Author + information
- Received January 9, 2019
- Revision received March 29, 2019
- Accepted March 31, 2019
- Published online July 10, 2019.
- Søren Lund Kristensen, MD, PhDa,b,∗ (, )
- Wayne C. Levy, MDc,
- Ramin Shadman, MDd,
- Jens C. Nielsen, MD, DMSce,
- Jens Haarbo, MD, DMScf,
- Lars Videbæk, MD, PhDg,
- Niels E. Bruun, MD, DMSch,i,
- Hans Eiskjær, MD, DMSce,
- Henrik Wiggers, MDe,
- Axel Brandes, MDg,
- Anna Margrethe Thøgersen, MD, PhDj,
- Christian Hassager, MD, DMSca,k,
- Jesper H. Svendsen, MD, DMSca,k,
- Dan E. Høfsten, MD, PhDa,
- Christian Torp-Pedersen, MD, DMScj,
- Steen Pehrson, MD, DMSca,
- James Signorovitch, PhDl,
- Lars Køber, MD, DMSca,k and
- Jens Jakob Thune, MD, PhDb,k
- aDepartment of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
- bDepartment of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark
- cUniversity of Washington, Seattle, Washington
- dSouthern California Permanente Medical Group, Los Angeles, California
- eDepartment of Cardiology, Aarhus University Hospital, Aarhus, Denmark
- fDepartment of Cardiology, Gentofte University Hospital, Copenhagen, Denmark
- gDepartment of Cardiology, Odense University Hospital, Odense, Denmark
- hDepartment of Cardiology, Zealand University Hospital, Roskilde, Denmark
- iClinical Institute, Copenhagen and Aalborg Universities, Denmark
- jDepartment of Cardiology, Aalborg University Hospital, Aalborg, Denmark
- kDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark
- lAnalysis Group, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. Søren Lund Kristensen, Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, 2100, Denmark.
Objectives This study aims to identify patients with nonischemic heart failure who are more likely to benefit from implantable cardioverter-defibrillator (ICD) implantation by use of established risk prediction models.
Background It has been debated whether an ICD for primary prevention reduces mortality in patients with nonischemic heart failure.
Methods The Seattle Heart Failure Model (SHFM) predicts all-cause mortality whereas the Seattle Proportional Risk Model (SPRM) predicts the proportion of sudden cardiac death (SCD) versus nonsudden death, with a higher score indicating a greater proportion of SCD. We report the effect of ICD implantation on all-cause mortality and SCD, according to median SPRM and SHFM scores in all 1,116 patients enrolled in the DANISH (Danish study to Assess the Efficacy of ICDs in Patients with Non-ischemic Systolic Heart Failure on mortality) trial.
Results Among patients with an SPRM score above the median (n = 558), ICD implantation reduced all-cause mortality (hazard ratio [HR]: 0.63, 95% confidence interval [CI]: 0.43 to 0.94), whereas patients with lower SPRM scores (n = 558) had no effect (HR: 1.08, 95% CI: 0.78 to 1.49, p for interaction = 0.04). The corresponding numbers for SHFM score above and below the median were HR: 0.84, 95% CI: 0.62 to 1.13 and HR: 0.82, 95% CI: 0.53 to 1.28, respectively (p for interaction = 0.980). In 177 patients with upper SPRM/upper SHFM, ICD implantation reduced all-cause mortality (HR: 0.45, 95% CI: 0.25 to 0.80) when compared to 381 patients with lower SPRM/upper SHFM (HR: 1.09, 95% CI: 0.76 to 1.55) (p for interaction < 0.001).
Conclusions Nonischemic heart failure patients with high predicted relative likelihood of SCD, as estimated by higher SPRM score, seemed to benefit from ICD implantation. (DANISH [Danish ICD Study in Patients With Ditaled Cardiomyopathy]; NCT00542945)
The DANISH trial was supported by unrestricted grants from Medtronic, St. Jude Medical, TrygFonden, and the Danish Heart Foundation. The University of Washington Comotion owns the copyrights to the SHFM and SPRM and has received licensing fees for the SHFM from various companies. Dr. Levy is on Steering Committee for GE Healthcare; is on the Clinical Endpoint Committee for CardioMems (Abbott) and EBR Systems, Inc; and is a consultant to Novartis and Impulse Dynamics. Dr. Nielsen has received a research grant from Novo Nordisk Foundation. Dr. Videbæk has received fees for serving on advisory boards from Novartis, AstraZeneca, and Boehringer Ingelheim; and has received lecture fees from Novartis. Dr. Bruun has received lecture fees from Biotronik. Dr. Brandes has received lecture fees from Bayer, Boehringer Ingelheim, MSD, and Pfizer. Dr. Svendsen has received fees for serving on an advisory board from Medtronic; has received lecture fees from Medtronic, Biotronik, AstraZeneca, and Boehringer Ingelheim; and has received grant support from Medtronic, Biotronik, and Gilead Sciences. Dr. Torp-Pedersen has received lecture fees and grant support from Bayer. Dr. Pehrson has received lecture fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Servier. Dr. Køber has received lecture fees from Sanofi and Novartis. Dr. Thune has received lecture fees from Bristol-Myers Squibb; and has received personal fees and travel support from Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 9, 2019.
- Revision received March 29, 2019.
- Accepted March 31, 2019.
- 2019 American College of Cardiology Foundation
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