Effectiveness of tisagenlecleucel versus real-world standard of care in relapsed/refractory follicular lymphoma.

Aim: To contextualize the effectiveness of tisagenlecleucel versus real-world standard of care (SoC) in relapsed/refractory follicular lymphoma. Materials & methods: A retrospective indirect matched comparison study using data from the phase II ELARA trial and the US Flatiron Health Research Database. Results: Complete response rate was 69.1 versus 17.7% and the overall response rate was 85.6 versus 58.1% in tisagenlecleucel versus SoC, post weighting by odds. For overall survival, an estimated reduction in the risk of death was observed in favor of tisagenlecleucel over SoC. The hazard ratio for progression-free survival was 0.45 (95% CI: 0.26, 0.88), and for time-to-next treatment was 0.34 (95% CI: 0.15, 0.78) with tisagenlecleucel versus SoC. Conclusion: A consistent trend toward improved efficacy end points was observed in favor of tisagenlecleucel versus SoC.

Thirty-Day and 90-Day Episode of Care Spending Following Heart Failure Hospitalization Among Medicare Beneficiaries.

BACKGROUND: Despite growing interest in value-based models, utilization patterns and costs for heart failure (HF) admissions are not well understood. We sought to characterize Medicare spending for patients with HF for 30- and 90-day episodes of care (which include an index hospitalization and 30 or 90 days following discharge) and to describe the patterns of post-acute care spending. METHODS: Using Medicare fee-for-service administrative claims data from 2016 to 2018, we performed a retrospective analysis of patients discharged after hospitalization with primary discharge diagnoses of systolic HF, diastolic HF, hypertensive heart disease (HHD) with HF, and HHD with HF and chronic kidney disease. We analyzed coding patterns across these groups over time, median 30- and 90-day payments, and costs allocated to index hospitalization and postacute care. RESULTS: The study included 935 962 patients discharged following hospitalization for HF (systolic HF: 178 603; diastolic HF: 165 156; HHD with HF: 226 929; HHD with HF and chronic kidney disease: 365 274). The proportion of HHD codes increased from 26% of HF hospitalizations in 2016 to 91% in 2018. There was substantial spending on 30-day (median $13 330, interquartile range $9912-$22 489) and 90-day episodes (median $21 658, interquartile range $12 423-$37 630) for HF with significant variation, such that the third quartile of patients incurred costs 3 times the amount of the first quartile. Across all codes, the index hospitalization accounted for ≈70% of 30-day and 45% of 90-day spending. Sixty-one percent of postacute care spending occurred 31 to 90 days following discharge, with readmissions and observation stays (36%) and skilled nursing facilities (27%) comprising the largest categories. CONCLUSIONS: This patient episode-level analysis of contemporary Medicare beneficiaries is the first to examine 90-day spending, which will become an increasingly important pasyment benchmark with the expansion of the Medicare Bundled Payments for Care Improvement Program. Further investigation into the drivers of costs will be essential to provide high-value HF care.

Association of Daily Growth Hormone Injection Adherence and Height Among Children With Growth Hormone Deficiency.

OBJECTIVE: Recombinant human growth hormone (somatropin) is recommended for children with growth hormone deficiency (GHD) to normalize adult height. Prior research has indicated an association between adherence to somatropin and height velocity. Further research is needed using real-world data to quantify this relationship; hence the objective of this study was to investigate the association between adherence to somatropin and change in height among children with GHD. METHODS: This retrospective cohort study included patients in the IQVIA PharMetrics Plus and Ambulatory Electronic Medical Records databases aged 3 to 15 years, with ≥1 GHD diagnosis code claim and newly initiated on somatropin between January 1, 2007 and November 30, 2019. Adherence was measured over the follow-up using the medication possession ratio (MPR); patients were classified as adherent (MPR ≥ 0.8) or nonadherent (MPR < 0.8). RESULTS: Among 201 patients initiated on somatropin, 74.6% were male, mean age was 11.4 years, and the mean follow-up was 343.3 days. Approximately 76.6% of patients were adherent to somatropin over the follow-up period. Adjusted growth trajectories were similar between adherent and nonadherent patients pre-treatment initiation (P = .15). Growth trajectories post-initiation were significantly different (P = .001). On average, adherent patients gained an additional 1.8 cm over 1 year compared with nonadherent patients, adjusted for covariates. CONCLUSION: Greater adherence to somatropin therapy is associated with improved height velocity. As suboptimal adherence to daily somatropin therapy is an issue for children with GHD, novel strategies to improve adherence may improve growth outcomes.

Trends in ICD Implantations and in-Hospital Outcomes After DOJ Investigation.

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.

Variation in Risk-standardized Rates and Causes of Unplanned Hospital Visits Within 7 Days of Hospital Outpatient Surgery.

OBJECTIVES: The objectives of this study were to compare risk-standardized hospital visit ratios of the predicted to expected number of unplanned hospital visits within 7 days of same-day surgeries performed at US hospital outpatient departments (HOPDs) and to describe the causes of hospital visits. SUMMARY OF BACKGROUND DATA: More than half of procedures in the US are performed in outpatient settings, yet little is known about facility-level variation in short-term safety outcomes. METHODS: The study cohort included 1,135,441 outpatient surgeries performed at 4058 hospitals between October 1, 2015 and September 30, 2016 among Medicare Fee-for-Service beneficiaries aged ≥65 years. Hospital-level, risk-standardized measure scores of unplanned hospital visits (emergency department visits, observation stays, and unplanned inpatient admissions) within 7 days of hospital outpatient surgery were calculated using hierarchical logistic regression modeling that adjusted for age, clinical comorbidities, and surgical procedural complexity. RESULTS: Overall, 7.8% of hospital outpatient surgeries were followed by an unplanned hospital visit within 7 days. Many of the leading reasons for unplanned visits were for potentially preventable conditions, such as urinary retention, infection, and pain. We found considerable variation in the risk-standardized ratio score across hospitals. The 203 best-performing HOPDs, at or below the 5th percentile, had at least 22% fewer unplanned hospital visits than expected, whereas the 202 worst-performing HOPDs, at or above the 95th percentile, had at least 29% more post-surgical visits than expected, given their case and surgical procedure mix. CONCLUSIONS: Many patients experience an unplanned hospital visit within 7 days of hospital outpatient surgery, often for potentially preventable reasons. The observed variation in performance across hospitals suggests opportunities for quality improvement.

Longitudinal Outcomes Associated With Non-Evidence-Based Implantable Cardioverter-Defibrillators Among Medicare Beneficiaries (From the National Cardiovascular Data Registry).

Primary prevention implantable cardioverter-defibrillators (ICDs) in patients with recent myocardial infarction or coronary revascularization and those with newly diagnosed or severe heart failure (HF) are considered non-evidence-based, as defined by pivotal randomized clinical trials. Although non-evidence-based ICDs have been associated previously with greater risk of in-hospital adverse events, longitudinal outcomes are not known. We used Medicare-linked data from the National Cardiovascular Data Registry's ICD Registry to identify patients discharged alive following first-time primary prevention ICD implantations performed between 2010 and 2013. We compared longitudinal outcomes, including all-cause mortality and all-cause hospital readmission among patients receiving non-evidence-based versus evidence-based ICDs, up to 4.75 years after implantation, using multivariable time-to-event analyses. Of 71,666 ICD implantations, 9,609 (13.4%) were classified as non-evidence-based. Compared to patients receiving evidence-based ICDs, non-evidence-based ICD recipients had greater mortality risk at 90 days (HR = 1.44, CI: 1.37 - 1.52, p <0.0001) and at 1 year (HR = 1.19, CI: 1.15 - 1.24, p <0.0001), but similar mortality risk at 3 years (HR = 1.03, CI: 0.98 - 1.08, p = 0.2630). Risk of all-cause hospitalization was higher in patients with non-evidence-based ICDs at 90 days (HR = 1.17, CI: 1.14 - 1.20, p <0.0001), but the difference diminished at 1 year (HR = 1.04, CI 1.00 - 1.07, p = 0.0272) and at 3 years (HR = 0.94, CI: 0.90 - 0.99, p = 0.0105). In conclusion, among patients undergoing primary prevention ICD implantations between 2010 and 2013, those with non-evidence-based ICDs were at increased risk of mortality and readmission during longitudinal follow-up. Differences in the risk of mortality and hospitalization were highest in the first year following device implantation.

Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock.

Importance: Mechanical circulatory support (MCS) devices, including intravascular microaxial left ventricular assist devices (LVADs) and intra-aortic balloon pumps (IABPs), are used in patients who undergo percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock despite limited evidence of their clinical benefit. Objective: To examine trends in the use of MCS devices among patients who underwent PCI for AMI with cardiogenic shock, hospital-level use variation, and factors associated with use. Design, Setting, and Participants: This cross-sectional study used the CathPCI and Chest Pain-MI Registries of the American College of Cardiology National Cardiovascular Data Registry. Patients who underwent PCI for AMI complicated by cardiogenic shock between October 1, 2015, and December 31, 2017, were identified from both registries. Data were analyzed from October 2018 to August 2020. Exposures: Therapies to provide hemodynamic support were categorized as intravascular microaxial LVAD, IABP, TandemHeart, extracorporeal membrane oxygenation, LVAD, other devices, combined IABP and intravascular microaxial LVAD, combined IABP and other device (defined as TandemHeart, extracorporeal membrane oxygenation, LVAD, or another MCS device), or medical therapy only. Main Outcomes and Measures: Use of MCS devices overall and specific MCS devices, including intravascular microaxial LVAD, at both patient and hospital levels and variables associated with use. Results: Among the 28 304 patients included in the study, the mean (SD) age was 65.4 (12.6) years and 18 968 were men (67.0%). The overall MCS device use was constant from the fourth quarter of 2015 to the fourth quarter of 2017, although use of intravascular microaxial LVADs significantly increased (from 4.1% to 9.8%; P < .001), whereas use of IABPs significantly decreased (from 34.8% to 30.0%; P < .001). A significant hospital-level variation in MCS device use was found. The median (interquartile range [IQR]) proportion of patients who received MCS devices was 42% (30%-54%), and the median proportion of patients who received intravascular microaxial LVADs was 1% (0%-10%). In multivariable analyses, cardiac arrest at first medical contact or during hospitalization (odds ratio [OR], 1.82; 95% CI, 1.58-2.09) and severe left main and/or proximal left anterior descending coronary artery stenosis (OR, 1.36; 95% CI, 1.20-1.54) were patient characteristics that were associated with higher odds of receiving intravascular microaxial LVADs only compared with IABPs only. Conclusions and Relevance: This study found that, among patients who underwent PCI for AMI complicated by cardiogenic shock, overall use of MCS devices was constant, and a 2.5-fold increase in intravascular microaxial LVAD use was found along with a corresponding decrease in IABP use and a significant hospital-level variation in MCS device use. These trends were observed despite limited clinical trial evidence of improved outcomes associated with device use.

Impact of insurance status on ICD implantation practice patterns: Insights from the NCDR ICD registry.

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.

Trends in Use and In-Hospital Outcomes of Subcutaneous Implantable Cardioverter Defibrillators in Patients Undergoing Long-Term Dialysis.

BACKGROUND AND OBJECTIVES: Patients on dialysis are at high risk of complications related to implantable cardioverter defibrillator (ICD) implantation; use of subcutaneous ICDs may be preferred over transvenous devices due to lower risk of bloodstream infection and interference with vascular access sites. We evaluated trends in use and in-hospital outcomes of subcutaneous compared with transvenous ICDs among patients on dialysis in the United States. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Retrospective analysis of ICD implants from 2012 to 2018 among patients on dialysis reported to the National Cardiovascular Data Registry ICD Registry, a nationally representative US ICD Registry. We examined overall trends in subcutaneous ICD adoption as a proportion of all eligible ICD implants among patients on dialysis and then compared in-hospital outcomes between eligible subcutaneous ICD and transvenous ICD recipients using inverse probability of treatment weighting. RESULTS: Of the 23,136 total ICD implants in patients on dialysis during the study period, 3195 (14%) were subcutaneous ICDs. Among eligible first-time ICD recipients on dialysis, the proportion of subcutaneous ICDs used increased yearly from 10% in 2012 to 69% in 2018. In propensity score-weighted analysis of 3327 patients, compared with transvenous ICDs, patients on dialysis receiving subcutaneous ICDs had a higher rate of in-hospital cardiac arrest (2% versus 0.4%, P=0.002), but there was no significant difference in total in-hospital complications (2% versus 1%, P=0.08), all-cause death, or length of hospital stay. CONCLUSIONS: The utilization of subcutaneous ICDs among US patients on dialysis has been steadily increasing. The overall risk of short-term complications is low and comparable with transvenous ICDs, but higher risks of in-hospital cardiac arrest merits closer monitoring and further investigation. PODCAST: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_09_23_CJN07920520.mp3.

Comparison of Mortality and Readmission in Non-Ischemic Versus Ischemic Cardiomyopathy After Implantable Cardioverter-Defibrillator Implantation.

Data is lacking on the contemporary risk of death and readmission following implantable cardioverter-defibrillator (ICD) implantation in patients with non-ischemic cardiomyopathies (NICM) compared with ischemic cardiomyopathies (ICM) in a large nationally representative cohort. We performed a retrospective cohort study using the National Cardiovascular Data Registry ICD Registry linked with Medicare claims from April 1, 2010 to December 31, 2013. We established a cohort of NICM and ICM patients with a left ventricular ejection fraction ≤35% who received a de novo, primary prevention ICD. We compared mortality and readmission using Kaplan-Meier curves and Cox proportional hazard regressions models. We also evaluated temporal trends in mortality. In 31,044 NICM and 68,458 ICM patients with a median follow up of 2.4 years, 1-year mortality was significantly higher in ICM patients (12.3%) compared with NICM (7.9%, p < 0.001). The higher mortality in ICM patients remained significant after adjustment for covariates (hazard ratio [HR] 1.40; 95% confidence interval [CI] 1.36 to 1.45), and was consistent in subgroup analyses. These findings were consistent across the duration of the study. ICM patients were also significantly more likely to be readmitted for all causes (adjusted HR 1.15, CI 1.12 to 1.18) and for heart failure (adjusted HR 1.25, CI 1.21 to 1.31). In conclusion, the risks of mortality and hospital readmission after primary prevention ICD implantation were significantly higher in patients with ICM compared with NICM which was consistent across all patient subgroups tested and over the duration of the study.

Contemporary Trends, Predictors and Outcomes of Perforation During Percutaneous Coronary Intervention (From the NCDR Cath PCI Registry).

Coronary artery perforation (CP) is a rare but potentially life-threatening complication of percutaneous coronary intervention (PCI). Given the marked increase in high-risk and complex PCIs, careful review and understanding of PCI complications may help to improve procedural and clinical outcomes. Our aim was to study the trends, predictors and outcomes of CP in the contemporary era. This cross-sectional multicenter analysis included data collected from institutions participating in the National Cardiovascular Data Registry CathPCI Registry between July 2009 and June 2015. Multivariable logistic regression models were created to identify predictors of CP and compare the in-hospital outcomes of CP and non-CP patients. Of 3,759,268 PCIs performed during the study period, there were 13,779 CP (0.37%). During the study period, the proportion of PCI that developed CP remained unchanged (0.33% to 0.4%) (p for trend 0.16). Chronic total occlusion (CTO) PCI as percentage of total PCI volume increased over the study period (3% to 4%) (p for trend <0.001) with a concomitant significant increase in CTOs with perforation (1.2% to 1.5%, p for trend = 0.02). CTO PCI (Odds Ratio [OR] 2.59) female gender (OR 1.38), saphenous vein graft PCI (OR 1.2), ACC Type C lesion (1.48), cardiogenic shock on presentation (1.15), and use of atherectomy (laser/ rotational) (OR 2.38) were significant predictors of CP. CP patients had significantly higher rates of cardiogenic shock (7.73% vs 1.02%), tamponade (9.6% vs 0.05%) and death (4.87% vs 1.14%) compared with those without CP. Strongest predictors of any adverse events amongst CP were cardiogenic shock (OR 3.93), cardiac arrest (OR 2.02) and use of atherectomy device (OR 2.5). Use of covered stents was also strongly associated with adverse events (OR 3.67) reflecting severity of these CPs. CP in CTO PCI had higher rates of any adverse event than non-CTO CP (26.8% vs 22%, p < 0.001). However non-CTO CP had higher rates of coronary artery bypass grafting (CABG) (urgent, emergent, or salvage) (5.8% vs 4.5%, p = 0.03) and death (6.9% vs 5.6%, p = 0.04). CP in CABG PCI had fewer adverse events compared with those without previous CABG (16.1% vs 24.7%). In a large real world experience, we identified several clinical and procedural factors associated with increased risk of CP and adverse outcomes. The trends in CP remained constant over the study period.

Periprocedural Risk and Survival Associated With Implantable Cardioverter-Defibrillator Placement in Older Patients With Advanced Heart Failure.

Importance: Little is known about the utilization rates and outcomes of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) placement among patients with advanced heart failure (HF). Objective: To examine utilization rates, patient characteristics, and outcomes of ICD and CRT-D placements among patients with advanced HF. Design, Setting, and Participants: This cohort study was a post hoc analysis of 81 492 Medicare fee-for-service beneficiaries enrolled in the National Cardiovascular Data Registry ICD Registry between January 2010 and December 2014. Inclusion criteria were patients who had received an HF diagnosis, had a left ventricular ejection fraction of 35% or lower, and showed evidence of advanced HF, which was defined as New York Heart Association (NYHA) class IV symptoms, inotrope use within the last 60 days, left ventricular assist device in situ, or orthotopic heart transplant listing. The comparator group included patients with NYHA class II and no HF hospitalization within the last 12 months, no left ventricular assist device, no orthotopic heart transplant listing, and no current or recent inotrope use. All eligible patients underwent first-time ICD or CRT-D placement for primary prevention of sudden cardiac death. Data were analyzed from January 2010 to December 2014. Main Outcomes and Measures: All-cause mortality and periprocedural complications. Results: Of 81 492 Medicare patients, 3343 had advanced HF (4.1%) and 19 424 were in the comparator group (23.8%). Among the advanced HF population, the mean (SD) age of patients was 74 (9) years, and patients were predominantly white individuals (81.5%) and men (71.1%). The all-cause mortality rate at 30 days was 3.1% (95% CI, 2.6%-3.8%) in the advanced HF group vs 0.5% (0.4%-0.6%) in the comparator group (P < .001). In the advanced HF population, the aggregate in-hospital periprocedural complication rate was 3.74% (95% CI, 3.12%-4.44%) vs 1.10% (95% CI, 0.95%-1.25%) in the comparator group (P < .001). Most adverse events in this group were in-hospital fatality (1.82%; 95% CI, 1.40%-2.34%) and resuscitated cardiac arrest (1.05%; 95% CI, 0.73%-1.45%). Patients with NYHA class IV (hazard ratio, 1.40; 95% CI, 1.02-1.93; P = .04), ischemic heart disease (hazard ratio, 1.24; 95% CI, 1.04-1.48; P = .02), or diabetes (hazard ratio, 1.17; 95% CI, 1.04-1.33; P = .01) had a higher risk of death. Conclusions and Relevance: Among patients undergoing ICD or CRT-D placement for primary prevention of sudden cardiac death, only a small proportion had advanced HF. These patients experienced clinically important periprocedural complication rates associated with in-hospital death and cardiac arrest relative to patients with nonadvanced HF.

Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data.

Background More than 600 000 coronary stents are implanted during percutaneous coronary interventions (PCIs) annually in the United States. Because no real-world surveillance system exists to monitor their long-term safety, claims data are often used for this purpose. The extent to which adverse events identified with claims data can be reasonably attributed to a specific medical device is uncertain. Methods and Results We used deterministic matching to link the NCDR (National Cardiovascular Data Registry) CathPCI Registry to Medicare fee-for-service claims for patients aged ≥65 years who underwent PCI with drug-eluting stents (DESs) between July 1, 2009 and December 31, 2013. We identified subsequent PCIs within 1 year of the index procedure in Medicare claims as potential safety events. We linked these subsequent PCIs back to the NCDR CathPCI Registry to ascertain how often the revascularization could be reasonably attributed to the same coronary artery as the index PCI (ie, target vessel revascularization). Of 415 306 DES placements in 368 194 patients, 33 174 repeat PCIs were identified in Medicare claims within 1 year. Of these, 28 632 (86.3%) could be linked back to the NCDR CathPCI Registry; 16 942 (51.1% of repeat PCIs) were target vessel revascularizations. Of these, 8544 (50.4%) were within a previously placed DES: 7652 for in-stent restenosis and 1341 for stent thrombosis. Of 16 176 patients with a claim for acute myocardial infarction in the follow-up period, 4446 (27.5%) were attributed to the same coronary artery in which the DES was implanted during the index PCI (ie, target vessel myocardial infarction). Of 24 288 patients whose death was identified in claims data, 278 (1.1%) were attributed to the same coronary artery in which the DES was implanted during the index PCI. Conclusions Most repeat PCIs following DES stent implantation identified in longitudinal claims data could be linked to real-world registry data, but only half could be reasonably attributed to the same coronary artery as the index procedure. Attribution among those with acute myocardial infarction or who died was even less frequent. Safety signals identified using claims data alone will require more in-depth examination to accurately assess stent safety.

Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock.

Importance: Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice. Objective: To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices. Design, Setting, and Participants: A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017. Exposures: Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only. Main Outcomes and Measures: The primary outcomes were in-hospital mortality and in-hospital major bleeding. Results: Among 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI. Conclusions and Relevance: Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients.

Quadripolar versus bipolar leads in cardiac resynchronization therapy: An analysis of the National Cardiovascular Data Registry.

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.

Association of Statewide Certificate of Need Regulations With Percutaneous Coronary Intervention Appropriateness and Outcomes.

Background Certificate of need ( CON ) regulations are intended to coordinate new healthcare services, limit expansion of unnecessary new infrastructure, and limit healthcare costs. However, there is limited information about the association of CON regulations with the appropriateness and outcomes of percutaneous coronary interventions ( PCI ). The study sought to characterize the association between state CON regulations and PCI appropriateness. Methods and Results We used data from the American College of Cardiology's Cath PCI Registry to analyze 1 268 554 PCI s performed at 1297 hospitals between January 2010 and December 2011. We used the Appropriate Use Criteria to classify PCI procedures as appropriate, maybe appropriate, or rarely appropriate and used Chi-square analyses to assess whether the proportions of PCI s in each Appropriate Use Criteria category varied depending on whether the procedure had been performed in a state with or without CON regulations. Analyses were repeated stratified by whether or not the procedure had been performed in the setting of an acute coronary syndrome ( ACS ). Among 1 268 554 PCI procedures, 674 384 (53.2%) were performed within 26 CON states. The proportion of PCI s classified as rarely appropriate in CON states was slightly lower compared with non- CON states (3.7% versus 4.0%, P<0.01). Absolute differences were larger among non- ACS PCI (23.1% versus 25.0% [ P<0.01]) and were not statistically significantly different in ACS (0.62% versus 0.63% [ P>0.05]). Conclusions States with CON had lower proportions of rarely appropriate PCI s, but the absolute differences were small. These findings suggest that CON regulations alone may not limit rarely appropriate PCI among patients with and without ACS .

Combined Smoking Cues Enhance Reactivity and Predict Immediate Subsequent Smoking.

Introduction: Cue reactivity (CR) research has reliably demonstrated robust cue-induced responding among smokers exposed to common proximal smoking cues (eg, cigarettes, lighter). More recent work demonstrates that distal stimuli, most notably the actual environments in which smoking previously occurred, can also gain associative control over craving. In the real world, proximal cues always occur within an environment; thus, a more informative test of how cues affect smokers might be to present these two cue types simultaneously. Methods: Using a combined-cue counterbalanced CR paradigm, the present study tested the impact of proximal (smoking and neutral) + personal environment (smoking and nonsmoking places) pictorial cues, on smokers' subjective and behavioral CR; as well as the extent to which cue-induced craving predicts immediate subsequent smoking in a within-subjects design. Results: As anticipated, the dual smoking cue combination (ProxS + EnvS) led to the greatest cue-induced craving relative to the other three cue combinations (ProxS + EnvN, ProxN + EnvS, and ProxN ± EnvN), ps < .004. Dual smoking cues also led to significantly shorter post-trial latencies to smoke, ps < .01. Overall CR difference score (post-trial craving minus baseline craving) was predictive of subsequent immediate smoking indexed by: post-trial latency to smoke [B = -2.69, SE = 9.02; t(143) = -2.98, p = .003]; total puff volume [B = 2.99, SE = 1.13; t(143) = 2.65, p = .009]; and total number of puffs [B = .053, SE = .027; t(143) = 1.95, p = .05]. Conclusions: The implications of these findings for better understanding the impact of cues on smoking behavior and cessation are discussed. Implications: This novel cue reactivity study examined smokers' reactivity to combined proximal and distal smoking cues. Exposure to a combination of two smoking cues (proximal and environment) led to the greatest increases in cue-induced craving and smoking behavior compared to all other cue combinations. Further, the overall magnitude of cue-induced craving was found to significantly predict immediate subsequent smoking. This work provides new insight on how exposure to various cues and cue combinations directly affect smokers' craving and actual smoking behavior, as well as the relationship between those two indices of reactivity.

Is Time From Last Hospitalization for Heart Failure to Placement of a Primary Prevention Implantable Cardioverter-Defibrillator Associated With Patient Outcomes?

BACKGROUND: Landmark studies have demonstrated the safety and efficacy of implantable cardioverter-defibrillators (ICDs) in selected stable ambulatory patients with heart failure (HF) with a reduced ejection fraction receiving optimal medical therapy. It is not known whether a recent hospitalization for HF before ICD placement is associated with subsequent outcomes. METHODS: A post hoc analysis was performed of Medicare beneficiaries enrolled in the National Cardiovascular Data Registry's ICD Registry with a known diagnosis of HF and an ejection fraction ≤35% underdoing a new ICD placement for primary prevention. Patients were grouped based on the timing of ICD placement from the last hospitalization for HF. The association between timing of ICD placement and outcomes was assessed by using multivariable logistic regression models. RESULTS: The final analytic cohort included 81 180 patients undergoing initial ICD placement for primary prevention who were currently hospitalized for HF (n=11 563, 14%), hospitalized for HF within 3 months (n=6252, 8%), or hospitalized for HF >3 months previously or had no previous hospitalizations for HF (n=63 365, 78%). Patients currently or recently hospitalized for HF had a higher unadjusted composite periprocedural complication rate (2.60% versus 1.71% versus 1.25%, P<0.001). After adjusting for potential confounders, patients currently hospitalized for HF were at higher risk for death (odds ratio, 2.25; 95% CI, 2.02-2.52; P <0.001) and all-cause readmission (odds ratio, 1.89; 95% CI, 1.79-1.99; P <0.001) at 90 days. CONCLUSION: Older patients currently or recently hospitalized for HF undergoing initial ICD placement for primary prevention experienced a higher rate of periprocedural complications and were at increased risk of death in comparison with those receiving an ICD without recent HF hospitalization. Additional prospective, real-world, pragmatic, comparative effectiveness studies should be conducted to define the optimal timing of ICD placement.