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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., (© 2023. Springer Nature Japan KK, part of Springer Nature.)

Sutureless offers an alternative to standard valves in surgical aortic valve replacement (SAVR). We sought to confirm the efficacy and safety of the Perceval sutureless valve in Japanese patients. Prospective observational study of 204 patients who underwent SAVR with Perceval at 19 sites in Japan between March and December 2019. The primary outcomes were 30-day mortality and postoperative complications; the secondary outcome was all-cause mortality at 1 year. Efficacy outcomes were changed in New York Heart Association (NYHA) class, pressure gradients, effective orifice area (EOA), EOA indexed to body surface area (EOAi) and severity of aortic regurgitation. Mean age was 77.7 years, 62.7% were female. Procedural success rate was 99.0%. The median cross-clamp and cardiopulmonary bypass times were 68.0 and 108 min. Perceval size S and M were implanted in 95 (46.6%) and in 76 (37.3%) of patients, respectively. The 30-day and late mortality rate were 0.5% and 4.4%, while the new permanent pacemaker implantation rate was 4.4%. Mean pressure gradient was 13.0 mmHg at discharge, reaching 11.0 mmHg at 1 year; while the mean EOA was 1.5 cm 2 at discharge remaining stable up to 1 year. No moderate or severe leakages were present at discharge or at 1 year. NYHA class improved by ≥ 1 level in 55.1% of the patients at discharge and in 69.4% of the patients at 1 year. 1-year outcomes of SAVR with the Perceval sutureless valve in Japanese patients were favorable. This valve offers a promising alternative to conventional biological AVR in this Japanese population., (© 2023. The Author(s).)

Background: Long-term survival after surgery for severe aortic stenosis (AS) provides important information regarding the choice between surgical (SAVR) and transcatheter (TAVR) aortic valve replacement. This study investigated the long-term survival of AS patients with low or intermediate surgical risk who underwent SAVR or TAVR in our institution versus that of the Japanese general population., Methods: From 2009 to 2019, 1276 consecutive patients underwent SAVR or TAVR for severe AS. Among them, we retrospectively investigated those with low (n = 383) or intermediate (n = 137) surgical risk treated with SAVR and those with low (n = 86) or intermediate (n = 333) surgical risk treated with TAVR. Their post-intervention survival was compared with that of an age- and gender-matched Japanese general population., Results: The overall 5-year survival rate of SAVR for patients with low surgical risk (mean age, 72 ± 9 years) was not significantly different from that of the general population (90 % vs. 89 %, respectively; p = 0.58), whereas that of patients with intermediate surgical risk (77 ± 6 years) was significantly lower than that of the general population (77 % vs. 84 %, respectively; p = 0.03). After TAVR, the 5-year survival of patients with low (78 ± 8 years) or intermediate (83 ± 5 years) surgical risk was significantly lower than that of the general population (low risk, 64 % vs. 81 %, p < 0.01; intermediate risk, 66 % vs. 71 %, respectively, p = 0.01)., Conclusions: Our study demonstrated that long-term survival after SAVR for AS patients with low surgical risk was as good as that of the age- and gender-matched general population, while the long-term survival after SAVR for intermediate-risk or TAVR for low- or intermediate-risk patients was lower than that of the general population. These findings suggest that SAVR is an appropriate option for AS patients with low surgical risk and good life expectancy, especially in Japan, where the life expectancy is the longest worldwide., Competing Interests: Declaration of competing interest None to declare., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization-by-Doing) between the 2 countries. Methods and Results The patient-level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J-TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45-97) in the United States and 28 (interquartile range, 19-41) in Japan. Overall, patients in J-TVT were older (United States: mean-age, 80.1±8.7 versus Japan: 84.4±5.2; P <0.001), were more frequently women (45.9% versus 68.1%; P <0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; P <0.001) than patients in the United States. Japan had lower unadjusted 30-day mortality (1.3% versus 3.2%; P <0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; P <0.001) but had higher conversion to open surgery (0.94% versus 0.56%; P <0.001). Conclusions This collaborative analysis between the United States and Japan demonstrated the feasibility of international comparison using the national registries coded under mutual variable definitions. Both countries obtained excellent outcomes, although the Japanese had lower 30-day mortality and major morbidity. Harmonization-by-Doing is one of the key steps needed to build global-level learning to improve patient outcomes.

Geometric changes caused by volume reduction early after aortic valve replacement (AVR) for aortic regurgitation (AR) may not be uniform, resulting in varying regional end-systolic wall stress (ESS). This study compared changes in regional ESS between AR and aortic stenosis (AS) patients in the early phase following AVR. Computer-tomographic left ventricular (LV) angiography was performed for 10 patients with AR and 13 with AS before and three months after AVR. Regional ESS at the base, middle, and apex levels, each subdivided into four segments, was calculated based on the Janz equation: ESS = end-systolic LV pressure × local cross-sectional area of LV cavity/that of LV wall. Following AVR, median LV end-diastolic volume index fell from 106 to 69 ml/m 2 (P = 0.001) in AR and 60 to 46 ml/m 2 (P = 0.01) in AS patients. Global ESS also declined in both (AR, 186 to 124 kdyne/cm 2 , P = 0.02; AS, 187 to 108 kdyne/cm 2 , P < 0.001, respectively). Regional ESS was reduced in all segments in AS patients, accompanied by left ventricular ejection fraction (LVEF) improvement (71-80%, P = 0.02). In contrast, regional ESS in AR patients was heterogeneously reduced, as regional ESS fell significantly in the antero-septal wall but was unchanged in the infero-lateral wall, and LVEF remained unchanged (65 to 62%, P = 0.42). In the early postoperative phase after AVR, the loading condition of the regional LV wall in AR patients was characterized by a heterogeneous reduction in regional ESS in contrast to a uniform decline in AS patients., (© 2021. The Japanese Society for Artificial Organs.)

A 41-year-old patient with achondroplasia who had undergone surgery for congenital aortic stenosis >20 years ago presented with dyspnoea due to severe aortic stenosis. Computed tomography confirmed a small (16-mm) aortic annulus, thickened aortic valve leaflets without calcification and subaortic fibrous tissues. Intraoperatively, 3 non-calcific aortic leaflets were observed. Enlargement of the aortic root using a modified Manouguian technique for good exposure enabled the resection of subaortic tissues and replacement of the valve with a mechanical valve. The aortic root can be extremely small in patients with aortic stenosis and achondroplasia. The anatomy of the aortic root should be carefully assessed to enable appropriate surgical planning., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Background: Dialysis patients with aortic stenosis are generally considered as being at extreme or high surgical risk. Herein, the first clinical trial was conducted to investigate clinical safety and effectiveness of transcatheter aortic valve replacement (TAVR) using the balloon-expandable transcatheter aortic valve (SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) in Japanese dialysis patients., Methods: The clinical trial is a single arm, prospective, open, non-randomized, Japanese multicenter study. The primary purpose of this trial is to evaluate the efficacy and safety of TAVR using SAPIEN 3 in 28 Japanese dialysis patients., Results: Mean age was 79.2 years and 67.9% were male (Mean STS score was 14.3%). Transfemoral and transapical approaches were performed in 25 (89.3%) and 3 patients (10.7%), respectively. All bioprostheses were successfully implanted. Median intensive care unit stay and hospital stay after TAVR were 1.4 days and 6.3 days, respectively. In-hospital mortality was 3.6% and freedom from all-cause mortality at 1 year was 89.3%. Disabling stroke and life-threatening bleeding at 1 year was 7.7% and 8.5%, respectively. There was no structural valve deterioration during follow-up. New York Heart Association functional status, six-minute walk test, and EuroQOL visual analogue scale score significantly improved through 1 year compared with baseline., Conclusions: TAVR using SAPIEN 3 is safe and effective for the treatment of Japanese dialysis patients with symptomatic severe aortic valve stenosis., (Copyright © 2021. Published by Elsevier Ltd.)

An 86-year-old woman with severe aortic stenosis was thought to be at a high risk for surgical aortic valve replacement and inoperability due to old age and porcelain aorta. Furthermore, transcatheter aortic valve replacement (TAVR) was considered difficult due to high risk of coronary obstruction secondary to the aortic root anatomy and poor vascular access associated with marked atherosclerotic lesions on the distal aortic arch with peripheral artery disease. We successfully treated her with TAVR via the brachiocephalic artery in combination with prophylactic off-pump coronary artery bypass grafting., (© 2021. The Japanese Association for Thoracic Surgery.)

Background: The REPRISE Japan study, a prospective multicenter single-arm trial, was undertaken to confirm the safety and effectiveness of transcatheter aortic valve replacement (TAVR) with the LOTUS valve in Japanese subjects with severe symptomatic calcific aortic stenosis at extreme or high surgical risk.Methods and Results:REPRISE Japan enrolled 40 subjects in the transfemoral (TF) cohort (mean age 84 years; mean [±SD] Society of Thoracic Surgeons [STS] score 6.4±2.9%); 10 additional subjects were treated with a transaortic (TAo) approach (mean age 84 years; mean STS score 6.3±3.3%). A subanalysis was also performed on subjects treated with the 21-mm LOTUS valve (n=15; mean age 84 years; mean STS score 5.3±2.1%). The primary safety endpoint (a composite of all-cause mortality, stroke, life-threatening or major bleeding events, acute kidney injury [Stage 2/3], and major vascular complications at 30 days) occurred in 15% of TF subjects. The primary effectiveness endpoint (a composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak [PVL; core laboratory assessed] at 6 months) occurred in 5.3% of TF subjects. Across the TF, TAo, and 21-mm LOTUS valve cohorts, no subjects exhibited moderate or greater PVL at 6 months. The 30-day rate of pacemaker implantation was 22.5% in the TF cohort (TAo: 20%; 21 mm: 13.3%)., Conclusions: Data from REPRISE Japan confirm the safety and efficacy of the LOTUS Valve when used in Japanese clinical practice.

Background: Current guidelines for transcatheter aortic valve replacement (TAVR) recommend that TAVR should be performed in patients with a life expectancy > 1 year. However, it is challenging to estimate the patients' life expectancy because it is related to various factors, including frailty and nutritional status., Hypothesis: A new risk model can estimate the prognosis of patients after TAVR., Methods: We randomly divided 388 patients with aortic stenosis (AS) undergoing TAVR from October 2009 to August 2016 into two groups (2:1 ratio; training cohort, 259; validation cohort, 129). Using 94 baseline factors in the training cohort, we developed possible scoring models by the Cox proportional hazard regression model with the overall survival as the endpoint. Then, cross-validated 5-year C-statistics were calculated to assess the accuracy of the model., Results: Of 94 baseline factors, 12 factors were finally identified (5-year C-statistics in the training cohort: 0.709)-age, gender, body mass index, left ventricular ejection fraction, % vital capacity, forced expiratory volume 1.0 (s) %, albumin, hemoglobin, creatine, platelet, creatine kinase, and prothrombin time-international normalized ratio. The cross-validated 1-, 3-, and 5-year C-statistics in the validation cohort were 0.792, 0.758, and 0.778, respectively. Furthermore, calibration plots in the validation cohort revealed that 5-year survival is well predicted (r = 0.962)., Conclusions: The new survival prediction model after TAVR could provide appropriate guidance during decision making regarding the TAVR implementation.

Few studies have evaluated transcatheter aortic valve implantation (TAVI) beyond 5 years. We investigated long-term outcomes (≥5 years) and transcatheter heart valve (THV) performance in patients who had undergone TAVI at least 5 years previously, based on annual follow-up. We reviewed 114 consecutive patients who were of high surgical risk or inoperable and underwent TAVI for severe aortic stenosis from October 2009 to November 2013. There was no lost to follow-up, and median time to death or latest follow-up was 5.0 years (range: 0.1 to 8.5). Structural valve degeneration (SVD) was defined on transthoracic echocardiography (TTE) as follows: (1) mean pressure gradient ≥20 mm Hg with a >10 mm Hg increase from the post-TAVI baseline, and/or (2) moderate or severe transvalvular regurgitation. The mean patient age was 82.7 ± 6.4 years, and 37.7% of patients were men. Median Society of Thoracic Surgeons score was 7.6% (interquartile range 5.8 to 10.9). TTE ≥5 years was 76.1% complete (51 of 67 patients who survived ≥5 years postoperatively). The estimated cumulative survival rates at 1, 3, 5, and 7 years were 88.6%, 72.8%, 58.8%, and 45.3%, respectively. Albumin <3.5 g/dl was strongly associated with increased long-term mortality on multivariate analysis. Longitudinal TTE confirmed durable performance of THV up to 7 years in the majority of patients; however, 6 patients (5.3% of the total cohort) experienced SVD during the follow-up. In conclusion, this study demonstrated favorable long-term survival and stable THV performance after TAVI, although SVD was not rare., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Little is known about late outcomes after transcatheter aortic valve replacement (TAVR) in dialysis patients.Methods and Results:We enrolled 25 dialysis patients (mean age 76.5 years; mean STS score 14.7%; men 60.0%) with aortic valve stenosis undergoing TAVR at our institute. Cardiovascular mortality and stroke were defined according to the VARC-2 criteria, and major adverse cardiac and cerebrovascular events (MACCE) were investigated. Twenty-three patients (92.0%) were discharged, and the median hospital stay after TAVR was 9 days (IQR, 7.5-11 days). Mortality at 30 days was not observed. The overall survival rate at 1 and 3 years were 80.0% and 55.7%, respectively (follow-up period, 879±493 days; range, 40-1,826 days). At 1 and 3 years, rates of freedom from cardiovascular mortality, disabling stroke, and MACCE were 100% and 83.0%, 91.2% and 84.7%, and 69.8% and 39.9%, respectively. Three patients required redo-TAVR for valve dysfunction at 23, 36, and 38 months after the first TAVR, respectively (The rate of freedom from severe structural valve deterioration at 1 and 3 years was 100% and 85.9%, respectively)., Conclusions: Satisfactory in-hospital outcomes were achieved in dialysis patients after TAVR. Various problems, however, such as complications particular to dialysis patients and valve durability, remained at midterm follow-up. Further studies are recommended to solve these problems, and prudent preoperative assessments should be mandatory.

Aims: The aim of this study was to assess the safety and performance of the ACURATE neo transcatheter heart valve and its transfemoral delivery system., Methods and Results: The prospective, multicentre "CE-approval cohort" consists of a prospective series of the first 89 patients implanted with the ACURATE neo prosthesis. The primary endpoint was all-cause mortality at 30 days. Mean patient age was 83.7±4.4 years and logistic EuroSCORE I was 26.5±7.7%. Procedural success was obtained in 84 patients (94.4%). At 30 days, three patients had died, and two major strokes and one reintervention for a ventricular septal defect occurred, leading to a major adverse cardiac and cerebrovascular event (MACCE) rate of 6.7%. Eight patients (10.3%) received a permanent pacemaker. At one year, 20 patients (22.5%) had died and the MACCE rate was 27%. Effective orifice area was 1.76±0.34 cm2, and mean gradient 7.5±2.8 mmHg. Only three patients (4.5%) had moderate paravalvular regurgitation. NYHA Class III/IV was present in 94.4% of patients at baseline, in 9.9% at 30 days and in 4.5% at one year post procedure., Conclusions: This first-in-human experience with a novel self-expanding heart valve showed low rates of procedural mortality, major stroke and pacemaker implantation, and good performance outcomes.

Background: Transcatheter aortic valve implantation (TAVI) is a viable alternative to surgical aortic valve replacement in high-risk or inoperable patients with aortic stenosis (AS). Here we report the midterm outcomes of high-risk Japanese patients with severe AS who underwent TAVI with a self-expandable TAV.Methods and Results:The CoreValve Japan Trial was a prospective, multicenter trial of the CoreValve System. A group of 55 patients (mean age 82.5±5.5 years, 30.9% male, 100% NYHA class III/IV, STS 8.0±4.2%) were enrolled in the 26-mm/29-mm CoreValve study, and 20 patients (mean age 81.0±6.6 years, 5.0% male, 100% NYHA class III/IV, STS 7.0±3.3%) were enrolled in the 23-mm CoreValve study, which started 1 year later. For the 26-mm/29-mm cohort, the 3-year all-cause mortality rate was 32.6%; major stroke was 15.4%. Mean pressure gradient (MPG), effective orifice area (EOA), and NYHA class showed sustained improvement. Paravalvular regurgitation (PVR) at 3 years was 28.6% (none), 25.7% (trace), 40.0% (mild), 5.7% (moderate), and 0.0% (severe). For the 23-mm cohort, the 2-year all-cause mortality rate was 5.0%; major stroke was 5.0%. MPG, EOA, and NYHA class showed sustained improvement. PVR at 2 years was 16.7% (none), 33.3% (trace), 44.4% (mild), 5.6% (moderate), and 0.0% (severe)., Conclusions: TAVI with the CoreValve System was associated with sustained clinical and functional cardiac improvement in high surgical risk Japanese patients with severe AS. (Clinicaltrials.gov Identifiers: NCT01437098 and NCT01634269.).

Background: Transcatheter aortic valve replacement (TAVR) has been an alternative less invasive therapy for high-surgical risk/inoperable patients with aortic valve stenosis (AS) in Japan. We report 5-year outcomes of the first pivotal clinical trial of TAVR in Japan (PREVAIL JAPAN).Methods and Results:A total of 64 patients with AS who were considered unsuitable candidates for surgery were enrolled at 3 centers in Japan (mean age: 84.3±6.1 years, female: 65.6%, STS score: 9.0±4.5%). Transfemoral approach (TF) and transapical approach (TA) was performed in 37 patients and 27 patients, respectively. At 5 years, freedom from all-cause death was 52.7% (TF: 51.3%, TA: 56.3%). Risk of all stroke at 5-year was 15.8% (TF: 8.9%, TA: 25.5%) and risk of major adverse cardiac and cerebrovascular events at 5 years was 58.0% (TF: 51.3%, TA: 69.2%). Mild or greater aortic regurgitation (AR) at 1 week was not associated with increased all-cause death at 5 years (69.1%) compared with none or trace AR (48.3%) (P=0.184). Patients with high STS score (>8) had higher mortality rate than those with low STS scores (≤8)., Conclusions: The 5-year data from PREVAIL JAPAN show the clinical benefit of TAVR and suggest that balloon-expandable TAVR is an effective treatment option for Japanese patients with severe AS who are not suitable for surgery. (Funded by Edwards Lifesciences Limited; ClinicalTrials.gov number, NCT01113983.).

Purpose: We examined the impact of advanced age on left ventricular mass regression and the change in the diastolic function after aortic valve replacement in patients with aortic stenosis., Methods: The present study included 129 patients who underwent either surgical or transcatheter aortic valve replacement and 1-year postoperative echocardiography. The patient characteristics and echocardiographic findings were compared between patients who were <80 years of age (group Y: n = 69) and those who were ≥80 years of age (group O: n = 60)., Results: Preoperative echocardiography revealed that although the left ventricular mass was similar between the groups, the patients in group O had more severe diastolic dysfunction in comparison to those in group Y. Postoperatively, left ventricular mass regression was significantly greater (p = 0.02) and diastolic dysfunction was less prevalent in group Y (p = 0.02) in comparison to group O. The change in E/e' was significantly correlated with the left ventricular mass regression in group Y (p = 0.02), but not in Group O (p = 0.21)., Conclusions: The patients in group O were less susceptible to improvements in myocardial remodeling and the diastolic function in comparison to those in group Y. The altered physiological response to aortic valve replacement might help to determine the appropriate timing of surgery in elderly patients.

Background: Dual antiplatelet therapy (DAPT) is commonly used after transcatheter aortic valve implantation (TAVI); however, the supporting evidence is limited. To determine if aspirin alone is a better alternative to DAPT, we compared the outcomes of patients treated with DAPT or aspirin alone after TAVI.Methods and Results:We analyzed a total of 144 consecutive patients (92 females, mean age 83±6 years) who underwent implantation of a balloon-expandable transcatheter valve (SAPIEN or SAPIEN XT, Edwards Lifesciences). Patients were divided into DAPT (n=66) or aspirin-alone treatment groups (n=78). At 1 year after TAVI, the composite endpoint, which consisted of all-cause death, myocardial infarction, stroke, and major or life-threatening bleeding complications, occurred significantly less frequently (Kaplan-Meier analysis) in the aspirin-alone group (15.4%) than in the DAPT group (30.3%; P=0.031). Valve function assessed by echocardiography was similar between the 2 treatment groups with respect to effective orifice area (1.78±0.43 cm 2 in DAPT vs. 1.91±0.46 cm 2 in aspirin-alone group; P=0.13) and transvalvular pressure gradient (11.1±3.5 mmHg in DAPT vs. 10.3±4.1 mmHg in aspirin-alone group; P=0.31)., Conclusions: Treatment with aspirin alone after TAVI had greater safety benefits and was associated with similar valve function as DAPT. These results suggest that treatment with aspirin alone is an acceptable regimen for TAVI patients.

Background: It is well-documented that persistent myocardial hypertrophy in patients with aortic stenosis is related to suboptimal postoperative outcomes after aortic valve replacement. Although diabetes is known to potentially exacerbate myocardial hypertrophy, it has yet to be examined if it affects postoperative left ventricular mass regression (LVMR)., Methods: A single-centre, retrospective analysis was performed on 183 consecutive patients who underwent either surgical or transcatheter aortic valve replacement between 2010 and May 2013. Patient demographics, postoperative outcomes and echocardiographic data were obtained preoperatively and a year after surgery., Results: There were 42 diabetic and 141 non-diabetic patients. Preoperative characteristics of diabetic patients were statistically similar to those of non-diabetic patients, except for higher prevalence of hyperlipidaemia (p <0.001) and history of cerebrovascular disorder (p=0.046) in diabetic patients. Median value of postoperative LVMR of all patients was -36.5 g/m(2), and was significantly greater in the non-diabetics compared to the diabetics (-39.1 vs. -22.2 g/m(2), p=0.008). Univariate and multivariate analyses were performed on preoperative variables, and stepwise multiple regression analysis demonstrated that diabetes (standardised partial regression coefficient (SPRC)=-0.187, p=0.018), female gender (SPRC=0.245, p=0.026) and age (SPRC=0.203, p=0.018) were associated with poor postoperative LVMR., Conclusions: Patients with diabetes showed suboptimal postoperative LVMR, and the disease was a prognostic factor that was associated with poor LVMR. These findings suggest that diabetes may predispose the particular group of patients to worse postoperative outcomes., (Copyright © 2015 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Objective: To identify the risk factors of prolonged hemodynamic compromise caused by rapid pacing for valve deployment during transcatheter aortic valve implantation., Design: A retrospective study., Setting: Academic hospital., Participants: Forty-seven patients with severe aortic stenosis who underwent transcatheter aortic valve implantation., Interventions: The time after the end of rapid pacing until systolic arterial pressure and SvO2 recovery (systolic arterial pressure>90 mmHg and SvO2>65%) was defined as "the hemodynamic recovery time" and was measured from online anesthetic charts. The total study population was divided into 2 groups according to the recovery time (third quartile in all patients; 33 and 14 patients in the early and delayed recovery groups, respectively). Subsequently, the factors associated with prolonged hemodynamic compromise after rapid pacing for valve deployment were identified by univariate and multivariate analyses., Measurements and Main Results: Multivariate analysis identified left ventricular end-diastolic diameter (odds ratio, 0.774; 95% confidence interval, 0.608-0.915) and SvO2 (odds ratio, 0.748; 95% confidence interval, 0.590-0.868) as independent factors associated with prolonged hemodynamic compromise after rapid pacing for valve deployment., Conclusions: SvO2 and left ventricular end-diastolic diameter were found to be significant independent predictors of prolonged hemodynamic compromise immediately after rapid pacing for valve deployment during transcatheter aortic valve implantation., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Recent evidence suggests that transcatheter aortic valve replacement (TAVR) is feasible for treating severe aortic valve stenosis (AS) in patients who are considered high risk for elective surgery. However, it is still unclear whether TAVR is a better option than surgical aortic valve replacement for severe AS with acute decompensated heart failure. We report a case of severe AS with acute heart failure, which was treated successfully by urgent TAVR, with cardiopulmonary support.

With the improvement in the overall life expectancy, the incidence of aortic stenosis has been increasing. Although aortic valve replacement is a standard therapy, many patients do not undergo surgery for various reasons, including advanced age or the presence of multiple comorbidities. Transcatheter aortic valve implantation (TAVI) has been proposed as a less invasive and equally effective treatment for inoperable or high-risk symptomatic aortic stenosis. Numerous rigorous global clinical trials, as well as a pivotal clinical trial in Japan, have been conducted. In this review, we provide data on the development of TAVI worldwide and discuss the prospects for TAVI in Japan.

Background: The efficacy and safety of transcatheter aortic valve implantation (TAVI) in Asian populations were unknown. The purpose of this study was to compare directly the clinical outcomes of the first Japanese trial and a European single-center experience after TAVI., Methods and Results: Between April 2010 and October 2011, 64 patients were included in the PREVAIL JAPAN multicenter trial which was set up to evaluate the safety and efficacy of the Edwards SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) in high-risk Japanese patients with severe aortic stenosis. Between March 2010 and January 2012, 237 consecutive patients treated with TAVI using the Edwards SAPIEN XT™ prosthesis at Institut Cardiovasculaire Paris Sud were prospectively included in the Massy cohort. We compared the clinical outcomes of these two cohorts. Patients were of similar age (83.4±6.6 years vs. 84.5±6.1 years, p=0.25), but logistic EuroSCORE was higher in the Massy cohort (20.2±11.7% vs. 15.6±8.0%, p<0.01). Body surface area was smaller in the PREVAIL JAPAN cohort (1.41±0.14m(2) vs. 1.72±0.18m(2); p<0.01) as was the annulus diameter (20.4±1.46mm vs. 22.0±1.84mm, p<0.01). The transfemoral approach was used in 57.8% in the Japanese cohort vs. 51.5% in the Massy cohort. Device success was similar (89.1% vs. 94.1%, p=0.21, respectively), as well as 30-day and 6-month survival rates (92.2% vs. 90.7% and 89.1% vs. 83.1%, p=0.71 and p=0.25, respectively). The incidence of major vascular complications was not significantly different between the two groups (9.4% vs. 5.9%, p=0.23, respectively). A higher post-procedural mean pressure gradient was observed in the PREVAIL JAPAN cohort (12.7±11.4mmHg vs. 10.1±3.6mmHg, p=0.01), but satisfactory improvement in 6-month functional status was obtained in both cohorts (76.5% vs. 77.2%, p=0.91)., Conclusions: Clinical outcomes after TAVI in the patients included in the PREVAIL JAPAN trial were acceptable and as safe as that of a single-center European cohort., (Copyright © 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Purpose: Transcatheter aortic valve replacement (TAVR) is suggested to be less invasive and/or equally effective in comparison to conventional aortic valve replacement for high-risk symptomatic aortic stenosis patients. We herein report the initial results of a pivotal clinical trial of TAVR in Japan (the PREVAIL JAPAN)., Methods: Sixty-four aortic stenosis patients (mean age 84.3 ± 6.1 years) not suitable for surgery were enrolled at three centers in Japan, with a primary composite endpoint of the 6-month post-procedure improvements in the aortic valve area and New York Heart Association (NYHA) functional classification., Results: A transfemoral approach was used in 37 patients and a transapical approach was used in 27. The device success rate was 91.9 %. After 30 days and 6 months, the rates of mortality from any cause were 8.1 and 11.3 %, respectively. At 6 months, symptomatic stroke was found in 3.1 % of the patients, and silent infarction in 7.8 %. The aortic valve area and mean pressure gradient were significantly improved over time with both approaches (p < 0.001). At 6 months, the NYHA functional classification based on a conventional physician's assessment was improved in 87.9 % of the patients., Conclusions: We found results that were equivalent to those in other major TAVR trials, such as an acceptable 30-day survival (91.9 %), suggesting that balloon-expandable TAVR is effective for small Japanese AS patients classified as high-risk or inoperable.

Background: Feasibility and early results of transfemoral aortic valve implantation using the ACURATE neo/TF(TM)self-expanding stent are reported., Methods and Results: The study group of 15 patients (mean age 83.3±6.0) was enrolled with a mean EuroSCORE and STS score of 21.9±11.6% and 7.5±3.1%, respectively. Clinical and echocardiographic evaluations were performed at baseline, discharge, 30 days and 6 months. The primary endpoint was all-cause mortality at 30 days. Transcatheter aortic valve implantation (TAVI) using the ACURATE neo/TF device was successful in 14 patients; 1 patient underwent valve-in-valve implantation because the prosthetic valve embolized during withdrawal of the delivery system. Conversion to surgery, coronary obstruction, peri-operative stroke, and pacemaker implantation did not occur at 30 days. Mean transvalvular gradients at discharge significantly decreased from 44.2±10.5 mmHg (preprocedural) to 7.7±3.1 mmHg (P<0.0001) and effective orifice area significantly increased from 0.77±0.12 to 1.69±0.25 cm(2)(P<0.0001). None or trace paravalvular leak was revealed in 50.0%, and no patient exhibited moderate or higher paravalvular leak. The overall mortality at 30 days and 6 months was 0% and 6.7%, respectively., Conclusions: A new self-expanding TF TAVI device, ACURATE neo/TF, is safe and effective in the treatment of severe aortic stenosis in elderly patients at high risk for surgery.

Background: Although transcatheter aortic valve implantation (TAVI) is a new alternative treatment with acceptable midterm results for high surgical risk patients, at present performing the procedure in dialysis patients is not reimbursed in Japan., Methods and results: The study group of 17 dialysis patients (mean age, 76.7±5.0 years) underwent TAVI with the SAPIEN/SAPIEN XT. EuroSCORE and STS score were 25.0±19.0% and 15.4±12.3%, respectively. Transiliofemoral and transapical approaches were performed in 7 (41.2%) and 10 patients (58.8%), respectively. ICU and hospital stays after TAVI were 1.8±1.6 and 12.9±12.7 days, respectively. Mean transvalvular gradients at discharge significantly decreased from 45.9±13.3 mmHg to 10.7±4.3 mmHg (P<0.0001) and effective orifice area significantly increased from 0.78±0.17 to 1.69±0.37 cm(2)(P<0.0001). Device success was 87.5%. One patient required a valve-in-valve procedure on 187-postoperative-day for an acute increase in paravalvular leakage caused by initial lower implantation of the device. The overall mortality at 1 year was 0% and clinical efficacies at 30 days, 6 months, and 1 year were 93.8%, 83.3%, and 69.2%, respectively., Conclusions: Satisfactory early results were achieved with TAVI in Japanese dialysis patients with a high surgical risk, indicating it is a safe and effective alternative for the treatment of aortic valve stenosis in such patients.

Moyamoya disease (MMD) is a rare disease characterized by occlusive intracranial arteriopathy with formation of abnormal cerebrovascular collateral networks. Conventional cardiovascular surgical procedures using cardiopulmonary bypass for patients with MMD is challenging because low cerebral perfusion pressure and nonpulsatile (continuous) flow during cardiopulmonary bypass can cause severe cerebral ischemia. We successfully performed transcatheter aortic valve replacement in 3 women with severe aortic valve stenosis complicated with MMD. Transcatheter aortic valve replacement may be useful for patients with severe aortic valve stenosis complicated with severe cerebral ischemia, including MMD., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

While transcatheter aortic valve replacement( TAVR) has spread rapidly all over the world for highrisk patients with severe aortic stenosis (AS), SAPIEN XT was approved in Japan in October 2013. Since that, approximately 400 TAVR cases were performed in Japan. In our institute, we have performed 164 cases since first case in Japan in 2009 and have achieved satisfactory early results(30-day mortality:1.2%). At the same time, however, simultaneously various TAVR-related complications including a paravalvular leak, stroke, vascular complications, and coronary obstruction were observed. A reduction in the incidence and severity of these complications had led technical improvements in various new devices(2nd generation TAVR device such as the SAPIEN 3, ACURATE, and JenaValve) and in implantation techniques including repositioning/recapturing features, paravalvular sealing technologies, and prevention of coronary obstruction. Furthermore, there is also increasing experience with special indications for TAVR such as pure aortic valve insufficiency or valve-in-valve techniques. Currently, an increasing number of publications of midterm results demonstrate good prosthetic valve function and durability, with good quality of life and low morbidity after TAVR. There are also some randomized trials such as PARTNER 2 or SURTAVI to investigate potential benefits of TAVR for intermediate-risk patients. These improvements in the TAVR devices promises the expansion of TAVR towards the treatment of lower-risk patients in the near future.

Transcatheter aortic valve replacement (TAVR) for patients with a bicuspid aortic valve (BAV) is challenging as the extent and location of valve calcification as well as bulky leaflets and an enlarged root may increase the risk of transcatheter heart valve (THV) displacement, distortion, or malfunctioning. We report successful TAVR for an 84-year-old man with a BAV. The THV was implanted closer to the aorta than usual to avoid spreading of the bulky leaflets over the THV outflow. Following implantation, there was trivial paravalvular leakage, with no distortion or malfunction detected.

Background: Transcatheter aortic valve implantation (TAVI) may be a viable solution for inoperable or high-risk patients with aortic stenosis (AS), providing the benefit of valve replacement without the associated risks of surgery., Methods and Results: The prospective, multicenter MDT-2111 Japan Trial evaluated the efficacy and safety of a self-expandable TAV in patients with severe AS. A total of 55 patients were enrolled (October 2011 to October 2012). Mean age was 82.5±5.5 years; 30.9% male, 100% NYHA III/IV, and STS 8.0±4.2%. At 6 months, 91.7% of the iliofemoral patients had met the primary endpoint (an improvement of at least 1 NYHA class and an effective orifice area >1.2 cm(2) for iliofemoral patients). For all patients, freedom from all-cause mortality at 6 months was 90.8%. At 30 days, the Kaplan-Meier rate of major vascular complications was 10.9%, the rate of permanent pacemaker implantation was 22.2% and the rate of major stroke was 3.7%. The incidences of paravalvular regurgitation for all implanted patients at 6 months were: 38.3% (none), 25.5% (trace), 31.9% (mild), 4.3% (moderate), and 0.0% (severe)., Conclusions: This is the first study to evaluate a self-expandable TAV in a Japanese patient population. The data show successful achievement of the study's primary objective and demonstrate the functional and anatomical effectiveness of the MDT-2111 TAV system.

Transient constrictive pericarditis (CP) is quite rare, with only a few reports presented. Herein, we report 2 cases of transient CP following cardiac surgery. Case 1 was an 80-year-old man who underwent repair of a left ventricular free wall rupture, while Case 2 was a 69-year-old woman who underwent a conventional aortic valve implantation procedure. In both cases, constrictive features developed about 2 weeks after surgery, which were treated successfully by administrations of non-steroidal anti-inflammatory drugs (NSAIDs). Prior to performing a pericardiectomy, NSAID administration should be considered for affected patients who are hemodynamically stable.

Background: Transcatheter aortic valve replacement (TAVR) is a new alternative treatment with acceptable early results for patients with aortic valve stenosis considered to be inoperable. The first TAVR was performed in Japan in October 2009, and a total of 51 have been performed up to February 2012., Methods and Results: Because it is not possible to disclose details for 36 patients at the time of writing due to ongoing clinical trials, the early and mid-term results of 15 patients are presented for the Edwards SAPIEN valves. Age was 83.4 ± 6.1 years. Mean pressure gradient and aortic valve area were 60.3 ± 21.1 mmHg and 0.64 ± 0.19 cm(2), respectively. Left ventricular ejection fraction was 55.5 ± 15.4%. The Logistic EuroSCORE, EuroSCORE II, and Society of Thoracic Surgeons score were 28.5 ± 21.5%, 11.1 ± 15.8%, and 10.0 ± 7.4%, respectively. All of the procedures were successful and did not require conversion to surgery. Perioperative stroke did not occur, although pacemakers were implanted in 2 patients (13.3%). At discharge, mean pressure gradient and aortic valve area were improved to 10.8 ± 4.4 mmHg and 1.77 ± 0.36 cm(2), respectively. Except for 1 patient who died of cancer 7 months after operation, all patients were alive at the time of writing (11-848 days after procedure; mean follow-up period, 184 days)., Conclusions: Satisfactory early and mid-term results have been achieved with TAVR, indicating that this is a good alternative to treat aortic valve stenosis.

Transcatheter aortic valve replacement (TAVR) has recently been shown to be feasible in patients with severe aortic stenosis who are considered inoperable. We perform TAVR with cardiopulmonary support (CPS) for patients with low left ventricular (LV) function. We report two successful cases of TAVR on CPS in patients with low LV function and describe this technique., (© 2012 Wiley Periodicals, Inc.)

We report a successful transcatheter aortic valve replacement (TAVR) using syngo DynaCT (Siemens AG, Forchheim, Germany) in an 86-year-old man who had severe aortic valve stenosis. Syngo DynaCT is a cross-sectional radiological imaging system that facilitates intraoperative imaging via interventional angiographic systems; this navigation system is useful during TAVR, especially in cases of poor calcification at the annulus., (© 2012 Wiley Periodicals, Inc.)

Conventional aortic valve replacement (AVR) is the gold standard surgical treatment for symptomatic aortic valve stenosis. However, some patients are not referred for open surgical procedure because of their high risk due to complicated co-morbidities. We describe the first case in Japan of successful transcatheter aortic valve implantation (TAVI). An 81-year-old woman with severe interstitial pneumonia was referred for significant aortic valve stenosis. Conventional AVR might have been risky, so TAVI was planned after informed consent was obtained. Under general anesthesia was established, a 23-mm Edwards SAPIEN transcatheter heart valve was implanted through the common iliac artery. Postoperative echocardiographic assessment showed satisfactory hemodynamic function with a stable valve position, and she was discharged on day 7 without complications. At the 6-month follow-up, there had been no untoward events, and there was marked improvement in her functional status. TAVI for symptomatic aortic valve stenosis is a less invasive, alternative approach for high-risk patients.

Objective: The impact of untreated mild-to-moderate mitral regurgitation (MR) on patients undergoing isolated aortic valve replacement (AVR) is uncertain. The aim of this study is to investigate its long-term effects on outcomes., Method: We retrospectively reviewed 193 consecutive patients undergoing isolated AVR between 1993 and 2007. The mean age of the study group was 64+/-12 years, 59% were male and the mean preoperative ejection fraction was 59+/-12%. The pathologic aetiology and degree of MR was determined on preoperative echocardiogram. Patients were stratified into preoperative no/trivial MR (group I; n=134) versus mild-to-moderate MR (group II; n=59). The aetiology of MR in group II was either organic (n=35, 60%) or functional (n=24, 41%). Survival and functional outcome were compared between the two groups and analyses for predictors of adverse events were performed by the Cox proportional hazard model., Results: Operative mortality was 2.6% (n=5). In group II, mean degree of MR significantly decreased from 2.1+/-0.3 to 1.6+/-0.8 during the late period (p=0.003). The improvement in MR grade was more obvious in patients with functional aetiology. Although the actuarial survival was not significantly different between groups, freedom from re-admission for heart failure at 10 years was significantly lower in group II than in group I (23% vs 83%; p=0.002). Multivariate analysis demonstrated that independent predictors of heart failure were presence of mild-to-moderate MR (p=0.012, odds ratio (OR) 3.8) and left ventricular ejection fraction (p=0.004, OR 0.95)., Conclusion: Despite the significant reduction after isolated AVR, preoperative mild-to-moderate MR is an independent risk factor impacting long-term functional outcome. Our results suggested that the concomitant mitral valve surgery for mild-to-moderate MR is warranted, especially in patients with reduced left ventricular function., (Copyright 2009. Published by Elsevier B.V.)

Background: The aims of this study were to quantify the microcirculatory dysfunction in aortic stenosis (AS) and to measure the changes in transmural perfusion after aortic valve replacement (AVR), using quantitative myocardial contrast echocardiography., Methods: Myocardial contrast echocardiography was used to quantify the myocardial blood flow in both the subendocardium and subepicardium in 22 patients with AS (A group), before, 2 weeks after, and 1 year after AVR. Healthy volunteers (C group, n = 10) and patients with mitral regurgitation (M group, n = 10) were included as controls. Triggered myocardial contrast echocardiography was performed, and the endosystolic 1.5 harmonic images were recorded., Results: The myocardial contrast echocardiography study showed that, before AVR, the myocardial blood flow in the subendocardium was significantly lower in the A group than in the other groups (CI = -18.6 +/- 3.0 dB, -11.8 +/- 4.1 dB, and -12.7 +/- 4.1 dB, respectively, in A, M, and C groups; p < 0.05), whereas there was no significant difference in blood flow in the subepicardium. In the A group, the myocardial blood flow in the subendocardium was significantly improved 2 weeks after AVR (-13.1 +/- 3.5 dB after AVR), and this improvement was preserved 1 year after AVR., Conclusions: In patients with AS, the myocardial blood flow in the subendocardium declined preoperatively, and the coronary microcirculatory function was recovered after AVR in both the short and long term.

Background: We examined the relationships of left ventricular (LV) contractile state with LV geometry and hypertrophy in patients with aortic valve disease, and investigated the reversibility of LV hypertrophy and contractility following aortic valve replacement., Methods: Preoperative data from quantitative cineangiography and pressure measurements in 132 patients with chronic aortic valve disease, of whom 82 aortic regurgitation (AR), 41 aortic stenosis (AS), and 9 had mixed stenosis and regurgitation (AS-AR), were reviewed. Late after surgery, 59 of the patients (39 with AR, 20 with AS) were studied to elucidate the postoperative reversibility of LV performance and regression of LV hypertrophy., Results: Preoperatively, multiple comparison tests found significant changes in the variables of LV volumes and dimensions in relation to LV contractile state. In stepwise regression analysis, the LV mass index was initially incorporated into a multivariate regression model as an important correlate of LV contractile state. LV geometric variables showed either no or a poor correlation with contractile state. Following aortic valve replacement, improvement of LV contractile dysfunction and regression of LV hypertrophy were limited in many of the patients who had severe preoperative hypertrophy (LV mass index 200% of normal or greater). Further, a close association between LV hypertrophy and LV contractility persisted postoperatively., Conclusion: Our results suggest that the development of LV hypertrophy in terms of an increase in LV mass index, in contrast to changes in geometric patterns, is significantly associated with deterioration in contractile function. LV hypertrophy may become irreversible and pathological at equivalent degrees of hypertrophy (LV mass index >/=200% of normal), regardless of the type of aortic valve lesion.

Background and Aim of the Study: The study aim was to investigate the in-vivo flow profiles of a stentless aortic bioprosthetic valve by MRI flow quantification, and to identify the clinical implication of prosthesis size and implantation method., Methods: Twenty-six patients with a Freestyle stentless aortic bioprosthetic valve were studied using three-dimensional flow velocity profile by MRI, and compared with four patients with a stented aortic bioprosthetic valve and four healthy volunteers. Flow velocity profiles were analyzed quantitatively by the hydromechanics parameter, mean to peak velocity ratio at peak systole and compared with parameters monitored echocardiographically., Results: In larger-sized valves or full root implantation, flow profiles showed an optimal pattern with low gradients, a high mean to peak velocity ratio, and minimum disturbance which approximated that of a normal valve. By contrast, a subset of patients, notably with 21 mm valves and subcoronary implantation, showed suboptimal flow pattern with high gradient and low mean to peak velocity ratio which approximated that of stented valves. The mean to peak velocity ratio was more strongly related to peak velocity than to the indexed effective orifice area., Conclusion: Although stentless aortic bioprostheses have excellent hemodynamic performance, some patients show suboptimal results. This seems to occur more often when the subcoronary technique is used, and especially with 21-mm valves. Care must be taken when using the subcoronary technique with a 21-mm valve in patients with a small body surface area.

This study aimed to assess the predictors of patient–prosthesis mismatch (PPM) after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) using preoperative computed tomography. We enrolled 323 patients undergoing SAVR (n = 85) or TAVR (n = 238) for aortic stenosis. The end point was any degree of PPM (effective orifice area index <0.85 cm2/m2). We assessed the predictors of PPM after SAVR or TAVR and compared the incidence of PPM between both arms. Furthermore, we compared the hemodynamic performance using the propensity score matching. The occurrence of PPM was significantly higher in the SAVR arm (24.7% vs 7.1%; P <.001). A small sinotubular junction was an independent predictor of PPM in the SAVR arm (odds ratio, 0.79; 95% confidence interval, 0.65-0.96; P =.015), but not a significant predictor in the TAVR arm. In patients with a small sinotubular junction, the prevalence of PPM in the SAVR arm was higher (57.9% vs 2.9%; P <.001). Furthermore, among the propensity score-matched patients, the incidence of PPM in the SAVR arm was higher than that in the TAVR arm (26.3% vs 12.5%; P =.031). In patients with a small sinotubular junction detected by preoperative computed tomography assessment, the incidence of PPM in patients undergoing SAVR was higher. [ABSTRACT FROM AUTHOR]