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

BackgroundThere are currently few reports on pre-existing left bundle branch block (LBBB) in patients undergoing transcatheter aortic valve replacement (TAVR). Nor are there any studies comparing patients with new onset LBBB to those with pre-existing LBBB. This study aimed to investigate the association with pre-existing or new-onset LBBB and clinical outcomes after TAVR.MethodsUsing data from the Japanese multicenter registry, 5996 patients who underwent TAVR between October 2013 and December 2019 were included. Patients were classified into 3 groups: no LBBB, pre-existing LBBB and new onset LBBB. The 2-year clinical outcomes were compared between 3 groups using Cox proportinal hazard models and propensity score analysis to adjust the differences in baseline characteristics.ResultsOf 5996 patients who underwent TAVR, 280 patients (4.6%) had pre-existing LBBB and new onset LBBB occurred in 1658 patients (27.6%). Compared with no LBBB group, multivariable Cox regression analysis showed that pre-existing LBBB was associated with a higher 2-year all-cause (adjusted hazard ratio [aHR]: 1.39; 95% confidence interval [CI]: 1.06-1.82; p =0.015) and cardiovascular mortality (aHR: 1.62; 95% CI: 1.05-2.54; p =0.027), but also with higher all-cause (aHR:1.43, 95% CI:1.07-1.91; p =0.016) and cardiovascular mortality (aHR: 1.84, 95% CI: 1.14-2.98; p =0.012) than new onset LBBB group. Heart failure was the most common cause of cardiovascular death, with more heart failure deaths in the pre-existing LBBB group.ConclusionsPre-existing LBBB was independently associated with poor clinical outcomes reflecting increased risk of cardiovascular mortality after TAVR. Patients with pre-existing LBBB should be carefully monitored.What is Known?There are currently few reports on pre-existing left bundle branch block (LBBB) in patients undergoing transcatheter aortic valve replacement (TAVR). Nor are there any studies comparing patients with new onset LBBB to those with pre-existing LBBB.What the Study Add?Patients with pre-existing LBBB not only had a higher mortality than those without LBBB, but also had a worse prognosis than those with new onset LBBB.This was because patients with pre-existing LBBB had more heart failure deaths.Patients with pre-existing LBBB should be carefully monitored after TAVR. Further investigation will be required to corroborate our findings.

BackgroundRecent studies suggested short-term mortality after transcatheter edge-to-edge repair (TEER) was comparable between male and female. However, the sex-specific prognostic difference in long-term follow-up after TEER is still unknown. To evaluate the impact of sex on long-term mortality after TEER for functional mitral regurgitation (FMR) using multicenter registry data.MethodsWe retrospectively analyzed 1220 patients (male 60.3%) who underwent TEER for FMR at 24 centers. Impact of sex on all-cause death and hospitalization for heart failure (HF) after TEER was evaluated using multivariate regression analysis and propensity score (PS) matching methods.ResultsDuring the two-year follow-up, 205 all-cause death and 259 hospitalizations for HF were observed after TEER for FMR. Male had a significantly lower incidence of all-cause death than female (18.7% vs. 14.0%, log-rank p < 0.01). After adjustment by multivariate Cox-regression and PS matching, male was significantly associated with a higher incidence of all-cause mortality after TEER than female (hazard ratio [HR] 2.24, 95% confidence interval [CI] 1.48 to 3.39 in multivariate Cox-regression; HR 2.04, 95% CI 1.17 to 3.57 in PS matching). The sex-specific prognostic difference was even more pronounced after 1-year of TEER. On contrary, there was no sex-related difference in hospitalization for HF after TEER.ConclusionsMale had a higher incidence of two-year all-cause death during after TEER for FMR than female, while this was not observed in hospitalization for HF. This result might indicate that female with FMR is more likely to benefit from TEER for better prognosis.What is known?There were conflicting results in sex-related prognostic difference after TEER for FMR.What the study addsDuring two-year follow-up period, male had higher increased risk of mortality after TEER than female in multivariate regression and propensity score matched analysis, while there was no sex-related difference in hospitalization for HF after TEER. Female with FMR might be likely to derived benefit from TEER concomitant with GDMT as compared to male.

We herein report a case of acute myocarditis possibly related to the second dose of an mRNA-coronavirus disease 2019 vaccine in a 45-year-old woman with no remarkable medical history. She had a fever for one week following the second dose of the mRNA-1273 severe acute respiratory syndrome coronavirus 2 vaccine. One week later, she presented with chest pain and electrocardiogram changes. Her serum troponin levels were elevated upon admission. Echocardiography showed segmental wall motion abnormalities of the apex, apical portion of the anterior and inferior walls. The findings of cardiac magnetic resonance imaging were consistent with acute myocarditis.

BACKGROUND Current guidelines favor transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement in patients with porcelain aorta (PAo). The clinical relevance of PAo in patients undergoing TAVI is however incompletely understood. The purpose of this study is to evaluate clinical outcome of patients with PAo undergoing TAVI. METHODS Consecutive patients undergoing TAVI were enrolled in a prospective single-center registry. Presence of PAo was evaluated by ECG-gated multi-slice computed tomography prior to the intervention. The primary endpoint was disabling stroke. RESULTS Among 2199 patients (mean age, 82.0������������6.3 years; 1135 females [51.6%]) undergoing TAVI between August 2007 and December 2019, 114 patients (5.2%) met VARC-2 criteria for PAo. Compared to individuals without PAo, patients with PAo were younger (79.4������������7.4 years vs. 82.1������������6.2 years; p�����

BackgroundNon-calcified aortic stenosis (AS) is rare and is associated with a high risk of transcatheter valve embolization and migration (TVEM) because aortic valve complex calcification is important for stable anchoring of the prosthesis. Therefore, transcatheter aortic valve implantation (TAVI) for non-calcified AS is not preferred. However, a universally accepted strategy for TAVI in such patients is not yet established.Case summaryA 69-year-old woman with symptomatic severe AS and a high surgical risk was admitted to our institution for TAVI. Pre-procedural computed tomography (CT) revealed a non-calcified bicuspid aortic valve. Implantation of a 23 mm self-expandable valve (SEV) was planned according to the manufacturer’s recommended optimal size based on CT measurements. Intraoperatively, the 23 mm SEV did not snugly fit at the aortic apparatus level. Thus, we deployed a 26 mm SEV with stable anchoring because of the stronger radial force. She was discharged without any complication. Echocardiography at 3 months follow-up showed a well-functioning transcatheter heart valve (THV) without migration or paravalvular leakage.DiscussionIn our patient with non-calcified bicuspid AS, an SEV that was one size larger than the optimal as measured on CT was successfully implanted without THV embolization. An upsized SEV may be considered when performing TAVI in patients with severe non-calcified AS.

Achilles tendon xanthoma (ATX) is one of the typical features of familial hypercholesterolemia (FH). The morphological evaluation of ATX by X-ray radiography is widely recognized; however, the utility of other imaging modalities remains unclear. We herein report two cases of FH in which Doppler ultrasound imaging demonstrated a microvascular flow in ATX that only rarely could be observed in normal Achilles tendons. Neoangiogenesis accompanies chronic inflammation and it may play an important role in the deposition of cholesterol crystals leading to ATX. In addition to the morphological evaluation of ATX, the assessment of neoangiogenesis may therefore be essential for the evaluation of ATX.

Previous reports on cardiac intervention in cases with antithrombin deficiency are extremely limited. We report a case of acute coronary syndrome with antithrombin deficiency in a 62-year-old man with multiple histories of thrombosis. He had worsening chest pain, and laboratory data showed an elevated level of troponin T, suggesting acute myocardial infarction. Currently, there is no fixed anticoagulation strategy for coronary intervention in patients with antithrombin deficiency. In this case, we performed coronary intervention with heparin in addition to antithrombin concentrate. The intervention was successfully performed without thrombosis or bleeding complications. LEARNING OBJECTIVE: Antithrombin deficiency is a rare disorder and data about coronary intervention for cases with antithrombin deficiency are limited. We successfully performed intervention with our anticoagulant management and it would be beneficial for future reference.

Increased left ventricular (LV) afterload in patients with aortic stenosis consists of valvular and vascular loads; however, the effects of vascular load induced by arterial stiffness on clinical outcomes after transcatheter aortic valve replacement (TAVR) remain unclear. This study evaluated the prognostic value of brachial-ankle pulse wave velocity (baPWV) after TAVR.A retrospective study including 161 consecutive patients who underwent TAVR with a pre-procedural baPWV assessment was conducted. We investigated the association between baPWV and the 1-year composite outcome comprising all-cause death and rehospitalization related to heart failure. Echocardiographic measurements including the LV mass index (LVMi) and LV diastolic function at 1, 6, and 12 months after TAVR were assessed.Of the 161 patients, 31 patients experienced composite outcome within 1 year after TAVR. The receiver operating characteristic curve analysis revealed that the discriminating baPWV level to discern 1-year composite outcome was 1,639 cm/s, and all subjects were allocated to two groups based on the result. Baseline characteristics were comparable between the high baPWV (n = 72) and low baPWV groups (n = 89). The Kaplan-Meier curve revealed a significantly higher cumulative 1-year composite outcome in the high baPWV group than in the low baPWV group (31% vs. 10%; log-rank test, p0.001). High baPWV was an independent predictor of the 1-year composite outcome (adjusted hazard ratio, 3.42; 95% confidence interval, 1.62-7.85; p = 0.002). Furthermore, post-procedural echocardiography revealed that the high baPWV group had less LVMi regression and higher E/e' after TAVR compared to the low baPWV group. The delayed reversal in LVMi and diastolic function attributable to arterial stiffness might be linked to impaired clinical outcomes after TAVR.Higher baPWV could be associated with adverse clinical outcomes and delayed reverse LV remodeling after TAVR.

To assess the inter methodological agreement of membrane septum (MS) length measurement and additive value for risk stratification of new pacemaker implantation (PMI) over the established predictors after transcatheter aortic valve replacement (TAVR).Recent studies have suggested MS length and implantation depth (ID) as predictors for PMI after TAVR. However, the measurement of MS length is neither uniform nor validated in different cohort.We retrospectively analyzed patients who underwent TAVR at five centers. The MS length was measured by two previously proposed methods (coronal and annular view method). Predictive ability of risk factors, including MS length and ID, for new PMI within 30 days after TAVR were evaluated.Among 754 patients of study population, 31 patients (4.1%) required new PMI within 30 days of TAVR. There was a weak correlation (ρ = 0.47) and a poor agreement between the two methods. The ID and the difference between MS length and ID (ΔMSID), were independent predictors for new PMI, whereas MS length alone was not. Further, for predicting new PMI after TAVR, discrimination performance was not significantly improved when MS length was added to the model with ID alone (integrated discrimination improvement = 0, p= 0.99; continuous net-reclassification improvement = 0.10, p= 0.62).External validity and predictive accuracy of MS length for PMI after TAVR were not sufficient to provide better risk stratification over the established predictors in our cohort. Moreover, the ID and ΔMSID, but not MS length alone, are predictive of future PMI after TAVR.

Background Left ventricular hypertrophy (LVH) develops with both structural and electrical remodeling in response to elevated afterload due to aortic stenosis (AS). This study evaluated the prognostic value of electrocardiographic LVH (ECG LVH) after transcatheter aortic valve replacement (TAVR). Methods A retrospective study including 157 consecutive patients who underwent TAVR was conducted. ECG LVH was defined as Sokolow–Lyon voltage (S in V1 + R in V5/6) before TAVR was ≥3.5mV. We investigated the association between ECG LVH and the 1-year composite outcome comprising all-cause death and rehospitalization related to heart failure. ECG and echocardiographic measurements at 1, 6, and 12 months after TAVR were assessed. Results The baseline characteristics were comparable between the ECG LVH (n = 74) and non-ECG LVH groups (n = 83). The ECG LVH was associated with a significantly greater reduction of Sokolow–Lyon voltage and LV mass index than the non-ECG LVH after TAVR. The absence of ECG LVH was an independent predictor of the 1-year composite outcome [adjusted hazard ratio (HR), 2.27; 95% confidence interval (CI), 1.01 – 5.60; p = 0.04]. Furthermore, a reduction of Sokolow–Lyon voltage from baseline to 1-month follow-up, but not a reduction of LV mass index, was associated with a lower cumulative composite outcome from 1 month to 1 year (adjusted HR, 0.36; 95% CI, 0.15 – 0.86; p = 0.02). Conclusions ECG LVH was associated with a low incidence of adverse clinical outcomes and greater reverse LV remodeling after TAVR. Preprocedural and serial LVH assessment by ECG might be useful in AS patients undergoing TAVR.

BACKGROUND Abnormal invasive hemodynamics after transcatheter aortic valve replacement (TAVR) is associated with poor survival; however, the mechanism is unknown. HYPOTHESIS Diastolic dysfunction will modify the association between invasive hemodynamics postTAVR and mortality. METHODS Patients with echocardiographic assessment of diastolic function and postTAVR invasive hemodynamic assessment were eligible for the present analysis. Diastology was classified as normal or abnormal (Stages 1 to 3). The aorto-ventricular index (AVi) was calculated as the difference between the aortic diastolic and the left ventricular end-diastolic pressure divided by the heart rate. AVi was categorized as abnormal (AVi

BACKGROUND Increased left ventricular afterload resulting from severe aortic stenosis (AS) leads to progressive cardiac remodeling. Left atrial enlargement (LAE) is an early manifestation in a series of maladaptive changes and may affect clinical outcomes after valvular replacement therapy. The aim of this study is to determine the impact of LAE on clinical outcomes in symptomatic patients with severe AS undergoing transcatheter aortic valve implantation (TAVI). METHODS In a prospective single-center TAVI registry, we analyzed LA dimensions measured by echocardiography before intervention. Patients with atrial fibrillation or concomitant mitral valve disease were excluded. LAE was defined as indexed LA volume >34���ml/m2 . The primary endpoint was cardiovascular death (CVD) at 1 year. RESULTS Among 1663 patients undergoing TAVI between August 2007 and December 2016, 768 (46.2%) were eligible for the present analysis and 486 patients had LAE. The prevalence of LAE was higher in males (68.3%) as compared to females (58.8%). Patients with LAE were older (82.3��������6.7 years vs. 80.0��������6.4 years) and had a higher STS-PROM score (6.1��������4.7% vs. 4.7��������2.9%). After adjustment, patients with LAE had an increased risk of CVD at 1-year compared to patients with normal LA dimensions (49 [10.4%] vs. 8 [2.9%]; HRadj , 3.52; 95% CI, 1.66-7.44)]. In multivariable analysis, LAE was independently associated with an increased risk of CVD at 1-year (HRadj , 3.52; 95% CI, 1.66-7.44). CONCLUSIONS LAE secondary to AS was documented in a significant proportion of patients undergoing TAVI and was associated with a more than threefold increased risk of CVD at 1-year.

In patients with heart failure (HF) with reduced ejection fraction (HFrEF), malnutrition can be associated with intestinal congestion and systemic inflammation. These relationships have not been fully investigated in HF with mildly reduced EF (HFmrEF) and with preserved EF (HFpEF). We analyzed 420 patients with HF who underwent right heart catheterization. The relationships between hemodynamic parameters, C-reactive protein, and the controlling nutritional (CONUT) score were investigated in HFrEF, HFmrEF and HFpEF. The CONUT score of all patients was 2 [1, 4] (median [interquartile range]), and was not significantly different between the left ventricular EF (LVEF) categories (2 [1, 3] for HFrEF, 2 [1, 3] for HFmrEF, and 3 [1, 4] for HFpEF, p = 0.279). In multivariate linear regression analyses, there was a significant association between CRP and the CONUT score in HFmrEF and HFpEF, while brain natriuretic peptide and right atrial pressure were significantly associated with the CONUT score in HFrEF. Higher CONUT scores predicted a higher incidence of the composite endpoint of death or HF hospitalization within 12 months without an interaction with LVEF (p = 0.980). The CONUT score was an independent predictor of the composite endpoint, death, and HF hospitalization after adjustment for confounders in the multivariate analysis. In conclusion, inflammation was associated with malnutrition in HFmrEF and HFpEF, while congestion was an independent predictor of malnutrition in HFrEF. Malnutrition predicted worse outcomes regardless of LVEF.

BackgroundCerebrovascular events (CVE) are one of the most feared complications of transcatheter aortic valve replacement (TAVR). CVE appear difficult to predict due to their multifactorial origin incompletely explained by clinical predictors. We aimed to build a deep learning-based predictive tool for TAVR-related CVE.MethodsIntegrated clinical and imaging characteristics from consecutive patients enrolled into a prospective TAVR registry were analysed. CVE comprised any strokes and transient ischemic attacks. Predictive variables were selected by recursive feature reduction to train an autoencoder predictive model. Area under the curve (AUC) represented the model’s performance to predict 30-day CVE.ResultsAmong 2,279 patients included between 2007 and 2019, both clinical and imaging data were available in 1,492 patients. Median age was 83 years and STS score was 4.6%. Acute (ConclusionsTAVR-related CVE can be estimated using a deep learning-based predictive algorithm. The model was implemented online for broad usage. (https://www.welcome.alviss.ai/#/cvecalculator).

Objectives This study sought to compare the frequency of prosthesis-patient mismatch (PPM) with self-expandable valves (SEV) to balloon-expandable valves (BEV). Background PPM has been associated with increased mortality after transcatheter aortic valve replacement. Data on the frequency of PPM as a function of supra-annular or intra-annular position of transcatheter heart valves are insufficient. Methods A total of 757 patients treated with SEV (CoreValve, Evolut R) and BEV (SAPIEN THV/XT/3) were enrolled in the present analysis between August 2007 and June 2017. PPM was classified based on discharge prosthetic effective orifice area indexed to body surface area (BSA) as severe ( Results Propensity score matching resulted in 224 matched pairs. At discharge, SEV were associated with a lower incidence of PPM compared with BEV (PPM, 33.5% vs. 46.9%; p = 0.004; severe PPM, 6.7% vs. 15.6%; p = 0.003). The lower frequency of severe PPM in SEV was observed even in patients with larger annulus. Although patients with BSA >1.83 m2 had a significantly lower incidence of PPM with SEV compared with BEV, there was no significant difference in patients with BSA ≤1.83 m2. We found no impact of PPM on cardiovascular mortality or New York Heart Association functional class at 1 year. Conclusions SEV were associated with a lower frequency of PPM compared with BEV irrespective of annulus area. The difference was mainly driven by larger patients with BSA >1.83 m2.

Objectives The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices. Background The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR. Methods The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)–2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles. Results A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation. Conclusions In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices.

Objectives A large, prospective international registry was developed to evaluate the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices. Background TTVI for native tricuspid valve dysfunction has been emerging during the last few years as an alternative therapeutic option to serve a large high-risk population of patients with severe symptomatic tricuspid regurgitation (TR). Methods The TriValve Registry included 312 high-risk patients with severe TR (76.4 ± 8.5 years of age; 57% female; EuroSCORE II 9 ± 8%) at 18 centers. Interventions included repair at the level of the leaflets (MitraClip, Abbott Vascular, Santa Clara, California; PASCAL Edwards Lifesciences, Irvine, California), annulus (Cardioband, Edwards Lifesciences; TriCinch, 4tech, Galway, Ireland; Trialign, Mitraling, Tewksbury, Massachusetts), or coaptation (FORMA, Edwards Lifesciences) and replacement (Caval Implants, NaviGate, NaviGate Cardiac Structures, Lake Forest, California). Clinical outcomes were prospectively determined during mid-term follow-up. Results A total of 108 patients (34.6%) had prior left heart valve intervention (84 surgical and 24 transcatheter, respectively). TR etiology was functional in 93%, and mean annular diameter was 46.9 ± 9 mm. In 75% of patients the regurgitant jet was central (vena contracta 1.1 ± 0.5; effective regurgitant orifice area 0.78 ± 0.6 cm2). Pre-procedural systolic pulmonary artery pressure was 41 ± 14.8 mm Hg. Implanted devices included: MitraClip in 210 cases, Trialign in 18 cases, TriCinch first generation in 14 cases, caval valve implantation in 30 cases, FORMA in 24 cases, Cardioband in 13 cases, NaviGate in 6 cases, and PASCAL in 1. In 64% of the cases, TTVI was performed as a stand-alone procedure. Procedural success (defined as the device successfully implanted and residual TR ≤2+) was 72.8%. Greater coaptation depth (odds ratio: 24.1; p = 0.002) was an independent predictor of reduced device success. Thirty-day mortality was 3.6% and was significantly lower among patients with procedural success (1.9% vs. 6.9%; p = 0.04); Actuarial survival at 1.5 years was 82.8 ± 4% and was significantly higher among patients who had procedural success achieved. Conclusions TTVI is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Mid-term survival is favorable in this high-risk population. Greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality.

Aims Multivalvular disease is of increasing concern in elderly patients undergoing transcatheter aortic valve replacement (TAVR). The objective of the present analysis was to investigate the impact of concomitant mitral stenosis (MS) on clinical outcomes in patients undergoing TAVR for severe, symptomatic aortic stenosis (AS). Methods and results Among 1339 patients undergoing TAVR between August 2007 and December 2015, adequate echocardiographic data for the assessment of severity and aetiology of MS was available in 971 (72.5%) patients. Patients were stratified according to degree and aetiology of concomitant MS. Mitral stenosis was documented in 176 (18.1%) TAVR patients (mean mitral valve area 1.9 ± 0.4 cm2) and considered degenerative in 110 (62.5%) and rheumatic in 66 (37.5%) patients, respectively. Mitral stenosis was categorized as moderate/severe in 28 patients (2.9%). Baseline characteristics were comparable between patients with vs. without MS. At 1 year, patients with MS were at increased risk of cardiovascular death [36 (21.4%) vs. 66 (8.7%); adjusted hazard ratio (HRadj) 3.64, 95% confidence interval (CI) 2.38–5.56] and disabling stroke [12 (7.1%) vs. 23 (3.0%); HRadj 2.98, 95% CI 1.46–6.09] as compared to patients without MS. Differences in cardiovascular death and disabling stroke emerged within 30 days of the index procedure and were largely driven by a difference in patients with rheumatic MS [cardiovascular death: 7 (10.6%) vs. 24 (3.2%), HRadj 4.80, 95% CI 1.98–11.6; disabling stroke: 4 (6.1%) vs. 16 (2.0%), HRadj 4.18, 95% CI 1.34–13.0]. Conclusion Concomitant MS was documented in approximately one-fifth of patients undergoing TAVR for severe, symptomatic AS and associated with a three-fold increased risk of cardiovascular adverse events at 1 year. The difference emerged early and was largely driven by patients with rheumatic MS.

Background Renal impairment is a common phenomenon that portends a poor prognosis of heart failure (HF). The renal arterial resistance index (RRI) can be useful for defining renal function and predicting outcomes in patients with HF. This study aimed to investigate the determining factors of the RRI in HF patients with preserved ejection fraction (HFpEF) and with reduced EF (HFrEF). Methods This retrospective study included 330 patients with HF. We investigated the determining factors for the RRI and the association between the RRI and 1-year composite outcome, comprising all-cause mortality and re-hospitalization for HF. Results The independent predictors of the RRI were tricuspid regurgitation peak gradient and estimated glomerular filtration rate in HFpEF, and pulse pressure and blood urea nitrogen in HFrEF. During the follow-up, 30 (9.1%) patients presented the composite outcome. Cox proportional hazard analysis revealed the association of the RRI with the composite outcome in both HFrEF (HR 1.08; 95% CI 1.03–1.14) and HFpEF (HR 1.07; 95% CI 1.03–1.12) without an interaction (p for interaction = 0.770). Conclusions The RRI was a consistent prognosticator in patients with HFpEF and those with HFrEF, while factors defining RRI were different between these groups.

BACKGROUND Newest generation drug-eluting stents combine biodegradable polymers with ultrathin stent platforms in order to minimize vessel injury and inflammatory response. Evidence from randomized controlled trials suggested that differences in stent design translate into differences in clinical outcome. The aim of the present study was to evaluate the safety and efficacy of ultrathin strut, biodegradable polymer sirolimus eluting stents (BP SES) compared with thin strut, durable polymer everolimus-eluting stents (DP EES) among patients undergoing percutaneous coronary intervention (PCI). METHODS We pooled individual participant data from 5 randomized trials (NCT01356888, NCT01939249, NCT02389946, NCT01443104, NCT02579031) including a total of 5,780 patients, and performed a one-stage meta-analysis using a mixed effects Cox regression model. RESULTS At a median duration of follow-up of 739 days (interquartile range 365-1,806 days), target-lesion failure occurred in 337 (10.3%) and 304 (12.2%) patients treated with BP SES and DP EES (HR 0.86, 95%CI 0.71-1.06, P = .16). There were no significant differences between BP SES and DP EES with regards to cardiac death (111 (3.4%) vs 102 (4.1%); HR 1.05, 95%CI 0.80-1.37, P���=���.73), target-vessel myocardial infarction (136 (4.1%) vs 126 (5.0%), HR 0.79, 95%CI 0.62-1.01, P���=���.061), and clinically-driven target-lesion revascularization (163 (5.0%) vs 147 (5.9%); HR 0.94, 95%CI 0.75-1.18, P���=���.61). The effect was consistent across major subgroups. In a landmark analysis, there was no significant interaction between treatment effect and timing of events. CONCLUSIONS In this patient-level meta-analysis of 5 randomized controlled trials, BP SES were associated with a similar risk of target-lesion failure compared with DP EES among patients undergoing PCI. STUDY REGISTRATION PROSPERO registry (CRD42018109098).

BACKGROUND Mitral annular calcification (MAC) has been associated with mitral valve (MV) disease and cardiovascular events in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to investigate the incidence and impact of mitral calcium volume (MCV) quantified by multidetector computed tomography (MDCT) on MV function and clinical outcomes after TAVI. METHODS Consecutive patients with exploitable echocardiography and MDCT performed during TAVI screening were enrolled in this retrospective analysis. Mitral calcium was assessed visually and measured using a semi-automatic tool developed for the aortic valve in an off-label fashion. RESULTS MCV >0 mm3 was found in 65% of the 875 included patients. Patients with calcification were older (82 ± 6 versus 81 ± 7; P = 0.002) and had high prevalence of renal dysfunction (69% versus 61%; P = 0.017) and mitral stenosis (25% versus 4%, P

Self-expanding valves have been associated with superior hemodynamics versus balloon-expandable valves. Our aim was to compare invasive gradients between valve types for similarly sized valves. Patients who underwent transcatheter aortic valve replacement (TAVR) at the Malcom Randall Veterans Affairs Medical Center and the Bern University Hospital were considered for this analysis. From 1623 subjects who underwent TAVR, a total of 566 had available invasive hemodynamic data. After applying exclusion criteria, we included 499 for analysis. With immediate invasive hemodynamic assessment, balloon- expandable valves were associated with similar/marginally lower transvalvular gradients versus self-expanding valves. With postoperative echocardiography within 24 hours, self-expanding valves were associated with lower Doppler gradients versus balloon-expandable valves for all size categories.

Background The optimal antithrombotic therapy after transcatheter aortic valve implantation (TAVI) is unsettled. Short and longer-term thromboembolic and bleeding risk post TAVI remain high. Non-vitamin K oral anticoagulant drugs (NOAC) may be attractive after TAVI but the implications of prolonged NOAC in this setting require further research. The aim of this study was to assess the HAS-BLED bleeding risk in a contemporary TAVI population and explore its correlation with the effective bleeding complications with or without (N)OAC. Methods This study included 986 consecutive successful TAVI patients from 2 tertiary care facilities. Statistical analysis consisted of Cox regression. Bleedings were classified according to VARC-2 criteria. Results Mean age was 80.5 years, mean STS was 4.7 and 54% were males. A total of 483 patients (49.2%) had AF and 42.1% were on (N)OAC. The median HAS-BLED score was 2, 42.6% had a HAS-BLED≥3. Overall 216 patients (21.9%) experienced at least 1 bleeding, 166 (16.9%) occurred early after TAVI. HAS-BLED≥3 was an independent predictor of overall and pre-discharge bleeding (respectively HR 1.347 CI 1.029-1.763, P=0.03: HR 1.403 CI 1.032-1.905, P=0.05). The incidence of bleeding was similar in patient on (N)OAC vs. patients not on (N)OAC, both in the low and high HAS-BLED cohorts (P=0.93, P=0.42 respectively). Cardiovascular mortality was significantly higher in the high HAS-BLED cohort (37.5% vs. 24%, P=0.04) and HAS-BLED≥3 was an independent predictor of late mortality (HR 1.452 CI 1.028-2.053, P=0.03). Conclusions In our series, contemporary TAVI patients had an elevated HAS-BLED score. The HAS-BLED score correlated with early bleedings and mortality after TAVI. Use of (N)OAC was not associated with more bleedings after TAVI.

Aims Mitral annular calcification (MAC) has been associated with adverse outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) but has been investigated in isolation of co-existent mitral regurgitation or mitral stenosis, which may represent important confounders. This study sought to investigate the effect of MAC with and without concomitant mitral valve disease (MVD) on clinical outcomes in patients treated with TAVR. Methods and results Computed tomography (CT) and echocardiographic data in consecutive TAVR patients enrolled into a prospective registry were categorized according to presence or absence of severe MAC and significant MVD, respectively. A total of 967 patients with adequate CT and echocardiography data were included between 2007 and 2017. Severe MAC was found in 172 patients (17.8%) and associated with MVD in 87 patients (50.6%). Compared to TAVR patients without severe MAC or MVD, all-cause mortality at 1 year was significantly increased among patients with severe MAC in combination with MVD [adjusted hazard ratio (HRadj): 1.97, 95% confidence interval (CI): 1.12–3.44, P = 0.018] and patients with isolated MVD (HRadj: 2.33, 95% CI: 1.56–3.47, P Conclusion We found no effect of isolated MAC on clinical outcomes following TAVR in patients with preserved mitral valve function. Patients with MVD had an increased risk of death at 1 year irrespective of MAC.

Background Natural history of coronary plaque progression (PP) in patients with diabetes mellitus (DM) remains unclear. This study aimed to investigate the clinical predictors of coronary PP in patients with DM. Methods In this prospective observational study, we analyzed 70 asymptomatic patients (age, 64.4 years; male, 67%) with type 2 DM without prior history of coronary artery disease who underwent serial 320-row computed tomography coronary angiography with an interscan interval of more than 24 months (median 37.7 months). Study endpoint was PP, which was defined if coronary plaque volumes (PVs) at follow-up minus PVs at baseline was >0. We evaluated plaque composition using the Hounsfield Unit thresholds and insulin resistance estimated by the homeostasis model assessment of insulin resistance (HOMA-IR). Results Thirty-nine patients who showed PP had a higher increase in hemoglobin A1c (⊿HbA1c) from baseline to follow-up than those without PP (0.3% ± 0.8% vs −0.4% ± 1.1%; p = 0.01), although there was no statistical difference in HbA1c at baseline (7.1 ± 0.5% vs. 7.3 ± 1.4%; p = 0.24). In multivariable analysis, ⊿HbA1c [odds ratio (OR): 3.05; 95% confidence interval (CI): 1.39–6.67; p = 0.001] was an independent predictor for PP. Increase in low-density lipoprotein cholesterol (⊿LDL-C), not ⊿HbA1c, was significantly correlated to percent change in necrotic core (NC) volume (β-coefficients: 0.04; 95% CI: 0.004 - 0.08; p = 0.03). Among 48 patients without insulin therapy, patients with PP (n = 28) had a higher increase in HOMA-IR than those without PP (n = 20) (0.95 ± 2.00 vs. −0.63 ± 1.31; p = 0.003). Conclusions Increase in HbA1c and HOMA-IR was associated with PP in asymptomatic patients with type 2 DM, whereas increase in LDL-C was correlated to increase in NC.

Summary Background Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications. Methods In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov , NCT02439749 . Findings From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was −3·9 mm Hg (Bayesian 95% credible interval −6·2 to −1·6) and for office systolic blood pressure the difference was −6·5 mm Hg (−9·6 to −3·5). No major device-related or procedural-related safety events occurred up to 3 months. Interpretation SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications. Funding Medtronic.

We report an autopsy case of an 80-year-old woman who underwent left atrial appendage closure with a WATCHMAN (Boston Scientific, St. Paul, MN, USA) device. This is the first report of histologic assessment following left atrial appendage closure with a WATCHMAN device at 3 months. Gross and histopathological examinations revealed neoendocardial coverage of the WATCHMAN device. Partial endothelialization was verified by CD34 staining; however, it remains unclear when complete endothelialization is likely to occur.

A 51-year-old woman with cardiac sarcoidosis presented with 2:1 atrial flutter (AFL) ([Figure 1Ai][1]) and was referred for catheter ablation. During sinus rhythm, a 12-lead electrocardiogram revealed trifascicular block ([Figure 1Aii][1]). Echocardiography revealed basal thinning of the