On-X aortic valve replacement patients treated with low-dose warfarin and low-dose aspirin.

OBJECTIVES: To assess if warfarin targeted to international normalized ratio (INR) 1.8 (range 1.5-2.0) is safe for all patients with an On-X aortic mechanical valve. METHODS: This prospective, observational registry follows patients receiving warfarin targeted at an INR of 1.8 (range 1.5-2.0) plus daily aspirin (75-100 mg) after On-X aortic valve replacement. The primary end point is a composite of thromboembolism, valve thrombosis and major bleeding. Secondary end points include the individual rates of thromboembolism, valve thrombosis and major bleeding, as well as the composite in subgroups of home or clinic-monitored INR and risk categorization for thromboembolism. The control was the patient group randomized to standard-dose warfarin (INR 2.0-3.0) plus daily aspirin 81 mg from the PROACT trial. RESULTS: A total of 510 patients were enroled at 23 centres in the UK, USA and Canada. Currently, the median follow-up duration is 3.4 years, and median achieved INR is 1.9. The primary composite end point rate in the low INR patients is 2.31% vs 5.39% (95% confidence interval 4.12-6.93%) per patient-year in the PROACT control group, constituting a 57% reduction. Results are consistent in subgroups of home or clinic-monitored, and high-risk patients, with reductions of 56%, 57% and 57%, respectively. Major and total bleeding are decreased by 85% and 73%, respectively, with similar rates of thromboembolic events. No valve thrombosis occurred. CONCLUSIONS: Interim results suggest that warfarin targeted at an INR of 1.8 (range 1.5-2.0) plus aspirin is safe and effective in patients with an On-X aortic mechanical valve with or without home INR monitoring.

Low-dose warfarin with a novel mechanical aortic valve: Interim registry results at 5-year follow-up.

OBJECTIVES: To evaluate whether warfarin targeted at an international normalized ratio of 1.8 (range, 1.5-2.0) after On-X mechanical aortic valve implant is safe for all patients. METHODS: This prospective, observational clinical registry assessed adverse event rates in adult patients receiving low-dose warfarin (target international normalized ratio, 1.8; range, 1.5-2.0) plus daily aspirin (75-100 mg) during a 5-year period after On-X aortic valve implant. The primary end point is the combined rate of major bleeding, valve thrombosis, and thromboembolism overall and in 4 subgroups. The comparator is the Prospective Randomized On-X Anticoagulation Trial control group patients on standard-dose warfarin (international normalized ratio, 2.0-3.0) plus aspirin 81 milligrams daily. RESULTS: A total of 510 patients were recruited at 23 centers in the United States, United Kingdom, and Canada between November 2015 and January 2022. This interim analysis includes 229 patients scheduled to complete 5-year follow-up by August 16, 2023. The linearized occurrence rate (in percent per patient-year) of the primary composite end point of major bleeding, valve thrombosis, and thromboembolism is 1.83% compared with 5.39% (95% confidence interval, 4.12%-6.93%) in the comparator group. Results are consistent in clinic-monitored and home-monitored patients and in those at high risk for thromboembolism. Major bleeding and total bleeding were reduced by 87% and 71%, respectively, versus the comparator group, without an increase in thromboembolic events. CONCLUSIONS: Interim results support the continued safety of the On-X aortic mechanical valve with a target international normalized ratio of 1.8 plus low-dose aspirin through 5 years after implant, with or without home monitoring.

Consensus statement on the interhospital transfer of patients with acute aortic syndrome: TRAVERSING Delphi study.

BACKGROUND: Standardisation of referral pathways and the transfer of patients with acute aortic syndromes (AAS) to regional centres are recommended by NHS England in the Acute Aortic Dissection Toolkit. The aim of the Transfer of Thoracic Aortic Vascular Emergencies to Regional Specialist INstitutes Group study was to establish an interdisciplinary consensus on the interhospital transfer of patients with AAS to specialist high-volume aortic centres. METHODS: Consensus on the key aspects of interhospital transfer of patients with AAS was established using the Delphi method, in line with Conducting and Reporting of Delphi Studies guidelines. A national patient charity for aortic dissection was involved in the design of the Delphi study. Vascular and cardiothoracic surgeons, emergency physicians, interventional radiologists, cardiologists, intensivists and anaesthetists in the United Kingdom were invited to participate via their respective professional societies. RESULTS: Three consecutive rounds of an electronic Delphi survey were completed by 212, 101 and 58 respondents, respectively. Using predefined consensus criteria, 60 out of 117 (51%) statements from the survey were included in the consensus statement. The study concluded that patients can be taken directly to a specialist aortic centre if they have typical symptoms of AAS on the background of known aortic disease or previous aortic intervention. Accepted patients should be transferred in a category 2 ambulance (response time <18 min), ideally accompanied by transfer-trained personnel or Adult Critical Care Transfer Services. A clear plan should be agreed in case of a cardiac arrest occurring during the transfer. Patients should reach the aortic centre within 4 hours of the initial referral from their local hospital. CONCLUSIONS: This consensus statement is the first set of national interdisciplinary recommendations on the interhospital transfer of patients with AAS. Its implementation is likely to contribute to safer and more standardised emergency referral pathways to regional high-volume specialist aortic units.

Intraoperative Open Aortoscopy-A New Emerging Technique in Hybrid Aortic Arch Surgery.

Intraoperative open aortoscopy is a new emerging technique in hybrid aortic arch surgery using hybrid open stent grafts for frozen elephant trunk operation. It is performed on a detumescent open aortic arch during the period of deep hypothermic circulatory arrest. It aids in operative planning and choice of open stent graft and confirms proper deployment and distal seal prior to resumption of circulation.

Is It Safe to Let Trainees Operate on High Risk Cardiac Surgery Cases?

Increasing complexity in cardiac operations has raised the discussion on trainee autonomy and the number of cases required to achieve competency. This study compares outcomes among cases done by trainees vs consultants for high risk patients. 696 (trainee=158 vs consultant=438) major high risk cardiac operations (Euroscore >10) were reviewed at a single center. Observations were propensity matched to consultant or trainee based on several baseline characteristics. Euroscore was: Trainee; 12.3 ± 1.6 versus Consultant; 12.8 ± 2.2, p=.036. Multivariable analysis did not identify trainee as a risk factor for worse in-hospital mortality (OR; 0.95, CI; 0.4-2.2, p=.914) or composite outcome of length of stay >30 days, deep sternal infection, new hemodialysis, new stroke or transient ischemic attack, in-hospital death or reoperation (OR; 0.64, CI; 0.39-1.03, p=.069). NYHA class, diabetes and emergency/salvage surgery were predictors of worse composite outcome. After propensity matching (130 pairs), there was no difference in reoperation rates (3.1% versus 4.6%, p=.727), inhospital death (5.4% versus 7.7%, p=.607) or composite outcome (20.8% versus 29.2%, p=.152). There was no statistical difference in cross clamp times (Trainee; 74.0 ± 32.7 min vs Consultant; 82.6 ± 51.1, p=.229) and bypass times (Trainee; 116.3 ± 52.8 min versus Consultant 135.3 ± 72.6 min, p=.055). The length of stay was similar (18.2 ± 13.2 days versus 19.9 ± 15.6 days, p=.302). It is possible for trainees to perform high risk cardiac surgery without compromising the quality of patient care.

Calcification of Gore-Tex Neochord After Mitral Repair: Electron Microscopy.

A 76-year-old woman presented with severe mitral valve regurgitation 6 years after mitral valve repair with Gore-Tex (expanded polytetrafluoroethylene, W.L. Gore & Associates Inc) neochords and ring annuloplasty. Echocardiography revealed a ruptured neochord. During successful mitral valve replacement, the explanted Gore-Tex neochords were found to be stiff and calcified, with a fracture. Electron microscopy was used to examine the explant and a control neochord. There was disruption of the microstructure with extensive calcium infiltration at the fracture point. Although this is a rare cause of late repair failure, it warrants yearly follow-up with echocardiography.

Decade-long trends in surgery for acute Type A aortic dissection in England: A retrospective cohort study.

BACKGROUND: Little is known about variations in care and outcomes of patients undergoing surgical repair for type A aortic dissection(TAAD). We aim to investigate decade-long trends in TAAD surgical repair in England. METHODS: Retrospective review of the National Adult Cardiac Surgery Audit, which prospectively collects demographic and peri­operative information for all major adult cardiac surgery procedures performed in the UK. We identified patients undergoing surgery for TAAD from January 2009-December 2018, reviewed trends in operative frequency, patient demographics, and mortality. FINDINGS: Over the 10-year period,3,680 TAAD patients underwent surgical repair in England. A doubling in the overall number of operations conducted in England was observed (235 cases in 2009 to 510 in 2018). Number of procedures per hospital per year also doubled(9 in 2009 to 23 in 2018). Overall, in-hospital mortality was 17.4% with a trend toward lower mortality in recent years(23% in 2009 to 14.7% in 2018). There was a significant variation in operative mortality between hospitals and surgeons. We also found that most patients presented towards the middle of the week and during winter. INTERPRETATION: Surgery is the only treatment for acute TAAD but is associated with high mortality. Prompt diagnosis and referral to a specialist center is paramount. The number of operations conducted in England has doubled in 10 years and the associated survival has improved. Variations exist in service provision with a trend towards better survival in high volume centers. FUNDING: British Heart Foundation and NIHR Biomedical Research center(University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol).

European registry of type A aortic dissection (ERTAAD) - rationale, design and definition criteria.

BACKGROUND: Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD. METHODS: Nineteen centers of cardiac surgery from seven European countries have collaborated to create a multicentre observational registry (ERTAAD), which will enroll consecutive patients who underwent surgery for acute TAAD from January 2005 to March 2021. Analysis of the impact of patient's comorbidities, conditions at referral, surgical strategies and perioperative treatment on the early and late adverse events will be performed. The investigators have developed a classification of the urgency of the procedure based on the severity of preoperative hemodynamic conditions and malperfusion secondary to acute TAAD. The primary clinical outcomes will be in-hospital mortality, late mortality and reoperations on the aorta. Secondary outcomes will be stroke, acute kidney injury, surgical site infection, reoperation for bleeding, blood transfusion and length of stay in the intensive care unit. DISCUSSION: The analysis of this multicentre registry will allow conclusive results on the prognostic importance of critical preoperative conditions and the value of different treatment strategies to reduce the risk of early adverse events after surgery for acute TAAD. This registry is expected to provide insights into the long-term durability of different strategies of surgical repair for TAAD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04831073 .

Neuroprotective strategies in acute aortic dissection: an analysis of the UK National Adult Cardiac Surgical Audit.

OBJECTIVES: The risk of brain injury following surgery for type A aortic dissection (TAAD) remains substantial and no consensus has still been reached on which neuroprotective technique should be preferred. We aimed to investigate the association between neuroprotective strategies and clinical outcomes following TAAD repair. METHODS: Using the UK National Adult Cardiac Surgical Audit, we identified 1929 patients undergoing surgery for TAAD (2011-2018). Deep hypothermic circulatory arrest (DHCA) only, unilateral (uACP), bilateral antegrade cerebral perfusion (bACP) and retrograde cerebral perfusion were used in 830, 117, 760 and 222 patients, respectively. The primary end point was a composite of death and/or cerebrovascular accident (CVA). Generalized linear mixed model was used to adjust the effect of neuroprotective strategies for other confounders. RESULTS: The use of bACP was associated with longer circulatory arrest (CA) compared to other strategies. There was a trend towards lower incidence of death and/or CVA using uACP only for shorter CA. In particular, primary end point rate was 27.7% overall and 26.5%, 12.5%, 28.0% and 22.9% for CA <30 min and 28.6%, 30.4%, 33.3% and 33.0% for CA ≥30 min with DHCA only, uACP, bACP and retrograde cerebral perfusion, respectively. The use of DHCA only was associated with five-fold [odds ratio (OR) 5.35, 95% confidence interval (CI) 1.36-21.02] and two-fold (OR 1.77, 95% CI 1.01-3.09) increased risk of death and/or CVA compared to uACP and bACP, respectively, but the effect of uACP was significantly associated with CA duration (hazard ratio 0.97, 95% CI 0.94-0.99; P = 0.04). CONCLUSIONS: In TAAD repair, the use of uACP and bACP was associated with a lower adjusted risk of death and/or CVA when compared to DHCA. uACP can offer some advantage but only for a shorter CA duration.

Outcomes of patients with acute prosthetic aortic valve endocarditis.

BACKGROUND: Prosthetic valve endocarditis is burdened by high mortality and morbidity. We reviewed our experience in the management of patients with acute prosthetic aortic valve infection and studied the implications and outcomes associated with surgical treatment and medical therapy. METHODS: Data of 118 consecutive patients admitted during the period 2008-2018 with definite acute prosthetic aortic valve endocarditis, and presenting a surgical indication, were retrieved from the hospital database. Univariate and multivariate analysis were undertaken to study the association of preoperative characteristics with hospital mortality and the probability of undergoing a reoperation. Survival was assessed with Kaplan-Meier analysis. RESULTS: In the overall population, prosthesis dehiscence was independently associated with the possibility of undergoing surgical reoperation, while presentation with embolic stroke was associated with medical treatment. Hospital mortality was 24%, medical treatment was found to be independently associated with early death. One hundred (85%) patients underwent redo procedures; aortic valve replacement was performed in 53 and full root replacement in 47. Postoperative hospital mortality was 17%. Survival at 1-, 5-, and 8-years was 78%, 74%, and 66%, respectively. Freedom from reoperation and recurrent endocarditis was 95% at 8-year follow-up.Hospital mortality in patients who did not receive a redo operation was 61% with a survival rate of 17% at 1-year follow-up. CONCLUSIONS: Surgical mortality after reoperation for prosthetic aortic valve endocarditis is still high but mid-term outcomes are satisfactory. Failure to undertake surgery when indicated is an independent risk factor for early death.

Is Resident Training Safe in Cardiac Surgery?

BACKGROUND: There exists a knowledge gap regarding the safety of training in cardiac surgery. The purpose of this analysis was to establish the safety of resident training in cardiac surgery and compare the results of the trainee cases to those performed by consultants. METHODS: In all, 5894 (trainee, 3343; consultant, 2551) major cardiac operations (European System for Cardiac Operative Risk Evaluation less than 10) from 2013 to 2018 were reviewed. Multivariate analysis was performed for inhospital mortality and composite outcome of length of stay longer than 30 days, deep sternal infection, new hemodialysis, new stroke or transient ischemic attack, inhospital death, or reoperation. Observations were propensity matched to consultant or trainee with the 16 covariates. RESULTS: Trainees performed 56.7% of cases. Multivariate analysis identified renal disease (odds ratio [OR] 2.93; 95% confidence interval [CI], 1.3 to 6.7; P < .02), peripheral vascular disease (OR 4.62; 95% CI, 1.82 to 11.71; P < .01), and emergency/salvage procedure (OR 7.23; 95% CI, 2.00 to 26.11; P < .01) as predictors of inhospital mortality. Emergency/salvage procedure was the only predictor of worse composite outcomes (OR 2.65; 95% CI, 1.54 to 4.55; P < .001). Trainee cases had similar inhospital mortality and composite outcomes. After propensity matching (1842 observations), bypass time and cross-clamp time were significantly longer for trainees for isolated coronary artery bypass graft surgery and aortic valve replacement. There was no difference between deep sternal infection, new hemodialysis, new stroke/transient ischemic attack, inhospital death, or reoperation. Overall composite outcome differed between groups (trainee 9% vs consultant 16.6%, P = .001) owing to difference in the length of stay longer than 30 days (trainee 4.2% vs consultant 9.9%, P = .001). CONCLUSIONS: Resident training is safe in cardiac surgery without compromising the quality of patient care.

Age-related presentation of acute type A aortic dissection.

BACKGROUND: We evaluated the clinical and anatomic presentations of acute type A aortic dissection according to patient age. METHODS: We retrospectively reviewed 235 consecutive patients who underwent acute type A dissection repair between January 2000 and December 2014. The influence of age on anatomical and clinical presentation, surgical management in the entire cohort and also after exclusion of patients with known connective tissue disorders was assessed using logistic regression. RESULTS: Males presented with type A acute aortic dissection at a younger age than females. Acute onset with signs of myocardial ischemia, connective tissue disorders, or bicuspid aortic valve characterized the younger population. Extension to the coronary sinus(es) ( p = 0.0003), descending thoracic aorta ( p = 0.016), and abdominal aorta ( p = 0.029), and an intimal tear at the level of the aortic root ( p = 0.0017) correlated inversely with patient age. Similar findings were obtained after exclusion of patients with connective tissue disorders or a bicuspid aortic valve. CONCLUSIONS: More frequent proximal and distal progression of the dissection flap occurs in younger patients with acute type A aortic dissection. Older age is associated with a lower probability of an intimal tear at the level of the sinus of Valsalva. These findings, associated with prognostic implications, account for the choice of more radical proximal procedures for repair of aortic dissection in younger patients.

Feasibility of a novel, synthetic, self-assembling peptide for suture-line haemostasis in cardiac surgery.

BACKGROUD: To assess the feasibility and efficacy of PuraStat®, a novel haemostatic agent, in achieving suture line haemostasis in a wide range of cardiac surgical procedures and surgery of the thoracic aorta. METHODS: A prospective, non-randomised study was conducted at our institution. Operative data on fifty consecutive patients undergoing cardiac surgery where PuraStat® was utilised in cases of intraoperative suture line bleeding was prospectively collected. Questionnaires encompassing multiple aspects of the ease of use and efficacy of PuraStat® were completed by ten surgeons (five consultants and five senior registrars) and analysed to gauge the performance of the product. RESULTS: No major adverse cardiac events were reported in this cohort. Complications such as atrial fibrillation, pacemaker requirement and pleural effusions were comparable to the national average. Mean blood product use of packed red cells, platelets, fresh-frozen plasma (FFP) and cryoprecipitate was below the national average. There was one incidence of re-exploration, however this was due to pericardial constriction rather than bleeding. Analysis of questionnaire responses revealed that surgeons consistently rated PuraStat® highly (between a score of 7 and 10 in the various subcategories). The transparent nature or PuraStat® allowed unobscured visualisation of suture sites and possessed excellent qualities in terms of adherence to site of application. The application of PuraStat® did not interfere with the use of other haemostatic agents or manipulation of the suture site by the surgeon. CONCLUSION: PuraStat® is an easy-to-use and effective haemostatic agent in a wide range of cardiac and aortic surgical procedures.