Rationale and Design of the OPTION Study: Optimal Antitachycardia Therapy in ICD Patients without Pacing Indications

Kolb, Christof; Tzeis, Stylianos; Sturmer, Marcio; Babuty, Dominique; Schwab, Jörg O.; Mantovani, Giuseppe; Janko, Sabine; Aimè, Ezio; Ocklenburg, Rolf; Sick, Peter

doi:10.1111/j.1540-8159.2010.02790.x

Cited by 4 publications

(4 citation statements)

References 33 publications

(36 reference statements)

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“…The design and main results of the OPTION trial have been published 7 8 . In brief, this prospective, randomised (1:1), multicentre, single-blinded (patients), parallel-group trial enrolled 462 patients eligible for ICD therapy for primary or secondary prevention of sudden cardiac death (left ventricular ejection fraction ≤40% despite optimal tolerated heart-failure therapy).…”

Section: Methodsmentioning

confidence: 99%

Relation between detection rate and inappropriate shocks in single versus dual chamber cardioverter-defibrillator – an analysis from the OPTION trial

Kolb

Sturmer

Babuty

et al. 2016

Sci Rep

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The programming of implantable cardioverter-defibrillators (ICDs) influences inappropriate shock rates. The aim of the study is to analyse rates of patients with appropriate and inappropriate shocks according to detection zones in the OPTION trial. All patients received dual chamber (DC) ICDs randomly assigned to be programmed either to single chamber (SC) or to DC settings including PARAD+ algorithm. In a post-hoc analysis, rates of patients with inappropriate and appropriate shocks were calculated for shocks triggered at heart rates ≥170 bpm (ventricular tachycardia zone) and at rates ≥200 bpm (ventricular fibrillation zone). In the SC group, higher rates of patients with total and inappropriate shocks were delivered at heart rates ≥170 bpm than at rates ≥200 bpm (total shocks: 21.1% vs. 16.6%; p = 0.002; inappropriate shocks: 7.6% vs. 4.5%, p = 0.016; appropriate shocks: 15.2% vs. 13.5%; p = n.s.). No such differences were observed in the DC group (total shocks: 14.3% vs. 12.6%; p = n.s.; inappropriate shocks: 3.9% vs. 3.6%; p = n.s.; appropriate shocks: 12.2% vs. 10.4%; p = n.s.). The higher frequency of patients with total shocks with SC settings than with DC settings that benefit from PARAD+ was driven by a higher percentage of patients with inappropriate shocks in the VT zone (170–200 bpm) in the SC population.

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Section: Methodsmentioning

confidence: 99%

Relation between detection rate and inappropriate shocks in single versus dual chamber cardioverter-defibrillator – an analysis from the OPTION trial

Kolb

Sturmer

Babuty

et al. 2016

Sci Rep

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“…All patients received an ICD device (PARADYM DR and CRT-D models; Sorin Group Italia S.r.l., Saluggia, Italy) featuring the discrimination algorithm PARAD1 (Figure 1). 17,18 PARAD1 allows the differentiation of supraventricular from ventricular arrhythmias based on ventricular rate stability, AV association analysis, long cycle search, rate onset analysis, and chamber of origin in the case of 1:1 tachycardia (Supplementary Figures S1 and S2).…”

Section: Devices and Programmingmentioning

confidence: 99%

Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination–Implantable Cardioverter Defibrillator Study

et al. 2019

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BACKGROUND Inappropriate shocks (IS) continue to have a major negative impact on patients implanted with defibrillators.OBJECTIVE The purpose of this study was to assess IS reduction with the PARAD1 discrimination algorithm in a general population implanted for primary or secondary prevention. METHODS ISIS-ICD (Inappropriate Shock Reduction wIth PARAD1Rhythm DiScrimination-Implantable Cardioverter Defibrillator) was a 2-year international, interventional study in patients implanted with a dual implantable cardioverter-defibrillator (ICD) or triple-chamber defibrillator (cardiac resynchronization therapy-defibrillator [CRT-D]) featuring PARAD1. IS (shocks not delivered for ventricular tachycardia or fibrillation) were independently adjudicated. The primary endpoint was percentage of IS-free patients at 24 months. Primary and worst-case analyses of annual incidence rates of patients with 1 IS, overall and per defibrillator type, were conducted. RESULTSIn total, 1013 patients (80.7% male; age 67.1 6 11.4 years; 68%/30%/2% primary/secondary/other indication) were enrolled and followed for a median of 552 days (interquartile range 354; 725). Of 993 analyzed patients programmed with PARAD1, 14 had 1 IS, corresponding to a percentage free from IS of 98.1% (95% confidence interval [CI] 96.8%-98.9%). Annual incidence rates (per 100 personyears) of patients with IS were 1.0 (95% CI 0.59-1.69) and 2.1 (95% CI 1.46-3.02) in the primary and worst-case analyses, respectively. In ICD patients, rates were 1.2 (95% CI 0.68-2.23) and 2.3 (95% CI 1.47-3.53), and in CRT-D patients 0.59 (95% CI 0.19-1.83) and 1.8 (95% CI 0.93-3.44) per 100 person-years.CONCLUSION The annual rate of defibrillator patients with IS using the enhanced PARAD1 discrimination algorithm alone ranged from 1.0 to 2.1 per 100 person-years in a general population implanted for primary or secondary prevention.

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“…Moreover, additional factors should be considered when choosing single-versus dual-chamber ICD settings, including the risk for complications (23), as well as the detrimental effect of unnecessary ventricular pacing (24). Therefore, the potential superiority of dual-chamber over singlechamber ICD settings in terms of inappropriate shocks can be assessed only in the light of optimal tachyarrhythmia discrimination algorithms combined with optimized bradycardia parameters for minimized ventricular pacing (25).…”

mentioning

confidence: 99%

“…The rationale and design of OPTION have been published previously(25). The OPTION trial is a prospective, randomized, multicenter, 2-arm, single-blinded, parallel-group trial.…”

mentioning

confidence: 99%

Reduced Risk for Inappropriate Implantable Cardioverter-Defibrillator Shocks With Dual-Chamber Therapy Compared With Single-Chamber Therapy

Kolb

Sturmer

Sick³

et al. 2014

JACC: Heart Failure

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Therapy with dual-chamber settings for ICD discrimination combined with algorithms for minimizing ventricular pacing was associated with reduced risk for inappropriate shock compared with single-chamber settings, without increases in mortality and morbidity. (Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator [ICD] Patients Without Pacing Indications [OPTION]; NCT00729703).

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Rationale and Design of the OPTION Study: Optimal Antitachycardia Therapy in ICD Patients without Pacing Indications

Abstract: The study will evaluate the relative performance of DC in comparison to SC ICDs in terms of inappropriate shock reduction and patient outcome.

Cited by 4 publications

References 33 publications

Relation between detection rate and inappropriate shocks in single versus dual chamber cardioverter-defibrillator – an analysis from the OPTION trial

Relation between detection rate and inappropriate shocks in single versus dual chamber cardioverter-defibrillator – an analysis from the OPTION trial

Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination–Implantable Cardioverter Defibrillator Study

Reduced Risk for Inappropriate Implantable Cardioverter-Defibrillator Shocks With Dual-Chamber Therapy Compared With Single-Chamber Therapy

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