PMID- 21315441 OWN - NLM STAT- MEDLINE DCOM- 20110329 LR - 20220408 IS - 1474-547X (Electronic) IS - 0140-6736 (Linking) VI - 377 IP - 9766 DP - 2011 Feb 19 TI - Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. PG - 658-66 LID - 10.1016/S0140-6736(11)60101-3 [doi] AB - BACKGROUND: Results of previous studies support the hypothesis that implantable haemodynamic monitoring systems might reduce rates of hospitalisation in patients with heart failure. We undertook a single-blind trial to assess this approach. METHODS: Patients with New York Heart Association (NYHA) class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure were enrolled in 64 centres in the USA. They were randomly assigned by use of a centralised electronic system to management with a wireless implantable haemodynamic monitoring (W-IHM) system (treatment group) or to a control group for at least 6 months. Only patients were masked to their assignment group. In the treatment group, clinicians used daily measurement of pulmonary artery pressures in addition to standard of care versus standard of care alone in the control group. The primary efficacy endpoint was the rate of heart-failure-related hospitalisations at 6 months. The safety endpoints assessed at 6 months were freedom from device-related or system-related complications (DSRC) and freedom from pressure-sensor failures. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00531661. FINDINGS: In 6 months, 83 heart-failure-related hospitalisations were reported in the treatment group (n=270) compared with 120 in the control group (n=280; rate 0.31 vs 0.44, hazard ratio [HR] 0.70, 95% CI 0.60-0.84, p<0.0001). During the entire follow-up (mean 15 months [SD 7]), the treatment group had a 39% reduction in heart-failure-related hospitalisation compared with the control group (153 vs 253, HR 0.64, 95% CI 0.55-0.75; p<0.0001). Eight patients had DSRC and overall freedom from DSRC was 98.6% (97.3-99.4) compared with a prespecified performance criterion of 80% (p<0.0001); and overall freedom from pressure-sensor failures was 100% (99.3-100.0). INTERPRETATION: Our results are consistent with, and extend, previous findings by definitively showing a significant and large reduction in hospitalisation for patients with NYHA class III heart failure who were managed with a wireless implantable haemodynamic monitoring system. The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved heart failure management. FUNDING: CardioMEMS. CI - Copyright (c) 2011 Elsevier Ltd. All rights reserved. FAU - Abraham, William T AU - Abraham WT AD - Ohio State University Heart and Vascular Center, Columbus, OH, USA. FAU - Adamson, Philip B AU - Adamson PB FAU - Bourge, Robert C AU - Bourge RC FAU - Aaron, Mark F AU - Aaron MF FAU - Costanzo, Maria Rosa AU - Costanzo MR FAU - Stevenson, Lynne W AU - Stevenson LW FAU - Strickland, Warren AU - Strickland W FAU - Neelagaru, Suresh AU - Neelagaru S FAU - Raval, Nirav AU - Raval N FAU - Krueger, Steven AU - Krueger S FAU - Weiner, Stanislav AU - Weiner S FAU - Shavelle, David AU - Shavelle D FAU - Jeffries, Bradley AU - Jeffries B FAU - Yadav, Jay S AU - Yadav JS CN - CHAMPION Trial Study Group LA - eng SI - ClinicalTrials.gov/NCT00531661 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Lancet JT - Lancet (London, England) JID - 2985213R SB - IM EIN - Lancet. 2012 Feb 4;379(9814):412 CIN - Lancet. 2011 Feb 19;377(9766):616-8. PMID: 21315440 CIN - Lancet. 2011 Jun 25;377(9784):2176-7; author reply 2177. PMID: 21704862 CIN - Lancet. 2011 Jun 25;377(9784):2176; author reply 2177. PMID: 21704863 MH - Aged MH - Blood Pressure Monitoring, Ambulatory/*instrumentation MH - Cardiac Catheterization/instrumentation MH - *Electrodes, Implanted MH - Equipment Design MH - Equipment Failure Analysis MH - Follow-Up Studies MH - Heart Failure/*diagnosis/*physiopathology MH - Hemodynamics/*physiology MH - Hospitalization/statistics & numerical data MH - Humans MH - *Lab-On-A-Chip Devices MH - Middle Aged MH - Pulmonary Artery MH - Pulmonary Wedge Pressure/*physiology MH - Remote Sensing Technology/*instrumentation MH - Single-Blind Method FIR - Abraham, William T IR - Abraham WT FIR - Adamson, Philip B IR - Adamson PB FIR - Bourge, Robert B IR - Bourge RB FIR - Aaron, Mark F IR - Aaron MF FIR - Stevenson, Lynne W IR - Stevenson LW FIR - Aranda, Juan IR - Aranda J FIR - Smith, Andy IR - Smith A FIR - Jessup, Mariel IR - Jessup M FIR - Starling, Randy IR - Starling R FIR - Lindenfeld, JoAnn IR - Lindenfeld J FIR - Greenberg, Barry IR - Greenberg B FIR - Wexler, Randy IR - Wexler R FIR - D'Agostino, Ralph Jr IR - D'Agostino R Jr FIR - Lazarra, Ralph IR - Lazarra R FIR - Ghali, Jalal IR - Ghali J FIR - Miller, Alan IR - Miller A FIR - Carson, Peter IR - Carson P FIR - Teerlink, John IR - Teerlink J FIR - Levy, Wayne IR - Levy W FIR - Chung, Gene IR - Chung G FIR - Gilbert, Mike IR - Gilbert M FIR - Scharrer, Carol IR - Scharrer C FIR - Hasan, Ayesha IR - Hasan A FIR - Yamokoski, Laura IR - Yamokoski L FIR - Box, Laura IR - Box L FIR - Staehling, Heidi IR - Staehling H FIR - Johnson, Kristina IR - Johnson K FIR - Welch, Tanya IR - Welch T FIR - Fitzner, Helen IR - Fitzner H FIR - Eley, Melanie IR - Eley M FIR - VanPatten, Laura IR - VanPatten L FIR - Boshart, Shari IR - Boshart S FIR - Murphy, Greg IR - Murphy G FIR - Holt, Linda IR - Holt L FIR - Mayoralgo, Cecile IR - Mayoralgo C FIR - Shea, Deanna IR - Shea D FIR - Chronos, Nick IR - Chronos N FIR - Allen, Rebecca IR - Allen R FIR - Pamboukian, Salpy IR - Pamboukian S FIR - Horton, Gina IR - Horton G FIR - Roher, Karen IR - Roher K FIR - Cotts, William IR - Cotts W FIR - Trocchio, Wendy IR - Trocchio W FIR - Francis, Gary IR - Francis G FIR - Wilson, Betsy IR - Wilson B FIR - Neiderman, Alan IR - Neiderman A FIR - Toot, Cynthia IR - Toot C FIR - Patel, Amar IR - Patel A FIR - LaCorte, Jennifer IR - LaCorte J FIR - Weinstock, Barry IR - Weinstock B FIR - Viera-Fleetwood, Ingrid IR - Viera-Fleetwood I FIR - Jimenez, Javier IR - Jimenez J FIR - Silva, Adriana IR - Silva A FIR - Bensimhon, Daniel IR - Bensimhon D FIR - Garman, Vivian IR - Garman V FIR - French, William IR - French W FIR - Barillas, Olga IR - Barillas O FIR - Hott, Brenda IR - Hott B FIR - Nesbitt, Gina IR - Nesbitt G FIR - Youngman, Darrell IR - Youngman D FIR - Collie, Donna IR - Collie D FIR - Shawl, Fayaz IR - Shawl F FIR - Shaddinger, Dawn IR - Shaddinger D FIR - Kfoury, A G IR - Kfoury AG FIR - Endo, Michelle IR - Endo M FIR - Aranda, Juan IR - Aranda J FIR - Leach, Dana IR - Leach D FIR - Goldberg, Lee IR - Goldberg L FIR - Pickering, Faith IR - Pickering F FIR - Jonsson, Orvar IR - Jonsson O FIR - Reilly, Karla IR - Reilly K FIR - Givertz, Michael IR - Givertz M FIR - Anello, Susan IR - Anello S FIR - Boemer, John P IR - Boemer JP FIR - Dwyer, Karen IR - Dwyer K FIR - Myers, Andrea IR - Myers A FIR - Bouchard, Alain IR - Bouchard A FIR - Deramus, Susan IR - Deramus S FIR - Dorogy, Mark IR - Dorogy M FIR - Knott, Carrie IR - Knott C FIR - Parrott, Charles IR - Parrott C FIR - Flock, Cheryl IR - Flock C FIR - Mann, Tift IR - Mann T FIR - Reddersen, Lindsey IR - Reddersen L FIR - Goldsmith, Steven IR - Goldsmith S FIR - Lascewski, Debra IR - Lascewski D FIR - Burnham, Kenneth IR - Burnham K FIR - Greenwell, Dawn IR - Greenwell D FIR - Eagan, Tom IR - Eagan T FIR - Frew, Suzanne IR - Frew S FIR - Frank, Theodore IR - Frank T FIR - Dellinger, Connie IR - Dellinger C FIR - Karia, Darshak IR - Karia D FIR - Murthy, Kannari IR - Murthy K FIR - Kilgallon, Kathleen IR - Kilgallon K FIR - Johnson, Frances IR - Johnson F FIR - Larew, Cynthia IR - Larew C FIR - Ewald, Gregory IR - Ewald G FIR - Flanagan, Jean IR - Flanagan J FIR - Clemson, Barry IR - Clemson B FIR - Pierson, Marsha IR - Pierson M FIR - Jaski, Brian IR - Jaski B FIR - Kohlmyer, Chris IR - Kohlmyer C FIR - Loyalka, Pranav IR - Loyalka P FIR - Parker, Anita IR - Parker A FIR - Torre-Amione, Guillermo IR - Torre-Amione G FIR - Arredondo, Jeannie IR - Arredondo J FIR - Mathier, Michael IR - Mathier M FIR - Pisarcik, Jessica IR - Pisarcik J FIR - Haeusslein, Ernest IR - Haeusslein E FIR - McDonagh, Shelia IR - McDonagh S FIR - Saxon, Leslie IR - Saxon L FIR - Adams, Karen IR - Adams K FIR - Williams, Celeste IR - Williams C FIR - Teats, Jill IR - Teats J FIR - Dickinson, Michael IR - Dickinson M FIR - McClain, Kim IR - McClain K FIR - Reisman, Mark IR - Reisman M FIR - Crawford, Luba IR - Crawford L FIR - Garret, Ed IR - Garret E FIR - Lee, Amanda IR - Lee A FIR - Simoni, Eugene IR - Simoni E FIR - Sullin, Sam IR - Sullin S FIR - Snell, Gail IR - Snell G FIR - Mancini, Donna IR - Mancini D FIR - Williams, Paula IR - Williams P FIR - Silver, Marc IR - Silver M FIR - Ichniowski, Lauretta IR - Ichniowski L FIR - Wrona, Laura IR - Wrona L FIR - Waksman, Ron IR - Waksman R FIR - Griffin, Sandra IR - Griffin S FIR - Mullen, G Martin IR - Mullen GM FIR - Baumann, Mary Lou IR - Baumann ML FIR - Benza, Raymond IR - Benza R FIR - Carothers, Joe IR - Carothers J FIR - Small, Roy IR - Small R FIR - Bowman, Linda IR - Bowman L FIR - Freudenberger, Ronald IR - Freudenberger R FIR - Vermeersch, Marika IR - Vermeersch M FIR - Ferniak, Henry IR - Ferniak H FIR - O'Donnell, Kathleen IR - O'Donnell K FIR - Nygaard, Thomas IR - Nygaard T FIR - White, Joyce IR - White J FIR - Bertolet, Barry IR - Bertolet B FIR - Tutor, Terri IR - Tutor T FIR - Heywood, Thomas IR - Heywood T FIR - Reyes, Maria IR - Reyes M EDAT- 2011/02/15 06:00 MHDA- 2011/03/30 06:00 CRDT- 2011/02/15 06:00 PHST- 2011/02/15 06:00 [entrez] PHST- 2011/02/15 06:00 [pubmed] PHST- 2011/03/30 06:00 [medline] AID - S0140-6736(11)60101-3 [pii] AID - 10.1016/S0140-6736(11)60101-3 [doi] PST - ppublish SO - Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3.