Seek and Ye Shall Find: Surprising Findings When Using the ILR-LINQ

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Seek and Ye Shall Find: Surprising Findings When Using the ILR-LINQ Suneet Mittal, MD, FACC, FHRS Director, Electrophysiology Laboratory Valley Health System www.arrhythmia.org; @drsuneet October 31, 2015 Disclosures: Consultant to Boston Scientific, Medtronic, Sorin, and St. Jude Medical

Tools for Diagnosis and Evaluation Mittal S et al. JACC 2011; 58: 1741-1749

Tools for Diagnosis and Evaluation Mittal S et al. JACC 2011; 58: 1741-1749

ILR Based Daily ECG Monitoring

Candidates for ILRs Unexplained palpitations

Case Presentation 75-year old female with hypertension and a recent history of paroxysmal episodes of palpitations associated with chest pain and pre-syncope. Her baseline ECG and echocardiogram were normal. Diagnostic evaluation: 24-hour Holter: negative Cardiac catheterization: no coronary artery disease and normal LV function Primary concern: Patient has a CHA 2 DS 2 -VASc score of 4 based on her age, gender, and history of hypertension. Is she having atrial fibrillation?

Case Presentation 8 weeks following ILR implant, she had recurrent symptoms The ILR recorded a tachy episode, which lasted 9 minutes and 30 seconds

Case Presentation

Case Presentation

Candidates for ILRs Unexplained palpitations Unexplained syncope

Structural Heart Disease Absent Present vasovagal (POTS) (non-cardiac) Brugada syndrome hypertrophic cardiomyopathy short or long QT syndrome ventricular tachycardia or ventricular fibrillation sinus node, AV node, and/or His-Purkinje system dysfunction (CSH) (OH) Age (years)

ESC Syncope Guidelines: Recommendations for ILRs Class I (Indications) An early phase of evaluation in patients with recurrent syncope of uncertain origin, absence of high risk criteria, and a high likelihood of recurrence within longevity of the device Moya et al 2009. Eur Heart J. doi:10.1093/eurheartj/ehp298

Case Presentation 83-year old obese female with hypertension and diabetes was admitted following her 4 th syncopal episode in the past 2 years. Her baseline ECG and echocardiogram were normal. During her most recent episode, she was standing in her kitchen talking with her daughter when she started to feel lightheaded and then had frank syncope. She hit the back of her head but quickly regained consciousness There was no post-ictal state

Case Presentation 46-year old male presented for evaluation because of frequent episodes of palpitations (typically during periods of exertion) as well as frequent episodes of pre-syncope (typically when he is lying down). He denied any episodes of syncope. In addition, he had a strong family history of sudden death. His brother died suddenly at age 25 and his father died suddenly at age 44; an autopsy demonstrated a ruptured aortic aneurysm in the father. The patient had previously used a 30-day event recorder; no symptoms occurred during the monitoring period.

Case Presentation Recurrent pre-syncope while driving

ESC Syncope Guidelines: Recommendations for ILRs Class I (Indications) An early phase of evaluation in patients with recurrent syncope of uncertain origin, absence of high risk criteria, and a high likelihood of recurrence within longevity of the device High risk patients in whom a comprehensive evaluation did not demonstrate a cause of syncope or lead to treatment Moya et al 2009. Eur Heart J. doi:10.1093/eurheartj/ehp298

Case Presentation 70-year old female referred in April 2014 for evaluation following 2 episodes of syncope. She had known moderate mitral regurgitation and LBBB. Malignancies In September 2012, she was diagnosed with breast cancer and underwent bilateral radical mastectomy followed by chemotherapy and radiation. Unfortunately, in early 2014 she was diagnosed with acute myelogenous leukemia. While in the midst of chemotherapy, she had 2 episodes of syncope. The second episode resulted in a subdural hematoma, subarachnoid hemorrhage, and a laceration to her forehead.

Case Presentation Diagnostic evaluation An echocardiogram showed mild left ventricular dysfunction (ejection fraction 40-45%) A nuclear stress test showed no perfusion defects and confirmed the mild left ventricular dysfunction.

Question To Ponder What would you recommend next? 1. Tilt table test 2. Electrophysiology study 3. Loop recorder implantation 4. Pacemaker (+/- LV lead) 5. ICD (+/- LV lead)

Long-Term ECG Monitoring in Bundle Branch Block Patients 17 (33%) pts - AV block 23 (44%) pts received PPM AV block tended NOT to develop in pts with Isolated RBBB Patients with a > 2 year history of syncope Brignole et al. Circulation 2001; 104: 2045

Syncope: Pacing or Recording in the Later Years (SPRITELY) Inclusion criteria Age > 50 years, and >1 syncopal spell within 1 year preceding enrollment, and Bifascicular block on a 12-lead ECG Randomization: ILR vs (single or dual chamber) PPM Primary endpoint: composite at 2-years of one of the following syncope, symptomatic bradycardia, asymptomatic CHB, acute and chronic ILR and PPM related complications, and death NCT01423994

Case Presentation She was advised by another consultant to consider dual chamber ICD implantation. Following a second opinion, she underwent a His-bundle study, which showed a HV interval of 64 msec. She received an ILR for long-term ECG monitoring. Four months later, she suffered another syncopal episode while walking from her bed to the bathroom. She suffered a fracture of her left arm. The patient s husband immediately used the patient activator to store the patient s ECG. No arrhythmia was recorded during the episode.

ESC Syncope Guidelines: Recommendations for ILRs Class I (Indications) An early phase of evaluation in patients with recurrent syncope of uncertain origin, absence of high risk criteria, and a high likelihood of recurrence within longevity of the device High risk patients in whom a comprehensive evaluation did not demonstrate a cause of syncope or lead to treatment Class IIa (Indications) An ILR should be considered to assess the contribution of bradycardia before embarking on cardiac pacing in patients with suspected or certain reflex syncope presenting with frequent or traumatic syncopal episodes Moya et al 2009. Eur Heart J. doi:10.1093/eurheartj/ehp298

Case Presentation 78-year old female with known hypertension, hypercholesterolemia, and coronary artery disease. History of PCI Normal ECG and echocardiogram She had multiple episodes of pre-syncope and syncope, all of which sounded neurally-mediated in etiology. She presented following another episode of syncope Resulted in spinal cord injury transient paralysis Electrophysiology study unremarkable Primary question: Do we implant an ILR, a pacemaker, or do nothing?

Case Presentation

Case Presentation

ISSUE 3 512 Patients With an ILR Age 40 years; EF > 40 % 3 syncopal episodes in past 2 years, likely due to NMS 89 Patients with Syncope Syncope + asystole 3 secs Asystole 6 secs 77 Patients Agreed to PPM 38 Patients PPM ON 39 Patients PPM OFF Brignole M et al. Circulation 2012; 125: 2566-2571

ISSUE 3 25% 57% 57% reduction in risk Brignole M et al. Circulation 2012; 125: 2566-2571

Candidates for ILRs Unexplained palpitations Unexplained syncope Atrial fibrillation Suspected (e.g., cryptogenic stroke)

Case Presentation 66-year old right-handed male with hypertension (on lisinopril), diabetes (on metformin), and hypercholesterolemia developed left arm numbness and clumsiness along with difficulty speaking Symptoms resolved in 10 minutes

Case Presentation ECG: normal TEE: bicuspid aortic valve with mild aortic calcification, mitral annual calcification, mild-moderate mitral regurgitation, normal ventricular function, no evidence of patient foramen ovale Head CT, CT angiogram, carotid and trans-cranial Doppler examinations all within normal limits Head MRI: Acute right frontal lobe infarct

4 Months Later Asymptomatic 5 Hours and 36 Minutes Atrial Fibrillation NSR

Real World Data: Richards M et al. ISC 2015 15 1247 patients Median follow-up: 182 days [IQR: 152-182 days] 1521 AF episodes in 147 patients AF Detection Rate (%) 12 9 6 3 2 minutes 6 minutes 30 minutes 60 minutes 0 0 30 60 90 120 150 180 Days after Device Insertion Median time to AF detection: 58 [IQR: 11-101] days

Candidates for ILRs Unexplained palpitations Unexplained syncope Atrial fibrillation Suspected (e.g., cryptogenic stroke) Patients at high risk for developing AF Atrial flutter Post-pulmonary vein isolation

Am J Cardiol 2001; 87: 346-9

Case Presentation 62-year old female with hypertension and an unexplained TIA episode 25 years ago (no further details) presented with palpitations and was found to have paroxysms of typical atrial flutter CHA 2 DS 2 -VASc score = 2 or 4 An echocardiogram showed a dilated left atrium and normal left ventricular function At electrophysiology study, typical counterclockwise isthmus-dependent atrial flutter was inducible and successfully ablated

Question to Ponder How long should anticoagulation be continued? 1. For one month post-ablation only 2. For one month post-ablation and then resumed if intermittent/continuous ECG monitoring shows AF 3. Indefinitely

Case Presentation ABLATION 9/14/2010 MULTIPLE EPISODES OF AF AS LONG AS 6 HOURS; ALL ASYMPTOMATIC

Case Presentation Mittal S et al. Heart Rhythm 2013; 10: 1598-1604

Case Presentation 49-year old male with hypertension, diabetes mellitus, obstructive sleep apnea, and paroxysmal atrial fibrillation CHA 2 DS 2 -VASc score = 2 He underwent cryoballoon based pulmonary vein isolation on May 15, 2013 Last known recurrence of atrial fibrillation occurred on May 30, 2013 He is maintained on Xarelto 20 mg daily, which he wishes to discontinue ILR Implanted April 29, 2014

Case Presentation Recurrent episode of AF on January 10, 2015, nearly 18 months out from index ablation

Duration of Follow-Up: Very Late Recurrences of AF Steinberg JS, Mittal S, et al. Heart Rhythm 2014; 11: 771-776

REACT.COM Rhythm Evaluation for Anticoagulation Therapy with Continuous Monitoring CHADS 2 score of 1 or 2 Non-continuous AF in whom a rhythm control strategy has been adopted (ablation, surgery, AAD) or patients with infrequent episodes of AF (none > 1 hour in 3 consecutive months) without a rhythm control strategy

AF Monitoring 1. Scheduled Daily Transmission 2. Patient Initiated Transmission 3. Alert Triggered Transmission YES AF Duration 1 Hour NO Anticoagulation D/C ASA Continue Anticoagulation NO Freedom from AF Duration 1 Hour for 30 consecutive days YES STOP Anticoagulation Start ASA

Candidates for ILRs Unexplained palpitations Unexplained syncope Atrial fibrillation Suspected (e.g., cryptogenic stroke) Patients at high risk for developing AF Atrial flutter Post-pulmonary vein isolation Known Establish pattern of atrial fibrillation Evaluate burden of atrial fibrillation Guide decisions regarding further therapy

Case Presentation ILR detected episode of atrial fibrillation Multiple such episodes recorded by the device

Case Presentation

Candidates for ILRs Unexplained palpitations Unexplained syncope Atrial fibrillation Suspected (e.g., cryptogenic stroke) Patients at high risk for developing AF Atrial flutter Post-pulmonary vein isolation Known Establish pattern of atrial fibrillation Evaluate burden of atrial fibrillation Guide decisions regarding further therapy