Clinical efficacy of tolvaptan in acute decompensated heart failure patients with severe aortic stenosis and atrial fibrillation: a sub-analysis from the LOHAS registry.

BACKGROUND: Severe aortic valve stenosis (AS) and atrial fibrillation (AF) are risk factors of hemodynamic instability in heart failure (HF) management due to low cardiac output, respectively. Therefore, the treatment of HF due to severe AS complicated with AF is anticipated to be difficult. Tolvaptan, a vasopressin V2 receptor inhibitor, is effective in controlling acute decompensated heart failure (ADHF) with hemodynamic stability. However, its clinical efficacy against ADHF caused by AS with AF remains to be determined. METHODS: Clinical information (from September 2014 to December 2017) of 59 patients diagnosed with ADHF due to severe AS (20 patients with AF; 39 patients with sinus rhythm [SR]) was obtained from the LOHAS registry. The registry collected data from seven hospitals and assessed the short-term effects of tolvaptan in patients hospitalized for ADHF with severe AS. We attempted to identify clinical differences from baseline up to 4 days, comparing patients with AF (AF group) versus those with SR (SR group). RESULTS: There were no significant differences between the groups in age (83.7 ± 4.5 vs. 85.8 ± 6.9 years, respectively; p = 0.11) and aortic valve area (0.60 [0.46-0.73] vs. 0.56 [0.37-0.70] cm2, respectively; p = 0.50). However, left atrial volume was larger (104 [85-126] vs. 87 [64-103] mL, respectively; p < 0.01), whereas stroke volume was lower (51.6 ± 14.8 vs. 59.0 ± 18.7 mL, respectively; p = 0.08) in the AF group versus the SR group. Body weight decreased daily from baseline up to day 4 in both groups (from 55.4 to 53.2 kg [p < 0.01] and from 53.5 to 51.0 kg [p < 0.01], respectively) without change in heart rate. Notably, the systolic blood pressure decreased slightly in the AF group after 2 days of treatment with tolvaptan. CONCLUSIONS: Short-term treatment with tolvaptan improved HF in patients hospitalized for severe AS, regardless of the presence of AF or SR. After achieving sufficient diuresis, a slight decrease in blood pressure was observed in the AF group, suggesting an appropriate timeframe for safe and effective use of tolvaptan.

Effect of oral tolvaptan for 1 year in patients with functional mitral regurgitation.

The effect of the oral selective vasopressin V2-receptor antagonist tolvaptan for chronic phase therapy on patients with FMR remains unclear. We aimed to determine the efficacy of oral tolvaptan in patients with significant functional mitral regurgitation (FMR) to reduce the mortality and rehospitalization due to worsening heart failure (HF). We enrolled 219 patients (mean age 76 ± 9 years, 59.4% men) who were admitted at our hospital due to congestive HF during different two 1-year periods. The patients were divided into 2 groups: those who had significant FMR (MR ≥ grade 2 [n = 76]) and those who did not (MR < grade 2 [n = 143]) at discharge. The patients were further divided into a study group that received tolvaptan during follow-up and a control group that did not receive tolvaptan. We used an inverse probability of treatment weighting method with the primary end point defined as overall all-cause mortality and rehospitalization due to worsening HF within 1 year. Of the 76 patients with significant FMR at discharge, 2 of 20 (10%) who were administered tolvaptan died and 8 (40%) were readmitted to a hospital. Of the 56 patients who did not receive tolvaptan, 2 (3.5%) died and 18 (27.5%) required rehospitalization. After multiple adjustments, there were no significant differences for overall survival and rehospitalization between the groups (log-rank p = 0.700 and 0.510, respectively). Our results suggest that oral tolvaptan administration in addition to conventional diuretics had less impact on outcomes in patients with significant FMR.

Medical student medium-term skill retention following cardiac point-of-care ultrasound training based on the American Society of Echocardiography curriculum framework.

BACKGROUND: No studies have demonstrated medium- or long-term skill retention of cardiac point-of-care ultrasound (POCUS) curriculum for medical student. Based on the American Society of Echocardiography (ASE) curriculum framework, we developed a blended-learning cardiac POCUS curriculum with competency evaluation. The objective of this study was to investigate the curriculum impact on image acquisition skill retention 8 weeks after initial training. METHODS: This study was a prospective, pre-post education intervention study for first- and second-year medical students, with blinded outcome assessment. The curriculum included a pre-training ASE online module and healthy volunteer hands-on training to obtain 5 views: parasternal long-axis (PLAX), parasternal short-axis (PSAX), apical 4-chamber (A4C), subcostal 4-chamber (S4C), and subcostal inferior vena cava (SIVC) views. Students took 5-view image acquisition skill tests at pre-, immediate post-, and 8-week post-training, using a healthy volunteer. Three blinded assessors rated the image quality using a validated 10-point maximum scoring system. Students used a hand-held ultrasound probe (Butterfly iQ). RESULTS: Fifty-four students completed hands-on training, and pre- and immediate post-training skill tests. Twenty-seven students completed 8-week post-training skill tests. Skill test score improvement between pre- and 8-week post-training was 2.11 points (95% CI, 1.22-3.00; effect size, 1.13). CONCLUSION: The cardiac POCUS curriculum demonstrated medium-term skill retention. The curriculum was sufficient for S4C and SIVC skill retention, but inadequate for PLAX, PSAX, and A4C. Therefore, instructional design modifications or re-training for PLAX, PSAX, and A4C are needed to make the curriculum more effective for clinically relevant skill retention.

Short-term dual anti-platelet therapy decreases long-term cardiovascular mortality after transcatheter aortic valve replacement.

No data are available on extended dual anti-platelet therapy (DAPT) duration which may influence long-term prognosis (later than 1 year) after transcatheter aortic valve replacement (TAVR). Therefore, this study is aimed to evaluate whether discontinuing DAPT within 1 year had an impact on adverse events after TAVR. Using data from the OCEAN-TAVI registry, we assessed 1008 patients who survived the first year after TAVR with DAPT since discharge. Patients were divided into 'DAPT group' (n = 462), comprising patients who took DAPT at both discharge and 1 year, and 'stop-DAPT group' (n = 546), comprising patients who took DAPT at discharge and single anti-platelet therapy (SAPT) at 1 year. We compared the incidence of cardiovascular (CV) death, major and minor bleeding, and ischemic stroke later than 1 year after TAVR between the two groups. A total of 28 CV deaths were observed later than 1 year after TAVR. The stop-DAPT group had a significantly lower incidence of CV death than the DAPT group (1.8% vs. 4.9%, log-rank P = 0.029). Stop DAPT was associated with lower CV death later than 1 year of TAVR in Cox regression analysis (adjusted hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.20-0.99), and in analysis with inverse probability of treatment weighting method using propensity score (adjusted HR, 0.45; 95% CI, 0.20-0.98). Our study demonstrated that switching from DAPT to SAPT within 1 year of TAVR was significantly associated with a lower CV death later than 1 year after TAVR.

Comparison of long-term mortality in patients who underwent transcatheter aortic valve replacement with or without anti-atherosclerotic therapy.

Atherosclerosis is a risk factor for both aortic stenosis (AS) and coronary artery disease. This study aimed to investigate whether anti-atherosclerotic therapy (AT), defined as the simultaneous use of antiplatelet agents, statins, and renin aldosterone system inhibitors, had long-term clinical benefits for patients who underwent transcatheter aortic valve replacement (TAVR). Between October 2013 and May 2017, 2518 patients (31% men; median age, 85 years) who underwent TAVR in 14 Japanese centers were divided into two groups: patients who were prescribed anti-atherosclerotic therapy (AT, n = 567) and patients who were not (no AT, n = 1951). The median follow-up period for this cohort was 693 days (interquartile range, 389-870 days). Compared to no AT group, AT group was associated with significantly lower 2-year all-cause mortality (11.7% vs. 16.5%; log-rank p = 0.002) and 2-year cardiovascular mortality rates (3.5% vs. 6.0%; log-rank p = 0.017). In a propensity-matched cohort (n = 495 each; median follow-up, 710 days [IQR, 394 - 896 days]), patients in AT group had a lower prevalence of 2-year cardiovascular mortality (3.8% vs. 6.2%, log-rank p = 0.024) than that in the no AT group. In the multivariate stepwise regression analysis, AT was a significant predictor of cardiovascular mortality (hazard ratio 0.45; 95% confidence interval 0.25-0.80; p = 0.007). AT may improve survival in post-TAVR patients. Future studies are necessary to identify an optimal treatment regimen to improve long-term outcomes after TAVR.

Prevalence and Predictors of Atherosclerotic Peripheral Arterial Obstructive Disease in Severe Heart Valve Diseases.

Despite witnessing an upsurge in heart valve diseases (HVDs), the correlation between HVDs and atherosclerotic peripheral arterial obstructive disease (PAOD) remains unclear. This study aims to investigate the prevalence and predictors of PAOD in HVDs.In this study, a total of 245 consecutive patients were examined: 153 with severe aortic valve stenosis (AS), 66 with severe primary mitral valve regurgitation (MR), and 26 with severe pure native aortic valve regurgitation (AR). All patients underwent ultrasound scan of the carotid artery to ascertain the presence of internal carotid artery stenosis (ICAS). ICAS was defined as a peak systolic velocity ≥ 125 cm/second and/or ≥ 50% reduction in diameter. In addition, we measured the ankle-brachial index in each leg using a volume plethysmograph. A result of ≤ 0.9 was considered lower extremity artery disease (LEAD).The presence of ICAS was statistically more frequent in patients with severe AS than in patients with severe MR and AR (11.1% versus 1.5% versus 3.8%; P = 0.038). LEAD was present in patients with severe AS (17.6%) and MR (10.6%) but not in patients with severe AR (P = 0.037). The multivariate analysis revealed that the presence of severe AS (OR, 5.6 [1.3-24.9]; P = 0.023) was an independent predictor for ICAS, while history of coronary artery disease (OR, 4.8 [2.2-10.5]; P < 0.001) was an independent predictor for LEAD.The prevalence of PAOD varies depending on each valvular disease. Individual screening should be considered on the basis of atherosclerotic risk factors, especially for patients with severe AS.

Clinical safety and efficacy of tolvaptan for acute phase therapy in patients with low-flow and normal-flow severe aortic stenosis.

Conventional diuretic therapy for low-flow (LF) severe aortic stenosis (SAS) often has an inadequate effect or causes hemodynamic instability. Tolvaptan is used for acute heart failure in addition to conventional diuretics, and it does not cause intravascular dehydration. This study aimed to retrospectively investigate the safety and efficacy of tolvaptan in the acute phase in 56 consecutive patients with SAS and compared LF-SAS with normal-flow (NF) SAS. The primary endpoints were adverse clinical events (death, worsening heart failure, worsening renal failure, fatal arrhythmia, cardiogenic or hypovolemic shock, and use of inotropic agents) and the volume of urine within 48 h of tolvaptan administration. Among 56 patients, 16 had LF-SAS (29%), and 40 had NF-SAS (71%). Severe adverse clinical events were not observed 48 h after tolvaptan administration. In both groups, the urine volume significantly increased after tolvaptan administration in comparison to 24 h before tolvaptan administration (both, p < 0.01). There were no changes in the urine volume during the initial 24 and 48 h. In the LF-SAS group, tolvaptan resulted in a significant decrease in fluid balance during the initial 24 and 48 h compared to 24 h before tolvaptan administration (p < 0.05). Adding tolvaptan to conventional treatment is safe and effective without renal dysfunction and hypotension in patients with SAS, including those with LF.

Association between valvuloarterial impedance after transcatheter aortic valve implantation and 2-year mortality in elderly patients with severe symptomatic aortic stenosis: the OCEAN-TAVI registry.

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.

The MAGGIC risk score predicts mortality in patients undergoing transcatheter aortic valve replacement: sub-analysis of the OCEAN-TAVI registry.

This study is aimed to evaluate the performance of MAGGIC risk score for predicting mortality by external validation using multicenter transcatheter aortic valve replacement (TAVR) registry. We assessed 1383 patients who underwent TAVR from October 2013 to April 2016. Patients were divided into 2 groups according to the median of MAGGIC score and we compared the incidence of all-cause death between high and low MAGGIC score. To assess whether the MAGGIC risk score add prognostic value on STS risk score, we also compared the incidence of all-cause death between the 2 groups according to low, intermediate, and high STS score. The median of MAGGIC score was 29 (interquartile range: 13-46). Within 2 years, 147 cases of all-cause death were observed. The high MAGGIC (30-46) risk score was significantly associated with an increased risk of all-cause death as compared to low MAGGIC (11-29) risk score and this relationship was also observed in patients with high STS risk score. However, this relationship was not observed in patients with low and intermediate STS score. Multivariate analysis showed that the MAGGIC risk score was an independent predictor of all-cause death (hazard ratio, 1.07; 95% confidence interval, 1.03-1.11). Our results demonstrated that the MAGGIC score predicts all-cause death in TAVR population and provides better risk stratification, particularly in patients with high STS risk.

Comparison of midterm outcomes of transcatheter aortic valve implantation in patients with and without previous coronary artery bypass grafting.

The midterm safety and feasibility of transcatheter aortic valve implantation (TAVI) for patients with a history of coronary artery bypass graft (CABG) and high operative risk are unclear. This study compared the midterm outcomes of patients undergoing TAVI with or without previous CABG surgery. Between October 2013 and July 2016, 1,613 patients underwent TAVI according to the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI registry (previous CABG: n = 120; no previous CABG: n = 1493). The propensity score comprised the variables of the Society of Thoracic Surgeons Score, previous myocardial infarction, peripheral artery disease, chronic kidney disease > stage 2 (estimated glomerular filtration rate < 60 mL/min/1.73 m2), and the TAVI approach method. After propensity matching, 118 patients were classified into the CABG and non-CABG groups. Kaplan-Meier analysis revealed that the incidence of overall cardiovascular death in the CABG group was significantly higher than in the non-CABG group (log-rank; p = 0.004). Overall mortality due to heart failure was higher in the CABG than in the non-CABG group (8.5 vs. 1.7%, p = 0.038). The present study demonstrated that patients with a history of CABG who underwent TAVI had a higher frequency of cardiovascular death, mainly due to heart failure. Heart failure detection and rigorous heart failure management are required after TAVI.

Incidence, Predictors, and Midterm Clinical Outcomes of Myocardial Injury After Transcatheter Aortic-Valve Implantation.

Our aim was to assess the clinical effects of myocardial injury after transcatheter aortic-valve implantation (TAVI). Between October 2013 and July 2016, 157 patients underwent TAVI with Sapien XT, Sapien 3, or CoreValve prostheses at our institute. Of these, 130 patients for whom the transapical approach was not used were included in this study. Myocardial injury was defined as a peak troponin I level of ≥1.5 ng/mL within 48 hours after TAVI. We evaluated the predictors of myocardial injury and compared the clinical outcomes of 82 patients classified as the myocardial injury group and 44 patients classified as the non-myocardial injury group. The patients were aged 85 ± 6 years. Myocardial injury occurred in 82 patients (65.1%). Age (per 1 increase) (odds ratio [OR]: 1.11, 95% confidence interval [CI]: 1.01-1.22, P = 0.041), female sex (OR: 3.88, 95% CI: 1.23-12.22, P = 0.021), valve type (Sapien XT; OR: 4.22, 95% CI: 1.15-15.47, P = 0.03, Core valve; OR: 18.12, 95% CI: 2.86-114.59, P = 0.002), balloon aortic valvuloplasty as a bridge therapy (OR: 0.10, 95% CI: 0.02-0.42, P = 0.002), and left ventricular end-diastolic volume (LVEDV) (per 1 increase) (OR: 0.97, 95% CI: 0.95-0.99, P = 0.003) were associated with myocardial injury in a multivariate model. The myocardial injury group did not have a higher rate of midterm (365-day) mortality (log-rank test P = 0.57) than the non-myocardial injury group on Kaplan-Meier analysis. Myocardial injury after TAVI was not associated with midterm mortality.

Transient Ischemic Dilatation during Stress Echocardiography: An Additional Marker of Significant Myocardial Ischemia.

AIM: Left ventricular (LV) transient ischemic dilatation (TID) is not clear how it relates to inducible myocardial ischemia during stress echocardiography (SE). METHODS AND RESULTS: Eighty-eight SEs were examined from the site certification phase of the ISCHEMIA Trial. LV end-diastolic volume (EDV) and end-systolic volume (ESV) were measured at rest and peak stages and the percent change calculated. Moderate or greater ischemia was defined as ≥3 segments with stress-induced severe hypokinesis or akinesis. Optimum cut points in stress-induced percent EDV and ESV change that identified moderate or greater myocardial ischemia were analyzed. Analysis from percentage distribution identified a > 13% LV volume increase in EDV or a > 9% LV volume increase in ESV as the optimum cutoff points for moderate or greater ischemia. Using these definitions for TID, there were 27 (31%) with TIDESV and 12 (14%) with TIDEDV . By logistic regression analysis and receiver operating characteristic curves, the percent change in ESV had a stronger association with moderate or greater myocardial ischemia than that of EDV change. Compared to those without TIDESV , cases with TIDESV had larger extent of inducible wall-motion abnormalities, lower peak stress LVEF, and higher likelihood of moderate or grater ischemia. For moderate or greater myocardial ischemia detection, TIDESV had a sensitivity of 46%, specificity of 83%, positive predictive value of 70%, and negative predictive value of 64%. CONCLUSION: Transient ischemic dilatation by SE is a marker of extensive myocardial ischemia and can be used as an additional marker of higher risk.

The value of core lab stress echocardiography interpretations: observations from the ISCHEMIA Trial.

BACKGROUND: Stress echocardiography (SE) is dependent on subjective interpretations. As a prelude to the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) Trial, potential sites were required to submit two SE, one with moderate or severe left ventricular (LV) myocardial ischemia and one with mild ischemia. We evaluated the concordance of site and core lab interpretations. METHODS: Eighty-one SE were submitted from 41 international sites. Ischemia was classified by the number of new or worsening segmental LV wall motion abnormalities (WMA): none, mild (1 or 2) or moderate or severe (3 or more) by the sites and the core lab. RESULTS: Core lab classified 6 SE as no ischemia, 35 mild and 40 moderate or greater. There was agreement between the site and core in 66 of 81 total cases (81%, weighted kappa coefficient [K] =0.635). Agreement was similar for SE type - 24 of 30 exercise (80%, K = 0.571) vs. 41 of 49 pharmacologic (84%, K = 0.685). The agreement between poor or fair image quality (27 of 36 cases, 75%, K = 0.492) was not as good as for the good or excellent image quality cases (39 of 45 cases, 87%, K = 0.755). Differences in concordance were noted for degree of ischemia with the majority of discordant interpretations (87%) occurring in patients with no or mild LV myocardial ischemia. CONCLUSIONS: While site SE interpretations are largely concordant with core lab interpretations, this appears dependent on image quality and the extent of WMA. Thus core lab interpretations remain important in clinical trials where consistency of interpretation across a range of cases is critical. TRIAL REGISTRATION: ClinicalTrials.gov NCT01471522.

MitraClip: a review of its current status and future perspectives.

Mitral regurgitation (MR), among the most common valvular heart diseases, is closely associated with heart failure and worse clinical outcomes. Surgical repair or replacement as an intervention for MR is deemed too high risk in patients who are elderly or have multiple comorbidities; thus, nearly half of all patients with severe symptomatic MR are not referred for surgical therapy. MitraClip, a transcatheter mitral valve repair system for MR that mimics the Alfieri surgical edge-to-edge technique for mitral valve repair, was developed in the late 1990s. After clinical trials demonstrated its safety and efficacy, it received approval for clinical use, particularly for aging and inoperable or high-risk patients for heart surgery in Europe, the US, and Japan. Since the start of its clinical use, randomized clinical trials (RCTs) have optimized patient selection, and the latest generation MitraClip can increase procedural success, even in patients with challenging mitral valve anatomy. Therefore, here, we review evidence from clinical trials and RCTs and discuss optical patient selection and future perspectives for the MitraClip.

Increasing Venous Return Blood Flow to the Right Atrium Using the Party Balloon Inflation Maneuver.

The party balloon inflation maneuver increases intrathoracic pressure, decreases venous return, and after release enhances venous return to the right atrium more effectively than does the conventional Valsalva maneuver. Therefore, it shows potential for more effective detection of right-to-left shunts in patients with a patent foramen ovale. (Level of Difficulty: Intermediate.).

New perforated radiation shield for anesthesiologists: Monte Carlo simulation of effects.

Catheterization for structural heart disease (SHD) requires fluoroscopic guidance, which exposes health care professionals to radiation exposure risk. Nevertheless, existing freestanding radiation shields for anesthesiologists are typically simple, uncomfortable rectangles. Therefore, we devised a new perforated radiation shield that allows anesthesiologists and echocardiographers to access a patient through its apertures during SHD catheterization. No report of the relevant literature has described the degree to which the anesthesiologist's radiation dose can be reduced by installing radiation shields. For estimating whole-body doses to anesthesiologists and air dose distributions in the operating room, we used a Monte Carlo system for a rapid dose-estimation system used with interventional radiology. The simulations were performed under four conditions: no radiation shield, large apertures, small apertures and without apertures. With small apertures, the doses to the lens, waist and neck surfaces were found to be comparable to those of a protective plate without an aperture, indicating that our new radiation shield copes with radiation protection and work efficiency. To simulate the air-absorbed dose distribution, results indicated that a fan-shaped area of the dose rate decrease was generated in the area behind the shield, as seen from the tube sphere. For the aperture, radiation was found to wrap around the backside of the shield, even at a height that did not match the aperture height. The data presented herein are expected to be of interest to all anesthesiologists who might be involved in SHD catheterization. The data are also expected to enhance their understanding of radiation exposure protection.

Predictors of bioprosthetic valve dysfunction after transcatheter aortic valve implantation.

Background: Recently, the Valve Academic Research Consortium (VARC)-3 criteria redefined bioprosthetic valve dysfunction (BVD) after transcatheter aortic valve implantation (TAVI). However, the rate of BVD is scarcely reported in current practice. Aims: We aimed to evaluate the rate and predictors of BVD after TAVI based on the VARC-3 criteria. Methods: We retrospectively analysed patients who had undergone TAVI using single-centre data. BVD was reported as exposure-adjusted event rates with a patient-year unit (per 100 patient-years). Predictors of BVD after TAVI were analysed using Fine-Gray competing risk regression to account for the competing risk of death. Results: Among 514 patients, the rate of BVD was 7.5 events per 100 patient-years (n=74) at a median follow-up of 1.9 years. The main cause of BVD was moderate or severe prosthesis-patient mismatch (PPM; n=59). The Fine-Gray model demonstrated that predilatation was associated with a lower rate of BVD, mainly moderate or severe PPM (adjusted subdistribution hazard ratio [sub-HR] 0.42, 95% confidence interval [CI]: 0.21-0.88). In a subgroup analysis, the patients with a small aortic annulus (area <400 mm2 or perimeter <72 mm) tended to benefit from predilatation (p for interaction=0.03). The same regression model also demonstrated that a small balloon-expandable valve (BEV; ≤23 mm) was associated with a higher rate of BVD (adjusted sub-HR 2.46, 95% CI: 1.38-4.38). Conclusions: Our study suggested that the rate of BVD in patients undergoing TAVI is relatively low at midterm follow-up. Predilatation, particularly in small annuli and small BEV might have an impact on BVD, mainly caused by moderate or severe PPM, after TAVI.

Appropriate Use Criteria for the Management of Aortic Stenosis: Insight From the Japanese Expert Panel.

Background: The indication for transcatheter aortic valve replacement (TAVR) for aortic stenosis (AS) significantly varies among physicians and institutions. Objectives: This study aims to develop a set of appropriate use criteria for AS management to assist physicians in decision-making. Methods: The RAND-modified Delphi panel method was used. A total of >250 common clinical scenarios were identified in terms of whether to perform the intervention for AS and the mode of intervention (surgical aortic valve replacement vs TAVR). Eleven nationally representative expert panelists independently rated the clinical scenario appropriateness on a scale of 1-9, as "appropriate" (7-9), "may be appropriate" (4-6), or "rarely appropriate" (1-3); the median score of the 11 experts was then assigned to an appropriate-use category. Results: The panel identified 3 factors that were associated with a rarely appropriate rating in terms of performing the intervention: 1) limited life expectancy; 2) frailty; and 3) pseudo-severe AS on dobutamine stress echocardiography. Clinical scenarios that were deemed rarely appropriate for TAVR were also identified: 1) patients with low surgical risk and high TAVR procedural risk; 2) patients with coexistent severe primary mitral regurgitation or rheumatic mitral stenosis; and 3) bicuspid aortic valve that was not suitable for TAVR. Importantly, any TAVRs for patients who were older than 75 years of age were not rated as rarely appropriate. Conclusions: These appropriate use criteria provide a practical guide for physicians regarding clinical situations commonly encountered in daily practice and elucidates scenarios deemed rarely appropriate that are clinical challenges for TAVR.

Body Surface Radiation Exposure in Interventional Echocardiographers During Structural Heart Disease Procedures.

Background: The distribution of radiation exposure on the body surface of interventional echocardiographers during structural heart disease (SHD) procedures is unclear. Objectives: This study estimated and visualized radiation exposure on the body surface of interventional echocardiographers performing transesophageal echocardiography by computer simulations and real-life measurements of radiation exposure during SHD procedures. Methods: A Monte Carlo simulation was performed to clarify the absorbed dose distribution of radiation on the body surface of interventional echocardiographers. The real-life radiation exposure was measured during 79 consecutive procedures (44 transcatheter edge-to-edge repairs of the mitral valve and 35 transcatheter aortic valve replacements [TAVRs]). Results: The simulation demonstrated high-dose exposure areas (>20 µGy/h) in the right half of the body, especially the waist and lower body, in all fluoroscopic directions caused by scattered radiation from the bottom edge of the patient bed. High-dose exposure occurred when obtaining posterior-anterior and cusp-overlap views. The real-life exposure measurements were consistent with the simulation estimates: interventional echocardiographers were more exposed to radiation at their waist in transcatheter edge-to-edge repair than in TAVR procedures (median 0.334 µSv/mGy vs 0.053 µSv/mGy; P < 0.001) and in TAVR with self-expanding valves than in those with balloon-expandable valves (median 0.067 µSv/mGy vs 0.039 µSv/mGy; P < 0.01) when the posterior-anterior or the right anterior oblique angle fluoroscopic directions were used. Conclusions: During SHD procedures, the right waist and lower body of interventional echocardiographers were exposed to high radiation doses. Exposure dose varied between different C-arm projections. Interventional echocardiographers, especially young women, should be educated regarding radiation exposure during these procedures. (The development of radiation protection shield for catheter-based treatment of structural heart disease [for echocardiologists and anesthesiologists]; UMIN000046478).