Pilot evaluation of an integrated monitor-adhesive patch for long-term cardiac arrhythmia detection in India

Abstract

Electrocardiographic monitoring represents one of the most reliable and time-tested methods for reducing ambiguity in cardiac arrhythmia diagnosis. In India, the resting ECG is generally the first tool of choice for in-clinic diagnosis. The external loop recorder (ELR) is another useful tool that compounds the advantages of traditional tools by coupling ambulatory monitoring with a long-term window. Thus, the objective was to test the use of a 7-day ELR for arrhythmia diagnosis in India for a broad range of presenting symptoms. In this study set in the Indian healthcare environment, an auto-triggered, wireless patch-type ELR was used with 125 patients (62.5 ± 16.7 years, 76 males) presenting a broad range of symptoms. Eighty percent of the symptoms were related to syncope, presyncope or palpitations. Patients were administered an ELR for 7–28 days depending on the physician’s prescription. Prespecified significant arrhythmias included sinus pause >2 s, symptomatic bradycardia <40 b.p.m., second-degree (and higher) AV block, complete heart block, ventricular fibrillation, sustained/nonsustained ventricular tachycardia (>3 beats), atrial fibrillation (chronic or paroxysmal), atrial flutter and supraventricular tachycardia (SVT) >130 b.p.m. Diagnostic yield was 38% when a stringent tabulation methodology considering only clinically significant arrhythmia was used. When first-degree AV block, premature atrial and ventricular beats, couplets (both atrial and ventricular in origin), bigeminy or trigeminy, or sudden changes in rate (noted as sinus arrhythmia) were included in the calculation, diagnostic yield was 80%. Patient compliance was 98%; patients wore the patch for the entire prescribed monitoring period without disruption. Seventy percent of the reported symptoms corresponded with an arrhythmia. Use of the ELR led to therapy change in 24% of patients: 15 patients went on to receive an implantable cardioverter defibrillator or pacemaker, 4 received ablation therapy and 11 altered their medication after diagnosis. This study demonstrates that a high diagnostic yield for clinically significant arrhythmias and high patient compliance can be achieved with a wearable patch monitor in Indian patients suffering from a variety of symptoms.

Keywords::

• arrhythmia
• diagnosis
• ECG
• external loop recorder
• India
• pacemaker

Acknowledgements

The authors gratefully acknowledge a number of Medtronic employees for their assistance, support, and guidance: Shamik Dasgupta, Saurin Shah, Sanjeev Nair, Milind Shah, Chetan Joshi, Kaustubh Patil, Rupesh Nagda, Rajesh Radhakrishnan, Hriday Nayak, Sanket Prabhu, Eddy Warman, Paul Ziegler, James Coles and the One Cardiology team.

Financial & competing interests disclosure

M Shrivastav and S Padte are employees of Medtronic Inc. V Arora and M Biffi are consultants for Medtronic. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Diagnosis of transient cardiac symptoms remains a challenge for physicians who must balance quality care and cost consciousness. This study evaluated a novel, wireless external loop recorder with monitoring center capabilities.

• This study resulted in diagnostic yield of 38% for clinically significant arrhythmias and 80% when clinically insignificant arrhythmias were included.

• The patient compliance was 98%, which can be ascribed to the device’s small form factor, wireless attributes and water-resistant nature.

• Approximately 70% of the symptomatic episodes corresponded with arrhythmias (symptom to rhythm correlation).

Notes