Percent right ventricular pacing predicts outcomes in the DAVID trial

doi:10.1016/j.hrthm.2005.05.015

Heart Rhythm

Volume 2, Issue 8, August 2005, Pages 830-834

https://doi.org/10.1016/j.hrthm.2005.05.015 Get rights and content

Background

The Dual-Chamber and VVI Implantable Defibrillator (DAVID) trial demonstrated a worse outcome in patients with implantable cardioverter-defibrillators (ICDs) programmed to DDDR at 70 bpm compared with patients who had ICDs programmed to VVI backup pacing at 40 bpm. Pacing was more frequent in the DDDR group.

Objectives

The purpose of this study was to determine whether right ventricular pacing (RV) is an independent predictor of outcome in the DAVID trial.

Methods

We evaluated the relationship of percent RV pacing to the composite endpoint of death or hospitalization for congestive heart failure. Patients who had a 3-month follow-up and who had not yet reached an endpoint were included in the study. Using Cox regression analysis (VVI group N = 195; DDDR group N = 185), we examined multiple factors, including percent RV pacing at 3-month follow-up, that might be associated with adverse outcomes.

Results

Percent RV pacing as a continuous variable was correlated with the primary endpoint. As a dichotomous variable, the best separation for predicting endpoints occurred with DDDR RV pacing >40% vs DDDR RV pacing ≤40% (P = .025). Patients with DDDR RV pacing ≤40% had similar or better outcomes to the VVI backup group (P = .07). Correction for baseline variables predictive of the composite outcome in the (nonpaced) VVI group (use of nitrates, increased heart rate, and increased age) did not change the findings for RV pacing (P = .008). In contrast, atrial pacing was not predictive of worse outcomes.

Conclusion

These results suggest, but do not prove, a causal relationship between frequent RV pacing and adverse outcomes in patients with left ventricular ejection fraction ≤40%.

Introduction

Clinical trials have demonstrated the efficacy of implantable cardioverter-defibrillators (ICDs) to reduce mortality in patients at high risk for potentially malignant ventricular arrhythmias.1, 2, 3, 4, 5, 6, 7, 8 Most of these clinical trials used single-chamber pacing (VVI) ICDs. The recently published Dual-chamber and VVI Implantable Defibrillator (DAVID) trial was a single-blind, parallel-group, randomized prospective clinical trial comparing patients with dual-chamber pacing ICDs programmed to either VVI at 40 bpm (VVI-40) or DDDR at 70 bpm (DDDR-70).9, 10 The major new finding was that dual-chamber pacing was associated with an increase in the composite primary endpoint of death or hospitalization for congestive heart failure (CHF) at 1 year: 16.1% for the VVI-40 group vs 26.7% for the DDDR-70 group.

Several ICD and pacemaker trials have suggested that right ventricular (RV) pacing may have detrimental effects.5, 11, 12 The DAVID trial included patients needing an ICD who had a depressed ejection fraction (≤40%) and who had no clinical indication for pacing.¹⁰ The hypothesis in this trial was that the DDDR-70 mode would provide rate support to maintain or increase cardiac output and suppress arrhythmias, while allowing optimal medical therapy with drugs with known negative chronotropic effects (beta-blockers and class III antiarrhythmics). As a result of the ICD programming in relation to the intrinsic AV conduction, 60% of ventricular beats were RV paced in the DDDR-70 group compared with 2% in the VVI-40 group.¹⁰ The percent RV pacing could not be predetermined but was measured at first device follow-up at approximately 3 months. In this study, we investigated whether percent RV pacing was an independent predictor of outcomes or merely a reflection of other predisposing clinical variables. We also investigated predictors of RV pacing, as this information may assist with decisions regarding device choice and/or mode selection.

This study not only could have implications for the pacing modality used for ICDs but also could affect the choice of pacemaker programming for patients with pacemakers and intact AV conduction.

Section snippets

Methods

The DAVID trial methodology and outcomes have been previously described.9, 10 All patients had a standard indication for ICD placement for treatment of ventricular tachyarrhythmias. No patients had any indication for antibradycardia pacing. All patients gave written informed consent.

Transvenous dual-chamber pacemakers ICDs (Photon V-230HV, Photon Micro V-232, or Atlas V-240, St. Jude Medical, Sylmar, CA, USA) were implanted in all patients. Successful implantation of both the atrial and

Factors predictive of primary outcome (death or hospitalization for CHF) in the “unpaced” VVI arm patients

In the VVI group (mean percent RV pacing 0.5%), baseline factors predictive of the composite endpoint included faster baseline heart rate (hazard ratio [HR] per 10 bpm = 1.4, P = .005) and increasing age (HR per 10 years = 1.4, P = .04). At 3 months, the only additional factor predictive of outcome was nitrate use (HR = 3.8, P = .002). NYHA class, ejection fraction, and QRS duration were not predictive of outcome in the mainly unpaced VVI group.

Relationship between RV pacing and primary outcome in the DDDR arm patients

The percent RV pacing was correlated with the time

Discussion

Clinical trials demonstrating the efficacy of the ICD in improving survival were performed mostly using single-chamber (VVI) RV pacing ICDs.1, 2, 3, 4, 5, 6, 7, 8 However, the majority of defibrillators currently implanted in the United States are dual-chamber pacing devices.¹⁴

The DDDR-70 pacing limb in the DAVID trial showed a significant association with adverse outcomes.¹⁰ This retrospective analysis shows that death or hospitalization for CHF, subsequent to 3-month follow-up, was 5.3-fold

Conclusion

RV pacing is at least a univariate predictor of death and hospitalization for CHF. The most significant separation of outcomes occurs with RV pacing at a frequency >40%.

These data have implications for all patients with intact AV conduction and implanted ICDs and pacemakers, suggesting that these devices need to be programmed to minimize RV pacing. Furthermore, the excellent outcomes in the group with DDDR pacing ≤40% support the need for a study of rate support without RV pacing.

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: A complete list of the DAVID Investigators and Coordinators is given in JAMA 2002;288:3115–3123.

: Supported by a grant from the St. Jude Medical, Sylmar, California.

View full text

Original-clinicalPercent right ventricular pacing predicts outcomes in the DAVID trial

Background

Objectives

Methods

Results

Conclusion

Introduction

Section snippets

Methods

Factors predictive of primary outcome (death or hospitalization for CHF) in the “unpaced” VVI arm patients

Relationship between RV pacing and primary outcome in the DDDR arm patients

Discussion

Conclusion

Lancet

Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators

N Engl J Med

A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias

N Engl J Med

Canadian implantable defibrillator study (CIDS)a randomized trial of the implantable cardioverter defibrillator against amiodarone

Circulation

Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrestthe Cardiac Arrest Study Hamburg (CASH)

Circulation

Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction

N Engl J Med

A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators

N Engl J Med

Original-clinical
Percent right ventricular pacing predicts outcomes in the DAVID trial