Key result
Two-lead CRT-DX is associated with comparable freedom from major events versus conventional three-lead CRT-D.
Why the study?
Intravascular hardware in CRT-D carries risks of infection and lead failure, but the safety and efficacy of reducing lead burden using a two-lead DX-based system versus conventional three-lead CRT-D needed evaluation.
Does a two-lead DX-based CRT system improve clinical and echocardiographic outcomes compared to a conventional three-lead CRT-D system in patients meeting CRT indications without sick sinus syndrome?
Cohort (n=210)
No
Does a two-lead DX-based CRT system improve clinical and echocardiographic outcomes compared to a conventional three-lead CRT-D system in patients meeting CRT indications without sick sinus syndrome?
Answers are grounded in this paper and cite their sources.
The two-lead DX-based CRT system provides equivalent long-term clinical and echocardiographic benefits compared to conventional three-lead CRT-D in patients without an indication for atrial pacing.
Background Cardiac resynchronization therapy with defibrillator (CRT-D) is a well-established therapy for patients with heart failure (HF) and intraventricular conduction delays, but a non-negligible risk of infection and of lead functionality loss overtime is related to intravascular hardware. The novel DX system enables atrial sensing through a floating dipole integrated into the ICD lead, reducing the intravascular burden. Purpose In this prospective nonrandomized study, we aimed to evaluate the safety and efficacy of a two-lead DX-based CRT system compared to a conventional three-lead (3L) CRT-D system. Methods A total of 210 patients meeting CRT indications and no signs of sick sinus syndrome (SSS) (baseline HR ≥ 45 bpm, or at least 85 bpm at 6 minute walking test ) were enrolled. Patients were assigned to either the CRT-DX (97/210) or conventional 3L CRT-D group (113/210). The clinical endpoint was a composite freedom from cardiovascular death, HF hospitalization, or new-onset atrial fibrillation (AF) while the ecocardiographic response was defined as left ventricular end-systolic volume (LVESV) reduction (using both cut offs of ≥15% or ≥ 9.3% LVESV reduction available in literature) Results After a mean follow-up of 46.5 ± 1.9 months, both groups had comparable clinical outcomes with a mean 64% freedom from composite clinical endpoint (p=ns). CRT delivery was high in both groups (mean 95%) and it was paralleled by an eleveted mean ecocardiographic response of 75 % (9.3 % cut-off) and 71 % (9.3% cut-off) and a mean LVESV reduction of 47 mL by the end of follow-up. Of note, CRT-DX patients exhibited higher atrial sensing amplitudes and no significant differences in loss of lead function. 3/113 atrial displacements occurred in the 3L CRT-D group while 1/97 CRT-DX patient developed atrial undersensing (requiring revision to enable CRT) and 1/97 developed SSS (requiring upgrade to 3L-CRT-D at the time of generator replacement). Conclusions In conclusion the CRT-DX system provides equivalent clinical and echocardiographic benefits compared to conventional CRT-D in patients without an indication for atrial pacing in the long term. This study supports the use of the DX system as a safe and effective alternative in the majority of CRT recipients.Patients' selection
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Carecci et al. (2026) conducted a cohort in Heart failure with intraventricular conduction delays (n=210). Two-lead DX-based CRT system vs. Conventional three-lead (3L) CRT-D system was evaluated on Composite freedom from cardiovascular death, HF hospitalization, or new-onset atrial fibrillation (AF) (p=ns). The two-lead DX-based CRT system provided comparable freedom from cardiovascular death, HF hospitalization, or new-onset AF compared to a conventional three-lead CRT-D system.
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