Fall POA - Comp Readiness

Question 1

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

Answer 1

ACE-DETECT and ACE-CONVERT

Question 2

T or F: Neither Kestra trial used the fully functional, complete commercial system.

Answer 2

True

Question 3

Kestra claims that the ASSURE garment is more modern and comfortable. Often a famous designer or design house are cited as collaborators for the final product. Occasionally claims are made about closing the gender gap with female cardiology patients. The FACTS are that their garment sizes are:

Answer 3

The ASSURE garment has both a female and male version and comes in 7 sizes which fit patients from 28”-52”. Note: LifeVest has five sizes that fit a larger range of patient sizes (26”-56”). The electrodes are embedded into the garment.

Question 4

Background on Sensitive Skin and Allergies claims: Kestra representatives frequently cite sensitive skin and allergies to nickel (implying that LifeVest has nickel touching the patient’s skin) as reasons to prescribe ASSURE. The FACTS are:

Answer 4

In ACE-DETECT patients were excluded from the trial if they had known skin allergies, sensitivity to garment materials, and those with existing breached or compromised skin on the upper body. Still, 34% of patients wearing the Kestra device experienced an adverse event (AE) with 25% of patients reporting skin-related AE in only 30-days of wear.

LifeVest does not contain exposed nickel that touches the skin. The electrodes are made of tantalum, and the mesh is silver coated. 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 contact with the patient’s skin.

Question 5

Kestra makes two claims about inappropriate alarms. The first claim is that LifeVest has a high rate of inappropriate alarms. The comparator they chose to make the claim is from a discontinued version of LifeVest (LV3100 - 0.29 alarms/pt day).

A second and newer claim was released in advertisements in February 2024. Kestra claims that “more than 90% of ASSURE system patients never experience a false alarm vs. 54% of the other WCD (LifeVest) patients experience an alarm after AArD. The citation is data file from ACE-PAS from 1651 patients. It is important to clarify which claim prior to deciding the most appropriate response. Which responses below are acceptable to High Inappropriate Alarm Rate Claim:

Answer 5

• The data cited for the alarm rate is from an older LifeVest 3100 model and a previous version of the garment which have both been discontinued for more than a decade. A recent clinical study published of 96,000 patients wearing the current model with Advanced Arrhythmia Detection (AArD) has demonstrated that the majority of patients do not receive an inappropriate alarm over 90 days
• LifeVest inappropriate shock rate in published clinical trials is <1% per month even with a default VT threshold of 150 bpm, 20 bpm lower that the ASSURE WCD. With over a million patients of experience, the balance between detection and treatment has verified the approach
• In ACE-DETECT ASSURE detected 163 WCD episodes in 18 patients. (93.9% of the detection were reported noise and were adjudicated as “other physiological rhythms” or “uncertain and presumed not shockable”

Question 6

Kestra has made claims “in the field” around “general compliance.” If your customer mentions this, which statements below would be acceptable:

Answer 6

• With >20+ years of experience, ZOLL has focused on garment innovations to optimize patient comfort without compromising performance
• LifeVest has a median wear time of 23.4 hours per day in real world use
• Multiple peer reviewed clinical trials demonstrate high median wear time >22 hours over time

Question 7

Background on Kestra’s Female Garment: ACE-DETECT included only 30% women, which equates to 40 female patients’ total, which statements below would be acceptable:

Answer 7

• I am only aware of data on ~40 patients that were published. Has the other WCD representative shown you data on more patients than they have published for females?
• ZOLL has focused on garment innovations to optimize patient comfort without compromising performance for both female and male patients.
• Multiple clinical trials confirm that LifeVest compliance with females is similar to males and sometimes even better

Question 8

Which of these statements are both accurate and acceptable to “say” to a customer:

Answer 8

LifeVest has a combined gender median wear time of 23.4 hours per day in real world use

For patients with insurance, most have in-network access to LifeVest with 95% of commercially covered lives in the US having in-network access plus 100% of Medicare Part B and >90% of state Medicaid plans.

Question 9

What’s the LifeVest inappropriate shock rate?

Answer 9

LifeVest has a <1% inappropriate shock rate.

Question 10

When they say “all females” preferred Kestra over LifeVest they mean how many? And compared to what?

Answer 10

5 females
Comparing to a decade old device

Question 11

Which of the 3 trials is the only one published?

Answer 11

ACE-CONVERT

Question 12

Doc, when you’re considering two devices what breaks the tie?

Answer 12

Usually straight forward answer