ZOLL LIFE VEST - Evidence of Saving Lives

Increased Risk of Sudden Cardiac Death in First 90 Days Post MI

Leading Cause of death in US

Rank

Patients who have had MI are 4 to 6 times more likely to have cardiac arrests than general population

4 to 6 Times

Unmet Need

First 3 Months -

Higher Risk

Circulation. 2014;129:2426–2435

Only FDA Approved Wearable CardioVerter

Committed to Evidence for Over 20 years

Body of Evidence

Evidence from >20,000 Patients Across Multiple Etiologies

Randomized Placebo Controlled Trials

Registry

VEST

Randomized controlled trial of over 2,000 patients to study the use of the WCD and its effect on sudden death and total mortality in early post-MI, low-EF (EF ≤ 35%) patients at 90 days, including an initial intent-to-treat analysis and subsequent per-protocol analysis. Read more

WCD Meta-Analysis

Analysis of 11 studies, with almost 20,000 non-overlapping patients prescribed the WCD, which assessed the occurrence of sustained VT events and evaluated the use and effectiveness of WCDs among at-risk cardiac patients. Read more

WEARIT-II Registry

Prospective registry of 2,000 US patients assessed the safety and efficacy of the WCD in real world setting. Read more

WEARIT France

Multi-centered, observational study of more than 1,000 French patients evaluated WCD efficacy and patient experience in real world setting. Read more

U.S. National WCD Experience

Retrospective study compared the long-term survival of more than 3,500 patients who wore the WCD to the patients who underwent first ICD implantation. Read more

German WCD Study

Retrospective study of more than 6,000 German patients evaluated safety and efficacy of the WCD in the German healthcare system. Read more

Post-MI WCD Study

Retrospective study examined the utility of providing the WCD to more than 8,400 patients determined to be at high risk of SCD during the post-MI waiting period. Read more

Post-Revascularization Study

Retrospective observational parallel cohort study compared mortality outcomes of nearly 5,000 post-revascularization high-risk SCD patients. Read more

WEARIT/BIROAD

Multi-center clinical trial which led to FDA approval of the LifeVest WCD. Read more

The 2016 AHA recommendations for wearable cardioverter-defibrillator therapy (WCD)

A WCD

is Reasonable

Evidence-based Guidelines

• when there is a clear indication for an implanted/permanent device accompanied by a transient contraindication or interruption in ICD care (ie, infection) (Class IIa; level of evidence: C).
• as a bridge to more definitive therapy such as cardiac transplantation. (Class IIa; level of evidence: C)
• when there is concern about a heightened risk of SCD that may resolve over time or with treatment of left ventricular dysfunction. (Class IIb; level of evidence: C)

• as bridging therapy in situations associated with increased risk of death in which ICDs have been shown to reduce SCD but not overall survival. (Class IIb; level of evidence: C)

• when nonarrhythmic risk is expected to significantly exceed arrhythmic risk, particularly in patients who are not expected to survive >6 months. (Class III)

may be Appropriate

Should Not be Used

How to Succeed:

PERSONALIZED PATIENT INSIGHTS

Offices

Global

Issues

Bespoke Evidence Communicator

Why Himanish

• Rapidly supplements existing baseline knowledge with other relevant evidence to present balanced insights

• Demonstrated knack for uncovering key mis-perceptions or gaps in knowledge and sharing relevant, trusted evidence to change behavior

• Targeted and deliberate approach to identifying and prioritizing influencers