The key to unlock early Bradyarrhytmia diagnosis

The latest research presented at American College of Cardiology Scientific Sessions indicates that optimizing monitoring duration increases diagnostic yield for Bradyarrhythmia. The ability to prolong the monitoring duration up to 30 days allows to significantly increase the diagnostic yield over shorter monitoring methods. Early detection of Bradycardia can, in turn, result in earlier treatment, which may include pacemaker implantation.

Bradyarrhythmia, including unusually slow heart rate (bradycardia < 40 BPM), or blocked heart beats (2nd and 3rd degree atrioventricular blocks) and pauses, carries a significant risk of sudden cardiac death. While guidelines currently recommend the use of cardiac monitoring to evaluate patients who present with an abnormally slow heart rate, this research suggests that short-term monitoring may not be sufficient to accurately diagnose some patients, who may require an implantable pacemaker to regulate their heart rhythm.

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Show Research Background & Methods

A full-disclosure, mobile cardiac telemetry (MCT) device – PocketECG, provides continuous ECG data transfer and rhythm identification for up to 30 days, providing newer methods to identify high risk patients. Determining the optimal monitoring duration has significant impact on healthcare quality and cost implications.

 

The following dataset is a collection of all MCT recordings that were made with PocketECG system in 2017.

The cumulative diagnostic yield (DY) on the composite outcome of a clinically relevant Bradyarrhythmia defined as:

  • a Pause >3s,
  • second- and third-degree Atrioventricular Block (AVB), or
  • Bradycardia with average rate <40 beats per minute

was analyzed using the Kaplan-Meier estimator and was compared to 24-hour, 7-day, and 11-day monitoring, using the same dataset.

 

 

The median age of the study was 71 and the average monitoring duration for the MCT studies was 17.6 days.

Research results

The retrospective study analyzed 26,567 diagnostic summary reports from full-disclosure telemetry tests recorded between Jan. 1, and Dec. 31, 2017 by US-based Medi-Lynx Cardiac Monitoring. Researchers identified 3,325 cases of bradyarrhythmia using the full-disclosure PocketECG device.

The DY of bradyarrhythmia for continuous full-disclosure MCT monitoring for up to 30 days was:

  • 175% higher than 24 hours of continuous monitoring (Holter)
  • 37% higher than 7 days of continuous monitoring (Holter)
  • 19% higher than 11 days of  continuous monitoring (Patch)

 

Of the reports analyzed:

  • 618 patients were diagnosed with 2nd or 3rd degree atrioventricular block,
  • 1,223 patients diagnosed with pause > 3s,
  • 1,997 patients with bradycardia < 40 BPM.

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Detailed DY of MCT vs alternative monitoring technologies for individual Bradyarrhythmia

Conclusions and impact on the pacemaker industry

“The combination of flexible monitoring duration and continuous full-disclosure ECG data, resulted in higher diagnostic yield of bradyarrhythmia, suggesting full-disclosure MCT may provide a valuable a new approach to more accurately diagnose at-risk patients and potentially identify those requiring pacemaker implantation to prevent serious adverse events,” said Marek Dziubinski, PhD, lead author, chief technology officer and inventor of PocketECG.

The slowing or stopping of the heart, in conjunction with injuries sustained during faint-induced falls (particularly in the elderly), increases the risk of sudden cardiac death. Worldwide, over one million pacemakers are implanted annually for Bradyarrhythmia, with an expected increase every year due to an aging global population. With a primary objective of providing the best treatment to patients suffering from fainting, shortness of breath, chest pain, or lethargy, prompt and accurate diagnosis is the key. That is why early Bradyarrhythmia detection is the crucial in minimizing this health risk worldwide.

The study proves that optimizing the duration of monitoring leading to conclusive data in shortest possible time is one of the easiest ways to ensure early Bradyarrhythmia detection and treatment as well as increasing the number of diagnosed Bradyarrhythmia patients with indication to pacemaker implantation.