FALL POA - Competitive Readiness Flashcards by Kaylin Willis

What does “PAS” stand for?

Post-Approval Study

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ACE-PAS – What is the effectiveness objective?

To evaluate shock effectiveness in converting ventricular tachycardia/ventricular fibrillation (VT/VF)

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ACE-PAS - What is the Primary Endpoint?

Overall shock conversion rate

[percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks] =89.0%

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ACE-PAS - What is the Secondary Endpoint?

First shock conversion rate

[percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) converted with a single shock] (report only)

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ACE-PAS - Why did they choose a goal of “89%” as their conversion rate for VT & VF?

The overall performance goal is based on results from LifeVest German Registry data in which the overall shock conversion rate was 94.0% for 163 appropriate shocks delivered in a population of 6,043 patients. Applying a non-inferiority margin of 5% results in a performance goal of 89%.

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ACE-PAS - How many shocks do they need to meet their endpoint?

271 Shocks

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ACE-PAS - How many patients do they anticipate needing to be enrolled to accomplish their endpoint?

5179 Enrolled Patients

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ACE-PAS Progress – “Late Breaking News” - How many patients are actually enrolled vs how many are needed?

9,573 vs need 17,205

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Safety Objective of ACE-PAS?

To evaluate the prevalence of inappropriate shocks.

(Think: ACE-PAS, Pass the test)

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ACE-PAS Primary Safety Endpoint?

Inappropriate shocks per patient-month of use

[total inappropriate shocks/cumulative months of device use for all patients] = 0.0075

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ACE-PAS Secondary Safety Endpoint?

Inappropriate shock rate

[percent of patients who experience at least one inappropriate shock] (report only)

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ACE-PAS Rational for Safety Endpoint

Based on results from two registry studies and the manufacturer reported rate which cumulatively report 0.0071 inappropriate shocks per patient month

(1363 inappropriate shocks/191,743 months of cumulative wear time). The upper bound of a two-sided 95% confidence interval around 0.0071 is 0.0075.

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What is the LifeVest inappropriate shock rate?

0.9%

from WCD Meta Analysis of 19,882 patients

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Response to a Kestra Key selling message,

“Contemporary Garment: Quality, comfort, built-in bra for women”

LifeVest next generation garment

> 1 Million Patients over a 20-year period!!!

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Name the 5 aspects of the LifeVest Next Generation Garment (add a WIFM)

Designed for comfort - lightweight and breathable, following the latest trends in performance wear
Plastic Snaps - low profile increase comfort
Strap Materials - softer, more comfortable, double plush material
Electrode Attachment - 360 degree placement of electrodes for cord management
Front closure - butterfly clasp for patients with dexterity issues

(Hint: Comfort, Snaps, Straps, Electrodes, Butterfly – “BECSS”

“I provide comfort, yet I hold you tight, With snaps and straps, I fit just right. My electrodes may help in a different way, And a butterfly’s touch can brighten your day. What am I?”)

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Response to a Kestra Key selling message,

“Reduction in alarms yields better patient compliance”

Arrythmia alarms both false and positive occurred in 72% of the participants w/ 9.6% of the participants being exposed to more than 100 alarms over the 90 day period

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What % of LifeVest treatments occur at a rate less than 170bpm?

11%

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What Innovation was added in 2018 to LifeVest?

TruVector

56% relative reduction in total arrythmia alarms

0 median false alarms

AArD was designed to reduce an already low rate of false detections

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Describe AArD

AArD is a machine learning classifier that determines if input is noise or artifact

Designed to filter additional false detections
caused by non-physiological signal artifact
and noise

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When was AArD introduced vs when was AArD standard in all WCDs?

Introduced in 2018; standard in all LifeVest WCDs since 2019

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The ASSURE device was approved by the FDA based on two small clinical trials called?

ACE-CONVERT
ACE-DETECT

(One trial was used to
demonstrate treatment efficacy, and a second trial was used to demonstrate appropriate detection)

Neither ASSURE trial used the _________________________.

Neither ASSURE trial used the fully functional, complete commercial system.

ACE-CONVERT consisted of how many patients and in what setting?

13 patients in an EP lab setting

In ACE-CONVERT patients were ____________ into ___________ .

Induced into VT/VF

In ACE-CONVERT patients were induced into VT/VF while wearing _________________ that were modified to be attached to the ____________.

Adhesive therapy pads that were modified to be attached to the ASSURE device

This study showed that ASSURE had an 83% first shock and 95% second shock success rate

ACE-CONVERT

LifeVest has a consistent ____ first shock success rate in clinical research and real-world use

>95% first shock success rate

Why is the LifeVest first shock success rate different than ASSURE's?

Because it's based on research and real-world use. Also, it was captured from patients in the real world utilizing our device instead of in an EP lab with a modified device

ACE-DETECT included ____ patients with active ______

ACE-DETECT included 130 patients with active ICDs

ACE-DETECT - Enrolled pts to wear an ASSURE device with therapies disabled for up to ___ days.

30 days

ACE-DETECT - name the the primary endpoint.

A false positive shock alarm rate

ACE-DETECT - What were the results of this trial?

The study achieved the primary endpoint of false detections. Of the 15 VT/VF episodes captured by ICDs, 11 were not detected by ASSURE. Four were due to patients not wearing the device at the time of the episode and 7 were due to not meeting the ASSURE detection threshold of 170bpm

ACE-DETECT - name additional endpoints beyond the Primary!

ICD-detected episodes and adverse event rates

What Kestra is incomplete due to lack of enrollment?

ACE-PAS (FDA required post-approval study)

New advertising from Kestra claims ASSURE to have a >95% first shock success rate. The citation is data on file and based on the reported n=_______.

n=1651 (26 reported appropriate shocks) It should be noted that this is a small sample size to base a claim

Does the “Freedom of Choice Act” apply to WCD's?

A case manager focused message is based on misrepresenting the “Freedom of Choice Act” by stating that it is required that patient must be given a choice of vendor when being offered an WCD. The Freedom of Choice Act does not apply to WCDs due to differences in the devices and associated clinical data. It is important that case managers understand that WCDs are not equal

Appropriate Responses for Ordering Process and Speed to Fit:

* Patient-first approach * Slightly different for each patient (individual coverage policy or ability to pay) because we never want a patient to get an unnecessary bill. * The LifeVest ordering designed to collect the appropriate information required for the approval process by payers. * This process has been continuously informed by 20+ years of experience * The benefit of the process is that patients do not get unexpected large bills after discharge. * PSR'S - ZOLL has the largest network of medically trained professionals to fit and service LifeVest patients, both before and after discharge. * ZOLL also offers vast patient resources designed to educate, engage, and motivate the patient throughout their wear.

ZOLL Payor Coverage?

95% of commercially covered lives in the US having in-network access plus 100% of Medicare Part B and >90% of state Medicaid plans

The LifeVest's median wear time is?

23.4 hrs

Multiple peer reviewed clinical trials demonstrate high median wear time >_____ hrs over time

22 hours

How many patients had AE while wearing the Kestra device?

34% of patients

How many patients had a skin-related AE wearing the Kestra device?

25% of patients reporting skin-related

How many days were the patients in Kestra that reported the AE?

Only 30-days of wear

Does LifeVest contain exposed Nickel that touches the skin? Tell us about nickel in the LifeVest and where it might be located?

No, LifeVest does not contain exposed nickel that touches the skin. The therapy pads contain high-grade stainless steel which contains a small percentage of bound nickel, which is considered hypoallergenic. However, they do not come in direct

The LifeVest 1-year survival in patients who experienced VT/VF is?

90%

What's the Adverse Event rate for LifeVest and what clinical trial is it found in?

In the Vest Trial, a skin irritation rate of 15.3% was observed.

How many people were treated by ASSURE in ACE-DETECT?

Zero, defibrillation capability was turned off

ACE-DETECT - What was the default VT threshold?

170 bpm

ACE - CONVERT - Were these patients treated in an ambulatory setting?

No, these patients were in a lab undergoing medically necessary electrophysiology procedures

ACE-CONVERT - Were the treatments delivered via the FDA approved ASSURE or a somewhat modified method?

Patients had 2 pairs of commercially available disposable adhesive defibrillation pads attached

Does Kestra have any data on defibrillation in ambulatory setting?

Nope

“I heard Kestra had a low rate of false detections compared to LifeVest.” – What would your response be?

– Kestra is comparing inappropriate alarms to a device that is no longer available – AArD has reduced what was a low rate of alarms – Kestra WCD only detected 4 out of 15 actual VT/VF events – Their default VT threshold is set at 170 bpm