Dataset Information

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

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.

SUBMITTER: Nauffal V

PROVIDER: S-EPMC5384669 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Nauffal Victor V Zhang Yiyi Y Tanawuttiwat Tanyanan T Blasco-Colmenares Elena E Rickard John J Marine Joseph E JE Butcher Barbara B Norgard Sanaz S Dickfeld Timm-Michael TM Ellenbogen Kenneth A KA Guallar Eliseo E Tomaselli Gordon F GF Cheng Alan A

PloS one 20170407 4

<h4>Background</h4>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.<h4>Methods and results</h4>We followed 305 primary prevention CRT-D recipients for the two primary outcomes of HF hosp ...[more]

PMID: 28388657

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Project description:AIMS:Diabetes mellitus (DM) has a negative impact on prognosis in patients with heart failure (HF). The role impact of DM in HF patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices might differ and remains unclear. The aim of our study was to investigate the impact of DM on periprocedural complications and clinical outcome in HF patients undergoing ICD or CRT implantation. METHODS AND RESULTS:Within the German Device Registry, data from 50 German centres were collected between January 2007 and February 2014. A retrospective analysis of n = 5329 patients undergoing ICD implantation was conducted. Patients' characteristics, procedural data, periprocedural complications, and post-procedural clinical outcome, including a composite clinical endpoint of all-cause mortality, stroke, and myocardial infarction (MACCE), were analysed. Subgroup analysis were performed for ICD and CRT implantations. Median follow-up was 15.7 (12.9; 20.0) and 16.2 (12.8; 21.2) months in DM and non-DM patients. Of 5329 patients enrolled, n = 1448 (27.2%) had a diagnosis of DM. Within the cohort, 94% of DM and 90% of non-DM patients had a diagnosis of HF. Patients with DM were older, had higher body mass index, and higher rate of cardiovascular comorbidities compared with non-DM patients. Unadjusted and adjusted analyses revealed similar all-over intrahospital periprocedural complication rates in both groups (4.1% vs 3.9%). Unadjusted Kaplan-Meier survival analysis showed higher all-cause mortality after 1 year (9.0% vs 6.3%; log-rank P = 0.001) with higher MACCE rates (10.0% vs 7.3%; P < 0.001) in the DM group versus non-DM patients. After multivariable adjustment for relevant covariates, the association of DM to MACCE disappeared [HR 1.11 (0.89-1.38)]. Because chronic kidney disease (CKD) was clearly associated with increased 1 year MACCE after multivariate adjustment [odds ratio (OR) 2.11 (1.68-2.64)], a subgroup analysis was performed showing a strong trend towards more perioperative complications in DM patients with CKD [OR 2.16 (0.9-5.21)], while no effect of DM was observed in patients without CKD [OR 0.73 (0.42-1.28)]. CONCLUSIONS:The overall risk of periprocedural complications and short-term (1 year) clinical outcome in patients with DM and HF undergoing ICD or CRT defibrillator (CRT-D) implantation was not increased. In contrast, CKD was associated with an increased risk of 1 year MACCE in HF patients undergoing ICD/CRT-D implantation.

Project description:AimsThe aim of this study is to report heart failure hospitalization (HFH) rates and associated costs within 12 months following implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) device replacement or upgrade from ICD to CRT-D.Methods and resultsThe DEtect long-term COmplications after icD rEplacement (DECODE) was a prospective, single-arm, multicentre cohort study that explored complications in ICD/CRT-D recipients. All clinical and survival data at 12 months were prospectively analysed. For each adjudicated HFH, admission and discharge dates and ICD-9-CM diagnosis and procedure codes were recorded. The reimbursement for each HFH was calculated for each diagnosis-related group code. Between 2013 and 2015, 983 patients (mean age 71 years, male 76%, mean left ventricular ejection fraction 35%, and New York Heart Association Class I/II 75.6%) were enrolled. Patients underwent device replacement (900; 91.6%, 446 ICD/454 CRT-D) or ICD upgrade to CRT-D (83; 8.4%). Post-replacement hospitalizations occurred in 220 patients, with the primary discharge diagnosis identifying cardiovascular causes in 175 patients (80%). Fifty-five (5.6%) patients experienced at least one HFH. Overall, 91 HFH events occurred (9.6% event rate, 95% confidence interval: 7.7-11.7) in 70 patients; 66 (6.7%) patients died, 40 (60.6%) of cardiovascular causes. The HFH rate was significantly higher following upgrades, and the occurrence of HFH was associated with an 11-fold increased mortality risk (95% confidence interval: 5.9-20.5, P < 0.0001). Medical diagnosis-related group accounted for 91.2% of HFH; the mean cost per HFH was €5662 ± 9497, and the mean cost per patient was €9369 ± 12 687. On multivariate analysis, predictors of HFH were atrial fibrillation, chronic kidney disease, and all-cause hospitalization within 30 days prior to the procedure.ConclusionsIn the DECODE registry, HFH and mortality rates in the year following ICD/CRT-D replacement or upgrade were low. In this particular subset, underlying cardiac disease was the main driver of HFH, mortality, and higher healthcare expenditures.

Dataset Information

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

Background

Methods and results

Conclusions

Trial registration

Publications

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

Similar Datasets

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