Post-hospitalization Treatment Regimen and Readmission for C. difficile Colitis in Medicare Beneficiaries.

BACKGROUND: C. difficile (CDI) has surpassed methicillin-resistant staph aureus as the most common nosocomial infection with recurrence reaching 30% and the elderly being disproportionately affected. We hypothesized that post-discharge antibiotic therapy for continued CDI treatment reduces readmissions. STUDY DESIGN: We queried a 5% random sample of Medicare claims (2009-2011 Part A and Part D; n = 864,604) for hospitalizations with primary or secondary diagnosis of CDI. We compared demographics, comorbidities, and post-discharge CDI treatment (no CDI treatment, oral metronidazole only, oral vancomycin only, or both) between patients readmitted with a primary diagnosis of CDI within 90 days and patients not readmitted for any reason using univariate tests of association and multivariable models. RESULTS: Of 7042 patients discharged alive, 945 were readmitted ≤90 days with CDI (13%), while 1953 were not readmitted for any reason (28%). Patients discharged on dual therapy had the highest rates of readmission (50%), followed by no post-discharge CDI treatment (43%), vancomycin only (28%), and metronidazole only (19%). Patients discharged on only metronidazole (OR 0.28) or only vancomycin (OR 0.42) had reduced odds of 90-day readmission compared to patients discharged on no CDI treatment. Patients discharged on dual therapy did not vary in odds of readmission. CONCLUSIONS: Thirteen percent of patients discharged with CDI are readmitted within 90 days. Patients discharged with single-drug therapy for CDI had lower readmission rates compared to patients discharged on no ongoing CDI treatment suggesting that short-term monotherapy may be beneficial in inducing eradication and preventing relapse. Half of patients requiring dual therapy required readmission, suggesting patients with symptoms severe enough to warrant discharge on dual therapy may benefit from longer hospitalization.

Occurrence and predictors of recurrence after a first episode of acute venous thromboembolism: population-based Worcester Venous Thromboembolism Study.

Venous thromboembolism (VTE) has multiple risk factors and tends to recur. Despite the benefits of anticoagulation, the prevalence of, and case-fatality rate associated with, recurrent VTE remains a concern after an acute episode; it is particularly high during the acute treatment phase. We sought to quantify the magnitude, identify predictors, and develop risk score calculator of recurrence within 3 years after first-time VTE. This was a population-based surveillance study among residents of central Massachusetts (MA), USA, diagnosed with an acute first-time pulmonary embolism and/or lower-extremity deep vein thrombosis from 1999 to 2009 in hospital and ambulatory settings in all 12 central MA hospitals. Medical records were reviewed and validated. The 2989 study patients were followed for 5836 person-years [mean follow-up 23.4 (median 30) months]. Mean age was 64.3 years, 44 % were men, and 94 % were white. The cumulative incidence rate of recurrent VTE within 3 years after an index VTE was 15 % overall, and 25, 13, and 13 % among patients with active cancer, provoked, or unprovoked VTE, respectively. Multivariable regression indicated that active cancer, varicose vein stripping, and inferior vena cava filter placement were independent predictors of recurrence during both 3-month and 3-year follow-up. A risk score calculator was developed based on the 3-month prognostic model. In conclusion, the rate of VTE recurrence over 3 years of follow-up remained high. The risk score calculator may assist clinicians at the index encounter in determining the frequency of clinical surveillance and appropriate outpatient treatment of VTE during the acute treatment phase.

The Agency for Healthcare Research and Quality Inpatient Quality Indicator #11 overall mortality rate does not accurately assess mortality risk after abdominal aortic aneurysm repair.

OBJECTIVE: The Agency for Healthcare Research and Quality (AHRQ) Inpatient Quality Indicator (IQI) #11, abdominal aortic aneurysm (AAA) repair mortality rate, is a measure of hospital quality that is publically reported but has not been externally validated. Because the IQI #11 overall mortality rate includes both intact and ruptured aneurysms and open and endovascular repair, we hypothesized that IQI #11 overall mortality rate does not provide accurate assessment of mortality risk after AAA repair and that AAA mortality cannot be accurately assessed by a single quality measure. METHODS: Using AHRQ IQI software version 4.2, we calculated observed (O) and expected (E) mortality rates for IQI #11 for all hospitals performing more than 10 AAA repairs per year in the Nationwide Inpatient Sample for the years 2007 to 2011. We used Spearman correlation coefficient to compare expected rates as determined by IQI #11 overall mortality rate risk adjustment methodology and observed rates for all AAA repairs in four cohorts stratified by aneurysm stability (ruptured vs intact) and method of repair (open vs endovascular). RESULTS: Among 187,773 AAA repairs performed at 1268 U.S. hospitals, hospitals' IQI #11 overall expected rates correlated poorly with their observed rates (E: 5.0% ± 4.4% vs O: 6.0% ± 9.8%; r = .49). For ruptured AAAs, IQI #11 overall mortality rate methodology underestimated the mortality risk of open repair (E: 34% ± 7.2% vs O: 40.1% ± 38.2%; r = 0.20) and endovascular repair (E: 24.8% ± 9% vs O: 27.3% ± 37.9%; r = 0.08). For intact AAA repair, IQI #11 overall mortality rate methodology underestimated the mortality risk of open repair (E: 4.3% ± 2.4% vs O: 6.3% ± 16.1%; r = .24) but overestimated the mortality risk of endovascular repair (E: 1.3% ± 0.8% vs O: 1.1% ± 3.7%; r = 0.25). Hospitals' observed mortality rates after intact AAA repair were not correlated with their mortality rates after ruptured AAA repair (r = 0.03). CONCLUSIONS: IQI #11 overall mortality rate fails to provide accurate assessment of inpatient mortality risk after AAA repair. Thus, it is inappropriate to use IQI #11 overall mortality rate for quality reporting. The accuracy of separate quality measures that assess mortality risk after repair of ruptured and intact AAAs, stratified by the use of open or endovascular repair, should be examined.

Obesity, health-care utilization, and health-related quality of life after fracture in postmenopausal women: Global Longitudinal Study of Osteoporosis in Women (GLOW).

Fractures may be associated with higher morbidity in obese postmenopausal women than in nonobese women. We compared health-care utilization, functional status, and health-related quality of life (HRQL) in obese, nonobese, and underweight women with fractures. Information from the GLOW study, started in 2006, was collected at baseline and at 1, 2, and 3 years. In this subanalysis, self-reported incident clinical fractures, health-care utilization, HRQL, and functional status were recorded and examined. Women in GLOW (n = 60,393) were aged ≥55 years, from 723 physician practices at 17 sites in 10 countries. Complete data for fracture and body mass index were available for 90 underweight, 3,270 nonobese, and 941 obese women with one or more incident clinical fractures during the 3-year follow-up. The median hospital length of stay, adjusted for age, comorbidities, and fracture type, was significantly greater in obese than nonobese women (6 vs. 5 days, p = 0.017). Physical function and vitality score were significantly worse in obese than in nonobese women, both before and after fracture; but changes after fracture were similar across groups. Use of antiosteoporosis medication was significantly lower in obese than in nonobese or underweight women. In conclusion, obese women with fracture undergo a longer period of hospitalization for treatment and have poorer functional status and HRQL than nonobese women. Whether these differences translate into higher economic costs and adverse effects on longer-term outcomes remains to be established.

Real-World Outcomes in Patients with Spinal Muscular Atrophy Treated with Onasemnogene Abeparvovec Monotherapy: Findings from the RESTORE Registry.

Background: Long-term, real-world effectiveness and safety data of disease-modifying treatments for spinal muscular atrophy (SMA) are important for assessing outcomes and providing information for a larger number and broader range of SMA patients than included in clinical trials. Objective: We sought to describe patients with SMA treated with onasemnogene abeparvovec monotherapy in the real-world setting. Methods: RESTORE is a prospective, multicenter, multinational, observational registry that captures data from a variety of sources. Results: Recruitment started in September 2018. As of May 23, 2022, data were available for 168 patients treated with onasemnogene abeparvovec monotherapy. Median (IQR) age at initial SMA diagnosis was 1 (0-6) month and at onasemnogene abeparvovec infusion was 3 (1-10) months. Eighty patients (47.6%) had two and 70 (41.7%) had three copies of SMN2, and 98 (58.3%) were identified by newborn screening. Infants identified by newborn screening had a lower age at final assessment (mean age 11.5 months) and greater mean final (SD) CHOP INTEND score (57.0 [10.0] points) compared with clinically diagnosed patients (23.1 months; 52.1 [8.0] points). All patients maintained/achieved motor milestones. 48.5% (n = 81/167) experienced at least one treatment-emergent adverse event (AE), and 31/167 patients (18.6%) experienced at least one serious AE, of which 8/31 were considered treatment-related. Conclusion: These real-world outcomes support findings from the interventional trial program and demonstrate effectiveness of onasemnogene abeparvovec over a large patient population, which was consistent with initial clinical data and published 5-year follow-up data. Observed AEs were consistent with the established safety profile of onasemnogene abeparvovec.

Risk-assessment models for predicting venous thromboembolism among hospitalized non-surgical patients: a systematic review.

Venous thromboembolism (VTE) prophylaxis is suboptimal in American hospitals despite long-standing evidence-based recommendations. Data from observational studies indicate a lower uptake of effective prophylaxis in patients hospitalized with medical versus surgical conditions. Reluctance to use prophylaxis in medical patients has been attributed to difficulty in identifying at-risk patients and balancing risks of bleeding against occurrence of VTE. Several risk-assessment models (RAMs) have been proposed to assist physicians in identifying non-surgical patients who need prophylaxis. We conducted a systematic review of published RAMs, based on objective criteria, to determine whether any RAM is validated sufficiently to be employed in clinical practice. We identified 11 RAMs, six derived from primary data and five based on expert opinion. The number, types, and strength of association of VTE risk predictors were highly variable. The variability in methods and outcome measurement precluded pooled estimates of these different models. Published RAMs for VTE lack generalizability and adequate validation. As electronic health records become more ubiquitous, validated dynamic RAMs are needed to assess VTE risk at the point-of-care in real time.

Cardiogenic shock complicating acute coronary syndromes: insights from the Global Registry of Acute Coronary Events.

INTRODUCTION: Despite advances in the management of patients with an acute coronary syndrome (ACS), cardiogenic shock (CS) remains the leading cause of death in these patients. The objective of this observational study was to describe the characteristics, management, and hospital outcomes of patients with an ACS complicated by CS. Our secondary study objective was to describe trends in the incidence and hospital case-fatality rates (CFRs) of CS and predictors of increased hospital mortality in these high-risk patients. METHODS: The population consisted of patients enrolled in the GRACE study between 1999 and 2007 who were hospitalized with an ACS. RESULTS: During the years under study, 2,992 patients (4.6%) developed CS. Patients with CS were more likely to be older, have a history of diabetes or atrial fibrillation, and present with a higher pulse rate or cardiac arrest. Cardiac catheterization was performed on 1,706 (57%) and in-hospital revascularization on 1,408 patients (47%) with CS. Patients with CS were less likely to receive evidence-based cardiac medications compared with patients who did not develop CS. The in-hospital CFR of patients with CS was 59.4%, compared with 2.3% in those who did not develop CS. Factors associated with an increased risk of dying in patients with CS included advanced age, diabetes mellitus, angina, and stroke. Adjusted incidence rates and hospital CFRs of CS showed modest declines over time. CONCLUSION: Continued efforts are needed to reduce the incidence and CFRs of CS complicating ACS.

Prevention of venous thromboembolism after hip or knee arthroplasty: findings from a 2008 survey of US orthopedic surgeons.

A survey was mailed to a representative sample of US orthopedic surgeons to assess protocols for the prevention of venous thromboembolism after lower extremity total joint arthroplasty. Practices were examined by type of operation, annual surgical volume, and opinions of consensus guidelines issued by the American Academy of Orthopaedic Surgeons and the American College of Chest Physicians. Although there was near-unanimous agreement that routine thromboprophylaxis should be the standard practice for patients who undergo hip or knee arthroplasty, surgeons were divided as to the exact management approach.

Acute kidney injury and cardiovascular outcomes in acute severe hypertension.

BACKGROUND: Little is known about the association of kidney dysfunction and outcome in acute severe hypertension. This study aimed to measure the association between baseline chronic kidney disease (estimated glomerular filtration rate), acute kidney injury (AKI, decrease in estimated glomerular filtration rate > or =25% from baseline) and outcome in patients hospitalized with acute severe hypertension. METHODS AND RESULTS: The Studying the Treatment of Acute Hypertension (STAT) registry enrolled patients with acute severe hypertension, defined as > or =1 blood pressure measurement >180 mm Hg systolic and/or >110 mm Hg diastolic and treated with intravenous antihypertensive therapy. Data were compared across groups categorized by admission estimated glomerular filtration rate and AKI during admission. On admission, 79% of the cohort (n=1566) had at least mild chronic kidney disease (estimated glomerular filtration rate <60 mL/min in 46%, <30 mL/min in 22%). Chronic kidney disease patients were more likely to develop heart failure (P<0.0001), non-ST-elevation myocardial infarction (P=0.003), and AKI (P<0.007). AKI patients were at greater risk of heart failure and cardiac arrest (P< or =0.0001 for both). Subjects with AKI experienced higher mortality at 90 days (P=0.003). Any acute loss of estimated glomerular filtration rate during hospitalization was independently associated with an increased risk of death (odds ratio, 1.05; P=0.03 per 10-mL/min decline). Other independent predictors of mortality included increasing age (P<0.0001), male gender (P=0.016), white versus black race (P=0.003), and worse baseline kidney function (P=0.003). CONCLUSIONS: Chronic kidney disease is a common comorbidity among patients admitted with acute severe hypertension, and AKI is a frequent form of acute target organ dysfunction, particularly in those with baseline chronic kidney disease. Any degree of AKI is associated with a greater risk of morbidity and mortality.

Clinical practices, complications, and mortality in neurological patients with acute severe hypertension: the Studying the Treatment of Acute hyperTension registry.

OBJECTIVE: To determine the demographic and clinical features, hospital complications, and predictors of 90-day mortality in neurologic patients with acute severe hypertension. DESIGN: Studying the Treatment of Acute hyperTension (STAT) was a multicenter (n=25) observational registry of adult critical care patients with severe hypertension treated with intravenous therapy. SETTING: Emergency department or intensive care unit. PATIENTS: A qualifying blood pressure measurement>180 mm Hg systolic or >110 mm Hg diastolic (>140/90 mm Hg for subarachnoid hemorrhage) was required for inclusion in the STAT registry. Patients with a primary neurologic admission diagnosis were included in the present analysis. INTERVENTIONS: All patients were treated with at least one parenteral (bolus or continuous infusion) antihypertensive agent. MEASUREMENTS AND MAIN RESULTS: Of 1,566 patients included in the STAT registry, 432 (28%) had a primary neurologic diagnosis. The most common diagnoses were subarachnoid hemorrhage (38%), intracerebral hemorrhage (31%), and acute ischemic stroke (18%). The most common initial drug was labetalol (48%), followed by nicardipine (15%), hydralazine (15%), and sodium nitroprusside (13%). Mortality at 90 days was substantially higher in neurologic than in non-neurologic patients (24% vs. 6%, p<.0001). Median initial blood pressure was 183/95 mm Hg and did not differ between survivors and nonsurvivors. In a multivariable analysis, neurologic patients who died experienced lower minimal blood pressure values (median 103/45 vs. 118/55 mm Hg, p<.0001) and were less likely to experience recurrent hypertension requiring intravenous treatment (29% vs. 51%, p=.0001) than those who survived. Mortality was also associated with an increased frequency of neurologic deterioration (32% vs. 10%, p<.0001). CONCLUSION: Neurologic emergencies account for approximately 30% of hospitalized patients with severe acute hypertension, and the majority of those who die. Mortality in hypertensive neurologic patients is associated with lower minimum blood pressure values, less rebound hypertension, and a higher frequency of neurologic deterioration. Excessive blood pressure reduction may contribute to poor outcome after severe brain injury.

Characteristics, practice patterns, and outcomes in patients with acute hypertension: European registry for Studying the Treatment of Acute hyperTension (Euro-STAT).

INTRODUCTION: Although effective strategies are available for the management of chronic hypertension, less is known about treating patients with acute, severe elevations in blood pressure. Using data from the European registry for Studying the Treatment of Acute hyperTension (Euro-STAT), we sought to evaluate 'real-life' management practices and outcomes in patients who received intravenous antihypertensive therapy to treat an episode of acute hypertension. METHODS: Euro-STAT is a European, hospital-based, observational study of consecutive adult patients treated with intravenous antihypertensive therapy while in the emergency department, perioperative unit or ICU. Enrolment took place between 1 July and 15 October 2009 in 11 hospitals in 7 European countries (Austria, Belgium, Germany, Italy, Spain, Sweden and the United Kingdom). RESULTS: The study population was composed of 791 consecutive patients (median age 69 years, 37% women). Median arterial blood pressure before treatment was 166 mmHg systolic blood pressure (IQR 141 to 190 mmHg) and 80 mmHg diastolic blood pressure (IQR 68 to 95). Nitroglycerine was the most commonly used antihypertensive treatment overall (40% of patients), followed by urapidil (21%), clonidine (16%) and furosemide (8%). Treatment was associated with hypotension in almost 10% of patients. Overall 30-day mortality was 4%, and new or worsening end-organ damage occurred in 19% of patients. CONCLUSIONS: High blood pressure requiring intravenous therapy is currently managed with a variety of agents in Europe, with those most commonly used being nitroglycerine, urapidil and clonidine. Patients with acute hypertension have substantial concomitant morbidity and mortality, and intravenous antihypertensive treatment is associated with hypotension in almost 10% of cases.

Chronic nitrate therapy is associated with different presentation and evolution of acute coronary syndromes: insights from 52,693 patients in the Global Registry of Acute Coronary Events.

AIMS: Brief episode(s) of ischaemia may increase cardiac tolerance to a subsequent major ischaemic insult ('preconditioning'). Nitrates can pharmacologically mimic ischaemic preconditioning in animals. In this study, we investigated whether antecedent nitrate therapy affords protection toward acute ischaemic events using data from the Global Registry of Acute Coronary Events. METHODS AND RESULTS: The dataset comprised 52,693 patients from 123 centres in 14 countries: 42,138 (80%) were nitrate-naïve and 10,555 (20%) were on chronic nitrates at admission. In nitrate-naïve patients, admission diagnosis was ST-segment elevation myocardial infarction (STEMI) in 41%, whereas 59% presented with non-ST-segment elevation acute coronary syndrome (NSTE-ACS). In contrast, only 18% nitrate users showed STEMI, whereas 82% presented with NSTE-ACS. Thus, among nitrate users clinical presentation was tilted toward NSTE-ACS by more than four-fold, STEMI occurring in less than one of five patients (P < 0.0001). After adjustment (age, sex, medical history, prior therapy, revascularization, previous angina), chronic nitrate use remained independent predictor of NSTE-ACS (OR 1.36; 95% CI 1.26-1.46; P < 0.0001). Furthermore, regardless of presentation, within both STEMI and NSTEMI populations, antecedent nitrate use was associated with significantly lower levels of CK-MB and troponin (P < 0.0001 for all). CONCLUSION: In this large multinational registry, chronic nitrate use was associated with a shift away from STEMI in favour of NSTE-ACS and with less release of markers of cardiac necrosis. These findings suggest that in nitrate users acute coronary events may develop to a smaller extent. Randomized, placebo-controlled trials are warranted to establish whether nitrate therapy may pharmacologically precondition the heart toward ischaemic episodes.

Delay to reperfusion in patients with acute myocardial infarction presenting to acute care hospitals: an international perspective.

AIMS: To examine the extent of delay from initial hospital presentation to fibrinolytic therapy or primary percutaneous coronary intervention (PCI), characteristics associated with prolonged delay, and changes in delay patterns over time in patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: We analysed data from 5170 patients with STEMI enrolled in the Global Registry of Acute Coronary Events from 2003 to 2007. The median elapsed time from first hospital presentation to initiation of fibrinolysis was 30 min (interquartile range 18-60) and to primary PCI was 86 min (interquartile range 53-135). Over the years under study, there were no significant changes in delay times to treatment with either strategy. Geographic region was the strongest predictor of delay to initiation of fibrinolysis >30 min. Patient's transfer status and geographic location were strongly associated with delay to primary PCI. Patients treated in Europe were least likely to experience delay to fibrinolysis or primary PCI. CONCLUSION: These data suggest no improvements in delay times from hospital presentation to initiation of fibrinolysis or primary PCI during our study period. Geographic location and patient transfer were the strongest predictors of prolonged delay time, suggesting that improvements in modifiable healthcare system factors can shorten delay to reperfusion therapy even further.

Venous thromboembolism risk and prophylaxis in the acute care hospital setting (ENDORSE survey): findings in surgical patients.

OBJECTIVE: To evaluate venous thromboembolism (VTE) risk in patients who underwent a major operation, including the use of, and factors influencing, American College of Chest Physicians-recommended types of VTE prophylaxis. SUMMARY BACKGROUND DATA: The Epidemiologic International Day for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting (ENDORSE) survey, conducted in 358 hospitals in 32 countries, reported that globally, more than 40% of at-risk patients do not receive VTE prophylaxis. Limited data are available regarding VTE prophylaxis practices according to surgery type and patient characteristics. METHODS: Patients aged >or=18 years undergoing major surgery were included in this prespecified subanalysis. VTE risk and use of prophylaxis were determined from hospital medical records according to the 2004 American College of Chest Physicians guidelines. Multivariable analyses were performed to identify factors associated with VTE prophylaxis use. RESULTS: Of the 18,461 patients in ENDORSE who had undergone major surgery, 17,084 (92.5%) were at-risk for VTE and 10,638 (62.3%) received prophylaxis. Use of prophylaxis varied according to major surgery type from 86.0% for orthopedic surgery to 53.8% in urologic/gynecologic and 53.6% in other procedures. Major orthopedic surgery was most strongly associated with prophylaxis use (hip replacement: odds ratio 6.2, 95% confidence interval [CI] 5.0-7.6; knee replacement: odds ratio 5.9, 95% CI 4.6-7.8). CONCLUSIONS: The majority of surgical patients are at high-risk for VTE. Despite long-standing recognition of the high-risk for VTE in surgical patients, thromboprophylaxis remains underutilized.

Can an elderly woman's heart be too strong? Increased mortality with high versus normal ejection fraction after an acute coronary syndrome. The Global Registry of Acute Coronary Events.

BACKGROUND: Coronary artery disease is the leading cause of death in women. We sought to validate previous clinical experience in which we have observed that elderly women with a very high left ventricular ejection fraction (LVEF) are at increased risk of death compared with elderly women with acute coronary syndromes with a normal LVEF. METHODS: Data from 5,127 elderly female patients (age >65 years) enrolled in the Global Registry of Acute Coronary Events were collected. Patients were divided into 3 groups based on their LVEF: group I had a low ejection fraction (<55%), group II had a normal ejection fraction (55%-65%), and group III had a high ejection fraction (>65%). χ² test and multiple logistic regression analysis were performed. The main outcome measures were death in-hospital and death, stroke, rehospitalization, and myocardial infarction at 6-month follow-up. RESULTS: Hospital mortality was 12% in group I. Patients in group III were more likely to die in-hospital than those in group II (P = .003). Multivariable logistic regression showed that high ejection fraction was an independent predictor of hospital death (odds ratio [OR] 2.5, 95% CI [CI] 1.2-5.2, P = .01), 6-month death (OR 2.0, 95% CI 1.1-3.4, P = .01), and cardiac arrest/ventricular fibrillation (OR 2.5, 95% CI 1.2-5.0, P = .01) compared with the normal ejection fraction group. CONCLUSIONS: Having a very high LVEF (> 65%) is associated with worse survival and higher rates of sudden cardiac death than an LVEF considered to be in the reference range.

Predictors of 90-day readmission among patients with acute severe hypertension. The cross-sectional observational Studying the Treatment of Acute hyperTension (STAT) study.

BACKGROUND: Acute severe hypertension can be a life-threatening emergency. The objective of this study was to describe the frequency of rehospitalization for patients with acute severe hypertension and to identify clinical predictors of 90-day rehospitalization. METHODS: In this observational cross-sectional study, consecutive patients were identified retrospectively (January 2007 to April 2008) through uniform data query of hospital pharmacy databases in 25 hospitals in the United States. Eligible patients were > or =18 years old, had systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg, and had received intravenous antihypertensive therapy within 24 hours of presentation. Data were collected on patient demographics, medical history, laboratory findings, antihypertensive therapies, resource utilization, hospital-associated events, readmission within 90 days of hospital discharge, and death up to 6 months following the index hospitalization. RESULTS: The 90-day readmission rate was 35% (354/1,009) of patients discharged home alive and with known readmission status; 41% (144/354) were readmitted more than once. Of these 354 patients, readmission was for acute severe hypertension in 29% (n = 101). Eighteen (1.9%) patients died between hospital discharge and 90 days. Factors associated with readmission for hypertension included previous hospitalization for acute severe hypertension, history of drug abuse, and presenting with seizures or shortness of breath. Patients with an admitting diagnosis of hypertension were 94% more likely to be readmitted. CONCLUSIONS: More than one third of patients discharged home after hospitalization for severe hypertension were rehospitalized at least once within 90 days, more than one quarter for acute severe hypertension. Further studies are warranted to determine the impact of other variables on readmission rates and clinical outcomes in this population.

Unprotected left main revascularization in patients with acute coronary syndromes.

AIMS: In acute coronary syndromes (ACS), the optimal revascularization strategy for unprotected left main coronary disease (ULMCD) has been little studied. The objectives of the present study were to describe the practice of ULMCD revascularization in ACS patients and its evolution over an 8-year period, analyse the prognosis of this population and determine the effect of revascularization on outcome. METHODS AND RESULTS: Of 43 018 patients enrolled in the Global Registry of Acute Coronary Events (GRACE) between 2000 and 2007, 1799 had significant ULMCD and underwent percutaneous coronary intervention (PCI) alone (n = 514), coronary artery bypass graft (CABG) alone (n = 612), or no revascularization (n = 673). Mortality was 7.7% in hospital and 14% at 6 months. Over the 8-year study, the GRACE risk score remained constant, but there was a steady shift to more PCI than CABG over time. Patients undergoing PCI presented more frequently with ST-segment elevation myocardial infarction (STEMI), after cardiac arrest, or in cardiogenic shock; 48% of PCI patients underwent revascularization on the day of admission vs. 5.1% in the CABG group. After adjustment, revascularization was associated with an early hazard of hospital death vs. no revascularization, significant for PCI (hazard ratio (HR) 2.60, 95% confidence interval (CI) 1.62-4.18) but not for CABG (1.26, 0.72-2.22). From discharge to 6 months, both PCI (HR 0.45, 95% CI 0.23-0.85) and CABG (0.11, 0.04-0.28) were significantly associated with improved survival in comparison with an initial strategy of no revascularization. Coronary artery bypass graft revascularization was associated with a five-fold increase in stroke compared with the other two groups. CONCLUSION: Unprotected left main coronary disease in ACS is associated with high mortality, especially in patients with STEMI and/or haemodynamic or arrhythmic instability. Percutaneous coronary intervention is now the most common revascularization strategy and preferred in higher risk patients. Coronary artery bypass graft is often delayed and performed in lower risk patients, leading to good 6-month survival. The two approaches therefore appear complementary.

Identifying unreliable predictions in clinical risk models.

The ability to identify patients who are likely to have an adverse outcome is an essential component of good clinical care. Therefore, predictive risk stratification models play an important role in clinical decision making. Determining whether a given predictive model is suitable for clinical use usually involves evaluating the model's performance on large patient datasets using standard statistical measures of success (e.g., accuracy, discriminatory ability). However, as these metrics correspond to averages over patients who have a range of different characteristics, it is difficult to discern whether an individual prediction on a given patient should be trusted using these measures alone. In this paper, we introduce a new method for identifying patient subgroups where a predictive model is expected to be poor, thereby highlighting when a given prediction is misleading and should not be trusted. The resulting "unreliability score" can be computed for any clinical risk model and is suitable in the setting of large class imbalance, a situation often encountered in healthcare settings. Using data from more than 40,000 patients in the Global Registry of Acute Coronary Events (GRACE), we demonstrate that patients with high unreliability scores form a subgroup in which the predictive model has both decreased accuracy and decreased discriminatory ability.

RESTORE: A Prospective Multinational Registry of Patients with Genetically Confirmed Spinal Muscular Atrophy - Rationale and Study Design.

BACKGROUND: Dramatic improvements in spinal muscular atrophy (SMA) treatment have changed the prognosis for patients with this disease, leading to important new questions. Gathering representative, real-world data about the long-term efficacy and safety of emerging SMA interventions is essential to document their impact on patients and caregivers. OBJECTIVES: This registry will assess outcomes in patients with genetically confirmed SMA and provide information on the effectiveness and long-term safety of approved and emerging treatments. DESIGN AND METHODS: RESTORE is a prospective, multicenter, multinational observational registry. Patients will be managed according to usual clinical practice. Both newly recruitedSMAtreatment centers and sites involved in existing SMA registries, including iSMAC, Treat-NMD, French SMA Assistance Publique- Hôpitaux de Paris (AP-HP), Cure-SMA, SMArtCARE, will be eligible to participate; de novo; sites already participating in another registry may be included via consortium agreements. Data from patients enrolled in partnering registries will be shared with the RESTORE Registry and data for newly diagnosed patients will be added upon enrollment. Patients will be enrolled over a 5-year period and followed for 15 years or until death. Assessments will include SMA history and treatment, pulmonary, nutritional, and motor milestones, healthcare resource utilization, work productivity, activity impairment, adverse events, quality of life, caregiver burden, and survival.Status:Recruitment started in September 2018. As of January 3, 2020, 64 patients were enrolled at 25 participating sites. CONCLUSIONS: The RESTORE Registry has begun recruiting recently diagnosed patients with genetically confirmed SMA, enabling assessment of both short- and long-term patient outcomes.

Impact of in-hospital revascularization on survival in patients with non-ST-elevation acute coronary syndrome and congestive heart failure.

BACKGROUND: Patients with non-ST-elevation acute coronary syndrome complicated by congestive heart failure (CHF) have a poor prognosis. The aims of this study were to describe the use of revascularization in non-ST-elevation acute coronary syndrome and CHF and to analyze its impact on survival. METHODS AND RESULTS: In the Global Registry of Acute Coronary Events, 29 844 patients with non-ST-elevation acute coronary syndrome were enrolled at 120 hospitals in 14 countries between April 1999 and June 2007; 4953 had CHF at presentation. One fifth of the patients with CHF underwent revascularization versus 35% of those without CHF (P<0.001). Among CHF patients, revascularized patients had lower-risk baseline clinical characteristics than nonrevascularized patients and were more likely to receive evidence-based cardiac medications. Hospital rates were not affected by revascularization (adjusted hazard ratio 0.97, 95% confidence interval 0.72 to 1.33, P=0.87). Death from discharge to 6-month follow-up was lower in patients who underwent revascularization than in those who did not (odds ratio 0.51, 95% confidence interval 0.35 to 0.74, P<0.001). This difference persisted after adjustment for GRACE risk score variables, country, and propensity for revascularization (odds ratio 0.58, 95% confidence interval 0.40 to 0.85, P=0.005). When revascularization as a time-varying covariate was taken into account in an adjusted Cox regression, the rate of death was again lower in patients undergoing revascularization (hazard ratio 0.64, 95% confidence interval 0.45 to 0.93, P=0.02). CONCLUSIONS: This observational study suggests a low use of in-hospital revascularization in non-ST-elevation acute coronary syndrome patients with CHF. The consistent reduction in postdischarge death in revascularized patients suggests that broader application of revascularization in this high-risk group may be beneficial.