Search

Background: Insertion of electrode catheters into the coronary sinus (CS) through the right internal jugular vein (RIJV) carries risks of pneumothorax and severe hematoma formation. This study was performed to compare the safety and feasibility of catheterization through the left cubital superficial vein versus the RIJV. Methods: This prospective nonrandomized study involved consecutive patients who underwent catheter ablation from September 2021 to February 2023. Blind puncture techniques were used in the left cubital vein group; ultrasound‐guided insertion was performed in the RIJV group. The success rates of sheath insertion and CS catheterization, the procedure and fluoroscopy times of CS cannulation, and complications were compared between groups. Results: The left cubital vein group comprised 152 patients, and the RIJV group comprised 58 patients. The sheath insertion success rate was significantly lower in the cubital vein group than in the RIJV group (84.9% vs 100%, respectively; p =.0008). In the cubital vein group, blind puncture attempts failed in 20 patients; three patients developed guidewire‐induced venous injury. One arterial puncture occurred in the RIJV group. After successful sheath insertion, no significant differences were observed in the CS cannulation success rate (97% vs 100%, p =.55), procedure time (median [range], 93 [51–174] vs 74 [44–129] s; p =.19), or fluoroscopy time (median [range], 66 [36–134] vs 48 [30–92] s; p =.17). No serious complications requiring procedural discontinuation occurred. Conclusion: The left cubital vein approach is practical, offering a viable alternative to the RIJV approach. [ABSTRACT FROM AUTHOR]

Background: We validated the prevalence of albuminuria and its association with kidney function and hemodynamics in pre-school children who underwent surgery for congenital heart disease (CHD). Methods: From 403 patients who had undergone surgery for CHD at least 6 months before pre-school and were admitted to our hospital between 2011 and 2015, 75 who underwent blood and urine tests and cardiac catheterization were included in this study. The urinary albumin-to-creatinine ratio (ACR) was quantified, and the relationship of ACR with physical and laboratory findings and hemodynamics assessed using cardiac catheterization was analyzed. Results: The study cohort was divided into three groups: Fontan group (n = 25), tetralogy of Fallot (TOF) group (n = 18), and control group (other biventricular CHDs; n = 32). The median age of patients was 5.9 years. ACR was higher in the Fontan group than in the TOF and control groups (median: 15.0 vs. 5.0 and 0.0 mg/g, p < 0.001). Moreover, albuminuria (ACR > 30 mg/g) was observed in 20.0% of Fontan patients, while ACR was associated with potential complicating factors of Fontan circulation: high central venous pressure, high mean pulmonary artery pressure, and worse than moderate atrioventricular regurgitation. ACR showed a moderate correlation with the cystatin C-based estimated glomerular filtration rate (r = − 0.725, p < 0.001). Conclusions: Measurement of albuminuria in Fontan patients before they join elementary school is useful because it reflects kidney function and hemodynamic factors that can worsen their condition. Identification and management of patients with albuminuria may facilitate early therapeutic intervention for worsening Fontan factors, eventually delaying the deterioration of kidney function. [ABSTRACT FROM AUTHOR]

Inhaled iloprost is an established treatment for pulmonary arterial hypertension (PAH). However, the long‐term hemodynamic changes that inhaled iloprost induces are unclear. Here, we retrospectively enrolled 18 patients with PAH who received inhaled iloprost as add‐on to oral combination therapy from December 2016 to January 2021 at our institute in Japan. We then examined the changes in hemodynamic parameters induced by iloprost in these patients during right heart catheterization (RHC). To examine the long‐term effects of iloprost, we repeated the RHC examination at follow‐up (median time to follow‐up, 8.5 months). During both catheterization procedures, iloprost was administered by using an Ineb AAD system (Philips NV). In a comparison of pre‐inhalation values at the first and follow‐up RHCs, inhaled iloprost significantly improved mean pulmonary artery pressure (mPAP; 39.9 ± 7.8 to 32.5 ± 7.2 mmHg, p = 0.016) and pulmonary vascular resistance (PVR; 588.5 ± 191.7 to 464.4 ± 188.5 dyn s cm−5, p = 0.047). During the follow‐up RHC, in a comparison of the pre‐inhalation and best recorded values out to 30 min after the end of iloprost inhalation, iloprost significantly decreased mPAP (32.5 ± 7.2 to 30.0 ± 6.6 mmHg, p = 0.007) and PVR (457.8 ± 181.4 to 386.2 ± 142.8 dyn s cm−5, p = 0.025) and significantly increased cardiac output (4.19 ± 0.91 to 4.64 ± 1.01 L/min, p = 0.035). Iloprost may have not only acute vasodilation effects but also long‐term hemodynamic benefits in PAH patients receiving combination therapy. [ABSTRACT FROM AUTHOR]

Background: A combination of dexmedetomidine and propofol is considered advantageous for maintaining spontaneous breathing with a satisfactory depth of anesthesia. However, the incidence of upper airway obstruction under sedation with dexmedetomidine and propofol in patients with Fontan circulation remains unanswered. This study aimed to evaluate upper airway patency and oxygen desaturation during sedation with dexmedetomidine and propofol for cardiac catheterization in pediatric patients with Fontan circulation. Methods: In this descriptive study, we reviewed medical records of patients with Fontan circulation who underwent cardiac catheterization between December 2018 and August 2020 at a single-center 200-bed academic children's hospital in Japan. Results: A total of 35 patients with Fontan circulation sedated with a departmental protocol of dexmedetomidine and propofol infusion for cardiac catheterization were reviewed. Overall, the incidence of airway interventions and oxygen desaturation were 31.4% and 28.6%, respectively. In children with a history of snoring and additional use of intravenous midazolam, the rates of airway interventions were 50% and 100%, respectively. In patients ≤2 years old with recent upper respiratory infection (URI) symptoms, oxygen desaturation rate was 75%. Conclusions: In children with Fontan circulation, the incidence rate of upper airway obstruction was high under sedation with dexmedetomidine and propofol during cardiac catheterization, which is commonly considered safe in children without Fontan circulation. A history of snoring, an additional bolus of IV midazolam, and the presence of recent URI symptoms in patients ≤2 years old are potential risks for upper airway obstruction. [ABSTRACT FROM AUTHOR]

The 2015 European Society of Cardiology/European Respiratory Society guidelines for the diagnosis and treatment of pulmonary hypertension include a multidimensional risk assessment for patients with pulmonary arterial hypertension (PAH). However, prognostic validations of this risk assessment are limited, especially outside Europe. Here, we validated the risk assessment strategy in PAH patients in our institution in Japan. Eighty consecutive PAH patients who underwent right heart catheterization between November 2006 and December 2018 were analyzed. Patients were classified as low, intermediate, or high risk by using a simplified version of the risk assessment that included seven variables: World Health Organization functional class, 6-min walking distance, peak oxygen consumption, brain natriuretic peptide, right atrial pressure, mixed venous oxygen saturation, and cardiac index. The high-risk group showed significantly higher mortality than the low- or intermediate-risk group at baseline (P < 0.001 for both comparisons), and the mortalities in the intermediate- and low-risk groups were both low (P = 0.989). At follow-up, patients who improved to or maintained a low-risk status showed better survival than those who did not (P = 0.041). Our data suggest that this risk assessment can predict higher mortality risk and long-term survival in PAH patients in Japan. [ABSTRACT FROM AUTHOR]

In the current era of treatment of pulmonary hypertension (PH) in Japan, combination therapy has been frequently used thanks to the medical insurance system. Additionally, pulmonary balloon angioplasty (BPA) is widely performed for chronic thromboembolic PH (CTEPH). To elucidate the long-term prognosis and the prognostic factors among all five subtypes of PH in this new era, we examined the current status of management of PH from November 2012 to April 2016 in the multicenter registry by the Japanese Pulmonary Circulation Society. Among 1253 consecutive patients registered from 20 PH centers in Japan, we analyzed 997 patients with mean pulmonary arterial pressure ≥ 25 mmHg by right heart catheterization. Transplant-free survival at 5 years in pulmonary arterial hypertension (PAH), PH due to left-heart disease, PH due to lung diseases, CTEPH, and miscellaneous PH were 74.0, 69.3, 63.7, 92.0, and 55.3%, respectively. Of note, 32% of PAH patients were treated with double combination therapy and 42% of those with triple combination therapy, and 66% of CTEPH patients with BPA. Although PAH patients with triple combination therapy had worse hemodynamic parameters than those with other medications, triple combination therapy showed the best prognosis. BPA in CTEPH improved survival even when adjusted for the key background factors. In the current era of PH treatment in Japan, the five-year transplant-free survival rate in this study was 74% for PAH and 92% for CTEPH, in which active combination medical therapy for PAH and higher performance rate of BPA for CTEPH may be involved. • The five-year transplant-free survival rate was 74% for PAH and 92% for CTEPH. • Triple combination therapy showed better survival than other treatments in PAH. • Balloon angioplasty was an effective procedure to improve prognosis in CTEPH. [ABSTRACT FROM AUTHOR]

Background: Most previous studies on outpatient cardiac catheterization have been conducted in Western countries, but Japanese studies are rare. We aimed to describe patient characteristics and short-term clinical outcomes of outpatient cardiac catheterization compared to those of inpatient cardiac catheterization in Japan., Methods: We conducted a retrospective cohort study using data from the JMDC Claims Database. We identified all adult patients aged ≥18 years who underwent cardiac catheterization between April 2012 and October 2021. We investigated patient characteristics and clinical outcomes (i.e. all-cause mortality, stroke, acute kidney injury, bleeding, vascular complications, percutaneous coronary intervention, and total healthcare costs) within 2, 7, and 30 days between patients who underwent outpatient cardiac catheterization (outpatient group) and those who underwent inpatient cardiac catheterization (inpatient group)., Results: Of the 37,002 eligible patients (57.6 % <60 years old, and 80.2 % male), 1853 (5.01 %) underwent outpatient cardiac catheterization. The outpatient group was more likely to be male, have more comorbidities, and be performed at non-university hospitals than the inpatient group. The proportion of patients who underwent right heart catheterization and imaging was lower in the outpatient group. There were no significant differences in 7-day major complications between the two groups (all-cause mortality, 0.0 % versus 0.0 %, p = 0.57; acute kidney injury, 0.0 % versus 0.1 %, p = 0.10, bleeding, 0.5 % versus 0.9 %, p = 0.052; vascular complication, 0.0 % versus 0.1 %, p = 0.23, respectively). The 30-day total healthcare costs were lower in the outpatient group than in the inpatient group (mean 3212 US dollars versus 3955 US dollars, p = 0.003)., Conclusions: Approximately 5 % of cardiac catheterizations were performed in an outpatient setting. Given the low adverse event risk observed in this study, it may be a reasonable option to widen outpatient cardiac catheterization to include potential populations in Japan, warranting further studies., Competing Interests: Declaration of competing interest Nao Setogawa is an employee of Terumo Corporation. All other authors have reported that they have no relationships relevant to the contents of this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: Balloon pulmonary angioplasty (BPA) is an alternative therapy for patients with chronic thromboembolic pulmonary hypertension who are ineligible for pulmonary endarterectomy-the standard therapy. Currently, most reported results of BPA are from relatively small cohorts treated at single centers. The present study evaluated the safety and efficacy of BPA for chronic thromboembolic pulmonary hypertension based on a multicenter registry.Methods and Results: A total of 308 patients (62 men and 246 women; mean age, 61 years) underwent 1408 procedures at 7 institutions in Japan. Data were retrospectively reviewed to evaluate clinical outcome and complications. Hemodynamics were significantly improved in 249 patients in whom BPA was terminated, most often because of improvement in mean pulmonary arterial pressure or symptomatic improvement after 1154 procedures. In 196 patients who underwent follow-up right heart catheterization, improvement of hemodynamic parameters was maintained. Mean pulmonary arterial pressure decreased from 43.2±11.0 to 24.3±6.4 mm Hg after final BPA and 22.5±5.4 mm Hg at follow-up, with significant reduction of concomitant use of pulmonary hypertension-targeted therapy and oxygen supplementation. Complications occurred in 511 (36.3%), including pulmonary injury (17.8%), hemoptysis (14.0%), and pulmonary artery perforation (2.9%). Twelve patients (3.9%) died during follow-up, including 8 patients who died within 30 days after BPA. The leading causes of death were right heart failure, multiorgan failure, and sepsis. Overall survival was 96.8% (95% confidence interval, 93.7%-98.4%) at 1 and 2 years and 94.5% (95% confidence interval, 89.3%-97.3%) at 3 years, respectively, after the initial BPA procedure for all 308 patients.Conclusions: This multicenter registry suggested improved hemodynamic results after BPA. Complication rates were high, but overall survival was comparable with pulmonary endarterectomy. BPA may be an important therapeutic option in patients with chronic thromboembolic pulmonary hypertension. [ABSTRACT FROM AUTHOR]

Background: Increases in hemosiderin-laden macrophages (HLM) are reported to be observed in idiopathic pulmonary fibrosis (IPF). According to a recent study, significant correlation between hemosiderin deposition in the lung tissue of IPF and pulmonary hypertension evaluated by echocardiography has been suspected. In this study, we aimed to evaluate whether HLM in bronchoalveolar lavage fluid (BALF) is a factor correlated with pulmonary hemodynamic parameters evaluated by right heart catheterization in patients with IPF.Methods: Initial data from 103 consecutive patients with IPF who underwent surgical lung biopsy between November 2007 and March 2014 were retrospectively analyzed. The "HLM score" of BALF was established by dividing the number of Perls' Prussian blue stain positive macrophages by the total number of macrophages counted.Results: BALF showed an elevated HLM score (38.2%). Right heart catheterization revealed mean pulmonary arterial pressure (mPAP) of 16.3 mmHg and pulmonary vascular resistance (PVR) of 1.55 Wood units. HLM score was positively correlated with mPAP (ρ = 0.204; p = 0.038) and PVR (ρ = 0.349, p < 0.001). In multivariate analysis, 6-min walk distance (standardized partial regression coefficient [β], -0.391; p < 0.001), minimum oxygen saturation during 6-min walk distance (β, -0.294; p = 0.001) and HLM score (β, 0.265; p = 0.002) were independently correlated with PVR.Conclusions: HLM score in BALF is an independent factor correlated with PVR in patients with IPF. [ABSTRACT FROM AUTHOR]

Background The association between the incidence of contrast-induced nephropathy (CIN) and subsequent clinical outcomes is unclear in Japan. We evaluated the association between CIN and cardiovascular and renal events after cardiac catheterization. Methods The CINC-J multicenter prospective cohort study examined 853 patients undergoing cardiac catheterization from 27 hospitals. CIN was defined as increase in serum creatinine (SCr) ≥ 0.5 mg/dL or ≥ 25% from baseline between 48 and 72 h after exposure to contrast. Major adverse cardiovascular and cerebrovascular events (MACCE) included all-cause deaths, non-fatal myocardial infarction, acute decompensated heart failure (ADHF), and stroke. Renal events included newly-required hemodialysis and increase of SCr ≥ 2 × from baseline. Results During follow-up periods (477 ± 214 days), CIN, MACCE, and renal events occurred in 44 (5.2%), 71 (8.3%), and 26 (3.0%) patients, respectively. Kaplan–Meier analysis showed that CIN yielded increasing risk for MACCE, ADHF, newly-required hemodialysis, and renal events. In multivariable Cox proportional hazards analysis, age (HR: 1.03; 95% CI, 1.00–1.07; P = 0.0425), anemia (HR: 1.94; 95% CI, 1.08–3.61; P = 0.0264), and diabetes mellitus (HR: 1.86; 95% CI, 1.10–3.21; P = 0.0119) were independent predictors of MACCE, whereas CIN (HR: 7.78; 95% CI, 3.23–17.9; P = 0.0005) and SCr (HR: 2.09; 95% CI, 1.56–2.73; P = 0.0006) were independent predictors of renal events. Compared to subjects without both anemia and CIN as the reference, those with both were high risk for MACCE (HR: 3.97; 95% CI, 1.25–10.6; P = 0.0218). Conclusion CIN was a significant predictor of subsequent renal events after cardiac catheterization. CIN and anemia were associated with increased risk for worse long-term clinical outcome, especially when both were present. [ABSTRACT FROM AUTHOR]

To propose reference values for air-kerma at the reference point (Ka,r), air-kerma area product (PKA), fluoroscopy time (FT) and number of cine images (CI) for four age groups in Japan, a nationwide questionnaire was posted to 132 pediatric catheterisation of certified facility in Japan, using the conventional post system, to which 43 facilities responded. For diagnostic cardiac angiography, reference values were as follows: Ka,r: 86, 102, 165 and 264 mGy; PKA: 9.3, 9.5, 16 and 34 Gy.cm2; FT: 33, 29, 26 and 30 min and CI: 1904, 1966, 2405 and 1871 images. For therapeutic cardiac angiography, reference values were as follows: Ka,r: 107, 163, 103 and 202 mGy; PKA: 7.5, 18, 7 and 24 Gy.cm2; FT: 56, 52, 42 and 30 min and CI: 3886, 3232, 2212 and 4316 images for less than 1, 1-5, 6-10 and 11-15 y, respectively. To optimal patient exposure from diagnostic and therapeutic cardiac catheterisation, it is therefore necessary to establish reference values for pediatric cardiac catheterisation examinations for four age groups., (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background: Point-by-point catheter ablation is an established treatment for drug-refractory paroxysmal atrial fibrillation (PAF). However, it is time consuming, requires excellent technique to achieve complete pulmonary vein (PV) isolation, and is associated with severe complications.Objectives: The purpose of this study was to evaluate the safety and effectiveness of a HotBalloon ablation (HBA) compared with antiarrhythmic drug therapy (ADT) for the treatment of PAF.Methods: A prospective multicenter randomized controlled study was conducted in Japan. Patients with symptomatic PAF refractory to antiarrhythmic drugs (Class I to IV) were randomized to HBA or ADT at a 2:1 ratio and assessed for effectiveness in a comparable 9-month follow-up period.Results: A total of 100 patients in the HBA group and 43 patients in the ADT group received treatment at 17 sites. HBA procedure produced acute complete PV isolation in 98.0% (392 of 400) of the PVs and in 93.0% (93 of 100) of patients in the HBA group. The chronic success rates after the 9-month effective evaluation period were 59.0% in the HBA group (n = 100) and 4.7% in the ADT group (n = 43; p < 0.001). The incidence of major complications was 11.2% (15 of 134 patients). The incidences of PV stenosis (>70%) and transient phrenic nerve injury were 5.2% and 3.7%, respectively. The mean fluoroscopy time was 49.4 ± 26.6 min (n = 134), and the mean procedure duration was 113.9 ± 31.9 min (n = 133).Conclusions: This study demonstrates the superiority of HBA compared with ADT for treatment of patients with PAF, and a favorable safety profile. [ABSTRACT FROM AUTHOR]

Objective: Postprocedural ischaemic and bleeding risks after transcatheter aortic valve replacement (TAVR) remain a major concern. Nevertheless, no reliable risk models incorporating both possibilities are currently available. We aimed to assess the accuracy of percutaneous coronary intervention (PCI)-derived models and the performance of a recalibrated model that included variables more applicable to TAVR., Methods: This study included 26 869 patients who had been enrolled in a national registry. Ischaemic events were defined as myocardial infarction, stroke, transient ischaemic attack or peripheral embolism at 1 year. Bleeding events were defined as any bleeding based on the Valve Academic Research Consortium-2 consensus document at 1 year. Patterns of Non-adherence to Anti-Platelet Regimen in Stented Patients (PARIS) and Coronary Revascularisation Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) integer scoring systems were tested. The models were recalibrated by applying new variables using the Fine and Gray method., Results: The 1-year cumulative incidences for ischaemic and bleeding events were 2.7% and 3.1%. Patients with high PARIS and CREDO-Kyoto risk scores had higher incidences of both ischaemic (3.3% vs 2.4% vs 2.4%, p<0.001 and 2.8% vs 2.0% vs 0.8%, p<0.001) and bleeding events (3.3% vs 2.5% vs 0.8%, p<0.001 and 3.7% vs 3.0% vs 2.4%, p<0.001) when compared with intermediate and low-risk patients. The receiver operating characteristic area under the curves for these models were 0.53, 0.58, 0.56 and 0.55, respectively. After the models were recalibrated to incorporate variables more applicable to TAVR, the performance of ischaemic and bleeding models modestly improved (0.58 and 0.61, respectively)., Conclusions: The PCI-derived models demonstrated modest accuracy but was inadequate for risk stratification of TAVR patients at 1-year follow-up., Trial Registration Number: 3395., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The red blood cell distribution width (RDW) is a quantitative measure of the variability in the size of circulating erythrocytes. We aimed to study whether higher levels of the RDW were associated with heart failure in a Fontan circulation and to analyze its clinical value compared to brain natriuretic peptide. This retrospective study included 38 consecutive pediatric patients with a Fontan circulation who underwent routine cardiac catheterization at the International Medical Center, Saitama Medical University from October 2010 to July 2014. We assessed the relation between the RDW and catheterization data such as the central venous pressure (CVP), mixed venous oxygen saturation (SvO2), and cardiac index (CI). The RDW was positively correlated with the CVP (p = 0.0002). The elevated RDW group had a significantly greater CVP than the normal RDW group (p = 0.0003). Also, the RDW was negatively correlated with the SvO2 (p = 0.0004). The elevated RDW group had a significantly less SvO2 than the normal RDW group (p <0.0001). The CI in the elevated RDW group was lower than that in the normal RDW group (p = 0.0421). In the multivariate regression analysis, the RDW was a significant independent predictor of the CVP and SvO2. The BNP level did not have any significant relation with the CVP, SvO2, or CI. The RDW is a convenient and powerful marker for detecting heart failure in a Fontan circulation. [ABSTRACT FROM AUTHOR]

Introduction: There have been several attempts to overcome the poor graft patency of saphenous vein grafts. "No-touch" saphenous vein graft (NT-SVG) could be a solution to improve graft patency. We aimed to investigate the early and midterm outcomes of coronary artery bypass grafting (CABG) using NT-SVGs in our hospitals., Methods: This is a retrospective study of 105 patients who underwent CABG using 130 NT-SVGs between August 2013 and December 2021. NT-SVGs were harvested with about a 5-mm margin of surrounding tissue on both sides of the vein with minimal manipulation. Then, the NT-SVG was dilated by natural arterial pressure without manual distension. After surgery, most of NT-SVGs were assessed by cardiac catheterization or multidetector computed tomography (MDCT) to determine early graft patency. Late graft assessments by MDCT were performed about every five years after surgery., Results: The early graft patency of NT-SVGs was 100% (125/125); however, two cases of graft twisting were found. Both cases spontaneously resolved. Leg wound infections of NT-SVG harvesting site were seen in 6.2% of patients. Peripheral neuropathy of the legs such as skin numbness and tingling were frequently observed, which lasted up to one year, but no more than two years after surgery. The midterm graft patency of NT-SVGs was excellent (five-year patency of NT-SVGs was 95.8%)., Conclusion: The early and midterm graft patency of NT-SVGs was satisfactory. Although leg wound complications can be seen on the harvesting NT-SVG site, the "no-touch" harvesting technique of SVG could improve graft patency and clinical outcomes of CABG.

Fractional flow reserve and instantaneous wave-free ratio are widely accepted and recommended in Western and Japanese guidelines for appropriate percutaneous coronary intervention. There are, however, many differences in clinical situations between Japan and Western countries. Therefore, the Task Force on coronary physiology of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) has proposed an expert consensus document to summarize current evidence and suggest the practical use of physiological lesion assessment in Japan., (© 2022. The Author(s) under exclusive licence to Japanese Association of Cardiovascular Intervention and Therapeutics.)

We hypothesized that left ventricular (LV) diastolic dysfunction assessed by cardiac catheterization may be associated with increased risk for cardiovascular events. To test the hypothesis, we assessed diastolic function by cardiac catheterization (relaxation time constant (Tau) and end-diastolic pressure (EDP)) as well as Doppler echocardiography (early diastolicmitral annular velocity (e') and a ratio of early diastolic mitral inflow to annular velocities (E/e')) in 222 consecutive patients undergoing cardiac catheterization for coronary artery disease (CAD). During a followup of 1364 ± 628 days, 5 cardiac deaths and 20 unscheduled cardiovascular hospitalizations were observed. Among LV diastolic function indices, Tau > 48 ms and e' < 5.8 cm/s were each significantly associated with lower rate of survival free of cardiovascular hospitalization. Even after adjustment for potential confounders (traditional cardiovascular risk factors, the severity of CAD, and cardiovascular medications), the predictive value of Tau > 48 ms and e' < 5.8 cm/s remained significant. No predictive value was observed in EDP, E/e', or LV ejection fraction. In conclusion, LV diastolic dysfunction, particularly impaired LV relaxation assessed by both cardiac catheterization and Doppler echocardiography, is independently associated with increased risk for cardiac death or cardiovascular hospitalization in patients with known or suspected CAD. [ABSTRACT FROM AUTHOR]

We assessed the usefulness of serum cystatin C for predicting contrast-induced nephropathy (CIN) in patients (n = 100) undergoing coronary catheterization. After a 12-month follow-up, the incidence of CIN was 8.3% (n = 5) in patients with mild renal insufficiency (estimated glomerular filtration rate [eGFR] 60-89 mL/min per 1.73 m2), 34.4% (n = 10) in those with moderate renal insufficiency (eGFR 30-59 mL/min per 1.73 m2), and 100% (n = 3) in those with severe renal insufficiency (eGFR 15-29 mL/min per 1.73 m2). The sensitivity was 81.8% and specificity was 90.9% at the cutoff level of serum cystatin C >1.18 mg/L. Serum cystatin C levels were significantly (P < .001) higher in the patients with moderate renal insufficiency in the CIN group than those in the non-CIN group. Multivariate logistic regression analysis demonstrated that baseline serum cystatin C independently predicted short-term mortality (odds ratio [OR], 0.311; 95% confidence interval [CI] 0.058-0.538; P = .026). Baseline serum cystatin C significantly predicted the occurrence of CIN in the patients with moderate renal insufficiency. [ABSTRACT FROM AUTHOR]

Background: The MitraClip NT System was approved for marketing in Japan on October 31, 2017, and a prospective, multi-center, single-arm Post-Marketing use Surveillance (PMS) study was launched in 2018. This is the first report of the Japan PMS study with 1-year subject outcomes., Methods and results: A total of 500 patients were registered between April 2018 and January 2019. Patients with symptomatic chronic moderate-to-severe (3+) or severe mitral regurgitation (MR; 4+), MR with a Society of Thoracic Surgery (STS) replacement score of ≥8%, or presence of 1 pre-defined risk factor were enrolled. Primary outcome measures included acute procedural success (APS), and rate of Single Leaflet Device Attachment (SLDA) at 30 days. The overall cohort was elderly (77.9±9.48 years) with functional MR etiology in 71.6% of the subjects. The majority of subjects were New York Heart Association (NYHA) class III/IV (68.9%), with mean STS replacement score of 11.95±9.66%. The APS rate was 91.13% and the 30-day SLDA rate was 1.21%. Durable MR reduction was achieved with 88.1% of subjects at MR ≤2+ at 1 year. Significant improvement in the functional capacity was observed, with 93% of subjects at NYHA class I/II at 1 year., Conclusions: In the Japan PMS experience, the MitraClip procedure resulted in improvements in MR severity, with significantly improved functional outcomes. These results demonstrate safety and efficacy of MitraClip therapy in the eligible Japanese population.

Peripheral pulmonary arterial stenosis (PPAS) is known to cause pulmonary hypertension (PH). Although adult patients at advanced stage have been increasingly reported, there are few reports on clinical characteristics and pulmonary angiography (PAG) findings of early stage PPAS. We present two Japanese siblings with PPAS with homozygosity of RNF213 p.Arg4810Lys-one with advanced stage and the other with early stage. The latter case was an asymptomatic 37-year-old woman with mild PH. Notably, her PAG demonstrated nonthrombotic stenosis in the subsegmental branches of the pulmonary arteries with varying degrees of stenosis among lung segments. Taken together with a family history, genetic analysis, and cerebral angiography, the obtained images were considered as showing PPAS with early stage. This result is clinically informative to diagnose PPAS at an early stage and is also important to understand the pathogenesis of PPAS., (Copyright © 2021 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Percutaneous left atrial appendage occlusion (LAAO) using a WATCHMAN device could be a treatment option for patients with non-valvular atrial fibrillation (AF) with thromboembolic and bleeding risk. We sought to determine the prevalence and characteristics of patients with AF ablation who are potential candidates for WATCHMAN implantation in a Japanese population., Methods: We enrolled 2443 consecutive patients who had previously undergone AF ablation and transesophageal echocardiography (TEE). We assessed their clinical characteristics and measured their LAA orifice diameter and depth retrospectively using the obtained TEE images. We defined patients who met both anatomical criteria (LAA orifice max diameter: 17-31 mm and LAA max depth > LAA orifice max diameter) and clinical criteria (CHA 2 DS 2 -VASc score ≥ 2 and HAS-BLED score ≥ 3) as LAAO candidates., Results: Among the 2443 enrolled patients, 361 (15%) met the clinical criteria, and 1928 (79%) met the anatomical criteria. Thus 12% (293/2443) of the total patient group met the criteria of LAAO candidates. LAAO candidates showed larger left atrial (LA) volume (77.6 ± 30.1 vs. 67.7 ± 29.1 mL, P < 0.001), larger LAA orifice diameter (22.5 ± 3.2 vs. 22.0 ± 4.3 mm, P = 0.026), and larger LAA depth (28.9 ± 4.6 vs. 27.0 ± 4.8 mm, P < 0.001). LAAO candidates made up only 23% of patients with CHA 2 DS 2 -VASc score ≥ 2 (N = 1295), whereas 78% of patients with a HAS-BLED score ≥ 3 (N = 378) were LAAO candidates., Conclusion: Twelve percent of patients who underwent AF ablation were potential candidates for LAAO using a WATCHMAN device in this Japanese population. It is imperative to evaluate bleeding risk when considering the indications for LAAO., (© 2021. Japanese Society of Echocardiography.)

Objective Percutaneous patent foramen ovale (PFO) closure is a procedure widely used to prevent recurrence of cryptogenic stroke. Since December 2019, the Amplatzer PFO occluder device has been available in Japan through medical insurance. However, data on the clinical experience with this device are lacking, as it has been approved for use in only a limited number of institutions. This study assessed the clinical data of Japanese patients who underwent PFO closure using the Amplatzer PFO occluder. Methods Between February and October 2020, 14 patients at our institution underwent percutaneous PFO closure using the Amplatzer PFO occluder. The procedural characteristics, safety, and adverse events were retrospectively analyzed. Results The mean age of the patients was 52.4±13.3 years old, and 57.1% were women. Deep vein thrombosis was revealed in 2 patients, and the risk of paradoxical embolism score was 6.6±1.2 points. The PFO height and tunnel length were 2.3±1.4 mm and 11.5±4.1 mm. All patients had a PFO during the bubble study of grade >3 at the Valsalva maneuver on transthoracic echocardiography or transesophageal echocardiography. The average diameter of the PFO measured using a stiff guidewire and sizing balloon was 5.1±1.3 and 7.9±2.3 mm, respectively. Almost all cases (92.9%) were performed with a 25-mm device and without significant complications within approximately 1 hour. Conclusion Percutaneous closure using Amplatzer PFO occluder is a safe procedure for Japanese patients. However, further investigations with a larger sample and longer follow-up are needed to confirm this result.

The purpose of this study is to assess the cost-impact of cardiac magnetic resonance imaging (CMR) and its advantages over conventional cardiac catheterization to detect cardiac allograft vasculopathy (CAV) and myocardial inflammation derived from possible rejection in heart transplant (HTx) recipients. A sizable institutions still perform an endomyocardial biopsy (EMB) and coronary artery angiogram (CAG) in routine practice. Non-invasive diagnostic tools such as echocardiography and gene expression profiling have been reported as a possible alternative to EMBs, but its application is limited. Stress echo is a powerful tool for sorting those who require invasive assessment, but it cannot detect ongoing CAV. CMR is free from radiation exposure and allows the visualization of coronary artery narrowing without using contrast agents. We estimated medical care expense needed for rejection and CAV surveillance for HTx recipients at 3 years to 15 year-posttransplant in Japan (n=320), consisting of those with 10 % rejection rate up to 5 years and 20% CAV occurrence thereafter, as a hypothetical cohort. Three models were created. Model-1: Annual investigation using CMR-angiography to assess CAV, and T2W imaging to detect myocardial inflammation. For patients with a suspicion of the development of rejection or CAV, EMBs and CAG are performed. Model-2: Annual evaluation using CAG and EMBs up to 10 years posttransplant. After 10 year-posttransplant, the invasive procedure is done as needed. Model-3: Using echocardiography as a primary modality to detect rejection. CAG biennial and EMBs if any change in echo. If patients never developed rejection or CAV, Model-1 is the least costly with ¥228,800 to 324,860 per patient, whereas Model-2 costs ¥1,064,000 to 2,190,000 and Model-3, ¥445,200 to 689,000, respectively. When we include patients with rejection or CAV according to a hypothetical cohort, Model-1 and Model-3 were equally cost-effective. When we set sensitivity and specificity of CMR and echo as 70%, 80% and 70%, 90%, respectively, Model-1 is most cost-effective with sufficient diagnostic accuracy. Utilization of CMR as an annual follow-up tool in HTx recipients would be beneficial from a viewpoint of medical economics. [ABSTRACT FROM AUTHOR]

Background: Addressing cachexia in chronic heart failure (CHF) patients is an urgent issue in Japan, the most aged country in the world. We investigated the possible relationships between cachexia and, metalloproteinases and haemodynamics assessed by the cardiac catheterization. We also clarified the prognostic value of cardiac cachexia in the Japanese CHF population., Methods and Results: A total of 370 participants (median age, 69 years; 35% women) were included. The haemodynamic effects of cachexia were analysed by right heart catheterization. The serum levels of matrix metalloproteinase (MMP) and tissue inhibitors of MMP (TIMP), as myocardial collagen turnover markers, were also assessed. Cachexia was present in 88 patients (31%). Overall, 59 patients (16%) had all-cause death. Serum MMP-2 and TIMP-2 levels were higher in cachectic patients than in noncachectic patients (797.5 [649.0-1066.8] vs 610.0 [461.8-756.8] ng/mL; P = .004 and 39.0 [28.0-49.0] vs 24.0 [19.0-37.0] ng/mL; P = .008, respectively). Cachectic patients had greater values of pulmonary vascular resistance (PVR) (161.9 [119.4-225.4] vs 127.8 [90.7-164.8] dynes/sec/cm -5 , P = .020). Kaplan-Meier survival analysis demonstrated higher probabilities of all-cause death in the cachexia group (log-rank P = .010). Cox proportional hazards modelling showed cachexia was an independent predictor of mortality (hazard ratio, 1.89; 95% confidence interval, 1.06-3.37; P = .029). The random forest model showed that C-reactive protein, age, haemoglobin, PVR and MMP-2 were predictors of cardiac cachexia., Conclusions: Cachexia, applying the globally accepted definition, was associated with adverse outcomes in the Japanese CHF population and accompanied by increased activity of MMP species and PVR., (© 2020 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.)

Background: The balloon-expandable SAPIEN 3 (S3) is superior to the older-generation balloon-expandable SAPIEN XT (XT) in a lower incidence of paravalvular aortic regurgitation, lower complication rates and better survival in transcatheter aortic valve implantation (TAVI). However, prosthesis-patient mismatch (PPM) more frequently occurs in S3 than XT. Further, little information is available on PPM after TAVI using S3 in Asians. This study aims to determine the incidence and predictors of PPM in S3 by focusing on the difference between S3 and XT using data from a Japanese multicentre registry., Methods: From the Optimised transCathEter vAlvular iNtervention-TAVI (OCEAN-TAVI) registry, 2134 patients undergoing TAVI using S3 or XT were included. PPM was defined as moderate if ≧0.65 but ≦0.85 cm 2 /m 2 or severe if <0.65 cm 2 /m 2 at the indexed effective orifice area by postprocedural echocardiography., Results: The incidence of moderate and severe PPM in S3 was 13.3% and 1.3%, respectively. The 20 mm transcatheter heart valve (THV) was more frequently used in S3 than XT (7.4% vs 2.4%, p<0.0001). PPM was more frequently observed in S3 than XT (14.7% vs 8.8%, p<0.0001). Multivariate logistic regression analysis revealed S3 predicted PPM (OR 1.92 (95% CI 1.35 to 2.74), p=0.0003). The mutual predictors for PPM between S3 and XT were younger age, larger body surface area, smaller aortic valve area, no balloon postdilatation and the use of 20 mm and 23 mm THV. When comparing 23 mm, 26 mm and 29 mm S3, the ORs of 20 mm S3 were 5.67 (95% CI 2.88 to 11.12), 19.24 (95% CI 8.13 to 46.86) and 51.03 (95% CI 12.28 to 280.77), respectively., Conclusions: The incidence of PPM after TAVI using S3 was 14.6% overall in this Asian population. PPM was more frequently observed in S3 than XT. A considerable number of patients were treated by the 20 mm S3 in an Asian cohort. The 20 mm THV was identified as a strong predictor for PPM., Competing Interests: Competing interests: NT, MY, TN, SS, KM, MT, HU and YW are clinical proctors for Edwards Lifesciences and Medtronic. KT and KH are clinical proctors of Edwards Lifesciences., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Low CFR is associated with poor prognosis, whereas it is a heterogeneous condition according to the actual coronary flow, such as high resting or low hyperemic coronary flow, which should have different physiological traits and clinical implications. This study aimed to detect and define the sub-phenotypes of vessels with low coronary flow reserve (CFR) epicardial disease by unsupervised machine-learning methods. Hierarchical clustering was applied to 376 vessels from 364 patients with CFR less than the median and fractional flow reserve ≤ 0.8 from a global, multicenter registry. Detailed features of coronary flow physiology and survivals from vessel-oriented composite outcomes (VOCO) were assessed according to the clusters. Clustering defined three distinct physiological subgroups (PS). PS1 (n = 151) were characterized by high resting coronary flow, dominantly left anterior descending artery (LAD) lesions. PS2 (n = 131) were, in contrast, low hyperemic coronary flow, mainly LAD lesions. PS3 (n = 82) mostly consisted of non-LAD lesions with similar flow status to PS1 except for the low hyperemic Pd. Survivals from VOCO were significantly different according to the clusters (p = 0.005) and PS3 had the highest rate of VOCO. In a COX proportional model predicting VOCO, there was a significant interaction between PCI and PSs, suggesting potentially different effects of PCI on outcome between PS1 and PS2. The unsupervised machine-learning approaches provided unique insights into low CFR condition. Among low CFR epicardial lesions, high resting flow with low hyperemic Pd might be related to poor prognosis, and low hyperemic flow in LAD could benefit from elective PCI. CLINICAL TRIAL REGISTRATION INFORMATION: https://clinicaltrials.gov/ct2/show/NCT03690713 , NCT03690713.

Objectives: The aim of this study was to develop a risk model incorporating clinical, angiographic, and physiological parameters to predict future clinical events after drug-eluting stent implantation., Background: Prognostic factors after coronary stenting have not been comprehensively investigated., Methods: A risk model to predict target vessel failure (TVF) at 2 years was developed from 2,200 patients who underwent second-generation drug-eluting stent implantation and post-stent fractional flow reserve (FFR) measurement. TVF was defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization. A random survival forest model with automatic feature selection by minimal depth analysis was used for risk model development., Results: During 2 years of follow-up, the cumulative incidence of TVF was 5.9%. From clinical, angiographic, and physiological parameters, 6 variables were selected for the risk model in order of importance within the model as follows: total stent length, post-stent FFR, age, post-stent percentage diameter stenosis, reference vessel diameter, and diabetes mellitus. Harrell's C index of the random survival forest model was 0.72 (95% confidence interval [CI]: 0.62 to 0.82). This risk model showed better prediction ability than models with clinical risk factors alone (Harrell's C index = 0.55; 95% CI: 0.41 to 0.59; p for comparison = 0.005) and with clinical risk factors and angiographic parameters (Harrell's C index = 0.65; 95% CI: 0.52 to 0.77; p for comparison = 0.045). When the patients were divided into 2 groups according to the median of total stent length (30 mm), post-stent FFR and total stent length showed the highest variable importance in the short- and long-stent groups, respectively., Conclusions: A risk model incorporating clinical, angiographic, and physiological predictors can help predict the risk for TVF at 2 years after coronary stenting. Total stent length and post-stent FFR were the most important predictors. (International Post PCI FFR Registry; NCT04012281)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: To explore the value of right heart contrast echocardiography in etiological diagnosis and severity assessment of pulmonary hypertension (PH). Methods: A retrospective analysis was conducted on 74 patients who underwent transthoracic contrast echocardiography in China-Japan Friendship Hospital from May 2015 to July 2018, all of whom were diagnosed as PH by right heart catheterization. Patients were divided into three groups according to contrast echocardiography: the intra-cardiac shunt group (<4 cardiac cycles with microbubbles in the left heart); Intrapulmonary shunt group (>4 cardiac cycles with microbubbles in the left heart); non-shunt group. The etiology, partial arterial oxygen pressure (PO(2)), N-terminal pro-brain natriuretic peptide (NT-proBNP), mean pulmonary artery pressure (mPAP), right atrial pressure (RAP), pulmonary vascular resistance (PVR) and cardiac output (CO) were analyzed. Central nervous system complications were also compared among the three groups. Results: Among the 74 patients, right-to-left shunt was found in 28 cases (37.8%) by contrast echocardiography, including 11 cases (14.9%) of intra-cardiac shunt and 17 cases (23.0%) of intrapulmonary shunt. In the 11 cases of intra-cardiac shunt, 7 were diagnosed with congenital heart disease and 4 were patent foramen. Two with hereditary hemorrhagic telangiectasia (HHT) and 1 with pulmonary arteriovenous malformation (PAVM) were included in the 16 cases of intrapulmonary shunt. There was no statistical difference in PO(2), mPAP, PVR, NT-proBNP, RAP, CO and functional class among the three groups (all P >0.05). A total of 5 cases (6.8%) were found with nervous system comorbidities, 4 cases (5.4%) with cerebral infarction and 1 cases epilepsy, and 2 cases of cerebral infarction were diagnosed as paradoxical embolism. Nervous system complications were more common in patients with intra-cardiac shunt than in other groups. Conclusion: While right-to-left shunt detected by contrast echocardiography has no relationship with disease severity, it has complementary value in the etiological diagnosis of PH, and intra-cardiac shunt may increase the risk of nervous system complications.

Background: Development of pulmonary arteriovenous fistulas in patients with cavopulmonary anastomosis may result in a significant morbidity. Although the use of bubble contrast echocardiography with selective injection into both the branch pulmonary arteries in identifying pulmonary arteriovenous fistulas has been increasing, the actual efficacy of this diagnostic modality has not been properly evaluated. Thus, this study aimed to assess the efficacy of bubble contrast echocardiography in detecting pulmonary arteriovenous fistulas in children with total cavopulmonary connection., Methods: A total of 140 patients were included. All patients underwent cardiac catheterisation. Bubble contrast echocardiographic studies were performed by injecting agitated saline solution into the branch pulmonary arteries. Transthoracic echocardiograms that use an apical view were conducted to assess the appearance of bubble contrast in the systemic ventricles. Then, the contrast echocardiogram results and other cardiac parameters were compared., Results: No correlation was found between contrast echocardiogram grade and other cardiac parameters, such as pulmonary capillary wedge saturation and pulmonary artery resistance. Moreover, only 13 patients had negative results on both the right and left contrast echocardiograms, and 127 of the 140 patients had positive results on contrast echocardiograms even though they had normal pulmonary capillary wedge saturation. Results showed that bubble contrast echocardiography was a highly sensitive method and was likely to obtain false-positive results., Conclusions: Bubble contrast echocardiography might be highly false positive in detecting pulmonary arteriovenous fistulas in patients with cavopulmonary anastomosis. We have to consider how we make use of this method. Further standardisation of techniques is required.

Background: The safety of fractional flow reserve (FFR)-based deferral of revascularization remains to be fully established in real-world practice. We sought to assess clinical outcomes after deferral of revascularization based on FFR., Methods: The J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry) prospectively enrolled 1263 patients with 1447 lesions in whom revascularization was deferred based on FFR at 28 Japanese centers. The primary study end point was the cumulative 2-year incidence of target vessel failure, including cardiac death, target-vessel related myocardial infarction, and clinically driven target vessel revascularization., Results: The mean FFR was 0.86±0.06. At 2 years, the target vessel failure rate was 5.5% in deferred lesions, mainly driven by a high rate of clinically driven target vessel revascularization (5.2%), and significantly increased with decreasing FFR, especially in the proximal location. Cardiac death and target-vessel related myocardial infarction rarely occurred during the 2-year follow-up (0.41% and 0.41%, respectively). Independent predictors of 2-year target vessel failure were FFR value (per 0.01 decrease; hazard ratio [HR] 1.07 [95% CI, 1.04-1.11], P <0.001), left main coronary artery lesion (HR, 5.89 [95% CI, 2.72-12.8], P <0.001), moderately to severely calcified lesion (HR, 2.49 [95% CI, 1.36-4.58]; P =0.003), hemodialysis (HR, 2.90 [95% CI, 1.11-7.58]; P =0.03), and right coronary artery lesion (HR, 1.78 [95% CI, 1.02-3.11], P =0.042)., Conclusions: The J-CONFIRM registry demonstrated the 2-year target vessel failure rate was 5.5% in deferred lesions, highlighting the safety of FFR-based deferral of revascularization in daily practice., Clinical Trial Registration: URL: http://www.umin.ac.jp. Unique identifier: UMIN000014473.

Hypertrophic cardiomyopathy (HCM) with severe diastolic dysfunction is a major cause of heart failure and sudden cardiac death (SCD) associated with lethal arrhythmia. Although various risk factors for cardiac events have been reported in HCM patients, previous studies have reported that some HCM patients exhibit either no risk or a low risk of SCD experienced cardiac events. The mid-diastolic transmitral flow velocity curve (mitral L-wave) is an echocardiographic index of left ventricular compliance, and it has been reported as one of the parameters of advanced diastolic dysfunction assessed noninvasively. However, little is known about the association between the mitral L-wave and long-term clinical outcomes in HCM patients without SCD risk factors. Between July 2005 and February 2016, 112 patients were diagnosed with HCM and 96 patients without risk factors were enrolled. After excluding 3 patients whom we could not detect L-wave more than once, 93 patients (mean age 57.7 ± 13.1 years, 33 females) were divided into the following two groups, according to the presence or absence of the mitral L-wave: Group L (+) (with the mitral L-wave) and Group L (-) (without the mitral L-wave). The correlations between the mitral L-wave and rates of cardiac events were investigated. The mitral L-wave was present in 14 (15.1%) patients [Group L]. During the follow-up period [4.7 (2.9-7.5) years], patients experienced 7 cardiac events. Kaplan-Meier survival analysis showed that the event-free rate was significantly lower in Group L (+) than in Group L (-) (log-rank P = 0.002). Additionally, in multivariate analysis, L-wave positivity was identified as independent predictors of cardiac events. Existence of the mitral L-wave can predict cardiac events, even in HCM patients without SCD risk factors.

Coronary catheterization by a distal radial approach at the site of the anatomical snuffbox has recently been reported to be both safe and useful. No data are available on the diameter of the distal radial artery (DRA) in Japan, and it is unclear whether the DRA is large enough to withstand the insertion of a conventional sheath by a traditional radial approach. We enrolled 142 patients who underwent coronary catheterization and evaluated the vessel diameter of the DRA using ultrasound. The vessel diameter of the DRA in the anatomical snuffbox (2.6 ± 0.5 mm) was significantly smaller than that of the proximal radial artery (PRA) at the conventional puncture site (3.1 ± 0.4 mm). The difference in vessel diameter between the DRA and PRA was 0.5 ± 0.4 mm, and the DRA/PRA ratio was 0.8 ± 0.1. Although the vessel diameter of the DRA was positively correlated with that of the PRA (r = 0.66, p < 0.0001), in some cases the DRA was extremely small compared to the PRA. When the vessel diameter of the DRA is smaller than the outer diameter of the sheath scheduled for use, we should puncture the PRA at the outset. We could perform coronary catheterization by a distal radial approach without major bleeding or adverse events, and there was no radial artery occlusion at the site of the anatomical snuffbox or the forearm. For coronary catheterization by a distal radial approach, we should evaluate whether there is sufficient vessel diameter using ultrasound before the procedure. In addition, this approach can be an effective option from the viewpoint of radial artery preservation.

The efficacy of percutaneous transcatheter closure for preventing recurrent cerebrovascular events in elderly patients with high-risk patent foramen ovale (PFO) remains unclear, whereas in young patients, it has been shown to effectively prevent the recurrence of embolic stroke. The aim of this study was to investigate the safety and efficacy of percutaneous PFO closure in elderly patients with high-risk PFO. Between September 2012 and October 2018, 14 patients ≥ 60 years old with high-risk PFO underwent percutaneous closure to prevent recurrence of cerebrovascular events. The primary end point was recurrence of cerebrovascular events after closure in elderly patients with high-risk PFO, and the secondary end points were occurrence of device-related complications, cerebral hemorrhage, and new-onset atrial fibrillation (AF). The mean patient age and number of cerebrovascular events before closure were 75.2 ± 6.5 years and 1.7 ± 0.7, respectively. All procedures were successfully performed under general anesthesia by transesophageal echocardiography and using a 25-mm Amplatzer Cribriform device. No procedure-related complications occurred. Patients were followed up for a mean 2.6 ± 1.8 years. No patients experienced device-related complications or recurrent cerebrovascular events. However, one patient had AF-related device closure complications at 1 month postoperatively. In addition, other patient had a cerebral hemorrhage with unknown relationship to PFO closure 3 years postoperatively. Percutaneous closure of high-risk PFO in elderly patients may be as effective and safe as in younger patients. It is crucial to evaluate PFO morphology regardless of age in cases of paradoxical embolism.

Background: The prognostic impact of coronary microvascular dysfunction after percutaneous coronary intervention (PCI) remains unclear in patients with stable coronary artery disease. This study sought to investigate the prognostic value of microvascular function measured immediately after PCI in patients with stable coronary artery disease., Methods: We enrolled 572 patients with stable coronary artery disease who underwent PCI and elective measurement of the index of microcirculatory resistance (IMR) immediately after PCI from 8 centers in 4 countries. Impaired microvascular function was defined as IMR≥25 (high IMR). Major adverse cardiac events, including death, myocardial infarction (MI) and target vessel revascularization, were evaluated., Results: During a median follow-up duration of 4.0 years, the cumulative major adverse cardiac events rate was significantly higher in the high IMR group (n=66/148) compared with the low IMR group (n=128/424; hazard ratio [HR], 1.56; 95% CI, 1.16-2.105; P =0.001), primarily due to a higher rate of periprocedural MI (HR, 1.59; 95% CI, 1.11-2.28; P =0.004) but also due to higher rates of mortality (HR, 1.59; 95% CI, 0.76-3.35; P =0.22), spontaneous MI (HR, 2.10; 95% CI, 0.67-6.63; P =0.20) and target vessel revascularization (HR, 1.40; 95% CI, 0.77-2.54; P =0.27). Cumulative risk for death, spontaneous MI, and target vessel revascularization was higher in the high IMR group (HR, 1.55; 95% CI, 0.99-2.43; P =0.056), as was death and spontaneous MI alone (HR, 1.79; 95% CI, 0.96-3.36; P =0.065). On multivariable analysis, high IMR post-PCI was an independent predictor of major adverse cardiac events., Conclusions: IMR measured immediately after PCI predicts adverse events in patients with stable coronary artery disease.

Background: In patients with stable coronary artery disease, the amount of myocardium subtended by coronary stenoses constitutes a major determinant of prognosis, as well as of the benefit of coronary revascularization. We devised a novel method to estimate partial myocardial mass (PMM; ie, the amount of myocardium subtended by a stenosis) during physiological stenosis interrogation. Subsequently, we validated the index against equivalent PMM values derived from applying the Voronoi algorithm on coronary computed tomography angiography., Methods: Based on the myocardial metabolic demand and blood supply, PMM was calculated as follows: PMM (g)=APV×D 2 ×π/(1.24×10 - 3 ×HR×sBP+1.6), where APV indicates average peak blood flow velocity; D, vessel diameter; HR, heart rate; and sBP, systolic blood pressure. We calculated PMM to 43 coronary vessels (32 patients) interrogated with pressure and Doppler guidewires, and compared it with computed tomography-based PMM., Results: Median PMM was 15.8 g (Q1, Q3: 11.7, 28.4 g) for physiology-based PMM, and 17.0 g (Q1, Q3: 12.5, 25.9 g) for computed tomography-based PMM ( P =0.84). Spearman rank correlation coefficient was 0.916 ( P <0.001), and Passing-Bablok analysis revealed absence of both constant and proportional differences (coefficient A: -0.9; 95% CI, -4.5 to 0.9; and coefficient B, 1.00; 95% CI, 0.91 to 1.25]. Bland-Altman analysis documented a mean bias of 0.5 g (limit of agreement: -9.1 to 10.2 g)., Conclusions: Physiology-based calculation of PMM in the catheterization laboratory is feasible and can be accurately performed as part of functional stenosis assessment.

Background: Mesenchymal stem cells (MSCs), which have the potential to differentiate into cardiomyocytes or vascular endothelial cells, have been used clinically as therapy for cardiomyopathy. In this study, we aimed to evaluate the long-term follow-up results.Methods and Results:We studied 8 patients with symptomatic heart failure (HF) on guideline-directed therapy (ischemic cardiomyopathy, n=3; nonischemic cardiomyopathy, n=5) who underwent intracardiac MSC transplantation using a catheter-based injection method between May 2004 and April 2006. Major adverse events and hospitalizations were investigated up to 10 years afterward. Compared with baseline, there were no significant differences in B-type natriuretic peptide (BNP) (from 211 to 173 pg/mL), left ventricular ejection fraction (LVEF) (from 24% to 26%), and peak oxygen uptake (from 16.5 to 19.2 mL/min/kg) at 2 months. During the follow-up period, no patients experienced serious adverse events such as arrhythmias. Three patients died of pneumonia in the 1st year, liver cancer in the 6th year, and HF in the 7th year. Of the remaining 5 patients, 3 patients were hospitalized for exacerbated HF, 1 of whom required heart transplantation in the 2nd year; 2 patients survived for 10 years without worsening HF., Conclusions: The results of this exploratory study of intracardiac MSCs administration suggest further research regarding the feasibility and efficacy is warranted.

Pre-procedural valvuloarterial impedance (Zva) is considered as a useful predictor of mortality in patients diagnosed as having severe aortic stenosis (AS) who undergo transcatheter aortic valve implantation (TAVI). However, the prognostic significance of post-procedural Zva remains unclear. We aimed to evaluate the prognostic significance of Zva after TAVI. We retrospectively analyzed the clinical and echocardiographic data of 1004 consecutive elderly patients (median 84 years old, 27.5% men) who underwent TAVI for severe symptomatic AS. Zva was calculated after TAVI, and patients were divided into three groups based on tertile values: the high [> 3.33 (n = 335)], intermediate [2.49-3.33 (n = 334)], and low Zva groups [< 2.49 (n = 335)]. The estimated 2-year all-cause and cardiovascular mortalities using Kaplan-Meier analysis were 16.2% [95% confidence interval (CI) 11.8-20.4] and 5.9% (95% CI 3.2-8.6), respectively. There were no significant intergroup differences in each endpoint (long-rank p = 0.518 for all-cause mortality, p = 0.757 for cardiovascular mortality). Multivariable Cox regression analyzes with adjustments of patient characteristics and medications showed that the post-procedural Zva was not associated with the 2-year all-cause mortality [intermediate Zva group versus (vs.) low Zva group: adjusted hazard ratio (aHR) = 1.34, 95% CI 0.75-2.40, p = 0.316; high Zva group vs. low Zva group: aHR = 1.17, 95% CI 0.64-2.16, p = 0.613] and cardiovascular mortality (intermediate Zva group vs. low Zva group: aHR = 1.50, 95% CI 0.56-4.06, p = 0.421; high Zva group vs. low Zva group: aHR = 1.25, 95% CI 0.43-3.65, p = 0.682). Our results suggest that post-procedural Zva was not associated with 2-year all-cause or cardiovascular mortalities in patients with severe symptomatic AS who underwent TAVI.

Background: Even in the current drug-eluting stent era, revascularization for coronary stenosis with fractional flow reserve (FFR) between 0.75 and 0.80, the so-called "gray zone," is a matter of debate. Previous studies have reported conflicting results regarding outcomes of revascularization versus deferral for coronary stenosis when FFR values are in the gray zone, but these studies have had differing designs and populations. We therefore will investigate whether medical therapy plus percutaneous coronary intervention (PCI) is superior to medical therapy alone in reducing major cardiovascular events in patients presenting with coronary stenosis with gray zone FFR values., Methods/design: This is a prospective, multicenter, open-label, parallel group, randomized, controlled, superiority study. A total of 410 eligible participants will be recruited and randomized to either the medical therapy plus PCI group or the medical therapy alone group. The primary endpoint is 1-year major adverse cardiac events (MACEs), defined as a combined endpoint of all-cause death, nonfatal myocardial infarction (MI), or unplanned target vessel revascularization (TVR). Secondary endpoints include MACE at 2 and 5 years. Moreover, each individual component of the primary endpoint, cardiovascular death, target vessel-related and non-target vessel-related MI, all MI, clinically driven TVR or non-TVR, all revascularization, stent thrombosis, and angina symptom status will be evaluated at 1, 2, and 5 years., Discussion: This is the first prospective, multicenter, randomized, controlled study to investigate the superiority of medical therapy plus PCI over medical therapy by itself in reducing major cardiovascular events in patients presenting with coronary stenosis with "gray zone" FFR values. The results will help interventional cardiologists in making revascularization decisions regarding coronary stenosis with gray zone FFR values., Trial Registration: University Hospital Medical Information Network Clinical Trials Registry, UMIN000031526 . Registered on 1 March 2018.

The influence of shunts between the coronary artery (CA) and the left ventricle (LV), on chest pain (CP) in patients with hypertrophic cardiomyopathy (HCM) is unknown. We examined the incidence of CA-LV shunts and their influence on CP in HCM patients. Twenty normal control subjects (NCS), 3 with CP due to CA-LV shunts (CP patients), and 60 with HCM participated. Interventricular septal wall thickness (IVST), LV posterior wall thickness (LVPWT), cardiac and stroke indexes (CI and SI), LV end-diastolic pressure (LVEDP), and proximal diameters of the CA were measured. Twenty-five HCM patients had a CA-LV shunt (41.7%). Both IVST and LVPWT were greater in the HCM patients than in NCS and CP patients. These values showed no significant differences between the HCM with shunt and HCM without shunt groups. CI and SI were lower in the HCM patients than in NCS and CP patients. LVEDP was higher in the HCM and CP patients than in NCS. CA diameters were larger in the HCM and CP patients than in NCS. CP was found in 32 HCM patients (53%). The incidence of CP was greater in the HCM with shunt group than in HCM without shunt group (80 vs. 34%, p < 0.0005). There was no significant difference in CA diameters between the HCM patients with CP and those without CP. CA-LV shunts are often found in HCM patients and are closely related to CP. Thus, CA-LV shunts are an important factor behind CP in HCM patients.

Objectives: The study sought to investigate the prognostic implications of relative increase of fractional flow reserve (FFR) with PCI in combination with post-percutaneous coronary intervention (PCI) FFR., Background: FFR, measured after PCI has been shown to possess prognostic implications. The relative increase of FFR with PCI can be determined by the interaction of baseline disease pattern, adequacy of PCI, and residual disease burden in a target vessel. However, the role of relative increase of FFR with PCI has not yet been evaluated., Methods: A total of 621 patients who underwent PCI using second-generation drug-eluting stents based on low pre-PCI FFR (≤0.80) and available post-PCI FFR were analyzed. The relative increase of FFR was calculated by %FFR increase with PCI ([post-PCI FFR - pre-PCI FFR]/pre-PCI FFR × 100). Patients were divided according to the optimal cutoff values of post-PCI FFR (<0.84) and %FFR increase (≤15%). The primary outcome was target vessel failure (TVF) (a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization) at 2 years., Results: Among the total population, 66.0% showed high post-PCI FFR (≥0.84) and 69.2% showed high %FFR increase (>15%). Patients with low post-PCI FFR showed a higher risk of 2-year TVF than did those with high post-PCI FFR (9.1% vs. 2.6%; hazard ratio [HR]: 3.367; 95% confidence interval [CI]: 1.412 to 8.025; p = 0.006). Patients with low %FFR increase also showed a higher risk of 2-year TVF compared with those with high %FFR increase (9.2% vs. 3.0%; HR: 3.613; 95% CI: 1.543 to 8.458; p = 0.003). Among the high post-PCI FFR group, there were no significant differences in clinical outcomes according to %FFR increase. Conversely, among the low post-PCI FFR group, those with low %FFR increase showed a significantly higher risk of TVF than did those with high %FFR increase (14.3% vs. 4.1%; HR: 4.334; 95% CI: 1.205 to 15.594; p = 0.025). Percent FFR increase significantly increased discriminant and reclassification ability for the occurrence of TVF when added to a model with clinical risk factors and post-PCI FFR (C-index 0.783 vs. 0.734; relative integrated discrimination improvement 0.702; p = 0.009; category-free net reclassification index 0.479; p = 0.031)., Conclusions: Percent FFR increase with PCI showed similar prognostic implications with post-PCI FFR. Adding the relative increase of FFR to post-PCI FFR would enable better discrimination of high-risk patients after stent implantation. (Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention [PERSPECTIVE]; NCT01873560)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study investigated the diagnostic performance of instantaneous wave-free ratio (iFR) in patients with aortic valve stenosis (AS)., Background: The iFR was introduced as a new, nonpharmacologic stress index of coronary stenosis severity. However, the diagnostic performance of iFR has not been sufficiently explored in patients with severe AS., Methods: We analyzed 95 consecutive patients with AS (57 women) demonstrating intermediate coronary artery stenosis (116 vessels), and compared the iFR values with fractional flow reserve (FFR) values and with adenosine-stress myocardial perfusion imaging as indicators of myocardial ischemia., Results: The median value and interquartile range (first quartile [Q1], third quartile [Q3]) of the iFR was 0.86 (Q1 to Q3 range, 0.76 to 0.93), and that of the FFR was 0.84 (Q1 to Q3 range, 0.76 to 0.91). The iFR values correlated well with the FFR values (R = 0.854; p < 0.0001). A receiver operating characteristic analysis demonstrated an optimal cutoff of 0.82 for the iFR to indicate an FFR ≤0.75, with an area under the curve of 0.92. The optimal iFR cutoff value indicating myocardial ischemia on perfusion scintigraphy was 0.82 (area under the curve: 0.84)., Conclusions: In patients with severe AS, a good correlation exists between iFR and FFR. Both the iFR and FFR values exhibit good correlation with perfusion scintigraphy-identified myocardial ischemia. The iFR could be a safe diagnostic tool for patients with severe AS. (The Impact of FFR and iFR in Patients with Severe Aortic Stenosis; UMIN000024479)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to investigate the prognostic implication of functional incomplete revascularization (IR) and residual functional SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (rFSS) in comparison with 3-vessel fractional flow reserve (FFR) and residual SYNTAX score., Background: IR is associated with poor clinical outcomes in patients who underwent percutaneous coronary intervention., Methods: A total of 385 patients who underwent 3-vessel FFR measurement after stent implantation were included in this study. The rFSS was defined as residual SYNTAX score measured only in vessels with FFR ≤0.8. The study population was divided into the functional IR group (rFSS ≥1) and the functional complete revascularization (CR) group (rFSS = 0). The primary outcome was major adverse cardiac events (MACEs; a composite of cardiac death, myocardial infarction, and ischemia-driven revascularization) at 2 years., Results: Functional CR was achieved in 283 patients (73.5%). At 2-year follow-up, the functional IR group showed a significantly higher risk for MACEs (functional IR vs. CR, 14.6% vs. 4.2%; hazard ratio: 4.09; 95% confidence interval: 1.82 to 9.21; p < 0.001) than the functional CR group. In a multivariate-adjusted model, functional IR was an independent predictor of MACEs (adjusted hazard ratio: 4.17; 95% confidence interval: 1.85 to 9.44; p < 0.001). The rFSS showed a significant association with estimated 2-year MACE rate (hazard ratio: 1.09 per 1-U increase; 95% confidence interval: 1.02 to 1.17; p = 0.018). When added to clinical risk factors, rFSS showed the highest integrated discrimination improvement value for MACEs (3.5%; p = 0.002) among 3-vessel FFR, residual SYNTAX score, and rFSS., Conclusions: Patients with functional IR showed significantly higher rate of 2-year MACEs than those with functional CR. A combined anatomic and physiological scoring system (rFSS) after stent implantation better discriminated the risk for adverse events than anatomic or physiological assessment alone. (Clinical Implication of 3-Vessel Fractional Flow Reserve [FFR]; NCT01621438)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Large V waves in the pulmonary capillary wedge pressure (PCWP) waveform traditionally indicate severe mitral regurgitation (MR). However, our understanding of MR etiology and hemodynamics has changed in recent decades., Objectives: We aimed to reevaluate the association between large V waves and current MR to determine whether traditional large V wave criteria remain optimal., Method: We reviewed 1,964 right heart catheterizations (RHCs) performed at our institution from 2010 to 2017, and retrospectively selected 126 patients with sinus rhythm who underwent echocardiography within 2 days (0.3 ± 0.5 days) of the RHC. The diagnostic accuracy of 3 traditional criteria for large V waves was assessed, and the optimal cut-off points were determined as those with the maximal Youden indices., Results: Severe MR was observed on echocardiography in 26 (21%) patients, including 15 (58%) with Carpentier classification type II MR and 11 (42%) with type IIIB MR. Large V waves, defined as a difference between the peak V wave and mean PCWP ≥10 mm Hg, had a high specificity of 94% (95% confidence interval: 87-98%), but a low sensitivity of 27% (12-48%) for diagnosing severe MR. The optimal cut-off point for the V wave was 3 mm Hg above the mean PCWP, with a sensitivity of 73% (52-88%) and a specificity of 64% (54-73%)., Conclusions: For diagnosing current MR, the cut-off point for a large V wave should be reduced from that previously employed for rheumatic valvular heart disease. This information may be useful in guiding contemporary transcatheter therapies for MR under RHC monitoring., (© 2018 S. Karger AG, Basel.)

A 63-year-old Japanese woman with an adrenal tumor was transferred to our hospital due to cardiogenic shock. Right and left ventriculography showed severe hypokinesis of the middle segment and the apex in both ventricles, and an endomyocardial biopsy demonstrated a small number of necrotic myocytes and cellular infiltration. She was diagnosed with pheochromocytoma and quickly recovered after treatment with an α-blocker. The functional disability of both the right and left ventricles with less myocardial damage due to an excessive level of catecholamine seemed to be related to the early recovery the present patient with catecholamine-induced cardiomyopathy due to pheochromocytoma.

Objectives: Our aim was to assess midterm safety and clinical outcomes of intracoronary infusion of cardiosphere-derived cells (CDCs) after staged palliation in patients with hypoplastic left heart syndrome (HLHS)., Methods: In this prospective, controlled study, 14 consecutive patients with HLHS who were undergoing 2- or 3-stage surgical palliations were assigned to receive intracoronary CDC infusion 1 month after cardiac surgery (n = 7), followed by 7 patients allocated to a control group with standard care alone. The primary end point was to assess procedural feasibility and safety; the secondary end point was to evaluate cardiac function and heart failure status through 36-month follow-up., Results: No complications, including tumor formation, were reported within 36 months after CDC infusion. Echocardiography showed significantly greater improvement in right ventricular ejection fraction (RVEF) in infants receiving CDCs than in controls at 36 months (+8.0% ± 4.7% vs +2.2% ± 4.3%; P = .03). These cardiac function improvements resulted in reduced brain natriuretic peptide levels (P = .04), lower incidence of unplanned catheter interventions (P = .04), and higher weight-for-age z score (P = .02) at 36 months relative to controls. As independent predictors of treatment responsiveness, absolute changes in RVEF at 36 months were negatively correlated with age, weight-for-age z score, and RVEF at CDC infusion., Conclusions: Intracoronary CDC infusion after staged procedure in patients with HLHS is safe and improves RVEF, which persists during 36-month follow-up. This therapeutic strategy may enhance somatic growth and reduce incidence of heart failure., (Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)