Rationale and Design of Prospective, Multicenter, Double-Arm Clinical Trial to Investigate the Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus (TOP-HFPEF Trial).

BACKGROUND: Recent large clinical trials have revealed that sodium-glucose cotransporter 2 (SGLT2) inhibitors improve cardiovascular outcomes not only in patients with heart failure with reduced ejection fraction, but also in patients with heart failure with mildly reduced or preserved ejection fraction (HFpEF). However, the effect of SGLT2 inhibitors on left ventricular (LV) diastolic function is still controversial. METHODS AND RESULTS: The TOP-HFPEF trial (Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus) is a multicenter, double-arm, open-label, confirmatory, investigator-initiated clinical study to investigate the effect of SGLT2 inhibitor on LV diastolic function in patients with HFpEF and type 2 diabetes mellitus. The participants are randomly assigned (1:1) to the tofogliflozin group (20 mg once daily) or the control group (administration or continuation of antidiabetic drugs other than SGLT2 inhibitors). The estimated number of patients to be enrolled in this trial is 90 in total (45 in each group). The participants are followed up for 52 weeks with tofogliflozin or control drugs. The primary endpoint is the change in E/e' assessed by echocardiography from the baseline to the end of this study (52 weeks). This trial will also evaluate the effects of tofogliflozin on cardiovascular events, biomarkers, other echocardiographic parameters, the occurrence of atrial fibrillation, and renal function. CONCLUSIONS: The TOP-HFPEF trial will clarify the efficacy of an SGLT2 inhibitor, tofogliflozin, on LV diastolic function in patients with HFpEF and type 2 diabetes mellitus.

Large Tissue Debris Causing Cerebral Embolism After Transcatheter Aortic Valve Replacement.

Cerebral vascular embolism is one of the complications of transcatheter aortic valve replacement (TAVR). Thrombolytic therapy is not expected to be effective when embolic material consists of a large tissue fragment. Instead, mechanical aspiration may be more effective therapy for acute cerebral infarction after TAVR. Here, we describe the case of an 87-year-old woman with aortic valve stenosis and heart failure who underwent TAVR using a self-expandable valve. Acute cerebral infarction with left middle cerebral artery occlusion caused by a large tissue fragment developed after the procedure.

Is narrowest QRS the best? A case of cardiac resynchronization therapy in a patient with left anterior fascicular block.

The efficacy of cardiac resynchronization therapy (CRT) in patients with a narrow QRS duration has not been established. We present a patient with a narrow QRS duration and left anterior fascicular block in which CRT was effective. Left ventricular lead implantation at the optimal site and appropriately-timed left ventricular pacing (LVP) resulted in left ventricle reverse remodeling. Left ventricular dyssynchrony did not improve with LVP at a timing that resulted in narrower QRS than an intrinsic QRS duration. The optimization of LVP timing in CRT for patients with a narrow QRS duration is discussed.

Utility of Routine Transthoracic Echocardiographic Parameters to Predict Functional Recovery after Catheter Ablation Therapy in Patients with Atrial Fibrillation and Left Ventricular Systolic Dysfunction.

Arrhythmia-induced cardiomyopathy (AIC) occurring in patients with atrial fibrillation (AF) is a reversible form of cardiomyopathy characterized by LV systolic dysfunction. However, it is difficult to predict the reversibility before rhythm control therapy. We performed this study to develop a parameter for the identification of AIC in routine transthoracic echocardiography (TTE) in patients with presumptive AIC due to AF.We retrospectively studied 72 patients treated with catheter ablation therapy for persistent AF, and LV ejection fraction (LVEF) ≤ 45%. The patients were divided into 2 groups by follow-up TTE performed within 12 ± 6 months postoperatively. Patients with ≥ 15% improvement in LVEF or ≥ 10% improvement and ≥ 50% in LVEF were classified as the AIC group, and the others were classified as the non-AIC group.A total of 57 (79%) patients were classified as the AIC group. In the stepwise multivariate logistic regression model, LV end-diastolic dimension (LVDd) and e' (septal) were independent predictors of AIC. The sensitivities of LVDd ≤ 53 mm and e' (septal) ≥ 6.3 cm/second were 60% and 75%, respectively. Their specificities were 80% and 67%, respectively. The presence of either LVDd ≤ 53 mm or e' (septal) ≥ 6.3 cm/second had a higher sensitivity (90%); their co-occurrence had a higher specificity (93%) in predicting AIC.The functional recovery in patients with AIC can occur in LV systolic dysfunction without remodeling and impairment of relaxation. The combination of LVDd and e' (septal) is useful in predicting AIC due to AF with routine TTE.

Bachmann's bundle-ridge related biatrial tachycardia with a long epicardial circuit.

Biatrial tachycardia (BiAT), involving Bachmann's bundle in the circuit, has sometimes been observed after mitral anterior line ablation. In this article, we present a case of BiAT, involving a long epicardial circuit, composed of Bachmann's bundle and the left atrial ridge (LAR). We discuss the optimal ablation technique for this tachycardia based on our experience in addition to the relationship between Bachmann's bundle and the LAR. Furthermore, the evaluation method for the mitral anterior block line is also discussed.

Achievement rate and learning curve of left bundle branch capture in left bundle branch area pacing procedure performed to demonstrate output-dependent QRS transition.

INTRODUCTION: Recently, output-dependent QRS transition was reported to be required to confirm left bundle branch (LBB) capture in LBB area pacing (LBBAP) procedure. This study aimed to evaluate the achievement rate and the learning curve of LBB capture in LBBAP procedure performed with the goal of demonstrating output-dependent QRS transition, and investigate predictors of LBB capture. METHODS AND RESULTS: The LBBAP procedure was performed in 126 patients with bradyarrhythmia. LBB capture was defined as a demonstration of output-dependent QRS transition. The following pacing definitions were used for evaluation: (1) LBBAP, which met the previously reported LBBAP criteria, (2) LBB pacing (LBBP), LBB capture was confirmed, and (3) available LBBP, LBB threshold was clinically usable (<3 V at 0.4 ms). The learning curve was evaluated by division into three time-periods. The achievement rates of LBBAP, LBBP, and available LBBP were 88.1%, 41.2%, and 35.7%, respectively. The achievement rates of all three pacing definitions significantly increased with experience (p < .01), but the achievement rate of available LBBP was still 50% in the third period. As predictors of LBB capture, the interval between LBB-Purkinje potential and QRS onset ≥22 ms had high specificity of 98.3%, while R wave peak time in V6 < 68 ms had insufficient sensitivity of 79% and specificity of 68%. CONCLUSION: Even if LBB capture was aimed in LBBAP procedure, it was not easy to achieve, and there was a clear learning curve. Much of LBBAP may be left ventricular septal pacing that does not capture LBB.

Aortomitral angle affects cardiovascular events after mitral valve repair for atrial functional mitral regurgitation.

PURPOSE: This study aimed to elucidate the geometric parameters of the aortomitral (AM) complex affecting postoperative cardiovascular events (CVEs) in patients with atrial functional mitral regurgitation (MR). METHODS: From October 2008 to August 2018, we performed mitral and tricuspid valve repairs in 58 patients with atrial functional MR. We examined the determinants of CVEs using preoperative and postoperative echocardiographic data. Furthermore, we analyzed the effect of left atrial (LA) plication on AM geometries after surgery. The follow-up period ranged from 56 to 3283 days (median, 1073 days). RESULTS: All patients underwent mitral and tricuspid annuloplasty. Seventeen patients (29%) underwent additional LA plication. The AM angle was narrowed after surgery in patients with CVEs (115° ± 6.8° to 106° ± 4.2°, p = .00336), whereas it widened in patients without CVEs (115° ± 7.4° to 118° ± 8.4°, p = .0278). The postoperative AM angle was an independent predictor of postoperative CVEs (p = .000829). LA plication was not a predictor of CVEs; however, it was a predictor of the obtuse postoperative AM angle (p = .0071). CONCLUSIONS: Our results suggest that a narrow postoperative AM angle is an independent predictor of postoperative CVEs. Additional LA plication reduces the sharpening of the AM angle, which may prevent CVEs after mitral valve repair for atrial functional MR.

Characteristics and proposed mechanisms of QRS morphology observed during the left bundle branch pacing procedure.

BACKGROUND: In performing left bundle branch pacing (LBBP), various QRS morphologies are observed as the lead penetrates the ventricular septum (VS). This study aimed to evaluate these characteristics and infer the mechanism underlying each QRS morphology. METHODS: In 19 patients who met the strict criteria for LBB capture, we classified the QRS morphologies observed during the LBBP procedure into seven patterns, the first five of which were determined by the depth of penetration: right ventricular septal pacing (RVSP), intraventricular septal pacing (IVSP1 and IVSP2), endocardial side of left ventricular septal pacing (LVSeP), nonselective LBBP (NS-LBBP), selective LBBP (S-LBBP), and NS-LBBP with anodal capture. The parameters of the QRS morphologies in these seven patterns were evaluated. RESULTS: Among the first five patterns, stimulus-QRSend duration (s-QRSend) was the narrowest in IVSP1 rather than in NS-LBBP, and stimulus-to-peak of R wave in V6 (s-LVAT) was significantly shortened in two steps, from RVSP to IVSP1 (96 ± 11; 82 ± 8 ms, p < .01) and from LVSeP to NS-LBBP (76 ± 7; 60 ± 4 ms, p < .01). The late-R duration in V1 was significantly prolonged in the order of LVSeP, NS-LBBP, and S-LBBP (45 ± 7; 53 ± 10; 71 ± 15 ms, respectively, p < .01). CONCLUSIONS: s-QRSend was the narrowest in IVSP1 rather than in NS-LBBP among the QRS morphologies observed during lead penetration through the VS. The prolonged late-R duration in V1 and abrupt shortening of the s-LVAT in V6 may help determine LBB capture during lead penetration.

Editorial Commentary: Guidelines for Wrist Triangular Fibrocartilage Complex Foveal Tears: A Compass for a Broad Voyage.

The ulnar head attachment of triangular fibrocartilage complex is divided into 2 sections: the distal radioulnar ligament consists of superficial and deep bundles on both the palmar and dorsal sides, which attach at the fovea and the base of the ulnar styloid. A tear on the ulnar side of triangular fibrocartilage complex inevitably occurs at these attachments. Both magnetic resonance imaging and distal radioulnar joint (DRUJ) arthroscopy are crucial. DRUJ arthroscopy can clarify the tear location. An ulnar styloid tear can be treated by capsular repair. However, a foveal tear should be reattached to the fovea because this tear could cause gross DRUJ instability. There are several ways to reattach the bundles to the fovea, including single- or double-tunnel or bone anchors, and open versus arthroscopic.

Loop technique for degenerative mitral regurgitation due to extended prolapse.

PURPOSE: Our study aims to examine the midterm outcomes of the loop technique for extended mitral valve (MV) prolapse patients. METHODS: From October 2008 to August 2020, we performed MV repairs in 407 patients with severe mitral regurgitation (MR). Follow-up ranged in duration from 287 to 2899 days (median, 872 days). The prolapse extensiveness (p-score) was determined based on the ratio of prolapsing segment's areas to whole area. We divided the whole MV into 10 segments (A1, A2 medial, A2 lateral, A3, P1, P2 medial, P2 lateral, P3, AC, and PC). Patients were categorized into three groups according to the p-score: simple (0.1-0.2), intermediate (0.3-0.4), and extensive (0.5-0.9). RESULTS: All patients underwent MV repair with the loop technique. The rates of freedom from significant (moderate to severe or severe) MR at 5 and 7 years after surgery were 91% and 91%, respectively. There were 252, 115, and 40 patients in simple group, intermediate group, and extensive group, respectively. The following were significantly increased in extended group: Barlow disease (23/40 patients, p < .001), the number of loops (p for trend < .0001), and the technique score (p for trend < .0001). The rates of freedom from significant MR at 7 years after surgery were 92% in simple group, 87% in intermediate group, and 94% in extended group, respectively (p = .995). Receiver-operating characteristic curves showed a postoperative mild MR with a sensitivity of 86% and a specificity of 68% for predicting significant MR recurrence. CONCLUSIONS: MV repair using the loop technique was useful even in groups with extended prolapse.

The Impact of Aorto-Mitral Angle on New-Onset Atrial Arrhythmia after Mitral Valve Repair in Patients with Mitral Regurgitation.

In this study, we hypothesized that post-operative aorto-mitral angle might be associated to the occurrence of post-operative atrial arrhythmia (AA), including atrial fibrillation and atrial tachycardia, after mitral valve repair in patients with mitral regurgitation (MR). Thus, this present study aims to determine the effects of post-operative aorto-mitral angle on new-onset AA after mitral valve repair with mitral annuloplasty for the treatment of MR.In total, 172 patients without any history of AA underwent mitral valve repair with mitral annuloplasty in our institution between 2008 and 2017. Patient information, including medical records and echocardiographic data, were retrospectively studied.As per our findings, AA occurred in 15 (8.7%) patients during the follow-up period (median, 35.7 months; range, 0.5-132 months). The patients with AA were noted to have a longer cardiopulmonary bypass time and a smaller aorto-mitral angle at post-operative TTE than the others (119 ± 6° versus 125 ± 10°, P = 0.003). No significant difference was noted in the degree of post-operative residual MR or functional MS between the groups. In a multivariate Cox proportional hazards analysis, the longer cardiopulmonary bypass time and the smaller post-operative aorto-mitral angle were independent predictors of the occurrence of AA during the follow-up period (odds ratio per 10 minutes 1.11; 95% CI 1.02-1.22, P = 0.019: odds ratio 0.91; 95% CI 0.85-0.98, P = 0.012).A small aorto-mitral angle at post-operative TTE was determined to be a predictor of new-onset AA after a mitral valve repair for treating MR.

Mitral Valvular Coaptation-Zone Area Is Associated with the Severity of Atherosclerosis Assessed by Cardio-Ankle Vascular Index.

Preservation of the mitral valve (MV) size is essential for valve function, and a reduced MV coaptation-zone area increases the risk of developing functional mitral regurgitation (FMR). We aimed to determine if the MV leaflet and coaptation-zone areas were associated with the severity of atherosclerosis assessed by cardio-ankle vascular index (CAVI) in patients with normal left ventricle (LV) systolic function and size by real-time 3D echocardiography (RT3DE).We performed RT3DE analysis in 66 patients with normal LV size and ejection fraction who underwent 2D echocardiography and CAVI. MV coaptation-zone areas were measured by custom 3D software and indexed by body surface area (BSA). The associations of clinical factors and mean CAVI with MV leaflet and coaptation-zone areas were evaluated by univariable and multivariable linear regression analyses.On univariable analysis, MV leaflet area/BSA was significantly associated with age (r = -0.335, P = 0.0069) and mean CAVI (r = -0.464, P < 0.001), and MV coaptation-zone area was significantly associated with age (r = -0.626, P < 0.001), hypertension (r = -0.626, P < 0.001), dyslipidemia (r = -0.626, P < 0.001), E/e' (r = -0.626, P < 0.001), and CAVI (r = -0.740, P < 0.001). On multivariable analysis, mean CAVI was independently associated only with MV leaflet area/BSA (standardized coefficient = -0.611, P < 0.001) and MV coaptation-zone area/BSA (standardized coefficient = -0.74, P < 0.001).In patients with normal LV systolic function and size, MV leaflet and coaptation-zone areas might be reduced according to advancing atherosclerosis. Patients with atherosclerosis might be at increased risk of developing FMR.

Etiology of Atrial Functional Mitral Regurgitation: Insights from Transthoracic Echocardiography in 159 Consecutive Patients with Atrial Fibrillation and Preserved Left Ventricular Ejection Fraction.

BACKGROUND: Left atrial (LA) dilatation in patients with atrial fibrillation (AF) can induce functional mitral regurgitation (MR) despite a preserved left ventricular ejection fraction (LVEF). The purpose of this study was to investigate the etiology of this functional MR. METHODS: We retrospectively examined clinical and echocardiographic data from 5,202 consecutive cases that underwent transthoracic echocardiography. AF appeared in 544 patients, and we selected 159 with AF and LVEF ≥50% after excluding patients with other underlying heart diseases. RESULTS: Significant (moderate or greater) degrees of functional MR were seen in 13 (8.2%) patients and were more frequently seen in patients with an AF duration of >10 years than in others (27 vs. 4%, p = 0.0057). Multiple regression analysis revealed that both the LA dimension index and the left ventricular (LV) systolic dimension index were independent determinants of the MR grading. Among the mitral morphologic parameters, the mitral annular (MA) dimension index and the hamstringing phenomenon of the posterior mitral leaflet were independent determinants of MR grading. Significant MR was not seen in patients without LA dilatations, but it occurred in 14% of patients with LA dilatation alone and in 55% with both LA and LV dilatations; the MA dimension index increased in this order. CONCLUSIONS: The grading of functional MR occurring in patients with AF and preserved LVEF depends on both the LA dimension and the LV systolic dimension. The MR grading also depends on both the MA dilatation and the hamstringing phenomenon of the posterior mitral leaflet.

Editorial Commentary: Triangular Fibrocartilage Complex "Fovea"-An Attractive and Complicated Structure-Is "The Anchor" Not Only for Distal Radioulnar Joint but Also for Wrist Surgeons.

A triangular fibrocartilage complex foveal lesion is one of the key structures for stabilizing the distal radioulnar joint. Its anatomy is unique and healing potential is still controversial. If surgical repair is necessary, ulnar abutment is contraindicated, evaluation of the ligament condition using distal radioulnar joint arthroscopy is crucial to achieve satisfactory results.

Utility of the combination of simple electrocardiographic parameters for identifying mid-septal pacing.

INTRODUCTION: The electrocardiograms (ECG) criteria to anchor the lead to the right ventricular septum have not been established. This study aimed to identify ECG criteria of pacing at the right ventricular mid septum (RVMS) and investigate whether the paced QRS duration (pQRSd) from the RVMS was narrow. METHODS AND RESULTS: In 42 patients, ECG pacing at the basal anterior wall (BA), mid-anterior wall (MA), apex (AP), and mid septum (MS) was recorded. The pacing sites were validated by using right ventriculography and computed tomography. We estimated the ECG parameters and compared them among the four pacing sites. The combination of simple four paced-ECG parameters could reliably confirm the pacing at the RVMS. The area under the receiver-operating characteristics curve for the number of positive findings among the following: (a) positive QRS in lead aVL, (b) QRS notching in lead I, (c) precordial leads transition at less than V5, and (d) presence of isoelectric QRS in the inferior leads was 0.95 (95% confidence interval, 0.91-0.98) and the number of positive findings (≥3) had a sensitivity of 83.3% and a specificity of 93.7% for discriminating MS from the other sites. The pQRSd with three or more positive findings was significantly narrower than that with less than three positive findings (≥3: 137.4 ± 9.2 ms, <3: 151.8 ± 13.1 ms, P ≤ .05). CONCLUSION: The combination of ECG parameters can help identify right ventricular mid-septal pacing. The use of these parameters may enable the implantation of the pacing lead in the RVMS accurately and obtain a narrower QRS duration.

Efficacy of the current of injury in envisaging the dislodgement of leads implanted in the right atrial septum or the right ventricular septum.

BACKGROUND: The implantation of leads in the right atrial septum (RAS) or the right ventricular septum (RVS) is technically challenging, and dislodgement occurs occasionally. This study aims to determine a predictor for the dislodgement of leads implanted in the RAS or RVS. METHODS: This retrospective cohort study enrolled 137 consecutive patients who underwent the cardiac implantable electronic devices implantation, using active fixation leads in the RAS and RVS. We compared the pacing threshold, R- or P-wave amplitude, slew rate, and presence of the current of injury (COI) between dislodged and nondislodged leads. RESULTS: We performed lead fixation for 74 and 125 times in the RAS and RVS, respectively. Atrial lead dislodgement occurred five times (6.8%) intraoperatively and five times (6.8%) postoperatively, whereas ventricular lead dislodgement occurred eight times (6.4%) intraoperatively and three times (2.4%) postoperatively. Although there were no lead parameters that showed a significant difference common to RAS lead and RVS lead, the presence of the COI was significantly different between nondislodged and dislodged leads in both the RAS and RVS (atrial leads: 57.8% vs 0%, P < 0.001; ventricular leads: 67.5% vs 9.1%, P < 0.001). The positive predictive value of COI presence for predicting no lead dislodgement was 100% and 98.7% in the RAS and RVS, respectively. CONCLUSION: Lead dislodgement is more likely when the COI is absent; documentation of COI should be pursued during lead implantation in challenging sites as the RAS and RVS.

The usefulness of right ventriculography to aid anchoring a pacing lead to the right ventricular septum.

Aims: Although right ventricular septal pacing is thought to be more effective in minimizing pacing-induced left ventricular dysfunction, the accurate way to anchor the lead to the right ventricular septum (RVS) has not been established. Our aim was to clarify the usefulness of right ventriculography (RVG) to aid accurate anchoring of the lead to the RVS. Methods and results: Eighty-four patients who underwent pacemaker implantation were enrolled. We anchored the lead to the RVS by using an RVG image obtained at a 30° right anterior oblique view as a reference. We confirmed the actual lead position by performing computed tomography after the procedure and examined the characteristics of the paced QRS complex. Of the 81 patients, except 3 patients whose leads were anchored to the apex due to high pacing thresholds in the RVS, the leads were successfully anchored to the RVS in the 79 (98%) patients, and the number of leads placed in the high-, mid-, and low-RVS was 3 (4%), 58 (73%), and 18 (23%), respectively. The paced QRS duration in these 79 patients was 140 ± 13 ms. The paced QRS duration from mid-RVS was considerably narrower than that from high- or low-RVS (137 ± 12 ms vs. 146 ± 12 ms; P = 0.012). Conclusion: Right ventriculography was very useful in aiding accurate anchoring of the lead to the RVS. Further, pacing from mid-RVS may be more effective in minimizing the QRS duration than pacing from other RVS sites.

Prevalence and Prognostic Significance of Functional Mitral and Tricuspid Regurgitation Despite Preserved Left Ventricular Ejection Fraction in Atrial Fibrillation Patients.

BACKGROUND: We investigated the prevalence and prognostic significance of functional mitral regurgitation (MR) and tricuspid regurgitation (TR) in patients with atrial fibrillation (AF) and preserved left ventricular ejection fraction (LVEF).Methods and Results:We retrospectively studied the cases of 11,021 consecutive patients who had undergone transthoracic echocardiography. AF appeared in 1,194 patients, and we selected 298 with AF and LVEF ≥50% but without other underlying heart diseases. Moderate or greater (significant) degree of functional MR and of TR was seen in 24 (8.1%) and in 44 (15%) patients, respectively (P=0.0045). In contrast, significant MR and TR were more frequently seen in patients with AF duration >10 years (28% vs. 25%, respectively). During the follow-up period of 24±17 months, 35 patients (12%) met the composite endpoint defined as cardiac death, admission due to heart failure, or mitral and/or tricuspid valve surgery. On Cox proportional hazard ratio analysis, both MR and TR grading predicted the endpoint, independently of other echocardiographic parameters. On Kaplan-Meyer analysis, presence of both significant functional MR and TR was associated with poor prognosis, with an event-free rate of only 21% at the mean follow-up period of 24 months. CONCLUSIONS: Significant functional MR and TR are seen in a substantial proportion of patients with longstanding AF, despite preserved LVEF. This MR/TR combination predicts poor outcome for AF patients, who may have to be treated more intensively.

The Accuracy of a Large V Wave in the Pulmonary Capillary Wedge Pressure Waveform for Diagnosing Current Mitral Regurgitation.

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.

Rationale and Design of the Multicenter Trial on Japan Working Group on the Effects of Angiotensin Receptor Blockers Selection (Azilsartan vs. Candesartan) on Diastolic Function in the Patients Suffering from Heart Failure with Preserved Ejection Fraction: J-TASTE Trial.

BACKGROUND: Previous studies suggest that the pathophysiology of heart failure with preserved ejection fraction (HFpEF) is characterized not only by high ventricular stiffness, but also by vascular stiffness. Azilsartan has higher vascular affinity compared with other angiotensin II receptor blockers (ARBs), which were proven to have no beneficial effects on clinical outcomes in patients with HFpEF in earlier clinical trials. We aimed to test the hypothesis that azilsartan may improve left ventricular diastolic function in HFpEF patients with hypertension in this trial. METHODS: The Effects of Angiotensin Receptor Blockers on Diastolic Function in Patients Suffering from Heart Failure with Preserved Ejection Fraction: J-TASTE trial is a multicenter, randomized, open-labeled, and assessor(s)-blinded, active controlled using candesartan, parallel-group clinical trial, to compare changes in left ventricular (LV) diastolic dysfunction between HFpEF patients with hypertension who have received candesartan or azilsartan for 48 weeks. The primary endpoint is the change in early diastolic wave height/early diastolic mitral annulus velocity (E/e') assessed by echocardiography from the baseline to the end of the study (48 weeks). A total of 190 patients will be recruited into the study. CONCLUSIONS: The design of the J-TASTE trial will provide data on whether differences between the effects of the two tested drugs on LV diastolic function exist in HFpEF patients with hypertension and will improve understanding of the pathophysiological role of vascular stiffness on diastolic function.