What question did this study set out to answer?

To determine the incidence of inappropriate shocks using standardized programming and enhanced discrimination algorithms in primary prevention patients with low ejection fraction receiving a subcutaneous implantable cardioverter-defibrillator (S-ICD).

October 19, 2020CirculationOpen Access

Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial

Q: What are the key findings of this study?

The S-ICD demonstrated an 18-month freedom from inappropriate shocks of 95.9%, surpassing the performance goal of 91.6% in patients with low ejection fraction.

Q: What does this research mean for the field?

The S-ICD demonstrated an 18-month freedom from inappropriate shocks of 95.9%, surpassing the performance goal of 91.6% in patients with low ejection fraction. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

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Key result

S-ICD beats performance goals with ~96% freedom from inappropriate shocks in low EF patients.

Why the study?

Previous S-ICD studies enrolled patients with fewer comorbidities and higher inappropriate shock rates than typical transvenous ICD trials, leaving outcomes uncertain in standard primary prevention populations.

Does the subcutaneous ICD with standardized high-rate programming reduce inappropriate shocks in primary prevention patients with low ejection fraction?

Population

1116 primary prevention patients with LVEF ≤35% and no pacing indications

Comparison

Standardized S-ICD programming vs a historical 91.6% performance goal derived from MADIT-RIT

Design

Prospective single-arm trial

Follow-up

18 months

Authors

MGMichael R. GoldElectrophysiology PLPier D. LambiaseElectrophysiology MEMikhael F. El‐ChamiElectrophysiology

Discussion

Member takes

Implication

May support high-rate programming with S-ICD to limit inappropriate shocks in low-EF patients; leaves open need for randomized confirmation.

Key Points

To determine the incidence of inappropriate shocks using standardized programming and enhanced discrimination algorithms in primary prevention patients with low ejection fraction receiving a subcutaneous implantable cardioverter-defibrillator (S-ICD).
Multicenter trial evaluating primary prevention patients with left ventricular ejection fraction (LVEF) ≤35% and no pacing indications, following 1111 implanted patients for 18 months (NCT02433379).
Patients received Generation 2 or 3 S-ICD devices programmed with rate-based therapy delivery for rates ≥250 bpm and morphology discrimination for rates ≥200 and <250 bpm.
The primary endpoint was the 18-month inappropriate shock (IAS)-free rate compared against a 91.6% performance goal derived from the MADIT-RIT study using Kaplan-Meier analysis.
The 18-month freedom from IAS was 95.9% (lower confidence limit, 94.8%), successfully exceeding the 91.6% prespecified performance goal.
The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 89.0%), meeting the prespecified performance goal of 85.8%.
Conversion success for discrete appropriate ventricular episodes was 98.4%, and the 18-month complication-free rate was 92.7%.

Structured PICO

Does the subcutaneous ICD with standardized high-rate programming reduce inappropriate shocks in primary prevention patients with low ejection fraction?

Population

1,116 primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications. Mean age 55.8 years, 25.6% women, 23.4% Black, multinational (110 sites in the United States, Canada, and Europe). 87.7% had symptomatic heart failure, 53.5% had ischemic heart disease.

Intervention

Generation 2 or 3 subcutaneous implantable cardioverter-defibrillator (S-ICD) programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute, followed for 18 months.

Comparator

No concurrent control group; compared against a 91.6% performance goal derived from the results for the ICD-only patients in the MADIT-RIT study.

Outcome

Inappropriate shock (IAS)-free rate at 18 months compared with a 91.6% performance goal, adjudicated by an independent clinical events committee.safety

Contemporary subcutaneous ICD devices with standardized high-rate programming achieve a very low inappropriate shock rate (3.1% at 1 year) in primary prevention patients with reduced ejection fraction.

Cite This Study

Gold et al. (2020) studied this question. The S-ICD demonstrated an 18-month freedom from inappropriate shocks of 95.9%, surpassing the performance goal of 91.6% in patients with low ejection fraction.

synapsesocial.com/papers/69714deaf0a245e8b19d1978 https://doi.org/10.1161/circulationaha.120.048728

Topics

HFrEF treatment Cardiac device therapy Heart failure

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Implication

May support high-rate programming with S-ICD to limit inappropriate shocks in low-EF patients; leaves open need for randomized confirmation.

Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Topics

Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Topics

Also Consider