Background Anaphylaxis is a potentially life-threatening allergic reaction. The risk of anaphylaxis after vaccination has not been well described in adults or with newer vaccines in children. ...Objective We sought to estimate the incidence of anaphylaxis after vaccines and describe the demographic and clinical characteristics of confirmed cases of anaphylaxis. Methods Using health care data from the Vaccine Safety Datalink, we determined rates of anaphylaxis after vaccination in children and adults. We first identified all patients with a vaccination record from January 2009 through December 2011 and used diagnostic and procedure codes to identify potential anaphylaxis cases. Medical records of potential cases were reviewed. Confirmed cases met the Brighton Collaboration definition for anaphylaxis and had to be determined to be vaccine triggered. We calculated the incidence of anaphylaxis after all vaccines combined and for selected individual vaccines. Results We identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95% CI, 0.90-1.84) per million vaccine doses. The incidence did not vary significantly by age, and there was a nonsignificant female predominance. Vaccine-specific rates included 1.35 (95% CI, 0.65-2.47) per million doses for inactivated trivalent influenza vaccine (10 cases, 7,434,628 doses given alone) and 1.83 (95% CI, 0.22-6.63) per million doses for inactivated monovalent influenza vaccine (2 cases, 1,090,279 doses given alone). The onset of symptoms among cases was within 30 minutes (8 cases), 30 to less than 120 minutes (8 cases), 2 to less than 4 hours (10 cases), 4 to 8 hours (2 cases), the next day (1 case), and not documented (4 cases). Conclusion Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat.
General Considerations...e70 Risk Assessment Using Clinical Parameters...e71 Advanced Testing: Resting and Stress Noninvasive Testing...e72 Resting Imaging to Assess Cardiac Structure and Function: ...Recommendations...e72 Stress Testing and Advanced Imaging in Patients With Known SIHD Who Require Noninvasive Testing for Risk Assessment: Recommendations...e74 Risk Assessment in Patients Able to Exercise...e74 Risk Assessment in Patients Unable to Exercise...e74 Risk Assessment Regardless of Patients' Ability to Exercise...e74 Exercise ECG...e75 Exercise Echocardiography and Exercise Nuclear MPI...e76 Dobutamine Stress Echocardiography and Pharmacological Stress Nuclear MPI...e77 Pharmacological Stress CMR Imaging...e77 Special Patient Group: Risk Assessment in Patients Who Have an Uninterpretable ECG Because of LBBB or Ventricular Pacing...e77 Prognostic Accuracy of Anatomic Testing to Assess Risk in Patients With Known CAD...e78 Coronary CT Angiography...e78 Coronary Angiography...e78 Coronary Angiography as an Initial Testing Strategy to Assess Risk: Recommendations...e78 Coronary Angiography to Assess Risk After Initial Workup With Noninvasive Testing: Recommendations...e78 Treatment...e80 Definition of Successful Treatment...e80 General Approach to Therapy...e82 Factors That Should Not Influence Treatment Decisions...e83 Assessing Patients' Quality of Life...e84 Patient Education: Recommendations...e84 Guideline-Directed Medical Therapy...e86 Risk Factor Modification: Recommendations...e86 Lipid Management...e86 Blood Pressure Management...e88 Diabetes Management...e89 Physical Activity...e91 Weight Management...e92 Smoking Cessation Counseling...e92 Management of Psychological Factors...e93 Alcohol Consumption...e94 Avoiding Exposure to Air Pollution...e94 Additional Medical Therapy to Prevent MI and Death: Recommendations...e95 Antiplatelet Therapy...e95 Beta-Blocker Therapy...e96 Renin-Angiotensin-Aldosterone Blocker Therapy...e97 Influenza Vaccination...e98 Additional Therapy to Reduce Risk of MI and Death...e99 Medical Therapy for Relief of Symptoms...e100 Use of Anti-ischemic Medications: Recommendations...e100 Alternative Therapies for Relief of Symptoms in Patients With Refractory Angina: Recommendations...e104 Enhanced External Counterpulsation...e104 Spinal Cord Stimulation...e105 Acupuncture...e105 CAD Revascularization...e106 Heart Team Approach to Revascularization Decisions: Recommendations...e106 Revascularization to Improve Survival: Recommendations...e108 Revascularization to Improve Symptoms: Recommendations...e109 CABG Versus Contemporaneous Medical Therapy...e109 PCI Versus Medical Therapy...e110 CABG Versus PCI...e110 CABG Versus Balloon Angioplasty or BMS...e110 CABG Versus DES...e111 Left Main CAD...e111 CABG or PCI Versus Medical Therapy for Left Main CAD...e111 Studies Comparing PCI Versus CABG for Left Main CAD...e111 Revascularization Considerations for Left Main CAD...e112 Proximal LAD Artery Disease...e112 Clinical Factors That May Influence the Choice of Revascularization...e113 Completeness of Revascularization...e113 LV Systolic Dysfunction...e113 Previous CABG...e113 Unstable Angina/Non-ST-Elevation Myocardial Infarction...e113 DAPT Compliance and Stent Thrombosis: Recommendation...e113 Transmyocardial Revascularization...e114 Hybrid Coronary Revascularization: Recommendations...e114 Special Considerations...e114 Women...e115 Older Adults...e115 Diabetes Mellitus...e116 Obesity...e117 Chronic Kidney Disease...e118 HIV Infection and SIHD...e118 Autoimmune Disorders...e119 Socioeconomic Factors...e119 Special Occupations...e119 Patient Follow-Up: Monitoring of Symptoms and Antianginal Therapy...e119 Clinical Evaluation, Echocardiography During Routine, Periodic Follow-Up: Recommendations...e120 Follow-Up of Patients With SIHD...e121 Focused Follow-Up Visit: Frequency...e121 Focused Follow-Up Visit: Interval History and Coexisting Conditions...e121 Focused Follow-Up Visit: Physical Examination...e122 Focused Follow-Up Visit: Resting 12-Lead ECG...e122 Focused Follow-Up Visit: Laboratory Examination...e122 Noninvasive Testing in Known SIHD...e122 Follow-Up Noninvasive Testing in Patients With Known SIHD:
Background Improvement in lung function after macrolide antibiotic therapy has been attributed to reduction in bronchial infection by specific bacteria. However, the airway might be populated by a ...more diverse microbiota, and clinical features of asthma might be associated with characteristics of the airway microbiota present. Objective We sought to determine whether relationships exist between the composition of the airway bacterial microbiota and clinical features of asthma using culture-independent tools capable of detecting the presence and relative abundance of most known bacteria. Methods In this pilot study bronchial epithelial brushings were collected from 65 adults with suboptimally controlled asthma participating in a multicenter study of the effects of clarithromycin on asthma control and 10 healthy control subjects. A combination of high-density 16S ribosomal RNA microarray and parallel clone library-sequencing analysis was used to profile the microbiota and examine relationships with clinical measurements. Results Compared with control subjects, 16S ribosomal RNA amplicon concentrations (a proxy for bacterial burden) and bacterial diversity were significantly higher among asthmatic patients. In multivariate analyses airway microbiota composition and diversity were significantly correlated with bronchial hyperresponsiveness. Specifically, the relative abundance of particular phylotypes, including members of the Comamonadaceae, Sphingomonadaceae, Oxalobacteraceae, and other bacterial families were highly correlated with the degree of bronchial hyperresponsiveness. Conclusion: The composition of bronchial airway microbiota is associated with the degree of bronchial hyperresponsiveness among patients with suboptimally controlled asthma. These findings support the need for further functional studies to examine the potential contribution of members of the airway microbiota in asthma pathogenesis.
Background It is unknown if the radiographic fibrosis score predicts mortality in persistent hypersensitivity pneumonitis (HP) and if survival is similar to that observed in idiopathic pulmonary ...fibrosis (IPF) when adjusting for the extent of radiographic fibrosis. Methods We reviewed records from 177 patients with HP and 224 patients with IPF whose diagnoses were established by multidisciplinary consensus. Two thoracic radiologists scored high-resolution CT (HRCT) scan lung images. Independent predictors of transplant-free survival were determined using a Cox proportional hazards analysis. Kaplan-Meier survival curves were constructed, stratified by disease as well as fibrosis score. Results HRCT scan fibrosis score and radiographic reticulation independently predicted time to death or lung transplantation. Clinical predictors included a history of cigarette smoking, auscultatory crackles on lung examination, baseline FVC, and FEV1 /FVC ratio. The majority of HP deaths occurred in patients with both radiographic reticulation and auscultatory crackles on examination, compared with patients with only one of these manifestations ( P < .0001). Patients with IPF had worse survival than those with HP at any given degree of radiographic fibrosis (hazard ratio 2.31; P < .01). Conclusions Survival in patients with HP was superior to that of those with IPF with similar degrees of radiographic fibrosis. The combination of auscultatory crackles and radiographic reticulation identified patients with HP who had a particularly poor outcome.
Abstract Background Recent studies have demonstrated relatively high rates of percutaneous coronary interventions (PCIs) classified as “inappropriate.” The New York State Department of Health shared ...rates with hospitals and announced the intention of withholding reimbursement pending demonstration of clinical rationale for Medicaid patients with inappropriate PCIs. Objectives The objective was to examine changes over time in the number and rate of inappropriate PCIs. Methods Appropriate use criteria were applied to PCIs performed in New York in patients without acute coronary syndromes or previous coronary artery bypass graft surgery in periods before (2010 through 2011) and after (2012 through 2014) efforts were made to decrease inappropriateness rates. Changes in the number of appropriate PCIs were also assessed. Results The percentage of inappropriate PCIs for all patients dropped from 18.2% in 2010 to 10.6% in 2014 (from 15.3% to 6.8% for Medicaid patients, and from 18.6% to 11.2% for other patients). The total number of PCIs in patients with no acute coronary syndrome/no prior coronary artery bypass graft surgery that were rated as inappropriate decreased from 2,956 patients in 2010 to 911 patients in 2014, a reduction of 69%. For Medicaid patients, the decrease was from 340 patients to 84 patients, a decrease of 75%. For a select set of higher-risk scenarios, there were higher numbers of appropriate PCIs per year in the period from 2012 to 2014. Conclusions The inappropriateness rate for PCIs and the use of PCI for elective procedures in New York has decreased substantially between 2010 and 2014. This decrease has occurred for a large proportion of PCI hospitals.
Objectives The purpose of this study was to examine the differences in in-hospital and longer-term mortality for ST-segment elevation myocardial infarction (STEMI) patients with multivessel disease ...as a function of whether they underwent single-vessel (culprit vessel) percutaneous coronary interventions (PCIs) or multivessel PCI. Background The optimal treatment of patients with STEMI and multivessel disease is of continuing interest in the era of drug-eluting stents. Methods STEMI patients with multivessel disease undergoing PCIs in New York between January 1, 2003, and June 30, 2006, were subdivided into those who underwent culprit vessel PCI and those who underwent multivessel PCI during the index procedure, during the index admission, or staged within 60 days of the index admission. Patients were propensity-matched and mortality rates were calculated at 12, 24, and 42 months. Results A total of 3,521 patients (87.5%) underwent culprit vessel PCI during the index procedure. A total of 259 of them underwent staged PCI during the index admission and 538 patients underwent staged PCI within 60 days of the index procedure. For patients without hemodynamic compromise, culprit vessel PCI during the index procedure was associated with lower in-hospital mortality than multivessel PCI during the index procedure (0.9% vs. 2.4%, p = 0.04). Patients undergoing staged multivessel PCI within 60 days after the index procedure had a significantly lower 12-month mortality rate than patients undergoing culprit vessel PCI only (1.3% vs. 3.3%, p = 0.04). Conclusions Our findings support the American College of Cardiology/American Heart Association (ACC/AHA) recommendation that culprit vessel PCI be used for STEMI patients with multivessel disease at the time of the index PCI when patients are not hemodynamically compromised. However, staged PCI within 60 days after the index procedure, including during the index admission, is associated with risk-adjusted mortality rates that are comparable with the rate for culprit vessel PCI alone.
An organized and directed approach to a thorough review of evidence has resulted in the production of clinical practice guidelines that assist physicians in selecting the best management strategy for ...an individual patient. ...clinical practice guidelines can provide a foundation for other applications, such as performance measures, appropriate use criteria, and both quality improvement and clinical decision support tools. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and are ranked as LOE C.\n Sanborn Official Reviewer--SCAI None The Medicines Company Merck None St. Jude Medical (DSMB) None None Jeffrey L. Anderson Content Reviewer--ACCF/AHA Task Force on Practice Guidelines BMS/sanofi-aventis Daiichi-Sankyo Eli Lilly None None None None None William E. Boden Content Reviewer Abbott CV Therapeutics/Gilead* Sanofi-aventis Schering-Plough Medicure Pharma None None None None Matthew Budoff Content Reviewer--ACCF Imaging Council None None None None None None Kim A. Eagle Content Reviewer None None None None None None Gordon A. Ewy Content Reviewer None None None None None None Victor Ferrari Content Reviewer--ACCF Imaging Council None None None None None None Raymond J. Gibbons Content Reviewer Cardiovascular Clinical Studies Lantheus Medical Imaging Medscape Molecular Insight TherOx None None Velomedix* None None Linda Gillam Content Reviewer--ACCF Imaging Council Abbott Vascular Edwards Lifesciences None None None Core Lab Services None Robert A. Guyton Content Reviewer--ACCF/AHA Task Force on Practice Guidelines None None None Edwards Lifesciences None None L. David Hillis Content Reviewer None None None None None None David R. Holmes Content Reviewer--ACCF Interventional Scientific Council None None None None None None Hani Jneid Content Reviewer-- AHA Council on Clinical Cardiology None None None None None None Sanjay Kaul Content Reviewer None None None None None None Howard C. Lewin Content Reviewer--ACCF Imaging Council None None Positron Imaging Partners None None None Todd D. Miller Content Reviewer--AHA Council on Clinical Cardiology The Medicines Company TherOx None None Kai Pharmaceuticals King Pharmaceuticals Lantheus Medical Imaging Molecular Insight Pharmaceuticals None None L. Kristin Newby Content Reviewer-- AHA Council on Clinical Cardiology Adolor Biovascular CV Therapeutics Inverness Medical Johnson & Johnson Novartis Roche Diagnostics Daiichi-Sankyo None AstraZeneca BG Medicine Carvio Dx* GlaxoSmithKline* Medicare* Millennium Pharmaceuticals Schering-Plough* None None Elizabeth Ross Content Reviewer None None None None None None William S. Weintraub Content Reviewer AstraZeneca* Bayer* Bristol-Myers Squibb Cardionet Eli Lilly Pfizer* Sanofi-aventis Shionogi None None Abbott* AstraZeneca* Bristol-Myers Squibb* Otsuka* Sanofi-aventis* None 2004; Defendant; Aprotinin 2008; Defendant; Quetiapine 2008; Defendant; Celebrex * This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review. Relationships noted in this table are modest unless otherwise noted.AATS indicates American Association for Thoracic Surgery; ACCF, American College of Cardiology Foundation; ACP, American College of Physicans; AHA, American Heart Association; NIH, National Institutes of Health; PCNA, Preventive Cardiovascular Nurses Association; SCAI, Society for Cardiovascular Interventions and Angiography; and STS, Society of Thoracic Surgeons.
Abstract Background Few recent studies have compared the outcomes of coronary artery bypass graft (CABG) surgery with percutaneous coronary interventions (PCIs) in patients with isolated (single ...vessel) proximal left anterior descending (PLAD) coronary artery disease in the era of drug-eluting stents (DES). Objectives The goal of this study was to compare outcomes in patients with PLAD who underwent CABG and PCI with DES. Methods New York’s Percutaneous Coronary Interventions Reporting System was used to identify and track all patients who underwent CABG surgery and received DES for isolated PLAD disease between January 1, 2008 and December 31, 2010, and who were followed-up through December 31, 2011. A total of 5,340 of 6,064 (88%) patients received DES. Patients were matched to vital statistics data to obtain mortality after discharge and matched to New York’s administrative data to obtain readmissions for myocardial infarction (MI) and stroke. To minimize selection bias, patients were propensity matched into 715 CABG and/or DES pairs, and 3 outcome measures were compared across the pairs. Results Kaplan-Meier estimates for CABG and DES did not significantly differ for mortality or mortality, MI, and/or stroke, but repeat revascularization rates were lower for CABG (7.09% vs. 12.98%; p = 0.0007). After further adjustment with Cox proportional hazards models, there were still no significant differences in 3-year mortality rates (CABG and/or DES adjusted hazard ratio (AHR): 1.14; 95% confidence interval CI: 0.70 to 1.85) or mortality, MI, and/or stroke rates (AHR: 1.15; 95% CI: 0.76 to 1.73), and the repeat revascularization rate remained significantly lower for CABG patients (AHR: 0.54; 95% CI: 0.36 to 0.81). Conclusions Despite the higher rating in current guidelines of CABG (Class IIa vs. Class IIb) for patients with isolated PLAD disease, there were no differences in mortality or mortality, MI, and/or stroke, although CABG patients had significantly lower repeat revascularization rates.
Objectives The purpose of this study was to determine appropriateness of percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery performed in New York for patients ...without acute coronary syndrome (ACS) or previous CABG surgery. Background The American College of Cardiology Foundation (ACCF) and 6 other societies recently published joint appropriateness criteria for coronary revascularization. Methods Data from patients who underwent CABG surgery and PCI without acute coronary syndrome or previous CABG surgery in New York in 2009 and 2010 were used to assess appropriateness and to examine the variation across hospitals in inappropriateness ratings. Results Of the 8,168 patients undergoing CABG surgery in New York without ACS/prior CABG who could be rated, 90.0% were appropriate for revascularization, 1.1% were inappropriate, and 8.6% were uncertain. Of the 33,970 PCI patients eligible for rating, 28% lacked sufficient information to be rated. Of the patients who could be rated, 36.1% were appropriate, 14.3% were inappropriate, and 49.6% were uncertain. A total of 91% of the patients undergoing PCI who were classified as inappropriate had 1- or 2-vessel disease without proximal left anterior descending artery disease and had no or minimal anti-ischemic medical therapy. Conclusions For patients without ACS/prior CABG, only 1% of patients undergoing CABG surgery who could be rated were found to be inappropriate for the procedure according to the ACCF appropriateness criteria, but 14% of the PCI patients who could be rated were found to be inappropriate, and 28% lacked enough noninvasive test information to be rated.
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