BIOTRONIK launches HeartInsight for early prediction of heart failure hospitalizations

BIOTRONIK today announced the CE approval for HeartInsight^®, its remote heart failure (HF) management solution that accurately identifies patients at higher risk of HF decompensation early on. HeartInsight predicts two out of three HF hospitalizations, coupled with an industry-low false alert rate. Compared to other available solutions, HeartInsight provides the earliest notification, a median advance notice of 42 days before an impending HF hospitalization, which allows clinicians to proactively care for their patients.^1,2,3 HeartInsight will be presented to clinicians for the first time at the EHRA Congress which takes place in Copenhagen, Denmark, from April 3 to 5, 2022.

“Heart failure is one of the most burdensome diseases – for patients, healthcare professionals and the healthcare system”, said Dr. David Hayes, Chief Medical Officer at BIOTRONIK. “Early identification of patients at higher risk for heart failure has the potential to improve outcomes, reduce hospital admissions and ultimately decrease overall costs while hopefully improving the patient’s quality of life. HeartInsight’s predictive alert allows clinicians to address problems before they turn into a clinical crisis.”

HeartInsight will be available for patients with compatible CRT-D and ICD devices and is integrated into BIOTRONIK’s Home Monitoring^® platform which displays patient health data that is transmitted from their cardiac implant automatically every day. HeartInsight’s algorithm combines relevant HF parameters into one predictive score and alerts the clinical team that a patient is at higher risk of hospitalization once a pre-set threshold has been crossed. All relevant information is organized in an insightful dashboard, designed for improved collaboration and decision-making.

Based on the multi-center SELENE HF study¹, key features of HeartInsight include: 

• Predicts 2 out of 3 HF hospitalizations (66% alert sensitivity) 
• Low false alert burden with only one false alert every 17 months (0.7 per patient/year)
• Median of 42 days alert time before an impending HF hospitalization
• All-in-one alert: 8 parameters combined into one score to support confident decision-making

“During the on-going pandemic, we see the increasing relevance of remote monitoring”, said Prof. Gianfranco Sinagra, University of Trieste. “For my heart failure patients, HeartInsight can support this by providing an early alert, useful data and insights that allow me to care for my patients early on, possibly avoiding potential hospitalization and improving their quality of life.”

Heart failure is a leading cause of hospitalizations, and each decompensation and hospitalization reflect a deteriorating prognosis for the patient.^4,5 This results in poor patient outcomes as well as a significant burden on healthcare systems.⁶ In Europe, 44 percent of patients are re-admitted within the subsequent 12 months.⁷ Early identification of decompensation may increase therapy options for patients and thus decrease re-hospitalization rates.

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More information:

• Find out more about HeartInsight, clinical data and its clinical workflow on the HeartInsight website
• Clinical Data: The multi-center SELENE HF study published online in EUROPACE in August 2021 confirmed that heart failure (HF) decompensation can be predicted early when monitored using an algorithm that combines existing remote monitoring trends and baseline risk stratification.

References: 

1. D’Onofrio A et al. Combining home monitoring temporal trends from implanted defibrillators and baseline patient risk profile to predict heart failure hospitalisations: results from the SELENE HF study Europace (2022) 24, 234–244 doi:10.1093/europace/euab170.

2. Comparison of alerting time in validation studies: D'Onofrio et al. Europace 2022 24, 234-244); Boehmer JP et al. J Am Coll Cardiol Heart Fail. 2017 Mar, 5 (3) 216–225; Cowie MR et al. European Heart Journal (2013) 34, 2472–2480 doi:10.1093/eurheartj/eht083.

3. Comparison of false alert rate in validation studies: D'Onofrio et al. Europace 2022 24, 234-244); Boehmer JP et al. J Am Coll Cardiol Heart Fail. 2017 Mar, 5 (3) 216–225; Cowie MR et al. European Heart Journal (2013) 34, 2472–2480 doi:10.1093/eurheartj/eht083.

4. Ambrosy AP et al. The Global Health and Economic Burden of Hospitalizations for Heart Failure Lessons Learned From Hospitalized Heart Failure Registries. J Am Coll Cardiol 2014; 63:1123–33.

5. Gheorghiade M et al. Pathophysiologic Targets in the Early Phase of Acute Heart Failure Syndromes. Am J Cardiol; 2005; 96:11G–17G.

6. Ponikowski Pet al. HF preventing disease and death worldwide. ESC Heart Fail 2014 Sep;1(1):4–25.

7. Maggioni AP et al. EURObservational Research Programme: regional differences and 1-year follow-up results of the Heart Failure Pilot Survey (ESC-HF Pilot) European Journal of Heart Failure (2013) 15, 808–817; doi:10.1093/eurjhf/hft05

* 42 days refers to median alert time.