Prothrombin complex concentrate vs. fresh frozen plasma in adult patients undergoing heart surgery - a pilot randomised controlled trial (PROPHESY trial).

There is equipoise regarding the use of prothrombin complex concentrate vs. fresh frozen plasma in bleeding patients undergoing cardiac surgery. We performed a pilot randomised controlled trial to determine the recruitment rate for a large trial, comparing the impact of prothrombin complex concentrate vs. fresh frozen plasma on haemostasis (1 h and 24 h post-intervention), and assessing safety. Adult patients who developed bleeding within 24 h of cardiac surgery that required coagulation factor replacement were randomly allocated to receive prothrombin complex concentrate (15 IU.kg-1 based on factor IX) or fresh frozen plasma (15 ml.kg-1 ). If bleeding continued after the first administration of prothrombin complex concentrate or fresh frozen plasma administration, standard care was administered. From February 2019 to October 2019, 180 patients were screened, of which 134 (74.4% (95%CI 67-81%)) consented, 59 bled excessively and 50 were randomly allocated; 25 in each arm, recruitment rate 35% (95%CI 27-44%). There were 23 trial protocol deviations, 137 adverse events (75 prothrombin complex concentrate vs. 62 fresh frozen plasma) and 18 serious adverse events (5 prothrombin complex concentrate vs. 13 fresh frozen plasma). There was no increase in thromboembolic events with prothrombin complex concentrate. No patient withdrew from the study, four were lost to follow-up and two died. At 1 h after administration of the intervention there was a significant increase in fibrinogen, Factor V, Factor XII, Factor XIII, α2 -antiplasmin and antithrombin levels in the fresh frozen plasma arm, while Factor II and Factor X were significantly higher in the prothrombin complex concentrate group. At 24 h, there were no significant differences in clotting factor levels. We conclude that recruitment to a larger study is feasible. Haemostatic tests have provided useful insight into the haemostatic changes following prothrombin complex concentrate or fresh frozen plasma administration. A definitive trial is needed to ascertain the benefits and safety for each.

Variation between hospitals in outcomes following cardiac surgery in the UK.

INTRODUCTION: We examine the influence of variations in provision of cardiac surgery in the UK at hospital level on patient outcomes and also to assess whether there is an inequality of access and delivery of healthcare. Cardiothoracic surgery has pioneered the reporting of surgeon-specific outcomes, which other specialties have followed. We set out to identify factors other than the individual surgeon, which can affect outcomes and enable other surgical specialties to adopt a similar model. MATERIALS AND METHODS: A retrospective analysis of prospectively collected data of patient and hospital level factors between 2013 and 2016 from 16 cardiac surgical units in the UK were analysed through the Society for Cardiothoracic Surgery of Great Britain and Ireland and the Royal College of Surgeons Research Collaborative. Patient demographic data, risks factors, postoperative complications and in-hospital mortality, as well as hospital-level factors such as number of beds and operating theatres, were collected. Correlation between outcome measures was assessed using Pearson's correlation coefficient. Associations between hospital-level factors and outcomes were assessed using univariable and multivariable regression models. RESULTS: Of 50,871 patients (60.5% of UK caseload), 25% were older than 75 years and 29% were female. There was considerable variation between units in patient comorbidities, bed distribution and staffing. All hospitals had dedicated cardiothoracic intensive care beds and consultants. Median survival was 97.9% (range 96.3-98.6%). Postoperative complications included re-sternotomy for bleeding (median 4.8%; range 3.5-6.9%) and mediastinitis (0.4%; 0.1-1.0%), transient ischaemic attack/cerebrovascular accident (1.7%; range 0.3-3.0%), haemofiltration (3.7%; range 0.8-6.8%), intra-aortic balloon pump use (3.3%; range 0.4-7.4%), tracheostomy (1.6%; range 1.3-2.6%) and laparotomy (0.3%; range 0.2-0.6%). There was variation in outcomes between hospitals. Univariable analysis showed a small number of positive associations between hospital-level factors and outcomes but none remained significant in multivariable models. CONCLUSIONS: Variations among hospital level factors exists in both delivery of, and outcomes, following cardiac surgery in the UK. However, there was no clear association between these factors and patient outcomes. This negative finding could be explained by differences in outcome definition, differences in risk factors between centres that are not captured by standard risk stratification scores or individual surgeon/team performance.

Robotics in cardiac surgery.

A summary of its uses in mitral valve surgery and coronary artery revascularisation.

Does off-pump coronary revascularization reduce mortality in re-operative coronary artery surgery? A meta-analysis of observational studies.

BACKGROUND: Re-operative coronary artery bypass grafting (CABG) is a challenging operation that is often performed in a high-risk patient group. Avoiding cardiopulmonary bypass (CPB) in these patients is hypothesised to be advantageous due to the reduced invasiveness and physiological stress of off-pump coronary artery bypass grafting (OPCAB). The aims of this study were to assess whether OPCAB may improve outcomes in patients undergoing re-operative CABG. METHODS: Twelve studies, incorporating 3471 patients, were identified by systematic literature review. These were meta-analysed using random-effects modelling. Primary endpoints were 30-day and mid-term mortality. Secondary endpoints were completeness of revascularization, mean number of grafts per patient and the effect of intra-operative conversion on mortality. RESULTS: A significantly lower rate of 30-day mortality was observed with OPCAB (OR 0.51, 95% CI [0.35, 0.74]), however, no difference was demonstrated in mid-term mortality. Significantly less complete revascularization and mean number of grafts per patient were observed in the OPCAB group. Meta-regression revealed no change in 30-day mortality when the effect of conversion from one technique to the other was assessed. CONCLUSIONS: Off-pump techniques may reduce early mortality in selected patients undergoing re-operative CABG; however, this does not persist into mid-term follow-up. OPCAB may also lead to intra-operative conversion and, although this did not affect outcomes in this study, these results are constrained by the limited data available. Furthermore, OPCAB may increase target vessel revascularization and, consequently, incomplete revascularization which, whilst not reflected in the short-term outcomes, requires longer-term follow-up in order to be fully assessed.

Management of the left subclavian artery during endovascular stent grafting for traumatic aortic injury - a systematic review.

OBJECTIVES AND DESIGN: Traumatic thoracic aortic injuries are serious and may be associated with high morbidity and mortality. Endovascular stent grafting is now an established treatment option which often requires proximal landing zone extension through left subclavian artery (LSA) origin coverage. This in turn can lead to downstream ischaemic complications which may be lessened by LSA revascularisation. This study investigates the consequence of LSA coverage and potential benefit of revascularisation. MATERIALS AND METHODS: Systematic literature review of studies between 1997 and 2010 identified 94 studies incorporating 1704 patients. Chronological trends in LSA management practice for trauma were sought. Designated outcomes of interest were prevalences of left arm ischaemia, stroke, spinal cord ischaemia, endoleak, stent migration, need for additional procedure and mortality. These outcomes were compared in patients with and without LSA coverage (taking account of the degree of coverage). The impact of revascularisation on these outcomes was also explored. Statistical analysis included examination with Chi-Square or Fisher's tests as appropriate. RESULTS: Isolated total LSA coverage without revascularisation increases the prevalence of left arm ischaemia [prevalence of 4.06% versus 0.0% (p < 0.001)]; stroke [prevalence of 1.19% versus 0.23% (p = 0.025)]; and need for additional procedure [prevalence of 2.86% versus 0.86% (p = 0.004). In contrast there were no reported cases of stroke, spinal cord ischaemia, endoleak, stent migration or mortality when the LSA origin was only partially covered. When the LSA territory was revascularised, again no cases of left arm ischaemia, stroke, spinal cord ischaemia, endoleak, or mortality were reported. CONCLUSION: Current evidence suggests that LSA coverage in patients undergoing endovascular stent grafting of the thoracic aorta for trauma should be avoided where possible to avoid ensuing downstream ischaemic complications. When coverage is anatomically necessary, partial coverage is better than complete in terms of avoiding these complications and revascularisation may be considered, however these decisions must be made in the context of the individual patient scenario.