Changing haemodynamic status of patients referred for transcatheter aortic valve intervention during the COVID-19 pandemic.

INTRODUCTION: Delays in the diagnosis and referral of aortic stenosis (AS) during the coronavirus disease 2019 (COVID-19) pandemic may have affected the haemodynamic status of AS patients. We aimed to compare clinical and haemodynamic characteristics of severe AS patients referred for transcatheter aortic valve implantation (TAVI) or balloon aortic valvuloplasty (BAV) before the pandemic versus two subsequent periods. METHODS: This study compared three 1­year historical cohorts: a pre-COVID-19 group (PCOV), a 1st-year COVID-19 group (COV-Y1) and a 2nd-year COVID-19 group (COV-Y2). The main parameters were baseline New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF) and left ventricular end-diastolic pressure (LVEDP). Demographics, procedural characteristics and 30-day clinical outcomes were assessed. The transition time between heart team decision and TAVI was examined. Pairwise group comparisons were performed (PCOV vs COV-1Y and COV-1Y vs COV-2Y). RESULTS: A total of 720 patients were included with 266, 249 and 205 patients in the PCOV, COV-Y1 and COV-Y2 groups, respectively. BAV was performed in 28 patients (4%). NYHA class did not differ across the cohorts. Compared to PCOV, LVEF was slightly lower in COV-Y1 (58% (49-60%) vs 57% (45-60%), p = 0.03); no difference was observed when comparing COV-Y1 and COV-Y2. LVEDP was higher in COV-Y1 than in PCOV (20 mm Hg (16-26 mm Hg) vs 17 mm Hg (13-24 mm Hg), p = 0.01). No difference was found when comparing LVEDP between COV-Y1 and COV-Y2. Thirty-day mortality did not differ between groups. Transition time was reduced in the COVID era. Duration of hospital stay declined over the study period. CONCLUSIONS: Patients undergoing TAVI during the COVID-19 pandemic had more advanced AS illustrated by lower LVEF and higher LVEDP, but there were no differences in clinical outcome. The TAVI pathway became more efficient.

Insights in a restricted temporary pacemaker strategy in a lean transcatheter aortic valve implantation program.

OBJECTIVES: To study the safety and feasibility of a restrictive temporary-RV-pacemaker use and to evaluate the need for temporary pacemaker insertion for failed left ventricular (LV) pacing ability (no ventricular capture) or occurrence of high-degree AV-blocks mandating continuous pacing. BACKGROUND: Ventricular pacing remains an essential part of contemporary transcatheter aortic valve implantation (TAVI). A temporary-right-ventricle (RV)-pacemaker lead is the standard approach for transient pacing during TAVI but requires central venous access. METHODS: An observational registry including 672 patients who underwent TAVI between June 2018 and December 2020. Patients received pacing on the wire when necessary, unless there was a high-anticipated risk for conduction disturbances post-TAVI, based on the baseline-ECG. The follow-up period was 30 days. RESULTS: A temporary-RV-pacemaker lead (RVP-cohort) was inserted in 45 patients, pacing on the wire (LVP-cohort) in 488 patients, and no pacing (NoP-cohort) in 139 patients. A bailout temporary pacemaker was implanted in 14 patients (10.1%) in the NoP-cohort and in 24 patients (4.9%) in the LVP-cohort. One patient in the LVP-cohort needed an RV-pacemaker for incomplete ventricular capture. Procedure time was significantly longer in the RVP-cohort (68 min [IQR 52-88.] vs. 55 min [IQR 44-72] in NoP-cohort and 55 min [IQR 43-71] in the LVP-cohort [p < 0.005]). Procedural high-degree AV-block occurred most often in the RVP-cohort (45% vs. 14% in the LVP and 16% in the NoP-cohort [p ≤ 0.001]). Need for new PPI occurred in 47% in the RVP-cohort, versus 20% in the NoP-cohort and 11% in the LVP-cohort (p ≤ 0.001). CONCLUSION: A restricted RV-pacemaker strategy is safe and shortens procedure time. The majority of TAVI-procedures do not require a temporary-RV-pacemaker.

Vascular complications with a plug-based vascular closure device after transcatheter aortic valve replacement: Predictors and bail-outs.

BACKGROUND: The MANTA vascular closure device (VCD) is dedicated to large bore access closure and associated with favorable results in selected study populations. Anatomical predictors for access site complications are lacking. AIM: To evaluate MANTA in a real-world population and identify predictors for vascular complications. METHODS: All patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) between January 2016 and May 2020 with MANTA closure were included. Baseline characteristics were collected, pre-procedural computed tomography and post-deployment femoral angiograms were analyzed for anatomical differences. The primary endpoint was a composite of access site related major and minor vascular complications at 30 days follow-up according to the VARC-2 definitions. Secondary endpoints included bleeding, time to hemostasis, procedural length and incomplete arteriotomy closure or arterial occlusion by angiography. A Cox proportional hazards model was used to compare all-cause mortality for patients with and without an access site complication. RESULTS: The 512 patients underwent TAVR with MANTA access closure. Median age was 80 (IQR 75-85), 53% was male, median BMI was 26.4 kg/m2 (IQR 23.4-29.7). Access site related major- or minor vascular complication occurred in 20 (4%) and 23 (4%) of patients respectively. Median time to hemostasis was 42 s (IQR 28-98). Post deployment angiogram showed an occlusion in 24 patients (5%), incomplete closure in 60 patients (12%) or both in three patients (1%). Of these 87 patients, 36 (41%) had a vascular complication. Femoral artery diameter (OR 0.70 [0.53-0.93]), low- (OR 3.47 [1.21-10.00]) and high (OR 2.43 [1.16-5.10]) arteriotomies were independent predictors for vascular complications. CONCLUSION: In this contemporary TAVR population, access-site related complications occurred in 8% of patients and were mainly due to percutaneous closure device failure. Small artery diameter and off-target punctures were independent predictors.

Transcatheter Repair and Replacement Technologies for Mitral Regurgitation: a European Perspective.

PURPOSE OF REVIEW: We aimed to picture the contemporary landscape of available catheter-based repair and replacement solutions for mitral regurgitation (MR) in Europe. RECENT FINDINGS: Edge-to-edge repair remains the dominant technique for transcatheter mitral valve repair especially in the context of secondary mitral regurgitation. Two recent randomized trials reported seemingly contradicting clinical results with transcatheter edge-to-edge repair for patients with heart failure and severe secondary MR. A proportionality framework related to secondary MR was proposed to help explain inconsistencies but requires further research. (In)Direct annuloplasty primarily aims to correct secondary MR; however, the scientific basis seems less robust. One dedicated transcatheter heart valve has the CE mark for mitral valve replacement but requires transapical access. Balloon-expandable transcatheter aortic valve platforms are emerging for transvenous transseptal mitral replacement in the context of mitral annular calcification, a failing surgical mitral bioprosthesis, or annuloplasty. Advanced computed tomography imaging techniques improved pre-procedural planning and introduced the option for modeling and simulation. Development of a toolbox of catheter-based technologies, complementary imaging modalities, and refined patient selection offer novel perspectives to high-risk patients with primary or secondary MR. Clinical trials are required to help formulate evidence-based guidelines for the management of mitral valve disease.

Impact of frailty on health-related quality of life 1 year after transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) brings symptom relief and improvement in health-related quality of life (HRQoL) in the majority of patients treated for symptomatic, severe aortic stenosis. However, there is a substantial group of patients that do not benefit from TAVI. The aim of this study is to investigate the impact of frailty on HRQoL 1 year after TAVI. METHODS: The TAVI Care & Cure Program is an ongoing, prospective, observational study including patients referred for TAVI to our institution. A comprehensive geriatric assessment was performed to evaluate existence of frailty using the Erasmus Frailty Score (EFS). HRQoL was assessed using the EQ-5D-5 L at baseline and 1 year after TAVI. RESULTS: 239 patients underwent TAVI and completed HRQoL assessment 1 year after TAVI. Seventy (29.3%) patients were classified as frail (EFS ≥ 3). In non-frail patients, the EQ-5D-5 L index did not change (0.71(± 0.22) to 0.68(± 0.33) points, P = 0.22); in frail patients, the EQ-5D-5 L index decreased from 0.55(±0.26) to 0.44 points (±0.33) (P = 0.022). Frailty was an independent predictor of deteriorated HRQoL 1 year after TAVI (OR 2.24, 95% CI 1.07-4.70, P = 0.003). In frail patients, the absence of peripheral artery disease (OR 0.17, 95% 0.05-0.50, P = 0.001) and renal dysfunction (OR 0.13, 95% CI 0.04-0.41, P = <0.001) at baseline was associated with improved HRQoL 1 year after TAVI. CONCLUSION: Frailty is associated with deterioration of HRQoL 1 year after TAVI. Notably, HRQoL did improve in frail patients with no peripheral arterial disease or renal impairment at baseline.

Safety and feasibility of early discharge after transcatheter aortic valve implantation with ACURATE Neo-the POLESTAR trial.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) serves a growing range of patients with severe aortic stenosis (AS). TAVI has evolved to a streamlined procedure minimizing length of hospital stay. AIMS: To evaluate the safety and efficacy of an early discharge (ED) strategy after TAVI. METHODS: We performed an international, multi-center, prospective observational single-arm study in AS patients undergoing TAVI with the ACURATE valve platform. Eligibility for ED was assessed prior to TAVI and based on prespecified selection criteria. Discharge ≤ 48 h was defined as ED. Primary Valve Academic Research Consortium (VARC)-3-defined 30-day safety and efficacy composite endpoints were landmarked at 48 h and compared between ED and non-ED groups. RESULTS: A total of 252 patients were included. The median age was 82 [25th-75th percentile, 78-85] years and the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.2% [25th-75th percentile, 1.6-3.3]. ED and non-ED were achieved in 173 (69%) and 79 (31%) patients respectively. Monitoring for conduction disturbances was the principal reason for non-ED (33%). Overall, at 30 days, all-cause mortality was 1%, new permanent pacemaker rate was 4%, and valve- or procedure-related rehospitalization was 4%. There was no difference in the primary safety and efficacy endpoint between the ED and non-ED cohorts (OR 0.84 [25th-75th percentile, 0.31-2.26], p = 0.73, and OR 0.97 [25th-75th percentile, 0.46-2.06], p = 0.94). The need for rehospitalization was similarly low for ED and non-ED groups. CONCLUSION: Early discharge after TAVI with the ACURATE valve is safe and feasible in selected patients. Rhythm monitoring and extended clinical observation protracted hospital stay.

Validation of a Three-Dimensional Computed Tomography Reconstruction Tool for Aortic Valve Calcium Quantification.

Background: Aortic valve calcification correlates with the severity of aortic valve stenosis and a high calcium score is associated with conduction disturbances and paravalvular leakage after transcatheter aortic valve replacement. The 3mensio Structural Heart is a semiautomated software package to facilitate aortic root analysis by multislice computed tomography.The aim of the contemporary study is to validate a semiautomated calcium quantification scoring tool with a conventional manual calcium quantification tool. Methods: Fifty randomly selected patients who underwent multislice computed tomography for preprocedural planning were retrospectively selected to compare the semiautomated aortic valve Agatston calcium score by 3mensio with the manually obtained score using IntelliSpace Portal as standard reference. Results: Patients had a mean age of 76.7 ± 7.4 years and 60% were male. The median Agatston score was 3390 [interquartile range 1877-4509] with 3mensio and 3434 [interquartile range 1839-4620] with IntelliSpace.The mean difference was -0.18 [95% confidence interval (CI) -53.8 to 53.4]. The intraclass correlation coefficient between the Agatston scores using IntelliSpace and 3mensio showed an excellent correlation of 0.995 [95% CI 0.992-0.997], p ≤ 0.001. The interobserver and intraobserver variability was 0.993 ([95% CI 0.961-0.998], p ≤ 0.001) and 0.995([95%CI 0.981-0.999], p = <0.001), respectively. Conclusions: The semiautomated calcium quantification module in 3mensio Structural Heart highly correlated with a conventional manual calcium scoring tool.

Sex-specific aortic valve calcifications in patients undergoing transcatheter aortic valve implantation.

AIMS: To study sex-specific differences in the amount and distribution of aortic valve calcification (AVC) and to correlate the AVC load with paravalvular leakage (PVL) post-transcatheter aortic valve intervention (TAVI). METHODS AND RESULTS: This registry included 1801 patients undergoing TAVI with a Sapien3 or Evolut valve in two tertiary care institutions. Exclusion criteria encompassed prior aortic valve replacement, suboptimal multidetector computed tomography (MDCT) quality, and suboptimal transthoracic echocardiography images. Calcium content and distribution were derived from MDCT. In this study, the median age was 81.7 (25th-75th percentile 77.5-85.3) and 54% male. Men, compared to women, were significantly younger [81.2 (25th-75th percentile 76.5-84.5) vs. 82.4 (78.2-85.9), P ≤ 0.01] and had a larger annulus area [512 mm2 (25th-75th percentile 463-570) vs. 405 mm2 (365-454), P < 0.01] and higher Agatston score [2567 (25th-75th percentile 1657-3913) vs. 1615 (25th-75th percentile 905-2484), P < 0.01]. In total, 1104 patients (61%) had none-trace PVL, 648 (36%) mild PVL, and 49 (3%) moderate PVL post-TAVI. There was no difference in the occurrence of moderate PVL between men and women (3% vs. 3%, P = 0.63). Cut-off values for the Agatston score as predictor for moderate PVL based on the receiver-operating characteristic curve were 4070 (sensitivity 0.73, specificity 0.79) for men and 2341 (sensitivity 0.74, specificity 0.73) for women. CONCLUSION: AVC is a strong predictor for moderate PVL post-TAVI. Although the AVC load in men is higher compared to women, there is no difference in the incidence of moderate PVL. Sex-specific Agatston score cut-offs to predict moderate PVL were almost double as high in men vs. women.

Transcatheter Aortic Valve Replacement in Patients With Reduced Ejection Fraction and Nonsevere Aortic Stenosis.

BACKGROUND: The potential benefit of transcatheter aortic valve replacement (TAVR) in patients with nonsevere aortic stenosis (AS) and heart failure is controversial. This study aimed to assess outcomes of patients with nonsevere low-gradient AS (LGAS) and reduced left ventricular ejection fraction undergoing TAVR or medical management. METHODS: Patients undergoing TAVR for LGAS and reduced left ventricular ejection fraction (<50%) were included in a multinational registry. True-severe low-gradient AS (TS-LGAS) and pseudo-severe low-gradient AS (PS-LGAS) were classified according to computed tomography-derived aortic valve calcification thresholds. A medical control group with reduced left ventricular ejection fraction and moderate AS or PS-LGAS was used (Medical-Mod). Adjusted outcomes between all groups were compared. Among patients with nonsevere AS (moderate or PS-LGAS), outcomes after TAVR and medical therapy were compared using propensity score-matching. RESULTS: A total of 706 LGAS patients undergoing TAVR (TS-LGAS, N=527; PS-LGAS, N=179) and 470 Medical-Mod patients were included. After adjustment, both TAVR groups showed superior survival compared with Medical-Mod patients (all P<0.001), while no difference was found between TS-LGAS and PS-LGAS TAVR patients (P=0.96). After propensity score-matching among patients with nonsevere AS, PS-LGAS TAVR patients showed superior 2-year overall (65.4%) and cardiovascular survival (80.4%) compared with Medical-Mod patients (48.8% and 58.5%, both P≤0.004). In a multivariable analysis including all patients with nonsevere AS, TAVR was an independent predictor of survival (hazard ratio, 0.39 [95% CI, 0.27-0.55]; P<0.0001). CONCLUSIONS: Among patients with nonsevere AS and reduced left ventricular ejection fraction, TAVR represents a major predictor of superior survival. These results reinforce the need for randomized-controlled trials comparing TAVR versus medical management in heart failure patients with nonsevere AS. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04914481.

Automated mitral valve assessment for transcatheter mitral valve replacement planning.

Transcatheter mitral valve replacement (TMVR) has emerged as a minimally invasive alternative for treating patients suffering from mitral valve disease. The number of TMVR procedures is expected to rise as devices currently in clinical trials obtain approval for commercialization. Automating the planning of such interventions becomes, therefore, more relevant in an attempt to decrease inter-subject discrepancies and time spent in patient assessment. This study evaluates the performance of an automated method for detection of anatomical landmarks and generation of relevant measurements for device selection and positioning. Cardiac CT scans of 70 patients were collected retrospectively. Fifty scans were used to generate a statistical shape model (SSM) of the left heart chambers at ten different timepoints, whereas the remaining 20 scans were used for validation of the automated method. The clinical measurements resulting from the anatomical landmarks generated automatically were compared against the measurements obtained through the manual indication of the corresponding landmarks by three observers, during systole and diastole. The automatically generated measurements were in close agreement with the user-driven analysis, with intraclass correlation coefficients (ICC) consistently lower for the saddle-shaped (ICCArea = 0.90, ICCPerimeter 2D = 0.95, ICCPerimeter 3D = 0.93, ICCAP-Diameter = 0.71, ICCML-Diameter = 0.90) compared to the D-shaped annulus (ICCArea = 0.94, ICCPerimeter 2D = 0.96, ICCPerimeter 3D = 0.96, ICCAP-Diameter = 0.95, ICCML-Diameter = 0.92). The larger differences observed for the saddle shape suggest that the main discrepancies occur in the aorto-mitral curtain. This is supported by the fact that statistically significant differences are observed between the two annulus configurations for area (p < 0.001), 3D perimeter (p = 0.009) and AP diameter (p < 0.001), whereas errors for 2D perimeter and ML diameter remained almost constant. The mitral valve center deviated in average 2.5 mm from the user-driven position, a value comparable to the inter-observer variability. The present study suggests that accurate mitral valve assessment can be achieved with a fully automated method, what could result in more consistent and shorter pre-interventional planning of TMVR procedures.

Left atrial appendage thrombus and cerebrovascular events post-transcatheter aortic valve implantation.

AIMS: To elucidate the frequency and clinical impact of left atrial appendage thrombus (LAAT) in patients set for transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: All patients undergoing TAVI between January 2014 and June 2020 with analysable multislice computed tomography (MSCT) for LAAT were included. Baseline and procedural characteristics were collected, pre-procedural MSCT's were retrospectively analysed for LAAT presence. The primary endpoint was defined as the cumulative incidence of any cerebrovascular event (stroke or transient ischaemic attack) within the first year after TAVI. A Cox proportional hazards model was used to identify predictors.A total of 1050 cases had analysable MSCT. Median age was 80 [interquartile range (IQR) 74-84], median Society of Thoracic Surgeons' Predicted Risk Of Mortality (STS-PROM) was 3.4% (IQR 2.3-5.5). Thirty-six percent were on oral anticoagulant therapy for atrial fibrillation (AF). LAAT was present in 48 (4.6%) of cases. Patients with LAAT were at higher operative risk [STS-PROM: 4.9% (2.9-7.1) vs. 3.4% (2.3-5.5), P = 0.01], had worse systolic left ventricular function [EF 52% (35-60) vs. 55% (45-65), P = 0.01] and more permanent pacemakers at baseline (35% vs. 10%, P < 0.01). All patients with LAAT had a history of AF and patients with LAAT were more often on vitamin K antagonist-treatment than patients without LAAT [43/47 (91%) vs. 232/329 (71%), P < 0.01]. LAAT [hazard ratio (HR) 2.94 (1.39-6.22), P < 0.01] and the implantation of more than one valve [HR 4.52 (1.79-11.25), P < 0.01] were independent predictors for cerebrovascular events. CONCLUSION: Patients with MSCT-identified LAAT were at higher risk for cerebrovascular events during the first year after TAVI.

Impact of membranous septum length on pacemaker need with different transcatheter aortic valve replacement systems: The INTERSECT registry.

BACKGROUND: New permanent pacemaker implantation (new-PPI) remains a compelling issue after Transcatheter Aortic Valve Replacement (TAVR). Previous studies reported the relationship between a short MS length and the new-PPI post-TAVR with a self-expanding THV. However, this relationship has not been investigated in different currently available THV. Therefore, the aim of this study was to investigate the association between membranous septum (MS)-length and new-PPI after TAVR with different Transcatheter Heart Valve (THV)-platforms. METHODS: We included patients with a successful TAVR-procedure and an analyzable pre-procedural multi-slice computed tomography. MS-length was measured using a standardized methodology. The primary endpoint was the need for new-PPI within 30 days after TAVR. RESULTS: In total, 1811 patients were enrolled (median age 81.9 years [IQR 77.2-85.4], 54% male). PPI was required in 275 patients (15.2%) and included respectively 14.2%, 20.7% and 6.3% for Sapien3, Evolut and ACURATE-THV(p â€‹< â€‹0.01). Median MS-length was significantly shorter in patients with a new-PPI (3.7 â€‹mm [IQR 2.2-5.1] vs. 4.1 â€‹mm [IQR 2.8-6.0], p â€‹= â€‹<0.01). Shorter MS-length was a predictor for PPI in patients receiving a Sapien3 (OR 0.87 [95% CI 0.79-0.96], p â€‹= â€‹<0.01) and an Evolut-THV (OR 0.91 [95% CI 0.84-0.98], p â€‹= â€‹0.03), but not for an ACURATE-THV (OR 0.99 [95% CI 0.79-1.21], p â€‹= â€‹0.91). By multivariable analysis, first-degree atrioventricular-block (OR 2.01 [95% CI 1.35-3.00], p = <0.01), right bundle branch block (OR 8.33 [95% CI 5.21-13.33], p = <0.01), short MS-length (OR 0.89 [95% CI 0.83-0.97], p â€‹< â€‹0.01), annulus area (OR 1.003 [95% CI 1.001-1.005], p â€‹= â€‹0.04), NCC implantation depth (OR 1.13 [95% CI 1.07-1.19] and use of Evolut-THV(OR 1.54 [95% CI 1.03-2.27], p â€‹= â€‹0.04) were associated with new-PPI. CONCLUSION: MS length was an independent predictor for PPI across different THV platforms, except for the ACURATE-THV. Based on our study observations within the total cohort, we identified 3 risk groups by MS length: MS length ≤3 â€‹mm defined a high-risk group for PPI (>20%), MS length 3-7 â€‹mm intermediate risk for PPI (10-20%) and MS length > 7 â€‹mm defined a low risk for PPI (<10%). Anatomy-tailored-THV-selection may mitigate the need for new-PPI in patients undergoing TAVR.

Rationale and Design of the Project to Look for Early Discharge in Patients Undergoing TAVR With ACURATE (POLESTAR Trial).

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is now an established treatment strategy for elderly patients with symptomatic aortic stenosis (AS) across the entire operative risk spectrum. Streamlined TAVR protocols along with reduced procedure time and expedited ambulation promote early hospital discharge. Selection of patients suitable for safe early discharge after TAVR might improve healthcare efficiency. STUDY DESIGN: The POLESTAR trial is an international, multi-center, prospective, observational study which aims to evaluate the safety of early discharge in selected patients who undergo TAVR with the supra-annular functioning self-expanding ACURATE Neo transcatheter heart valve (THV). A total of 250 patients will be included based on a set of baseline criteria indicating potential early discharge (within 48 h post-TAVR). Primary study endpoints include Valve Academic Research Consortium (VARC)-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year. Endpoints will be compared between early discharge and non-early discharge cohorts with a distinct landmark analysis at 48 h post-TAVR. Secondary endpoints include quality of life assessed using EQ5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires and resource costs compared between discharge groups. SUMMARY: The POLESTAR trial prospectively evaluates safety and feasibility of an early discharge protocol for TAVR using the ACURATE Neo THV.

Leaflet Thickening and Motion After Transcatheter Aortic Valve Replacement: Design and Rationale of the Rotterdam Edoxaban Trial.

BACKGROUND: Multislice computed tomography (MSCT) may reveal hypo-attenuated leaflet thickening (HALT) and/or reduced leaflet motion (RELM) in approximately 15 % of patients after transcatheter aortic valve replacement (TAVR). These supposedly thrombogenic phenomena may be associated with neurological events and increased transprosthetic gradients. It is unclear whether oral anticoagulant therapy -specifically a factor Xa inhibitor- could affect the incidence of HALT/RELM. STUDY DESIGN: The Rotterdam EDOXaban (REDOX) trial is an investigator-initiated, single-center, prospective registry in which 100 patients with no formal indication for oral anticoagulant drugs or dual antiplatelet therapy, will receive a 3-month treatment with edoxaban, followed by a MSCT to detect HALT/RELM. The primary endpoint is the incidence of HALT at 3-months follow-up. Secondary endpoints include the incidence of RELM at 3 months; change in transprosthetic gradients at 1 year and the clinical composite endpoint of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism, valve thrombosis and major bleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) at 1 year follow up. The study is powered to demonstrate with 90 % statistical power and a 0.025 alpha a 4 % incidence of HALT with edoxaban as compared to the expected 15 % rate with an antiplatelet regimen and will enroll 100 patients to account for loss of follow-up or CT-drop out. CONCLUSION: The REDOX trial will investigate the short-term effect of an Xa-inhibitor on the incidence of HALT after TAVR. (ClinicalTrials.gov Identifier: NCT04171726).

Transcatheter Edge-to-Edge Repair in Proportionate Versus Disproportionate Functional Mitral Regurgitation.

BACKGROUND: Functional mitral regurgitation (FMR) can be subclassified on the basis of its proportionality relative to left ventricular (LV) volume and function, indicating potential differences in underlying etiology. The aim of this study was to evaluate the association of FMR proportionality with FMR reduction, heart failure hospitalization and mortality after transcatheter edge-to-edge mitral valve repair (TEER). METHODS: This multicenter registry included 241 patients with symptomatic heart failure with reduced LV ejection fraction treated with TEER for moderate to severe or greater FMR. FMR proportionality was graded on preprocedural transthoracic echocardiography using the ratio of the effective regurgitant orifice area to LV end-diastolic volume. Baseline characteristics, follow-up transthoracic echocardiography, and 2-year clinical outcomes were compared between groups. RESULTS: Median LV ejection fraction, effective regurgitant orifice area and LV end-diastolic volume index were 30% (interquartile range [IQR], 25%-35%), 27 mm2, and 107 mL/m2 (IQR, 90-135 mL/m2), respectively. Median effective regurgitant orifice area/LV end-diastolic volume ratio was 0.13 (IQR, 0.10-0.18). Proportionate FMR (pFMR) and disproportionate FMR (dFMR) was present in 123 and 118 patients, respectively. Compared with patients with pFMR, those with dFMR had higher baseline LV ejection fractions (median, 32% [IQR, 27%-39%] vs 26% [IQR, 22%-33%]; P < .01). Early FMR reduction with TEER was more pronounced in patients with dFMR (odds ratio, 0.45; 95% CI, 0.28-0.74; P < .01) than those with pFMR, but not at 12 months (odds ratio, 0.93; 95% CI, 0.53-1.63; P = .80). Overall, in 35% of patients with initial FMR reduction after TEER, FMR deteriorated again at 1-year follow-up. Rates of 2-year all-cause mortality and heart failure hospitalization were 30% (n = 66) and 37% (n = 76), with no differences between dFMR and pFMR. CONCLUSIONS: TEER resulted in more pronounced early FMR reduction in patients with dFMR compared with those with pFMR. Yet after initial improvement, FMR deteriorated in a substantial number of patients, calling into question durable mitral regurgitation reductions with TEER in selected patients. The proportionality framework may not identify durable TEER responders.

Center Valve Preference and Outcomes of Transcatheter Aortic Valve Replacement: Insights From the AMTRAC Registry.

BACKGROUND: Data on outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves (BEVs) or self-expandable valves (SEVs) as well as the impact of center valve preference on these outcomes are limited. OBJECTIVES: The aim of this study was to compare outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference. METHODS: In a multicenter registry (n = 17), 13 centers exhibited valve preference (66.6%-90% of volume) and were included. Outcomes were compared between BEVs and SEVs stratified by center valve preference. RESULTS: In total, 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs) were included. The mean age was 81 years, and the mean Society of Thoracic Surgeons score was 5.2. Baseline characteristics were similar between BEVs and SEVs. Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [P < 0.001] and 12.7% vs 10.0% [P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [P < 0.001] and 2.2% vs 1.4% [P = 0.162]; HR: 2.08; P for interaction < 0.01). Aortic regurgitation greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [P < 0.001] and 3.4% vs 3.7% [P = 0.504], respectively). Two-year mortality was higher with SEVs at BEV-dominant centers but not at SEV-dominant centers (21.9% vs 16.9% [P = 0.021] and 16.8% vs 16.5% [P = 0.642], respectively; HR: 1.20; P for interaction = 0.032). CONCLUSIONS: Periprocedural outcomes, aortic regurgitation greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers. Outcomes are similar regardless of valve type at SEV-dominant centers. The present results stress the need to account for this factor when comparing BEV and SEV outcomes. (The Aortic+Mitral Transcatheter [AMTRAC] Valve Registry; NCT04031274).

Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry.

BACKGROUND: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing. AIMS: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old. METHODS: All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups. RESULTS: Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715). CONCLUSIONS: Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. ((ClinicalTrials.gov: NCT04031274).

Management and Outcome of Failed Percutaneous Edge-to-Edge Mitral Valve Plasty: Insight From an International Registry.

OBJECTIVES: This study evaluated the incidence, management, and outcome of patients who experienced MitraClip (Abbott Vascular) failure secondary to loss of leaflet insertion (LLI), single leaflet detachment (SLD), or embolization. BACKGROUND: Transcatheter edge-to-edge repair with MitraClip is an established therapy for the treatment of mitral regurgitation (MR), but no data exist regarding the prevalence and outcome according to the mode of clip failure. METHODS: Between January 2009 and December 2020, we retrospectively screened 4,294 procedures of MitraClip performed in 19 centers. LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets. RESULTS: A total of 147 cases of MitraClip failure were detected (overall incidence = 3.5%), and these were secondary to LLI or SLD in 47 (31.9%) and 99 (67.3%) cases, respectively, whereas in 1 (0.8%) case clip embolization was observed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR, and 16 (10.8%) with mixed etiology. Although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%) including 4 cases of surgical conversion of the index procedure and 7 cases of bailout surgery after unsuccessful redo MitraClip. After a median follow-up of 163 days (IQR: 22-720 days), 50 (43.9%) subjects presented moderate to severe MR, and 43 (29.3%) patients died. An up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death. CONCLUSIONS: MitraClip failure secondary to LLI and SLD is not a rare phenomenon and may occur during and also beyond hospitalization. Redo MitraClip strategy demonstrates a trend toward a reduced risk of death compared with bailout surgery and conservative management. A third of those patients remained with more than moderate MR and had substantial mortality at the intermediate-term follow-up.

Accuracy of three-dimensional computational modeling in prediction of the dynamic neo left ventricular outflow tract with transcatheter mitral valve replacement.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) offers a valuable treatment option for inoperable patients suffering from a degenerated mitral valve after previous ring annuloplasty. Dynamic obstruction of the left ventricular outflow tract(LVOT) is a procedural risk with detrimental consequences and can be estimated upfront using a multi-slice computed tomography(MSCT) derived 3D computational model(3DCM). This study explored the accuracy of pre-procedural neo-LVOT prediction in TMVR using 3DCMs of multiple cardiac phases. METHODS: We obtained both pre- and post-procedural MSCT scans of a patient who underwent uncomplicated TMVR and derived 3DCMs from each cardiac phase. Virtual implantations of the deployed valve were performed and neo-LVOT dimensions were semi-automatically calculated in the pre-procedural models and matched with the post-procedural models. Predicted and post-procedural neo-LVOTs were compared between 3DCMs. RESULTS: From cardiac phases 20-70%, 11 matched 3DCM pairs were generated. The mean difference between predicted and post-TMVR neo-LVOT area was 3 ± 23 mm2. The intra-class correlation coefficient for absolute agreement between predicted and post-procedural neo-LVOT area was 0.86 (95%CI 0.56-0.96, p < 0.001). CONCLUSION: 3DCMs could accurately predict post-TMVR neo-LVOT dimensions in a patient with a pre-existing mitral annular ring. Prospective research is warranted to demonstrate the accuracy of these models in larger samples and different mitral annular phenotypes.