Aortic regurgitation (AR) is a common valvular heart disease, but the optimal timing of surgical intervention remains controversial. In the natural history of chronic severe AR, sudden death is rare, and the annual mortality rate is comparatively low. Considering the hemodynamic features of combined volume and pressure overload and long-term compensation in patients with chronic AR, symptoms related to AR do not frequently occur. Therefore, the progression of left ventricular (LV) dysfunction is a key factor in determining the timing of surgical intervention in patients with severe chronic AR. In addition to symptoms, an ejection fraction <50% and an LV endsystolic diameter (LVESD) >45 mm are appropriate cutoff values for surgical intervention in Japanese patients, whereas LV end-diastolic diameter is not a good indicator. An LVESD index of 25 mm/m²is controversial, because adjusting for body size may cause overcorrection in Japanese patients who have a small body size compared with Westerners. Accumulation of data from the Japanese population is indispensable for establishing guidelines on optimal management of patients with chronic AR.

Background: Current guidelines equally recommend direct oral anticoagulants (DOACs) and warfarin for atrial fibrillation (AF) patients with a bioprosthetic valve (BPV); however, there are limited data comparing DOACs and warfarin in AF patients with an aortic BPV.

Methods and Results: This post-hoc subgroup analysis of a multicenter, prospective, observational registry (BPV-AF Registry) aimed to compare DOACs and warfarin in AF patients with an aortic BPV. The primary outcome was a composite of stroke, systemic embolism, major bleeding, heart failure requiring hospitalization, all-cause death, or BPV reoperation. The analysis included 479 patients (warfarin group, n=258; DOAC group, n=221). Surgical aortic valve replacement was performed in 74.4% and 36.7% of patients in the warfarin and DOAC groups, respectively. During a mean follow up of 15.5 months, the primary outcome occurred in 45 (17.4%) and 32 (14.5%) patients in the warfarin and DOAC groups, respectively. No significant difference was found in the primary outcome between the 2 groups (adjusted hazard ratio: 0.88, 95% confidence interval: 0.51–1.50). No significant multiplicative interaction was observed between the anticoagulant effects and type of aortic valve procedure (P=0.577).

Conclusions: Among AF patients with an aortic BPV, no significant difference was observed in the composite outcome of adverse clinical events between patients treated with warfarin and those treated with DOACs, suggesting that DOACs can be used as alternatives to warfarin in these patients.

Background: This study aimed to elucidate the short-term surgical outcomes and hemodynamics of the Intuity valve compared to the standard bioprosthesis in Japanese patients.

Methods and Results: Among the 307 consecutive patients who underwent aortic valve replacement (AVR) between February 2019 and March 2021, the Intuity valve was implanted in 95 patients (Intuity group) and a conventional stented bioprosthesis was implanted in 193 patients (conventional group). After propensity score matching, there was no significant difference in in-hospital mortality between the Intuity (n=2, 3%) and conventional groups (n=0, P=0.490). Operation, cardiopulmonary bypass, and aortic cross-clamping times were significantly shorter in the Intuity group. Although the effective orifice area index, trans-prosthetic mean pressure gradient, and peak velocity were similar between the 2 groups at 1 week postoperatively, the Intuity group showed a better mean pressure gradient and peak velocity at 1 year postoperatively. Complete atrioventricular block requiring permanent pacemaker implantation developed in 2 patients (3%) in the Intuity group and none in the conventional group (P=0.476). Mild or greater paravalvular leakage was present in 8 patients (13%) in the Intuity group and 2 patients (3%) in the conventional group (P=0.095).

Conclusions: AVR using the Intuity valve in Japanese patients is satisfactory, with a better valve performance and a low incidence of complete atrioventricular block at 1 year postoperatively.

Background: Postoperative cognitive dysfunction (POCD) is widely recognized and reported, but the lack of a uniform definition makes it difficult to evaluate its clinical impact. The aim of this study is to establish the optimal neuropsychological tests and definition of POCD relevant to clinical outcomes in heart valve surgeries.

Methods and Results: Between June 2015 and December 2019, 315 patients undergoing elective heart valve surgeries (age ≥65 years) were enrolled. The Mini-Mental Status Examination, Montreal Cognitive Assessment (MoCA), and the Trail Making Test A and B were performed to evaluate cognitive function. Clinical endpoints were defined as readmission and death. The postoperative readmission and death rate were 17% and 3% (54/315 and 8/315; follow-up 266–1,889 days). By multivariable Cox hazard analysis, Short Physical Performance Battery (adjusted hazard ratio [HR]: 0.84, 95% confidence interval [CI]: 0.49–0.98, P=0.001), MoCA change rate (adjusted HR: 0.64, 95% CI: 0.01–1.22, P=0.024), and intensive care unit stay (adjusted HR: 0.55%, 95% CI: 0.99–1.12, P=0.054) were detected as independent risk factors for combined events. The cutoff value was −12% in the change rate of MoCA.

Conclusions: MoCA was the only neuropsychological test that predicted the clinical impact on complex events and has the potential to define POCD.

Background: For elderly people, the benefit of minimally invasive cardiac surgery (MICS) is unclear, so we evaluated the safety, recovery, and long-term survival in elderly MICS patients.

Methods and Results: 63 propensity score-matched pairs of 213 consecutive patients (≥70 years old) who underwent mitral and/or tricuspid valve surgery between 2010 and 2020 (121 right mini-thoracotomies vs. 92 full sternotomies) were compared. The primary outcome was safety (composite endpoint of in-hospital death or major complication). Secondary outcomes were early ambulation and discharge to home. There were no differences between the groups for in-hospital death (3.2% vs. 0.0%, P=0.157) and primary outcome (14.3% vs. 17.5%, P=0.617). The rate of early ambulation (73.0% vs. 55.6%, P=0.048) and discharge to home (66.7% vs. 49.2%, P=0.034) were significantly higher in the mini-thoracotomy group. Major complication was an independent negative predictor of early ambulation for mini-thoracotomy but not for a conservative approach. Survival was 87.8±4.4% vs. 86.8±4.7% at 5 years, which was not significantly different.

Conclusions: Similar safety but better recovery were observed for mini-thoracotomy, and long-term survival was comparable between groups. Major complication was a negative predictor of early ambulation after mini-thoracotomy. Careful preoperative risk stratification would enhance the benefits of MICS in elderly patients.

Background: Minimally invasive sutureless aortic valve replacement with the Perceval bioprosthetic heart valve (MISUAVR) is commonly performed through a right anterior thoracotomy (AT). However, a lateral thoracotomy (LT) may be superior as it does not require rib and right internal thoracic artery (RITA) cutting.

Methods and Results: In total, 38 MISUAVRs performed from May 2019 to approximately August 2021 were retrospectively reviewed; 21 through LT (Group L), and 17 through AT (Group A). In Group L, the skin incision was made on the right anterior axillary line and third intercostal space, and in group A, on the right anterior chest and second or third intercostal space. All other surgical techniques were the same. Age, body surface area, EuroSCORE II, and ejection fraction were similar between the patients. Cardiopulmonary bypass (L: 82±19 vs. A: 93±28 min, P=0.19) and cross-clamp times (L: 57±13, vs. A: 64±23 min, P=0.19) were similar. Rib and/or RITA cutting were required in 94.6% of patients in group A and in none of group L (P<0.001). Surgical visualization score was better in group L (L: 1.19±0.40 vs. A: 1.94±0.69, P<0.01). Total amount of intraoperative bleeding was lower in group L (L: 623±141 vs. A: 838±316 mL, P<0.01). Duration of hospital stay was similar (P=0.30).

Conclusions: MISUAVR through LT has multiple advantages over AT.

Background: Transcatheter mitral valve repair with the MitraClip system has been established in selected high-risk patients. The MitraClip procedure results in a relatively large iatrogenic atrial septal defect (iASD). This study aimed to investigate the prevalence and clinical course of iASD requiring transcatheter closure following the MitraClip procedure.

Methods and Results: This study was conducted at all 59 institutions that perform transcatheter mitral valve repair with the MitraClip system in Japan. The data of patients on whom transcatheter iASD closure was performed were collected. Of the 2,722 patients who underwent the MitraClip procedure, 30 (1%) required transcatheter iASD closure. The maximum iASD size was 9±4 mm (range, 3–18 mm). The common clinical course of transcatheter iASD closure was hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt. Of the 30 patients, 22 (73%) required transcatheter closure within 24 h following the MitraClip procedure, including 12 with hypoxemia and 5 with right-sided heart failure complicated with cardiogenic shock. Of the 5 patients, 2 required mechanical circulatory support devices. Twenty-one patients immediately underwent transcatheter iASD closure, and hemodynamic deteriorations were resolved; however, 1 patient died without having undergone transcatheter closure.

Conclusions: Transcatheter iASD closure was required in 1% of patients who underwent the MitraClip procedure. Many of these patients immediately underwent transcatheter iASD closure because of hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt.

Background: Transcatheter aortic valve implantation (TAVI) is increasingly being performed in very elderly patients, although its efficacy and validity remain unclear. This study evaluated real-world TAVI outcomes in Japanese nonagenarians with severe aortic stenosis.

Methods and Results: This single-center study retrospectively assessed the early and long-term clinical outcomes of TAVI in nonagenarians (n=35) and in patients aged <90 years (group Y; n=171). There were no in-hospital deaths in either group. The device success rate and early safety were comparable between the 2 groups. The 5-year rates of freedom from cardiac events and deaths were equivalent in both groups. The cumulative survival rate at 5 years was non-significantly lower in nonagenarians (32.6% in nonagenarians vs. 57.5% in patients aged <90 years, P=0.49). There were no differences in the 5-year survival between nonagenarians after TAVI and the sex- and age-matched populations (P=0.18). The Cox regression model revealed that lower hemoglobin levels were associated with all-cause mortality (P=0.02), and age ≥90 years was not associated with all-cause mortality.

Conclusions: The early and long-term clinical outcomes of TAVI for selected Japanese nonagenarians were comparable to those in patients aged <90 years. Nonagenarians who underwent TAVI achieved an acceptable prognosis compared to the sex- and age-matched population; thus, TAVI appears to be effective for treating aortic stenosis in Japanese nonagenarians.

Background: Japanese patients undergoing transcatheter aortic valve replacement (TAVR) are often female and have a small body size, potentially impacting bleeding risk with antithrombotic therapy. Outcomes of direct oral anticoagulant use in these patients with atrial fibrillation (AF) need to be clarified.

Methods and Results: This prespecified analysis included Japanese patients from ENVISAGE-TAVI AF, a prospective, randomized, open-label, adjudicator-masked trial that compared treatment with edoxaban and vitamin K antagonists (VKAs) in patients with AF after TAVR. The primary efficacy and safety outcomes were net adverse clinical events (NACE; composite of all-cause death, myocardial infarction, ischemic stroke, systemic embolic event, valve thrombosis, and International Society on Thrombosis and Haemostasis [ISTH]-defined major bleeding) and ISTH-defined major bleeding, respectively. Intention-to-treat (ITT) and on-treatment analyses were performed. Overall, 159 Japanese patients were enrolled (edoxaban group: 82, VKA group: 77) and followed for on average 483 days. Mean patient age was 83.8 years; 52.2% were female. In the ITT analysis, NACE rates were 10.9%/year with edoxaban and 12.5%/year with VKA (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.38–1.90); major bleeding occurred in 8.9%/year and 7.3%/year, respectively (HR, 1.17; 95% CI, 0.45–3.05). In edoxaban- and VKA-treated patients, rates of ischemic stroke were 1.8%/year and 1.0%/year, respectively; fatal bleeding rates were 0.9%/year and 2.0 %/year. On-treatment results were similar to ITT.

Conclusions: In Japanese patients with AF after successful TAVR, edoxaban and VKA treatment have similar safety and efficacy profiles.

Background: The use of hybrid operating rooms (HOR) for transcatheter aortic valve implantation (TAVI) has increased, so radiation exposure during procedures that use X-ray fluoroscopy is a fundamental problem not only for patients but also for surgeons and interventional cardiologists, increasing the risk of cataracts among operators. We investigated the efficacy of leaded glasses and protective sheets for ocular radiation protection.

Methods and Results: Between January 2020 and February 2021 we enrolled 54 TAVI procedures using the transfemoral approach. The subjects were divided into a curtain protection group (Group C, n=20), glass protection group (Group G, n=17), and sheet protection group (Group S, n=17). The cumulative dose (CD) of the operators showed a decreasing trend in Group S compared with the other two groups. The CD normalized by dose area product (CD/DAP) of the operators was significantly reduced in Group S compared with Group C. However, Group G showed no significant difference compared with Group C. Regarding the distribution of CD/DAP, Group S had a significantly lower distribution than that in groups C and G.

Conclusions: Protective sheets provide more stable radiation protection than conventional curtains or leaded glasses.

Background: There is scarce data evaluating the current practice pattern and clinical outcomes for patients with severe aortic stenosis (AS), including both those who underwent surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) and those who were managed conservatively in the TAVI era.

Methods and Results: The Contemporary outcomes after sURgery and medical tREatmeNT in patients with severe Aortic Stenosis (CURRENT AS) Registry-2 is a prospective, physician-initiated, multicenter registry enrolling consecutive patients who were diagnosed with severe AS between April 2018 and December 2020 among 21 centers in Japan. The rationale for the prospective enrollment was to standardize the assessment of symptomatic status, echocardiographic evaluation, and other recommended diagnostic examinations such as computed tomography and measurement of B-type natriuretic peptide. Moreover, the schedule of clinical and echocardiographic follow up was prospectively defined and strongly recommended for patients who were managed conservatively. The entire study population consisted of 3,394 patients (mean age: 81.6 years and women: 60%). Etiology of AS was degenerative in 90% of patients. AS-related symptoms were present in 60% of patients; these were most often heart failure symptoms. The prevalence of high- and low-gradient AS was 58% and 42%, respectively, with classical and paradoxical low-flow low-gradient AS in 4.6% and 6.7%, respectively.

Conclusions: The CURRENT AS Registry-2 might be large and meticulous enough to determine the appropriate timing of intervention for patients with severe AS in contemporary clinical practice.

Background: The fibrosis-4 (FIB-4) index is used to evaluate liver disease patients. It can also be used to evaluate the prognosis for heart disease patients; however, its ability to determine the prognosis of severe isolated tricuspid regurgitation (TR) patients is unclear. This study aimed to clarify the association between FIB-4 index scores and the cardiovascular prognosis for severe isolated TR patients.

Methods and Results: This was a dual-center, retrospective study. From 2011 to 2019, 111 consecutive outpatients with severe isolated TR (mean age, 68.6 years; 53.2% male) were evaluated. Major adverse cardiovascular events (MACEs) were defined as the composite of cardiovascular death, hospitalization for heart failure, myocardial infarction, and stroke. The association between FIB-4 index scores and echocardiography was also evaluated. During a median follow up of 3.0 years, 24 patients were lost to follow up and 40 MACEs occurred. Baseline FIB-4 index scores for patients with MACEs were significantly higher than those for patients without MACEs. A multivariate analysis revealed that FIB-4 index scores are significantly associated with MACEs (hazard ratio, 1.89; 95% confidence interval, 1.01–3.54; P=0.046). A linear regression analysis indicated that FIB-4 index scores were correlated with echocardiographic parameters, including the left atrial volume index and left ventricular end-diastolic diameter.

Conclusions: The FIB-4 index score may be a useful predictor of MACEs for patients with severe isolated TR.