Search

Transcatheter aortic valve implantation (TAVI) is effective in older patients with symptomatic severe aortic stenosis, while the indication has recently broadened to younger patients at lower risk. Although thromboembolic and bleeding complications after TAVI have decreased over time, such adverse events are still common. The recommendations of the latest 2017 ESC/EACTS Guidelines for the management of valvular heart disease on antithrombotic therapy in patients undergoing TAVI are mostly based on expert opinion. Based on recent studies and randomized controlled trials, this viewpoint document provides updated therapeutic insights in antithrombotic treatment during and after TAVI., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

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: Systems of care have been challenged to control progression of the COVID-19 pandemic. Whether this has been associated with delayed reperfusion and worse outcomes in French patients with ST-segment elevation myocardial infarction (STEMI) is unknown., Aim: To compare the rate of STEMI admissions, treatment delays, and outcomes between the first peak of the COVID-19 pandemic in France and the equivalent period in 2019., Methods: In this nationwide French survey, data from consecutive STEMI patients from 65 centres referred for urgent revascularization between 1 March and 31 May 2020, and between 1 March and 31 May 2019, were analysed. The primary outcome was a composite of in-hospital death or non-fatal mechanical complications of acute myocardial infarction., Results: A total of 6306 patients were included. During the pandemic peak, a 13.9±6.6% (P=0.003) decrease in STEMI admissions per week was observed. Delays between symptom onset and percutaneous coronary intervention were longer in 2020 versus 2019 (270 [interquartile range 150-705] vs 245 [140-646]min; P=0.013), driven by the increase in time from symptom onset to first medical contact (121 [60-360] vs 150 [62-420]min; P=0.002). During 2020, a greater number of mechanical complications was observed (0.9% vs 1.7%; P=0.029) leading to a significant difference in the primary outcome (112 patients [5.6%] in 2019 vs 129 [7.6%] in 2020; P=0.018). No significant difference was observed in rates of orotracheal intubation, in-hospital cardiac arrest, ventricular arrhythmias and cardiogenic shock., Conclusions: During the first peak of the COVID-19 pandemic in France, there was a decrease in STEMI admissions, associated with longer ischaemic time, exclusively driven by an increase in patient-related delays and an increase in mechanical complications. These findings suggest the need to encourage the population to seek medical help in case of symptoms., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

High-risk transcatheter procedures requiring hemodynamic support are growing and require multiple vascular access that may be challenging in cases of peripheral artery disease or lack of radial access and exposure to a higher risk of vascular complications. We report the novel utilization of a Y-shaped arterial extracorporeal membrane oxygenation (ECMO) cannula used as a single femoral access to perform percutaneous coronary intervention (PCI) and aortography during high-risk transcatheter aortic valve replacement (TAVR). The utilization of this 2-in-1 ECMO cannula may simplify vascular access and reduce vascular and bleeding complications during high-risk ECMO-supported transcatheter procedures., (© 2020 Wiley Periodicals LLC.)

After 15 years of successive randomized, controlled trials, indications for transcatheter aortic valve replacement (TAVR) are rapidly expanding. In the coming years, this procedure could become the first line treatment for patients with a symptomatic severe aortic stenosis and a tricuspid aortic valve anatomy. However, randomized, controlled trials have excluded bicuspid aortic valve (BAV), which is the most frequent congenital heart disease occurring in 1% to 2% of the total population and representing at least 25% of patients 80 years of age or older referred for aortic valve replacement. The use of a less invasive transcatheter therapy in this elderly population became rapidly attractive, and approximately 10% of patients currently undergoing TAVR have a BAV. The U.S. Food and Drug Administration and the "European Conformity" have approved TAVR for low-risk patients regardless of the aortic valve anatomy whereas international guidelines recommend surgical replacement in BAV populations. Given this progressive expansion of TAVR toward younger and lower-risk patients, heart teams are encountering BAV patients more frequently, while the ability of this therapy to treat such a challenging anatomy remains uncertain. This review will address the singularity of BAV anatomy and associated technical challenges for the TAVR procedure. We will examine and summarize available clinical evidence and highlight critical knowledge gaps regarding TAVR utilization in BAV patients. We will provide a comprehensive overview of the role of computed tomography scans in the diagnosis, and classification of BAV and TAVR procedure planning. Overall, we will offer an integrated framework for understanding the current role of TAVR in the treatment of bicuspid aortic stenosis and for guiding physicians in clinical decision-making.

Background: A reduction of admission for MI has been reported in most countries affected by COVID-19. No clear explanation has been provided., Methods: To report the incidence of myocardial infarction (MI) admission during COVID-19 pandemic and in particular during national lockdown in two unequally affected French provinces (10-million inhabitants) with a different media strategy, and to describe the magnitude of MI incidence changes relative to the incidence of COVID-19-related deaths. A longitudinal study to collect all MIs from January 1 until May 17, 2020 (study period) and from the identical time period in 2019 (control period) was conducted in all centers with PCI-facilities in northern "Hauts-de-France" province and western "Pays-de-la-Loire" Province. The incidence of COVID-19 fatalities was also collected., Findings: In "Hauts-de-France", during lockdown (March 18-May 10), 1500 COVID-19-related deaths were observed. A 23% decrease in MI-IR (IRR=0.77;95%CI:0.71-0.84, p <0.001) was observed for a loss of 272 MIs (95%CI:-363,-181), representing 18% of COVID-19-related deaths. In "Pays-de-la-Loire", 382 COVID-19-related deaths were observed. A 19% decrease in MI-IR (IRR=0.81; 95%CI=0.73-0.90, p <0.001) was observed for a loss of 138 MIs (95%CI:-210,-66), representing 36% of COVID-19-related deaths. While in "Hauts-de-France" the MI decline started before lockdown and recovered 3 weeks before its end, in "Pays-de-la-Loire", it started after lockdown and recovered only by its end. In-hospital mortality of MI patients was increased during lockdown in both provinces (5.0% vs 3.4%, p =0.02)., Interpretation: It highlights one of the potential collateral damages of COVID-19 outbreak on cardiovascular health with a dramatic reduction of MI incidence. It advocates for a careful and weighted communication strategy in pandemic crises., Funding: The study was conducted without external funding., Competing Interests: Dr. Lemesle reports personal fees from Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Lilly, MSD, Mylan, Novartis, Novonordisk, Pfizer, Sanofi Aventis, Servier, outside the submitted work. Dr Delhaye reports personal fees from Medtronic outside the submitted work. Dr. Cayla reports personal fees from Amgen, personal fees from Astra Zeneca, personal fees from Bayer, personal fees from Biotronik, personal fees from Bristol Myers Squibb, grants and personal fees from Medtronic, personal fees from MSD, personal fees from Pfizer, personal fees from Sanofi, outside the submitted work. The other authors do not report any conflict of interest., (© 2021 The Authors.)

Mechanical circulatory support (MCS) devices are effective tools in managing refractory cardiogenic shock (CS). Data comparing veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and IMPELLA ® are however scarce. We aimed to assess outcomes of patients implanted with these two devices and eligible to both systems. From 2004 to 2020, we retrospectively analyzed 128 patients who underwent VA-ECMO or IMPELLA ® in our institution for refractory left ventricle (LV) dominant CS. All patients were eligible to both systems: 97 patients were first implanted with VA-ECMO and 31 with IMPELLA ® . The primary endpoint was 30-day all-cause death. VA-ECMO patients were younger (52 vs. 59.4, p = 0.006) and had a higher lactate level at baseline than those in the IMPELLA ® group (6.84 vs. 3.03 mmol/L, p < 0.001). Duration of MCS was similar between groups (9.4 days vs. 6 days in the VA-ECMO and IMPELLA ® groups respectively, p = 0.077). In unadjusted analysis, no significant difference was observed between groups in 30-day mortality: 43.3% vs. 58.1% in the VA-ECMO and IMPELLA ® groups, respectively ( p = 0.152). After adjustment, VA-ECMO was associated with a significant reduction in 30-day mortality (HR = 0.25, p = 0.004). A higher rate of MCS escalation was observed in the IMPELLA ® group: 32.3% vs. 10.3% ( p = 0.003). In patients eligible to either VA-ECMO or IMPELLA ® for LV dominant refractory CS, VA-ECMO was associated with improved survival rate and a lower need for escalation.

Importance: The efficacy of endovascular thrombectomy (EVT) for symptomatic large anterior vessel occlusion (sLAVO) sharply decreases with time. Because EVT is restricted to comprehensive stroke centers, prehospital triage of patients with acute stroke codes for sLAVO is crucial, and although several prediction scales are already in use, external validation, head-to-head comparison, and feasibility data are lacking., Objective: To conduct external validation and head-to-head comparisons of 7 sLAVO prediction scales in the emergency medical service (EMS) setting and to assess scale feasibility by EMS paramedics., Design, Setting, and Participants: This prospective cohort study was conducted between July 2018 and October 2019 in a large urban center in the Netherlands with a population of approximately 2 million people and included 2 EMSs, 3 comprehensive stroke centers, and 4 primary stroke centers. Participants were consecutive patients aged 18 years or older for whom an EMS-initiated acute stroke code was activated. Of 2812 acute stroke codes, 805 (28.6%) were excluded, because no application was used or no clinical data were available, leaving 2007 patients included in the analyses., Exposures: Applications with clinical observations filled in by EMS paramedics for each acute stroke code enabling reconstruction of the following 7 prediction scales: Los Angeles Motor Scale (LAMS); Rapid Arterial Occlusion Evaluation (RACE); Cincinnati Stroke Triage Assessment Tool; Prehospital Acute Stroke Severity (PASS); gaze-face-arm-speech-time; Field Assessment Stroke Triage for Emergency Destination; and gaze, facial asymmetry, level of consciousness, extinction/inattention., Main Outcomes and Measures: Planned primary and secondary outcomes were sLAVO and feasibility rates (ie, the proportion of acute stroke codes for which the prehospital scale could be reconstructed). Predictive performance measures included accuracy, sensitivity, specificity, the Youden index, and predictive values., Results: Of 2007 patients who received acute stroke codes (mean [SD] age, 71.1 [14.9] years; 1021 [50.9%] male), 158 (7.9%) had sLAVO. Accuracy of the scales ranged from 0.79 to 0.89, with LAMS and RACE scales yielding the highest scores. Sensitivity of the scales ranged from 38% to 62%, and specificity from 80% to 93%. Scale feasibility rates ranged from 78% to 88%, with the highest rate for the PASS scale., Conclusions and Relevance: This study found that all 7 prediction scales had good accuracy, high specificity, and low sensitivity, with LAMS and RACE being the highest scoring scales. Feasibility rates ranged between 78% and 88% and should be taken into account before implementing a scale.

Objective: The study's aim was to analyze the capacity of human valve interstitial cells (VICs) to participate in aortic valve angiogenesis. Approach and Results: VICs were isolated from human aortic valves obtained after surgery for calcific aortic valve disease and from normal aortic valves unsuitable for grafting (control VICs). We examined VIC in vitro and in vivo potential to differentiate in endothelial and perivascular lineages. VIC paracrine effect was also examined on human endothelial colony-forming cells. A pathological VIC (VIC p ) mesenchymal-like phenotype was confirmed by CD90 + /CD73 + /CD44 + expression and multipotent-like differentiation ability. When VIC p were cocultured with endothelial colony-forming cells, they formed microvessels by differentiating into perivascular cells both in vivo and in vitro. VIC p and control VIC conditioned media were compared using serial ELISA regarding quantification of endothelial and angiogenic factors. Higher expression of VEGF (vascular endothelial growth factor)-A was observed at the protein level in VIC p -conditioned media and confirmed at the mRNA level in VIC p compared with control VIC. Conditioned media from VIC p induced in vitro a significant increase in endothelial colony-forming cell proliferation, migration, and sprouting compared with conditioned media from control VIC. These effects were inhibited by blocking VEGF-A with blocking antibody or siRNA approach, confirming VIC p involvement in angiogenesis by a VEGF-A dependent mechanism., Conclusions: We provide here the first proof of an angiogenic potential of human VICs isolated from patients with calcific aortic valve disease. These results point to a novel function of VIC p in valve vascularization during calcific aortic valve disease, with a perivascular differentiation ability and a VEGF-A paracrine effect. Targeting perivascular differentiation and VEGF-A to slow calcific aortic valve disease progression warrants further investigation.

Background: Currently, there are no recommendations regarding the minimum duration of in-hospital monitoring after transfemoral (TF) transcatheter aortic valve replacement (TAVR) and practices are extremely heterogeneous. We, therefore, aimed to evaluate length of stay (LOS) and predictive factors for late discharge after TF TAVR using data from the FRANCE TAVI registry., Methods: TAVR was performed in 12,804 patients in 48 French centers between 2013 and 2015. LOS was evaluated in 5857 TF patients discharged home. LOS was calculated from TAVR procedure (day 0) to discharge. The study population was divided into three groups based on LOS values. Patients discharged within 3 days constituted the "very early" discharge group, patients with a LOS between 3 and 6 days constituted the "early" discharge group, and patients with a length of stay > 6 days constituted the "late" discharge group., Results: The median LOS was 7 (5-9) days and was extremely variable among centers. The proportion of patients discharged very early, early, and late was 4.4% (n = 256), 33.7% (n = 1997), and 61.9% (n = 3624) respectively. Variables associated with late discharge were female sex, co-morbidities, major complications, self-expandable valve, general anesthesia, and a significant center effect. In contrast, history of previous pacemaker was a protective factor. The composite of death and re-admission in the very early and early versus late discharge groups was similar at 30 days (3.3% vs. 3.5%, p = 0.66)., Conclusions: LOS is extremely variable after TF TAVR in France. Co-morbidities and complications were predictive factors of late discharge after TAVI. Interestingly, the use of self-expandable prosthesis and general anesthesia may also contribute to late discharge. Our results confirm that early discharge is safe.

Background: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement., Methods: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days., Results: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; P =0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; P =0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; P =0.03) and 1 year (8.4% versus 3.9%; P =0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; P =0.002) were significantly increased in the ACURATE neo group., Conclusions: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813.

Background/objectives: Clinicians use validated scores to risk-stratify patients undergoing transcatheter aortic valve replacement (TAVR). However, evaluation by the Heart Team often deems patients to be at higher risk than their formal scores suggest. We sought to assess clinical outcomes of TAVR patients defined as high-risk by the Heart Team's assessment versus the patient's logistic EuroSCORE (LES)., Methods: The BRAVO-3 trial randomized patients at high risk (LES ≥ 18, or deemed inoperable by the Heart Team) to TAVR with periprocedural anticoagulation with unfractionated heparin versus bivalirudin. Endpoints included net adverse cardiac events (NACE: the composite of all-cause mortality, MI, stroke, or bleeding), major adverse cardiovascular events (MACE: death, MI, or stroke), the individual components of MACE, major vascular complications, BARC ≥ 3b bleeding and VARC life-threatening bleeding at 30 days. We compared patients deemed high-risk based on LES ≥ 18 versus high-risk by the Heart Team despite lower LES., Results: A total of 467/800 (58.4%) patients were deemed high-risk by the Heart Team despite LES < 18. After multivariable analysis, there were no differences in the odds of endpoints between groups (NACE, OR LES≥18 : 1.32, 95% CI 0.86-2.02, p = .21; MACE, OR LES≥18 : 1.27, 95% CI 0.72-2.25, p = .41; major vascular complications, OR LES≥18 : 0.97, 95% CI 0.65-1.44, p = .88; BARC ≥3b, OR LES≥18 : 1.38, 95% CI 0.82-2.33, p = .23; and VARC life-threatening bleeding, OR LES≥18 : 0.99, 95% CI 0.69-1.41, p = .95)., Conclusion: Patients undergoing TAVR and labeled high-risk by LES ≥ 18 or Heart Team assessment despite LES < 18 have comparable short-term outcomes. Assignment of high-risk status to over 50% of patients is attributable to Heart Team's clinical assessment., (© 2020 Wiley Periodicals, Inc.)

Aims: No randomised study comparing the outcomes of transcarotid (TC) and transaxillary (TAx) TAVR has been conducted to date. The purpose of this study was to understand which approach should be the preferred alternative by comparing their outcomes using a propensity-matched comparison in a French multicentre registry., Methods and Results: From 2010 to 2018, a French multicentre prospective registry included 502 patients, with 374 undergoing TC-TAVR and 128 TAx-TAVR for symptomatic aortic stenosis. Patients treated through TAx access were matched 1:2 with patients treated through the TC route by using a propensity score (20 clinical, anatomical and procedural variables) and by date of the procedure. The first outcome was mortality at one-month follow-up. The second outcome was one-month stroke/transient ischaemic attack (TIA). In propensity-matched analyses, the incidence of the primary outcome was similar in the TAx and TC groups (TAx 5.5% vs TC 4.5%, OR 1.23, 95% CI: 0.40-3.70). The secondary outcome was similar in TAx (3.2%) and TC (6.8%, OR 0.52, 95% CI: 0.14-1.84). Minor bleeding (2.7% vs 9.3%, OR 0.26, 95% CI: 0.07-0.92) and main access haematoma (3.6% vs 10.3%, OR 0.034, 95% CI: 0.09-0.92) were significantly more frequent with the TC access. One-month clinical efficacy and safety and one-year mortality did not differ according to the different routes., Conclusions: One-month mortality, one-month stroke/TIA and one-year mortality are similar with TAx-TAVR and TC-TAVR. However, TC-TAVR is accompanied by more minor bleeding and main access haematoma compared with the transaxillary route.

Approximately 10% of patients resuscitated from out-of-hospital cardiac arrest survive to hospital discharge. Improved management to improve outcomes is required, and it is proposed that such patients should be preferentially treated in cardiac arrest centres. The minimum requirements of therapy modalities for the cardiac arrest centre are 24/7 availability of an on-site coronary angiography laboratory, an emergency department, an intensive care unit, imaging facilities such as echocardiography, computed tomography and magnetic resonance imaging, and a protocol outlining transfer of selected patients to cardiac arrest centres with additional resources (out-of-hospital cardiac arrest hub hospitals). These hub hospitals are regularly treating a high volume of patients and offer further treatment modalities. This consensus document describes the aims, the minimal requirements for therapeutic modalities and expertise, and the structure, of a cardiac arrest centre. It represents a consensus among the major European medical associations and societies involved in the treatment of out-of-hospital cardiac arrest patients.

Background: The SAPIEN 3 (S3) addresses several limitations of the SAPIEN XT (SXT) for the performance of transfemoral (TF-) balloon expandable transcatheter aortic valve implantation (TAVI)., Objectives: We aimed to determine whether their altered features translate into improved outcomes in a real-world TF-TAVI patient population., Methods: Data for 3,314 patients were extracted from the European registries SOURCE-XT and SOURCE-3. Patients were propensity-score (PS) matched (n = 1,169/group)., Results: In the PS matched comparison, device success was higher in the S3 (99.2%) compared to the SXT group (98.2%; p = .04). S3 patients experienced a lower rate of procedural death (0.7 vs. 2.6%; p = .0004), moderate/severe paravalvular leakage (PVL; 1.4 vs. 5.5%; p < .0001), and procedure-related stroke (1.2 vs. 2.4%; p = .04) while higher rates of mean aortic valve gradients ≥20 mmHg, and new permanent pacemaker implantations were seen. At 30 days a lower rate of all-cause mortality was seen (2.1% vs. 4.3%; p = .003), which was preserved after 1 year (10.7% vs. 14.9%; p = .002). A Cox regression predicting 1-year mortality resulted in a hazard ratio of 0.684 in favor of S3 (p = .0026). The same was true of stroke (2.8% vs. 5.7%; p = .0007), and moderate/severe PVL (2.7 vs. 7.3%; p = .0002) at 1 year. The rate of new pacemaker implantations (13.6% vs. 9.5%; p = .001) and NYHA III/IV (12.8 vs. 8.6%; p = .004) was higher with the S3., Conclusions: The improved features of the S3 appear to translate into improved survival and reduced rates of adverse complications, with the exception of a higher rate of new pacemaker implantations., (© 2019 Wiley Periodicals LLC.)

Background: Patient participation is fundamental to nursing care and has beneficial effects on patient outcomes. However, it is not well embedded yet and little is known on how nurses could effectively stimulate patient participation in hospital care. The Tell-us Card is a communication tool for inviting patients to talk about their preferences and needs, and to increase patient participation in daily care., Objectives: To assess feasibility and early effectiveness of the Tell-us Card communication tool for enhanced patient participation during hospitalisation., Design and Method: A pilot cluster randomised controlled study design was used including four nursing wards. Effectiveness was measured with the Individualized Care Scale (ICS) and the Quality from the Patients' Perspective (QPP) questionnaire. Linear mixed model analysis was used for analysis. Feasibility was assessed with an evaluative questionnaire for patients and nurses and by reviewing the content of Tell-us Cards using the Fundamentals of Care Framework (FOCF) for analysis. Ethical approval was attained., Results: Data of 265 patients showed a significant increase at one intervention ward on the ICS (effect size 0.61, p = 0.02) and most ICS subscales. No effect was visible on the QPP. The majority of patients regarded the intervention as beneficial; nurses however experienced barriers with incorporating the Tell-us Card into daily care. Analysis of the Tell-us Card content showed many elements of the FOCF being mentioned, with most patients indicating psychosocial needs like being involved and informed., Conclusions: This pilot study showed a positive early effect of the Tell-us Card communication tool on patient participation, although integration in daily nursing care appeared to be complex and an optimal fit has not yet been reached. Patients were positive about the intervention and wrote meaningful issues on the Tell-us Cards. More research is needed on how to incorporate patient participation effectively in complex hospital care., (© 2020 The Authors. Scandinavian Journal of Caring Sciences published by John Wiley & Sons Ltd on behalf of Nordic College of Caring Science.)

Background: Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials., Objectives: This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices., Methods: Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications., Results: A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016)., Conclusions: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to investigate the clinical outcomes of patients with and without peripheral artery disease (PAD) in the BRAVO-3 trial with respect to the effect of bivalirudin versus unfractionated heparin (UFH)., Background: PAD is found frequently in patients undergoing transcatheter aortic valve replacement (TAVR) and is reported to confer an increased risk of adverse events. It is unknown whether patients with and without PAD may demonstrate a differential response to bivalirudin versus UFH., Methods: BRAVO-3 was a randomized multicenter trial comparing transfemoral TAVR with bivalirudin versus UFH (31 centers, n = 802). Major adverse cardiovascular events (MACE) were a composite of 30-day death, myocardial infarction, or cerebrovascular accidents (CVA). Net adverse cardiovascular events (NACE) were a composite of major bleeding or MACE., Results: The total cohort included 119 patients with PAD. Vascular complications occurred significantly more frequently in patients with PAD both in-hospital (25.2 vs. 16.7%; OR 1.68) and at 30 days (29.4 vs. 17.3%; OR 1.99). No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD. In patients with PAD, bivalirudin was associated with an increased risk of minor vascular complications at 30 days., Conclusions: Patients with PAD undergoing transfemoral TAVR did not exhibit an increased risk of any major adverse events, according to the procedural anticoagulant randomization. However, patients treated with Bivalirudin had significantly higher rates of minor vascular complications., (© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

Background: Intracoronary physiology is increasingly used in nonculprit stenoses of patients with acute coronary syndromes (ACS). However, evidence regarding the safety of fractional flow reserve-based deferral in patients with ACS, compared with patients with stable angina pectoris (SAP), is scarce., Objectives: The aim of this study was to evaluate the safety of revascularization deferral on the basis of fractional flow reserve interrogation of nonculprit lesions in patients with ACS., Methods: A pooled analysis was performed of individual patient data included in 5 large international published studies on physiology-guided revascularization. The primary endpoint was major adverse cardiac events (MACE) (a composite of death, nonfatal myocardial infarction, or unplanned revascularization) at 1-year follow-up. Clinical outcomes of patients with ACS and SAP were compared in both the deferred and the revascularized groups., Results: A total of 8,579 patients were included in the analysis, 6,461 with SAP and 2,118 with ACS and nonculprit stenoses. Using fractional flow reserve, revascularization was deferred in 5,129 patients (59.8%) and performed in 3,450 patients (40.2%). In the deferred ACS group, a higher MACE rate was observed compared with the deferred SAP group (4.46% vs. 2.83%; adjusted hazard ratio [HR]: 1.72; 95% confidence interval [CI]: 1.17 to 2.53; p < 0.01). In particular, early unplanned revascularization (3.34% and 2.04% in ACS and SAP; adjusted HR: 1.81; 95% CI: 1.09 to 3.00; p = 0.02) contributed to this excess in MACE but the difference between the ACS and SAP groups did not reach statistical significance. On the contrary, no differences in outcomes linked to clinical presentation were found in treated patients (MACE rate 6.51% vs. 6.20%; adjusted HR: 1.21; 95% CI: 0.88 to 1.26; p = 0.24)., Conclusions: Patients with ACS in whom revascularization of nonculprit lesions was deferred on the basis of fractional flow reserve have more MACE at 1 year compared with patients with SAP with deferred revascularization. Unplanned revascularization mainly contributed to this excess of MACE., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: To explore how nurses in hospitals enact person-centred fundamental care delivery., Background: Effective person-centred care is at the heart of fundamental nursing care, but it is deemed to be challenging in acute health care as there is a strong biomedical focus and most nurses are not trained in person-centred fundamental care delivery. We therefore need to know if and how nurses currently incorporate a person-centred approach during fundamental care., Design: Focused ethnography approach., Methods: Observations of 30 nurses on three different wards in two Dutch hospitals during their morning shift. Data were collected through passive observations and analysed using framework analysis based on the fundamentals of care framework. The COREQ guideline was used for reporting., Results: Some nurses successfully integrate physical, psychosocial and relational elements of care in patient interactions. However, most nurses were observed to be mainly focused on physical care and did not take the time at their patients' bedside to care for their psychosocial and relational needs. Many had a task-focused way of working and communicating, seldom incorporating patients' needs and experiences or discussing care planning, and often disturbing each other., Conclusions: This study demonstrates that although some nurses manage to do so, person-centred fundamental care delivery remains a challenge in hospitals, as most nurses have a task-focused approach and therefore do not manage to integrate the physical, relational and physical elements of care. For further improvement, attention needs to be paid to integrated fundamental care and clinical reasoning skills., Relevance to Clinical Practice: Although most nurses have a compassionate approach, this study shows that nurses do not incorporate psychosocial care or encourage patient participation when helping patients with their physical fundamental care needs, even though there seems to be sufficient opportunity for them to do so., (© 2019 The Authors. Journal of Clinical Nursing Published by John Wiley & Sons Ltd.)

Background Ultrasound (US) guidance provides the unique opportunity to control the puncture zone of the artery during transfemoral transcatheter aortic valve replacement and may decrease major vascular complications (VC) and life-threatening or major bleeding complications. This study aimed to evaluate the clinical impact of US guidance using a propensity score-matched comparison. Methods and Results US guidance was implemented as the default approach for all transfemoral transcatheter aortic valve replacement cases in our institution in June 2013. We defined 3 groups of consecutive patients according to the method of puncture (fluoroscopic/US guidance) and the use of a transcatheter heart valve. Patients in the US-guided second-generation group (Sapien XT [Edwards Lifesciences, Irvine, CA], Corevalve [Medtronic, Dublin, Ireland]) were successfully 1:1 matched with patients in the fluoroscope-guided second-generation group (n=95) with propensity score matching. In a second analysis we described the consecutive patients of the US-guided third-generation group (Evolut-R [Medtronic], Sapien 3 [Edwards Lifesciences], n=308). All vascular and bleeding complications were reduced in the US-guided second-generation group compared with the fluoroscope-guided second-generation group: VC (16.8% versus 6.3%; P =0.023); life-threatening or major bleeding (22.1% versus 6%; P =0.004); and VC related to vascular access (12.6% versus 4.2%; P =0.052). In the US-guided third-generation group the rates of major VC and life-threatening or major bleeding were 3.2% (95% CI, 1.6% to 5.9%) and 3.6% (95% CI, 1.8% to 6.3%). In the overall population (n=546), life-threatening or major bleeding was associated with a 1.7-fold increased mortality risk ( P =0.02). Conclusions We demonstrated that US guidance effectively reduced VC and bleeding complications for transfemoral transcatheter aortic valve replacement and should be considered the standard puncture method. Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02628509.

Importance: Approximately one-third of patients considered for coronary revascularization have diabetes, which is a major determinant of clinical outcomes, often influencing the choice of the revascularization strategy. The usefulness of fractional flow reserve (FFR) to guide treatment in this population is understudied and has been questioned., Objective: To evaluate the usefulness and rate of major adverse cardiovascular events (MACE) of integrating FFR in management decisions for patients with diabetes who undergo coronary angiography., Design, Setting, and Participants: This cross-sectional study used data from the PRIME-FFR study derived from the merger of the POST-IT study (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease [March 2012-November 2013]) and R3F study (French Study of FFR Integrated Multicenter Registries Implementation of FFR in Routine Practice [October 2008-June 2010]), 2 prospective multicenter registries that shared a common design. A population of all-comers for whom angiography disclosed ambiguous lesions was analyzed for rates, patterns, and outcomes associated with management reclassification, including revascularization deferral, in patients with vs without diabetes. Data analysis was performed from June to August 2018., Main Outcomes and Measures: Death from any cause, myocardial infarction, or unplanned revascularization (MACE) at 1 year., Results: Among 1983 patients (1503 [77%] male; mean [SD] age, 65 [10] years), 701 had diabetes, and FFR was performed for 1.4 lesions per patient (58.2% of lesions in the left anterior descending artery; mean [SD] stenosis, 56% [11%]; mean [SD] FFR, 0.81 [0.01]). Reclassification by FFR was high and similar in patients with and without diabetes (41.2% vs 37.5%, P = .13), but reclassification from medical treatment to revascularization was more frequent in the former (142 of 342 [41.5%] vs 230 of 730 [31.5%], P = .001). There was no statistical difference between the 1-year rates of MACE in reclassified (9.7%) and nonreclassified patients (12.0%) (P = .37). Among patients with diabetes, FFR-based deferral identified patients with a lower risk of MACE at 12 months (25 of 296 [8.4%]) compared with those undergoing revascularization (47 of 257 [13.1%]) (P = .04), and the rate was of the same magnitude of the observed rate among deferred patients without diabetes (7.9%, P = .87). Status of insulin treatment had no association with outcomes. Patients (6.6% of the population) in whom FFR was disregarded had the highest MACE rates regardless of diabetes status., Conclusions and Relevance: Routine integration of FFR for the management of coronary artery disease in patients with diabetes may be associated with a high rate of treatment reclassification. Management strategies guided by FFR, including revascularization deferral, may be useful for patients with diabetes.

Purpose: Evaluation of reendothelialization with a new thin struts cobalt chromium alloy stent coated with a nano-layer of Polyzene™-F (PzF) in a rabbit iliac artery model., Methods: Fifteen stented external rabbit iliac arteries were harvested at Day 7 for electron microscopy analysis following Cobra PzF stents implantation to assess reendothelialization and compare to historical data. Ten additional rabbits were used to assess time course of reendothelialization at 3 and 5 days., Results: At Day 7, almost complete coverage of endothelial cells was observed with a coverage of 99.54 ± 0.25% of the stented area. No thrombus area was noted. At Day 3, more than half of examined pieces was reendothelialized and reached 78.30 ± 3.7% at Day 5 (p < .01 between each group). All stents were well expanded against the arterial wall and no struts were mal-apposed., Conclusions: Reendothelialization was rapid and complete at Day 7. This is the fastest reendothelization process after stenting in this model. No stent occlusion was observed., Competing Interests: Declaration of competing interest LM is consultant (modest) for CeloNova. MB is employee at CeloNova. The other authors have nothing to disclose. This work was supported by a research grant from CeloNova., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date., Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality., Results: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; P <0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; P <0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; P =0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; P =0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis., Conclusion: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV., Clinical Trial Registration: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.

Objectives: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation., Background: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR)., Methods: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days., Results: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001)., Conclusions: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Transcatheter mitral valve replacement (TMVR) is a promising therapeutic solution to treat high-risk patients with severe mitral regurgitation (MR) contraindicated to surgery. Optimal selection of patients who will benefit from the procedure is of paramount importance. We aimed to investigate factors associated with TMVR screening., Methods and Results: From November 2016 to July 2018, we examined conditions associated with TMVR screening success in patients referred to the two French heart valve clinics with the greatest TMVR experience. Among a total of 40 consecutively screened patients, 16 (40%) were selected for TMVR (8 Twelve Intrepid, 7 Tendyne and 1 HighLife), while 24 patients (60%) were refused for TMVR mainly because of a too large mitral annulus (MA) (n=15, 62% of those refused), or too small anatomy and risk of neo-left ventricular outflow tract (LVOT) obstruction (n=6, 25% of those refused). Patients with suitable anatomy for TMVR were more often male and more frequently suffered from secondary MR (p=0.01) associated with previous myocardial infarction and presented a commissure-to-commissure diameter less than 39 mm (AUC=0.72, p=0.0085) and LVESD greater than 32 mm (AUC=0.83, p<0.0001) on transthoracic echocardiography, and an MA area less than 17.6 cm² (AUC=0.95, p<0.0001) and anteroposterior diameter greater than 41.6 mm (AUC=0.87, p<0.001) on CT scan., Conclusions: Despite several prostheses being available, most patients referred to heart valve clinics who are good candidates with regard to their clinical profile cannot have TMVR because of mismatch between their anatomy and prosthesis characteristics. Our findings suggest the need to develop new prostheses adapted to larger mitral annuli but with a lower impact on the LVOT.

Background: Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral accesses exist, although they have not been accurately compared with femoral access., Objectives: This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR., Methods: Using the data from the national prospective French registry (FRANCE TAVI [French Transcatheter Aortic Valve Implantation]), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score-based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed., Results: Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers., Conclusions: n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The transcarotid (TC) approach for transcatheter aortic valve implantation (TAVI) is potentially an optimal alternative to the transfemoral (TF) approach. Our goal was to compare the safety and efficacy of TC- and TF-TAVI., Methods: Patients who underwent TF-TAVI or TC-TAVI in the prospectively collected FRANCE TAVI registry between January 2013 and December 2015 were compared. Propensity score inverse probability weighting methods were employed to minimize the impact of bias related to non-random treatment assignment., Results: Of the 11 033 patients included in the current study, 10 598 (96%) underwent a TF-TAVI and 435 (4.1%) had a TC-TAVI. Patients in the TC-TAVI access group presented with a higher risk profile but were significantly younger. There were no differences in the perioperative and 2-year mortality rates after adjustment [odds ratio (OR) 1.02, 95% confidence interval (CI) 0.62-1.68; P = 0.99 and hazard ratio 1.03, 95% CI 0.7-1.35; P = 0.83). TC-TAVI was associated with a significant risk of stroke (OR 2.42, 95% CI 2.01-2.92; P < 0.001), ST-elevation myocardial infarction (OR 7.32, 95% CI 3.87-13.87; P < 0.001), infections (OR 2.36, 95% CI 2.04-2.71; P < 0.001), bleeding (OR 2.01, 95% CI 1.76-2.29; P < 0.001), renal failure (OR 2.23, 95% CI 1.90-2.60; P < 0.001) and need for dialysis (OR 2.36, 95% CI 2.01-2.76, P < 0.001). Conversely, TC-TAVI was not confirmed as a risk factor for pacemaker implantation after adjustment (OR 1.05, 95% CI 0.96-1.15; P < 0.28) and was a protective factor for vascular complications (OR 0.37, 95% CI 0.32-0.43; P < 0.001)., Conclusions: TC-TAVI is a safe procedure compared to TF-TAVI, although it holds an increased risk of perioperative complications. It should be considered in case of non-femoral peripheral access as the second access choice, to increase the overall safety of TAVI procedures., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objective: The long-term outcome of allogenic islet transplantation is unknown. The aim of this study was to evaluate the 10-year outcome of islet transplantation in patients with type 1 diabetes and hypoglycemia unawareness and/or a functioning kidney graft., Research Design and Methods: We enrolled in this prospective parallel-arm cohort study 28 subjects with type 1 diabetes who received islet transplantation either alone (ITA) or after a kidney graft (IAK). Islet transplantation consisted of two or three intraportal infusions of allogenic islets administered within (median [interquartile range]) 68 days (43-92). Immunosuppression was induced with interleukin-2 receptor antibodies and maintained with sirolimus and tacrolimus. The primary outcome was insulin independence with A1C ≤6.5% (48 mmol/mol). Secondary outcomes were patient and graft survival, severe hypoglycemic events (SHEs), metabolic control, and renal function., Results: The primary outcome was met by (Kaplan-Meier estimates [95% CI]) 39% (22-57) and 28% (13-45) of patients 5 and 10 years after islet transplantation, respectively. Graft function persisted in 82% (62-92) and 78% (57-89) of case subjects after 5 and 10 years, respectively, and was associated with improved glucose control, reduced need for exogenous insulin, and a marked decrease of SHEs. ITA and IAK had similar outcomes. Primary graft function, evaluated 1 month after the last islet infusion, was significantly associated with the duration of graft function and insulin independence., Conclusions: Islet transplantation with the Edmonton protocol can provide 10-year markedly improved metabolic control without SHEs in three-quarters of patients with type 1 diabetes, kidney transplanted or not., (© 2019 by the American Diabetes Association.)

Objectives: This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)- and fractional flow reserve (FFR)-guided revascularization strategies., Background: An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes., Methods: This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization., Results: Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919)., Conclusions: An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Importance: Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been fully investigated., Objective: To compare 1-year clinical outcomes of iFR-guided or FFR-guided treatment in patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial., Design, Setting, and Participants: The DEFINE-FLAIR trial is a multicenter, international, randomized, double-blinded trial that randomly assigned 2492 patients in a 1:1 ratio to undergo either iFR-guided or FFR-guided coronary revascularization. Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015., Interventions: According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred., Main Outcomes and Measures: The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. The incidence of MACE was compared according to the presence of diabetes in iFR-guided and FFR-guided groups., Results: Among the total trial population (2492 patients), 758 patients (30.4%) had diabetes. Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465). In the nondiabetes population (68.5%; 1707 patients), iFR guidance was associated with a significantly higher rate of deferral of revascularization than the FFR-guided group (56.5% [n = 477 of 844] vs 46.6% [n = 402 of 863]; P < .001). However, it was not different between the 2 groups in the diabetes population (42.1% [n = 161 of 382] vs 47.1% [n = 177 of 376]; P = .15). At 1 year, the diabetes population showed a significantly higher rate of MACE than the nondiabetes population (8.6% vs 5.6%; adjusted hazard ratio [HR], 1.88; 95% CI, 1.28-2.64; P < .001). However, there was no significant difference in MACE rates between iFR-guided and FFR-guided groups in both the diabetes (10.0% vs 7.2%; adjusted HR, 1.33; 95% CI, 0.78-2.25; P = .30) and nondiabetes population (4.7% vs 6.4%; HR, 0.83; 95% CI, 0.51-1.35; P = .45) (interaction P = .25)., Conclusions and Relevance: The diabetes population showed significantly higher risk of MACE than the nondiabetes population, even with the iFR-guided or FFR-guided treatment. The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes., Trial Registration: ClinicalTrials.gov identifier: NCT02053038.

Background/objective: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear., Methods: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke)., Results: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death., Conclusions: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR., (© 2019 Wiley Periodicals, Inc.)

P2Y 12 -inhibitor initiation with clopidogrel using a loading dose (LD) versus no LD (NLD) provides more rapid inhibition of platelet activation and reduced risk of ischemic events after coronary stenting. Whether a similar beneficial effect is achieved in the setting of transcatheter aortic valve implantation (TAVI) is unknown. We evaluate the effects of preprocedural clopidogrel LD versus no NLD on 48-hour and 30-day clinical outcomes after TAVI. In the BRAVO-3 trial, 802 patients with severe aortic stenosis who underwent transfemoral TAVI were randomized to intraprocedural anticoagulation with bivalirudin or unfractionated heparin. Administration of clopidogrel LD was left to the discretion of the treating physician. For this analysis, patients were stratified according to receiving clopidogrel LD (n = 294, 36.6%) or NLD (n = 508, 63.4%) before TAVI. LD patients more often received a self-expandable prosthesis using larger sheaths. P2Y 12 -inhibitor maintenance therapy pre-TAVI was similar in patients with LD versus NLD (28.2% vs 33.1%, p = 0.16). LD versus NLD was associated with similar incidences of major adverse cardiovascular events (i e., death, myocardial infarction, or stroke) (4.1% vs 4.1%, p = 0.97) and major bleeding (8.5% vs 7.7%, p = 0.68), but a higher rate of major vascular complications (11.9% vs 7.1%, p = 0.02). Multivariable adjustment showed that clopidogrel LD did not affect any of the studied clinical events, including major vascular complications (odds ratio 0.91, 95% confidence interval 0.60 to 1.39, p = 0.67). Also patients on clopidogrel maintenance therapy and thus considered in steady state were not at reduced risk of major adverse cardiovascular events compared with patients not on clopidogrel (3.7% vs 5.2%, p = 0.36). In conclusion, in patients who underwent TAVI, use of clopidogrel LD was associated with higher vascular complications and otherwise similar clinical events compared to NLD patients., (Copyright © 2019. Published by Elsevier Inc.)

For decades, numerous observations have shown an intimate relationship between von Willebrand factor (VWF) multimer profile and heart valve diseases (HVD). The current knowledge of the unique biophysical properties of VWF helps us to understand the longstanding observations concerning the bleeding complications in patients with severe HVD. Not only does the analysis of the VWF multimer profile provide an excellent evaluation of HVD severity, it is also a strong predictor of clinical events. Also of importance, VWF responds within minutes to any significant change in hemodynamic valve status, making it an accurate marker of the quality of surgical and transcatheter therapeutic interventions. The authors provide in this review a practical, comprehensive, and evidence-based framework of the concept of VWF as a biomarker in HVD, advocating for its implementation into the clinical decision-making process besides usual clinical and imaging evaluation. They also delineate critical knowledge gaps and research priorities to definitely validate this concept., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Physicians are not always comfortable deferring treatment of a stenosis in the left anterior descending (LAD) artery because of the perception that there is a high risk of major adverse cardiac events (MACE). The authors describe, using the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) trial, MACE rates when LAD lesions are deferred, guided by physiological assessment using fractional flow reserve (FFR) or the instantaneous wave-free ratio (iFR)., Objectives: The purpose of this study was to establish the safety of deferring treatment in the LAD using FFR or iFR within the DEFINE-FLAIR trial., Methods: MACE rates at 1 year were compared between groups (iFR and FFR) in patients whose physiological assessment led to LAD lesions being deferred. MACE was defined as a composite of cardiovascular death, myocardial infarction (MI), and unplanned revascularization at 1 year. Patients, and staff performing follow-up, were blinded to whether the decision was made with FFR or iFR. Outcomes were adjusted for age and sex., Results: A total of 872 patients had lesions deferred in the LAD (421 guided by FFR, 451 guided by iFR). The event rate with iFR was significantly lower than with FFR (2.44% vs. 5.26%; adjusted HR: 0.46; 95% confidence interval [CI]: 0.22 to 0.95; p = 0.04). This was driven by significantly lower unplanned revascularization with iFR and numerically lower MI (unplanned revascularization: 2.22% iFR vs. 4.99% FFR; adjusted HR: 0.44; 95% CI: 0.21 to 0.93; p = 0.03; MI: 0.44% iFR vs. 2.14% FFR; adjusted HR: 0.23; 95% CI: 0.05 to 1.07; p = 0.06)., Conclusions: iFR-guided deferral appears to be safe for patients with LAD lesions. Patients in whom iFR-guided deferral was performed had statistically significantly lower event rates than those with FFR-guided deferral., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)