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.

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.

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.

Feasibility of His-bundle pacing in patients with conduction disorders following transcatheter aortic valve replacement.

BACKGROUND: Conduction disorders requiring permanent pacemaker implantation occur frequently after transcatheter aortic valve replacement (TAVR). This multicenter study explored the feasibility and safety of His bundle pacing (HBP) in TAVR patients with a pacemaker indication to correct a TAVR-induced left bundle branch block (LBBB). METHODS: Patients qualifying for a permanent pacemaker implant after TAVR were planned for HBP implant. HBP was performed using the Select Secure (3830; Medtronic) pacing lead, delivered through a fixed curve or deflectable sheath (C315HIS or C304; Medtronic). Successful HBP was defined as selective or nonselective HBP, irrespective of LBB recruitment. Successful LBBB correction was defined as selective or nonselective HBP resulting in paced QRS morphology similar to pre-TAVR QRS and paced QRS duration (QRSd) less than 120 milliseconds with thresholds less than 3.0 V at 1.0-millisecond pulse width. RESULTS: The study enrolled 16 patients requiring a permanent pacemaker after TAVR (age 85 ± 4 years, 31% female, all LBBB; QRSd: 161 ± 14 milliseconds). Capture of the His bundle was achieved in 13 of 16 (81%) patients. HBP with LBBB correction was achieved in 11 of 16 (69%) and QRSd narrowed from 162 ± 14 to 99 ± 13 milliseconds and 134 ± 7 milliseconds during S-HBP and NS-HBP, respectively (P = .005). At implantation, mean threshold for LBBB correction was 1.9 ± 1.1 V at 1.0 millisecond. Thresholds remained stable at 11 ± 4 months follow-up (1.8 ± 0.9 V at 1.0 millisecond, P = .231 for comparison with implant thresholds). During HBP implant, one temporary complete atrioventricular block occurred. CONCLUSION: Permanent HBP is feasible in the majority of patients with TAVR requiring a permanent pacemaker with the potential to correct a TAVR-induced LBBB with acceptable pacing thresholds.

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).

Device-associated thrombus formation after left atrial appendage occlusion: A systematic review of events reported with the Watchman, the Amplatzer Cardiac Plug and the Amulet.

OBJECTIVES: This study aimed to provide a systematic review of device-associated thrombosis (DAT) after left atrial appendage occlusion (LAAO) with the Watchman, Amplatzer Cardiac Plug, and Amulet devices. BACKGROUND: DAT is known as a complication of LAAO but data about its clinical impact is scarce. METHODS: A systematic review of studies evaluating the incidence, treatment and clinical implications of DAT from January 2008 to September 2015 was conducted. RESULTS: A total of 30 studies describing DAT events were included in the analysis. The overall incidence of DAT was 3.9% (82 DAT for 2118 implanted devices). The median time from procedure to diagnosis of DAT was 1.5 months (IQR: 0-2.9). Most cases were diagnosed with transesophageal echocardiogram (TEE). The treatment consisted of low molecular weight heparin (LMWH) in 45.5% of cases, and oral anticoagulation (OAC) or other treatment modalities in 54.5%. Complete thrombus resolution was achieved in 95.0% of cases (100% with LMWH and 89.5% with OAC). Treatment duration varied greatly with a median treatment duration of 45 days (IQR: 14-135). Clinical events related to DAT consisted of neurologic events namely two transient ischemic attacks (2.4%) and four ischemic strokes (4.9%). CONCLUSIONS: DAT is an infrequent complication of percutaneous LAAO. It occurs mainly early after the procedure and is associated with a low rate of neurological complications. In the majority of cases, diagnosis is made during follow-up imaging with TEE. Anticoagulation treatment seems to be safe and highly effective. Further studies are needed to evaluate the optimal management of DAT. © 2017 Wiley Periodicals, Inc.

Transcatheter Aortic Valve Replacement Using the Portico System: 10 Things to Remember.

The Portico system (St. Jude Medical, Minneapolis, MN, USA) consists of a self-expanding valve prosthesis and a delivery system designed for transcatheter aortic valve replacement (TAVR). We describe this system, its 10-steps implantation procedure, and provide tips and tricks based on our personal experience with this system.

Left atrial appendage occlusion with the Amplatzer Cardiac Plug could improve survival and prevent thrombo-embolic and major bleeding events in atrial fibrillation patients with increased bleeding risk.

AIMS: Literature suggests a beneficial effect of percutaneous left atrial appendage occlusion (LAAO) to prevent thrombo-embolic events in patients with non-rheumatic atrial fibrillation (AF). We compared outcome of LAAO versus 'suboptimal standard' treatment in AF patients with high bleeding risk. METHODS AND RESULTS: Patients with sufficient follow-up data (n = 125) who underwent LAAO with the Amplatzer Cardiac Plug (ACP) were selected from the Belgian ACP database. AF patients who survived intracranial haemorrhage were recruited from the Leuven Neurosurgical Registry (LNR, n = 113). After propensity score adjustment, the outcome of both groups was compared for the combined end point (death, stroke, transient ischaemic attack, systemic emboli, and major bleeding event). The LAAO group did not differ from the LNR group for mean age and gender (74 ± 7 versus 75 ± 10 years, P = 0.29; female 39% versus 48%, P = 0.18). However, the CHA2DS2-VASc and HAS-BLED scores were both higher in the LAAO group (4.8 ± 1.7 versus 3.9 ± 1.7, P = 0.0001; 3.5 ± 1.4 versus 3.2 ± 1.4, P = 0.036). After propensity score adjustment, the risk for the primary end point was significantly higher for the LNR group (HR 2.012, 95% CI 1.113-3.638). CONCLUSION: LAAO with ACP seems to improve the combination of survival and the prevention of thrombo-embolic and major bleeding events in patients with atrial fibrillation and increased bleeding risk.

Embolization of left atrial appendage closure devices: A systematic review of cases reported with the watchman device and the amplatzer cardiac plug.

OBJECTIVES: We sought to provide a systematic review of reported cases of LAA closure device embolization by focusing on the two most commonly implanted devices: the Watchman (WM) device and the Amplatzer Cardiac Plug (ACP). METHODS: A comprehensive search of the Pubmed database was conducted until October 1, 2014. Studies were included if they described at least 1 case of embolization of the WM and/or the ACP. RESULTS: A total of 20 studies reporting 31 cases of device embolization were identified, including 13 cases with WM and 18 cases. The timing of embolization was described in 29 cases and was categorized as acute in 20 cases (65%) and late in 9 cases (30%). The anatomical location of embolized devices was reported in 21 cases: into the aorta in 9 cases, into the left ventricle (LV) in 9 cases and into the left atrial cavity in 3 cases. As compared to embolization into the aorta or the left atrial cavity, device embolization into the LV was associated with a higher rate of surgical retrieval (8/9 vs 2/12; 88% vs 17%, P = 0.0019). Major adverse events related to device embolization occurred in three patients (9.6%). CONCLUSIONS: LAA closure device embolization occurs mainly in the periprocedural period but late embolizations are not uncommon. Although embolization into the aorta or the left atrium can be successfully managed by percutaneous techniques in most cases, device embolization into the LV is associated with a higher rate of surgical retrieval, increasing thereby procedure-related morbidity.

Midterm clinical outcome following Edwards SAPIEN or Medtronic Corevalve transcatheter aortic valve implantation (TAVI): Results of the Belgian TAVI registry.

OBJECTIVE: To assess midterm (3 years) clinical outcomes of transcatheter aortic valve implantation (TAVI) in Belgium using the Edwards SAPIEN valve or the Medtronic CoreValve transcatheter heart valve (THV). BACKGROUND: Medium and long term follow-up data of both THVs are still relatively scarce, although of great clinical relevance for a relatively new but rapidly expanding treatment modality. Therefore, reporting mid- and long term clinical outcome data, coming from large "real world" national registries, remains contributive. METHODS: Between December 2007 and March 2012, 861 "real world" patients who were not candidates for surgical aortic valve replacement as decided by the local heart teams, underwent TAVI at 23 sites. Eleven sites exclusively used SAPIEN THV (n = 460), while 12 exclusively used CoreValve THV (n = 401). Differences in clinical outcomes by valve system were assessed, according to access route and baseline EuroSCORE risk profile (<10%: low, 10-20%: intermediate and >20%: high risk). RESULTS: Overall cumulative survival at 3 years was 51% for SAPIEN vs. 60% for CoreValve (P = 0.021). In transfemorally treated patients, SAPIEN and CoreValve had similar survival at 3 years for each of the baseline EuroSCORE cohorts (low risk: 72% vs. 76%, P = 0.45; intermediate risk: 62% vs. 59%, P = 0.94; high risk: 48% vs. 53%, P = 0.65). CONCLUSION: Cumulative midterm 3 year survival after transfemoral TAVI in "real world" patients refused for surgery with similar baseline EuroSCORE risk profile is not different between SAPIEN or CoreValve.

Transcatheter Sapien valve implantation in a native tricuspid valve after failed surgical repair.

OBJECTIVES: We describe the first report of a transcatheter Sapien implantation in a native tricuspid valve after multiple failed surgical repairs with a lack of prosthetic material and radiographic landmarks. METHODS AND RESULTS: A 47-year old female underwent multiple valve repairs and replacements including three tricuspid valve repairs without surgical ring or bioprosthesis implantation. She developed signs of right heart failure associated with a mixed tricuspid disease combining a severe stenosis and regurgitation. After surgical turn down, a revalvulation using a transcatheter approach was attempted. The challenges in this case were the absence of a stiff region to anchor the percutaneous valve, the lack of radiographic landmarks and the difficulties of precise annulus measurements. The applied strategy was -under general anesthesia and extracorporeal membrane oxygenation-: balloon sizing, prestenting of the tricuspid annulus using covered stents followed by Sapien valve implantation through the femoral vein under fluoroscopy and transoesophageal echocardiography (TEE). The procedure was successfull, solving the tricuspid leak and stenosis (peak gradient from 22 to 3 mm Hg) using two Sapien for a perfect positioning. It was complicated by pulmonary bleeding due to a distal wire exit, treated successfully by coil embolization. The clinical and echocardiographic outcome was good up to 5 months. CONCLUSIONS: Transcatheter Sapien valve implantation in a native tricuspid valve after failed multiple surgical repairs is feasible by the femoral vein. Technical challenges due to the lack of rigid landing zone and fluoroscopic markers were solved by prestenting and valve implantation under bi-plane fluoroscopic and TEE guidance.

Rationale and design of the Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial.

UNLABELLED: The SYMPLICITY studies showed that renal denervation (RDN) is feasible as novel treatment for resistant hypertension. However, RDN is a costly and invasive procedure, the long-term efficacy and safety of which has not yet been proven. Therefore, we designed the INSPiRED trial to compare the blood pressure lowering efficacy and safety of RDN vs usual medical therapy. INSPiRED is a randomized controlled trial enrolling 240 treatment-resistant hypertensive patients at 16 expert hypertension centres in Belgium. Eligible patients, aged 20-69 years old, have a 24-h ambulatory blood pressure of 130 mmHg systolic or 80 mmHg diastolic or more, while taking at least three antihypertensive drugs. They are randomized to RDN (EnligHTN(TM), SJM system) plus usual care (intervention group) or usual care alone (control group) in a ratio of 1:1. The primary endpoints for efficacy and safety, measured after 6 months, are the baseline-adjusted between-group differences in 24h systolic blood pressure and in glomerular filtration rate as estimated by the Chronic Kidney Disease Epidemiology Collaboration equation. Follow-up will continue up to 36 months after randomization. INSPiRED is powered to demonstrate a 10-mmHg difference in systolic blood pressure between randomized groups with a two-sided p-value of 0.01 and 90% power. It will generate long-term efficacy and safety data, identify the subset of treatment-resistant hypertensive patients responsive to RDN, provide information on cost-effectiveness, and by doing so INSPiRED will inform guideline committees and health policy makers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT 01505010.

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.

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.

Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label?

INTRODUCTION: Percutaneous pulmonary valve implantation is now considered feasible and safe. "Native" right ventricular outflow tract (RVOT), small diameter conduits (<16 mm) and relatively large RVOT with a dynamic outflow aneurysm are currently considered off-label uses. Extending indications creates concerns of safety, ethics, reimbursement, and liability. AIM OF STUDY: To report the safety and feasibility of off-label application of percutaneous pulmonary valve implantation. DESIGN: Retrospective analysis of prospectively collected data. PATIENTS AND METHODS: Off-label indications: conduit-free RVOT or patients with an existing but undersized conduit. RESULTS: Twenty-one Melody® valves and two Sapien® valves were successfully implanted in 23 patients (16.9 years; range 6.1-80.5 years). In 22 patients, prestenting was performed 4.8 months (range 0-69.2) before valve implantation (15 covered and 13 bare stents). Stent endothelial ingrowth was allowed for at least 2 months prior to implantation of the percutaneous valve if stent stability or sealing by the covering was presumed to be insufficient. Group 1 patients (n = 8) had a "conduit-free" RVOT after transannular/infundibular patch and after prestenting underwent percutaneous pulmonary valve implantation (PPVI), with a final RVOT diameter of 21.5 mm (range 16-26 mm). Group 2 patients consisted of two elderly patients with pulmonary valve stenosis and severe RVOT calcifications. Group 3 (n = 13) had an existing conduit (nominal 15.9 ± 3.2 mm; range 10-20 mm). The conduit was augmented from 14.7 ± 3.5 to 20 ± 1.6 mm with PPVI. The RVOT preparation and valve implantations were uneventful. CONCLUSIONS: PPVI is safe and feasible in selected patients with an off-label indication. Creating an adequate "landing zone" by prestenting makes the procedure safe and predictable. Updating the indications for PPVI should be considered.

Cerebral embolization during percutaneous valve implantation does not occur during balloon inflation valvuloplasty: prospective diffusion-weighted brain MRI study.

BACKGROUND AND AIM OF THE STUDY: The study aim was to define the timing of cerebral embolization events during transcatheter aortic valve implantation (TAVI), and to determine if events were more closely associated with valve implantation or with balloon inflation. METHODS: Between January 2008 and November 2011, a total of 114 patients underwent TAVI at the author's institution. Of these patients, 44 had previously undergone imaging before and after TAVI, and were included in the study (26 transfemoral (TF); 18 transapical (TA)). Eleven patients who had only balloon valvuloplasty (BV) during the same period were included, as were 22 patients who had open aortic valve replacement (AVR), as controls. All 77 patients underwent neurological examination, and all had cerebral MRIs before and after their procedures. RESULTS: Fifty of the 77 patients who underwent postprocedural MRI had new cerebral lesions, as follows: 24/26 (92%) in TF patients; 17/18 (94%) in TA patients; 3/11 (27%) in BV patients; and 6/22 (27%) in AVR patients (TF and TA versus BV and AVR, p < 0.0001). The mean number and volume of embolic lesions per patient were respectively 5.4/438 mm3 for TF, 11.6/3414 mm3 for TA, 0.7/46 mm3 for BV, and 0.4/48 mm3 for AVR (TF versus TA and BV versus AVR, p = NS; TF and TA versus BV and AVR, p < 0.0001). No association was found between either the EuroSCORE or patient age and the number of events. CONCLUSION: In the present study, an incidence of silent cerebral embolic lesions after TAVI was identified which was significantly higher than that for BV or AVR. This indicated an association of embolism with valve implantation rather than with balloon inflation.

Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac plug: the Belgian Registry.

AIMS: The aim of the present study was to evaluate the procedural feasibility, the safety and the 1-year outcome following left atrial appendage (LAA) closure using the Amplatzer cardiac plug (ACP) in Belgium. METHODS AND RESULTS: Data were prospectively collected among 90 consecutive patients, undergoing LAA closure with an ACP in 7 Belgian centres between June 2009 and September 2012. The patients (56 males, 74 +/- 8 years) were at high risk for stroke (CHA2DS2-VASc = 4.4 +/- 1.8) and bleeding (HAS-BLED = 3.3 +/- 1.3).Technical success was obtained in all but one patient and procedural success was 95%. Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case. Minor complications were 3 insignificant pericardial effusions, 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm. At 1-y follow-up, there were 4 deaths, 2 minor strokes, 1 tamponade and 1 myocardial infarction. Overall survival was 94% and freedom from MAE was 88%. In our population, the expected annual stroke risk according to the CHA2DS2-VASc score was 5.08%, while the observed stroke rate was 2.14%/year. CONCLUSIONS: The Belgian registry shows that LAA closure using the ACP device is feasible and safe. At 1-y follow-up, the observed stroke rate was 2.14%/year, less than predicted by the CHA2DS2-VASc score. Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke.

Impact of frailty scores on outcome of octogenarian patients undergoing transcatheter aortic valve implantation.

BACKGROUND: For selected patients with symptomatic aortic stenosis, transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement (AVR). In addition to co-morbidities, frailty has to be taken into account in the decision-making process. Criteria for patient selection, according to current guidelines, include EuroSCORE and STS score but frailty is not easy to quantify. ISAR (Identification of Seniors At Risk) detects seniors at risk for adverse health outcome after an emergency visit and SHERPA (Score Hospitalier d'Evaluation du Risque de Perte d'Autonomie) assesses the risk of functional decline after hospitalization. OBJECTIVES: The aim of the present study was to evaluate the impact of ISAR and SHERPA scores in the prediction of patient outcome afterTAVI. METHODS AND RESULTS: A prospective cohort of 30 consecutive octogenarian patients (16 males, 86 +/- 3 y, EuroSCORE 34 +/- 12%) underwent a transfemoral TAVI and a complete geriatric assessment in our institution. Survival at one year was 73%. The ISAR score was similar between both groups (3.1 +/- 1 vs. 3.6 +/- 1; P = 0.10) but the SHERPA score was significantly higher in non-survivors (7.8 +/- 1.6) than among survivors (4.9 +/- 2.4; P = 0.001). With multivariate analysis, SHERPA score and BMI were independent predictors of 1-year mortality. Kaplan-Meier analysis showed that 1-year survival was significantly lower in patients with than in those without a SHERPA score > 7 (40 vs. 89%; P = 0.004). CONCLUSIONS: The result of this study showed that SHERPA score predicts 1-year survival after transfemoral TAVI and could be considered as a useful frailty score in patient selection.

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.

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.