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 procedural refinement of transfemoral transcatheter aortic valve implantation on outcomes and costs: a single-centre retrospective study.

Objectives: To determine the effect of introducing several procedural refinements of transfemoral transcatheter aortic valve implantation (TAVI) on clinical outcomes and costs. Design: Retrospective analysis comparing two consecutive 1-year periods, before and after the introduction of procedural refinements. Setting: Tertiary hospital aortic valve programme. Participants: Consecutive patients undergoing transfemoral TAVI treated between April 2014 and August 2015 using the initial setup (n=70; control group) or between September 2015 and August 2016 after the introduction of procedural refinements (n=89). Interventions: Introduction of conscious sedation, percutaneous access and closure, omission of transoesophageal echocardiography during the procedure, and an early discharge procedure. Outcome measures: Procedural characteristics, complications and outcomes; length of stay in intensive care unit (ICU) and hospital; hospital-related direct costs associated with TAVI. Results: There were no statistically significant differences in the incidence of complications or mortality between the two groups. The mean length of stay in the ICU was significantly shorter in the procedural-refinement group compared with the control group (5.1 vs 57.2 hours, p<0.001), as was the mean length of hospital stay (4.7 vs 6.6 days, p<0.001). The total cost per TAVI procedure was significantly lower, by £3580, in the procedural-refinement group (p<0.001). This was largely driven by lower ICU costs. Conclusions: Among patients undergoing transfemoral TAVI, procedural refinement facilitated a shorter stay in ICU and earlier discharge from hospital and was cost saving compared with the previous setup.

Transapical valve-in-ring mitral valve implantation through the anterior mitral valve leaflet.

Transcatheter mitral valve implantation (TMVI) is a relatively novel intervention used to replace the mitral valve of individuals deemed too high risk or unsuitable for surgery. It is associated with a number of specific risks, including left ventricular outflow tract obstruction (LVOTO).  In this video tutorial we present the case of a 75-year-old man who was unable to undergo redo surgical repair and had a number of risk factors for LVOTO. To minimize these risks, we deployed the TMVI within the anterior mitral valve leaflet. The postoperative result was mild mitral valve regurgitation and no LVOTO.  The long-term outcome of this approach is yet to be determined but we believe this technique offers a novel method to manage a select group of patients suffering with mitral valve disease and at risk of LVOTO.

The use of an esophageal catheter to check the results of left atrial posterior wall isolation in the treatment of atrial fibrillation.

BACKGROUND: Left atrial posterior wall isolation (LAPWI) via catheter, surgical, and hybrid techniques is a promising treatment for persistent atrial fibrillation (PersAF). We investigated whether confirmation of LAPWI can be achieved using an esophageal pacing and recording electrode. METHODS: Patients undergoing PersAF ablation with the intention to achieve LAPWI were enrolled. Two approaches to LAPWI were tested: (1) ablation using endocardial catheter ablation only, and (2) "Staged Hybrid" ablation with thoracoscopic epicardial ablation, followed by endocardial left atrial electrophysiological study and catheter ablation where necessary. Patients enrolled in the study all required further catheter ablation to achieve LAPWI in this group. In both the groups, esophageal recording and esophageal pacing was performed at the start of mapping and electrophysiological study and compared with endocardial electrophysiological findings. This was repeated at the end of the procedure. RESULTS: Twenty patients (16 M, four F) were studied. Endocardial electrophysiological study showed that in none of the cases was the posterior left atrial wall electrically isolated at the start of the study. One patient with Barrett's esophagus failed to sense or pace from the esophagus at any point in the study. In the remaining 19/19, esophageal pacing captured the atrial rhythm at the start of the procedure. LAPWI was then achieved in 17/19 using endocardial catheter ablation; retesting at this point showed sensing and capture of the atrium from the esophagus was abolished. In the remainder sensing and capture persisted. CONCLUSIONS: Esophageal pacing can be used to confirm or refute electrical isolation of the left atrial posterior wall.

Transapical valve-in-ring mitral valve implantation through the anterior mitral valve leaflet.

Transcatheter mitral valve implantation is a relatively novel intervention that replaces the mitral valve of individuals deemed too high-risk or unsuitable for surgery. It is associated with a number of specific risks, including left ventricular outflow tract obstruction. In this report, we present the case of a 75-year-old man who was unable to undergo redo surgical repair and had a number of risk factors for left ventricular outflow tract obstruction. To minimize this risk, we deployed transcatheter mitral valve implantation within the anterior mitral valve leaflet resulting in mild mitral valve regurgitation postoperatively and no left ventricular outflow tract obstruction. Long-term durability of this approach is yet to be determined, but we believe that this intervention adds to the armamentarium of the heart team.

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).

Mitral Valve Repair in Degenerative Mitral Regurgitation: State of the Art.

In industrialized countries, the most common etiology of mitral regurgitation (MR) is degenerative mitral valve (MV) disease. The natural history of severe degenerative MR is poor. However, its appropriate and timely correction is associated with a life expectancy similar to that of the normal population. Surgical MV repair is the gold standard treatment. This review will focus on the most recent evidence with a specific emphasis on surgical indications, timing of treatment, contemporary surgical techniques, Heart Teams and Centers of Excellence.

National Registry Data and Record Linkage to Inform Postmarket Surveillance of Prosthetic Aortic Valve Models Over 15 Years.

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.

Long-term outcomes following high intensity focused ultrasound ablation for atrial fibrillation.

BACKGROUND AND OBJECTIVE: The aim of this study is to assess the safety and efficacy of the Epicor high intensity focused ultrasound (St. Jude, Inc.®, Minneapolis, MN, USA) system using seven-day ambulatory electrocardiogram (ECG) monitoring over a two-year follow-up period. METHODS: One hundred and ten patients undergoing ablation were included from a single center between January 2006 and December 2009. Rhythm was assessed using seven-day ambulatory ECG or permanent pacemaker interrogation. Seventeen patients were lost to follow-up, seven through death. Results were reported according to atrial fibrillation (AF) class preoperatively: paroxysmal, persistent, and long-standing persistent (LSP). RESULTS: Forty-nine percent of patients remained in sinus rhythm at greater than two years. The percentage of patients in sinus rhythm according to preoperative AF class were 81% (paroxysmal AF), 56% (persistent AF), and 18% (long-standing AF). The class of AF prior to surgery, left atrium size, and body mass index determined the long-term outcome. There were no procedure-related complications. CONCLUSIONS: We conclude that high intensity focused ultrasound ablation for atrial fibrillation using the Epicor system is safe and effective for surgical patients with paroxysmal AF. The persistent and LSP AF results suggest that alternative ablation strategies should be considered for these patients.

A prospective randomized comparison of Medtronic Mosaic and Carpentier-Edwards-SAV in the aortic position: an interim report.

BACKGROUND AND AIM OF THE STUDY: The study aim was to compare prospectively the clinical performance and long-term durability of the Medtronic Mosaic and Carpentier-Edwards porcine (CE-SAV) bioprostheses in the aortic position over 10 years. METHODS: Between January 2001 and July 2003, a total of 242 patients undergoing bioprosthetic aortic valve replacement (AVR) were prospectively randomized to receive either Medtronic Mosaic (n = 126) or CE-SAV (n = 116) valves, and followed up annually. RESULTS: The mean follow up period was 1.7 +/- 0.8 years; total follow up was 411 patient-years. Early mortality and 40-month actuarial survival were 5.5% and 93 +/- 1% for the Mosaic valve, and 2.6% and 90 +/- 1% for the CE-SAV. Among patients, 78% showed symptomatic improvement in their NYHA functional class after AVR. To date there have been no structural failures, and one patient required reoperation for prosthetic valve (Mosaic) endocarditis. Early thromboembolic events occurred in 2.9% of patients (two Mosaic, five CE-SAV). Echocardiographic evaluations between the two valves demonstrated comparable hemodynamic performance for a given size at one year after surgery. CONCLUSION: At this stage of the study there were no differences in clinical or hemodynamic outcome in patients undergoing AVR using either the Mosaic or CE-SAV porcine xenograft.

Single-layer versus multiple-layer closure of leg wounds after long saphenous vein harvest: a prospective randomized trial.

BACKGROUND: The long saphenous vein harvested by traditional techniques is an important conduit for coronary artery bypass grafting (CABG). The purpose of this study was to determine if a single-layer closure over a drain improved wound healing compared with the traditional two-layer closure after harvest. METHODS: Seventy-eight consecutive patients undergoing CABG were prospectively randomized to have their leg wound closed by either a single-layer technique with a suction drain or multiple layers. All wounds were assessed using the additional treatment, presence of serous discharge, erythema, purulent exudate, and separation of the deep tissues, isolation of bacteria, and the duration of inpatient stay (ASEPSIS) score postoperatively and 6 weeks later. RESULTS: Forty-four patients (5 females) had their wound closed by the single-layer technique and 34 (6 females) closed in multiple layers. The ASEPSIS scores were significantly lower (p = 0.001) in those patients closed with a single layer (mean, 4.4) than those with multiple layers (mean, 6.8). Patients whose legs were closed with the single-layer technique had less peripheral edema compared with the multiple-layer group (chi2, p < 0.001). Using univariate analysis there was no correlation between ASEPSIS scores and length of wound incision (p = 0.49), whereas increasing age was found to have a weak positive correlation (r =0.24; p = 0.04). CONCLUSIONS: Single-layer leg wound closure over a suction drain is superior to the traditional multiple-layer closure. A possible mechanism of better wound healing in the former technique might be through decreased tissue handling and a reduction in leg edema.

Safety and efficacy of perioperative cell salvage and autotransfusion after coronary artery bypass grafting: a randomized trial.

BACKGROUND: The aim of this study was to ascertain whether cell salvage and autotransfusion after first time elective coronary artery bypass grafting is associated with a significant reduction in the use of homologous blood, a clinically significant derangement of postoperative clotting profiles, or an increased risk of postoperative bleeding. METHODS: Patients were randomized to autotransfusion (n = 98) receiving autotransfused washed blood from intraoperative cell salvage and postoperative mediastinal fluid cell salvage after coronary artery bypass surgery or control (n = 102) receiving stored homologous blood only after coronary artery bypass surgery. RESULTS: There was no statistical difference between the groups in terms of demographics, comorbidity, risk stratification, or operative details. Mean volume of blood autotransfused was 367 +/- 113 mL. Patients in the autotransfusion group were significantly less likely to receive a homologous blood transfusion compared with controls (odds ratio 0.40, 95% confidence interval [CI] 0.22-0.71) and received significantly fewer units of blood per patient compared with controls (0.43 +/- 1.5 vs 0.90 +/- 2.0 U, p = 0.02). There was no difference between the groups in terms of postoperative blood loss, fluid requirements, blood product requirements, or in the incidence of adverse clinical events (p = NS chi(2)). Autotransfusion did not produce any significant derangement of thromboelastograph values or laboratory measures of clotting pathway function (prothrombin time, activated partial thromboplastin time, fibrinogen, and fibrinogen D-dimer levels) when compared with the effect of homologous blood transfusion (p = NS, repeated measures analysis of variance [MANOVA]). CONCLUSIONS: Autotransfusion is a safe and effective method of reducing the use of homologous bank blood after routine first time coronary artery bypass grafting.

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

BACKGROUND AND AIM OF THE STUDY: The study aim was to assess the risk of reoperation for patients with a failing stented tissue valve. METHODS: Between 1980 and 1999, 259 patients (118 males, 141 females; mean age 60.1+/-15.4 years) underwent redo valve replacement to replace a failing stented tissue valve. 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. RESULTS: The early mortality was (6.5%; n = 17), including three patients who had AVR, five DVR, and nine MVR. A higher preoperative NHYA status (p <0.0004) and emergency surgery (p <0.0001) were significantly associated with an increased risk of operative death (univariate analysis). Age at surgery (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. Including those patients who died, 88 (34.0%) experienced a peri- or postoperative complication, seven of which (2.7%) were permanent. CONCLUSION: A failing tissue valve can be replaced, with acceptable operative mortality and morbidity. The choice of valve is a balance of its advantages and disadvantages, and these must be discussed with the patient. It appears, however, that the trend towards reducing the age at which tissue valve implantation is performed may be justified.