Search

Jeannette A Goudzwaard,1 Eleonora Disegna,1 Marjo JAG de Ronde-Tillmans,2 Mattie J Lenzen,2 Peter PT de Jaegere,2 Francesco US Mattace-Raso11Section of Geriatric Medicine, Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; 2Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the NetherlandsBackground: Both aortic valve stenosis and aortic stiffness are moderators of arterio ventricular coupling and independent predictors of cardiovascular morbidity and mortality. Studies on the effect of transcatheter aortic valve implantation (TAVI) on aortic functional properties are limited. We performed a study to investigate the possible short-term changes in aortic stiffness and other aortic functional properties after TAVI in older patients.Methods: TAVI Care&Cure is an observational ongoing study including consecutive patients undergoing a TAVI procedure. Central and peripheral hemodynamic measurements were measured non invasively 1 day before (T-1) and 1 day after (T+1) TAVI using a validated oscillometric method using a brachial cuff (Mobil-O-Graph).Results: 40 patients were included. Mean aortic valve area at baseline was 0.76±0.24 cm2. Indices of severity of aortic valve stenosis improved significantly. Systolic blood pressure (SBP) dropped by 8.5%, from 130.3±22.9 mmHg to 119.5±15.8 mmHg (p=0.005). Diastolic blood pressure (DBP) dropped by 13.1% from 74.8±14.5 mmHg to 65.0±11.3 mmHg (p

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)., Competing Interests: Declaration of competing interest Joost Daemen received institutional research support from Abbott Vascular, Boston Scientific, Medtronic, Pie Medical and PulseCath BV, and consultancy and speaker fees from Boston Scientific, ReCor, Pie Medical, Medtronic and PulseCath BV. Nicolas Van Mieghem received research grants from Abbott, Boston Scientific, Edwards Lifesciences, Teleflex, Medtronic, Daiichi Sankyo, PulseCath BV. All other authors declared no conflict of interest., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The mechanically-expandable transcatheter valve is no longer commercially available, yet clinical and echocardiographic surveillance is imperative for thousands of patients who received transcatheter aortic valve implantation (TAVI) with this platform., Aims: We aimed to determine the incidence and mechanism of bioprosthetic valve dysfunction (BVD) following TAVI with mechanically-expandable valves., Methods: From 2013 to 2020, all 234 patients who underwent TAVI with the LOTUS valve were included. BVD was categorised as (i) structural valve deterioration (SVD), (ii) non-structural valve dysfunction (NSVD), (iii) clinical valve thrombosis and (iv) endocarditis, according to the Valve Academic Research Consortium-3 criteria., Results: The mean age was 79±7 years, 60% were male, and the mean Society of Thoracic Surgeons score was 4.2±2.9%. The technical success rate was 94% and the 30-day device success rate was 78%. All-cause mortality at 1 year was 15%; median follow-up duration was 36 (IQR 18-60) months during which 47% of patients died. One hundred and three patients had ≥1 type of BVD (44%), which predominantly consisted of NSVD (39%, mostly because of ≥moderate patient-prosthesis mismatch). BVD during follow-up included endocarditis (3.4%), clinical valve thrombosis (3.4%) and SVD (1.3%). Both endocarditis and clinically apparent valve thrombosis occurred early and late after TAVI and resulted in valve-related deaths in 38% and 13% of patients, respectively. Overall, ≥moderate haemodynamic valve deterioration occurred in 5.5% and bioprosthetic failure in 7.3%, leading to valve-related deaths in 36% of cases., Conclusions: BVD represents a relevant health issue after TAVI with a mechanically-expandable valve. Serious but reversible causes of BVD include endocarditis and clinically apparent valve thrombosis, both carrying a time-independent hazard post-TAVI.

Background: Calcium is a determinant of paravalvular leakage (PVL) after transcatheter aortic valve implantation (TAVI). This is based on a fixed contrast attenuation value while X-ray attenuation is patient-dependent and without considering frame expansion and PVL location. We examined the role of calcium in (site-specific) PVL after TAVI using a patient-specific contrast attenuation coefficient combined with frame expansion., Methods: 57 patients were included with baseline CT, post-TAVI transthoracic echocardiography and rotational angiography (R-angio). Calcium load was assessed using a patient-specific contrast attenuation coefficient. Baseline CT and post-TAVI R-angio were fused to assess frame expansion. PVL was assessed by a core lab., Results: Overall, the highest calcium load was at the non-coronary-cusp-region (NCR, 436 mm 3 ) vs. the right-coronary-cusp-region (RCR, 233 mm 3 ) and the left-coronary-cusp-region (LCR, 244 mm 3 ), p < 0.001. Calcium load was higher in patients with vs. without PVL (1,137 vs. 742 mm 3 , p = 0.012) and was an independent predictor of PVL (odds ratio, 4.83, p = 0.004). PVL was seen most often in the LCR (39% vs. 21% [RCR] and 19% [NCR]). The degree of frame expansion was 71% at the NCR, 70% at the RCR and 74% at the LCR without difference between patients with or without PVL., Conclusions: Calcium load was higher in patients with PVL and was an independent predictor of PVL. While calcium was predominantly seen at the NCR, PVL was most often at the LCR. These findings indicate that in addition to calcium, specific anatomic features play a role in PVL after TAVI., Competing Interests: The authors have no financial conflicts of interest., (Copyright © 2022 Korean Society of Echocardiography.)

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., Competing Interests: Conflict of interest: J.D. received institutional research support from Abbott Vascular, Boston Scientific, Medtronic, Pie Medical and PulseCath BV, and consultancy and speaker fees from Boston Scientific, ReCor, Pie Medical, Medtronic and PulseCath BV. N.M.V.M. received research grants from Abbott, Boston Scientific, Edwards, Essential Medical/Teleflex, Medtronic, PulseCath BV. All other authors declared no conflict of interest regarding the publication of this article., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Background: The integration of computed tomography (CT)-derived left ventricular outflow tract area into the echocardiography-derived continuity equation results in the reclassification of a significant proportion of patients with severe aortic stenosis (AS) into moderate AS based on aortic valve area indexed to body surface area determined by fusion imaging (fusion AVA i ). The aim of this study was to evaluate AS severity by a fusion imaging technique in patients with low-gradient AS and to compare the clinical impact of reclassified moderate AS versus severe AS., Methods: We included 359 consecutive patients who underwent transcatheter aortic valve implantation for low-gradient, severe AS at two academic institutions and created a joint database. The primary endpoint was a composite of all-cause mortality and rehospitalisations for heart failure at 1 year., Results: Overall, 35% of the population (n = 126) were reclassified to moderate AS [median fusion AVAi 0.70 (interquartile range, IQR 0.65-0.80) cm 2 /m 2 ] and severe AS was retained as the classification in 65% [median fusion AVAi 0.49 (IQR 0.43-0.54) cm 2 /m 2 ]. Lower body mass index, higher logistic EuroSCORE and larger aortic dimensions characterised patients reclassified to moderate AS. Overall, 57% of patients had a left ventricular ejection fraction (LVEF) <50%. Clinical outcome was similar in patients with reclassified moderate or severe AS. Among patients reclassified to moderate AS, non-cardiac mortality was higher in those with LVEF <50% than in those with LVEF ≥50% (log-rank p = 0.029)., Conclusions: The integration of CT and transthoracic echocardiography to obtain fusion AVAi led to the reclassification of one third of patients with low-gradient AS to moderate AS. Reclassification did not affect clinical outcome, although patients reclassified to moderate AS with a LVEF <50% had worse outcomes owing to excess non-cardiac mortality., (© 2020. The Author(s).)

With innovations in therapeutic technologies and changes in population demographics, transcatheter interventions for structural heart disease have become the preferred treatment and will keep growing. Yet, a thorough clinical selection and efficient pathway from diagnosis to treatment and follow-up are mandatory. In this review we reflect on how artificial intelligence may help to improve patient selection, pre-procedural planning, procedure execution and follow-up so to establish efficient and high quality health care in an increasing number of patients., (Copyright © 2021. Published by Elsevier Inc.)

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., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Introduction: We aimed to compare conduction dynamics and need for permanent pacemaker implantation (PPI) after CoreValve, Evolut R and PRO (transcatheter aortic valve replacement (TAVR))., Methods: Patients were stratified based on conduction at baseline; Cohort A had normal conduction, Cohort B had conduction abnormalities including atrioventricular (AV)-block, fascicular block or complete bundle branch block. Three different dynamic QRS-patterns were defined: stable QRS-duration, transient QRS-prolongation and persistent QRS-prolongation. We performed multivariable regression analysis to estimate the effect of the three separate transcatheter heart valves (THV's) on need for PPI at 30 days., Results: TAVR was performed with CoreValve (N = 113), Evolut R (N = 157) or Evolut PRO (N = 92). Conduction dynamics were similar between the different THVs. Overall, Evolut R and PRO showed a tendency towards less PPI compared to CoreValve (17% vs. 19% vs. 27%, P = 0.08), which was driven by a lower PPI rate in Cohort A (6% vs. 11% vs. 25%, P = 0.002). Need for PPI was restricted to patients with persistent QRS-prolongation in Cohort A (26/106) but did not correlate with conduction dynamics in Cohort B. In multivariable logistic regression analysis the use of Evolut R (OR 0.38, 95% CI 0.19-0.78, P = 0.008) and PRO (OR 0.41, 95% CI 0.19-0.91, P-value = 0.028) were independently associated with less need for PPI., Conclusion: The newer generations Evolut R and PRO were associated with less PPI compared to CoreValve. Acquired persistent conduction abnormalities predicted PPI after TAVR only in patients with normal conduction at baseline. Our findings may help identify eligible patients for early discharge after Evolut R/PRO TAVR., Competing Interests: Declaration of competing interest HK:no conflicts of interest to declare. LVG:no conflicts of interest to declare. MVW:no conflicts of interest to declare. JO:no conflicts of interest to declare. FZ:no conflicts of interest to declare. ZR:no conflicts of interest to declare. NEF:no conflicts of interest to declare. AM:no conflicts of interest to declare. IK:no conflicts of interest to declare. JD:no conflicts of interest to declare. PDJ:is proctor for Boston Scientific. NVMhas received research grants from Medtronic, Boston scientific, Edwards Lifesciences, Abbott, PulseCath. He is advisor to PulseCath, Ancora, Boston Scientific, Medtronic., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

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 mm 2 , and 107 mL/m 2 (IQR, 90-135 mL/m 2 ), 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., (Copyright © 2021 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)

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., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

A plethora of catheter-based strategies have been developed to treat mitral valve disease. Evolving 3-dimensional (3D) multidetector computed tomography (MDCT) technology can accurately reconstruct the mitral valve by means of 3-dimensional computational modeling (3DCM) to allow virtual implantation of catheter-based devices. 3D printing complements computational modeling and offers implanting physician teams the opportunity to evaluate devices in life-size replicas of patient-specific cardiac anatomy. MDCT-derived 3D computational and 3D-printed modeling provides unprecedented insights to facilitate hands-on procedural planning, device training, and retrospective procedural evaluation. This overview summarizes current concepts and provides insight into the application of MDCT-derived 3DCM and 3D printing for the planning of transcatheter mitral valve replacement and closure of paravalvular leaks. Additionally, future directions in the development of 3DCM will be discussed., Competing Interests: Funding Support and Author Disclosures Dr. Wang has served as a consultant for Edwards Lifesciences, Boston Scientific, and Materialise. Dr. Redwood has served as a proctor and consultant for Edwards Lifesciences. Dr. Popma has received institutional grants from Medtronic, Boston Scientific, Edwards Lifesciences, and Abbott; and is a member of the Medical Advisory Board of Edwards Lifesciences. Dr. Little has served as a consultant for Abbot Cardiovascular and Medtronic; and has received a research grant from Siemens Health. Dr. Pfeiffer has served as a consultant for LivaNova Inc.; and has served as a speaker and proctor for Edwards Lifesciences and Abbott Cardiovascular. Dr. Dahle has served as a proctor for Abbot Cardiovascular. Mrs. Minet is a former employee of Materialise NV. Dr. O’Neill has served as a consultant for Boston Scientific. Dr. Van Mieghem has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has served as a consultant for Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Pie Medical, and Materialise NV. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background The need for new permanent pacemaker implantation (PPI) after Transcatheter Aortic Valve Implantation (TAVI) remains a critical issue. Membranous Septum (MS) length is associated with PPI after TAVI. The aim of this study was to identify different MS thresholds for the contemporary THV-platforms. Methods This retrospective, case-control study enrolled all patients who underwent a successful TAVI procedure with contemporary THV-platforms in the Erasmus University Medical Center between January 2016 and March 2020. The follow-up period for new PPI was 30 days. MS-length was determined by Computed Tomography. Results The study consisted 653 TAVI patients with median age 80.6 years (IQR 74.7-84.8). New PPI occurred in 120 patients (18.4%). Patients with new PPI had a shorter MS-length (2.9 mm (IQR 2.3-4.3) vs. 4.2 mm (IQR 2.9-5.7), p < 0.001). MS-length < 3 mm identified a high-risk phenotype with 30.3% PPI-rate (OR 6.5 [95%CI 2.9-14.9]), MS-length 3-6 mm an intermediate-risk phenotype with 15.4% PPI-rate (OR 2.7 [95%CI 1.2-6.2]) and MS > 6 mm a low-risk phenotype with a 6.3% PPI-rate (reference). For the Lotus valve, there was no significant difference in PPI-rates between the high-risk (45.8%, OR 3.5 [95%CI 0.8-15.1]) and low-risk group (20%). By multivariate analysis MS-length, Agatston-score, use of Lotus valve, and ECG with first-degree AV block, RBBB or bifascular block were independent predictors for new PPI. Conclusion MS-length was an independent predictor for new PPI post-TAVI. Three phenotypes were found based on MS-length. MS < 3 mm was universally associated with a high risk for new PPI (>30%). MS > 6 mm represented a low-risk phenotype with PPI-rate < 10%. PPI-rate varied per THV type in the intermediate phenotype. PPI-rate with Lotus was high regardless of MS-length., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

Little data are available on access strategy outcomes for cardiac catheterizations in patients with prior coronary artery bypass graft surgery (CABG). We investigated the effect of transradial access (TRA) and transfemoral access (TFA) on short-term major vascular complications (MVC) and long-term major adverse cardiovascular events (MACE). In this single-center, retrospective cohort study, 1084 patients met our inclusion criteria (TRA = 469; TFA = 615). The cumulative incidence for the primary safety endpoint MVC at 30 days (a composite of major bleeding, retroperitoneal hematoma, dissection, pseudoaneurysm, and arteriovenous fistula) was lower with TRA (0.7% vs 3.0%, P < .01) and this difference remained significant after propensity score adjustment (odds ratio: 0.24; 95% CI, 0.07-0.83; P = .024). The cumulative incidence for the primary efficacy endpoint MACE at 36 months (a composite of all-cause mortality, myocardial infarction, stroke, and urgent target vessel revascularization) was 28.6% with TRA and 27.6% with TFA, respectively. Kaplan-Meier curves showed no difference for the primary efficacy endpoint ( P = .65). Contrast use (mL) was significantly lower with TRA (130 [100-180] vs 150 [100-213], P < .01). In conclusion, in patients with prior CABG, TRA was associated with significantly fewer short-term MVC and contrast use, but not with a difference in long-term MACE, compared with TFA.

Objectives: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers., Background: The MANTA is a novel plug-based device for large bore arteriotomy closure., Methods: We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications., Results: Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications., Conclusion: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions., (© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: The axillary artery is an alternative route for patients with comorbidities and unfavorable femoral arteries who need transcatheter aortic valve replacement (TAVR). Simplified trans-axillary transcatheter aortic valve replacement (TAx-TAVR) implies a completely percutaneous approach under local anesthesia and arteriotomy closure with vascular closure techniques. Herein, we report on early experience with simplified TAx-TAVR under local anesthesia., Methods: We enrolled all consecutive patients who underwent simplified TAx-TAVR in our center. Main study parameter was the incidence of axillary access related major vascular complications within 30 days. Secondary parameters included a composite early safety endpoint, axillary access-site related vascular/bleeding complications and short-term mortality. Post TAVR axillary stent patency was evaluated during follow-up by CT-analysis., Results: Between July 2018 and April 2020, Tax-TAVR was attempted in 35 patients with a mean age of 79 years. Local anesthesia and conscious sedation were used in 91.4% (n = 32) and 8.6% (n = 3) respectively. A covered stent was needed for complete axillary hemostasis in 44.1% (n = 15). Device success was achieved in 91.2% (n = 31/34). The 30-day axillary artery major vascular and ≥major bleeding complication rates were 14% (n = 5) and 11% (n = 4). The early safety endpoint was reached in 22.9% (n = 8). Mortality rates at 30 days and six months were 2.9% and 11.6%. Computed tomography (CT) confirmed axillary stent patency during follow-up in 82% (n = 9/11)., Conclusions: In patients with high/prohibitive surgical risk and unsuitable femoral access, simplified TAx-TAVR under local anesthesia offers a valuable alternative for transfemoral TAVR but requires advanced access site management techniques including covered stents. Our data suggest an unmet clinical need for dedicated TAx closure devices., Competing Interests: Declaration of competing interest Professor Van Mieghem has received a research grant support from Boston Scientific, Edwards Lifesciences, Abbott Vascular and PulseCath B.V. which were received for activities outside the submitted work. Dr. Daemen received institutional grant/research support from Astra Zeneca, Abbott Vascular, Boston Scientific, ACIST Medical, Medtronic, Pie Medical, ReCor Medical and PulseCath, and consultancy and speaker fees from ACIST Medical, Boston Scientific, ReCor Medical, Pie Medical, Medtronic and PulseCath. The other authors have no conflict of interest to declare., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD., Background: Vascular complications after TAVR are relevant and often associated with VCD failure., Methods: The MASH (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) trial is an international, 2-center pilot randomized controlled trial comparing the MANTA VCD (Teleflex, Wayne, Pennsylvania) versus 2 ProGlides (Abbott Vascular, Abbott Park, Illinois). The primary composite endpoint consisted of access site-related major or minor vascular complications at 30-days' follow-up. Secondary endpoints included clinically relevant access site bleeding, time to hemostasis, and modified VCD failure (defined as failure to achieve hemostasis within 5 min or requiring additional endovascular maneuvers such as endovascular stenting, surgical techniques, or additional closure devices). Adverse events were adjudicated by an independent clinical events committee according to the VARC-2 definitions., Results: A total of 210 TAVR patients were included between October 2018 and January 2020. Median age was 81 years, 54% were male, and the median STS score was 2.7%. There was no significant difference in the primary endpoint of access site-related vascular complications between MANTA and ProGlide (10% vs. 4%; p = 0.16). Clinically significant access site bleedings were similar with both closure techniques (9% vs. 6%; p = 0.57). Modified VCD failure occurred less frequently in MANTA versus ProGlide (20% vs. 40%; p < 0.01). Suture-based closure required more often additional closure devices, whereas MANTA numerically needed more covered stents and surgical bailouts., Conclusions: Plug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers., Competing Interests: Author Disclosures Dr. Tchétché has been a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and 4Tech. Dr. Daemen has received institutional research support from Abbott Vascular, Boston Scientific, Medtronic, Pie Medical, and PulseCath BV; and has received consultancy and speaker fees from Boston Scientific, ReCor, Pie Medical, Medtronic, and PulseCath BV. Dr. Dumonteil has received consultancy and proctoring fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Van Mieghem has received research grants and advisory fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Essential Medical/Teleflex, Medtronic, and PulseCath BV. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

Precision medicine has recently become widely advocated. It revolves around the individual patient, taking into account genetic, biomarker, phenotypic or psychosocial characteristics and uses biological, mechanical and/or personal variables to optimise individual therapy. In silico testing, such as the Virtual Physiological Human project, is being promoted to predict risk and to test treatments and medical devices. It combines artificial intelligence and computational modelling to select the best therapeutic option for the individual patient., Competing Interests: Conflicts of interest: The authors have no conflicts of interest to declare., (Copyright © 2020, Radcliffe Cardiology.)

Objectives: To assess the performance of the commercially available Magmaris sirolimus-eluting bioresorbable scaffold (BRS) with invasive imaging at different time points., Background: Coronary BRS with a magnesium backbone have been recently studied as an alternative to polymeric scaffolds, providing enhanced vessel support and a faster resorption rate. We aimed to assess the performance of the commercially available Magmaris sirolimus-eluting BRS at different time points., Methods: A prospective, single-center, nonrandomized study was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. Six patients with stable de novo coronary artery lesions underwent single-vessel revascularization with the Magmaris sirolimus-eluting BRS. Invasive follow-up including intravascular imaging using optical coherence tomography (OCT) was performed at different time points., Results: At a median of 8 months (range 4-12 months) target lesion failure occurred in one patient. Angiography revealed a late lumen loss of 0.59 ± 0.39 mm, a percentage diameter stenosis of 39.65 ± 15.81%, and a binary restenosis rate of 33.3%. OCT showed a significant reduction in both minimal lumen area (MLA) and scaffold area at the site of the MLA by 43.44 ± 28.62 and 38.20 ± 25.74%, respectively. A fast and heterogeneous scaffold degradation process was found with a significant reduction of patent struts at 4-5 months., Conclusions: Our findings show that the latest iteration of magnesium BRS suffers from premature dismantling, resulting in a higher than expected decrease in MLA., (© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

Aims: To correlate dynamics in electrical conduction after transcatheter aortic valve implantation (TAVI) with need for permanent pacemaker implantation (PPM) and assess implications for early discharge., Methods and Results: Daily electrocardiograms after TAVI were analysed for rhythm and conduction times and were correlated with PPM. Transcatheter aortic valve implantation was performed in 291 consecutive patients with three contemporary transcatheter heart valve designs: Medtronic CoreValve (n = 111), Edwards Sapien XT (n = 29) and Sapien 3 (n = 72), and Boston Lotus (n = 79). We considered two cohorts: (A) Patients with normal baseline conduction; and (B) patients with pre-existent conduction disturbances. Based on QRS dynamics, three patterns were discerned: stable normal QRS duration, transient QRS prolongation, and persistent QRS prolongation. In Cohort B, QRS dynamics did not correlate with PPM. In contrast, in Cohort A, QRS dynamics and PPM appeared highly correlated. Neither patients with stable normal QRS duration (0/47), nor patients with transient QRS prolongation required PPM (0/26). All PPMs occurred in patients with persistent QRS prolongation until discharge (27/85). Persistent QRS prolongation was typically seen with Lotus and CoreValve, whereas stable normal QRS duration was typically seen with Sapien XT and Sapien 3., Conclusion: Three distinct patterns of QRS dynamics can be discerned after TAVI and their predictive probabilities for PPM strongly relate to the baseline conduction status. Patients with normal conduction at baseline and stable QRS duration after TAVI are potentially eligible for early discharge.

Moderate aortic stenosis (AS) and reduced left ventricular ejection fraction (LVEF) constitute a clinical entity that has been proposed as a therapeutic target for transcatheter aortic valve replacement (TAVR). It is defined by a mean trans-aortic gradient between 20 and 40 mmHg and an aortic valve area between 1.0 and 1.5 cm 2 in patients with LVEF < 50%. Retrospective data suggests a prevalence of 0.8% among patients referred for echocardiographic assessment. These patients are younger and show a higher frequency of previous myocardial infarction than those with severe AS randomized to TAVR in recent trials. In two retrospective studies including patients with moderate AS and reduced LVEF, a one-year mortality rate of 9 and 32% was reported, the latter in patients treated with medical therapy only during follow-up. Echocardiographic diagnosis of moderate AS poses challenges as current guidelines are directed to determine severe AS, and different presentations of moderate and mild AS have been generally neglected. Thus, the nomenclature would need to be revised and a description of possible scenarios is provided in this review. Dobutamine stress echocardiography and computed tomography are promising complementary tools. Likewise, a standardized clinical pathway is needed, in which a high level of suspicion and a low threshold for referral to a heart valve center is warranted. The Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with Advanced heart failure (TAVR UNLOAD) trial (NCT02661451) is exploring whether TAVR would improve outcomes in patients receiving optimal heart failure therapy.

Background and Aims: Significant left main (LM) stem disease is potentially life-threatening and mandates revascularization. This study aimed to assess how patients rate the importance of particular features of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), how this determines their preference for a particular treatment strategy, and whether particular personality characteristics influence this preference., Methods and Results: In total, 1145 patients who visited the outpatient clinic of the Erasmus Medical Center for stable coronary artery disease were asked to complete a case vignette-questionnaire on a hypothetical significant LM stenosis amenable to PCI or CABG. To assess the individual's personality disposition and general distress level, each patient had to complete a set of 3 standardized, validated questionnaires with satisfactory psychometric properties. Overall 89% of patients preferred PCI to CABG. PCI was the preferred strategy despite a higher risk for repeat revascularization and need for more medication. Remarkably, the fact that a risk for repeat revascularization is more common in the PCI group is less important for the patients who opt for PCI. Risk for stroke and bleeding were the most important arguments to opt for PCI over CABG. Type D personality, depression, and anxiety were all associated with a relatively higher preference for CABG as revascularization strategy., Conclusion: Overall, when given the choice patients seem to have a clear preference for PCI over CABG and consider stroke and bleeding important procedure-related complications. Patients with Type D personality, depression, or anxiety favor CABG., (Copyright © 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe symptomatic aortic stenosis (AS) considered at very high risk for surgical aortic valve replacement. The purpose of this sub-study was to evaluate long-term (> 4 years) health-related quality of life (QoL) in octogenarians who underwent TAVI., Methods: A single center observational registry in twenty patients who underwent frame analysis assessment ≥ 4 years after TAVI. Health-related QoL was evaluated, using the Short Form-36 (SF-36), the EuroQoL-5D (EQ-5D) and the visual analogue score (EQ-VAS) questionnaires., Results: The mean SF-36 subscale scores at follow-up were physical functioning 40.8 ± 26.3, role physical functioning 67.7 ± 34.9, vitality 54.6 ± 21.6, general health 52.1 ± 20.4, social functioning 63.8 ± 37.7, role emotional functioning 70.2 ± 36.0, mental health 73.2 ± 23.3 and bodily pain 80.9 ± 22.9. The mean EQ-VAS score > 4 years after TAVI was 64.7 ± 15.1. With respect to functional class, 80% of the patients were in NYHA class I/II at follow-up compared to 15% prior to TAVI., Conclusions: This sub-study reports a significant improvement in functional class (NYHA) in a selected group of very elderly patients > 4 years after TAVI. Furthermore, all patients showed a satisfactory QoL despite their age and multiple comorbidities. In addition, our study reveals a lower QoL when compared with the general age matched Dutch population.

Objectives: To evaluate the value of left vertebral artery filter protection in addition to the current filter-based embolic protection technology to achieve complete cerebral protection during TAVR., Background: The occurrence of cerebrovascular events after transcatheter aortic valve replacement (TAVR) has fueled concern for its potential application in younger patients with longer life expectancy. Transcatheter cerebral embolic protection (TCEP) devices may limit periprocedural cerebrovascular events by preventing macro and micro-embolization to the brain. Conventional filter-based TCEP devices cover three extracranial contributories to the brain, yet leave the left vertebral artery unprotected., Methods: Patients underwent TAVR with complete TCEP. A dual-filter system was deployed in the brachiocephalic trunk and left common carotid artery with an additional single filter in the left vertebral artery. After TAVR all filters were retrieved and sent for histopathological evaluation by an experienced pathologist., Results: Eleven patients received a dual-filter system and nine of them received an additional left vertebral filter. In the remaining two patients, the left vertebral filter could not be deployed. No periprocedural strokes occurred. We found debris in all filters, consisting of thrombus, tissue derived debris, and foreign body material. The left vertebral filter contained debris in an equal amount of patients as the Sentinel filters. The size of the captured particles was similar between all filters., Conclusions: The left vertebral artery is an important entry route for embolic material to the brain during TAVR. Selective filter protection of the left vertebral artery revealed embolic debris in all patients. The clinical value of complete filter-based TCEP during TAVR warrants further research., (© 2017 Wiley Periodicals, Inc.)

Background: Coronary artery perforation (CAP) is a potentially lethal complication of percutaneous coronary intervention. We report on the incidence, clinical characteristics, and management of iatrogenic coronary perforations based on an 11-year single-center experience., Methods and Results: From February 9, 2005, through November 20, 2016, 150 CAP cases were identified from our percutaneous coronary intervention database of 21 212 procedures (0.71%). Mean age of CAP patients was 66±11 years, and 62.7% were male. Treated lesion type was B2/C in 94.6%, and 31.3% were chronic total occlusions. Nonworkhorse guidewires were applied in 74.3%. CAP types were Ellis type I in 2.9%, Ellis type II in 40.4%, Ellis type III in 54.8%, and Ellis type III cavity spilling in 1.9%. CAP treatment was conservative (including prolonged balloon inflation) in 73.3%. Covered stents, coiling, and fat embolization were used in 24.0%, 0.7%, and 2.0%, respectively. Pericardiocentesis for tamponade was required for 72 patients (48.0%), of whom 28 were initially unrecognized. Twelve patients (12.7%) required emergency cardiac surgery to alleviate tamponade. Periprocedural myocardial infarction occurred in 34.0%, and in-hospital all-cause mortality was 8.0%. All-cause mortality accrued to 10.7% at 30 days and 17.8% at 1 year., Conclusions: CAP is a rare complication of percutaneous coronary intervention, but morbidity and mortality are considerable. Early recognition and adequate management are of paramount importance., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Backgkground: The aim of this paper was to explore the determinants of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using multi-slice computed tomography (MSCT) instead of echocardiography-guided sizing., Methods: Determinants of AR were assessed in 313 consecutive patients who underwent TAVI with the Medtronic (MCS, N.=259) or Edwards Sapien or XT (ESV, N.=54) using MSCT-guided sizing. AR was assessed by angiography immediately after TAVI (N.=313, Sellers) and by echocardiography at discharge (N.=285, VARC-2). Distinction was made between patients with grade 0-1 and grade ≥2 AR post-TAVI., Results: AR≥2 post-TAVI was seen in 91 patients or 29% (MCS 85/259: 33% vs. ESV 6/54:11%) by angiography and 94 patients or 33% (MCS 87/239:36% vs. ESV 7/46:15%) by echocardiography. By univariable analysis, patients with AR≥2 post TAVI had more AR≥2 at baseline (70% vs. 52%, P=0.003), a larger mean and maximal annulus diameter (25.0 [23.5-26.3] vs. 24.0 [22.6-26.0], P=0.025 and 27.9±2.7 mm vs. 27.0±2.8 mm, P=0.018, respectively) and a higher Agatston Score (3.9 [2.9-5.3] vs. 2.6 [1.8-3.8], P≤0.001). AR≥2 post-TAVI was more frequent after MCS than ESV (33% vs. 11%, P=0.001). There was no difference in nominal valve size relative to the patient's annulus, nor depth of implantation. By propensity score adjusted multivariable analysis, AR≥2 at baseline (odds 2.407 [95% CI: 1.472-3.938]) but above all MCS (odds: 6.047 [95% CI; 1.307- 27.976]) were independent determinants of AR≥2 post-TAVI. The latter was also confirmed by propensity score adjusted multivariable analysis in the echocardiography population (N.=285) (odds: 5.259 [95% CI; 1.070-25.851])., Conclusions: AR≥2 is more prevalent after MCS valve implantation and is an independent determinant of AR also when using MSCT guided-sizing.

Background: A new-generation everolimus eluting platinum-chromium stent (EePCS), offering improved radial strength, radiopacity and conformability compared to everolimus-eluting cobalt-chromium stents (EeCCS), was evaluated with regard to safety and efficacy in an all-comer cohort., Methods: A total of 1000 consecutive all-comer patients (including acute coronary syndrome, multivessel disease, calcified lesions) treated with an EePCS (Promus Premier™, Boston Scientific, Natick, Massachusetts) from May 2013 to October 2014 were compared to 1000 consecutive patients treated with an EeCCS (Xience Prime™, Abbott Vascular, Santa Clara, California) from April 2012 to May 2013. Patients were clinically followed for 1year., Results: Mean age was 66±12years with diabetes in 20.7%, previous infarction in 22.7%, and ACS as the indication in 71.2% of patients. The mean number of stents per patient was 1.8±1.13. Total stented length was 35±25mm. Lesion classification was B2/C in 73.9% of patients. At 1year the primary endpoint of major adverse cardiac events (all-cause mortality, myocardial infarction [MI], ischemia-driven target vessel revascularization [TVR]) was reached in 11.7% in the EePCS cohort and 10.9% in the EeCCS cohort (adjusted HR 1.01 [0.77-1.33]; p=0.95). No significant differences were noted in the individual clinical endpoints all-cause mortality (6.8% versus 6.4%), MI (2.2% versus 2.3%), and TVR (4.3% versus 3.7%) in the respective EePCS and EeCCS cohorts. Stent thrombosis occurred in 0.8% and 1.0% respectively., Conclusions: In all-comer patients undergoing percutaneous coronary intervention, the use of EePCS was associated with similar 1-year clinical outcome as compared to EeCCS., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Limited data are currently available on the performance of everolimus eluting bioresorbable vascular scaffold (BVS) for treatment of complex coronary lesions representative of daily practice., Methods: This is a prospective, mono-center, single-arm study, reporting data after BVS implantation in patients presenting with stable, unstable angina, or non-ST segment elevation myocardial infarction caused by de novo stenotic lesions in native coronary arteries. No restrictions were applied to lesion complexity. Procedural results and 12-month clinical outcomes were reported., Results: A total of 180 patients have been evaluated in the present study, with 249 treated coronary lesions. Device Success per lesion was 99.2%. A total of 119 calcified lesions were treated. Comparable results were observed among severe, moderate and noncalcified lesions in term of %diameter stenosis (%DS) (20.3 ± 10.5%, 17.8 ± 7.7%, 16.8 ± 8.6%; P = 0.112) and acute gain (1.36 ± 0.41 mm, 1.48 ± 0.44 mm, 1.56 ± 0.54 mm; P = 0.109). In bifurcations (54 lesions), side-branch ballooning after main vessel treatment was often performed (33.3%) with low rate of side-branch impairment (9.3%). A total of 29 cases with coronary total occlusions were treated. After BVS implantation %DS was not different from other lesion types (17.2 ± 9.4%, vs. 17.7 ± 8.6%; P = 0.780). At one year, all-cause mortality was reported in three cases. The rate of target lesion revascularization and target vessel revascularization was 3.3%. The rate of definite scaffold thrombosis was 2.6%., Conclusions: The implantation of the everolimus eluting bioresorbable vascular scaffold in an expanded range of coronary lesion types and clinical presentations was observed to be feasible with promising angiographic results and mid-term clinical outcomes. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background: Left ventricular (LV) systolic dysfunction and moderate aortic stenosis (AS) are more frequent with advancing age and often coexist. Afterload reduction is the mainstay of pharmacological treatment of heart failure (HF). Aortic valve replacement (AVR) is only formally indicated for symptomatic severe AS., Objectives: This study sought to determine the clinical outcome of patients with concomitant moderate AS and LV systolic dysfunction., Methods: Echocardiographic and clinical data of patients with moderate AS and LV systolic dysfunction between 2010 and 2015 from 4 large academic institutions were retrospectively analyzed. Moderate AS was defined as aortic valve area between 1.0 and 1.5 cm 2 and LV systolic dysfunction defined as LV ejection fraction <50%. The primary endpoint was a composite of all-cause death, AVR, and HF hospitalization., Results: A total of 305 patients (mean age 73 ± 11 years; 75% male) were included. The majority were symptomatic at the time of index echocardiogram (New York Heart Association [NYHA] functional class II: 42%; NYHA functional class III: 28%; and NYHA functional class IV: 4%). Ischemic heart disease was present in 72% of patients. At 4-year follow-up, the primary composite endpoint occurred in 61%. The main predictors for the primary endpoint were male sex (p = 0.022), NYHA functional class III or IV (p < 0.001), and peak aortic jet velocity (p < 0.001). The rate of the composite of all-cause death or HF hospitalization was 48%, rate of all-cause death was 36%, and rate of HF hospitalization was 27%. AVR occurred in 24% of patients., Conclusions: Patients with concomitant moderate AS and LV systolic dysfunction are at high risk for clinical events. Further studies are needed to determine if earlier AVR in these patients might improve clinical outcome., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Previous studies have reported the safety and feasibility of both time-domain optical coherence tomography (TD-OCT) and Fourier-domain OCT (FD-OCT) in highly selected patients and clinical settings. However, the generalizability of these data is limited, and data in unselected patient populations reflecting a routine cathlab practice are lacking. We compared safety of intracoronary FD-OCT imaging to intravascular ultrasound (IVUS) imaging in a large real-world series of consecutive patients who underwent invasive imaging during coronary catheterization in our centre., Methods and Results: This is a prospective, single-centre registry of patients scheduled for coronary angiography or intervention undergoing intracoronary imaging with FD-OCT or IVUS between April 2008 and December 2013. Intra-procedural and major in-hospital adverse events that could be possibly related to invasive imaging were registered routinely by the operator as part of our clinical report and prospectively recorded in our database. These events were retrospectively individually adjudicated by an independent safety committee. Between April 2008 and December 2013, 13 418 diagnostic or interventional coronary catheterization procedures were performed. Of these, 1142 procedures used OCT and 2476 procedures used IVUS. Invasive imaging-related complications were rare, did not differ between the two imaging methods (OCT: n = 7, 0.6%; IVUS: n = 12, 0.5%; P = 0.6), and were self-limiting after retrieval of the imaging catheter or easily treatable in the catheterization laboratory. No major adverse events, prolongation of hospital stay, or permanent patient harm was observed., Conclusion: FD-OCT is safe in an unselected and heterogeneous group of patients with varying clinical settings., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Objectives: The authors sought to study the safety and efficacy of the MANTA Vascular Closure Device (VCD), a novel collagen-based technology dedicated to closure of large-bore arteriotomies., Background: Novel transfemoral therapeutic interventions requiring large-bore catheters have become valid minimally invasive options but have inherent access management challenges. To date, no dedicated vascular closure devices exist for large arteriotomies., Methods: A prospective, single-arm clinical investigation enrolling patients who underwent elective percutaneous interventions with large-bore catheters and planned percutaneous arteriotomy closure in 3 European institutions., Results: A total of 50 patients with a mean age of 79.5 ± 8.3 years underwent high-risk percutaneous coronary intervention, balloon aortic valvuloplasty, or transcatheter aortic valve replacement with large-bore catheters sized 12-F to 19-F. MANTA closure was performed by 9 different operators. The 14-F MANTA VCD was deployed in one-third of the overall cohort (16 of 50, 32%), and the 18-F MANTA VCD in the remainder. The MANTA VCD was deployed successfully in all patients. The mean time to hemostasis was 2 min, 23 s. One patient had a major vascular and major bleeding complication with prolonged femoral bleeding that was successfully treated with a covered stent and eventual surgical repair. There were no other access site-related complications., Conclusions: This first multicenter experience demonstrates rapid and reliable hemostasis and low complication rates with the use of the plug-based MANTA VCD for large-bore arteriotomy closure., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM implantations in patients with pre-existent right bundle branch block and categorize for different transcatheter heart valves., Methods and Results: We pooled data on 306 transcatheter aortic valve replacement patients from 4 high-volume centers in Europe and selected those with right bundle branch block at baseline without a previously implanted PPM. Logistic regression was used to evaluate whether PPM rate differed among transcatheter heart valves after adjustment for confounders. Mean age was 83±7 years and 63% were male. Median Society of Thoracic Surgeons score was 6.3 (interquartile range, 4.1-10.2). The following transcatheter valve designs were used: Medtronic CoreValve (n=130; Medtronic, Minneapolis, MN); Edwards Sapien XT (ES-XT; n=124) and Edwards Sapien 3 (ES-3; n=32; Edwards Lifesciences, Irvine, CA); and Boston Scientific Lotus (n=20; Boston Scientific Corporation, Marlborough, MA). Overall permanent pacemaker implantation rate post-transcatheter aortic valve replacement was 41%, and per valve design: 75% with Lotus, 46% with CoreValve, 32% with ES-XT, and 34% with ES-3. The indication for PPM implantation was total atrioventricular block in 98% of the cases. Lotus was associated with a higher PPM rate than all other valves. PPM rate did not differ between ES-XT and ES-3. Ventricular paced rhythm at 30-day and 1-year follow-up was present in 81% at 89%, respectively., Conclusions: Right bundle branch block at baseline is associated with a high incidence of PPM implantation for all transcatheter heart valves. PPM rate was highest for Lotus and lowest for ES-XT and ES-3. Pacemaker dependency remained high during follow-up., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. The objective of this paper is to present such a model and illustrate its potential clinical utility via a few case studies., Competing Interests: Conflict of interestN. El Faquir, B. Ren, N.M. Van Mieghem, J. Bosmans and P.P. de Jaegere declare that they have no competing interests.

Aims: Left bundle branch block (LBBB) is induced in approximately one-third of all transcatheter aortic valve implantation (TAVI) procedures. We investigated electrophysiological remodelling in patients with TAVI-induced LBBB., Methods and Results: This retrospective study comprises 107 patients with initially narrow QRS complex of whom 40 did not and 67 did develop persistent LBBB after TAVI. 12-lead electrocardiograms (ECGs) taken before TAVI, within 24 hours ('acute'), and 1-12 months after TAVI ('chronic') were used to reconstruct vectorcardiograms. From these vectorcardiograms, QRS and T-wave area were calculated as comprehensive indices of depolarization and repolarization abnormalities, respectively. TAVI-induced LBBB resulted in significant acute depolarization and repolarization changes while further repolarization changes were observed with longer lasting LBBB. The amount of long-term repolarization changes (remodelling) was highly variable between patients. The change in T-wave area between acute and chronic LBBB ranged from +57% to - 77%. After dividing the LBBB cohort into tertiles based on the change in T-wave area, only baseline QRS area was larger in the tertile with no significant change in T-wave area. During longer lasting LBBB, the spatial vector gradient (SVG) changed orientation towards the direction of the QRS-vector, indicating that later-activated regions developed shorter action potential duration., Conclusion: This study in patients with TAVI-induced LBBB shows that repolarization changes develop within months after onset of LBBB, and that these changes are highly variable between individual patients., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For Permissions, please email: journals.permissions@oup.com.)

Aims: We sought to evaluate the impact of permanent pacemaker (PPM) implantation on two-year mortality and one-year left ventricular ejection fraction recovery (∆LVEFR=one-year LVEF-baseline LVEF) after transcatheter aortic valve implantation (TAVI)., Methods and Results: We pooled patient-level data from four European institutions with significant TAVI volume. Outcomes were compared between patients without PPM (no-PPM), patients with PPM prior to TAVI (old-PPM) and patients with PPM implanted after TAVI (new-PPM). Out of 1,062 patients included in the pooled data set, 783 (73.7%) were in the no-PPM group, 164 (15.4%) in the new-PPM group and 115 (10.8%) in the old-PPM group. All-cause and cardiovascular mortality at two years were similar for patients with no-PPM and new-PPM (adjusted HR 1.11, 95% CI: 0.74-1.67; p=0.62; and adjusted HR 1.16, 95% CI: 0.68-1.98; p=0.59). Conversely, old-PPM was associated with increased risk of both all-cause and cardiovascular mortality vs. no-PPM. By multivariable analysis new-PPM did not affect LVEFR, while old-PPM did. We observed a multiplicative interaction, between new-PPM and post-procedural aortic regurgitation ≥1+ on two-year mortality and one-year LVEFR, with increased risk of death and impaired LVEFR in patients with new-PPM and post-procedural aortic regurgitation (PPAR) ≥1+ (both pinteraction<0.0001)., Conclusions: In patients undergoing TAVI, the presence of a PPM at baseline yielded a negative effect on long-term prognosis while new-PPM did not. The combination of new-PPM with PPAR adversely impacts on survival and LV function recovery.

Background: Limited data are available on bioresorbable vascular scaffolds (BVS) performance in bifurcations lesions and on the impact of BVS wider struts on side-branch impairment., Methods: Patients with at least one coronary bifurcation lesion involving a side-branch ≥2mm in diameter and treated with at least one BVS were examined. Procedural and angiographic data were collected and a dedicated methodology for off-line quantitative coronary angiography (QCA) in bifurcation was applied (eleven-segment model), to assess side-branch impairment occurring any time during the procedure. Two- and three-dimensional QCA were used. Optical coherence tomography (OCT) analysis was performed in a subgroup of patients and long-term clinical outcomes reported., Results: A total of 102 patients with 107 lesions, were evaluated. Device- and procedural-successes were 99.1% and 94.3%, respectively. Side-branch impairment occurring any time during the procedure was reported in 13 bifurcations (12.1%) and at the end of the procedure in 6.5%. Side-branch minimal lumen diameter (Pre: 1.45±0.41mm vs Final: 1.48±0.42mm, p=0.587) %diameter-stenosis (Pre: 26.93±16.89% vs Final: 27.80±15.57%, p=0.904) and minimal lumen area (Pre: 1.97±0.89mm(2) vs Final: 2.17±1.09mm(2), p=0.334), were not significantly affected by BVS implantation. Mean malapposed struts at the bifurcation polygon-of-confluence were 0.63±1.11., Conclusions: The results of the present investigation suggest feasibility and relative safety of BVS implantation in coronary bifurcations. BVS wide struts have a low impact on side-branch impairment when considering bifurcations with side-branch diameter≥2mm., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

Objective: The future promises many technological advances in the field of heart valve interventions, like tissue-engineered heart valves (TEHV). Prior to introduction in clinical practice, it is essential to perform early health technology assessment. We aim to develop a conceptual model (CM) that can be used to investigate the performance and costs requirements for TEHV to become cost-effective., Methods: After scoping the decision problem, a workgroup developed the draft CM based on clinical guidelines. This model was compared with existing models for cost-effectiveness of heart valve interventions, identified by systematic literature search. Next, it was discussed with a Delphi panel of cardiothoracic surgeons, cardiologists and a biomedical scientist (n=10)., Results: The CM starts with the valve implantation. If patients survive the intervention, they can remain alive without complications, die from non-valve-related causes or experience a valve-related event. The events are separated in early and late events. After surviving an event, patients can experience another event or die due to non-valve-related causes. Predictors will include age, gender, NYHA class, left ventricular function and diabetes. Costs and quality adjusted life years are to be attached to health conditions to estimate long-term costs and health outcomes., Conclusions: We developed a CM that will serve as foundation of a decision-analytic model that can estimate the potential cost-effectiveness of TEHV in early development stages. This supports developers in deciding about further development of TEHV and identifies promising interventions that may result in faster take-up in clinical practice by clinicians and reimbursement by payers., Competing Interests: Conflicts of Interest: None declared.