Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 55
Filter
1.
JAMA Intern Med ; 177(1): 79-86, 2017 01 01.
Article in English | MEDLINE | ID: mdl-27820610

ABSTRACT

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.


Subject(s)
Aortic Valve , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Medical Record Linkage , Product Surveillance, Postmarketing , Registries , England/epidemiology , Follow-Up Studies , Heart Valve Prosthesis Implantation/mortality , Humans , Outcome Assessment, Health Care , Reoperation/statistics & numerical data , Risk Factors , Survival Rate , Wales
2.
Innovations (Phila) ; 11(1): 15-23; discussion 23, 2016.
Article in English | MEDLINE | ID: mdl-26926521

ABSTRACT

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.


Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation/methods , Minimally Invasive Surgical Procedures/methods , Aged , Aged, 80 and over , Aortic Valve Stenosis/mortality , Female , Hospital Mortality , Humans , Length of Stay , Male , Middle Aged , Propensity Score , Randomized Controlled Trials as Topic , Retrospective Studies , Survival Analysis , Treatment Outcome
3.
Europace ; 18(10): 1521-1527, 2016 Oct.
Article in English | MEDLINE | ID: mdl-26850746

ABSTRACT

AIMS: We 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 RESULTS: Subset 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. CONCLUSIONS: Omega-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.


Subject(s)
Atrial Fibrillation/epidemiology , Connexin 43/metabolism , Connexins/metabolism , Coronary Artery Bypass/adverse effects , Fatty Acids, Omega-3/administration & dosage , Aged , Atrial Appendage/metabolism , Double-Blind Method , Electrocardiography , Female , Humans , Incidence , Male , Middle Aged , Multivariate Analysis , Postoperative Complications/epidemiology , Preoperative Care , RNA, Messenger/analysis , Regression Analysis , United Kingdom , Gap Junction alpha-5 Protein
4.
Ann Thorac Surg ; 101(5): 1670-6, 2016 May.
Article in English | MEDLINE | ID: mdl-26822345

ABSTRACT

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.


Subject(s)
Aorta/surgery , Databases, Factual , Elective Surgical Procedures/mortality , Hospital Mortality , Outcome Assessment, Health Care , Adult , Aged , Aged, 80 and over , Diagnosis-Related Groups , Female , Humans , Logistic Models , Male , Middle Aged , Retrospective Studies , Risk Factors
5.
Eur J Cardiothorac Surg ; 49(5): 1441-9, 2016 May.
Article in English | MEDLINE | ID: mdl-26586790

ABSTRACT

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.


Subject(s)
Coronary Artery Bypass/mortality , Coronary Artery Bypass/methods , Coronary Artery Disease/mortality , Coronary Artery Disease/surgery , Aged , Coronary Artery Bypass/statistics & numerical data , Coronary Artery Disease/epidemiology , Female , Humans , Kaplan-Meier Estimate , Male , Medical Audit , Middle Aged , Odds Ratio , Registries , Retrospective Studies , United Kingdom/epidemiology
6.
Eur J Cardiothorac Surg ; 49(4): 1164-73, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26276837

ABSTRACT

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.


Subject(s)
Aortic Valve/surgery , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve Stenosis/surgery , England , Female , Hospital Mortality , Humans , Length of Stay , Male , Middle Aged , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Transcatheter Aortic Valve Replacement/statistics & numerical data , Treatment Outcome , Wales
7.
BMJ Open ; 5(6): e008287, 2015 Jun 29.
Article in English | MEDLINE | ID: mdl-26124512

ABSTRACT

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.


Subject(s)
Cardiac Surgical Procedures/mortality , Hospital Mortality/trends , Length of Stay/statistics & numerical data , Postoperative Complications/mortality , Poverty , Registries/statistics & numerical data , Aged , England/epidemiology , Evidence-Based Medicine , Female , Humans , Life Style , Male , Middle Aged , Odds Ratio , Postoperative Complications/etiology , Poverty/statistics & numerical data , Prognosis , Prospective Studies , Risk Factors , Socioeconomic Factors
8.
Thorac Cardiovasc Surg ; 63(1): 58-66, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25291160

ABSTRACT

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.


Subject(s)
Cardiac Surgical Procedures , Liver Cirrhosis/complications , Blood Coagulation Disorders/etiology , Cardiac Surgical Procedures/mortality , Humans , Liver Cirrhosis/physiopathology , Liver Cirrhosis/therapy , Treatment Outcome
9.
Eur J Cardiothorac Surg ; 47(6): 1067-74, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25189704

ABSTRACT

OBJECTIVES: Biological 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. METHODS: Prospectively 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. RESULTS: A 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). CONCLUSIONS: There 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.


Subject(s)
Aortic Valve/surgery , Bioprosthesis/statistics & numerical data , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/mortality , Animals , Bicuspid Aortic Valve Disease , Bioprosthesis/adverse effects , Cattle , England , Female , Heart Defects, Congenital/surgery , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/adverse effects , Humans , Male , Postoperative Complications , Retrospective Studies , Swine , Treatment Outcome , Wales
10.
J R Soc Med ; 107(9): 355-64, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25193057

ABSTRACT

OBJECTIVES: To explore the relationship between in-hospital mortality following adult cardiac surgery and the time since primary clinical qualification for the responsible consultant cardiac surgeon (a proxy for experience). DESIGN: Retrospective analysis of prospectively collected national registry data over a 10-year period using mixed-effects multiple logistic regression modelling. Surgeon experience was defined as the time between the date of surgery and award of primary clinical qualification. SETTING: UK National Health Service hospitals performing cardiac surgery between January 2003 and December 2012. PARTICIPANTS: All patients undergoing coronary artery bypass grafts and/or valve surgery under the care of a consultant cardiac surgeon. MAIN OUTCOME MEASURES: All-cause in-hospital mortality. RESULTS: A total of 292,973 operations performed by 273 consultant surgeons (with lengths of service from 11.2 to 42.0 years) were included. Crude mortality increased approximately linearly until 33 years service, before decreasing. After adjusting for case-mix and year of surgery, there remained a statistically significant (p=0.002) association between length of service and in-hospital mortality (odds ratio 1.013; 95% CI 1.005-1.021 for each year of 'experience'). CONCLUSIONS: Consultant cardiac surgeons take on increasingly complex surgery as they gain experience. With this progression, the incidence of adverse outcomes is expected to increase, as is demonstrated in this study. After adjusting for case-mix using the EuroSCORE, we observed an increased risk of mortality in patients operated on by longer serving surgeons. This finding may reflect under-adjustment for risk, unmeasured confounding or a real association. Further research into outcomes over the time course of surgeon's careers is required.


Subject(s)
Cardiac Surgical Procedures/mortality , Hospital Mortality , Physicians , Thoracic Surgery , Adult , Aged , Clinical Competence , Consultants , Coronary Artery Bypass , Female , Heart Valves/surgery , Humans , Logistic Models , Male , Medical Audit , Middle Aged , Odds Ratio , Physicians/classification , Registries , Retrospective Studies , Risk Assessment , Time Factors , United Kingdom
11.
Circulation ; 129(23): 2395-402, 2014 Jun 10.
Article in English | MEDLINE | ID: mdl-24668286

ABSTRACT

BACKGROUND: Postinfarction ventricular septal defect carries a grim prognosis. Surgical repair offers reasonable outcomes in patients who survive a healing phase. Percutaneous device implantation represents a potentially attractive early alternative. METHODS AND RESULTS: Postinfarction ventricular septal defect closure was attempted in 53 patients from 11 centers (1997-2012; aged 72±11 years; 42% female). Nineteen percent had previous surgical closure. Myocardial infarction was anterior (66%) or inferior (34%). Time from myocardial infarction to closure procedure was 13 (first and third quartiles, 5-54) days. Devices were successfully implanted in 89% of patients. Major immediate complications included procedural death (3.8%) and emergency cardiac surgery (7.5%). Immediate shunt reduction was graded as complete (23%), partial (62%), or none (15%). Median length of stay after the procedure was 5.0 (2.0-9.0) days. Fifty-eight percent survived to discharge and were followed up for 395 (63-1522) days, during which time 4 additional patients died (7.5%). Factors associated with death after postinfarction ventricular septal defect closure included the following: age (hazard ratio [HR]=1.04; P=0.039), female sex (HR=2.33; P=0.043), New York Heart Association class IV (HR=4.42; P=0.002), cardiogenic shock (HR=3.75; P=0.003), creatinine (HR=1.007; P=0.003), defect size (HR=1.09; P=0.026), inotropes (HR=4.18; P=0.005), and absence of revascularization therapy for presenting myocardial infarction (HR=3.28; P=0.009). Prior surgical closure (HR=0.12; P=0.040) and immediate shunt reduction (HR=0.49; P=0.037) were associated with survival. CONCLUSIONS: Percutaneous closure of postinfarction ventricular septal defect is a reasonably effective treatment for these extremely high-risk patients. Mortality remains high, but patients who survive to discharge do well in the longer term.


Subject(s)
Cardiac Catheterization , Heart Septal Defects, Ventricular/mortality , Heart Septal Defects, Ventricular/surgery , Myocardial Infarction/mortality , Septal Occluder Device/statistics & numerical data , Aged , Aged, 80 and over , Female , Follow-Up Studies , Heart Septal Defects, Ventricular/etiology , Hospital Mortality , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Myocardial Infarction/complications , Prognosis , Risk Factors , Shock, Cardiogenic/etiology , Shock, Cardiogenic/mortality , United Kingdom/epidemiology
12.
Eur J Cardiothorac Surg ; 45(2): 225-33, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24071864

ABSTRACT

The Society for Cardiothoracic Surgery in Great Britain and Ireland (SCTS) has published named mortality data since 2001. The importance of accurate and robust clinical outcome reporting has been emphasized by a number of high-profile cases in England. In this article, we give a technical review of the United Kingdom National Adult Cardiac Surgery Governance Analysis 2008-11. The statistical and analytical assumptions and methods are discussed in order to add an additional layer of transparency to the clinical governance process and precipitate scrutiny with the aim of optimizing future analyses.


Subject(s)
Cardiac Surgical Procedures/legislation & jurisprudence , Cardiac Surgical Procedures/statistics & numerical data , Humans , Prospective Studies , Registries , Risk Adjustment , Risk Factors , Treatment Outcome , United Kingdom
13.
Heart ; 100(6): 500-7, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24345391

ABSTRACT

OBJECTIVE: Current guidelines recommend that most patients aged ≥65 years should undergo mitral valve replacement (MVR) using a biological prosthesis. The objectives of this study were to assess whether these guidelines are being followed in UK practice, and to investigate whether the guidelines are appropriate based on in-hospital mortality and mid-term survival. METHODS: Data from the National Institute for Cardiovascular Outcomes Research Adult Cardiac Surgery Audit database from all National Health Service (NHS) hospitals and some private hospitals performing adult cardiac surgery in the UK between April 2001 and March 2011 were analysed. The overall cohort included 3862 patients aged ≥65 years who underwent first-time MVR. Propensity score matching and regression adjustment were used to compare outcomes between prosthesis groups. RESULTS: The mean age was 73.0 years (SD 4.9) with 50% of patients having surgery with a mechanical prosthesis. This proportion decreased over the study period and with increasing patient age with marked variation between hospitals. In the propensity-matched cohort, in-hospital mortality in the biological group was 6.9%, and in the mechanical group it was 5.9% giving an unadjusted OR of 1.17 (95% CI 0.84 to 1.63). There was no significant difference in mid-term survival between the matched groups with an unadjusted HR for biological prosthesis of 1.08 (95% CI 0.93 to 1.24). Similar results were found when using regression adjustment on unmatched data. CONCLUSIONS: Current guidelines concerning age and mitral valve prosthesis choice are not being followed for patients aged ≥65 years. With regards to in-hospital and mid-term mortality, this study demonstrates that there is no difference between prosthesis types.


Subject(s)
Guideline Adherence , Heart Valve Diseases/surgery , Heart Valve Prosthesis , Mitral Valve/surgery , Practice Guidelines as Topic , Aged , Bioprosthesis , Female , Follow-Up Studies , Heart Valve Diseases/mortality , Hospital Mortality/trends , Humans , Male , Prospective Studies , Prosthesis Design , Survival Rate/trends , Treatment Outcome , United Kingdom/epidemiology
14.
Circ Cardiovasc Qual Outcomes ; 6(6): 649-58, 2013 Nov.
Article in English | MEDLINE | ID: mdl-24150044

ABSTRACT

BACKGROUND: The calibration of several cardiac clinical prediction models has deteriorated over time. We compare different model fitting approaches for in-hospital mortality after cardiac surgery that adjust for cross-sectional case mix in a heterogeneous patient population. METHODS AND RESULTS: Data from >300 000 consecutive cardiac surgery procedures performed at all National Health Service and some private hospitals in England and Wales between April 2001 and March 2011 were extracted from the National Institute for Cardiovascular Outcomes Research clinical registry. The study outcome was in-hospital mortality. Model approaches included not updating, periodic refitting, rolling window, and dynamic logistic regression. Covariate adjustment was made in each model using variables included in the logistic European System for Cardiac Operative Risk Evaluation model. The association between in-hospital mortality and some variables changed with time. Notably, the intercept coefficient has been steadily decreasing during the study period, consistent with decreasing observed mortality. Some risk factors, such as operative urgency and postinfarct ventricular septal defect, have been relatively stable over time, whereas other risk factors, such as left ventricular function and surgery on the thoracic aorta, have been associated with lower risk relative to the static model. CONCLUSIONS: Dynamic models or periodic model refitting is necessary to counteract calibration drift. A dynamic modeling framework that uses contemporary and available historic data can provide a continuously smooth update mechanism that also allows for inferences to be made on individual risk factors. Better models that withstand the effects of time give advantages for governance, quality improvement, and patient-level decision making.


Subject(s)
Computer Simulation , Thoracic Surgery/statistics & numerical data , Age Factors , England , Hospital Mortality , Humans , Logistic Models , Population Groups , Risk Assessment , Risk Factors , Sex Factors , Thoracic Surgery/methods , Treatment Outcome
17.
Eur J Cardiothorac Surg ; 44(3): e175-80, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23786918

ABSTRACT

OBJECTIVES: Continuous monitoring of surgical outcomes through benchmarking and the identification of best practices has become increasingly important. A structured approach to data collection, coupled with validation, analysis and reporting, is a powerful tool in these endeavours. However, inconsistencies in standards and practices have made comparisons within and between European countries cumbersome. The European Association for Cardio-Thoracic Surgery (EACTS) has established a large international database with the goals of (i) working with other organizations towards universal data collection and creating a European-wide repository of information on the practice of cardio-thoracic surgery, and (ii) disseminating that information in scientific, peer-reviewed articles. We report on the process of data collection, as well as on an overview of the data in the database. METHODS: The EACTS Database Committee met for the first time in Monaco, September 2002, to establish the ground rules for the process of setting up the database. Subsequently, data have been collected and merged by Dendrite Clinical Systems Ltd. RESULTS: As of December 2008, the database included 1,074,168 patient records from 366 hospitals located in 29 countries. The latest submission from the years 2006-08 included 404,721 records. The largest contributors were the UK (32.0%), Germany (20.9%) and Belgium (7.3%). Isolated coronary bypass surgery was the most frequently performed operation; the proportion of surgical workload that comprised isolated coronary artery bypass grafting varied from country to country: 30% in Spain and almost 70% in Denmark. Isolated valve procedures constituted 12% of all procedures in Norway and 32% in Spain. Baseline demographics showed an increase in the mean age and the percentage of patients that were female over time. Remarkably, the mortality rates for all procedures declined over the period analysed, to 2.2% (95% confidence interval [CI] 2.2-2.3%) for isolated coronary bypass, 3.4% (95% CI 3.3-3.5%) for isolated valve and 6.2% (95% CI 6.0-6.5%) for bypass + valve procedures. CONCLUSION: The EACTS database has proven to be an important step forward in providing opportunities for monitoring cardiac surgical care across Europe. As the database continues to expand, it will facilitate research projects, establish benchmarking standards and identify potential areas for quality improvements.


Subject(s)
Databases, Factual , Registries , Societies, Medical , Thoracic Surgical Procedures , Europe , Humans
18.
Anadolu Kardiyol Derg ; 13(4): 414-21, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23591588

ABSTRACT

This review covers the important publications in adult cardiac surgery in the last few years, including the current evidence base for surgical revascularisation and the use of off-pump surgery, bilateral internal mammary arteries and endoscopic vein harvesting. The changes in conventional aortic valve surgery are described alongside the outcomes of clinical trials and registries for transcatheter aortic valve implantation, and the introduction of less invasive and novel approaches of conventional aortic valve replacement surgery. Surgery for mitral valve disease is also considered, with particular reference to surgery for asymptomatic degenerative mitral regurgitation.


Subject(s)
Cardiac Surgical Procedures , Evidence-Based Medicine , Periodicals as Topic , Humans
19.
Rev. urug. cardiol ; 28(1): 71-82, abr. 2013.
Article in Spanish | LILACS | ID: biblio-962308

ABSTRACT

Resumen Esta revisión abarca las publicaciones más importantes en cirugía cardíaca en adultos de los últimos años; incluye la base de la evidencia actual sobre la revascularización quirúrgica y el uso de la cirugía sin circulación extracorpórea (CEC), los procedimientos con arterias mamarias internas bilaterales y la extracción de venas por vía endoscópica. Se describen los cambios en la cirugía convencional de la válvula aórtica junto con los resultados de los ensayos clínicos y los registros de implantación de válvula aórtica transcatéter, así como la introducción de métodos menos invasivos y novedosos de la cirugía convencional de reemplazo de la válvula aórtica. Asimismo, se considera la cirugía de valvulopatía mitral, haciendo especial referencia a la cirugía para el tratamiento de la insuficiencia mitral asintomática de causa degenerativa


Summary This review covers the important publications in adult cardiac surgery in the last few years, including the current evidence base for surgical revascularisation and the use of off-pump surgery, bilateral internal mammary arteries and endoscopic vein harvesting. The changes in conventional aortic valve surgery are described alongside the outcomes of clinical trials and registries for transcatheter aortic valve implantation, and the introduction of less invasive and novel approaches of conventional aortic valve replacement surgery. Surgery for mitral valve disease is also considered, with particular reference to surgery for asymptomatic degenerative mitral regurgitation

SELECTION OF CITATIONS
SEARCH DETAIL
...