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Comparative Effectiveness of Cardiac Resynchronization Therapy Among Patients With Heart Failure and Atrial Fibrillation: Findings From the National Cardiovascular Data Registry's Implantable Cardioverter-Defibrillator Registry.

ABSTRACT: Atrial fibrillation is common in patients with heart failure, but outcomes of patients with both conditions who receive cardiac resynchronization therapy with defibrillator (CRT-D) compared with an implantable cardioverter-defibrillator (ICD) alone are unclear.Using the National Cardiovascular Data Registry's ICD Registry linked with Medicare claims, we identified 8951 patients with atrial fibrillation who were eligible for CRT-D and underwent first-time device implantation for primary prevention between April 2006 and December 2009. We used Cox proportional hazards models and inverse probability-weighted estimates to compare outcomes with CRT-D versus ICD alone. Cumulative incidence of mortality (744 [33%] for ICD; 1893 [32%] for CRT-D) and readmission (1788 [76%] for ICD; 4611 [76%] for CRT-D) within 3 years and complications within 90 days were similar between groups. After inverse weighting for the probability of receiving CRT-D, risks of mortality (hazard ratio, 0.83; 95% confidence interval, 0.75-0.92), all-cause readmission (hazard ratio, 0.86; 95% confidence interval, 0.80-0.92), and heart failure readmission (hazard ratio, 0.68; 95% confidence interval, 0.62-0.76) were lower with CRT-D compared with ICD alone. There was no significant difference in the 90-day complication rate (hazard ratio, 0.88; 95% confidence interval, 0.60-1.29). We observed hospital-level variation in the use of CRT-D among patients with atrial fibrillation.Among eligible patients with heart failure and atrial fibrillation, CRT-D was associated with lower risks of mortality, all-cause readmission, and heart failure readmission, as well as with a similar risk of complications compared with ICD alone.

SUBMITTER: Khazanie P

PROVIDER: S-EPMC4910638 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Comparative Effectiveness of Cardiac Resynchronization Therapy Among Patients With Heart Failure and Atrial Fibrillation: Findings From the National Cardiovascular Data Registry's Implantable Cardioverter-Defibrillator Registry.

Khazanie Prateeti P Greiner Melissa A MA Al-Khatib Sana M SM Piccini Jonathan P JP Turakhia Mintu P MP Varosy Paul D PD Masoudi Frederick A FA Curtis Lesley H LH Hernandez Adrian F AF

Circulation. Heart failure 20160601 6

<h4>Background</h4>Atrial fibrillation is common in patients with heart failure, but outcomes of patients with both conditions who receive cardiac resynchronization therapy with defibrillator (CRT-D) compared with an implantable cardioverter-defibrillator (ICD) alone are unclear.<h4>Methods and results</h4>Using the National Cardiovascular Data Registry's ICD Registry linked with Medicare claims, we identified 8951 patients with atrial fibrillation who were eligible for CRT-D and underwent first ...[more]

PMID: 27296396

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Project description:ImportanceCardiac resynchronization therapy (CRT) reduces the risk for mortality and heart failure-related events in select patients. Little is known about the use of CRT in combination with an implantable cardioverter defibrillator (ICD) in patients who are eligible for this therapy in clinical practice.ObjectiveTo (1) identify patient, clinician, and hospital characteristics associated with CRT defibrillator (CRT-D) use and (2) determine the extent of hospital-level variation in the use of CRT-D among guideline-eligible patients undergoing ICD placement.Design, setting, and participantsMulticenter retrospective cohort from 1428 hospitals participating in the National Cardiovascular Data Registry ICD Registry between April 1, 2010, and June 30, 2014. Adult patients meeting class I or IIa guideline recommendations for CRT at the time of device implantation were included in this study.Main outcomes and measuresImplantation of an ICD with or without CRT.ResultsA total of 63 506 eligible patients (88.6%) received CRT-D at the time of device implantation. The mean (SD) ages of those in the ICD and CRT-D groups were 67.9 (12.2) years and 68.4 (11.5) years, respectively. In hierarchical multivariable models, black race was independently associated with lower use of CRT-D (odds ratio [OR], 0.77; 95% CI, 0.71-0.83) as was nonprivate insurance (OR, 0.90; 95% CI, 0.85-0.95 for Medicare and OR, 0.73; 95% CI, 0.65-0.82 for Medicaid). Clinician factors associated with greater CRT-D use included clinician implantation volume (OR, 1.01 per 10 additional devices implanted; 95% CI, 1.01-1.01) and electrophysiology training (OR, 3.13 as compared with surgery-boarded clinicians; 95% CI, 2.50-3.85). At the hospital level, the overall median risk-standardized rate of CRT-D use was 79.9% (range, 26.7%-100%; median OR, 2.08; 95% CI, 1.99-2.18).Conclusions and relevanceIn a national cohort of patients eligible for CRT-D at the time of device implantation, nearly 90% received a CRT-D device. However, use of CRT-D differed by race and implanting operator characteristics. After accounting for these factors, the use of CRT-D continued to vary widely by hospital. Addressing disparities and variation in CRT-D use among guideline-eligible patients may improve patient outcomes.

Project description:BackgroundAtrial fibrillation (AF) is a cardiac arrhythmia frequently documented in patients requiring implantable cardioverter defibrillators (ICDs) and/or cardiac resynchronization therapy with defibrillator (CRT-D). Patients with diagnosed AF at the point of ICD or CRT-D implantation may have an impaired follow-up outcome.MethodsThe German DEVICE I-II registry is a nationwide prospective multicentre database of patients implanted with ICD and CRT-D with clinical follow-up data. We analysed a 1-year follow up of implanted patients with AF and with sinus rhythm (SR).ResultsA total of 4,929 ICD/CRT patients are included in the present analysis: 946 (19.2%) were in AF and 3,983 (80.8%) were SR at time of device implantation. AF patients had a significantly more comorbid profile including older age {72 [interquartile range (IQR), 66-77] vs. 66 (IQR, 56-73) years; P<0.001}, and higher rate of patients with left ventricular ejection fraction <30% (68.2% vs. 61.0%; P<0.001), peripheral artery disease (4.5% vs. 2.7%; P=0.002), diabetes (33.6% vs. 25.5%; P<0.001), hypertension (58.4% vs. 51.1%; P<0.001) and renal failure (22.6% vs. 15.3%; P<0.001). The intra-hospital complication rate was 4.3% in the AF and 3.6% in the SR group (P=0.38). In 1-year follow-up AF patients experienced a significantly higher rate of defibrillator shocks (25% vs. 15.3%; P<0.001). One-year estimated mortality was 10.8% in the AF and 5.9% in the SR group (P<0.001), while estimated 1-year major adverse cardiac and cerebrovascular events (MACCE) rate was 11.2% vs. 7.0% (P<0.001). The effects of AF on electrical shocks and mortality persisted after adjusting for age, sex, advanced New York Heart Association (NYHA) class, severely impaired left ventricular ejection fraction (LVEF), coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), chronic renal failure (CRF), QRS duration, and type of indication for electronic device implantation.ConclusionsOur clinical data on an extended cohort of contemporary patients confirm the significant impact of AF, and its associated comorbidities, upon mortality and major adverse events after implantation of ICD/CRT.

Project description:BackgroundCompared with transvenous implantable cardioverter defibrillators (ICDs), subcutaneous (S)-ICDs require a higher energy for effective defibrillation. Although ventricular fibrillation conversion testing (CT) is recommended after S-ICD implantation to ensure an adequate margin between the defibrillation threshold and maximum device output (80J), prior work found that adherence to this recommendation is declining.MethodsWe studied first-time recipients of S-ICDs (between September 28, 2012, and April 1, 2016) in the National Cardiovascular Database Registry ICD Registry to determine predictors of use of CT, predictors of an insufficient safety margin (ISM, defined as ventricular fibrillation conversion energy >65J) during testing, and inhospital outcomes associated with use of CT. Multivariable logistic regression analysis was used to predict use of CT and ISM. Inverse probability weighted logistic regression analysis was used to examine the association between use of CT and inhospital adverse events including death.ResultsCT testing was performed in 70.7% (n=5624) of 7960 patients with S-ICDs. Although deferral of CT was associated with several patient characteristics (including increased body mass index, increased body surface area, severely reduced ejection fraction, dialysis dependence, warfarin use, anemia, and hypertrophic cardiomyopathy), the facility effect was comparatively more important (area under the curve for patient level versus generalized linear mixed model: 0.619 versus 0.877). An ISM occurred in 6.9% (n=336) of 4864 patients without a prior ICD and was more common among white patients and those with ventricular pacing on the preimplant ECG, higher preimplant blood pressure, larger body surface area, higher body mass index, and lower ejection fraction. A risk score was able to identify patients at low (<5%), medium (5% to 10%), and high risk (>10%) for ISM. CT testing was not associated with a composite of inhospital complications including death.ConclusionsUse of CT testing after S-ICD implantation was driven by facility preference to a greater extent than patient factors and was not associated with a composite of inhospital complications or death. ISM was relatively uncommon and is associated with several widely available patient characteristics. These data may inform ICD system selection and a targeted approach to CT.

Project description:ImportanceFrequent right ventricular (RV) pacing can cause and exacerbate heart failure. Cardiac resynchronization therapy (CRT) has been shown to be associated with improved outcomes among patients with reduced left ventricular ejection fraction who need frequent RV pacing, but the patterns of use of CRT vs dual chamber (DC) devices and the associated outcomes among these patients in clinical practice is not known.ObjectiveTo assess outcomes, variability in use of device type, and trends in use of device type over time among patients undergoing implantable cardioverter defibrillator (ICD) implantation who were likely to require frequent RV pacing but who did not have a class I indication for CRT.Design, setting, and participantsThis retrospective cohort study used the National Cardiovascular Data Registry (NCDR) ICD Registry. A total of 3100 Medicare beneficiaries undergoing first-time implantation of CRT defibrillator (CRT-D) or DC-ICD from 2010 to 2016 who had a class I or II guideline ventricular bradycardia pacing indication but not a class I indication for CRT were included. Data were analyzed from August 2018 to October 2019.ExposuresImplantation of a CRT-D or DC-ICD.Main outcomes and measuresAll-cause mortality, heart failure hospitalization, and complications were ascertained from Medicare claims data. Multivariable Cox proportional hazards models and Fine-Gray models were used to evaluate 1-year mortality and heart failure hospitalization, respectively. Multivariable logistic regression was used to evaluate 30-day and 90-day complications. All models accounted for clustering. The median odds ratio (MOR) was used to assess variability and represents the odds that a randomly selected patient receiving CRT-D at a hospital with high implant rates would receive CRT-D if they had been treated at a hospital with low CRT-D implant rates.ResultsA total of 3100 individuals were included. The mean (SD) age was 76.3 (6.4) years, and 2500 (80.6%) were men. The 1698 patients (54.7%) receiving CRT-D were more likely than those receiving DC-ICD to have third-degree atrioventricular block (828 [48.8%] vs 432 [30.8%]; P < .001), nonischemic cardiomyopathy (508 [29.9%] vs 255 [18.2%]; P < .001), and prior heart failure hospitalizations (703 [41.4%] vs 421 [30.0%]; P < .001). Following adjustment, CRT-D was associated with lower 1-year mortality (hazard ratio [HR], 0.70; 95% CI, 0.57-0.87; P = .001) and heart failure hospitalization (subdistribution HR, 0.77; 95% CI, 0.61-0.97; P = .02) and no difference in complications compared with DC-ICD. Hospital variation in use of CRT was present (MOR, 2.00), and the use of CRT in this cohort was higher over time (654 of 1351 [48.4%] in 2010 vs 362 of 594 [60.9%] in 2016; P < .001).Conclusions and relevanceIn this cohort study of older patients in contemporary practice undergoing ICD implantation with a bradycardia pacing indication but without a class I indication for CRT, CRT-D was associated with better outcomes compared with DC devices. Variability in use of device type was observed, and the rate of CRT implantation increased over time.

Dataset Information

Comparative Effectiveness of Cardiac Resynchronization Therapy Among Patients With Heart Failure and Atrial Fibrillation: Findings From the National Cardiovascular Data Registry's Implantable Cardioverter-Defibrillator Registry.

Publications

Comparative Effectiveness of Cardiac Resynchronization Therapy Among Patients With Heart Failure and Atrial Fibrillation: Findings From the National Cardiovascular Data Registry's Implantable Cardioverter-Defibrillator Registry.

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