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BACKGROUND: Procedure volumes are associated with outcomes for many cardiovascular procedures, leading to guidelines on minimum volume thresholds for certain procedures; however, the volume-outcome relationship with left atrial appendage occlusion is poorly understood. As such, we sought to determine the relationship between hospital and physician volume and WATCHMAN left atrial appendage occlusion procedural success overall and with the new generation WATCHMAN FLX device. METHODS: We performed an analysis of WATCHMAN procedures (January 2019 to October 2021) from the National Cardiovascular Data Registry LAAO Registry. Three-level hierarchical generalized linear models were used to assess the adjusted relationship between procedure volume and procedural success (device released with peridevice leak <5 mm, no in-hospital major adverse events). RESULTS: Among 87480 patients (76.2±8.0 years; 58.8% men; mean CHA2DS2-VASc score, 4.8±1.5) from 693 hospitals, the procedural success rate was 94.2%. With hospital volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (odds ratio [OR], 0.66 [CI, 0.57–0.77]) and Q2 (OR, 0.78 [CI, 0.69– 0.90]) but not Q3 (OR, 0.95 [CI, 0.84–1.07]). With physician volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (OR, 0.72 [CI, 0.63–0.82]), Q2 (OR, 0.79 [CI, 0.71–0.89]), and Q3 (OR, 0.88 [CI, 0.79–0.97]). Among WATCHMAN FLX procedures, there was attenuation of the volume-outcome relationships, with statistically significant but modest absolute differences of only ≈1% across volume quartiles. CONCLUSIONS: In this contemporary national analysis, greater hospital and physician WATCHMAN volumes were associated with increased procedure success. The WATCHMAN FLX transition was associated with increased procedural success and less heterogeneity in outcomes across volume quartiles. These findings indicate the importance of understanding the volume-outcome relationship for individual left atrial appendage occlusion devices. [ABSTRACT FROM AUTHOR]

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: Prior studies on the use of multivessel percutaneous coronary intervention (MV PCI) for patients with STsegment-elevation myocardial infarction (STEMI) and multivessel coronary artery disease have yielded heterogeneous results. The recent COMPLETE trial (Complete Versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease After Early PCI for STEMI) demonstrated that MV PCI was superior to culprit-only PCI among patients with STEMI. It is unclear how these trial results apply to clinical decisions encountered in routine practice. METHODS: We studied STEMI admissions among patients >65 years with multivessel disease and Centers for Medicare and Medicaid Services-linked data in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009 to December 31, 2017. MV PCI was defined as PCI to a nonculprit lesion ≤45 days of the index procedure. The primary outcome was the composite of death, myocardial infarction, and revascularization from 45 days through 1 year. To account for unmeasured confounders, an instrumental variable analysis was used to compare treatment strategies. The instrument was institutional rates of MV PCI. A falsification end point of postdischarge major bleeding was utilized to assess for residual confounding. RESULTS: Of 56 332 admissions from 1102 institutions, 37.7% received MV PCI =45 days of index STEMI PCI. Of those undergoing MV PCI, 74.8% received complete revascularization. In unadjusted analysis, MV PCI was associated with a lower cumulative incidence of the composite outcome between 45 days and 1 year (13.9% versus 18.2% for non-MV PCI, P<0.01). In the instrumental variable analysis, there was no association between MV PCI and the composite outcome (adjusted risk difference, -0.97% [95% CI, -3.52% to 1.59%]; P=0.46). An association between MV PCI and the falsification end point of major bleeding was not observed (adjusted risk difference, -2.54% [95% CI, -5.30% to 0.22%]; P=0.07). CONCLUSIONS: In this large, nationwide analysis, we did not find benefit of MV PCI by 1 year among older STEMI patients. The clinical benefit of MV PCI may not extend equally outside of trials to include all patients, including those with more extreme ages and more complex decision-making. [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 National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry (LAAO) includes the vast majority of transcatheter LAAO procedures performed in the United States. The objective of this study was to develop a model predicting adverse events among patients undergoing LAAO with Watchman FLX. METHODS: Data from 41 001 LAAO procedures with Watchman FLX from July 2020 to September 2021 were used to develop and validate a model predicting in-hospital major adverse events. Randomly selected development (70%, n=28 530) and validation (30%, n=12 471) cohorts were analyzed with 1000 bootstrapped samples, using forward stepwise logistic regression to create the final model. A simplified bedside risk score was also developed using this model. RESULTS: Increased age, female sex, low preprocedure hemoglobin, no prior attempt at atrial fibrillation termination, and increased fall risk most strongly predicted in-hospital major adverse events and were included in the final model along with other clinically relevant variables. The median in-hospital risk-standardized adverse event rate was 1.50% (range, 1.03%–2.84%; interquartile range, 1.42%–1.64%). The model demonstrated moderate discrimination (development C-index, 0.67 [95% CI, 0.65–0.70] and validation C-index, 0.66 [95% CI, 0.62–0.70]) with good calibration. The simplified risk score was well calibrated with risk of in-hospital major adverse events ranging from 0.26% to 3.90% for a score of 0 to 8, respectively. CONCLUSIONS: A transcatheter LAAO risk model using National Cardiovascular Data Registry and LAAO Registry data can predict in-hospital major adverse events, demonstrated consistency across hospitals and can be used for quality improvement efforts. A simple bedside risk score was similarly predictive and may inform shared decision-making. [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: Data from administrative claims may provide an efficient alternative for end point ascertainment in clinical trials. However, it is uncertain how well claims data compare to adjudication by a clinical events committee in trials of patients with cardiovascular disease. METHODS: We matched 1336 patients ≥65 years old who received percutaneous coronary intervention in the DAPT (Dual Antiplatelet Therapy) Study with the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims as part of the EXTEND (Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data) Study. Adjudicated trial end points were compared with Medicare claims data with International Classification of Diseases, Ninth Revision codes from inpatient hospitalizations using time-to-event analyses, sensitivity, specificity, positive predictive value, negative predictive value, and kappa statistics. RESULTS: At 21-month follow-up, the cumulative incidence of major adverse cardiovascular and cerebrovascular events (combined mortality, myocardial infarction, and stroke) was similar between trial-adjudicated events and claims data (7.9% versus 7.2%, respectively; P=0.50). Bleeding rates were lower using adjudicated events compared with claims (5.0% versus 8.6%, respectively; P<0.001). The sensitivity and positive predictive value of comprehensive billing codes for identifying adjudicated events were 65.6% and 85.7% for myocardial infarction, 61.5% and 47.1% for stroke, and 76.8% and 39.3% for bleeding, respectively. Specificity and negative predictive value for all outcomes ranged from 93.7% to 99.5%. All 39 adjudicated deaths were identified using Medicare data. Kappa statistics assessing agreement between events for myocardial infarction, stroke, and bleeding were 0.73, 0.52, and 0.49, respectively. CONCLUSIONS: Claims data had moderate agreement with adjudication for myocardial infarction and poor agreement but high specificity for bleeding and stroke in the DAPT Study. Deaths were identified equivalently. Using claims data in clinical trials could be an efficient way to assess mortality among Medicare patients and may help detect other outcomes, although additional monitoring is likely needed to ensure accurate assessment of events. [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: Transvenous lead extraction is an integral part of management of patients with cardiovascular implantable electronic devices. Real-world incidence and predictors of perioperative complications in extractions involving implantable cardioverter-defibrillator leads have not been described in detail.Methods and Results: Data from the National Cardiovascular Data Registry Implantable Cardioverter-Defibrillator Registry were analyzed. Lead extraction was defined as removal of leads implanted for >1 year. Predictors of major perioperative complications for all extraction procedures (11 304) and for high-voltage lead (8362, 74%), across 762 centers, were analyzed using univariate and multivariate logistic regression. Major complication occurred in 258 (2.3%) extraction procedures. Of these 258 with a complication, 41 (16%) required urgent cardiac surgery. Of these 41, 14 (34%) died during surgery. Among the total 98 (0.9%) deaths reported, 18 (0.16% of total) occurred during transvenous lead extraction. In multivariable logistic regression analysis, female sex, admission other than electively for procedure, ≥3 leads extracted, longer implant duration, dislodgement of other leads, and patient's clinical status requiring lead extraction (infection/perforation) were associated with increased risk of complications. Smaller lead diameter, flat versus round coil shape, and greater proximal surface coil area were multivariate predictors of major perioperative complications specific to high-voltage leads.Conclusions: The rate of major complications and mortality with transvenous lead extraction is similar in the real-world outcomes to that reported in recent single-center studies from high-volume centers. There is significant risk of urgent cardiac surgery, which carries a high mortality, and planning for appropriate cardiothoracic surgery backup is imperative. [ABSTRACT FROM AUTHOR]

Background: We assess the rates of device use and outcomes by race among patients undergoing lower extremity peripheral arterial intervention using the American College of Cardiology National Cardiovascular Data Registry-Peripheral Vascular Intervention (PVI) registry. Methods: Patients who underwent PVI between April 2014 and March 2019 were included. Socioeconomic status was evaluated using the Distressed Community Index score for patients' zip codes. Multivariable logistic regression was used to assess factors associated with utilization of drug-eluting technologies, intravascular imaging, and atherectomy. Among patients with Centers for Medicare and Medicaid Services data, we compared 1-year mortality, rates of amputation, and repeat revascularizations. Results: Of 63 150 study cases, 55 719 (88.2%) were performed in White patients and 7431 (11.8%) in Black patients. Black patients were younger (67.9 versus 70.0 years), had higher rates of hypertension (94.4% versus 89.5%), diabetes (63.0% versus 46.2%), less likely to be able to walk 200 m (29.1% versus 24.8%), and higher Distressed Community Index scores (65.1 versus 50.6). Black patients were provided drug-eluting technologies at a higher rate (adjusted odds ratio, 1.14 [95% CI, 1.06–1.23]) with no difference in atherectomy (adjusted odds ratio, 0.98 [95% CI, 0.91–1.05]) or intravascular imaging (adjusted odds ratio, 1.03 [95% CI, 0.88–1.22]) use. Black patients experienced a lower rate of acute kidney injury (adjusted odds ratio, 0.79 [95% CI, 0.72–0.88]). In Centers for Medicare and Medicaid Services-linked analyses of 7429 cases (11.8%), Black patients were significantly less likely to have surgical (adjusted hazard ratio, 0.40 [95% CI, 0.17–0.96]) or repeat PVI revascularization (adjusted hazard ratio, 0.42 [95% CI, 0.30–0.59]) at 1 year compared with White patients. There was no difference in mortality (adjusted hazard ratio [0.8–1.4]) or major amputation (adjusted hazard ratio, 2.5 [95% CI, 0.8–7.6]) between Black and White patients. Conclusions: Black patients presenting for PVI were younger, had higher prevalence of comorbidities and lower socioeconomic status. After adjustment, Black patients were less likely to have surgical or repeat PVI revascularization after the index PVI procedure. [ABSTRACT FROM AUTHOR]

Background: Among patients with implantable defibrillators (ICD), use of remote patient monitoring (RPM) is associated with lower risk of death and rehospitalization. Standard ICD RPM can be supplemented with weight and blood pressure data. It is not known whether standard RPM plus routine weight and blood pressure transmission (RPM+) is associated with better outcomes.Methods and Results: RPM+ patients (n=4106) were compared with patients who only transmitted standard ICD RPM data (n=14 183). Logistic regression models identified patient, physician, and hospital characteristics associated with RPM+ utilization. Mortality and rehospitalization were examined using landmark analyses at 180 days after ICD implant in Medicare fee-for-service patients. In these analyses, we examined the independent association between RPM+ utilization and times to events up to 3 years after device implantation with Cox regression models. We further examined whether the association between RPM+ and outcomes varied by frequency or type of transmissions. Determinants of RPM+ utilization included impaired ejection fraction, cardiac resynchronization therapy, and institutional practice. The risk of mortality of RPM+ patients was similar to standard ICD RPM patients (hazard ratio, 1.06; 95% confidence interval, 0.94-1.19; P=0.34). RPM+ patients also had similar risks of all-cause hospitalization (subdistribution hazard ratio, 1.03; 95% confidence interval, 0.94-1.14; P=0.52), cardiovascular hospitalization (subdistribution hazard ratio, 0.92; 95% confidence interval, 0.83-1.02; P=0.15), or heart failure hospitalizations (subdistribution hazard ratio, 0.90; 95% confidence interval, 0.78-1.05; P=0.18). RPM+ transmission frequency was not associated with outcomes.Conclusions: In patients using standard ICD RPM, the added transmission of weight and blood pressure data was not associated with improved outcomes. [ABSTRACT FROM AUTHOR]