1 9/14/2019 Deb ebate Str trategies: Deb ebate Str trategies: - - PDF document

9/14/2019 1

CON-LifeVest should be placed in post-infarct pts with EF <35%

Saturday, September 13, 2019

www.corvitascience.org

Martin C. Burke, DO Chief Scientific Officer CorVita Science Foundation

2

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,
• St. Jude Medical, Guidant, Inc. and Cameron Health, Inc.
• I am or have been a consultant to AJMD, Boston Scientific and

Cameron Health.

• I have an equity stake in AtaCor Medical, Inc. and am Chief Medical

Officer.

Event rates of SCD after acute MI

(Stratified by LVEF)

Solomon SD et al VALIANT Study, NEJM 2005 LVEF ≤ 30% LVEF 31-40% LVEF > 40%

Deb ebate Str trategies:

• Discredit your adversary

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Deb ebate Str trategies:

• Google search- I got nothing except 100 pages of academic accolade and

media for Dr. Olgin.

• Know your Adversary-
• 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.

Deb ebate Str trategies:

• Clearly my only option -I must go to

data!!

Chung, M. K. et al. J Am Coll Cardiol 2010;56:194-203 Actual WCD Use

Populations Studied with WCD

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Inclusion Criteria:

• Patients identified in the hospital or within

7 days after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI)

• LV ejection fraction ≤35% determined at

the following time point:

• 1. If no PCI within the first 8 hours

following the MI: ≥ 8 hours after MI

• 2. If acute PCI occurs within 8 hours of MI:

≥8 hours after PCI

• 3. If CABG is planned (before or within 7

days of discharge), wait to enroll and then use the most recent assessment at least 48 hours post CABG

• Age ≥ 18 years

Exclusion Criteria:

• Existing ICD or indication for an ICD at the time of

screening

• Existing unipolar pacemakers/leads
• Chronic renal failure requiring hemodialysis after hospital

discharge

• Chest circumference too small or too large for LifeVest

garment*

• Participants discharged to an institutional setting with an

anticipated stay > 7 days

• Pregnancy
• Inability to consent
• Any other condition or circumstance that in the judgment
• f the clinician makes the participant unsuitable for the

study.

VEST Trial : Criteria

Vest Trial Results

COMMENTARY

The VEST Trial Failed, and 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

Pee eer Reac eaction to to VEST Trial al Lif ifeVest Cost t

• It is not cheap.
• $1500-$3000 per month

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Gabriel C. Brooks et al. JACC 2016;67:1186-1196

PREDICTS

(Echo Mandated by Protocol) N=231

VEST Registry

(Echo not Mandated) N=236 90 days

VEST

(MI, EF≤35%) N=364 July 2008 to May 2011 N=509 A er May 2011 90 days

Deriva on Sample Valida on Sample

PREDICTS STUDY: Risk Score Predictive Value

Gabriel C. Brooks et al. JACC 2016;67:1186-1196 Recovery to EF >35% Recovery to EF ≥50% 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)

Recovery Probability by Risk Scores

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Event rates of SCD after acute MI

(Stratified by LVEF)

Solomon SD et al VALIANT Study, NEJM 2005 LVEF ≤ 30% LVEF 31-40% LVEF > 40%