Dr Vanita Arora - Arrhythmia Diagnosis in India

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Dr Vanita Arora is a Senior Consultant Cardiac Electrophysiologist & Interventional Cardiologist, Cardiac Electrophysiology Lab and Arrhythmia Services, 3D Mapping Radio frequency Ablation of the Complex Arrtymias and Arrhythmia Cardiac Diagnosis in India.

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Dr Vanita Arora - Arrhythmia Diagnosis in India

  1. 1. NEWER DIAGNOSTIC TOOL Vanita Arora Incharge of Department of Cardiac Electrophysiology & Arrhythmia Services Max Healthcare Superspeciality Hospital, Saket, New Delhi
  2. 2. Arrhythmia Diagnosis in India • Problem area : arrhythmia diagnosis • Current modalities for ambulatory cardiac diagnosis • Is ELR the solution..!!
  3. 3. Problem area: Arrhythmia Diagnosis There is a large unmet need in India for diagnosis of cardiac arrhythmia: •177 Million over age 65 by 2025 » Declining function of the SA node with age is a major health issue •Prevalence of arrhythmia in India: >20 million • >50% of symptomatic patients with possible arrhythmia are not correctly diagnosed …all of these result in a significant opportunity to address an unmet clinical need Sources: 1)Krahn AD et al. “The utility of Holter monitoring compared to loop recorders in the evaluation of syncope and pre-syncope.” ANE. 2000;5(3):284-289. 2)Singh H. “A 24 hour Holter study in asymptomatic early Indians.” JIACM. 2003;4(4):308-14. 3)CureResearch.com. “Statistics by country for arrhythmias.” October 26, 2011.
  4. 4. Arrhythmia Diagnostics: Technology Options Holter Monitor Event Recorder ELR / MCT • ~7-14 days, eventbased monitoring • Usually a wired system • Trans telephonic • 7- 14-30 days, wireless monitoring • Real time reporting Implantable Cardiac Monitor Description: • Well-known, globally available • 24-48 hr monitoring • Up to 3 years of continuous monitoring • Report via interrogation
  5. 5. Components of the patch Piix : Wearable Patch zLink : Wireless Data Transmitter • • • Reports generated every 7 days In case of urgent episodes like sinus pause, Vtach, etc, reports provided within 2 hours Key feature: Patient friendly reports, easy to use, comfortable for the patient * PiiX can collect approximately 500 ECGs and must be replaced at 7.5 days or when the End of Life indicator appears
  6. 6. Event reporting ECG Collection Conditions (PiiX) ECGs Included in Clinical Reports (Reportable Criteria)* ECGs that ALSO drive Notification (Urgent Criteria)* Ventricular Automatic Rate >= 130bpm Rate <= 40bpm Pause >= 3sec Atrial Fibrillation VTach/VFib Ventricular Fibrillation Ventricular Fibrillation Sustained VTach Sustained VTach Non-Sustained VTach Non-Sustained VTach >= 10 beats ICD Shock ICD Shock PVCs >= 6/min Not Urgent Supraventricular Sinus Tachycardia Patient-Triggered Driven by use of the Patient Trigger Magnet Not Urgent Supraventricular Tachycardia Not Urgent Chronic AFib/AFlutter Not Urgent Paroxysmal AFib/AFlutter Bradycardia & Conduction Defects Sinus Bradycardia <= 30bpm Sinus Bradycardia <= 30bpm 2nd Degree AV Block (Type I) 2nd Degree AV Block (Type I), HR <= 40bpm 2nd Degree AV Block (Type II) 2nd Degree AV Block (Type II) High Degree Heart Block High Degree Heart Block Complete Heart Block Complete Heart Block Pause >= 2.0 sec Pause >= 4.0 sec * Summary only…details available on the Corventis Monitoring Center Reportable & Urgent Criteria Form.
  7. 7. India ELR Pilot Patch system overview Piix patch • • • • • • zLink transmitter FDA approved, CE mark received 7 day recording, extendable with multiple patches Non-invasive, wireless, adhesive patch High patient compliance and comfort Monitoring center sends urgent & end of use report Staffed with ECG trained technicians
  8. 8. ELR vs. Holter ELRs have significant advantages over Holter Holter ELR < 10% Yield (symptom-rhythm correlation) 40-50% 24-48 hours Recording length 7-14 days Wired Patient Comfort Wireless Retrospective analysis Continuous Remote monitoring 24hours/day 7days/week Low – 53% patients remove (rash, showering, etc) Patient compliance High – showering possible Doctor involvement Easy: 1 minute installation, automatic activation Difficult: Apply many patches, adjustment, battery recharge Sources: •Ambulatory arrhythmia monitoring: choosing the right device. Zimetbaum, Peter and Goldman, Alena. Circulation, Vol. 122, pp. 1629-1636. •Detection of asymptomatic arrhythmias in unexplained syncope. Krahn, A D, et al., et al. 2004, American Heart Journal, Vol. 148, pp. 326-32. •Syncope: Review of Monitoring Modalities. Subbiah, R, et al., et al. 2008, Current Cardiology Reviews, Vol. 4, pp. 41-48.
  9. 9. ELR: Proven results Numerous publications about Nuvant ELR
  10. 10. ELR recommendations for use
  11. 11. Key points for use of ELR European Society of Cardiology Recommendations • Clinical evaluation is enough to establish a likely mechanism of syncope in the majority of patients • Exclude high-risk patients, i.e. those with a clear indication for ICD, pacemaker, or other treatments independent of a definite diagnosis of the cause of syncope • Be aware that the pre-test selection of the patients influences the subsequent findings. Include patients with a high likelihood of arrhythmic events • Include patients with a high probability of recurrence of syncope in a reasonable time period • Due to the unpredictability of syncope recurrence, be prepared to wait for a substantial time before obtaining such a correlation • Your ideal goal should be to obtain a correlation between ECG findings and syncopal relapse. Weaker end-points are non-syncopal arrhythmias. Source: EuroPace 2009.
  12. 12. End of Use Report
  13. 13. India ELR Pilot Case Report This patient received an Adapta pacemaker
  14. 14. India ELR Pilot Major results Overview • 125 patient pilot w/ Corventis 7day patch • 5 metro cities (Delhi, Mumbai, Bangalore, Calcutta, Pune) • 6 month pilot Customer value • Less involvement, time saved – do other procedures • No expensive capital equipment investments • Differentiation from peers/competitors Patient value • Comfort, ease of use, high quality and reliable Pilot Results Diagnostic yield 36% Patient compliance 98% ICD or Pacemaker Implants as a result of ELR monitoring 13
  15. 15. India ELR Pilot Patient Classification and yield (Stringent criteria) Enrolled Patients n = 125 Diagnosis Completed n = 122 Error (No EOU) n=1 Diagnostic patients n = 117 AF Monitoring patients n=5 Clinically significant arrhythmia (A) n = 42 ELR Diagnostic Yield = Non adherent patents n=2 Clinically insignificant arrhythmia/Normal rhythms (B) n = 75 A A+B = 42/117 = Takeaways: • Yield for clinically significant arrhythmias is 36% • Use of tip card increases yield. 36%
  16. 16. India ELR Pilot Patient Classification and yield (Liberal criteria) Enrolled Patients n = 125 Diagnosis Completed n = 122 Error (No EOU) n=1 Diagnostic patients n = 117 AF Monitoring patients n=5 Clinically significant arrhythmia (A) n = 42 Clinically insignificant arrhythmia (B) n = 53 Non adherent patents n=2 Normal rhythms (C) n = 22 Takeaways: • Yield for any arrhythmia is 81% ELR Diagnostic Yield = A+B A+B+C = 81%
  17. 17. Independent studies High yield and efficacy of ELRs for a variety of arrhythmias • ROTHMAN, S. A., et al . (2007), The Diagnosis of Cardiac Arrhythmias: A Prospective Multi-Center Randomized Study Comparing Mobile Cardiac Outpatient Telemetry Versus Standard Loop Event Monitoring. Journal of Cardiovascular Electrophysiology.
  18. 18. Value of ELRs Key benefits for you: •Less involvement for you – No data is analyzed or monitored, requiring less effort than a Holter device – Save time and effort •Better value, more service to your patients – Fulltime, long term and continuous monitoring for your patients •Zero investment, turnkey – No need to purchase an expensive Holter, no capital equipment maintenance •Differentiation from peers with cutting edge technology – These ELRs represent the latest technology, far ahead and far more

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