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High-throughput 'omics' technologies that generate molecular profiles for biospecimens have been extensively used in preclinical studies to reveal molecular subtypes and elucidate the biological mechanisms of disease, and in retrospective studies on clinical specimens to develop mathematical models to predict clinical endpoints. Nevertheless, the translation of these technologies into clinical tests that are useful for guiding management decisions for patients has been relatively slow. It can be difficult to determine when the body of evidence for an omics-based test is sufficiently comprehensive and reliable to support claims that it is ready for clinical use, or even that it is ready for definitive evaluation in a clinical trial in which it may be used to direct patient therapy. Reasons for this difficulty include the exploratory and retrospective nature of many of these studies, the complexity of these assays and their application to clinical specimens, and the many potential pitfalls inherent in the development of mathematical predictor models from the very high-dimensional data generated by these omics technologies. Here we present a checklist of criteria to consider when evaluating the body of evidence supporting the clinical use of a predictor to guide patient therapy. Included are issues pertaining to specimen and assay requirements, the soundness of the process for developing predictor models, expectations regarding clinical study design and conduct, and attention to regulatory, ethical, and legal issues. The proposed checklist should serve as a useful guide to investigators preparing proposals for studies involving the use of omics-based tests. The US National Cancer Institute plans to refer to these guidelines for review of proposals for studies involving omics tests, and it is hoped that other sponsors will adopt the checklist as well.

The US National Cancer Institute (NCI), in collaboration with scientists representing multiple areas of expertise relevant to 'omics'-based test development, has developed a checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials. The checklist criteria cover issues relating to specimens, assays, mathematical modelling, clinical trial design, and ethical, legal and regulatory aspects. Funding bodies and journals are encouraged to consider the checklist, which they may find useful for assessing study quality and evidence strength. The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy.

OBJECTIVES: Open-heart surgery with fibrillatory arrest has been reported to be associated with an increased risk of stroke. We examined whether minimally invasive mitral valve surgery with fibrillatory arrest conferred a higher risk of stroke/transient ischaemic attack (TIA) and other major complications compared with median sternotomy and cardioplegic arrest. METHODS: Data were collected prospectively for 387 patients who had mitral valve surgery; 239 had a minimally invasive surgical approach and 148 had median sternotomy. All minimally invasive surgeries were performed by surgeons who were experienced in minimally invasive techniques. The effect of operative approach on risk of stroke/TIA and major morbidity was examined. After propensity score matching (PSM) was conducted between the two groups, 76 patients remained in each group. RESULTS: Before matching, the incidence of stroke/TIA did not differ between patients who had minimally invasive surgery (0.5%, n = 1) and those who had median sternotomy (1.4%, n = 2; P = 0.56). Patients who had minimally invasive surgery had a lower incidence of other major morbidity (0.8%, n = 2) than patients who had median sternotomy (6.1%, n = 9; P = 0.004). After adjustment for age and Society of Thoracic Surgeons predicted risk, there was no effect of operative approach on the odds for stroke/TIA (odds ratio [OR] = 0.41, P = 0.49) or other major morbidity (OR = 0.40, P = 0.31). After PSM, patients were balanced on preoperative characteristics. No patient in either matched group experienced permanent stroke/TIA, and major morbidity did not differ between the two groups (minimally invasive, 1.3%, n = 1; median sternotomy, 1.3%, n = 1; P > 0.99). CONCLUSIONS: A minimally invasive approach for mitral valve surgery on a fibrillating heart was not associated with a greater incidence of stroke/TIA than was median sternotomy. When performed by highly experienced surgeons, the minimally invasive approach with fibrillatory arrest did not increase the risk of perioperative stroke. [ABSTRACT FROM AUTHOR]

There is a growing trend to perform off-bypass surgical ablation for atrial fibrillation (AF) because it is perceived to be safer and more effective than the Cox-Maze procedure with cardiopulmonary bypass (CPB) support. In this systematic review, we compared three minimally invasive stand-alone surgical ablation procedures for AF: the endocardial Cox-Maze procedure, epicardial surgical ablation and a hybrid epicardial surgical and catheter-based endocardial ablation procedure (hybrid procedure). Relevant studies were identified in MEDLINE and the Cochrane Database of Systematic Reviews according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. From 565 initial studies, 37 were included in this review. The total number of patients across all studies was 1877 (range 10-139). Two studies reported on endocardial Cox-Maze procedures (n = 145), 26 reported on epicardial surgical ablation (n = 1382) and 9 reported on hybrid surgical ablation (n = 350). For minimally invasive Cox-Maze, epicardial and hybrid groups, operative mortality rates were 0, 0.5 and 0.9%, perioperative permanent pacemaker insertion rates were 3.5, 2.7 and 1.5%, incidence of conversion to median sternotomy was 0, 2.4 and 2.5%, and reoperation for bleeding was 1.0, 1.5 and 2.2%, with mean length of stay (days) of 5.4, 6.0 and 4.6, respectively. At 12 months, rates of sinus rhythm restoration were 93, 80 and 70%, and sinus restoration without anti-arrhythmic medications was 87, 72 and 71%, for Cox-Maze, epicardial and hybrid procedures, respectively. Of the three procedures, the minimally invasive Cox-Maze procedure with CPB support was most effective for the treatment of stand-alone AF and had important safety advantages in conversion to sternotomy and major bleeding. The minimally invasive Cox-Maze procedure with CPB support also demonstrated the potential for a higher success rate 12 months following the procedure. [ABSTRACT FROM AUTHOR]

Objective: As with any medical therapy, identification of consistent and reliable outcome predictors is essential to understanding the efficacy of surgical ablation for atrial fibrillation. We originally intended to conduct a meta-analysis on atrial fibrillation surgical ablation to identify clinical factors that are most often associated with success. However, these studies are greatly heterogeneous. We conducted a systematic review to identify trends in outcome predictors and to provide recommendations for more uniform data analysis and reporting., Methods: Relevant studies published between January 2005 and September 2013 were identified. To minimize heterogeneity, data were extracted only from multivariate analyses of outcome predictors. The initial approach for meta-analytic analyses was abandoned for a systematic review approach., Results: From 604 initial citations, 19 studies with 5200 patients were included in the review. Systematic review of multivariable atrial fibrillation recurrence rates after surgical ablation revealed that studies were statistically heterogeneous, but atrial fibrillation recurrence after surgical ablation in mid-term follow-up was most often predicted by left atrium size, duration of atrial fibrillation, fine-wave atrial fibrillation, age of patient, and atrial fibrillation type., Conclusions: The innate heterogeneity of published data precludes a meta-analysis for predictors of surgical ablation success. Of the few published studies that allow comparison, the most consistent predictors of failure were enlarged left atrium and long atrial fibrillation duration. These results underscore the need for consistent and reliable outcome predictors. We strongly recommend the development of a standardized system of measurement for consistent clinical parameters that can be used in outcome analyses for surgical ablation of atrial fibrillation.

Objective: Factors influencing health-related quality of life (HRQL) after minimally invasive cardiac surgery have not been well described. We examined the trajectory of HRQL after minimally invasive cardiac surgery and the role of perioperative factors and rhythm on HRQL changes., Methods: Patients underwent minimally invasive surgical ablation for atrial fibrillation and/or valve surgery (n = 235). Health-related quality of life (SF-12) and clinical status were assessed preoperatively and postoperatively., Results: Physical summary HRQL (F = 36.2, P < 0.001) and mental summary HRQL (F = 3.2, P = 0.047) improved significantly by 12 months after surgery. Improvement on HRQL peaked at 6 months and plateaued between 6 and 12 months. Physical HRQL was similar to age-based normal values before surgery (P = 0.66) and surpassed norms by 6 months after surgery (P < 0.001). Younger age (r = -0.15, P = 0.02) and lower EuroSCORE II (r = -0.19, P = 0.003) correlated with greater HRQL improvements by 6 months. Only lower EuroSCORE II (r = -0.14, P = 0.04) correlated with greater HRQL improvement by 12 months. Length of stay and major morbidity were not related to HRQL improvement. In surgical ablation patients, restoration of stable sinus rhythm throughout the first 12 months was associated with greater physical HRQL improvement by 6 months compared with patients who had atrial arrhythmia recurrences (change, 5.0 vs. -1.0, P = 0.02)., Conclusions: Health-related quality of life improved significantly after minimally invasive cardiac surgery. These improvements were influenced by age, operative risk, symptoms, and rhythm status. Even patients with HRQL in a normal range before surgery can experience improved HRQL after surgery. Minimally invasive cardiac surgery can offer decreased postoperative complications and also improved HRQL.

Objective: Atrial fibrillation (AF) is associated with an increased risk for embolic stroke originating from the left atrial appendage (LAA). A recently introduced LAA epicardial clip occluder, the AtriClip PRO, can be applied through midsternotomy or small thoracotomy. We assessed the safety and efficacy of a new surgical approach to apply the AtriClip PRO and exclude the LAA through right minithoracotomy and transverse sinus., Methods: The AtriClip PRO was applied in 24 patients with the new approach. Intraoperative transesophageal echocardiography was used to exclude LAA thrombi at baseline and evaluate LAA perfusion and residual neck postoperatively., Results: Mean (SD) age was 64.5 (8.6) years; 95% of the patients had nonparoxysmal AF with median AF duration of 39 months (interquartile range, 9.3-85.3 months), and mean (SD) left atrium diameter was 4.5 (0.7) cm (range, 3.1-5.7 cm). In one attempt, the clip was not deployed because of severe adhesions in the transverse sinus area. The procedural success rate was 95%. Nine minimally invasive mitral valve repairs were combined with surgical ablation; the rest were isolated right minithoracotomy Cox maze procedures. There was no remaining LAA neck in 71% of the patients. Perioperative outcomes were acceptable, and median length of stay was 5.5 days., Conclusions: The development of a reliable approach to LAA management during minimally invasive surgical ablation through right minithoracotomy has been challenging. This new approach is safe and effective and should offer a superior and consistent early and long-term solution compared with the current approach of endocardial stitch closure.