Mini-Stern Trial: A randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement.

OBJECTIVE: Aortic valve replacement (AVR) can be performed either through full median sternotomy (FS) or upper mini-sternotomy (MS). The Mini-Stern trial aimed to establish whether MS leads to quicker postoperative recovery and shorter hospital stay after first-time isolated AVR. METHODS: This pragmatic, open-label, parallel randomized controlled trial (RCT) compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals. Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analyzed in the intent-to-treat population. RESULTS: In this RCT, 222 patients were recruited and randomized (n = 118 in the MS group; n = 104 in the FS group). Compared with the FS group, the MS group had a longer hospital length of stay (mean, 9.5 days vs 8.6 days) and took longer to achieve fitness for discharge home (mean, 8.5 days vs 7.5 days). Adjusting for valve type, sex, and surgeon, hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR, 0.874; 95% confidence interval [CI], 0.668-1.143; P = .3246) or time to fitness for discharge (HR, 0.907; 95% CI, 0.688-1.197; P value = .4914). During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group), 12 patients (10%) in the MS group and 7 patients (7%) in the FS group died (HR, 1.871; 95% CI, 0.723-4.844; P = .1966). Average extra cost for MS was £1714 during the first 12 months after AVR. CONCLUSIONS: Compared with FS for AVR, MS did not result in shorter hospital stay, faster recovery, or improved survival and was not cost-effective. The MS approach is not superior to FS for performing AVR.

Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation.

OBJECTIVES: Atrial fibrillation (AF) reduces survival and quality of life (QoL). It can be treated at the time of major cardiac surgery using ablation procedures ranging from simple pulmonary vein isolation to a full maze procedure. The aim of this study is to evaluate the impact of adjunct AF surgery as currently performed on sinus rhythm (SR) restoration, survival, QoL and cost-effectiveness. METHODS: In a multicentre, Phase III, pragmatic, double-blinded, parallel-armed randomized controlled trial, 352 cardiac surgery patients with >3 months of documented AF were randomized to surgery with or without adjunct maze or similar AF ablation between 2009 and 2014. Primary outcomes were SR restoration at 1 year and quality-adjusted life years at 2 years. Secondary outcomes included SR at 2 years, overall and stroke-free survival, medication, QoL, cost-effectiveness and safety. RESULTS: More ablation patients were in SR at 1 year [odds ratio (OR) 2.06, 95% confidence interval (CI) 1.20-3.54; P = 0.009]. At 2 years, the OR increased to 3.24 (95% CI 1.76-5.96). Quality-adjusted life years were similar at 2 years (ablation - control -0.025, P = 0.6319). Significantly fewer ablation patients were anticoagulated from 6 months postoperatively. Stroke rates were 5.7% (ablation) and 9.1% (control) (P = 0.3083). There was no significant difference in stroke-free survival [hazard ratio (HR) = 0.99, 95% CI 0.64-1.53; P = 0.949] nor in serious adverse events, operative or overall survival, cardioversion, pacemaker implantation, New York Heart Association, EQ-5D-3L and SF-36. The mean additional ablation cost per patient was £3533 (95% CI £1321-£5746). Cost-effectiveness was not demonstrated at 2 years. CONCLUSIONS: Adjunct AF surgery is safe and increases SR restoration and costs but not survival or QoL up to 2 years. A continued follow-up will provide information on these outcomes in the longer term. Study registration: ISRCTN82731440 (project number 07/01/34).

Effect of the full implementation of the European Working Time Directive on operative training in adult cardiac surgery.

OBJECTIVES: Surgical specialties rely on practice and apprenticeship to acquire technical skills. In 2009, the final reduction in working hours to 48 per week, in accordance with the European Working Time Directive (EWTD), has also led to an expansion in the number of trainees. We examined the effect of these changes on operative training in a single high-volume [>1500 procedures/year] adult cardiac surgical center. METHODS: Setting: A single high-volume [>1500 procedures/year] adult cardiac surgical center. Design: Consecutive data were prospectively collected into a database and retrospectively analyzed. Procedures and Main Outcome Measures: Between January 2006 and August 2010, 6688 consecutive adult cardiac surgical procedures were analyzed. The proportion of cases offered for surgical training were compared for 2 non-overlapping consecutive time periods: 4504 procedures were performed before the final implementation of the EWTD (Phase 1: January 2006-December 2008) and 2184 procedures after the final implementation of the EWTD (Phase 2: January 2009-August 2010). Other predictors of training considered in the analysis were grade of trainee, logistic European system for cardiac operative risk evaluation (EuroSCORE), type of surgical procedure, weekend or late procedure, and consultant. Logistic regression analysis was used to determine the predictors of training cases (procedure performed by trainee) and to evaluate the effect of the EWTD on operative surgical training after correcting for confounding factors. RESULTS: Proportion of training cases rose from 34.6% (1558/4504) during Phase 1 to 43.6% (953/2184) in Phase 2 (p < 0.0001), despite higher mean logistic EuroSCORE [4.29 (6.8) during Phase 1 vs 4.95 (7.2) during Phase 2, p < 0.0001] and higher proportion of cases performed out of hours [153 (3.4) during Phase 1 vs 116 (5.3) during Phase 2, p < 0.0001]. During Phase 1, senior trainees (last 2 years of training) performed 803 (17.8%) procedures, whereas other trainees (first 4 years of training) performed 755(16.8%) cases. During Phase 2, senior trainees performed 763 (34.9%) procedures, whereas other trainees performed 190 (8.7%) cases (p < 0.0001). Independent positive predictors of training cases emerging from the multivariable logistic regression model included consultant in charge, final EWTD, and senior trainees. Independent negative predictors of training cases included logistic EuroSCORE, out-of-hours' procedures, and surgery other than coronary artery bypass grafts. CONCLUSION: Implementation of the final phase of EWTD has not decreased training in a high-volume center. The positive adjustment of trainers' attitudes and efforts to match trainees' needs allow maintenance of adequate training, despite reduction in working hours and increasing patients' risk profile.

Obesity paradox in coronary artery bypass grafting: myth or reality?

OBJECTIVE: A high body mass index has been suggested to be protective in patients with coronary artery disease and in those undergoing coronary artery bypass grafting (CABG). However, these conflicting results might be related to the different risk profiles among the various body mass index categories. We sought to clarify the effect of varying degrees of excessive body weight on hard clinical outcomes in patients undergoing CABG. METHODS: A retrospective analysis of prospectively collected data was conducted to investigate the effect of a high body mass index on early and late mortality after first-time isolated CABG. Propensity score matching was used to adjust for confounding factors. RESULTS: The study sample consisted of 3269 normal weight, 6662 overweight, 3821 obese, and 211 morbidly obese patients. After matching, early mortality was not affected by overweight (mean difference, 0.7%; 95% confidence interval [CI], -0.2% to 1.5%), obesity (mean difference, 0.5%; 95% CI, -0.7% to 1.7%), and morbid obesity (mean difference, 1.6%; 95% CI, -1.0% to 1.0%), regardless of the patients' risk profile according to the European system for cardiac operative risk evaluation. Overweight status was not protective for late death (hazard ratio, 1.05; 95% CI, 0.9-1.08; P = .4). Compared with normal weight patients, both obese and morbidly obese patients had a higher risk of late death (hazard ratio, 1.22; 95% CI, 1.07-2.66; P = .006 for obese patients; hazard ratio, 1.36; 95% CI, 0.74-2.49; P = .3 for morbidly obese patients). CONCLUSIONS: Obesity did not increase operative mortality, but it was associated with reduced late survival in patients undergoing primary isolated CABG. Our results raise concerns in supporting any protective effect of obesity in cardiovascular disease, specifically in patients undergoing surgical myocardial revascularization.

Age cutoff for the loss of survival benefit from use of radial artery in coronary artery bypass grafting.

BACKGROUND: Controversy still exists about the superiority of the radial artery (RA) over the saphenous vein graft (SVG) as a second conduit for surgical myocardial revascularization. We aimed to investigate the presence of any survival benefit from use of the RA and relate it to patients' age. METHODS: Propensity score matching was conducted on 9005 patients who underwent first-time isolated coronary artery bypass grafting (CABG) using the left internal thoracic artery at a single institution from 1996 to 2012. The use of RA was recorded in 936 patients, whereas the use of SVGs only was recorded in 8069 patients. The primary study end point was all-cause death. The interaction between patients' age and any survival benefit from the RA was assessed by spline analysis. RESULTS: After propensity matching, the sample size consisted of 809 matched pairs. In the matched group, mean follow-up was 6.4 ± 3.6 years (range, 0-13.6 years). Survival was 96.8% ± 0.6% versus 96.0% ± 0.6% at 1 year, 91.4% ± 1.1% versus 90.1% ± 1.0% at 5 years, and 83.2% ± 1.7% versus 79.4% ± 1.9% at 10 years for patients receiving RA or SVG, respectively. RA use was associated with a lower risk for late death (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.57-0.98; P = .03). However, the protective effect from RA on late survival was not equally present across all age groups, as shown by spline analysis. The survival advantage from RA was maximum in patients 60 years and younger (upper limit of 95% CI, <1) and gradually declined with increasing age, until it was no longer present in patients older than 70 years (adjusted HR, 0.90; 95% CI, 0.63-1.28; P = .57). CONCLUSIONS: The use of the radial artery graft as a second conduit improves all-cause mortality in patients undergoing primary isolated CABG up to the age of 70 years.

Focus on the unique mechanisms involved in thoracic aortic aneurysm formation in bicuspid aortic valve versus tricuspid aortic valve patients: clinical implications of a pilot study.

OBJECTIVES: The involvement of different factors in the onset of thoracic aortic aneurysm (TAA) in patients with a bicuspid aortic valve (BAV) vs those with a tricuspid aortic valve (TAV) is well recognized. However, the molecular, genetic and cellular mechanisms driving TAA remain unclear. The aim of this study was to identify the different mechanisms involved in TAA development in patients with BAV vs TAV. METHODS: Aorta specimens and DNA samples were collected from 24 BAV (18 men and 6 women; mean age: 54.2 ± 14.39 years) and 110 TAV (79 men and 31 women, mean age: 66 ± 9.8 years) patients. A control group of 128 subjects (61 men and 67 woman, mean age: 61.1 ± 5.8 years) was also enrolled. Histopathological and immunohistochemical analyses were performed, as well as genotyping of 10 polymorphisms. RESULTS: In BAV-associated ascending aortas, significant severe plurifocal apoptosis of smooth muscle cells and matrix metalloproteinase-9 (MMP-9) amounts were detected. In contrast, TAV-associated ascending aortas were characterized by a significant severity of elastic fragmentation, cystic medial necrosis, medial fibrosis and inflammation. In addition, in BAV cases, the -1562TMMP-9 and -735TMMP-2 alleles represent independent risk factors for TAA. The effects of these genotypes combined with hypertension and smoking in BAV cases result in an increase in both the apoptosis (P = 0.0001) and levels of MMP-9 (P = 0.001). In TAV cases, the D angiotensin-converting enzyme and +896A Toll-like receptor-4 alleles seem to be the predictive factors for TAA risk. They, combined with hypertension and age, significantly increase both the microscopic lesions and inflammation. CONCLUSIONS: Our data seem to suggest that TAA in BAV and TAV patients arises from different molecular, cellular and genetic mechanisms. They might help to identify the potential molecular and genetic biomarkers that are useful to detect BAV subjects at high TAA risk, to monitor and treat them differently from those with TAV, with approaches such as the complete removal of the ascending aorta, including the aortic root with or without dilatation.

A particular phenotype of ascending aorta aneurysms as precursor of type A aortic dissection.

OBJECTIVES: We aimed to identify a phenotype of ascending thoracic aortic aneurysm (TAA), which, more than others, evolves into type A dissection (TAD). METHODS: Aortic specimens were obtained from patients undergoing surgical repair of TAA and TAD (108 and 26, respectively). Histopathological and immunohistochemical analyses were performed by using adequate tissue specimens, appropriate techniques and criteria. RESULTS: We identified the three following TAA phenotypes: phenotype I (cystic medial degeneration balanced by a substitutive fibrosis, in absence of medial apoptosis and with a faint collagenase concentration), phenotype II (cystic medial degeneration of higher grade, respectively, than substitutive fibrosis, with focal medial apoptosis and moderate collagenase concentration), and phenotype III (elevated cystic medial degeneration without substitutive fibrosis, with plurifocal medial apoptosis and severe collagenase concentration). The same medial degenerative lesions of TAA phenotype III were observed in TAD tissue samples. CONCLUSIONS: The morphological identity of medial lesions observed in both the TAA phenotype III and in TAD aortas might be assumed to be the precursor-and consequently the optimal biomarker- of dissection, independently of aneurysm diameter or valvular disorder. Identification of genetic risk factors, useful both in diagnostics and in developing more targeted treatment for individual patients, might also be needed.

Optimal myocardial protection strategy for coronary artery bypass grafting without cardioplegia: prospective randomised trial.

Although hypothermia and ischaemic preconditioning (IP) are independently recognised mechanisms of cardioprotection, interactions between myocardial temperature and preconditioning have not been investigated. Therefore, this study explored the possibility of inducing IP during hypothermia and quantifying its effects at two temperature regimens commonly used in clinical practice. One hundred and four patients undergoing coronary artery bypass grafting (CABG) with intermittent cross-clamping and ventricular fibrillation were randomised to four groups: N=normothermia (36.5+/-0.5 degrees C); NP=normothermia+preconditioning, H=hypothermia (31.5+/-0.5 degrees C), HP=hypothermia+preconditioning. The primary outcome measure was release of cardiac Troponin I (cTnI), measured at 6 time points from pre- to 72 h after the end of CPB. There were no hospital deaths and no significant differences in pre- and intra-operative variables (P>or=0.05). There were significant differences in cTnI release between all groups, as follows: N: 117+/-12 microg/l (P

Long-term outcomes following VATS lobectomy for non-small cell bronchogenic carcinoma.

OBJECTIVES: Despite advantages regarding pain and muscle function, video-assisted thoracic surgery (VATS) lobectomy is infrequently performed and is particularly controversial in bronchogenic carcinoma. We have, therefore, reviewed our experience with VATS lobectomy for non-small cell lung cancer (NSCLC) in an attempt to define the long-term results of VATS lobectomy in this setting. METHODS: Patients were selected for surgery on the basis of clinical Stage I or II disease with routine use of thoracic/upper abdominal CT scanning and cervical mediastinoscopy. VATS resection was performed using the endoscopic hilar dissection technique. All related hilar nodes were cleared and supportative sampling of mediastinal stations beyond the reach of mediastinoscopy was undertaken. Perioperative data were collected prospectively and oncologic outcomes were assessed by 6 monthly census. RESULTS: One hundred and fifty eight patients (mean age 66 years) underwent 159 VATS lobectomies for NSCLC between May 1992 and December 2001. One patient underwent staged bilateral resections. Twenty further procedures were uneventfully converted to open thoracotomy (rate=11.2%). The median operation time was 130 min and median operative blood loss was 60 ml. The median postoperative stay was 6 days. One patient (0.6%) died following VATS resection from acute respiratory distress syndrome (ARDS). Two VATS resection patients died following discharge but within 30 days of surgery. Combined, inpatient and 30-day outpatient mortality was, therefore, 1.8%. The stage distribution for resected lesions was: Stage I, 117; II, 33 and III, 8. Mean follow-up was 38 months (range: 1-107). Tumour recurred in 36 patients presenting as local recurrence in the hilum or mediastinum in nine (25%), metastatic disease in 23 (63.9%) and unknown pattern in four (11.1%). Kaplan-Meier calculated probabilities of freedom from cancer related or associated death at 60 months were Stage I, 77.9%; II, 51.4% and III, 28.6%. CONCLUSION: VATS lobectomy is a safe procedure which is associated with a low probability for conversion to open thoracotomy. The patterns of cancer recurrence do not suggest inadequate local clearance while the long-term survival data for Stage I NSLC cases is encouraging. We believe that this technique should become the operation of choice for early stage NSCLC.