DIAMondback Atherectomy With OCT Visualization for Calcified PAD Lesions (DIAMOCT-PAD Study).

OBJECTIVE: In this study, we aimed to describe the immediate and long-term vascular effects of OAS in patients with peripheral arterial disease (PAD) and moderate to severely calcified lesions. BACKGROUND: Debulking the calcified atherosclerotic plaque with the orbital atherectomy system (OAS) can potentially enhance vessel compliance and increase the chance of reaching a desirable angioplasty result. METHODS: A total of 7 patients were evaluated both at baseline and at 6-month follow-up. Following a diagnostic peripheral angiogram, patients with significant SFA disease had a baseline intravascular optical coherence tomography (IV-OCT) and the lesion was treated with OAS. Repeat IV-OCT was performed after atherectomy and after drug-coated balloon, if used. Patients were also evaluated with angiography and IV-OCT imaging at their 6-month follow-up. RESULTS: The majority of tissue removed was fibrous tissue. During follow-up, luminal volume increased for 4 of the 7 patients from baseline to 6-month follow-up and decreased in 3 patients. On average there was a 6% increase of luminal volume (P<.01 compared with baseline). A recent virtual histology algorithm was used for automatic classification of IV-OCT images unaided by any reader. The algorithm used convolutional neural networks to identify regions as either calcium, fibrous, or lipid plaque, and it agreed with an expert reader 82% of the time. CONCLUSION: To the best of our knowledge, the current report is the first to describe vascular effects of OAS in medial calcified lesions immediately after and at follow-up using IV-OCT in patients with severe PAD.

Assessment of Vascular Patency and Inflammation with Intravascular Optical Coherence Tomography in Patients with Superficial Femoral Artery Disease Treated with Zilver PTX Stents.

PURPOSE: Zilver PTX nitinol self-expanding drug-eluting stent with paclitaxel coating is effective for treatment of superficial femoral artery (SFA) disease. However, as with any stent, it induces a measure of vascular inflammatory response. The current clinical trial (NCT02734836) aimed to assess vascular patency, remodeling, and inflammatory markers with intravascular optical coherence tomography (OCT) in patients with SFA disease treated with Zilver PTX stents. METHODS: Serial OCT examinations were performed in 13 patients at baseline and 12-month follow-up. Variables evaluated included neointimal area, luminal narrowing, thrombus area, stent expansion as well as measures of inflammation including, peri-strut low-intensity area (PLIA), macrophage arc, neovascularization, stent strut apposition and coverage. RESULTS: Percentage of malapposed struts decreased from 10.3 ±â€¯7.9% post-intervention to 1.1 ±â€¯2.2% at 12-month follow-up, but one patient showed late-acquired stent malapposition (LASM). The percent of uncovered struts at follow-up was 3.0 ±â€¯4.5%. Average expansion of stent cross-sectional area from baseline to follow-up was 35 ±â€¯19%. The average neointimal area was 7.8 ±â€¯3.8 mm2. Maximal luminal narrowing was 61.1 ±â€¯25.0%, and average luminal narrowing was 35.4 ±â€¯18.2%. Average peri-strut low-intensity area (PLIA) per strut was 0.017 ±â€¯0.018 mm2. Average number of neovessels per mm of stent was 0.138 ±â€¯0.181. Average macrophage angle per frame at follow-up was 7 ±â€¯11°. Average thrombus area at follow-up was 0.0093 ±â€¯0.0184 mm2. CONCLUSION: At 12-month follow-up, OCT analysis of Zilver PTX stent shows outward remodeling and minimal neointimal growth, but evidence of inflammation including PLIA, neovessels, thrombus and macrophages. SUMMARY: Thirteen patients with PAD had paclitaxel-coated stents implanted in their SFAs and were then imaged with OCT at baseline and 12-month follow-up. OCT proxy metrics of inflammation were quantified.

Reflections on the judicialization of the right to health and its implications in the SUS. / Reflexões sobre a judicialização do direito à saúdee suas implicações no SUS.

This paper presents the issue of judicialization of the right to health in Brazil. Data from the National Council of Justice evidence a substantial increase in the number of lawsuits concerning the right to health. We emphasize that the national doctrine exhaustively discusses ways to make the authority more effective, but it does not, as a general rule, discuss the economic aspect of health judicialization. Using the concept of opportunity cost extracted from economics science, it is shown that the judge, by deferring the lawsuit formulated by the plaintiff, automatically forces the Executive Branch to reduce the scope of other policies to generate resources to meet the court order. In specific contexts, this setting ends up favoring individual rights at the expense of the collective rights of SUS users, in violation of the principle of isonomy and efficiency. Finally, the case of the judicialization promoted by the hemophiliac patients in the Federal District is shown as a way of evidencing, at the factual level, the consequences of judicialization in the SUS policies.

Apresenta-se a questão da judicialização do direito à saúde no Brasil, por meio da análise de estatísticas governamentais e revisão bibliográfica. Demonstra-se, a partir de dados do Conselho Nacional de Justiça, a existência de um incremento substancial no número de ações judiciais tratando do direito à saúde. Ressalta-se que a doutrina nacional discute efusivamente meios de tornar a prestação jurisdicional mais efetiva, mas não se discute, via de regra, o aspecto econômico da judicialização na saúde. Utilizando-se o conceito de custo de oportunidade, extraído da ciência da Economia, passa-se a demonstrar que o magistrado, ao deferir o pleito formulado pelo autor da ação judicial, automaticamente força o Poder Executivo a reduzir o escopo de outras políticas para gerar recursos visando custear o cumprimento da decisão judicial. Tal cenário, em determinados contextos, acaba por privilegiar o direito individual à custa dos da coletividade usuária do SUS, em ofensa ao princípio da isonomia e da eficiência. Por fim, apresenta-se o caso da judicialização promovida pelos pacientes hemofílicos no Distrito Federal como uma forma de demonstrar, no plano fático, as consequências da judicialização nas políticas do SUS.

Reflexões sobre a judicialização do direito à saúdee suas implicações no SUS / Reflections on the judicialization of the right to health and its implications in the SUS

Resumo Apresenta-se a questão da judicialização do direito à saúde no Brasil, por meio da análise de estatísticas governamentais e revisão bibliográfica. Demonstra-se, a partir de dados do Conselho Nacional de Justiça, a existência de um incremento substancial no número de ações judiciais tratando do direito à saúde. Ressalta-se que a doutrina nacional discute efusivamente meios de tornar a prestação jurisdicional mais efetiva, mas não se discute, via de regra, o aspecto econômico da judicialização na saúde. Utilizando-se o conceito de custo de oportunidade, extraído da ciência da Economia, passa-se a demonstrar que o magistrado, ao deferir o pleito formulado pelo autor da ação judicial, automaticamente força o Poder Executivo a reduzir o escopo de outras políticas para gerar recursos visando custear o cumprimento da decisão judicial. Tal cenário, em determinados contextos, acaba por privilegiar o direito individual à custa dos da coletividade usuária do SUS, em ofensa ao princípio da isonomia e da eficiência. Por fim, apresenta-se o caso da judicialização promovida pelos pacientes hemofílicos no Distrito Federal como uma forma de demonstrar, no plano fático, as consequências da judicialização nas políticas do SUS.

Abstract This paper presents the issue of judicialization of the right to health in Brazil. Data from the National Council of Justice evidence a substantial increase in the number of lawsuits concerning the right to health. We emphasize that the national doctrine exhaustively discusses ways to make the authority more effective, but it does not, as a general rule, discuss the economic aspect of health judicialization. Using the concept of opportunity cost extracted from economics science, it is shown that the judge, by deferring the lawsuit formulated by the plaintiff, automatically forces the Executive Branch to reduce the scope of other policies to generate resources to meet the court order. In specific contexts, this setting ends up favoring individual rights at the expense of the collective rights of SUS users, in violation of the principle of isonomy and efficiency. Finally, the case of the judicialization promoted by the hemophiliac patients in the Federal District is shown as a way of evidencing, at the factual level, the consequences of judicialization in the SUS policies.

Endovascular Therapy for Acute Ischemic Stroke: A Comprehensive Review of Current Status.

Stroke remains among the leading causes of disability and death worldwide. Fibrinolytic therapy is associated with poor patency and functional outcomes. Recently, multiple randomized trials have been published that have consolidated the role of endovascular therapy for ischemic stroke due to large vessel occlusion in the anterior cerebral circulation. This manuscript reviews the current understanding of the endovascular management of acute stroke including technical aspects and current evidence base.

Same versus next day discharge after elective transradial PCI: The RAdial SAme Day DischArge after PCI trial. (The RASADDA-PCI trial).

BACKGROUND AND PURPOSE: Transradial percutaneous coronary intervention (TR-PCI) has been increasingly popular over the last decade in the US. Previous studies have shown that same-day (SD) discharge after elective PCI is as safe as overnight (ON) observation. Our study was performed to assess the clinical and financial impact of early discharge in patients undergoing TR-PCI. METHODS: This is a single center registry of patients undergoing elective TR-PCI. Timing of discharge was determined by the treating physician. (Groups: Same Day Discharge -SD-; Overnight Stay -ON-). Demographic data, procedural characteristics and adverse outcomes were recorded. Outcomes included 30 day-MACE and procedure- related complications, as well as total operative costs in patients from both groups. Propensity score matching for patient demographics, coronary symptoms and procedure indicators was used to compare both groups. RESULTS: The entire cohort included 852 patients (429 in SD group and 423 in ON group) and the propensity score matched groups of 245 patients in the SD group and 245 patients in the ON group. The two groups had no significant baseline clinical differences, and had similar clinical outcomes. Specifically, no significant difference was noted in procedural complications (3.7% vs 2.5%, p = 0.43), re-hospitalization (4.1% vs 4.1%, p = 0.92), re-intervention (2.5% vs 2.1%, p = 0.77), myocardial infarction (0% vs 0.08%, p = 0.15), stroke (0% vs 0%, p = 1.0) and all-cause mortality (0% vs 0%, p = 1.0). SD Group patients had a significant lower procedure-related cost compared to overnight stay patients ($3,346.45 vs $4,681.99, p < 0.0001) and lower 30-day post procedure-associated cumulative costs/total operating costs ($4,493.22 vs $7,112.21, p < 0.0001). CONCLUSION: In elective patients undergoing low risk TR-PCI, same-day discharge seems to be a safe and feasible clinical practice, with significant potential savings to the US healthcare system.

Equilíbrio Postural em Crianças com Deficiência Intelectual / Postural Balance in Children with Intellectual Disabilities

Crianças com deficiência intelectual podem apresentar problemas estruturais e de maturação ligados ao sistema nervoso central, vestibular e proprioceptivo, sendo caracterizados pela escolha da estratégia motora e de equilíbrio postural inadequadas ou em atraso para a sua idade cronológica. Este estudo objetivou avaliar o equilíbrio postural em crianças com deficiência intelectual. Trinta crianças de ambos os sexos, com idade entre 7 a 13 anos, foram divididas em dois grupos, sendo quinze com deficiência intelectual (grupo DI) e quinze com desenvolvimento típico (grupo controle GC). O equilíbrio postural foi avaliado sobre a plataforma de força BIOMEC400 em apoio bipodal e unipodal. Os seguintes parâmetros de equilíbrio, baseados no centro de pressão (COP), foram analizados: área de elipse do COP, velocidade de oscilações do COP e frequência de oscilações do COP, nas direções antero-posterior (AP) e médio-lateral (ML). Os parâmetros de equilíbrio baseados no COP mostraram diferenças significativas entre os grupos em apoio bipodal para a velocidade média AP (DI=2,56; GC=3,55; p=0,02) e ML (DI=2,58; GC=3,59; p=0,03) e para frequência média AP (DI=0,53; GC=0,77; p=0,008). No teste em apoio unipodal, a frequência média AP foi a única variável a apresentar diferença significante entre os grupos (DI=0,85; GC=1,06; p=0,03). O grupo de participantes com deficiência intelectual apresenta, tanto em apoio bipodal como unipodal, resultados semelhantes ou superiores ao grupo controle. Estes resultados mostram que a deficiência intelectual não influenciou o equilíbrio postural estático em crianças de 7 a 13 anos.(AU).

Children with intellectual disability may present structural and maturation disorders associated with the central nervous system, proprioceptive and vestibular system. These children are characterized by the inappropriate choice or dalayed response in motor strategy and postural balance for their chronological age. The purpose of this study was to evaluate the postural balance in children with intellectual disability. Thirty children of both sexes, aged between 7 and 13 years, were divided in two groups, fifteen with intellectual disability (group ID) and fifteen with typical development (control group CG). The postural balance was evaluated based on the force platform BIOMEC400 in bipodal and unipodal support. The main balance parameters analyzed were: ellipse area of the pressure center (COP), mean velocity and mean frequency of COP oscillations, in both directions of the movement anteroposterior (AP) and mediolateral (ML). The balance parameters based on COP revealed significant differences between the groups in bipodal support to the mean velocity AP (ID=2,56; CG=3,55; p=0,02) and ML (ID=2,58; CG=3,59; p=0,03) and to mean frequency AP (ID=0,53; CG=0,77; p=0,008). In the unipodal support test, the mean frequency AP was the only that showed significant difference between groups (ID=0,85; CG=1,06; p=0,03). The intellectual disability group achieved in both bipodal and unipodal support, similar or better results than the control group. These results indicate that the intellectual disability did not influence the static postural balance in children from 7 to 13 years old. (AU).

"Bringing on the light" in a complex clinical scenario: Optical coherence tomography-guided discontinuation of antiplatelet therapy in cancer patients with coronary artery disease (PROTECT-OCT registry).

BACKGROUND: Cancer patients with recently placed drug-eluting stents (DESs) often require premature dual antiplatelet therapy (DAPT) discontinuation for cancer-related procedures. Optical coherence tomography (OCT) can identify risk factors for stent thrombosis such as stent malapposition, incomplete strut coverage and in-stent restenosis and may help guide discontinuation of DAPT. METHODS: We conducted a single-center prospective study in cancer patients with recently placed (1-12 months) DES who required premature DAPT discontinuation. Patients were evaluated with diagnostic coronary angiogram and OCT. Individuals with appropriate stent strut coverage, expansion, apposition, and absence of in-stent restenosis or intraluminal masses were considered low risk and transiently discontinued DAPT to allow optimal cancer therapy. Patients who did not meet all these criteria were considered high risk and underwent further endovascular treatment when appropriate and bridging with low-molecular weight heparin. The incidence of adverse cardiovascular events was assessed after the procedure and at 12 months. RESULTS: A total of 40 patients were included. Twenty-seven patients (68%) were considered low risk by OCT criteria and DAPT was transiently discontinued. Thirteen patients (32%) were considered high risk with one or more OCT findings: uncovered stent struts (4 patients, 10%); stent underexpansion (3 patients, 8%); malapposition (8 patients, 20%); in-stent restenosis (2 patients, 5%). The high-risk patients with uncovered stent struts and malapposition underwent additional stent dilatation. There were no cardiovascular events in the low-risk group. One myocardial infarction occurred in the high-risk group. Fourteen non-cardiac deaths were registered before 12 months due to cancer progression or cancer therapy. CONCLUSION: OCT imaging allows identification of low-risk cancer patients with DES placed who may safely discontinue DAPT and proceed with cancer-related surgery or procedures.

PVL closure after TAVR: Yes, we can do it.

Paravalvular leak (PVL) remains a significant problem after transcatheter aortic valve replacement. PVL is associated with long-term morbidity and mortality. Percutaneous management of post-TAVR PVL seems to be feasible and should be adopted by the structural heart interventionalist.

Defining coronary artery calcium concordance and repeatability - Implications for development and change: The Dallas Heart Study.

BACKGROUND: Development and change of coronary artery calcium (CAC) are associated with coronary heart disease. Interpretation of serial CAC measurements will require better understanding of changes in CAC beyond the variability in the test itself. METHODS: Dallas Heart Study participants (2888) with duplicate CAC scans obtained minutes apart were analyzed to determine interscan concordance and 95% confidence bounds (ie: repeatability limits) for each discrete CAC value. These data derived cutoffs were then used to define change above measurement variation and determine the frequency of CAC development and change among 1779 subjects with follow up CAC scans performed 6.9 years later. RESULTS: Binary concordance (0 vs. >0) was 91%. The value of CAC denoting true development of CAC by exceeding the 95% confidence bounds for a single score of 0 was 2.7 Agatston units (AU). Among those with scores >0, the 95% confidence bounds for CAC change were determined by the following formulas: for CAC≤100AU: 5.6√CAC + 0.3*CAC - 3.1; for CAC>100AU: 12.4√CAC - 67.7. Using these parameters, CAC development occurred in 15.0% and CAC change occurred in 48.9%. Although 225 individuals (24.9%) had a decrease in CAC over follow up, only 1 (0.1%) crossed the lower confidence bound. Compared with prior reported definition of CAC development (ie: >0), the novel threshold of 2.7AU resulted in better measures of model performance. In contrast, for CAC change, no consistent differences in performance metrics were observed compared with previously reported definitions. CONCLUSION: There is significant interscan variability in CAC measurement, including around scores of 0. Incorporating repeatability estimates may help discern true differences from those due to measurement variability, an approach that may enhance determination of CAC development and change.

Paravalvular Leaks: One Size (or Shape) Doesn't Always Fit All?

Paravalvular leak (PVL) remains as uncommon but serious complication after surgical prosthetic valve implantation. PVL when associated which congestive heart failure, hemolytic anemia, or infective endocarditis may require percutaneous treatment. High-surgical risk is common in this population. Dedicated PVL devices are lacking often limiting optimal treatment.

Immediate and intermediate-term results of optical coherence tomography guided atherectomy in the treatment of peripheral arterial disease: Initial results from the VISION trial.

BACKGROUND: Long-term patency rates for percutaneous peripheral arterial interventions are suboptimal. Optical coherence tomography (OCT) guided atherectomy may yield superior patency by optimizing plaque removal while preserving the tunica media and adventitia. METHODS: The VISION study is a multicenter prospective study of patients with peripheral arterial disease undergoing OCT guided atherectomy with the Pantheris™ device. In 11 patients enrolled in a single center, we report procedural and clinical outcomes, at 30days and 6months. RESULTS: The mean age was 63±11years and 73% (n=8) were men. The target lesion was in the superficial femoral artery in 82% (n=9) of the patients. Mean stenosis severity was 87%±10% and mean lesion length was 39±31mm. Procedural success was observed in all patients with no device related complications. Mean post-atherectomy stenosis was 18%±15%. Almost all excised tissue consisted of intimal plaque (94%). At 30days, significant improvements in Rutherford class, VascuQoL scores and ABI were observed, 0.9±0.8 vs. 3.1±0.7 (p=0.01), 4.9±1.9 vs. 3.6±1.5 (p=0.03) and 1.04±0.19 vs. 0.80±0.19 (p<0.01) respectively. At 6months, there were significant improvements in Rutherford class (1.0±1.0 vs. 3.1±0.7, p=0.01) and ABI (0.93±0.19 versus 0.80±0.19, p=0.02) but not in VascuQoL scores (3.7±1.4 versus 3.6±1.5, p=0.48). Target lesion revascularization occurred in 18% (n=2) of the patients. CONCLUSION: OCT guided atherectomy resulted in high procedural success, no device related complications and encouraging results up to 6months. Histological analysis suggested little injury to the media and adventitia. Larger studies are needed to confirm the efficacy of this approach.

Progression of CAC Score and Risk of Incident CVD.

OBJECTIVES: The authors sought to determine the relative contributions of baseline coronary artery calcification (CAC), follow-up CAC, and CAC progression on incident cardiovascular disease (CVD). BACKGROUND: Repeat CAC scanning has been proposed as a method to track progression of total atherosclerotic burden. However, whether CAC progression is a useful predictor of future CVD events remains unclear. METHODS: This was a prospective observational study of 5,933 participants free of CVD who underwent 2 examinations, including CAC scores, and subsequent CVD event assessment. CAC progression was calculated using the square root method. The primary outcome was total CVD events (CVD death, nonfatal myocardial infarction, nonfatal atherosclerotic stroke, coronary artery bypass surgery, percutaneous coronary intervention). Secondary outcomes included hard CVD events, total coronary heart disease (CHD) events, and hard CHD events. RESULTS: CAC was detected at baseline in 2,870 individuals (48%). The average time between scans was 3.5 ± 2.0 years. After their second scan, 161 individuals experienced a total CVD event during a mean follow-up of 7.3 years. CAC progression was significantly associated with total CVD events (hazard ratio: 1.14, 95% confidence interval: 1.01 to 1.30 per interquartile range; p = 0.042) in the model including baseline CAC, but the contribution of CAC progression was small relative to baseline CAC (chi-square 4.16 vs. 65.92). Furthermore, CAC progression was not associated with total CVD events in the model including follow-up CAC instead of baseline CAC (hazard ratio: 1.05, 95% confidence interval: 0.92 to 1.21; p = 0.475). A model that included follow-up CAC alone performed as well as the model that included baseline CAC and CAC progression. CONCLUSIONS: Although CAC progression was independently, but modestly, associated with CVD outcomes, this relationship was no longer significant when including follow-up CAC in the model. These findings imply that if serial CAC scanning is performed, the latest scan should be used for risk assessment, and in this context, CAC progression provides no additional prognostic information.

Coronary Artery Calcium Improves Risk Classification in Younger Populations.

OBJECTIVES: This study sought to assess the effect of coronary artery calcium (CAC) on coronary heart disease (CHD) risk prediction in a younger population. BACKGROUND: CAC measured by computed tomography improves CHD risk classification in older adults, but the effectiveness of CAC in younger populations has not been fully assessed. METHODS: In the DHS (Dallas Heart Study), a multiethnic probability-based population sample, traditional CHD risk factors and CAC were measured in participants without baseline cardiovascular disease or diabetes. Incident CHD-defined as CHD death, myocardial infarction, or coronary revascularization-was assessed over a median follow-up of 9.2 years. Predicted CHD risk was assessed with a Weibull model inclusive of traditional risk factors before and after the addition of CAC as ln(CAC + 1). Participants were divided into 3 10-year risk categories, <6%, 6% to <20%, and ≥20%, and the net reclassification improvement (NRI) was calculated. We also performed a random-effects meta-analysis of NRI from previous studies inclusive of older individuals. RESULTS: The analysis comprised 2,084 participants; mean age was 44.4 ± 9.0 years. CAC was independently associated with incident CHD (hazard ratio per SD: 1.90, 95% confidence interval [CI] 1.51 to 2.38; p < 0.001). The addition of CAC to the traditional risk factor model resulted in significant improvement in the C-statistic (delta = 0.03; p = 0.003). Among participants with CHD events, the addition of CAC resulted in net correct upward reclassification of 21%, and among those without CHD, a net correct downward reclassification of 0.5% (NRI: 0.216, p = 0.012). Results remained significant when the outcome was restricted to CHD death and myocardial infarction and when individuals with diabetes were included. The NRI observed in this study was similar to the pooled estimate from previous studies (0.200, 95% CI: 0.140 to 0.258) and the addition of our study to the meta-analysis did not result in significant heterogeneity (I(2) = 0%). CONCLUSIONS: CAC scoring also improves CHD risk classification in younger adults.

Risk factor burden and control at the time of admission in patients with acute myocardial infarction: Results from the NCDR.

BACKGROUND: Understanding risk factor burden and control as well as perceived risk prior to acute myocardial infarction (MI) presentation may identify gaps in contemporary systems of care. METHODS: Patients presenting with MI in the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry--Get With the Guidelines between January 2007 and November 2013 (N = 443,117) were stratified into 5 mutually exclusive risk categories: Framingham Risk Score (FRS) <10% 74,990 (16.9%), FRS 10% to 20% 90,429 (20.4%), FRS >20% 25,701 (5.8%), diabetes without cardiovascular disease (CVD) 67,779 (15.3%), and prior CVD 184,218 (41.6%). Low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol (non-HDL-C) goals and statin eligibility were determined based on the Third Adult Treatment Panel. RESULTS: At presentation, 66.3% met the low-density lipoprotein cholesterol goal, 66.8% met the non-HDL-C goal, 63.7% were nonsmokers, and 65.1% of patients with prior CVD were on aspirin. Only 36.1% of patients met all assessed risk factor control metrics. Overall statin eligibility prior to MI was 60.8%, and 61.1% of statin-eligible patients reported statin use. CONCLUSION: Risk factor control prior to MI was suboptimal, with the majority of individuals failing to meet at least 1 risk factor control metric. More effective system-based interventions are needed to promote adherence to prevention targets.

Diagnosis of cardiogenic shock without the use of a pulmonary artery catheter.

BACKGROUND: Current diagnostic criteria for cardiogenic shock (CS) require the use of a pulmonary artery catheter (PAC), which is time-consuming and may cause complications. A set of simple yet accurate noninvasive diagnostic criteria would be of significant utility. METHODS: Candidate components for the Noninvasive Parameters for Assessment of Cardiogenic Shock (N-PACS) criteria were required to be objective, readily available, and noninvasive. Variables encompassing hypotension, hypoperfusion, predisposing conditions, and elevated intracardiac filling pressures were optimized versus a PAC-based standard in a retrospective developmental cohort of 122 patients with acute myocardial infarction (AMI). The finalized criteria were validated in a prospective cohort of coronary care unit patients in whom a PAC was placed for clinical indications. RESULTS: According to invasive criteria, CS was present in 32 of 217 consecutive patients undergoing PAC. Compared to the PAC-based standard, the N-PACS criteria had a sensitivity of 96.9% (95% confidence interval (CI) 82.0-99.8), specificity of 90.8% (95% CI 85.5-94.4), positive predictive value of 64.6% (95% CI 49.4-77.4), negative predictive value of 99.4% (95% CI 96.2-100), positive likelihood ratio of 10.5 (95% CI 6.7-16.7), negative likelihood ratio of 0.03 (95% CI 0.00-0.24), and diagnostic odds ratio of 306.4. Results were similar among patients with and without AMI. CONCLUSION: A simple, echocardiography-based set of noninvasive diagnostic criteria can be used to accurately diagnose CS.