Assessment of Chronic Disease to Determine Appropriateness of Implantable Cardioverter-Defibrillator Therapy

Background: Implantable cardioverter-defibrillator (ICD) therapy is considered appropriate when a patient is felt to have a reasonable expectation of 1-year survival. Chronic diseases have been estimated to be associated with greater than 10% annual mortality and may reduce benefits of ICD therapy. Frailty has been estimated to be associated with greater than 20% annual mortality and has been suggested to contraindicate ICD therapy. Purpose: Determine a risk score that may identify patients in whom ICD implantation may not be appropriate. Methods: Patients who received an ICD for primary and secondary prevention from 2008 through 2013 at the Aurora Health Care network were studied retrospectively. Using Cox regression, a scoring system based on hazard ratios was devised to reflect risk associated with comorbidities. Survival was evaluated by Kaplan-Meier estimates. Results: The study cohort includes 1,558 patients (mean age: 61.3 years; 495 female). Comorbidities associated with mortality included in the risk score were need for hemodialysis, myocardial infarct within 3 months prior to ICD implantation, sustained monomorphic ventricular tachycardia, New York Heart Association functional class III, age greater than 70 years, intraventricular conduction delay, diabetes mellitus, and chronic lung disease. A risk score of greater than or equal to 6 was associated with 10% mortality at 1 year and more than 20% mortality by 2 years. Conclusion: Chronic comorbidities have a cumulative effect on mortality. Using our scoring system, patients with a risk score of 6 or greater have at least 10% mortality at 1 year and more than 20% mortality by 2 years

PO06-27: Predictors of mortality in patients with transient severe left ventricular systolic dysfunction

Introduction: About 25% of patients who develop left ventricle (LV) systolic dysfunction will have improvement in LV ejection fraction (EF) overtime. This patient cohort is generally excluded from large sudden death trials and hence under studied. Methods: Patients who had transient LV systolic dysfunction between 2010-2014 within Aurora Health System who had LVEF improved≥40%, irrespective of implantable cardioverter-defribillator (ICD) implant, were studied and predictors of mortality were identified using Cox proportional hazard model. Patients were then divided into groups based on LVEF \u3e50% or Results: 1364 patients met inclusion criteria. 58.4% were male and mean BMI was 29+/-7. Mean age at improved LVEF was 66 years+/- 14, and with each added year the hazard rate increased by 5% [Hazard Ratio (HR) 1.05,p =0.0001]. Several clinical characteristics emerged as predictors of mortality, including smoking (HR 1.8, p=0.0002), chronic renal disease (HR 2.3,p = 0.0001), atrial fibrillation (HR 1.4, p=0.013) and no-ICD (HR 2.1, p=0.012). But with each percentage increase in LVEF hazard rate decreased by 2% (HR 0.97, p=0.007). However, presence of ICD did not significantly improve mortality in the group with LVEF \u3e50% (figure). Conclusions: Clinical predictors of mortality in patients with transient LV systolic dysfunction may help further risk stratify this cohort of patients. It appears that patients with LVEF 40-49% continue to derive benefit from ICD therapy

PO06-21: Benefit of implantable cardioverter defibrillator in patients with improved left ventricular systolic function

Introduction: About 25% patients with primary prevention implantable cardioverter-defibrillator (ICD) will have improved left ventricular (LV) ejection fraction (EF) on follow-up. Whether ICD benefits this cohort is largely unknown. Methods: Clinical characteristics and outcomes of patients in the Aurora Health System with transient LV dysfunction (initial LVEF≤35% that improved to ≥40%, during 1/1/2010-12/31/2014, were compared between primary prevention ICD recipients and those without ICD. Patients with cardiac resynchronization therapy, cardiac transplant and LV assist devices were excluded. We used Kaplan-Meier, chi-square and Fisher exact test for analysis. Results:One thousand three hundred sixty-four patients developed transient LV dysfunction. One hundred forty-eight (10.8%) had ICD implant. ICD recipients (vs. non-ICD patients) were more likely to be male (72% vs. 28.4%, p Conclusions: ICD is associated with mortality benefit in patients with transient LV dysfunction suggesting continued sudden death protection in patients with LVEF≥40%. This highlights the drawbacks of LVEF as ICD implant criterion

Predictors and rates of mortality in implantable cardioverter defibrillator recipients in the central midwest

Background: Implantable cardioverter defibrillator (ICD) therapy is expensive, but cost effectiveness has been demonstrated over longterm follow-up. Short-term mortality negatively impacts cost-effectiveness and ICD therapy is contraindicated in patients with expected longevityrecipients. Methods: Patients who underwent initial ICD implant from 2008-14 within the Aurora Health Care network (Wisconsin and northern Illinois) with at least 3 years of follow-up and/or suffered the primary endpoint of death were evaluated. Cox regression was used to determine hazard ratios (HR) for significant predictors identified through forward stepwise analysis. Results: In our ICD population (n=1560), total mortality was 194 (12.9%) and 42 patients died within 1 year of ICD implant (2.8%, 21.6% of total mortality). Clinical characteristics at the time of initial ICD implant that emerged as predictors of mortality included bradycardic arrest (HR 9.06, p70 (HR=2.39, p100 not meeting left bundle branch block [BBB] or right BBB criteria; HR 1.90, p Conclusions: A small but substantial percentage of central Midwestern ICD patients are at risk for 1-year mortality, and 1/5 of our total ICD mortality occurred within 1 year of implant. Several clinical characteristics at initial ICD implant predict mortality, including 1-year mortality, in our large cohort. Applying a priori knowledge of predictors of mortality, particularly 1-year mortality, may improve patient selection and cost-effectiveness of ICD therapy

Predictors of Mortality in Patients With Transient Severe Left Ventricular Systolic Dysfunction

Background: About 20% of patients who develop left ventricular (LV) systolic dysfunction will have improvement in ejection fraction (LVEF) over time. This patient cohort is generally excluded from large sudden death trials and, hence, understudied. Purpose: To evaluate the predictors of mortality in patients with severe LV systolic dysfunction who have improvement in LVEF during follow-up. Methods: Patients who had transient LV systolic dysfunction from 2010 to 2014 within the Aurora Health Care system and who had LVEF improve to ≥ 40%, irrespective of implantable cardioverter-defibrillator (ICD) implant, were studied. Predictors of mortality were identified using Cox proportional hazards model. Patients were then divided into groups based on LVEF \u3e 50% or \u3c 50% to assess for benefit of ICD using Kaplan-Meier estimates. Results: A total of 1,364 patients met inclusion criteria; 58.4% were male, and mean BMI was 29 ± 7. Mean age post-LVEF improvement was 66 ± 14 years, and with each added year the hazard rate increased by 5% (hazard ratio [HR]: 1.05, P \u3c 0.0001). Several clinical characteristics emerged as predictors of mortality, including smoking (HR: 1.8, P = 0.0002), chronic renal disease (HR: 2.3, P \u3c 0.0001), atrial fibrillation (HR: 1.4, P = 0.013) and no-ICD (HR: 2.1, P = 0.012). With each percentage increase in LVEF, hazard rate decreased by 2% (HR: 0.97, P = 0.007). However, presence of ICD did not significantly improve mortality in the group with LVEF \u3e 50% (P = 0.2), whereas it continued to show benefit in the group with LVEF of 40%–49% (P = 0.001). Conclusion: Clinical predictors of mortality in patients with transient LV systolic dysfunction may help further risk-stratify this cohort of patients. It appears that patients with LVEF of 40%–49% continue to derive benefit from ICD therapy

Predictors of Mortality in Patients With Transient Severe Left Ventricular Systolic Dysfunction

Background: About 20% of patients who develop left ventricular (LV) systolic dysfunction will have improvement in ejection fraction (LVEF) over time. This patient cohort is generally excluded from large sudden death trials and, hence, understudied. Purpose: To evaluate the predictors of mortality in patients with severe LV systolic dysfunction who have improvement in LVEF during follow-up. Methods: Patients who had transient LV systolic dysfunction from 2010 to 2014 within the Aurora Health Care system and who had LVEF improve to ≥ 40%, irrespective of implantable cardioverter-defibrillator (ICD) implant, were studied. Predictors of mortality were identified using Cox proportional hazards model. Patients were then divided into groups based on LVEF \u3e 50% or \u3c 50% to assess for benefit of ICD using Kaplan-Meier estimates. Results: A total of 1,364 patients met inclusion criteria; 58.4% were male, and mean BMI was 29 ± 7. Mean age post-LVEF improvement was 66 ± 14 years, and with each added year the hazard rate increased by 5% (hazard ratio [HR]: 1.05, P \u3c 0.0001). Several clinical characteristics emerged as predictors of mortality, including smoking (HR: 1.8, P = 0.0002), chronic renal disease (HR: 2.3, P \u3c 0.0001), atrial fibrillation (HR: 1.4, P = 0.013) and no-ICD (HR: 2.1, P = 0.012). With each percentage increase in LVEF, hazard rate decreased by 2% (HR: 0.97, P = 0.007). However, presence of ICD did not significantly improve mortality in the group with LVEF \u3e 50% (P = 0.2), whereas it continued to show benefit in the group with LVEF of 40%–49% (P = 0.001). Conclusion: Clinical predictors of mortality in patients with transient LV systolic dysfunction may help further risk-stratify this cohort of patients. It appears that patients with LVEF of 40%–49% continue to derive benefit from ICD therapy

Withholding ICDs after EF improves to \u3e 35% can not be justified in all patients with CAD and left ventricular systolic dysfunction (LVSD)

BACKGROUND: When EF≤35% is identified, ICDs are considered for SCD protection, but are withheld if EF improves to \u3e35% within 90 days. This practice is not supported by direct evidence and may leave a significant segment of the population exposed to SCD risk. OBJECTIVE: Evaluate relationship of EF to timing of appropriate ICD therapy, as well as impact of withholding ICD after EF improves to \u3e35%, in CAD patients with at least moderate LVSD. METHODS: Aurora Healthcare patients with EF≤35% and subsequent improvement at any time to EF\u3e35% were included; excluding patients with: EF recovery in ≤7 days, CRT, LVAD, transplant, and inherited sudden death syndromes. After propensity matching, the study cohort (n=798) was segregated by presence/absence of ICD. SCD events and appropriate ICD therapies (ApprRx) were tabulated in ICD patients, as well as EF at the time of the event. RESULTS: Of 133 ICD recipients (48.1%\u3e65 years, 31.6% female) 6% suffered ApprRx over 23±13 months. In 62.5% of patients with ApprRx the EF was confirmed \u3e35%, including in 75% of primary prevention patients with AppRx. In secondary prevention (2°) patients, a greater percentage (25%) of patients with EF\u3e35% received ApprRx, compared to those with EF≤35% (7.1%). Alarmingly, 22.2% of 2° patients did not have an ICD at the time of their initial SCD event because they were disqualified due to EF recovery. CONCLUSION: In patients with CAD, the ICD provides sudden death protection even after EF improves to \u3e35%. The practice of withholding ICD therapy for EF recovery to \u3e35% was associated with sudden death events in this analysis, and requires reexamination

Withholding ICDs after EF improves to \u3e 35% can not be justified in all patients with CAD and left ventricular systolic dysfunction (LVSD)

BACKGROUND: When EF≤35% is identified, ICDs are considered for SCD protection, but are withheld if EF improves to \u3e35% within 90 days. This practice is not supported by direct evidence and may leave a significant segment of the population exposed to SCD risk. OBJECTIVE: Evaluate relationship of EF to timing of appropriate ICD therapy, as well as impact of withholding ICD after EF improves to \u3e35%, in CAD patients with at least moderate LVSD. METHOD: Aurora Healthcare patients with EF≤35% and subsequent improvement at any time to EF\u3e35% were included; excluding patients with: EF recovery in ≤7 days, CRT, LVAD, transplant, and inherited sudden death syndromes. After propensity matching, the study cohort (n=798) was segregated by presence/absence of ICD. SCD events and appropriate ICD therapies (ApprRx) were tabulated in ICD patients, as well as EF at the time of the event. RESULTS: Of 133 ICD recipients (48.1%\u3e65 years, 31.6% female) 6% suffered ApprRx over 23±13 months. In 62.5% of patients with ApprRx the EF was confirmed \u3e35%, including in 75% of primary prevention patients with AppRx. In secondary prevention (2°) patients, a greater percentage (25%) of patients with EF\u3e35% received ApprRx, compared to those with EF≤35% (7.1%). Alarmingly, 22.2% of 2° patients did not have an ICD at the time of their initial SCD event because they were disqualified due to EF recovery. CONCLUSION: In patients with CAD, the ICD provides sudden death protection even after EF improves to \u3e35%. The practice of withholding ICD therapy for EF recovery to \u3e35% was associated with sudden death events in this analysis, and requires reexamination