Wyniki kliniczne: WEARIT-II Registry

Prospektywny rejestr 2000 przypadków amerykańskich pacjentów oceniający bezpieczeństwo i skuteczność kamizelki WCD w rzeczywistych warunkach.

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Cardiologist sitting and talking with a LifeVest wearable cardioverter defibrillator patient

Use of the Wearable Cardioverter Defibrillator (WCD) in High-Risk Cardiac Patients: Data from the Prospective Registry of Patients Using the Wearable Cardioverter Defibrillator (WEARIT-II Registry)

Purpose

Prospective registry designed to provide data on the safety and efficacy of the WCD in a real-world setting.
- Identify the rate of ejection fraction improvement and the need for ICD implantation at the end of WCD use.

Methods

Prospective registry of 2,000 patients (median age = 62 years, median EF = 25%) prescribed a WCD between August 2011 and February 2014.
Included patients with ischemic cardiomyopathy (n=805, 40%), non-ischemic cardiomyopathy (n=927, 46%), and congenital/inherited heart disease (n=268, 13.4%).
Clinical data, arrhythmia events, ICD implantation rate, and improvement in ejection fraction (EF) rate were captured.

Table showing arrhythmic events experienced, including percentage of patients and event rate per 100 patient-years

Initial study results¹

The sustained VT/VF event rate was high with 22 events per 100 patient-years. 2.1% of patients had a VT/VF event.
1 in 14 patients experienced an arrhythmic event.¹ (See chart.)
There was a low occurrence of inappropriate therapy (0.5%).
Patient wear time with the WCD was high, with a median daily use of 22.5 hours each day.
Upon termination of WCD use, EF improved in 41% of patients to the point that an ICD was not longer indicated, while 42% of patients required permanent implantation of an ICD.

Conclusions

The registry demonstrated a high rate of sustained VT/VF at 3 months in high-risk patients of all etiologies who are not eligible for an ICD, suggesting that a WCD can be safely used to protect patients during this time period of risk assessment.
In addition to Sudden Cardiac Death (SCD) protection and treatment, the LifeVest WCD captures valuable data about the patient’s broader cardiac function that offers meaningful clinical value during the early period following a cardiac event.
The high rate of both EF improvement and persistent arrhythmic risk in a high SCD risk population affirms the unpredictability of patient outcomes early after a cardiovascular event.
Patient prescribed with the LifeVest WCD experience a high one-year survival following LifeVest use.

Sources:

1. Kutyifa V, Moss AJ, Klein H, et al. Use of the wearable cardioverter defibrillator in high-risk cardiac patients: Data from the prospective registry of patients using the wearable cardioverter defibrillator (WEARIT-II Registry) . Circulation 2015;132(17):1613–1619.

2. Kutyifa V, Moss A, Klein H, et al. O ne-Year Follow-Up of the Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II Registry) . Pacing Clin Electrophysiol. 2018;1–7. https://doi.org/10.1111/pace.13448

READ THE ORIGINAL PUBLICATION READ THE ONE-YEAR-FOLLOW-UP-PUBLICATION

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