Importance Postmarket evidence generation for medical devices is important yet limited for prosthetic aortic valve devices in the United Kingdom. Objective To identify prosthetic aortic valve models that display unexpected patterns of mortality or reintervention using routinely collected national registry data and record linkage. Design, Setting, and Participants This observational study used data from all National Health Service and private hospitals in England and Wales that submit data to the National Adult Cardiac Surgery Audit (NACSA). All patients undergoing first-time elective and urgent aortic valve replacement surgery (with or without coronary artery bypass grafting) with a biological (n = 15 series) or mechanical (n = 10 series) prosthetic valve from 5 primary suppliers, and satisfying prespecified data quality criteria (n = 43 782 biological; n = 11 084 mechanical) between 1998 and 2013 were included. Valves were classified into series of related models. Outcome tracking was performed using multifaceted record linkage. The median follow-up was 4.1 years (maximum, 15.3 years). Cox proportional hazards regression with random effects (frailty models) were used to model valve effects on the outcomes, with and without adjustment for preoperative and intraoperative covariates. Main Outcomes and Measures Time to all-cause mortality or aortic valve reintervention (surgical or transcatheter). There were 13 104 deaths and 723 reinterventions during follow-up. Results Of 79 345 isolated aortic valve replacement procedures with or without coronary artery bypass grafting, 54 866 were analyzed. Biological valve implantation rates increased from 59% in 1998 and 1999 to 86% in 2012 and 2013. Two series of valves associated with significantly increased hazard of death or reintervention were identified (first series: frailty, 1.18; 95% prediction interval [PI], 1.06-1.32 and second series: frailty, 1.19; 95% PI, 1.09-1.31). These results were robust to covariate adjustment and sensitivity analyses. There were 3 prosthetic valves with a significant reduction in hazard (valve 1: frailty, 0.88; 95% PI, 0.80-0.96; valve 2: frailty, 0.88; 95% PI, 0.80-0.96; and valve 3: frailty, 0.88; 95% PI, 0.78-0.98). Conclusions and Relevance Meaningful evidence from the analysis of routinely collected registry data can inform postmarket surveillance of medical devices. Although the findings are associated with a number of caveats, 2 specific biological aortic valve series identified in this study may warrant further investigation.

AIMSWe previously reported omega-3 polyunsaturated fatty acids (n-3PUFAs) supplementation does not reduce atrial fibrillation (AF) following coronary artery bypass graft (CABG) surgery. The aim of the present study is to evaluate the impact of n-3 PUFAs on electrocardiogram (ECG) atrial arrhythmic markers and compare with expression of gap-junction proteins, Connexins.METHODS AND RESULTSSubset of clinical trial subjects with right atrial sampling during CABG surgery included. Twelve-lead ECG performed at recruitment and at surgery [after supplementation with n-3 PUFA (∼1.8 g/day) or matched placebo] for ∼14 days. Electrocardiograms analysed for maximum P-wave duration (P-max) and difference between P-max and minimum P-wave duration, P-wave dispersion (PWD). Right atrial specimens analysed for expression of Connexins 40 and 43 using real-time quantitative polymerase chain reaction (qPCR) and western blot. Serum levels of n-3 PUFA at baseline, at surgery, and atrial tissue levels at surgery collated from file. Postoperative AF was quantified by analysing data from stored continuous electrograms. A total of 61 patients (n-3 PUFA 34, Placebo 27) had ECG analysis and AF burden, of which 52 patients (26 in each group) had qPCR and 16 (8 in each group) had western blot analyses for Connexins 40 and 43. No difference between the two groups in ECG parameters or expression of Connexin 40 or 43. P-wave dispersion in the preoperative ECG independently predicted occurrence of AF following CABG surgery.CONCLUSIONSOmega-3 polyunsaturated fatty acids supplementation does not alter pro-arrhythmic P-wave parameters in ECG or connexin expression in human atrium with no effect on the incidence of AF following CABG surgery.

Objective Minimally invasive aortic valve replacement (MIAVR) has been demonstrated as a safe and effective option but remains underused. We aimed to evaluate outcomes of isolated MIAVR compared with conventional aortic valve replacement (CAVR). Methods Data from The National Institute for Cardiovascular Outcomes Research (NICOR) were analyzed at seven volunteer centers (2006–2012). Primary outcomes were in-hospital mortality and midterm survival. Secondary outcomes were postoperative length of stay as well as cumulative bypass and cross-clamp times. Propensity modeling with matched cohort analysis was used. Results Of 307 consecutive MIAVR patients, 151 (49%) were performed during the last 2 years of study with a continued increase in numbers. The 307 MIAVR patients were matched on a 1:1 ratio. In the matched CAVR group, there was no statistically significant difference in in-hospital mortality [MIAVR, 4/307,(1.3%); 95% confidence interval (CI), 0.4%-3.4% vs CAVR, 6/307 (2.0%); 95% CI, 0.8%-4.3%; P = 0.752]. One-year survival rates in the MIAVR and CAVR groups were 94.4% and 94.6%, respectively. There was no statistically significant difference in midterm survival (P = 0.677; hazard ratio, 0.90; 95% CI, 0.56–1.46). Median postoperative length of stay was lower in the MIAVR patients by 1 day (P = 0.009). The mean cumulative bypass time (94.8 vs 91.3 minutes; P = 0.333) and cross-clamp time (74.6 vs 68.4 minutes; P = 0.006) were longer in the MIAVR group; however, this was significant only in the cross-clamp time comparison. Conclusions Minimally invasive aortic valve replacement is a safe alternative to CAVR with respect to operative and 1-year mortality and is associated with a shorter postoperative stay. Further studies are required in high-risk (logistic EuroSCORE > 10) patients to define the role of MIAVR.

OBJECTIVES To determine if the use of cardiopulmonary bypass is associated with all-cause in-hospital and mid-term survival for patients undergoing left internal mammary artery (LIMA) to left anterior descending (LAD) coronary artery bypass grafting (CABG) for single coronary vessel disease. METHODS Data from the National Adult Cardiac Surgery Audit registry for all elective and urgent isolated CABG procedures performed between April 2003 and March 2013 in first-time cardiac surgery patients were extracted. Experienced surgeons (those with ≥300 records) were classified by their technique preference (as 'off-pump preference', 'mixed practice', 'on-pump preference') based on their entire isolated CABG data. In-hospital mortality and time to death were analysed using logistic and Cox proportional hazards regression models, respectively. RESULTS From a total of 3402 records, 65.5% were performed off-pump. There were 16 (0.47%) in-hospital deaths: 6 (0.51%) in the on-pump group and 10 (0.45%) in the off-pump group. The risk-adjusted odds ratio of in-hospital mortality in the direction of on-pump was 1.09 [95% confidence interval (CI): 0.39-3.04; P = 0.86]. The overall 5-year survival in the on- and off-pump groups was 93.1 and 93.4%, respectively. The adjusted hazard ratio (HR) for mortality in the direction of on-pump CABG was 1.15 (95% CI: 0.89-1.49; P = 0.28). Comparing off-pump cases performed by experienced CABG surgeons with a preference for the off-pump technique with on-pump cases performed by surgeons with a preference for the on-pump technique indicated a significant difference (HR for on-pump = 1.72; 95% CI: 1.19-2.47; P = 0.004). CONCLUSIONS Elective and urgent first-time CABG for isolated LAD disease is associated with excellent mid-term survival in the England and Wales population, conferring a 5-year survival rate of 93.1 and 93.4% in the on-pump and off-pump groups, respectively. There was no difference in risk-adjusted survival between the on-pump and off-pump techniques when analysing all procedures; however, supportive analysis demonstrated that off-pump surgery performed by experienced surgeons with a preference for the off-pump technique in their CABG caseload is associated with improved mid-term survival when compared with on-pump surgery performed by surgeons with a preference for the on-pump technique.

Background. To facilitate patient choice and the risk adjustment of consultant outcomes in aortic operations, reliable predictive tools are required. Our objective was to develop a risk prediction model for in-hospital mortality after operation on the proximal aorta.Methods. Data for 8641 consecutive UK patients undergoing proximal aortic operation from the National Institute for Cardiovascular Outcomes Research database from April 2007 to March 2013 were analyzed. Multivariable logistic regression was used to identify independent predictors of in-hospital mortality. Model calibration and discrimination were assessed.Results. In-hospital mortality was 4.6% in elective operations and 16.5% in nonelective operations. In the elective model, previous cardiac operation (adjusted odds ratio [OR] 4.1, 95% confidence interval [CI]: 3.0 to 4.7) and ejection fraction greater than 30% (adjusted OR 2.3, 95% CI: 1.7 to 3.1) were the strongest predictors of mortality (p < 0.001). The area under the receiver operating characteristic (AUROC) curve was 0.805 (95% CI: 0.802 to 0.807) with a bias-corrected value of 0.795. Model calibration was acceptable (p = 0.427) on the basis of the Hosmer-Lemeshow goodness-of-fit test. In the nonelective model, salvage operations (adjusted OR 9.9, 95% CI: 6.5 to 15.2) and previous cardiac operation (adjusted OF 3.9, 95% CI: 3.0 to 5.0) were the strongest predictors of mortality (p < 0.001). The AUROC curve was 0.761 (95% CI: 0.761 to 0.765) with a bias-corrected value of 0.756, and model calibration was also found to be acceptable (p = 0.616).Conclusions. We propose the use of these risk models to improve patient choice and to enhance patients' awareness of risks and risk-adjust aortic operation outcomes for case-mix. (C) 2016 by The Society of Thoracic Surgeons

GENERAL COMMENTS Barnard and colleges undertake a retrospective analysis of a national cohort of nearly a quarter of a million patients who received cardiothoracic surgery between 2003 and 2013. The authors suggest that socio-economic status (SES), quantified using the Index of Multiple Deprivation composite score, is associated with both early and late all-cause mortality. The authors note that SES is not routinely accounted for when considering variation in mortality rates from cardiothoracic surgery, and suggest that because IMD predicts outcome, this Index could be considered in future provider performance analyses.

This chapter contains sections titled: Introduction Presentation and analysis of data Dealing with outlying performance Summary References

Objectives The objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation (TAVI), regardless of technology or access route, and to evaluate their clinical outcome over the mid to long term.Background Although a substantial body of data exists in relation to early clinical outcomes after TAVI, there are few data on outcomes beyond 1 year in any notable number of patients.Methods The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry was established to report outcomes of all TAVI procedures performed within the United Kingdom. Data were collected prospectively on 870 patients undergoing 877 TAVI procedures up until December 31, 2009. Mortality tracking was achieved in 100% of patients with mortality status reported as of December 2010.Results Survival at 30 days was 92.9%, and it was 78.6% and 73.7% at 1 year and 2 years, respectively. There was a marked attrition in survival between 30 days and 1 year. In a univariate model, survival was significantly adversely affected by renal dysfunction, the presence of coronary artery disease, and a nontransfemoral approach; whereas left ventricular function (ejection fraction <30%), the presence of moderate/ severe aortic regurgitation, and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multi-variate model.Conclusions Midterm to long-term survival after TAVI was encouraging in this high-risk patient population, although a substantial proportion of patients died within the first year. (J Am Coll Cardiol 2011;58:2130-8) (C) 2011 by the American College of Cardiology Foundation

OBJECTIVESBiological valves are the most commonly implanted prostheses for aortic valve replacement (AVR) surgery in the UK. The aim of this study was to compare performance of porcine and bovine pericardial valves implanted in AVR surgery with respect to survival and reintervention-free survival in a retrospective observational study.METHODSProspectively collected clinical data for all first-time elective and urgent AVRs with or without concomitant coronary artery bypass graft (CABG) surgery performed in England and Wales between April 2003 and March 2013 were extracted from the National Institute for Cardiovascular Outcomes Research database. Patient life status was tracked from the Office for National Statistics. Time-to-event analyses were performed using log-rank tests and Cox proportional hazards regression modelling with random effects/grouped frailty for responsible cardiac surgeons.RESULTSA total of 38,040 patients were included (64.9% bovine pericardial; 35.1% porcine). Patient characteristics were similar between the groups. The median follow-up was 3.6 years. There was no statistically significant difference in survival (P = 0.767) (the 10-year survival rates were 49.0 and 50.3% in the bovine pericardial and porcine groups, respectively) or reintervention-free survival. The adjusted hazard ratio for porcine valves was 0.98 (95% confidence interval 0.93-1.03). Sensitivity analysis in small valve sizes showed no difference in reintervention-free survival. After adjustment, there was some evidence of a protective effect for porcine valves in relatively younger patients (P = 0.075).CONCLUSIONSThere were no differences in reintervention-free survival between bovine pericardial and porcine valves used in first-time AVR ± CABG up to a maximum of 10 years.

Collecting data on clinical practice, including activity, case mix and clinical outcomes, is key to improving quality of care and supporting patient decision making. Publishing the data helps to maintain public trust. There are numerous options that can be employed, including routine audit of all practice or targeted approaches to areas of special interest or concern. Data can include routine clinical or administrative data or bespoke clinical datasets and the methodology utilized should be robust. All departments should have a well-considered audit strategy embedded within their clinical and management systems.

The intra-aortic balloon pump (IABP) is a mechanical device designed to support the failing or ischaemic myocardium. It is usually inserted percutaneously through the femoral arteries, with the tip just distal to the left subclavian artery. The principle lies in diastolic counterpulsation (augmentation) that inflates at the start of diastole and deflates just before systole. This allows increased coronary perfusion during diastole and also reduces the impedance to forward flow during systole. This scenario of reduced cardiac workload and increased supply of oxygen results in increased cardiac output. Indications include mechanical complications of myocardial infarction, refractory unstable angina, high-risk cardiac surgery, and support of the failing myocardium before transplantation. Contraindications include aortic dissection, aortic regurgitation and severe peripheral vascular disease.

OBJECTIVES:Social deprivation impacts on healthcare outcomes but is not included in the majority of cardiac surgery risk prediction models. The objective was to investigate geographical variations in social deprivation of patients undergoing cardiac surgery and identify whether social deprivation is an independent predictor of outcomes. METHODS:National Adult Cardiac Surgery Audit data for coronary artery bypass graft (CABG), or valve surgery performed in England between April 2003 and March 2013, were analysed. Base hospitals in England were divided into geographical regions. Social deprivation was measured by quintile groups of the index of multiple deprivation (IMD) score with the first quintile group (Q1) being the least, and the last quintile group (Q5) the most deprived group. In-hospital mortality and midterm survival were analysed using mixed effects logistic, and stratified Cox proportional hazards regression models respectively. RESULTS:240,221 operations were analysed. There was substantial regional variation in social deprivation with the proportion of patients in IMD Q5 ranging from 34.5% in the North East to 6.5% in the East of England. Following adjustment for preoperative risk factors, patients undergoing all cardiac surgery in IMD Q5 were found to have an increased risk of in-hospital mortality relative to IMD Q1 (OR=1.13; 95%CI 1.03 to 1.24), as were patients undergoing isolated CABG (OR=1.19; 95%CI 1.03 to 1.37). For midterm survival, patients in IMD Q5 had an increased hazard in all groups (HRs ranged between 1.10 (valve+CABG) and 1.26 (isolated CABG)). For isolated CABG, the median postoperative length of stay was 6 and 7 days, respectively, for IMD Q1-Q4 and Q5. CONCLUSIONS:Significant regional variation exists in the social deprivation of patients undergoing cardiac surgery in England. Social deprivation is associated with an increased risk of in-hospital mortality and reduced midterm survival. These findings have implications for health service provision, risk prediction models and analyses of surgical outcomes.

Increasing prevalence of hepatic disease is likely to translate in a growing number of patients with significant hepatic disease requiring cardiac surgery. Available cardiac risk stratification models do not address the risk associated with hepatic disease. However, weighted mean mortality rates based on previous studies of cardiac surgery in patients with hepatic disease demonstrate operative mortality rates that range from 9.88% (standard deviation [SD] 9.69) for patients in Child-Turcotte-Pugh (CTP) class A cirrhosis to 69.23% (SD 28.55) for patients with CTP class C cirrhosis. This review comprehensively appraises the pathophysiology of hepatic disease, reported clinical outcomes and considerations for risk stratification.

I t would be easy to read the article from Westaby and colleagues and come to the conclusion that UK medical policymakers had completely lost the plot. If you take what the authors say at face value, the programme to publish named surgeons’ outcomes has proved to be a terrible mistake in the US and is now creating carnage in the UK. What you might also conclude is that the RCS has been ‘duped’ into giving support to a fatally flawed initiative. Why is there such a difference in perspective? The public accountability agenda in surgery is unpopular with some surgeons. It is part of a wider initiative of transparency driven by the government. But it was not, as Westaby suggests, the government that was originally responsible for the recommendation to report surgeons’ outcomes as a ‘punitive post-Bristol political directive’. It came from Sir Ian Kennedy, a lawyer, in the Bristol Public Inquiry report back in 2001. Those recommendations were fulfilled for adult cardiac surgery in 2005, but other specialties lagged behind. When Robert Francis heard the evidence associated with the events at Mid Staffs, he came up with a similar view. The current consultant outcomes publication programme across 13 specialties is the response. So is this all directly antagonistic to the evidence from the US? The argument is, of course, much more subtle. Public reporting was introduced in the US in New York State in 1990 and has been in place in some other states also. The pertinent questions posed by Hannan et al in a recent review of the NY experiences are: Does it improve quality? Are there unintended negative consequences? Does it act to maintain trust in hospitals and the medical profession? There are quite a lot of data on all of this, but they are generally of fairly low level and not all of them are cited by Westaby and colleagues. For example, some major database studies have shown

Transcatheter aortic valve implantation (TAVI) is a treatment for patients with aortic stenosis deemed high risk for aortic valve replacement (AVR). Advancing age independently predictors mortality after AVR, so that most patients undergoing TAVI are elderly. This study presents UK trends in

Monitoring the real-time physiological status of patients in intensive care following surgery is essential to predict and prevent deterioration. Most of the scoring systems currently available are offline and static, cannot detect multi-dimensional trends, rely on arbitrary thresholds to generate alarms and cannot be customised for each patient. Waveform data such as electrocardiograms carry a vast amount of information about the underlying health state of an individual; most of these data is constantly recorded but most of the acquired information is never processed or analysed. Using a Bayesian statistical modelling approach, we present a real-time adaptive dynamic monitoring system sensitive to internal variability.

OBJECTIVES The first transcatheter aortic valve implantation (TAVI) in England and Wales was performed in 2007. This study presents the subsequent national activity and outcomes for both TAVI and aortic valve replacement (AVR). METHODS Data for all AVR and TAVI procedures between January 2006 and December 2012 in England and Wales were included. The number of procedures, patient characteristics, in-hospital and 30-day mortality, postoperative length of stay (PLOS) and survival were analysed separately for: isolated AVR; AVR + coronary artery bypass graft (CABG) surgery; AVR + other surgery and TAVI. RESULTS The number of TAVIs increased from 66 in 2007 (0.8% of all implants) to 1186 in 2012 (10.9% of all implants). AVR activity also increased over the study period. TAVI patients were older and had a higher mean logistic EuroSCORE than all AVR groups. The 30-day mortality rates were 2.1% for isolated AVR, 3.9% for AVR + CABG, 7.7% for AVR + other surgery and 6.2% for TAVI. In-hospital mortality has significantly improved for all groups. The 5-year survival rates were 82.6% for isolated AVR, 81.7% for AVR + CABG, 74.5% for AVR + other surgery and 46.1% for TAVI. The median PLOS after TAVI was similar to that of isolated AVR but shorter than that of the other AVR groups. CONCLUSIONS Since the introduction of TAVI, there has been an increase in both TAVI and AVR activity. TAVIs now represent over 10% of all aortic valve implants. There are distinct differences between procedural groups with respect to patient risk factors. Outcomes for all procedural groups have improved, but long-term TAVI results are required before its role in the treatment of aortic stenosis can be fully defined.