Medtronic plc. · NYSE:MDT
Medtronic — Technical Presentation (August 2018)
20 slides from Medtronic's technical presentation, August 2018
Slide 1: 2018 ESC Syncope Guidelines Summary
2018 ESC SYNCOPE GUIDELINES SUMMARY
Slide 2: Overview of Updated Recommendations Since 2009
GUIDELINES OVERVIEW OF UPDATED RECOMMENDATIONS SINCE 2009
Slide 3: Goals of 2018 Task Force
2018 EUROPEAN SOCIETY OF CARDIOLOGY SYNCOPE GUIDELINES Goals of 2018 Task Force1 Reducing Cost & Providing Practical Driving Multidisciplinary Admissions: Guidance: Approach: Focus of recommendations is Guidelines include clinical Most multidisciplinary syncope on the need to reduce hospital recomme
Slide 4: New Concepts in 2018 Guidelines
2018 EUROPEAN SOCIETY OF CARDIOLOGY SYNCOPE GUIDELINES New Concepts in 2018 Guidelines1 Extensive changes based on new evidence: § Increased role of prolonged ECG monitoring with ILR § Revised recommendation from Class I to Class II for Holter monitors and tilt tests § Increased importance of risk s
Slide 5: Guidelines Recommendation Classifications
GUIDELINES RECOMMENDATION CLASSIFICATIONS1 Class I, Level of evidence “A” is HIGHEST recommendation 1 Brignole M, et al. Eur Heart J. 2018;39:1883-1948. Table 1 and Table 2 in Guidelines Introduction. 2018 ESC Guidelines for Diagnosis and Management of Syncope | August 2018
Slide 6: Comparison of Changes in ILR Recommendations
COMPARISON OF CHANGES IN ILR RECOMMENDATIONS 2009 Guidelines1 2018 Guidelines2 Class I Level B Class I Level A § Indicated in early phase evaluation in patients with § Indicated in early phase evaluation in patients with recurrent syncope of uncertain origin, absence of recurrent syncope of uncertai
Slide 7: T-LOC Monitoring Recommendations
T-LOC MONITORING RECOMMENDATIONS T-LOC suspected syncope Certain diagnosis/mechanism Uncertain Diagnosis Treat appropriately Syncope T-LOC Non-syncopal High risk* Low risk* Low risk* Low risk* Unconfirmed epilepsy arrhythmia arrhythmia likely and reflex likely and need and rare episodes or likely re
Slide 8: Evidence Support: Recommendations for Diagnosing Unexplained Syncope
EVIDENCE SUPPORT RECOMMENDATIONS FOR DIAGNOSING UNEXPLAINED SYNCOPE
Slide 9: Evidence Support in Guidelines: ILR Diagnostic Yield 3.6X
EVIDENCE SUPPORT IN GUIDELINES 2009 2018 ILR is indicated in an early phase of evaluation in patients with recurrent syncope of Class I Class I uncertain origin, absence of high-risk criteria, and a high likelihood of recurrence within the battery life of the device. LOE: B LOE: A § NEW — Meta-analy
Slide 10: Evidence Support in Guidelines: High-Risk Patients
EVIDENCE SUPPORT IN GUIDELINES 2009 2018 ILR is indicated in patients with high-risk criteria in whom a comprehensive evaluation Class I Class I did not demonstrate a cause of syncope or lead to a specific treatment, and who do not have conventional indications for primary prevention ICD or pacemake
Slide 11: Evidence Support in Guidelines: Reflex Syncope
EVIDENCE SUPPORT IN GUIDELINES 2009 2018 ILRs should be considered in patients with suspected or certain reflex syncope Class Ila Class Ila presenting with frequent or severe syncopal episodes. LOE: B LOE: B ILR monitoring in reflex syncope patients to identify those that benefit from cardiac pacing
Slide 12: Evidence Support in Guidelines: Cost-Effectiveness
EVIDENCE SUPPORT IN GUIDELINES 2009 2018 ILR is indicated in an early phase of evaluation in patients with recurrent syncope of Class I Class I uncertain origin, absence of high-risk criteria, and a high likelihood of recurrence… LOE: B LOE: A Holter monitoring should be considered in patients who h
Slide 13: Evidence Support: Expanded Recommendations for Diagnosing T-LOC
EVIDENCE SUPPORT EXPANDED RECOMMENDATIONS FOR DIAGNOSING T-LOC
Slide 14: Evidence Support in Guidelines: Unexplained Falls
EVIDENCE SUPPORT IN GUIDELINES NEW 2018 Class IIb ILR may be considered in patients with unexplained falls. LOE: B § “Despite the lack of controlled trials and an overall modest quality of studies, there is strong consensus that the management of unexplained falls should be the same as that for unex
Slide 15: Evidence Support in Guidelines: Unconfirmed Epilepsy
EVIDENCE SUPPORT IN GUIDELINES NEW 2018 ILR may be considered in patients in whom epilepsy was suspected but the treatment Class IIb has proven ineffective. LOE: B § “Syncope and Epilepsy have similar clinical features, including abrupt T-LOC without warning, abnormal limb movements such as myocloni
Slide 16: Evidence Support in Guidelines: ILR Instead of ICD
EVIDENCE SUPPORT IN GUIDELINES NEW 2018 Instead of an ICD, an ILR may be considered in patients with recurrent episodes of unexplained syncope Class IIb who are at low risk for SCD and without current indication for ICD. LOE: C § Unexplained syncope in this population is defined as “suspected arrhyt
Slide 17: 2018 ESC Syncope Guidelines: Conclusions
2018 ESC SYNCOPE GUIDELINES: CONCLUSIONS § The increasing need to reduce inappropriate admissions & tests and new 1 evidence led to creation of the 2018 ESC Syncope Guidelines § ILR recommendation upgraded from a Class I/Level B to a Class I/Level A for unexplained syncope as meta-analysis shows 3.6
Slide 18: Risk Assessment Recommendations
*RISK ASSESSMENT RECOMMENDATIONS1 Assessment of Syncopal Event Low risk High risk (red flag) 1. Associated with prodrome typical of reflex syncope (e.g., Major light-headedness, feeling of warmth, sweating, nausea, 1. New onset of chest discomfort, breathlessness, abdominal vomiting) pain, or headac
Slide 19: Risk Assessment Recommendations: Physical Examination and ECG
*RISK ASSESSMENT RECOMMENDATIONS1 Physical Examination Low risk High risk (red flag) 1. Normal examination Major 1. Unexplained systolic BP in the ED < 90 mmHg 2. Suggestion of gastrointestinal bleed on rectal examination 3. Persistent bradycardia (< 40 bpm) in awake state and in absence of physical
Slide 20: Brief Statement
Brief Statement See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan ™ device, see the MRI SureScan technical manual before performing an