Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure
Lars Køber, Jens J Thune, Jens C Nielsen, Jens Haarbo, Lars Videbæk, Eva Korup, Gunnar Jensen, Per Hildebrandt, Flemming H Steffensen, Niels E Bruun, Hans Eiskjær, Axel Brandes, Anna M Thøgersen, Finn Gustafsson, Kenneth Egstrup, Regitze Videbæk, Christian Hassager, Jesper H Svendsen, Dan E Høfsten, Christian Torp-Pedersen, Steen Pehrson, DANISH Investigators, Eva Korup, Anna Margrethe Thøgersen, Jens Cosedis Nielsen, Hans Eiskjær, Olav Wendelboe Nielsen, Jens Jakob Thune, Nana Valeur Køber, Ilan Esra Raymond, Niels Eske Bruun, Jens Haarbo, Jawdat Abdulla, Morten Schou, Peter Kaiser-Nielsen, Jens Handberg, Henrik Ancher Sørensen, Karen Kaae Dodt, Søren Lind Rasmussen, Ulrik Dixen, Tonni Nielsen, Flemming H Steffensen, Lisbeth Tingsted, Lars Videbæk, Axel Brandes, Lars Køber, Steen Pehrson, Jesper Hastrup-Svendesen, Berit Thronvig Philbert, Helen Høgh Pedersen, Line Olesen, Gunnar Jensen, Pernille Buch, Hanne Elming, Henrik Ryde, Jens Refsgaard, Lars Køber, Jens J Thune, Jens C Nielsen, Jens Haarbo, Lars Videbæk, Eva Korup, Gunnar Jensen, Per Hildebrandt, Flemming H Steffensen, Niels E Bruun, Hans Eiskjær, Axel Brandes, Anna M Thøgersen, Finn Gustafsson, Kenneth Egstrup, Regitze Videbæk, Christian Hassager, Jesper H Svendsen, Dan E Høfsten, Christian Torp-Pedersen, Steen Pehrson, DANISH Investigators, Eva Korup, Anna Margrethe Thøgersen, Jens Cosedis Nielsen, Hans Eiskjær, Olav Wendelboe Nielsen, Jens Jakob Thune, Nana Valeur Køber, Ilan Esra Raymond, Niels Eske Bruun, Jens Haarbo, Jawdat Abdulla, Morten Schou, Peter Kaiser-Nielsen, Jens Handberg, Henrik Ancher Sørensen, Karen Kaae Dodt, Søren Lind Rasmussen, Ulrik Dixen, Tonni Nielsen, Flemming H Steffensen, Lisbeth Tingsted, Lars Videbæk, Axel Brandes, Lars Køber, Steen Pehrson, Jesper Hastrup-Svendesen, Berit Thronvig Philbert, Helen Høgh Pedersen, Line Olesen, Gunnar Jensen, Pernille Buch, Hanne Elming, Henrik Ryde, Jens Refsgaard
Abstract
Background: The benefit of an implantable cardioverter-defibrillator (ICD) in patients with symptomatic systolic heart failure caused by coronary artery disease has been well documented. However, the evidence for a benefit of prophylactic ICDs in patients with systolic heart failure that is not due to coronary artery disease has been based primarily on subgroup analyses. The management of heart failure has improved since the landmark ICD trials, and many patients now receive cardiac resynchronization therapy (CRT).
Methods: In a randomized, controlled trial, 556 patients with symptomatic systolic heart failure (left ventricular ejection fraction, ≤35%) not caused by coronary artery disease were assigned to receive an ICD, and 560 patients were assigned to receive usual clinical care (control group). In both groups, 58% of the patients received CRT. The primary outcome of the trial was death from any cause. The secondary outcomes were sudden cardiac death and cardiovascular death.
Results: After a median follow-up period of 67.6 months, the primary outcome had occurred in 120 patients (21.6%) in the ICD group and in 131 patients (23.4%) in the control group (hazard ratio, 0.87; 95% confidence interval [CI], 0.68 to 1.12; P=0.28). Sudden cardiac death occurred in 24 patients (4.3%) in the ICD group and in 46 patients (8.2%) in the control group (hazard ratio, 0.50; 95% CI, 0.31 to 0.82; P=0.005). Device infection occurred in 27 patients (4.9%) in the ICD group and in 20 patients (3.6%) in the control group (P=0.29).
Conclusions: In this trial, prophylactic ICD implantation in patients with symptomatic systolic heart failure not caused by coronary artery disease was not associated with a significantly lower long-term rate of death from any cause than was usual clinical care. (Funded by Medtronic and others; DANISH ClinicalTrials.gov number, NCT00542945 .).
Source: PubMed