Clinical Outcomes: Post-Revascularization Study

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

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Cardiologist sitting and talking with a LifeVest wearable cardioverter defibrillator patient

Early Risk of Mortality after Coronary Artery Revascularization in Patients with Left Ventricular Dysfunction and Potential Role of the Wearable Cardioverter Defibrillator (WCD)

Purpose

This study was created to determine the mortality risk in post-revascularization patients with left ventricular dysfunction (ejection fraction [EF] ≤ 35%) and to compare survival with patients protected by the WCD.

Methods

Retrospective, observational study comparing post-PCI and post-CABG patients with a low EF (EF ≤35%) from the national database of WCD users (n=809) propensity score-matched to patients from the surgical and interventional registries at Cleveland Clinic (n=4149) from August 1, 2002 through December 31, 2009.
Kaplan-Meier analysis was used to determine the difference in survival between the patient cohorts.
In addition to observing mortality differences over a 3-year period, a more detailed mortality analysis was conducted that analyzed mortality in the first 90 days and mortality that occurred after day 90.

Key results

Post-PCI: 90-day mortality for patients who received the WCD was 2% compared to 13% of patients who did not receive the WCD. WCD use was associated with an 85% reduction in 90-day mortality.
Post-CABG: 90-day mortality for patients who received the WCD was 4% and 7% for patients who did not receive the WCD. WCD use was associated with a 43% reduction in 90-day mortality.
Predictors of increased mortality included LVEF, age, female gender, and diabetes mellitus.
Overall survival was significantly higher in the WCD group than the no WCD group (10% vs. 34% mortality) at a median follow-up time of 2.8 years.

KM Curve showing survival within the first 90 days in Post-PCI WCD patients, showing 2% 90-day mortality in WCD patients and 13% 90-day mortality in No WCD patients

KM Curve showing survival within the first 90 days in Post-CABG WCD patients, showing 4% 90-day mortality in WCD patients and 7% 90-day mortality in No WCD patients

Conclusions

Patients with LV dysfunction are at significant mortality risk after coronary revascularization procedures.
WCD use is associated with significant reductions in 90-day mortality rates post-CABG and post-PCI, by 43% and 85% respectively.
1.3% of patients received appropriate WCD treatment.
In patients who received the WCD, ICDs were subsequently implanted in 32% of the CABG cohort and 30% of the PCI cohort.

Source: Zishiri ET, Williams S, Cronin EM, et al. Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator. Circ Arrhythm Electrophysiol. 2013;6:117–128.

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