Effect of Pacing for Soft Indications on Mortality and Heart Failure in the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial

Kutalek, Steven P.; Sharma, Arjun D.; McWilliams, Michael J.; Wilkoff, Bruce L.; Leonen, Anna; Hallstrom, Alfred P.; Kudenchuk, Peter J.

doi:10.1111/j.1540-8159.2008.01106.x

Cited by 22 publications

(17 citation statements)

References 33 publications

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“…Heart failure disease progression and ventricular dyssynchrony might differently affect the prognosis as compared with overall population and ICD recipients without left ventricle dyssynchrony. These data have been confirmed by major trials, including the Mode Selection Trial (MOST) and the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial . These studies have determined that right ventricular pacing is detrimental in terms of heart failure symptoms, and the current practice is to avoid unnecessary ventricular pacing in ICD recipients .…”

Section: Discussionmentioning

confidence: 86%

Telemonitoring in heart failure patients treated by cardiac resynchronisation therapy with defibrillator (CRT-D): the TELECART Study

Sardu

Santamaria²,

Rizzo

et al. 2016

Int J Clin Pract

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SUMMARY Aim Telemonitoring (TM) is a safe and efficient monitoring system for internal cardioverter defibrillator device (ICD) recipients. TM has been used to track info on the clinical status of heart failure patients treated by ICD and/or cardiac resynchronisation therapy defibrillator (CRT-D). The aim of this study was to investigate the impact of TM on clinical outcomes in a population of CRT-D patients with heart failure. Methods In a multicentre, randomised study, patients with chronic heart failure, New York Heart Association (NYHA) functional class II or III, left bundle branch block, severe left ventricle ejection fraction reduction (LVEF < 35%) have been identified and screened. Results One hundred and ninety-one patients have been randomised to receive either a CRT-D with TM or a CRT-D with traditional ambulatory monitoring (control group) and completed the 12-month study follow-up. Primary endpoints were all cause death, cardiac death and hospital admission for heart failure. Secondary endpoints were atrial fibrillation, sustained episodes, non-sustained and self terminated ventricular tachyarrhythmia, sustained ventricular tachycardia, and ventricular fibrillation, ICD shocks and percentage of CRT-D responder patients. Univariate analysis identified the following factors predicting hospitalisation: TM, age, chronic kidney disease, hypercholesterolaemia, LVEF and NYHA class. At multivariate analysis, TM was the only factor predicting heart failure hospitalisation (hazard ratio 0.6, 0.42–0.79, 95% CI, p = 0.002), without affecting overall mortality and cardiac deaths events. Conclusions Taken together, our data indicate the importance of TM in predicting heart failure hospitalisation in patients treated with CRT-D.

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Section: Discussionmentioning

confidence: 86%

Telemonitoring in heart failure patients treated by cardiac resynchronisation therapy with defibrillator (CRT-D): the TELECART Study

Sardu

Santamaria²,

Rizzo

et al. 2016

Int J Clin Pract

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“…16 Interestingly, a substudy from the DAVID trial showed that the outcome with DDD pacing versus VVI was similarly unfavorable in patients with a long PR (>200 ms). 17 Hence, introducing dyssynchrony by right ventricular pacing in patients with HF outweighed the benefit from improved AV timing.…”

Section: Discussionmentioning

confidence: 99%

PR Interval Identifies Clinical Response in Patients With Non–Left Bundle Branch Block

Kutyifa

Stockburger

Daubert

et al. 2014

Circ: Arrhythmia and Electrophysiology

102

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Therapy (MADIT-CRT) trial showed that the benefit from CRT was evident in patients with left bundle branch block (LBBB) but not in those with non-LBBB. Clinical Perspective on p 651It has also been shown that in patients with HF, a prolonged PR interval is associated with unfavorable clinical outcome, 7,8 and there is a benefit from shortening atrioventricular (AV) conduction delay in CRT patients. We hypothesized that this effect is more relevant in patients with non-LBBB and may identify responders to CRT with defibrillator (CRT-D).The effects of CRT-D therapy on clinical outcome in non-LBBB patients (including right bundle branch block [RBBB] and intraventricular conduction delay [IVCD] Original ArticleBackground-In Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT), patients with non-left bundle branch block (LBBB; including right bundle branch block, intraventricular conduction delay) did not have clinical benefit from cardiac resynchronization therapy with defibrillator (CRT-D). We hypothesized that baseline PR interval modulates clinical response to CRT-D therapy in patients with non-LBBB. Methods and Results-Non-LBBB patients (n=537; 30%) were divided into 2 groups based on their baseline PR interval as normal (including minimally prolonged) PR (PR <230 ms) and prolonged PR (PR ≥230 ms). The primary end point was heart failure or death. Separate secondary end points included heart failure events and all-cause mortality. Cox proportional hazards regression models were used to compare risk of end point events by CRT-D to implantable cardioverter defibrillator therapy in the PR subgroups. There were 96 patients (22%) with a prolonged PR and 438 patients (78%) with a normal PR interval. In non-LBBB patients with a prolonged PR interval, CRT-D treatment was associated with a 73% reduction in the risk of heart failure/death (hazard ratio, 0.27; 95% confidence interval, 0.13-0.57; P<0.001) and 81% decrease in the risk of all-cause mortality (hazard ratio, 0.19; 95% confidence interval, 0.13-0.57; P<0.001) compared with implantable cardioverter defibrillator therapy. In non-LBBB patients with normal PR, CRT-D therapy was associated with a trend toward an increased risk of heart failure/death (hazard ratio, Therefore, the aim of the present study was (1) to investigate the effect of baseline PR interval on clinical outcome in patients with non-LBBB, and (2) to assess clinical response to CRT-D versus implantable cardioverter-defibrillator (ICD) therapy in patients with non-LBBB and normal or prolonged PR interval at baseline. Methods Study PopulationThe design, protocol, and results of the MADIT-CRT study have been published previously. 4,9 In short, 1820 patients with ischemic cardiomyopathy (New York Heart Association functional class I or II) or nonischemic cardiomyopathy (New York Heart Association functional class II only), left ventricular (LV) EF <30%, and a wide QRS with a duration ≥130 ms were randomized to receive CRT-D or ICD therapy in a 3:2 ratio. ...

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“…Of the vast array of sophisticated programming possibilities (2), pacing options can mitigate bradycardia, chronotropic incompetence, episodic asystole and atrioventricular (AV) block should they develop (3), as they often do (4 -6). However, dual chamber pacing for these and other soft indications may lead to adverse outcomes (7).…”

Section: Iowa City Iowamentioning

confidence: 99%

DAVID II Did Not Slay Goliath

Olshansky

Gopinathannair

Sullivan

2009

Journal of the American College of Cardiology

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Effect of Pacing for Soft Indications on Mortality and Heart Failure in the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial

Abstract: Sinus bradycardia or first-degree atrioventricular block did not ameliorate the poor outcomes associated with dual-chamber compared with VVI pacing, and do not justify conventional dual-chamber pacing in defibrillator recipients with ventricular dysfunction.

Cited by 22 publications

References 33 publications

Telemonitoring in heart failure patients treated by cardiac resynchronisation therapy with defibrillator (CRT-D): the TELECART Study

Telemonitoring in heart failure patients treated by cardiac resynchronisation therapy with defibrillator (CRT-D): the TELECART Study

PR Interval Identifies Clinical Response in Patients With Non–Left Bundle Branch Block

DAVID II Did Not Slay Goliath

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