Heart Rhythm Society

Heart Rhythm Society

Perspective from Andrew D. Krahn, MD, FHRS
Source:

Gold MR, et al. LBCT02-05. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).

Disclosures: The study was funded by Boston Scientific. Gold reports he received clinical trial and consultant fees from Boston Scientific and Medtronic.
May 08, 2020
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UNTOUCHED: Subcutaneous ICD meets performance goal for inappropriate shock

Perspective from Andrew D. Krahn, MD, FHRS
Source:

Gold MR, et al. LBCT02-05. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).

Disclosures: The study was funded by Boston Scientific. Gold reports he received clinical trial and consultant fees from Boston Scientific and Medtronic.
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Michael R. Gold

A subcutaneous implantable cardioverter defibrillator had a high rate of freedom from inappropriate shock at 18 months, exceeding a performance goal, according to the primary results of the UNTOUCHED study.

As Healio previously reported, in preliminary results, the device (Emblem S-ICD, Boston Scientific) had a more than 95% rate of freedom from complications at 30 days. Michael R. Gold, MD, PhD, FHRS, professor of medicine and Michael E. Assey Endowed Chair of Cardiology at Medical University of South Carolina and past president of HRS, presented the main results at the virtual Heart Rhythm Society Annual Scientific Sessions.

All 1,111 patients (mean age, 56 years; 26% women) had an indication for primary prevention of sudden cardiac death and left ventricular ejection fraction of 35% or less.

“The UNTOUCHED study was an attempt to extend the use of the S-ICD to a very sick population, as well as to investigate the newer algorithms and more novel programming of this device to see if we could reduce the number of shocks, particularly inappropriate shocks, to levels seen with the best programming of transvenous ICDs,” Gold said during a press conference.

At 18 months, the rate of freedom from inappropriate shock was 95.9% and the 95% lower confidence limit was 94.8%, beating the performance goal of 91.6% (P < .0001), Gold said during the press conference.

History of atrial fibrillation predicted inappropriate shocks (HR = 4.3; 95% CI, 2-9.2), as did nonischemic etiology (HR for ischemic etiology vs. nonischemic = 0.4; 95% CI, 0.2-0.9), lower LVEF (HR as a continuous variable = 0.9; 95% CI, 0.9-1) and the two-incision technique (HR vs. three-incision technique = 3.5; 95% CI, 1.3-9), Gold said.

In addition, he said, patients implanted with a third-generation device including the SMART Pass filter had reduced risk for inappropriate shock (HR = 0.5; 95% CI, 0.2-0.9).

“This feature is the latest technology improvement intended to reduce the risk of inappropriate shocks,” Gold said during the press conference. “Those who had the newest technology, which was introduced during the study, only had a 2.2% rate of inappropriate shocks at 18 months.”

The 1-year inappropriate shock rate of 3.1% is the lowest recorded to date for multicenter trials of an ICD, Gold said, noting that recent studies of transvenous ICDs using modern devices and programming strategies have reported rates between 4.8% and 6.4%.

The device also achieved its performance goal for the secondary endpoint of freedom from all-cause shock (90.6%), Gold said, noting the lower confidence limit was 89%, beating the goal of 85.8% (P < .0001).

The overall survival rate during the study was 94.9% (lower confidence limit, 93.7%), and of the 53 deaths, only three were arrhythmia-related, Gold said. by Erik Swain and Darlene Dobkowski

Reference:

Gold MR, et al. LBCT02-05. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).

Disclosure: The study was funded by Boston Scientific. Gold reports he received clinical trial and consultant fees from Boston Scientific and Medtronic.