Heart Rhythm Society

Heart Rhythm Society

Issue: June 2020
Perspective from Andrew D. Krahn, MD, FHRS
Source:

Knops RE, et al. LBCT01-02. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).

Disclosures: Knops reports he received consultant fees and research grants from Abbott, Boston Scientific, Cairdac and Medtronic and has stock options from AtaCor Medical.
May 08, 2020
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Subcutaneous ICD noninferior to transvenous ICD for primary, secondary prevention

Issue: June 2020
Perspective from Andrew D. Krahn, MD, FHRS
Source:

Knops RE, et al. LBCT01-02. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).

Disclosures: Knops reports he received consultant fees and research grants from Abbott, Boston Scientific, Cairdac and Medtronic and has stock options from AtaCor Medical.
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Reinoud E. Knops

A subcutaneous implantable cardioverter defibrillator was noninferior to a transvenous ICD regarding major ICD-related adverse events in patients indicated for such treatment, according to data from the PRAETORIAN trial presented at the virtual Heart Rhythm Society Annual Scientific Sessions.

Patients indicated for ICD

Researchers analyzed data from 849 patients from 39 centers in the United States and Europe with a class I or IIa indication for ICD therapy for primary or secondary prevention. Patients were assigned subcutaneous ICD (Emblem S-ICD System, Boston Scientific; n = 426; median age, 63 years; 21% women) or transvenous ICD (n = 423; median age, 64 years; 18% women).

“The [subcutaneous] ICD was introduced already 12 years ago to overcome lead issues with transvenous ICDs,” Reinoud E. Knops, MD, PhD, cardiac electrophysiologist at Academic Medical Center in Amsterdam, said during the press conference. “However, not having a lead in the heart makes sensing of the heart rhythm difficult. That might lead to more inappropriate shocks, so that might be a negative aspect of the [subcutaneous] ICD.”

The primary endpoint was ICD-related complications and inappropriate shocks, which was assessed for a median of 48 months.

“The important part of this study is that since the inappropriate shocks are part of the composite endpoint, it’s obviously important that programming in this study is similar, so programming of ICDs in the [subcutaneous] ICD group and transvenous ICD groups are similar,” Knops said during the presentation.

Knops also said long follow-up time is important. During the press conference, he said: “The main results, we waited quite a long time. We’ve been working on this study for almost 10 years, quite some time, because we felt that to really look at complications of ICD therapy, you have to wait a while. It takes time, for instance, lead complications to develop, so that’s why we had a minimum of 4 years of follow-up.”

The primary composite endpoint occurred in 15.7% of patients in the transvenous ICD group and 15.1% in the subcutaneous ICD group.

“Since this was a noninferiority design in the study, the initial results of this study show that with regard to primary composite endpoint, the [subcutaneous] ICD is noninferior to the transvenous ICDs,” Knops said during the press conference.

Individual endpoint components

Researchers also assessed individual components of the primary endpoint. Inappropriate shocks occurred in 9.7% of patients assigned subcutaneous ICD vs. 7.3% of those assigned transvenous ICD (HR = 1.43; 95% CI, 0.89-2.3). Device-related complications were observed in 9.8% of patients in the transvenous ICD group and 5.9% of those in the subcutaneous ICD group (HR = 0.69; 95% CI, 0.44-1.09).

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Assessment of individual components of device-related complications between the subcutaneous ICD group and transvenous ICD showed differences, including the occurrence of infection (4 vs. 8, respectively), bleeding (8 vs. 2, respectively) and thrombotic event (1 vs. 2, respectively).

“I think that helps physician-guided choices when you have to select the proper device for the proper patient,” Knops said during the presentation.

When assessing lead-related complications, more events occurred in the transvenous ICD group vs. the subcutaneous ICD group (6.6% vs. 1.4%; HR = 0.24; 95% CI, 0.1-0.54).

There was no difference in all-cause mortality in patients assigned subcutaneous ICD and transvenous ICD (16.4% vs. 13.1%, respectively; P = .2).

“The main conclusion is that the [subcutaneous] ICD should be considered in all patients in need of an ICD that do not have a pacing indication,” Knops said during the press conference.

Knops said final results of the PRAETORIAN trial were accepted for publication in The New England Journal of Medicine. – by Darlene Dobkowski

Reference:

Knops RE, et al. LBCT01-02. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).

Disclosure: Knops reports he received consultant fees and research grants from Abbott, Boston Scientific, Cairdac and Medtronic and has stock options from AtaCor Medical.