New Study Shows Two-Lead CRT-DX System Can Provide Equivalent Therapy With Fewer Complications

Sub-Analysis Of Large Multi-Center Study Shows DX Technology Provides Similar CRT Responses To Conventional Three-Lead System With Reduced Risk

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BIOTRONIK

May 27, 2020, 10:00 ET

LAKE OSWEGO, Ore., May 27, 2020 /PRNewswire/ -- Results recently published in the Journal of Cardiovascular Electrophysiology confirm that BIOTRONIK's unique two-lead CRT-DX system provides equivalent therapy to more conventional three-lead systems. CRT-DX systems consist of a CRT-DX pulse generator and a DX implantable cardioverter defibrillator (ICD) lead. While continuing to provide atrial sensing, the CRT-DX system helps reduce complications associated with an additional atrial lead for patients who do not need atrial pacing.

Results recently published in the Journal of Cardiovascular Electrophysiology confirm that BIOTRONIK's unique two-lead CRT-DX system provides equivalent therapy to more conventional three-lead systems.

The analysis represents the first comparison of complication rates between heart failure patients implanted with two-lead CRT-DX devices and conventional three-lead CRT-D devices. A total of 240 patients from the QP ExCELs multi-center study were selected to identify 120 matched pairs (each CRT-DX patient matched with a CRT-D control) with similar demographic characteristics. The patients were enrolled from 50 centers across the United States and had a minimum of six months of follow-up. The primary endpoint was the complication-free rate, and patients had a mean follow-up time of approximately 1.4 years.

The results demonstrated that BIOTRONIK's unique CRT-DX system provides similar CRT responses and significantly fewer complications when compared to a conventional three-lead system. These results are consistent with findings from previous studies which have shown that single-lead ICD implantation is associated with a decrease in procedural complications when compared with dual-chamber ICDs.¹ Importantly, the dual-chamber ICD complications have been shown to result in prolonged hospitalization by an additional three days and a 20% increase in medical cost.²

Key findings:

Complication-free survival favored the CRT-DX group (92.5% vs 85.0% in the CRT-D cohort, an absolute difference of 7.5%)
Similar CRT response and health status outcomes including all-cause mortality, heart failure hospitalizations, and NYHA class improvement between the two groups
Lower rates of inappropriate shock were seen in the CRT-DX cohort compared to the CRT-D cohort (0.8% vs 5.8%)

"The novel DX technology delivers similar therapy to conventional three-lead systems, with fewer complications," explained principal investigator Dr. Naushad Shaik from Advent Health, Orlando, Florida. "The additional atrial lead can create more opportunities for lead-related dislodgements, increasing the risk to patients and cost to the healthcare system. Eliminating the extra lead for patients who do not need atrial pacing is an asset for physicians and health systems."

"The DX technology is unique to BIOTRONIK and it embodies our dedication to developing innovations where technology meets function," said Dr. David Hayes, Chief Medical Officer of BIOTRONIK Inc. "The choice of not using an atrial lead but still maintaining AV synchrony when possible makes sense: it simplifies procedures and helps reduce risk – it is good for patients and physicians alike."

References:

Dewland TA et al., J Am Coll Cardiol. 2011, 58(10).
Reynolds MR et al., J Am Coll Cardiol. 2006, 47(12).

About BIOTRONIK:
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.

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