Rationale and design of the Early valve replacement in severe ASYmptomatic Aortic Stenosis Trial

Background: Aortic valve replacement in asymptomatic severe aortic stenosis is controversial. The Early valve replacement in severe ASYmptomatic Aortic Stenosis (EASY-AS) trial aims to determine whether early aortic valve replacement improves clinical outcomes, quality of life and cost-effectiveness compared to a guideline recommended strategy of ‘watchful waiting’. Methods: In a pragmatic international, open parallel group randomized controlled trial (NCT04204915), 2844 patients with severe aortic stenosis will be randomized 1:1 to either a strategy of early (surgical or transcatheter) aortic valve replacement or aortic valve replacement only if symptoms or impaired left ventricular function develop, or other cardiac surgery becomes nessessary. Exclusion criteria include other severe valvular disease, planned cardiac surgery, ejection fraction &lt;50%, previous aortic valve replacement or life expectancy &lt;2 years. The primary outcome is a composite of cardiovascular mortality or heart failure hospitalization. The primary analysis will be undertaken when 663 primary events have accrued, providing 90% power to detect a reduction in the primary endpoint from 27.7% to 21.6% (hazard ratio 0.75). Secondary endpoints include disability-free survival, days alive and out of hospital, major adverse cardiovascular events and quality of life. Results: Recruitment commenced in March 2020 and is open in the UK, Australia, New Zealand, and Serbia. Feasibility requirements were met in July 2022, and the main phase opened in October 2022, with additional international centers in set-up. Conclusions: The EASY-AS trial will establish whether a strategy of early aortic valve replacement in asymptomatic patients with severe aortic stenosis reduces cardiovascular mortality or heart failure hospitalization and improves other important outcomes.</p

Minithoracotomy vs Conventional Sternotomy for Mitral Valve Repair: A Randomized Clinical Trial

Importance: The safety and effectiveness of mitral valve repair via thoracoscopically-guided minithoracotomy (minithoracotomy) compared with median sternotomy (sternotomy) in patients with degenerative mitral valve regurgitation is uncertain. Objective: To compare the safety and effectiveness of minithoracotomy vs sternotomy mitral valve repair in a randomized trial. Design, Setting, and Participants: A pragmatic, multicenter, superiority, randomized clinical trial in 10 tertiary care institutions in the UK. Participants were adults with degenerative mitral regurgitation undergoing mitral valve repair surgery. Interventions: Participants were randomized 1:1 with concealed allocation to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon. Main Outcomes and Measures: The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) version 2 physical functioning scale 12 weeks after the index surgery, assessed by an independent researcher masked to the intervention. Secondary outcomes included recurrent mitral regurgitation grade, physical activity, and quality of life. The prespecified safety outcomes included death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year. Results: Between November 2016 and January 2021, 330 participants were randomized (mean age, 67 years, 100 female [30%]); 166 were allocated to minithoracotomy and 164 allocated to sternotomy, of whom 309 underwent surgery and 294 reported the primary outcome. At 12 weeks, the mean between-group difference in the change in the SF-36 physical function T score was 0.68 (95% CI, −1.89 to 3.26). Valve repair rates (≈ 96%) were similar in both groups. Echocardiography demonstrated mitral regurgitation severity as none or mild for 92% of participants at 1 year with no difference between groups. The composite safety outcome occurred in 5.4% (9 of 166) of patients undergoing minithoracotomy and 6.1% (10 of 163) undergoing sternotomy at 1 year. Conclusions and relevance: Minithoracotomy is not superior to sternotomy in recovery of physical function at 12 weeks. Minithoracotomy achieves high rates and quality of valve repair and has similar safety outcomes at 1 year to sternotomy. The results provide evidence to inform shared decision-making and treatment guidelines. Trial Registration: isrctn.org Identifier: ISRCTN1393045

Non-anemic iron deficiency predicts prolonged hospitalisation following surgical aortic valve replacement: a single-centre retrospective study

Background Iron deficiency has deleterious effects in patients with cardiopulmonary disease, independent of anemia. Low ferritin has been associated with increased mortality in patients undergoing cardiac surgery, but modern indices of iron deficiency need to be explored in this population. Methods We conducted a retrospective single-centre observational study of 250 adults in a UK academic tertiary hospital undergoing median sternotomy for non-emergent isolated aortic valve replacement. We characterised preoperative iron status using measurement of both plasma ferritin and soluble transferrin receptor (sTfR), and examined associations with clinical outcomes. Results Measurement of plasma sTfR gave a prevalence of iron deficiency of 22%. Patients with non-anemic iron deficiency had clinically significant prolongation of total hospital stay (mean increase 2.2 days; 95% CI: 0.5–3.9; P = 0.011) and stay within the cardiac intensive care unit (mean increase 1.3 days; 95% CI: 0.1–2.5; P = 0.039). There were no deaths. Defining iron deficiency as a plasma ferritin Conclusions These findings indicate that when defined using sTfR rather than ferritin, non-anemic iron deficiency predicts prolonged hospitalisation following surgical aortic valve replacement. Further studies are required to clarify the role of contemporary laboratory indices in the identification of preoperative iron deficiency in patients undergoing cardiac surgery. An interventional study of intravenous iron targeted at preoperative non-anemic iron deficiency is warranted

Prehabilitation for people undergoing cardiac surgery

ObjectivesThis is a protocol for a Cochrane Review (intervention). The objectives are as follows:The overarching aim of this review is to determine the benefits and harms of prehabilitation on postoperative outcomes in people undergoing cardiac surgery. The specific objectives are:to identify and describe all prehabilitation interventions that have been administered prior to cardiac surgery (urgent and elective pathways);to compare the effectiveness of the different interventions against no intervention or usual care on postoperative and long‐term outcomes (general and cardiac surgery‐specific); andto identify the harms associated with prehabilitation interventions

Early outcomes and complications following cardiac surgery in patients testing positive for coronavirus disease 2019: an international cohort study

The outbreak of severe acute respiratory syndromecoronavirus-2, the cause of coronavirus disease 2019 (COVID-19) in December 2019 represented a global emergency accounting for more than 2.5 million deaths worldwide.1 It has had an unprecedented influence on cardiac surgery internationally, resulting in cautious delivery of surgery and restructuring of services.2 Understanding the influence of COVID-19 on patients after cardiac surgery is based on assumptions from other surgical specialties and single-center studies. The COVIDSurg Collaborative conducted a multicenter cohort study, including 1128 patients, across 235 hospitals, from 24 countries demonstrating perioperative COVID-19 infection was associated with an overall mortality of 24% and postoperative pulmonary complications in half of all patients.3 Cardiac surgery arguably represents a higher risk population than general or orthopedic surgery due to the high American Society of Anesthesiologists grades and multiple comorbidities usually seen. We present a subgroup analysis of COVIDSurg data, including patients who underwent cardiac surgery between March 1, 2020, and July 31, 2020, across 13 countries, with a confirmed perioperative (7 days preoperative up to 30 days postoperative) diagnosis of COVID-19 infection. This is presented in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology statement for cohort studies.4 Categorical variables were expressed as frequency and percentages and c2 or Fisher exact test was used to compare categorical variables. Only anonymized data were collected. Patient consent was obtained unless it was waived by local research committees. In the United Kingdom, the study was registered at each site as either a clinical audit or service evaluation and consent was waived. In other countries, local investigators were responsible for contacting research ethics committees to obtain local or national approvals in line with applicable regulation