BACKGROUND: For allocation of primary ICD-therapy, a possible lower limit of inclusion criteria--defining overly advanced heart failure--is less well investigated. Also, a multi-variable approach to stratification beyond ejection fraction (LVEF) appears warranted. We examined whether adding a selection limit of peak VO(2) <or= 14 ml/kg/min to LVEF <or= 20% improves stratification. Furthermore, we sought to provide current survival data and a size-estimate for prospective trials based on real-life data for this high risk cohort. METHODS: In our prospective clinical registry 1,926 patients with systolic CHF were recruited consecutively since 1994. Of these patients, 292 met the selection criteria described above. The mean age was 57.6 +/- 9.5 years, 83% were male, 37% had ischemic cardiomyopathy and 28% received primary ICD-therapy. All cause mortality was considered as end point. RESULTS: Median follow-up was 45 (18-86) months. ICD was not a significant predictor of outcome either for the entire population, or grouped according to aetiology of CHF. Still, 3-year mortality was 15% (ICD-patients) Vs. 28% (non-ICD-patients); P = 0.05; under combination medical therapy. Inversely, in ICD-patients medical combination therapy conveyed a significant survival benefit (P < 0.001). Consequently, the number-needed-to-treat was eight under combination therapy and the size estimate amounts to 300 patients for a prospective trial in this cohort. CONCLUSION: A cut-off of LVEF <or= 20% and pVO(2) <or= 14 ml/kg/min could identify patients that do not draw a significant survival benefit from adjunct primary ICD-therapy. Our results indicate the need for a specific randomized trial in this cohort. The according mortality data and a size estimate are provided.
BACKGROUND: For allocation of primary ICD-therapy, a possible lower limit of inclusion criteria--defining overly advanced heart failure--is less well investigated. Also, a multi-variable approach to stratification beyond ejection fraction (LVEF) appears warranted. We examined whether adding a selection limit of peak VO(2) <or= 14 ml/kg/min to LVEF <or= 20% improves stratification. Furthermore, we sought to provide current survival data and a size-estimate for prospective trials based on real-life data for this high risk cohort. METHODS: In our prospective clinical registry 1,926 patients with systolic CHF were recruited consecutively since 1994. Of these patients, 292 met the selection criteria described above. The mean age was 57.6 +/- 9.5 years, 83% were male, 37% had ischemic cardiomyopathy and 28% received primary ICD-therapy. All cause mortality was considered as end point. RESULTS: Median follow-up was 45 (18-86) months. ICD was not a significant predictor of outcome either for the entire population, or grouped according to aetiology of CHF. Still, 3-year mortality was 15% (ICD-patients) Vs. 28% (non-ICD-patients); P = 0.05; under combination medical therapy. Inversely, in ICD-patients medical combination therapy conveyed a significant survival benefit (P < 0.001). Consequently, the number-needed-to-treat was eight under combination therapy and the size estimate amounts to 300 patients for a prospective trial in this cohort. CONCLUSION: A cut-off of LVEF <or= 20% and pVO(2) <or= 14 ml/kg/min could identify patients that do not draw a significant survival benefit from adjunct primary ICD-therapy. Our results indicate the need for a specific randomized trial in this cohort. The according mortality data and a size estimate are provided.
Authors: Arthur J Moss; Wojciech Zareba; W Jackson Hall; Helmut Klein; David J Wilber; David S Cannom; James P Daubert; Steven L Higgins; Mary W Brown; Mark L Andrews Journal: N Engl J Med Date: 2002-03-19 Impact factor: 91.245
Authors: Gust H Bardy; Kerry L Lee; Daniel B Mark; Jeanne E Poole; Douglas L Packer; Robin Boineau; Michael Domanski; Charles Troutman; Jill Anderson; George Johnson; Steven E McNulty; Nancy Clapp-Channing; Linda D Davidson-Ray; Elizabeth S Fraulo; Daniel P Fishbein; Richard M Luceri; John H Ip Journal: N Engl J Med Date: 2005-01-20 Impact factor: 91.245
Authors: A J Moss; W J Hall; D S Cannom; J P Daubert; S L Higgins; H Klein; J H Levine; S Saksena; A L Waldo; D Wilber; M W Brown; M Heo Journal: N Engl J Med Date: 1996-12-26 Impact factor: 91.245
Authors: Michel Komajda; Pablo Lapuerta; Nancy Hermans; José Ramon Gonzalez-Juanatey; Dirk J van Veldhuisen; Erland Erdmann; Luigi Tavazzi; Philip Poole-Wilson; Claude Le Pen Journal: Eur Heart J Date: 2005-04-12 Impact factor: 29.983
Authors: S Adam Strickberger; John D Hummel; Thomas G Bartlett; Howard I Frumin; Claudio D Schuger; Scott L Beau; Cynthia Bitar; Fred Morady Journal: J Am Coll Cardiol Date: 2003-05-21 Impact factor: 24.094
Authors: F Peters-Klimm; T Müller-Tasch; D Schellberg; A Remppis; A Barth; N Holzapfel; J Jünger; W Herzog; J Szecsenyi Journal: Clin Res Cardiol Date: 2007-11-28 Impact factor: 5.460
Authors: Eric S Ketchum; Arnold F Jacobson; James H Caldwell; Roxy Senior; Manuel D Cerqueira; Gregory S Thomas; Denis Agostini; Jagat Narula; Wayne C Levy Journal: J Nucl Cardiol Date: 2012-09-05 Impact factor: 5.952