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Inhibition of Unnecessary RV Pacing with AV Search Hysteresis in ICDs Trial. INTRINSIC RV Trial. Presented at The Heart Rhythm Society Meeting May 2006 Presented by Dr. Brian Olshansky. INTRINSIC RV Trial: Background.

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Intrinsic rv trial

Inhibition of Unnecessary RV Pacing with AV Search Hysteresis in ICDs Trial

INTRINSIC RV Trial

Presented at

The Heart Rhythm Society Meeting

May 2006

Presented by Dr. Brian Olshansky


Intrinsic rv trial background
INTRINSIC RV Trial: Background Hysteresis in ICDs Trial

  • The goal of the trial was to evaluate dual vs. single chamber pacing among patients implanted with an internal cardioverter defibrillator (ICD) for standard indications.

Presented at HRS 2006


Intrinsinc rv trial study design
INTRINSINC RV Trial: Study Design Hysteresis in ICDs Trial

988 patients, standard indications for ICD implantation, implanted with a VITALITY AVT ICD programmed to dual chamber rate adaptive pacemaker (DDDR) mode

Randomized.

22% female, mean age 63 years, mean follow-up 1 year

67% of patients had coronary artery disease, 78% received beta-blockers,

64% received ACE-inhibitors and 50% received diuretics

Patients with RV pacing ≤20% were randomized

Continued programming of DDDR AV search hysteresis (AVSH) 60-130

n=502

Reprogramming to VVI-40

n=486

  • Primary Endpoint: All-cause mortality or hear failure hospitalization through one year, evaluated for non-inferiority

Presented at HRS 2006


Intrinsic rv trial primary endpoint
INTRINSIC RV Trial: Primary Endpoint Hysteresis in ICDs Trial

Primary endpoint of death or heart failure hospitalization

  • The primary endpoint of death or heart failure hospitalization occurred in 6.4% of the DDDR AVSH group and 9.5% of VVI-40 group, meeting the threshold for non-inferiority.

  • For superiority of DDDR AVSH, p=0.072 and the risk ratio was 0.67.

Presented at HRS 2006


Intrinsic rv trial all cause mortality
INTRINSIC RV Trial: All – Cause Mortality Hysteresis in ICDs Trial

Primary endpoint of all-cause mortality

p<0.001

  • All-cause mortality also met the criteria for non-inferiority (3.6% for DDDR AVSH vs. 5.1% for VVI-40 group, p<0.001 for non-inferiority, p=0.23 for superiority).

  • During follow-up, RV pacing in the DDDR AVSH group averaged 10%.

Presented at HRS 2006


Intrinsic rv trial summary
INTRINSIC RV Trial: Summary Hysteresis in ICDs Trial

  • Among patients implanted with an ICD for standard indications, use of dual chamber DDDR AVSH pacing was non-inferior to single chamber VVI-40 pacing for death or heart failure hospitalization at one year.

  • Results of the present trial differ from those of the DAVID trial, which showed treatment with dual-chamber pacing was associated with an increase in mortality or CHF hospitalizations by 1 year compared with ventricular backup pacing in patients with LV dysfunction and standard indications for ICD therapy but not for pacing.

  • There are several major differences between the trials, including pacing at a lower threshold in the present trial (60 bpm vs. 70bpm in DAVID) and the patient population, which in INTRINSIC RV excluded patients with >20% pacing in the first week

Presented at HRS 2006


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