Joint Shock/Death Risk Prediction Model for Patients Considering Implantable Cardioverter-Defibrillators

Abstract

Background: The risk of death or appropriate therapy varies widely among recipients of implantable cardioverter-defibrillators (ICDs). The goals of this study were to develop a risk prediction tool that jointly considers future outcome probabilities of ICD shock and death. Methods and Results: We performed a secondary analysis of patients receiving ICDs as part of the SCD-HeFT trial (Sudden Cardiac Death in Heart Failure Trial). We applied an illness-death regression model to jointly model both ICD shocks and death under the semi-competing risks framework, which predicts for each patient their probability of having received ICD shocks, dying, or both at any given point in time. Among 803 ICD recipients (mean age, 60 years; 23% women) followed for a median of 41.1 months, 430 (53.5%) patients completed the study without dying or receiving an ICD shock, 206 (25.7%) received at least 1 shock but survived, 113 (14.1%) died before experiencing a shock, and 54 (6.7%) received at least 1 shock and subsequently died. Predicted outcome probabilities based on baseline demographic and clinical variables reveal substantial heterogeneity in joint shock and death risks, both between patients at each time point and for each single patient across time. Overall, predictive performance for ICD shock and death individually was adequate, based on area under the curve at 5 years of 0.65 for shocks and of 0.79 for death. Conclusions: Our analysis of outcomes after ICD implantation provides an alternative predictive model for individual risk of death or ICD shocks. If validated, this may provide a useful tool for individualized counseling regarding likely outcomes after device implantation, while also informing the design of further studies to focus the clinical effectiveness and cost-effectiveness of ICD therapy. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00000609.

N-Terminal Pro-B-Type Natriuretic Peptide in Risk Stratification of Heart Failure Patients With Implantable Cardioverter-Defibrillator

“…Nonetheless, our findings raised key questions about the utility of NT-proBNP in the risk stratification of SCD. According to current guidelines (6, 7), a lot of HF patients implanted with ICDs would not receive appropriate ICD shock in the long-term follow-up (8)(9)(10)(11). Consequently, there is an urgent need to find a new risk stratification marker in addition to LVEF and NYHA.…”

“…According to current guidelines ( 6 , 7 ), a lot of HF patients implanted with ICDs would not receive appropriate ICD shock in the long-term follow-up ( 8 – 11 ). Consequently, there is an urgent need to find a new risk stratification marker in addition to LVEF and NYHA.…”

“…Nevertheless, the selection of patients is mainly based on New York Heart Association (NYHA) functional class and left ventricular ejection fraction (LVEF) (6,7). A large number of ICD recipients, especially those with Non-ischemic etiology, do not receive appropriate therapy in the long-term follow-up (8)(9)(10)(11)(12)(13)(14). Therefore, there is an urgent need to find an additional indicator to identify patients more likely to benefit from ICD therapy.…”

Modeling semi-competing risks data as a longitudinal bivariate process

“…Although less familiar than competing risks, semi-competing risks arise in a wide range of clinical settings including: Alzheimer's disease, as illustrated in this paper; graft-versushost disease among patients who have undergone hematopoietic stem cell transplantation for leukemia [8]; readmission following discharge from a hospitalization during which a patient is diagnosed of a terminal disease such as pancreatic cancer [21,20]; shock among patients with implanted cardiac devices [32]; and, preeclampsia a severe pregnancy-associated disease that affects between 3-10% of all pregnancies [16]. A distinguishing feature of semicompeting risks, relative to competing risks, is that there is at least partial information about the joint distribution between T 1 and T 2 .…”

Cardiac magnetic resonance left atrial volumes and function to predict appropriate device therapy and death

“…However, LVEF being the sole determinant of guiding ICD implantation has proven to be inadequate in multiple subsequent studies. Studies have shown the majority of patients experiencing SCD have LVEF > 35% [6,7], and a high proportion of patients implanted with ICDs do not receive an ICD shock even before death [8]. In terms of patient outcomes, the 2016 DANISH trial [9] showed that prophylactic ICD implantation in patients with symptomatic non-ischaemic heart failure and LVEF < 35% was not associated with a significant reduction in mortality.…”