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Left ventricular (LV) lead implantation is often the most challenging aspect of cardiac resynchronization therapy (CRT) procedures; early studies reported implant failure rates in ∼10% of cases. The purpose of this study was to define rates, reasons for, and factors independently associated with LV lead implant failure. We studied patients with left bundle branch block and ejection fraction ≤ 35% who underwent planned de novo transvenous CRT implantation (2010–2016) and were reported to the National Cardiovascular Data Registry ICD Registry. Independent predictors of LV lead implant failure were determined using logistic regression; age, sex, and variables with a univariable P value of <.15 were considered for inclusion in the model. Of the 111,802 patients who underwent a planned CRT procedure, 3.6% of patients (n = 3979) had LV lead implant failure. Reasons for implant failure included venous access (7.5%), coronary sinus access (64.3%), tributary vein access (13.5%), coronary sinus dissection (7.6%), unacceptable threshold (4.4%), and diaphragmatic stimulation (1.7%). Significant independent predictors of LV lead implant failure included younger age (odds ratio [OR] 1.01; 95% confidence interval [CI] 0.1.01–1.02), female sex (OR 1.38; 95% CI 1.29–1.47), black race (vs white, OR 1.44; 95% CI 1.32–1.57), Hispanic ethnicity (OR 1.23; 95% CI 1.08–1.40), QRS duration (OR 1.055 per 10 ms; 95% CI 1.038–1.072 per 10 ms), obstructive sleep apnea (OR 1.14; 95% CI 1.04–1.24), and implantation by a physician without specialized training (vs electrophysiology trained, OR 1.53; 95% CI 1.34–1.76). LV lead implant failure is uncommon in the current era and is most commonly due to coronary sinus access failure. Predictors of LV lead implant failure included younger age, female sex, black race, Hispanic ethnicity, increased QRS duration, sleep apnea, and absence of electrophysiology training. [ABSTRACT FROM AUTHOR]

Acute kidney injury (AKI) is the most common complication after percutaneous coronary intervention (PCI). Accurately estimating patients' risks not only creates a means of benchmarking performance but can also be used prospectively to inform practice. The authors sought to update the 2014 National Cardiovascular Data Registry (NCDR) AKI risk model to provide contemporary estimates of AKI risk after PCI to further improve care. Using the NCDR CathPCI Registry, we identified all 2020 PCIs, excluding those on dialysis or lacking postprocedural creatinine. The cohort was randomly split into a 70% derivation cohort and a 30% validation cohort, and logistic regression models were built to predict AKI (an absolute increase of 0.3 mg/dL in creatinine or a 50% increase from preprocedure baseline) and AKI requiring dialysis. Bedside risk scores were created to facilitate prospective use in clinical care, along with threshold contrast doses to reduce AKI. We tested model calibration and discrimination in the validation cohort. Among 455,806 PCI procedures, the median age was 67 years (IQR: 58.0-75.0 years), 68.8% were men, and 86.8% were White. The incidence of AKI and new dialysis was 7.2% and 0.7%, respectively. Baseline renal function and variables associated with clinical instability were the strongest predictors of AKI. The final AKI model included 13 variables, with a C-statistic of 0.798 and excellent calibration (intercept = −0.03 and slope = 0.97) in the validation cohort. The updated NCDR AKI risk model further refines AKI prediction after PCI, facilitating enhanced clinical care, benchmarking, and quality improvement. [Display omitted] [ABSTRACT FROM AUTHOR]

In patients with intermittent claudication (IC), short-term amputation rates from clinical trial data following lower extremity femoropopliteal (FP) peripheral vascular intervention (PVI) are <1% with unknown longer-term rates. The aim of this study was to identify revascularization and amputation rates following PVI in the FP segment and to assess 4-year amputation and revascularization rates after FP PVI for IC. From 2016 to 2020, 19,324 patients undergoing FP PVI for IC were included from the PINC AI Healthcare Database and evaluated by treatment level (superficial femoral artery [SFA], popliteal artery [POP], or both). The primary outcome was index limb amputation (ILA) assessed by Kaplan-Meier estimate. The secondary outcomes were index limb major amputation and repeat revascularization. HRs were estimated using Cox proportional hazard regression. The 4-year index limb amputation rate following FP PVI was 4.3% (95% CI: 4.0-4.7), with a major amputation rate of 3.2% (95% CI: 2.9-3.5). After POP PVI, ILA was significantly higher than SFA alone (7.5% vs 3.4%) or both segment PVI (5.5%). In multivariate analysis, POP PVI was associated with higher ILA rates at 4 years compared with isolated SFA PVI (HR: 2.10; 95% CI: 1.52-2.91) and index limb major amputation (HR: 1.98; 95% CI: 1.32-2.95). Repeat FP revascularization rates were 15.2%; they were highest in patients undergoing both SFA and POP PVI (18.7%; P < 0.0001) compared with SFA (13.9%) and POP (17.1%) only. IC patients undergoing FP PVI had 4-year rates of index limb repeat revascularization of 16.7% and ILA rates of 4.3%. Further risk factors for amputation requires further investigation. [Display omitted] [ABSTRACT FROM AUTHOR]

Despite strong guideline recommendations for cardiac resynchronization therapy-defibrillator (CRT-D) in select patients, this therapy is underutilized with substantial variation among hospitals, and the association of this variation with outcomes is unknown. The purpose of this study was to assess whether facility variation in CRT-D utilization is associated with differences in hospital-level outcomes. We linked Medicare claims data with the National Cardiovascular Data Registry's ICD Registry from 2010 to 2015. We calculated the intraclass correlation coefficient to quantify the degree of variation in patient-level CRT use that can be explained by interfacility variation on a hospital level. To quantify the degree of hospital variation in patient-level outcomes (all-cause mortality, readmissions, and cardiac readmissions) that can be attributed to variations in CRT-D use, we utilized multilevel modeling. The study included 30,134 patients across 1377 hospitals. The median rate of CRT-D implantation in those meeting guideline indications was 89%, but there was a wide variation across hospitals. After adjustment, most of the variation (74%) in hospital rates of CRT-D utilization was attributable to the hospital in which the patient was treated. Differences in hospital CRT-D utilization was associated with 8.76%, 5.26%, and 4.71% of differences in hospital mortality, readmissions, and cardiac readmission rates, respectively (P <.001 for all outcomes). There is a wide variation in the use of CRT-D across hospitals that was not explained by case mix. Hospital-level variation in CRT-D utilization was associated with clinically significant differences in outcomes. A measure of CRT-D utilization in eligible patients may serve as a useful metric for quality improvement efforts. [ABSTRACT FROM AUTHOR]

The impact of preprocedure imaging on the safety and effectiveness of left atrial appendage occlusion (LAAO) remains unclear. This study sought to determine the rates of use of preprocedure computed tomography (CT)/cardiac magnetic resonance (CMR) and its association with safety and effectiveness of LAAO procedures. The National Cardiovascular Data Registry LAAO Registry was used to evaluate patients who underwent attempted LAAO with the WATCHMAN and WATCHMAN FLX devices between January 1, 2016, and June 30, 2021. Safety and effectiveness of LAAO procedures was compared by use vs nonuse of preprocedural CT/CMR. Outcomes of interest included implantation success (deployment and release of device), device success (device released with peridevice leak <5 mm), and procedure success (device released with peridevice leak <5 mm and no in-hospital major adverse events [MAE]). Multivariable logistic regression was used to assess the relationship between preprocedure imaging and outcomes. Preprocedure CT/CMR was used for 18.2% (n = 20,851) of the 114,384 procedures in this study. CT/CMR use was more common among government and university hospitals and hospitals in the Midwest and South; it was less common among patients with uncontrolled hypertension, with abnormal renal function, and without prior thromboembolism. Overall rates of implantation success, device success, and procedure success were 93.4%, 91.2%, and 89.4%, respectively. Preprocedure CT/CMR was independently associated with an increased likelihood of implantation success (OR: 1.08; 95% CI: 1.00-1.17), device success (OR: 1.10; 95% CI: 1.04-1.16), and procedural success (OR: 1.07; 95% CI: 1.02-1.13). MAE were uncommon (2.3%) and not associated with use of preprocedure CT/CMR (OR: 1.02; 95% CI: 0.92-1.12). Preprocedure CT/CMR was associated with an increased likelihood of successful LAAO implantation; however, the magnitude of benefit appears small and it was not associated with MAE. [Display omitted] [ABSTRACT FROM AUTHOR]

Clinical events committee (CEC) evaluation is the standard approach for end point adjudication in clinical trials. Due to resource constraints, large registries typically rely on site-reported end points without further confirmation, which may preclude use for regulatory oversight. We developed a novel automated adjudication algorithm (AAA) for end point adjudication in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry using an iterative process using CEC adjudication as the "gold standard." A ≥80% agreement rate between automated algorithm adjudication and CEC adjudication was prespecified as clinically acceptable. Agreement rates were calculated. A total of 92 in-hospital and 127 post-discharge end points were evaluated between January 1, 2016 and June 30, 2019 using AAA and CEC. Agreement for neurologic events was >90%. Percent agreement for in-hospital and post-discharge events was as follows: ischemic stroke 95.7% and 94.5%, hemorrhagic stroke 97.8% and 96.1%, undetermined stroke 97.8% and 99.2%, transient ischemic attack 98.9% and 98.4% and intracranial hemorrhage 100.0% and 94.5%. Agreement was >80% for major bleeding (83.7% and 90.6%) and major vascular complication (89.1% and 97.6%). With this approach, <1% of site reported end points require CEC adjudication. Agreement remained very good during the period after algorithm derivation. An AAA-guided approach for end point adjudication was successfully developed and validated for the LAAO Registry. With this approach, the need for formal CEC adjudication was substantially reduced, with accuracy maintained above an 80% agreement threshold. After application specific validation, these methods could be applied to large registries and clinical trials to reduce the cost of event adjudication while preserving scientific validity. [ABSTRACT FROM AUTHOR]

Procedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described. The aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device. The National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX. The study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001). Transcatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation. [Display omitted] [ABSTRACT FROM AUTHOR]

The aim of this study was to compare outcomes among patients from the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) left atrial appendage occlusion (LAAO) trials with matched patients from the National Cardiovascular Data Registry LAAO Registry using patient-level data. Patients undergoing LAAO in clinical practice generally have more comorbidities than trial participants. Propensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models. A total of 1,904 registry patients were matched to 667 trial LAAO patients; 1,010 registry patients were matched to 348 warfarin patients. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention (3.8% vs 0.6%, P < 0.001), periprocedural ischemic stroke (0.9% vs 0.2%, P = 0.005), and failed device implantation (7.5% vs 3.6%, P < 0.001). The 425-day risk of ischemic stroke in trial LAAO patients was higher than in registry patients (2.70% vs 1.21%; HR: 1.951; P = 0.03); warfarin patients had comparable rates of ischemic stroke compared with registry patients (1.15% vs 1.29%; HR: 0.728; P = 0.57). Hemorrhagic stroke risk was similar among trial LAAO and registry patients (P = 0.88). Hemorrhagic stroke risk was greater among warfarin patients versus registry patients (1.44% vs 0.20%; HR: 5.871, P = 0.03). Mortality was lower in trial LAAO patients than in registry patients (2.92% vs 6.23%; HR: 0.477; P = 0.004), a difference attributable to noncardiovascular deaths. Mortality was similar (P = 0.44) among trial warfarin (4.48%) and registry (5.86%) patients. In clinical practice, patients who meet trial criteria and undergo LAAO experience a lower risk of ischemic stroke, a similar risk of hemorrhagic stroke, and a higher risk of death after implant versus LAAO trial patients. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation [PROTECT-AF], NCT00129545 ; Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL], NCT01182441) [Display omitted] [ABSTRACT FROM AUTHOR]

The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States. The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported. Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates. The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA 2 DS 2 -VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier–estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure. This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Implantable cardioverter-defibrillators (ICDs) are recommended for patients with cardiac sarcoidosis (CS) with an indication for pacing, prior ventricular arrhythmias, cardiac arrest, or left ventricular ejection fraction <35%, but data on outcomes are limited.Methods: Using data from the National Cardiovascular Data Registry ICD Registry between April 1, 2010 and December 31, 2015, we evaluated a propensity matched cohort of CS patients implanted with ICDs versus non-ischemic cardiomyopathies (NICM). We compared mortality using Kaplan-Meier survival curves and Cox proportional hazards models.Results: We identified 1,638 patients with CS and 8,190 propensity matched patients with NICM. The rate of death at 1 and 2 years was similar in patients with CS and patients with NICM (5.2% vs 5.4%, P = 0.75 and 9.0% vs 9.3%, P = 0.72, respectively). After adjusting for other covariates, patients with CS had similar mortality at 2 years after ICD implantations compared with NICM patients (RR 1.03, 95% CI 0.87-1.23). Among patients with CS, multivariable logistic regression identified 6 factors significantly associated with increased 2-year mortality: presence of heart failure (HR 1.92, 95% CI 1.44-3.22), New York Heart Association (NYHA) Class III heart failure (HR 1.68, 95% CI 1.16-2.45), NYHA Class IV heart failure (HR 3.08, 95% CI 1.49-6.39), atrial fibrillation/flutter (HR 1.66, 95% CI 1.17-2.35), chronic lung disease (HR 1.64, 95% CI 1.17-2.29), creatinine >2.0 mg/dL (HR 4.07, 95% CI 2.63-6.30), and paced rhythm (HR 2.66, 95% CI 1.07-6.59).Conclusion: Mortality following ICD implantation was similar in CS patients compared with propensity matched NICM patients. Presence of heart failure, NYHA class, atrial fibrillation/flutter, chronic lung disease, renal dysfunction, and paced rhythm at time of implantation were all predictors of increased 2-year mortality among CS patients with ICDs. [ABSTRACT FROM AUTHOR]

Background: Bleeding is a common and costly complication of percutaneous coronary intervention (PCI). Bleeding avoidance strategies (BAS) are used paradoxically less in patients at high-risk of bleeding: "bleeding risk-treatment paradox" (RTP). We determined whether hospitals and physicians, who do not align BAS to PCI patients' bleeding risk (ie, exhibit a RTP) have higher bleeding rates.Methods: We examined 28,005 PCIs from the National Cardiovascular Data Registry CathPCI Registry for 7 hospitals comprising BJC HealthCare. BAS included transradial intervention, bivalirudin, and vascular closure devices. Patients' predicted bleeding risk was based on National Cardiovascular Data Registry CathPCI bleeding model and categorized as low (<2.0%), moderate (2.0%-6.4%), or high (≥6.5%) risk tertiles. BAS use was considered risk-concordant if: at least 1 BAS was used for moderate risk; 2 BAS were used for high risk and bivalirudin or vascular closure devices were not used for low risk. Absence of risk-concordant BAS use was defined as RTP. We analyzed inter-hospital and inter-physician variation in RTP, and the association of RTP with post-PCI bleeding.Results: Amongst 28,005 patients undergoing PCI by 103 physicians at 7 hospitals, RTP was observed in 12,035 (43%) patients. RTP was independently associated with a higher likelihood of bleeding even after adjusting for predicted bleeding risk, mortality risk and potential sources of variation (OR 1.66, 95% CI 1.44-1.92, P < .001). A higher prevalence of RTP strongly and independently correlated with worse bleeding rates, both at the physician-level (Wilk's Lambda 0.9502, F-value 17.21, P < .0001) and the hospital-level (Wilk's Lambda 0.9899, F-value 35.68, P < .0001). All the results were similar in a subset of PCIs conducted since 2015 - a period more reflective of the contemporary practice.Conclusions: Bleeding RTP is a strong, independent predictor of bleeding. It exists at the level of physicians and hospitals: those with a higher rate of RTP had worse bleeding rates. These findings not only underscore the importance of recognizing bleeding risk upfront and using BAS in a risk-aligned manner, but also inform and motivate national efforts to reduce PCI-related bleeding. [ABSTRACT FROM AUTHOR]

Background: The Department of Justice (DOJ) investigated implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria, resulting in increased adherence to the NCD criteria. Trends of the specific reasons for patients not meeting the NCD criteria and in-hospital outcomes for those patients are not known.Methods and Results: We analyzed 300,151 primary-prevention ICDs from 2007-2015 at 1809 hospitals. We calculated the rates of in-hospital adverse events and the proportion of ICDs not meeting the 4 NCD criteria before and after the announcement of the DOJ investigation, stratified by whether hospitals paid settlements to the DOJ. Most reductions in the use of devices in patients not meeting NCD criteria were in patients with recently diagnosed heart failure (15.5%-6.8% for settled; 13.5%-7.3% for nonsettled) and who had had a recent myocardial infarction (8.4%-1.3% for settled; 7.4% to 1.5% for nonsettled). Adverse-event rates were significantly higher for ICDs not meeting NCD criteria (odds ratio 1.26 for settled; P < 0.001; 1.18 for nonsettled; P = 0.001).Conclusions: After the investigation, there was a rapid reduction in the placement of ICDs in patients with recent acute myocardial infarction or recent diagnosis of heart failure. Patients who did not meet NCD criteria experienced more in-hospital adverse events and higher mortality rates. [ABSTRACT FROM AUTHOR]

The study sought to assess the proportion of patients in modern U.S. interventional practice that fulfilled criteria for enrollment in the ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial. The ISCHEMIA trial, which enrolled patients with stable ischemic heart disease (SIHD), showed that revascularization improved angina symptoms with little effect on death or myocardial infarction. A cross-sectional analysis of the National Cardiovascular Data Registry CathPCI Registry (v5.0), including 1,662 hospitals, was performed. Patients undergoing percutaneous coronary intervention (PCI) for SIHD in routine clinical practice meeting ISCHEMIA trial inclusion criteria and those that did not were evaluated. During the study period, 388,212 patients underwent PCI for SIHD, comprising 41.88% of all patients undergoing PCI during the study period. Of these, 125,302 (32.28%; 13.52% of all patients undergoing PCI) met criteria for enrollment in the ISCHEMIA trial. Among SIHD patients that did not meet criteria, 71,852 (18.51%) had SIHD with high-risk features (35.2% left main disease, 43.7% left ventricular systolic dysfunction, 16.8% end-stage renal disease), 67,159 (17.3%) had SIHD with negative or low-risk functional testing, and 123,899 (31.92%) either had no stress testing or did not have ischemic burden reported. At the median hospital, 32.1% (interquartile range: 23.5%-40.6%) of SIHD patients met criteria for enrollment in the ISCHEMIA trial, with these patients experiencing lower unadjusted in-hospital mortality rate than comparator groups who met exclusion criteria for the trial (0.11%) (P < 0.01 for all comparisons). Among contemporary U.S. patients undergoing PCI for SIHD, 32.28% clearly met enrollment criteria for the ISCHEMIA trial. There was significant variation among individual centers in the proportion of SIHD patients meeting criteria for the ISCHEMIA trial. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Whether insurance status influences practice patterns in implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) defibrillators, when indicated, is not known.Methods and Results: We analyzed the NCDR ICD Registry to evaluate associations of insurance status with guidelines-based receipt of CRT, as well as device-type, complication rates, and use of optimal medical therapy defined by guidelines. Among 798,028 patients with de novo ICD implants, we included only patients < 65 years (those older have Medicare) and excluded those admitted before 2006 (n=1,835) or with insurance coverage other than Medicare, Medicaid or private insurance (n=25,695) leaving 286,556 for analysis. Inverse probability of treatment weighting was used to control for imbalances between groups. Mean age was 53 years, 29% were female. Patients with private insurance and Medicare were more likely to receive CRT-D when indicated (79.6%, OR 1.19 95% CI 1.09-1.28, P <.001 and 78.5%, OR 1.11 95% CI 1.01-1.21 P = .03, respectively) compared to the uninsured (76.7%). The uninsured were also more likely than other groups to receive a single-chamber device. Complication rates did not differ. Uninsured patients were, however, more likely to receive optimal medical therapy, particularly in the subgroup receiving the implant for primary prevention.Conclusions: In propensity-weighted analysis, uninsured patients are less likely to receive CRT when indicated but more likely to be receiving optimal medical therapy at discharge. Reasons for differences in device implantation practices based on insurance status require further study. [ABSTRACT FROM AUTHOR]

Background: The connection between paclitaxel-coated devices (PCD) use during peripheral vascular interventions (PVI) and mortality is debated. We aimed to analyze patterns of PCD use and the safety and effectiveness of PCD use in the superficial femoral and/or popliteal arteries.Methods: Patients undergoing PVI of femoropopliteal lesions with and without PCD between January 1, 2015 and June 30, 2017 were compared using the American College of Cardiology's National Cardiovascular Data Registry PVI Registry. Outcomes were derived from Centers for Medicare & Medicaid claims data. The primary outcome was all-cause mortality at 6-, 12-, and 24-months following PVI. Inverse probability weighting and frailty models were used to assess the differences between groups. The analysis was IRB-approved.Results: In the overall cohort consisting of 6,302 femoropopliteal PVIs, PCD-PVI patients were more likely to be treated for claudication (63.5% vs 51.3%, P< .001), less likely to have a chronic total occlusion (24.6% vs 34.7%, P < .001), and more likely to be treated in certain geographic and practice settings. In the analytic cohort consisting of 1,666 femoropopliteal PVIs with linked claims outcomes (888 PCD-PVI, 53.3%), unadjusted rates of all outcomes were lower in PCD-PVI patients. After adjustment, there were no significant differences in mortality following PCD-PVI versus non-PCD PVI at 1 year (adjusted RR 0.78, 95% CI 0.60-1.01, P= .055) or 2 years (aRR 0.98, 95% CI 0.77-1.24, P= .844).Conclusion: There were significant differences between the patients in whom and settings in which PCD-PVI was versus was not used. PCD-PVI was not associated with an increased risk of 2-year mortality in real-world use. [ABSTRACT FROM AUTHOR]

Background: Randomized trials evaluating cardiac resynchronization therapy (CRT) have excluded patients with a pre-existing implantable cardioverter-defibrillator (ICD). The association of CRT upgrade with clinical outcomes in patients with a pre-existing ICD is unclear.Objective: The purpose of this study was to examine a CRT-eligible population to evaluate clinical outcomes associated with CRT upgrade compared to patients who did not undergo CRT.Methods: Using the National Cardiovascular Data Registry (NCDR) ICD Registry between April 2010 and December 2014, we created a hierarchical logistic regression model to identify predictors of CRT upgrade in a CRT-eligible ICD population. In the subpopulation of patients with Medicare-linked claims data, differential outcomes were determined with censoring at 3 years. The primary endpoint of this study was all-cause mortality, with secondary endpoints of rates of hospitalization and procedural complications.Results: CRT upgrade was performed in 75.5% of CRT-eligible patients with pre-existing ICD (n = 15,803). Presence of left bundle branch block conduction was the strongest predictor of CRT upgrade (odds ratio [OR] 4.56; 95% confidence interval [CI] 4.08-5.11; P <.0001). In both unadjusted and adjusted analyses, CRT upgrade was associated with a reduction in mortality at 3 years (unadjusted hazard ratio [HR] 0.80; 95% CI 0.70-0.92; P = .001; adjusted HR 0.84; 95% CI 0.72-0.98; P = .02, respectively). Compared to patients with ICD generator replacement only, patients who underwent CRT upgrade experienced no different 3-year rates of hospitalization (adjusted HR 1.01; 95% CI 0.91-1.12; P = .81) or 1-year periprocedural complication rates (adjusted HR 1.07; 95% CI 0.79-1.45; P = .66).Conclusion: In a national registry of CRT-eligible patients with pre-existing ICD, upgrade to CRT was associated with lower rates of mortality than continued medical management. [ABSTRACT FROM AUTHOR]

Background: Patients with heart failure having a low expected probability of arrhythmic death may not benefit from implantable cardioverter defibrillators (ICDs).Objective: The objective was to validate models to identify cardiac resynchronization therapy (CRT) candidates who may not require CRT devices with ICD functionality.Methods: Heart failure (HF) patients with CRT-Ds and non-CRT ICDs from the National Cardiovascular Data Registry and others with no device from 3 separate registries and 3 heart failure trials were analyzed using multivariable Cox proportional hazards regression for survival with the Seattle Heart Failure Model (SHFM; estimates overall mortality) and the Seattle Proportional Risk Model (SPRM; estimates proportional risk of arrhythmic death).Results: Among 60,185 patients (age 68.6 ± 11.3 years, 31.9% female) meeting CRT-D criteria, 38,348 had CRT-Ds, 11,389 had non-CRT ICDs, and 10,448 had no device. CRT-D patients had a prominent adjusted survival benefit (HR 0.52, 95% CI 0.50-0.55, P < .0001 versus no device). CRT-D patients with SHFM-predicted 4-year survival ≥81% (median) and a low SPRM-predicted probability of an arrhythmic mode of death ≤42% (median) had an absolute adjusted risk reduction attributable to ICD functionality of just 0.95%/year with the majority of survival benefit (70%) attributable to CRT pacing. In contrast, CRT-D patients with SHFM-predicted survival median had substantially more ICD-attributable benefit (absolute risk reduction of 2.6%/year combined; P < .0001).Conclusions: The SPRM and SHFM identified a quarter of real-world, primary prevention CRT-D patients with minimal benefit from ICD functionality. Further studies to evaluate CRT pacemakers in these low-risk CRT candidates are indicated. [ABSTRACT FROM AUTHOR]

Background: The introduction of quadripolar (QP) cardiac resynchronization therapy (CRT) leads aimed to improve procedural and clinical outcomes.Objective: The National Cardiovascular Data Registry was analyzed to characterize the use as well as the procedural and clinical outcomes of QP leads in comparison with unipolar and bipolar (BP) leads.Methods: We evaluated data on 175,684 procedures reported between September 1, 2010, and December 31, 2015. Clinical outcomes were analyzed using Centers for Medicare & Medicaid Services claims data.Results: Among all CRT device implants, there was a drop in reported lead placement failure from 6.04% to 5.21% (P < .0001 for trend) and a drop in the reported diaphragmatic stimulation rates from 0.07% to 0.01% (P < .007 for trend) between the last quarters of 2010 and 2015. No significant difference in procedural complication rates between QP and BP leads occurred (1.34% and 1.39%, respectively; P = .50). Among patients linked to Centers for Medicare & Medicaid Services claims data, no statistically significant difference in the combined primary outcome of death, congestive heart failure admission, device malfunction, and reoperation between BP and QP leads was observed (34.15 and 34.19 events per 100 patient-years, respectively; P = .89).Conclusion: Since the introduction of QP leads, there was a reduction in CRT lead placement failure rates and a reduction in diaphragmatic stimulation rates. However, no statistically significant difference in long-term clinical outcomes between BP and QP leads was observed in elderly patients undergoing CRT implantation. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials are the "gold standard" for comparing the safety and efficacy of therapies but may be limited due to high costs, lack of feasibility, and difficulty enrolling "real-world" patient populations. The Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study seeks to evaluate whether data collected within procedural registries and claims databases can reproduce trial results by substituting surrogate non-trial-based variables for exposures and outcomes.Methods and Results: Patient-level data from 2 clinical trial programs-the Dual Antiplatelet Therapy Study and the United States CoreValve Studies-will be linked to a combination of national registry, administrative claims, and health system data. The concordance between baseline and outcomes data collected within nontrial data sets and trial information, including adjudicated end point events, will be assessed. We will compare the study results obtained using these alternative data sources to those derived using trial-ascertained variables and end points using trial-adjudicated end points and covariates.Conclusions: Linkage of trials to registries and claims data represents an opportunity to use alternative data sources in place of and as adjuncts to randomized clinical trial data but requires further validation. The results of this research will help determine how these data sources can be used to improve our present and future understanding of new medical treatments. [ABSTRACT FROM AUTHOR]

Background: Some patients with heart failure (HF) experience recovery of left ventricular (LV) systolic function by the end of their implantable cardioverter-defibrillator (ICD) generator battery life. Outcomes following generator replacement in this setting are poorly understood.Objective: We sought to describe outcomes following ICD generator replacement associated with recovery of LV systolic function.Methods: We evaluated 26,197 Medicare beneficiaries enrolled in the American College of Cardiology's National Cardiovascular Data Registry ICD Registry who underwent primary prevention ICD generator replacement between 2006 and 2009, stratified by LV ejection fraction (LVEF): reduced (LVEF ≤35%), partially recovered (LVEF >35% and ≤50%), and recovered (LVEF >50%).Results: At the time of generator replacement, 1915 (7.3%) patients had recovered LVEF and 4576 (17.5%) had partially recovered LVEF. Periprocedural events were rare (<1%) in all patients. In patients with reduced LVEF, the incidence of HF readmission and mortality at 3 years was 27.5% and 32.7%, respectively. In comparison, the rates of HF readmission and mortality were lower for patients with partially recovered LVEF (readmission: 15.9%; hazard ratio [HR] 0.66; 95% confidence interval [CI] 0.61-0.72; mortality: 23.0%; HR 0.82; 95% CI 0.76-0.87) and those with recovered LVEF (readmission: 12.2%; HR 0.55; 95% CI 0.48-0.63; mortality: 18.2%; HR 0.72; 95% CI 0.64-0.80).Conclusion: Patients with partially recovered and recovered LVEF have lower risks of mid-term adverse outcomes than do those with reduced LVEF following ICD generator replacement. Approximately 3 in 4 patients continue to have reduced LVEF at the time of generator replacement and are at high risk of HF readmission and mortality. These data highlight the prognostic associations of LVEF in patients undergoing generator replacement as well as the clinical encounter for generator replacement as an opportunity to identify those at increased risk of adverse outcomes. [ABSTRACT FROM AUTHOR]

Background: Long-term outcomes and predictors of mortality after implantable cardioverter-defibrillator (ICD) implantation related complication are unclear.Objective: The purpose of this study was to determine the risk of mortality and hospitalization after complication during ICD implantation and identify predictors of adverse outcomes.Methods: We performed a retrospective registry study of Medicare beneficiaries who were first-time ICD recipients enrolled in the National Cardiovascular Data Registry ICD Registry between January 2006 and March 2010. Mortality and hospitalization rates were examined using Kaplan-Meier survival analysis and multivariable Cox proportional hazards regression analysis. Covariates associated with mortality 3 years after ICD implantation complication were investigated.Results: The study cohort comprised 136,143 Medicare beneficiaries. Complications during the index hospitalization occurred in 7046 patients (5.18%), and complications within 90 days of device implantation occurred in 10,005 patients (7.34%). In adjusted analyses, complications within 90 days of implantation were associated with an increased risk of all-cause mortality at 1 year (hazard ratio [HR] 1.13; 95% confidence interval [CI] 1.05-1.20; P = .006) and 3 years (HR 1.09; 95% CI 1.05-1.13; P <.0001). These results were consistent for a combined endpoint of all-cause mortality or hospitalization. Patient, device, and hospital characteristics associated with 3-year mortality were similar between those with and those without complications.Conclusion: Among Medicare beneficiaries, the occurrence of complications within 90 days of ICD implantation was associated with increased risk of all-cause mortality and all-cause mortality or hospitalization at 1 and 3 years. Patient, procedure, and hospital characteristics associated with mortality at 3 years after implantation were similar regardless of whether acute procedural complication occurred. [ABSTRACT FROM AUTHOR]

Background: Prior studies have reported that more than 20% of implantable cardioverter-defibrillator (ICD) implantations in the United States do not adhere to trial-based criteria.Objective: We sought to investigate the patient characteristics associated with not meeting the inclusion criteria of the clinical trials that have demonstrated the efficacy of primary prevention ICDs.Methods: Using data from the National Cardiovascular Data Registry's ICD Registry, we identified patients who received ICDs for primary prevention from January 2006 to December 2008. We determined whether patients met the inclusion criteria of at least 1 of the 4 ICD primary prevention trials: Multicenter Automatic Defibrillator Implantation Trial (MADIT), MADIT-II, Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Multicenter Unsustained Tachycardia Trial (MUSTT).Results: Among 150,264 patients, 86% met criteria for an ICD implantation based on trial data. The proportion of patients who did not meet trial-based criteria increased as age decreased. In multivariate analysis, the significant predictors for not meeting trial criteria included prior cardiac transplantation (odds ratio [OR] 2.1), pediatric electrophysiology operator (OR 2.0), and high-grade atrioventricular conduction disease (OR 1.4).Conclusion: Among National Cardiovascular Data Registry registrants receiving first-time ICDs for primary prevention, the majority met trial-based criteria. Multivariate analyses suggested that many patients who did not meet the trial-based criteria may have had clinical circumstances that warranted ICD implantation. These findings caution against the use of trial-based indications to determine site quality metrics that could penalize sites that care for younger patients. The planned incorporation of appropriate use criteria into the ICD registry may better characterize patient- and site-level quality and performance. [ABSTRACT FROM AUTHOR]

Background Clinical trials have demonstrated the benefit of implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death in selected high-risk individuals. Because of small numbers of women enrolled in these trials, outcomes for women after hospital discharge have not been well described. We compared procedure-related complications and outcomes after hospital discharge between men and women undergoing single- or dual-chamber ICD implantation for primary prevention. Methods In patients 65 years or older with Medicare fee-for-service coverage, we identified 38,912 initial implants (25% women) who received single- or dual-chamber ICDs for primary prevention between January 2006 and December 2009 in the NCDR and evaluated gender differences in outcomes. Results Women had greater comorbidity and more advanced heart failure (HF) at the time of ICD implantation than did men. Device-related complications, death at 6 months, all-cause readmissions, and HF readmissions at 6 months were significantly more common in women (7.2% vs 4.8%, 6.5% vs 5.6%, 37.2% vs 31.7%, and 14.0% vs 10.0% respectively; P < .001 for all). Women continued to have higher odds of procedural complications (odds ratio [OR] 1.39, 95% CI 1.26-1.53, P < .001), 6-month all-cause readmission (OR 1.22, 95% CI 1.16-1.28, P < .001), and 6-month HF readmission (OR 1.32, 95% CI 1.23-1.42, P < .001), with a trend toward higher 6-month mortality (OR 1.08, 95% CI 0.98-1.20, P = .123), compared with men, after adjusting for differences in baseline characteristics and device type (single vs dual chamber). Conclusions Among older patients receiving ICDs for primary prevention in clinical practice, women experience worse outcomes than do men. Reasons for gender differences in outcomes are poorly understood and require further investigation. [ABSTRACT FROM AUTHOR]

Background Prior studies have suggested that women have better outcomes than men after cardiac resynchronization therapy-defibrillator (CRT-D) implantation. Objectives The purpose of this study was to compare mortality after CRT-D implantation by sex, QRS morphology, and duration. Methods Survival curves and covariate adjusted hazard ratios (HR) were used to assess mortality by sex in 31,892 CRT-D patients in the National Cardiovascular Data Registry (NCDR), implantable cardioverter defibrillator (ICD) registry between 2006 and 2009, with up to 5 years’ follow-up (median 2.9 years, interquartile range: 2.0 to 3.9 years). Patients were grouped by QRS morphology and 10-ms increments in QRS duration. Results Among patients with left bundle branch block (LBBB), women had a 21% lower mortality risk than men (HR: 0.79; 95% CI: 0.74 to 0.84; p < 0.001); however, there was no sex difference in non-LBBB (HR: 0.95; 95% CI: 0.85 to 1.06; p = 0.37). Longer QRS duration was associated with better survival in both sexes with LBBB, but not in patients without LBBB. Compared with women with LBBB and QRS of 120 to 129 ms, women with LBBB and QRS of 140 to 149 ms had a 27% lower mortality (HR: 0.73; 95% CI: 0.60 to 0.88; p = 0.001); this difference was 18% in men (HR: 0.82; 95% CI: 0.71 to 0.93; p = 0.003). Mortality in LBBB and QRS of 150 ms or longer compared with those with LBBB and QRS of 120 to 129 ms was similar between sexes (HR: 0.61 to 0.68; p < 0.001 for women and HR: 0.58 to 0.66; p < 0.001 for men). Sex interactions within 10-ms groups were not significant. Conclusions Among patients with LBBB who received CRT-D, mortality is lower in women than men. Additionally, longer QRS duration in LBBB is associated with better survival in both sexes. In contrast, there is no sex difference in patients without LBBB, regardless of QRS duration. Further studies should include a non-CRT comparator group to confirm these findings. [ABSTRACT FROM AUTHOR]

Background: Older women experience higher complication rates and mortality after percutaneous coronary intervention (PCI) than men, but there is limited evidence about sex-based differences in outcomes among younger patients. We compared rates of complications and inhospital mortality by sex for younger and older PCI patients. Methods: A total of 1,079,751 hospital admissions for PCI were identified in the CathPCI Registry® from 2005 to 2008. Complication rates (general, bleeding, bleeding with transfusion, and vascular) and inhospital mortality after PCI were compared by sex and age (<55 and ≥55 years). Analyses were adjusted for demographic and clinical factors and stratified by PCI type (elective, urgent, or emergency). Results: Overall, 6% of patients experienced complications, and 1% died inhospital. Unadjusted complication rates were higher for women compared with men in both age groups. In risk-adjusted analyses, younger women (odds ratio 1.24, 95% CI 1.16-1.33) and older women (1.27, 1.09-1.47) were more likely to experience any complication than similarly aged men. The increased risk persisted across complication categories and PCI type. Within age groups, risk-adjusted mortality was marginally higher for young women (1.19, 1.00-1.41), but not for older women (1.03, 0.97-1.10). In analyses stratified by PCI type, young women had twice the mortality risk after an elective procedure as young men (2.04, 1.15-3.61). Conclusions: Women, regardless of age, experience more complications after PCI than men; young women are at increased mortality risk after an elective PCI. Identifying strategies to reduce adverse outcomes, particularly for women younger than 55 years, is important. [Copyright &y& Elsevier]

Objectives: This study sought to update and validate a contemporary model for inpatient mortality following percutaneous coronary intervention (PCI), including variables indicating high clinical risk. Background: Recently, new variables were added to the CathPCI Registry data collection form. This modification allowed us to better characterize the risk of death, including recent cardiac arrest and duration of cardiogenic shock. Methods: Data from 1,208,137 PCI procedures performed between July 2009 and June 2011 at 1,252 CathPCI Registry sites were used to develop both a “full” and pre-catheterization PCI in-hospital mortality risk model using logistic regression. To support prospective implementation, a simplified bedside risk score was derived from the pre-catheterization risk model. Model performance was assessed by discrimination and calibration metrics in a separate split sample. Results: In-hospital mortality was 1.4%, ranging from 0.2% among elective cases (45.1% of total cases) to 65.9% among patients with shock and recent cardiac arrest (0.2% of total cases). Cardiogenic shock and procedure urgency were the most predictive of inpatient mortality, whereas the presence of a chronic total occlusion, subacute stent thrombosis, and left main lesion location were significant angiographic predictors. The full, pre-catheterization, and bedside risk prediction models performed well in the overall validation sample (C-indexes 0.930, 0.928, 0.925, respectively) and among pre-specified patient subgroups. The model was well calibrated across the risk spectrum, although slightly overestimating risk in the highest risk patients. Conclusions: Clinical acuity is a strong predictor of PCI procedural mortality. With inclusion of variables that further characterize clinical stability, the updated CathPCI Registry mortality models remain well-calibrated across the spectrum of PCI risk. [Copyright &y& Elsevier]

Current guidelines recommend patients with ST-elevation myocardial infarction receive primary percutaneous coronary intervention (PCI) within 90 minutes of admission, although there are conflicting data regarding the relation between time to treatment and mortality in these patients. We used logistic regression analyses employing a fractional polynomial model to evaluate the association between door-to-balloon time and 1-year mortality in patients with ST-elevation myocardial infarction ≥65 years old undergoing primary PCI from 1994 to 1996 (n = 1,932). Median door-to-balloon time was 128 minutes (interquartile range 92 to 178, 24.2% treated within 90 minutes). Overall 1-year mortality was 21.1%. Longer door-to-balloon times were associated with higher 1-year mortality in a continuous, nonlinear fashion (30 minutes 10.9%, 60 minutes 13.6%, 90 minutes 16.5%, 120 minutes 19.5%, 150 minutes 22.5%, 180 minutes 25.3%, 210 minutes 27.9%). The nature of the association between door-to-balloon time and 1-year mortality was best modeled by a second-degree fractional polynomial (p <0.001). Findings were similar after multivariable adjustment as any increase in door-to-balloon time was associated with successive increases in patients'' 1-year mortality (30 minutes 8.8%, 60 minutes 12.9%, 90 minutes 16.6%, 120 minutes 19.9%, 150 minutes 22.9%, 180 minutes 25.5%, 210 minutes 27.7%). In conclusion, any delay in primary PCI is associated with increased 1-year mortality, suggesting efforts should focus on decreasing time to treatment as much as possible, even among those centers currently providing primary PCI within 90 minutes. [Copyright &y& Elsevier]

Background: Little is known about the clinical profile of end-stage renal disease (ESRD) patients who undergo implantable cardioverter-defibrillator (ICD) implantation. Objective: This study sought to analyze the risk profile of ESRD patients admitted for ICD implantation. Methods: Patients undergoing first-time device implantation in National Cardiovascular Data Registry/ICD registry from 01/01/06 to 12/31/07 were analyzed (n = 164,069). Patients with ESRD (defined as those requiring dialysis) were compared with patients without ESRD. Primary outcome was in-hospital complications. Because length of hospital stay for ERSD patients was significantly longer (8 vs. 4 days), complications within 2 days of ICD implantation were also examined. The proportion of patients meeting approved indications for ICD implantation was evaluated. Results: ESRD patients (n = 6,851, 4.4%) had higher rates of comorbid medical conditions, major complications, and total complications, and were less likely to receive an ICD for primary prevention. ESRD patients who received ICD implantation for primary prevention were more likely to meet trial criteria. ESRD patients were less likely to receive beta-blockers and angiotensin inhibitors (P <.0001). Unadjusted in-hospital mortality was almost 5-fold among patients with ESRD (1.9% vs. 0.4%, P <.0001). Multivariable analysis confirmed that ESRD was independently associated with total in-hospital complications (odds ratio [OR] = 1.38, 95% confidence interval: 1.23 to 1.54, P <.0001), and total complications at 2 days (OR = 1.20, 95% confidence interval: 1.05 to 1.36, P = .006). Conclusion: ESRD patients presenting for ICD implantation are sicker, and have higher rates of in-hospital complications even when accounting for overall longer length of hospital stay. Strategies to decrease complications among ESRD patients who undergo ICD implantation need exploration. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to report on the all-cause readmission and repeat revascularization rates after percutaneous coronary intervention (PCI). Background: Although PCIs are frequently performed, 30-day rates of readmission and repeat revascularization after PCI are not known. Methods: Retrospective analysis of a cohort of Medicare fee-for-service admissions associated with a PCI in 2005. Primary outcomes were 30-day all-cause readmission rates and 30-day readmission rates associated with a revascularization procedure. Results: A total of 315,241 PCI procedures performed at 1,108 hospitals were included in the analysis. The all-cause 30-day readmission rate was 14.6%, and the all-cause 30-day mortality rate was 1.0%. All-cause 30-day mortality among readmitted patients was higher than patients who were not readmitted (3.6% vs. 0.6%; p < 0.001). The 30-day readmission rate of acute myocardial infarction (AMI) patients was significantly higher than that of non-AMI patients (AMI 17.5%, non-AMI 13.6%, p < 0.001). Among all patients readmitted within 30 days after the index PCI, 27.5% had an associated revascularization procedure (PCI 25.8%, coronary artery bypass grafting 1.7%). The median readmission rates varied across hospitals, from 8.9% in the lowest decile to 22.0% in the highest decile. Conclusions: A substantial proportion of PCI patients are readmitted within 30 days of discharge, and readmission rates vary widely across hospitals. Readmissions within 30 days of an index PCI procedure were associated with a significantly higher 30-day mortality rate, and more than one-quarter of such readmissions resulted in a repeat revascularization procedure. These findings warrant further attention to determine whether these readmissions are preventable. [Copyright &y& Elsevier]

Background: Fewer women than men undergo implantable cardioverter defibrillator (ICD) implantation for the primary prevention of sudden cardiac death. The criteria used to select patients for ICD implantation may be more permissive among men than for women. We hypothesized that women who undergo primary prevention ICD implantation more often meet strict trial enrollment criteria for this therapy. Methods: We studied 59,812 patients in the National Cardiovascular Data Registry ICD registry undergoing initial primary prevention ICD placement between January 2005 and April 2007. Patients were classified as meeting or not meeting enrollment criteria of either the MADIT-II or SCD-HeFT trials. Multivariable analyses assessed the association between gender and concordance with trial criteria adjusting for demographic, clinical, and system characteristics. Results: Among the cohort, 27% (n = 16,072) were women. Overall, 85.2% of women and 84.5% of men met enrollment criteria of either trial (P = .05). In multivariable analyses, women were equally likely to meet trial criteria (OR 1.04, 95% CI 0.99-1.10) than men. Significantly more women than men met the trial enrollment criteria among patients older than age 65 (86.6% of women vs 85.3% of men, OR 1.11, 95% CI 1.03-1.19), but this difference was not found among younger patients (82.5% of women vs 83.0% of men, OR 0.97, 95% CI 0.89-1.07). Conclusions: In a national cohort undergoing primary prevention ICD implantation, older women were only slightly more likely then men to meet the enrollment criteria for MADIT II or SCD-HeFT. Relative overutilization in men is not an important explanation for gender differences in ICD implantation. [Copyright &y& Elsevier]

Background: Racial/ethnic differences in the use of cardiac resynchronization therapy with defibrillator (CRT-D) may result from underprovision or overprovision relative to published guidelines. Objective: The purpose of this study was to examine the National Cardiovascular Data Registry (NCDR) ICD Registry for ethnic/racial differences in use of CRT-D. Methods: We studied white, black, and Hispanic patients who received either an implantable cardioverter-defibrillator (ICD) or CRT-D between January 2005 and April 2007. Two multivariate logistic regression models were fit with the following outcome variables: (1) receipt of either ICD or CRT-D and (2) receipt of CRT-D outside of published guidelines. Results: Of 108,341 registry participants, 22,205 met inclusion criteria for the first analysis and 27,165 met criteria for the second analysis. Multivariate analysis indicated CRT-eligible black (odds ratio [OR] 0.84; 95% confidence interval [CI], 0.75–0.95; P <.004) and Hispanic (OR 0.83; 95% CI, 0.71–0.99; P <.033) patients were less likely to receive CRT-D than were white patients. A substantial proportion of patients received CRT-D outside of published guidelines, although black (OR 1.18; 95% CI, 1.02–1.36; P = .001) and Hispanic (OR 1.17; 95% CI, 1.02–1.36; P = .03) patients were more likely to meet all three eligibility criteria. Conclusion: Black and Hispanic patients who were eligible for CRT-D were less likely to receive therapy compared with white patients. Conversely, in the context of widespread out-of-guideline use of CRT-D, black and Hispanic patients were more likely to meet established criteria. Our findings suggest systematic racial/ethnic differences in the treatment of patients with advanced heart failure. [Copyright &y& Elsevier]

Although current evidence supporting a more precise strategy for identifying patients at highest risk for sudden cardiac death (SCD) is sparse, strategies for translating existing and future evidence into clinical practice and policy are needed today. A great many unanswered questions exist. Examples include the following: At what level of risk for SCD should we pursue further testing or therapy? How should clinical strategies ethically and economically balance alternative outcomes? How can we best translate optimal strategies into clinical practice so as to prevent tomorrow''s SCDs? On July 20 and 21, 2006, a group of individuals with expertise in clinical cardiovascular medicine, biostatistics, economics, and health policy was joined by government (Food and Drug Administration; Centers for Medicare and Medicaid Services; National Heart, Lung, and Blood Institute; Agency for Healthcare Research and Quality), professional societies (Heart Rhythm Society), and industry to discuss strategies for risk assessment and prevention of SCD. The meeting was organized by the Duke Center for the Prevention of Sudden Cardiac Death and the Duke Clinical Research Institute. This article, the second of 2 documents, summarizes the policy discussions of that meeting, discusses an analytic framework for evaluating the risks and benefits associated with SCD prevention and risk stratification, and addresses the translation of SCD risk assessment strategies into practice and policy. [Copyright &y& Elsevier]

Accurate and timely prediction of sudden cardiac death (SCD) is a necessary prerequisite for effective prevention and therapy. Although the largest number of SCD events occurs in patients without overt heart disease, there are currently no tests that are of proven predictive value in this population. Efforts in risk stratification for SCD have focused primarily on predicting SCD in patients with known structural heart disease. Despite the ubiquity of tests that have been purported to predict SCD vulnerability in such patients, there is little consensus on which test, in addition to the left ventricular ejection fraction, should be used to determine which patients will benefit from an implantable cardioverter defibrillator. On July 20 and 21, 2006, a group of experts representing clinical cardiology, cardiac electrophysiology, biostatistics, economics, and health policy were joined by representatives of the US Food and Drug administration, Centers for Medicare Services, Agency for Health Research and Quality, the Heart Rhythm Society, and the device and pharmaceutical industry for a round table meeting to review current data on strategies of risk stratification for SCD, to explore methods to translate these strategies into practice and policy, and to identify areas that need to be addressed by future research studies. The meeting was organized by the Duke Center for the Prevention of SCD at the Duke Clinical Research Institute and was funded by industry participants. This article summarizes the presentations and discussions that occurred at that meeting. [Copyright &y& Elsevier]

Objectives: The aim of this study was to determine the use of pre-hospital electrocardiogram (ECG) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing reperfusion therapy, and evaluate the effect of pre-hospital ECG on door-to-reperfusion times. Background: Although national guidelines recommend the use of pre-hospital ECG, there is limited contemporary information about its current use and effectiveness. Methods: Using data from the National Registry of Myocardial Infarction-4, we studied patients with STEMI or left bundle branch block who received acute reperfusion with either fibrinolytic therapy (n = 35,370) or primary percutaneous coronary intervention (PCI) (n = 21,277) within 6 h of admission. We determined the prevalence of pre-hospital ECG use, evaluated the association between pre-hospital ECG and door-to-reperfusion time, and estimated the incremental reduction in time to reperfusion using hierarchical models to adjust for differences in patient and hospital characteristics. Results: A pre-hospital ECG was performed in 4.5% of the fibrinolytic therapy cohort and in 8.0% of the PCI cohort. After adjusting for patient and hospital characteristics, the use of pre-hospital ECG was associated with a significantly shorter geometric mean door-to-drug time: 24.6 min (95% confidence interval [CI]: 23.7 to 25.5) vs. 34.7 min (95% CI: 34.2 to 35.3; p < 0.0001), and a significantly shorter geometric mean door-to-balloon time (94.0 min [95% CI: 91.8 to 96.3] vs. 110.3 min [95% CI: 108.7 to 112.0]; p < 0.0001). Conclusions: The national use of pre-hospital ECG to diagnose and facilitate the treatment of STEMI remains low. When used, however, pre-hospital ECG is associated with a significantly shorter time to reperfusion. [Copyright &y& Elsevier]

We investigated the effect of smaller dose, weight-adjusted heparin with earlier monitoring of activated partial thromboplastin time on the incidence of ischemic and hemorrhagic complications in patients with ST-elevation myocardial infarction treated with full-dose tenecteplase. We compared the outcomes of patients enrolled in the Second Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT-2; n = 8,461) who received heparin stratified by weight (patients weighing >67 kg received a 5,000-U bolus plus infusion at 1,000 U/hour; those weighing ≤67 kg received a 4,000-U bolus plus infusion at 800 U/hour) with patients in ASSENT-3 who received weight-adjusted heparin (60-U/kg bolus, maximum 4,000 U/hour, followed by a 12-U/kg/hour infusion, maximum 1,000 U/hour). Compared with patients in ASSENT-2, those in ASSENT-3 had similar rates of 30-day mortality, recurrent infarction, and intracranial hemorrhage, less major bleeding (2.2% vs 4.7%, p <0.001), and less refractory ischemia (6.5% vs 8.6%, p <0.001). After adjustment for baseline characteristics, patients in ASSENT-3 had similar rates of 30-day mortality (odds ratio [OR] 0.96, 95% confidence interval [CI] 0.77 to 1.19) and intracranial hemorrhage (OR 1.02, 95% CI 0.61 to 1.69) but less major bleeding (OR 0.49, 95% CI 0.35 to 0.67) than did patients in ASSENT-2. These findings support the use of smaller dose, weight-adjusted heparin in patients with ST-elevation myocardial infarction treated with tenecteplase. [Copyright &y& Elsevier]

: ObjectivesThe aim of this study was to assess the prognostic importance of left ventricular ejection fraction (LVEF) in stable outpatients with heart failure (HF).: BackgroundAlthough LVEF is an accepted prognostic indicator of prognosis in HF patients, the relationship of LVEF and mortality across the full spectrum of LVEF is incompletely understood.: MethodsWe examined the association of LVEF and outcomes among 7,788 stable HF patients enrolled in the Digitalis Investigation Group trial.: ResultsDuring mean follow-up of 37 months, mortality was substantial in all LVEF groups (range, LVEF ≤ 15%, 51.7%, LVEF > 55%, 23.5%). Among patients with LVEF ≤ 45%, mortality decreased in a near linear fashion across successively higher LVEF groups (LVEF < 15%, 51.7%; LVEF 36% to 45%, 25.6%; p < 0.0001). This association was present after multivariable adjustment, although the magnitude of this associated risk was reduced (LVEF ≤ 15%: hazard ratio [HR] 1.77, 95% confidence interval [CI] 1.48 to 2.11; LVEF 16% to 25%: HR 1.44, 95% CI 1.28 to 1.61; LVEF 26% to 35%: HR 1.10, 95% CI 0.98 to 1.28; LVEF 36% to 45%: referent). In contrast, mortality rates were comparable among patients with LVEF > 45% both before (LVEF 46% to 55%: 23.3%; LVEF > 55%: 23.5%; p = 0.25), and after multivariable adjustment (LVEF 46% to 55%: HR 0.92, 95% CI 0.77 to 1.10; LVEF > 55%: HR 0.88, 95% CI 0.71 to 1.09; LVEF 36% to 45%: referent). Patients with lower LVEF were at increased absolute risk of death due to arrhythmia and worsening HF, but these were leading causes of death in all LVEF groups.: ConclusionsAmong HF patients in sinus rhythm, higher LVEFs were associated with a linear decrease in mortality up to an LVEF of 45%. However, increases above 45% were not associated with further reductions in mortality. [Copyright &y& Elsevier]