Michael E Nassif1, Yuanyuan Tang1, John G Cleland1, William T Abraham1, Cecilia Linde1, Michael R Gold1, James B Young1, J Claude Daubert1, Lou Sherfesee1, Dan Schaber1, Anthony S L Tang1, Philip G Jones1, Suzanne V Arnold1, John A Spertus2. 1. From the Division of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., Y.T., P.G.J., S.V.A., J.A.S.); Division of Bioinformatics, University of Missouri-Kansas City (M.E.N., P.G.J., S.V.A., J.A.S.); Division of Cardiology, National Heart and Lung Institute, Imperial College London, England, United Kingdom (Royal Brompton and Harefield Hospitals) (J.G.C.); Department of Cardiology, Castle Hill Hospital, University of Hull, Kingston upon Hull, United Kingdom (J.G.C.); Division of Cardiovascular Medicine (W.T.A.) and Davis Heart and Lung Research Institute (W.T.A.), Ohio State University, Columbus (W.T.A.); Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden (C.L.); Division of Cardiology, Medical University of South Carolina, Charleston (M.R.G.); Division of Cardiology, Cleveland Clinic Lerner College of Medicine, OH (J.B.Y.); Departement de Cardiologie, CHU Rennes, France (J.C.D.); Medtronic, Inc, Minneapolis, MN (L.S., D.S.); and Division of Cardiology, Island Medical Program, University of British Columbia, Vancouver, Canada (A.S.L.T.). 2. From the Division of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., Y.T., P.G.J., S.V.A., J.A.S.); Division of Bioinformatics, University of Missouri-Kansas City (M.E.N., P.G.J., S.V.A., J.A.S.); Division of Cardiology, National Heart and Lung Institute, Imperial College London, England, United Kingdom (Royal Brompton and Harefield Hospitals) (J.G.C.); Department of Cardiology, Castle Hill Hospital, University of Hull, Kingston upon Hull, United Kingdom (J.G.C.); Division of Cardiovascular Medicine (W.T.A.) and Davis Heart and Lung Research Institute (W.T.A.), Ohio State University, Columbus (W.T.A.); Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden (C.L.); Division of Cardiology, Medical University of South Carolina, Charleston (M.R.G.); Division of Cardiology, Cleveland Clinic Lerner College of Medicine, OH (J.B.Y.); Departement de Cardiologie, CHU Rennes, France (J.C.D.); Medtronic, Inc, Minneapolis, MN (L.S., D.S.); and Division of Cardiology, Island Medical Program, University of British Columbia, Vancouver, Canada (A.S.L.T.). spertusj@umkc.edu.
Abstract
BACKGROUND: Clinical trials have established the average benefit of cardiac resynchronization therapy (CRT), but estimating benefit for individual patients remains difficult because of the heterogeneity in treatment response. Accordingly, we created a multivariable model to predict changes in quality of life (QoL) with and without CRT. METHODS AND RESULTS: Patient-level data from 5 randomized trials comparing CRT with no CRT were used to create a prediction model of change in QoL at 3 months using a partial proportional odds model for no change, small, moderate, and large improvement, or deterioration of any magnitude. The C statistics for not worsening or obtaining at least a small, moderate, and large improvement were calculated. Among the 3614 patients, regardless of assigned treatment, 33.3% had a deterioration in QoL, 9.2% had no change, 9.2% had a small improvement, 13.5% had a moderate improvement, and the remaining 34.9% had a large improvement. Patients undergoing CRT were less likely to have a decrement in their QoL (28.2% versus 38.9%; P<0.001) and more likely to have a large QoL improvement (38.7% versus 30.6%; P<0.001). A partial proportional odds model identified baseline QoL, age, and an interaction of CRT with QRS duration as predictors of QoL benefits 3 months after randomization. C statistics of 0.65 for not worsening, 0.68 for at least a small improvement, 0.69 for at least a moderate improvement, and 0.73 for predicting a large improvement were observed. CONCLUSIONS: There is marked heterogeneity of treatment benefit of CRT that can be predicted based on baseline QoL, age, and QRS duration.
BACKGROUND: Clinical trials have established the average benefit of cardiac resynchronization therapy (CRT), but estimating benefit for individual patients remains difficult because of the heterogeneity in treatment response. Accordingly, we created a multivariable model to predict changes in quality of life (QoL) with and without CRT. METHODS AND RESULTS:Patient-level data from 5 randomized trials comparing CRT with no CRT were used to create a prediction model of change in QoL at 3 months using a partial proportional odds model for no change, small, moderate, and large improvement, or deterioration of any magnitude. The C statistics for not worsening or obtaining at least a small, moderate, and large improvement were calculated. Among the 3614 patients, regardless of assigned treatment, 33.3% had a deterioration in QoL, 9.2% had no change, 9.2% had a small improvement, 13.5% had a moderate improvement, and the remaining 34.9% had a large improvement. Patients undergoing CRT were less likely to have a decrement in their QoL (28.2% versus 38.9%; P<0.001) and more likely to have a large QoL improvement (38.7% versus 30.6%; P<0.001). A partial proportional odds model identified baseline QoL, age, and an interaction of CRT with QRS duration as predictors of QoL benefits 3 months after randomization. C statistics of 0.65 for not worsening, 0.68 for at least a small improvement, 0.69 for at least a moderate improvement, and 0.73 for predicting a large improvement were observed. CONCLUSIONS: There is marked heterogeneity of treatment benefit of CRT that can be predicted based on baseline QoL, age, and QRS duration.
Authors: William T Abraham; Westby G Fisher; Andrew L Smith; David B Delurgio; Angel R Leon; Evan Loh; Dusan Z Kocovic; Milton Packer; Alfredo L Clavell; David L Hayes; Myrvin Ellestad; Robin J Trupp; Jackie Underwood; Faith Pickering; Cindy Truex; Peggy McAtee; John Messenger Journal: N Engl J Med Date: 2002-06-13 Impact factor: 91.245
Authors: Anthony S L Tang; George A Wells; Mario Talajic; Malcolm O Arnold; Robert Sheldon; Stuart Connolly; Stefan H Hohnloser; Graham Nichol; David H Birnie; John L Sapp; Raymond Yee; Jeffrey S Healey; Jean L Rouleau Journal: N Engl J Med Date: 2010-11-14 Impact factor: 91.245
Authors: Michael R Gold; Claude Daubert; William T Abraham; Stefano Ghio; Martin St John Sutton; John Harrison Hudnall; Jeffrey Cerkvenik; Cecilia Linde Journal: Heart Rhythm Date: 2014-11-15 Impact factor: 6.343
Authors: Robbert Zusterzeel; Kimberly A Selzman; William E Sanders; Daniel A Caños; Kathryn M O'Callaghan; Jamie L Carpenter; Ileana L Piña; David G Strauss Journal: JAMA Intern Med Date: 2014-08 Impact factor: 21.873
Authors: John G F Cleland; Jean-Claude Daubert; Erland Erdmann; Nick Freemantle; Daniel Gras; Lukas Kappenberger; Luigi Tavazzi Journal: N Engl J Med Date: 2005-03-07 Impact factor: 91.245
Authors: Robbert Zusterzeel; Jeptha P Curtis; Daniel A Caños; William E Sanders; Kimberly A Selzman; Ileana L Piña; Erica S Spatz; Haikun Bao; Angelo Ponirakis; Paul D Varosy; Frederick A Masoudi; David G Strauss Journal: J Am Coll Cardiol Date: 2014-09-02 Impact factor: 24.094
Authors: Suzanne V Arnold; Khaja M Chinnakondepalli; John A Spertus; Elizabeth A Magnuson; Suzanne J Baron; Saibal Kar; D Scott Lim; Jacob M Mishell; William T Abraham; JoAnn A Lindenfeld; Michael J Mack; Gregg W Stone; David J Cohen Journal: J Am Coll Cardiol Date: 2019-03-17 Impact factor: 24.094
Authors: Suzanne V Arnold; Zhuokai Li; Sreekanth Vemulapalli; Suzanne J Baron; Michael J Mack; Andrzej S Kosinski; Matthew R Reynolds; James B Hermiller; John S Rumsfeld; David J Cohen Journal: JAMA Cardiol Date: 2018-12-01 Impact factor: 14.676
Authors: Paul A Heidenreich; Gregg C Fonarow; Khadijah Breathett; Corrine Y Jurgens; Barbara A Pisani; Bunny J Pozehl; John A Spertus; Kenneth G Taylor; Jennifer T Thibodeau; Clyde W Yancy; Boback Ziaeian Journal: Circ Cardiovasc Qual Outcomes Date: 2020-11-02
Authors: Paul A Heidenreich; Gregg C Fonarow; Khadijah Breathett; Corrine Y Jurgens; Barbara A Pisani; Bunny J Pozehl; John A Spertus; Kenneth G Taylor; Jennifer T Thibodeau; Clyde W Yancy; Boback Ziaeian Journal: J Am Coll Cardiol Date: 2020-11-02 Impact factor: 24.094