Aims Concerns about the prognostic value of NYHA functional class (FC) in heart failure (HF) patients carrying a prophylactic implantable cardioverter defibrillator (ICD) are still present. We aimed to compare whether mortality and arrhythmic risk were different, in a cohort of HF patients undergoing ICD‐only implant, according to their FC. Methods and results HF patients with left ventricle ejection fraction (LVEF) ≤35%, undergoing first prophylactic ICD‐only implant were collected from a multicentre nationwide registry (2006–2015). Six hundred and twenty‐one patients were identified (101 patients in NYHA I; 411 in NYHA II; 109 in NYHA III). After a mean follow‐up of 4.4 years (±2.1), 126 patients died (20.3%). All‐cause mortality risk was higher in symptomatic patients: 13.9% in NYHA I patients, 18.3% in NYHA II patients (HR: 1.8, 95% CI 1.1–3.2), and 32.9% in NYHA III patients (HR: 3.9, 95% CI 2.1–7.3). Seventy‐eight out of all deaths were due to cardiovascular causes (12.6%). Cardiovascular mortality risk was also higher in symptomatic patients: 6.9% in NYHA I patients, 11% in NYHA II patients (HR: 2.2, 95% CI 1.1–4.9), and 23.9% in NYHA III (HR: 5.5, 95% CI 2.4–12.7). One hundred and seventeen patients received a first appropriate ICD therapy (19.4%). Arrhythmia free survival did not differ among study groups [20.8% in NYHA I patients, 18.7% in NYHA II (HR: 1.1, 95% CI 0.6–1.7) and 20.8% in NYHA III patients (HR: 1.3, 95% CI 0.7–2.5)]. NYHA class independently predicted cardiovascular mortality (NYHA III vs. NYHA I: HR, 4.7; 95% CI, 1.7–12.8, P = 0.002; NYHA II vs. NYHA I: HR, 2.1, 95% CI, 1.0–5.6, P = 0.05) but not all‐cause death (NYHA III vs. NYHA I: HR: 1.8, 95% CI 0.8–3.9, P = 0.11; NYHA II vs. NYHA I: HR, 1.1, 95% CI 0.6–2.2, P = 0.71;). Atrial fibrillation, chronic kidney disease, and diabetes emerged as predictors of both all‐cause death [(HR: 1.8, 95% CI 1.2–2.8, P = 0.005), (HR: 2.2, 95% CI 1.4–3.4, P < 0.001), (HR: 2.0, 95% CI 1.3–3.1, P = 0.001), respectively] and cardiovascular mortality [(HR: 1.8, 95% CI 1.1–3.1, P = 0.02), (HR: 3.1, 95% CI 1.8–5.4, P < 0.001), (HR: 1.7, 95% CI 1.1–3, P = 0.032), respectively]. Conclusions Mortality in HF patients undergoing prophylactic ICD implantation was higher in symptomatic patients. NYHA functional class along with other comorbidities might be helpful to identify a subgroup of ICD carriers with poorer prognosis and higher risk of cardiovascular death.
Background NYHA functional class (FC) is used for selection of heart failure (HF) patients who are candidates to primary prevention (PP) implantable cardioverter defibrillator (ICD) therapy. However, FC is subjectively estimated and concerns about its real prognostic value are still present in this setting. Purpose To compare whether mortality and arrhythmic risk are different, in a cohort of HF patients undergoing PP ICD-only implant, according to their FC. Methods All HF patients with left ventricle ejection fraction (LVEF) ≤35%, undergoing first prophylactic ICD-only implant were collected from the UMBRELLA nationwide registry (2006–2015). The sample was divided into three groups: no symptoms (NYHA I), mildly symptomatic patients (NYHA II) and severely symptomatic (NYHA III) patients. Outcomes were studied as follow: all-cause death, cardiovascular mortality and arrhythmia free survival (surrogate marker of sudden cardiac death) defined as survival free of first appropriate ICD therapy delivered in ventricular fibrillation (VF) window. Arrhythmic events were collected by remote monitoring and reviewed by a committee of experts. Results Six hundred and twenty one patients were identified (61.1±11.4 years, 87.3% male). Distribution of study groups was as follow: 101 patients in NYHA I; 411 in NYHA II; and 109 in NYHA III. More symptomatic patients were older and had higher prevalence of atrial fibrillation (AF) and chronic kidney disease (CKD). Higher rates of optimal medical treatment were present among study groups (beta-blockers: 92.1%; ACEI or ARB: 86.8%; aldosterone antagonists: 60.2%). After a median follow-up of 4.2 years (IQR, 2.7–5.7 years) 126 patients died (event rate: 20.3%). All-cause mortality was higher in patients with worse FC (13.9% vs. 18.3% vs. 32.9% for NYHA I, II and III respectively; p<0.001, log-rank test). Seventy-eight out of 126 deaths were related to cardiovascular causes (overall event rate: 12.6%). Cardiovascular mortality risk was also higher in more symptomatic patients (6.9% vs. 11% vs. 23.9% for NYHA I, II and III respectively; p<0.001, log-rank test). One hundred and seventeen patients received afirst appropriate ICD therapy (19.4%). Arrhythmia free survival was not different among study groups (20.8% vs. 18.7% vs. 20.8% for NYHA I, II and III, respectively; p=0.495, log-rank test). Cumulative incidence curves for the three outcomes are shown in Figure 1. After multivariate analysis, worse NYHA class independently predicted cardiovascular mortality but not all-cause death. Moreover, diabetes, AF and CKD strongly predicted both all-cause and cardiovascular mortality. Figure 1 Conclusions In HF patients, prophylactic ICD seems to be useful in preventing death due to life threatening arrhythmias, regardless of the baseline FC. Nevertheless, the combination of NYHA class with other comorbidities may be useful to select those ICD candidates who obtain less survival benefit.
Background Adaptive cardiac resynchronization therapy (aCRT) algorithm provides synchronized left ventricular (LV) only pacing and ambulatory optimization of the intrinsic atrioventricular and interventricular conduction intervals. Studies reporting morbidity and mortality outcomes of aCRT carriers in daily clinical practice are lacking. Purpose To determine in a real-life setting, whether 1-year outcomes were different among CRT carriers undergoing aCRT pacing and those under conventional biventricular (biV) pacing. Methods Symptomatic heart failure (HF) patients with sinus rhythm undergoing first CRT-defibrillator implant were selected from the UMBRELLA nationwide registry (2012–2017). The primary endpoint was the composite of all-cause mortality or HF hospitalization at 12-month follow-up. HF admission was defined as hospitalization due to symptoms requiring intravenous diuretic treatment. Primary healthcare records were used to prospectively collect all data. Results Two hundred and six patients were collected (66.1±8.7 years; 73.3% male). Eighty-seven out of 206 patients were implanted with an aCRT capable device, but this algorithm was activated at implant and remained enabled at 1-year in 59 patients (aCRT group). The other 147 patients composed the non-aCRT group. At implant left bundle branch block was present in 93% of patients, 69.6% of population was in functional class III or IV and mean left ventricle ejection fraction was of 26.5±5.6%. Non-ischemic cardiomyopathy was present in 63.1% of patients and optimal medical treatment was achieved in majority of population (92% of patients with beta-blockers; angiotensin-converting enzyme inhibitorsor angiotensin II receptor blockersin 89%). The percentage of ventricular pacing through 12 months was 96.1±9.4% in non-aCRT patients and 97.5±2.7% in aCRT patients (p=0.261). In aCRT patients, LV-only pacing accounted for a mean of 53.3±37.6% of all ventricular pacing. After 12-month follow-up period, 25 patients (12.1%) met the primary composite endpoint of death or HF hospitalization. Nine patients died and nineteen patients were admitted due to worsening HF. There was no difference in the risk of all-cause death or HF hospitalization between aCRT and non-aCRT patients (10.2% vs. 12.9% respectively; OR=0.76, CI: 0.29–2.01, p=0.585) Conclusions In this contemporary cohort of HF patients undergoing CRT with high percentages of ventricular pacing, clinical performance of aCRT algorithm was adequate. The risk of death or HF hospitalization was low and no differences were observed at one-year follow-up. Future randomized studies will clarify the role of this algorithm in CRT carriers. Acknowledgement/Funding None
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