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Clinical decision tool for CRT-P vs. CRT-D implantation: Findings from PROSE-ICD

View Article: PubMed Central - PubMed

ABSTRACT

Background: Cardiac resynchronization therapy (CRT) devices reduce mortality through pacing-induced cardiac resynchronization and implantable cardioverter defibrillator (ICD) therapy for ventricular arrhythmias (VAs). Whether certain factors can predict if patients will benefit more from implantation of CRT pacemakers (CRT-P) or CRT defibrillators (CRT-D) remains unclear.

Methods and results: We followed 305 primary prevention CRT-D recipients for the two primary outcomes of HF hospitalization and ICD therapy for VAs. Serum biomarkers, electrocardiographic and clinical variables were collected prior to implant. Multivariable analysis using Cox-proportional hazards model was used to fit the final models. Among 282 patients with follow-up outcome data, 75 (26.6%) were hospitalized for HF and 31 (11%) received appropriate ICD therapy. Independent predictors of HF hospitalization were atrial fibrillation (HR = 1.8 (1.1,2.9)), NYHA class III/IV (HR = 2.2 (1.3,3.6)), ejection fraction <20% (HR = 1.7 (1.1,2.7)), HS-IL6 >4.03pg/ml (HR = 1.7 (1.1,2.9)) and hemoglobin (<12g/dl) (HR = 2.2 (1.3,3.6)). Independent predictors of appropriate therapy included BUN >20mg/dL (HR = 3.0 (1.3,7.1)), HS-CRP >9.42mg/L (HR = 2.3 (1.1,4.7)), no beta blocker therapy (HR = 3.2 (1.4,7.1)) and hematocrit ≥38% (HR = 2.7 (1.03,7.0)). Patients with 0–1 risk factors for appropriate therapy (IR 1 per 100 person-years) and ≥3 risk factors for HF hospitalization (IR 23 per 100-person-years) were more likely to die prior to receiving an appropriate ICD therapy.

Conclusions: Clinical and biomarker data can risk stratify CRT patients for HF progression and VAs. These findings may help characterize subgroups of patients that may benefit more from the use of CRT-P vs. CRT-D systems.

Trial registration: ClinicalTrials.gov NCT00733590

No MeSH data available.


Multivariable hazard ratios for appropriate therapy and HF hospitalization.
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pone.0175205.g001: Multivariable hazard ratios for appropriate therapy and HF hospitalization.

Mentions: Over the follow-up period, 31 patients received appropriate ICD therapy for VAs (20 shocks, 11 ATP). Ventricular tachycardia was the underlying rhythm in 87.1% cases with the remaining due to ventricular fibrillation. Median heart rate of treated arrhythmias was 215bpm (interquartile range, 194-240bpm). Median time to appropriate therapy was 1.7 years [0.8–3]. Male gender, no beta blocker therapy, elevated inflammatory markers (i.e., HS-CRP and HS-IL6), and elevated blood urea nitrogen (BUN) were associated with a significantly increased risk of appropriate ICD therapy (Tables 2–4). On the other hand, advanced NYHA class III/IV and anemia were associated with a non-significant trend for decreased risk of appropriate ICD therapy. In multivariable analysis, four variables were identified as significant predictors of appropriate ICD therapy: BUN >20mg/dL (HR = 3.0 (1.3,7.1); p = 0.01), HS-CRP >9.42mg/L (HR = 2.3 (1.1,4.7); p = 0.03), no beta blocker therapy (HR = 3.2 (1.4, 7.1); p = 0.006) and hematocrit ≥38% (HR = 2.7 (1.03,7.0); p = 0.04) (Fig 1). The Harrell’s c-statistic of the final model was 0.76 (0.67, 0.85). Three distinct score categories were identified: category 1 (score 0–1 (n = 149, 52.8%)), category 2 (score 2 (n = 96, 34.1%)) and category 3 (score 3–4 (n = 37, 13.1%)). Five-year cumulative risk of appropriate therapy was 4%, 14.6% and 47.2% for score categories 1, 2 and 3, respectively (p< 0.001) (Fig 2A).


Clinical decision tool for CRT-P vs. CRT-D implantation: Findings from PROSE-ICD
Multivariable hazard ratios for appropriate therapy and HF hospitalization.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5384669&req=5

pone.0175205.g001: Multivariable hazard ratios for appropriate therapy and HF hospitalization.
Mentions: Over the follow-up period, 31 patients received appropriate ICD therapy for VAs (20 shocks, 11 ATP). Ventricular tachycardia was the underlying rhythm in 87.1% cases with the remaining due to ventricular fibrillation. Median heart rate of treated arrhythmias was 215bpm (interquartile range, 194-240bpm). Median time to appropriate therapy was 1.7 years [0.8–3]. Male gender, no beta blocker therapy, elevated inflammatory markers (i.e., HS-CRP and HS-IL6), and elevated blood urea nitrogen (BUN) were associated with a significantly increased risk of appropriate ICD therapy (Tables 2–4). On the other hand, advanced NYHA class III/IV and anemia were associated with a non-significant trend for decreased risk of appropriate ICD therapy. In multivariable analysis, four variables were identified as significant predictors of appropriate ICD therapy: BUN >20mg/dL (HR = 3.0 (1.3,7.1); p = 0.01), HS-CRP >9.42mg/L (HR = 2.3 (1.1,4.7); p = 0.03), no beta blocker therapy (HR = 3.2 (1.4, 7.1); p = 0.006) and hematocrit ≥38% (HR = 2.7 (1.03,7.0); p = 0.04) (Fig 1). The Harrell’s c-statistic of the final model was 0.76 (0.67, 0.85). Three distinct score categories were identified: category 1 (score 0–1 (n = 149, 52.8%)), category 2 (score 2 (n = 96, 34.1%)) and category 3 (score 3–4 (n = 37, 13.1%)). Five-year cumulative risk of appropriate therapy was 4%, 14.6% and 47.2% for score categories 1, 2 and 3, respectively (p< 0.001) (Fig 2A).

View Article: PubMed Central - PubMed

ABSTRACT

Background: Cardiac resynchronization therapy (CRT) devices reduce mortality through pacing-induced cardiac resynchronization and implantable cardioverter defibrillator (ICD) therapy for ventricular arrhythmias (VAs). Whether certain factors can predict if patients will benefit more from implantation of CRT pacemakers (CRT-P) or CRT defibrillators (CRT-D) remains unclear.

Methods and results: We followed 305 primary prevention CRT-D recipients for the two primary outcomes of HF hospitalization and ICD therapy for VAs. Serum biomarkers, electrocardiographic and clinical variables were collected prior to implant. Multivariable analysis using Cox-proportional hazards model was used to fit the final models. Among 282 patients with follow-up outcome data, 75 (26.6%) were hospitalized for HF and 31 (11%) received appropriate ICD therapy. Independent predictors of HF hospitalization were atrial fibrillation (HR = 1.8 (1.1,2.9)), NYHA class III/IV (HR = 2.2 (1.3,3.6)), ejection fraction &lt;20% (HR = 1.7 (1.1,2.7)), HS-IL6 &gt;4.03pg/ml (HR = 1.7 (1.1,2.9)) and hemoglobin (&lt;12g/dl) (HR = 2.2 (1.3,3.6)). Independent predictors of appropriate therapy included BUN &gt;20mg/dL (HR = 3.0 (1.3,7.1)), HS-CRP &gt;9.42mg/L (HR = 2.3 (1.1,4.7)), no beta blocker therapy (HR = 3.2 (1.4,7.1)) and hematocrit &ge;38% (HR = 2.7 (1.03,7.0)). Patients with 0&ndash;1 risk factors for appropriate therapy (IR 1 per 100 person-years) and &ge;3 risk factors for HF hospitalization (IR 23 per 100-person-years) were more likely to die prior to receiving an appropriate ICD therapy.

Conclusions: Clinical and biomarker data can risk stratify CRT patients for HF progression and VAs. These findings may help characterize subgroups of patients that may benefit more from the use of CRT-P vs. CRT-D systems.

Trial registration: ClinicalTrials.gov NCT00733590

No MeSH data available.