Keith D Aaronson1, Garrick C Stewart2, Francis D Pagani3, Lynne W Stevenson4, Maryse Palardy3, Dennis M McNamara5, Donna M Mancini6, Kathleen Grady7, John Gorcsan5, Robert Kormos5, Neal Jeffries8, Wendy C Taddei-Peters8, Blair Richards9, Shokoufeh Khalatbari9, Cathie Spino10, J Timothy Baldwin8, Douglas L Mann11. 1. University of Michigan Medical School, Ann Arbor, Michigan. Electronic address: keith@med.umich.edu. 2. Brigham and Women's Hospital, Boston, Massachusetts. 3. University of Michigan Medical School, Ann Arbor, Michigan. 4. Vanderbilt University, Nashville, Tennessee. 5. University of Pittsburgh, Pittsburgh, Pennsylvania. 6. Mount Sinai, New York, New York. 7. Northwestern University, Chicago, Illinois. 8. National Heart, Lung and Blood Institute, Bethesda, Maryland. 9. Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, Michigan. 10. Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, Michigan; University of Michigan School of Public Health, Ann Arbor, Michigan. 11. Washington University, St. Louis, Missouri.
Abstract
INTRODUCTION: Improved understanding of the clinical course of ambulatory advanced chronic systolic heart failure may improve the provision of appropriate care and is central to the design of clinical trials in this population. METHODS: Twenty-one implanting ventricular assist device (VAD) centers enrolled 400 subjects in the Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL), a prospective, observational study in ambulatory, chronic, advanced systolic heart failure, designed to identify a cohort with an approximately 25% 1-year risk of the primary composite outcome of death, urgent transplant, or durable mechanical circulatory support. Inclusion criteria utilized only information collected during routine clinical care. Exclusion criteria identified patients with contraindications to VAD. Study inclusion required at least 1 of 10 high-risk criteria derived from established hospitalization and non-hospitalization markers of increased mortality risk. We evaluated the test performance characteristics of the high-risk criteria. RESULTS: Data on 373 subjects evaluable for the primary composite outcome at the 1-year visit are presented. Baseline data were consistent with a less advanced cohort than Medical Arm for Mechanically Assisted Circulatory Support or Risk Assessment (MedaMACS) and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients (ROADMAP). Freedom from the primary composite outcome was 75.9%. Non-hospitalization inclusion criteria identified 89% of patients with events. CONCLUSIONS: Using routinely obtained clinical information for enrollment, REVIVAL successfully recruited an ambulatory chronic systolic heart failure cohort with an approximately 25% annual risk of the primary composite outcome. Information from this registry will be relevant to the planning of future trials of earlier VAD use and of other interventions in this population.
INTRODUCTION: Improved understanding of the clinical course of ambulatory advanced chronic systolic heart failure may improve the provision of appropriate care and is central to the design of clinical trials in this population. METHODS: Twenty-one implanting ventricular assist device (VAD) centers enrolled 400 subjects in the Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL), a prospective, observational study in ambulatory, chronic, advanced systolic heart failure, designed to identify a cohort with an approximately 25% 1-year risk of the primary composite outcome of death, urgent transplant, or durable mechanical circulatory support. Inclusion criteria utilized only information collected during routine clinical care. Exclusion criteria identified patients with contraindications to VAD. Study inclusion required at least 1 of 10 high-risk criteria derived from established hospitalization and non-hospitalization markers of increased mortality risk. We evaluated the test performance characteristics of the high-risk criteria. RESULTS: Data on 373 subjects evaluable for the primary composite outcome at the 1-year visit are presented. Baseline data were consistent with a less advanced cohort than Medical Arm for Mechanically Assisted Circulatory Support or Risk Assessment (MedaMACS) and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart FailurePatients (ROADMAP). Freedom from the primary composite outcome was 75.9%. Non-hospitalization inclusion criteria identified 89% of patients with events. CONCLUSIONS: Using routinely obtained clinical information for enrollment, REVIVAL successfully recruited an ambulatory chronic systolic heart failure cohort with an approximately 25% annual risk of the primary composite outcome. Information from this registry will be relevant to the planning of future trials of earlier VAD use and of other interventions in this population.
Authors: Francis D Pagani; Keith D Aaronson; Robert Kormos; Douglas L Mann; Cathie Spino; Neal Jeffries; Wendy C Taddei-Peters; Donna M Mancini; Dennis M McNamara; Kathleen L Grady; John Gorcsan; Ralph Petrucci; Allen S Anderson; Henry A Glick; Michael A Acker; J Eduardo Rame; Daniel J Goldstein; Salpy V Pamboukian; Marissa A Miller; J Timothy Baldwin Journal: J Heart Lung Transplant Date: 2016-10-06 Impact factor: 10.247
Authors: Mandeep R Mehra; Nir Uriel; Yoshifumi Naka; Joseph C Cleveland; Melana Yuzefpolskaya; Christopher T Salerno; Mary N Walsh; Carmelo A Milano; Chetan B Patel; Steven W Hutchins; John Ransom; Gregory A Ewald; Akinobu Itoh; Nirav Y Raval; Scott C Silvestry; Rebecca Cogswell; Ranjit John; Arvind Bhimaraj; Brian A Bruckner; Brian D Lowes; John Y Um; Valluvan Jeevanandam; Gabriel Sayer; Abeel A Mangi; Ezequiel J Molina; Farooq Sheikh; Keith Aaronson; Francis D Pagani; William G Cotts; Antone J Tatooles; Ashok Babu; Don Chomsky; Jason N Katz; Paul B Tessmann; David Dean; Arun Krishnamoorthy; Joyce Chuang; Ia Topuria; Poornima Sood; Daniel J Goldstein Journal: N Engl J Med Date: 2019-03-17 Impact factor: 91.245
Authors: Amrut V Ambardekar; Michelle M Kittleson; Maryse Palardy; Maria M Mountis; Rhondalyn C Forde-McLean; Adam D DeVore; Salpy V Pamboukian; Jennifer T Thibodeau; Jeffrey J Teuteberg; Linda Cadaret; Rongbing Xie; Wendy Taddei-Peters; David C Naftel; James K Kirklin; Lynne W Stevenson; Garrick C Stewart Journal: J Heart Lung Transplant Date: 2018-10-01 Impact factor: 10.247
Authors: Jerry D Estep; Randall C Starling; Douglas A Horstmanshof; Carmelo A Milano; Craig H Selzman; Keyur B Shah; Matthias Loebe; Nader Moazami; James W Long; Josef Stehlik; Vigneshwar Kasirajan; Donald C Haas; John B O'Connell; Andrew J Boyle; David J Farrar; Joseph G Rogers Journal: J Am Coll Cardiol Date: 2015-10-20 Impact factor: 24.094
Authors: Emelia J Benjamin; Salim S Virani; Clifton W Callaway; Alanna M Chamberlain; Alexander R Chang; Susan Cheng; Stephanie E Chiuve; Mary Cushman; Francesca N Delling; Rajat Deo; Sarah D de Ferranti; Jane F Ferguson; Myriam Fornage; Cathleen Gillespie; Carmen R Isasi; Monik C Jiménez; Lori Chaffin Jordan; Suzanne E Judd; Daniel Lackland; Judith H Lichtman; Lynda Lisabeth; Simin Liu; Chris T Longenecker; Pamela L Lutsey; Jason S Mackey; David B Matchar; Kunihiro Matsushita; Michael E Mussolino; Khurram Nasir; Martin O'Flaherty; Latha P Palaniappan; Ambarish Pandey; Dilip K Pandey; Mathew J Reeves; Matthew D Ritchey; Carlos J Rodriguez; Gregory A Roth; Wayne D Rosamond; Uchechukwu K A Sampson; Gary M Satou; Svati H Shah; Nicole L Spartano; David L Tirschwell; Connie W Tsao; Jenifer H Voeks; Joshua Z Willey; John T Wilkins; Jason Hy Wu; Heather M Alger; Sally S Wong; Paul Muntner Journal: Circulation Date: 2018-01-31 Impact factor: 29.690
Authors: Garrick C Stewart; Michelle M Kittleson; Parag C Patel; Jennifer A Cowger; Chetan B Patel; Maria M Mountis; Frances L Johnson; Maya E Guglin; J Eduardo Rame; Jeffrey J Teuteberg; Lynne W Stevenson Journal: Circ Heart Fail Date: 2016-11 Impact factor: 8.790
Authors: Randall C Starling; Nader Moazami; Scott C Silvestry; Gregory Ewald; Joseph G Rogers; Carmelo A Milano; J Eduardo Rame; Michael A Acker; Eugene H Blackstone; John Ehrlinger; Lucy Thuita; Maria M Mountis; Edward G Soltesz; Bruce W Lytle; Nicholas G Smedira Journal: N Engl J Med Date: 2013-11-27 Impact factor: 91.245
Authors: Michelle M Kittleson; Amrut V Ambardekar; Lynne W Stevenson; Nisha A Gilotra; Palak Shah; Gregory A Ewald; Jennifer T Thibodeau; Josef Stehlik; Maryse Palardy; Jerry D Estep; Thomas M Cascino; J Timothy Baldwin; Neal Jeffries; Shokoufeh Khalatbari; Matheos Yosef; Wendy Taddei Peters; Blair Richards; Douglas L Mann; Keith D Aaronson; Garrick C Stewart Journal: J Heart Lung Transplant Date: 2021-09-16 Impact factor: 10.247
Authors: Josef Stehlik; Maria Mountis; Donald Haas; Maryse Palardy; Amrut V Ambardekar; Jerry D Estep; Gregory Ewald; Stuart D Russell; Shawn Robinson; Ulrich Jorde; Wendy C Taddei-Peters; Neal Jeffries; Blair Richards; Shokoufeh Khalatbari; Catherine Spino; J Timothy Baldwin; Douglas Mann; Garrick C Stewart; Keith D Aaronson Journal: J Heart Lung Transplant Date: 2019-11-20 Impact factor: 10.247
Authors: Thomas M Cascino; Michelle M Kittleson; Anuradha Lala; Josef Stehlik; Maryse Palardy; Salpy V Pamboukian; Gregory A Ewald; Maria M Mountis; Douglas A Horstmanshof; Shawn W Robinson; Palak Shah; Ulrich P Jorde; Rhondalyn C McLean; Blair Richards; Shokoufeh Khalatbari; Cathie Spino; Wendy C Taddei-Peters; Kathleen L Grady; Douglas L Mann; Lynne W Stevenson; Garrick C Stewart; Keith D Aaronson Journal: Circ Heart Fail Date: 2020-05-18 Impact factor: 8.790