No abstract

Results-There were significant diVerences (p < 0.05) between the British and American populations from which the STS risk algorithm was derived with respect to most variables. The observed mortality in the British population was 3.7% (65 of 1774). The mean predicted mortality by STS score, PACCN, Parsonnet score, and UK algorithms were 1.1%, 1.6%, 4.6%, and 4.7% respectively. The overall predictive ability of the models as measured by the area under the receiver operating characteristic curve were 0.64, 0.60, 0.73, and 0.75, respectively. Conclusions-There are diVerences between the British and American populations for CABG and the North American algorithms are not useful for predicting mortality in the United Kingdom. The UK Society of Cardiothoracic Surgeons algorithm is the best of the models tested but still only has limited predictive ability. Great care must be exercised when using methods of this type for comparisons of units and surgeons. (Heart 1998;79:350-355)

Valve repair, where feasible, rather than valve replacement is the guideline recommended treatment for severe mitral regurgitation. To characterise 'real-world' clinical practice data were reviewed on 12,255 mitral valve operations performed in the UK between 2004 and 2008, as reported in the 2009 UK Adult Cardiac Surgical Database Report. The data demonstrate a large variation in the use of mitral valve repair; while the national repair rate was 51%, this varied from 20% to 90% among different hospitals. Outcomes were worse in patients who had valve replacement as opposed to repair, including a higher risk of operative mortality and stroke, in all subgroups examined. Some patients were, by virtue of the hospitals they attend, therefore, less likely to survive and more likely to have complications, because of a low use of valve repair in those centres. Concentration of mitral valve surgery in designated regional reference centres should allow more equitable access to mitral valve repair.

Post-market evidence generation for medical devices is important yet limited for prosthetic aortic valve devices in the United Kingdom (UK). Objective: To identify prosthetic aortic valve models that display unexpected patterns of mortality or re-intervention using routinely collected national registry data and record linkage. Design: Observational study using the UK National Adult Cardiac Surgery Audit (NACSA) registry for procedures performed between 1998 and 2013. 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 (pre-)operative covariates. Setting: All National Health Service and private hospitals in England and Wales who submit data to the NACSA registry. Patients and Interventions: All patients undergoing first-time elective and urgent aortic valve replacement surgery (± coronary artery bypass graft) with a mechanical (n=10 series) or biological (n=15 series) prosthetic valve from 5 primary suppliers, and satisfying pre-specified data quality criteria were included (n=43,782 biological, n=11,084 mechanical). Main Outcome Measures: Time to all-cause mortality or aortic valve re-intervention (surgical or trans-catheter). There were 13,104 deaths and 723 re-interventions during follow-up. Results: Two series of valves were associated with significantly increased hazard of death or reintervention were identified: Sorin Biological Series (frailty 1.18 [95%PI: 1.06 to 1.32]) and 4 Sorin Mitroflow series (frailty 1.19 [95%PI: 1.09 to 1.31]). These results were robust to covariate adjustment, and sensitivity analyses. Three biological valve series were associated with significantly decreased hazard. Conclusions: Meaningful evidence from the analysis of routinely-collected registry data can inform post-market surveillance of medical devices. Although the findings are associated with a number of caveats, two specific biological aortic valve series identified in this study may warrant further investigation.