Rationale and design of the ELEANOR trial early aortic valve surgery versus watchful waiting strategy in severe asymptomatic aortic regurgitation, ACRONYM: ELEANOR.

Background: The optimal treatment of patients with severe symptomatic aortic regurgitation (AR) is state-of-the-art surgery. Asymptomatic patients with advanced left ventricular (LV) dilatation and/or impaired ejection fraction should undergo surgical treatment, but there is no guidelines consensus on cut-off values for this recommendation. Multimodality imaging has brought new tools for the accurate selection of asymptomatic patients at risk of early clinical deterioration, however, prospective and randomized data are pending. Cardiac magnetic resonance (CMR)-derived AR quantification along with LV remodeling assessment appears to be the most accurate tool for a selection of such patients at risk. Trial design: The objective of our prospective and multicenter study is to determine whether patients at risk of early clinical deterioration as per CMR assessment will benefit from early surgical treatment. The study is designed as a superiority trial to demonstrate that early surgical treatment is safe and more effective than the standard treatment. A total of 217 asymptomatic patients with severe AR, but without current guidelines-based surgical indication, will be enrolled across all centers. We expect 24 % of patients identified as high clinical risk and therefore eligible for 1:1 randomization to early surgical treatment within 3 months or a watchful waiting strategy. Follow-up will be annual. We expect a complete restoration of LV size and function along with improved quality of life and physical performance in a short-term follow-up of 12 months. The primary endpoint will be a composite safety and efficacy with all criteria mandatory: 15 % or larger reduction of baseline CMR-derived LV end-diastolic volume index, LV ejection fraction >50 %, and no major adverse cardiovascular events. The annual follow-up will continue for a minimum of 4 years until the required number of endpoints is achieved to show a statistically significant difference in cardiovascular morbidity and mortality in early surgically treated patients. Conclusion: The ELEANOR trial is the first multicenter randomized controlled study to compare early surgical treatment with a watchful waiting strategy in asymptomatic patients with chronic severe AR at high risk of early clinical deterioration as per CMR assessment but without guidelines-based indications for surgical treatment.

Technical considerations and sizing of external annuloplasty in the Ross procedure.

Pure aortic regurgitation and dilation of aortic annulus are the most significant risk factors for the failure of pulmonary autograft after the Ross procedure. Aortic annuloplasty has a positive effect on the durability of the autograft. Previously, we described a technique for external annuloplasty with dedicated CORONEO ring. In the present manuscript, we suggest the sizing of annuloplasty based on the diameter of pulmonary autograft annulus.

Left atrial appendage occlusion: Percutaneous and surgical approaches in everyday practice.

Prophylactic left atrial appendage occlusion has been suggested as a means of reducing cardioembolism risk in patients with atrial fibrillation. Its clinical benefits have been discussed together with potential endocrine or hemodynamic adverse effects, with conflicting conclusions. We aimed to provide a thorough overview of the current literature and a recommendation for daily clinical decision-making. A comprehensive Medline search through PubMed was conducted to search for relevant articles, which were further filtered using the title and abstract. Sixty-five articles were selected as relevant to the topic. Concomitant left atrial appendage occlusion during cardiac surgery for other reasons is effective in terms of thromboembolism risk reduction in patients with a history of atrial fibrillation and higher CHA2DS2-VASc scores. Surgical occlusion is safe, and epicardial closure techniques are preferred. Thoracoscopic and transcatheter techniques are also feasible, and the individual treatment choice must be tailored to the patient. The concerns about endocrine imbalance or risk of heart failure after occlusion are not supported by evidence. Current evidence is conflicting with regard to hemodynamic consequences of appendage occlusion.

Impact of early versus class I-triggered surgery on postoperative survival in severe aortic regurgitation: An observational study from the Aortic Valve Insufficiency and Ascending Aorta Aneurysm International Registry.

OBJECTIVES: Class I triggers for severe and chronic aortic regurgitation surgery mainly rely on symptoms or systolic dysfunction, resulting in a negative outcome despite surgical correction. Therefore, US and European guidelines now advocate for earlier surgery. We sought to determine whether earlier surgery leads to improved postoperative survival. METHODS: We evaluated the postoperative survival of patients who underwent surgery for severe aortic regurgitation in the international multicenter registry for aortic valve surgery, Aortic Valve Insufficiency and Ascending Aorta Aneurysm International Registry, over a median follow-up of 37 months. RESULTS: Among 1899 patients (aged 49 ± 15 years, 85% were male), 83% and 84% had class I indication according to the American Heart Association and European Society of Cardiology, respectively, and most were offered repair surgery (92%). Twelve patients (0.6%) died after surgery, and 68 patients died within 10 years after the procedure. Heart failure symptoms (hazard ratio, 2.60 [1.20-5.66], P = .016) and either left ventricular end-systolic diameter greater than 50 mm or left ventricular end-systolic diameter index greater than 25 mm/m2 (hazard ratio, 1.64 [1.05-2.55], P = .030) predicted survival independently over and above age, gender, and bicuspid phenotype. Therefore, patients who underwent surgery based on any class I trigger had worse adjusted survival. However, patients who underwent surgery while meeting early imaging triggers (left ventricular end-systolic diameter index 20-25 mm/m2 or left ventricular ejection fraction 50% to 55%) had no significant outcome penalty. CONCLUSIONS: In this international registry of severe aortic regurgitation, surgery when meeting class I triggers led to postoperative outcome penalty compared with earlier triggers (left ventricular end-systolic diameter index 20-25 mm/m2 or ventricular ejection fraction 50%-55%). This observation, which applies to expert centers where aortic valve repair is feasible, should encourage the global use of repair techniques and the conduction of randomized trials.

Aorto-mitral curtain reconstruction in invasive double-valve endocarditis: mid-term outcomes.

Background: Invasive double-valve endocarditis with structural damage (abscess or perforation) of the aorto-mitral curtain is a relatively rare but fatal diagnosis requiring complex surgical reconstruction. This study presents the short-term and mid-term outcomes from a single center. Methods: From 2014 to 2021, 20 patients with double-valve endocarditis with structural damage of the aorto-mitral curtain underwent surgical reconstruction (Hemi-Commando procedure n = 16 and Commando procedure n = 4). Data were obtained retrospectively. Results: In 13 cases, the procedure was a reoperation. The mean cardiopulmonary bypass time was 239 ± 47 min and the mean cross-clamp time was 186 ± 32 min. Concomitant procedures were tricuspid valve repair in two, coronary revascularization in one, closure of a ventricular septal defect in one and hemiarch (using circulatory arrest) in one patient. Eleven patients (55%) required surgical revision for bleeding. Thirty-day mortality was 30% (6 patients)-3 patients from the Hemi-Commando group (19%) and 3 patients from the Commando group (75%). Overall survival at 1, 3 and 5 years was 60%, 50% and 45% respectively. Reoperation was required by 4 patients. Freedom from reoperation at 1, 3 and 5 years was 86%, 71% and 71% respectively. Conclusion: Despite the high postoperative morbidity and mortality, complex surgical reconstruction of the aorto-mitral continuity of patients with double-valve endocarditis represents the only real chance for survival. Mid-term outcomes are acceptable, but strict follow-up is required due to the risk of valve failure.

Renal cell carcinoma with intracardiac tumor thrombus extension: Radical surgery yields 2 years of postoperative survival in a single-center study over a period of 30 years.

Background: Renal cell carcinoma (RCC) with tumor thrombus extension into the right atrium (level IV) is a rare life-threatening clinical condition that can only be managed by means of a combined urological and cardiac surgical approach. The early and late outcomes of this radical treatment were analyzed in a large single-institution series over a period of 30 years. Methods: In 37 patients with RCC and intracardiac tumor thrombus extension, nephrectomy was performed followed by the extraction of the intracaval and intracardiac tumor thrombus under direct visual control during deep hypothermic circulatory arrest (DHCA). Recently, in 13 patients, selective aortic arch perfusion (SAAP) was instituted during DHCA. Results: In all patients, precise removal of the tumor thrombus was accomplished in a bloodless field. The mean duration of isolated DHCA was 15 ± 6 min, and 31.5 ± 10.2 min in the case of DHCA + SAAP, at a mean hypothermia of 22.7 ± 4°C. In-hospital mortality was 7.9% (3 patients). In Kaplan-Meier analysis, the estimated median survival was 26.4 months whereas the 5-year cancer-related survival rate was 51%. Conclusions: Despite its complexity, this extensive procedure can be performed safely with a generally uneventful postoperative course. The use of cardiopulmonary bypass with DHCA, with the advantage of SAAP, allows for a safe, precise, and complete extirpation of intracaval and intracardiac tumor mass. Late outcomes after radical surgical treatment in patients with RCC and tumor thrombus reaching up in the right atrium in our series justify this extensive procedure.

Impact of smoking on the outcomes of minimally invasive direct coronary artery bypass.

BACKGROUND: Tobacco smoking has been associated with an increased risk of complications after conventional coronary surgery. However, the impact of smoking on the risk of postoperative complications in minimally invasive coronary surgery is yet to be studied. We aimed to analyze the impact of the preoperative smoking status on the short- and long-term outcomes of minimally invasive direct coronary artery bypass grafting (MIDCAB) in the context of isolated surgical revascularization or in association with percutaneous coronary intervention. METHODS: This was a retrospective observational study of all patients undergoing MIDCAB at our institution between 2006 and 2020. Patients were divided into three groups: active smokers, ex-smokers who have quit smoking for at least 1 month before surgery, and non-smokers. The groups were compared using conventional statistical methods. Multivariate analysis was then performed where significant differences were found to eliminate bias. RESULTS: Throughout the study period, 541 patients underwent MIDCAB, of which 135 (25%) were active smokers, 183 (34%) were ex-smokers, and 223 (41%) were non-smokers. Smokers presented for surgery at a younger age (p < 0.0001), more frequently with a history of myocardial infarction (p < 0.001), peripheral artery disease (p < 0.001) and chronic obstructive pulmonary disease (p < 0.0001). Using multivariate analysis, active smoking was determined to be a significant risk factor for the need of urgent revascularization (odds ratio 2.36 [1.00-5.56], p = 0.049) and the composite of pulmonary complications (including pneumothorax, respiratory infection, respiratory dysfunction, subcutaneous emphysema and exacerbation of chronic obstructive pulmonary disease; odds ratio 2.84 [1.64-4.94], p < 0.001). Preoperative smoking status did not influence the long-term survival (p = 0.83). CONCLUSIONS: In our study, active smokers presented for MIDCAB at a younger age and more often with signs of atherosclerotic disease (history of myocardial infarction and peripheral artery disease). Active smoking was found to be the most significant risk factor for postoperative pulmonary complications, and is also associated with a more frequent need for urgent surgery at diagnosis. Long-term postoperative survival is not affected by the preoperative smoking status.

Unicuspid Aortic Valve in Patients Undergoing the Ross Procedure.

BACKGROUND: The prevalence and outcomes of the unicuspid aortic valve (UAV) in patients undergoing the Ross procedure have been strongly underreported in the current literature. We sought to evaluate this in comparison with bicuspid (BAV) and tricuspid valve (TAV) in our Ross cohort. METHODS: This was a retrospective observational study of patients undergoing the Ross procedure at 2 dedicated centers between 2009 and 2020. Primary end points were the risks of midterm autograft reoperation and the onset of at least moderate aortic regurgitation during follow-up. The secondary end point was to compare the perioperative outcomes between the groups. RESULTS: Included in the analysis were 286 patients, of those 39% with UAV, 52% with BAV, and 9% with TAV. UAV patients were operated on at the youngest age (P < .001) and more often for a combined hemodynamic aortic valve pathology (P = .02). They had the largest aortic root dimensions: annulus (P = .01), Valsalva sinuses (P = .11), sinotubular junction (P = .001), and ascending aorta (P < .0001). The risks of reoperation (P = .86) and the onset of aortic regurgitation (P = .75) were comparable among the groups over the follow-up of 4.1 years. There was no difference in perioperative outcomes. CONCLUSIONS: UAV is a separate unit characterized by a distinct hemodynamic pathology and generated aortopathy. It is not associated with a higher risk of reoperation or new onset of aortic regurgitation after the Ross procedure in the midterm postoperatively. At the current state, UAV remains acceptable for the Ross procedure.

Multiparametric Strategy to Predict Early Disease Decompensation in Asymptomatic Severe Aortic Regurgitation.

BACKGROUND: Use of the current echocardiography-based indications for aortic regurgitation (AR) surgery might result in late valve replacement at the stage of irreversible myocardial damage. Therefore, we aimed to identify simple models combining multiple echocardiography or magnetic resonance imaging (MRI)-derived indices and natriuretic peptides (BNP [brain natriuretic peptide] or NT-proBNP [N-terminnal pro-B type natriuretic peptide]) to predict early disease decompensation in asymptomatic severe AR. METHODS: This prospective and multicenter study included asymptomatic patients with severe AR, preserved left ventricular ejection fraction (>50%), and sinus rhythm. The echocardiography and MRI images were analyzed centrally in the CoreLab. The study end point was the onset of indication for aortic valve surgery as per current guidelines. RESULTS: The derivative cohort consisted of 127 asymptomatic patients (age 45±14 years, 84% males) with 41 (32%) end points during a median follow-up of 1375 (interquartile range, 1041-1783) days. In multivariable Cox regression analysis, age, BNP, 3-dimensional vena contracta area, MRI left ventricular end-diastolic volume index, regurgitant volume, and a fraction were identified as independent predictors of end point (all P<0.05). However, a combined model including one parameter of AR assessment (MRI regurgitant volume or regurgitant fraction or 3-dimensional vena contracta area), 1 parameter of left ventricular remodeling (MRI left ventricular end-diastolic volume index or echocardiography 2-dimensional global longitudinal strain or E wave), and BNP showed significantly higher predictive accuracy (area under the curve, 0.74-0.81) than any parameter alone (area under the curve, 0.61-0.72). These findings were confirmed in the validation cohort (n=100 patients, 38 end points). CONCLUSIONS: In asymptomatic severe AR, multimodality and multiparametric model combining 2 imaging indices with natriuretic peptides, showed high accuracy to identify early disease decompensation. Further prospective studies are warranted to explore the clinical benefit of implementing these models to guide patient management. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02910349.

Case report: Robotic repair of unroofed coronary sinus.

Unroofed coronary sinus is a rare congenital heart disease caused by the partial or complete absence of the common wall between the coronary sinus and left atrium. When indicated for repair, it is done either percutaneously or surgically. Repair using a totally endoscopic robotic procedure is rarely performed nor reported in the literature. We report a case of a 47-year-old male who underwent a successful totally endoscopic robotic repair of this anomaly.

Robot-assisted vs. conventional MIDCAB: A propensity-matched analysis.

Background: Robotic assistance (RA) in the harvesting of internal thoracic artery during minimally invasive direct coronary artery bypass grafting (MIDCAB) provides several potential benefits for surgeon and patient in comparison with conventional MIDCAB. The two technical options have not been thoroughly compared in the literature yet. We aimed to perform this in our cohort with the use of propensity-score matching (PSM). Methods: This was a retrospective comparison of all consecutive patients undergoing conventional MIDCAB (2005-2021) and RA-MIDCAB (2018-2021) at our institution with the use of PSM with 27 preoperative covariates. Results: Throughout the study period 603 patients underwent conventional and 132 patients underwent RA-MIDCAB. One hundred and thirty matched pairs were selected for further comparison. PSM successfully eliminated all preoperative differences. Patients after RA-MIDCAB had lower 24 h blood loss post-operatively (300 vs. 450 ml, p = 0.002). They had shorter artificial ventilation time (6 vs. 7 h, p = 0.018) and hospital stay (6 vs. 8 days, p < 0.001). There was no difference in the risk of perioperative complications, short-term and mid-term mortality between the groups. Conclusions: RA-MIDCAB is an attractive alternative to conventional MIDCAB. It is associated with lower post-operative blood loss and potentially faster rehabilitation after surgery. The mortality and the risk of perioperative complications are comparable among the groups.

Comparison of bicuspidization and Ross procedure in the treatment of unicuspid aortic valve disease in adults - Insight from the AVIATOR registry.

Background: Unicuspid aortic valve (UAV) is the second most common underlying cause of aortic valve dysfunction in young adults after the bicuspid valve. The valve may be replaced (for example by pulmonary autograft) or repaired using the bicuspidization technique. The aim of our study was to compare short- and mid-term outcomes of Ross procedure with bicuspidization in patients with severe UAV dysfunction. Methods: This was a multi-center retrospective observational cohort study comparing data from two dedicated Ross centers in the Czech Republic with bicuspidization outcomes provided by AVIATOR registry. As for the Ross group, only the patients with UAV were included. Primary endpoint was mid-term freedom from reintervention. Secondary endpoints were mid-term freedom from major adverse events, endocarditis and pacemaker implantation. Results: Throughout the study period, 114 patients underwent the Ross procedure (years 2009-2020) and 126 patients underwent bicuspidization (years 2006-2019). The bicuspidization group was significantly younger and presented with a higher degree of dyspnea, a lower degree of aortic valve stenosis and more often with pure regurgitation. The primary endpoint occurred more frequently in the bicuspidization group than in the Ross group - 77.9 vs. 97.9 % at 5 years and 68.4 vs. 75.2 % at 10 years (p < 0.001). There was no difference in secondary endpoints. Conclusion: Ross procedure might offer a significantly lower mid-term risk of reintervention than bicuspidization in patients with UAV. Both procedures have comparable survival and risk of other short- and mid-term complications postoperatively.

Transforming growth factor serum concentrations in patients with proven non-syndromic aortopathy.

Background: The mechanism underlying aortic dilatation is still unknown. Vascular dilatation is thought to be the result of progressive aortic media degeneration caused by defective vascular matrix hemostasis, including TGF-ß1 dysregulation. The goal of this study is to draw attention to the potential utility of TGF-ß1 as a diagnostic marker in non-syndromic patients with aortic dilatation. Methods: TGF-ß1 levels in plasma were measured in 50 patients who had undergone surgery and had a tricuspid or bicuspid aortic valve as well as a normal or dilated ascending aorta. A pathologist also examined thirty resected aorta samples. To specify the reference range of TGF-ß1, a control group of 40 volunteers was enrolled in this study. Results: We discovered a significant difference in TGF-ß1 levels between patients with aortic dilatation and the control group (32.5 vs. 63.92; P < 0.001), as well as between patients with non-dilated aorta but with aortic valve disease, and the control group (27.68 vs. 63.92; P < 0.001). There was no difference between the dilated ascending aorta group and the non-dilated ascending aorta group. We found a poor correlation between TGF-ß1 levels and ascending aorta diameter as well as the grade of ascending aorta histopathological abnormalities. Conclusion: TGF-ß1 concentration does not meet the criteria to be a specific marker of aortic dilatation, but it is sensitive to aortic valvulopathy-aortopathy. A larger patient cohort study is needed to confirm these findings.

Surgical treatment of primary cardiac tumors: 20-year single center experience.

Introduction: Primary cardiac tumors are a rare condition presenting with a variety of symptoms. The outcomes of their surgical treatment in the modern era from central Europe have not been recently reported. Aim: To evaluate the short- and long-term outcomes of the cardiac tumor operations at our department throughout the last 20 years. Material and methods: This was a retrospective analysis of all primary cardiac tumor operations performed at our institution between 2000 and 2020. Perioperative data were extracted from patient records. Long-term data were provided by the National Registry of Cardiac Surgery. Results: Sixty procedures for primary cardiac tumor were performed throughout the study period. The most common type of tumor was myxoma (88%), followed by fibroelastoma (8%), lipoma (2%) and sarcoma (2%). There were 2 perioperative deaths (3%). The most common perioperative complication was atrial fibrillation (47%). One (2%) patient underwent reoperation 6 years later because of myxoma recurrence. We recorded 13 long-term deaths, but only 1 patient died as a consequence of cardiac tumor (sarcoma) 15 months after the surgery. Long-term survival of the cohort was comparable with the age- and sex-matched general population up to 15 years postoperatively (relative survival 0.91, CI 0.68-1.23). Rich histopathological illustrations are provided in the online supplementary material. Conclusions: Surgical resection is the standard treatment of primary cardiac tumors. The outcomes of benign tumors are excellent and the long-term postoperative survival is comparable with the general population. The prognosis of malignant tumors remains poor.