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 costeffectiveness. 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

Endoscopic vein harvesting with the aid of carbon dioxide insufflation

Endoscopic harvesting of the long saphenous vein has been introduced to decrease the morbidity of obtaining venous conduit for coronary artery bypass grafting. Herein is described an endoscopic method using carbon dioxide insufflation into the tissues around the vein. This has several advantages; improved vision, no physical retraction required, easier development of tissue planes, and improved hemostasis

Autotransfusion decreases blood usage following cardiac surgery - a prospective randomized trial

Introduction: 10% of blood issued by the National Blood Service (220 000) is utilised in cardiac procedures. Transfusion reactions, infection risk and cost should stimulate us to decrease this transfusion rate. We tested the efficacy of autotransfusion of washed postoperative mediastinal fluid in a prospective randomized trial.Patients and methods: 166 patients undergoing coronary artery bypass grafting (CABG), valve or CABG+valve procedures were randomized into three groups. The indication for transfusion was a postoperative haemoglobin (Hb) <10g/l or a packed cell volume (PCV) <30. When applicable, group A patients received washed post-operative drainage fluid. Group B all received blood processed from the cardiopulmonary bypass (CPB) circuit following separation from CPB and if appropriate washed post-operative drainage fluid. Group C were controls. Groups were compared using analysis of variance.Results: There was no significant difference in age, sex, type of operation, CPB time and preoperative Hb and PCV between the groups. Blood requirements were as shown. [see table 3 in main text]Twelve patients in group A and 10 in group B did not require a homologous transfusion following processing of the mediastinal drainage fluid.Conclusion: Autotransfusion of washed postoperative mediastinal fluid can decrease the amount of homologous blood transfused following cardiac surgery. There was no demonstrable benefit in processing blood from the CPB circuit as well as mediastinal drainage fluid

Risk of reoperation for structural failure of aortic and mitral tissue valves

In order to assess the risk of reoperation in the case of a failing stented tissue valve, 259 patients (118 males, 141 females; mean age 60.1 ± 15.4 years) underwent redo valve replacement. Of these patients, 94 (36.3%) underwent redo aortic valve replacement (AVR), 105 (40.5%) redo mitral valve replacement (MVR), and 60 (23.2%) redo aortic and mitral valve replacement (DVR). Twenty patients (7.7%) had previous coronary artery bypass grafting (CABG); further CABG were performed in 32 cases (12.4%). Preoperatively, 216 patients (83.3%) were in NYHA functional class III or IV. Early mortality was (6.5%; n = 17). A higher preoperative NHYA status (p <0.0004) and emergency surgery (p <0.0001) were associated with an increased risk of operative death. Age at operation (p = 0.45), previous CABG (p = 0.45), position of the valve replaced (p = 0.2), type of implant (p = 0.06) and presence of coronary artery disease (p = 0.51) were not associated with a significant risk of operative mortality. A failing tissue valve may be replaced, with acceptable operative mortality and morbidity. The trend towards reducing the age at which tissue valve implantation is performed may be justified

Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral)

Introduction Numbers of patients undergoing mitral valve repair (MVr) surgery for severe mitral regurgitation have grown and will continue to rise. MVr is routinely performed via median sternotomy; however, there is a move towards less invasive surgical approaches.There is debate within the clinical and National Health Service (NHS) commissioning community about widespread adoption of minimally invasive MVr surgery in the absence of robust research evidence; implementation requires investment in staff and infrastructure.The UK Mini Mitral trial will provide definitive evidence comparing patient, NHS and clinical outcomes in adult patients undergoing MVr surgery. It will establish the best surgical approach for MVr, setting a standard against which emerging percutaneous techniques can be measured. Findings will inform optimisation of cost-effective practice.Methods and analysis UK Mini Mitral is a multicentre, expertise based randomised controlled trial of minimally invasive thoracoscopically guided right minithoracotomy versus conventional sternotomy for MVr. The trial is taking place in NHS cardiothoracic centres in the UK with established minimally invasive mitral valve surgery programmes. In each centre, consenting and eligible patients are randomised to receive surgery performed by consultant surgeons who meet protocol-defined surgical expertise criteria. Patients are followed for 1 year, and consent to longer term follow-up.Primary outcome is physical functioning 12 weeks following surgery, measured by change in Short Form Health Survey (SF-36v2) physical functioning scale. Early and 1 year echo data will be reported by a core laboratory. Estimates of key clinical and health economic outcomes will be reported up to 5 years.The primary economic outcome is cost effectiveness, measured as incremental cost per quality-adjusted life year gained over 52 weeks following index surgery.Ethics and dissemination A favourable opinion was given by Wales REC 6 (16/WA/0156). Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer reviewed publication.Trial registration number ISRCTN13930454

Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of −2.0% (1-sided 97.5% CI, −∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173