9/14/2019 COI DISCLOSURES • I have received lecture and proctoring honoraria from Spectranetics. • I have been funded by and NIH/SBIR grant to AJ Medical Devices, Inc. (AJMD) and research grants from Boston Scientific, Medtronic, CON-LifeVest should be placed in St. Jude Medical, Guidant, Inc. and Cameron Health, Inc. post-infarct pts with EF <35% • I am or have been a consultant to AJMD, Boston Scientific and Cameron Health. Saturday, September 13, 2019 • I have an equity stake in AtaCor Medical, Inc. and am Chief Medical Martin C. Burke, DO Officer. Chief Scientific Officer CorVita Science Foundation www.corvitascience.org 2 Event rates of SCD after acute MI Deb ebate Str trategies: ( Stratified by LVEF ) • Discredit your adversary LVEF ≤ 30% LVEF 31-40% LVEF > 40% Solomon SD et al VALIANT Study, NEJM 2005 1
9/14/2019 Deb ebate Str trategies: Deb ebate Str trategies: • Google search- I got nothing except 100 pages of academic accolade and • Clearly my only option -I must go to media for Dr. Olgin. • Know your Adversary- data!! • Dr. Jeffery Olgin • Scopus h-index • Olgin, J. 171 publications with index of 51. • Dr. Marty Burke • Scopus h-index • Burke, M.C. 82 publications with index of 24. Populations Studied with WCD Actual WCD Use Chung, M. K. et al. J Am Coll Cardiol 2010;56:194-203 2
9/14/2019 VEST Trial : Criteria Vest Trial Results Exclusion Criteria: Inclusion Criteria: Existing ICD or indication for an ICD at the time of Patients identified in the hospital or within • • screening 7 days after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI) Existing unipolar pacemakers/leads • LV ejection fraction ≤35% determined at Chronic renal failure requiring hemodialysis after hospital • • the following time point: discharge 1. If no PCI within the first 8 hours Chest circumference too small or too large for LifeVest • following the MI: ≥ 8 hours after MI garment* 2. If acute PCI occurs within 8 hours of MI: Participants discharged to an institutional setting with an • ≥8 hours after PCI anticipated stay > 7 days 3. If CABG is planned (before or within 7 Pregnancy • days of discharge), wait to enroll and Inability to consent • then use the most recent assessment at Any other condition or circumstance that in the judgment least 48 hours post CABG • of the clinician makes the participant unsuitable for the Age ≥ 18 years • study. Pee eer Reac eaction to to VEST Trial al Lif ifeVest Cost t • It is not cheap. COMMENTARY The VEST Trial Failed, and • $1500-$3000 per month So Did the Press Release John M. Mandrola, MD March 11, 2018[ Medscape] Another Shock for Sudden Death Prevention after Myocardial Infarction Michael E. Field, M.D. and Richard L. Page, M.D. • NEJM 2018 Editorial in response to VEST Trial results • 3
9/14/2019 Deriva on� Sample� PREDICTS� N=364� VEST� 90� days� July� 2008� to� (Echo� Mandated� by� Protocol)� (MI,� EF ≤ 35%)� May� 2011� N=231� N=509� A er� May� 2011� 90� days� VEST� Registry� (Echo� not� Mandated)� N=236� Valida on� Sample� Gabriel C. Brooks et al. JACC 2016;67:1186-1196 PREDICTS STUDY: Risk Score Predictive Value Recovery Probability by Risk Scores Recovery to EF ≥50% Recovery to EF >35% Score (n) Recovery Probability% (95% CI) Score (n) Recovery Probability% (95% CI) 0 (4) 9.1 (2.5-21.7) 0-2 (45) 4.4 (2.7-6.8) 1-3 (83) 31.9 (28.8-35.2) 3-4 (43) 2.3 (1.1 – 4.3) 4-5 (63) 57.9 (53.9-61.8) 5-6 (78) 10.3 (8.2-12.6) 6 (35) 78.6 (73.9-82.8) 7-8 (23) 27.1 (21.4-33.4) ≥7 (47) 87.2 (83.8-90.1) ≥9 (43) 48.7 (43.9-53.6) Gabriel C. Brooks et al. JACC 2016;67:1186-1196 4
9/14/2019 Event rates of SCD after acute MI ( Stratified by LVEF ) LVEF ≤ 30% LVEF 31-40% LVEF > 40% Solomon SD et al VALIANT Study, NEJM 2005 5
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