmonary artery (PA) pressures in patients with heart failure are associated with a high risk for hospitalization and mortality. Recent clinical trial evidence demonstrated a direct relationship between lowering remotely monitored PA pressures and heart failure hospitalization risk reduction with a novel implantable PA pressure monitoring system (CardioMEMS HF System, St. Jude Medical). This study examines PA pressure changes in the first 2000 US patients implanted in general practice use.
  
  
  METHODS
  Deidentified data from the remote monitoring Merlin.net (St. Jude Medical) database were used to examine PA pressure trends from the first consecutive 2000 patients with at least 6 months of follow-up. Changes in PA pressures were evaluated with an area under the curve methodology to estimate the total sum increase or decrease in pressures (mm Hg-day) during the follow-up period relative to the baseline pressure. As a reference, the PA pressure trends were compared with the historic CHAMPION clinical trial (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association [NYHA] Functional Class III Heart Failure Patients). The area under the curve results are presented as mean±2 SE, andPvalues comparing the area under the curve of the general-use cohort with outcomes in the CHAMPION trial were computed by thettest with equal variance.
  
  
  RESULTS
  Patients were on average 70±12 years old; 60% were male; 34% had preserved ejection fraction; and patients were followed up for an average of 333±125 days. At implantation, the mean PA pressure for the general-use patients was 34.9±10.2 mm Hg compared with 31.3±10.9 mm Hg for CHAMPION treatment and 32.0±10.5 mm Hg for CHAMPION control groups. The general-use patients had an area under the curve of -32.8 mm Hg-day at the 1-month time mark, -156.2 mm Hg-day at the 3-month time mark, and -434.0 mm Hg-day after 6 months of hemodynamic guided care, which was significantly lower than the treatment group in the CHAMPION trial. Patients consistently transmitted pressure information with a median of 1.27 days between transmissions after 6 months.
  
  
  CONCLUSIONS
  The first 2000 general-use patients managed with hemodynamic-guided heart failure care had higher PA pressures at baseline and experienced greater reduction in PA pressure over time compared with the pivotal CHAMPION clinical trial. These data demonstrate that general use of implantable hemodynamic technology in a nontrial setting leads to significant lowering of PA pressures.
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.). heywood.james@scrippshealth.org.
authors.forename: J Thomas
authors.initials: JT
authors.lastname: Heywood
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: Rita
authors.initials: R
authors.lastname: Jermyn
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: David
authors.initials: D
authors.lastname: Shavelle
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: Arvind
authors.initials: A
authors.lastname: Bhimaraj
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: Kunjan
authors.initials: K
authors.lastname: Bhatt
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: Fareed
authors.initials: F
authors.lastname: Sheikh
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: Eric
authors.initials: E
authors.lastname: Eichorn
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: Sumant
authors.initials: S
authors.lastname: Lamba
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: Rupinder
authors.initials: R
authors.lastname: Bharmi
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: Rahul
authors.initials: R
authors.lastname: Agarwal
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: Charisma
authors.initials: C
authors.lastname: Kumar
authors.affiliation: From the Division of Cardiology, Scripps Clinic Torrey Pines, La Jolla, CA (J.T.H.); St. Francis Hospital, Roslyn, NY (R.J.); Division of Cardiovascular Medicine, Keck School of Medicine, Los Angeles, CA (D.S.); The Ohio State University, Columbus (W.T.A.); Houston Methodist Hospital, TX (A.B.); Austin Heart Hospital, Austin, TX (K.B.); St. Rose Dominican Hospital, Las Vegas, NV (F.S.); Medical City of Dallas, TX (E.E.); First Coast Cardiovascular Institute, Jacksonville, FL (S.L.); Clinical Research and Development, St. Jude Medical, Inc, Sylmar, CA (R.B., R.A., C.K.); and Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (L.W.S.).
authors.forename: Lynne W
authors.initials: LW
authors.lastname: Stevenson
mesh_terms: D000368:Aged; D018660:Blood Pressure Monitoring, Ambulatory / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D011651:Pulmonary Artery / Q000503:physiopathology*; D011669:Pulmonary Wedge Pressure / Q000502:physiology*
keywords: heart failure; hemodynamics; pulmonary artery