Comparison of migraine with left- versus right-sided headache: A cross-sectional study.

OBJECTIVE: The goal of this study was to clarify whether clinical differences exist between patients with migraine who experience headache that is typically left-sided ("left-migraine") versus right-sided ("right-migraine") during attacks. BACKGROUND: Migraine has been associated with unilateral headache for millennia and remains a supportive trait for the clinical diagnosis of migraine of the International Classification of Headache Disorders. It is currently unknown why headache in migraine is commonly unilateral, and whether headache-sidedness is associated with other clinical features. METHODS: This is a cross-sectional study comparing left- versus right-migraine using all available intake questionnaires of new patients evaluated at an academic tertiary headache center over a 20-year period. Eligibility was based on patient written responses indicating the typical location of headache during attacks. In our analyses, the side of headache (left or right) was the predictor variable. The outcomes included various migraine characteristics and psychiatric comorbidities. RESULTS: We identified 6527 patients with migraine, of which 340 met study eligibility criteria. Of these, 48.8% (166/340) had left migraine, and 51.2% (174/340) had right migraine. When comparing patients with left- versus right-migraine, patients with left migraine experienced 3.6 fewer headache-free days (95% confidence interval [CI] 1.3-5.9; p = 0.002) and 2.4 more severe headache days (95% CI 0.8-4.1; p = 0.004) in the previous 4 weeks. No significant differences in age, sex, handedness, migraine characteristics, or psychiatric comorbidities were identified between the two groups. CONCLUSIONS: Patients with migraine with typically left-sided headache during attacks reported a higher burden of headache frequency and severity than those with typically right-sided headache during attacks. These findings may have implications for our understanding of migraine pathophysiology, treatment, and clinical trial design.

Imaging modality for left ventricular ejection fraction estimation and effect of implantable cardioverter-defibrillator on mortality in patients with heart failure.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) improve outcomes in patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≤35%. Less is known about whether outcomes varied between the 2 noninvasive imaging modalities used to estimate LVEF-2-dimensional echocardiography (2DE) and multigated acquisition radionuclide ventriculography (MUGA)-which use different principles (geometric vs count-based, respectively). OBJECTIVE: The purpose of this study was to examine whether the effect of ICD on mortality in patients with HF and LVEF ≤35% varied on the basis of LVEF measured by 2DE or MUGA. METHODS: Of the 2521 patients with HF with LVEF ≤35% in the Sudden Cardiac Death in Heart Failure Trial, 1676 (66%) were randomized to either placebo or ICD, of whom 1386 (83%) had LVEF measured by 2DE (n = 971) or MUGA (n = 415). Hazard ratios (HRs) and 97.5% confidence intervals (CIs) for mortality associated with ICD were estimated overall, checking for interaction, and within the 2 imaging subgroups. RESULTS: Of the 1386 patients in the present analysis, all-cause mortality occurred in 23.1% (160 of 692) and 29.7% (206 of 694) of patients randomized to ICD or placebo, respectively (HR 0.77; 97.5% CI 0.61-0.97), which is consistent with that in 1676 patients in the original report. HRs (97.5% CIs) for all-cause mortality in the 2DE and MUGA subgroups were 0.79 (0.60-1.04) and 0.72 (0.46-1.11), respectively (P = .693 for interaction). Similar associations were observed for cardiac and arrhythmic mortalities. CONCLUSION: We found no evidence that in patients with HF and LVEF ≤35%, the effect of ICD on mortality varied by the noninvasive imaging method used to measure LVEF.

Direct Comparison of Outcomes After Transcatheter Aortic Valve Replacement in Veterans and Non-Veterans Using the Transcatheter Valve Therapy Registry.

OBJECTIVES: This study aims to compare veterans and non-veterans undergoing transcatheter aortic valve replacement (TAVR) using data from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) registry. METHODS: Patients undergoing TAVR at George Washington University (GWU) and veterans treated at Washington DC Veterans Affairs Medical Center (VAMC) who underwent TAVR at GWU from 2014-2020 were included. All patients were reported in the TVT registry. Emergency and valve-in-valve TAVR were excluded. Cohorts were divided based on veteran status. Operators were the same for both groups. Outcomes were compared at 30 days and 1 year. The primary outcome was mortality and secondary outcomes were morbidity metrics. RESULTS: A total of 299 patients (91 veterans, 208 non-veterans) were included. Veterans had higher rates of hypertension (87.9% vs 77.9%; P=.04), diabetes (46.7% vs 28.9%; P<.01), and lung disease (2.4% vs 11.0%; P<.001). Outcomes were not significantly different between veterans and non-veterans, including 30-day mortality (0% vs 2.9%, respectively; P=.18), 1-year mortality (9.8% vs 10.7%, respectively; P=.61), stroke incidence (0% vs 2.5%, respectively; P=.73), median intensive care unit stay (24 hours in both groups), and overall hospital stay (2 days in both groups). CONCLUSIONS: The affiliation between a VAMC and an academic medical center allowed for direct comparison between veterans and non-veterans undergoing TAVR by the same operators using the TVT registry. Despite significantly higher rates of comorbidities, veterans had equivalent outcomes compared with non-veterans. This may be in part due to the comprehensive care that veterans receive in the VAMC and this institution's integrated heart center team.

Multi-parametric approach to predict prosthetic valve size using CMR and clinical data: insights from SAVR.

The purpose of this investigation was to characterize the CMR and clinical parameters that correlate to prosthetic valve size (PVS) determined at SAVR and develop a multi-parametric model to predict PVS. Sixty-two subjects were included. Linear/area measurements of the aortic annulus were performed on cine CMR images in systole/diastole on long/short axis (SAX) views. Clinical parameters (age, habitus, valve lesion, valve morphology) were recorded. PVS determined intraoperatively was the reference value. Data were analyzed using Spearman correlation. A prediction model combining imaging and clinical parameters was generated. Imaging parameters had moderate to moderately strong correlation to PVS with the highest correlations from systolic SAX mean diameter (r = 0.73, p < 0.0001) and diastolic SAX area (r = 0.73, p < 0.0001). Age was negatively correlated to PVS (r = - 0.47, p = 0.0001). Weight was weakly correlated to PVS (r = 0.27, p = 0.032). AI and bicuspid valve were not predictors of PVS. A model combining clinical and imaging parameters had high accuracy in predicting PVS (R2 = 0.61). Model predicted mean PVS was 23.3 mm (SD 1.1); actual mean PVS was 23.3 mm (SD 1.3). The Spearman r of the model (0.80, 95% CI 0.683-0.874) was significantly higher than systolic SAX area (0.68, 95% CI 0.516-0.795). Clinical parameters like age and habitus impact PVS; valve lesion/morphology do not. A multi-parametric model demonstrated high accuracy in predicting PVS and was superior to a single imaging parameter. A multi-parametric approach to device sizing may have future application in TAVR.

Long-Term Outcomes of Coronary Artery Bypass Grafting in Veterans with Ischemic Cardiomyopathy.

BACKGROUND: The Surgical Treatment for Ischemic Heart Failure (STICH) trial showed that surgical revascularization in ischemic cardiomyopathy (ICM) patients improves long-term mortality compared with medical treatment alone. This study examines how veterans with ICM undergoing revascularization fare against patients without ICM; it also examines the outcomes in the veteran population. METHODS: This is a retrospective review of a single-center database. From 2000 to 2018, 1,461 patients underwent isolated coronary artery bypass grafting (CABG). Two-hundred-one patients with an ejection fraction less than 35% were classified as the ICM cohort. The primary outcome was mortality. Secondary outcomes included postoperative complications. Subgroup analysis was performed within the ICM cohort comparing off-pump CABG (OPCAB) versus on-pump CABG (ONCAB). RESULTS: ICM patients had a higher incidence of myocardial infarction (MI), diabetes, chronic kidney disease (CKD), and preoperative intra-aortic balloon pump (IABP) use. The non-ICM cohort was more functionally independent. OPCAB was performed in 80.1% of ICM and 66.3% of non-ICM cohorts. There was no statistical difference between ICM and non-ICM cohorts in 30-day mortality (OR 1.94[0.79 - 4.75], P = .15). The ICM cohort had an increased 5-year mortality (OR 1.75[1.14 - 2.69], P = .01) and 10-year mortality (OR 1.71[1.09 - 2.67], P = .02). The ICM cohort showed improved, although not statistically significant, short-term mortality with OPCAB compared with ONCAB (3.1% versus 12.5%, OR 0.31[0.05 - 1.82], P = .20). CONCLUSION: Veterans with ICM undergoing CABG demonstrated similar short-term survival compared with non-ICM veterans. The long-term survival in the ICM cohort still is inferior to patients without ICM. There is a trend toward improved short-term survival in patients with ICM undergoing OPCAB.

Influence of Age on Cardiac Surgery Outcomes in United States Veterans.

OBJECTIVE: Heart disease is still the leading cause of death for both men and women in the United States, and the rate of cardiovascular disease in veterans is even higher than in civilians. This study examines age-related outcomes for veterans undergoing cardiac surgeries at a single institution. METHODS: We included all veterans undergoing coronary artery bypass grafting (CABG) and/or valve surgery between 1997 to 2017 at a single Veterans Affairs (VA) medical center. We stratified this cohort into 4 age groups: ≤59 years old, 60-69 years old, 70-79 years old, and ≥80 years old. Outcomes in age groups were compared using standard statistical methods with the ≤59 years old group as reference. RESULTS: A total of 2,301 patients underwent open cardiac procedures at our institution. The frequency of simultaneous CABG and valve operations increased with age. Usage of cardiopulmonary bypass versus off-pump CABG and operative time was not associated with age. Increased pulmonary and renal complications as well as rates of postoperative arrhythmias all were associated with increasing age. There was no statistically significant difference in 30-day mortality. However, multivariable analysis adjusted for covariates showed all-cause mortality significantly was increased with older age groups (aHR ≥80 years old: 2.94 [2.07-4.17], P < .01; aHR 70-79 years old: 2.15 [1.63-2.83], P < 0.01, with ≤59 years old as reference). CONCLUSIONS: Older patients may have comparable perioperative mortality as their younger counterparts. However, age still is a significant predictor of all-cause mortality, pulmonary and renal complications, and postoperative arrhythmia, and should be considered as a major factor in preoperative risk assessment.

B-type Natriuretic Peptide Predicts Morbidity and Long-Term Mortality in Coronary Artery Bypass Grafting and Valve Surgery.

OBJECTIVE: To assess whether B-type natriuretic peptide (BNP) levels are a useful predictor of morbidity and mortality as well as long-term survival in patients after coronary artery bypass grafting (CABG) and valve surgery. METHODS: A retrospective review of CABG and/or valve surgery patients from 2012 to 2015 at a single center was conducted. A total of 432 patients were identified (CABG, 295 patients; valve, 82 patients; and CABG + valve, 55 patients). B-type natriuretic peptide levels were divided into quartiles (Q1-Q4). Mortality data were available for up to 3.4 years after surgery. RESULTS: B-type natriuretic peptide quartile was independently associated with any complication on multivariate analysis. Patients in Q4 were at highest risk (adjusted odds ratio, 3.81; P = 0.047 vs Q1). There was a significant association between BNP quartile and time to death (log-rank χ, 8.30; P = 0.04) with greatest association 9 months postoperatively. B-type natriuretic peptide quartile was significantly associated with time to death in Cox regression in Q2 (hazard ratio [HR], 3.73 (1.04-13.44); P = 0.044) and Q4 (HR, 4.33 (1.14-16.44); P = 0.031). Q3 also had a higher risk of death (HR, 3.5 vs Q1); however, this was only significant at a trend level (P = 0.06). Using a risk model generated from logistic regression, we determined that the highest risk group had relative risk of complications 30 times higher than the lowest risk group. CONCLUSIONS: B-type natriuretic peptide levels are an independent predictor of morbidity after CABG and/or valve surgery regardless of type of procedure or on/off bypass usage. B-type natriuretic peptide levels also correlate with time to death, highlighting the need for sustained follow-up and heart failure management to improve survival in patients with elevated BNP levels presenting for all cardiac surgery.

Progress at the Intersection of Patient Safety and Medical Liability: Insights from the AHRQ Patient Safety and Medical Liability Demonstration Program.

OBJECTIVE: To identify lessons learned from the experience of the Agency for Healthcare Research and Quality (AHRQ) Patient Safety and Medical Liability (PSML) Demonstration Program. DATA SOURCES/STUDY SETTING: On September 9, 2009, President Obama directed the Secretary of Health and Human Services to authorize demonstration projects that put "patient safety first" with the intent of reducing preventable adverse outcomes and stemming liability costs. Seven demonstration projects received 3 years of funding from AHRQ in the summer of 2010, and the program formally came to a close in June 2015. STUDY DESIGN: The seven grantees implemented complex, broad-ranging innovations addressing both patient safety and medical liability in "real-world" contexts. Some projects featured novel approaches, while others implemented adaptations of existing models. Each project was funded by AHRQ to collect data on the impact of its interventions. In addition, AHRQ funded a cross-cutting qualitative evaluation focused on lessons learned in implementing PSML interventions. DATA COLLECTION/EXTRACTION METHODS: Site visits and follow-up interviews supplemented with material abstracted from formal project reports to AHRQ. PRINCIPAL FINDINGS: The PSML demonstration projects focused on three broad approaches: (1) improving communication around adverse events through disclosure and resolution programs; (2) preventing harm through implementation of clinical "best practices"; and (3) exploring alternative methods of settling claims. Although the demonstration contributed to accumulating evidence that these kinds of interventions can positively affect outcomes, there is also evidence to suggest that these interventions can be difficult to scale. CONCLUSIONS: In addition to producing at least preliminary positive outcomes, the demonstration also lends credence to the idea that targeted interventions that improve some aspect of patient safety or malpractice performance may also contribute more broadly to institutional culture and the alignment of all parties around reducing risk and preventing harm. However, more empirical work needs to be carried out to quantify the effect of such interventions.

Chronic Type A Aortic Dissection: Two Cases and a Review of Current Management Strategies.

Stanford Type A aortic dissection is a rapidly progressing disease process that is often fatal without emergent surgical repair. A small proportion of Type A dissections go undiagnosed in the acute phase and are found upon delayed presentation of symptoms or incidentally. These chronic lesions may have a distinct natural history that may have a better prognosis and could potentially be managed differently then those presenting acutely. The method of repair depends on location and extent of the false lumen, as well as involvement of critical structures and branch arteries. Surgical repair techniques similar to those employed for acute dissection management are currently first-line therapy for chronic cases that involve the aortic valve, sinuses of Valsalva, coronary arteries, and supra-aortic branch arteries. In patients with high-risk for surgery, endovascular repairs have been successful, and active development of delivery systems and grafts will continue to enhance outcomes. We present two cases of chronic Type A aortic dissection and review the current literature.

Long-term Effects of Off-Pump Coronary Bypass Versus Conventional Coronary Bypass Grafting on Renal Function.

OBJECTIVE: This study aimed to evaluate the short- and long-term effects of conventional on-pump coronary bypass grafting (cCABG) compared with off-pump coronary artery bypass (OPCAB) on renal function. METHODS: A retrospective review of patients undergoing coronary bypass grafting from 2004 through 2013 at a single center was conducted. Preoperative renal function, perioperative acute kidney injury, and long-term glomerular filtration were evaluated. Multivariable analyses were used to determine factors contributing to short- and long-term renal impairment. RESULTS: A total of 234 patients underwent cCABG, and 582 underwent OPCAB. Patients undergoing OPCAB were significantly older, had greater preoperative renal dysfunction, had greater functional dependence, and took more hypertension medications. Multivariable analyses found that 30-day acute kidney injury was an independent risk factor for a 10% decline in glomerular filtration rate at 1 and 5 years (P < 0.0001 and 0.002, respectively). However, the use of cardiopulmonary bypass was not found to influence long-term renal function (P = 0.78 at 1 year, P = 0.76 at 5 years). The percentage of patients experiencing a 10% drop in renal function from baseline at 1 year (33% OPCAB, 35% cCABG; P = 0.73) and 5 years (16% OPCAB, 16% cCABG; P = 0.93) were not significantly different. Independent predictors of acute kidney injury included baseline kidney function (P = 0.04) and age (P < 0.0001), whereas cardiopulmonary bypass did not affect the incidence (P = 0.17). A propensity-matched analysis confirmed these findings. CONCLUSIONS: Acute kidney injury is a risk factor for long-term renal dysfunction after either bypass method and was not greater after cCABG compared with OPCAB. Patients undergoing OPCAB did not experience greater decrease in long-term kidney function despite having worse baseline kidney function.

Authorities and Mechanisms for Purchased Care at the Department of Veterans Affairs.

The Veterans Access, Choice, and Accountability Act of 2014 addressed the need for access to timely, high-quality health care for veterans. Section 201 of the legislation called for an independent assessment of various aspects of veterans' health care. The RAND Corporation was tasked with an assessment of the authorities and mechanisms by which the Department of Veterans Affairs (VA) pays for health care services from non-VA providers. Purchased care accounted for 10 percent, or around $5.6 billion, of VA's health care budget in fiscal year 2014, and the amount of care purchased from outside VA is growing rapidly. VA purchases non-VA care through an array of programs, each with different payment processes and eligibility requirements for veterans and outside providers. A review and analysis of statutes, regulations, legislation, and literature on VA purchased care, along with interviews with expert stakeholders, a survey of VA medical facilities, and an evaluation of local-level policy documents revealed that VA's purchased care system is complex and decentralized. Inconsistencies in procedures, unclear goals, and a lack of cohesive strategy for purchased care could have ramifications for veterans' access to care. Adding to the complexity of VA's purchased care system is a lack of systematic data collection on access to and quality of care provided through VA's purchased care programs. The analysis also explored concepts of "episodes of care" and their implications for purchased care by VA.

Coronary Artery Bypass Grafting During Acute Coronary Syndrome: Outcomes and Comparison of Off-Pump to Conventional Coronary Artery Bypass Grafting at a Veteran Affairs Hospital.

OBJECTIVE: The management of acute coronary syndrome (ACS) has evolved dramatically over the last 50 years. Currently, management includes a multidisciplinary approach potentially including catheter-based therapy, surgery, or purely medical management. Where surgical therapy is indicated, data regarding long-term outcomes are limited. In particular, little data exist regarding on-pump (conventional coronary artery bypass grafting, cCABG) versus off-pump (OPCABG) outcomes for this group. METHODS: A retrospective review of prospectively collected data was undertaken. Patients undergoing isolated CABG from January 2000 to December 2011 with ACS were identified (n = 271); non-ACS patients (n = 854) were established as a control. Data were analyzed with a χ or a t test, where appropriate. Survival was compared using Kaplan-Meier analysis and Cox proportional hazards model. RESULTS: Thirty-day mortality between the ACS and the control groups was similar; however, long-term mortality was worse for the ACS group (P = 0.032; median follow-up, 5.5 years). Length of stay and composite morbidity were higher in the ACS group (P < 0.01). Subgroup analysis of ACS patients (OPCABG vs cCABG) demonstrated worse preoperative comorbidities in the OPCABG group, but similar 30-day and long-term mortality. However, the cCABG group had higher rates of reoperation (P = 0.034) and longer length of stay (P = 0.017) and operative time (P < 0.0001). Cox proportional hazards model was applied. Risk factors for the non-ACS cohort included age, diabetes, OPCABG, and ACS (P < 0.05). Among the ACS cohort, only age remained a statistically significant factor (P < 0.0001). CONCLUSIONS: ACS appears to negatively impact long-term, but not short-term, mortality. Within the ACS group, OPCABG compares favorably to cCABG in the long-term and also improves short-term morbidity.

Using cardiac magnetic resonance imaging to evaluate cardiac function and predict outcomes in patients with valvular heart disease.

OBJECTIVE: In valvular heart disease, elevated left atrial and pulmonary pressures contribute to right ventricular strain and, ultimately, right ventricle failure. Elevated pulmonary artery (PAP) and left ventricular end diastolic pressures are used as markers of right ventricle dysfunction and correlate with poor outcomes. Using cardiac magnetic resonance imaging (CMR), it is possible to directly quantify both left and right ventricular ejection function (LVEF and RVEF), and here, we compare CMR with traditional markers as outcome predictors. METHODS: A retrospective review of prospectively collected data was performed for patients from January 2004 to February 2008 at a single center (n = 103). Patients were divided into those receiving CMR (n = 56) and those receiving only catheterization (n = 47). Univariate and multivariate logistic regression models were applied to determine predictors of mortality. Finally, predictive models for mortality using PAP, mean PAP, and left ventricular end diastolic pressure were compared to models using LVEF and RVEF obtained from CMR. RESULTS: Preoperative average CMR LVEF and RVEF were 57% and 46%, respectively. Only age emerged as an isolated predictor of mortality (P = 0.01) within the univariate models. Stepwise regression models were created using the catheterization or CMR data. When compared, the CMR model has a slightly better R, c (prediction accuracy), and sensitivity/specificity (0.22 vs 0.28, 0.77 vs 0.82, and 0.63/0.62 vs 0.69/0.64, respectively). CONCLUSIONS: Within our population, LVEF and RVEF predict mortality as least as well as traditional catheterization values. Additionally, CMR may identify of elevated PAPs caused by right ventricle dysfunction and those due to other causes, allowing these other causes to be addressed preoperatively.

The effect of malpractice reform on emergency department care.

BACKGROUND: Many believe that fear of malpractice lawsuits drives physicians to order otherwise unnecessary care and that legal reforms could reduce such wasteful spending. Emergency physicians practice in an information-poor, resource-rich environment that may lend itself to costly defensive practice. Three states, Texas (in 2003), Georgia (in 2005), and South Carolina (in 2005), enacted legislation that changed the malpractice standard for emergency care to gross negligence. We investigated whether these substantial reforms changed practice. METHODS: Using a 5% random sample of Medicare fee-for-service beneficiaries, we identified all emergency department visits to hospitals in the three reform states and in neighboring (control) states from 1997 through 2011. Using a quasi-experimental design, we compared patient-level outcomes, before and after legislation, in reform states and control states. We controlled for characteristics of the patients, time-invariant hospital characteristics, and temporal trends. Outcomes were policy-attributable changes in the use of computed tomography (CT) or magnetic resonance imaging (MRI), per-visit emergency department charges, and the rate of hospital admissions. RESULTS: For eight of the nine state-outcome combinations tested, no policy-attributable reduction in the intensity of care was detected. We found no reduction in the rates of CT or MRI utilization or hospital admission in any of the three reform states and no reduction in charges in Texas or South Carolina. In Georgia, reform was associated with a 3.6% reduction (95% confidence interval, 0.9 to 6.2) in per-visit emergency department charges. CONCLUSIONS: Legislation that substantially changed the malpractice standard for emergency physicians in three states had little effect on the intensity of practice, as measured by imaging rates, average charges, or hospital admission rates. (Funded by the Veterans Affairs Office of Academic Affiliations and others.).

Multiple patient safety events within a single hospitalization: a national profile in US hospitals.

The objective was to examine co-occurrence of iatrogenic events in US hospitals. Using Agency for Healthcare Research and Quality patient safety indicators (PSIs), the authors defined multiple patient safety events (MPSEs) as the occurrence of multiple PSIs during a single hospitalization. The National Inpatient Sample was analyzed to estimate the national prevalence of MPSEs, risk factors for MPSEs, and the average length of stay and average hospital charges associated with MPSEs. MPSEs occurred in approximately 1 in every 1000 hospitalizations, affecting more than 30 000 patients in 2004. Significant risk factors for MPSEs include age, black race, Medicare coverage, and treatment at urban teaching hospitals. Compared with all admissions, the average length of stay for MPSE admissions was 4 times longer, and the average charge for MPSE admissions was 8 times greater. Despite the low prevalence, MPSEs affect large numbers of hospital patients in America. MPSEs have distinct characteristics and are far more resource intensive than hospital admissions generally.

Speckle tracking-derived mitral annular velocities predict mortality in patients with acute coronary syndrome.

BACKGROUND: Myocardial ischemia can impair myocardial relaxation and result in increased left ventricular (LV) diastolic pressure. Noninvasive measurements of mitral annular velocities have been used to evaluate LV diastolic pressure. We sought to determine whether mitral annular velocities, derived from novel speckle tracking echocardiography (STE), could predict mortality in patients with acute coronary syndrome (ACS). METHODS: A total of 246 patients with ACS were retrospectively studied. STE was analyzed offline with the sample volume placed on septal, lateral, inferior, and anterior mitral annulus. Peak early (E') and late (A') diastolic velocities of the mitral annulus were measured and averaged from the four regions. Peak early diastolic mitral inflow velocity (E) was obtained using pulsed-wave Doppler. RESULTS: Lower E' (P = 0.03), lower A' (P = 0.001), higher E'/A' ratio (P = 0.007), and higher E/E' ratio (P = 0.003) were independently associated with increased risk of death with adjustment for clinical and echocardiographic variables over the follow-up period of 21 months. The optimal cutoff value of E/E' ratio derived from the receiver operating characteristic analysis for predicting death was 30 (area under the curve = 0.65). E/E' ratio greater than 30 was predictive of death in univariate (HR, 2.40; CI, 1.42-4.06; P = 0.001) and multivariate (adjusted HR, 1.91; CI, 1.09-3.32; P = 0.02) models. CONCLUSION: The measurements of mitral annular velocities by STE are predictive of mortality in patients with ACS.

Conservative versus liberal red cell transfusion in acute myocardial infarction (the CRIT Randomized Pilot Study).

Red blood cell transfusion is common in patients with acute myocardial infarction (AMI). However, observational data suggest that this practice may be associated with worse clinical outcomes and data from clinical trials are lacking in this population. We conducted a prospective multicenter randomized pilot trial in which 45 patients with AMI and a hematocrit level ≤30% were randomized to a liberal (transfuse when hematocrit <30% to maintain 30% to 33%) or a conservative (transfuse when hematocrit <24% to maintain 24% to 27%) transfusion strategy. Baseline hematocrit was similar in those in the liberal and conservative arms (26.9% vs 27.5%, p = 0.4). Average daily hematocrits were 30.6% in the liberal arm and 27.9% in the conservative arm, a difference of 2.7% (p <0.001). More patients in the liberal arm than in the conservative arm were transfused (100% vs 54%, p <0.001) and the average number of units transfused per patient tended to be higher in the liberal arm than in the conservative arm (2.5 vs 1.6, p = 0.07). The primary clinical safety measurement of in-hospital death, recurrent MI, or new or worsening congestive heart failure occurred in 8 patients in the liberal arm and 3 in the conservative arm (38% vs 13%, p = 0.046). In conclusion, compared to a conservative transfusion strategy, treating anemic patients with AMI according to a liberal transfusion strategy results in more patients receiving transfusions and higher hematocrit levels. However, this may be associated with worse clinical outcomes. A large-scale definitive trial addressing this issue is urgently required.

Is Better Patient Safety Associated with Less Malpractice Activity?: Evidence from California.

In principle, efforts to improve patient safety, if they are successful, should lead to reductions in claims of medical malpractice. In practice, however, this has not yet been systematically demonstrated to be so. The authors examined the relationship between safety outcomes in hospitals and malpractice claiming against providers, using administrative data and measures for California from 2001 to 2005. They found that decreases in the county-level frequency of adverse safety outcomes were positively and significantly associated with decreases in the volume of malpractice claims, as captured by records from four of the largest malpractice insurers in the state. This result suggests that policy options that improve patient safety may offer a new avenue for reducing malpractice pressure on physicians, at the same time that they improve clinical outcomes.

Medical malpractice and new devices: defining an elusive standard of care.

Early adoption of a new medical device by a physician carries with it some degree of malpractice liability risk. The legal standard for malpractice varies from place to place, but generally requires an evaluation of the physician's conduct either against that of a hypothetical "reasonable physician," or else against professional custom. Where the use of a new device involves a significant departure from traditional modalities of care, and a bad clinical result follows, questions may arise about whether the legal standard for malpractice has been violated. We suggest that a liberal interpretation of the malpractice standard of care is appropriate, and even necessary to avoid the potential for perverse disincentives to technical innovation in medicine.