Rationale and design of the intravenous iron for treatment of anemia before cardiac surgery trial.

Background Approximately 20% to 30% of patients awaiting cardiac surgery are anemic. Anemia increases the likelihood of requiring a red cell transfusion and is associated with increased complications, intensive care, and hospital stay following surgery. Iron deficiency is the commonest cause of anemia and preoperative intravenous (IV) iron therapy thus may improve anemia and therefore patient outcome following cardiac surgery. We have initiated the intravenous iron for treatment of anemia before cardiac surgery (ITACS) Trial to test the hypothesis that in patients with anemia awaiting elective cardiac surgery, IV iron will reduce complications, and facilitate recovery after surgery. Methods ITACS is a 1,000 patient, international randomized trial in patients with anemia undergoing elective cardiac surgery. The patients, health care providers, data collectors, and statistician are blinded to whether patients receive IV iron 1,000 mg, or placebo, at 1-26 weeks before their planned date of surgery. The primary endpoint is the number of days alive and at home up to 90 days after surgery. Results To date, ITACS has enrolled 615 patients in 30 hospitals in 9 countries. Patient mean (SD) age is 66 (12) years, 63% are male, with a mean (SD) hemoglobin at baseline of 118 (12) g/L; 40% have evidence (ferritin <100 ng/mL and/or transferrin saturation <25%) suggestive of iron deficiency. Most (59%) patients have undergone coronary artery surgery with or without valve surgery. Conclusions The ITACS Trial will be the largest study yet conducted to ascertain the benefits and risks of IV iron administration in anemic patients awaiting cardiac surgery.

Open-heart techniques and mitral valve plasty for mitral regurgitation in toy- and small-breed dogs: A review.

In human medicine, in the past, open-heart techniques for low-bodyweight children and newborn babies with congenital heart disease were more difficult than high-bodyweight adults. In toy- and small-breed dogs with mitral regurgitation (MR), an acquired heart disease, these techniques are more difficult to perform than for congenital heart diseases in young medium-sized or large dogs because of old age and low body weight. Therefore, improved open-heart techniques and mitral valve surgery for severe MR in older toy- and small-breed dogs are essential. Through our surface-cooling hypothermia (sHT) studies, we designed a new, improved open-heart method, namely, "the low-flow cardiopulmonary bypass (CPB) combined with deep sHT in toy- and small-breed dogs (Japan method)"; sHT was later replaced by blood-cooling hypothermia (bHT). At the same time, we devised a new, improved mitral valve plasty (MVP) applicable to severe MR, instead of mitral valve replacement, in toy- and small-breed dogs. This MVP technique was combined with artificial chordal reconstruction, semi-circular suture annuloplasty (AP), and direct scallop-suture valvuloplasty. These MVP techniques are simple, durable, and lead to good long-term quality of life in toy- and small-breed dogs. This review highlights the benefits of our improved CPB and MVP techniques (Japan method) for severe MR in toy-and small-breed dogs, which have led to a high success rate for MVP in severe clinical MR cases in Japan. It may further contribute to the development of more robust techniques for MR in toy- and small-breed dogs. This also represents the first comprehensive review of the history of open-heart surgery, CPB techniques, and MVP methods for MR in toy- and small-breed dogs.

Robustness of the Comparative Observational Evidence Supporting Class I and II Cardiac Surgery Procedures.

Background Current cardiac surgery guidelines give Class I and II recommendations to valve-sparing root replacement over the Bentall procedure, mitral valve (MV) repair over replacement, and multiple arterial grafting with bilateral internal thoracic artery based on observational evidence. We evaluated the robustness of the observational studies supporting these recommendations using the E value, an index of unmeasured confounding. Methods and Results Observational studies cited in the guidelines and in the 3 largest meta-analyses comparing the procedures were evaluated for statistically significant effect measures. Two E values were calculated: 1 for the effect-size estimate and 1 for the lower limit of the 95% CI. Thirty-one observational studies were identified, and E values were computed for 75 effect estimates. The observed effect estimates for improved clinical outcomes with valve-sparing root replacement versus the Bentall procedure, MV repair versus replacement, and grafting with bilateral internal thoracic artery versus single internal thoracic artery could be explained by an unmeasured confounder that was associated with both the treatment and outcome by a risk ratio of more than 16.77, 4.32, and 3.14, respectively. For MV repair versus replacement and grafting with bilateral internal thoracic artery versus single internal thoracic artery, the average E values were lower than the effect sizes of the other measured confounders in 33.3% and 60.9% of the studies, respectively. For valve-sparing root replacement versus the Bentall procedure, no study reported effect sizes for associations of other covariates with outcomes. Conclusions The E values for observational evidence supporting the use of valve-sparing root replacement, MV repair, and grafting with bilateral internal thoracic artery over the Bentall procedure, MV replacement, and grafting with single internal thoracic artery are relatively low. This suggests that small-to-moderate unmeasured confounding could explain most of the observed associations for these procedures.

Staging of Surgical Procedures in Comorbid Congenital Tracheal Stenosis and Congenital Cardiovascular Disease.

BACKGROUND: Comorbid long segment congenital tracheal stenosis and congenital cardiovascular abnormalities in children pose significant challenges with regard to repairing these abnormalities simultaneously or in stages. The aim of this study was to explore whether this combination of abnormalities needs a staged approach for surgical repairs. METHODS: All children who underwent both tracheal and cardiac surgical procedures at a tertiary hospital from 1995 to 2018 were analyzed retrospectively for mortality, ventilation days, postoperative intensive care unit days, mediastinitis, and unplanned reoperation by dividing them into simultaneous repairs (group 1), staged repairs within the same admission (group 2), and staged repairs during different admissions (group 3). RESULTS: Of 110 patients included in the study (group 1, 74; group 2. 10; and group 3, 26 patients), there was no significant difference in mortality (P = .85), median ventilation days (P = .99), median intensive care unit days (P = .23), unplanned airway reoperation (P = .36), and unplanned cardiac reoperation (P = .77). There was a significant difference in the rate of mediastinitis (group 1, 3%; group 2, 10%; and group 3, 19%; P = .02). There was no significant difference in 5-year survival (group 1, 86.2%; group 2, 77.8%; and group 3, 85.1%; P = .86). A higher STAT category was identified to be a risk factor for mortality in multivariate Cox regression analysis (relative risk, 5.45). CONCLUSIONS: Combined tracheal and cardiac abnormalities need a stratified approach to facilitate better clinical outcomes. Although the trajectory of care is often based on the clinical presentation, establishing a management protocol will be helpful, for which setting an international database will be useful.

Evaluation of five different renal recovery definitions for estimation of long-term outcomes of cardiac surgery associated acute kidney injury.

BACKGROUND: The commonly used recommended criteria for renal recovery are not unequivocal. This study compared five different definitions of renal recovery in order to evaluate long-term outcomes of cardiac surgery associated acute kidney injury (CSA-AKI). METHODS: Patients who underwent cardiac surgery between April 2009 and April 2013 were enrolled and divided into acute kidney injury (AKI) and non-AKI groups. The primary endpoint was 3-year major adverse events (MAEs) including death, new dialysis and progressive chronic kidney disease (CKD). We compared five criteria for complete renal recovery: Acute Renal Failure Trial Network (ATN): serum creatinine (SCr) at discharge returned to within baseline SCr + 0.5 mg/dL; Acute Dialysis Quality Initiative (ADQI): returned to within 50% above baseline SCr; Pannu: returned to within 25% above baseline SCr; Kidney Disease: Improving Global Outcomes (KDIGO): eGFR at discharge ≥60 mL/min/1.73 m2; Bucaloiu: returned to ≥90% baseline estimated glomerular filtration rate (eGFR). Multivariate regression analysis was used to compare risk factors for 3-year MAEs. RESULTS: The rate of complete recovery for ATN, ADQI, Pannu, KDIGO and Bucaloiu were 84.60% (n = 1242), 82.49% (n = 1211), 60.49% (n = 888), 68.60% (n = 1007) and 46.32% (n = 680). After adjusting for confounding factors, AKI with complete renal recovery was a risk factor for 3-year MAEs (OR: 1.69, 95% CI: 1.20-2.38, P <  0.05; OR: 1.45, 95% CI: 1.03-2.04, P <  0.05) according to ATN and ADQI criteria, but not for KDIGO, Pannu and Bucaloiu criteria. We found that relative to patients who recovered to within 0% baseline SCr or recovered to ≥100% baseline eGFR, the threshold values at which significant differences in 3-year MAEs were observed were > 30% or > 0.4 mg/dL above baseline SCr or < 70% of baseline eGFR. CONCLUSIONS: ADQI or ATN-equivalent criteria may overestimate the extent of renal recovery, while KDIGO, Pannu and Bucaloiu equivalent criteria may be more appropriate for clinical use. Our analyses revealed that SCr at discharge > 30% or > 0.4 mg/dL of baseline, or eGFR < 70% of baseline led to significant 3-year MAE incidence differences, which may serve as hints for new definitions of renal recovery.

Prognostic factors of mortality after surgery in infective endocarditis: systematic review and meta-analysis.

PURPOSE: There is a lack of consensus about which endocarditis-specific preoperative characteristics have an actual impact over postoperative mortality. Our objective was the identification and quantification of these factors. METHODS: We performed a systematic review of all the studies which reported factors related to in-hospital mortality after surgery for acute infective endocarditis, conducted according to PRISMA recommendations. A search string was constructed and applied on three different databases. Two investigators independently reviewed the retrieved references. Quality assessment was performed for identification of potential biases. All the variables that were included in at least two validated risk scores were meta-analyzed independently, and the pooled estimates were expressed as odds ratios (OR) with their confidence intervals (CI). RESULTS: The final sample consisted on 16 studies, comprising a total of 7484 patients. The overall pooled OR were statistically significant (p < 0.05) for: age (OR 1.03, 95% CI 1.00-1.05), female sex (OR 1.56, 95% CI 1.35-1.81), urgent or emergency surgery (OR 2.39 95% CI 1.91-3.00), previous cardiac surgery (OR 2.19, 95% CI 1.84-2.61), NYHA ≥ III (OR 1.84, 95% CI 1.33-2.55), cardiogenic shock (OR 4.15, 95% CI 3.06-5.64), prosthetic valve (OR 1.98, 95% CI 1.68-2.33), multivalvular affection (OR 1.35, 95% CI 1.01-1.82), renal failure (OR 2.57, 95% CI 2.15-3.06), paravalvular abscess (OR 2.39, 95% CI 1.77-3.22) and S. aureus infection (OR 2.27, 95% CI 1.89-2.73). CONCLUSIONS: After a systematic review, we identified 11 preoperative factors related to an increased postoperative mortality. The meta-analysis of each of these factors showed a significant association with an increased in-hospital mortality after surgery for active infective endocarditis. Graph summary of the Pooled Odds Ratios of the 11 preoperative factors analyzed after the systematic review and meta-analysis.

Standards of reporting in open and endovascular aortic surgery (STORAGE guidelines).

The number of patients undergoing surgery on the thoracic and thoraco-abdominal aorta has been steadily increasing over the past decade. This document aims to give guidance to authors reporting on results in aortic surgery by clarifying definitions of aortic pathologies, open and endovascular techniques and by listing clinical parameters that should be provided for full presentation of patients' clinical profile and in particular, their outcome. The aim is to help find a common language in the treatment of aortic disease and to contribute to a better understanding of this patient population.

Establishing Cardiac Surgery in Eastern Nepal: Early Results.

BACKGROUND: Only few dedicated cardiac centres provide cardiac surgery service in Nepal. We are the only government affiliated centre outside the capital providing this service. In this study, we aim to present our early results of cardiac surgery. METHODS: This retrospective study was conducted at B P Koirala Institute of Health Sciences with objective of analysing the early results of cardiac surgery in the patients operated from July 2016 to March 2017.The data were analysed for patient demographics, type of surgery and cardiac disease, mortality, hospital and intensive care unit stay, valve related complications. RESULTS: Total 51 major cardiac surgeries (42 on pump and nine off pump) were performed. There were 27 (53%) males and 24 (47%) females with median age of 36 years (range: 1 to 70 years).The cardiac diseases consisted of 28 rheumatic heart disease, 12 congenital heart diseases, five coronary artery disease, five chronic constrictive pericarditis and one left atrial myxoma. The mean cardiopulmonary bypass and cross clamp times were 106 ±35 and 80±26 minutes respectively. The mean intensive care unit and hospital stay was 4±2 and 8±3 days respectively. Two (4%) patients required re-exploration for mediastinal bleeding. There was no prosthetic valve thrombosis or infection.Two patients (4%) had superficial wound infections.There were four (7.8%) in hospital mortalities. Remaining 47 patients (91.8%) are in NYHA class I aftermean follow up duration of five months. CONCLUSIONS: Our early result of cardiac surgery is encouraging and has established the safety and feasibility of starting open heart surgery in other parts of Nepal.

Reclassifying by highest complexity operation rather than first operation influences mortality after pediatric heart surgery.

OBJECTIVE: To evaluate the effect on mortality of reclassifying patients undergoing pediatric heart reoperations of varying complexity by operation of highest complexity instead of by first operation. METHODS: Data from the Virtual Pediatric Systems Database on children aged < 18 years who underwent heart surgery (with or without cardiopulmonary bypass) were included (2009-2015). Only patients who underwent reoperations during the same hospitalization were included. Patients were classified based on the first cardiovascular operation (the index operation), and on the complexity of the operation (the operation with the highest Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery [STAT] mortality category of each hospital admission) performed. RESULTS: Of 51,047 patients (73 centers), 22,393 met inclusion criteria. Using index operation as the classifying operation, the number of patients classified in the STAT 1 category increased by approximately 2.5 times compared with the highest-complexity operation (index, 7,077 and highest complexity, 2,654). In contrast, when the highest-complexity classification was used, we noted an increase in the number of patients in other STAT categories. We also noted higher mortality in all STAT categories when patients were classified by index operation instead of by highest complexity (index vs highest STAT category 1, 0.6% vs 0.2%; category 2, 2.4% vs 0.8%; category 3, 3.1% vs 2.1%; category 4, 5.8% vs 5.6%; and category 5, 16.7% vs 16.5%). CONCLUSIONS: This study demonstrates differences in the reported number of patients and reported mortality in each STAT category among children undergoing various heart reoperations during the same hospitalization by classifying patients based on index operation compared with the operation of highest complexity.

Medical Devices; Cardiovascular Devices; Classification of the Temporary Catheter for Embolic Protection During Transcatheter Intracardiac Procedures. Final order.

The Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporary catheter for embolic protection during transcatheter intracardiac procedures' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Performance of the Cox-maze IV procedure is associated with improved long-term survival in patients with atrial fibrillation undergoing cardiac surgery.

OBJECTIVE: Atrial fibrillation (AF) is associated with an increased mortality risk. The Cox-maze IV procedure (CM4) performed concomitantly with other cardiac procedures has been shown to be effective for restoring sinus rhythm. However, few data have been published on the late survival of patients undergoing a concomitant CM4. METHODS: Patients undergoing cardiac surgery were retrospectively reviewed from 2001 to 2016 (n = 10,859). Patients were stratified into 3 groups: patients with a history of AF receiving a concomitant CM4 (CM4; n = 438), patients with a history of AF unaddressed during surgery (Untreated AF; n = 1510), and patients without AF history (No AF; n = 8911). Propensity score matching was conducted between the CM4 and Untreated AF groups, and between the CM4 and No AF groups. RESULTS: Thirty-day mortality was similar between the matched groups. Kaplan-Meier analysis showed greater survival for CM4 compared to Untreated AF (P = .004). Ten-year survival was 62% for CM4 and 42% for Untreated AF. Adjusted hazard ratio was 0.47 (95% confidence interval, 0.26-0.86, P = .014). No difference in survival was found between CM4 and No AF groups with the Kaplan-Meier analysis (P = .847). Ten-year survival was 63% for CM4 and 55% for No AF. Adjusted hazard ratio was 1.03 (95% confidence interval, 0.51-2.11, P = .929). CONCLUSIONS: For selected patients with a history of AF undergoing cardiac surgery, concomitant CM4 did not add significantly to postoperative morbidity or mortality and was associated with improved late survival compared with patients with untreated AF and a similar survival to patients without a history of AF.

Positive Impact of an Aortic Center Designation.

BACKGROUND: In January 2015, we created a multidisciplinary Aortic Center with the collaboration of Vascular Surgery, Cardiac Surgery, Interventional Radiology, Anesthesia and Hospital Administration. We report the initial success of creating a Comprehensive Aortic Center. METHODS: All aortic procedures performed from January 1, 2015 until December 31, 2016 were entered into a prospectively collected database and compared with available data for 2014. Primary outcomes included the number of all aortic related procedures, transfer acceptance rate, transfer time, and proportion of elective/emergent referrals. RESULTS: The Aortic Center included 5 vascular surgeons, 2 cardiac surgeons, and 2 interventional radiologists. Workflow processes were implemented to streamline patient transfers as well as physician and operating room notification. Total aortic volume increased significantly from 162 to 261 patients. This reflected an overall 59% (P = 0.0167) increase in all aorta-related procedures. We had a 65% overall increase in transfer requests with 156% increase in acceptance of referrals and 136% drop in transfer denials (P < 0.0001). Emergent abdominal aortic cases accounted for 17% (n = 45) of our total aortic volume in 2015. The average transfer time from request to arrival decreased from 515 to 352 min, although this change was not statistically significant. We did see a significant increase in the use of air-transfers for aortic patients (P = 0.0041). Factorial analysis showed that time for transfer was affected only by air-transfer use, regardless of the year the patient was transferred. Transfer volume and volume of aortic related procedures remained stable in 2016. CONCLUSIONS: Designation as a comprehensive Aortic Center with implementation of strategic workflow systems and a culture of "no refusal of transfers" resulted in a significant increase in aortic volume for both emergent and elective aortic cases. Case volumes increased for all specialties involved in the center. Improvements in transfer center and emergency medical services communication demonstrated a trend toward more efficient transfer times. These increases and improvements were sustainable for 2 years after this designation.

Positive predictive value of cardiac examination, procedure and surgery codes in the Danish National Patient Registry: a population-based validation study.

OBJECTIVE: Danish medical registries are widely used for cardiovascular research, but little is known about the data quality of cardiac interventions. We computed positive predictive values (PPVs) of codes for cardiac examinations, procedures and surgeries registered in the Danish National Patient Registry during 2010-2012. DESIGN: Population-based validation study. SETTING: We randomly sampled patients from 1 university hospital and 2 regional hospitals in the Central Denmark Region. PARTICIPANTS: 1239 patients undergoing different cardiac interventions. MAIN OUTCOME MEASURE: PPVs with medical record review as reference standard. RESULTS: A total of 1233 medical records (99% of the total sample) were available for review. PPVs ranged from 83% to 100%. For examinations, the PPV was overall 98%, reflecting PPVs of 97% for echocardiography, 97% for right heart catheterisation and 100% for coronary angiogram. For procedures, the PPV was 98% overall, with PPVs of 98% for thrombolysis, 92% for cardioversion, 100% for radiofrequency ablation, 98% for percutaneous coronary intervention, and 100% for both cardiac pacemakers and implantable cardiac defibrillators. For cardiac surgery, the overall PPVs was 99%, encompassing PPVs of 100% for mitral valve surgery, 99% for aortic valve surgery, 98% for coronary artery bypass graft surgery, and 100% for heart transplantation. The accuracy of coding was consistent within age, sex, and calendar year categories, and the agreement between independent reviewers was high (99%). CONCLUSIONS: Cardiac examinations, procedures and surgeries have high PPVs in the Danish National Patient Registry.

Factors associated with prolonged length of stay following cardiac surgery in a major referral hospital in Oman: a retrospective observational study.

OBJECTIVES: Two objectives were set for this study. The first was to identify factors influencing prolonged postoperative length of stay (LOS) following cardiac surgery. The second was to devise a predictive model for prolonged LOS in the cardiac intensive care unit (CICU) based on preoperative factors available at admission and to compare it against two existing cardiac stratification systems. DESIGN: Observational retrospective study. SETTINGS: A tertiary hospital in Oman. PARTICIPANTS: All adult patients who underwent cardiac surgery at a major referral hospital in Oman between 2009 and 2013. RESULTS: 30.5% of the patients had prolonged LOS (≥11 days) after surgery, while 17% experienced prolonged ICU LOS (≥5 days). Factors that were identified to prolong CICU LOS were non-elective surgery, current congestive heart failure (CHF), renal failure, combined coronary artery bypass graft (CABG) and valve surgery, and other non-isolated valve or CABG surgery. Patients were divided into three groups based on their scores. The probabilities of prolonged CICU LOS were 11%, 26% and 28% for group 1, 2 and 3, respectively. The predictive model had an area under the curve of 0.75. Factors associated with prolonged overall postoperative LOS included the body mass index, the type of surgery, cardiopulmonary bypass machine use, packed red blood cells use, non-elective surgery and number of complications. The latter was the most important determinant of postoperative LOS. CONCLUSIONS: Patient management can be tailored for individual patient based on their treatments and personal attributes to optimise resource allocation. Moreover, a simple predictive score system to enable identification of patients at risk of prolonged CICU stay can be developed using data that are routinely collected by most hospitals.

Risk factors and outcomes of in-hospital cardiac arrest following pediatric heart operations of varying complexity.

BACKGROUND: Multi center data regarding cardiac arrest in children undergoing heart operations of varying complexity are limited. METHODS: Children <18 years undergoing heart surgery (with or without cardiopulmonary bypass) in the Virtual Pediatric Systems (VPS, LLC) Database (2009-2014) were included. Multivariable mixed logistic regression models were adjusted for patient's characteristics, surgical risk category (STS-EACTS Categories 1, 2, and 3 classified as "low" complexity and Categories 4 and 5 classified as "high" complexity), and hospital characteristics. RESULTS: Overall, 26,909 patients (62 centers) were included. Of these, 2.7% had cardiac arrest after cardiac surgery with an associated mortality of 31%. The prevalence of cardiac arrest was lower among patients undergoing low complexity operations (low complexity vs. high complexity: 1.7% vs. 5.9%). Unadjusted outcomes after cardiac arrest were significantly better among patients undergoing low complexity operations (mortality: 21.6% vs. 39.1%, good neurological outcomes: 78.7% vs. 71.6%). In adjusted models, odds of cardiac arrest were significantly lower among patients undergoing low complexity operations (OR: 0.55, 95% CI: 0.46-0.66). Adjusted models, however, showed no difference in mortality or neurological outcomes after cardiac arrest regardless of surgical complexity. Further, our results suggest that incidence of cardiac arrest and mortality after cardiac arrest are a function of patient characteristics, surgical risk category, and hospital characteristics. Presence of around the clock in-house attending level pediatric intensivist coverage was associated with lower incidence of post-operative cardiac arrest, and presence of a dedicated cardiac ICU was associated with lower mortality after cardiac arrest. CONCLUSIONS: This study suggests that the patients undergoing high complexity operations are a higher risk group with increased prevalence of post-operative cardiac arrest. These data further suggest that patients undergoing high complexity operations can be rescued after cardiac arrest with a high survival rate.

When is 'Urgent' Really Urgent and Does it Matter? Misclassification of Procedural Status and Implications for Risk Assessment in Cardiac Surgery.

BACKGROUND: Many patients classified as "urgent" in Australia New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) registry contradict the prescribed definition (surgery within 72hours of angiogram or unplanned admission). The aim was to examine the impacts of this misclassification on the prediction of 30-day mortality following cardiac surgery. METHODS: The 'reported clinical status' was compared with a 'corrected clinical status' following reclassification based on the standard definition calculated from raw data. Observed-to-predicted risk ratios (OPRs) of 30-day mortality were calculated for the model using reported status and corrected status and compared. A Bland-Altman plot was generated to examine the level of agreement between the two OPRs. RESULTS: Of 18496 cases reported as urgent, 49.9% were operated after 72hours, leading to misclassification of 14.6% in the registry. Misclassified patients had significantly higher mortality (3.5%) than true urgent patients (2.9%). Underweight (OR:1.6,CI:1.2-2.1), dialysis (OR:1.4,CI:1.1-1.7), endocarditis (OR:2.1,CI:1.7-2.5), shock (OR:1.6,CI:1.3-2.0) and poor ejection fraction (OR:1.2,CI:1.1-1.4) were significant predictors of misclassification. Bland- Altman plot demonstrates significant disagreement between two risk estimates (P<0.001). Misclassification results in overestimation of risk by 9.1%. Observed-to-predicted risk increased with corrected definition (0.8975 vs 0.9875), suggesting poorer calibration with reported status. CONCLUSIONS: In the ANZSCTS database, misclassification prevalence is 14.6%. Misclassification compromises the discrimination capacity and calibration of the model and results in overestimation of mortality risk.

Neurological complications of cardiac surgery.

As increasing numbers of elderly people undergo cardiac surgery, neurologists are frequently called upon to assess patients with neurological complications from the procedure. Some complications mandate acute intervention, whereas others need longer term observation and management. A large amount of published literature exists about these complications and guidance on best practice is constantly changing. Similarly, despite technological advances in surgical intervention and modifications in surgical technique to make cardiac procedures safer, these advances often create new avenues for neurological injury. Accordingly, rapid and precise neurological assessment and therapeutic intervention rests on a solid understanding of the evidence base and procedural variables.

Cardiovascular devices; reclassification of intra-aortic balloon and control systems for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure; effective date of requirement for premarket approval for intra-aortic balloon and control systems for septic shock or pulsatile flow generation. Final order.

The Food and Drug Administration (FDA) is issuing a final order to reclassify intra-aortic balloon and control system (IABP) devices when indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for IABPs when indicated for septic shock or pulsatile flow generation.