Procedural and clinical impact of intracoronary lithotripsy in heavily calcified aorto-ostial coronary lesions.

BACKGROUND: Percutaneous coronary intervention of calcified aorto-ostial lesions (AOL) pose unique challenges due to anatomical propensity for recoil, leading to poorer outcomes compared to non-AOL. Although intravascular lithotripsy (IVL) has shown excellent success and safety in heavily calcified plaques, evidence specific to AOL is limited. This study aims to evaluate the efficacy and safety of IVL in AOL versus non-AOL. METHODS: Patients treated with IVL between 2019 and 2023 from an ongoing prospective multicenter registry were eligible for inclusion. Patients were therefore classified in AOL and non-AOL groups, based on anatomical location. The primary technical endpoint was device success, defined as the ability to deliver the IVL catheter and pulses at the target lesion, without angiographic complications. Secondary technical endpoint encompassed procedural success <30%, consisting of device success with residual stenosis <30%, final thrombolysis in myocardial infarction grade 3 flow, and no in-hospital major adverse cardiovascular events (MACE). The primary clinical endpoint was in-hospital MACE, including cardiac death, nonfatal myocardial infarction, or target lesion revascularization. RESULTS: A total of 321 patients underwent IVL, including 48 with AOL. Device success showed no significant difference between AOL and non-AOL groups (100% vs. 98.2%; p = 0.35). A nonsignificant trend toward worse procedural success with residual stenosis <30% was observed in the AOL arm (AOL 81.3% vs. non-AOL 90.5%, p = 0.06). In-hospital MACE was significantly higher in AOL (4.2% vs. 0.7%, p = 0.048), attributed entirely to cardiac deaths. At 6-month follow-up, the incidence of MACE (AOL 8.3% vs. non-AOL 4.0%, p = 0.19), and cardiac deaths (AOL 4.2% vs non-AOL1.1%, p = 0.11) were comparable between groups. CONCLUSION: IVL treatment for heavily calcified AOL demonstrates comparable procedural and 6-month clinical outcomes when compared to non-AOL, despite a higher incidence of in-hospital MACE.

Intravascular lithotripsy in heavily calcified chronic total occlusion: procedural and one-year clinical outcomes.

BACKGROUND: Calcification within chronic total occlusions (CTO) is strongly associated with worse outcomes. Despite the excellent success and safety of intravascular lithotripsy (IVL) in heavily calcified lesions, evidence in CTO remains scarce. AIM: This study aimed to evaluate the procedural and long-term clinical outcomes of IVL in heavily calcified CTO. METHODS: Patients who underwent IVL between 2019 and 2024 from an ongoing prospective multicenter registry were eligible for inclusion. Patients were therefore classified in CTO and non-CTO groups. The efficacy and safety endpoints of CTO percutaneous coronary interventions were defined according to the CTO-ARC consensus. In-hospital major adverse cardiovascular events (MACE) included cardiac death, nonfatal myocardial infarction and target lesion revascularization (TVR). RESULTS: A total of 404 patients underwent IVL, of which the treated lesion was a CTO in 33 (8.2%). The mean J-CTO score was 2.3 ± 1.1. Device success showed no significant difference between CTO and non-CTO groups (100% vs 98.4%; p = 0.35). Comparable technical success with residual stenosis <30% was observed in both groups (90.1% in CTO vs 89.2% in non-CTO, p = 0.83). The incidence of MACE was similar across groups during hospital stays (CTO 6.0% vs. non-CTO 1.9%, p = 0.12), at 30-day (CTO 9.1% vs. non-CTO 3.0%, p = 0.07), and at 12-month follow-up (CTO 9.1% vs. non-CTO 7.3%, p = 0.70). CONCLUSION: IVL provides high procedural success and consistent clinical outcomes in both CTO and non-CTO cases, reinforcing its role in managing heavily calcified coronary lesions.

Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

Transcatheter aortic valve implantation versus surgical aortic valve replacement in severe aortic stenosis patients at low surgical mortality risk: a cost-effectiveness analysis in Belgium.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device has recently shown significant clinical benefits, compared to surgical aortic valve replacement (SAVR), in patients at low risk for surgical mortality (PARTNER 3 trial, NCT02675114). Currently in Belgium, TAVI use is restricted to high-risk or inoperable patients with severe symptomatic aortic stenosis (sSAS). This cost-utility analysis aimed to assess whether TAVI with SAPIEN 3 could lead to potential cost-savings compared with SAVR, in the low-risk sSAS population in Belgium. METHODS: A previously published, two-stage, Markov-based cost-utility model was used. Clinical outcomes were captured using data from PARTNER 3 and the model was adapted for the Belgian context using cost data from the perspective of the Belgian National Healthcare System, indexed to 2022. A lifetime horizon was chosen. The model outputs included changes in direct healthcare costs, survival and health-related quality of life using TAVI versus SAVR. RESULTS: TAVI with SAPIEN 3 provides meaningful clinical and cost benefits over SAVR, in terms of an increase in quality-adjusted life years (QALYs) of 0.94 and cost-saving of €3 013 per patient. While initial procedure costs were higher for TAVI compared with SAVR, costs related to rehabilitation, disabling stroke, treated atrial fibrillation, and rehospitalization were lower. The cost-effectiveness of TAVI over SAVR remained robust in sensitivity analyses. CONCLUSION: TAVI with SAPIEN 3 may offer a meaningful alternative intervention to SAVR in Belgian low-risk patients with sSAS, showing both clinical benefits and cost savings associated with post-procedure patient management.

Aortic Coarctation Stenting in Adolescents and Adults: A Single-Center Experience.

PURPOSE/BACKGROUND: The aim of this study was to evaluate the short and midterm results of aortic coarctation (AoCo) stenting in an adolescent and adult population. METHODS: All patients with a AoCo older than 14 years treated by stent placement between December 2000 and November 2016 were included in this study. Twenty-eight patients with an invasive peak systolic pressure gradient >20 mmHg were identified. Number of redilations, non-invasive systolic blood pressure, peak systolic pressure gradient, antihypertensive medication intake, claudication status and complications were evaluated. RESULTS: Twenty-two covered and 6 uncovered stents were successfully placed. Peak systolic pressure gradient decreased immediately after stenting from a mean of 32 mmHg to 0 mmHg (± 7 mmHg). Mean AoCo diameter increased from 8 tot 16 mm (± 4 mm). Peripheral arterial injury was seen in 2 patients (7.1%). The mean follow-up time was 60 ± 49 months. Redilation of the stent was required in 4 patients, 2 to accommodate for growth and 2 for restenosis. Six (35%) patients could stop all antihypertensive medication. All claudicants (6/28) became and remained asymptomatic after surgery and during their follow-up. No aneurysms, stent fractures or dissections were noticed. There were 2 stent migrations during the first procedure with only 1 needing additional stent placement. CONCLUSION: Aortic coarctation stenting is a safe and effective treatment that significantly reduces the peak systolic pressure gradient. Antihypertensive medication can be reduced, and increase of walking distance in claudicants can be obtained. Younger patients may need more frequent reinterventions to accommodate for growth.

iFR/FFR/IVUS Discordance and Clinical Implications: Results From the Prospective Left Main Physiology Registry.

OBJECTIVES: This study aimed to assess discordance between results of instantaneous wave-free ratio (iFR), fractional flow reserve (FFR), and intravascular ultrasound (IVUS) in intermediate left main coronary (LM) lesions, and its impact on clinical decision making and outcome. METHODS: We enrolled 250 patients with a 40%-80% LM stenosis in a prospective, multicenter registry. These patients underwent both iFR and FFR measurements. Of these, 86 underwent IVUS and assessment of the minimal lumen area (MLA), with a 6 mm2 cutoff for significance. RESULTS: Isolated LM disease was recognized in 95 patients (38.0%), while 155 patients (62.0%) had both LM disease and downstream disease. In 53.2% of iFR+ and 56.7% of FFR+ LM lesions, the measurement was positive in only one daughter vessel. iFR/FFR discordance occurred in 25.0% of patients with isolated LM disease and 36.2% of patients with concomitant downstream disease (P=.049). In patients with isolated LM disease, discordance was significantly more common in the left anterior descending artery and younger age was an independent predictor of iFR-/FFR+ discordance. iFR/MLA and FFR/MLA discordance occurred in 37.0% and 29.4%, respectively. Within 1 year of follow-up, major cardiac adverse events (MACE) occurred in 8.5% and 9.7% (P=.763) of patients whose LM lesion was deferred or revascularized, respectively. Discordance was not an independent predictor of MACE. CONCLUSIONS: Current methods of estimating LM lesion significance often yield discrepant findings, complicating therapeutic decision-making.

OLD-TAVR score to predict 2-year mortality in patients aged 75 years and more undergoing transcatheter aortic valve replacement.

PURPOSE: Decision-making on transcatheter aortic valve replacement (TAVR) in patients aged 75 years and older is complex. It could be facilitated by the identification of predictors of long-term mortality. This study aimed to identify predictors of 2-year mortality to develop a 2-year mortality risk score. METHODS: Cohort study of consecutive patients aged ≥ 75 years who underwent TAVR after a comprehensive geriatric assessment (CGA) at our university hospital between 2012 and 2019. Predictors of 2-year mortality were determined using multivariable Cox regression. A point-based predictive model was developed based on risk factors and subsequently internally validated by fivefold cross-validation. RESULTS: The 345 patients (median age 87 years, 54% women) were fit/vulnerable (32%), mildly frail (37%), or moderately/severely frail (31%). The overall 2-year mortality rate was 26%, predicted by atrial fibrillation, hemoglobin ≤ 10 g/dL, age ≥ 87 years, BMI ≤ 24, eGFR ≤ 50 ml/min, and moderate/severe frailty. The risk score (range 0-12), named OLD-TAVR score, for 2-year mortality showed good discriminative power (AUC 0.70) and remained consistent after fivefold cross-validation (cvAUC 0.69). A risk score ≥ 8 (prevalence 20%) predicted a 45% (95%CI: 34-58%) two-year mortality, with high specificity (86%) and good positive predictive power (+ LR 2.43). CONCLUSION: A 2-year mortality risk score (OLD-TAVR score) for very old patients undergoing TAVR was developed based on six bio-clinical items. A score ≥ 8 identified patients in whom 2-year mortality was very high and thereby the TAVR futile. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: Study protocol B403, 26/09/2022, retrospectively registered.

Impact of Computational Modeling on Transcatheter Left Atrial Appendage Closure Efficiency and Outcomes.

BACKGROUND: When performing transcatheter left atrial appendage (LAA) closure, peridevice leaks and device-related thrombus (DRT) have been associated with worse clinical outcomes-hence, their risk should be mitigated. OBJECTIVES: The authors sought to assess whether use of preprocedural computational modeling impacts procedural efficiency and outcomes of transcatheter LAA closure. METHODS: The PREDICT-LAA trial (NCT04180605) is a prospective, multicenter, randomized trial in which 200 patients were 1:1 randomized to standard planning vs cardiac computed tomography (CT) simulation-based planning of LAA closure with Amplatzer Amulet. The artificial intelligence-enabled CT-based anatomical analyses and computer simulations were provided by FEops (Belgium). RESULTS: All patients had a preprocedural cardiac CT, 197 patients underwent LAA closure, and 181 of these patients had a postprocedural CT scan (standard, n = 91; CT + simulation, n = 90). The composite primary endpoint, defined as contrast leakage distal of the Amulet lobe and/or presence of DRT, was observed in 41.8% in the standard group vs 28.9% in the CT + simulation group (relative risk [RR]: 0.69; 95% CI: 0.46-1.04; P = 0.08). Complete LAA closure with no residual leak and no disc retraction into the LAA was observed in 44.0% vs 61.1%, respectively (RR: 1.44; 95% CI: 1.05-1.98; P = 0.03). In addition, use of computer simulations resulted in improved procedural efficiency with use of fewer Amulet devices (103 vs 118; P < 0.001) and fewer device repositionings (104 vs 195; P < 0.001) in the CT + simulation group. CONCLUSIONS: The PREDICT-LAA trial demonstrates the possible added value of artificial intelligence-enabled, CT-based computational modeling when planning for transcatheter LAA closure, leading to improved procedural efficiency and a trend toward better procedural outcomes.

Antithrombotic Therapy Duration after Patent Foramen Ovale Closure for Stroke Prevention: Impact on Long-Term Outcome.

Background: The optimal duration of antithrombotic therapy (ATT) after patent foramen ovale (PFO) closure remains under debate. This study sought to compare the clinical outcome of patients receiving antithrombotic agents for a short (6 months) versus extended (>6 months) period after the procedure. Methods: This was a retrospective cohort study using a propensity score matching analysis on 259 consecutive patients (131 males, 43 ± 10 years) undergoing PFO closure due to cryptogenic stroke, with complete follow-up (median duration of 10 [4-13] years). The outcome was compared between patients receiving short-term (Group short, N = 88) versus extended ATT (Group long, N = 171). Results: The PFO closure device was successfully implanted in all cases, with 3% of minor complications. After propensity score matching, there were no differences between Groups short and long in the rate of stroke (0.3 vs. 0.4% patient-year, p=1.00), bleeding (2 vs. 2% patient-year, p=0.17), and device thrombosis (0.3 vs. 0.1% patient-year; p=0.60). Univariate analysis showed that short-term ATT was not associated with an increased risk of recurrent stroke (HR: 1.271 [95% CI: 0.247-6.551], p=0.775) or prosthesis thrombus (HR: 0.50 [95% CI: 0.070-3.548], p=0.72). Kaplan-Meier analysis revealed similar overall survival in Group short and long (100 vs. 99 ± 1%, respectively; p=0.25). Conclusions: Short-term (6 months) ATT after PFO closure did not impair the clinical outcome, with a preserved low rate of recurrent stroke (0.3% patient-year) and device thrombosis (0.2% patient-year) at 10-year follow-up.

Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial.

BACKGROUND: Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. OBJECTIVES: The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. METHODS: DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. RESULTS: Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups. CONCLUSIONS: With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time.

Treatment of a severe distal thoracic and abdominal coarctation with cutting balloon and stent implantation in an infant: From fetal diagnosis to adolescence.

Background and Aims: Abdominal coarctations are rare. Surgical treatment is difficult and requires re-interventions to adjust the graft material to patient growth. We report effective treatment by interventional catheterization in an infant with the concern to allow adjustment for growth and prevention of vessel damage. Methods and Results: After the diagnosis of abdominal coarctation at 27 weeks of gestation, an infant developed hypertension (170/70 mmHg) at 3 months of age despite medical therapy. Angio CT confirmed a 2 mm diameter, 2.3-cm-long coarctation of the descending aorta. At 4 months, a dilatation was performed using a 3 mm cutting balloon and a 5 mm Opta® balloon, Cordis®. Two noncovered Palmaz® Genesis™ XD PG1910P stents were required to keep the aortic lumen open. At 15 months, an Adventa™ V12 vascular 12 × 61 mm long covered stent was implanted to exclude an aneurysm which developed between the two stents. At 3 and 9.5 years, the stents were further dilated with a high-pressure balloon to reach 11 mm aortic diameter with no residual pressure gradient, and normal blood pressure. Conclusions: The use of cutting balloons and stent implantation is an effective way to relieve severe obstruction in middle aortic syndrome in neonates. The technical issues encountered were the need for a low profile sheath and material to avoid femoral artery damage, and the need to use stents that can be further expanded to adult size.

Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study.

BACKGROUND: Transradial access (TRA) has become the default access method for coronary diagnostic and interventional procedures. As compared to transfemoral access, TRA has been shown to be safer, cost-effective and more patient-friendly. Radial artery occlusion (RAO) represents the most frequent complication of TRA, and precludes future coronary procedures through the radial artery, the use of the radial artery as a conduit for coronary artery bypass grafting or as arteriovenous fistula for patients on hemodialysis. Recently, distal radial access (DRA) has emerged as a promising alternative to TRA, yielding potential for minimizing the risk of RAO. However, an international multicenter randomized comparison between DRA, and conventional TRA with respect to the rate of RAO is still lacking. TRIAL DESIGN: DISCO RADIAL is a prospective, multicenter, open-label, randomized, controlled, superiority trial. A total of 1300 eligible patients will be randomly allocated to undergo coronary angiography and/or percutaneous coronary intervention (PCI) through DRA or TRA using the 6 Fr Glidesheath Slender sheath introducer. Extended experience with both TRA and DRA is required for operators' eligibility and optimal evidence-based best practice to reduce RAO systematically implemented by protocol. The primary endpoint is the incidence of forearm RAO assessed by vascular ultrasound at discharge. Several important secondary endpoints will also be assessed, including access-site cross-over, hemostasis time, and access-site related complications. SUMMARY: The DISCO RADIAL trial will provide the first large-scale multicenter randomized evidence comparing DRA to TRA in patients scheduled for coronary angiography or PCI with respect to the incidence of RAO at discharge.

Reduction of Lipid-Core Burden Index in Nonculprit Lesions at Follow-Up after ST-Elevation Myocardial Infarction: A Randomized Study of Bioresorbable Vascular Scaffold versus Optimal Medical Therapy.

BACKGROUND: Non-flow-limiting nonculprit lesions (NCL) that contain a large lipid-rich necrotic core (nonculprit lipid-rich plaques (NC-LRP)) are most likely to cause recurrent acute coronary syndrome after ST-elevation myocardial infarction (STEMI). Near-infrared spectroscopy (NIRS) detects LRPs using the maximum 4 mm lipid-core burden index (maxLCBI4 mm). Few data are available regarding NIRS-guided therapy of these NC-LRPs, which are a potential target for preventive stenting. Bioresorbable vascular scaffold (BVS) provides local drug delivery and could facilitate plaque passivation after resorption. This study sought to assess the safety of BVS implantation in NC-LRPs and its efficacy in reducing maxLCBI4 mm at 2-year follow-up after STEMI. METHODS AND RESULTS: In total, 33 non-flow-limiting NCLs from 29 STEMI patients were included in this study. Of these, 15 were LRPs and were randomly assigned to either the BVS + optimal medical therapy (OMT) arm (group 1; N = 7) or the OMT arm (group 2; N = 8). At baseline, there were no differences in plaque characteristics between groups (fractional flow reserve: 0.85 ± 0.04 vs. 0.89 ± 0.06; diameter stenosis (DS): 43.4 ± 8 vs. 40.1 ± 10.7%; plaque burden 54.98 ± 5.8 vs. 49.76 ± 8.31%; and maxLCBI4 mm 402 [348; 564] vs. 373 [298; 516]; p=NS for all comparisons between groups 1 and 2, respectively). Seven BVSs were implanted 3 ± 1 days after STEMI in six patients, without complications. At angiographic follow-up (712 [657; 740] days), a significant and similar reduction of maxLCBI4 mm was observed in both groups, with a median change of 306 [257; 377] in group 1 vs. 300 [278; 346] in group 2 (p=0.44). DS was significantly lower in group 1 vs. group 2 (19.8 ± 7 vs. 41.7 ± 13%, p=0.003), while plaque burden remained unchanged in both groups. Overall survival was 100%, target lesion failure was 13%, and stent thrombosis was 0%. CONCLUSIONS: BVS + OMT and OMT appear as similarly safe and effective in reducing maxLCBI4mm in NC-LRPs at 2-year follow-up after STEMI.

EAPCI Core Curriculum for Percutaneous Cardiovascular Interventions (2020): Committee for Education and Training European Association of Percutaneous Cardiovascular Interventions (EAPCI). A branch of the European Society of Cardiology.

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.

Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study.

BACKGROUND: Optimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA). DESIGN: The PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605). Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA) will be enrolled in the study. Patients will be allocated to a computational simulation arm (experimental) or standard treatment arm (control) using a 1:1 randomisation. For patients randomised to the computational simulation arm, preprocedural planning will be based on the analysis of cardiac computed tomography (CCT)-based patient-specific computational simulations (FEops HEARTguide, Ghent, Belgium) in order to predict optimal device size and position. For patients in the control arm, preprocedural planning will be based on local practice including CCT analysis. The LAA closure procedure and postprocedural antithrombotic therapy will follow local practice in both arms. The primary endpoint of the study is incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT. Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months. CONCLUSION: The objective of the PREDICT-LAA study is to test the hypothesis that a preprocedural planning for LAA closure with the Amplatzer Amulet device based on patient-specific computational simulations can result in a more efficient procedure, optimised procedural outcomes and better clinical outcomes as compared with a standard preprocedural planning. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04180605).

Early thrombogenicity of coronary stents: comparison of bioresorbable polymer sirolimus-eluting and bare metal stents in an aortic rat model.

BACKGROUND: Although 1-month dual antiplatelet therapy (DAPT) in patients treated with bare metal stents (BMS) is well established, the optimal duration of DAPT after implantation of a drug-eluting stent (DES) is still a matter of debate. The safety of shortened DAPT is under investigation due to concern about the risk of stent thrombosis. Data on platelet activation and prothrombotic response in vivo following bioresorbable polymer sirolimus-eluting stent (BP-SES) implantation are scarce. OBJECTIVES: The aim of our study was to compare the early thrombogenicity of BP-SES with that of BMS in an aortic rat model. METHODS AND RESULTS: Overall, 30 rats underwent stent implantation in the abdominal aorta: BMS (Pro-Kinetic Energy; N=15) and BP-SES (Ultimaster Tansei; N=15) were compared in terms of their early thrombogenicity. CD62P exposure at the platelet surface and fibrinogen binding at the integrin receptor were not different between BMS and BP-SES over time. The thrombus coverage of the scaffold (0 vs. 0.1%, P=0.84) was similarly low in both groups at Day 28; thrombotic deposits had totally disappeared at Day 84. The endothelial strut coverage was similarly high at 1 month (90 vs. 95%, P=0.64) and 3 months (87 vs. 97%, P=0.99) following BMS and BP-SES implantation, respectively. CONCLUSIONS: This study demonstrates the low early thrombogenicity of a BP-SES implanted in an aortic rat model, which did not differ from a BMS. These data could be helpful to support the safety of a shortened 1-month DAPT duration following BP-SES implantation in the human coronary artery.

Pulmonary hypertension due to left heart disease: diagnostic value of pulmonary artery distensibility.

OBJECTIVES: To evaluate how pulmonary artery (PA) distensibility performs in detecting pulmonary hypertension due to left heart disease (PH-LHD) in comparison with parameters from ungated computed tomography (CT) and echocardiography. METHODS: One hundred patients (79 men, mean age = 63 ± 17 years) with either severe heart failure with reduced ejection fraction (HFrEF), aortic stenosis, or primary mitral regurgitation prospectively underwent right heart catheterization, ungated CT, ECG-gated CT, and echocardiography. During the ECG-gated CT, the right PA distensibility was calculated. In ungated CT, dPA, dPA/AA, the ratio of dPA to the diameter of the vertebra, segmental PA diameter, segmental PA-to-bronchus ratio, and the main PA volume were measured; the egg-and-banana sign was recorded. During echocardiography, the tricuspid regurgitation (TR) gradient was measured. The areas under the ROC curves (AUC) of these signs were computed and compared with DeLong test. Correlation between PA distensibility and PA pressure (PAP) was investigated through Pearson's coefficient. RESULTS: PA distensibility was lower in patients with PH than in those without PH (11.4 vs. 21.2%, p < 0.001) and correlated negatively with mean PAP (r = - 0.72, p < 0.001). Age, PA size, and mean PAP were independent predictors of PA distensibility. PA distensibility < 18% detected PH-LHD with 96% sensitivity and 73% specificity; its AUC was 0.92, larger than that of any other sign at ungated CT and TR gradient (AUC ranging from 0.54 to 0.83, DeLong: p ranging from 0.020 to < 0.001). CONCLUSION: PA distensibility on an ECG-gated CT can detect PH-LHD better than the parameters reflecting PA dilatation in ungated CT or TR gradient in the echocardiography of patients with severe HFrEF, aortic stenosis, or mitral regurgitation. KEY POINTS: • In left heart disease, pulmonary artery distensibility is lower in patients with PH than in those without pulmonary hypertension (11.4 vs. 21.2%, p < 0.001). • In left heart disease, pulmonary artery distensibility detects pulmonary hypertension with an area under the receiver operating curve of 0.92. • In left heart disease, the area under the receiver operating curve of pulmonary artery distensibility for detecting pulmonary hypertension is larger than that of all other signs at ungated CT (p from 0.019 to < 0.001) and tricuspid regurgitation gradient at echocardiography (p = 0.020).

Resheathing of self-expanding bioprosthesis: Impact on procedural results, clinical outcome and prosthetic valve durability after transcatheter aortic valve implantation.

BACKGROUND: New transcatheter aortic valves were recently developed, enabling to resheath and reposition the prosthesis. The aim of the present study was to investigate whether the resheath manoeuvre did not impair the outcome of patients and the bioprosthesis durability after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: On the 346 consecutive patients (84 ±â€¯7 yrs-old, mean STS 6.7 ±â€¯5%) undergoing a transfemoral TAVI in our institution since January 2008, 170 patients were implanted using a self-expanding valve (SEV). Among those, 39 (Group 1) required resheathing to achieve a successful implantation, while 131 did not require it (Group 2, N = 131). A balloon-expanding valve (BEV) was used in 176 patients (Group 3). Baseline characteristics were similar between groups. Device success was 98%, the rate of in-hospital death was 2%, and the number of procedural complications was similarly low, with no significant difference between groups. The follow-up was complete in 337 of 338 patients undergoing a successful TAVI (781 patients-year). Kaplan-Meier analysis showed that overall survival was 80 ±â€¯2% and 42 ±â€¯3% at 1 and 5 years respectively, with no difference between groups. On multivariate analysis, acute kidney injury, post-dilatation, pulmonary hypertension, porcelain aorta and STS score, but not resheath, were independant predictors of death after TAVI. The annual event rate of structural valve deterioration was 0.6% patients-year, and similar between groups. CONCLUSIONS: Our study shows that SEV resheath did not impair the procedural results, the outcome of patients nor the valve durability at short term after TAVI.