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Introduction: Based on European guidelines, transcatheter aortic valve implementation (TAVI) could be the therapy of choice in patients with severe aortic stenosis aged ≥ 75 years. In the Netherlands, there has been a debate between healthcare providers and the National Health Care Institute regarding reimbursement for TAVI, which resulted in an indication document that defines TAVI patients who are eligible for reimbursement. This document has been effective since 1 January 2021. Methods: We extracted data from the Netherlands Heart Registry for patients who underwent biological surgical aortic valve replacement (SAVR) or TAVI in the Netherlands from 2018 through 2021. We compared baseline characteristics and variables from the indication document for the subsequent years and age groups. We also analysed the annual SAVR/TAVI ratio. Results: The total number of patients treated with SAVR or TAVI was constant in 2018–2021. Baseline characteristics of patients treated with TAVI did not differ throughout the years. The SAVR/TAVI ratio shifted towards a higher percentage of TAVI from 2018 to 2019. From 2019 to 2020, the TAVI percentage was constant. Since the implementation of the indication document (in 2021), a change in the SAVR/TAVI ratio was not found either. Conclusion: Since the implementation of the national indication document for AVR in 2021, no major effect was seen for the SAVR versus TAVI landscape in the Netherlands. [ABSTRACT FROM AUTHOR]

BACKGROUND The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied. METHODS We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successlisted ful TAVR. The primary efficacy outcome was a composite of adverse events conavailable sisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding. On the basis of a hierarchical testing plan, the primary efficacy and safety outcomes were tested sequentially for noninferiority, with noninferiority of edoxaban established if the upper boundary of the 95% confidence interval for the hazard ratio did not exceed 1. 38. Superiority testing of edoxaban for efficacy would follow if noninferiority and superiority were established for major bleeding. RESULTS A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women. Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P=0.01 for noninferiority). Rates of major bleeding were 9.7 per 100 person-years and ZO per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P= 0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban. Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11). CONCLUSIONS In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists. (Funded by Daiichi Sankyo; ENVISAGE-TAVI AF ClinicalTrials.gov number, NCT02943785.). [ABSTRACT FROM AUTHOR]

We report the first patient experiences with the CardioMEMS device in the Erasmus MC Thorax Center in the Netherlands. In line with clinical trial evidence, the device is applicable in patients with chronic heart failure in functional New York Heart Association class III with at least 1 admission for heart failure in the past 12 months. CardioMEMS has been shown to be safe and reliable, and effective in reducing the number of hospitalisations for heart failure by guided therapy based on pulmonary artery pressures. [ABSTRACT FROM AUTHOR]

Background One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism. Methods We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI. Download a PDF of the Plain Language Summary. Results A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], −3.1 to 6.6; P=0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, −3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6). Conclusions In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. [ABSTRACT FROM AUTHOR]

Limited evidence exists concerning the prognostic impact of baseline left ventricular ejection fraction (LVEF) on outcomes among women undergoing transcatheter aortic valve implantation (TAVI), which we aimed to investigate in the present analysis. Patients from the Women's International Transcatheter Aortic Valve Implantation (WIN-TAVI) registry were categorized according to baseline LVEF into 3 groups: reduced (LVEF ≤40%), mildly reduced (LVEF between 41% and 49%), and preserved (LVEF ≥50%) LVEF. The primary (Valve Academic Research Consortium 2 [VARC-2]) efficacy point was defined as a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure, or valve-related dysfunction at 1 year. The primary (VARC-2) safety end point included all-cause mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 to 3 acute kidney injury, coronary artery obstruction requiring intervention, or valve-related dysfunction requiring repeated procedures. A Cox regression model was performed using the preserved LVEF group as the reference. Among the 944 patients included, 764 (80.9%) exhibited preserved, 80 (8.5%) had mildly reduced, and 100 (10.6%) had reduced LVEF. The 1-year incidence of VARC-2 efficacy end point was numerically higher in patients with reduced LVEF, albeit not resulting in a significant risk difference. Notably, reduced LVEF was associated with a higher risk of the 1-year VARC-2 safety end point, still significant after adjustment (28.0% vs 19.6%, Hazard Ratio 1.78, 95% Confidence Interval 1.12- 2.82, p = 0.014). These differences were primarily driven by trends toward increased rates of all-cause mortality, cardiovascular mortality, and major vascular complications. Clinical outcomes were similar between patients with mildly reduced and preserved LVEF. In conclusion, when performed in women with reduced LVEF, TAVI was associated with a worse (VARC-2) safety profile at 1-year follow-up. In contrast, patients with mildly reduced LVEF appeared to align more closely with outcomes observed in the preserved LVEF group than with the reduced LVEF group., Competing Interests: Declaration of competing interest Dr. Bay is supported by a grant from the German Heart Foundation, grant no. S/06/23. Dr. Petronio received consultancy fees from Medtronic, Abbott, and Boston and funds from Boston and Abbott. Dr. Mehilli received institutional grants from Boston Scientific and lecture fees from AstraZeneca, Bristol-Myers Squibb, Boston Scientific, and Edwards Lifesciences. Dr. Lefèvre proctors for Edwards, Boston, and Abbott. Dr. Sardella received sponsorships from Medtronic in terms of technical training courses and congress assistance. Dr. Van Mieghem received research grant support and advisory fees from Abbott, Boston Scientific, and Medtronic, and research grant support from Edwards Lifesciences. Dr. Dumonteil received proctoring and consultancy fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Mikhail is the Director of Imperial Valve and Cardiovascular Course, which is supported by several device and pharmaceutical companies; he has received an educational grant from Abbott for an Interventional Fellowship. Dr. Ferrer-Gracia received sponsorships from Medtronic and Edwards companies in terms of technical training courses and congress assistance. Dr. Sharma served on the Speakers Bureau of Abbott Vascular, Boston Scientific, and Cardiovascular Systems, Inc. Dr. Morice is CEO and shareholder of CERC, a CRO based in Massy that had no role in WIN-TAVI. Dr. Dangas received consulting fees from GE Healthcare, Janssen Pharmaceuticals, Inc., and Medtronic, Inc.; <1% equity with Claret Medical and Elixir Medical; delivered industry-sponsored lectures for The Medicines Company; and is on the Scientific Advisory Board of AstraZeneca. Dr. Chieffo received speaker/consultant fees from Abiomed, Abbott Vascular, Biosensor, Cardinal Health, GADA, and Magenta Medical. Dr. Mehran received research grants to the institution from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Amgen, Applied Therapeutics, Arena, AstraZeneca, BAIM, Bayer, Beth Israel Deaconess, Biosensors, Biotronik, Boston Scientific, Bris- tol-Myers Squibb, CardiaWave, CellAegis, CeloNova, CERC, Chiesi, Concept Medical, CSL Behring, Cytosorb- ents, DSI, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe AG, Magenta, Medtronic, Novartis, OrbusNeich, PhaseBio, Philips, RenalPro, Shock- wave, Vivasure, and Zoll and consulting fees from Cine-Med Research, WebMD. The authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Advances in personalized medicine and Systems Biology have introduced probabilistic models and error discovery to cardiovascular care, aiding disease prevention and procedural planning. However, clinical application faces cultural, technical, and methodological hurdles. Patient autonomy remains essential, with shared decision-making (SDM) gaining importance in managing complex cardiovascular treatment options. Effective SDM relies on collaboration between providers and patients, guided by P5 Medicine principles, which combine psycho-cognitive considerations with predictive, personalized, preventive, and participatory care. Here we propose a three-step methodological proposal for implementing SDM and enhancing consent acquisition in cardiovascular care. The approach emphasizes personalized patient engagement and the need for clear, comprehensive consent processes. It identifies and addresses significant gaps in current practices, including the complexity of consent language, information dispersion, and the specific needs of vulnerable populations. Issues of Medical Responsibility and/or Liability may raise in the case of absence of consent acquisition or invalid consent due to insufficient/incorrect information. The International Guidelines on Medico-Legal Methods of Ascertainment and Evaluation Criteria are reported. In conclusion, the paper proposes practical solutions, including the use of artificial intelligence (AI) to enhance decision-making and patient counseling, and strategies to ensure that consent processes are both thorough and legally sound and respectful to the individual's autonomy., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Giuseppe Tarantini reports a relationship with Edwards Lifesciences Corporation that includes: speaking and lecture fees. Giuseppe Tarantini reports a relationship with Abbott Vascular Inc that includes: speaking and lecture fees. Giuseppe Tarantini reports a relationship with Medtronic that includes: speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2025. Published by Elsevier Inc.)

Background: Vascular and bleeding complications remain a concern after transfemoral transcatheter aortic valve replacement (TAVR). The impact of the sheath type on these complications remains unclear., Methods: The prospective MARVEL registry study analyzed enrolled 500 patients undergoing large-bore transfemoral procedures and arteriotomy closure with the MANTA vascular closure device from 10 hospitals in Europe and Canada. We stratified these patients according to type of sheath used (expandable or conventional). A propensity-matched analysis was performed using VARC-2 major or minor vascular and bleeding complications as the primary endpoint. The secondary endpoint was time to hemostasis., Results: We identified 196 propensity-matched pairs. Major vascular complications occurred in 3.6% in the expandable sheath group and 4.1% in the conventional sheath group (p = 1.0). Minor vascular complications occurred in 5.6% in the expandable sheath group and 4.6% in the conventional sheath group (p = 0.819). There were no significant differences in bleeding complications between groups. Time to hemostasis after MANTA closure was significantly shorter in the expandable sheath group (30 vs. 60 s, p < 0.001)., Conclusions: A propensity-matched analysis demonstrated no significant differences in vascular complication rates with MANTA arteriotomy closure after removal of large bore expandable or conventional sheaths. Time to hemostasis was significantly shorter in the expandable sheath group., (© 2025 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Despite the challenges associated with periprocedural imaging, transcatheter tricuspid valve interventions have shown important impact on outcomes. A comprehensive understanding of the anatomy of the right heart and surrounding structures is crucial. One way to optimize these interventions is by identifying the optimal fluoroscopic viewing angles along the S-curve of the tricuspid valve. Integration of chamber views using multimodality imaging (multislice computed tomography, fluoroscopy, and echocardiography) may increase operator confidence and reduce procedural duration, radiation exposure, contrast volume, and complication rates., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Prosthesis-patient mismatch after transcatheter aortic valve replacement (TAVR) can be measured echocardiographically (measured prosthesis-patient mismatch [PPMm]) or predicted (predicted prosthesis-patient mismatch [PPMp]) using published effective orifice area (EOA) reference values. However, the clinical implications of PPM post-TAVR remain unclear., Objectives: This study aimed to elucidate the prevalence of PPMm and PPMp post-TAVR and their impact on mortality in a large international cohort., Methods: The IMPPACT TAVR (Impact of Measured or Predicted Prosthesis-pAtient mismatCh after TAVR) registry included 38,808 TAVR patients from 26 international centers. Valve Academic Research Consortium 3 criteria were used to define prosthesis-patient mismatch severity. EOA was determined echocardiographically (PPMm) or predicted (PPMp) based on core lab-derived EOA reference values. The primary endpoint was 2-year all-cause mortality., Results: The prevalence of PPMp (moderate: 6.8%, severe: 0.6%) was significantly lower than that of PPMm (moderate: 20.7%, severe: 4.3%; P < 0.001) with negligible correlation between the 2 methods (Kendall's tau c correlation coefficient: 0.063; P < 0.001). In unadjusted analyses, severe PPMm adversely influenced 2-year survival (HR: 1.22; 95% CI: 1.02-1.45; P = 0.027), whereas severe PPMp was not associated with outcomes (HR: 0.81; 95% CI: 0.55-1.19; P = 0.291). After adjusting for confounders, neither PPMm nor PPMp had a significant effect on 2-year all-cause mortality., Conclusions: PPMm and PPMp were associated with different patient characteristics, with PPMm tending toward worse (especially low flow) and PPMp toward better (especially women) survival. After adjusting for confounders, neither PPMm nor PPMp significantly affected 2-year all-cause mortality. Hence, valve selection should not solely be based on hemodynamics but rather on a holistic approach, including patient and procedural specifics., Competing Interests: Funding Support and Author Disclosures This work was supported by the Deutsche Forschungsgemeinschaft (397484323) to Drs Guthoff, Matti Adam and Stephan Baldus, and Mauri; PA 2409/5-2 to Drs Thurow and Pauly; the Dean’s Office, Faculty of Medicine, University of Cologne (clinician scientist position) to Dr Guthoff; and the Center for Molecular Medicine Cologne (Baldus B-02) to Dr Stephan Baldus. Dr Abdel-Wahab’s institution has received speaker honoraria and/or consultancy fees from Abbott, Boston Scientific, and Medtronic. Dr Kim has received proctor and personal fees from Abbott, Boston Scientific, Meril Life Sciences, and Shockwave Med; is a member of the advisory boards for Abbott, Boston Scientific, and HID Imaging; and Dr Kim’s institution has received fees from Boston Scientific. Dr Nombela-Franco has served as proctor for Abbott and Edwards Lifesciences. Dr Matjaz Bunc served as proctor for TAVR procedures with Edwards Lifesciences, Medtronic, Meril, and Abbott. Matjaz Bunc is a member of the advisory boards for Medtronic and Edwards Lifesciences. Dr Veulemans has received speaker and/or study honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Tanja Rudolph has received lecture fees from Abbott, SIS Medical and Translumina. Dr Zeus has received speaker and/or study honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

We assessed the diagnostic performance of both ultra-high-resolution (UHR) and high-resolution (HR) modes of photon-counting detector (PCD)-CT within the confines of standard pre-TAVI CT scans, as well as the performance of UHR mode adjusted specifically for coronary imaging, using quantitative coronary angiography (QCA) as the reference. We included 60 patients undergoing pre-TAVI planning CT scans. Patients were divided into 3 groups: 20 scanned in HR mode, 20 in UHR mode, and 20 in adjusted UHR mode, on a dual-source PCD-CT. The adjusted UHR mode employed a lower tube voltage (90 kV vs. 120 kV) and a higher image quality level (65 vs. 34) to enhance coronary artery visualization. Patients underwent invasive coronary angiography as part of clinical routine. CCTA and QCA were reviewed to assess CAD presence defined as stenosis ≥ 50% in proximal and middle coronary segments. We included 60 patients (mean age 79 ± 7 years; 39(65%) men). Mean heart rate during scanning was 72 ± 13 bpm. Median coronary calcium score was 973 [379-2007]. QCA identified significant CAD in 24 patients (40%): 9 patients scanned with HR mode, 10 patients with the UHR mode, and 5 patients with the UHR adjusted mode. Per-patient area under the curves were 0.57 for HR, 0.80 for UHR, and 0.80 for adjusted UHR, with no significant differences between the scan modes, and per-vessel the area under the curves were 0.73 for HR, 0.69 for UHR, and 0.87 for adjusted UHR, with significant differences between UHR and adjusted UHR (p = 0.04). UHR and adjusted UHR modes of dual source PCD-CT show potential for improved sensitivity and negative predictive value for detecting CAD in patients undergoing pre-TAVI scans, however, no statistically significant difference from HR mode was observed., (© 2024. The Author(s).)

The percutaneous treatment of structural, valvular, and non-valvular heart disease (SHD) is rapidly evolving. The Core Curriculum (CC) proposed by the EAPCI describes the knowledge, skills, and attitudes that define competency levels required by newly trained SHD interventional cardiologists (IC) and provides guidance for training centres. SHD ICs are cardiologists who have received complete interventional cardiology training. They are multidisciplinary team specialists who manage adult SHD patients from diagnosis to follow-up and perform percutaneous procedures in this area. They are competent in interpreting advanced imaging techniques and master planning software. The SHD ICs are expected to be proficient in the aortic, mitral, and tricuspid areas. They may have selective skills in either the aortic area or mitral/tricuspid areas. In this case, they must still have common transversal competencies in the aortic, mitral, and tricuspid areas. Additional SHD domain competencies are optional. Completing dedicated SHD training, aiming for full aortic, mitral, and tricuspid competencies, requires at least 18 months. For full training in the aortic area, with basic competencies in mitral/tricuspid areas, the training can be reduced to 1 year. The same is true for training in the mitral/tricuspid area, with competencies in the aortic area. The SHD IC CC promotes excellence and homogeneous training across Europe and is the cornerstone of future certifications and patient protection. It may be a reference for future CC for national associations and other SHD specialities, including imaging and cardiac surgery.

The demonstrated safety and effectiveness of transcatheter aortic valve implantation (TAVI) among low surgical risk patients opened the road to its application in younger low-risk patients. However, the occurrence of conduction abnormalities and need for permanent pacemaker implantation remains a frequent problem associated with adverse outcomes. The clinical implications may become greater when TAVI shifts towards younger populations, highlighting the need for comprehensive strategies to address this issue. Beyond currently available clinical and electrocardiographic predictors, patient-specific anatomical assessment of the aortic root using multi-sliced CT (MSCT) imaging can refine risk stratification. Moreover, leveraging MSCT data for computational 3D simulations to predict device-anatomy interactions may help guide procedural strategy to mitigate conduction abnormalities. The aims of this review are to summarise the incidence and clinical impact of new left bundle branch block and permanent pacemaker implantation post-TAVI using contemporary transcatheter heart valves; and highlight the value of MSCT data interpretation to improve the management of this complication., Competing Interests: Disclosure: RJN received consulting fees from Abbott, Edwards Lifesciences, Boston Scientific and Vifor Pharma. JD received institutional grant/research support from AstraZeneca, Abbott Vascular, Boston Scientific, ACIST Medical, Medtronic, MicroPort, Pie Medical and Recor Medical; and consultancy and speaker fees from Abbott Vascular, Abiomed, ACIST Medical, Boston Scientific, Cardialysis BV, CardiacBooster, Kaminari Medical, Recor Medical, PulseCath, Pie Medical, Sanofi, Siemens Healthcare and Medtronic. NVM received grant funding from or has contracts with Abbott, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, PulseCath BV, Abiomed and Daiichi Sankyo; consulting fees from JenaValve, Daiichi Sankyo, Abbott, Boston Scientific and Medtronic; payments or honoraria for lectures, presentations, speaking, manuscripts and educational events from Abiomed and Amgen; support for attending meetings and or travel from JenaValve; and is a deputy editor of Interventional Cardiology; this did not affect peer review. All other authors have no conflicts of interest to declare., (Copyright © The Author(s), 2024. Published by Radcliffe Group Ltd.)

Structural heart disease interventions rely heavily on preprocedural planning and simulation to improve procedural outcomes and predict and prevent potential procedural complications. Modeling technologies, namely 3-dimensional (3D) printing and computational modeling, are nowadays increasingly used to predict the interaction between cardiac anatomy and implantable devices. Such models play a role in patient education, operator training, procedural simulation, and appropriate device selection. However, current modeling is often limited by the replication of a single static configuration within a dynamic cardiac cycle. Recognizing that health systems may face technical and economic limitations to the creation of "in-house" 3D-printed models, structural heart teams are pivoting to the use of computational software for modeling purposes., Competing Interests: Funding Support and Author Disclosures Dr Harb has received consulting fees from Abbott, Boston Scientific, and Mitria Medical LLC. Dr Wang is a consultant for Edwards Lifesciences, Abbott, Boston Scientific, and Materialise; and has received research grant support from Boston Scientific assigned to employer Henry Ford Health. Dr Little has received support from the John S. Dunn Chair in Clinical Cardiovascular Research and Education. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Unwitnessed out-of-hospital cardiac arrest is associated with low survival chances because of the delayed activation of the emergency medical system in most cases. Automated cardiac arrest detection and alarming using biosensor technology would offer a potential solution to provide early help. We developed and validated an algorithm for automated circulatory arrest detection using wrist-derived photoplethysmography from patients with induced circulatory arrests., Methods: In this prospective multicentre study in three university medical centres in the Netherlands, adult patients (aged 18 years or older) in whom short-lasting circulatory arrest was induced as part of routine practice (transcatheter aortic valve implantation, defibrillation testing, or ventricular tachycardia induction) were eligible for inclusion. Exclusion criteria were a known bilateral significant subclavian artery stenosis or medical issues interfering with the wearing of the wristband. After providing informed consent, patients were equipped with a photoplethysmography wristband during the procedure. Invasive arterial blood pressure and electrocardiography were continuously monitored as the reference standard. Development of the photoplethysmography algorithm was based on three consecutive training cohorts. For each cohort, patients were consecutively enrolled. When a total of 50 patients with at least one event of circulatory arrest were enrolled, that cohort was closed. Validation was performed on the fourth set of included patients. The primary outcome was sensitivity for the detection of circulatory arrest., Findings: Of 306 patients enrolled between March 14, 2022, and April 21, 2023, 291 patients were included in the data analysis. In the development phase (n=205), the first training set yielded a sensitivity for circulatory arrest detection of 100% (95% CI 94-100) and four false positive alarms; the second training set yielded a sensitivity of 100% (94-100), with six false positive alarms; and the third training set yielded a sensitivity of 100% (94-100), with two false positive alarms. In the validation phase (n=86), the sensitivity for circulatory arrest detection was 98% (92-100) and 11 false positive circulatory arrest alarms. The positive predictive value was 90% (95% CI 82-94)., Interpretation: The automated detection of induced circulatory arrests using wrist-derived photoplethysmography is feasible with good sensitivity and low false positives. These promising findings warrant further development of this wearable technology to enable automated cardiac arrest detection and alarming in a home setting., Funding: Dutch Heart Foundation (Hartstichting)., Competing Interests: Declaration of interests KE is a data scientist at Corsano Health. RJB received a research grant from Biosense Webster, and payment for a lecture from The Cardiovascular Education Institute. KV received a research grant from Medtronic; consulting fees from Medtronic, Abbott, and Biosense Webster; a speakers fee from Philips; participates in the advisory board of Medtronic; and received educational grants from Medtronic, Abbott, and Biosense Webster. S-CY is a consultant of Boston Scientific; has received research grants from Biotronik, Medtronic, and Boston Scientific; received personal payments for presentations from Boston Scientific, Biotronik, and Medtronic; and his institution received payment for his participation on a Data Safety Monitoring Board from Boston Scientific. ER received consulting fees from Corsano Health. NvM received grants from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi Sankyo, and AstraZeneca; received personal consulting fees from Abbott Vascular, Boston Scientific, Medtronic, Anteris, JenaValve, Daiichi Sankyo, AstraZeneca, Amgen, Siemens, and Pie Medical; and received payment for presentations from Abbott Vascular, Biotronik, Amgen, Daiichi Sankyo, Medtronic, and Boston Scientifc. PCS is the CEO of Corsano Health. NvR received a research grant from the Dutch Heart Foundation related to this manuscript; received research grants from Biotronik, Abbott, Medtronic, and Philips, not related to this manuscript; and speaker fees were received from Abbott, Bayer, RainMed, and Microport, not related to this manuscript. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Debulking lesions with severe coronary artery calcification (CAC) is highly recommended to obtain good procedural and long-term success. Utilization and performance of coronary intravascular lithotripsy (IVL) after rotational atherectomy (RA) has not been thoroughly studied. This study aimed to evaluate the efficacy and safety of IVL with the Shockwave Coronary Rx Lithotripsy System in lesions with severe CAC as elective or bail-out strategy after RA. This observational, prospective, single-arm, multicenter, international, open-label Rota-Shock registry included patients with symptomatic coronary artery disease and lesions with severe CAC treated by percutaneous coronary intervention, including lesion preparation with RA and IVL, at 23 high-volume centers. Primary efficacy end point was procedural success, defined as final diameter stenosis <30% by quantitative coronary angiography. Primary safety end point was freedom from serious angiographic complications, which included >National Heart, Lung and Blood Institute type B dissection, perforation, abrupt closure, slow or no flow, final thrombolysis in myocardial infarction flow <3, and acute thrombosis. A total of 160 patients were enrolled between June 2020 and June 2022. The primary efficacy end point was observed in 155 patients (96.9%). The primary safety end point occurred in 145 cases (90.6%). Dissections >National Heart, Lung and Blood Institute type B occurred in 3 patients (1.9%), whereas slow or no flow occurred in 8 (5.0%), final thrombolysis in myocardial infarction flow <3 in 3 (1.9%), and perforation in 4 patients (2.5%). Free from inhospital major adverse cardiac and cerebrovascular events, including cardiac death, target vessel myocardial infarction, target lesion revascularization, cerebrovascular accident, definite/probable stent thrombosis, and major bleeding, occurred in 158 patients (98.7%). In conclusion, IVL after RA in lesions with severe CAC was effective and safe, with a very low incidence of complications as either elective or bail-out strategy., Competing Interests: Declaration of Competing Interest Dr. Stefanini discloses speaker fees from Abbott Vascular, Boston Scientific, and Pfizer/Bristol-Myers Squibb. Dr. Van Mieghem discloses research grant support by Abbott Vascular, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, PulseCath BV, Daiichi Sankyo, and Pie Medical and consultancy fees from Siemens, Amgen, Daiichi Sankyo, Abbott Vascular, Biotronik, Medtronic, and Abiomed. The remaining authors have no conflicts of interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Over the last decades, we have witnessed considerable improvements in diagnostics and risk stratification of patients with significant aortic stenosis (AS), paralleled by advances in operative and anesthetic techniques. In addition, accumulating evidence points to the potential benefit of early valve replacement in such patients prior to the onset of symptoms. In parallel, interventional randomized trials have proven the benefit of transcatheter aortic valve replacement in comparison to a surgical approach to valve replacement over a broad risk spectrum in symptomatic patients with AS. This article reviews contemporary management approaches and scrutinizes open questions regarding timing and mode of intervention in asymptomatic patients with severe AS. We also discuss the challenges surrounding the management of symptomatic patients with moderate AS as well as emerging dilemmas related to the concept of a life-long treatment strategy for patients with AS., Competing Interests: Marko Banovic, Bernard Iung, Jozef Bartunek, Wojtek Wojakowski are investigators in the Avatar trial; Jozef Bartunek receives consultancy fees from Occlutech (unrelated to the topic of the manuscript). The other author had no conflicts to declare., (© 2023 The Author(s).)

Background: Large-bore arteriotomies can be percutaneously closed with suture-based or plug-based vascular closure device (VCD) strategies. The efficacy of both techniques remains controversial., Aims: We conducted a meta-analysis of comparative studies between both VCD strategies, focusing on the most commonly applied VCDs (MANTA and ProGlide)., Methods: We searched MEDLINE, the Cochrane Central Register of Controlled Trials and Google scholar for observational studies (OS) and randomized controlled trials (RCT) comparing vascular closure with the MANTA-based and the ProGlide-based technique. The principal endpoint of this analysis was access-site related vascular complications. Both study types were analyzed separately., Results: Access-site related vascular complications were less frequent after vascular closure with the MANTA technique in the analysis of OS (RR 0.61 [95%CI 0.43-0.89], p = 0.01, I 2  = 0%), but more frequent in the analysis of RCT data (RR 1.70 [95%CI 1.16-2.51], p = 0.01, I 2  = 0%). Both data sets provided no significant difference between the VCD techniques in terms of overall bleeding events (OS: RR 0.57 [95%CI 0.32-1.02], p = 0.06, I 2  = 70%; and RCT: RR 1.37 [95%CI 0.82-2.28], p = 0.23, I 2  = 30%). RCT data showed that endovascular stenting or vascular surgery due to VCD failure occurred more often after MANTA application (RR 3.53 [95%CI 1.07-11.33], p = 0.04, I 2  = 0%)., Conclusions: While OS point to favorable outcomes for large-bore vascular closure with the MANTA-based technique, RCT data show that this strategy is associated with more access-site related vascular complications as well as endovascular stenting or vascular surgery due to device failure compared with the ProGlide-based technique., (© 2023. The Author(s).)

Background: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce., Aims: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3)., Methods: The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year., Results: The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups., Conclusions: Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.

Most transcatheter aortic valve replacement-related procedures (eg, transcatheter aortic valve replacement implantation depth, commissural alignment, coronary access, bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction, paravalvular leak closure) require an optimal fluoroscopic viewing angle located somewhere along the aortic annulus S-curve. Chamber views, coronary cusp and coronary anatomy, can be understood along the aortic annulus S-curve. A better understanding of the optimal fluoroscopic viewing angles along the S-curve may translate into increased operator confidence and improved safety and efficacy while reducing procedural time, radiation dose, contrast volume, and complication rates., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) with the ACURATE neo device has been associated with a non-negligible incidence of paravalvular aortic regurgitation (AR). The new-generation ACURATE neo2 has been designed to mitigate this limitation., Aims: The aim of the study was to compare TAVR with the ACURATE neo and neo2 devices., Methods: The NEOPRO and NEOPRO-2 registries retrospectively included patients undergoing transfemoral TAVR with self-expanding valves at 24 and 20 centres, respectively. Patients receiving the ACURATE neo and neo2 devices (from January 2012 to December 2021) were included in this study. Predischarge and 30-day VARC-3 defined outcomes were evaluated. The primary endpoint was predischarge moderate or severe paravalvular AR. Subgroup analyses per degree of aortic valve calcification were performed., Results: A total of 2,026 patients (neo: 1,263, neo2: 763) were included. Predischarge moderate or severe paravalvular AR was less frequent for the neo2 group (2% vs 5%; p<0.001), resulting in higher VARC-3 intended valve performance (96% vs 90%; p<0.001). Furthermore, more patients receiving the neo2 had none/trace paravalvular AR (59% vs 38%; p<0.001). The reduction in paravalvular AR with neo2 was mainly observed with heavy aortic valve calcification. New pacemaker implantation and VARC-3 technical and device success rates were similar between the 2 groups; there were more frequent vascular and bleeding complications for the neo device. Similar 1-year survival was detected after TAVR (neo2: 90% vs neo: 87%; p=0.14)., Conclusions: TAVR with the ACURATE neo2 device was associated with a lower prevalence of moderate or severe paravalvular AR and more patients with none/trace paravalvular AR. This difference was particularly evident with heavy aortic valve calcification.

Background: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking., Study Objectives: To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications., Study Design: This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands., Summary: The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use., Nct Trial Number: NCT04676880., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background/purpose: The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications., Methods/materials: This patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting., Results: Eight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17-76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46-4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17-4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26-4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype., Conclusions: Large-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance., Competing Interests: Declaration of competing interest Dr. Van Mieghem received research grants from Teleflex. Other authors have nothing to declare., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: To report on the experience with a selective prophylactic permanent pacemaker (PPx-PPM) implantation strategy in patients with pre-existing right bundle branch block (RBBB) undergoing transcatheter aortic valve replacement (TAVR)., Background: Pre-existing RBBB is an independent predictor for PPM after TAVR and has been linked to increased mortality., Methods: Hospital patient flow and longer-term clinical endpoints were compared for TAVR patients with pre-existing RBBB treated in a period with and without selective PPx-PPM strategy (2013-2020)., Results: A total of 260 patients were included: 170 in the early period without PPx-PPM strategy and 90 patients in the late period with selective PPx-PPM strategy. A PPx-PPM was implanted in 44% of patients in the late period. Overall, 69% versus 80% of all patients in the early versus late period ended up with a PPM (p = .06). Streamlined transfemoral TAVR was routinely used from 2017-in this series of patients, both TAVR procedural time and hospital length of stay (LoS) were significantly shorter in the late versus early period (mean procedural time: 70 vs. 83 min and LoS ≥5 days: 15% vs. 40%; p < .05). No difference in all-cause/cardiovascular mortality was observed between both strategies, whereas cardiac rehospitalization was significantly higher for patients treated in the early versus late period (hazard ratio 2.33 [1.04-5.26]; p = .042)-this mainly due to (sub)acute PPM-implantation early after discharge., Conclusions: Selective prophylactic PPM implantation in TAVR candidates with pre-existing RBBB results in shorter TAVR procedural time and hospital LoS and prevents early cardiac rehospitalization related to complete heart block., (© 2021 Wiley Periodicals LLC.)

There has been a significant increase in the use of short-term percutaneous ventricular assist devices (pVADs) as acute circulatory support in cardiogenic shock and to provide haemodynamic support during interventional procedures, including high-risk percutaneous coronary interventions. Although frequently considered together, pVADs differ in their haemodynamic effects, management, indications, insertion techniques, and monitoring requirements. This consensus document summarizes the views of an expert panel by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the Association for Acute Cardiovascular Care (ACVC) and appraises the value of short-term pVAD. It reviews the pathophysiological context and possible indications for pVAD in different clinical settings and provides guidance regarding the management of pVAD based on existing evidence and best current practice.

The proposed 2020 Core Curriculum for Percutaneous Cardiovascular Interventions aims to provide an updated European consensus that defines the level of experience and knowledge in the field of percutaneous cardiovascular intervention (PCI). It promotes homogenous education and training programmes among countries, and is the cornerstone of the new EAPCI certification, designed to support the recognition of competencies at the European level and the free movement of certified specialists in the European Community. It is based on a thorough review of the ESC guidelines and of the EAPCI textbook on percutaneous interventional cardiovascular medicine. The structure of the current core curriculum evolved from previous EAPCI core curricula and from the "2013 core curriculum of the general cardiologist" to follow the current ESC recommendations for core curricula. In most subject areas, there was a wide - if not unanimous - consensus among the task force members on the training required for the interventional cardiologist of the future. The document recommends that acquisition of competence in interventional cardiology requires at least two years of postgraduate training, in addition to four years devoted to cardiology. The first part of the curriculum covers general aspects of training and is followed by a comprehensive description of the specific components in 54 chapters. Each of the chapters includes statements of the objectives, and is further subdivided into the required knowledge, skills, behaviours, and attitudes.

Background: Elevated pulmonary artery pressure (PAP) in patients with severe aortic stenosis (AS) is a strong predictor of adverse prognosis. This study sought to assess the relation between PAP and clinical and echocardiographic parameters in elderly patients with severe AS, as well as to identify the determinants of the change in PAP after transcatheter aortic valve implantation (TAVI)., Methods: The study included 170 subjects (age 81 ± 7 years, 45% men) with symptomatic severe AS who were treated by TAVI. They underwent a clinical evaluation and a transthoracic echocardiography before the TAVI procedure and 6 months after., Results: In a multivariable analysis, the independent predictors for baseline PAP were the body mass index (BMI) ( β  = 0.21, p  = .006), COPD GOLD class ( β  = 0.20; p  = .009), the E / e ' ratio ( β  = 0.20; p  = .02) and the degree of aortic regurgitation ( β  = 0.20; p  = .01). After TAVI, there was significantly less (51% vs. 29%, p <.0001) pulmonary hypertension, defined as a tricuspid regurgitation velocity ≥2.8 m/s. The baseline variables related to an improvement in PAP were the tricuspid regurgitation velocity ( p  = .0001) and the E / e ' ( p  = .005). From the parameters potentially modified with TAVI, the only independent predictor of PAP variation was the change in the E / e ' ratio ( β  = 0.23; p  = .01)., Conclusions: Independent predictors for baseline PAP in elderly patients with symptomatic AS were the BMI, GOLD class, the aortic regurgitation and the E / e ' ratio. The baseline predictors for a change in PAP 6 months after TAVI were the baseline PAP and E / e ', with only the change in the E / e ' ratio being correlated to the change in PAP.

This article provides supplementary tables and figures to the research article: Frequency, Impact and Predictors of Access Complications with Plug-Based Large-Bore Arteriotomy Closure - A patient level meta-analysis [1]. The data provide insight in the type and management of access complications related to the plug-based MANTA vascular closure device (VCD) for large-bore catheter-based cardiovascular interventions. Since MANTA is mostly used in transcatheter aortic valve replacement (TAVR) procedures, this article also contains a sub-group analysis on TAVR procedures using contemporary valve-platforms. Further, data describing MANTA hemostasis times and mortality causes are included. For this dataset, individual patient data were derived from a European and a North American device approval study (the Conformite Européene [CE] mark study and the investigational device exemption SAFE-MANTA study [2,3]) in addition to a post-approval registry (the MARVEL registry [4]) covering a total of 891 patients who were enrolled between 2015 and 2019 across 28 investigational sites. Eligibility criteria were most stringent in the SAFE MANTA study (38% of patients) whereas the MARVEL registry applied liberal and only relative exclusion criteria (56% of patients). A total of 78 Roll-in cases (i.e. first or second time operator use of the MANTA VCD) who were excluded from analysis in SAFE MANTA were included in the present to evaluate a potential learning curve effect. Therefore, this dataset reflects the largest study population undergoing arteriotomy closure with the MANTA VCD by operators at various levels of experience, which can be valuable to further build on research regarding percutaneous large-bore arteriotomy management., Competing Interests: Dr. Van Mieghem reports receiving grant support from Teleflex. The other authors declare that they have no known competing financial interests or personal relationships which have or could be perceived to have influenced the work reported in this article., (© 2021 The Authors. Published by Elsevier Inc.)

The use of mechanical circulatory support for patients presenting with cardiogenic shock is rapidly increasing. Currently, there is only limited and conflicting evidence available regarding the role of the Impella (a microaxial, continuous-flow, short-term, left or right ventricular assist device) in cardiogenic shock; further randomized trials are needed. Patient selection, timing of implantation, and post-implantation management in the cardiac intensive care unit are crucial elements for success. Particular challenges at the bedside include the practical management of anticoagulation, evaluation of correct device position, and the approach to use in a patient with signs of insufficient hemodynamic support. Profound knowledge of these issues is required to enable the maximal potential of the device. This review provides a comprehensive overview of the short-term assist device and describes a practical approach to optimize care for patients supported with the device., Competing Interests: Funding Support and Author Disclosures Drs. Balthazar, Vandenbriele, Engström, Meyns, Van Mieghem, and Price have reported receiving research and/or travel funding, as well as speaker fees, from Abiomed. Dr. Balthazar was supported by a grant from the Van De Werf fund for clinical research. Dr. Vandenbriele has reported being supported by a grant from University Hospitals Leuven (Klinische onderzoeks-en opleidingsraad). Dr. Verbrugge has reported being supported by a Fellowship of the Belgian American Educational Foundation and by the Special Research Fund of Hasselt University (BOF19PD04). Dr. Adriaenssens has received speaker fees from Abiomed. 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. All rights reserved.)