Efficacy and Safety of Edoxaban in Anticoagulant Therapy Early After Surgical Bioprosthetic Valve Replacement: Rationale and Design of the ENBALV Trial.

BACKGROUND AND PURPOSE: Anticoagulant therapy with vitamin K antagonists is recommended within 3 to 6 months after bioprosthetic valve replacement to prevent thromboembolic events. However, data regarding whether direct oral anticoagulants can be an alternative to warfarin in such patients are limited. The purpose of this study is to compare the efficacy and safety of edoxaban versus warfarin within 3 months after bioprosthetic valve replacement. METHODS: The ENBALV trial is an investigator-initiated, phase 3, randomized, open-label, multicenter study. It involves patients aged 18 to 85 years undergoing bioprosthetic valve replacement at the aortic and/or mitral position. They are randomized 1:1 to receive either edoxaban or warfarin. Administration of edoxaban or warfarin is to be continued for 12 weeks after surgery. The primary outcome is the occurrence rate of stroke or systemic embolism at 12 weeks after surgery. The net clinical outcome is a composite of stroke, systemic embolism, or major bleeding, which is included in the secondary outcomes. CONCLUSION: The ENBALV trial demonstrates the efficacy and safety of edoxaban compared with warfarin in patients early after bioprosthetic valve replacement, including patients with sinus rhythm, which will bring a significant benefit to patients in clinical practice. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) 2051210209. 30 Mar 2022 https://jrct.niph.go.jp/latest-detail/jRCT2051210209 .

A Novel Method of Real-Time Assessment for Coronary Artery Anastomosis Skill.

PURPOSE: Coronary anastomosis is the most key factor to accomplish coronary artery bypass grafting, which is one of the largest areas in cardiovascular surgery. Although we have organized on-site simulator training courses of coronary anastomosis using BEAT YOUCAN, it became difficult to continue it because of COVID-19. Therefore, we established a real-time evaluation sheet instead of an Objective Structured Assessment of Technical Skills (OSATS) evaluation sheet. The purposes of this study was to develop the real-time assessment system and to prove the correlation between the score obtained by the OSATS and the score obtained by the real-time evaluation system. SUBJECTS AND METHODS: A total of 22 videos from the qualifying round of real-time coronary anastomosis competition evaluated by both the modified OSATS and the real-time evaluation system were utilized in this study. The global rating score of OSATS was compared with the global rating score of real-time evaluation system. RESULTS: When examined the relationship between the OSATS total score and the real-time total score, there was a significant correlation (R = 0.752, p <0.001). The OSATS general definition score and the real-time total score also showed a strong correlation (R = 0.733, p <0.001). CONCLUSIONS: We developed a real-time assessment sheet to evaluate coronary anastomosis. This assessment sheet had a good correlation with the OSATS evaluation sheet.

Mid-term outcomes of surgical aortic valve replacement using a mosaic porcine bioprosthesis with concomitant mitral valve repair.

This study retrospectively evaluated the mid-term outcomes of surgical aortic valve replacement (SAVR) using a stented porcine aortic valve bioprosthesis (Mosaic; Medtronic Inc., Minneapolis, MN, USA) with concomitant mitral valve (MV) repair. From 1999 to 2014, 157 patients (median [interquartile range] age, 75 [70-79] years; 47% women) underwent SAVR with concomitant MV repair (SAVR + MV repair), and 1045 patients (median [interquartile range] age, 76 [70-80] years; 54% women) underwent SAVR only at 10 centers in Japan as part of the long-term multicenter Japan Mosaic valve (J-MOVE) study. The 5-year overall survival rate was 81.5% ± 4.1% in the SAVR + MV repair group and 85.1% ± 1.4% in the SAVR only group, and the 8-year overall survival rates were 75.2% ± 5.7% and 78.1% ± 2.1%, respectively. Cox proportional hazards analysis showed no significant difference in the survival rates between the two groups (hazard ratio, 0.87; 95% confidence interval, 0.54-1.40; P = 0.576). Among women with mild or moderate mitral regurgitation who were not receiving dialysis, those who underwent SAVR + MV repair, were aged > 75 years, and had a preoperative left ventricular ejection fraction of 30-75% tended to have a lower mortality risk. In conclusion, this subgroup analysis of the J-MOVE cohort showed relevant mid-term outcomes after SAVR + MV repair.

Multicenter Study of Surgical Ablation for Atrial Fibrillation in Aortic Valve Replacement.

There is controversy regarding appropriate surgical ablation procedures concomitant with nonmitral valve surgery. We retrospectively investigated the impact of surgical ablation for atrial fibrillation during aortic valve replacement between 2010 and 2015 in 16 institutions registered through the Japanese Society for Arrhythmia Surgery. Clinical data of 171 patients with paroxysmal and nonparoxysmal atrial fibrillation undergoing aortic valve replacement were collected and classified into full maze operation (n = 79), pulmonary vein isolation (PVI) (n = 56), and no surgical ablation (n = 36) groups. All patients were followed up and electrocardiograms were recorded in 68% at 2 years. The myocardial ischemia time was significantly longer in the maze group than the others during isolated aortic valve replacement (p ≤ 0.01), but there were no significant differences in 30-day or 2-year mortality rates between groups. The ratios of sinus rhythm at 2 years in paroxysmal and nonparoxysmal atrial fibrillation in the maze group versus PVI group were 87% versus 97%, respectively (p = 0.24) and 53% versus 42%, respectively (p = 0.47). No patients with nonparoxysmal atrial fibrillation in the no surgical ablation group maintained sinus rhythm at 2 years. In conclusion, both maze and PVI during aortic valve replacement are valuable strategies to restore sinus rhythm at 2 years and result in favorable early and midterm survival rates.

Side-by-side deployment of gore excluder legs at a narrow terminal aorta for endovascular aneurysm repair.

PURPOSE: A narrow terminal aorta is a risk factor for endograft occlusion after endovascular aneurysm repair. To minimize limb complications, we used Gore Excluder legs positioned side-by-side at the terminal aorta. We investigated the outcomes of our strategy for endovascular aneurysm repair in patients with a narrow terminal aorta. METHODS: We enrolled 61 patients who underwent endovascular aneurysm repair with a narrow terminal aorta (defined as < 18 mm in diameter) from April 2013 to October 2021. The standard procedure involves complete treatment with the Gore Excluder device. When other types of main body endografts were used, they were deployed proximal to the terminal aorta, and we used the Gore Excluder leg device in the bilateral limbs. Postoperatively, the intraluminal diameter of the legs at the terminal aorta was measured to assess the configuration. RESULTS: During the follow-up period (mean: 2.7 ± 2.0 years), there were no aorta-related deaths, endograft occlusions, or leg-related re-interventions. There were no significant differences between the pre- and postoperative ankle-brachial pressure index values in the dominant and non-dominant legs (p = 0.44 and p = 0.17, respectively). Postoperatively, the mean difference rate (defined as [dominant leg diameter-non-dominant leg diameter]/terminal aorta diameter) was 7.5 ± 7.1%. The difference rate was not significantly correlated with the terminal aortic diameter, calcification thickness, or circumferential calcification (r = 0.16, p = 0.22; r = 0.07, p = 0.59; and r = - 0.07, p = 0.61, respectively). CONCLUSIONS: Side-by-side deployment of Gore Excluder legs produces acceptable outcomes for endovascular aneurysm repair with a narrow terminal aorta. The endograft expansion at the terminal aorta is tolerable without influencing calcification distribution.

Doppler Underestimates Transvalvular Gradient Measured by Catheterization in Patients With Severe Aortic Stenosis.

We sought to clarify characteristics of patients with severe aortic stenosis (AS) in whom transvalvular mean pressure gradient (MPG) was underestimated with Doppler compared with catheterization. Study subjects included 127 patients with severe AS who underwent transcatheter aortic valve implantation. Between subjects with Doppler MPG underestimation ≥10 mm Hg (group U) and those without (group C), we retrospectively compared echocardiographic parameters and aortic valve calcification score using the Agatston method. Despite a strong correlation (rS = 0.88) and small absolute difference (2.1 ± 10.1 mm Hg) between Doppler and catheter MPG, 27 patients (21%) were in group U. Among 48 patients with catheter MPG ≥60 mm Hg, 10 patients (21%) revealed Doppler MPG of 40 to 59 mm Hg, suggesting they had been misclassified as having severe AS instead of very severe AS. According to the guidelines, indication of valve replacement for patients without symptoms should be considered for very severe AS but not for severe AS. Therefore, sole reliance on Doppler MPG could cause clinical misjudgments. Group U had larger relative wall thickness (median [interquartile range: 0.60 [0.50 to 0.69] vs 0.53 [0.46 to 0.60], p = 0.003) and higher calcification score (3,024 [2,066 to 3,555] vs 1,790 [1,293 to 2,501] arbitrary units, p <0.001). Both calcification score (per 100 arbitrary unit increment, odds ratio 1.10, 1.04 to 1.17, p = 0.002) and relative wall thickness (per 0.05 increment, odds ratio 1.29, 95% confidence interval 1.05 to 1.60, p = 0.02) were independently associated with Doppler underestimation. In conclusion, Doppler might underestimate transvalvular gradient compared with catheterization in patients with severe AS who have heavy valve calcification and prominent concentric remodeling left ventricular geometry.

A sealant with a hemostatic mechanism independent of the blood coagulation function was effective in both elective and emergency surgery for thoracic aorta.

OBJECTIVES: Matsudaito is a unique surgical sealant with a powerful hemostatic effect that works independent of a patient's blood coagulation function. Because of its mechanism, this sealant is expected to be particularly useful in patients with a poor blood coagulation function, such as in cases of acute aortic syndrome requiring emergency surgery. We, therefore, evaluated the hemostatic static effect of the sealant in both emergency and elective surgery of the thoracic aorta. METHODS: We used data obtained from post-marketing surveillance of the sealant. Patients who underwent replacement of the thoracic aorta were enrolled. The hemostatic effect was evaluated as effective if a further hemostatic procedure was not performed after applying the sealant. RESULTS: From 46 hospitals in Japan, a total of 542 patients (327 elective and 215 emergency cases) were enrolled. Hospital mortality was 4.0% and 11.6% in elective and emergency cases, respectively (p < 0.05). Among the 1039 anastomoses (609 elective and 430 emergency cases), effective hemostasis was confirmed in 436 (71.6%) elective and 259 (60.2%) emergency cases. The data from the clinical trial of the sealant showed a hemostatic rate of 44.4% in elective control cases without the sealant. CONCLUSION: Given that the hemostatic rate in emergency surgery with the sealant seemed to be better than that in elective surgery without the sealant (determined from the clinical trial), we concluded that the sealant was effective in both emergency and elective thoracic surgery of the aorta.

Left ventricular hypertrophy as a predictor of cardiovascular outcomes after transcatheter aortic valve replacement.

AIMS: This study aimed to clarify the relationship between cardiovascular prognosis and left ventricular hypertrophy (LVH) in patients with severe aortic stenosis who underwent transcatheter aortic valve replacement (TAVR) and to investigate the relationship between cardiac sympathetic nerve (CSN) function and these factors using 123 I-metaiodobenzylguanidine scintigraphy. METHODS AND RESULTS: In this single-centre, retrospective observational study, 349 patients who underwent TAVR at our institution between July 2017 and May 2020 were divided into two groups: those with severe LVH pre-operatively [severe LVH (+) group] and those without LVH pre-operatively [severe LVH (-) group]. The rates of freedom from cardiovascular events (cardiovascular death and heart failure hospitalization) were compared. The relationship between changes in left ventricular mass index (LVMi) and changes in delay heart-mediastinum ratio (H/M) from before TAVR to 6 months after TAVR was also investigated. The event-free rate was significantly lower in the severe LVH (+) group (87.1% vs. 96.0%, log-rank P = 0.021). The severe LVH (+) group exhibited a significantly lower delay H/M value, scored by 123 I-metaiodobenzylguanidine scintigraphy, than the severe LVH (-) group (2.33 [1.92-2.67] vs. 2.67 [2.17-3.68], respectively, P < 0.001). Moreover, the event-free rate of post-operative cardiovascular events was lower among patients with a delay H/M value < 2.50 than that among other patients (87.7% vs. 97.2%, log-rank P = 0.012). LVMi was significantly higher (115 [99-130] vs. 90 [78-111] g/m2 , P < 0.001) and delay H/M value was significantly lower (2.53 [1.98-2.83] vs. 2.71 [2.25-3.19], P = 0.025) in the severe LVH (+) group than in the severe LVH (-) group at 6 months after TAVR. Patients with improved LVH at 6 months after TAVR also had increased delay H/M (from 2.51 [2.01-2.81] to 2.67 [2.26-3.02], P < 0.001), whereas those without improved LVH had no significant change in delay H/M (from 2.64 [2.23-3.06] to 2.53 [1.97-3.00], P = 0.829). CONCLUSIONS: Severe LVH before TAVR is a prognostic factor for poor post-operative cardiovascular outcomes. LVH associated with aortic stenosis and CSN function are correlated, suggesting their involvement in LVH prognosis.

Multiple Pulmonary Artery Plasty With Tissue-Engineered Vascular Grafts.

In pediatric cardiovascular surgery, the autologous pericardium is useful for pulmonary artery augmentation. However, in some cases, the autologous pericardium may not be available for various reasons. Since 2014, we have developed tissue-engineered vascular grafts (TEVGs) and obtained good results. We report a successful case of multiple pulmonary artery plasty with TEVGs for pulmonary atresia/ventricular septal defect with major aortopulmonary collateral arteries. TEVGs are useful alternatives to autologous pericardium in pediatric cardiovascular operations that often require multistage procedures.

Effect of Left Ventricular Hyperenhancement in Magnetic Resonance Imaging on Reverse Remodeling After Mitral Valve Repair for Moderate Ischemic Mitral Regurgitation.

We aimed to investigate cardiac magnetic resonance imaging (MRI)-derived predictors of a lack of left ventricular (LV) reverse remodeling after undersized mitral annuloplasty (uMAP) for moderate ischemic mitral regurgitation (IMR). We retrospectively reviewed 31 patients who underwent uMAP for moderate IMR and cardiac MRI evaluation between 2004 and 2017. Cardiac MRI evaluation included cine MRI LV and right ventricular volumetric measurements and gadolinium-enhanced MRI assessment of myocardial scarring. LV dimensions were assessed preoperatively, postoperatively, and at follow-up using serial transthoracic echocardiography, and the mid-term (median, 49 months) predictors of a lack of LV reverse remodeling were analyzed. At the mid-term follow-up (mean follow-up period: 85 ± 40 months), 15 patients exhibited reverse LV remodeling. The relative reduction in LV dimension at follow-up was negatively correlated with the preoperative number of LV segments with myocardial infarction (MI) (defined as an LV segment with >25% enhancement). The optimal cut-off for predicting a lack of reverse LV remodeling at follow-up was >5 LV segments with MI, with a sensitivity and specificity of 92% and 92%, respectively. This cut-off value also predicted all-cause mortality at follow-up, with a sensitivity and specificity of 88% and 67%, respectively. The presence of >5 LV segments with MI on gadolinium-enhanced MRI might be a useful predictor of lack of reverse LV remodeling and all-cause mortality outcomes after undersized mitral annuloplasty for moderate IMR.

15-year outcomes of the JOCRI study (JOCRIED study): a randomised comparison of off-pump and on-pump multiple arterial coronary revascularisation.

OBJECTIVE: The Japanese Off-Pump Coronary Revascularization Investigation (JOCRI) study reported a non-significant difference in early outcomes and graft patency between off-pump coronary artery bypass grafting and on-pump coronary artery bypass grafting in 2005. The JOCRIED study aimed to review the long-term outcomes of the JOCRI study participants. METHOD AND RESULTS: The JOCRIED study enrolled 123 of the JOCRI study participants completing the clinical follow-up between August 2018 and August 2020; 61 patients in the off-pump group and 62 patients in the on-pump group. The follow-up period was 13.8 ± 2.8 years. The groups were compared regarding mortality, the incidence of major adverse cardiac and cerebrovascular events and repeat revascularisation. The 15-year cumulative survival rate (off-pump vs on-pump, respectively; 77.7% vs 75.3%; p = 0.85), major adverse events-free survival rate (62.5% vs 55.6%; p = 0.27) and repeat revascularisation-free rate (84.8% vs 78.0%; p = 0.16) were not significantly different between the two groups. Revascularisation was the most common major adverse events in the JOCRIED participants. Although percutaneous coronary intervention was performed in 8 patients (13%) in the off-pump group and in 14 patients (23%) in the on-pump group (p = 0.23), no patients underwent redo coronary artery bypass grafting. CONCLUSIONS: Off-pump coronary artery bypass grafting provides comparable 15-year outcomes to on-pump coronary artery bypass grafting.

[Robot-assisted Cardiac Surgery Council and Current Status and Future Prospect of Robotic Mitral Valve Surgery in Japan].

The Robot-assisted Cardiac Surgery Council (RACSC) was established in 2015, and consists of the members of three closely related surgical societies and associations. The RACSC conducts the review and approval of applicant surgeons and institutions. A registry system has also been established through the Japan Cardiovascular Surgery Database-National Clinical Database( JCVSD-NCD). For the last five years, including the time when robotic mitral valve surgery was first approved as a procedure covered by the Japanese social insurance system in 2018, a total of 1,161 patients were enrolled in the JCVSDNCD, with an increase of nearly 500 cases per year. These cases underwent operations in 25 approved hospitals. The mean patient age was 59±13 years( range:20-90 years), and the male to female patient ratio was 1.8 male dominant. The most common procedure was mitral valve reconstruction, and 79% of all patients underwent annuloplasty. The mean operative time was 238±100 min, the mean cardiopulmonary bypass (CPB) time was 158±69 min, and the mean aortic cross-clamp (AXC) time was 102±49 min. When these results were compared with those of the Cleveland Clinic, which treated more than 1,000 cases as an initial institutional experience, both CPB and AXC times were nearly the same. It is believed that 200 cases are needed to stabilize the CPB and AXC time. Currently in Japan, only 3 or 4 out of the 25 approved hospitals have performed more than 200 cases over the past 5 years. The 30-day hospital mortality and redo operation rate for persisting mitral regurgitation was 0.3% and 0.6%, respectively, almost equivalent to that of the Cleveland Clinic. We believe that the 5-year result for robotic mitral surgery in Japan is acceptable. It is of note, however, that the length of hospital stay was 10.8±7.6 days, much longer than that of patients at the Cleveland Clinic( 5.2±2.8 days), and the homologous blood transfusion rate was 40.3%, twofold higher than that of the Cleveland Clinic( 20.5%). Therefore, the full benefits of less invasive robotic mitral repair surgery have not yet been achieved. Further improvements in results are both essential and anticipated.

Surgical repair of a posterior left ventricular aneurysm in a 4-year-old boy.

Left ventricular aneurysms are rarely encountered in pediatric patients. A 4-year-old boy was diagnosed with severe mitral regurgitation and a posterior left ventricular aneurysm associated with a viral infection. The aneurysm was surgically resected and plicated longitudinally with a combination of an interrupted mattress and continuous over-and-over sutures with an outer felt reinforcement. The mitral regurgitation was reduced to a trivial degree postoperatively. The patient's postoperative recovery was good. He was discharged 31 days after surgery without cardiac dysfunction or lethal arrhythmia. Considering the location and spread of the aneurysm, an appropriate surgical procedure should be adopted for pediatric patients.

Cystatin C in risk prediction after transcatheter aortic valve replacement: a retrospective analysis.

AIMS: No study has evaluated the prognostic value of the chronic kidney disease (CKD) classification by cystatin C-based estimated glomerular filtration rate (eGFR) (CKDCys classification) in patients undergoing transcatheter aortic valve replacement (TAVR). This study aimed to compare the prognostic value of CKDCys classification and CKD classification by creatinine-based eGFR (CKDCr classification) in risk prediction after TAVR. METHODS AND RESULTS: We retrospectively analysed consecutive 219 patients with symptomatic severe aortic stenosis who underwent TAVR at our institute between December 2016 and June 2019. Pre-operative CKDCr and CKDCys classifications were evaluated for their prognostic value of 2-year major adverse cardiovascular and cerebrovascular events (MACCE) after TAVR. MACCE was defined as the composite of all-cause mortality, non-fatal myocardial infarction, stroke, and rehospitalization for worsening congestive heart failure. Participants had a median age of 86.0 years and were predominantly female (76.9%). In 96.6% of the cases, TAVR was performed using transfemoral access. The median creatinine-based eGFR (52.85 mL/min/1.73 m2 ) was higher than the cystatin C-based eGFR (41.50 mL/min/1.73 m2 ). Downward reclassification in CKD stages based on eGFRCys was observed in 49.0% of patients. During a median follow-up period of 575.5 (interquartile range: 367.0-730.0) days, 58 patients presented with MACCE. CKDCys classification, but not CKDCr classification, significantly stratified the risk of 2-year MACCE in patients after TAVR by log-rank test (P = 0.003). In multivariate Cox regression analysis, only CKDCys stage 3b [hazard ratio (HR) = 4.37; 95% confidence interval (CI): 1.28-14.91; P = 0.019] and CKDCys stage 4 + 5 (HR = 3.72; 95% CI: 1.06-12.99; P = 0.040) were significant predictors of MACCE after adjustment for potential confounders. CONCLUSIONS: The CKDCys classification could better assess the risk than the CKDCr classification in patients undergoing TAVR. CKDCys stage 3b and stage 4 + 5 correlated with adverse outcomes.

Coronary artery bypass grafting for coronary artery anomalies in infants and young children.

OBJECTIVES: Coronary artery bypass grafting (CABG) has been reported for coronary artery diseases in patients with Kawasaki disease and coronary artery complications after arterial switch operations for transposition of the great arteries. However, only a few studies have explored this modality for congenital coronary artery anomalies. As congenital coronary artery anomalies, particularly left coronary artery atresia and stenosis, are one of the reasons for sudden death, coronary revascularization is often required in infants and young children. Therefore, we aimed to investigate the outcome of CABG for such anomalies in infants and young children. METHODS: From 2014 to 2018, 3 infants and 2 children (median age: 10 months; range: 6-40 months) with coronary artery anomalies underwent CABG at our hospital. The indications for the procedure included left main coronary artery atresia and stenosis in 2 and 3 patients, respectively. Graft patency was evaluated postoperatively by contrast-enhanced computed tomography or coronary angiography, and postoperative outcomes (including death and cardiac events) were assessed during the follow-up period. RESULTS: No 30-day or in-hospital mortalities were noted. Postoperative examinations revealed patent grafts in all patients. They were discharged without any cardiac complications. Regarding the outcomes at the follow-up period, the graft patency rate was 80.0% (4/5 grafts), with no deaths or cardiac events. CONCLUSIONS: CABG is a useful strategy for coronary revascularization in infants and young children with coronary artery anomalies. Although the mid-term outcomes and patency are satisfactory, careful follow-up is necessary because the long-term outcomes remain unknown.

Multicenter randomized study evaluating the outcome of ganglionated plexi ablation in maze procedure.

OBJECTIVE: The benefit of adding ganglionated plexi ablation to the maze procedure remains controversial. This study aims to compare the outcomes of the maze procedure with and without ganglionated plexi ablation. METHODS: This multicenter randomized study included 74 patients with atrial fibrillation associated with structural heart disease. Patients were randomly allocated to the ganglionated plexi ablation group (maze with ganglionated plexi ablation) or the maze group (maze without ganglionated plexi ablation). The lesion sets in the maze procedure were unified in all patients. High-frequency stimulation was applied to clearly identify and perform ganglionated plexi ablation. Patients were followed up for at least 6 months. The primary endpoint was a recurrence of atrial fibrillation. RESULTS: The intention-to-treat analysis included 69 patients (34 in the ganglionated plexi ablation group and 35 in the maze group). No surgical mortality was observed in either group. After a mean follow-up period of 16.3 ± 7.9 months, 86.8% of patients in the ganglionated plexi ablation group and 91.4% of those in the maze group did not experience atrial fibrillation recurrence. Kaplan-Meier atrial fibrillation-free curves showed no significant difference between the two groups (P = .685). Cox proportional hazards regression analysis indicated that left atrial dimension was the only risk factor for atrial fibrillation recurrence (hazard ratio: 1.106, 95% confidence interval 1.017-1.024, P = .019). CONCLUSION: The addition of ganglionated plexi ablation to the maze procedure does not improve early outcome when treating atrial fibrillation associated with structural heart disease.

Pulmonary artery augmentation and aortic valve repair using novel tissue-engineered grafts.

Objectives: The objectives of this study were to evaluate the results when tissue-engineered vascular grafts (TEVGs) are used as alternatives to autologous pericardium for surgically augmenting the pulmonary artery (PA) or aortic valve. Methods: TEVG molds were embedded into subcutaneous spaces for more than 4 weeks preoperatively. Since 2014, 6 patients have undergone PA reconstruction, whereas 1 has undergone aortic valve plasty (AVP) with TEVGs. The time from mold implantation to the operation was 8.9 (range, 6.0-26.4) months. The age and body weight at the time of operation were 2.7 (range, 1.8-9.2) and 11.6 (range, 7.9-24.4) kg, respectively. Concomitant procedures comprised the Rastelli, palliative Rastelli, and Fontan operations in 2, 2, and 1 patient, respectively. Results: The median follow-up period was 14.4 (range, 3-39.6) months. There were no early or late mortalities. Moreover, there were no TEVG-related complications, including aneurysmal changes, degeneration, and infection. In 5 patients who underwent PA augmentation, the postoperative PA configuration was satisfactorily dilated. The reconstructed aortic valve function was good in the patient who underwent AVP. Decreased leaflet flexibility due to leaflet thickening was not observed. One patient had postoperative PA re-stenosis; therefore, re-PA augmentation with TEVGs was performed. On histological examination, TEVGs consisted of collagen fibers and few fibroblasts, and elastic fiber formation and/or smooth muscle cells were not observed. Conclusions: The midterm results of PA reconstruction and AVP with TEVGs were satisfactory. TEVGs might be a useful alternative to autologous pericardium in pediatric cardiovascular surgeries that often require multistage operations.

Preoperative Left Ventricular Energy Loss in the Operating Theater Reflects Subjective Symptoms in Chronic Aortic Regurgitation.

BACKGROUND: There is currently no subjective, definitive evaluation method for therapeutic indication other than symptoms in aortic regurgitation. Energy loss, a novel parameter of cardiac workload, can be visualized and quantified using echocardiography vector flow mapping. The purpose of the present study was to evaluate whether energy loss in patients with chronic aortic regurgitation can quantify their subjective symptoms more clearly than other conventional metrics. METHODS: We studied 15 patients undergoing elective aortic valve surgery for aortic regurgitation. We divided the patients into symptomatic and asymptomatic groups using their admission records. We analyzed the mean energy loss in one cardiac cycle using transesophageal echocardiography during the preoperative period. The relationships between symptoms, energy loss, and other conventional metrics were statistically analyzed. RESULTS: There were seven and eight patients in the symptomatic and asymptomatic groups, respectively. The mean energy loss of one cardiac cycle was higher in the symptomatic group (121 mW/m [96-184]) than in the asymptomatic group (87 mW/m [80-103]) (p = 0.040), whereas the diastolic diameter was higher in the asymptomatic group (65 mm [59-78]) than in the symptomatic group (57 mm [51-57]) (p = 0.040). There was no significant difference between the symptomatic and asymptomatic groups in terms of other conventional metrics. CONCLUSIONS: An energy loss can quantify patients' subjective symptoms more clearly than other conventional metrics. The small sample size is the primary limitation of our study, further studies assessing larger cohort of patients are warranted to validate our findings.