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ADVANCEIII: Long-detection programming beneficial for patients with single-chamber ICDs
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CHICAGO — In patients with single-chamber implantable cardioverter defibrillators, extending the duration of monitoring delay before initiating therapy decreased the risk for therapies, shocks, hospitalization and death, according to results from the ADVANCEIII trial.
“We already had three major trials highlighting the importance of long detection in patients implanted with an ICD, but the ADVANCEIII trial is the only one that included the three types of ICDs — single-chamber, dual-chamber and triple-chamber — and included single-chamber ICDs for both primary and secondary prevention indications,” Maurizio Gasparini, MD, of the Humanitas Research Hospital in Rozzano-Milano, Italy, said during a presentation at the Heart Rhythm Society Annual Scientific Sessions.
ADVANCEIII was a prospective superiority trial evaluating the effect of long-detection interval programming (30 of 40 intervals), compared with standard-interval programming (18 of 24 intervals), on reducing unnecessary therapies in patients with ICDs. The present analysis was restricted to patients with single-chamber ICDs.
Of 545 patients receiving a single-chamber ICD, 267 were randomly assigned to long-detection programming and 278 to standard programming. For all patients, anti-tachycardia pacing therapy during charging was programmed for episodes with cycle length ranging from 320 ms to 200 ms and shock for cycle length shorter than 200 ms. Wavelet and stability functions were also enabled.
During a median follow-up of 12 months, overall therapies were reduced by 48% with long detection vs. standard detection (112 vs. 257; incidence rate ratio [IRR] = 0.52; 95% CI, 0.36-0.76). Additionally, with long detection vs. standard detection, shocks were reduced by 40% (24 per 100 patient-years vs. 48 per 100 patient-years; IRR = 0.6; 95% CI, 0.38-0.94) and anti-tachycardia pacing therapy was reduced by 51% (IRR = 0.49; 95% CI, 0.33-0.72).
In terms of appropriate therapies, results also linked long detection with a 55% decrease in overall therapies (IRR = 0.45; 95% CI, 0.28-0.71), a 51% decrease in appropriate shocks (IRR = 0.49; 95% CI, 0.26-0.94) and a 57% decrease in anti-tachycardia pacing therapy (IRR = 0.43; 95% CI, 0.27-0.71).
Inappropriate therapies, however, occurred infrequently in both groups, which prevented the researchers from identifying any statistically significant difference between the long-detection and standard-detection groups.
The risk for hospitalization for any cause was lower in the long-detection group vs. the standard group at 1 year (27% vs. 36%; P = .04) — a difference that was primarily driven by CV-related hospitalizations (20% vs. 28%; P = .04), according to the data. Although syncopal events did not differ between groups, long detection, compared with standard detection, was associated with a 59% reduction in mortality risk at 1 year (HR = 0.41; 95% CI, 0.17-0.99).
The results show that even in single-chamber ICDs, long detection with anti-tachycardia pacing during charging is extremely safe and is associated with a significant reduction in appropriate therapies as well as a reduction in hospitalizations, according to Gasparini.
“It seems that with the single-chamber ICD, the power of the long detection window is even more important than in the general population; we do not observe any significant effect on certain inappropriate therapies; and last but not least, while in the overall population long detection does not significantly affect mortality, in this subset of patients with single-chamber ICD, a borderline mortality reduction has been observed,” he said. – by Melissa Foster
References:
Gasparini M, et al. LBCT01-03. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 10-13, 2017; Chicago.
Gasparini M, et al. JACC Clin Electrophysiol. 2017;doi:10.1016/j.jacep.2017.05.001.
Disclosure: The study was sponsored by Medtronic. Gasparini reports no relevant financial disclosures.
Perspective
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Jagmeet P. Singh, MD, DPhil, FACC, FHRS
ADVANCEIII has an elegant study design in which the researchers randomly assigned patients to a control or intervention arm. All patients had single-chamber ICDs and were followed for up to 12 months. The programming was different in the intervention arm — 30 of 40 intervals had to detect the arrhythmia — whereas the control arm had standard programming.
At follow-up, patients in the long-detection study arm had reduced burden of therapy, with an almost 48% reduction in anti-tachycardia pacing or shock therapy and a 40% reduction in appropriate shock therapy. We know that increased shocks are indirectly associated with increased hospitalizations and higher mortality, so we can presume indirectly from these results that a reduction in shock therapy is actually a good thing. It reduces burden on the patient but also improves outcomes in the long term.
There have been other studies that have looked at this before, including MADIT-RIT, which was able to show that, through a similar kind of delayed programming, long-term mortality and HF hospitalizations could be improved. ADVANCEIII kind of replicates that in terms of reducing shock burden, so it does reinforce some of the programming strategies that are in place and certainly affects clinical practice. Hopefully, it should significantly impact outcomes in the future.
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