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.

Computed tomography is better than echocardiography in predicting balloon-expandable transcutaneous implantation valve size in a real-world clinical practice single-center study.

AIMS: Transcatheter aortic valve replacement (TAVR) has become the standard of care for selected patients with severe aortic stenosis. Multidetector computed tomography (MDCT) and transoesophageal 2D/3D (two-dimensional/three-dimensional) echocardiography (ECHO) are used for aortic annulus (AA) sizing. The aim of this study was to compare the accuracy of AA sizing by ECHO versus MDCT for Edwards Sapien balloon expandable valve in a single center. METHODS AND RESULTS: Data from 145 consecutive patients with TAVR (Sapien XT or Sapien S3) were analyzed retrospectively. A total of 139 (96%) patients had favorable outcomes after TAVR (at most mild aortic regurgitation and only one valve implanted). The 3D ECHO AA area and area-derived diameter were smaller than the corresponding MDCT parameters (464 ± 99 vs. 479 ± 88 mm2 , p < .001, and 24.2 ± 2.7 vs. 25.0 ± 5.5 mm, p = .002, respectively). The 2D ECHO annulus measurement was smaller than both the MDCT and 3D ECHO area-derived diameters (22.6 ± 2.9 vs. 25.0 ± 5.5 mm, p = .013, and 22.6 ± 2.9 vs. 24.2 ± 2.7 mm, p < .001, respectively) but larger than the minor axis diameter of the AA derived from MDCT and 3D ECHO by multiplanar reconstruction (p < .001). The 3D ECHO circumference-derived diameter was also smaller than the MDCT circumference-derived diameter (24.3 ± 2.5 vs. 25.0 ± 2.3, p = .007). The sphericity index by 3D ECHO was smaller than that by MDCT (1.2 ± .1 vs. 1.3 ± .1, p < .001). In up to 1/3 of the patients, 3D ECHO measurements would have predicted different (generally smaller) valve size than was the valve size implanted with favorable result. The concordance of the implanted valve size with the recommended size based on preprocedural MDCT and 3D ECHO AA area was 79.4% versus 61% (p = .001), and for the area-derived diameter, the concordance was 80.1% versus 61.7% (p = .001). 2D ECHO diameter concordance was similar to MDCT (78.7%). CONCLUSIONS: 3D ECHO AA measurements are smaller than MDCT measurements. If 3D ECHO-based parameters alone are used to size the Edwards Sapien balloon expandable valve, then the selected valve size would have been smaller than the valve size implanted with favorable result in 1/3 of the patients. MDCT preprocedural TAVR assessment should be the preferred method over 3D ECHO in routine clinical practice to determine Edwards Sapien valve size.

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.

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.

Ross procedure provides survival benefit over mechanical valve in adults: a propensity-matched nationwide analysis.

OBJECTIVES: The choice of optimal surgical treatment for young and middle-aged adults with aortic valve disease remains a challenge. Mechanical aortic valve replacement (mAVR) is generally preferred despite promising recent outcomes of the Ross procedure. Our goal was to compare the strategies at a nationwide level. METHODS: This study was a retrospective analysis of prospectively recorded data from the National Registry of Cardiac Surgery of the Czech Republic. Using propensity score matching, we compared the outcomes of patients undergoing the Ross procedure in 2 dedicated centres with all mAVRs performed in country between 2009 and 2020. RESULTS: Throughout the study period, 296 adults underwent the Ross procedure and 5120 had an mAVR. We found and compared 291 matched pairs. There were no in-hospital deaths, and the risk of perioperative complications was similar in both groups. Over the average follow-up period of 4.1 vs 6.1 years, the Ross group had a lower all-cause mortality (0.7 vs 6.5%; P = 0.015). This result remained significant even when accounting for cardiac- and valve-related deaths only (P = 0.048). Unlike the Ross group, the mAVR group had a significantly lower relative survival compared with the age- and sex-matched general population. There was no difference in the risk of reoperation (4.5 vs 5.5%; P = 0.66). CONCLUSIONS: The Ross procedure offers a significant midterm survival benefit over mAVR. The procedures have a comparable risk of perioperative complications. Patients after mAVR have reduced survival. Thus, the Ross procedure should be the preferred treatment option for young and middle-aged adults with aortic valve disease in dedicated centres.

Valve cuspidity: a risk factor for aortic valve repair?

BACKGROUND: The aim of this study was to analyze short- and mid-term results after aortic valve (AV) repair with particular regard to the impact of valve cuspidity (bicuspid versus tricuspid aortic valve). METHODS: One hundred patients with aortic regurgitation (AR) undergoing aortic valve repair between November 2007 and October 2012 were included in the study. Sixty patients had bicuspid AV (BAV group; 11 females) and 40 patients had tricuspid AV (TAV group; 13 females). AR > grade 2 was present in 47 (78%) patients in the BAV and in 35 (88%) patients in the TAV group. Follow-up was complete in 100% and median was 25 months. RESULTS: Isolated aortic valve repair was performed in 27 (45%) of BAV patients and in six (15%) of TAV patients. Replacement of the ascending aorta and/or aortic root was performed in 33 (55%) of BAV patients and in 34 (86%) of TAV patients. There was no death within 30 days postoperatively, while two patients died (TAV group) during the follow-up period. There was no statistical difference between BAV and TAV groups with regard to the survival (100 ± 0% vs. 95 ± 4%, p = 0.102), the three-year freedom from AV-related reoperation (90 ± 5% vs. 89 ± 6%, p = 0.456), and the three-year freedom from AR grade > 2 (86 ± 6% vs. 82 ± 7%, p = 0.866), respectively. CONCLUSIONS: This study demonstrates no difference in mid-term results after regurgitant bicuspid and tricuspid aortic valve repair, suggesting that bicuspid valve may not be a risk factor for aortic valve repair.

Coronary subclavian steal syndrome causing acute myocardial infarction in a patient undergoing coronary-artery bypass grafting.

Coronary subclavian steal syndrome with retrograde blood flow in the left internal mammary-coronary bypass graft is a rare but severe complication of cardiac surgery. The authors present a case of a 68-year-old man after coronary-artery bypass grafting using an internal mammary artery. He had been suffering from angina pectoris for the last several years before surgery. The patient was resuscitated at home by emergency medical service because of primary ventricular fibrillation due to an acute myocardial infarction 5 years after surgery. An occlusion of the left subclavian artery with the retrograde blood flow in the left internal mammary coronary bypass was found. This could have been the cause of insufficiency in coronary blood flow and ischemia of the myocardial muscle. The subclavian artery occlusion was successfully treated with percutaneous transluminal angioplasty and implantation of 2 stents. The patient remained free of any symptoms 2 years after this procedure.

Posttraumatic pneumopericardium: a sign of severe injury or radiodiagnostic rarity?

We present three cases of pneumopericardium following blunt chest trauma injury. All three patients were victims of road traffic accidents. All had multiple associated injuries and pneumopericardium was found as the additional finding. Pneumopericardium was treated conservatively with thoracic drains placement and patients observation. Transesophageal echocardiography was used as a method of choice for exclusion of cardiac air tamponade. All three patients survived.